Examination of Myriad-Mayo Guidance Comments -- ACLU

By Donald Zuhn --

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance") to implement a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  At a biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, the Office announced that it would be hosting a public forum in May to receive public feedback on the Guidance, and at that forum encouraged shareholders to submit written comments on the Guidance.  The original "end of June" deadline for submitting comments on the Guidance was subsequently extended to July 31.  With that extended deadline now passed, Patent Docs will focus on selected comments in a series of posts.

The Office has posted the comments that were submitted on the USPTO website.  The comments are divided into five groups (with the number of submissions in each group also provided):  Intellectual property organizations and other associations (18), academic and research institutions (7), law firms (6), companies (9), and individuals (42).  Today, we examine the comments submitted by the American Civil Liberties Union (ACLU).

The ACLU begins its comments letter by noting the organization's role in the sequence of events that led to the creation of the Guidance -- i.e., as petitioners in the Association for Molecular Pathology v. Myriad Genetics, Inc. case.  While "commend[ing] the PTO for releasing guidance that synthesizes the Supreme Court case law on Section 101 of the Patent Act," the ACLU offers two recommendations for amendments to the Guidance and spends the last page of its letter addressing the Office's "Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.," which were issued on June 25.

Before outlining its recommendations, the ACLU indicates its support for the Office's "expansive" view of the subject matter to be assessed under the Guidance -- i.e., encompassing more than the nucleic acid molecules at issue in Myriad.  Stating that "[t]he Guidance correctly recognizes that the PTO must apply the Supreme Court's decisions to all patent applications that may claim products and laws of nature," the ACLU argues that "[w]hile Myriad examined nucleic acids, the reasoning of the Court was not limited to nucleic acids."  Noting that the Myriad Court "relied heavily on the standards it previously articulated in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Bros. Seed. Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) -- namely, that the claimed composition must have 'a distinctive name, character, and use,' 'markedly different characteristics from any found in nature,' and that the 'invention' must be more than 'the discovery of the natural principle itself,'" the ACLU contends that "the body of Supreme Court case law on Section 101 must be examined together, as each case often relies on and further elaborates on earlier cases."

In the ACLU's opinion, however, the Guidance is not without fault, and the organization offers two recommendations for amendments the Office could make to the Guidance.  First, the ACLU suggests that "Section 101 patent eligibility must turn on both the structure and function of a claimed composition."  In particular, the ACLU argues that "[t]he Guidance examines only the structure of a claimed product, but a close reading of the Court's decisions lays out the requirement that the composition must have markedly different characteristics from any found in nature in both structure and function" (emphasis in original). Looking to past Supreme Court decisions, the letter contends that:

[T]he Funk Bros. bacteria arguably had a different "character," as the strains of bacteria did not appear together in nature.  But the function -- their ability to fix nitrogen without inhibiting each other -- was not invented by the patentee.  The fruit in American Fruit Growers had a different structure -- borax in the rind -- but not a different function; it was still intended for human consumption.  . . .  The Chakrabarty bacterium had both a markedly different structure and function than any found in nature.

Second, the ACLU indicates that the organization is "concerned that the factor-weighing analysis laid out in the Guidance does not comport with the Supreme Court's Section 101 decisions and will only confuse the analysis."  Explaining that "[t]he [Supreme] Court generally makes its Section 101 determinations by evaluating whether what is claimed has markedly different characteristics from any found in nature, or whether there is an inventive concept," the ACLU argues that "[t]here may be different components to each of these evaluations, but they should not be parsed out as individual elements of the Section 101 question," adding that "[w]eighing multiple factors on each side of the Section 101 threshold introduces the likelihood that a claim will meet several competing factors for or against eligibility and muddle the analysis."

The ACLU letter closes by turning to the Office's Preliminary Examination Instructions, noting that "[a]s the PTO revisits its guidance on abstract ideas, we provide some thoughts to help inform its analysis."  Among those thoughts are the following:  (1) agreement with the Office's position that the Court's case law does not set up different Section 101 standards for abstract ideas versus laws of nature (or products of nature); (2) guidance on abstract ideas should not permit any patents that claim mental thought or steps; (3) the Office should not rely on the inclusion of a machine in patent claims.

The ACLU concludes its letter by declaring that "Section 101 issues are of particular significance to the wider public as they are at the heart of the constitutional mandate that patents 'promote the progress of Science and useful Arts,' rather than impede it."

Patent Docs will examine other Guidance comments in subsequent posts.

Comments

[EG]

Don,

The ACLU hath no shame. The only thing that will be "impeded" if Section 101 screens out too much subject matter is innovation. Has the ACLU contemplated what would happen to the next Taxol under their restrictive view?

[Dr. Sinai Yarus]

If the ACLU determines policy, we will all be spending more time on section 101 than 102/103.

That is because the proposed functional criteria are too subjective.

For Example, the fruit in American Fruit Growers had a different structure -- borax in the rind -- but not a different function; it was still intended for human consumption.

That is the way the Supreme Court saw the issue. Another way to view it is that the Grapefruit rind without Borax functioned to promote growth of blue mold; while the rind with borax functions to retard growth of blue mold.

As another example, the Supreme court informed us that the Chakrabarty bacterium had both a markedly different structure and function than any found in nature. However, at the level of the plasmids involved, each plasmid had the same structure and function as when found in nature. The only difference was putting several plasmids together in a single bacteria.

It is worrisome that Examiners, operating under extreme time pressure, will find it all too convenient to focus on section 101 rejections which require no research.

If we adopt the 'distinctive name, character, and use,' standard some real inventions might never get through the section 101 gate.

Consider the example of the first derailleur gear shift for bicycles:
The apparatus as a whole has no distinctive name, it remains a bicycle. It's use remains unchanged, it is a device for locomotion. As for character, an Examiner pressed for time could easily say that the derailleur still employs a chain which engages teeth on a gear, so that is not significantly different in character than previous single speed bicycles.

Nonetheless, few among us would dispute the contention that the first derailleur gear system was a breakthrough in cycling technology and well within the scope of patentable subject matter.

As troublesome as the recent spate of Supreme Court 101 decisions has been, it seems that the societal interest is best served by leaving section 101 invalidation in the hands of the court.

[Kevin E. Noonan]

Dear Dr. Yarus:

But the problem with leaving it to the courts is that we substitute one person's subjective judgment (the Examiner's, with review by the Board) with another's (a district court judge). Properly informed, my money is with the Office; at least they understand the technology and the advance in the art that any particular invention may represent.

Great example about the bicycle, by the way.

Thanks for the comment

[Skeptical]

The debate between the good doctors is interesting in that the law is being placed in each of two wrong branches of the government (with the simple and best solution being the branch undiscussed and unchampioned: the Legislative branch).

How about we simply get our Congress to weigh in on this ever shifting, ever subjective, may I dare even call it a nose of wax, issue?

That we as a nation see the value of such directness, well, sadly, I remain...

[Moocow]

ACLU argues that there must be marked differences in structure AND function? So - even a molecule that was markedly changed by man would still be rejected if it retains the natural function? They're obviously trying to destroy cDNA claims through the back door. The Supreme Court made clear that cDNA has no markedly different function compared to the genomic sequence, yet one is patentable and the other is not. But under ACLU's inspired reading both should now be rejected in the PTO.
What I find curious is that they don't even acknowledge all the rejections for things other than DNA that are now going on. Medicinal molecules, pharmaceutical compositions, vaccine preparations and even laundry detergent enzymes are now being rejected on the grounds of their theory. What are they trying to accomplish? I don't get it.

[Kevin E. Noonan]

Skeptical:

As we discussed elsewhere, it doesn't matter what Congress does. Suppose Congress amended Section 101 to say "This section specifically authorizes patent claims for products of nature isolated or substantially isolated from their natural setting and having a use within the meaning of the terms of this statute," what does SCOTUS do? Overturn the law as being beyond the scope of Congressional power, insofar as SCOTUS believes such claims do not "promote the progress . . . of the useful arts."

Only way to overcome this situation would be to amend the Constitution to take away from the judicial branch matters about which they are clueless. What do you think the likelihood of that might be (let's just say I'm skeptical).

[Skeptical]

Touché

Although, personally, I would like to see more than mere conjecture about this future diminution of progress based on some broad patent.

One would like to think that if a broad patent is patentable (under the other aspects of law), that it would be sufficiently different so as to have ushered in what it was worth - if we truly meet the novelty/nonobviousness requirements, than what came before ANY invention would be enough protection from something NEWLY broad and wonderful.

[leslie fischer]

Agree with Moscow. The ACLU misses that cDNA, which, at least to SCOTUS, had no different function from genomic DNA (i.e., it carried the same information), was nevertheless patent eligible because of the difference in structure. For cDNA the structural difference overcame lack of functional difference. It should be a balanced test - kind of a sliding scale a la J. Moore in Myriad I and II.

Also, the Hartranft test (which is not a bad test) actually should be a "distinctive name, character OR use." The original quote in the tariff cases used the disjunctive "or" rather than the conjuntive "and". It was Chakrabarty that swapped an "and" for the original "or" - and Myriad quotes Chakrabarty (thus bringing the "and" into Myriad). But, quite frankly, the use of "and" by Chakrabarty was simply to fit the facts of Chakrabarty (the bacterium did have a distinctive name, character, and use).

The correct original Hartranft test - "distinctive name, character, or use" - is much less onerus. For example, one need only argue that the first derailleur gear shift changed the character of the bike.

But, realistically, we are applying a test to determine eligibility of natural products - not a novelty/obvious test. The bike example given by Dr. Yaris is a bit of a red herring because it compares a new bike to an old bike - not a new bike to a product of nature. If we do a comparison of the new bike to a product of nature (e.g., a cheetah!) the bike is clearly different in name, character or use (and here, like in Chakrabarty, we can use "and").

[Karnak]

Moocow--it appears the ACLU thinks that if there are no patents, medicine will be free. I myself wonder how long it will take US-based pharmaceutical companies to move at least part of their operations to Europe where the patentability standard has not been changed. I also wonder whether the ACLU will continue its attack on patents by trying to invalidate the patent on Ebola 'serum,' which as a collection of antibodies might be analogized to a Funk-like collection of natural products (entirely incorrectly, in my opinion). If that happens, Karnak predicts that in the future, the company making the experimental hail-Mary drug will be European, as will the first patients receiving it.