The invention here is a treatment claim — that is therefore patent eligible. 

by Dennis Crouch

The decision here is an important case adding substantial nuance to the product and law of nature exceptions.

Natural Alternatives Int’l. Inc. v. Creative Compounds, LLC (Fed. Cir. 2019)

Earlier this week I wrote about a separate Natural Alternatives reexamination appeal pending before the US Supreme Court on the issue of improper priority claims.

The case at hand focuses on patent eligibility.  Natural Alternatives sued Creative for infringing six of its patents covering various forms of the naturally-occurring compound beta-alanine and its use as a muscle-building supplement.  The district court dismissed the lawsuit on the pleadings for lack of eligibility — finding that the claims were directed toward a product of nature (beta-alanine) and a law of nature (that taking beta-alanine in sufficient quantities builds muscle).

On appeal the Federal Circuit has sided with the patentee.  In an opinion written by Judge Moore and joined by Judge Wallach, the court explained that we shouldn’t take the law-of-nature prohibition too far since “[w]e live in the natural world, and all inventions are constrained by the laws of nature.”

The decision here adds an important nuance to Vanda and CellzDirect.  In particular, the court explains that an important clue of eligibility for treatment claims is whether “homeostasis is overcome” in a way that leads to “specific physiological benefits.” This physiological impact tells us that the invention here is a treatment claim — that is therefore patent eligible.

The claims … they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits. These are treatment claims and as such they are patent eligible.

One element of this case that could be distinguished from ordinary treatment claims is that the purpose of taking beta-alanine is to alter the body’s operation away from normal whereas most drug treatments are in pursuit of normalcy.

The court considered the fact that beta-alanine occurs in nature and is very longstanding part of the human diet. In the end, however, the court found that the law “expressly permits patenting a new use of an existing product.”  Here, the patentee argues that “the quantities being administered” do not exist in nature.

At this point in the analysis, claim construction became important.  At the pleadings stage, the district court agreed to follow the patentee’s proposed construction that would require that the dosage “elevate beta-alanine above natural levels to cause an increase in the synthesis of beta-alanylhistidine in the tissue.”

Looking at the product claims, the following claim is perhaps the broadest:

1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

In similar fashion to the method claims, the district court followed the patentee’s claim construction that a “human dietary supplement” should be construed as excluding “natural or conventional food” that “is manufactured.”

Although the appellate court found the claims ineligible even under this construction, the appellate panel sided with the patentee — finding that the not-natural and manufacture construed limitations sufficient to take the patents outside of the law of nature and product of nature exceptions.

Although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine. A claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and “the potential for significant utility.” See Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

Judge Reyna wrote in dissent — arguing that the majority’s eligibility analysis relied upon a faulty claim construction “that improperly imports limitations into the claims and is contradicted by the written description.”

68 thoughts on “The invention here is a treatment claim — that is therefore patent eligible. 

  1. 8

    Wow – boy I didn’t expect this to get some many comments and responses…do some of you not have clients to do things for classes to teach? Man. Wish I had the time to argue here as it is great fun, but not what my clients pay me for. Still will try to go through all the new arguments and comment on the serious ones (so likely about 50% of the posts). Will be in one post though so I am not replying to thousands of different posts.

    Man – I really need to remember not to click the notify me of followup comments way to much of a time sink…

  2. 7

    Indeed, the record contains an expert declaration stating that “one 3.2 gram daily supplement of beta-alanine is the equivalent to eating at least 109 Big Macs per day.” J.A. 914.

    1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

    (Does some mathz)

    I am available for proof of anticipation.

    1. 7.1

      So the item within the range of 3.2 yields a Big Mac equivalent of 0.03 per sandwich.

      To reach the minimum of a very generous spread, you would have to eat more than 13 Big Macs each day.

      Do you really want to hold yourself out as an example of anticipation as if your obese habits would be considered anywhere close to what an ordinary person (even one skilled in the art of fast food consumption) would consume?

      Or maybe you just need to spend more time on your “mathz” skulls and less time on your anti-patent snark.

      1. 7.1.1

        Professional athletes and weightlifters have been taking protein and amino acid supplements for a long time. They don’t eat a lot of Big Macs because they’re filled with junk.

        1. 7.1.1.1

          That’s a cogent point, Malcolm – with several helpful aspects.

          1. 7.1.1.1.1

            Also cogent is the fact that many many many people have consumed the protein equivalent of 15 Big Macs in a day, including for the purpose of building muscle mass. Not that big of a deal.

            1. 7.1.1.1.1.1

              Cogent perhaps – but absolutely missing from what Random provides.

              In other words, your posts support my position.

              So thanks for that

      2. 7.1.2

        Do you really want to hold yourself out as an example of anticipation as if your obese habits would be considered anywhere close to what an ordinary person (even one skilled in the art of fast food consumption) would consume?

        Does anticipation care about what an ordinary person does or have anything to do with the art or ones skill therein?

        To reach the minimum of a very generous spread, you would have to eat more than 13 Big Macs each day.

        Although my joke seems to have gone over your head, you do bring up an important point.

        Is the claim a method claim that requires ingestion, or is the claim a composition claim that requires possessing a certain amount of something?

        Can someone eat 13 big macs that aren’t produced?

        I tried to respond to Les down below with this but I’m caught in the filter, so I’ll leave it to you to ask yourself: If someone could eat 13 big macs in a day, that means 13 big macs had to be made. Does the claim require selling 13 big macs and watching someone consume them? Or can the claim be anticipated by purchasing raw material which you would break up to put on 13 big macs?

        Food for thought.

        1. 7.1.2.1

          Merely “could” is clearly not enough for anticipation.

          Why are you an Examiner?

          1. 7.1.2.1.1

            … furthermore (and to show the inanity of your position), show me ANY patent claim EVER granted that does NOT violate a “could” provisio.

            If something violates the “could,” that something is in the same class as a perpetual energy machine.

  3. 6

    The quoted “statement” that “these are treatment claims and as such they are patent eligible” is plainly incorrect and shame on the CAFC for writing some so silly. Examples of “treatment” claims which are ineligible are easy to envision. One huge class would be method claims which recite only prior art treatment steps in addition to a new step of communicating or thinking a specified non-obvious thought during the course of the treatment.

    That’s an ineligible treatment claim. Why is this hard for judges and attorneys to understand?

    With regards to the specifics of this case, the eligibility issue with the composition claims is (if I have the facts straight) better understood as arising from the existence of the composition in the prior art (and not in nature). The eligibility issue is the attempt to patent the prior art composition (or an obvious variation of that prior art composition) as a composition by affixing to the description of the broadly claimed composition an intended use for it and/or a newly discovered property of the composition.

  4. 5

    ” … finding that the claims were directed toward a product of nature (beta-alanine) AND a law of nature (that taking beta-alanine in sufficient quantities builds muscle).”

    And yet another mistake by the Dist. Ct. — alleging not the SCOTUS-required ONE eligibility exception, but instead TWO alleged exceptions.

    Such multiple alleged exceptions directed against claims — common during examination and among all judicial fora — are an epidemic pox on innovation.

    Stop letting folks get away with this nonsense — call them on it.

    1. 5.1

      Eh? If evidence for more than one exists shouldn’t they deal with both at the same time for judicial economy? Certainly the patent office presents everything it has evidence for at once – and should. I don’t see anything in the Supreme Court cases that makes this improper. Yes you don’t have to do it, but that is very different than not being allowed to do it.

      1. 5.1.1

        “If evidence for more than one exists shouldn’t they deal with both at the same time for judicial economy?”

        Respectfully Daniel, the answer to your question is no; because that’s not the proper SCOTUS-decreed Mayo/Alice analysis (and as a related side point, if SCOTUS cared about judicial economy, they wouldn’t have made believe they were Congress when they made new law — and make no mistake, it was new law — with their unconstitutional Mayo and Alice decisions):

        “We hold that the claims at issue are drawn to the abstract
        idea of intermediated settlement …” Alice at 2352

        “First, we determine whether the claims at issue are directed to
        one of those patent-ineligible concepts.” Alice at 2355

        “We must first determine whether the claims at issue are
        directed to a patent-ineligible concept.” Alice at 2355

        “The claims at issue in Bilski described a method for hedging against
        the financial risk of price fluctuations.” Alice at 2355

        “It follows from our prior cases, and Bilski in particular, that the claims
        at issue here are directed to an abstract idea.” Alice at 2356

        “Because the claims at issue are directed to the abstract idea
        of intermediated settlement …”Alice at 2357

        “First, we determine whether the claims at issue are directed
        to one of those patent-ineligible concepts.” Mayo at 1296-1297

        Make no mistake — the difference and distinction between one and who knows how many concepts is a critical Mayo / Alice analytical factor indeed. Arguably the most important factor.

        Parties – including the Patent Office and the Courts – trying to deal with multiple-abstract-concept assertions – going against the Supreme Court’s express dictate and directive when they do so — would quickly find themselves mired in a due-process-denying (and unconstitutional) factual and legal morass.

        Swallowing all of patent law in the process.

        If not just one, how about two concepts directed to the claims at issue being acceptable (which is what the Dist. Ct. did in the instant case)? Would three concepts be O.K.? What about four? Five? Ten? Or how about one concept for each claim? Two for each claim? Three? Four? Five? Ten?

        Where would such patent madness end?

        All of patent law would indeed be swallowed.

        Which; as we all know; is exactly what’s been happening.

        There’s no confusion here. No subjectivity. No uncertainty. No gray area. No interpretation.

        The Supreme Court said what it means and means what it says:

        One abstract idea. All the claims at issue. One can’t be identified?

        Then the claims are §101 eligible. The Alice / Mayo analysis stops there. Step two is moot.

        Simple as that.

        If any court, the patent office, or infringer can’t come up with one and only one alleged eligibility exception, the Mayo / Alice / 101 analysis is done. Over. Finished.

        All the claims are 101 eligible.

        It’s frankly startling how many attorneys and law firms are letting themselves and their clients be bamboozled and hoodwinked by these multiple alleged eligibility exceptions.

        Stop it.

      2. 5.1.2

        DC,

        While I do not agree (per se) with what Pro Say is saying, his view is actually more than a little reflected in the comments to the eligibility protocol submitted by none other than Dave Boundy.

        Boundy reflects that each asserted “abstract idea” cannot be assembled in some “piecemeal” way — or conflated manner — which in essence really just reflects a “typical” attempt to parse and treat elements all alone under the 101 requirement as opposed to treating the claim as a whole.

        Boundy is somewhat different in that he does allow a review of multiple different “Abstract Ideas.”

        However, even with his view, EACH “abstract idea” must be treated with “inte11ectual honesty” in that for EACH, the examination is not only separate, but that in the new protocol, all aspects outside of the recited “abstract idea” are provided weight (even if some of those items would fall to a separate analysis).

        As with the Berkheimer Memorandum, it is NOT to be lost that often the aspect of “claim as a whole” is critical.

        1. 5.1.2.1

          EACH “abstract idea” must be treated with “inte11ectual honesty” in that for EACH, the examination is not only separate, but that in the new protocol, all aspects outside of the recited “abstract idea” are provided weight (even if some of those items would fall to a separate analysis).

          If (and emphasis on the “if”) Boundy is suggesting that combining multiple non-obvious ineligible abstractions can impart eligibility to a claim (without more), then Boundy is surely incorrect.

          I suspect that he is not saying that, but it’s not clear from the description given here that he is not saying that.

          Regardless of what Boundy is saying, the most significant fact at the end of the day is whether there is a recitation in the claim of a non-obvious structure (in structural terms) or a step that results in a non-obvious transformation of matter. That’s never ever going to change.

          1. 5.1.2.1.1

            of a non-obvious structure (in structural terms)

            Yet again, Malcolm surfaces with his canard of wanting an optional claim format to be (somehow) NOT optional…

            You do get that what you want is simply not required under the law, right?

          2. 5.1.2.1.2

            Directly from Boundy:

            A “focus” for Step One must:
            • be based on a focused idea—Step One may not designate multiple bits of a claim that are unrelated to each other. If the examiner believes that more than one Step One abstract idea is present, then the examiner must set forth a complete § 101 analysis (with both steps), separately, for each such abstract idea.
            • consider each word of the claim language. Examiners are not permitted to reduce claims to stock phrases such as “obtaining, classifying, and displaying information.” Claim interconnections must be given the same consideration as nouns.
            If an applicant designates a “focus” for step 1, the examiner may decline to accept the applicant’s designation if it has no such support. An examiner may not otherwise substitute the examiner’s own judgment or choice for the “directed to” concept for Step One.
            Examination Guidance should expressly address situations in which an examiner believes that multiple distinct “abstract ideas” exist in a claim by requiring (a) that each “abstract idea” be independently identified, and (b) that for each such “abstract idea,” all other claim elements shall be regarded as the “remainder” of the claim for purposes of Step Two analysis. Examination guidance should required that Steps One and Two must be repeated for each “abstract idea.”

            1. 5.1.2.1.2.1

              If the examiner believes that more than one Step One abstract idea is present, then the examiner must set forth a complete § 101 analysis (with both steps), separately, for each such abstract idea.

              And what? I mean lets assume that the first analysis ends with ineligible and the second ends with eligible. Is the claim eligible or not?

              I discover e=mc^2. I claim a machine that calculates e=mc^2 and acceleration. For the first analysis it is directed to a law of nature (e=mc^2) and does not contain significantly more (a calculator and known acceleration). Ineligible. For the second analysis it is directed to a law of nature (acceleration) and contains significantly more (e=mc^2 is unconventional). Eligible. What’s the outcome?

              I claim a system comprising a book and an abstract story in it. Ineligible because book is conventional. I claim a system comprising a book and a first abstract chapter and a second abstract chapter. Both ineligibility analysis fail because the alternate chapter is unconventional at step two. Eligible. Well that doesn’t seem right, now does it?

              That’s ignoring the fact that that’s simply not the procedure in any case that expressed multiple ineligible subject matters.

              consider each word of the claim language.

              As always, considering each word does not mean you give the same weight to each word. This has been true for nonfunctional printed material in 103 analysis for years and has been true for preambles for as long as there have been non-Jepson claims.

              Examiners are not permitted to reduce claims to stock phrases such as “obtaining, classifying, and displaying information.”

              Why not, that’s what EPG did? You’ll be happy to know that what this really wants us to do is “Don’t apply at Alice at all” and per the new guidance, you have gotten your wish. Of course, that won’t make your claim any more valid when it gets to the courts, as they won’t stop applying EPG just because you don’t like it, it just means you paid me a lot of money to not do part of my job for you.

              Boundy appears to forget the iron law of examining – I simply don’t care whether your claims get allowed or not. In fact, if they get allowed its less paperwork for me. Creating a system where I don’t examine according to the law just means you’re paying me to rubber stamp legally worthless subject matter, which (so long as all parties involved including my employer agree) is completely fine by me.

              If an applicant designates a “focus” for step 1, the examiner may decline to accept the applicant’s designation if it has no such support. An examiner may not otherwise substitute the examiner’s own judgment or choice for the “directed to” concept for Step One.

              Hahaha. Why stop at 101? Why not “If an Applicant designates a combination non-obvious, the Examiner may decline if it has no support, but may not otherwise substitute the examiner’s own judgement.” Even better – you come sit at my desk and type up my papers and I’ll just sign them and collect my check.

              Why not ask the defendant if he thinks he should go to jail?

              Examination Guidance should expressly address situations in which an examiner believes that multiple distinct “abstract ideas” exist in a claim by requiring (a) that each “abstract idea” be independently identified,

              Already done

              and (b) that for each such “abstract idea,” all other claim elements shall be regarded as the “remainder” of the claim for purposes of Step Two analysis.

              Is this still the compound abstract idea thing? Or is he saying that for compact prosecution we should do multiple 101 rejections for all abstractions it could be?

              As long as we’re wishing upon a star, I have a few for the practicioners:

              1) For each element, the claim will include a citation to which paragraphs if the specification provide a technical teaching sufficiently detailed to make and use the feature or otherwise state on the record that no detailed teaching is necessary because the element is conventionally known to the art

              2) With each amendment, Applicant will provide a theory as to why the claimed subject matter is non-obvious. The theory “may not designate multiple bits of a claim that are unrelated to each other” and must explain what advancement one of skill in the art has learned over the the sum of all cited prior art.

              3) When Applicant alleges the prior art does not teach an element, Applicant will point to where in his specification there is a technical teaching sufficiently detailed to make the feature or consent to waive a new rejection challenge to a newly made enablement rejection.

              4) During any first interview, Applicant will be able to answer the questions “Without looking at the claims, please tell me what you believe your invention is” and “Give me one concrete embodiment of the claim language.”

              5) When a 112f determination is made, Applicant may “decline to accept the examiner’s designation if it has no such support” in the specification by pointing to a definition that explicitly invokes/does not invoke 112f in the specification. “An applicant may not otherwise substitute the applicant’s own judgment or choice” for the examiner’s claim construction.

              6) Applicant may not request continued examination a fourth time without first appealing one of the previous seven appealable actions.

              7) Applicant will stop trying afcp 2.0s.

              8) For any IDS filing of more than one full page of references, Applicant will include a key indicating any portions of the references are believed to possibly be relevant to which features of the claims.

              Hey these wish lists are fun!

              1. 5.1.2.1.2.1.1

                Your wish list is more of an indictment against you than you (clearly) realize.

                You indicate desire for things that are either NOT the law, show a confusion on “conventionality,” or seek to make the applicant do YOUR job.

                It is downright scary to think that you are an Examiner in real life.

                1. You indicate desire for things that are either NOT the law, show a confusion on “conventionality,” or seek to make the applicant do YOUR job.

                  Oh I thought that’s what me and Boundy were doing?

        2. 5.1.2.2

          I think Pro Say that you are putting to much emphasis on the use of the word one in those excreted quotes. The case as a whole certainly doesn’t limit to finding more than one and presenting both at the same time separately. Yes each has to be treated as a new case a new test, but if a natural law and an abstract idea are implicated in the claims I don’t see a reason why an office action or the court should not deal with both at once.

          Yes this would lead to lots of factual questions long cases but *shrug* this is better than having two separate cases which is what you would have under your suggestion.

          As for the larger question of the Supreme Court making law – welcome to what we in the Federalist society have been warning about since um….before I was born? At least since the wheat case in the 1930s the Supreme Court has been making law rather than interpreting the constitution.

          Still – the historical cases they used as precedent do fit with their interpretation so those of us (such as myself) who want them to remove these cases need to recognize we are asking them to overturn some very old cases and plan accordingly. We also need to be careful as their is a constitutional argument the court can make – one I think is wrong but it does exist.

          I wrote on this over at IP Watchdog actually…

          As for Anon – I agree with everything you said. Certainly the claims as a whole need to be used. You seem to be implying that Dave Boundy is a name I should recognize…I do not. Please feel free to let me know who he is.

    2. 5.2

      And yet another mistake by the Dist. Ct. — alleging not the SCOTUS-required ONE eligibility exception, but instead TWO alleged exceptions.

      Aggregating exceptions is precisely what the federal circuit did in Electric Power Group.

      Ineligible subject matter is ineligible subject matter. According to you, Alice and Ultramercial would have been eligible if you just created a computer that both served content in exchange for advertising and also intermediated settlement. A ridiculous notion.

      Parties – including the Patent Office and the Courts – trying to deal with multiple-abstract-concept assertions – going against the Supreme Court’s express dictate and directive when they do so

      There’s no express dictate. The cases the Supreme Court did just all happened to be single concept issues, which is often the case when the lower court is getting even the basics wrong.

      There are members of the federal circuit that are heavily pro-patent, you think they’re not raising this just for fun?

      If any court, the patent office, or infringer can’t come up with one and only one alleged eligibility exception, the Mayo / Alice / 101 analysis is done. Over. Finished.

      I seem to recall someone saying that eligibility doesn’t depend on the draftsman’s art. Why should eligibility turn upon whether the defendant views some subject matter as one thing and the patentee views that exact same subject matter as three things?

      In other words, what’s the difference between saying that EPG has three ineligible abstractions – 1) collecting data, 2) analyzing data and 3) displaying the results of data analysis and conversely saying that displaying the subsequent results of an analysis on collected data is ineligible? They all require a means to collect data, the data, a means to analyze data, an analysis, a means to display, and displaying of the results.

      1. 5.2.1

        See Boundy’s point above.

        EPG is the epitome of the broken scoreboard.

        1. 5.2.1.1

          EPG is the epitome of the broken scoreboard.

          Or what other people would call “Reciting the law.” Do your clients pay you to lose cases but lose them in an arrogant “But I’m the one that’s really right” manner?

          1) Pro Say says something.
          2) RandomGuy points out that Federal Circuit expressly did the opposite of what Pro Say says.
          3) anon complains RandomGuy knows Federal Circuit precedent.

          Unless step 4 is “Federal Circuit, bowing under anon’s withering and not-at-all-repetitive complaints, reverses itself, pledges never to follow its own precedent or Supreme Court again” the only thing I’m hearing is “RandomGuy knows Federal Circuit precedent”

          1. 5.2.1.1.1

            Or what other people would call “Reciting the law.”

            Nope.

            Take your pick from several Constitutional infirmities of the NON-Congressional written Common Law as rendered (and mis-rendered) by the Court.

            1. 5.2.1.1.1.1

              Anon – these would be great arguments to make to the Supreme Court or congress (or in places like here) but as I am sure you know the Federal Circuit isn’t going to change the way they decide cases based on this – and the USPTO can’t either.

              Rule of law and all that.

          2. 5.2.1.1.2

            Reply caught in the “Count Filter”

          3. 5.2.1.1.3

            While the first comment seeks its way out of “Count Purgatory,” your comment as to what you “only see” is ALSO an indictment against YOU and your penchant for confirmation bias, as even your boss (as noted in your binding marching orders — see part one of Boundy’s comments) expressly states that the Common Law law writing by the courts has yielded a Gordian Knot of contradictions.

  5. 4

    The quoted “statement” that “these are treatment claims and as such they are patent eligible” is plainly incorrect and shame on the CAFC for writing some so silly. Examples of “treatment” claims which are ineligible are easy to envision. One huge class would be method claims which recite only prior art treatment steps in addition to a new step of communicating or thinking a specified non-obvious thought during the course of the treatment.

    That’s an ineligible treatment claim. Why is this hard for judges and attorneys to understand?

    With regards to the specifics of this case, the eligibility issue with the composition claims is (if I have the facts straight) better understood as arising from the existence of the composition in the prior art (and not in nature). The eligibility issue is the attempt to patent the prior art composition as a composition by affixing to the description of the broadly claimed composition an intended use for it and/or a newly discovered property of the composition.

    1. 4.1

      Malcolm, you continue to be confused and conflated.

      1. 4.1.1

        You’re confused, Billy. If I’ve written anything you disagree with, identify exactly what it is and identify the error. Try to do it without ad hominem and through the use of reason and logic. Good luck. Dennis, keep an eye on your boy, mkay?

        1. 4.1.1.1

          Lol – lovely bunch of Accuse Others from you, Malcolm.

          Tell me again who more than anyone else (combined) has had more posts expunged for being inappropriate?

          Hello?

          Hello?

          Now where did Malcolm run away to…?

    2. 4.2

      I am not sure your example would be ineligible under current 101 law. It might fail under usefulness but 101 is NOT the European technical expression limitation. It might also fail under these things are not related. It would also be completely unenforceable as proving someone has thought something while doing something else is unprovable. As such worrying about if a claim like this should or should not be patented is silly.

      Your second paragraph is more reasonable only that it highlights a potential real patenting problem BUT not a 101 problem. ANYTHING to do with prior art is almost always better examined under 102 or 103. If the issue here is that the composition existed in the prior art that is automatically a 102 or 103 issue.

      If someone wanted to patent Asprin (a natural product) for preventing heart disease – there is no 101 issue under the fact Asprin is already known. Any issues for claiming a new use or discovered property (which have always been patentable) is a 102 or 103 issue.

      1. 4.2.1

        Daniel : I am not sure your example would be ineligible under current 101 law.

        Then you don’t understand the law, or subject matter eligibility in general.

        It might fail under usefulness

        Please assume for the sake of discussion that it’s useful. Most people don’t bother to claim “useless” subject matter and prior art treatments are, generally speaking, useful to the person being treated.

        101 is NOT the European technical expression limitation.

        I’ve no idea why you are bringing Europe into this.

        It might also fail under these things are not related.

        They are related.

        It would also be completely unenforceable as proving someone has thought something while doing something else is unprovable.

        Now you must be pulling my leg. We are talking about a legal determination. What if you have a video of me admitting that I thought about X while doing Y? Most of us would agree that’s good evidence.

        worrying about if a claim like this should or should not be patented is silly.

        LOL When you were born? I was a practicing attorney when Mayo was decided and the facts in Mayo were c r a z y.

        ANYTHING to do with prior art is almost always better examined under 102 or 103.

        Good grief please stop and think before you type ridiculous things like this. Literally everything we do and say is done in the context of prior art. Every claim has “something to do with prior art” but it’s definitely not the case that every claim is “better examined under 102 or 103.”

        If the issue here is that the composition existed in the prior art that is automatically a 102 or 103 issue.

        No. Books are prior art compositions. But claiming books that comprise non-obvious information is not “automatically a 102 or 103 issue”. Yes, the CAFC has occasionally (and, arguably, illegally) invoked subject matter eligibility considerations into its 103 analysis but that’s not the Supreme Court’s problem. That’s the CAFC’s problem.

        1. 4.2.1.1

          We have a disagreement – see the patent heads recent comments on computers and automating something that was done previously using a computer. This is not a 101 abstract idea issue but a 102 or 103 issue.

          A book that has non obvious information would not be ineligible under 101 as an abstract idea but more generally as not an invention. OR the fact you are claiming the book aspect would be immaterial as it is the supposed non obvious idea that is inside the book that would determine the 101 issue. The fact you have added the book to the claims would be non material.

          I am bringing Europe into this as people like yourself seem philosophically to be attempting to turn 101 into a Europe like technical expression limitation this was NEVER the purpose of 101. Things that were not patentable in Europe have and should remain patentable in the US.

          As for usefulness the treatment might be useful but you thinking the unobvious idea (the aspect we are talking about here) would not be. It certainly would not effect the treatment. If this was the only nonobvious part of the claim and this part fails the usefulness test I would argue the claim fails the usefulness test. Don’t think their is any law on this though as we are again in the realm of impracticable academic argument (not that I don’t enjoy this – I am a lawyer after all)

          As for you admitting you were thinking it while doing the treatment on camera – yeah I don’t see that happening but even if it did somehow so what? That isn’t a reason to make it ineligible philisophically or legally.

          Yes every claim has something to do with prior art AND if what you are looking at is obviousness or novelty of the claim you should use 102 or 103.

          The Supreme Court unfortunately conflated these issues in some of their cases but they are not patent lawyers – the rest of us should not fall into this trap.

          As for how long I have been practicing irrelevant. Especially since you talked about others not doing ad homminem attacks. I did not please do not also.

          I paid close attention to constitution law when in school (actually enjoyed it – and the class massively influenced my political beliefs the fact my constitutional law book was 100000 times thicker than the constitution was itself scary).

          Do continue to reply philosophically and legally though. I do not always agree with Gene Quin – (he didn’t like some of the things I wrote on his site actually) but I do think he is write here when he talks about the issues that happen when 101, 102, and 103 are conflated.

          link to google.com

          1. 4.2.1.1.1

            DC,

            The linked article is actually by Ron Laurie (not Gene Quinn).

            Quinn often has guest columnists with whom he will not agree, so there is no immediate or direct ability to consider the article expressing Quinn’s views.

            (just curious, any relation to Paul?)

          2. 4.2.1.1.2

            A book that has non obvious information [is] not an invention.

            Says who? It’s an article of manufacture, it’s useful, and it’s new. What’s the argument that “it’s not an invention”? Because “Daniel Cole says so”? You’re going to have to do a lot better than this, Daniel.

            people like yourself seem philosophically to be attempting to turn 101 into a Europe like technical expression limitation;p this was NEVER the purpose of 101.

            I think you’d be better off just addressing the facts and arguments that are before you, Daniel, then worrying about similarities between subject matter eligibility analysis in the US versus Europe. As long as both jurisdictions are analyzing claims, then both jurisdictions are going to be approaching the issue of subject matter eligibility with a “philosophy” that is fairly consistent. It’s not a policy choice so much as a legal/logical necessity.

            If this was the only nonobvious part of the claim and this part fails the usefulness test I would argue the claim fails the usefulness test. Don’t think their is any law on this

            The reason that there isn’t any law declaring that a process of thinking a non-obvious thought (or series of thoughts) is “not useful” is because it’s a very strange argument for a lawyer to make to a judge. It’s much more straightforward (and intellectually satisfying) to argue (for example) that mental processes and facts are ineligible for patenting because the First Amendment (at least) gets in the way.

            As for you admitting you were thinking it while doing the treatment on camera – yeah I don’t see that happening

            Why would it have to be admitted in real time? Also, it’s rather odd that Prometheus would have taken their claims to the Supreme Court if they thought they couldn’t enforce them.

            even if it did somehow so what

            It’s evidence. You said it could never be proven what someone was thinking. I was correcting you because you were wrong (and rather strikingly so, for an alleged attorney).

            The Supreme Court unfortunately conflated these issues in some of their cases but they are not patent lawyers – the rest of us should not fall into this trap.

            Are you for real? Because this is pretty funny. The Supreme Court is the Supreme Court and you don’t have to be a “patent lawyer” to appreciate what was wrong with the claims presented by Prometheus. Also, I have no idea what the “conflation” is that you are referring to. Making a distinction between ineligible subject matter and eligible subject matter is pretty much an essential part of any determination of the eligibility of a claim. Engaging in that activity is not “conflation”. Nor is admitting that the prior art is relevant to every patent claim an example of “conflation.” Nor is understanding how the ineligible (e.g., abstract) subject matter in a claim relates to the eligible subject matter in the claim an example of “conflation.” And it’s also not “conflation” to appreciate that you can’t protect ineligible subject matter — no matter how non-obvious it is — just by reciting some prior art context that might be patentable if that context weren’t in the prior art.

            the fact my constitutional law book was 100000 times thicker than the constitution was itself scary

            Was your m 0 m m y there to hold your hand? Gosh, I hope so.

            1. 4.2.1.1.2.1

              Malcolm, maybe you can stop pretending that the answer you seek has not already been presented to you – in a clear and simple manner with direct English in the Simple Set Theory explication of the exceptions to the judicial doctrine of printed matter.

              We both know why you have refused to engage.

              1. 4.2.1.1.2.1.1

                Weirdest. Blogtr0ll. Ever.

                1. Yes, you are Malcolm (noting your number one meme of Accuse Others…), but hey, you are good to show what NOT to do…

            2. 4.2.1.1.2.2

              because the First Amendment (at least) gets in the way.

              Yay, Malcolm mouths First Amendment again – sans any real First Amendment constructed (yes, read that as cogent) argument.

              Come man, provide an actual legal argument that would be a proper First Amendment argument. Do some dazzling besides in your own mind.

            3. 4.2.1.1.2.3

              Wow – not since middle school has a response been so ridiculous. Let me try to answer the facts presented.

              A book with nonobvious information is not an invention

              I am here using the very basics of patent law and the difference between patent and copyright. Yes a book is an article of manufacture but writing books is very well known and the information in books has been proven time and again to be copyrightable but not patentable. – So it would fail under 102 or 103 as the book is obvious. This of course assumes the claim is written as “a book with (nonobvious information)” now trying to claim the information itself would depend on what the information is and how it is claimed.

              EU patent law

              I have found that engaging with the underlying philosophy of the people I am arguing with is usually necessary. As such I try to read between the lines and do so – especially when I am talking with attorneys who are trained to hide the ball. I also don’t agree that policy issues are not important here. In one of your later posts you talk about “patent owners doing well” for example. Such things show underlying philosophies which are certainly important and control how people decide issues.

              The facts you preset and the methods you use to determine what is and what is not eligible look a lot like the EU system. I was simply pointing that out. The EU system has some very different policy positions underling it (which I don’t agree with) which is why the system is very different. The fundamental policies underlying the American patent system being very different it is incorrect to incorporate EU systems into American patent law.

              First amendment application

              Interesting thought process – has implications for trademark law that are likely bad. Certainly I should not be able though to patent thinking something – and no one here has said you should be able to do so.

              Evidence
              Yes I can certainly admit something is true but I would say that isn’t really you proving it. I can try in court to say I didn’t admit it either in writing or on camera you can prove I did admit it, but that still isn’t me proving I thought it. Until we scientifically get to the point that you can tell what someone is thinking by reading brainwaves – I don’t think you can prove what someone is thinking.

              Conflation of 101, 102, and 103.
              Here we disagree. The way the 101 law reads currently in the 101 section the court has to make a determination about use of normal everyday techniques (they use different language I don’t feel like or have time to look up). The idea being that if all you did was apply normal techniques to an abstract idea that doesn’t make it eligible under 101. I call this a 102 or 103 argument. The whole part of 101 where you are taking a known idea and applying a computer to it – or taking a known process and doing it on the internet. I consider this a 102 or 103 issue not a 101 issue. I am a biotech not a computer person technologically but Alice looks to me like it should have been decided under 102 or 103 not 101. I expect you disagree.

              Constitutional book size.
              I wasn’t clear here – it wasn’t scary from a class perspective (the more unclear the law the better it is for grades actually) Con law was my highest grade in law school actually. I was attempting to slyly make a political point. Let me do so bluntly – it does not take so many pages to explain the constitution. The Supreme Court expanded law and made law not really consistent with the constitution at least starting with the wheat case in the 1930s. This s why I am a paying dues member of the federalist society.

          3. 4.2.1.1.3

            This is not a 101 abstract idea issue but a 102 or 103 issue. A book that has non obvious information would not be ineligible under 101 as an abstract idea but more generally as not an invention. OR the fact you are claiming the book aspect would be immaterial as it is the supposed non obvious idea that is inside the book that would determine the 101 issue. The fact you have added the book to the claims would be non material.

            Never have a seen someone recognize the need for 101 within two sentences of denying it before.

  6. 3

    Contrast this Natural Alternatives Int’l. Inc. v. Creative Compounds, LLC (Fed. Cir. 2019) statement that “These are treatment claims and as such they are patent eligible” vis a vis all the prior prognostications that no diagnostic claims are any longer patentable after Mayo v. Prometheus (2012) (9-0). Isn’t the former often just one small claim drafting additional step from the latter?

    1. 3.1

      just one small claim drafting additional step from the latter?

      Damm scriviners, who do they think that they are?

    2. 3.2

      Of course like many of these 101 cases the subject claim has never yet had a thorough 103 evaluation anywhere in its entire lengthy and highly inefficient litigation path from the PTO to several District Courts and then on to the Federal Circuit here.

    3. 3.3

      Maybe a better contrast might be between this panel of Moore, Wallach and (dissenting in part) Reyna — and the panel of Lourie, Stoll and (dissenting) Newman in Athena

      (see link to cafc.uscourts.gov ).

  7. 2

    So does it infringe to pump some beta-alanine into an apple and sell the enhanced apple?

    Without a new composition, how is the new use limited since dietary supplements are not prescribed drugs? Sellers can claim any benefit they wish. Clearer skin or softer toenails or whatever….

    1. 2.1

      1. Yes, a pumped up apple with amounts within the claimed range would infringe. Why did you even ask?

      “1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.”

      2. What is claimed is a unit dose. There is no mention of a benefit.

      Your comments regarding advertised benefits are off point.

      1. 2.1.1

        Uh – so long as we read claims from the perspective of someone having ordinary skill in the art, I have my doubts whether a pumped-up apple would qualify. If “dietary supplement” weren’t a limitation, the claim would probably read on a standard 12-oz ribeye steak.

        1. 2.1.1.1

          An apple is not a dietary supplement Les. How will it infringe? How does eating an apple go off-label?

          1. 2.1.1.1.1

            Marty,

            To the extent that you have made “equal” the enhanced apple of your first post with the “just an apple” of your reply, you have moved the goal posts and are no longer talking about the same thing.

            1. 2.1.1.1.1.1

              Ya happy now Marty? I gotta agree with anon!

          2. 2.1.1.1.2

            all of this of course is a 103 or 102 issue rather than a 101 issue. It matters under which aspect of law you are deciding.

      2. 2.1.2

        “1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.”

        Dietary supplement was construed at patentee’s request as “an addition to the human diet, ingested as a pill, capsule, powder or liquid, which is not a natural or conventional food, meat or food flavoring or extract, or pharmaceutical product which effectively increases the function of a tissue when administered to the human over a period of time”

        An apple, even an enhanced apple, is not ingested as a pill, capsule, powder or liquid.

        And since food flavoring is intended use, virtually anything is non-infringing. You could pour 16 grams of powder on your burger and say you do it for the taste.

        It must be so fun for you guys just redefining your claims as soon as you find an infringer, huh?

        1. 2.1.2.1

          Your “enhanced apple” is covered if the enhancement is a dietary supplement.

          The ingestion need not be all on its own.

          Easy F A 1 L for you.

          Likewise, merely calling it “but it’s for taste” is an easy F A 1 L for you.

          Maybe Random, come to the table without your anti-patent mindset…

          Everything for you is filtered through your anti-patent confirmation bias. That’s no way to go through life, son.

          1. 2.1.2.1.1

            The ingestion need not be all on its own.

            That’s not how I would read that term, as simple construction would tell you that “which is not a natural or conventional food, meat or food flavoring or extract” has to be exempted from the previous recitation “an addition to the human diet, ingested as a pill, capsule, powder or liquid.” Since no pills, capsules, powders or liquids are conventional food or meat, the only way to construe pills, capsules, powders or liquids are as being distinct from, and additional to the diet to, the conventional food or meat upon which they may reside.

            The purpose of that construction is the exempt my burger toppings from the prior art. The solution for non-infringement is to make it a burger topping.

            Regardless, let them prove that it was in powder or liquid form when it was ingested from my apple.

            Likewise, merely calling it “but it’s for taste” is an easy F A 1 L for you.

            The claim has a negative functional limitation, just as if it was asserted in the body of the claim (as that is what construction is). The claim requires it not be a “natural or conventional…food flavoring…” It does not exempt it only when it is a conventional food flavoring, it exempts it when it naturally flavors food. Everything that is naturally occurring and taken with food naturally flavors food. I could sprinkle penicillin on my burger and it would unconventionally, naturally flavor it. Whether it flavors it positively or not is a matter of taste, but that is irrelevant, as the claim does not speak to that. Adding it for the flavor is just as non-infringing as taking a .3 gram dose. He’s free to argue I didn’t take it for the flavor, nobody’s stopping him.

            I didn’t write his claim construction, he did.

            1. 2.1.2.1.1.1

              Apples — as conventional food — are clearly not augmented apples.

              How YOU would read anything is clearly biased.

        2. 2.1.2.2

          Random

          Martin asked if it would be infringement to “pump some beta-alanine into an apple.”

          When I read pump, I think liquid. Are you aware of some other way to “pump” beta-alanine into an apple?

          Alternatively, perhaps the apple with beta-alanine pumped into it is a capsule, or a pill. You know, like an apple flavored Flintstone Vitamin.

          Still further, perhaps the beta-alanine is infringing prior to the pumping.

          1. 2.1.2.2.1

            Still further, perhaps the beta-alanine is infringing prior to the pumping.

            Well obviously that could be true.

            When I read pump, I think liquid. Are you aware of some other way to “pump” beta-alanine into an apple?

            I’m suggesting that it is not all liquids which infringe, but liquids that fall outside the category of:

            “which is not a natural or conventional food, meat or food flavoring or extract”

            Each term in a definition should be read such that it is not superfluous. Since there is no such thing as “a pill, capsule, powder or liquid” which is “a natural or conventional food [or] meat” the only reason the words “which is not a natural or conventional food, meat” could mean is that when pills, capsules, powders or liquids are placed on the food, they merge with the “natural or conventional food or meat” and become noninfringing. If you don’t take that interpretation, the words “natural or conventional food, meat” would have no meaning in the definition – they wouldn’t exclude anything.

            That conclusion finds agreement with the other two parts of the statement – food flavoring or extract.

            In other words, the claim seeks to exclude from its definition (and, likely more importantly, from its prior art) toppings for food which, by happenstance, contain .4mg of beta-alanine. That ridiculous definition probably exists because the patentee in fact knows of or suspects a pre-existing meal which in fact anticipates a non-pill composition of .4mg.

            Since the definition is crafted to avoid that prior art, one can avoid infringement in the same manner. It may be that the liquid, sitting by itself, is infringing, but when the liquid is pumped into an apple the “enhanced apple” as it is being called is non-infringing because the system no longer contains a liquid which is not a natural or conventional food as it has merged with the apple.

            Alternatively, perhaps the apple with beta-alanine pumped into it is a capsule, or a pill. You know, like an apple flavored Flintstone Vitamin.

            It doesn’t matter whether one views the apple + liquid as a capsule, a pill, or a system comprising a liquid, all three of them are subject to a negative limitation. The same is true of a powder. If there exists a powder which contains non-zero beta-alanine, but a whole bucket is conventionally purchased by a restaurant to stock as food flavoring, that bucket is not an infringing capsule and the powder is not infringing powder. That’s not by happenstance. There probably is food flavoring which is sold in mass quantities and the sum of which would contain enough beta-alanine to be anticipatory – that’s why the patentee took the time to seek a definition which excludes it.

            Eh, I’ll stop being coy. From 7.0 above –

            Indeed, the record contains an expert declaration stating that “one 3.2 gram daily supplement of beta-alanine is the equivalent to eating at least 109 Big Macs per day.” J.A. 914.

            1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

            To reach the minimum of a very generous spread, you would have to eat more than 13 Big Macs each day. – From anon at 7.1

            Of course, the claim isn’t a method claim that requires taking the supplement. It’s not about whether someone eats 13 Big Macs a day. The claim requires a composition that makes up the supplement. Therefore, to be anticipatory, all you need to know is whether a single McDonalds possesses enough stuff to generate 13 Big Macs every day. If they do, then they possess a unit dosage of about .4grams, and since they didn’t make it in store it’s highly likely that whatever causes Big Macs to have beta-alanine is purchased in such large quantities that it is more than .4grams. In other words, if one ignores the negative limitations, some drug dealer (within the meaning of the claim) is pushing to McDonalds and anticipating the claim without knowing it. That’s why the negative limitation exists. That’s why you can pump apples and sell enhanced apples – because if generating food infringed, McDonalds would be prior art.

            1. 2.1.2.2.1.1

              ““enhanced apple” as it is being called is non-infringing because the system no longer contains a liquid which is not a natural or conventional food as it has merged with the apple.”

              NO. An enhanced apple, by definition, is not a conventional food. Neither is a hamburger with a supplement sprinkled on.

          2. 2.1.2.2.2

            Still further, perhaps the beta-alanine is infringing prior to the pumping.

            Well obviously that could be true.

            When I read pump, I think liquid. Are you aware of some other way to “pump” beta-alanine into an apple?

            I’m suggesting that it is not all liquids which infringe, but liquids that fall outside the category of:

            “which is not a natural or conventional food, meat or food flavoring or extract”

            Each term in a definition should be read such that it is not superfluous. Since there is no such thing as “a pill, capsule, powder or liquid” which is “a natural or conventional food [or] meat” the only reason the words “which is not a natural or conventional food, meat” could mean is that when pills, capsules, powders or liquids are placed on the food, they merge with the “natural or conventional food or meat” and become noninfringing. If you don’t take that interpretation, the words “natural or conventional food, meat” would have no meaning in the definition – they wouldn’t exclude anything.

            That conclusion finds agreement with the other two parts of the statement – food flavoring or extract.

            In other words, the claim seeks to exclude from its definition (and, likely more importantly, from its prior art) toppings for food which, by happenstance, contain .4mg of beta-alanine. That ridiculous definition probably exists because the patentee in fact knows of or suspects a pre-existing meal which in fact anticipates a non-pill composition of .4mg.

            Since the definition is crafted to avoid that prior art, one can avoid infringement in the same manner. It may be that the liquid, sitting by itself, is infringing, but when the liquid is pumped into an apple the “enhanced apple” as it is being called is non-infringing because the system no longer contains a liquid which is not a natural or conventional food as it has merged with the apple.

            Alternatively, perhaps the apple with beta-alanine pumped into it is a capsule, or a pill. You know, like an apple flavored Flintstone Vitamin.

            It doesn’t matter whether one views the apple + liquid as a capsule, a pill, or a system comprising a liquid, all three of them are subject to a negative limitation. The same is true of a powder. If there exists a powder which contains non-zero beta-alanine, but a whole bucket is conventionally purchased by a restaurant to stock as food flavoring, that bucket is not an infringing capsule and the powder is not infringing powder. That’s not by happenstance. There probably is food flavoring which is sold in mass quantities and the sum of which would contain enough beta-alanine to be anticipatory – that’s why the patentee took the time to seek a definition which excludes it.

            Eh, I’ll stop being coy. From 7.0 above –

            Indeed, the record contains an expert declaration stating that “one 3.2 gram daily supplement of beta-alanine is the equivalent to eating at least 109 Big Macs per day.” J.A. 914.

            1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

            To reach the minimum of a very generous spread, you would have to eat more than 13 Big Macs each day. – From anon at 7.1

            Of course, the claim isn’t a method claim that requires taking the supplement. It’s not about whether someone eats 13 Big Macs a day. The claim requires a composition that makes up the supplement. Therefore, to be anticipatory, all you need to know is whether a single McDs possesses enough stuff to generate 13 Big Macs every day. If they do, then they possess a unit dosage of about .4grams, and since they didn’t make it in store it’s highly likely that whatever causes Big Macs to have beta-alanine is purchased in such large quantities that it is more than .4grams. In other words, if one ignores the negative limitations, some dealer (within the meaning of the claim) is pushing to McDs and anticipating the claim without knowing it. That’s why the negative limitation exists. That’s why you can pump apples and sell enhanced apples – because if generating food infringed, McDs would be prior art. (edited for possible filter compliance)

            1. 2.1.2.2.2.1

              That’s not coy – that’s beyond ignorant and just plain stU p1d.

              How the F are you an Examiner?

        3. 2.1.2.3

          “An apple, even an enhanced apple, is not ingested as a pill, capsule, powder or liquid.”

          No, but the liquid or power pumped into the apple is still a liquid or a power, even when its distributed throughout the apple.

          Furthermore, why doesn’t the apple become a capsule?

          cap·sule
          /ˈkapsəl,ˈkapˌs(y)o͞ol/
          noun
          noun: capsule; plural noun: capsules; modifier noun: capsule

          1.
          a small case or container, especially a round or cylindrical one.
          a small soluble case of gelatin containing a dose of medicine, swallowed whole.
          synonyms: pill, tablet, lozenge, pastille, pilule, drop, caplet, pellet, bolus, troche; informaltab
          “he placed a capsule under his tongue”
          short for space capsule.
          2.
          Anatomy
          a tough sheath or membrane that encloses something in the body, such as a kidney, a lens, or a synovial joint.

          I say an apple qualifies as a capsule.

          1. 2.1.2.3.1

            So I didn’t pay much attention to this as it was away from the 101 area that I care about but I really don’t see how an apple qualifies as a capsule here using your definition. Apples are not small certainly not small using the idea of small for capsules in daily life. I certainly don’t swallow my apples whole, and I haven’t seen an apple that contains a dose of medicine. That just leaves round or cylindrical. Apples are certainly round – but then so are all fruits and wheels, and soda cans…these are not capsules.

            Interesting argument you have but I don’t think it would fly.

  8. 1

    Another “ping-pong” as the direct take-away here is one of “the patent has utility.”

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