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Volume XI, Number 301

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Part II: The Current State of Precedential Opinions and Denials of Institution at the USPTO Patent Trial and Appeal Board – Advanced Bionics and Section 325(d) Discretionary Denials

The Patent Trial and Appeal Board (Board) has the discretion to deny instituting petitions in AIA post-grant proceedings.[1]And the USPTO has issued precedential opinions interpreting this power’s statutory sources,[2] giving the Board guidance on how to exercise its discretion when deciding whether to institute petitions. This is the second article of a three-part series that discusses how the Board is applying these precedential opinions.[3]

Under 35 U.S.C. § 325(d), the Director may decline to institute a petition when “the same or substantially the same prior art or arguments previously were presented to the Office.”[4]Advanced Bionics LLC v. Med-EL Elektromedizinische Geräte GMBH,[5]designated precedential on March 24, 2020, organized the Becton, Dickinson[6]factors into a two-part framework for the Board to apply when faced with § 325(d) considerations. This article summarizes some of the Board’s § 325(d) decisions applying Advanced Bionics, the USPTO’s Request for Comments, and practitioner takeaways. Part I of this series discussed denials in light of co-pending litigation,[7]and Part III will review the Board’s decisions relating to serial petitions.

Section 325(d) and the Advanced Bionics Framework

When determining whether to institute a post-grant proceeding, § 325(d) states that the Director (through delegation to the Board) “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”[8]

The first precedential decision to interpret this statute was Becton, Dickinson & Co. v. B. Braun Melsungen AG,[9]which outlined six factors the Board should consider when deciding whether to deny institution under § 325(d), including:

  1.  the similarities and material differences between the asserted art and the prior art involved during examination;

  2. the cumulative nature of the asserted art and the prior art evaluated during examination;

  3. the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;

  4. the extent of the overlap between the arguments made during examination and the manner in which petitioner relies on the prior art;

  5. whether petitioner has pointed out sufficiently how the examiner erred in its evaluation of the asserted prior art; and

  6. the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments.[10]

In 2020, the Advanced Bionics decision organized the Becton, Dickinson factors into a two-part framework.[11]In part one, the Board considers “whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office.”[12] The Board has noted this “is a highly factual inquiry, which may be resolved by reference to the factors set forth in Becton, Dickinson [(a), (b), and (d)].”[13] If the answer to either of the questions in part one is yes, the Board then turns to part two. In part two, the Board determines “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims [Becton, Dickinson factors (c), (e), and (f)].”[14]

The Advanced Bionics framework raises several issues for practitioners:

What does “previously was presented” mean?

The Board has interpreted “previously was presented” broadly when applying Advanced Bionics. This may include art made of record during prosecution by the examiner or the applicant.[15]An examiner may put art in the record by using it in a rejection, and an applicant may do so by including it on an information disclosure statement. Previously presented art or arguments can also include those presented during “reexamination of the challenged patent, a reissue application for the challenged patent, and AIA post-grant proceedings involving the challenged patent.”[16]Although this standard may be broad, it is not all encompassing.[17]For example, if a reference used in a rejection is combined with new references not considered during prosecution, then the Board may find that it “alone is insufficient to satisfy the first prong of Advanced Bionics.”[18] 

What does “substantially the same” mean?

Neither the Board in Advanced Bionics nor the statute explicitly defines “substantially the same prior art or arguments.” When making this determination, the Board considers how a petitioner distinguishes the art used in the petition from the previously presented art.[19] In one recent case, the Board found that art was substantially similar when the petitioner relied on it for the same subject matter as a reference used in a rejection during prosecution.[20]Using a reference that discloses new or additional subject matter, however, may prevent the Board from finding the art to be substantially the same.[21]

Whether an argument is “substantially the same” usually depends on an analysis of Becton, Dickson factor (d) (“the extent of the overlap between the arguments made during examination and the manner in which petitioner relies on the prior art”).[22]For example, the Board determined that the petitioner’s arguments were substantially the same when the “[p]etitioner advance[d] grounds of unpatentability that [were] structured substantially identically to those previously considered by the Office.” [23] In another case, the Board found that even though the reference used in a petition contained the same disclosures as one previously cited in a rejection, the petitioner’s argument was not substantially the same because the petitioner’s argument relied on the reference for new reasons and disclosures not discussed during prosecution.[24]

What does “the Office erred in a manner material to the patentability” mean?

The Board’s decision in Advanced Bionics suggests that there are at least two arguments a petitioner may make to effectively show that the Office previously erred in a manner material to patentability: (1) the Office overlooked a reference’s disclosures, or its discussion of the reference was underdeveloped; and (2)  there “is a disagreement with a specific finding of record by the Office.”[25] Subsequent decisions have further outlined the scope of these arguments.

For example, where a petitioner raised the first argument, the Board found that the Office erred when it overlooked (or rather did not consider) prior art that was cited in the body and on the face of the challenged patent.[26]This constituted an error because, in the Board’s view, the examiner should have made a rejection based on the prior art’s disclosures.[27] On the other hand, the Board found there was no error when an examiner made a rejection based on some, but not all, figures in a reference.[28] This was not error, in the Board’s view, because the figures cited by the examiner were representative of the reference’s whole teachings, thus including those asserted in the petition.[29]

In a case where the petitioner raised the second argument, the Board, closely following Advanced Bionics, determined the Office did not err when “reasonable minds could differ regarding” the obviousness of modifying prior art.[30] But the Board found a material error in another case where an examiner accepted a patent owner’s arguments regarding a lack of reasonable expectation of success.[31]The Board concluded that the examiner erred because he lacked “the benefit of the teachings of [] additional references, which show that the skilled artisan would have had a reasonable expectation of success in making the claimed” invention.[32]

USPTO’s Request for Comments

In October 2020, the USPTO requested comments on whether it should promulgate rules regarding its discretionary denial frameworks, including § 325(d).[33]The Office received over 800 comments in response and released an executive summary of them.[34]The summary does not substantively discuss changes to the Advanced Bionics framework but does refer to comments from the American Intellectual Property Law Association (AIPLA) and Intellectual Property Owners Association (IPO). 

The AIPLA suggested that there is an overlap between denials using the Advanced Bionics factors under § 325(d) and “discretionary denial of institution under 35 U.S.C. §§ 314(a) and 324(a).”[35]And it recommended that “fairness is likely supported by first evaluating whether § 325(d) applies.”

The IPO, on the other hand, advocated for a rule that slightly changes the Advanced Bionics factors.[36]The IPO suggested adding the following regulation to 37 C.F.R. § 42.108(d) and 37 C.F.R. § 42.208(e):

“Insufficient grounds. A petition for inter partes review shall not be granted based on prior art that is the same or substantially the same as that previously presented and relied upon 1) in a rejection during prosecution of the challenged patent, or 2) in another proceeding before the Patent Office involving the challenged patent, unless the petition specifically identifies a factual or legal issue that was misapprehended or overlooked and that establishes a reasonable likelihood that at least one claim challenged in the petition is unpatentable.”

The IPO’s proposed language appears to advocate for a narrower definition of “previously was presented” and adds the “reasonable likelihood” language found in 35 U.S.C. § 314(a), which may be an attempt to harmonize the standards. 

The USPTO has not indicated whether it is considering any of these suggestions.

Takeaways

For now, petitioners who are relying on the same or similar reference previously considered in prosecution or another USPTO proceeding should consider whether to proactively address in their petitions why the panel should not exercise its discretion under § 325(d). Patent owners should consider whether the facts support raising § 325(d) arguments in their Preliminary Responses. 

In the final part of this series, we will discuss precedential decisions in a third discretionary denial context: whether to deny serial petitions under 35 U.S.C. § 314(a) and the seven-factor test in General Plastic Industries Co. v. Canon Kabushiki Kaisha.[37]


[1] See, e.g., 35 U.S.C. §§ 314, 325; Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016).

[2] See USPTO, Precedential and Informative Decisions, https://www.uspto.gov/patents/ptab/precedential-informative-decisions (last accessed Sept. 2, 2021).

[3] Neer, et al., “The Current State of Precedential Opinions and Denials of Institution at the USPTO Patent Trial and Appeal Board,” https://www.finnegan.com/en/insights/blogs/at-the-ptab-blog/the-current-....

[4] Note, NHK Spring Co., Ltd. v. Intri-Plex Technologies, Inc., IPR2018-00752, 2018 WL 4373643 (2018) (precedential), says a decision under § 325(d) does not preclude a decision under § 314(a).

[5] IPR2019-01469, Paper 6, (P.T.A.B. Feb. 13, 2020) (precedential).

[6] IPR2017-01586, Paper 8, at 17-18 (P.T.A.B. Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).

[7] https://www.finnegan.com/en/insights/blogs/at-the-ptab-blog/the-current-....

[8] 35 U.S.C. § 325(d).

[9] IPR2017-01586, Paper 8, at 17-18 (P.T.A.B. Dec. 15, 2017) (precedential as to § III.C.5, first paragraph); Note, there are also 11 PTAB decisions designated “informative” relating to 35 U.S.C. §325(d), though none were issued after Advanced BionicsSee https://www.uspto.gov/patents/ptab/precedential-informative-decisions.

[10] Becton, Dickinson, Paper 8 at 17-18.

[11] Advanced Bionics, Paper 6 at 8-11.

[12] Id.

[13] Id. at 7.

[14] Id.

[15] Weatherford U.S., L.P. v. Enventure Global Tech., Inc., IPR2020-01661, Paper 19, at 16-21 (P.T.A.B. Apr. 15, 2021) (showing examples of when art was and was not previously presented).

[16] Id. at 7-8.

[17] See, e.g.Adello Biologics LLC v. Amgen Inc., PGR2019-00001, Paper 13, at 10-12 (P.T.A.B. Apr. 19, 2019) (“Thus, under the circumstances, we do not consider the Examiner’s mere acknowledgement of the IDS as a sufficient basis to warrant denial of institution under § 325(d)). This decision interprets § 325(d) using the Becton, Dickson factors but came before Advanced Bionics.

[18] Thorne Research, Inc. v. Tr. of Dartmouth Coll., IPR2021-00491, Paper 18, at 8-9 (P.T.A.B. Aug. 12, 2021).

[19] Albany Int’l Corp. v. Kimberly-Clark Worldwide, Inc., PGR2021-00019, Paper 22, at 40 (P.T.A.B. June 22, 2021).

[20] Id.

[21] Thorne, Paper 18 at 8-9.

[22] Becton, Dickinson, Paper 8 at 17-18; see also Dropworks, Inc. v. Univ. of Chicago, IPR2021-00100, Paper 9, at 11-14 (P.T.A.B. May 14, 2021).

[23] Dropworks, Paper 9 at 14.

[24] Agrofresh Solutions, Inc. v. Lytone Enterprise, Inc., IPR2021-00451, Paper 11, at 11-13 (P.T.A.B. July 27, 2021).

[25] Advanced Bionics, Paper 6 at 10-11.

[26] Vudu, LLC v. Ideahub, Inc., IPR2020-01689, Paper 16, at 18-19 (P.T.A.B. Apr. 19, 2021).

[27] Id.

[28] Albany, Paper 22 at 40.

[29] Id.

[30] Weatherford, Paper 19 at 27.

[31] Agrofresh, Paper 11 at 13-15.

[32] Id. at 14.

[33] Request for Comments on Discretion to Institute Trials Before the Patent Trial and Appeal Board, 85 Fed. Reg. 66502 (Oct. 20, 2020), https://www.uspto.gov/sites/default/files/documents/85_fr_66502_20201020....

[34] USPTO, Executive Summary of Public Views on Discretionary Institution on AIA Proceedings (Jan. 19, 2021), https://www.uspto.gov/sites/default/files/documents/USPTOExecutiveSummar....

[35] See USPTO, AIPLA Comment on Discretion to Institute Trials Before the Patent Trial and Appeal Board (Dec. 3, 2020), https://www.uspto.gov/sites/default/files/documents/1232020AmericanIntel....

[36] See USPTO, IPO Comment on Discretion to Institute Trials Before the Patent Trial and Appeal Board (Dec. 3, 2020), https://www.uspto.gov/sites/default/files/documents/1232020IntellectualP....

[37] IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) (precedential).

© 2021 Finnegan, Henderson, Farabow, Garrett & Dunner, LLPNational Law Review, Volume XI, Number 251
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About this Author

Associate

William Neer’s practice encompasses patent litigation and prosecution in the areas of chemicals, cosmetics, plants, and pharmaceuticals.  

William worked as a summer associate at Finnegan, where he assisted with a variety of matters, including complex pharmaceutical patent litigation under Hatch-Waxman, proceedings before the Patent Trial and Appeal Board (PTAB), and patent prosecution.

During law school, William served as a judicial intern at the U.S. Court of Appeals for the Federal Circuit. He also interned for Unified Patents, LLC.

While completing his...

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Thomas L. Irving Intellectual Property Finnegan, Henderson, Farabow, Garrett & Dunner Washington, DC
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Tom Irving has some 45 years of experience in intellectual property law. His U.S. pharma practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, reissue, and reexamination. In addition to advising on procuring strong U.S. patents, Tom counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability, supplemental examination, and validity analysis. He has served as lead counsel in numerous patent interferences...

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Brooke Wilner Patent Attorney Finnegan
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Brooke Wilner, a registered patent attorney, enjoys a varied trial and appellate litigation practice. She practices before U.S. district courts, state courts, the Patent Trial and Appeal Board (PTAB), the U.S. Court of Appeals for the Federal Circuit (CAFC), and the U.S. International Trade Commission (ITC).

Brooke represents both patent owners and accused infringers across a broad range of mechanical and electrical technologies, including clients in the aerospace, automotive, consumer products, software, and hardware industries. She has...

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