DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Status 03/13/2026 has been entered.
3. Claims 15-18, 20-32 and 34-41 are pending.
4. Claims 15-18, 19-27, 35-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
5. Claims 28-32, 34 and 39-41 are under examination as they read on a prophylactic and/or therapeutic method of an inflammatory disease, and the species of the antibody comprising CDRs of SEQ ID NOs: 7-9 and 22-24.
6. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claims 28-32, 34 and 39-41 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18512090 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `090 application are directed to method of treating inflammatory diseases with anti-S100A8/A9 antibodies including (clone No. 45, AB45) comprising the CDRs of SEQ ID NO: 7-9 and 22-24. Construing claims in light of the specification, the claimed genus in the `090 application is used to determine the scope of the anti-S100A8/A9 antibodies genus. The `090 specification discloses same anti-S100A8/A9 antibodies species as the claimed species (clone No. 45, AB45) comprising the CDRs of SEQ ID NO: 7-9 and 22-24), thus the genus of anti-S100A8/A9 antibodies claims is interpreted broadly to include those species. Accordingly, the claimed species of anti-S100A8/A9 antibodies are within the genus’s scope of the `090 application.
The claims of the `090 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/12/2026, have been fully considered, but have not been found convincing.
Applicant submits that claim 28 specifically recites heavy chain variable regions and light chain variable regions. The claims of copending Application No. 18/512,090 fail to recite any details about heavy chain variable regions or light chain variable regions of the antibody or the antibody fragment. Thus, the present claims with the recitation of the heavy chain variable regions and the light chain variable regions are patentably distinct from claims 1-20 of copending Application No. 18/512,090. The final Office Action fails to address this patentable distinction.
This is not found persuasive because construing claims of the `090 application in light of the specification, the specification of `090 application is used to determine the scope of the anti-S100A8/A9 antibodies genus. The `090 specification discloses same anti-S100A8/A9 antibodies species as the claimed species (clone No. 45, AB45) comprising the CDRs of SEQ ID NO: 7-9 and 22-24), thus the genus of anti-S100A8/A9 antibodies claims is interpreted broadly to include those species. Accordingly, the claimed species of anti-S100A8/A9 antibodies are within the genus’s scope of the `090 application. Applicant does not dispute this fact.
Applicant further argues that the final Office Action asserts that the mechanism of action does not have a bearing on patentability of the invention if the invention was already known or obvious, addressing the TMPRSS2 expression recited in the claims. However, claim 28 specifically recites a method of suppressing TMPRSS2 expression by administering to a subject in need thereof a suppressing TMPRSS2 expression agent. This is a new method of administration that was not taught nor suggested in copending Application No. 18/512,090, let alone recited in the claims of copending Application No. 18/512,090.
According to MPEP 2112.02, "[t]he discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957)." Given that copending Application No. 18/512,090 does not mention anything about suppressing TMPRSS2 expression, it can only be concluded that this property was unknown to the inventors of the copending Application No. 18/512,090 at the time this application was filed. Thus, the present claims include a new use of a known structure based on unknown properties, and the present claims should be considered patentably distinct from the claims of copending Application No. 18/512,090 for this reason as well.
This is not found persuasive because the instant case, the claims are concerned with mechanisms of action, suppressing TMPRSS2 expression by administering to a subject in need thereof a suppressing TMPRSS2 expression agent including an antibody or an antibody fragment as an active ingredient (i.e., a statement of effect, reciting the purpose or intended use of the claimed invention, merely extolling benefits or features of the invention). The mechanism of action is inherent property. In Jansen v. Rexall Sundown, Inc., the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated. If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
The prior art reference meets the single step method of administering the anti-S100A8/A9 antibodies to a subject. Preamble language in claims of the instant application is directed to "suppressing TMPRSS2 expression" is expressions of purposes and intended results, and as such are non-limiting, since language does not result in manipulative differences in steps of claims. It does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. In re Hirao 190 USPQ 15, 15-16, (CCPA 179) held that the preamble was non-limiting because it merely recited the purpose of the process, which was fully set forth in the body of the claim.
Therefore, it is clear that both the `090 application and applicant administer the same composition comprising the same antibody to the same subject to achieve the same results. The instant methods do not negate or preclude the mechanism of action indicated by the prior art nor does applicant provide objective evidence to distinguish the prior art from the claimed invention.
8. Claims 28-32, 34 and 39-41 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11858984 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `984 patent are directed to anti-S100A8/A9 antibodies used to treat an inflammatory disease selected from the group consisting of pulmonary fibrosis, lung injury (including acute lung injury and chronic lung injury). The claims of the `984 patent anticipate the instant claims.
Applicant’s arguments, filed 02/12/2026, have been fully considered, but have not been found convincing.
Applicant submits that claim 28 specifically recites a method of suppressing TMPRSS2 expression by administering to a subject in need thereof a suppressing TMPRSS2 expression agent. This is a new method of administration that was not taught nor suggested in the '984 patent, let alone recited in the claims of the '984 patent.
According to MPEP 2112.02, "[t]he discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re- 17 Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957)." Given that the '984 patent does not mention anything about suppressing TMPRSS2 expression, it can only be concluded that this property was unknown to the inventors of the '984 patent at the time this patent was filed. Thus, the present claims include a new use of a known structure based on unknown properties, and the present claims should be considered patentably distinct from the claims of the '984 patent for at least this reason.
This is not found persuasive because the instant case, the claims are concerned with mechanisms of action, suppressing TMPRSS2 expression by administering to a subject in need thereof a suppressing TMPRSS2 expression agent including an antibody or an antibody fragment as an active ingredient (i.e., a statement of effect, reciting the purpose or intended use of the claimed invention, merely extolling benefits or features of the invention). The mechanism of action is inherent property. In Jansen v. Rexall Sundown, Inc., the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated. If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
The prior art reference meets the single step method of administering the anti-S100A8/A9 antibodies to a subject. Preamble language in claims of the instant application is directed to "suppressing TMPRSS2 expression" is expressions of purposes and intended results, and as such are non-limiting, since language does not result in manipulative differences in steps of claims. It does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. In re Hirao 190 USPQ 15, 15-16, (CCPA 179) held that the preamble was non-limiting because it merely recited the purpose of the process, which was fully set forth in the body of the claim.
Therefore, it is clear that both the `984 patent and applicant administer the same composition comprising the same antibody to the same subject to achieve the same results. The instant methods do not negate or preclude the mechanism of action indicated by the `984 patent nor does applicant provide objective evidence to distinguish the prior art from the claimed invention.
9. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 28-32, 34 and 39 stand rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Pat. 11858984/US20210054061 for the same reasons set forth in the previous Office Action mailed 09/30/2025.
Applicant’s arguments, filed 02/12/2026, have been fully considered, but have not been found convincing.
Applicant submits each of the inventors of the present application are listed as inventors of Sakaguchi et al. Further, the inventors of the present application including Masakiyo Sakaguchi, Shinichi Toyooka, Rie Kinoshita, and Kota Araki invented the subject matter in Sakaguchi et al. that is relied upon in the final Office Action to reject claims 28-34 and 39 under 35 U.S.C. §102(a)(2). The other inventors listed in Sakaguchi et al., including Shuta Tomida, Kazuhiko Shien, Hiroki Sato, Junichiro Futami, Mikio Okazaki, Eisaku Kondo, Yusuke Inoue, and Akira Yamauchi did not contribute to the specific subject matter of Sakaguchi et al. that is being relied upon in the final Office Action when rejecting the claims of the present application. The specific roles of the inventors listed in Sakaguchi et al., which are not listed as inventors of the present application, is provided in the Declaration under 37 C.F.R. § 1.130, submitted herewith. Further documents supporting the statements of the Declaration, including AMED(P-CREATE) Published reports, Kinoshita et al., and Araki et al. are submitted herewith. Accordingly, Sakaguchi et al. should not be considered prior art under the exception of 35 U.S.C. §102(b)(2)(A).
The declaration filed 02/12/2026, under 37 CFR §1.130 is insufficient to overcome the rejection because the declaration is missing the name of the declarant. The declaration is an incomplete declaration due to the blank space being inadvertently left unfilled with the name of the declarant. Otherwise, the Declaration would be sufficient to overcome the US Pat. 11858984/US20210054061 rejections.
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 16, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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