DETAILED ACTION
All objections or rejections not mentioned below have been withdrawn.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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 62/541,457, filed on 8/4/2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/02/2021 and 02/04/2020 are being considered by the examiner.
Claim Interpretation
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The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives. For example aryl, heterocycle and heteroaryl is defined in the claims to be:
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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) 77 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 825601-36-3, 04 Feb 2005.
The reference STN, CAS Registry 825601-36-3 teaches the following compound, which is the same exact compound as the first compound of instant claim 77. This anticipates claim 77.
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Claim(s) 1, 72, 110 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 54513-03-0, Entered STN: 16 Nov 1984.
The reference STN, CAS Registry 54513-03-0 teaches the following compound, wherein X=CH, R2=S-alkyl, R1=alkenyl, n=0. This anticipates claims 1, 72, 110.
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837
990
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Claim(s) 1, 2, 72 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 951460-94-9, Entered STN: 26 Oct 2007.
The reference STN, CAS Registry 951460-94-9 teaches the following compound, wherein X=CH, R2=heteroaryl, R1=alkylene-N(H)-C(O)-alkyl, n=0. This anticipates claims 1, 2, 72.
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Claim(s) 1, 25, 72 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 94579-59-6, Entered STN: 1985.
The reference STN, CAS Registry 94579-59-6 teaches the following compound, wherein R2=N=C(H)-optionally substituted aryl, R1=cycloalkyl, n=0, X=CH. This anticipates claims 1, 25, 72.
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Claim(s) 1, 25, 70, 72 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 1284223-98-8, Entered STN: 22 Apr 2011.
The reference STN, CAS Registry 1284223-98-8 teaches the following compound, wherein R1=cycloalkyl, R2=NH-cycloalkyl, R3=methyl, n=1, X=CH. This anticipates claims 1, 25, 70, 72.
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Claim(s) 1, 25, 72, 104, 105 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 1259837-81-4, Entered STN: 19 Jan 2011.
The reference STN, CAS Registry 1259837-81-4 teaches the following compound, wherein R2=NH-aryl, R1=Cycloalkyl, n=0, X=CH. This anticipates claims 1, 25, 72, 104, 105.
The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives.
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Claim(s) 1, 25, 72, 94, 104, 105 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WANG (WANG et al., WO2010151441A1, 2010-12-29).
The reference WANG teaches the following compound(page 20), wherein R2=NH-aryl, R1=Cycloalkyl, n=0, X=CH. This anticipates claims 1, 25, 72, 104, 105.
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The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives.
The reference WANG teaches “Pharmaceutical compositions that include the disclosed compound may also include a pharmaceutically acceptable carrier. Carriers include any substance that may be administered with the disclosed compound with the intended purpose of facilitating, assisting, or helping the administration or other delivery of the compound. Carriers include any liquid, solid, semisolid, gel, aerosol or anything else that may be combined with the disclosed compound to aid in its administration. Examples include diluents, adjuvants, excipients, water, oils (including petroleum, animal, vegetable or synthetic oils.) Such carriers include particulates such as a tablet or powder, liquids such as an oral syrup or injectable liquid, and inhalable aerosols. Further examples include saline, gum acacia, gelatin, starch paste, talc, keratin, colloidal silica, and urea. Such carriers may further include binders such as ethyl cellulose, carboxymethylcellulose, microcrystalline cellulose, or gelatin; excipients such as starch, lactose or dextrins; disintegrating agents such as alginic acid, sodium alginate, Primogel, and corn starch; lubricants such as magnesium stearate or Sterotex; glidants such as colloidal silicon dioxide; sweetening agents such as sucrose or saccharin, a flavoring agent such as peppermint, methyl salicylate or orange flavoring, or coloring agents”(pages 8-9).
This anticipates claim 94.
Claim(s) 1, 2, 25, 70, 72, 104, 105, 109, 114 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 1219122-25-4, Entered STN: 2010.
The reference STN, CAS Registry 1219122-25-4 teaches the following compound, wherein R2=NH-aryl, R1=alkylene-N(H)-C(O)-alkyl, n=1, X=CH, R3=alkyl. This anticipates claims 1, 2, 25, 70, 72, 104, 105, 109, 114.
The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives.
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Claim(s) 1, 25, 104, 106, 107, 108, 109 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 325729-84-8, Entered STN: 2001.
The reference STN, CAS Registry 325729-84-8 teaches the following compound, wherein R2=NH-alkylene-aryl, R1=heterocycloalkyl, n=0, X=CH. This anticipates claims 1, 25, 104, 106, 107, 108, 109.
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The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives.
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Claim(s) 1, 25, 72, 111 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by STN, CAS Registry 468092-53-7, Entered STN: 2002.
The reference STN, CAS Registry 468092-53-7 teaches the following compound, wherein R2=NH-alkyl, R1=alkyllene-C(O)-cycloalkyl, n=0, X=CH. This anticipates claims 1, 25, 72, 111.
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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) 104, 112, 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over CHENG (CHENG et al., US 7030139 B2, 2006-04-18).
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The reference Cheng teaches the following general formula(columns 2-3):
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The reference Cheng teaches “N-{[1-(cyclopropylmethyl)-2-(4-ethoxybenzyl)-1H-benzimidazol-5-yl]methyl}-N-ethylethanamine”(table 3, column 81-82) as an example compound, wherein X=CH, n=1, R3= alkyl. The reference also teaches “Compounds of general formula (I), are disclosed and claimed in the present application, as well as salts and pharmaceutical compositions comprising the novel compounds and their use in therapy, in particular in the management of pain” (abstract). The chemical variable alkyl, aryl, heterocycle and heteroaryl used in the claims are defined in the specifications to include the substituted derivatives.
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This helps to teach claims 104, 112, 113.
The reference Cheng does not specifically teach a compound of instant claims 112 or 113, instant it teaches variables in the general formula that covers these 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 Cheng to produce a compound of the instant claims 112 and 113 because the general formula teaches R1= alkenyl (claim 112) and R1= R4(C=O) alkyl, wherein R4 can be alkyl and alkyl can be a cyclic group(claim 113) and because X=NH is taught attached to a substituted aryl. One would be motivated to make different compounds of the reference invention to determine which had the best properties for the purpose of the treatment of pain as suggested by Cheng. One would have a reasonable expectation of success because it is a suggested variation under the general formula.
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Response to Arguments
Applicant’s arguments ( 05/26/2026) with respect to the claim(s), have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 1, 2, 25, 70, 72, 77, 94, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114 are rejected.
Claims 26, 38, 95-98, 101, 103 are withdrawn.
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
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