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 .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9, 2026 has been reviewed by the examiner and entered of record in the file.
3. Claims 10 and 24 are amended; claims 1, 3, 7, 9, 11 and 13-16 are newly canceled.
Status of the Claims
4. Claims 20-25 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Claims 10 and 17 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112(b)
6. Claims 10, 11 and 17 were previously 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.
7. Claim 10 was previously rejected for lacking antecedent basis for species in which the moiety corresponding to Ar1 is naphthyl, indolyl, or phenyl; and species in which the Ar2 moiety is benzoxazole or benzimidazole; and species in which the 4-carboxamide substitution on the piperidine ring is missing from each compound. Claim 10 was also rejected because the compound structures depicted were fuzzy/ unclear, such that the metes and bounds of the claim could not be ascertained.
8. In view of Applicant’s amendatory changes to change claim 10 to an independent claim and to replace the compound structures with clear structures, the previous indefiniteness rejection is overcome and is withdrawn.
9. Claim 17 was previously rejected for being dependent on and including all of the limitations of claim 10. In view of Applicant’s amendatory changes to claim 10, the previous indefiniteness rejection of claim 17 is also withdrawn.
10. Claim 11 has been canceled; therefore the previous indefinite rejection is withdrawn.
Previous Claim Rejections - 35 USC § 102
11. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 878258-94-7, entered STN March 28, 2006.
12. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 879150-12-6, entered STN April 4, 2006.
13. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 919882-83-0, entered STN February 8, 2007.
14. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1624126-48-2, entered STN September 22, 2014.
15. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 2214031-19-1, entered STN April 17, 2018.
16. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 2217177-64-3, entered STN April 22, 2018.
17. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 2217201-40-4, entered STN April 22, 2018, (cited on Applicant’s IDS of May 2, 2022).
18. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 2217251-42-6, entered STN April 22, 2018, (cited on Applicant’s IDS of May 2, 2022).
19. Claims 1, 3, 7 and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 2217274-23-0, entered STN April 22, 2018, (cited on Applicant’s IDS of May 2, 2022).
20. Claims 1, 3, 7, and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1298780-03-6, entered STN May 22, 2011.
21. Claims 1, 3, 7, and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1386118-95-1, entered STN August 3, 2012.
22. Claims 1, 3, 7, and 9 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry No. 1376315-79-5, entered STN June 7, 2012.
23. In view of the cancellation of claims 1, 3, 7 and 9, each of the previous anticipation rejections are withdrawn.
Previous Claim Rejections - 35 USC § 103
24. Claim 11 was previously rejected under 35 U.S.C. 103 as being unpatentable over Min et al., U.S. 2018/0256558 A1.
25. In view of the cancellation of claim 11, the previous obviousness rejection is withdrawn.
New Claim Rejections - 35 USC § 103
26. 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.
27. 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.
28. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over STN Registry No. 1042898-85-0, (entered STN August 22, 2008). This rejection is newly applied as a result of Applicant’s amendment to claim 10.
Claim 10 recites the compound species MAGLZ-II-06:
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180
188
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.
29. STN Registry No. 1042898-85-0 discloses the following compound:
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433
727
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, which differs from Applicant’s instant compound MAGLZ-II-06 in the placement of the hydroxy substitution on the phenyl ring, i.e., 2-hydroxy substituted rather than the instantly claimed 4-hydroxy substituted.
30. As such, the only difference between the compound taught by STN Registry No. 1042898-85-0 and Applicant’s instant compound MAGLZ-II-06 is that compound of STN Registry No. 1042898-85-0 is a positional isomer of Applicant’s instantly claimed compound, i.e., STN Registry No. 1042898-85-0 discloses a hydroxy substitution in the ortho-position on the phenyl ring, while Applicant recites a hydroxy substitution in the para-position on the phenyl ring.
31. However, compounds which are positional isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)
32. Therefore one skilled in the art would be motivated to prepare the instantly recited positional isomer of the structurally similar compound previously disclosed by STN Registry No. 1042898-85-0, and would reasonably expect that said compound would have similar pharmacokinetic properties. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). See MPEP § 2144 for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds.
As such, claim 10 is prima facie obvious.
33. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over STN Registry No. 1684443-71-7, or STN Registry No. 1684445-74-6, or 1684445-91-7, (each entered STN August 15, 2015).
Claim 10 recites the compound species MAGLZ-II-18(a):
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195
198
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.
34. STN Registry No. 1684443-71-7 teaches the following compound:
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438
689
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,
or STN Registry No. 1684445-71-7 teaches the following compound:
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437
689
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, and STN Registry No. 1684445-91-7 teaches the following compound:
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426
687
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, each of which differs from Applicant’s instant compound MAGLZ-II-18(a) in the halogen substitution(s) on the indolyl and/or phenyl rings, i.e., Applicant’s recited MAGLZ-II-18(a) has a fluorine substitution on the indolyl ring rather than chlorine (as taught by each of STN Registry No. 1684443-71-7, Registry No. 1684445-74-6, and Registry No. 1684445-91-7); and a chlorine substitution on the phenyl ring rather than fluorine (as taught by STN Registry No. 1684445-91-7).
35. However, in Ex parte Wiseman, 98 USPQ 277 (Bd. App. 1953), it was held that the claimed compound was rejected over prior art wherein the only structural difference between the claimed compound and the known compound taught by the prior art was two fluorine atoms versus two chlorine atoms. The basis of this reasoning was that fluorine and chlorine are both halogen elements from the seventh group of the periodic system having substantially similar activity and function (i.e., “halogen equivalents”), such that the claimed compound was expected to have close structural similarity and substantially similar properties as the compound disclosed in the prior art. In the instant case, the recited compound MAGLZ-II-18(a) differs from the prior art compounds only in the substitution of one halogen for another, i.e., halogen equivalency, (specifically in the substitution of chlorine for fluorine or vice versa), and is therefore expected to possess similar properties differing only in degree.
36. Thus claim 10 is prima facie obvious.
Claim Objections
37. Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the allowable limitations of the base claim and any intervening claims.
Conclusion
38. Claims 10, 17 and 20-25 are present in the application. Claims 20-25 are withdrawn as directed to non-elected subject matter. Claims 10 and 17 are rejected. No claim is presently allowed.
39. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628