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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/7/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of:
(i) 5-Methyl-1H-pyrazole-3-carboxylic acid (4-hydroxy-phenyl)-amide; claim 4 reading under this election:
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(ii) oral administration;
(iii) neuropathic pain
(iv-b) not present,
in the reply filed on 4/6/2022 remains acknowledged.
Claims 11-13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/22/2024.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson et al. (US 2015/0209339 A1; 2015; cited in a prior Office action); in view of Hall et al. (“An observational descriptive study of the epidemiology and treatment of neuropathic pain in a UK general population”; 2013; BMC Family Practice; 14:28, pp. 1-10; http://www.biomedcentral.com/1471-2296/14/28).
Claims 2, 14 have been canceled.
Carson teaches hetero-substituted acetanilide derivatives are disclosed as analgesic agents (abstract). A method of controlling, inter alia, pain in a subject in need thereof comprising administering to the subject a compound of formula (I) same structure as prior instant claims 3 and 5 recite), wherein the compound of formula (I) is selected from a group that includes Applicant elected 5-Methyl-1H-pyrazole-3-carboxylic acid (4-hydroxy-phenyl)-amide ([0143]; Example 7; Table 2; claim 21; reading on the claimed compound of instant amended claim 1). Causes of pain include musculoskeletal pain inter alia ([0004]; [0165]; claim 9). Administration to the patient is taught [0146].
The patient with pain due to arthritis is still excluded from neuropathic pain recited by amended claim 1.
Regarding the elected oral dosing, the elected embodiment of claim 14, Carson teaches the compounds as part of pharmaceutical compositions [0150]; that preferably the compositions are administered orally [0154].
Regarding dose range of claim 15, doses taught by Carson, include, inter alia, 500 mg, for Applicant elected oral administration [0161], reading on the claimed therapeutically effective ranges. A single daily dose is among frequencies [0159].
Regarding amended claim 1, Carson teaches the compounds of Formula (I) are useful in treatment of inflammation [0166]. Thus, selecting a condition of neuropathic pain, and associated with inflammation (as required by claim 1 amendment) would have been obvious to select to treat, in view of both of these types of pain taught.
Carson does not explicitly discuss the length of pain; i.e., does not mention “chronic” or teach the disclosed at least three months of pain defined as chronic.
The Examiner notes that these compounds invented are of the type para-aminophenol type nonnarcotic analgesics/antipyretics, which have been known for over a century [0003]-[0004].
Hall teaches a study of UK primary care neuropathic pain incidence rates and prescribing practices; patients with a first diagnosis of post-herpetic neuralgia (PHN), painful diabetic neuropathy (PDN) or phantom limb pain (PLP) were identified in the General Practice Research Database and incidence rates were calculated. Prescription records were also searched; recording of neuropathic back and post-operative pain was investigated; results identified include paracetamol being prescribed (abstract).
Inspection of Table 2, the first line treatment by pain condition includes all four listed pain conditions were treated by paracetamol, co-codamol (contains paracetamol as a component) and/or co-dydramol (contains paracetamol as a component) among the top 5 most common medications. All average durations are in excess of 28 days, i.e., these are chronic pain treatments (see also discussion of chronic pain at p. 1, first paragraph). The average duration of treatment for painful diabetic neuropathy is 121 days, and standard deviations for three of the pain conditions named in Table 2 is in excess of 90 days; i.e., many of the patients had a treatment duration at least 3 months, rendering this extension to this duration, recited in claim 1 as obvious, during the period the pain is being treated and pain is ongoing. Three months is a named duration for post herpetic neuralgia (p. 6, 2nd paragraph).
The skilled artisan would have noted that that paracetamol (a.k.a., acetaminophen or TYLENOL) or combinations containing paracetamol was frequently used among the top 5 prescribed first line treatments for the four neuropathic pain types studied. The skilled artisan would have recognized that the instant claimed compound is in the same class of compounds as paracetamol per the teachings of Carson, and both are non-opioid analgesic and antipyretic agents. Hall establishes paracetamol is frequently used to treat neuropathic (in conditions not associated with arthritis) pain according to the Hall study for treatment of chronic pain, and would have been motivated to also utilize the instant active compound to treat the same neuropathic pain types, with a reasonable expectation of similar efficacy as that of acetaminophen. The motivation would have been to utilize the alternate compound as a substitute in the same class of compounds for the conditions of Hall.
Applicant argues that the Office action relies on improper hindsight reconstruction.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
This is not persuasive. Regarding the two compounds, structures are clearly similar; the claim 1 compound has the same identical portion of the compounds as paracetamol, except the right side terminal methyl of paracetamol corresponds to the heterocyclic ring (pyrazole), which is then substituted with a terminal methyl. Clearly these compounds are structurally similar.
Applicant further argues that acetaminophen does not possess any anti-inflammatory activity because it is a weak inhibitor of COX and does not inhibit neutrophil activation.
The Examiner has reviewed this teaching of Ohashi et al (IDS reference), but it is followed with the finding that acetaminophen metabolite AM404 introduces analgesia via TRPV1 receptors on the spinal dorsal horn in a rat model of inflammatory pain and these analgesic effects were stronger in the inflammatory pain model than in naïve rats (3rd page, first paragraphs). Thus, acetaminophen administration does result in inflammatory pain relief, in contrast to the partial representation argued. Regardless, the teachings of Carson explicitly names inflammatory pain treatment as benefitting from the compounds taught [0166], as well as other diseases or conditions characterized by pain, including, for instance, musculoskeletal pain [0165] (this is similar to Hall’s neuropathic back pain). Thus, the combination with Hall is obvious, and the conditions lasting longer than 3 months (many of the Hall pain conditions of Table 2 had durations in excess of this length) are reasonably expected to benefit.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614