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 .
Withdrawn rejections
Rejections of claims 45-49, 51, 55, 57, 61-63, 65 and 69 under 35 USC 112(b) are withdrawn in view of amendments to the claims filed on 2/5/26.
Rejection of claims 57, 61-63, 69, 95, 100 and 107 under 35 USC 102(a)(1) over Berthiaume et al is withdrawn in view amendments to the claims (2/4/26) limiting the subject population to subjects who have an autoimmune disorder or an inflammatory disorder.
Rejection of claims 45 and 49 under 35 USC 102(a)(1) over Smith et al is withdrawn in view of amendments to the claims (2/4/26) that limit the active agent to DDD85646, PCLX-001 or IMP1008.
Rejection of claims 45 and 49 under 35 USC 103 over Rampoldi in view of Berthiaume and Stankiewicz is withdrawn in view of applicant’s argument. Rampoldi suggests exploring use of NMT1 inhibitors for development of immunosuppressive drugs. However, no example of NMT1 inhibitor used in an art recognized model of a disease is presented. Examiner agrees with the applicants that there is not sufficient for a skilled artisan to have an expectation of success in a therapeutic efficacy of administrating the claimed NMT inhibitors.
For the same reasons as detailed above rejection of claims 45 and 49 under 35 USC 103 over Rampoldi in view of Berthiaume and Zenlea is withdrawn.
Maintained rejections
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) 45, 49, 51 and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berthiaume et al (WO 2014/067002).
Independent claims 45 and 51.
Claim interpretation:
Claim 45 is directed to treatment of autoimmune disorder
Claim 49 is directed to treatment of inflammatory disorder
The sole active step in claims 45 and 49 is administration of NMT inhibitor to a human.
Applicants define the term “treatment” to encompass prophylactic administration (paragraph [00177]):
“Treating” and “treatment” as used herein also include prophylactic treatment (paragraph [00117]).
Berthiaume discloses a method of treating a subject having cancer by administering to said subject an NMT inhibitor [0011]. Claim 4 of Berthiaume is directed to a method of treating cancer comprising administering a small molecule inhibitor DDD85646 (page 87). Since Berthiaume discloses administration of NMT inhibitor, and specifically DDD85646, to a subject, the sole active step of the rejected claims is met. By administering NMT inhibitor to a subject, the subject inherently benefits from prophylactic properties of the NMT inhibitor with regards to autoimmune diseases and inflammatory diseases. The onset of such diseases is either prevented or delayed in the subject.
Applicants have amended claims 45 and 51 to recite “a subject in need thereof”. Since the term treatment encompasses prophylactic administration, “a subject in need thereof” is interpreted as subject who could develop an autoimmune or inflammatory disorder, which is any human subject.
New rejection
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) 45, 63, 69, 95, 100 and 107 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanofi (Clinical Trials ID NCT02704429 Update posted 8/17/20).
Sanofi discloses administrating PRN1008 (same as currently claimed IMP 1088) to subjects with pemphigus vulgaris (see study description). The study was completed on 1/10/2020, prior to filing of the current application (See study status). Pemphigus vulgaris meets the limitation “autoimmune disorder”. Sanofi therefore meets the limitation directed to administration of IMP1008 to subject with autoimmune disorder.
Regarding claim 45: Sanofi discloses treatment of an autoimmune disorder by administrating IMP 1008
Regarding claim 63 and 69: Sanofi administers the claimed agent to the claimed subject population. Reduction in activity of a T-cell or a B-cell is derived from administration of IMP 1008 and is therefore inherently present in the method described by Sanofi.
Regarding claims 95 and 100: reduction in the activity of a monocyte cell is inherently practiced by Sanofi because Sanofi discloses administration of the claimed agent to the claimed subject population.
Regarding claim 107: reduction in the amount of cytokine secretion by a T-cell is inherently practiced by Sanofi because Sanofi discloses administration of the claimed agent to the claimed subject population.
Allowed claims
Claims 57, 61 and 62 are allowed. Closest art is Sanofi (Clinical Trials ID NCT02704429 Update posted 8/17/20). Sanofi discloses treatment of pemphigus vulgaris (an autoimmune disease) by administrating to a subject PRN1008, an NMT inhibitor. There is no suggestion to use a different inhibitor for treatment of the specified disorder.
Conclusion
Claims 45, 49, 51, 55, 57, 61-63, 69, 95, 100, and 107 are pending
Claims 45, 49, 51, 55, 63, 69, 95, 100, and 107 are rejected
Claims 57, 61, and 62 are allowed
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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