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 .
Summary
Receipt of Applicant's Remarks and Amendments filed on 06/06/2025 is
acknowledged. Claims 1-33 are pending and under examination in this application.
Withdrawn Claim Rejections
The objection to claim 6 and the rejection under 35 USC 112(d) of claims 14 and 19 are withdrawn in view of the amendments. The rejection of claims 1-10, 16-19, and 21-33 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendments to the claims. All claims are now included in the revised rejection under 35 USC 103, necessitated by amendment. Finally, the rejection under non-statutory double patenting is withdrawn in view of the fact that conflicting application 17916677 has an earliest priority date of 4/3/2020 which is later than the instant earliest priority date of 3/17/2020. It is noted that the other case has an nsdp rejection of record over the instant application.
Modified Claim Rejection
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.
Claims 1-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al., evidenced by Burness et al., Qutenza Prescribing Information, revision date: 07/2024 (Hereinafter “Qutenza”), Cassano et al. and Gordon et al.
Regarding claims 1 and 16-17, Wagner et al. teach treating patients with capsaicin 8% patch wherein 22 (patients) received two treatments, five received three treatments, and one patient received four treatments (page 1204 right column). The patients suffered from failed back surgery syndrome, face neuropathy, peripheral neuropathy, polyneuropathy and peripheral neuropathic pain (page 1205 table 1). Figure 3A shows that 70% of patients achieved pain relief by at least 30% versus baseline, meaning 30% patients did not who fall within the instantly claimed patient population. Since Wagner et al. teach re-treatment (page 1205 right column), the concept of additional treatments for all patients is contemplated, although specific retreatment of non-responders is not taught. The 8% patch taught by Wagner et al. reads on the instantly claimed at least 2.5 wt %. "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." MPEP 2131.03 I. Additionally, since Wagner et al. teach patch application, the instant limitation of “topically administering” is met. It is also noted that evidentiary reference Burness provides the evidence that 8% referred to by Wagner et al. is 8 % w/w (abstract). This is because Wagner et al. use “The capsaicin 8% patch (Qutenza™)” (page 1203 left column) and Burness provides this information for the same Qutenza patch.
Cassano et al. discuss what they do with non-responders. At page 798, right column, penultimate paragraph they say that non-responders received etanercept 50 mg from week 13 to week 24 and on page 800 indicate that patients who did not respond to the lower dose underwent dose escalation; they refer to those patients as non-responders.
Gordon et al. state, on page 601, left column, “Patients who became eligible for dosage escalation were considered non-responders in the primary analysis.”
It is clear from the teachings of Cassano et al. and Gordon et al. that the concept of re-treating non-responders is known and the effect of the up-dosing was to convert non-responders into responders.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to repeat the dosing on non-responders in order to turn them into responders with the reasonable expectation of success, raised by the success of doing so discussed by Cassano et al. and Gordon et al.
Regarding claims 2-3, Wagner et al. teach as discussed above. 8% taught by Wagner et al. reads on both “at least 5 wt%” and “at least 8 wt%.”
Regarding claims 4-5, Figure 1 of Wagner et al. (page 1206) evidences that retreated patients overall achieved less pain indicating that upon re-treatment, at least some patients achieved pain relief by at least 30% versus baseline. Additionally, Wagner et al. teach “Of these patients, 63% (N = 10) exhibited a 30% reduction in NPRS score from baseline to Weeks 1–8.” (page 1205 right column) for the re-treated patients.
Regarding claim 6, Wagner et al. teach that among the 22 retreated patients, 20 of them had exhibited a 30% reduction in NPRS score from baseline to Weeks 1–8 following their first treatment (page 1205) meaning the two remaining patients were either non-responders or insufficient responders.
Regarding claims 7-8, Wagner et al. teach “the capsaicin 8% patch was applied for 30 minutes” and was later removed (page 1203 right column under “Procedure”), which is within the instantly claimed 15-90 minutes (for claim 7) and 30-60 minutes (for claim 8).
Regarding claim 9, Wagner et al. teach “Twenty-two patients were re-treated with the capsaicin 8% patch between 8 and 21 weeks after the first treatment” (page 1204 right column under “Re-Treatment”. This is interpreted as a range where at least one patient received a treatment at week 8 which is within the instantly claimed 2 to 4 months.
Regarding claim 10, Wagner et al. teach as discussed above. Since Wagner et al. teach a range of from 8 weeks to 21 weeks, at least one patient received re-treatment at day 56 which is within the instantly claimed less than 90 days.
Regarding claim 11, while Wagner et al. doesn’t explicitly disclose a retreatment at about 3 months, as discussed above, Wagner et al. teach “Twenty-two patients were re-treated with the capsaicin 8% patch between 8 and 21 weeks after the first treatment” (page 1204 right column under “Re-Treatment”). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I. 3 months (12 weeks) is within the 8-21 weeks range taught by Wagner et al.
Regarding claim 12, as discussed above, Wagner et al. teach “five received three treatments, and one patient received four treatments (page 1204 right column) evidencing that there have been treatments with repeated previous administrations. That said, Wagner et al. does not disclose whether any of these patients with multiple dose administrations did not perceive pain relief at least 30% versus baseline. Regardless, it would be obvious to a person of ordinary skill in the art at the time of instant application to treat patients repeatedly who have not had pain relief at least 30% versus baseline.
Regarding claims 13-15 and 20, Wagner et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art at the time of instant application to have modified the embodiments of Wagner and achieve the instant invention. As stated above, Wagner does not explicitly disclose a re-treatment after about 3 months, however, Wanger does teach a range which covers 3 months. Absent evidence of criticality for about 3 months limitation, a prima facie case of obviousness has been established per MPEP 2144.05 I.
Regarding claims 18-19, Wagner et al. teach as discussed above. Note that steps b-ii to b-iv are optional, and thus, do not need to be performed.
Regarding claims 21-23, absent evidence of the contrary, Wagner et al.’s calculation of 8% did not include release liner of the pharmaceutical patch, since a release liner is added for storage/preservation of the patch and its ingredients.
Regarding claim 24, evidentiary reference “Qutenza” provides the evidence that the patch used in Wagner et al. comprises a backing layer, adhesive layer and a release liner (page 4).
Regarding claim 25, Wagner et al. teach as discussed above.
Regarding claims 26-27, evidentiary reference “Qutenza” provides the evidence that “QUTENZA contains 8% capsaicin (640 mcg per cm2). Each QUTENZA contains a total of 179 mg of capsaicin.” (page 1).
Regarding claim 28, Wagner et al. teach as discussed above.
Regarding claims 29-32, Wagner et al. teach as discussed above. Wagner et al. teach treatment of failed back surgery syndrome, face neuropathy, peripheral neuropathy, polyneuropathy and peripheral neuropathic pain (page 1205 table 1). Failed back surgery syndrome meets post-surgical neuropathic pain (for claims 31-32).
Regarding claim 33, Wagner et al. teach “Capsaicin, the active component of chili peppers, is an agonist of transient receptor potential vanilloid 1 (TRPV1) channels, which play an important role in the transmission of pain signals [9]. Continuous activation of TRPV1 causes nociceptor defunctionalization—accompanied by a reversible reduction in epidermal nerve fiber density.” (page 1203 left column) which indicates that upon treatment nerve fiber density would be restored.
Response to Arguments
Applicant's arguments filed June 6, 2025 have been fully considered and are persuasive. However, the amendments to the claim necessitated rewriting the obviousness rejection, accounting for the new limitations of turning non-responders into responders. As this concept is taught by Cassano et al. and Gordon et al. the claims are still considered to have been obvious to one of ordinary skill in the art.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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