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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
Amended claims 1-9, 11, 15-28 and new claim 29 are pending.
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 1-9, 11, 15-28 and new claims 29 are rejected under 35 U.S.C. 103 as being unpatentable over Peppin, Ther Adv Neurol Disord. (2014) 7(1) 22–3; Baranidharan : Therapeutic Advances in Neurological Disorders, Vol. 6, No. 5, 1 January 2013, Pages 287-297; Wagner: Pain Medicine, Vol. 14, 1 January 2013, Pages 1202-1211; Backonja : PAIN MEDICINE, Vol. 11, 1 January 2010, Pages 600-608; Gimenez-Mila : BMC Anesthesiology, Biomed Central, London, GB, Vol. 14, No. 1, 15 December 2014, Pages 2-7; Ilie, EXPERIMENTAL AND THERAPEUTIC MEDICINE 18: 916-925, 2019; Burness, Drugs (2016) 76:123–134); Brown, AIDS RESEARCH AND THERAPY, BIOMED CENTRAL, LONDON, GB, vol. 10, no. 1, 28 January 2013; and Fattori, MOLECULES,vol. 21, no. 7, 28 June 2016 (2016-06-28.
Peppin:
In the Review article on Capsaicinoids in the treatment of neuropathic pain, at page 22, Peppin teaches currently existing data for capsaicin 8% in the
treatment of post-herpetic neuralgia. Peppin further reviews data for the low-dose capsaicin products and the current status in the development of other capsaicinoids, e.g. resiniferotoxin, and high-concentration liquid capsaicin.
The teachings of Peppin are also among many admitted to prior art in the instant specification at pages 2-3.
More specifically, relevant to the instant claims. Peppin teaches at column A page 22, that Low-concentration (LC), i.e. <1.0%, and over-the-counter (OTC) capsaicin preparations have been available for decades, although these products have suffered from problems of efficacy and patient compliance, due to the fact that the application has to be performed multiple times a day for multiple days and months. However, higher concentrations have been shown to circumvent some of these problems. A much higher concentration capsaicin product, such as the capsaicin 8% patch (C8P), is a fairly new therapy that produces relief after a single topical application. Other newer capsaicinoid therapies are being developed, e.g. the high-concentration (HC; 10% and 20%) liquid capsaicin and resiniferotoxin, a natural substance present in a Moroccan cactus-like plant.
Baranidharan:
Baranidharan (A review of the high-concentration capsaicin patch and experience in its use in the management of neuropathic pain), discloses the use of 8% capsaicin patches to treat various peripheral neuropathies, including HIV-DSP and post-herpetic neuralgia. The patients were retreated in intervals of no less than 12 weeks, which corresponds to 84 days (see p. 290, col. 2, para.1 and p. 291, col.1, para.4).
Wagner:
Wagner (NEUROPATHIC PAIN SECTION Original Research Article The Capsaicin 8% Patch for Neuropathic Pain in Clinical Practice: A Retrospective Analysis") discloses the use of 8% capsaicin patches to treat neuropathic pain. Wagner provides high-concentration capsaicin topical treatment of neuropathic pain and also discloses reapplication in patients when pain increased. Wagner article teaches relevant teachings with regards to limitations item (b) of base claim. The term ‘days’ occurs 17 times in Wagner document. Some of the patients were administered a patch multiple times, at a time interval of as low as 55 days (see p.1203, col.2, para.1 and p.1204, col.2, para. 3-4). For example, at page 1203 column B, Wagner teaches that five patients were re-treated with the capsaicin 8% patch less than 90 days following their prior treatment, at Days 55, 57, 77, and 84.
Backonja:
Again, 8% capsaicin patches are well-known in the art. For example, Backonja (Original Research Articles NGX-4010, a High-Concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: A Randomized, Double-Blind, Controlled Study with an Open-Label Extension), discloses a treatment of post-herpetic neuralgia with 8% capsaicin patches. Some of the patients received multiple re-treatments (see p.605, table 3). Further, Gimenez (Assessment of the feasibility of high-concentration capsaicin patches in the pain unit of a tertiary hospital for a population of mixed refractory peripheral neuropathic syndromes in Non-diabetic patients), discloses the use of capsaicin patches in the treatment of neuropathies in patients classified as non-responders to previous treatments.
Ilie:
Ilie, (Capsaicin: Physicochemical properties, cutaneous reactions and potential applications in painful and inflammatory conditions), state of the art of neuropathic pain, including regeneration and restoring of sensory nerve fibers under repeated or prolonged application of capsaicin (see page 920 column A, last but paragraph). Reinnervation of the epidermis begins during the first 3–4 weeks after capsaicin injection and is characterized by re-emergence of an intact sub-epidermal nerve plexus, of CGRP immunoreactive nerve fibers and scarce intraepidermal fibers. At the same time, one can observe the gradual restoration of pain sensation induced by heat and mechanical stimuli. Immunoreactivity for PGP 9.5 is gradually restored and is associated with progressive regeneration of the sub-epidermal nervous plexus and with reinnervation of the epidermis, although the number of regenerated fibers immunoreactive for PGP 9.5 is lower than that of normal skin, even 4 to 6 weeks following capsaicin injection. The loss and further reoccurrence of immunoreactivity for PGP 9.5 is correlated with loss and recovery of somatic sensations.
Burness:
Burness provides the evidence that 8% referred to by Wagner is 8 % w/w (abstract). This is because Wagner uses “The capsaicin 8% patch (Qutenza™)” (page 1203 left column) and Burness provides this information for the same Qutenza patch. Brown teaches discloses treatment of HIV-associated polyneuropathy with high concentration capsaicin patch. 40% of patients were classified as responders (those exhibiting 30% reduction in NPRS score from baseline) over 12 weeks after 30 and 60 minute application of the patch. No disclosure of repeat treatment in non-responders.
Backonja:
Backonja teaches an open-label extension of treatment of postherpetic neuralgia with high-concentration 8% wt capsaicin. Patients initially treated with the patch, could receive up to three additional treatments no sooner than 12 weeks after initial treatment. The mean percentage reduction in baseline NPRS scores after the first, second and third treatments -31.4%, -30.0% and -34.1%. It would appear that all patients were considered as responders to initial treatment after four weeks (Table 2) and that the reduction in NPRS score is maintained during weeks 2-12 and during subsequent re-treatment cycles over a 48-week period. It is concluded that 1-hour applications of NGX-4010 can reduce pain in patients with PHN and that pain reductions can be maintained with repeated administration over a 1 year period.
Fattori:
Fattori teaching is concerned with Capsaicin: Current Understanding of Its Mechanisms and Therapy of Pain and Other Pre-Clinical and Clinical Uses. More specifically, Fattori provides an overview of capsaicin and its mechanism in therapy of pain. Reference is made to topical application of 8% capsaicin patch to patients with post-herpetic neuralgia and pain relief for 12 weeks (reference to Backonja). No disclosure of treatment of non-responders. Wagner as well as Brown and Backonja acknowledge non-responders to capsaicin treatment. However the focus is on treatment of the responders. Wagner does however teach that patients were retreated if their pain significantly increased and were in discomfort again, thus indicating a level of non-responsiveness, but not defined by parameters. Backonja also discloses re-treatment over a longer period of time to maintain efficacy i.e. repeated administration for responders. Fattori supports the general knowledge that the mechanism of action of capsaicin involves desensitization of TRVP1 receptors, leading to inhibition of receptor function and analgesia. Therefore it would suggest that repeated administration to non-responders would eventually lead to desensitization and analgesia. The continued repeated treatment is already disclosed in Wagner to manage returning pain.
Disclosure in the specification, working examples 1 and 2 are particularly limited to a specific concentration of capsaicin (namely 8%wt) and within a specific time window (84 days or less), not as broadly claimed in the instant base claim with regards to dose and any and all days as recited in claims.
Applicant is encouraged to use word search technique in this action and in the cited references:
Ctrl+F keyboard shortcut is a quick way to find specific words or phrases of the limitations within the cited documents or webpage. The technique opens a search box where the words/limitations can be typed and the program will then search for and highlight all instances of that text.
For example, searching for the term ‘repeated’ in Peppin document returns 9 hits; the term ‘patch’ returns 28 hits. Similarly, using such word technique, teachings in the prior art and in the instant office-action, limitations with respect to % amount of capsaicin, repeated administration, responders or non-responder as well as days after previous dosing can be found, as further noted below, more specifically with respect to Wagner art:
Regarding claims 1. 16: The cited reference 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 teaches re-treatment (page 1205 right column), the instant claim is anticipated by Wagner. The 8% patch taught by Wagner anticipates 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 teaches 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 is 8 % w/w (abstract). This is because Wagner uses “The capsaicin 8% patch (Qutenza™)” (page 1203 left column) and Burness provides this information for the same Qutenza patch.
Regarding claims 2-3, Wagner teaches as discussed above. 8% taught by Wagner anticipates both “at least 5 wt%” and “at least 8 wt%.”
Regarding claims 4-5, Figure 1 of Wagner (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 teaches “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 teaches 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 teaches “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 claim1 9, 11 Wagner teaches “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. Wagner teaches as discussed above. Since Wagner teaches 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 15: Claim 14 depends on cancelled claim 14 (See section under 112-2).
Regarding claims 17-20; see above for claims 1 and 16.
Regarding claims 21-23, absent evidence of the contrary, Wagner’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 claims 24-27, Wagner teaches as discussed above. Wagner teaches 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). Wagner teaches as discussed above. Wagner teaches treatment of failed back surgery syndrome, face neuropathy, peripheral neuropathy, polyneuropathy and peripheral neuropathic pain (page 1205 table 1).
Regarding claim 24, evidentiary reference “Qutenza” provides the evidence that the patch used in Wagner comprises a backing layer, adhesive layer and a release liner (page 4).
Regarding claim 25, Wagner teaches 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 claims 28. See above. Ilie teaches state of the art of neuropathic pain, including regeneration and restoring of sensory nerve fibers under repeated or prolonged application of capsaicin (see page 920 column A, last but paragraph).
Regarding new claim 29. See above. Burness provides the evidence that 8% referred to by Wagner is 8 % w/w (abstract). This is because Wagner uses “The capsaicin 8% patch (Qutenza™)” (page 1203 left column) and Burness provides this information for the same Qutenza patch. Brown teaches discloses treatment of HIV-associated polyneuropathy with high concentration capsaicin patch. 40% of patients were classified as responders (those exhibiting 30% reduction in NPRS score from baseline) over 12 weeks after 30 and 60 minute application of the patch. No disclosure of repeat treatment in non-responders.
Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. 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.
As found in In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Response to Applicants arguments filed 12/23/2025
Applicant:
Applicant’s arguments focus on the following:
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This W<X
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has to be
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limitation is/was not being considered by the Examiner.
Response:
Applicants arguments are not persuasive. The rejection is under 103, not under 102.
Consider for example, Applicants arguments with respect to ‘responders’ and ‘non-responders at page 13 (Remarks 12/23/2025) first full paragraph onwards. The term ‘responder’ appears multiple times in the previous action. Likewise, none of the instant claims limitations corresponding to
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(see bottom of Remarks page 13).
Similarly, Applicant arguments with respect to ‘shortening the time between the first and second period’ is at best confusing. With regards to this specious argument that W is less than X. W and X are defined with same numbers, see claims 6 and 7. According to working Example 1 would appear to demonstrate that responder rates were best improved when reapplication was within 110 days, most preferably <84 days. A longer period of time between treatments (>100 days) did not improve the response rate compared to the other treatment windows. As such if W = 60 days, X = 61 days, it is unclear how this provides unexpected results. Further, disclosure at bottom of page 32
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is not found in the claims. Thus none of the ‘unexpected results’ emphasized by the applicant at Remarks numbered page 15 is found in the claims. In contrast these numbers are buried in the plethora of identical possibilities for W and X (as per claims 6-9), further with the phrase ‘the average ever’ with respect to W and X undefined in claims or specification. Under MPEP 2111 and 2173, it is improper to import limitations from the specification into patent claims, even if those features are described in the only embodiment. While claims are construed in light of the specification, unrecited, specific details from the description cannot be used to narrow the claim scope.
Also see previous action 10/06/2025 page 3 onwards.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 11, 15-28 and new claims 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-33 of copending Application No. 17912280 (reference application) further in view of Peppin, Ther Adv Neurol Disord. (2014) 7(1) 22–3; Baridhara: Therapeutic Advances in Neurological Disorders, Vol. 6, No. 5, 1 January 2013, Pages 287-297; Wagner: Pain Medicine, Vol. 14, 1 January 2013, Pages 1202-1211; Backonja : PAIN MEDICINE, Vol. 11, 1 January 2010, Pages 600-608; Gimenez-Mila : BMC Anesthesiology, Biomed Central, London, GB, Vol. 14, No. 1, 15 December 2014, Pages 2-7; Ilie, EXPERIMENTAL AND THERAPEUTIC MEDICINE 18: 916-925, 2019; Burness, Drugs (2016) 76:123–134); Brown, AIDS RESEARCH AND THERAPY, BIOMED CENTRAL, LONDON, GB, vol. 10, no. 1, 28 January 2013; and Fattori, MOLECULES,vol. 21, no. 7, 28 June 2016 (2016-06-28. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
Claim 1 of 17912280:
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The base claim of 1 and depended claims of 17912280 are drawn to same patient with the same dose of the same drug multiple times after initial administration at days (see claim 18 of 17912280) that overlap with the instant claims.
That the limitations of the instant claims and conflicting claims are obvious variants of each other known to one of skill in the art, is discussed in the secondary references discussed under section 103 of this action. Applicants arguments at page 16 of Remarks with respect to surprising results are not persuasive as discussed above, further because none of the specific parameters with respect to, for example, W<X is found in the claims.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32
(2010) 324–330.
Note: See Remarks 06/06/2025 numbered page 18, in the file wrapper of Application No. 17912280.
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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/NIZAL S CHANDRAKUMAR/ Primary Examiner, Art Unit 1625