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 .
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.
Claim(s) 2, 4, 6-9, 11-13, 15-17, 19, 22-29, 31-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besidski WO2007073303; Quding PAIN, vol. 154, no. 6, 19 February 2013, pages 808-812; Rowen US9757401; Fracassi US10588871; and Barr US6653352.
Besidski teaches the active ingredient of compound of the instant claim at page 60 top on the list Entry #52 (Besidski claims 1 and claim 25 selection from a single list) in a pharmaceutical composition (claim 28) suitable for topical administration to treat pain (see Besidski page 19 for topical administration e.g. as an ointment, patch or cream). Besidski teaches use to treat ‘pain’ occurs more 60 times. This compound is AZD1386 as admitted to in specification page 2. Quding teaches the TRP activity of AZD1386 and its use for treating pain after tooth extraction. Quding does not teach for topical use.
As such base method claim 2 limitations are found in the above teachings.
Limitations of (dependent) claims 4, 6-9, 11-13, 15-17, 19, 22-29, 31-40 (methods and compositions) are drawn to amount (W/W 4, 11) of the active ingredient, topical use, surface applied (6-9 ), excipients such as penetration enhancers (9, 11), solubility enhancers (12, 13, 15), sequestering agents (19, 29) ratios/amount of these (16) generically, specifically (17, 19) and specific pain (34) in the method claims and in the corresponding composition (claims 22-29, 31, 32, 33 40). These features (common pharmaceutical excipients, choice of excipients content) in topical creams are routinely used and are within the repertoire of one the skilled person in the art engaged in arriving at new formulations of pharmaceutically active old compounds. For example, see Rowen section under Description and Claims which teaches transient receptor (TRP) modulator compound compositions for topical administration with recited excipients:
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Likewise, see Fracassi section under claims 1, 9, 12-14 and 18-19 for topical formulation (gel, cream, sequestering agent etc.).
See Barr section under claims for patch cream formulation for (different) pains for skin, solubility agents.
Neuropathic pain market size is about 10 billion US $ as per Applicant provided NPL#16 in IDS 09/04/2024 .
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant active ingredient and excipients for their known benefit since each is well known in the art for their beneficial properties. Again, 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 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).
Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Remarks:
Applicants arguments are not persuasive and the rejection is maintained for reasons of record.
The position taken is that
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proper.
According to Applicant,
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In
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and
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And further
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The above noted Example 52 is the instant active ingredient
Besidski teachings at page 19, line 25 that the above compound maybe in a form
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was pointed out in the previous action.
Applicants arguments that Besidski or Quding, Rowen, Fracassi or Barr fail to provide experimental data
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of the claimed compound is not persuasive.
That, Rowen teachings
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is, at the minimum, not suggestive to one of skill in the art that contradicts KSR rationale for obviousness analysis.
That Quding teaches away because oral administration results in short duration of action is not persuasive.
Argued upon on subject matters such as ‘relatively short duration (prior art), longer duration (instant)’ are not found in the instant claims.
The inclusion optionally of, excipients, in dependent claims, is routine in the pharmaceutical art for optimization of desired outcomes. It is one of commonsense to expect that the primary advantages of topical delivery are localized pain relief, faster local onset, and a significant reduction in systemic side effects. The expectation is not different from the
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as in ‘comparative results’ disclosed at page 39 of the specification.
As per KSR (see below) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. For examples see Dimassi Is there any role for topical non-steroidal anti-inflammatory drugs in the treatment of mild to moderate musculoskeletal pain in a Lebanese community pharmacy? Springerplus. 2016 Aug 2;5(1):1236.
As noted previously, “[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.” The position taken is that one of skill in the art would achieve
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by routine optimization of excipients, doses and routes of administration in topical formulations.
The rejection is not under 35 USC § 102.
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.
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.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office.
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.
Suggestion:
Amend claims by including excipients and their amounts, exemplified, that provide(s) for argued upon benefits.
THIS ACTION IS MADE FINAL. 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.
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
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