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PTO Presentation Seeks to Clarify Subject Matter Eligibility Requirements

On August 9, 2022, the US Patent & Trademark Office (PTO) gave a public presentation, “Subject Matter Eligibility Under 35 U.S.C. § 101: USPTO Guidance and Policy.” During the presentation, the PTO indicated that its goal is to identify eligible subject matter and not reject patent applications under 35 U.S.C. § 101 where possible. However, subject matter eligibility must be determined in accordance with Supreme Court precedent as set forth in Bilski v. Kappos (2010); Mayo Collaborative Servs. v. Prometheus Labs, Inc. (2012); Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Alice Corp. v. CLS Bank International (2014). The PTO presented several biotech examples demonstrating how subject matter ineligible claims could be redrafted to encompass eligible subject matter.

The PTO presented a detailed explanation of the two-step subject matter eligibility flowchart in MPEP § 2106 and emphasized the differences between the two prongs of Step 2A. The first prong is to evaluate whether the claim recites a judicially recognized exception to eligibility. If the claims do not recite an exception, they qualify as eligible subject matter. If the claims do recite a judicial exception, the analysis proceeds to the second prong of Step 2A, which is to evaluate whether the claims recite additional elements that integrate the exception into a practical application of the exception. If the claims do recite additional elements integrating the exception into a practical application of the exception, they qualify as eligible subject matter. If the claims do not do so, the analysis proceeds to Step 2B to determine whether the claims recite additional elements that amount to significantly more than the judicial exception.

While there is significant overlap between Step 2A prong two and Step 2B, the PTO noted that under Step 2A prong two, the additional elements may be well understood, routine, conventional activity, unlike in Step 2B. For example, if conventional steps were used to affect a particular treatment or prophylaxis for a disease or medical condition, or if conventional material was used in an unconventional application, the claims would be subject matter eligible.

The PTO warned against claiming methods as a series of mental processes, mere data gathering or steps that merely apply the judicial exception.

As noted, the PTO highlighted techniques for transforming subject matter ineligible claims into subject matter eligible claims. These techniques include reciting properties that naturally occurring compositions do not possess, showing that the claimed composition possesses properties not found in naturally occurring compositions, using a conventional material or conventional method in an unconventional application and specifying a particular treatment.

Practice Note: Readers may be interested in an IP Update Legislative Alert reporting on a bill introduced by Senator Tillis to amend §101, which can be found here.




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Rage against the Machine: Inventors Must Be Human

The US Court of Appeals for the Federal Circuit found that an artificial intelligence (AI) software system cannot be listed as an inventor on a patent application because the Patent Act requires an “inventor” to be a natural person. Thaler v. Vidal, Case No. 21-2347 (Fed. Cir. Aug. 5, 2022) (Moore, Taranto, Stark, JJ.)

Stephen Thaler develops and runs AI systems that generate patentable inventions, including a system that he calls his “Device for the Autonomous Bootstrapping of Unified Science” (DABUS). In 2019, Thaler sought patent protection for two of DABUS’s putative inventions by filing patent applications with the US Patent & Trademark Office (PTO). Thaler listed DABUS as the sole inventor on both applications. The PTO found that the patent applications lacked valid inventorship and sent a Notice of Missing Parts requesting that Thaler identify a valid inventor. Thaler petitioned the director to vacate the notices. The PTO denied the petitions, explaining that a machine does not qualify as an inventor and that inventors on patent applications must be natural persons. Thaler then pursued judicial review in the district court. The district court agreed with the PTO, concluding that an “inventor” under the Patent Act must be an “individual,” and that the plain meaning of “individual” is a natural person. Thaler appealed.

The sole issue on appeal was whether an AI software system can be an “inventor” under the Patent Act. The Federal Circuit started with the statutory language of the Patent Act, finding that it expressly provides that inventors are “individuals.” The Court noted that while the Patent Act does not define “individual,” the Supreme Court has explained that the term “individual” refers to a human being unless there is some indication that Congress intended a different reading. The Federal Circuit also found that this result was consistent with its own precedent, which found that neither corporations nor sovereigns can be inventors; instead only natural persons can be inventors.

The Federal Circuit rejected Thaler’s policy argument that inventions generated by AI should be patentable to encourage innovation and public disclosure. The Court found that these policy arguments were speculative, lacked any basis in the text of the Patent Act, and were contrary to the unambiguous text of the Patent Act. The Court also rejected Thaler’s reliance on the fact that South Africa has granted a patent with DABUS as an inventor, explaining that the South African Patent Office was not interpreting the US Patent Act. The Court concluded that since Congress has determined that only a natural person can be an inventor, AI cannot be an inventor.

Practice Note: The Federal Circuit’s decision comes on the heels of a decision from the US Copyright Office Review Board finding that a work must be created by a human being to obtain a copyright. The Federal Circuit also noted that it was not confronted with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.




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PTO Issues Notice on Duties of Disclosure and Reasonable Inquiry

The US Patent & Trademark Office (PTO) issued a notice on July 29, 2022, titled “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board.” The notice comes in response to US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and to a September 9, 2021, letter from Senators Patrick Leahy (D-VT) and Thom Tillis (R-NC), who requested that the PTO “take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [PTO] and other federal agencies.”

PTO Director Vidal explained in the notice that parties involved in proceedings before the PTO should not take a position about the patentability of the claims that is inconsistent with positions taken in submissions to other government agencies regarding the same subject matter. If a party to a PTO proceeding discovers that an earlier position taken in a submission to the PTO or another government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record.

When an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other government agencies, such as the US Food & Drug Administration (FDA).

Any party presenting a paper to the PTO has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise a review of documents that are submitted to or received from other government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the PTO, the party has a duty to submit the information to the PTO.

Each individual with a duty to disclose, or each party with a duty of reasonable inquiry, should ensure that statements made to the PTO and other government agencies, or any statements made on their behalf to other government agencies regarding the claimed subject matter, are consistent. Providing material information to other government agencies, including the FDA, while simultaneously withholding the same information from the PTO violates those duties.

Further, any individual with a duty to disclose, or any party with a duty of reasonable inquiry, should review documents it receives from other government agencies to determine whether the information should be submitted to the PTO. For example, a party receiving a paragraph IV certification related to a generic drug application (e.g., an Abbreviated New Drug Application (ANDA)) should review such documents to determine whether they are material to the patentability of any pending matters before the PTO. If any information that is part of the ANDA process is deemed material to patentability in a pending PTO matter, then such [...]

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PTO Proposes Standardization of the Patent Term Adjustment Statement Regarding Information Disclosure Statements

The US Patent & Trademark Office (PTO) announced on July 12, 2022, that it intends to revise the rules pertaining to patent term adjustment to require that the patent term adjustment statement regarding information disclosure statements (IDS) be submitted on a PTO form. The PTO believes that the use of the form will streamline prosecution and be more accurate and efficient by eliminating the need for a manual review of the patent term adjustment statement.

The regulations in 37 CFR 1.704(c)(1) through (14) establish the circumstances that constitute an applicant’s failure to engage in reasonable efforts to conclude processing or examination of an application and the resulting reduction of any patent term adjustment. 37 CFR 1.704(d)(1) also provides a safe harbor for filing IDS. Filing only an IDS in compliance with §§ 1.97 and 1.98 or a request for continued examination with only a compliant IDS is not considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (8), (9) or (10) if it is accompanied by the required statement. The statement required to accompany the paper or request for continued examination must affirm that each item of information contained in the IDS meets one of the following requirements:

  • It was first cited in any communication from a patent office in a counterpart foreign or international application or from the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.
  • It is a communication that was issued by a patent office in a counterpart foreign or international application or by the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.

The PTO proposes adding new paragraph (d)(3) to 37 CFR 1.704(d), which requires filers to submit the patent term adjustment statement under 37 CFR 1.704(d)(1) on a form PTO/SB/133 to derive the safe harbor benefit under 37 CFR 1.704(d). Form PTO/SB/133 includes the required statement described above. Filers who submit a 37 CFR 1.704(d)(1) patent term adjustment statement without using the form PTO/SB/133 and filers who submit the form PTO/SB/133 with any modification to the patent term adjustment statement will not receive the benefit of the safe harbor under 37 CFR 1.704(d). Under such circumstances, the IDS or the request for continued examination, with no submission other than an IDS, will be treated as unaccompanied by a patent term adjustment statement under 37 CFR 1.704(d)(1).

Comments on the proposed rule must be received by September 12, 2022, to ensure consideration.




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PTO Issues Report to Congress on Patent Eligible Subject Matter

On June 24, 2022, the US Patent & Trademark Office (PTO) issued a report to Congress titled “Patent Eligible Subject Matter: Public Views on the Current Jurisprudence in the United States.” The report comes in response to a March 5, 2021, letter from Senators Tillis (R-NC), Coons (D-DE), Hirono (D-HI) and Cotton (R-AR) expressing concern over a lack of consistency and clarity in US patent eligibility laws since the Supreme Court of the United States’ rulings in Alice Corp. v. CLS Bank International and Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. The PTO solicited public feedback until October 15, 2021, and the report summarizes the PTO’s findings based on the 141 comments it received.

The report found that supporters of the current state of the law on eligibility tended to be companies faced with abusive and costly litigation involving “overbroad” patents, mostly related to software. Those companies noted that the current law allows them to avoid or more efficiently resolve abusive and costly litigation. Some high-tech representatives noted that their investments and innovations have increased under current eligibility jurisprudence. Certain life sciences and patient advocacy organizations also favored the current law, noting its role in enhancing access to medical technologies.

Respondents critical of the current state of the law included many patent practitioners and innovative companies, especially companies involved in life sciences. These respondents stated that current law makes patents less available and rights less predictable and has inhibited investment in new technologies and companies. Several startups and small- and medium-sized enterprises also noted that the current law undermines innovation by decreasing the availability of private risk capital and works to concentrate markets in the hands of a few large, well-resourced entities, thereby decreasing competition. Some commenters stated that they no longer seek patents and instead rely on trade secrets, resulting in reduced public disclosure of technological innovations.

The PTO will continue to solicit feedback from stakeholders, including through listening sessions. The PTO noted that additional feedback and suggestions may be sent to 101@uspto.gov.




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PTO Lowers the Bar for Genericness Refusals

The US Patent & Trademark Office (PTO) recently issued Examination Guide 1-22, Clarification of Examination Evidentiary Standard for Marks Refused as Generic (Guide 1-22), which amends the PTO’s stance on the appropriate evidentiary burden for examining attorneys refusing registration based on genericness. Previously, the Trademark Manual of Examining Procedure (TMEP) required an examining attorney to meet the demanding “clear evidence” standard to establish the prima facie case necessary for a genericness refusal. Guide 1-22, however, sets forth a lesser burden, stating that examining attorneys need only sufficient evidence to support a “reasonable predicate” for finding a mark generic. The shift marks a clear departure from longstanding TMEP practice.

The PTO credits the US Court of Appeals for the Federal Circuit as the initial source of the “clear evidence” standard. In its 1987 case In re Merrill Lynch, Pierce, Fenner, and Smith, Inc., the Federal Circuit relied on language in the TMEP stating that “the showing [for a genericness refusal] must be based on clear evidence of generic use.” Following this decision, the TMEP was revised to include the “clear evidence” standard, and the Federal Circuit later found that “clear evidence” is equivalent to “clear and convincing evidence.”

Despite years of reliance on the “clear evidence” standard, Guide 1-22 asserts that “there is no statutory basis for applying a heightened standard.” The guide states that the Federal Circuit initially misinterpreted the TMEP: “Read in context, the term ‘clear’ was meant to convey the ordinary meaning of the term, not an evidentiary burden.” Further, the Federal Circuit’s interpretation of “clear evidence” as equivalent to “clear and convincing evidence” “was not intended by the TMEP and is inconsistent with the preponderance of the evidence burden the Federal Circuit requires to prove claims that a registered mark is generic in the inter partes cancellation context.”

Following issuance of Guide 1-22, the PTO revised the TMEP to reflect the “reasonable predicate” evidentiary standard for genericness refusals. (See TMEP § 1209.01(c)(i).)

Practice Note: Agency guidelines do not have the force of law, so it will be interesting to see how the Federal Circuit treats these updated guidelines.




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PTO Re-Opens to Public

The US Patent & Trademark Office (PTO) re-opened to the public on May 25, 2022. Both the headquarters in Alexandria, Virginia, and the regional offices in Dallas, Texas; Denver, Colorado; Detroit, Michigan and San Jose, California, are now open. The offices had been closed to the public since March 16, 2020, because of the COVID-19 pandemic.

Visitors will be required to complete a health questionnaire and may be denied entry depending on the results of the questionnaire. Local COVID-19 infection rates will determine whether masks are required in each office.

Although the PTO is open to the public, oral hearings before the Patent Trial & Appeal Board and Trademark Trial & Appeal Board will still be conducted by video or telephone. In-person interviews with examiners are now possible, however.




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PTO Updates DOCX Filings, Delays Surcharge Fee

The US Patent & Trademark Office (PTO) recently announced that the surcharge fee for patent applications that are not filed in DOCX format will not go into effect until January 1, 2023. During the period before non-DOCX filings are hit with the surcharge fee, the PTO is encouraging applicants to begin filing patent applications in DOCX format (87 Fed. Reg. 25226). To address concerns some applicants have raised and to allow applicants to get acclimated to the process of filing applications in DOCX format, the PTO is providing applicants with the option to submit an applicant-generated PDF version of their application along with the DOCX file(s) when filing an application in the Patent Center without having to pay additional fees, such as application size fees.

Applicants who choose to submit an applicant-generated PDF with the validated DOCX file(s) will be able to rely on the applicant-generated PDF if a discrepancy occurs during the filing process. Once the non-DOCX filing surcharge fee officially goes into effect, applicants who submit an applicant-generated PDF with the validated DOCX file(s) will need to pay the surcharge fee and any other additional fees as a consequence for filing the applicant-generated PDF. This new document description is called “Auxiliary PDF of application,” and the corresponding document code is AUX.PDF.

The PTO advises:

Applicants are strongly encouraged to review their applications, including the USPTO-generated PDF, shortly after filing the application to identify any errors or discrepancies in the record, as discussed above. The applicant should file any necessary petition to correct the record early in prosecution and promptly after discovering any errors or discrepancies.




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What Preclusion? Post-IPR Reexam Moves Forward

The US Court of Appeals for the Federal Circuit revived a petitioner’s validity challenge seeking ex parte review at the US Patent & Trademark Office (PTO), reversing a district court decision dismissing its complaint seeking Administrative Procedures Act (APA) review of the PTO Director’s vacatur decision. The Federal Circuit concluded that the petitioner was not subject to inter partes review (IPR) estoppel from pursuing reexamination after receiving IPR final written decisions concerning the same claims of the same patents. Alarm.com Inc. v. Hirshfeld, Case No. 21-2102 (Fed Cir, Feb 24, 2022) (Taranto, Chen, Cunningham, JJ.)

This case explores the tension between the ex parte reexam statute and the IPR estoppel statute. Under 35 U.S.C. § 302, “any person at any time may file a request for reexamination . . . of any claim of a patent on the basis of any prior art cited under [§ 301].” If the PTO Director determines “pursuant to [§ 303(a)] that no substantial new question of patentability is raised,” that determination “will be final and nonappealable.” § 303(c). If a substantial new question is deemed to have been raised, “the determination will include an order for reexamination of the patent for resolution of the question.” § 304. Under § 315(e)(1), a petitioner in an IPR that results in a final written decision is estopped from requesting or maintaining a proceeding before the PTO “with respect to that claim on any ground that the petitioner raised or reasonably could have raised during that inter partes review.”

Alarm.com filed several IPR petitions that resulted in three final written decisions holding that Alarm.com had not carried its burden of proving that the challenged claims at issue were unpatentable. The Federal Circuit affirmed all three decisions in its 2018 ruling in Vivint, Inc. v. Alarm.com. Alarm.com subsequently filed three requests for ex parte reexamination of the same claims under 35 U.S.C. § 302 and 37 C.F.R. § 1.510, presenting different grounds than were presented in the IPRs. Instead of rendering a § 303(a) decision on the issue of whether petitioner presented a substantial new questions of patentability, the Director vacated the requests, finding that Alarm.com reasonably could have raised its reexamination grounds in the IPRs and, therefore, was estopped under § 315(e)(1) from submitting the requests. Alarm.com filed a complaint in the Eastern District of Virginia against the Director and the PTO under 5 U.S.C. § 702, stating that the Director’s actions were arbitrary and capricious. Following dismissal of the complaint, Alarm.com appealed.

The PTO argued that the overall ex parte reexamination scheme precluded judicial review of the Director’s vacatur decision based on § 315(e)(1) estoppel, which brought Alarm.com’s challenge within the exception to APA review, i.e., where “statutes preclude judicial review.” 5 U.S.C. § 701(a)(1). The PTO did not raise any other arguments as to why judicial review would not be available under the APA.

The Federal Circuit explained that “[t]he only portion of the ex parte reexamination statutory scheme that expressly precludes judicial review is § [...]

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The PTO Isn’t Playing Around: More Sanctions for Improper Trademark Filings

The US Patent & Trademark Office (PTO) continues to uphold its promise to combat fraud and “protect the integrity of the U.S. trademark register” with initiatives to investigate and sanction actions before the PTO that appear to violate the Trademark Rules of Practice or the PTO website terms of use. The latest effort comes in the form of a January 25, 2022, sanctions order signed by the commissioner for trademarks against Abtach, 360 Digital Marketing and Retrocube based on evidence that each of the respondents engaged in an “egregious scheme to deceive and defraud both the PTO and individual applicants in more than 5,500 trademark applications, including engaging in the unauthorized practice of law and intentionally providing false, fictitious, or fraudulent information to the PTO in violation of the PTO’s rules of practice in trademark matters.” According to the sanctions order, the respondents were each given an opportunity to respond to a show cause order issued in November 2021, but the PTO received no responses from the noticed parties.

In the sanctions order, the PTO outlined the activities of the three respondents, which appear to operate as separate entities but are ultimately controlled by Abtach, a Pakistan-based company that is also under investigation by Pakistan’s Federal Investigation Agency for criminal fraud. The PTO’s use of the word “egregious” to describe the respondents’ actions might be an understatement. The sanctions order describes how the respondents set up dozens of websites to hold themselves out as providers of logo designs and low-cost trademark application filing services while forging documents that appear to be issued by the PTO, artificially modifying official PTO documents, threatening customers with legal action if they did not file for registration of their logos through the respondents, intentionally filing applications with errors to delay and increase the cost of the prosecution process, submitting invalid verifications and declarations and demanding payments for unnecessary services or fraudulently inflated fees. The respondents took these actions while failing to employ any US-licensed lawyers to do this work before the PTO.

In determining appropriate sanctions, the PTO considers several factors, including whether the conduct was willful or negligent, whether it was part of a pattern of activity or an isolated event, whether it infected the entire record or was limited to a single submission, whether it was intended to injure a party, what effect it has on the PTO and what is needed to deter similar conduct by others. In this case, the PTO found that the respondents had orchestrated a “widespread, intentional and coordinated effort to defraud both applicants and the USPTO.” Finding the respondents’ activities to be both willful and fraudulent, and to have harmed thousands of applicants while also delaying proceedings in the PTO and “eroding trust in the U.S. trademark registration process,” the PTO ordered termination of all trademark applications and proceedings submitted by the respondents. The PTO will also flag any issued registrations as being subject to a sanctions order. To the extent any victims of the respondents have [...]

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