Mayo Response Brief in Athena v. Mayo at CAFC Argues Athena Claims Impede Treatment Decisions

By Paul Cole
June 6, 2019

“The falsehood of the allegation that the asserted claims, like those in Mayo v. Prometheus, tied up a doctor’s treatment decision by covering any use of the correlation is belied by the existence of the ELISA alternative, and is arguably a statement that ought not to have been made by a competent attorney.”

The presently pending petition for en banc review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC has been addressed by Sherry Knowles and Meredith Addy and is supported by a number of amicus briefs. The patent in issue has been described by the present author as a paradigm of patent eligibility, supporting the argument that en banc review is merited.

Mayo has now filed its response brief, submitted on May 7, and argues that the panel’s decision invalidating the asserted claims as ineligible properly applied the two-step Alice framework in light of precedent, that the full Court need not re-examine it, and accordingly, that Appellants’ petition should be denied. It makes the following principal points:

  • The Panel correctly found the claims “directed to” a natural law after considering them as a whole.
  • The Panel’s step one conclusion is consistent with Supreme Court precedent and the CAFC’s § 101 opinions. The following cases should be applied:

The following cases should be distinguished:

  • Diamond v. Diehr, 450 U.S. 175 (1981), solution of a significant industrial problem;
  • Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016);
  • Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) in which the claims did not remain “open-ended”;
  • Endo Pharms. Inc. v. Teva Pharms. USA, Inc. (Fed. Cir. Mar. 28, 2019);
  • Alts. Int’l ,Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1345-47 (Fed. Cir. 2019).
  • Claims should not be held eligible based on recitation of man-made reagents and lack of complete pre-emption, see Mayo v. Prometheus, In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2015), Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303, 1335-37 (Fed. Cir. 2012) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594-95 (2013). The asserted claims here append admittedly conventional steps involving a man-made component to a claim directed to the natural correlation between the presence of MuSK antibodies and certain neurological disorders. “And because the asserted claims, like those in Mayo “tie up the doctor’s subsequent treatment decision” by covering any use of the correlation rather than applying it in a specific way, they fail the pre-emption test in any event.”
  • Well-known steps recited in the claim do not impart an inventive concept to the natural correlation, see Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016) and Ariosa at 1380. “The patent sets out the inventors’ discovery of a newfound correlation between certain autoantibodies and disease, and describes as “standard techniques in the art” the exact directives in the claims for observing that correlation in a method of diagnosis. (Id. at 4-6.)”

Examining the Claims

Arguably, the claim in issue is partly directed to an ineligible natural law, in this case the “correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.” However, it is also at least equally directed to an eligible laboratory procedure involving newly created 135I-MuSK, the newly created two-component complex autoantibody/125I-MuSK and the transformational immunoprecipitated three-component complex autoantibody/125I-MuSK/Sheep anti-IgG, the latter two newly created substances being considered neither in the Panel opinion nor in the Mayo reply brief. The U.S. law on eligibility contains both the positive provisions set out in the four eligible categories of Section 101 and the long-standing negative judicial exclusions. As Sir John Mummery, a retired judge of the UK Court of Appeal, advised this author at a seminar organized by Hogarth Chambers on June 5, in these circumstances it is important to consider the applicable law as a whole and in a balanced manner. A criticism of the approach hitherto adopted in the United States is that the necessary balance is not observed, undue emphasis being placed on factors pointing towards exclusion and factors pointing towards positive eligibility being substantially disregarded.

An essential fallacy in the approach proposed by Mayo is summed up in the final quoted paragraph and is over-emphasis on alleged admissions in the description of the patent without distinction between admittedly known generic approaches and the several species of steps set out in combination in the claim in issue. Perhaps the most critical statement in the patent description reads:

The actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art. Examples of suitable techniques include ELISA, radioimmunoassays and the like…

However, at the relevant date, assays for MuSK autoantibody in general and 135I-radioimmunoassay for MuSK autoantibody in particular, were unknown to those skilled in the art, had not been developed and more specifically had not been proved to work, iodination and immunoprecipitation being known as a generality but not having previously applied to the detection of MuSK autoantibody. As explained in the description, an ELISA assay, which apparently was the first choice of approach, proved difficult to standardize and the equivalence of the 135I-radioimmunoassay appears not to have been obvious to a skilled reader. It only became known as a result of the experiments reported in the patent.

In relation to the specific problems facing the inventors, it is not apparent that the specified method steps were “well known, routine, and conventional at the time the … patent was filed” in the language adopted in Genetic Technologies. The falsehood of the allegation that the asserted claims, like those in Mayo v. Prometheus, tied up a doctor’s treatment decision by covering any use of the correlation is belied by the existence of the ELISA alternative, and is arguably a statement that ought not to have been made by a competent attorney.

The eligibility problem can be overcome by specifying a further downstream activity e.g. administering a medicament to a patient at a newly selected dosage. Most commonly, however, the physician responsible for prescribing the new dosage will be separate from the organization that carries out the relevant tests. There will, therefore, be no single infringer against which proceedings can be instituted, and the patent, though granted and free from objection under section 101, will be of limited effectiveness. It is interesting to speculate whether this point has been made with sufficient force in proceedings before the Federal Circuit.

In Hope of Rehearing

The case will now go before the judges of the Federal Circuit for a decision on the documents presently before the Court as to whether rehearing should be ordered. It is hoped that the petition will succeed, at least to that extent and that there will be an opportunity for further submissions and oral argument before this important appeal is finally disposed of.

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The Author

Paul Cole

Paul Cole has over 40 years of practice as a patent attorney, is registered to practice before the UK and European patent offices, the UK and European trademark offices and to conduct proceedings for infringement of intellectual property rights before the UK courts. He received an MA in chemistry from Oxford University and an LLM from Nottingham Trent University, and has worked as a patent attorney in both industry and in private practice, becoming a partner in Lucas & Co in 1999.

For more information or to contact Paul, please visit his Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 17 Comments comments. Join the discussion.

  1. Pro Say June 6, 2019 5:12 pm

    Sickening.

    All these many giant companies … in at least a large share of the arts … on the one hand asserting that other’s patent claims are ineligible … while at the same time crying like babies to the Patent Office that their own claims … written in similar styles and manners … with many of the same elements … and even some of the same limitations … ARE eligible.

    Hypocrites all.

  2. Joachim Martillo June 7, 2019 7:41 am

    The discussion and discourse about § 101-eligibility doctrine is almost as off-track as § 101-eligibility doctrine itself.

    https://www.linkedin.com/pulse/fix-100-101-joachim-martillo

  3. Joachim Martillo June 7, 2019 10:40 am

    Sorry about the garbage link.

    The discussion and discourse about § 101-eligibility doctrine is almost as off-track as § 101-eligibility doctrine itself.

    Fixing § 101 Requires Fixing § 100

  4. TFCFM June 7, 2019 10:49 am

    I don’t think the post quite captures the real potential significance of this case.

    The post asserts:

    >>>However, at the relevant date, assays for MuSK autoantibody in general and 135I-radioimmunoassay for MuSK autoantibody in particular, were unknown to those skilled in the art, had not been developed and more specifically had not been proved to work, iodination and immunoprecipitation being known as a generality but not having previously applied to the detection of MuSK autoantibody.<<<

    I'm not certain this quite captures the issue. What was known was detection of autoantibodies to SUBSTANTIALLY ANY protein by methods including immunoprecipitation (including radio-labeled immunoprecipitation). That is, if you had asked a skilled artisan to detect MuSK autoantibodies (MuSKaAbs), use of radio-labelled immunoprecipitation would have been a method that would have come immediately to mind and been expected to work. (The same arguments apply to the ELISA assay — another utterly standard method — recited in Athena's claim 6). Athena's specification admits this, albeit not in these precise words.

    What was unknown was the *significance* of detecting MuSKaAbs (i.e., that their appearance can be diagnostic of myasthenia gravis(MG)). Put another way, even though every skilled worker in the world *could* have detected MuSKaAbs using the standard methods, there was no *reason* to do so before the patentee's inventors discovered the link to MG.

    Thus, the inventors discovered a link between occurrence MuSKaAbs and (at least) MG — a link that was clearly not previously recognized and which represents a valuable scientific advance.

    The inventors similarly recognized (and disclosed) that any of a variety of methods could be used to detect MuSKaAbs in a patient sample and to thereby diagnose the potential occurrence of MG in the patient.

    Under the first step of the Alice analysis, the link between MuSKaAbs and MG is a "natural law" and thereby not itself patentable. Applying the second step of the Alice analysis, reciting the natural law together with an admittedly known standard method of detecting the link is not patentable. So the Alice-based conclusion is plainly correct; the question is whether Alice is the proper standard for eligibility.

    The issue that this case clearly highlights is that DISCOVERY OF NATURAL LAWS ARE NOT PATENTABLE UNDER THE ALICE HEURISTIC. The question presented is thus whether discovery of "natural laws" like this is the sort of subject matter which OUGHT to be eligible for patenting. If so, Alice must be overruled or limited.

    A lot of folks (including me, not that that's determinative of anything) think that discoveries like this one ought to be patentable. At least one rationale is that we want to incentivize folks to make such discoveries, and patenting is an appropriate incentive for discoveries of this type. Critics point out that there are other potential incentives, such as professional recognition, that reward such discoveries, that those incentives are "enough," and that we don't want discoveries like these tied up in monopoly rights even for limited periods. (These are also credible arguments).

    Whether limiting one's claims to only one of several plainly standard, obvious, non-inventive methods of observing a natural law (once the law is known) seems, at best, a decidedly less important issue, and one without any substantial intellectual heft to it. This question seems to me like merely Gottschalk v. Benson repackaged in biotech language (i.e., performing a natural law using an ELISA mechanism or an immunoprecipitation mechanism — akin to Benson's algorithm performed using a computer).

    It is, I think, the broader, more fundamental question that makes this case a good test case for the patentability of newly-discovered diagnostic methods where it is the link between the diagnostic target and a health/disease state that is the "invention."

    In my opinion, Athena v. Mayo presents the courts the option to say clearly whether mere discovery of a link between natural occurrence of a non-inventively-detectable molecule and occurrence of a disease state is a patentable invention. However the courts decide the issue, the question is likewise presented to the legislative branch if the answer is other than what We the People think that answer should be.

    (As an aside: the scope of the claims — reciting detection of ANY "neurotransmission or developmental disorders related to [MuSK]" [Athena base claim], and not limited to MG troubles me. It seems to me that the entire case can be discarded on written description grounds — the patentee claims FAR more than what is disclosed. The link between MuSKaAbs and MG is disclosed. A similar link between MuSKaAbs and any-and-all-MuSK-related-disorders-whether-yet-discovered-or-not plainly is not. This trivial result potentially limits the value of this dispute as a test case for the issues discussed above.)

  5. Anon June 7, 2019 2:17 pm

    TFCFM,

    You use the term “discoveries like this.”

    Do you have any views on Sherry Knowles brief regarding the Supreme Court pruning the words of Congress and removing discoveries (in their totality) from patent law?

  6. Paul Cole June 7, 2019 2:25 pm

    @ TFCFM

    Many thanks for your long and careful comment.

    On the whole, this case is closer in my view to Diamond v Diehr where, if you take away the algorithm and its associated elements, all you are left with is a press for making rubber articles and a thermocouple, neither of which is at least arguably other than utterly conventional (despite what the Supreme Court said in that case). And I seem to remember learning about the Arrhenius equation and its significance for the rate of chemical reaction as a schoolboy aged 14.

    One of the questions we all deal with is whether a process claim involving elements A, B, C and D is new where elements B, C and D are broadly known. The answer is that the process as a whole is clearly novel, and that there may be invention in selecting a new starting material on which the process with elements B, C and D is carried out. I do not see that there is any difference in principle with the present autoantibodies.

    Another question is what should suffice to transform an ineligible discovery of a rule of nature into a patentable process. In my view, the inclusion of practical elements that bring the process into the laboratory should suffice, this being precisely in accordance with Diehr. The view which has prevailed so far is that it is not enough to bring the process into the laboratory, there has to be a second ingenious discovery in the laboratory, As argued in my earlier post, I think that this places an undue burden on inventors and goes too far.

  7. TFCFM June 7, 2019 3:26 pm

    >>>Do you have any views on Sherry Knowles brief regarding the Supreme Court pruning the words of Congress and removing discoveries (in their totality) from patent law?<<<

    I don't believe I've read her brief, but I recall her addressing the issue in an interview reported on one of the sources I read (this one?) and I recall a report on this site earlier this year reading either that she had or was about to file such a brief and again discussing the issue. In each instance, my recollection is that I thought the idea was overly-simplistic. (To be fair, I've never discussed the issue with Ms. Knowles, so I have no basis for saying this. I suppose that I should say that ***my understanding*** of the idea was overly-simplistic.)

    The way I've understood this line of argument, it's argued that because the patent statute refers to "inventions and discoveries," we should assume that anything that can be characterized as either an "invention" or a "discovery" should be eligible for patenting. (Note that the Constitution doesn't even mention "inventIONS" — only "discoveries" which might be made by "inventORS.")

    (Whether that is merely my understanding or the extent of the issue,) I think that is overly simplistic and overly literal.

    Our Constitution's justification for patenting turns on "promot[ing] the progress of science and useful arts." So we have an indication what we're trying to do.

    It seems to me a mere pretense that the English language (concocted long before our Constitution's patent clause) contains a single word — or even a string of words — having an indisputable definition that perfectly matches the notion of the subject matter intended to be the protectible under the patent clause. Even more removed, it seems doubtful even that the text of the Constitution's patent clause perfectly embodies the intention of the small committee of men who drafted it or the large committees of men who debated, ordained, established, and ratified it. In short, it is not the literal words of the statute (or even necessarily the Constitution itself) which best embody the intent of the patent clause. Executing and interpreting those words are, of course, why we have an Executive branch and a Judicial branch of our government. (And, as we see now, we also preserve a Legislative branch in case we need more/different words).

    Attempting to interpret and execute the intent of the Constitution and of the statute issued thereunder *starts* with the words. When the words turn out to be fuzzy around the edges (the more one focuses in on an edge), all three branches have to try to stay faithful to the intent. The IP implications of better understanding disease states seems to me one of those fuzzy edges. Neither the words of the Constitution nor the words of the current statue were drawn up expressly to address progress in science or useful arts relating to better-understood disease states. Therefore, simple-reminded resort to text is unavailing.

    Instead, courts and the legislature should look to the intent. Progress in science and useful arts can be promoted by providing rights to the first innovator. However, progress can also be inhibited by providing TOO MANY rights to the first innovator. Getting the balance right is important to promoting such progress.

    Plainly, it is useful to promote understanding of disease states. Recognizing when a disease state is occurring is — it seems to me — an important part of this understanding. Focusing on just this diagnostic aspect, there may be multiple WAYS of recognizing occurrence of the disease state. One who figures out one of these ways to the extent that it can be performed as a diagnostic method should, it seems me, be rewarded with exclusive rights — but ONLY for THAT method — not all diagnostic methods for detecting that disease states and not for use of the diagnostic method to detect a different disease state for which the one has not applied the method.

    Turning back to the case at bar, it seems to me that recognition by an investigator that occurrence of MuSKaAbs "cause" MD (assuming that to be adequately demonstrated in the patentee's specification) causes the investigator to be entitled to patent rights to the methods the investigator adequately describes (assuming all other requirements for patentability are satisfied) for those methods of diagnosing that the subject is afflicted with MD. Here, the investigator disclosed (and prior knowledge surely supports) both ELISA and radio-labelled immunoprecipitation assay methods, both types of methods ought to be patentable.

    Because that investigator (I am presuming) has not disclosed that the same method can be used to assess any other disease state, the disclosed methods should be limited to diagnosis of MD. (Discovery by another that the method can be used to diagnose different disease X may be patentable by the other, once this knowledge is discovered). Similarly, the investigator ought not to be entitled to patent methods not adequately disclosed for assessing MuSKaAbs. By way of example, not-yet-invented methods of detecting MuSKaAbs plainly ought not to be covered by the investigator's patent, despite the fact that they rely on the inventor's discovery about the relevance of MuSKaAbs.

    My point is not that any of this has anything to do with Ms. Knowles brief (which, I reiterate, I have not read), but rather that it has nothing to do with whether the investigator's work (in the preceding paragraph) is characterized as a "discovery," an "invention," a "practical application of a concept," or something else.

    The answer, in short, lies in the intent of the patent clause (to the extent we can discern it and/or further refine it where fuzzy), not in the literal words used over half-a-century ago in a statute or a constitution drafted over two centuries ago.

  8. Pro Say June 7, 2019 3:41 pm

    Paul: ” … there has to be a second ingenious discovery in the laboratory.”

    This goes to the heart of the problem with these judicial exceptions to eligibility.

    As I’ve felt all along, what SCOTUS did with Mayo/Alice/et. al. is to decide on their own, unconstitutional volition … that inventing ONE something new in some of the arts was no longer enough.

    That one now had to illogically invent TWO somethings in order to obtain a patent on the ONE new something (to say nothing about the fact that 101 states explicitly that discoveries are also patentable).

    This “something more” has been — and continues to be — a terrible pox on American innovation.

    A pox that only Congress can — and indeed must — cure.

    Ideally before their August recess.

  9. Paul Cole June 7, 2019 5:34 pm

    I am reminded that our UK patent system is derived from the phrase “manner of new manufacture” introduced in 1624 in the Statute of Monopolies. It is from those words and their interpretation in the common law that the four eligible categories of Section 101 developed.

    May I give thanks to Pro Say, TFCFM and Joachim for quite exceptionally interesting and pertinent comments (there may be more by Monday).

  10. Anon June 8, 2019 9:43 am

    Mr. Cole @ 9,

    I would emphasize in your post the word “developed” and contrast the beginning and ending of your lead sentence as you start with “our UK system” but end with “the four eligible categories of Section 101” — a US system attribute.

    The US development significantly branched away from the UK and the rest of the world systems from its start, and further branched away with the Act of 1952.

    I would further emphasize that for the US system, a major problem is this view that “common law” is perfectly acceptable.

    Common Law law writing IS the major driving force in why the US system concerning eligibility is in such disarray.

    In the US, most all** attorneys have an ethical obligation to NOT put the judicial branch (including the top of that branch, the Supreme Court) above the Constitution. But the perversity that exists is that people “generally” (which opens the floor to your own advocacy, even as you are not a US attorney and do not have that same ethical restraint) ACT as if the Supreme Court somehow “must be” correct in anything that they have done, and that attorneys must genuflect, when in truth (and again, for most all US attorneys) the very opposite is true.

    **I have long championed this position with callouts to any attorney who thinks otherwise to present their State oath of office which establishes their ethical duties. The only State oath ever presented that provides even a glimmer or an argument that the Constitution itself MUST come first is the State Oath from the Commonwealth of Massachusetts. Now, I recognize that you personally are NOT so bound – but you should be aware that your advocacy in our dominion will be picked up by those that ARE bound. When you want to discuss Section 101, it would be more helpful for these types of restraints (such as the proper place for common law) to be front and center.

  11. Anon June 8, 2019 11:35 am

    Second sentence, last paragraph should read:

    “The only State oath ever presented that provides even a glimmer [or] OF an argument that the Constitution itself MUST NOT come first is the State Oath from the Commonwealth of Massachusetts.”

    ALL other State attorney oaths provide that an attorney has an ethical obligation to challenge errors in law – even (and I would daresay, especially) those that come from the highest Court in our land.

    THAT Court makes mistakes. We — US attorneys — have an ethical obligation to challenge those mistakes — and not to genuflect to the Supreme Court when they make such mistakes.

    Further, I can easily guide you to a mulit-prong argument showing several mistakes that our Supreme Court has made in relation to the Constitution and the statutory law solely designated to a single particular branch of our government by our Constitution.

  12. Joachim Martillo June 8, 2019 1:26 pm

    Paul makes me feel obligated to provide a draft of my proposed fix to § 100 (Definitions) and § 101 (Inventions patentable).

    I pre-apologize to Anon because eliminating the circular definitions of current § 100 caused me to resort to basic Kantian thought. Any other epistemological system produces more complex definitions.

    I eliminated the common law of the Judicial exceptions by giving statutory definitions to them and other terms on which the courts a flinging with abandon.

    While I have eliminated the circular definitions, I left the recursive definitions and added a few because recursive definitions are acceptable in a system of logic.

    Fixing the US Patent System (Part 1)

  13. Paul Cole June 8, 2019 5:15 pm

    @ Anon

    The early divergence between UK and US patent law should not be exaggerated. If you look at the 1849 treatise of George Ticknor Curtis you will find very many UK cases discussed with numerous entries in the case law index to Webster’s Patent Cases. Later in the 19th century you will find that the number of UK cases decreases, presumably because by that time ample jurisprudence had been developed in the US. However “manufacture” derives from the Statute of Monopolies as I have said, and the UK common law expanded it to cover machines, processes and compositions of matter as in the US.

  14. Joachim Martillo June 8, 2019 5:49 pm

    My link above is correct, but little kids were distracting me as I wrote the comment.

    I meant the following.

    Paul makes me feel obligated to provide a draft of my proposed fix to § 100 (Definitions) and § 101 (Inventions patentable).

    I pre-apologize to Anon because eliminating the circular definitions of current § 100 caused me to resort to basic Kantian thought. Any other epistemological system produces more complex definitions.

    I eliminated the common law of the Judicial exceptions by giving statutory definitions to them and other terms which the courts ARE flinging with abandon.

    While I have eliminated the circular definitions, I left the recursive definitions and added a few MORE because recursive definitions are acceptable in a system of logic.

  15. Anon June 8, 2019 7:57 pm

    Tucker is not dispositive, Mr. Cole. That’s an opinion. Sure, it’s an opinion of the day, but no more and no less.

    Your “should not be exaggerated” goes both ways: should not be minimized.

    Further, the state of “acceptance” of Common Law influence has grown more wise over time. That is, more people are knowledgeable about what is and what is not proper law making coming from the judicial branch.

    Lastly, you omit probably the most important change in “process”: that which was ushered in with the Act of 1952.

    As is, my post stands, as I have the better position.

  16. Anon June 9, 2019 9:13 am

    Joachim,

    I appreciate the apologies beforehand, so with that in mind I attempted to digest your approach along the path of which that you are familiar with.

    Unfortunately, that path is full of legal errors.

    In a nutshell, you are attempting to “make logical” a set of Supreme Court decisions that cannot be made logical, while at the same time attempting to afford them deference.

    More than a little bit like the fatal flaw of Director Iancu’s attempt, one cannot affirm inconsistency, and then turn around and attempt to incorporate (in Director Iancu’s case) or “respect” (in your case) the very same flawed “reasoning” of the branch of the government that has caused the problems at heart.

    I have to say that while I appreciate your philosophical attempt at coming to the issue HEAD ON with defining “knowledge,” knowledge itself is NOT the aim of protecting innovation, and your attempt at differentiation — while no doubt aimed with the best intentions — distracts rather than illuminates.

    As well, I think that we could get into the weeds (albeit, some very interesting weeds) with how you have attempted to structure knowledge in your set of (a)(1) definitions. Suffice to say, that even those who devote their energies at a much higher level than you or I do not agree with each other.

    Kant is not gospel.

    Yes, he may inform, but one should not rest with him just because his view may align with how you want to approach innovation and laws to protect and promote** innovation.

    ** I “tag” this word because in part, “promote” itself carries more than one directive. Most often, people ONLY think of the one: linear (or semi-linear) advancement.

    But that is not the only directive.

    Another directive — more in line with either a “library sense” or perhaps more easily grasped in a business function of advertising sense, is that of “advertising promotion,” or in shorter form, “an ad.” Our courts have messed things up by nigh demanding an advance (and with their rebuked Flash of Genius, and the current reflection of that rebuked “policy” of “inventive step” which seems to insert “an invention within an invention” somehow (as in, undefined) making the innovation to be protected “worthy enough.”

    It is simply NOT the place of the Supreme Court to put their thumb on the scale of what is “worthy enough.”

    You express a concern about being “too complex,” to which I would rebut with Einstein’s maxim (paraphrased): A thing should be as simple as possible, but not simpler.

    Your aim falls to the wanting “too simple,” but then you turn to the tools that you are familiar with (and others frankly are not) and get too complicated in trying to be too simple – errors in approach compounded by errors in aim.

    Worrying about keeping changes “small enough” not to discourage the Supreme Court is akin to kowtowing to what has been wrong in the first place.

    THAT path is outright rejected.

    I can go on an on about individual aspects of your structured approach. For example, your attempt at defining math included in your (a)(4) comes close, but does not actually distinguish along the lines that I have laid out previously when I ask people to reflect upon 1) math; 2) applied math; and 3) MathS.

    I would have my item 2) reflect an input from an esteemed regular on these pages, but at a higher level, the “break” is cleaner in my approach between basic math (fundamental math) and applied math (which is reflected in most all engineering). MathS is a philosophy of math AND applied math, and as such, is not necessarily “cleanly” broken between the two, and items within and coming forth from MathS may well represent and warrant innovation protection. To this last point I would add a bit of Magritte’s Treachery of Images and offer that the man-made attempts to create a working model of reality is NOT reality itself. The map is not the land. To this end, your definition itself of “natural law” is a bit flawed. This can be seen by the fact that man has attempted to create statements of “natural law” that have proven false. Those statements are the map attempting to model the land. It is NOT as if the land changed and that is what rendered the map incorrect. Your attempt at (a)(5) to remove an ENTIRE field from innovation protection (the “intellectual” field of physics) simply goes WAY too far, and would incorporate the exact same type of “attempted line drawing” that is the BANE of what the Supreme Court attempts to do in their ham-fisted manner.

    Your (a)(6) is more muddling of this type. While this may help YOU “order” things, this is most unhelpful in the domain of law (specifically, law meant to promote — in the fullest sense of that word — innovation).

    Your definition of (b)(1) is FAR too limiting. Why ONLY sets of “mechanical, chemical, biochemical, electrical or electronic operations?

    Here, you kowtow to type of “reduce from Useful Arts to some type of Technical Arts” mindset. We do not – and cannot – tell where innovation will lead, and we need to NOT limit Arts to currently known (or “appreciated”) Technical Arts.

    One but study a bit of Deming and see that PURE business methods have seen the type of innovation worth protecting that falls outside of your attempt to narrow.

    Your (b)(4) is a bit too open, and would invite the criticism of those who would claim that the aim in the new law is to be able to patent people.

    Your (b)(5) and (B)(6) are expressly the items to which the error I discuss above in relation to incorporating the full sense of the word “promote” falls into.

    Again, I do appreciate the efforts that you have put into the topic. This DOES advance discussion, while so many others simply refuse to even try to grasp all of the points and counterpoints.

  17. Joachim Martillo June 11, 2019 11:03 am

    I will add another comment later, but I incline toward originalism. Hence my obsession with the epistemological concepts with which the founders would have been familiar either explicitly or implicitly. Kant provides a handy summary.

    I wrote (b)(1) as I did because the original version referred to useful art and not to process. I added electronic as a slight extrapolation, but I am fairly certain I understand the meaning of the phrase “useful art” from Cassiodorus to Jefferson.

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