Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?

By Kevin E. Noonan --

The U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on April 15th, and the parties and their different cadres of amici have submitted briefs of varying degrees of helpfulness and coherence to the Court.  In reviewing these briefs, and the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision that forms the basis for re-review by the Federal Circuit (albeit with little having been changed from that reconsideration), the question arises whether what is at issue in this case is the extent to which Myriad's claims unduly preempt what should be "free to all men and reserved exclusively to none."  Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,130 (1948).

The context for the Court's decision is its own recognition that patent eligibility should be given an expansive scope, as mandated by Congress under 35 U.S.C. § 101.  The Court recognized Congress's intent expressly in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), quoting the famous aphorism from the legislative history that statutory subject matter should "include anything under the sun that is made by man," a sentiment sounding in Thomas Jefferson's vision that "ingenuity should receive a liberal encouragement."  5 Writings of Thomas Jefferson 75-76 (Washington ed. 1871).  The Court has been parsimonious in setting forth what is not patent-eligible:  "laws of nature, physical phenomena, and abstract ideas" have fallen outside the statutory scope, and the Court has provided explicit examples of what should reside inside those excluded categories ("a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" and "[l]ikewise, Einstein could not patent his celebrated law that E=mc²; nor could Newton have patented the law of gravity."  Chakrabarty, 447 U.S. at 309).

These concerns were of primary importance in the Court's Mayo v Prometheus decision, in which the claims (according to the Court) were directed to a natural law relating to the proper therapeutic dosage of a drug for treating Crohn's disease.  In finding the claim ineligible for patenting, the Court said that:

The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.  We must determine whether the claimed processes have transformed these unpatentable natural laws into patent­ eligible applications of those laws.  We conclude that they have not done so and that therefore the processes are not patentable.

The deficiency in the claim was thus that it did no more than "inform a relevant audience about certain laws of nature," and "any additional steps [recited in the claim] consist of well ­understood, routine, conventional activity already engaged in by the scientific community."  Accordingly, "those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately" and thus the claimed method was unpatentable.

These concerns frequently arise when the claims produce nothing more than information ("inform a relevant audience about certain laws of nature"); this deficiency can be seen to be in common with Mayo and earlier cases involving the limits of statutory subject matter.  These include O'Reilly v. Morse, claiming a method of transmitting information using electromagnetism (56 U.S. 62 (1853)); Benson v. Gottschalk, claiming methods for converting binary-coded decimal (BCD) numerals into pure binary numerals on a general purpose digital computer using a particular algorithm (409 U.S. 63 (1972)); Parker v. Flook, claiming methods for determining an alarm limit (437 U.S. 584 (1978)); and Bilski v. Kappos, claiming methods for hedging commodity trading outcomes (130 S. Ct. 3218 (2010)).  These decisions of the Court stand in contrast with its decision in Diamond v. Diehr, where a method for curing rubber using an application of the Arrhenius equation was deemed patent-eligible (450 U.S. 175 (1981)).  The production of a tangible outcome, cured rubber, distinguishes the patent-eligible claims in Diehr from the information produced in those methods deemed patent-ineligible by the Court in Mayo, Morse, Benson, Flook, and Bilski.

The distinction can also be drawn that in Diehr the claimed methods were particularly drawn to a specific, tangible result (the cured rubber) and that the claim did not preempt all uses of the Arrhenius equation.  The Supreme Court has been wary of claims that preempt all uses of a law of nature, as it deemed them to be in Mayo, Benson, Flook, and Bilski; in Mayo, the Court warned that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" and would "threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo's test), that combine Prometheus' correlations with later discovered features of metabolites, human physiology or individual patient characteristics." These statements illustrate this Court's continuing concern voiced in Funk Brothers that laws of nature should not be burdened with patent exclusivity.

Unlike the method claims in Mayo, Benson, Flook, and Bilski, Myriad's composition of matter claims at issue in the Myriad case are not broadly preemptive in the same way.  They are both specific and particular and as such do not implicate the policy concerns enunciated by the Court in those earlier cases where preemption rendered claims patient-ineligible.  Myriad's claims, when considered as a whole are narrowly focused on isolated human DNA molecules that encode a protein having a particular amino acid sequence.  The consequences of this specificity narrow the scope of these claims substantially.  Taking claim 1 of Myriad's U.S. Patent No. 5,837,492 as an example:

An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

The scope of this claim should be understood by these affirmatively recited limitations:

• an isolated DNA molecule that
• encodes a specifically-recited amino acid sequence.

Much of the discussion surrounding these claims in the Federal Circuit's opinion and in Plaintiffs' and their amici's briefs to the Court focus on the requirement that the DNA molecule is isolated.  Neglected in this discussion, and particularly relevant to the question of preemption and the scope of Myriad's composition of matter claims, is the narrowness of the scope of this claim and the consequences of this narrow scope on the preemption issue.  First, the only isolated (human) DNA molecules falling within the scope of this claim are those that encode this (and only this) particular amino acid sequence encoding BRCA2, which in this case encompasses 3,418 amino acids arrayed in a particular and specific order.  An isolated human DNA comprising any change in this encoded amino acid sequence is not exclusive to the patentee and can be performed freely without literal infringement liability by anyone.  (The availability of the doctrine of equivalents for isolated human DNA claims is severely limited by U.S. Patent and Trademark Office practice in interpreting the application of 35 U.S.C. § 112(a) to such claims, and by ensuing prosecution history estoppel.)

The significance of this limitation in scope of Myriad's claims can be understood by the following example. If the single change in the amino acid sequence of the BRCA2 protein encoded by the claimed isolated human DNA is from a valine (Val) residue to an isoleucine (Ile) residue, the number of atoms in the protein would be increased by a mere 3 atoms (the difference in structure between these two amino acids is a methylene group,-CH₂-) out a total of more than 60,000 atoms in the protein.  Yet, even such a molecule changed to such a small degree would not literally infringe claim 1 of Myriad's '492 patent.  Similarly, insertions or deletions of the sequence, mutations and sequence variants (naturally occurring or man-made) do not fall within the scope of Myriad's claims to a specific, particular isolated human DNA, due to this restricted scope.  Properly construed, claims to isolated human DNA are the antithesis of the type of broadly preemptive claims that have concerned the Supreme Court in its earlier precedent, because by their nature such claims do not "impede the flow of information that might permit, indeed spur, invention" and thus do not call within the Court's proscriptions based on these concerns.

Moreover, such changes, insertions or deletions in the sequence, mutations and sequence variants (naturally occurring or man-made) are independently patentable to future researchers who describe such variants and satisfy the statutory requirements embodied in 35 U.S.C § 112.  (The Federal Circuit has interpreted the disclosure requirements of 35 US.C. § 112 to require that claims to isolated human DNA must disclose the specific sequence claimed (or provide a biological deposit thereof).  Regents of the University of California v. Eli Lilly & Co.; Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (en banc).  The U.S. Patent and Trademark Office has implemented this interpretation of the statutory requirements (see USPTO Written Description Examination Guidelines, 66 Fed. Reg. 1092 (2001)).  In fact, disclosure of the predicted amino acid sequence encoded by the human BRCA2 gene in Myriad's '492 patent, required as it is by 35 U.S.C. § 112(a) to provide "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and [] the best mode contemplated by the inventor or joint inventor of carrying out the invention" provides the best starting point for work by future inventors to identify or produce such changes, insertions or deletions of the sequence, mutations and sequence variants (naturally occurring or man-made) and patent them, independent of any restrictions that can be imposed by Myriad (or any other patentee).  Disclosure as required by the Patent Act is "the quid pro quo of the right to exclude."  Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 484 (1974), and Myriad's disclosure of the BRCA1 and BRCA2 gene sequence provides future researchers with the ability to continue to research and make improvements, as envisioned in Article I of the U.S. Constitution.

In view of these distinctions, it should be evident that Myriad's claims to isolated human DNA are different in both kind and effect than the claims the Court has proscribed due to their capacity to unduly preempt future invention.  Viewed in this light, and stripped of the emotional and political implications generated by presenting the question of whether human genes should be patent-eligible (a legal question) (as opposed to whether isolated human DNA should be patented, a policy decision best left to Congress), the real question before the Court is whether there are grounds consistent with the issues and concerns motivating prior decisions that support those who would have the Court apply a categorical rule that isolated human DNA should be proscribed.  The Court can certainly decide that such policymaking falls within its purview, but only by expanding the grounds is has previously applied for finding otherwise statutory subject matter not to be eligible for patenting.

Comments

[EG]

Kevin,

Your post highlights what Chris Holman has argued in his amicus briefs in this case: no one, including the courts, has bothered to articulate exactly what the scope of Myriad's isolated DNA sequence claims are. Unless you define exactly what the scope of these claims really is (sorry Justice Breyer, the "draftsman's art" does matter here), all this talk about "preemption" is stuff and nonsense.

I agree with you that what Myriad has claimed does not preempt, and certainly not in the sense that Morse tried to in O'Reilly v. Morse. And as I've long argued, "preemption" should not be treated as a 35 USC 101 patent-eligibility issue, but instead as an "enablement" issue under 35 USC 112, first paragraph. That's what O'Reilly v. Morse was really all about (i.e., Morse tried to claim all forms of electronic communication while only exemplifying telelgraphy), but is too often miscited (in my opinion) as a patent-eligibility case. Also, I would argue that Prometheus' claimed method in Mayo was not "preemptive" as it was focused on drug dosage calibration for a particular group of drugs (compared to what was claimed in certain instances in Classen Immunotherapies); Prometheus' claimed method may have been "abstract" but it was definitely not "preemptive" in my book.

[Bob Cook-Deegan]

I disagree with your analysis and EG's, Kevin. Why? Because anyone who studies, clones, sequences or does anything else with the BRCA1 gene found in someone's body will make molecules covered by the claim. That is not the claim infringed by diagnostics. The claims that do cover diagnostics may well be invalid because of novelty/nonobviousness (claims 5 and 6), but they were granted and have not been challenged (and are not challenges on 102 or 103 grounds in AMP v Myriad), and they definitely *do* preempt any research or other use that would entail any meaningful study of the gene. They give the patent-holder the right to exclude anyone from making or using the claimed molecules, and were deliberately crafted to cover diagnosis, and were enforced against such use.

The vast majority of those who have done research on BRCA in US-based labs have infringed one or more claims in one of the 24 Myriad patents. Myriad could have sued them to stop them. The fact that Myriad has not blocked research, except clinical research it defined as infringing, does not mean the pre-emption concern is vacuous. The narrowness of one claim that you analyze is falsely reassuring. That's not the claim that matters for diagnostics.

[Bob Cook-Deegan]

Sorry, caught in error in my post. Should have been anyone who studies BRCA would infringe *a* claim, not *the* claim.

[Paul San Quentin]

To me it seems that in the court of public opinion, by-and-large, the general idea of a "human gene" cannot be separated from a notion that it is somehow intangibly special, rather than it being just a specialized chemical. And that will be the potential downfall here.

DNA behaves like a chemical - it can be manipulated, synthesized, and put to beneficial use beyond the role it serves in cells residing in my body. A typical 'isolated sequence' claim should be viewed as meeting the subject matter eligibility requirement of 35 USC 101 in every instance -- it just does not always meet the novelty and non-obviousness requirements of 102/103. But, the Court has already infused old/routine in the 101 test analysis (Mayo).

@EG - I strongly dislike the Mayo decision. To me, however, the underlying problem with Prometheus was (IIRC) that at the DCt level it advanced a claim construction that encompassed a physician merely thinking about a metabolite level test result (a bad idea, further to the point Kevin makes about the prior failings of claims that cover "information" rather than something tangible). That, combined with the fact that the generalized actions of analyzing metabolite levels and administering the known drug were "old" opened the door for a parsing of the claim and asking 'what's new here?' - only the inherent metabolite levels generated by the natural action of the body and what they indicate to a physician. Thus, all the claim does is inform the relevant audience about a natural correlation and further includes routine pre/post solution activity. Of course, that should have been an 'obvious' obviousness analysis, but because it didn't 'feel right' to the court (the "something more" requirement) we now have aspects of old/routine infused into the 101 test for subject matter eligibility. That doesn't seem to increase Myriad's chances of success.

[EG]

"To me, however, the underlying problem with Prometheus was (IIRC) that at the DCt level it advanced a claim construction that encompassed a physician merely thinking about a metabolite level test result (a bad idea, further to the point Kevin makes about the prior failings of claims that cover "information" rather than something tangible)."

Paul,

I completely agree with this statement of yours. I heard that Prometheus advanced this view of what their claimed method covered, and in my opinion, that view was extremely inadvisable, as well as nonsensical. Unfortunately, the "powers that be" have latched onto this ill-advised (and in my opinion, incorrect) construction of Prometheus' claimed method.

[Francis Cricklestein]

This is one of your better articles on this topic, Kevin, although "pre-emption" seems inapplicable and pointless when we are dealing with a novel composition of matter. And that's why, as EG notes, claim construction (as always) is always essential (sometimes the scope of the claim is more readily apparent than it is here). If the claim is broad enough to prevent people from practicing the prior art (e.g., sequencing) or if it covers compositions found "in nature", then this is a simple case of inherent anticipation. That's going to be true of nearly all composition claims that are not claimed functionally (e.g., claims like Myriad's claims, that describe a composition in physical/structural terms, as opposed to merely reciting a desired property) and is going to be true as well for many compositions that are claimed functionally.

EG: "" preemption" should not be treated as a 35 USC 101 patent-eligibility issue, but instead as an "enablement" issue under 35 USC 112, first paragraph. That's what O'Reilly v. Morse was really all about (i.e., Morse tried to claim all forms of electronic communication while only exemplifying telelgraphy),"

This was also the problem in Funk Brothers, as noted by the concurrence in that decision. The composition claim in Funk Brothers did not describe a composition by its physical properties, but by its functional properties, which functions were not understood by skilled artisans to to be necessarily linked to any structure.

EG: "Your post highlights what Chris Holman has argued in his amicus briefs in this case: no one, including the courts, has bothered to articulate exactly what the scope of Myriad's isolated DNA sequence claims are."

Can anyone explain why that hasn't been done? What do you believe the scope of the claim is, EG (or Kevin)?

Does it include any 200kb+ sub-chromosomal fragment in a test tube, wherein the fragment comprises the sequence, regardless of what other fragments or biomolecules are in the test tube? Does it include any 50kb plus long restriction fragment migrating in an agarose gel, as long as that fragment comprises the sequence?

Or does the claim cover any composition of matter or mixture comprising the recited nucleic acid sequence *except* for "naturally occurring" human cells?

Does it go without saying that if any of these claim constructions are accurate, the 101 issue is probably the least of Myriad's worries?

[EG]

Bob,

With all due respect, how does "the vast vast majority of those who have done research on BRCA in US-based labs have infringed one or more claims in one of the 24 Myriad patents"? Again, no court has even bothered to construe what infringes those Myriad claims. Even you fellow co-author of your amicus brief, Chris Holman, says no court has properly construed what is infringed by these claims.

[Kevin E. Noonan]

Dear Bob:

Thanks for the clarification. It is important because it is this type of claim that is under consideration. (Your own work has convinced me that the oligo claims are likely to be invalid and hence I am less concerned by them.)

I disagree that the "gene" claims are necessarily infringed. Indeed, they are not usually; for example, a study of a subpopulation of women for detecting any or all known BRCA gene mutations would not infringe unless he full length gene was isolated and using modern (post-1987) technology that would not be necessary.

That does not cover research on the protein, antibodies, etc. or study of any cell that natively produces the protein and mRNA.

Thanks for the comment.

[Kevin E. Noonan]

Dear Francis:

I think the claim does not include 200kb fragments per se. Whether it would include a YAC or other high capacity vector would (in my view) depend on whether there were several other genes in the 200 Kbps. And I think the agarose gel is also unlikely to fall within the scope of the claim because there will be a great many 50 Kbps fragments at that site on the gel.

Thanks for the comment.

[EG]

"Can anyone explain why that hasn't been done? What do you believe the scope of the claim is."

Francis,

Because everyone, including the courts, keep talking about Myriad's claimed invention in a vacuum, without considering the "context" of what that claimed invention is and what it might be asserted against. That's because the suit here isn't an infringement action, but instead an effort to declare the claimed invention patent-ineligible under 35 USC 101 without ever considering what might or is infringing that claimed invention. That's one of the unfortunate problems created by Mayo which asserts (despotically in my view) that patent-eligibility under 35 USC 101 must be considered primary, and in a "vacuum" (i.e., without even considering how and whether that invention is properly defined by the claims as required under 35 USC 112, 2nd paragraph), rather than after considering the "reality" of what that claimed invention is and in what context it could be properly considered infringe. That's because SCOTUS patent law doctrine (especially relating to 35 USC 101) pays no attention to how the patent statutes work or what they actually, other than giving them "lip service."

[Francis Cricklestein]

EG: "Because everyone, including the courts, keep talking about Myriad's claimed invention in a vacuum, without considering the "context" of what that claimed invention is and what it might be asserted against."

Okay, fine .... so what do you think the proper construction of the claim is, EG? Kevin, at least, appears to have some idea because he was able to posit some answers about coverage.

"Mayo which asserts (despotically in my view) that patent-eligibility under 35 USC 101 must be considered primary, and in a "vacuum""

Where is that passage in the opinion? The Supreme Court was clear, I thought, that claims which recited patent ineligible steps (e.g., abstractions such as mental steps) must be analyzed in view of the prior art to determine if the claims are not an attempt to claim the ineligible subject matter.

[6]

"where a method for curing rubber using an application of the Arrhenius equation was deemed patent-eligible (450 U.S. 175 (1981)). "

More like a method of automatically opening an auto-opening mold during the curing of rubber, as the claims are less about the actual curing of the rubber.

[Francis Cricklestein]

Paul San Quentin: "all the claim does is inform the relevant audience about a natural correlation and further includes routine pre/post solution activity. Of course, that should have been an 'obvious' obviousness analysis, but because it didn't 'feel right' to the court"

As I recall, the Supreme Court explained itself quite clearly. First, there was nothing "obvious" about the numbers recited in the claim (the ineligible subject matter) and therefore to find the claim obvious, the limitation would have to be ignored. The Supreme Court correctly observed that there was no precedent cited for that approach (at least no Supreme Court precedent) and also noted that if ineligible subject matter is simply ignored, their 101 jurisprudence becomes a "dead letter".

Paul: "we now have aspects of old/routine infused into the 101 test for subject matter eligibility."

Certainly true of process claims. But why is that a problem? Without that analysis it would be possible to obtain claims that prevent people who are practicing the prior art from thinking new thoughts while doing so.

The Federal Circuit correctly recognized, I think, that approach taken by the Court in Prometheus was not relevant to analyzing composition claims. You can hardly blame the ACLU from seizing on whatever language they find helpful even it makes no sense at all. That's what litigants do. It's up to the Courts to sort it out. As you noted upthread, it wasn't the Court who overreached in Prometheus. It was the plaintiffs who accused Mayo's doctors of infringing their claim merely by thinking about results obtained using old data. But that was bound to happen eventually. I highly recommend Prof. Kevin Collins article on this subject if you haven't already read it.

http://www.houstonlawreview.org/wp-content/uploads/2013/02/3-Collins.pdf

[6]

"The production of a tangible outcome, cured rubber, distinguishes the patent-eligible claims in Diehr from the information produced in those methods deemed patent-ineligible by the Court in Mayo, Morse, Benson, Flook, and Bilski."

That may well be so, but it is quite irrelevant since the court rests its decision to uphold the Diehr claims on their lack of preempting any but one tiny use of the Arrhenius equation amongst many millions+.

[6]

Kevin, apart from my comments I just made in other posts, I'd like to address the topic generally right fast. Specifically I'd like to address that you seem to be missing the entire point of the preemption doctrine in the patent context. What specifically is being covered, whether it be a very specific atomic arrangement as here, or a device with a very specific listing of 1's and 0's thereon, or a very specific device or a very specific this or that, or even likewise a very UN-specific this or that, the doctrine is not at all concerned about how specific the claim is in so far as the specificity is being considered IN A VACUUM. What is at issue, in every single case where preemption of some judicially excepted subject matter even seems remotely tangentially related to the case is ALWAYS, ALWAYS, ALWAYS how the scope of claim, and that which falls within it, COMPARES to that which would fall within a claim to just the judicially excepted subject matter at issue in the case.

Here, the claim is as written.

Here, the judicially excepted subject matter are the naturally occuring genes and, as I later found, the discovery of the loci of the gene (the later probably being the more important judicially excepted subject matter so far as this case goes).

Thus: here, what you are COMPARING it against is what ACTIVITY (making, using selling of devices, methods, compositions o matter) would be covered by a hypothetical claim just to the natural gene itself

Note here that you are not at all concerned about what the actual scope of the claim is so much as you are concerned about how the one COMPARES to the other. That is to say, your lengthy explanation of just what the claim is covering is, while minutely relevant, barely relevant. What is at issue is how what your claim covers COMPARES to the judicially excepted subject matter in the case.

In any event, sorry about the caps but I wanted to emphasis those words for you. Hope this helps with your understanding of preemption as it appears to be a rather difficult concept for many to get hold of.

"In view of these distinctions, it should be evident that Myriad's claims to isolated human DNA are different in both kind and effect than the claims the Court has proscribed due to their capacity to unduly preempt future invention."

A point which hitherto I don't believe anyone has ever asserted the contrary.

[Francis Cricklestein]

6: "Here, the judicially excepted subject matter are the naturally occuring genes"

"What is at issue is how what your claim covers COMPARES to the judicially excepted subject matter in the case."

"in every single case where preemption of some judicially excepted subject matter even seems remotely tangentially related to the case is ALWAYS, ALWAYS, ALWAYS how the scope of claim, and that which falls within it, COMPARES to that which would fall within a claim to just the judicially excepted subject matter at issue in the case."

In any of these cases you allude to, 6, has the court ever found "pre-emption" where the claim does not cover the "judicially excepted subject matter"?

That is one point on which all parties seem to agree: the scope of Myriad's claim does not reach to the judicially excepted subject matter (the "naturally occuring gene") because the "naturally occuring gene" is not "isolated". It also surely hasn't escaped your attention that the analysis you describe, at least with respect to composition claims, is indistinguishable from a inherency analysis under 102 in every respect. Either I am inherently claiming the prior art (i.e., the "naturally occuring composition") or I'm not, and in the latter case there is no more "pre-emption" of the "judicially excepted subject matter" than there is in the case of any other composition that can be described as a new, man-modified but otherwise "natural" composition. If there is something in between ("sufficient pre-emption"?), you haven't managed to articulate it, with or without the help of capitalization. Is that what you're betting that the Supreme Court is going to do here?

[6]

"In any of these cases you allude to, 6, has the court ever found "pre-emption" where the claim does not cover the "judicially excepted subject matter"? "

The cases I allude to in the sections you quoted are not necessarily the cases that have gone to court, they are the thousands of cases at the PTO that will be 101'd moreso than the dozen or so big name cases everyone has heard about that went to the supremes or the CAFC. But no, I know of no case where a court (or the PTO for that matter) has mistakenly invalidated the claims based upon preemption. Although I'm sure it happens and will happen more in the future at the PTO, the USSC is quite good at what they've been doing for the last hundred years and from what I've seen all the lower courts do a decent job, I've seen no egregious rulings made in courts to date.

Your next paragraph seems to indicate that you don't understand what preemption is all about. You seem to think that the claim must literally cover the natural gene, and that is not so. What it must cover for preemption to apply is the exact same things (here, applications as defined above) which a claim to the natural gene would. Saving of course necessarily the actual natural gene here, since they have so generously allowed people to keep their natural genes in their bodies by disclaiming that one thing which would be covered by a claim to the natural gene. Again, as I have said some million times, you're looking for the overall effect of the claim not whether one or two, or even in some cases a few, embodiments would escape unclaimed while hundreds thousands or millions that would be covered by the claim to the natural gene are in fact covered by the claim at issue.

[6]

" It also surely hasn't escaped your attention that the analysis you describe, at least with respect to composition claims, is indistinguishable from a inherency analysis under 102 in every respect."

No, it isn't, and if you think that, then you're not understanding what I have "proposed" aka what has been done in all the big name 101 USSC cases for the last hundred years.

To be clear, what I "propose" is simply to take a gander at the claim, hopefully getting a claim construction on the record, and note what it covers.

Consider judicially excepted subject matter that might be relevant to the case. Perhaps the natural gene. Perhaps also the discovery of the loci of the BRCA gene(s).

Compare the scope of the actual claim to the scope of a claim to either of the judicially excepted subject matter above. If the scopes are practically (though not necessarily exactly) alike, then your claim dies. If not, then you're good.

There are a few caveats that Flook introduced, field of use, insignificant post solution activity and what have you, but bottom line is what I just described, and what happened in every single USSC 101 case that I've managed to read. Including Chakrabarty, though they wax poetic about this and that in that case.

[6]

"If there is something in between ("sufficient pre-emption"?), you haven't managed to articulate it, with or without the help of capitalization. Is that what you're betting that the Supreme Court is going to do here? "

I apologize if I hadn't sufficiently articulated it for the millionth time on here, but I ran through it in brief above. But no, I'm betting they'll do the same exact thing they do every time. Which is precisely what I laid out in the post above. And which is very hard to describe to someone new to it in print. I've been meaning to simply write up a comprehensive article but there are some good ones out there that really get it. Try Weeds and Seeds by Chisum, even though he advocates getting rid of the whole thing he puts his finger on exactly what is happening (notably a few years after I pointed it out).

[Skeptical]

I wonder if Francis Cricklestein is the same poster as Malcolm Mooney from other blogs.

Whether the Court is going to buy this over-reliance on mere "isolated," or the apparent assumption that 101 questions somehow must treat composition claims any different than any other claim category leaves me...

[EG]

"Where is that passage in the opinion? The Supreme Court was clear, I thought, that claims which recited patent ineligible steps (e.g., abstractions such as mental steps) must be analyzed in view of the prior art to determine if the claims are not an attempt to claim the ineligible subject matter."

Francis

Read the following passage from Mayo (all of it):

Third, the Government argues that virtually any stepbeyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentiallypatentable application sufficient to satisfy §101’s demands. Brief for United States as Amicus Curiae. The Government does not necessarily believe that claims that(like the claims before us) extend just minimally beyond alaw of nature should receive patents. But in its view, other statutory provisions—those that insist that a claimed process be novel, 35 U. S. C. §102, that it not be clear[ly], concise[ly], and exact[ly]” described, §112—canperform this screening function. In particular, it arguesthat these claims likely fail for lack of novelty under §102.

This approach, however, would make the “law of nature”exception to §101 patentability a dead letter. The approach is therefore not consistent with prior law. The relevant cases rest their holdings upon section 101, not later sections. Bilski, 561 U. S. ___; Diehr, supra; Flook, supra; Benson, 409 U. S. 63. See also H. R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952) (“A person may have ‘invented’ a machine or a manufacture, which may include anything under the sun that is made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled” (emphasis added)).

We recognize that, in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and,say, the §102 novelty inquiry might sometimes overlap.But that need not always be so. And to shift the patenteligibility inquiry entirely to these later sections riskscreating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do.

What role would laws of nature, including newly discovered (and “novel”) laws of nature, play in the Government’s suggested “novelty” inquiry? Intuitively, one wouldsuppose that a newly discovered law of nature is novel.The Government, however, suggests in effect that the novelty of a component law of nature may be disregarded when evaluating the novelty of the whole. See Brief for United States as Amicus Curiae 27. But §§102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections. Cf. Diehr, 450 U. S., at 188 (patent claims “must be considered as a whole”). And studiously ignoring all laws of nature when evaluating a patent application under §§102 and 103 would “make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementationobvious.” Id., at 189, n. 12. See also Eisenberg, Wisdom of the Ages or Dead-Hand Control? Patentable SubjectMatter for Diagnostic Methods After In re Bilski, 3 Case
W. Res. J. L. Tech. & Internet 1, ___ (forthcoming, 2012) (manuscript, at 85–86, online at http://www.patentlyo.com/files/eisenberg.wisdomordeadhand.patentlyo.pdf (as visited Mar. 16, 2012, and available in Clerk of Court’s case file)); 2 D. Chisum, Patents §5.03[3] (2005). Section 112 requires only a “written description of the invention . . . in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same.” It does not focus on the possibility that a law of nature (or its equivalent) that meets these conditions will nonetheless create the kind of risk that underlies the law of nature exception, namely the risk that apatent on the law would significantly impede future in-novation. See Lemley 1329–1332 (outlining differencesbetween §§101 and 112); Eisenberg, supra, at ___ (manuscript, at 92–96) (similar). Compare Risch, Everythingis Patentable, 75 Tenn. L. Rev. 591 (2008) (defending aminimalist approach to §101) with Lemley (reflecting Risch’s change of mind).

These considerations lead us to decline the Government’s invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.

[Paul San Quentin]

@EG - "These considerations lead us to decline the Government’s invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101." That's marvelous!! I'll grant some leeway with regard to the gobbledygook analysis of 103, but stating that the inquiries under 102 and 112 are less established than 101?! Just absurd.

@ Francis - thanks for the link, I'll read the article. You asked why is the infusion of old/routine in the subject matter eligibility analysis a problem, noting that without that analysis it would be possible to obtain claims that prevent people who are practicing the prior art from thinking new thoughts while doing so. I agree that not including something in a claim that carves out mere thought is a problem. But to your question, the problem is, as I see it, that the Mayo analysis is not well defined and can be construed to encompass too much (with regard the perspective from which you view the "natural law"). I see it as expanding the question of 101 subject matter eligibility to a question of patentability.

As an example (which lacks, I'm sure), I know dicta in Mayo indicated that a method for using a known drug to treat a newly identified (but otherwise known) disease indication remains patent eligible, but I'm not sure how the rule articulated in the decision (necessarily) allows for that result. For such a second medical use, we have (a) a known/old drug product; (b) known/old steps of administering (at least, let's assume for my meaniningless ranting); and (c) a natural phenomenon regarding how the (old) drug acts within the person being treated (by old steps) - it merely informs the relevant audience of the newly identified natural phenom. Further, that claim structure is similar to any diagnostic biomarker claim (that incorporates steps beyond 'analyzing a test result') - known gene/marker(drug); known assays(adm. steps); linked to a new disease.

[Francis Cricklestein]

6: "Compare the scope of the actual claim to the scope of a claim to either of the judicially excepted subject matter above. If the scopes are practically (though not necessarily exactly) alike, then your claim dies. If not, then you're good."

That's what I thought you were getting at, 6. That's what I meant when I referred to a "sufficient pre-emption" test above. I think we agree that, to date anyway, the Supreme Court has not found a composition claim such as Myriad's invalid under your theory (i.e., where the the composition claim did not in fact cover the judicial exception but merely made it very difficult for others to study the product of nature). Thanks for the replies.

[Francis Cricklestein]

Paul San Quentin: "stating that the inquiries under 102 and 112 are less established than 101?! Just absurd."

I think you're misreading that section of the case. The Court is saying that 102 and 112 are less established relative to 101 -for the purpose of preventing applicants from claiming judicially excepted subject matter -. In particular, they note that 102 and 112 would not suffice to eliminate claims like Prometheus' claims, which certainly did cover judicially excepted subject matter, unless those statutes were applied in new ways.

"I see it as expanding the question of 101 subject matter eligibility to a question of patentability."

Again, for process claims which include an ineligible step (e.g., a mental step or any other abstraction), it's absolutely necessary to understand how any eligible steps in the claim relate to the prior art. Otherwise applicants could simply do what they did in Prometheus: protect the new ineligible subject matter by appending any old conventional (but patent eligible) step to the claim.

"For such a second medical use, we have (a) a known/old drug product; (b) known/old steps of administering (at least, let's assume for my meaniningless ranting); and (c) a natural phenomenon regarding how the (old) drug acts within the person being treated (by old steps) - it merely informs the relevant audience of the newly identified natural phenom."

As you are surely aware, such inventions have -always- presented very serious traps for the careless claim drafter. Assuming your facts, if you drafted your claim in the following way "A method of treatment comprising administering old drug X to a subject, wherein X prevents disease Z" that claim is d.o.a. under 102 (inherently). Now we know that such a claim is also d.o.a. under 101. Hardly the first time that a claim fails under multiple sections of the patent act.

On the other hand, if you include a step of identifying a previously unknown group of patients who can be beneficially treated by administration of X and then a step of selectively treating those patients with an appropriate dose of the drug, I think you'll certainly avoid the issues that caused the claims in Prometheus to fail. Remember that the Supreme Court expressly acknowledged that "laws of nature" are implicated in every claim. They certainly were not trying to prevent practitioners from claiming new therapeutic treatments. If they wished to have done that, they could so (they are the Supreme Court, after all). But they didn't do that and they made a point of saying as much.

[6]

"I think we agree that, to date anyway, the Supreme Court has not found a composition claim such as Myriad's invalid under your theory"

A good question, and one I cannot definitely answer. But sure, I'll go along with it for now.