Patent Docs

Webinar on Supplementary Protection Certificates

January 30, 2021

J A Kemp will be offering a webinar entitled "SPCs — Update on Recent Political and Legal Developments" on February 2, 2021 from 2:30 to 3:30 pm GMT (Greenwich Mean Time). Ravi Srinivasan and Graham Lewis of J A Kemp will use case studies to illustrate tips for preparing a patent portfolio to take maximum advantage of the SPC system and to prepare for any post-Brexit changes. The webinar will address the following topics:

• Update on recent CJEU judgments, including C-650/17 (Royalty Pharma) and C-673/18 (Santen)
• Update on SPCs in the UK post-Brexit
• Optimising patent claims for SPC purposes
• Choosing the right patent for your SPC applications
• Planning ownership for multiple SPCs
• Third party considerations

Those wishing to register can do so here.
PTAB Grants CVC Motion for Marraffini Deposition

January 27, 2021

By Kevin E. Noonan —

The Patent Trial and Appeal Board (PTAB) entered an Order on Tuesday regarding the motion by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") in Interference No. 106,115, for leave to subpoena discovery from Luciano Marraffini and Shuailiang Lin, neither of whom is a party to this interference against Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad"). Specifically, CVC asserted in its motion under 37 C.F.R. § 41.156(a) that these subpoenas were necessary because these witnesses each possessed knowledge from their work with Feng Zhang and their prior statements CVC characterized as being "material to Broad's priority proofs [and] that contradict its priority statement allegations." This testimony, CVC asserted, was in the interest of justice because the Broad is likely not to proffer their testimony and without it "the PTAB's fair assessment of Broad's priority case will be frustrated."

Substantively, CVC asserted that Dr. Marraffini was expected to testify that Dr. Zhang did not conceive of an embodiment falling within the scope of the Count before publication of the Jinek 2012 reference (disclosing CVC's invention). This testimony would be consistent with assertions CVC made in its priority motion, stating without alleging that Broad derived its invention from CVC's disclosures (formal and otherwise). The motion further placed Dr. Marraffini in collaboration with Dr. Zhang from December 2011 as evidenced by publications and patent applications filed by research teams including Drs. Marraffini and Zhang. The motion set out quotations from Dr. Marraffini attributing development of single-guide RNA embodiments of CRISPR to CVC's inventors, and characterized this testimony as contradicting Broad's assertion in its priority statement that Dr. Zhang conceived an invention within the scope of the Count prior to publication of the Jinek 2012 reference. The motion identified four specific categories of testimony from Dr. Marraffini:

(1)     his knowledge of Zhang's work on CRISPR-Cas9 systems, particularly the status of that work before publication of Jinek 2012;

(2)     his knowledge of Zhang's failures to conceive and reduce to practice a single-guide RNA CRISPR-Cas9 system;

(3)     his communications with Zhang before the filing of [Application No. 61/736,527] about the use of single-guide RNA in a CRISPR-Cas9 system; and

(4)     related testimony that contradicts Broad's allegations of priority.

CVC supported its request for leave by recounting its unsuccessful attempts to obtain this testimony voluntarily, and contended that only by subpoena would the Junior Party be able to obtain the testimony.

Regarding Dr. Lin, CVC attested that, like Dr. Marraffini he was expected to testify that Dr. Zhang had not invented single-guide RNA species of CRISPR-Cas9 prior to publication of the Jinek 2012 reference. This expectation was based on certain correspondence to this effect between Dr. Lin and Jennifer Doudna from 2015. In addition, the motion contended that Dr. Jin prepared a laboratory presentation in June 2012 where he stated that "the lab had been unsuccessful in implementing a CRISPR-Cas9 system in eukaryotes." CVC asserted that Dr. Lin was expected to testify regarding these topics (and that his deposition will be limited to them):

(1) his involvement with Zhang's experiments;

(2) the circumstances surrounding Zhang's first awareness of a single-guide RNA in a CRISPR-Cas9 system;

(3) Zhang's failures in reducing a CRISPR-Cas9 system to practice before learning of the CVC inventors' work; and

(4) related communications between Lin and Zhang concerning such issues.

As with Dr. Marraffini, CVC argued that the subpoena was necessary because Dr. Lin had refused to testify voluntarily.

The Broad opposed, arguing that granting leave to subpoena these witnesses and their purportedly expected testimony would not be in the interests of justice. But in the event that the Board granted leave, Broad asked that it be awarded half of the maximum 7 hours for each deposition.

In the Board's Order, CVC was granted leave to subpoena Dr. Marraffini but not Dr. Lin, and Broad granted only one hour of cross-examination limited to the topics CVC raised in its deposition. The Order sets forth the basis for the Board's decision, reminding the Parties that additional discovery is granted at the Board's discretion and only on a showing that such discovery is in the interests of justice. Particularly prohibited are "[f]ishing expeditions" under Shiokawa v. Maienfisch, 56 U.S.P.Q.2d 1970 (BPAI 2000) (precedential). With these principles in mind, the Board reviewed CVC's arguments in support of permitting deposition of Dr. Marraffini, and found persuasive the allegation that there were communications (including telephone conversations) between Dr. Marraffini and Dr. Zhang that were not of record or contained in any of the documentary evidence before the Board, suggested by e-mails that were in evidence (by Broad). The Board asserted in this regard that "the evidence Broad presents indicates that Dr. Marraffini would likely be able to testify about other information the Board regarding Dr. Zhang's knowledge of the single-guide RNA." But while granting leave the Board limited CVC's deposition questioning to the topic of "[Dr. Marraffini's] communications with Dr. Zhang about the use of single-guide RNA in a CRISPR-Cas9 system before the filing of the Zhang B1 provisional application." The Board specifically denied CVC's request for "a broader range of testimony, including the status of Dr. Zhang's work before publication of Jinek 2012 and his knowledge of Dr. Zhang's failures to conceive and reduce to practice single-guide RNA CRISPR-Cas9 systems." Denial was based on CVC not establishing for the Board why evidence of such failures would be relevant under circumstances where the inventor is ultimately successful, the Order stating that it is Broad's burden to justify its priority claim (presumably including explaining, inter alia, why such failures were not evidence of defective conception). Thus CVC's requests for these other areas of Dr. Marraffini's testimony were denied by the Board.

CVC's arguments regarding the need for Dr. Lin's testimony was less persuasive overall. After setting forth both Parties' arguments for and against the Board granting CVC leave, the Board held that "[b]ecause CVC does not direct us to specific evidence that Dr. Lin was present in the Zhang laboratory when Dr. Zhang allegedly learned of the 'single guide RNA'" there was insufficient basis for believing that "his testimony on the circumstances surrounding Zhang's first awareness of a single-guide RNA in a CRISPR-Cas9 system would be productive" (based on facts asserted by Broad in opposition to CVC's motion). And as with the Board's treatment of Dr. Marraffini's putative testimony of Dr. Zhang's purported failures to reduce to practice single guide RNA mediated CRISPR in eukaryotic cells, the Board did not appreciate sufficient relevance in failure for it to grant the motion. The Board's Order states that "CVC fails to direct us to a sufficient basis why Dr. Lin's testimony about his involvement with Zhang's experiments, the circumstances surrounding Dr. Zhang's first awareness of single-guide RNA, alleged failures in reducing a CRISPR-Cas9 system to practice before learning of the CVC inventors' work or communications between Drs. Lin and Zhang would be productive," particularly in view of the "delay and expense" involved in compelling Dr. Lin's testimony contrary to the Board's mandate to seek a "just, speedy, and inexpensive resolution" to matters before it. Accordingly, CVC's request for leave to subpoena Dr. Lin was denied by the Board.

Regarding Broad's request in its motion for cross-examination, the Board found no justification for Broad's request for "equal time" with CVC, and thus granted CVC leave to depose Dr Marraffini for up to six hours and Broad one hour of cross-examination.

Finally, the Board granted an extension of the remaining schedule in the interference of one month to accommodate the parties in seeking and taking Dr. Marraffini's deposition. The resulting schedule for the remainder of the interference was set forth as follows (Time Periods 11 and 12 having already expired):

TIME PERIOD 13 …………………………………………………26 March 2021
File oppositions to all motions

TIME PERIOD 14 …………………………………………………….6 May 2021
File all replies

TIME PERIOD 15 ……………………………………………………19 May 2021
File request for oral argument
File list of issues to be considered
File motions to exclude
File observations

TIME PERIOD 16 ……………………………………………………31 May 2021
File oppositions to motions to exclude
File response to observations

TIME PERIOD 17 …………………………………………………….7 June 2021
File replies to oppositions to motions to exclude

ORAL ARGUMENT DATE (if ordered) ………………………………………..TBD
Do mRNA-based COVID Vaccines Have an Achilles Heel?

January 26, 2021

By Kevin E. Noonan —

The COVID-19 pandemic has spread throughout the globe, infecting more than 90 million people and causing almost two million deaths (see "Tracking coronavirus' global spread"). SARS-CoV-2 infection is the cause of the COVID-19 pandemic; this virus is recognized as the latest viral infection in humans of zoonotic origins, in this case bats first arising in Wuhan, China.

But the world's hope against the pandemic has been raised by the development of effective vaccines against virus infection in record time, using technology based on the mRNA encoding a particular viral protein called Spike. The rapidity of vaccine development is one of the advantages of using modern RNA technology, and this is a direct consequence of two aspects of this technology. First, RNA sequencing technology has permitted quick determination of the genetic sequence of the viral RNA. In particular, this technology identified the sequence of the viral Spike protein, which is major antigenic determinant and required for virus entry into infected cells, attaching to the angiotensin 1 converting enzyme 2 (ACE-2) receptor. Second, because this protein is necessary for infectivity, immunological responses directed at the encoded protein were believed to be (and turned out to be) particularly effective in provoking immunity to infection. And because just this specific protein can be produced in the laboratory (and then in industrial quantities) for producing the vaccine used to raise immunity, many of the deleterious effects, both biological and temporal, of using "whole" viruses can be avoided. It is a remarkable demonstration of applying technology developed over the past 40 years to solve a critical problem in global health. And it would have been almost impossible to have achieved these vaccines "the old fashioned way," i.e., using virus samples and either genetically attenuating them or inactivating them with heat, chemicals, and like methods.

But the capacity of the virus to mutate and change portions of the sequence of the Spike protein has raised concerns that the current vaccines, which were all raised with specific Spike protein-encoded RNAs, might be ineffective for such variants. This potential deficiency raises the possibility if not the likelihood that vaccination against the known ("original") Spike protein might in fact select for the variants, which could spread even in an inoculated population. The only way to forestall if not prevent such an outcome would be a massive inoculation effort that could prevent sufficient replication of the virus in naïve members of the population to not give the virus replication and mutation opportunities to outrun inoculation efforts.

But such a strategy is impractical in a global epidemic, if only due to the logistics of inoculating a large fraction of the world's population when transmission across national boundaries, oceans, and continents is facilitated by global travel. And the most draconian lockdown, quarantine, and travel ban regimes are unlikely to be effective unless aided by population and geography, for example, in New Zealand which is almost literally at the end of the world.

The variant problem is one that arises precisely because of the way the vaccine has been made. Viruses like all living things are genetically heterogenous, and the SARS-CoV-2 virus "in the wild" is likely comprised of thousands if not millions of slightly different genetic sequences, some of which are found in the Spike protein. In addition, the biologically active portion of the Spike protein, i.e., the portion that interacts with the ACE-2 receptor and facilitates virus entry into infected cells, is not necessarily the most antigenic portion of the protein, albeit because the vaccines are "neutralizing" antibodies (which means just what it sounds like) antibodies produced by the vaccine must interfere with such binding. When vaccines are prepared from populations of viruses they can be expected to comprise a somewhat representative population of these slightly variable proteins; for SARS-CoV-2 these would be not only the Spike protein but any protein antigenically available to the immune system.

As a result, any vaccines produced using mRNA technology cannot have the plurality of viral proteins and the populations of variant viral proteins that are provided by more conventional immunological methods. The immunity thereby provided is specific but its very specificity renders the immunological protection narrow compared with more traditional vaccines. This narrowness provides the virus with an opportunity for immune avoidance and thus infection even in individuals immunized against the current Spike protein. And paradoxically, the vaccine may in fact select (in the Darwin, "survival of the fittest" meaning) for such variants, which can propagate through the human population in spite of even robust vaccination efforts.

Fortunately, there may be two silver linings in this viral cloud. First, the very rapidness of the production of these first mRNA vaccines may permit equally (or perhaps even faster) development of mRNA vaccines specific for these variants, and the provision of immunological "cocktails" of vaccines directed against the most prevalent or infectious variants. Second, many variants may not be capable of immune evasion, so despite the genetic changes created during infection some portion of the new variants will not be capable of infecting vaccinated individuals. Third, there is a balance between such variants and their effectiveness in infection that could select for less infectious or perhaps less deleterious strains of the virus; the thought in classical immunology was that pathogens that were limited to human infections over time attenuated because the more virulent strains burned themselves out while the milder forms permitted their hosts to live long enough to infect more, other individuals. This is one explanation for why influenza infection is constant, because those viruses can be passed through fowl (ducks and chickens) and swine (pigs and hogs) as well as humans, and thus selection in these animal populations can produce virus populations more virulent in people.

There may be a grandeur in this biological view of life, but when it comes to pandemic infection a perhaps more apt meme is that nature truly is red in tooth and claw (and Spike proteins), and pathological infections are almost impossible to avoid in the long run. In the short term, however, the hope is that they can be tamped down enough to put out the fire this time, and for us to learn the lesson of the importance of eternal vigilance and preparedness against the next potential pandemic.
In re Fulton (Fed. Cir. 2020)

January 24, 2021

By Donald Zuhn –-

Last month, the Federal Circuit affirmed the final determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board affirming the Examiner's rejection of certain claims in U.S. Patent Application No. 12/789,280 as obvious.

The rejected claims of the '280 application are directed to methods of making a low-carbohydrate baked food product using egg-bound water and psyllium fiber instead of traditional flour. Psyllium is the common name for several members of the plant genus Plantago whose seeds are used commercially for the production of mucilage. The panel opinion explains that digestible starch in flour acts to bind the fiber and protein components of baked foods when wetted, but notes that starch can have a significant impact on blood glucose levels once consumed. The '280 application describes the reduction of digestible starch from baked foods by preparing low-starch, high-fiber baked food products using controlled hydration of mucilaginous hydrocolloids such as psyllium. The opinion notes that claim 22 is representative (wherein disputed claim limitations are italicized):

22. A method for producing a baked food product, comprising:
    mixing dry components together to form a dry mix, wherein said dry mix comprises a fiber component and baking soda, wherein said fiber component constitutes about 30% to 65% by weight of said dry mix, wherein said fiber component is substantially free of digestible carbohydrate, wherein said fiber component comprises psyllium fiber comprising ground psyllium husk, ground psyllium seed, or a mixture thereof, and wherein said fiber component is the only fiber component in said dry mix;
    mixing liquid components together to form a liquid mix, wherein said liquid mix comprises a liquid protein component and a fat component, wherein said liquid protein component comprises egg white or fresh whole egg;
    blending said dry mix with said liquid mix to form a dough, wherein said dry mix or said liquid mix or both comprise one or more additives selected from the group consisting of processing aids, emulsifiers, leavening agents, flavoring agents, sweeteners, bracers, colors, preservatives and acidulants, wherein proper hydration of said fiber is achieved by maintaining a fiber-to-water weight ratio in a range of 1:0.6 to 1:3 in said dough, wherein water from egg white or fresh whole egg or both provides over 90% of total water in said dough, and wherein said dough has a digestible starch content of 2% or less by weight and a digestible carbohydrate content of 4% or less by weight; and
    baking said dough without the use of yeast to allow an internal network to encapsulate hot gases re-leased during the baking process to inflate said dough into a baked food product selected from the group consisting of a bread or muffin.

During prosecution of the '280 application, the Examiner rejected claims 22, 25–27, 30–33, 36, 39–43, and 45–50 as obvious in view of in view of the combination of three prior-art references: European Patent Publication No. EP 0 642 737 A1 (Woestelandt), U.S. Patent No. 6,322,826 (Zohoungbogbo), and U.S. Patent Application Publication No. U.S. 2007/0275121 A1 (Malby). Woestelandt discloses a gluten-free bakery product made with 30–70% by weight gluten-free wheat flour and 30–70% by weight eggs, and also discloses that the problem of crumbling in gluten-free products made by conventional methods using water and gluten-free flour can be addressed by using egg as a binder. Zohoungbogbo discloses a low-carbohydrate flour comprising at least 50% protein, less than 15% carbohydrates (preferably less than 5%), and 35–50% plant fibers, and also discloses that this low-carbohydrate flour can be used as a substitute for wheat flour in the preparation of dietetic foods. Malby discloses a gluten-free bread made from eggs and gel-forming plant material such as psyllium fiber, and also discloses that the use of psyllium eliminates the traditional fermentation step (i.e., proving or raising).

In rejecting the claims of the '280 application, the Examiner found that Woestelandt discloses most of the limitations of claim 22, and that a person of ordinary skill in the art would have substituted Woestelandt's whole wheat flour with Zohoungbogbo's low-carbohydrate flour when preparing a dietetic baked food product. The Examiner also found that the fiber-to-water weight ratio of the resulting bakery product would be 1:0.64 to 1:0.91, falling within the range recited in claim 22. The Examiner concluded that it would have been obvious to use psyllium fiber as the plant fiber in baked products made without proving or fermentation (such as in the method of claim 22).

The Board affirmed the Examiner's rejection of claims 22, 25–27, 30–33, 36, 39–43, and 45–50, finding that the record supported the Examiner's finding of a motivation to combine Woestelandt and Zohoungbogbo, and also finding that a skilled artisan would have had a reasonable expectation of success in substituting psyllium fiber in Woestelandt's process. The Board also found that Woestelandt's process of mixing a gluten-free flour with egg without adding free water was substantially identical to the claimed process of the '280 application of providing water mainly from a protein source (e.g., eggs).

In affirming the Board's decision, the Federal Circuit determined that substantial evidence supported the Board's finding that a person of ordinary skill in the art would have modified Woestelandt in view of Zohoungbogbo and Malby to arrive at a baked food product containing psyllium-fiber flour. The panel noted that Woestelandt discloses a bread product made from essentially the same ingredients as the claimed invention, including egg as a binder and water source, with the exception that Woestelandt uses wheat flour instead of a low-carbohydrate, psyllium-fiber flour, and that Zohoungbogbo discloses a baking flour composed of 35–50% plant fibers and less than 5% carbohydrates that is a desirable substitute for wheat flour to prepare low-carbohydrate dietetic baked goods. The panel determined that "[t]hese teachings support the Board's determination that a skilled artisan would have found it obvious to substitute the wheat flour in Woestelandt with the plant-based flour in Zohoungbogbo in preparing a low-carbohydrate dietetic baked product." The panel also noted that Malby's teachings regarding the beneficial properties of psyllium support the Board's finding that a skilled artisan would have substituted the plant fiber in the Woestelandt-Zohoungbogbo baked product with psyllium plant fiber for the reasons suggested in Malby.

The Federal Circuit disagreed with the Appellant's argument that Zohoungbogbo does not teach or suggest a gluten-free flour, finding that Zohoungbogbo discloses the use of rice germ as one source of protein other than wheat gluten. The Federal Circuit also disagreed with the Appellant's argument that Woestelandt and Malby teach incompatible baking techniques, finding that the Appellant failed to cite anything in the record that undermined the Board's factual findings that the benefits taught by Malby would apply in the asserted combination. Having found the Appellant's arguments to be unpersuasive, the Federal Circuit affirmed the decision of the Board.

In re Fulton (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Taranto, and Stoll
Opinion by Circuit Judge Stoll
Conference & CLE Calendar

January 24, 2021

January 26, 2021 – "Second Medical Use Patents — Verifying Validity" (Gowling WLG) – 9:00 to 10:00 am EST

January 27, 2021 – "Videoconferencing at the EPO" (Intellectual Property Owners Association) – 11:00 am to 12:00 pm (ET)

January 27, 2021 – "Means Plus Function Claim Construction in Patent Prosecution and Litigation" (Fitch Even) – 12:00 pm to 1:00 pm (EST).

January 28, 2021 – "How Allyship Advances Diversity & Inclusion in the IP Legal Profession: Part 1 – Personal Experiences" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

January 28, 2021 – "IP Law and Strategy for AI — A European Perspective" (Gowling WLG) – 2:00 to 3:00 pm ET
IPO Webinar on Videoconferencing at the EPO

January 23, 2021

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Videoconferencing at the EPO" on January 27, 2021 from 11:00 am to 12:00 pm (ET). Mike Jennings of AA Thornton, James Pickford of Procter & Gamble, and Gwilym Roberts of Kilburn & Strode will provide an overview of how videoconferencing is being relied on increasingly for formal hearings at the European Patent Office — for examination, oppositions and appeals — and how this provides an option for applicants/proprietors and opponents to participate or observe from their home countries. The panel will summarize the changes to EPO rules and procedures (including December 2020 updates), share their tips and experiences, and also discuss EPO management's plans to promote videoconference examiner consultations, which have been an effective tool for U.S. attorneys working with the USPTO.

The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
IPO Webinar on Diversity & Inclusion in the IP Legal Profession

January 23, 2021

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "How Allyship Advances Diversity & Inclusion in the IP Legal Profession: Part 1 – Personal Experiences" on January 28, 2021 from 2:00 pm to 3:00 pm (ET). Eldora Ellison of Sterne, Kessler, Goldstein & Fox, PLLC; Natalie Gonzales of Baker Botts L.L.P.; Aamir Haq of Hewlett Packard Enterprise; Joshua Simmons of Kirkland & Ellis, LLP; Ritu Singh of Dinsmore & Shohl LLP; and Richard Watkins of Medtronic will share personal experiences where they experienced good or poor allyship, and will also share practical tips on how to be better allies — especially in the IP field.

There is no registration fee for the webinar. However, those interested in attending the webinar should register here.
Webinars on IP Law and Strategy for AI in Europe

January 23, 2021

Gowling WLG will be offering a three-part US Tech Webinar Series. The third webinar in that series, which is entitled "IP Law and Strategy for AI — A European Perspective," will be offered from 2:00 pm to 3:00 pm ET on January 28, 2021. Matt Hervey and Neil Hendron of Gowling WLG (London) will talk about IP law and strategy for AI in the context of evolving commercial, technical, legal, and regulatory environments.

Those wishing to register for the webinar can do so here.
Webinar on Means Plus Function Claim Construction

January 23, 2021

Fitch Even will be offering a webinar entitled "Means Plus Function Claim Construction in Patent Prosecution and Litigation" on January 27, 2021 from 12:00 pm to 1:00 pm (EST). Jon A. Birmingham of Fitch Even will discuss these topics and more:

• How to identify means plus function claim terms
• How to construe means plus function claim terms
• How to avoid a means plus function claim construction in patent prosecution
• How to use means plus function claim terms in patent prosecution
• Indefiniteness and means plus function claim terms
• Differences between the Doctrine of Equivalents and means plus function equivalents

While there is no cost to participate in the program, advance registration is required. Those interested in attending the webinar can register here.
USPTO Responds to Congressional Request for Information Regarding Criteria for Registration Examination for Admission to Patent Bar

January 21, 2021

By Donald Zuhn –-

On Tuesday, U.S. Patent and Trademark Office Director Andrei Iancu, in one of his last acts before stepping down from the post, sent a letter to Senators Thom Tillis (R-NC), Christopher Coons (D-DE), and Mazie Hirono (D-HI) of the Subcommittee on Intellectual Property for the Senate Judiciary Committee, responding to the Senators' letter of December 11, 2020 seeking information regarding the criteria for the registration examination for admission to the patent bar. The letter from the Senators sought the Office's response to the following six questions:

1. What percentage of registered patent practitioners are women? To the extent the USPTO does not currently have this data, do you commit to collecting it?

2. Has the USPTO performed or is the USPTO aware of any studies regarding the impact of its criteria/or admission to the patent bar on the diversity of patent practitioners?

3. When did the USPTO last evaluate its criteria for admission to the patent bar? Please provide the USPTO's reasons for either changing or maintaining the admission criteria at that time, including any proposed changes considered and objective arguments or data considered.

4. Over the past 5 years, has the USPTO received requests to change the criteria for admission to the patent bar? If so, describe each request and the USPTO's response to the request, including the USPTO's reasons for its response.

5. How many individuals have qualified to take the patent bar over the past 5 years? Please indicate the number of individuals, by gender, who qualified under each of Categories A, B, and C. And, for those individuals qualifying under Categories B and C, please provide a list of their undergraduate and graduate degrees.

6. How many individuals, broken down by gender, have requested to take the patent bar exam who did not qualify under Categories A, B, or C? Of those, how many individuals, broken down by gender, did the USPTO permit to take the patent bar exam? Please provide separate lists of the undergraduate and graduate degrees for those who were permitted to take the patent bar exam and those who were not, respectively.

Before addressing the questions posed by the Senators, Director Iancu noted that the Office continuously evaluates the criteria for the registration examination, and stated that "[t]hese criteria serve the important function of ensuring that those who practice before the USPTO have the requisite scientific and technical knowledge to competently represent our nation's inventors." The Director also acknowledged that the Office shared the Senators' belief that the criteria "not . . . act to discourage applications from women or individuals from other underrepresented groups."

For registered practitioners who may not be familiar with the categories referenced in the questions above, Categories A, B, and C relate to the different ways in which an applicant can demonstrate the scientific and technical training required by the Office in order to be allowed to take the examination for admission to the patent bar. In particular, applicants who possess a Bachelor's Degree in a recognized technical subject fall in Category A; applicants who possess a Bachelor's Degree in a subject other than a recognized technical subject, but who have completed a certain number of semester hours in specific courses or who have completed "other acceptable course work" fall in Category B; and applicants who do not qualify for Categories A or B, but who have passed the Fundamentals of Engineering (FE) test, fall in Category C.

With respect to the Senators' first question, the Office noted that while it has included a salutation field on the application for registration examination since FY2015, the Office only began accepting electronic applications in October 2019, and a manual review of the non-electronic applications "would be a lengthy process and was not able to be completed in the required timeframe for this response." However, in reviewing the 1,937 electronic applications that the Office had received since October 2019, the Office noted that of the 397 applicants in this group who passed the examination, 29.22% selected the "Ms." field on their applications and 70.78% selected the "Mr." field.

Turning to the second question, the Office noted that it had not undertaken nor was aware of any formal studies to evaluate the impact of admission criteria to the patent bar on the diversity of patent practitioners.

Regarding the third question, the Office noted that it "evaluates the criteria for applicants to sit for the registration examination on an ongoing basis," and that based on this ongoing evaluation, the Office was "currently looking into making a number of changes to the criteria." Among the possible changes would be to expand the list of Category A degrees, accept masters and doctoral degrees under Category A, and accept a combination of core sciences coursework under Category B.

In response to the fourth question, the Office noted that it had been contacted by a professor in 2019 who thought that changing the criteria for admission to the patent bar would result in more women being admitted, but received no further communication from the professor after directing the professor to the OED Director. The Office also indicated that after a review of petitions from applicants denied admission to take the registration examination, it identified three situations that appeared to be responsive to the Senators' letter. However, the Office explained that in two of the three situations, the applicant overcame the denial, and in the third, the applicant failed to provide supplemental information to the Office.

With respect to the fifth question, the Office noted that 8,540 applicants had applied to take the registration examination in the past five years, of which 8,049 (94.25%) had been approved to take the examination and 361 (4.23%) had been disapproved. Referring to the 1,937 applicants who filed electronic applications, the Office also noted that 65.67% of these applicants selected the "Mr." salutation and 34.33% chose the "Ms." salutation. As for the respective categories for these applicants, the Office pointed out that for Category A applicants, 67.45% were "Mr." and 32.55% were "Ms."; for Category B applicants, 59.37% were "Mr." and 40.63% were "Ms."; and for Category C applicants, 93.33% were "Mr." and 6.67% were "Ms." The Office did not provide a list of undergraduate and graduate degrees for the Category B and C applicants.

Finally, regarding the sixth question, the Office noted that of the 1,937 applicants who filed electronic applications, 31 of 1153 applicants (2.44%) who selected the "Mr." salutation were disapproved to take the registration examination and 25 of 585 applicants (3.76%) who selected the "Ms." salutation were disapproved to take the registration examination. The Office did not provide a list of undergraduate and graduate degrees for applicants who were permitted to take the registration examination and applicants who were not permitted to take the examination. The Office concluded its letter by indicating that "while the statistics based on the 'Mr./Ms.' field do not show the gender data for all currently registered practitioners, this data provides some insight into the possible gender breakdown for practitioners registered in the past 14 months." The Office also offered to provide technical assistance on legislation "[s]hould Congress desire that the USPTO collect more comprehensive data about the gender of applicants for the registration examination."

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