By Donald Zuhn —

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4.  According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.

On Monday, we reported on the opening remarks provided by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, and the overview of the Guidance provided by Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration.  Yesterday, we reported on the first of three groups of public presentations.  Today, we report on the second group of public presentations.  This group of presenters consisted of Courtenay C. Brinckerhoff of Foley & Lardner LLP; Dr. Leslie Fischer of Novartis Pharmaceuticals Corp.; and Dr. Warren D. Woessner of Schwegman Lundberg & Woessner, P.A.

Like prior presenters Dr. Sauer and Dr. Sonnenfeld, Ms. Brinckerhoff (at left) began her presentation by contending that the Guidance "[e]xtends Myriad to subject matter that was not before the Court and/or that the Court expressly stated that it was not addressing," including for example, compositions of matter, methods of treatment, and methods of manufacture.  Noting that the Supreme Court in Myriad and Mayo "warned against overly-broad applications of the subject matter eligibility exceptions [because] too broad an interpretation of this exclusionary principle could eviscerate patent law," Ms. Brinckerhoff declared that the Guidance "threatens to do just that — eviscerate patent law and stifle investment and innovation."  In support of her argument, she cited a Managing Intellectual Property article by Sherry Knowles that relied on a Journal of Natural Products paper by Dr. David J. Newman and Dr. Gordon M. Cragg entitled "Natural Products as Sources of New Drugs over the 30 Years from 1981 to 2010," (see "Sherry Knowles 'Speaks Truth to Power' on the PTO's § 101 Guidelines").  As shown in a slide from Ms. Brinckerhoff's presentation, 71% of the 1,355 drugs approved between 1981 and 2010 would fall outside the scope of the Guidance.

According to Ms. Brinckerhoff, the Office erred in two respects when crafting the Guidance.  In particular, she argued that the Office relied on an overly narrow interpretation of Funk Bros. that resulted in an overly broad application of that case, and the Office parsed claim elements rather than considering claims as a whole.  With respect to the Office's interpretation of Funk Bros., Ms. Brinckerhoff explained that the Guidance finds a composition comprising a combination of components to be non-eligible unless at least one of the components is not a natural product (as in the training slides example of pomelo juice) or unless the components have a specific physical interrelationship (as in the Guidance's firework example).

Pointing to a passage from Funk Bros. (see slide below), Ms. Brinckerhoff remarked that while she sees "mention after mention of function and utility" in the citation, the Office instead "sees that same passage as requiring a markedly different structure."  Ms. Brinckerhoff also reminded the Office (as did a number of presenters) that Chakrabarty spoke of "markedly different characteristics," and not "markedly different structure."

Contending that the Supreme Court did not question the eligibility of pharmaceutical compositions in either Myriad or Mayo, Ms. Brinckerhoff suggested an alternative test for compositions based on a proper reading of Funk Bros. (as set forth in the following slide from her presentation).

Ms. Brinckerhoff next inquired as to why method of treatment claims were subject to eligibility scrutiny as neither Mayo nor Myriad undermined the eligibility of such claims, and she indicated that she didn't understand why these types of claims were being rejected by examiners.  She concluded her presentation by noting that applicants had few options for dealing with the Guidance.  She asked whether applicants would need to take every adverse case to the Patent Trial and Appeal Board, and because the appeal route could take 3-5 years, inquired as to whether the Office would offer an expedited route to get a PTAB decision.

A copy of Ms. Brinckerhoff's presentation can be found here.

The second presenter, Dr. Leslie Fischer (at right), argued that the problem with the Guidance was that no consideration is given to the function of claimed subject matter.  Instead, "subject matter comprising only natural products must have a marked structural difference from the corresponding natural product in order to be patent eligible" (emphasis in presentation).  According to Dr. Fischer, the solution would be to use the following test for patent eligibility:

Whether the claimed subject matter, as a whole, has:
(1) a physical difference (e.g., structure, form, purity, etc.) relative to the natural product(s); and
(2) a different function or use relative to the natural product(s).

Dr. Fischer also noted that the Office's "web" of relevant cases (as shown in a slide from Mr. Tamayo's presentation) overlooked a few important decisions (which she indicated in her revised web).  These additional cases "tell us that function is important."

According to Dr. Fischer, the tariff cases Hartranft v. Wiegmann, 121 U.S. 609 (1877), and Lawrence v. Allen, 48 U.S. 785 (1849), indicate that a manufacture requires a new or distinctive form, character, name, or use.  Noting that Chakrabarty cites Hartranft in finding that the claimed bacteria in that case constituted "a product of human ingenuity 'having a distinctive name, character [and] use,'" Dr. Fischer concluded that "[t]he consideration of functional changes as relevant to patent eligibility is in accordance with historical tar[]iff and patent cases, which consider whether products derived from nature have different functions and uses" (emphasis in presentation).  Dr. Fischer also noted that the Myriad Court discussed Chakrabarty (and that case's citation to Hartranft) and Funk Bros. in similar terms, and concluded that "Myriad's use of Chakrabarty and Funk is perfectly compatible with considering whether a functional change can convert an otherwise 'natural product' into patent eligible subject matter."  Thus, she declared that "Myriad does not tell us to throw away function."

Dr. Fischer further suggested that Myriad's claims were not directed to discrete chemical compositions, but rather were directed to information.  She explained that the Myriad Court entwined DNA's functional aspect (i.e., information) with DNA's molecular structure (i.e., structure).  In her view, "Myriad addresses a product, that, according to the Court, does not have a different function or structure from that which is found in nature."  Dr. Fischer contended that the Myriad Court saw the characteristics of structure (sequence) and function (information) as inseparable, and argued that "Myriad has very limited applicability — [applying] only to subject matter in which molecular structure and function completely collapse, e.g., DNA."  Dr. Fischer concluded her presentation by asking why the Office had decided to use the most damaging interpretation of Myriad, when it did not have to, and by reminding the Office that "for natural products, function matters."

A copy of Dr. Fischer's presentation can be found here.

Noting that the Guidance "require[s] both that the claimed compound be 'non‐naturally occurring' and 'markedly different in structure from naturally occurring products' to be patent‐eligible," the final presenter in the second group, Dr. Woessner (at left), pointed out that "[n]either Myriad, Mayo nor Funk Bros. define 'natural product', much less a 'markedly structurally different, non‐naturally occurring product.'"  Dr. Woessner next reminded forum attendees that while the Supreme Court vacated In re Bergy, 596 F.2d 952 (CCPA 1979) (finding pure culture of bacterium producing antibiotic not to be a natural product) when it took up Chakrabarty, Bergy has nevertheless been extensively cited as precedent ever since.

Noting that Chakrabarty contains no language disparaging Bergy or requiring structural alterations, Dr. Woessner contended that the claimed subject matter of Bergy would satisfy the test in Chakrabarty.  Dr. Woessner concluded his presentation by declaring that neither Myriad nor Mayo provide a sufficient rationale for departing from about a century of practice that culminated in Bergy.  According to Dr. Woessner, the Guidance has been "disruptive, regressive and should be withdrawn."  He also reminded the Office that the first version of the written description guidelines were "taken back for a major overhaul after a public outcry just like this."

A copy of Dr. Woessner's presentation can be found here.

Before moving on to the third group of presentations, representatives from the Office fielded questions and received additional comments from attendees.  One attendee remarked that the Office had taken "a step backwards" and "gone way overboard" with the Guidance, and warned that "you will have your head handed to you" once the courts had a chance to consider the Guidance.  Mr. Hirshfeld noted that the Office was "exploring" the structural versus functional issue that had been raised by a number of presenters, but pointed out that the Office could not ignore Funk Bros., which he believed constrained what the Office could do.  Nevertheless, he asked attendees if there was "a way between Funk and Chakrabarty"?  June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration who presented on the Guidance at the biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting and at the BIO's 2014 Spring Intellectual Property Counsels Committee (IPCC) Conference, stated that she was particularly concerned about discerning function that is inherent from function that was "added" to the claimed subject matter by the applicant.

In the final post in this series, we will examine the comments made by the third group of public presenters as well as the open participation/question and answer session that concluded the forum.

For additional information regarding this topic, please see:

• "USPTO Holds Forum on Subject Matter Eligibility — Part II," May 14, 2014
• "Guest Post: How to Patent Grapefruit Juice — The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility — Part I," May 12, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014

By Donald Zuhn —

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4.  According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.  On Monday, we reported on the opening remarks provided by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, and the overview of the Guidance provided by Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration.  Today, we report on the comments provided by several of the public presenters.

As we noted in Part I, the ten public presenters were divided into three groups, with each presenter being given 10 minutes to provide feedback on the Guidance.  The first group of presenters consisted of Dr. Hans Sauer, Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization; Suzannah K. Sundby of Smith, Gambrell & Russell, LLP; Dr. Anthony D. Sabatelli of Dilworth IP LLC; and Dr. Kenneth H. Sonnenfeld of King & Spalding LLP.

Dr. Sauer (at left) began by noting that "BIO member companies operating in areas that have little or nothing to do with human genetics are beginning to receive 101 rejections of claims to pharmaceutical compositions, industrial enzymes, methods of treatment using medicinal molecules, and other inventions that were neither considered nor discussed in recent Supreme Court decisions."  He pointed out that BIO members believe that in crafting the Guidance, "the PTO has gone beyond interpretation of recent Supreme Court decisions, and has engaged in unwarranted extrapolation and expansion of law, in ways not prompted by the Myriad decision."  According to Dr. Sauer, notable examples of this expansion include "the application of a new 101 rationale to combination products," methods of drug administration or treatment, and "[t]he implicit but clear abandonment of cases like Parke‐Davis, In re Merz, In re Bergstrom, In re Kratz, and Merck v Olin Mathieson, which were briefed to the Supreme Court but neither discussed nor overruled."

Because "[t]he PTO is merely interpreting court decisions interpreting prior court decisions interpreting judicially‐created exceptions from the statute," Dr. Sauer contended that "the PTO is no better positioned to establish an authoritative interpretation of the Supreme Court’s 101 jurisprudence than are the lower courts."  He added that:

Expanding Myriad's holding to all claims to isolated or purified natural molecules like antibiotics and other medicinal substances, and combinations thereof, and fermentation or distillation products or bacterial enzymes, will not only prospectively block inventors from acquiring commercially meaningful protection for products that were never even mentioned by the Supreme Court [but will] also cast[] a shadow over thousands of issued patents that the PTO now says would never be issued if they were examined today and — implicitly — should never have been issued in the first place.

Dr. Sauer also noted that "[t]he PTO's interpretation of the Supreme Court cases, as applied to biotech, is not the only permissible one," and then set forth a series of questions:

So what policy choice did the PTO make when it picked its current interpretation from all the different reasonable interpretations of these cases?  Does the PTO believe the Supreme Court really meant to strike down claims to fungal antibiotics or industrial enzymes that go into laundry detergents?  Does the PTO believe it is implementing the intent of Congress when it last passed Section 101?  Or that a more draconian interpretation of Supreme Court pronouncements will advance the progress of the useful arts better than alternative readings?

As for answers to these questions, Dr. Sauer responded that "[w]e're left to guess, because that's a discussion we never had."  He concluded his comments by declaring that:

There is no unified reading of Funk, Benson, Flook, Diehr, Chakrabarty, Pioneer, Bilski, Mayo, and Myriad that is fully coherent, free of internal tension, and that operates harmonically with the other requirements of patentability.  We need the PTO to acknowledge that reality.  And we need a dialogue not only over how to best interpret the caselaw we've been given, but also whether that caselaw leads us to the right place.

A copy of Dr. Sauer's written testimony can be found here.

The second presenter, Suzannah Sundby (at right), argued that there were three problems with the Guidance:  (1) the factor-based approach set forth in the Guidance is inappropriate for § 101 eligibility determinations, (2) process and product claims should be evaluated using separate tests, and (3) the Office's interpretations of Mayo and Myriad in the Guidance are too broad.  With respect to the first issue, Ms. Sundby indicated that "[a]n ineligible factor can negate an eligible factor," and as an example, pointed out that if the Guidance's weighing of factors approach was applied to the claims of Diehr, "the steps of installing the rubber in the press and the subsequent closing of the press would negate the fact that the process integrated the algorithm into a practical application, i.e., curing and molding rubber."

As for the second issue, Ms. Sundby contended that the test for process claims should be the "significantly more" standard of Mayo, and the test for product claims should be the "markedly different characteristic" standard of Chakrabarty.  Moreover, as she pointed out "[n]owhere does the [Supreme] Court hold that a product must be both significantly more and markedly different."

In a theme repeated by many of the presenters, Ms. Sundby reminded the Office that the standard set forth in Chakrabarty was whether a naturally occurring product recited in a claim exhibits markedly different characteristics, and not whether that product exhibits markedly different structure.  She argued that this markedly different characteristic could be either a structural difference or a functional one, and that this interpretation would be consistent with both Funk Bros. and Myriad, where the patent ineligible products at issue did not possess new, different, or changed characteristics.

With respect to the Office's interpretations of Mayo and Myriad in the Guidance, Ms. Sundby contended that "the PTO seems to interpret the 'apply it' discussion in Mayo as requiring unduly specific process steps," and that the Office "appears to interpret Myriad as applying to all things, isolated or synthesized, that can be derived from a product of nature."  According to Ms. Sundby, the Supreme Court in Myriad "reasoned that information in the isolated DNA molecule is the same as it is in nature, and hence, the chemical changes resulting from its isolation did not result in a markedly different characteristic, e.g., change to the information."  She concluded, therefore, that "Myriad does not stand for the rigid proposition that all compositions and molecules that originate from products of nature are patent ineligible" (emphasis in presentation).  As a result of the Office's interpretation of Myriad, many therapeutic compositions will be found to be patent ineligible (as outlined in a slide from her presentation):

In concluding her presentation, Ms. Sundby suggested, inter alia, that the Office allow applicants of pending applications to switch elected inventions, make actual examples of claims and 101 analyses available to the public, and establish a procedure for reviewing eligibility determinations to ensure consistency and compact prosecution.

A copy of Ms. Sundby's presentation can be found here.

The next presenter in the group, Dr. Sabatelli (at left), began by focusing on the problems raised by the pomelo juice example in the Office's training slides and the Office's comments regarding the patent eligibility of gunpowder — a component of the claimed fountain-style firework of Example C in the Guidance.  While acknowledging that there was a need for the Guidance and conceding that the Guidance was "an initial step in the right direction," he asserted that the Guidance was too complex and set forth too many factors (and suggested that more factors were likely to be added by the Office or the courts).  He asked whether "we need[ed] a brighter, simpler line?"  As for changes to the Guidance, Dr. Sabatelli asked the Office to provide more examples.

A copy of Dr. Sabatelli's presentation can be found here.

The final presenter in the first group, Dr. Sonnenfeld (at right), began his presentation by a showing a slide listing the claims of Example B of the Guidance:

Claim 1:  Purified amazonic acid.

Claim 2:  Purified 5-methyl amazonic acid.

Claim 3:  A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

He argued that Example B created gaps in the available protection for many biotech and pharmaceutical applicants.  He noted, for example, that pharmaceutical composition claims (for which no exemplary claim was set forth in the Guidance) may be too narrow if a pharmaceutically acceptable carrier must impart a "significant difference," and that method of treatment claims could be limited to single indications and require the inclusion of multiple limiting elements.  With respect to claim 1 of Example B, he asked whether the Office was analyzing the claim as a whole, and suggested that a claim to "amazonic acid" was different from a claim to "purified amazonic acid" (stating that purified amazonic acid does not exist in nature).  In support for the patent eligibility of purified natural product claims, Dr. Sonnenfeld pointed to the Office's utility guidelines (as shown in the slide from his presentation):

And provided a list of patented purified natural product therapeutics:

Like Ms. Sundby, Dr. Sonnenfeld also argued that Myriad concerns genes and their information, and that the Myriad holding is limited to genes:

A copy of Dr. Sonnenfeld's presentation can be found here.

Before moving on to the second group of presentations, representatives from the Office fielded questions and received additional comments from attendees.  One attendee remarked that the Guidance had been a "process failure" because the Office had neglected to include the community of practitioners sooner.  In response, Mr. Hirshfeld stated that it was not the Office's intention to exclude the public from the discussion, but that the Office, in crafting the Guidance, was merely doing what it always had done with respect to the creation of examination guidelines.  When Office representatives were asked by another attendee whether there was a Supreme Court case that said "markedly different" was the test for determining the eligibility of claims reciting natural products, Mr. Tamayo responded that the Office believed "Myriad focused us on that being the test."  The forum then moved on to the second group of presenters.

In subsequent posts, we will examine the comments made by the remaining public presenters as well as the open participation/question and answer session that concluded the forum.

For additional information regarding this topic, please see:

• "Guest Post: How to Patent Grapefruit Juice — The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility — Part I," May 12, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014

By Anthony D. Sabatelli* —

What does grapefruit juice, or more specifically pomelo juice, have to do with all this?  I will get to that connection in just a bit.  For those of you not in the know, a pomelo is a large, grapefruit-like citrus fruit with a mild, sweet flavor, but without the characteristic bitterness of a grapefruit.  Now, on to the bitterness of the present situation.

On March 4th, the U.S. Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC § 101.  The guidelines were issued in light of the Supreme Court's decisions in Myriad, Prometheus, and related cases.  See, "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products."  The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

The Guidance sets forth a three-question inquiry with a complex twelve-factor analysis for determining whether a claim meets the criteria for patent eligibility under § 101.  The first question is whether the claim is directed to one of the four statutory categories of patentable subject matter, i.e., a process, machine, manufacture or composition of matter.  If the answer is "no", end of inquiry, and the claim is not patentable.  If "yes", one proceeds to the second question, which is whether the claim recites a judicial exception to patentability.  These exceptions are laws of nature (e.g., gravity), natural phenomena (e.g., wind), or abstract ideas (ideas in the abstract are not patentable — only applications of the ideas are).  If the answer to this second question is "no", the claim meets the eligibility requirements under § 101.  If "yes", the next inquiry is whether the claim "as a whole" recites something "significantly different" than these judicial exceptions.  This determination is made by analyzing the claim against the twelve factors — six of which weigh toward patent eligibility and six of which weigh against.

If you think this analysis is complicated, even the USPTO thinks likewise.  The Guidance actually states "[t]he determination of eligibility is not a single, simple determination, but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application."  Perhaps even more concerning is that the Guidance goes on to state "[t]hese factors are not intended to be exclusive or exhaustive as the developing case law may generate additional factors over time."  Need I say more?

So what does all this have to do with grapefruit juice — um, I mean pomelo juice?  The pomelo comes into play, because the USPTO used pomelo juice in a recent training slideshow presentation to its examiners.

The following three pomelo juice claims were analyzed under the Guidance.

Claim 1: A beverage composition comprising:
a) pomelo juice; and
b) a preservative.

Claim 2: A beverage composition comprising pasteurized pomelo juice.

Claim 3: A beverage composition comprising:
a) pomelo juice; and
b) preservative X.

Without going into excruciating detail — I will leave that for when you accidentally squirt the pomelo juice in your eye — the USPTO found the following.

Claim 1 is not patent eligible because it recites two components both found in nature, namely pomelo juice and a preservative (which in its "broadest, reasonable interpretation" would encompass vitamin E, which is another product of nature).  The USPTO likened this claim to the mixture of naturally occurring bacteria at issue in Funk Brothers, a pre-biotech era Supreme Court case that said the mixture was not patent eligible, because the bacteria themselves were not structurally altered by being mixed together.  In the present example, if instead the pomelo juice claim had specifically recited an artificial preservative, the USPTO would likely have come down in favor of patent eligibility.

Regarding Claim 2, the USPTO said this claim is patent eligible, because pasteurized pomelo juice is significantly different from what is found in nature.

As for Claim 3, the USPTO also determined this claim to be patent eligible.  Assuming that preservative X is non-naturally occurring (the USPTO didn't state this upfront in the presentation), then this composition is also significantly different from what is found in nature.

Keep in mind that even though Claims 2 and 3 would be patent eligible under the Guidance, they still need to be further analyzed for patentability under § 101 (for utility and double patenting), under § 102 (for novelty), under § 103 (for obviousness), and also under § 112 (for written description, enablement, and best mode).

It will indeed be very interesting to see how the Guidance is applied as applicants begin to receive office actions on their biotechnology patent applications.

* Dr. Sabatelli is a Partner with Dilworth IP.

Image of Citrus grandis 'Honey White Brand' or 'Khao Nam Phueng' grown in Nakhon Chai Si, Nakhon Pathom province in Thailand (above) from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.

By Donald Zuhn —

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4.  According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination.

After USPTO Deputy Director Michelle Lee welcomed attendees and viewers to the forum, Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, provided opening remarks on the Guidance, and then Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration, provided an overview of the Guidance.  Following Mr. Hirshfeld and Mr. Tamayo were several public presenters, who were divided into three groups, with each presenter being given 10 minutes to provide feedback on the Guidance.  The first group of presenters consisted of Dr. Hans Sauer, Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization; Suzannah K. Sundby of Smith, Gambrell & Russell, LLP; Dr. Anthony D. Sabatelli of Dilworth IP LLC; and Dr. Kenneth H. Sonnenfeld of King & Spalding LLP.  The second group of presenters consisted of Courtenay C. Brinckerhoff of Foley & Lardner LLP; Dr. Leslie Fischer of Novartis Pharmaceuticals Corp.; and Dr. Warren D. Woessner of Schwegman Lundberg & Woessner, P.A.  The final group of presenters consisted of Barbara Fiacco of Foley Hoag, representing the American Intellectual Property Law Association (AIPLA); Duane C. Marks of Roche Diagnostics Operations, Inc.; and Gregory A. Cox of Eli Lilly and Company, representing the American Bar Association Section of Intellectual Property Law (ABA-IPL).  Following the public presentations, the forum concluded with a hour of open participation, where USTO representatives answered questions from attendees and viewers and accepted public statements from those in attendance.

In his opening remarks, Mr. Hirshfeld (at left) noted that the process of crafting examination guidance is an iterative one in which the Office responds to significant decisions (such as Myriad) by moving as quickly as possible to get guidance to examiners, and then going back and developing further guidance, if needed, following public input and feedback.  Anticipating a question that he sensed was on the minds of most attendees, Mr. Hirshfeld indicated that he did not know what (if anything) would change in the Guidance as a result of public input and feedback, but suggested that "everything is on the table."  However, Mr. Hirshfeld declared that the Office strongly believes that the Guidance is based on principles mandated by case law (although he acknowledged that the challenge was in applying these principles).

For those who had attended the April 16 biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, Mr. Tamayo's (at right) overview of the Guidance was probably quite familiar.  In addition to reviewing the new examination procedure set forth in the Guidance for determining the subject matter eligibility of claims under 35 U.S.C. § 101, Mr. Tamayo also raised and answered several questions regarding the Guidance.

With respect to the question of why, in view of Myriad, the Guidance concerns anything more than DNA, Mr. Tamayo noted that the Guidance is not limited to Myriad, but considers a number of other Supreme Court decisions dealing with subject matter eligibility.  Mr. Tamayo also explained that the Guidance was so comprehensive because the relevant case law was so woven (as shown in the slide below).

In response to the query about why the Guidance gives short shrift to the word "discovery" in 35 U.S.C. § 101 ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter . . . ."), Mr. Tamayo noted in his presentation that "[o]ver the last 65 years, the Supreme Court has repeatedly explained that a mere discovery of nature’s handiwork is not eligible" (emphasis in original).  In support of the proposition that "discovery" is not enough for eligibility, he cited to four of the Court's decisions:

Mr. Tamayo next addressed the origin of the Guidance's "significantly different" standard, indicating that the phrase is meant to capture the two pathways to eligibility described in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).

Noting that the Court's decision in Myriad had changed the Office's understanding of the law, he explained that isolation or purification of an otherwise unchanged naturally occurring product could no longer be viewed as eligible subject matter.  According to Mr. Tamayo, the Federal Circuit's recent decision in In re Roslin added another data point that the proper test for all natural products — and not just DNA — was the "markedly different" standard of Chakrabarty.  With respect to the question of why the Office limited the marked difference analysis to structure, he explained in his presentation that the "Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature," citing to four of the Court's decisions (as shown in the slide below).

As to whether a functional difference could be used to establish a marked difference, Mr. Tamayo stated that the Office's response was "no."  In support of the Office's conclusion, he noted that while briefs submitted in the Myriad case had argued that the claimed DNA at issue in that case performed functions that native DNA could not, such arguments "did not alter the Court’s decision that eligibility hinged on a markedly different structural change."  That being said, Mr. Tamayo indicated that the Office was "open to hearing alternative interpretations and considering examples."

In lieu of convincing the Office to consider functional differences, and in the event that an applicant's claims recite molecules that are identical to naturally-occurring products, Mr. Tamayo suggested two ways to make such claims eligible:  (1) by excluding embodiments from the claim that do not possess markedly different characteristics, or (2) by combining the natural product with something that adds significantly more to the natural product (as shown in slide below).

Mr. Tamayo next addressed what he called the Guidance's most "explosive" example, Example C.

He explained that the example was intended to emphasize the important role of using the broadest reasonable interpretation (BRI) when analyzing claims for subject matter eligibility.  Mr. Tamayo noted that the Office's assertion in the Guidance that "calcium chloride and gunpowder as recited in the claim are not markedly different from what exists in nature" had drawn feedback in the patent community ranging from "disagreement to vociferous disagreement (with more of the latter)."  As in the Office's BCP presentation, Mr. Tamayo described the four types of gunpowder (simple mixture, corned gunpowder, glazed powder, and white powder) and explained that the simple mixture is not markedly different because none of the components (potassium nitrate, sulfur and charcoal) have been structurally changed.  He then explained that as a result of BRI, examiners and applicants might look at gunpowder differently (as shown in the slide below).

Mr. Tamayo concluded his presentation by answering one last question:  whether gunpowder was per se ineligible.  His response was "no," but only because, as he reminded everyone, the new examination procedure did not establish bright line rules.  He pointed out, for example, that an applicant might expressly disclaim a broad interpretation of gunpowder in the specification or use claim language that demonstrates that the particular claimed gunpowder is markedly different.

A copy of Mr. Tamayo's presentation can be found here.

In a subsequent post, we will examine the response of public presenters.

For additional information regarding this topic, please see:

• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014