Senators Push for USPTO Pilot Program Requiring “Sequenced Approach to Patent Examination” and “Full Examination of the Grounds of Patentability”

As previously reported on March 12, 2021, bipartisan members of the Senate Committee on the Judiciary Subcommittee on Intellectual Property sent a letter to the USPTO’s Commissioner for Patents1 “regarding the state of patent eligibility jurisprudence in the United States,” and the “lack of consistency and clarity in our nation’s patent eligibility laws.”2 

On March 22, 2021, minority members of the Subcommittee on Intellectual Property, Senator Tillis (R-NC), Ranking Member, and Senator Cotton (R-AR), sent a letter to the USPTO’s Commissioner for Patents “regarding the impact of current patent eligibility jurisprudence on the patent examination process.  In particular, we believe there may be ways to modify the compact patent examination process to avoid unnecessary and inefficient rejections on grounds of patent eligibility, and in the process improve Patent and Trademark Office (PTO) effectiveness.”3 

The senators write “that under current procedures, examiners review the eligibility of a patent application under 35 U.S.C. Section 101 in conjunction with assessing the patentability of the claim under Sections 102, 103, and 112” and express concern “that by conducting an eligibility analysis as per current practice, patent examiners may be issuing Section 101 rejections without the benefit of addressing prior art, clarity and enablement issues that may well inform the examiner that the claim is eligible under Section 101.”4 Noting “examination under Sections 102, 103, and 112 is based on well-developed and objective criteria under the law,” whereas “current patent eligibility jurisprudence lacks the clarity, consistency, and objectiveness the other grounds of patentability possess,” the senators contend, “examiners may be spending inordinate time on Section 101 at a time when it is difficult or impossible to conduct a meaningful examination under Section 101, at the expense of the more rigorous analysis and precise and thoughtful work that can be conducted at the outset of examination under Sections 102, 103, and 112.”5   

Challenging the current procedures, the senators urge the USPTO to adopt a “sequenced approach” for patent examinations which would: (1) “focus[] initial examination on the objective areas of patentability,” under Sections 102, 103 and 112 “leaving eligibility examination to a point in the process where it can be conducted much more effectively;” (2) “improve[] efficiency” and avoid wasting valuable resources and “applicant time on vague questions of patent eligibility as a threshold matter;” and (3) “lead[] to stronger, more reliable, and higher quality patents by focusing first on the more rigorous and easy to identify standards of patentability.”6   

The senators urge the USPTO to “initiate a pilot program” requesting, among other things, “full examination of the grounds of patentability and then, once that process is complete, a full examination of the grounds of eligibility” by “selected examiners” and “applicants who voluntarily elect to participate.”7 The senators request a “thorough and reasonable number of examinations” through the pilot program to “measure whether this approach is more effective, and produces higher quality patents, than the traditional compact examination approach.”8 The senators ask the USPTO to respond by April 20, 2021.  If the USPTO does not “elect” to “adopt such a program,” the senators request “a detailed explanation of why you will not conduct the requested pilot program.”9 

In our experience with innovations in medical diagnostics, personalized medicine, methods of treatment, genomic analysis, and artificial intelligence, the issue is not typically related to overcoming the grounds of patentability (in a many instances, especially with respect to bioinformatics, there are typically no 102 or 103 rejections asserted, the 101 rejection remains long after the 102 and 103 rejections have been withdrawn, or the 101 rejection is raised after the 102 and 103 rejections have been withdrawn), and instead the issue lies solely with patent eligibility. Thus, in our opinion we would expect the “sequenced approach” to examination, at least in these technology areas, would have little to no impact on the avoidance of unnecessary and inefficient rejections on the grounds of patent eligibility.  Nonetheless, for other technology areas where 102 or 103 rejections are prevalent, such as general computer software and business methods, we would, however, expect at least a slight decrease in patent eligibility issues primarily attributable to the amended limitations necessary to first overcome the 102 or 103 rejections.

As discussed previously, Congress has various options available to it regarding the state of patent eligibility jurisprudence. This appears to be an attempt by Congress to exercise one of those options at the agency level. Will the senators’ push for the USPTO to adopt a “sequenced approach” for patent examinations lead to improved examination, thus clarifying patent eligibility requirements at the agency level?  Or will the reform of patent eligibility requirements be left to the legislature or judiciary as previously reported on March 17, 2021? Although this specific attempt by Congress may not be what many of us hope for—a legislative answer to the lack of consistency and clarity in our nation’s patent eligibility laws—considering the lack of congressional activity on this topic in 2020, the recent “flurry” of activity is somewhat promising for 2021. Please contact the authors with any questions, and stay tuned for updates regarding this important topic.

The opinions expressed are those of the authors and do not necessarily reflect the views of the firm, its clients, or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.


1 Currently performing the functions and duties of the Director of the USPTO following Director Iancu’s resignation.
2 See Letter from Thom Tillis, Mazie K. Hirono, Tom Cotton & Christopher A. Coons, Sens., U.S. Senate, to Drew Hirshfeld, Comm’r for Pats., U.S. Pat. & Trademark Off. 1 (Mar. 5, 2021),; see also Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014); Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66 (2012).
3 See Letter from Thom Tillis & Tom Cotton, Sens., U.S. Senate, to Drew Hirshfeld, Comm’r for Pats., U.S. Pat. & Trademark Off. 1 (Mar. 22, 2021),  
4 Id.
5 Id.
6 Id.
7 Id.
8 Id.
9 Id.

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