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 .
Claims 1-2, 4-7, 9, 11, 14-15, 17-19, 22, 25-26 and 35-37 are pending. Claims 3, 8, 10, 12-13, 16, 20-21, 23-24 and 27-34 have been canceled. Preliminary amendment filed 29 September 2023.
Priority
This application is a 371 of PCT/NL2022/050176 filed 03/30/2022. This application claims foreign priority to NETHERLANDS NL2027866 filed 03/30/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
The parent application NETHERLANDS NL2027866 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-2, 4-7, 9, 11, 14-15, 17-19, 22, 25-26 and 35-37 of this application.
Claim Rejections - 35 USC § 112
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 22 and 36 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.
Claim 22 recites limitations within parentheses. It is not clear if this limitation is part of the claim. The claim is examined as drawn to any halogen as a substituent. This also applies to claim 36.
Regarding claim 36, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, claim 36 recites the broad recitation neurodegenerative diseases, and the claim also recites Alzheimer’s, Parkinson’s and Huntington diseases, schizophrenia which is the narrower statement of the range/limitation. 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.
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) 1, 4-5, 7, 9, 11, 14-15, 19 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (J. Med. Chem. 2019, 62, 10783-10797; Cited in IDS filed 02/07/2024).
Chen et al teaches compounds 1a-d, 1a*, 1j, 2a-d, 3a-b (Schemes 1, 3, 4 and 5, Figure 5). The said compounds read on the compound of formula I in claim 1. The above compounds also meet the limitations claim 4 for R3 is electron withdrawing group-ester group on the phenyl ring), claim 5 for the first and third formula for R wherein R1 = R2 = H, claim 7 X is N and Y is O, claim 9 for R1 = H, claim 11 for R1 = ethyl (compound 1a*) and H, claim 14 for R2 = H, claim 15 for R2 being the third formula which is an ester having the substitution R11 wherein R11 is C1-C6 alkyl, claim 19 for R4 = CONH2, and R5-R7 = H.
Chen teaches a method for the inhibition of NNMT comprising its compounds in vitro (page 10794, right col., first para; as in claim 37).
Therefore, Chen anticipates claims 1, 4-5, 7, 9, 11, 14-15, 19 and 37.
Claim(s) 1, 4-5, 7, 9, 11, 14, 19, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babault et al (J. Med. Chem., 2018, 61, 1541-1551; cited in IDS filed 02/07/2024).
Babault et al teaches compounds 6-7 (page 1543, Scheme 1). These two compounds read on the compound of formula I in claim 1, claim 4 for electron withdrawing group (carboxyl), claim 5 for first and third substitutions for R, claim 7, claim 9, claim 11 R1 = H, claim 14 for R2 is H, claim 19. Babault teaches a method for inhibition of NNMT using its compounds in vitro (page 1542, right col., first para; page 1544, left col. para under Fig. 4; page 1548, left col., last para; method of claim 37).
Therefore, Babault et al anticipates claims 1, 4-5, 7, 9, 11, 14, 19, and 37.
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) 1-2, 5-6, 9, 11, 14-15, 17, 19-22, 25-26, 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (J. Med. Chem. 2019, 62, 10783-10797; Cited in IDS filed 02/07/2024).
The teachings of Chen are set forth above. Chen does not expressly teach X = CH, L1 = C3-C5alkenyl, the other substitutions for R, R1-R7, pharmaceutically acceptable salts, stereoisomers or prodrug thereof as in claim 1, and some of the limitations of claims 2, 5-6, 9, 11, 14-15, 19, 25-26, 35-37.
Chen teaches compound 2a* which has an alkynyl group for L1(Scheme 4). The precursor to this compound is compound 2, which is obtained from compound 9. One of ordinary skill in the art will recognize that by a judicious choice of protecting groups (same as masking groups) one can obtain compound 2a* with ester and amino group also protected. The precursor compound 9 has the CN substitution on the phenyl ring which can be carried over to the final product. The CN and the amide groups are electron withdrawing groups. These groups can be moved around in the phenyl ring at different positions as in formula I in claim 1. This also renders obvious the substitution of other electron withdrawing groups on the phenyl ring 1, 6, 17-19, 22 and 25, and R2 = H as in claim 14, as variants. Since Chen teaches a linker group having an alkynyl moiety, one of ordinary skill in the art would make the compound of formula I as in claim 1 with an alkenyl moiety also since it would be structurally close (limitation of claim 2, 6 and 25-these have alkenyl moiety in the linker L1). The artisan can also use the substitutions for R as in claim 5-6, making groups C1-C6 alkyl and benzyl for R1as in claims 9-11 and the third and fourth substitution in claim 15 since these would serve as prodrugs of formula I (as in claim 1).
Since the compounds of Chen are inhibitors of NMMT and NMMT is has been linked to various diseases, the artisan would make the pharmaceutical compositions of the compounds including stereoisomers, solvates and salts as in claim 26 and use them as active agents in the method of treatment of a condition which is modulated by the inhibition of NNMT and the diseases/conditions as in claims 35-37 since Chen teaches that NMMT is associated with all of the claimed conditions/diseases (see Chen-Introduction).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, compounds embraced by instant formula I are NMMT inhibitors and NMMT is implicated in many diseases and conditions. Inhibitors of NMMT would be useful as active agents in a method of treating diseases and conditions associated with NMMT. Thus, it is obvious to arrive at the claimed compounds of formula (I), make their pharmaceutical compositions and use them in the claimed methods in view of Chen et al.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the teachings of Chen et al.
One of ordinary skill in the art would be motivated to look for other similar compounds that act as potent NMMT inhibitors for testing and using in the claimed methods of treatment.
Conclusion
1. Pending claims 1-2, 4-7, 9, 11, 14-15, 17-19, 22, 25-26 and 35-37 are rejected.
2. Claims 3, 8, 10, 12-13, 16, 20-21, 23-24 and 27-34 have been canceled.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693