DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
Claim Objections
Claims objected to because of the following informalities: poor compound image resolution of R4 groups. Appropriate correction is required.
Claim Rejections - 35 USC § 103 – Updated Due to Amendments
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.
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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over MARTIN (MARTIN et al., WO0236576A1, 2002-05-10, previously provided) in view of Barillari (Barillari et al., Classical Bioisosteres, Bioisosteres in Medicinal Chemistry, First Edition. Edited by Nathan Brown, 2012, previously provided).
The reference MARTIN teaches the following generic synthesis (page 40) and the following compound 697 Figure 9 (page 96), wherein Y1=Y2=H, R1=R2 =R3=H,R4=
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59
186
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:
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356
516
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429
859
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The reference MARTIN teaches “Further aspects of the invention provide for the use of compounds as defined in the first aspect of the invention in the preparation of a medicament for the treatment of: vascular disease; septic shock; ischaemic injury; neurotoxicity; haemorraghic shock; viral infection; or diseases ameliorated by the inhibition of the activity ofPARP”(page 6).
This helps to teach claim 1-4.
The reference MARTIN teaches “Includes Other Forms Included in the above are the well known ionic, salt, solvate, and protected forms of these substituents. For example, a reference to carboxylic acid (-COOH) also includes the anionic (carboxylate) form (-COO-), a salt or solvate thereof, as well as conventional protected forms. Similarly, a reference to an amino group includes the protonated form (-N+HR1R2), a salt or solvate of the amino group, for example, a hydrochloride salt, as well as conventional protected forms of an amino group”(page 20). This helps to teach claims 5-6 as it only differs from instant compound 181 in R4 and R3 ( H instead of a methyl).
The reference MARTIN does not teach the correct R4 group
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91
164
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, and instead has a methyl instead of a NH2 group (all claims) and R3 =H (claim 5).
The reference Barillari teaches “The discovery and development of a candidate for clinical evaluation is a long process that involves small modifications to a lead compound to improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics. This is often achieved by the medicinal chemists by replacing a functional group with groups sharing similar physical or chemical properties and maintaining similar activity, which are defined as bioisosteres”(page 15) and the bioisosteres shown below.
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187
559
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This helps to teach all claims.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified MARTIN with Barillari because MARTIN suggests compounds to treat diseases including compound 697 and Barillari teaches that it is common practice for drug candidates (such as compound 697) to have small modifications made to them to improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics. This is often achieved by the medicinal chemists by replacing a functional group with groups sharing similar physical or chemical properties and maintaining similar activity, which are defined as bioisosteres and that the change from CH3 to NH2 (as well as H to CH3) is one such bioisostere modification. One would have a reasonable expectation of success because CH3 and NH2 (as well as H to CH3) are bioisosteres. One would be motivated to do so to potentially improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics for improved treatment of the mentioned diseases. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c)
Response to Arguments
Applicant's arguments filed 08/27/2026 have been fully considered but they are not persuasive.
The argument that the 35 U.S.C. 103 rejection of claim 4 has been overcome because it has been amended to depend on claim 1 which was not rejected under the 35 U.S.C. 103 rejection is not persuasive because claim 1 was already previously rejected over a 35 USC § 102 rejection and thus a 35 U.S.C. 103 rejection was not required.
Conclusion
Claims 1-6 are rejected.
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.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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