DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/28/2026 has been entered.
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 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.
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) 67-71 and 83-84 is/are rejected under 35 U.S.C. 103 as being unpatentable over NISHI (NISHI et al., EP 0240015 A2, 1987-10-07) in view of Lima (Lima et al., Homologation: A Versatile Molecular Modification Strategy to Drug Discovery, Current Topics in Medicinal Chemistry, 2019, 19, 1734-1750).
The reference NISHI teaches the follow compound (pages 72 and 84, Table 2), wherein Q=CH2CH2, R1=R3=R4=H, J=
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95
157
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, B= heteroaromatic 5 membered ring, M2=phenyl.
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215
482
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728
1102
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This helps to teach claims 67-71 and 83.
The reference NISHI also teaches “Carbostyril derivatives and salts thereof represented by the general formula (1) according to the present invention can be used in any form of usual pharmaceutical compositions which are prepared by using usual pharmaceutically acceptable carriers”(page 56). This helps to teach claim 84.
The reference also teaches “Use of the compounds defined in any of claims 1 to 39·or the salts thereof, or the final products prepared in claims 40 to 43 or the salts thereof in the preparation of a medicament for inhibiting adhesion of thrombocytes”(reference claim 50).
The reference NISHI does not specifically teach a compound of the instant invention because the ‘A’ variable of example 48 has one too many CH2 groups.
The reference Lima teaches “Homologues are organic compounds belonging to the same chemical function, and their molecular formulas differ from each other by an integer number of methylene (CH2) groups. Gerhardt introduced the concept of homologous series in organic chemistry, in 1853 [1]. They exhibit similar chemical properties and they are placed in increasing order of their molecular masses, differing by a constant relative molecular weight. This concept is employed in medicinal chemistry as a versatile tool for molecular modification. Therefore, homologation can be defined as a molecular modification strategy based on increasing (or decreasing) the size of a substituent or a linker by the addition (or elimination) of methylene or methyl groups”(page 1734) and “Despite the enormous applicability and the use of homologation as a molecular modification strategy in drug discovery projects, this is the first article to systematically ad dress this topic. For this reason, we expect that this article helps in the dissemination of homologation strategy and in the construction of rational bases for its use by medicinal chemists, professionals and students of related field”(page 1748).
This helps to teach claims 67-71 and 83.
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 NISHI with Lima to produce a compound of the instant invention because the only difference between for instance
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85
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and the example 48 of NISHI is one CH2 group in a chain of CH2 groups. One would then find it obvious to modify the chain length because homologation is a standard and common practice in drug design that can improve physic-chemical properties. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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). Thus the small change of one CH2 unit would have close structural similarity and there is a presumed expectation of success that one such compound would possess similar properties as example 48 and thus would be useful in in the preparation of a medicament for inhibiting adhesion of thrombocytes. Thus one would be motivated to modify example 48 to structurally similar compounds that could also be useful to preparation of a medicament for inhibiting adhesion of thrombocytes and may provide a possible improvement in activity.
Allowable Subject Matter
Claims 72-82 and 85-86 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. The applicant argues that the instant compounds are not obvious variants of Nishi and have unexpected biological activity for ALDH1A3. The examiner doesn’t not find that this is persuasive because as stated in the 103 argument above one of ordinary skill in the art would be motivated to select any compound of Nishi because they are all suggested for preparation of a medicament for inhibiting adhesion of thrombocytes and may provide a possible improvement in activity. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Thus it would be obvious to select example 48. One would then find it obvious to modify the chain length because homologation is a standard and common practice (Lima et al.) in drug design that can improve physic-chemical properties. Additionally, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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). One would be motivated to modify example 48 to structurally similar compounds that could also be useful to preparation of a medicament for inhibiting adhesion of thrombocytes and may provide a possible improvement in activity. While the improvement is indeed speculative, the motivation it presents to search for this improvement is not.
Since the rejected claims are compound claims the rejection is not required to show that the obvious compounds must have the same properties as the examples in the instant specification only that they are obvious compounds within the instant claims. It is the Examiner’s understanding that Applicant repeatedly alleges the existence of unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, wherein such results are sufficient to rebut prima facie obviousness. However, to establish unexpected results, the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP § 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
If the applicant is arguing unexpected results the claims must be commensurate in scope with the unexpected results. Since the general formula of claim 67 is incredibly broad covering possibly hundreds of thousands of structurally different compounds the claims are not commensurate in scope with the unexpected results. Additionally, a comparison showing that the closest prior art Nishi would be required to demonstrate the two compounds are distinct due to this change in structure.
Conclusion
Claims 67-71 and 83-84 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights