A Mixture of Known Compounds is Unpatentable without a Transformation

Bhagat v. Iancu is a newly filed petition for writ of certiorari now pending before the United States Supreme Court. (Case No. 18-277).   Bhagat is the founder and CEO of Asha Nutrition and is seeking to patent a lipid-formulation – that contains a mixture of omega-6 and omega-3 faty acids at a ratio of 4:1 or greater.

The USPTO refused to issue the patent finding the claims barred both by on eligibility (101) and anticipation (102) grounds.  On appeal, the Federal Circuit affirmed.   The 101 denial is most interesting.  The PTAB found that that claimed fatty-acid mixtures already occur naturally in walnut oil and olive oil.  And, although the claims require (via disclaimer) that the mixture of oils come from different sources, the Board found them to be directed to a natural phenomenon.  On appeal, the Federal Circuit agreed — finding that the original ingredients of walnut oil and olive oil are natural products and the mixtures were not shown to be a “transformation of the natural products, or that the claimed mixtures have properties not possessed by these products in nature.”  [Query – are the the oils themselves product of nature?]

This opinion follows Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).  In that case, the Supreme Court explained that

The [claimed] combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. . . . They serve the ends nature originally provided and act quite independently of any effort of the patentee. . . .

The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.

The new petition raises three questions:

1. a. Whether the Federal Circuit erred in finding petitioner’s patent application claims unpatentable under 35 U.S.C. § 101 because the court failed to apply the correct patent eligibility standard under this Court’s conflicting holdings in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

1. b. Whether the Federal Circuit erred in finding petitioner’s patent application claims unpatentable under 35 U.S.C. § 101 because the court did not apply the patent-eligibility standard set forth in Myriad.

2. Whether the Federal Circuit erred in affirming the USPTO’s decisions under 35 U.S.C. §§ 101 and 102(b) because it failed to apply “meaningful review” to that decision, as required by the Administrative Procedure Act.

2018 Read the Petition

The broadest claim in contention reads as follows:

65. A lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater, contained in one or more complementing casings providing controlled delivery of the formulation to a subject, wherein at least one casing comprises an intermixture of lipids from different sources, and wherein (1) omega-6 fatty acids are 4-75% by weight of total lipids and omega-3 fatty acids are 0.1-30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams.

232 thoughts on “A Mixture of Known Compounds is Unpatentable without a Transformation

  1. 33

    much ado about nothing

  2. 32

    The one you’d writ that you weren’t impersonating yourself

  3. 31

    But, what is controlled ? Controlled in what way ? Is it control so that it is released only in the small intestine ? Or is it controlled some other way ? This is where written description helps, what does the spec say ? Absent direction from the spec., it is ordinary and plain meaning, but the word controlled by itself, to me at least, doesn’t provide enough for me to know “how” it is controlled, for what purpose, and how the purported control is achieved. Definiteness 112 ? If there’s support in the spec, import qualifying lingo into claims for how the comp. is “controlled” and that might give more novelty. Absent a definition for “controlled”, one opens themselves up to the whims and conjectures of those skilled in the art, which has been known to differ among scientists !

    1. 31.1

      Chris Whewell,

      We prefer to leave you guessing.

  4. 30

    Basically, to infringe, I take two tiny currants, one from India, the other from Pakistan, place them in an enterically coated capsule and swallow. But, why go thru the trouble when single-source black currant oil has the recited lipids within the claimed ratio ? Using different sources requires extra expense and work, and if there is no criticality regarding the sources, then what is the point ? Nature’s currant oil gets me the desired lipids in the claimed ratios and presumable also the desired effect without having to incur added expense. So, I could avoid the claims in any such granted patent by using single-source currant oil. Question is, can combining 1000 little currants in a press to make one liter of oil (ancient tech), be literally interpreted as each of the 1000 little currants being a “different source” ? Main issues I see are commercial, what good is a patent if its easily designed around, or if a 100% natural product achieves the same result ? Where’s the competitive advantage, and is it worth the money to make it sustainable via patenting ?? just sayin…

    1. 30.1

      Chris Whewell,

      We prefer to leave you guessing.

  5. 29

    So basically, the composition reads on black currants, except the inventive step is to source the lipids “from two different sources” ? Is that the novel feature here, or am I overlooking something ?

    1. 29.1

      These comments do not deserve any response, because these points have been previously answered. See 24.1, 14, 6.3, 5.1, 3.1.1.1.2.1.1, 1.2.2.3.

      NATURE IS NOT PREDICTABLE IN LIPID CONTENT!

      AT LEAST READ ALL THE COMMENTS BEFORE YOU ASK QUESTIONS!

      1. 29.1.1

        Inventive step is examined under § 103, this has also been answered many times. See 25, 23, 23.3, 14.3, 9.2, 6.3.

        I would have expected people on these posts to be more knowledgeable on patent law.

    2. 29.2

      Claims are examined as a whole, not in parts.

  6. 28

    heh-heh. Right ? Thanks for the merriment !

    1. 28.1

      Out of mere curiosity, to what post was this one intended as a response?

  7. 27

    This is a very interesting discussion. Just by reading this I feel that the author needs to move the last para;
    65. A lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater, contained in one or more complementing casings providing controlled delivery of the formulation to a subject, wherein at least one casing comprises an intermixture of lipids from different sources, and wherein (1) omega-6 fatty acids are 4-75% by weight of total lipids and omega-3 fatty acids are 0.1-30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams.to the top of the article. Because, unless all the limitations are noted upfront it can lead to misunderstanding by the reader that the claims are drawn only to; “ a mixture of omega-6 and omega-3 fatty acids at a ratio of 4:1 or greater.”

    Putting whole claim 65 upfront also clarifies that a mixture of lipid from different sources is recited in the claim itself.

    And it is perfectly clear from the claim itself that there is controlled delivery of the formulation.

    Skilled persons in this art are MDs and PhDs. Controlled delivery in this context is perfectly clear to them.

    1. 27.1

      Skilled persons in this art are MDs and PhDs. Controlled delivery in this context is perfectly clear to them.

      Agreed. The phrase “controlled delivery” is certainly in common use among physicians and pharma researchers. That observation alone, however, does not really answer any outcome-determinative question here.

      Rather, we must ask “what is the broadest reasonable signification that ‘controlled delivery’ would convey to the average physician or pharma researcher?” One encounters terms like “12 hour controlled delivery,” and the import there is clearly that the casing ensures that delivery continues over a 12 hour period. When one does not specify a time period however, it seems to me that the mere recitation “controlled delivery” is simply the opposite of “immediate release.” That is as much as to say, the “controlled delivery” casings must be sufficient to ensure that the entire lipid payload is not delivery in one immediate bolus, but if it take (e.g.) 30 min between when the lipids first start flowing to when they are entirely delivered, that would still come under the broadest reasonable reading of “controlled delivery.”

      If that is all that is meant by “controlled delivery” in this context, then the claims still do not distinguish over the natural olives and walnuts. When you eat an olive or a walnut, your digestive tract needs more than one minute to release all of the lipid content in there. Therefore, the natural membranes and vessicles in the olive or walnut are “casings providing controlled delivery” within the BRI of these claims.

      1. 27.1.1

        PHOSITA have testified on record as their interpretation.

        BRI does not mean BPI. Reasonable does not mean possible.

  8. 26

    There is… literally nothing about “controlled delivery” in the specification.

    This statement from my #14.2 is true as formulated (with an explicit clarification that the remark is directed to the exact language “controlled delivery”). I see, however, that there is mention of “controlled release capsule, soft-gel capsule, hard capsule, tablet, powder, lozenge, or pill…” in paragraph [0034] of the app as filed.

    This verbiage in the spec is not really enough to make clear that the broadest reasonable interpretation of “complementing casings providing controlled delivery” does not read on natural lipid vessicles in olives. If, however, the claims were amended to include the actual language from the spec (“controlled release capsule”), that should suffice to overcome the anticipation rejections.

    I would like to think that such an amendment would also overcome the §101 rejection, but §101 is so messed up that it is hard to say for sure.

    1. 26.1

      You still have not read the Specification. We are not going to spend time educating you. Your help is NOT needed.

      1. 26.1.1

        Your help is NOT needed.

        Just to make clear, nothing I wrote in #26 was intended as “help.” I was offering a hypothetical for consideration of the community on this board. Please do not misunderstand that hypothetical musing for unsolicited legal advice. As I am sure you understand, you are not my client and I am not offering you legal advice.

        1. 26.1.1.1

          consideration of the community on this board.

          LOL – how does that work for you? For anyone?

        2. 26.1.1.2

          “you are not my client and I am not offering you legal advice.”

          We are fortunate!

    2. 26.2

      There is PHOSITA TESTIMONY ON RECORD that testifies “Complimenting casings providing controlled delivery of the formulation to a subject” are supported by Specification. PHOSITA testimony Appx7230, Appx7239, Appx7320.

  9. 25

    Open Letter To Andrei Iancu, Director, US Patent and Trademark Office, and
    Sharon Prost, Chief Judge, United States Court Of Appeals For The Federal Circuit (CAFC) Regarding US Application 12/426, 034 and CAFC case #16-2525 (link to asha-nutrition.com)

    Attachments include:

    Appellant’s Combined Petition For Panel Rehearing And Rehearing En Banc

    Annotated Copy Of The Court’s Opinion Sought To Be Reheard

    “Federal Circuit Finds Composition of Matter Ineligible For Patenting,” March 27, 2018. Opinion by Courtenay Brinckerhoff, BS chemistry; IP Partner at Foley & Lardner Chemical Practice; Admitted at CAFC.

    “In Re Urvashi Bhagat: One More Decision Denying Patent Eligibility of Nature-Based Product Claims,” March 29, 2018. Opinion by Marina Miller, PhD. molecular biology/biochemistry; IP Partner at Oblon Chemical Patent Prosecution group; Admitted at CAFC.

    “In re Urvashi Bhagat – The Slippery Slope of Natural Product Claims,” March 22, 2018. Opinion by Warren Woessner, PhD organic chemistry; Patent Attorney; founding shareholder of Schwegman Lundberg & Woessner; Admitted at CAFC.

    “Omega-6 fatty acid” Wikipedia, accessed March 5, 2018

    Patents for Humanity Application

  10. 24

    Millions of people are suffering and someone who goes by the name “Enlightened” strongly believes he/she is entitled to earn a bunch of money by treating those people with walnut oil.

    Why not just put a sock in it with respect to the patent bullshirt and use your money and energy to educate people?

    I’m assuming, of course, that these “suffering people” couldn’t help themselves in some other more effective way than the way taught in your junky patent.

    1. 24.1

      Education about lipids alone is not enough, because healthful dosages of the various lipids vary for different members of the family and are hard to obtain. Lipid-rich foods such as oils and butters are unpredictable in lipid content. For example, omega-6 can be 6-80% in safflower oil and 2-20% in olive oil. Even olives from same tree vary seasonally in lipid content. Further, lipids can be potent in micrograms.

      If you are focused on money that is your problem. The language you use and the your lack of knowledge is also your problem.

  11. 23

    This invention was conceived because the inventor realized that there is mass confusion in the lipid art, that wrong teachings are coming from the Government itself, NIH was teaching MIXING foods to achieve omega-6 less than 0.5% of calories. Read attached Lands 2005.

    Inventor realized confusion around lipids is a massive public health hazard continuing for centuries, and wanted to remove the problem once and for all.

    Lipids were considered important for health 6000 years ago when oils were invented, but since then lipid delivery fundamental to health has not materially advanced. Periodically, certain fatty acids (e.g., omega-3) or oils or low-fat teachings have been hailed, only to reverse a few years later. To date random oils are randomly added to foods; no guidance is given that different batches of the oils can have significantly different lipid composition and that minor lipids components present in oils can be potent. Oil making has advanced but delivery of oil for ingestion by subjects is still archaic.

    Inventor comprehensively considered ALL factors, omega-6 and omega-3 dosage, dose-effect, hormones, other dietary lipids (all fatty acids, antioxidants, phytochemicals), climactic temperature, that effect omega-6 and omega-3 requirement, and invented the claimed formulations and methods to eradicate the problem.

    One big limiting factor with USPTO is innovation is KILLED by technical, moral, and intellectual limitations of USPTO personnel. Some of USPTO people said:
    -many people use omega-6 and omega-3, so we have to limit patent scope
    -nutrition patents are hard to get.

    The above translates into:
    -we have to give many patents even if it causes confusion
    -we don’t care about prevention, we would rather keep people on drugs

    This refusal to nurture innovation via patent grant because the scope of innovation is large is counter to purpose of patents and is harmful to public, particularly in the field of nutrition. Severely restricted nutrition patents are ineffective and create more confusion and chaos. These mini-patents give rise to millions of products, conflicting messages, and competition smearing each other with “our formulation is the best and everybody else is making snake oil.” Consequently, clear teaching is lost and public stops believing everything.

    117 million people live with chronic diseases associated with improper lipid intake, $3 trillion annually is spent on those diseases, 14 million people have died of the associated diseases since this application was filed.

    THIS IS A NATIONAL SCALE PROBLEM THAT SCOTUS MUST ADDRESS.

    1. 23.1

      Great. I agree that cardiac health is a major national problem, and if you think you have a solution to that problem, may the Lord prosper the work of your hands.

      To whatever extent that obtaining a patent is a hurdle you must clear to employ this solution that you believe that you have found, might I advise you to amend your claims to capture your real invention and exclude the prior art. I know that you do not want to hear this, but right now your claims still read on the prior art. Until and unless you come to terms with this fact, you are going to keep achieving the same undesirable outcome.

      Believe it or not, I actually want you get somewhere with this. When experienced patent lawyers up and down this thread take issue with these claims, it is because these claims are presently unpatentable. That problem is fixable, but only if you are willing to realize that you know less about patent law than you think that you know.

      1. 23.1.1

        Then you are NOT a good attorney.

      2. 23.1.2

        Any good attorney should know anticipating reference MUST function as claimed.

      3. 23.1.3

        Not mention some “attorneys” on this list are malpracticing. It takes days to read and understand cited references. Without properly reading cited references and prosecution history, they think they know better. Thanks but no thanks.

      4. 23.1.4

        Shakespear was right, “let’s first kill all the lawyers.” They pass opinions without reading, without knowing, and they like to create more filings to increase their revenue. People on this list have not read the art or the prosecution history nor are they privy to the private communications with the examiners. For example in one of the office actions, examiner says if applicant goes over such and such ratio, he will not reject the claims over such and such art. Examiner was arbitrarily limiting and applicant declined for some reasons which are also on the prosecution history.

        It is hubris, irresponsibility, and malpractice on part of lawyers on this list to comment without knowing all the facts.

      5. 23.1.5

        “might I advise you to amend your claims to capture your real invention and exclude the prior art.” What priori art???????

        Half a dozen times I have told you in 10 years of prosecution there isn’t a single prior art that could be legitimately cited under 102 has surfaced? ANTCIPATING reference must NECESSARILY work as claimed. What kind of a lawyer are you if you dont know that?

        Aren’t you who said, does CAFC have jurisdiction to make opinions precedential? What kind of a lawyer are you if you don’t know that?

        1. 23.1.5.1

          I had never previously appreciated how close is the link between enlightenment and willful ignorance.

          1. 23.1.5.1.1

            “I had never previously appreciated how close is the link between enlightenment and willful ignorance.”

            Precisely, because you don’t know the definition of either, enlightenment or willful ignorance. So you admit you are ignorant.

            You don’t know how anticipation works and you don’t know Federal Circuit rules e.g. IOP #10.

            Your bar admission should be revoked, may be it is already revoked.

          2. 23.1.5.1.2

            My 23.1.5.1 was a thoughtless remark. I regret making it. My apologies.

      6. 23.1.6

        “Experienced patent lawyers up and down this thread” DID NOT take issue with these claims. You think that because you are reading challenged.

        “That problem is fixable, but only if you are willing to realize that you know less about patent law than you think that you know.”

        The above is hubris, irresponsibility, and malpractice!!! Do you even realize how bizarre and unprofessional your statements are? Alleging “unpatentable” without a cited art. Shooting in the dark.

        This is why you are not an occupied lawyer. Thank you very much, but your services are not needed.

        1. 23.1.6.1

          Alleging “unpatentable” without a cited art.

          I have cited art. See my 1.2.2.3.1 below. For the record, that post has sat there since 10 Sept now without response.

          1. 23.1.6.1.1

            Greg,

            I am not sure the bare “renamed” hyperlink is being recognized as providing cited art.

            Enlightened may not be taking the time to hover over the type to see the link.

    2. 23.2

      Here is better citation of Lands WEM, Ann. N.Y. Acad. Sci. 1055: 179–192 (2005)

      Dietary Fat and Health: The Evidence and the Politics of Prevention Careful Use of Dietary Fats Can Improve Life and Prevent Disease

      “ABSTRACT: Every year, more young people start the slow progressive injury
      that eventually becomes cardiovascular disease and death. It could be prevented with nutrition education, but medical efforts focus more on treatments for older people than on preventing primary causes of disease in
      young people. Two avoidable risks are prevented by simple dietary interventions: (1) Eat more omega-3 and less omega-6 fats, so tissues have less intense n-6 eicosanoid action, and (2) eat less food per meal to lower vascular postprandial oxidant stress. An empirical diet–tissue relationship was developed and put into an interactive personalized software program to aid informed food choices.”

      “uncontrolled excessive production of omega-6 eicosanoids over prolonged periods of time is associated with heart attacks, thrombotic stroke, arrhythmia, arthritis, asthma, headaches, dysmenorrhea (menstrual cramps), inflammation, tumor metastases and osteoporosis. (21,25) We had been looking at essential vitamin-like fatty acids as “angels” but in excessive amounts they turn into devils. When the body goes out of control, something must be done, and it became my goal to prevent this loss of control.
      Two brief narrated presentations covering these general issues are available
      on the Internet.(d) The distance-learning site for the Office of Dietary Supplements has a section on dietary reference intakese with a graph and
      citations. (f) These show that most people are eating on the order of 20 times
      more of the essential vitamin-like n-6 linoleic acid than they need.As with vitamin A and vitamin D, from which the body makes potent hormone-like
      compounds, there is a probable risk in excessive intakes. The website notes
      evidence for requiring these substances in amounts on the order of 0.5% of
      calories or less, but a day’s menu in the United States far exceeds that.” (pp.183).

    3. 23.3

      Also see following teachings in 102 citations by the examiner. The point is the references do not function in accordance with the claimed inventions.

      “The ideal ratio of omega-3 to omega-6 is not known, but is estimated to be around 1:2; whereas, the current ratio in the typical American diet is more like 1:25. In order to achieve a more beneficial ratio, it is important to decrease the amount of omega-6 fatty acids in your diet, while increasing the amount of omega-3 fatty acids like EPA, DHA, and alpha-linolenic
      acid. This can be accomplished by reducing your comsumption of meats, dairy products, and refined foods, while increasing consumption of the omega-3 rich foods such as wild-caught cold-water fish like salmon, flaxseed oil, walnuts, and leafy green vegetables.” (link to web.archive.org)

      “In an embodiment, the composition further comprises an omega-3 to omega-6 fatty acid ratio of approximately 4:1 to 6:1 [i.e. omega-6 to omega-3 ratio 1:4 to 1:6].” Mark 5,549,905.

      As I said before (see 6.3), “There is a reason why §102 and §103 are legislated separately. Among the reasons is that if there is a critical problem that is not be solved even though it may be obvious to some, then patent protection is granted to nurture that invention. In this case there is overwhelming opposite teaching against the claimed subject matter, and there is a major public health issue here. Therefore, there is a critical unsolved problem and §103 is inapplicable. That is precisely [why] USPTO mutilated claims and applied 102 because they could not sustain 103.”

      A CRIME HAS BEEN COMMITTED AGAINST THE INVENTOR AND PUBLIC AT LARGE BY USPTO AND CAFC. THEY SHOULD HELD ACCOUNTABLE.

    4. 23.4

      Severely restricted nutrition patents are ineffective and create more confusion and chaos.

      LOL

      This is where I strongly support revoking people’s patent filing privileges.

      The “confusion and chaos” comes from charlatans selling worthless nutraceutical and h0meop@thic junk with the text “patent pending” (or worse “patented”) on the advertisements.

      1. 23.4.1

        Exactly, “charlatans selling worthless nutraceutical” is a problem. Agreed. Fewer but stronger patents should be granted.

      2. 23.4.2

        This is where I strongly support revoking people’s patent filing privileges.

        Because (somehow) dissuading people from filing patent applications serves some greater good….?

        Malcolm, you are in the wrong business. Your cognitive dissonance must be overwhelming.

    5. 23.5

      Right or wrong, do you understand that you are presuming that this type of “innovation” would not occur but-for the possibility of receiving a patent grant? I don’t think that this can be assumed. Moreover, what role exactly do patents have in creating confusion? What sector of the public will be confused by “severely restricted nutrition patents”? Do you think that consumers generally look at patents? With or without a patent, why wouldn’t someone be able claim that “our formulation is the best and everybody else is making snake oil.” There is no reason why someone couldn’t get a patent on snake oil.

      1. 23.5.1

        Are you picking our intellect to explain the obvious to you?

        For one thing it was said,
        “Lipids were considered important for health 6000 years ago when oils were invented, but since then lipid delivery fundamental to health has not materially advanced… Oil making has advanced but delivery of oil for ingestion by subjects is still archaic.”

        So we have concrete evidence that the art has been drifting sideways.

        That Sir is the purpose of patents, to nurture innovation.

        “Do you think that consumers generally look at patents?”
        Do you think that patents do not transform into products coupled with marketing?

        When proper and sufficient patent scope is granted clear messaging can be given. We should not have to teach this.

  12. 22

    Dennis,

    I actually take an issue with your title also “A Mixture of Known Compounds is Unpatentable without a Transformation”, you are basically giving into wrong doing on part of USPTO and Federal Circuit.

    More appropriate title is, “Whether A Mixture of Known Compounds is Unpatentable without a Transformation?” Then you invite proper discourse.

    Such statements take on life of their own, therefore it is better to ask a question. Federal circuit in fact DID NOT commit to this statement by issuing a NON PRECEDENTIAL opinion.

    1. 22.1

      Enlightened,

      A (possible) tangent to the immediate decision of your own case, but a “condition” that has long been contentious is the mucking up of patent law by the Supreme Court in their desire to stick their fingers into the wax nose of patent law vis a vis 35 USC 101.

      Yes, I know your immediate issue is with a lower court.

      But that lower court has been beat down by the Supreme Court on issues of 101 and this “product of nature” is only the latest sign of that psychological trauma.

      As can be seen (if you take a step back and consider the law outside of your case), there has been an awful lot of conflation and confusion between two very different legal concepts.

      The two concepts are patent eligibility and patent ability.

      Patent eligibility is a “front gate.”
      Patent eligibility is a “timeless” front gate.
      Patent eligibility, as devised and written by Congress, is much simpler than the mechanism unleashed by the Court. Per Congress, there are but two (rather low) hurdles:
      1) Can the innovation be classified in at least one statutory category (see Chakrabarty
      2) Is the utility of the innovation of the type belonging to the (US Sovereign choice of) Useful Arts

      Any other consideration is ultra vires.

      On the other hand,
      Patent ability is concerned with the rest of the requirements as set forth by Congress.
      Patent ability is very much concerned with timing, what and when something is considered to be “in the commons,” and — by extension — what may be taken out of the commons by way of innovation involving configurations of those things IN the commons.

      The notion of “natural products” highlights the conflation. The notion suspends reality and forces an unnatural “Universe must be static” view in order to jump from anything “found” in nature must be something that has existed in nature forever. Your opponents are trying to say that the record indicates that the “Gist” of your claim is nothing more than that which is in nature.

      “Gist” is a Supreme Court “gift.” That is a “tool” that the Supreme Court wielded in its anti-patent heyday of the 1930s and 1940s which generated the push back from Congress resulting in the Act of 1952.

      In the long running “dialogue” here for configurations of those things that themselves individually may not be patent able (and even may not be patent eligible), some here have refused to properly treat what it means to BE “a configuration.”

      The problem of course with attempting to do too much with 101 is that all of patent law can be consumed by the exceptions.

      Much like your case (I hope that I did not lose you by straying away from your case for too long), YOU purport to have a certain configuration. You are emphatic that YOUR configuration is certainly different than any configuration that nature offers. You are upset with the court (and remember, the court is doing this from being TRAINED by the Supreme Court) for the eligibility AND the ability “findings” that you feel simply do not accord with the record.

      I understand that such must be ultimately frustrating. You have put things on the record. The things on the record are clear and unmistakable, and the decision (you feel) simply cannot be IF those items on the record are recognized. What more can you do, but point out that the things on the record dictate a different result from the court?

      Your case has been caught up in the zeitgeist of modern day anti-patentism. Instead of looking at your claim as you provided, as a particular configuration and ALL of the elements of that particular configuration, your opponents have availed themselves of the gift from the Supreme Court and have “Gisted” your claim to be “nothing more” than what nature provides.

      Of course, they ALSO attack along the traditional 102 prior art grounds (as with most any legal case, multiple avenues of attack will be taken).

      Understanding the multiple attack, one can see why your petition is likewise multi-pronged.

      Unfortunately, this makes taking cert more difficult for you.
      Unfortunately, for the larger patent community, this also reinforces the tactic of conflation and obfuscation.

      We all lose with how your case has unfolded.
      Well, almost all of us – those who are anti-patent “win.”

      1. 22.1.1

        I am focused because otherwise I cannot handle my workload.

        YES WE ALL LOSE IF THIS IS ALLOWED TO STAND!!!

        AND THIS IS WHY MUST ALL SPEAK UP!!!

        FILE AMICUS BRIEFS AND WAKE THE SCOTUS!!!

        CAFC DID NOT do as SCOTUS directed them in Myriad and in many other cases. And CAFC is blatantly wrong at the expense of a pro se.

        I am considering sitting on hunger strike outside SCOTUS.

        1. 22.1.1.1

          You alight upon a greater problem:

          CAFC DID NOT do as SCOTUS directed them in Myriad and in many other cases.

          The CAFC cannot be consistent with what the Supreme Court has written because the Supreme Court has written themselves into a Gordian Knot.

          May I suggest that you clarify and separate your APA position from the Gordian Knot, lest that also falls down the rabbit hole?

          1. 22.1.1.1.1

            Of course, there is a “greater problem”, hence the cert.

            Cert is filed now. APA cannot be separated from 101 now.

            It had to be clear in the cert that both 101 and 102 rejections are wrong. The lawyer decided that 102 is best reviewed as part of APA issue.

  13. 21

    Query: does the CAFC even have constitutional jurisdiction to consider a petition from a losing appellant to make a non-precedential opinion to be precedential?

    MOST DEFINITELY!

    Additionally, losing party is the Court that lost credibility in issuing a worthless opinion.

    1. 21.1

      Judge Newman has lost credibility by issuing the worthless opinion in this case. It is simply is unacceptable. It is like living in third world 100 years ago.

  14. 20

    “Out yourself” is to mange my time. Entire day spent on talking to walls is not a good use of time. I have urgent matters that did not get my attention today.

    NO ONE is above the law, not even a Court. Court should be held accountable. That’s right. And making opinions precedential is a WAY of holding courts accountable. Because if they make an opinion precedential, they will have to abide by it in the next case. That is exactly why they did not make this one precedential, because they could not abide by it.

    Nobody is “hunting” for precedential the issue is that the Opinion is so WRONG that it could not be made precedential that’s why it was issued as NON PRECEDENTIAL, and that is evasion of law.

    1. 20.1

      Good point. The court should think long and hard before it designates something as non-precedential. What is good enough for this party is good enough for that one.

    2. 20.2

      Your statement is simply legal nonsense.

      I “get” what” you want. How you want it is just not what that mechanism is for.

      1. 20.2.1

        My statement is NOT legal nonsense. But I understand that the Court can be unjust and deny petitions. And it can get away with this because–good people are SILENT.

        “The ultimate tragedy is not the oppression and cruelty by the bad people but the silence over that by the good people.”​ MLK.

      2. 20.2.2

        Cert petition is the right forum for it.

  15. 19

    In response to David Stein, September 10, 1:29pm

    I admire your effort to rescue the Court’s dog of an opinion from its worst excesses…
    Thank you

    I am surprised that I am more informed about patent law on this blog than the “regulars”.

    Myriad has similarities with this case only to the extent that cDNA was held patent eligible despite conventional methods of making it and despite that cDNA sequence is dictated by nature. Therefore, if cDNA is patentable, instant claims are patent eligible.

    In Myriad SCOTUS said, “Myriad’s claims are simply not expressed in terms of chemical composition”. E.g., 282 patent claim 1 at issue states,
    “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”

    That is NOT the case here.

    Here the claims recite, “A lipid-containing FORMULATION, comprising a DOSAGE of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater, contained in one or more complementing CASINGS PROVIDING CONTROLLED DELIVERY OF THE FORMULATION TO A SUBJECT, wherein at least one casing comprises an INTERMIXTURE OF LIPIDS FROM DIFFERENT SOURCES, and wherein (1) omega-6 fatty acids are 4-75% by weight of total lipids and omega-3 fatty acids are 0.1-30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams.”

    These claims are NOTHING like Myriad.

    Furthermore, there was a big issue of preemption in Myriad, which does not apply here. Instant claims do not bar research, buying selling of isolated omega-6, omega-3 or any oil.

    1. 19.1

      :shrug: The part you quoted wasn’t about the case currently under review; we were discussing Myriad. Not sure why you conflated a discussion about Myriad with this patent.

      1. 19.1.1

        This is her patent, David.

        Everything revolves around that.

        1. 19.1.1.1

          Everything does not revolve around Bhagat patent, but that is the topic here so naturally we discuss Myriad in context of Bhagat patent.

          1. 19.1.1.1.1

            We weren’t discussing this patent at all. We were discussing the holding of the Myriad case as it relates to § 101 law.

            Conversations often drift, and that’s okay.

  16. 18

    Broadest reasonable interpretation DOES NOT mean broadest POSSIBLE interpretation.

    USPTO and FEDERAL CIRCUIT cannot excise REASONABLE from Broadest Reasonable interpretation.

  17. 17

    Greg DeLassus,

    You Sir are conflicted.

    Nonsense on the following. You don’t know how PBP works.

    This is a product-by-process limitation. Someone advancing a product-by-process limitation to distinguish a product claim has the burden to show that the process limitation imparts a structural difference. There is no such evidence on this record. Therefore, this limitation carries no patentable weight.

    Nonsense on the following:
    This phrase (in its broadest reasonable construction) reads on the natural membraneous tissues of the olive and walnut. I am not ignoring this language. This language, however, does not actually distinguish the claimed invention from the cited art.

    1. 17.1

      Read the cert petition and the briefs to Federal Circuit that will tell you how PBP works.

      I really don’t want to spend more tome on this.

      1. 17.1.1

        I really don’t want to spend more t[i]me on this.

        No one is forcing you to spend time on this. If you are looking for me to concede your point, however, you might want to advance plausibly persuasive arguments to the point.

        1. 17.1.1.1

          If you haven’t understood so far, then you have a mind unwilling to understand. We will conserve our energy.

  18. 16

    To “But this IS the Supreme Court that we are talking about…” by Anon

    That is exactly why “The ultimate tragedy is not the oppression and cruelty by the bad people but the silence over that by the good people.”​

    Speak up, submit amicus briefs, wake up the SCOTUS. What is this??? Millions of people suffer, the problem has been going on for centuries, rather than solve the problem head on by providing tailored lipid dosages to public, people are making different kinds of oils. Synthetic oil etc. etc. etc. This is madness. It will create more chaos.

  19. 15

    In this case there is ABSOLUTELY NO JUSTIFICATION for gisting away claim limitation “dosage”. The specification not only provides several tables listing different dosages by age and gender, but also emphasizes the dose-effect of omega-6 and omega-3, i.e. different response by the organism based on level of administration, body stores, etc. In fact, dependent claims recite steady and gradual delivery.

    Further, SCOTUS has clearly said every limitation is limiting. There are NO superfluous limitations.

    THIS IS AN EXTREME CASE OF MESS UP BY USPTO AND FEDERAL CIRCUIT.

  20. 14

    Another bad decision. The Courts fail to understand simple science and thus misapply patent law regarding subject matter ineligibility. The claim does not cover a product of nature. It specifies that the formulation, which might on its own be a product of nature, be “contained in one or more complementing casings providing controlled delivery of the formulation”. Natural products do not contain such casings and do not provide controlled delivery of the oils. The claim includes substantive additional elements (the casings) that substantially change the way the oils are delivered to a subject receiving said formulation. Without such casings, the oils (walnut oils and olive oil) would be delivered immediately and not in a controlled fashion. We need more scientists as judges. And there is no need to go down Alice’s rabbit trail which leads to a Myriad of Mayo. The better rejection would have been obviousness or anticipation: lots of prior art there.

    1. 14.1

      RIGHT ON!!! Thank you.

      The bad decision is not because the court does not have scientists as judges. Judge Newman is very well educated scientifically. They intentionally issued a BAD DECISION. It is NOT acceptable. This is why cert was filed. Please file amicus briefs. So SCOTUS pick it up.

    2. 14.2

      If there were more in the spec about what is meant by “controlled delivery” I could agree with you on this. There is, however, literally nothing about “controlled delivery” in the specification. In such a case, the phrase takes its broadest reasonable construction, which to my mind would be anything short of immediate delivery. As it happens, when you eat an olive, your body must gradually digest the membrane vessicles to release the totality of the lipid content. This, to my mind, makes those membrane “controlled release” casings within the BRI of these claims.

      1. 14.2.1

        There is more in the Spec on controlled delivery and in prosecution history. Definition given in prosecution history are relevant. See In re Zletz.

        1. 14.2.1.1

          You might want to go back and re-read Zletz. The court here held that prosecution history is not to be limiting in the context of an appeal from a rejection in ex parte examination. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1990). Accordingly to Zletz, definitions not recited in the claim but merely argued in prosecution are only to become limiting once the patent grants.

          1. 14.2.1.1.1

            Sir, I am too busy to respond.

            Zeltz says, “When the applicant states the meaning that the claim terms are intended to have, the claims are examined with that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art.”

            Moreover in this case, the claims recite
            “formulation”
            “a dosage of omega-6 and omega-3 fatty acids”
            “in one or more complementing casings providing controlled delivery of the formulation to a subject”
            Each of the above refers to controlled.

            I sense that you have a conflict of interest, therefore a mind unwilling to understand.

            1. 14.2.1.1.1.1

              I sense that you have a conflict of interest, therefore a mind unwilling to understand.

              Begging pardon, but you are not exactly a disinterested observer yourself, are you? The patent applicant is, of course, a party particularly well informed on the course of prosecution, but also the most personally interested party possible.

              Talk about a conflict of interest! If we are to discount the contributions of “conflicted” parties, there will not be much to discuss with yourself in the discussion.

              1. 14.2.1.1.1.1.1

                The issue is that you are conflicted with wrong motives. Putting forth arguments on something that is necessary advancement in the art is a good motive.

                Derailing something with mal-intent is bad motive. It is like putting water on putting greens to spoil the game of others. That is what you are doing.

                Others on this post have contributed meaningfully to the conversation. You on the other hand… not the least of which is you think synthetic walnut oil is advancement. You are so far off…

                1. you are conflicted with wrong motives.

                  You gotta admire the relentless slinging. Maybe there is something to this walnut oil after all.

            2. 14.2.1.1.1.2

              As for your reading of Zletz, I invite the interested reader to go read Zletz for himself or herself, and decide which of us better understands the rule from that case.

      2. 14.2.2

        If you find “literally nothing about “controlled delivery” in the specification” then you need to take reading lessons.

        1. 14.2.2.1

          By all mean, please cite me the portion of the specification that explains what one should understand the term “controlled delivery” to mean.

          1. 14.2.2.1.1

            Are you sure that you are not the USPTO examiner, or his accomplice, disguised as Greg DeLassus?

            1. 14.2.2.1.1.1

              If I were (scurrilously) to misappropriate the identity of some innocent patent attorney to mask my own identity and borrow the unearned authority of another’s brilliance, I would masquerade as Kevin Noonan, or Paul Cole, or Bryan Wheelock—someone genuinely brilliant and accomplished. No one would try to pass themselves off as Greg DeLassus, except for the real Greg DeLassus.

              1. 14.2.2.1.1.1.1

                That would be like laboring to counterfeit the one-dollar bill…

              2. 14.2.2.1.1.1.2

                I suspect Enlightened presumed that you were the Examiner because the Examiner had also asked them to show where the specification described “controlled delivery”.

                1. One who cannot see controlled delivery in a specification that is all about controlled delivery is pure evil.

                  There is wisdom in not responding anymore.

                2. Examiners are trained to object. It does not mean anything when they bs. The entire specification is focused on controlling n6 and n3 by demographics and delivering in casings like capsule, there is a control release capsule also .

    3. 14.3

      “The better rejection would have been obviousness or anticipation: lots of prior art there.” The “lots of prior art there” statement is WRONG.

      In 10 years of prosecution PTO could not PROPERLY sustain obviousness or anticipation rejections. 103 could not be sustained because of overwhelming opposite teachings and long-felt critical unsolved need.

      102 has been improperly maintained, by excising limitations from the claims. Anticipating art has to necessarily function as claimed. The cited art under 102 in this case does NOT necessarily function as claimed.

      It is a misplaced perception that there is “lots of prior art there”. Soon after the discovery of criticality of omega-6 and omega-3, omega-6 started to be vilified, which the Bhagat patent teaches against, so there is no prior art that necessarily functions as taught in Bhagat patent.

  21. 13

    “The ultimate tragedy is not the oppression and cruelty by the bad people but the silence over that by the good people.”​ -Martin Luther King, Jr.

    1. 13.1

      Er, o.k.

      A wee bit of perspective might be in order here…

      1. 13.1.1

        The entire thread is perspective…

        It was said,
        “Look around you, 99% of the public cannot name lipids, lipid dosages are hard to obtain, public cannot measure lipids in nature, and 117 million people suffer from chronic diseases, almost all of the chronic diseases are associated with improper lipid intake. It is an enormous national burden.”

        USPTO and Federal Circuit blatantly wronged not only the pro se but millions of people suffering from chronic diseases… Are they protecting public??? DEFINITELY NOT. They are protecting status quo. Keeping everybody confused and ill.

        Need I say more?

      2. 13.1.2

        SILENCE over “the Court’s [Federal Circuit’s] dog of an opinion from its worst excesses” is exactly the issue here.

        Where do we live? In USA, the “MOST ADVANCED COUNTRY” in the world. A “model” democracy.

        Who is Federal Circuit? The SECOND HIGHEST COURT in the most advanced country in the world.

        How can the SECOND HIGHEST COURT in the most advanced country in the world, issue such a worthless opinion??? They knew it was worthless, that is why they made it NON-PRECENDETIAL. They declined to make the opinion precedential because they knew they were EVADING the law.

        1. 13.1.2.1

          I “get” that you are getting excited about this, but what you post here evinces a clear misunderstanding about what it means for an opinion to be non-precedential.

          Such a designation simply does not mean that law has been “evaded,” and in a much more vanilla meaning, merely indicates that there is nothing special or unique about the proper application of law in the particular case.

          1. 13.1.2.1.1

            WRONG!

            Non-precendtial CAN BE used as a tool to evade law, and that is exactly what Federal Circuit did.

            1. 13.1.2.1.1.1

              You seem to want some “must” and seem not able to understand that “can” does not mean what you want it to mean.

              This is not “an opinion” open for debate – this is just you not understanding the legal terminology.

              You might want to learn which battles to pick to fight – this is not one of those.

              1. 13.1.2.1.1.1.1

                The problem is in your understanding of the legal terminology, and there is no issue of “legal terminology” here.

                There is NO “must” in deciding when the opinion is precedential versus non-precedential. This is largely discretionary.

                There are legitimate points raised in the motion to make precedential (link to asha-nutrition.com), yet the option was not made presidential because, it is a worthless opinion.

                Disclose your name and your line of work so we can assess your conflicts.

                1. “Out yourself” is a vestige of desperation.

                  You do not have to go there.

                  What I post is adequate enough.

                  You may very well argue FOR making the decision precedential, but the court is under no impetus – absolutely zero – to even respond to your motion. There is simply no legal mechanism to achieve what you merely “want.”

                  Further, the court NOT giving you what you want simply carries NO indication of anything other than the court not catering to a “want.”

                  I “get” that you feel aggrieved and that you want the court to be held accountable. Believe me, if you read the comments here regularly, you would see that I am one of the major proponents for doing exactly that.

                  But the “hunt” for precedential instead of non-precedential just does not get you where you want to be.

                2. Query: does the CAFC even have constitutional jurisdiction to consider a petition from a losing appellant to make a non-precedential opinion to be precedential?

                  What is the concrete interest that the losing party has in that contest that creates a “case or controversy” that the court can hear?

                3. Greg,

                  Her petition correctly provides the basis for her ability to ask for consideration of reclassification from non-precedential to precedential.

                  There is not issue with the asking.

                  The “why” is also clear – she feels aggrieved and sees this a legal mechanism to make the court accountable for what she sees as the court ignoring things clearly on the record that dictates a different result.

                  My issue (and a minor one at that) has been more along the lines of trying to FORCE the court to do something that is entirely within the discretion of the court to do. She seeks legal leverage where no such leverage exists. This is simply not something that the court MUST do – even if she is entirely correct.

                4. @anon

                  “She seeks legal leverage where no such leverage exists. This is simply not something that the court MUST do – even if she is entirely correct.”

                  You are saying Court is under no obligation to render justice. We get it.

                  Have you considered that the petitioner petitioned to make the opinion precedential knowing well that the petition would be denied, to make the point that the Opinion is so wrong that it could not be made precedential.

                5. I am saying that the legal mechanism is NOT for how you are attempting to “render Justice.”

                  I “get” why you are doing what you are doing (I “get” that you feel that your action somehow necessitates some higher “truth” moment for the court – do you understand what I am telling you? Your labels are emotive – not legal. You cannot get to where you want to down this path.

                  Your crusade does not change the legal landscape here.

                  It’s actually a bit of distraction from your more powerful arguments, and detracts from your aim.

                  Tell me this though (exploring possibilities):
                  What happens IF the court changes the designation?
                  What happens IF the court does not change the designation?

                  For you, how is your case impacted?

                  Does a designation change affect (to any degree) your OTHER arguments as to why the decision below should not stand?

                6. @anon

                  You missed the point, “Have you considered that the petitioner petitioned to make the opinion precedential knowing well that the petition would be denied, to make the point that the Opinion is so wrong that it could not be made precedential.”

                  So the movant knew that the Motion (accurately it is motion not petition) would be denied.

                  Here are the answers to your questions.

                  “What happens IF the court changes the designation?”
                  There is no chance that the CAFC would have changed the designation. It would invalidate 1000s of granted patents. Everyone wanting to invalidate someone else’s patent would cite that opinion. The CAFC judges would be bound by the BAD precedent in deciding other cases.

                  What happens IF the court does not change the designation?
                  CAFC judges are not bound by non-precedential rulings.

                  Greg DeLassus got this one. He said, “What is good enough for this party is good enough for that [other] one.

                  Movant knew that the motion would not be granted.
                  Movant just made a point that Opinion was so BAD. Movant is not focused on that Motion anymore, they have moved on to cert.

                  This is a dead horse, better to discuss other points. Thank you.

              2. 13.1.2.1.1.1.2

                This statement is complicit, “You may very well argue FOR making the decision precedential, but the court is under no impetus – absolutely zero – to even respond to your motion.”

                It shows resignation to injustice in the justice system.

          2. 13.1.2.1.2

            Read the Motion to make opinion precedential, with reasons why the opinion should be made precedential (link to asha-nutrition.com). The Court denied it exactly because the opinion is worthless.

            In this discourse we haven’t even touched on dependent claims. Over 30 dependent claims were thrown under the bus by USPTO and Federal Circuit under false pretenses.

            Then it is a CRIME system NOT justice system.

  22. 12

    Query – are the the oils themselves product of nature?

    Oils are not a product of nature. Oils are man-made products, during processing oils and oil flours are made. Carb, proteins, some fatty acids, and antioxidants remain in the flour. During processing chemical structure of fatty acids changes, such that physical and chemical properties of oils are different from lipids in nature, such as olives and walnuts.

    1. 12.1

      While you make a case here that “oils” are not products of nature, I am not certain that THAT postion helps you given that you point out below that the claim is not to “oils.”

      As to the “intermixture” limitation, pardon my not looking up directly, but what is the advantage of multi-sourcing?

      If there be one, then much like another recent case, the limitation would be one that would be improper to “Gist” away.

      If there not be one, then does the limitation have patentable weight (and thus may be used to patentably distinguish)?

      While I recognize that you are not a regular poster, a recurring theme here is a “logic” called the Big Box of Protons, Neutrons and Electrons. As you might easily grasp, differing sources of elementary particles would not provide a basis for patenably distinguishing any configuration of protons, neutrons and electrons. So too with configurations of non-elementary items.

      1. 12.1.1

        There is Federal Circuit precedent that holds claims are to be examined by plain words of the claims. When oil is not recited in claims, citation of oils is improper.

        Claims are examined in view of specification. Specification goes to great lengths in explaining using different sources avoids concentrated delivery of certain lipids. Read the cert for more.

        1. 12.1.1.1

          Thanks for the reply, it appears improper to attempt to not take into account the claim term (that’s not to say that the courts will heed that, after all, our top Court has provided a “Gist/Abstract” sword that directly contravenes the authority/responsibility as to exactly which entity gets to define what “the invention” is.

          1. 12.1.1.1.1

            Your statement is inaccurate. SCOTUS holds every claim term is limiting, and claims are examined by plain words of the claims. Specification states “claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby” not the abstract.

            1. 12.1.1.1.1.1

              My statement is correct (you appear to not be reading what I wrote).

              Hint: look for the word “IMproper.”

              1. 12.1.1.1.1.1.1

                I stand corrected. Thank you.

  23. 11

    Dennis,

    There are some problems with your article. For one thing, the following is wrong:
    “although the claims require (via disclaimer) that the mixture of oils come from different sources”

    (1) Claims do not require via “disclaimer”, claims expressly recite, “intermixture of lipids from different sources”.

    (2)Claims do not recite, “oil”.

  24. 10

    Having had a look at the corresponding EPO application it seems that the applicant has encountered difficulty and is now before the Enlarged Appeal Board which is definitely a last resort. There is a divisional application that has not yet been examined. Not indications for going to the US Supreme Court.

    1. 10.1

      PC, that leads to an interesting question. I wonder if the Sup. Ct. law clerks that wade through thousands of cert petitions would ever check for what happened to the same patent application in other countries, or for a cogent legal comment under this or another patent blog, unless someone opposing the cert petition does and points it out in a brief?

    2. 10.2

      The divisional application at EPO has been examined and allowable subject matter has been indicated in the divisional application.

      The way the patent offices work is that they copy each other in applying rejections. That is not an indication of not going to Supreme Court, but an indication of collective abuse by EPO and USPTO.

      1. 10.2.1

        @ Enlightened

        You are quite right, the search opinion identifies patentable subject matter where one of the sources includes nuts or nut oils. That is at the end of a 29-page opinion! Whether this will be acceptable to the applicants is another matter, but the grantable claim in Europe is narrower than the broad claim in issue in the US. Interestingly, the technical problem is formulated as being providing lipid-containing compositions that optimise delivery of omega-6 and omega-3 fatty acids and antioxidants, notably vitamins E and C, in order to improve or maintain health benefits relevant to the metabolism, especially as linked to lipid imbalance.

        1. 10.2.1.2

          Examiners are biased to find narrower claims allowable. Examiner’s definition of “technical problem” may not be applicant’s definition. Applicant’s original claims 1-3 are directed to just dosages of omega-6 and omega-3 (which are also phytochemicals) with open-ended ratios, nothing more. Applicant can rightfully amend original claims 1-3 with narrower limitations from the Specification.

          Yes it remains to be seen how the applicant responds.

  25. 9

    If you would like to read the patent in issue, it is US 2009/0264520.

    The author of the CAFC opinion in Judge Newman, who cannot be accused of being either anti-patent or unaware of patent law. If there had been any way of allowing the application, she would have been expected to find it. Her final analysis, however, is very brief.

    The patent has some credibility because there is an underlying theory accompanied by some (inevitably somewhat sparse) treatment examples.

    If anything is patentable, I would think it is to be found in method of treatment claims. The composition claims, I think, fall within the composition of matter eligible category (or manufacture if you include the packaging) and the ingredients form a true combination by virtue of their alleged novel curative properties, so application of section 101 raises issues of separation of powers. On the whole, it seems that 02 or 103 would have been the most appropriate grounds.

    1. 9.1

      I put it to you Paul, that if drafters knew better what the criteria were, for a claim to meet, in order to get through to issue, they would draft “better” claims, with the result that those inventors who invent something patentable (a method of treatment, or an EPC “use” claim, for example) could better get it through to issue.

      You use the word “credibility”, Paul. Is that not a synonym for “plausibility”? I’m wondering whether the application contain enough credibility to survive the EPO’s “plausibility” test. Perhaps I should read it for myself.

      1. 9.1.1

        You are missing the point. Claims are directed to formulations and dosages and they were always directed to formulations and dosages, the examiner excised the limitations, so the applicant added more limitations to overcome the impropriety.

        With regard to “credibility” “plausibility” applicant has to disclose what is new not rebuild the history of the art. Applications are directed to skilled persons. Applicant sufficiently discloses what is new, and which has later been validated by other scientists. EPO has already indicated allowable subject matter in the divisional application.

        1. 9.1.1.1

          May we know the EPO serial or publication number please, so we can ourselves read the EPO Examiner’s assessment of patentability?

    2. 9.2

      Judge Newman’s analysis is evasive for a reason. Judges did not want to commit to anything, because they knew they were misapplying the law. That is also why the opinion is non-precedential.

      Again the application only has to disclose new finding, which the application does. The applications adds to the prior art.

      Yes 102 and 103 are the more appropriate grounds but because PTO could not sustain 103 rejections because of OPPOSITE TEACHINGS in the art and in the CITED REFERENCES THEMSELVES , the PTO mutilated claims and rendered the rest of the claims unpatentable.

  26. 8

    “although the claims require (via disclaimer) that the mixture of oils come from different sources”

    Er… Product-by-process doctrine would say otherwise?

    1. 8.1

      Not via disclaimer, the claims expressly recite, “formulation” and “intermixture of lipids from different sources.”

    2. 8.2

      Not via disclaimer, the claims expressly recite the feature, “intermixture of lipids from different sources.”

    3. 8.3

      Product-by-process is misapplied here. Specification discloses that mixtures impart different characteristics to the formulation.

  27. 7

    Nobody could have predicted that the fine art of scrivening would be applied in gigantic thick dollops to nutraceutical “innovations” — perhaps the only field that rivals software for excessive verbiage in the service of dust kicking.

    Question: Do these charlatans have an infomercial?

    [By the way, I already filed my app on walnut oil plus olive oil plus argan oil — one drop of this stuff and you will never worry about getting the rarest form of cancer, as long as you follow the meditation instructions on the side of the package]

    1. 7.1

      B-b-b-but “objective physical structure”

    2. 7.2

      Lot more teaching is needed than infomercial.

    3. 7.3

      Charlatan is he/she who claims “walnut oil plus olive oil plus argan oil — one drop of this stuff and you will never worry about getting the rarest form of cancer”. NOT SO these substances have powerful antioxidants, which have to be delivered in measured dosages in context of subject’s diet.

      1. 7.3.1

        these substances have powerful antioxidants, which have to be delivered in measured dosages in context of subject’s diet.

        Well that partly explains why your composition claims got tanked.

        1. 7.3.1.1

          Your response explains your lack of knowledge.

  28. 6

    Two points:

    (1) It is very popular to speak of Funk as if it were decided on the basis of subject matter eligibility (that is how Chakrabarty styled Funk), but Funk never actually grounds its holding in a “natural products” exception to subject matter eligibility. Funk Bros. itself purports to be decided on the basis of “want of invention” (333 U.S. 127, 128). “Invention” is the pre-1952 analog to “obviousness,” not subject matter eligibility. Funk Bros. is a horrible precedent (one of many such SCotUS patent precedents), but it is made even worse by insisting on reverse-engineering it into being a subject matter eligibility case, rather than an obviousness case (as it was at its inception).

    (2) I doubt that the Court will take cert. on this one, but oh how I would love if they were to do so, and use this case as a vehicle to posthumously bless Justice Frankfurter’s Funk Bros. concurrence.

    (3) The reason why I doubt that they will take cert. is that (as Random Guy noted) there was a § 102 rejection that was upheld and rightly so. Claiming “man-made” walnut oil that is chemically identical to nature olive oil does nothing to advance the art, and merely attempts to loot the public domain. It is too late for you to invent walnut oil at this late date. If you have invented a synthetic scheme for making walnut oil, claim your method (which really may be a contribution over the art), not the walnut oil itself.

    1. 6.1

      Ah, as can be seen, I meant three points…

    2. 6.2

      Greg,

      Was not “want of invention” merely one of the dozens of terms associated with “Gist of Invention”…?

      While indeed Congress acted in 1952 to break up the former single paragraph into 101/102/103, and choose to eliminate “invention” with “obviousness,” the conflation of what is now 101 and 103 has a long history by the Court. Is not Funk merely one of those artifacts?

      1. 6.2.1

        In the context of Funk , the “want of invention” seems to refer to the absence of “something more,” or the absence of “inventive concept” beside the discovered law of nature that a few select strains of bacteria do not inhibit each other.

        1. 6.2.1.1

          Thank you PiKa – does that not augment my question for Greg?

          Note as well that the ENTIRE line of “something more” is nothing more than the Supreme Court acting as if the Act of 1952 never happened — I can certainly see WHY Greg feels as he does with his post, and my questions serve to highlight and emphasize the actions of the Court cannot be squared with what Congress has done.

          1. 6.2.1.1.1

            Instead of a slogan like eligible subject matte includes “anything under the sun that is made by man,” Congress should have stated that Funk is overturned. This is law, not marketing.

            1. 6.2.1.1.1.1

              See writings of Judge Rich – Congress fully did indicate that what the Court (in particular) had been doing was errant and that the single paragraph being broken into 101/102/103 was resetting the law from such error.

        2. 6.2.1.2

          Sure. You can map Funk onto the Mayo two-step if you like. In some measure, that is because Mayo purports to be following Chakrabarty, and Chakrabarty pre-fit Funk Bros into a § 101 context. It is, in other words, reverse engineering of a bad precedent into a worse precedent all the way down.

          That is really my gripe here. Funk Bros. reached the right outcome (claims invalid) for entirely the wrong reason (“want of invention”). Instead of covering their father’s nakedness (as it were), by posthumously affirming Funk Bros. on the basis of Justice Frankfurter’s concurrence, the Chakrabarty court compounded the error by making Funk Bros. into a § 101 case.

          They did not have to do that. They could have read it as an obviousness case. They could have declared it to have been legislatively over-ruled by the codification of §§ 101/103. They could (as I said) have retroactively blessed Justice Frankfurter’s concurrence. Instead of doing any of those things (any of which would have been better), they chose the worse option (as the SCotUS so routinely does in patent cases) and retroactively forced it onto a § 101 framework.

          1. 6.2.1.2.1

            Lots of “could haves” including the could have of respecting what Congress did in the Act of 1952.

          2. 6.2.1.2.2

            I am not sure the invention in Funk was obvious. Apparently, before the invention, everyone thought that different strains of bacteria would inhibit each other. I don’t know how obviousness was decided back then, but in today’s parlance, there would be a finding of “teaching against.”

            1. 6.2.1.2.2.1

              Interesting observation PiKa.

              On another thread, Joachim is engaged in a discussion with MaxDrei having to do with the EPO “inventive step” and it has just been remarked that “inventive step” and “obviousness” are not the same legal concept (even as they may be “related” and oft treated as interchangeable).

              One of the lessons to be learned from Funk was that the Court there reached a desired ends and then attempted to shovel their way to get there.

              1. 6.2.1.2.2.1.1

                There is no “something more” in Art 56 EPC. EPO Examiners must examine whether that which is claimed is “obvious”. If it is, that is enough to demonstrate that it is not “inventive”.

                In other words, “inventive” is the antonym of “obvious” no more, no less. At least, that’s how it is in Europe.

                Just to be clear, at the EPO, if you are “obvious” within the realm of technology, it helps not one jot or tittle that you are clever outside the realms of technology. You still fail the Art 56 obviousness test. An old coffee mug embossed with a brilliantly new and inventive insight (or joke) on its surface is a FAIL. Patents are for technical solutions for technical problems, and not for conjuring up ways to sell more product.

                1. Feel free to address any of the “loose ends” from that other conversation either here or there MaxDrei.

                  It does not do much for the dialogue for you to merely type in again the start of that exchange.

            2. 6.2.1.2.2.2

              I agree that Funk Bros’ claimed invention was not obvious. Come to that, however, it was also not a natural product. The real reason that claim rightly deserved to fail is that they discovered one non-naturally occurring combination of nitrogen-fixers with a novel utility, and then claimed all combinations that achieve such a utility, even though they could not have begun to describe a second such combination in anything other than functional terms.

              This is a written description/enablement problem. It was a category error to call it a “want of invention,” and that category error was merely compounded by transmogrifying that “want of invention” into “it was merely a product of nature.”

              1. 6.2.1.2.2.2.1

                This is a written description/enablement problem.

                While I may agree with you, that is most definitely NOT how the Court put it.

                I DO wish that case law could be treated on an “it should have been written” basis, but that would mean that most all of the Supreme Court writing would be thrown away.

    3. 6.3

      On your point no. (3):
      §102 was not upheld rightly so. The requirement under §102 is that each limitation must be disclosed in prior art exactly as in the claims. The claims at issue are different from the art cited under §102. USPTO and Federal Circuit excised limitations from claims to allege anticipation. Therefore, §102 was misapplied.

      There is a reason why §102 and §103 are legislated separately. Among the reasons is that if there is a critical problem that is not be solved even though it may be obvious to some, then patent protection is granted to nurture that invention. In this case there is overwhelming opposite teaching against the claimed subject matter, and there is a major public health issue here. Therefore, there is a critical unsolved problem and §103 is inapplicable. That is precisely USPTO mutilated claims and applied 102 because they could not sustain 103.

      Walnut oil is not identical to claimed compositions. Walnut oil does not provide dosages of omega-6, omega-3, or any other lipids. Lipids are unpredictable in walnuts, olives, or any other product of nature. Applicant does not claim walnut oil.

      Look around you, 99% of the public cannot name lipids, lipid dosages are hard to obtain, public cannot measure lipids in nature, and 117 million people suffer from chronic diseases, almost all of the chronic diseases are associated with improper lipid intake. It is an enormous national burden. This is a 2009 application and applicant is small entity. Applicant has spent 10 years in fighting for this cause at their own expense. You should be supportive.

      Claiming synthetic scheme for making walnut oil is NOT a contribution over the art. It would cause further confusion in the already confused marketplace with thousands of oils. Public is already LOST. Applicant goes to the root of the problem by providing pre-formulated lipid dosages to public. Unless this problem is solved the way applicant claims this problem will continue for centuries.

    4. 6.4

      Let me tell you what is looting the public, it is putting them on drugs and devices when 80% of the problems can be solved by correcting nutritional problems. What is that if not looting the public to fill pockets of big pharma?

      Further, large nutrition companies also make money by confusing people and creating millions of permutations and combinations of foods.

      Mind you there are only 150 or so basic foods. The millions of products you see on the market are permutations and combinations of the same.

      The millions of products do NOTHING to make it convenient for public to choose the combinations. There is NO need for another oil or another cereal. The need is to bring sanity into how these products are combined to keep consumer in the safe nutrient intake zone.

  29. 5

    You have to give some applicants credit for their sheer bs-ery.

    Applicant claims something. The Examiner finds an anticipatory reference. Applicant attempts to get around the anticipation by disclaiming it coming from a single source.

    Who knew novelty was so easy to achieve? When someone cites a single reference, you simply disclaim a single source. Since all novelty references will be from a single source (as who is going to specifically write that parts can come from multiple sources?) you can just avoid 102 all of the time. I say, why stop there – turn around and argue that the prior singular existence teaches away from any combination (I mean, why combine things just to get something that naturally occurs combined) and argue that there can’t be a 103 either.

    Not only that, but because the natural source is also singular, Applicant argues it avoids 101 as well.

    How dare you, PTO? Trying to prevent something from being patented just because that exact structure has existed before, including in nature.

    1. 5.1

      NO the examiner was bs-ing. The claims are and were drawn to a “formulation”. He cited olives or walnuts separately, applicant ADDED another limitation “intermixture of lipids from different sources” to overcome examiner’s bs. Further, claims are and were drawn to DOSAGES, which do not occur in nature. In case you don’t know nature is not predictable in lipid content.

  30. 4

    This case has zero chance of having SCOTUS grant cert. No reason to reach 101 if it can be affirmed under 102.

    1. 4.1

      102 rejection was also improperly maintained by Federal Circuit by excising limitations from the claims. Federal Circuit failed to give a meaningful review to the case. The cert petition calls for the Supreme Court to require the Federal Circuit to meaningfully review agency decisions as per APA, in addition to the review of § 101 issues.

  31. 3

    If the argument is that the composition occurred naturally in nature, shouldn’t the demonstration of that fact under 102 be (a) trivially easy to produce and (b) essential for proving the argument? Rather than just saying it’s so?

    There is a 102 based on a reference, and it was upheld.

    Given the sufficiency and directness of § 102 for this inquiry, what is the purpose of asserting § 101 here – if not a license to reject applications based on rank subjectivity?

    Because if you create X, and X is found in nature, you don’t get to claim X, even though you made X. In other words, if the claim was “I claim honey, where the honey was made by a human” it might not be anticipated by nature, but would still be ineligible. The method of a human making honey might be patentable, but its impossible for the person to have invented honey, since the honey preexisted the person. The exact same argument was made with respect to cutting out the full DNA chain, as opposed to modifying the chain to read only the important parts.

    1. 3.1

      [I]f the claim was “I claim honey, where the honey was made by a human” it might not be anticipated by nature…

      No, look, that is definitely anticipated by natural honey. “Made by a human” is a product-by-process limitation. Process limitations do not carry patentable weight in an anticipation challenge to a composition of matter claim. Abbott Labs v. Sandoz Inc., 566 F.3d 1282, 1305 (Fed. Cir. 2009). This is bog-ordinary anticipation (or obviousness) law. Dragging subject matter eligibility into this just makes the business more complicated than it needs to be.

      1. 3.1.1

        Fine – a system comprising a jar and honey, wherein the honey sits inside the jar.

        1. 3.1.1.1

          You would reject “honey in a jar” on § 101 grounds?!? Ohhhkay….

          1. 3.1.1.1.1

            I am shocked that you are shocked, Greg.

          2. 3.1.1.1.2

            You would reject “honey in a jar” on § 101 grounds?!? Ohhhkay….

            A jar is a conventional device for holding things. The claim is directed to a product of nature (honey) that is modified only by a conventional act (putting it in a jar).

            And that’s the way it should be. If tomorrow someone discovers naturally occurring unobtainium, they shouldn’t get to patent unobtainium on a shelf, or in a car, or in concert with any other well-known item. That’s an effort to patent the natural creation itself, modified only by a conventional device. 102/103 doesn’t solve it, because shelves aren’t naturally occurring (no 102) and there was no prior knowledge of unobtainium, so there was no motivation to do anything with it (no 103).

            Look if you want to expand what 103 is so that we can apply motivations to previously unknown structures, I guess I’m fine with that, but that’s not the law. If nobody has seen a widget before, a claim that includes a widget is going to be non-obvious. That’s why baby-DNA-in-mother’s-blood was non-obvious – nobody knew it was there so there was no motivation to test for it. But 102/103 does not currently solve the problem, so you NEED 101. The fact that you think honey is a jar is silly is irrelevant, because honey in a jar is ineligible for the same reason as testing-for-baby-DNA-in-Mom is.

            1. 3.1.1.1.2.1

              The claim is directed to a product of nature (honey) that is modified only by a conventional act (putting it in a jar).

              Er, o.k. If instead of “natural honey in a jar,” the claim had read “a jar containing natural honey,” would that have made a difference to the §101 analysis? At that point, the claim would be “directed to” (whatever that means) something that is not a natural product (a jar), modified based on the mere fact that it contains a natural product. Or is it your view that if the claim merely recites a natural product anywhere along the way, that drags us into exception land?

              The fact that you think honey is a jar is silly…

              I think that it more than “silly.” I think that it is absurd. That is to say, I think that the idea that one might argue that “honey in a jar” is §101-ineligible is more properly a reductio ad absurdum send up of Mayo than an actual rejection.

              I will say, however, that I admire the courage of your convictions. I think that your conclusion is patently absurd, but at least you see where your premises lead, and you do not flinch from it, or prevaricate to evade the issue. I tip my hat to your intellectual honesty.

              If tomorrow someone discovers naturally occurring unobtainium, they shouldn’t get to patent unobtainium on a shelf, or in a car, or in concert with any other well-known item.

              So you say. For whatever little my opinion is worth on this point (and I realize that it is worth less than a tinker’s cuss so long as Mayo is on the books as good law), I find the argument here thoroughly unconvincing. Under the terms of your hypo, the proposed claim takes nothing from the public that it had already prior to the disclosure, because the public never knew of unobtanium. That means that there are only two possibilities here: (1) unobtanium on a shelf is useless, in which case the claim fails under §101 on the utility prong; or (2) unobtanium on a shelf is useful, in which case we have a useful, novel, and nonobvious invention, the which is still to be understood as unpatentable for some ineffable reason. You will please forgive me, but this strikes me as patent nonsense (in both senses of the word).

              1. 3.1.1.1.2.1.1

                I am too busy to respond to this nonsense. This is my last reply to you.

                Under what pretense do you ignore “intermixture of lipids from different sources” which controls lipid content?

                Under what pretense do you ignore “dosage of omega-6 and omega-3 … providing controlled delivery of the formulation to a subject”????

                1. Under what pretense do you ignore “intermixture of lipids from different sources” which controls lipid content?

                  Asked an answered. This is a product-by-process limitation. Someone advancing a product-by-process limitation to distinguish a product claim has the burden to show that the process limitation imparts a structural difference. There is no such evidence on this record. Therefore, this limitation carries no patentable weight.

                  Under what pretense do you ignore “dosage of omega-6 and omega-3 … providing controlled delivery of the formulation to a subject”

                  This phrase (in its broadest reasonable construction) reads on the natural membraneous tissues of the olive and walnut. I am not ignoring this language. This language, however, does not actually distinguish the claimed invention from the cited art.

                2. Greg,

                  You are being pedantic – and incorrect.

                  Take the claim as a whole – there is NO WAY this reads on the items of nature. Not even under an unreasonably broad interpretation – just as you indicate elsewhere (for the case HEARD by the Supremes), claim terms are “Gisted” out of existence in order to have the item from nature “read” on the whole claim.

    2. 3.2

      Because if you create X, and X is found in nature, you don’t get to claim X, even though you made X.

      “Nature” doesn’t happen overnight. It’s not like: “I invented this composition six months ago, and evolution just happened to swoop in and reinvent it after I did.”

      Can you explain any conceivable situation where the 101 rejection of a “natural composition” is not covered – more directly – by 102? How is 101 not purely redundant in this class of cases?

      1. 3.2.1

        “Nature” may not happen overnight, but it DOES happen and the universe is NOT static; this very much means that nature does (not “may,” but “does”) change overnight. It may not have been last night, but there is a point of time that change occurs.

        Note as well that this may be the exception that proves the rule as far as 101 time impacts being one of decreasing the sphere of eligibility (albeit a decrease in neither statutory category nor Useful Arts; one of pure “exception” nature [pun intended]).

        Further note (as has been remarked), ALL patenting of any such affected innovation is not foreclosed, as the man “made” method may be patent able — and certainly is patent eligible.

        1. 3.2.1.1

          “Nature” may not happen overnight, but it DOES happen and the universe is NOT static; this very much means that nature does (not “may,” but “does”) change overnight. It may not have been last night, but there is a point of time that change occurs.

          Well, you’re correct in the tautological sense that every physical material had a threshold moment between when it didn’t first exist and when it did.

          But the time scales matter here. Evolution occurs over the course of millions and even billions of years. The odds of that moment of creation for a useful protein occurring within the five-year window of patent prosecution are so vanishingly small as to not be worth discussing.

          1. 3.2.1.1.1

            Not so.

            Yes on the larger scale, changes (plural) happen over huge amounts of time. But that matters not at all for the principle that AN actual change must happen at a pin-point of time.

            You do not have the power to declare that for “your” item, that the universe must obey some notion of unchangingness for your specific timeframe. The odds simply are immaterial to whether or not a change happened. To think otherwise is to force that “unchanging” nature “just because.”

            That is just not reality.

            1. 3.2.1.1.1.1

              (That is far more then merely “tautological.”)

            2. 3.2.1.1.1.2

              anon: Well, then, I’ll ask the inverse question I’ve had up my sleeve for most of this discussion.

              You invent a completely novel protein. Let’s say it’s literally from scratch – you imagined the kind of binding you wanted, and using some genius-level biochemistry intuition (maybe assisted by some automated tools), you come up with a novel protein with fantastic properties to bind to radioactive elements. Then you develop a way to manufacture it.

              You apply for a patent application, claiming both the novel protein and its method of manufacture. Examination is stalled for about four years.

              Two years after your filing date, a horrible industrial accident occurs in some part of the world that contaminates animals with high doses of radioactive pollution. Wildlife is damaged and induced to mutate. One of the animals, miraculously, mutates to generate the exact same protein, which its body uses to flush radioactive proteins from its system.

              The examiner reviews your patent application and finds no basis for a prior art rejection, and allows all claims to the method of manufacture. However, the examiner now rejects the composition claims under § 101… because your composition now exists in nature.

              Valid rejection?

              1. 3.2.1.1.1.2.1

                The great legal answer:

                That depends.

                Can the mutation be causally linked to “man’s hand;” that is, even though an accident, is it considered a man made process that generated the mutation or not.

                Chances are with your hypo, this would be classified as a “hand of man” process.

                Different hypo – with different result: see my post elsewhere re: Nebraska (that post may yet still be stuck in the ‘do not have a dialogue’ count filter).

                Basically, I provided a similar situation but had the premise that it was a purely natural event that yielded the exact same work of man.

                Technically speaking then, the granted patent immediately evaporated based on the judicial exception (I DID note that this effect was NOT related to either of the two Congressional portions of 101: statutory category or utility under the Useful Arts).

                Is this a less than satisfactory “answer?”

                Sure. But it was not me that causes this dissatisfaction and I suggest that you put any blame that you may feel squarely with the entity that such blame belongs to: the Supreme Court.

                1. anon: Where is “man’s hand” in this hypothetical? If it’s the industrial-accident bit – then let’s change it:

                  Presume that the mutation is caused by a highly radioactive meteorite, which (according to NASA records) crashed to Earth during the pendency of the patent application.

                  I don’t see your “Nebraska” hypothetical; I presume it’s a casualty of the filter.

                2. It is – and the second half of my post above gives the answer to your revised hypo (which matches my earlier but unpublished hypo).

                3. I provided a similar situation but had the premise that it was a purely natural event that yielded the exact same work of man.

                  Technically speaking then, the granted patent immediately evaporated based on the judicial exception.

                  I presume you’re suggesting that the “purely natural event” occurred after the filing of the application.

                  I believe that your conclusion really begs the question. In the unlikely event that it is ever litigated, I assert that “naturally occurring products” would be clarified to mean: “naturally occurring at the time of filing.”

                  Consider this. If you filed an application, today, with claims including as one step: “encoding the video stream in realtime with an MPEG-2 decoder,” an examiner would nod his/her head and say, “okay, I get that.”

                  If you were to file that same application 20 years ago, the examiner would say: “How in the world do you do that? This claim has a serious enablement issue.”

                  And if a patent with that claim that was allowed in 1998 and was subjected to reexamination today, the PTAB may well invalidate it on the basis of lack of enablement according to its filing date.

                  Nothing in 35 USC § 112(a) requires the standard of enablement to be judged by the state of the art at the time of filing, but it’s an obvious and implicit requirement. I submit to you that it’s the same for 101: the requisite tests are applied in the context of the moment of filing.

                4. David,

                  Your attempted assertion would not wash — precisely because 101 is not written as a time-dependent impact law.

                  There is no “begging the question,” as there is no place for time dependency IN the question.

                  And please, do not kick up dust with enablement. That is yet another different section of the law. Your attempted reach is dismal as enablement IS specific to time of filing (through 112). No such reach exists for 101.

                5. (by the way, THIS is a critical difference between eligibility and ability — as my first post to you indicated, you may not have enough appreciation of that difference)

                6. anon, you concede that 112 has a “specific to the time of filing” component, right?

                  I agree. And my point is that the text of 112 contains absolutely no such reference:

                  (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

                  (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. (etc.)

                  Q.E.D.: If 112 can have an “at the time of filing” qualification that is implied and not stated, so can 101 – viz-a-vis: “naturally occurring at the time of filing.” The fact that 101 is not “written” this way is obviously not dispositive.

      2. 3.2.2

        Can you explain any conceivable situation where the 101 rejection of a “natural composition” is not covered – more directly – by 102? How is 101 not purely redundant in this class of cases?

        Yeah there was a case on it – an isolated DNA sequence. The sequence appeared in nature but in a non-isolated form, therefore it wasn’t anticipated but it was existing in nature. The case wasn’t too long ago either.

        1. 3.2.2.1

          On a broader level, since you think the court is just making this up for fun, do you think the attorneys for a given side are just throwing their client’s money around? The BRCA patent was extremely valuable, and every day it remained in effect was a loss of a huge amount of money. You think the challenging parties decided to go through a series of appeals up to the Supreme Court when they could have just cited a well-known anticipatory reference? You think the office missed a 102 on a claim that was a sequence ID + the word isolating?

          1. 3.2.2.1.1

            Once again, “isolated” is a product-by-process limitation. It is bog-ordinary law that product by process limitations carry patentable weight only when they impart a structural difference on the claimed product relative to the allegedly anticipating prior art product. In this case, the process limitation (isolate) does impart a structural difference. Ass’n for Mol. Path. v. USPTO, 653 F.3d 1329, 1362 (Fed. Cir. 2011) (“Despite many similarities, it is impossible to find the isolated T-C structure in the A-T-C-G-T molecule. This is because, instead of being connected to a phosphate, the C subunit terminates in a different functional group, a hydroxyl.”). Therefore, an anticipation rejection would not have been sustainable here.

            1. 3.2.2.1.1.1

              For all the “talk” about structural differences, such were simply not important to the Court and those were gisted away.

              Who cares if Congress set forth someone other than the Court to determine what the invention is, the Court “knows better” and is not about to be “f001ed” by damm scriviners (as they themselves scrivin some of the most heinous “interpreted” wink-wink Law from the Bench.

              1. 3.2.2.1.1.1.1

                For all the “talk” about structural differences, such were simply not important to the Court and those were gisted away.

                No, they weren’t. Gisting is ignoring the difference. The opinion squarely considers the difference and found it ineffective and insufficient to confirm significantly more.

                There’s nothing shocking about this. If the prior art is element A and another part is element B, a finding that a claim to AB is obvious because there is a motivation to combine isn’t “gisting away” the separateness of the prior art. It is confronting the distinction and providing a rationale as to why it doesn’t meet the standard for patentability.

                1. Random,

                  Can you get anything correct?

                  Your sense of “considering” when coupled with the undefined “substantially more” is nothing BUT “not important and gisted away.”

                  You clearly do not understand what Gisting means.

            2. 3.2.2.1.1.2

              [A]n anticipation rejection would not have been sustainable here.

              Whoops. That is not as clear as it should be. An anticipation would not have been sustainable in Myriad.

            3. 3.2.2.1.1.3

              Once again, “isolated” is a product-by-process limitation.

              But “once again” one of two things is true – either a) the patentee, the office and a bunch of interested defendants all missed the fact that people had BRCA1 and 2 genes prior to the filing of a claim for isolating that gene, which is clear anticipation or b) your analysis is flawed.

              I would suggest to you that your analysis is flawed, but let’s assume that’s not the case. (The true answer is that isolated DNA is not the same structure as non-isolated DNA, and there was no obvious motivation to isolate that particular segment, so prior art doesn’t solve the issue, but let’s ignore that) If the patentee files a claim where he says “We know people have this gene before, because we did testing and that gene correllates with a higher chance of breast cancer”, and then the office submits no 102 on it, and then the patent exists for years, and then other people wishing to perform the same isolation don’t bring up the prior existence either, isn’t that kind of strong evidence that we would need 101 to correct the issue? Let’s assume you’re right – that 102 would have solved it. Did 102 solve it? No. So either all of these parties are just terribly terribly unintelligent on 102, in which case it sounds like we need 101, or 102 wasn’t a good vehicle for solving it, in which case we need 101.

              1. 3.2.2.1.1.3.1

                Whoops, I started responding before I finished your paragraph. So we’re in agreement – when David says there’s no situation where 101 would fix a wrong that 102 lets slide, you agree with me that there is such a case where 101 solves something 102 doesn’t

                1. You assume the conclusion that something NEEDS to be “solved” by 101.

                  You are celebrating the broken scoreboard.

                2. I have a better reply trapped in the filter, but “yes,” I am agreeing with your conclusion that § 101 is not always co-extensive with § 102 in these sorts of cases.

                3. Random, look at the holding in AMP v. Myriad:

                  “A naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated, but cDNA is patent-eligible because it is not naturally occurring.”

                  The Court recognized that the Federal Circuit judges reached a variety of opinions about the distinction between isolated DNA and regular DNA. Here’s what the Court wrote:

                  “Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation f a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”

                  You want to read AMP v. Myriad as holding that the chemical alteration is immaterial. On the contrary, the holding critically turned on the fact that the claims do not require the alterations induced by isolation. The claims are invalid under § 101 because they encompass un-isolated and naturally occurring DNA.

                  This is, in fact, exactly the same rationale as would occur to reject the claims as anticipated under § 102. Hence, my arguments in this thread.

                4. By that rationale, the fact that Morse claimed sending information using “electromagnetism” should also be patent-eligible, right? Because “electromagnetism” is a specific concept, and anybody should be able to figure out whether an allegedly infringing technique does or does not use “electromagnetism” to send signals.

                  Er, no. I must not have been sufficiently clear, because I was making a novelty argument, and you are responding as if I were making an indefiniteness argument.

                  A few points to (hopefully) clarify:

                  (1) If the set of end groups really were infinite, that would be a problem, but not a subject matter eligibility problem. The spec does not enable appending a Np atom on the end, so if the claim really were construed to read on a 5′-Np, that would be an enablement problem. In other words, I am not arguing that “isolated” solves all problems; just that is solves the specific product-by-process anticipation problem at issue here.

                  (2) In order for Myriad’s claimed “isolated” nucleotide to be novel over pre-existing nucleotides that everyone acknowledges to have the same base code sequence, there must be some structural difference imparted by the act of isolation. My point is that there is such a difference (5′ and 3′ hydroxyls instead of phosphodiester bonds). By contrast, Morse’s galvanic current was not some different galvanic current than the pre-existing natural galvanic current. It was exactly the same galvanic current as had long since publicly flown through lightning rods. Therefore, the analogy to Morse is inapposite.

              2. 3.2.2.1.1.3.2

                You might want to re-read my post. I am agreeing with you. Section 102 does not “solve” the case at issue in Myriad*. The Myriad claims fall on § 101 or not at all (actually, some of them should have fallen for indefiniteness, but not all). In other words, unlike the Bhagat claims at issue in the original post above, the Court needed to confront the § 101 issue with the Myriad claims.

                * From my perspective, there was no “problem” to solve in Myriad, except the problem of some infringers infringing Myriad’s legitimate patent rights. The Court got this one wrong (as usual when it takes patent cases).

                1. Greg, that is not correct.

                  Please see my post right above yours about the actual holding in Myriad.

                  The reason that the Myriad Court found the claims invalid under § 101 was because the claims were not specifically limited to chemically-altered isolated DNA: they also encompassed un-altered, non-isolated BRCA1/BRCA2 sequences as they exist in nature.

                  Those same claims could have been rejected under § 102 using identical rationale: the genus includes at least one variation that is indisutably non-novel.

                  Conversely, the point that you believe that the Myriad holding asserts – that a claim that is indisputably limited to chemically-altered DNA could still be rejected under § 101 – the Court explicitly refused to rule on, as per the last paragraph of the opinion.

                2. The reason that the Myriad Court found the claims invalid under § 101 was because the claims were not specifically limited to chemically-altered isolated DNA…

                  Uh huh. I admire your effort to rescue the Court’s dog of an opinion from its worst excesses, but go back and re-read the earlier part of Justice Thomas’ opinion. The opinion (133 S. Ct. 2107, 2113) quotes Claim 1 by saying “[t]he first claim asserts a patent on ‘[a]n isolated DNA coding for a BRCA1 polypeptide…'” (emphasis added). I do not know how one is to maintain with a straight face that a claim that recites “isolated” is not limited to “isolated” DNA. The only fair reading of the opinion as a whole is not that the Court considered the claim to read on unisolated DNA, but rather that the Court did not consider that such a limitation (such a routine and conventional limitation) makes a difference in the §101 context.

                  I suppose that one can imagine that they would have also considered that the limitation does not make a difference in the §102 context. Honestly, the Court’s approach to patent law in general (not just §101) is so untethered to either statute or precedent that it would not surprise me if they were to take such an approach.

                  If so, this sustains your thesis, but only in the worst possible sense. You are arguing that one need not bother with §101 in these natural product cases, because §102 should always get one to the same outcome, but by a more clean process. However, as we can see in the above, the Court could only get to where it got here by “gisting” away a limitation. If you mean to say that they are free to “gist” away the routine and conventional in §102 just as they do with §101, this strikes me as cold comfort.

                3. In Myriad SCOTUS found cDNA to be patent eligible, regardless of sequence being dictated by nature. PERIOD.

                  It would take too long to educate. Sorry, I cannot spend so much time on this.

                4. Ice Cold indeed,

                  As I noted above, the Court applied their “Gist/Abstract” sword.

                  Yes, the claim term “isolated” impacts the meaning of the claim is not something that should have been Gisted away.

                  But this IS the Supreme Court that we are talking about…

                5. I admire your effort to rescue the Court’s dog of an opinion from its worst excesses…

                  Eh, I don’t really have a dog in this race. I studied a bunch of chemistry in undergrad, and vowed never to touch it again. I don’t have an agenda; I’m just reading the opinion.

                  The opinion (133 S. Ct. 2107, 2113) quotes Claim 1 by saying “[t]he first claim asserts a patent on ‘[a]n isolated DNA coding for a BRCA1 polypeptide…’” (emphasis added). I do not know how one is to maintain with a straight face that a claim that recites “isolated” is not limited to “isolated” DNA.

                  I see that part, and my point still stands, for the following reason.

                  “Isolated” is an extremely open-ended adjective. It does not connote any particular structural change. It literally just means: Separated from other genes in the same DNA strand.

                  Yes, there’s got to be some kind of chemical change to make that happen. But there are two problems here:

                  1) The range of chemical changes that substitute for the bonds connecting the “isolated” DNA is literally infinite.

                  2) How “isolated” is “isolated,” anyway? “Isolated” does not even indicate where, in the sequence, the gene is spliced away from others. Does “isolated” mean zero nucleotides beyond those encoding the gene? Is one nucleotide okay? Two? Ten? Is it “isolated” if you literally remove one nucleotide from the end of that chromosome?

                  I don’t mean to be picky; I think that this is a legitimate question. During transcription into a protein, certain structural features of the DNA cause it to be spliced apart from the adjacent DNA sequences. So it certainly wouldn’t be fatal to the “isolation” to leave some nucleotides on either side of it. “Isolated” BRCA1/2 may be structurally almost identical to BRCA1/2.

                  This is why the opinion asserts that the claim is not limited to any particular chemical composition. The opinion goes on to infer that this expansiveness was deliberate by the patentee. (I don’t know whether that inference is correct or even fair, but it doesn’t matter: the Court’s interpretation of the claim is legitimate.)

                  The only fair reading of the opinion as a whole is not that the Court considered the claim to read on unisolated DNA, but rather that the Court did not consider that such a limitation (such a routine and conventional limitation) makes a difference in the §101 context.

                  That’s just incorrect.

                  First: As per the last paragraph of the opinion, the Court expressly declined to express any opinion about “such limitations,” writ broadly.

                  Second: Even despite that last paragraph, the Court implied that claims reciting the “isolation” as a specific chemical change are likely patent-eligible. It went out of its way to observe that the chemical changes that DNA isolation may require are not in the claim. It would be odd to have done so if that aspect of the claims wasn’t dispositive, or even relevant, in the § 101 inquiry.

                6. [T]here are two problems here:

                  1) The range of chemical changes that substitute for the bonds connecting the “isolated” DNA is literally infinite.

                  2) How “isolated” is “isolated,” anyway? “Isolated” does not even indicate where, in the sequence, the gene is spliced away from others. Does “isolated” mean zero nucleotides beyond those encoding the gene? Is one nucleotide okay? Two? Ten? Is it “isolated” if you literally remove one nucleotide from the end of that chromosome?

                  How are either of these “problems” for purposes of the present question?

                  (1) I am skeptical that the range is “infinite” or even very large. Just because you can imagine appending a uranium atom to the broken end of the sequence does not actually mean that the reaction is achievable in empirical practice.

                  Let us imagine, however, that the range really is infinite. How does that affect the outcome of the patentability analysis here. Even if there are an infinite number of options that are not the naturally occurring chemistry, so long as the word “isolated” excludes the naturally occurring chemistry (and, ex hypothesi, that is what “isolated” achieves), then we are still talking about not-a-natural-molecule.

                  (2) Why should it matter that there can be 1000 extra (naturally occurring) base pairs on either side of the claimed SEQ ID NO:1? What matters is that at the 5′ and 3′ ends stands at least one atom that is not there in the naturally occurring sequence. The 5′ and 3′ ends must necessarily be non-natural in order for the sequence to be “isolated,” and that non-natural bit should be good enough to avoid a § 102 problem.*

                  * To my mind it should be good enough to avoid the § 101 problem as well, but—for better or worse—I am not a justice of the Supreme Court.

                7. Let us imagine, however, that the range really is infinite. … Even if there are an infinite number of options that are not the naturally occurring chemistry, so long as the word “isolated” excludes the naturally occurring chemistry (and, ex hypothesi, that is what “isolated” achieves), then we are still talking about not-a-natural-molecule.

                  By that rationale, the fact that Morse claimed sending information using “electromagnetism” should also be patent-eligible, right? Because “electromagnetism” is a specific concept, and anybody should be able to figure out whether an allegedly infringing technique does or does not use “electromagnetism” to send signals.

                  § 112 requires “particularly pointing out and distinctly claiming” the invention, which is not satisfied by claims with ambiguous terms that require speculation and guesswork over just how far the claims extend.

                  Biochemists have been “isolating” DNA sequences since before they knew it was DNA. Arguably, simple cross-breeding of plant strains to select for certain genes (such as BRCA1) and to exclude other genes on the same chromosome leads to an “isolated” gene. Hundreds or thousands of “isolation” techniques must exist- producing hundreds to thousands of different structural variations of DNA resulting from such “isolation.” Do you imagine it fair to recite the use of any and all of them in a claim to a specific (naturally-occurring) DNA sequence merely by stapling on the term: “isolated?”

                  What if someone took a naturally occurring chemical composition – for instance, cinnamaldehyde, the naturally occurring chemical that is responsible for the odor and scent of cinnamon – and claimed any variant that was “altered,” using any chemical process whatsoever? Surely any chemist can determine whether an accused chemical has been “altered” from its natural state, yes?

                  If “altered” is too broad – how about “purified,” or “clarified,” or “filtered,” or “enriched,” or “preserved,” etc.? Which single adjectives are fair game for stapling onto the description of a naturally occurring product to garner patent-eligibility to capture an entire range of variants, produced by any process whatsoever?

                  How does that affect the outcome of the patentability analysis here.

                  Well, regrettably, modern “patentability analysis” is a hodgepodge of distinct concepts and requirements: conventionality, novelty, “abstractness” vs. application and implementation, etc.

                  Mayo involved preemption, in the same vein as O’Reilly v. Morse. This is clear from the parts I quoted above, to wit: “The patentee asserts that the composition claims are limited to compositions with specific structural features arising from the isolation – but the claims are not limited, and we believe that this was deliberate.” That’s the answer, as far as I’m concerned.

                  The 5′ and 3′ ends must necessarily be non-natural in order for the sequence to be “isolated,” and that non-natural bit should be good enough to avoid a § 102 problem.

                  First, note that the claims do not require “isolated at both ends.” Is it “isolated” if it is spliced only at one end? I suspect, as did the Court, that the patentee intended to leave that question open, so that the patentee could assert either answer as the circumstances may require.

                  Second, I think that you even read § 102 far too narrowly. Merely colorable, inconsequential changes are not enough to distinguish a claimed structure of any type from a preexisting structure. An argument that any change from the sequence renders it “non-natural” and thus not anticipated by the “natural” sequence is… well, not an argument that I would recommend in any imaginable circumstance.

                8. Thanks, David. I believe that I understand better the point that you are trying to make, now. I cannot say that I agree, but it is interesting to read your perspective on how these two sections are supposed to work.

  32. 2

    Presumably no criticality or unexpected efficacy result for the specific % ratio of the two oils was demonstrated?

    1. 2.1

      [Not to mention that a claim to a “ratio of 4: 1 or greater” is open-ended and would cover 10,000,000 : 1.]

      1. 2.1.1

        Those are good points – which makes the Funk history lesson even more painful.

      2. 2.1.2

        Reading the full claim, is there not an upper limit constraint from other claim elements?

      3. 2.1.3

        What does that have to do with §101 or §102, that may be a §112 issue but it was not raised by the examiner because:

        There is no issue with open-ended ratio because the claim requires “dosage” if your “dosage” requirement is 15g of omega-6, then ratio could be 10,000,000:1 as long as the dosage is less than 15g, and it still works.

        1. 2.1.3.1

          While I may agree that conflation of 112 with 101 is highly NOT desired, the use of “open-ended” ranges is NOT as clear as you would want to make it, Enlightened.

          What about 10,000,000,000,000 to 1?

          (no matter the dosage size)

          What you end up with is effectively (at some point, right?) a zero gram dosage of one of the two. Do you show that you possess the utility of such an item? Would not such a situation resolve into only one of the two items? Would not then prior art items come to bear?

          I “get” that you may want to bank on the examiner not raising the item, but such would (and should) not provide solace, as you can be certain that such WILL be raised if you ever go to enforce your claim.

          1. 2.1.3.1.1

            NOPE! You are wrong, this point has been addressed in prosecution.

            And you have NOT done your math right. There are additional limitations in the claims besides the open-ended ratio. According to which the ratio cannot reach much much lower limits than what you are talking about.

            1. 2.1.3.1.1.1

              There are additional limitations in the claims besides the open-ended ratio. According to which the ratio cannot reach much much lower limits than what you are talking about.

              I indicated as much above (on September 7, at post 2.1.2).

              By the way, THIS is a more powerful argument.

              1. 2.1.3.1.1.1.1

                Thank you for your voice of reason. It is exasperating talking to walls.

                Open upper limit serves an important function, not only because claims are directed to dosage, but also because they accommodate for omega-6 and/or omega-3 in base diet.

  33. 1

    This is a whole new dimension of 101 absurdity.

    If the argument is that the composition occurred naturally in nature, shouldn’t the demonstration of that fact under 102 be (a) trivially easy to produce and (b) essential for proving the argument? Rather than just saying it’s so?

    The statement here under § 101 is: “You don’t get a patent because we’re sure your composition occurs somewhere in nature, and we will neither present evidence that it does nor consider your evidence that it doesn’t.”

    Given the sufficiency and directness of § 102 for this inquiry, what is the purpose of asserting § 101 here – if not a license to reject applications based on rank subjectivity?

    1. 1.1

      Funklesson from history not learned : repeat

      (and will need to be repeated again)

    2. 1.2

      Agreed. There’s no 101 issue here – “contained in one or more complementing casings providing controlled delivery of the formulation to a subject” isn’t found in nature; if it is, the PTO needs to show it. THEN it can shoot down the claim under 102 or 103. But this is just 101 run amok. Dennis’ question about whether or not oils are natural products is also a good one – olive oil isn’t just there, the olives need to be processed.

      Disappointingly, it was Judge Newman who wrote the panel opinion. She knows better. (slip opinion at link to cafc.uscourts.gov)

      I wonder if things would have gone differently had the inventor hired counsel, as she did for the cert petition, instead of acting pro se before the CAFC.

      1. 1.2.1

        Atari Man,

        You forgot to employ the “Gist/Abstract” sword to cleave those “scrivining” claim elements that just “hide what the cohorts are up to.”

      2. 1.2.2

        “[C]ontained in one or more complementing casings providing controlled delivery of the formulation to a subject” isn’t found in nature…

        Are you sure of that?

        Dennis’ question about whether or not oils are natural products is also a good one – olive oil isn’t just there, the olives need to be processed.

        See, this is why I disagree—both about the oil and the casing. When you eat an olive, you eat the oil therein. You see, one does not need to process the olive to have “[a] lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater…” That much is there naturally. Similarly, when you eat the olive, the oil does not just immediately sluice into your bloodstream. Rather, you must first digest the natural casings encoating that naturally occurring oil composition. I really do not see anything in this claim that necessarily excludes natural olives, the which have definitely been on sale in this country for more than one year.

        [I]f it is, the PTO needs to show it.

        Here I agree. How sure are we, however, that the PTO did not show it? The CAFC considered that there was substantial evidence to support the PTAB’s fact findings. I have not gone back to review the record, but it is not clear to me from the four corners of the CAFC opinion that the PTO simply neglected to adduce evidence that these claims read on natural olives or walnuts.

        [T]his is just 101 run amok.

        I do not like it when § 101 is invoked to do the work of § 102, but this is really one of the less egregious cases of § 101 insanity. If—as seems clear—these claims really do read on natural olives and natural walnuts, then it is not such a wild leap to reject them on § 101 grounds.

        1. 1.2.2.1

          Here I agree. How sure are we, however, that the PTO did not show it?

          Yes, that appears to be the case, which is why § 102 was also involved.

          My point is that § 101 is nothing but a distraction from the § 102 issue. They should, precisely and unequivocally, rise and fall together. There is no useful purpose to engage in this patent-eligibility navel-gazing exercise, about whether or not evidence is required if the product occurs in nature, when “the product occurs in nature” is demonstrable by evidence and fatal to novelty.

          1. 1.2.2.1.1

            They should, precisely and unequivocally, rise and fall together.

            Without being pedantic, exactly why “should” these rise and fall together?

            Note Greg’s 3.2.2.1.1 response above providing an instance where 102 would not have sufficed where 101 eliminated the patent.

            1. 1.2.2.1.1.1

              I agree with Greg: a product-by-process claim is allowable if – and only if – the product is structurally different from the composition is found in nature. It’s precisely the same question for the purpose of 101 and 102.

              If the olive oil extracted by this process is chemically the same as naturally occurring olive oil, then it should not be patentable (nor patent-eligible). If it is changed in a way that reflects a difference as compared with its manifestation in nature, then it should be patentable (and also patent-eligible).

              I don’t mean to gloss over any distinction in this conversation. It’s just that I don’t understand why anyone else perceives that such a distinction exists.

              1. 1.2.2.1.1.1.1

                Lack of any MCLE requirements for PTO registrants?

                1. I don’t know who you were referencing with that comment. But if you’re contesting my argument, then please review this (taken from MPEP § 2113):

                  “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.)

              2. 1.2.2.1.1.1.2

                If it is changed in a way that reflects a difference as compared with its manifestation in nature, then it should be patentable…

                Agreed, but with the further refinement that the patentee needs to trouble itself to specify that difference in the claim. I do not see any such difference actually specified in the claim quoted in the original post above, which is why I am not going to shed many tears for the cert. petitioner here when this petition is rejected.

              3. 1.2.2.1.1.1.3

                David,

                I am not certain that I am understanding your response, but if you are saying that you do not understand a) that these IS a distinction between patent eligible and patent able and b) that this distinction is important in patent law; then I would have to suggest that you are missing a huge — and critical — understanding of the law related to eligibility.

                My (non-pedantic) question to you has to do with your suggested “MUST” rise and fall together, which indicated to me that you may not understand that there IS a critical difference between “eligibility” and “ability.”

                1. Patent-eligibility looks at the invention and asks whether it is among the types of ideas for which patents are issued. Patentability, specifically under 102/103, compares the claimed invention with the prior art to ask whether a patent can be granted over what was already known.

                  Yes, of course there’s a distinction… in theory. My point is that the distinction vanishes in this subset of cases.

                  § 101 Step 1 is resolved by looking solely at the statutory class of the claim. Fair enough; it comports with the stated inquiry of § 101.

                  § 101 Step 2A is resolved by asking whether the invention is any of three types of categorically-excluded subject matter: Laws of nature, abstract ideas, and “natural phenomena.” The first two types can, again, be resolved by looking solely at the claim and deciding whether it meets that definition.

                  The third type, in turn, involves several subsets: “physical phenomena,” “scientific principles,” “natural laws,” and “products of nature.” The first three, again, can be resolved solely by looking at the claim. Let’s talk about the last one.

                  Consider a claim reciting a composition: a DNA sequence, a specific composition of chemicals, a polymer with a specific structure. How does one determine whether any such claim recites a “product of nature” solely by looking at the claim? What kinds of structure or wording of the claim can inform that inquiry?

                  My argument is that, in this particular case and unlike every other area noted above, this determination is made by comparing the claimed composition to what actually exists in nature. If it exists in nature (or is an obvious modification of same), then the composition is a “product of nature.” If not, then not. The End.

                  And that inquiry, in turn, requires evidence. A rejection that merely speculates that a particular composition could arise in nature is materially deficient. Every example provided by the courts begins with a description of where and how the claimed composition arises in nature. It’s a tacit but critical requirement of every example given by the MPEP:

                  i. isolated DNA (presuming the DNA naturally exists, its isolation does not render it patent-eligible; presumably if the DNA is novel and non-obvious, so is its isolation)

                  ii. a cloned farm animal such as a sheep” (presumably of naturally occurring farm animals; a brand-new animal created by science – let’s say – is patent-eligible, and so is its clone)

                  viii. single-stranded DNA fragments known as ‘primers'” (same as (i))

                  x. the existence of cell-free fetal DNA (cffDNA) in maternal blood” (presuming both the maternal blood and fetal DNA arose through the natural process of human pregnancy)

                  Hopefully my point is clear: the 101 inquiry in this case collapses into the very same inquiry as 102. The decisions rise and fall together.

                  The challenge I’ve presented remains open: Can anyone suggest a composition claim that is allowable under § 102/103 and yet not allowable under § 101 because it is a “product of nature?” And what is the basis for that decision, if it does not critically depend on evidence of what does and does not naturally occur in nature?

                2. My point is that the distinction vanishes in this subset of cases.

                  Again, not to be pedantic (and to be more nuanced), that is not the point that I am asking about.

                  I am asking about your use of “must.”

                  I “get” that you are thinking about evidence. And evidence of “a natural product” MAY be the presentation of an actual item, AND that you are PRESUMING that any such presented item “must” be an item that pre-exists the man-made item…

                  But this is where the unpublished “Nebraska” AND “you may not demand an unchanging universe” come into play to DENY that there is that type of “must.”

          2. 1.2.2.1.2

            My point is that § 101 is nothing but a distraction from the § 102 issue.

            I basically agree. There used to be an informal doctrine of § 101 avoidance (an appellate court should avoid the § 101 issue if the case can be just as well resolved on another statutory ground). That was a sane and salutary doctrine—one of many such sane and salutary doctrines trampled under Mayo‘s feet.

            1. 1.2.2.1.2.1

              …which points to the actual mechanism in play: judicial activism and writing (NOT interpreting) statutory patent law from the Bench in violation of the separation of powers.

              But it appears that certain sAme ones do not like the idea of telling the emperor that he has no clothes.

              Near as can tell, this “tendency” is being aided and abetted by some odd notion of feality and placing the Supreme Court above the Constitution (and above reproach).

              The larger issue is — still — the scoreboard is broken.

        2. 1.2.2.2

          I think that you glossed over the actual claimed casing limitations.

          Maybe you just gisted those away…

        3. 1.2.2.3

          When you eat an olive or olives, you do not eat dosage of omega-6 or omega-3. Do you know olives can have no omega-3, and olives can have 2-20% omega-6?

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