Prosecution Insights
Last updated: April 19, 2026
Application No. 18/034,429

THERAPEUTIC AGENT FOR PERIPARTUM CARDIOMYOPATHY

Non-Final OA §102§103§112
Filed
Apr 28, 2023
Examiner
ALLEN, MARIANNE P
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Chugai Seiyaku Kabushiki Kaisha
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
78%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
588 granted / 981 resolved
At TC average
Strong +18% interview lift
Without
With
+18.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
56 currently pending
Career history
1037
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
18.6%
-21.4% vs TC avg
§102
16.1%
-23.9% vs TC avg
§112
44.2%
+4.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 981 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions Applicant’s election without traverse of the IL-6 antibody inhibitor satralizumab against the IL-6 receptor (IL-6R) in the reply filed on 1/20/2026 is acknowledged. Claims 3, 5, 7-8, 10-1 5 , and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 3 with dependent claims 5, 7-8 , and 13-14 ; claims 10-12; and claim 20), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/20/2026. Claims 1-2, 4, 6, 9, and 1 6 -19 are under consideration. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 9 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 9 is confusing in its dependency on non-elected claim 3. Claim 3 is directed to administering an antibody that binds IL-6. Claim 9 is directed to the elected antibody satralizumab. This antibody binds the IL-6 receptor (IL-6R). It appears that the claim dependency needs to be corrected to claim 4. Claim 16 is confusing in its dependency (through non-elected claim 15) on non-elected claim 3. Claim 3 is directed to administering an antibody that binds IL-6. Claim 16 is directed to the elected antibody satralizumab. This antibody binds the IL-6 receptor (IL-6R). It appears that the claim dependency needs to be corrected to claim 4. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-2, 4, 6, 17, and 1 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tokudome et al. (of record, available 18 March 2020) . The Tokudome et al. abstract discloses that administration of an anti-interleukin-6 receptor antibody reduced cardiac hypertrophy in lactating Npr1-knockout mice. This disclosure anticipates the claimed method. Cardiac hypertrophy is an aspect of peripartum cardiomyopathy. See instant specification at paragraph [0011]. With respect to claim 19, the instant specification indicates that this period begins after delivery. See at least paragraph [0102]. The lactating mice of Tokudome et al. would have been post-delivery. Claims 1-2, 4, 6, and 17- 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Wakabayashi et al . Wakabayashi et al. discloses administering anti-IL - 6R antibodies such as tocilizumab to inhibit preterm delivery by inflammation. The dosage was 12 mg/kg. See at least abstract and pages 719-720. The 12 mg/kg dosage is disclosed in the instant application as being an effective dose. See at least paragraph [0108] of the instant specification. As such, the treatment disclosed by Wakaba ya shi et al. would inherently treat or prevent peripartum cardiomyopathy in the pregnant mice and by extension inherently prevent or treat peripartum cardiomyopathy in lactating subjects or subjects in puerperium. The reference does not report any occurrence of peripartum cardiomyopathy. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim s 1-2, 4, 6, 9, and 16- 1 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tokudome et al. (of record, available 18 March 2020) in view of Kakehi et al. (U.S. Patent Application Publication 2018/0148509) and Kaplon et al . Tokudome et al. is applied as above but does not disclose the particular anti-IL6R antibody administered or treating pregnant subjects. Kakehi et al. discloses antibodies for treating IL-6 related diseases. The anti-IL-6 receptor antibody SA237 is disclosed. See at least paragraphs [0009 and 0027] and claims 16, 18, 20, and 21. The SA237 antibody corresponds to the satralizumab of instant claims 9 and 16 as evidenced by Kaplon et al. at page 230, right column. It would have been obvious to administer the SA237 antibody (i.e. satralizumab) of Kakehi et al. to the lactating and peripartum/puerperium mice of Tokudome et al. to treat or prevent per i partum cardiomyopathy. One would have been motivated to do so as satralizumab would have been a known and suitable anti-IL-6R antibody. With respect to claim 18, it would have been obvious to administer an anti-IL-6R antibody such as satralizumab prior to delivery (i.e. while pregnant) in order to prevent development of peripartum cardiomyopathy. Claim s 1-2, 4, 6, 9, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wa k abayashi et al. view of Kakehi et al. (U.S. Patent Application Publication 2018/0148509) and Kaplon et al . Wakabayashi et al., Kakehi et al., and Kaplon et al. are applied as above. It would have been obvious to administer the SA237 antibody (i.e. satralizumab) of Kakehi et al. in place of the anti-IL - 6R antibody tocilizumab in the method of Wakabayashi . One would have been motivated to do so as satralizumab would have been a known and suitable anti-IL-6R antibody. Administration of the satralizumab would have had the effect required by the instant claims. A product and its properties cannot be separated. Claim s 1-2, 4, 6, 9, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (of record) in view of Saro j ini et al. , Kakehi et al. (U.S. Patent Application Publication 2018/0148509), Kaplon et al . , and Sheriff et al. (U.S. Patent Application Publication 2012/0225069) Kakehi et al. (U.S. Patent Application Publication 2018/0148509) and Kaplon et al . are applied as above. Li et al. (of record) discloses that IL-6 knock -out ( KO ) improved cardiac function and inhibited myocardial remodeling. IL-6 KO suppressed the myocardial apoptosis level in mice with dilated cardiomyopathy (DCM). Il-6 knockout inhibited the phosphorylation of STAT3 i n heart tissues of DCM mice. See at least abstract and page 3049. Treating pregnant, lactating, or peripartum subjects is not specifically disclosed. Sarojini et al. discloses that increased IL-6 levels are a predictor for mortality in peripartum cardiomyopathy. Per i partum cardiomyopathy is a disorder in which s y mptoms of heart failure occur between the last month of pregnancy and 5 months post-partum. See at least abstract and first paragraph of the introduction. Sheriff et al. discloses that anti-IL-6 receptor antibodies can be used to treat dilated cardiomyopathy . See at least abstract ; claims ; and paragraphs [0011-0013 and 0032] . Treating pregnant, lactating, or peripartum subjects is not specifically disclosed. It would have been obvious to reduce IL-6 signaling in pregnant females to treat or prevent peripartum cardiomyopathy. Li et al. makes clear that reducing IL-6 signaling improves cardiac function and Sarojini et al. makes clear that increased IL-6 levels (and by inference the signaling through the IL-6 receptor) is a predictor for mortality in peripartum cardiomyopathy. Sheriff et al. makes clear that anti-IL-6R antibodies can be used to treat cardiomyopathy. One would have been motivated to administer in anti-IL-6R antibody such as satralizumab as taught by Kakehi et al. and Kaplon et al. to block IL-6 signaling in pregnant females thereby preventing or treating peripartum cardiomyopathy. As peripartum cardiomyopathy would have been known to occur during and following pregnancy as taught by Sarojini et al. , it would have been obvious to administer satralizumab to a pregnant subject, lactating subject, and/or subject in puerperium. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MARIANNE P ALLEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0712 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 7:00-3:30 EST Monday-Friday . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Joanne Hama can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2911 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Marianne P Allen/ Primary Examiner, Art Unit 1647 mpa
Read full office action

Prosecution Timeline

Apr 28, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
60%
Grant Probability
78%
With Interview (+18.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 981 resolved cases by this examiner. Grant probability derived from career allow rate.

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