Detailed Action
The present office action is in response to the amendments filed on 16 Jun 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, 13-15, 17-21, and 23-26 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 16 Jun 2026. Acknowledgement is made of the cancellation of claims 1-10, 12, 16, and 22.
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.
Response to Applicant Arguments
Acknowledgment is made of the remarks filed 16 Jun 2026.
The rejections of claims 12, 16, and 22 are rendered moot following the cancellation of the claims.
The objection to claims 13-14, 17-18, and 23-24 is rendered moot following applicant amendments
The rejection of claim 19 under 35 U.S.C. § 112(b) is rendered moot following applicant amendments
The rejection of claims 11-12, 15-16, 19-22, and 25 under 35 U.S.C. § 102 is rendered moot following applicant amendments
The nonstatutory double-patenting rejection of claims 11-12 is rendered moot following applicant amendments.
Regarding the rejection of claims 11, 13-15, 17-21, and 23-26 under 35 U.S.C. § 103 over US 2019/0308993 (cited in the office action mailed 09 Dec 2025), hereinafter '993, further in view of Muromoto et al. (ImmunoHorizons, 2019, 3:172-185; cited in the office action mailed 16 Mar 2026), hereinafter Muromoto, and Sernicola et al. (Immunotherapy, 2019, 12:417-429; cited in the office action mailed 16 Mar 2026), hereinafter Sernicola, in light of Wu et al. (Life Sci, 2020, 241:117115; cited in the office action mailed 16 Mar 2026), hereinafter Wu, and Coffey et al. (J Pharmacol Exp Ther, 2014, 351:538-548; cited in the office action mailed 16 Mar 2026), hereinafter Coffey; applicant arguments have been fully considered but are not persuasive. In light of the amended claims, the rejection has been modified to incorporate the new limitations. This new grounds of rejection is necessitated by applicant amendment.
Applicant argues that '993 does not disclose all the limitations of claims 11, 15, and 21; further that Muromoto, in light of Wu and Coffey, does not cure the deficiencies of '993; and finally that Sernicola does not cure all the deficiencies of '993 (pgs. 10-13 and pgs. 16-18).
These arguments are not persuasive. Attacking references individually is not evidence of nonobviousness when the rejection is based on the combination of references. See MPEP § 2145(IV).
Applicant argues that '993, Muromoto, and Semicola, in light of Wu and Coffey, do not teach or suggest each and every limitation of the independent claims (pg. 13).
This argument is not persuasive. The references together teach treatment of autoimmune diseases and diseases which are mediated by the JAK/SYK pathway, taught by '993; Muromoto, in light of Wu and Coffey, teach treatment of psoriasis cell models by administering the dual JAK/SYK inhibitor cerdulatinib; and Sernicola teaches that JAK/STAT pathway inhibitors are known to treat psoriasis while Syk tyrosine kinases are emerging targets in immune skin disordres such as psoriasis. Together, the references teach treatment of psoriasis by administration of C10R. Further, '993 teaches that the amount of the compound or pharmaceutical composition of the invention administered to a patient is not fixed and is usually administered in a pharmaceutically effective amount and the amount of the compound actually administered can be determined by the physician based on a variety of factors (paragraph [0123]).
Applicant argues that in view of the declaration filed 16 Jun 2026 the references do not teach the unexpected superior technical effect, satisfactory activity, low toxicity, and low side effect of the claimed method as demonstrated by the experimental results of the declaration (pg. 14 and 19-20).
This argument is not persuasive. The declaration describes experiments comparing the instant Compound (I) and cerdulatinib in low, medium, and high doses in two toxicity and one bioavailability test. It was shown that different drugs present different safety and bioavailability profiles in the mice and rats tested. There is no evidence in the declaration or remarks that different drugs having different safety considerations would be unexpected. '993 teaches that the amount of the compound or pharmaceutical composition of the invention administered to a patient is not fixed and is usually administered in a pharmaceutically effective amount and the amount of the compound actually administered can be determined by the physician based on a variety of factors (paragraph [0123]). The results presented in the declaration are therefore not enough to overcome the case of obviousness made in the office action mailed 16 Mar 2026.
Applicant argues that cerdulatinib and Compound C10R have significantly different biological activities based on the structural differences and as evidenced in Wu and Muromoto, where Wu teaches that curdulatinib is a JAK/SYK dual inhibitor while Muromoto focuses on TYK2 inhibition being important to treat psoriatic lesions. Applicant argues this is different than the teachings that '993 teaches Compound C10R as a JAK/SYK inhibitor (pg. 15).
This argument is not persuasive. As stated by applicant, Wu discloses that cerdulatinib is a JAK/SYK dual inhibitor and '993 teaches Compound C10R as a JAK/SYK inhibitor. Further Sernicola teaches that JAK/STAT pathway inhibitors are known to treat psoriasis while Syk tyrosine kinases are emergent targets in skin disorders such as psoriasis (see below). C10R and cerdulatinib therefore have similar utilities and a person having ordinary skill in the art would have a reasonable expectation of success that they may treat similar diseases.
Applicant argues that compounds with similar structures may not necessarily have the same activity and presents R333 as an example of a JAK/SYK dual inhibitor with skin inhibitory activity that had its evaluation discontinued due to phase II clinical failures (pg. 16).
This is not persuasive. Applicant arguments are not a replacement for evidence where evidence is needed. See MPEP § 2145(I).
Applicant argues that test results in Examples 2-5 demonstrate superior activity of Compound (I) in treating psoriasis, atopic dermatitis, and SLE while having no influence on the central nervous system, respiratory system, and cardiovascular system of animals (pgs. 19-20).
These arguments are not persuasive. Applicant has not explained why these results are unexpected and it is unclear from the examples provided how Compound (I) deviates from the expectation that JAK/SYK inhibitors treat psoriasis as is made obvious by the prior art discussed above.
In light of the discussion above, the rejection of claims 11, 13-15, 17-21, and 23-26 under 35 U.S.C. § 103, as obvious over ‘993, Muromoto, and Sernicola is amended for the reasons of record and restated below
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, 13-15, 17-21, and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘993 further in view of Muromoto, Sernicola, in light of Wu and 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]). '993 teaches that the amount of the compound or pharmaceutical composition of the invention administered to a patient is not fixed and is usually administered in a pharmaceutically effective amount and the amount of the compound actually administered can be determined by the physician based on a variety of factors (paragraph [0123]). Finally, ‘993 teaches that diseases associated with high expression of SYK and JAK may be treated by compounds of the reference (paragraph [0088]). 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.
Conclusion
No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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