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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/13/2026 has been entered.
Telephone Conversation:
Attorney confirmed on 7/9/2026 that no amendments to claims was filed after the office action 02/11/2026.
Claims 1 -6, 12-14, 19-20, 7-11, 15-18 are pending. Claims 1 -6, 12-14 and 19-20 remain withdrawn.
Claim Rejections - 35 USC § 103
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.
Claims 7-11 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kindler US 2831859, Meki, teach US 4837236, Yoshida WO 9013539, Giblin WO2006066968, Jones WO2006067587, Bit WO2006114272 and Kilbourn Nucl. Med. Biol. Vol. 16, No. 7, pp. 681-686, 1989, Kilbourn Nucl. Med. Biol. Vol. 16, No. 7, pp. 681-686, 1989) and Thornber, Isosterism and Molecular Modification in Drug Design, Chem. Soc. Rev., 1979,8, 563-580.
(Note the RN numbers below are Chemical Abstract Registry Numbers).
The cited prior art teaches compounds falling under the scope of formula claims 8 (and also dependent claim 15 formula).
Kindler teach at column 5
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212
348
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200
400
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RN 94686-35-8 RN 94966-03-7
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261
425
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261
420
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Similarly,
Meki teach
RN 115194-29-1
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259
391
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RN 115194-96-2
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259
391
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RN 115194-97-3
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234
395
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RN 115194-98-4
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234
390
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RN 115194-99-5
)
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259
391
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RN 115195-00-1
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301
391
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RN 115195-01-2
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301
391
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RN 115195-02-3
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301
391
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RN 115195-03-4
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301
391
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RN 115195-04-5
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259
391
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RN 115195-05-6
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301
391
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Yoshida teaches 132481-31-3 132481-33-5
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234
405
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234
446
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Bonvicino teach
RN 95696-69-8 and RN 96213-99-9
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271
424
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284
424
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Yoshida akso teach
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136
904
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142
928
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Giblin, WO2006066968 RN 892663-84-2
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274
428
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Jones, WO 2006067587 RN 895572-81-3
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273
413
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B = phenyl R11= halogen, CN; A= phenyl, W= O, R3 =H, m =0, R4 together makes CO, V= N and Z= CH2
Bit, WO 2006114272 RN 913957-36-5
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268
445
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A = phenyl R1 = H
B = furan R11= C(O))C2H5, X= CH2; A= phenyl, W= O, R3 =H, m =0,; p=1. R4 = H makes CO, V= CH and Z= CHR12 R12= H.
As such the above cited prior art compounds are similar to compounds of formulae of independent claims 8 and 15. These compounds are pharmaceutically active.
The difference between the compounds of instant formulae and the above cited pharmaceutically active compounds is that while some compounds are obvious variants and positional isomers of the prior art compounds (more on this later).
Applicant deliberately proviso-ed compounds and substituents
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92
628
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For example, the deletion of thiophene for ring B
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26
362
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is clearly to avoid rejection under 35 USC § 102 in view of above pointed out above Kindler thiophene compound. Kindler disclosure is not limited to thiophene. Throughout, Kindler teaches many benzene (that is phenyl for B) compounds with overall disposition of variables as per formulae of claim 8 and 15. Such interchangeable use of thiophene for benzene (and vice versa) is routine in the medicinal chemistry art, often called bioisosteric modifications. See Thornber, page 564
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124
688
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Consider for example, the R1 and R2 substituents for formula of claim 15. As per intentionally made amendment, these substituents are available when B of Y of formula of base claim 8 is other than phenyl as per claim 8 formula, in claim 15 these are available to avoid anticipation see pictured compounds of Yoshida. Also compare these with the first two compounds proviso-ed (see bottom of claim 8). Also compare Yoshida compounds pictured with the instant excluded compounds
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Applicant’s compound (claim 9) 1-methyl-4-(2-(4-methyl-2-(thiophen-2-ylmethyl)phenoxy)ethyl)piperazine is replacement of above phenyl group of (benzyl) with a thienyl group. Such isosteric modifications (Kilbourn, titled Thiophenes as phenyl bio-isosteres) are elementary ideas in medicinal chemistry art. Also compare the thiophene compound with that of pictured compound of Kindler. Decorating known structural templates with routinely used substituents in medicinal chemistry for optimization of desired properties to arrive at alternate versions of prior art compounds. The invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art.. There is no indication in the prior arts that such combination would lead one of ordinary skill in the art to doubt that the combination could not be made.
The invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements (variables and arrangements as per claimed formulae of independent claims 8 and 15) wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Response to Remarks filed 05/13/2026:
According Applicant the ‘routine optimization’ of result effective variables is not a motivation here, because, for example, Kindler is drawn to therapeutic applications for example, anesthesia. However instant compounds are for modulating TRPM8 receptor. (See Abeele teaching noted below). Similarly, Applicant points out that other cited references are drawn to uses other than for modulating TRPM8 receptor. Note that the examined claims are product claims. Further compounds and its properties are inseparable.
As MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
High-throughput assays to find new use for old compounds are routine in the art of drug discovery. See Mishra, Biomedicine & Pharmacotherapy (2008), 62(2), 94-98 (and also applicant admitted to references on specification page 1 lines 27-29).
Further Examination guidelines as to the position taken is also predicated on the following:
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abeele, Complex modulation of the cold receptor TRPM8 by volatile anaesthetics and its role in complications of general anaesthesia, Journal of Cell Science 126, 4479–4489.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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