Detailed Action
The present office action is in response to the amendments filed on 02 Feb 2026.
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 .
Status
Claims 11-26 of the pending application have been examined on the merits. Acknowledgement is made of the cancellation of claims 1-10.
Priority
Applicants identify the instant application, Serial #: 18/280,868, filed 07 Sep 2023, as a National Stage Entry of International Patent Application #: PCT/CN2022/079887, filed 09 Mar 2022, which claims foreign priority from Foreign Application #s: CN202110861899.6, filed 29 Jul 2021, and CN202110255275.X, filed 09 Mar 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 07 Sep 2023, 22 Jan 2025, and 01 May 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant's election with traverse of psoriasis as the species of disease in the reply filed on 02 Feb 2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden to search and examine all claims in this application on the merits under MPEP § 803.
This is not found persuasive because the instant application is subject to the “Unity of Invention” restriction standard and not the “Independent and Distinct/Undue Search Burden” restriction standard. Examiner respectfully reminds applicant that, as set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art."
The requirement is still deemed proper and is therefore made FINAL. A search of the elected species returned prior art.
Examiner notes that the relevant anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species where Compound 1 is used to treat autoimmune diseases. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim Objections
Claims 13-14, 17-18, and 23-24 objected to because of the following informalities: the claims listed do not contain proper transitional phrases in the limitations. For example, claim 13 does not contain a transitional phrase between “wherein the immune-mediated skin disease is psoriasis or atopic dermatitis” and “the autoimmune connective tissue disease is lupus erythematosus.” Applicant may overcome this rejection by adding transitional phrases in each claim in need of one. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 applicant regards as his invention.
Claims 19 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.
Regarding claim 19, the phrase "including" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 11-12, 15-16, 19-22, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0308993 (cited in the office action mailed 09 Dec 2025), hereinafter ‘993, in light of Cleveland Clinic (retrieved from https://web.archive.org/web/20190720183948/https://my.clevelandclinic.org/health/diseases/14803-connective-tissue-diseases, accessed 03/04/2026), hereinafter Cleveland Clinic. Examiner notes that the anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species where Compound 1 is used to treat autoimmune diseases. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
The instant claims are drawn to a method of treating an autoimmune disease by administering Compound (I) (below) to a subject in need (claim 11):
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The instant claims are also drawn to treating autoimmune diseases by administering compositions of Compound (I) and a pharmaceutically acceptable excipient or carrier (claim 15) and administering medicaments comprising Compound (I) and additional therapeutics (claims 20 and 21). The claims further limit the autoimmune diseases to immune-mediated skin disease or autoimmune connective tissue disorders (claim 12, 16, and 22). The limitations of Compound (I) include the route of administration (claim 19) and the amount administered to the subject (claim 25).
‘993 teaches Compound C10R which has the same structure as instant Compound (I) (paragraph [0245]):
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‘993 teaches that Compound C10R is a dual JAK/SYK inhibitor with good oral absorption (paragraphs [0324]-[0333]). ‘993 teaches treatment of diseases by administering the compounds of the reference, including compound C10R. These diseases include rheumatoid arthritis (paragraph [0120]). ‘993 further teaches that C10R may be administered in an ointment, powder, patch, propellant, or solvent and can be mixed with a physiologically acceptable carrier (paragraph [0152]). C10R can also be administered alone or in combination with other pharmaceutically acceptable compounds (paragraph [0153]) and can be administered as a dose from 1-2000 mg, preferably 5-500 mg (paragraph [0154]).
Cleveland Clinic, cited for evidence, identifies rheumatoid arthritis as a connective tissue disease and an autoimmune disease (pg. 2). Therefore, ‘993 anticipates the instant claims.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 11-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘993 further in view of Muromoto et al. (ImmunoHorizons, 2019, 3:172-185), hereinafter Muromoto, and Sernicola et al. (Immunotherapy, 2019, 12:417-429), hereinafter Sernicola, in light of Wu et al. (Life Sci, 2020, 241:117115), hereinafter Wu, and Coffey et al. (J Pharmacol Exp Ther, 2014, 351:538-548), hereinafter Coffey.
The instant claims are drawn to a method of treating an autoimmune disease by administering Compound (I) (below) to a subject in need (claim 11):
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The instant claims are also drawn to treating autoimmune diseases by administering compositions of Compound (I) and a pharmaceutically acceptable excipient or carrier (claim 15) and administering medicaments comprising Compound (I) and additional therapeutics (claims 20 and 21). The claims further limit the autoimmune diseases to immune-mediated skin disease or autoimmune connective tissue disorders (claim 12-14, 16-18, and 22-24). The limitations of Compound (I) include the route of administration (claim 19) and the amount administered to the subject (claim 25). Applicant elected psoriasis as the species of autoimmune disease in the reply filed 02 Feb 2026.
‘993 teaches Compound C10R which has the same structure as instant Compound (I) (paragraph [0245]):
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‘993 teaches that Compound C10R is a dual JAK/SYK inhibitor with good oral absorption (paragraphs [0324]-[0333]). ‘993 teaches treatment of diseases by administering the compounds of the reference, including compound C10R. These diseases include autoimmune diseases such as rheumatoid arthritis (paragraph [0120]). ‘993 further teaches that C10R may be administered in an ointment, powder, patch, propellant, or solvent and can be mixed with a physiologically acceptable carrier (paragraph [0152]). C10R can also be administered alone or in combination with other pharmaceutically acceptable compounds (paragraph [0153]) and can be administered as a dose from 1-2000 mg, preferably 5-500 mg (paragraph [0154]), and that specific doses can be determined by a skilled physician (paragraph [0154]). However, ‘993 does not teach that the autoimmune diseases include psoriasis.
Muromoto teaches that cerdulatinib treatment suppressed IL-17-induced increase of IkB-z and b-defensin 2 proteins in HaCaT cells (pg. 180, column 2; pg. 181, Fig. 6). Muromoto teaches that JAK/TYK2 inhibition can bring down the IL-17 response in keratinocytes of psoriatic lesions and may be an effective method to treat IL-17-mediated diseases (pg. 183, column 1). Wu, cited for evidence, teaches that HaCaT cells are a cell model for psoriasis (Abstract). Coffey, cited for evidence, identifies cerulatinib as a dual JAK/SYK inhibitor (Abstract).
Sernicola teaches that the JAK/STAT pathway inhibitors are known to treat psoriasis (pg. 418) and that Syk tyrosine kinases are emergent therapeutic targets in immune skin disorders such as psoriasis (pg. 419).
Based on the teachings of ‘993, Muromoto, and Sernicola, a person of ordinary skill in the art would swap cerdulatinib, a JAK/SYK inhibitor, for another JAK/SYK inhibitor, C10R, and have a reasonable expectation that C10R would function to inhibit IL-17-mediated response in HaCaT cells, a cell line model for psoriasis.
The artisan would further optimize the dose of C10R through routine experimentation as would be obvious to a person of skill in the art, as taught by ‘993, and arrive at the limitations of instant claim 26. See MPEP § 2144.05(II)(A).
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
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.
Claims 11-12 are rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1, 7, and 8 of U.S. Patent No. 10,730,887, hereinafter ‘887.
‘887 teaches a method of treating diseases which include rheumatoid arthritis by administering a compound of Formula (I) (claims 1 and 8):
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Formula (I) includes compound C10R which has the same structure as Compound (I) of the instant claims (claim 7):
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Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625