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 .
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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 14, 2026 has been entered.
The amendment filed August 14, 2026 has been entered. Claims 1-2 have been amended, claims 3-12, 15-18, 21-23, and 27-29 have been cancelled.
Applicant’s arguments filed August 14, 2026 were fully considered but they were not persuasive. Rejections and response to arguments are addressed below.
Claims 1-2, 13-14, 19-20, 24-26 are pending in this application.
Priority
This application is a 371 of PCT/US2021/061619 filed December 2, 2021 and claims the benefit of US provisional application 63/121,133 December 3, 2020.
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 1-2, 13-14, 19-20, 24-26 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 claims 1-2, 13-14, 19-20, 24-26: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 1-2 recites the broad recitation “(Scleroderma)”, and the claim also recites “systemic sclerosis” which is the narrower statement of the range/limitation. According to Gordon (HSS.edu, 2022, cited on PTO-892) when scleroderma only affects the skin, it is considered "localized." However, if it affects the skin and internal organs, it is viewed as "systemic" and called systemic sclerosis (SSc) (pg. 1, para. 1).
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 13-14, 19-20, 24-26 which depend from claim 1 are similarly rejected.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gotoh (Cell Reports, 2018, cited on PTO-892) in view of Kioon (Sci. Transl. Med., 2018, cited on PTO-892) and
Regarding claim 2: Gotoh teaches CPI-613 is a selective inhibitor of PDH and alpha-ketoglutarate dehydrogenase (pgs. 1808, cols. 1-2, bridging para.). Gotoh teaches pyruvate dehydrogenase activity are necessary for dendritic cell (DC) maturation in vitro and in vivo (title page, in brief). Gotoh teaches DCs include plasmacytoid DCs (pg. 1800, col. 2, para. 2). Gotoh teaches p32 interacts with the PDH complex and PDH activity may serve as a therapeutic target for DC-related autoimmune diseases (pg. 1802, col. 1, para. 2). Gotoh teaches DC have been implicated in the pathogenesis of multiple sclerosis, psoriasis, type 1 diabetes, and systemic lupus erythematosus (pgs. 1812-1813, bridging para.).
Gotoh does not teach a method of treating systemic sclerosis.
However, Kioon teaches pDC is an essential cell type involved in the pathogenesis of systemic sclerosis (SSc) and its removal using depleting antibodies or attenuating pDC function could be a novel approach to treat SSc patients (abstract)
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to apply the method of Gotoh to the treatment of systemic sclerosis as suggested by Kioon. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so as the art recognizes CPI-613 inhibits PDH activity, and suggests compounds that inhibit PDH activity are therapeutics for DC-related autoimmune diseases of which systemic sclerosis belongs, for the purpose of treating the disease.
Response to Arguments
Applicant’s arguments filed August 14, 2026 with respect to the claims have been fully considered but they are not persuasive.
On pages 5-8 of Applicant’s response, Applicant argues the prior art previously replied upon do not teach or suggest treatment of systemic sclerosis or scleroderma using the claimed compounds.
However, see rejections above which account for these specific limitations.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejections are maintained for reason of record and foregoing discussion.
Allowable Subject Matter
Claim 1 and dependent claims 13-14, 19-20, 24-26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Grandjean (Nat. Chem. Biol., 2020, IDS filed February 1, 2024) in view of Junjappa (Frontiers in Immunology, 2018, cited on PTO-892).
Grandjean teaches activation of the IRE1/XBP1s signaling arm of the unfolded protein response (UPR) is a promising strategy to correct defects in endoplasmic reticulum (ER) proteostasis implicated in diverse diseases (abstract). Grandjean teaches IXA4 is IRE1/XBP1 activator (pg. 1054, cols. 1-2, bridging para.).
Grandjean does not teach or suggest IXA4 for the treatment of systemic sclerosis.
Junjappa teaches IRE1 and XBP1 activation contribute to systemic sclerosis (pg. 13, col. 1, para. 3). Junjappy suggests inhibition of IRE1 as a therapeutic route in the treatment of systemic sclerosis (pg.13, col. 2, para. 1).
Taken together, it would be improper hindsight to suggest it would have been prima facie obvious to a person of ordinary skill in the art to utilize IXA4 as taught by Grandjean in the treatment of systemic sclerosis. A person of ordinary skill in the art would lack the motivation to do so with a reasonable expectation of success as the art suggests IRE1 inhibition rather than activation is beneficial in the treatment of systemic sclerosis. The instant specification demonstrates that IXA4 can activate IRE1a/XBP1 to abrograte IFNA expression (pg. 34, lines 3-15). The instant specification discloses IRE1-XBP1 activation induces PHGDH expression leading to IFN production which can treat systemic sclerosis (pg. 13, lines 1-5). Thus the method claims are found to be enabled.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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