Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights, 60130-60134 [2022-21481]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60130-60134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21481]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2022-0025]


Request for Comments on USPTO Initiatives To Ensure the 
Robustness and Reliability of Patent Rights

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Request for comments.

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SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) seeks initial public comments on proposed initiatives directed 
at bolstering the robustness and reliability of patents to incentivize 
and protect new and nonobvious inventions while facilitating the 
broader dissemination of public knowledge to promote innovation and 
competition. This request for comments (RFC) addresses a variety of 
topics, including prior art searching, support for claimed subject 
matter, request for continued examination (RCE) practice, and 
restriction practice, and certain initiatives related to these topics 
that are outlined in the USPTO's July 6, 2022, letter to the Food and 
Drug Administration (FDA). This RFC also seeks comments on the 
questions set forth in a June 8, 2022, letter to the USPTO from six 
United States Senators. The USPTO is studying additional topics and 
initiatives to bolster the robustness and reliability of U.S. patents 
and will seek public comments on those separately.

DATES: Comment Deadline: Written comments must be received on or before 
January 3, 2023, to ensure consideration.

ADDRESSES: For reasons of government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2022-0025 on the homepage and click ``search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this RFC and click on the 
``Comment Now!'' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. Because comments will be made available for public 
inspection, information that the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.
    Visit the Federal eRulemaking Portal (www.regulations.gov) for 
additional instructions on providing comments via the portal. If 
electronic submission of comments is not feasible due to a lack of 
access to a computer and/or the internet, please contact the USPTO 
using the contact information below for special instructions regarding 
how to submit comments by mail or by hand delivery, based on the 
public's ability to obtain access to USPTO facilities at the time.

FOR FURTHER INFORMATION CONTACT: Linda Horner, Administrative Patent 
Judge, at 571-272-9797; June Cohan, Senior Legal Advisor, Office of 
Patent Legal Administration, Office of the Deputy Commissioner for 
Patents, at 571-272-7744; or Raul Tamayo, Senior Legal Advisor, Office 
of Patent Legal Administration, Office of the Deputy Commissioner for 
Patents, at 571-272-7728.

SUPPLEMENTARY INFORMATION: The USPTO is seeking public input and 
guidance on proposed initiatives directed at bolstering the robustness 
and reliability of patents. These initiatives are meant to ensure that 
the patent rights granted by the USPTO fulfill their intended purpose 
of furthering the common good, incentivizing innovation, and promoting 
economic prosperity.

I. Background and the USPTO's July 6, 2022, Letter to the FDA

    On July 9, 2021, President Biden issued an Executive Order (E.O.) 
on ``Promoting Competition in the American Economy,'' 86 FR 36987 (July 
14, 2021) (``Competition E.O.''). To advance the Biden Administration's 
goals of promoting access to prescription pharmaceuticals for American 
families and increasing competition in the marketplace, section 
5(p)(vi) of the E.O. directs the Secretary of Health and Human Services 
(HHS) ``to help ensure that the patent system, while incentivizing 
innovation, does not also unjustifiably delay generic drug and 
biosimilar competition beyond that reasonably contemplated by 
applicable law.'' In particular, section 5(p)(vi) of the E.O. directs 
the HHS Secretary, ``through the Commissioner of Food and Drugs'' and 
``not later than 45 days after the date of this order,'' to ``write a 
letter to the Under Secretary of Commerce for Intellectual Property and 
Director of the United States Patent and Trademark Office enumerating 
and describing any relevant concerns of the FDA.''
    In response to the Competition E.O., on September 10, 2021, the FDA 
sent a letter to the USPTO outlining ideas for further engagement with 
the USPTO. On July 6, 2022, the USPTO sent a responsive letter (USPTO 
Letter) discussing specific initiatives the USPTO was exploring to 
further promote robust and reliable patent rights across all technology 
areas and suggesting additional ways in which the USPTO could work with 
the FDA to ensure that our patent system properly and adequately 
protects innovation while not unnecessarily delaying generic and 
biosimilar competition, which provides more affordable versions of 
pharmaceuticals for Americans who need them. The Competition E.O. and 
the letters are available at www.uspto.gov/initiatives/drug-pricing-initiatives.
    The USPTO Letter explains that the United States is a global leader 
in the development of drugs and biologics due to its strong patent 
system. Robust and reliable patents are needed to incentivize and 
protect the immense research and development investment

[[Page 60131]]

essential to bringing such products to market and to spur the 
collaboration necessary for quick and speedy drug and biologic 
development. Our laws also strive to ensure that our system, as a 
whole, does not unnecessarily delay generic and biosimilar competition, 
which provide cost savings to Americans when they purchase 
pharmaceutical products.
    To further the objectives of the Competition E.O., the USPTO 
recently outlined initiatives to execute the President's agenda. The 
USPTO's initiatives to ensure robust and reliable patents, as discussed 
in Paragraph 2 of the USPTO Letter, are reproduced below.

    2. Improve procedures for obtaining a patent so that the USPTO 
issues robust and reliable patents. Specifically, the USPTO will:
    a. Introduce more examining time into the patent examination 
system. The USPTO recently made changes to examination time and is 
exploring further changes, particularly in cases with several 
continuations (large family cases) and cases with evidence submitted 
in support of patentability.
    b. Give patent examiners more training and resources. The USPTO 
has released a new search system for patent examiners to use in 
identifying relevant prior art to make patentability determinations. 
The new Patents End-to-End Search system includes significant 
enhancements, such as access to more than 76 million foreign 
documents with high-quality English translations and new, improved 
search capabilities. The USPTO is exploring additional technology 
and resources of prior art to improve patent quality. The USPTO also 
recently announced a collaboration with the American Intellectual 
Property Law Association and the Intellectual Property Owners 
Association to develop examiner training on enhancing the clarity of 
the prosecution record. The USPTO also is exploring additional 
training for examiners on new matter, assessing claim scope, and the 
use of functional claiming.
    c. Enhance communication between patent examiners and the Patent 
Trial and Appeal Board (PTAB), which hears challenges to patents 
once they have issued as well as appeals from rejections of pending 
patent applications during examination. The USPTO has put in place 
processes for the PTAB to share feedback as it relates to ex parte 
appeals, including sharing final decision tables with detailed 
information about the PTAB's ruling on each individual rejection and 
claim in an ex parte appeal and using surveys to facilitate 
information sharing between PTAB judges and the patent examination 
corps. Examiners are also notified when they have an application 
related to an AIA proceeding, so they can easily access prior art 
and relevant statements that may impact their examination in the 
application before them. In addition, examiners are now able to more 
quickly identify prior art relied upon and PTAB's rulings on each 
individual ground and claim in the post-grant proceeding via final 
written decision tables, which are now incorporated into all final 
written decisions. The USPTO is also exploring how data collected 
from the decision tables in both ex parte appeal and AIA proceedings 
can be relied upon to identify quality trends, such as prior art 
trends in post-grant proceedings (e.g., commonly relied upon non-
patent literature and foreign language patents) as well as 
opportunities to develop examiner training or guidance based on 
findings or lessons learned from surveys.
    d. Consider enhancing the process for information disclosure 
statements. The USPTO will continue our efforts to explore changes 
to the procedures for identifying prior art on information 
disclosure forms to provide efficiencies for applicants and to allow 
examiners to more readily identify key prior art through the 
development of an automated tool for USPTO examiners that imports 
relevant prior art and other pertinent information into pending U.S. 
patent applications.
    e. Consider applying greater scrutiny to continuation 
applications in large families and/or the use of declaratory 
evidence to overcome rejections. The USPTO is considering additional 
guidance for examiners and quality reviews by the Office of Patent 
Quality Assurance when continuation applications in large families 
are filed, or when applicants submit declaratory evidence to rebut 
an examiner's determination of unpatentability.
    f. Revisit obviousness-type double patenting practice. 
Obviousness-type double patenting occurs when a patent owner tries 
to secure a patent for an obvious variation of the innovation 
covered by another of their own patents. In these instances, under 
current practices, a patent applicant is required to file a terminal 
disclaimer so that the later patent application on an obvious 
variant of an earlier-patented invention may not be used to extend 
the term of patent protection. Although a terminal disclaimer 
ensures that the later patent will remain commonly owned with and 
have the same patent term as the earlier patent, multiple patents 
directed to obvious variants of an invention could potentially deter 
competition if the number of patents is prohibitively expensive to 
challenge in post-grant proceedings before PTAB and in district 
court. And later issued patents to obvious variants may delay 
resolution of ongoing district court litigation thereby potentially 
delaying generic and biosimilar entry into the market. The USPTO 
will explore whether any changes need to be made to the patent 
system regarding obviousness-type double patenting.
    g. Revisit procedures for third-party input. The USPTO is 
considering revising its procedures for allowing third-party input 
during prosecution. The USPTO currently has a procedure to allow 
third-party submissions of prior art in applications under 
examination. This procedure is not widely used. The USPTO will seek 
public input on whether aspects of the current procedure could be 
changed to make it more useful.
    h. Conduct a comparative analysis of the examination and 
issuance of pharmaceutical and biological patents in the U.S. versus 
in other countries and any underlying lessons learned from the same. 
The USPTO plans to conduct a comparative analysis to evaluate 
whether any additional initiatives or changes will strengthen our 
intellectual property system. Director Vidal and the USPTO team will 
also explore this topic in bilateral and multilateral discussions 
with other countries.
    i. The USPTO will provide technical input on proposed 
legislative efforts.

    A primary intention of this RFC is to seek written public comments 
on the initiatives described in the USPTO Letter reproduced above 
(2(a)-2(i)), and as reflected in questions 1-5 below. The questions in 
this RFC focus on some of these initiatives, and the USPTO plans to 
issue an additional RFC that will address other initiatives and 
additional topics concerning improvements to the patent application 
process, including, without limitation, enhancing the information 
disclosure statement process, increasing clarity and certainty in 
functional claiming, and transcribing inventor interviews.

II. June 8, 2022, Letter From Senators to the USPTO

    On June 8, 2022, the USPTO received a letter from United States 
Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun 
raising a concern about ``large numbers of patents that cover a single 
product or minor variations on a single product, commonly known as 
patent thickets.'' In the letter, the Senators commented that the 
practice of obtaining large numbers of patents on a single drug product 
``impedes generic drugs' production, hurts competition, and can even 
extend exclusivity beyond the congressionally mandated patent term.'' 
The Senators requested that the USPTO consider changes to its 
regulations and practices by issuing a notice of proposed rulemaking or 
a public RFC on a list of six questions. We are including the Senators' 
six questions in this RFC (questions 6-11 below) and welcome feedback 
on them, in addition to the proposed USPTO initiatives as reflected in 
questions 1-5 below.

III. Specific Topics and Initiatives

A. Prior Art Searching

    The USPTO Letter, section 2(b), indicates the USPTO ``is exploring 
additional technology and resources of prior art.'' Patent examiners 
have access to many resources for searching for prior art during the 
examination of patent applications. The new Patents End-to-End Search 
system includes access to U.S. patents and pre-grant publications and 
more than 76 million foreign patent documents with high-quality English

[[Page 60132]]

translations and new, improved search capabilities. In addition, 
examiners search general and technology-specific databases for non-
patent prior art and are provided the services of trained professional 
online search personnel for non-patent prior art searching. See Manual 
of Patent Examining Procedure (MPEP) 904. In question 1 below, the 
USPTO seeks public input on specific sources of prior art to ensure 
that patent examiners have access to the most relevant information. 
Specifically, the USPTO seeks public input on robust sources of 
technology-specific, non-patent literature. The USPTO also seeks public 
input on best practices to ensure that examiners are aware of public 
use and on-sale activity that is relevant to examination.

B. Support for Patent Claims

    The USPTO Letter, section 2(e), indicates the USPTO will 
``[c]onsider applying greater scrutiny to continuation applications in 
large families.'' More broadly, to ensure that all claims are properly 
supported by the specification, greater scrutiny should be considered 
any time the claims presented do not form part of the original 
specification or specifications on which the claims rely for priority, 
i.e., when new claims are presented in continuing applications (e.g., 
continuation, continuation-in-part, and divisional applications) as 
well as when new claims are presented or claims are amended during 
prosecution. In all such circumstances, because such new claims and 
amendments to claims may not have support under 35 U.S.C. 112 since 
they do not form part of the original specification, these new and 
amended claims require additional scrutiny to: (1) ensure they have 
proper written description and enablement support in the application 
itself, see 35 U.S.C. 112(a); and (2) ensure they have proper written 
description and enablement support in the application from which they 
claim entitlement to the benefit of an earlier filing date (e.g., a 
benefit or priority claim under 35 U.S.C. 119, 120, 121, or 365). 
Because an examiner must establish the effective filing date of each 
claim in order to identify applicable prior art and evaluate the claims 
for compliance with the requirements of 35 U.S.C. 102 and 103, 
examiners often spend a significant amount of time, particularly on 
continuing applications, or applications that contain numerous benefit 
or priority claims, evaluating issues related to 35 U.S.C. 112(a) 
(e.g., ascertaining the filing date of individual claims).
    Currently, the MPEP states that applicants ``should'' show 
``support'' for claims during prosecution. See, e.g., MPEP 2163 II.A. 
(``With respect to newly added or amended claims, applicant should show 
support in the original disclosure for the new or amended claims.''). 
By contrast, the reexamination and reissue rules (rules 1.530(e) and 
1.173(c), respectively) require that during reexamination or reissue 
proceedings, patentees ``must'' supply an ``explanation of the support 
in the disclosure'' for new and amended claims:

    (e) Status of claims and support for claim changes. Whenever 
there is an amendment to the claims pursuant to paragraph (d) of 
this section, there must also be supplied, on pages separate from 
the pages containing the changes, the status (i.e., pending or 
canceled), as of the date of the amendment, of all patent claims and 
of all added claims, and an explanation of the support in the 
disclosure of the patent for the changes to the claims made by the 
amendment paper.

    Similarly, in inter partes review and post-grant review 
proceedings, motions to amend ``must'' set forth ``[t]he support in the 
original disclosure of the patent for each claim that is added or 
amended.'' 37 CFR 42.121(b)(1), 42.221(b)(1). In promulgating rules 
related to motions to amend, the Office explained that the rules 
``enhance efficiency,'' for example, because the PTAB may deny the 
motion to amend when the patent owner cannot show support for the new 
claims, as opposed to a more burdensome procedure of entering the 
amendment and then substantively rejecting the claims. 77 FR 48680, 
48706, Col. 2 to 3 (Aug. 14, 2012); later amended in 85 FR 82923 (Dec. 
21, 2021) (placing the burden of persuasion on the patent owner to 
show, by a preponderance of the evidence, that the motion to amend 
complies with the requirements of 35 U.S.C. 316(d)(1) and (3); 37 CFR 
42.121(a)(2), (a)(3), b(1), and (b)(2); and 42.221(a)(2), (a)(3), 
(b)(1), and (b)(2)).
    As detailed further in question 2 below, the USPTO seeks input on 
the impact of applying a similar approach to all applications and 
whether any change would enhance the public record and reduce the 
burden on examiners. This approach would impose minimal burden on 
applicants because they are required to file claims that ``conform to 
the invention as set forth in the remainder of the specification,'' 
with claim terms that ``find clear support or antecedent basis in the 
description so that the meaning of the terms in the claims may be 
ascertainable by reference to the description.'' 37 CFR 1.75(d)(1).

C. RCE Practice

    With rare exception, after an examiner closes prosecution, 
including after the mailing of a notice of allowance or when an appeal 
has been taken to the PTAB, an applicant may file an RCE under 37 CFR 
1.114. Upon receipt of an appropriate RCE, the examiner will reopen 
prosecution and issue another action. Currently, this cycle may proceed 
indefinitely, subject only to a finding of prosecution laches. See MPEP 
706.07(h) and 2190. The USPTO seeks input through question 3 below on 
this current practice and whether there should be internal process 
changes once the number of RCEs filed in an application reaches a 
certain threshold, such as transferring the application to a new 
examiner or increasing the scrutiny given in the examination of the 
application.

D. Restriction, Divisional, Rejoinder and Non-Statutory Double 
Patenting Practice

    In situations in which two or more independent and distinct 
inventions are claimed in a single patent application, the USPTO is 
authorized by the patent laws and implementing regulations to require 
the applicant to restrict the application to one invention. The 
practice for requiring an applicant to restrict an application to one 
invention in such situations is known as restriction practice. See MPEP 
800.
    According to the USPTO's records, the number of divisional 
applications fell from more than 21,000 in fiscal year (FY) 2010 to 
fewer than 15,500 in FY 2021, while the total application filings 
increased significantly. At the same time, the filing of continuation 
applications increased significantly. The USPTO has received feedback 
that one reason many continuing applications are filed is related to 
restriction practice. See MPEP 800.
    With respect to question 4 below, the USPTO seeks input on 
improvements to restriction practice, including by allowing for the 
examination of two or more distinct inventions in the same proceeding 
in a manner similar to the practice authorized by 37 CFR 1.129(b), and 
also seeks input on whether any offset to patent term adjustment should 
be considered in such cases. The USPTO also seeks input on whether the 
burden requirement before the examiner to impose a restriction should 
be revised, and if so, how. See MPEP 808.02. In particular, the USPTO 
seeks input on whether it should adjust the method by which an examiner 
appropriately establishes burden. The USPTO also seeks input on its

[[Page 60133]]

restriction practice with respect to Markush claims. See MPEP 803.02. 
For example, the USPTO seeks input on whether the applicant should be 
authorized to suggest how the scope of the claim searched should be 
expanded if the elected species is not found in an effort to present 
closely related inventions for consideration together. The USPTO also 
seeks input on the advantages, or disadvantages, of unity of invention 
practice as compared to restriction practice.
    Additionally, with respect to question 4 below the USPTO seeks 
feedback on serial filings of divisional applications, including 
whether the current practice of authorizing the filing of divisional 
applications in a series should be revised to require all divisional 
applications to be filed within a set period of time after the 
restriction requirement is made final and after any petition for review 
has been resolved.
    Specifically, the USPTO also seeks feedback on guidance, petition 
practice, rejoinder, and harmonization with respect to restriction 
practice. The USPTO seeks input on whether to make changes to the 
rejoinder practice after a final rejection has been made. See MPEP 
821.04(a). For example, the USPTO seeks input on whether applicants 
should be given a certain time period after final rejection to provide 
appropriate claims for rejoinder.
    As a corollary to restriction practice, non-statutory double 
patenting occurs when a patent owner tries to secure a patent for a 
patentably indistinct variation of the same invention, or otherwise 
tries to obtain an unjustified timewise extension of patent rights. See 
MPEP 804 and 1504.06. A common form of non-statutory double patenting 
occurs when a patent owner files a patent application claiming an 
obvious variation of the innovation covered by another of their own 
patents. In these instances, under current practices, a patent 
applicant is required to file a terminal disclaimer so that the later 
patent application on an obvious variant of an earlier-patented 
invention may not be used to extend the term of patent protection. 
Although a terminal disclaimer ensures that the later patent will 
remain commonly owned with and have the same patent term as the earlier 
patent, multiple patents directed to obvious variants of an invention 
could potentially deter competition if the number of patents is 
prohibitively expensive to challenge in post-grant proceedings before 
PTAB and in district court. Also, multiple patents directed to obvious 
variants of an invention can pose a heavy burden on examiners because 
examiners are required to compare the claims in these multiple patents 
and pending applications to determine if the claims are patentably 
indistinct from one another such that a non-statutory double patenting 
rejection is proper. The USPTO seeks input, through question 4 below, 
on whether any changes need to be made to the patent system regarding 
non-statutory double patenting.

IV. Questions for Public Comment

    The USPTO invites written responses to the following questions and 
requests. Commenters are welcome to respond to any or all of the 
questions.
    1. Identify any specific sources of prior art not currently 
available through the Patents End-to-End Search system that you believe 
examiners should be searching. How should the USPTO facilitate an 
applicant's submission of prior art that is not accessible in the 
Patents End-to-End Search system (e.g., ``on sale'' or prior public 
use)?
    2. How, if at all, should the USPTO change claim support and/or 
continuation practice to achieve the aims of fostering innovation, 
competition, and access to information through robust and reliable 
patents? Specifically, should the USPTO:
    a. require applicants to explain or identify the corresponding 
support in the written description for each claim, or claim limitation, 
upon the original presentation of the claim(s), and/or upon any 
subsequent amendment to the claim(s) (including requiring a showing of 
express or inherent support in the written description for negative 
claim limitations)?
    b. require applicants to explain or identify the corresponding 
support for each claim, or claim limitation, in the written description 
of every prior-filed application for which the benefit of an earlier 
filing date is sought, under, e.g., 35 U.S.C. 119, 120, 121, or 365?
    c. require applicants to explain or identify the corresponding 
support for each claim, or claim limitation, in the written description 
of every prior-filed application for which the benefit of an earlier 
filing date is sought, under, e.g., 35 U.S.C. 119, 120, 121, or 365 
(including requiring such support whenever a benefit or priority claim 
is presented, including upon the filing of a petition for a delayed 
benefit or priority claim and upon the filing of a request for a 
certificate of correction to add a benefit or priority claim)?
    d. make clear that claims must find clear support and antecedent 
basis in the written description by replacing the ``or'' in 37 CFR 
1.75(d)(1) with an ``and'' as follows: ``The claim or claims must 
conform to the invention as set forth in the remainder of the 
specification, and the terms and phrases used in the claims must find 
clear support or and antecedent basis in the description so that the 
meaning of the terms in the claims may be ascertainable by reference to 
the description?''
    e. require applicants to provide detailed analysis showing support 
for genus or Markush claims, and require applicants to identify each 
claim limitation that is a genus, and explain or identify the 
corresponding support in the written description for each species 
encompassed in the claimed genus?
    f. require applicants to describe what subject matter is new in 
continuing applications (e.g., continuation, continuation-in-part, and 
divisional applications) to explain or identify subject matter that has 
been added, deleted, or changed in the disclosure of the application, 
as compared to the parent application(s)?
    3. How, if at all, should the USPTO change RCE practice to achieve 
the aims of fostering innovation, competition, and access to 
information through robust and reliable patents? Specifically, should 
the USPTO implement internal process changes once the number of RCEs 
filed in an application reaches a certain threshold, such as 
transferring the application to a new examiner or increasing the 
scrutiny given in the examination of the application?
    4. How, if at all, should the USPTO limit or change restriction, 
divisional, rejoinder, and/or non-statutory double patenting practice 
to achieve the aims of fostering innovation, competition, and access to 
information through robust and reliable patents? Specifically, should 
the USPTO:
    a. allow for the examination of two or more distinct inventions in 
the same proceeding in a manner similar to the practice authorized by 
37 CFR 1.129(b), and, if so, consider an offset to patent term 
adjustment in such cases?
    b. revise the burden requirement before the examiner to impose a 
restriction, and if so, how?
    c. adjust the method by which an examiner appropriately establishes 
burden for imposing a restriction requirement?
    d. authorize applicants, in the case of a Markush group, to suggest 
how the scope of the claim searched should be expanded if the elected 
species is not found in an effort to present closely related inventions 
for consideration together?
    e. adopt a unity of invention requirement in place of the 
restriction requirement?
    f. revise the current practice of authorizing the filing of 
divisional

[[Page 60134]]

applications in a series to require all divisional applications to be 
filed within a set period of time after the restriction requirement is 
made final and after any petition for review has been resolved?
    g. make changes to the rejoinder practice after a final rejection 
has been made, such as giving applicants a certain time period after 
final rejection to provide appropriate claims for rejoinder?
    h. limit or change non-statutory double patenting practice, 
including requiring applicants seeking patents on obvious variations to 
prior claims to stipulate that the claims are not patentably distinct 
from the previously considered claims as a condition of filing a 
terminal disclaimer to obviate the rejection; rejecting such claims as 
not differing substantially from each other or as unduly multiplied 
under 37 CFR 1.75; and/or requiring a common applicant or assignee to 
include all patentably indistinct claims in a single application or to 
explain a good and sufficient reason for retaining patentably 
indistinct claims in two or more applications? See 37 CFR 1.78(f).
    5. Please provide any other input on any of the proposals listed 
under initiatives 2(a)-2(i) of the USPTO Letter, or any other 
suggestions to achieve the aims of fostering innovation, competition, 
and access to information through robust and reliable patents.
    The USPTO also invites public input on the following questions, 
which are presented verbatim (except for minor changes to internal 
citation format) as they appeared in the June 8 letter from Members of 
Congress. Any comments relating to fee setting will be taken into 
consideration when the USPTO takes up fee setting more broadly.
    6. Terminal disclaimers, allowed under 37 CFR 1.321(d), allow 
applicants to receive patents that are obvious variations of each other 
as long as the expiration dates match. How would eliminating terminal 
disclaimers, thus prohibiting patents that are obvious variations of 
each other, affect patent prosecution strategies and patent quality 
overall?
    7. Currently, patents tied together with a terminal disclaimer 
after an obviousness-type double patent rejection must be separately 
challenged on validity grounds. However, if these patents are obvious 
variations of each other, should the filing of a terminal disclaimer be 
an admission of obviousness? And if so, would these patents, when their 
validity is challenged after issuance, stand and fall together?
    8. Should the USPTO require a second look, by a team of patent 
quality specialists, before issuing a continuation patent on a first 
office action, with special emphasis on whether the claims satisfy the 
written description, enablement, and definiteness requirements of 35 
U.S.C. 112, and whether the claims do not cover the same invention as a 
related application?
    9. Should there be heightened examination requirements for 
continuation patents, to ensure that minor modifications do not receive 
second or subsequent patents?
    10. The Patent Act requires the USPTO Director to set a ``time 
during the pendency of the [original] application'' in which 
continuation status may be filed. Currently there is no time limit 
relative to the original application. Can the USPTO implement a rule 
change that requires any continuation application to be filed within a 
set timeframe of the ultimate parent application? What is the 
appropriate timeframe after the applicant files an application before 
the applicant should know what types of inventions the patent will 
actually cover? Would a benchmark (e.g., within six months of the first 
office action on the earliest application in a family) be preferable to 
a specific deadline (e.g., one year after the earliest application in a 
family)?
    11. The USPTO has fee-setting authority and has set [fees] for 
filing, search, and examination of applications below the actual costs 
of carrying out these activities, while maintenance fees for issued 
patents are above the actual cost. If the up-front fees reflected the 
actual cost of obtaining a patent, would this increase patent quality 
by discouraging filing of patents unlikely to succeed? Similarly, if 
fees for continuation applications were increased above the initial 
filing fees, would examination be more thorough and would applicants be 
less likely to use continuations to cover, for example, inventions that 
are obvious variations of each other?

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-21481 Filed 10-3-22; 8:45 am]
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