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 .
Status of the Application
Claims 1-5 and 7-18 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 09/12/2024 are acknowledged. Claims 7-9 and 17-18 remain withdrawn. Claims under consideration in the instant office action are claims 1-5 and 10-16.
Applicants' arguments, filed 09/12/2024, have been fully considered, but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 10-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Westphal (WO 2015/160843, as disclosed in IDS).
Westphal teaches treating muscle claudication pain due to inactivity or restriction as seen in peripheral artery disease by administering a TRPV1 channel activator (see abstract; pg. 75, third paragraph). Westphal teaches resiniferatoxin as an embodied TRPV1 channel activator (pg. 3, fourth paragraph; claims 22, 44). Westphal teaches intrathecal delivery of compositions comprising such compounds (pg. 70, second paragraph). Westphal teaches such compositions can be used with cilostazol (i.e. anti-platelet agents) (pg. 88, second paragraph). Westphal teaches treating lower lumbar injuries (pg. 77, third paragraph).
When the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 4). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Response to Arguments
Applicant argues that “it is without question that Westphal et al. only disclose oral administration of a composition, particularly in the context of treating a muscle condition such as muscle claudication pain.” The Examiner respectfully disagrees since Westphal teaches treating muscle claudication pain due to inactivity or restriction as seen in peripheral artery disease by administering a TRPV1 channel activator (see abstract; pg. 75, third paragraph). Westphal teaches resiniferatoxin as an embodied TRPV1 channel activator (pg. 3, fourth paragraph; claims 22, 44). Westphal teaches intrathecal delivery of compositions comprising such compounds (pg. 70, second paragraph).
Conclusion
Claims 1-5 and 10-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1621
/SAVITHA M RAO/Primary Examiner, Art Unit 1629