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.
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.
I have said before, lawyers should demonstrate sincerity and knowledge, unless their statements precede with “I am a novice learning patent law, please help me understand…” or the like. Although on this post several lawyers (assuming they are lawyers) do demonstrate knowledge and genuineness, but disturbingly enough don’t.
Therefore, it appears an academic session is necessary. Though I have said some of the following before, it is repeated because some people didn’t get it.
It was called to attention several times that novelty (§ 102) and obviousness (§ 103) have been legislated separately, for a REASON.
Anticipated (or not novel) means public has been informed sufficiently, that NO OTHER conclusion could be reached from the reference, and that a skilled person will ALWAYS reach the same conclusion. Each and every single element in the claims must be disclosed and enabled in the anticipatory prior art. On this post see 14.3.
“The anticipation analysis asks solely whether the prior art reference DISCLOSES AND ENABLES the claimed invention.” “Under the principles of inherency, if the prior art NECESSARILY FUNCTIONS in accordance with, OR includes, the CLAIM LIMITATIONS, it anticipates.” Perricone v. Medicis Pharm. Corp. 432 F.3d 1376 (Fed. Cir. 2005). (Emphasis added).
Obviousness (§103) is different. Among the reasons is that if there is a critical unsolved problem even though it may be obvious to some, then patent protection is granted to nurture that innovation. 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. On this post see 25, 23, 23.2-3, 23.5.1, 14.3, 9.2, 6.3.
The USPTO rational,
-many patent applicants claim omega-6 and omega-3, so we have to limit 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
§ 102 rejection was USPTO GAME. They excised “formulation”, “dosage of omega-6 and omega-3”, “one or more complementing casings providing controlled delivery of the formulation to a subject”, “intermixture of lipids from different sources” and rendered rest of the claim anticipated. Mind you there are OVER 30 CLAIMS that were similarly mutilated by USPTO.
Mind you there is PHOSITA testimony on record testifying to their interpretation of each of the claim terms, as asserted by the Applicant. On this post see 27.1.1, 26.2. It was said Broadest reasonable interpretation DOES NOT mean broadest POSSIBLE interpretation. On this post see 18, 15, 12.1.1.
Prior art at large including cited references teach the opposite of instant claims. “Mark”, “olives”, “Walnuts” neither disclose, nor enable the claimed limitations, and they do not necessarily function in accordance with the claims. Rather prior art, including the cited references teach the opposite. In this post see 23.3, 9.2.
The cited references themselves teach mixing foods top achieve lower n6/n3 ratios and amounts, see link to web.archive.org. In this post see 23.3.
Novelty has been fully rebutted. Read open letter, annotations on CAFC opinion, read the petition for en banc hearing. See link to asha-nutrition.com. On this post 25. Read other materials link to asha-nutrition.com. No need to repeat 100s of pages of arguments and evidence here.
Novelty is a GAME that USPTO played and people like you caved. There are NO novelty issues in this case. It is troubling that lawyers don’t understand that or intentionally overlook.
“The ultimate tragedy is not the oppression and cruelty by the bad people but the silence over that by the good people.”MLK.
much ado about nothing
The one you’d writ that you weren’t impersonating yourself
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 !
Chris Whewell,
We prefer to leave you guessing.
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…
Chris Whewell,
We prefer to leave you guessing.
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 ?
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!
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.
Claims are examined as a whole, not in parts.
heh-heh. Right ? Thanks for the merriment !
Out of mere curiosity, to what post was this one intended as a response?
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.
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.
PHOSITA have testified on record as their interpretation.
BRI does not mean BPI. Reasonable does not mean possible.
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.
You still have not read the Specification. We are not going to spend time educating you. Your help is NOT needed.
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.
“consideration of the community on this board.”
LOL – how does that work for you? For anyone?
“you are not my client and I am not offering you legal advice.”
We are fortunate!
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.
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
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.
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.
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.
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.
Then you are NOT a good attorney.
Any good attorney should know anticipating reference MUST function as claimed.
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.
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.
“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?
I had never previously appreciated how close is the link between enlightenment and willful ignorance.
“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.
My 23.1.5.1 was a thoughtless remark. I regret making it. My apologies.
“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.
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.
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.
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).
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.
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.
Exactly, “charlatans selling worthless nutraceutical” is a problem. Agreed. Fewer but stronger patents should be granted.
“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.
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.
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.
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.
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.”
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.
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?
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.
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.
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.
“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.
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.
Your statement is simply legal nonsense.
I “get” what” you want. How you want it is just not what that mechanism is for.
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.
Cert petition is the right forum for it.
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.
: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.
This is her patent, David.
Everything revolves around that.
Everything does not revolve around Bhagat patent, but that is the topic here so naturally we discuss Myriad in context of Bhagat patent.
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.
Broadest reasonable interpretation DOES NOT mean broadest POSSIBLE interpretation.
USPTO and FEDERAL CIRCUIT cannot excise REASONABLE from Broadest Reasonable interpretation.
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.
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.
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.
If you haven’t understood so far, then you have a mind unwilling to understand. We will conserve our energy.
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.
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.
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.