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 08/11/2025 are acknowledged. Claims under consideration in the instant office action are claims 1-5 and 7-18.
Applicants' arguments, filed 08/11/2025, have been fully considered, and they are deemed to be persuasive due to Applicant’s amendment. The rejection of claims 1-5 and 10-16 under 35 U.S.C. 102 is withdrawn. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-5, 7-12, and 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of peripheral artery disease comprising administering resiniferatoxin, does not reasonably provide enablement for the inhibition or treatment of peripheral artery disease by administering any TRPV1 agonist via epidural or intraganglionic administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'" (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
9. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of inhibiting or treating peripheral artery disease comprising administering an agonist of TRPV1 via epidural or intraganglionic administration. The breadth of the claims thus covers that any TRPV1 agonist is capable of inhibiting or treating peripheral artery disease via epidural or intraganglionic administration. Claim 4 also recites that any TRPV1 agonist administered via epidural or intraganglionic administration can inhibit claudication associated with peripheral artery disease.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
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). Westphal is thus silent as to the efficacy of administering TRPV1 channel activators via different routes.
Ruiz (Routes of Drug Administration) is drawn towards routes of drug administration (see abstract), and teaches that “There are situations in which direct administration on a given region, tissue or organ may be needed, in order to achieve high drug concentrations in the site of action, almost immediately.” (pg. 11, 6.2.4). Ruiz teaches epidural administration as “administration on or over the dura mater. The drug must be filtered through fat and veins to reach the nervous roots, thus delaying the beginning of the effect. It supports permanent catheter collation.” (see Table 6.1). It would thus be beyond the skill of one of ordinary skill in the art to determine which TRPV1 agonist is suitable for treating peripheral artery disease or inhibiting claudication associated with peripheral artery disease via different routes of administration.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification provides working examples only for the epidural administration of resiniferatoxin. Thus, the specification has not provided any working examples for other TRPV1 agonists via epidural or intraganglionic administration or examples demonstrating inhibition of claudication associated with peripheral artery disease.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Westphal and Ruiz above, the high unpredictability in the art as evidenced therein, and the lack of adequate guidance provided by the specification for all TRPV1 agonists, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 1-2, 4-5, 7-12, and 17-18 are rejected.
Claims 3 and 13-15 are 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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