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
Receipt of applicant’s remarks and claim amendments filed on 03/27/2026 are acknowledged.
In light of claim amendments, previous Claim Objections and 103 rejection are withdrawn. However, a new grounds of rejection, necessitated by applicant’s current amendments to the claims, has been made. The rejection is based on the different interpretation of the previously applied reference, which provides an explanation of the rejection.
Also a new Claim Objections is made to claim 1.
Response to Arguments
Applicants’ arguments are moot in view of above new grounds of rejection.
Claim objections
Claim 1 is objected to because of the following informalities: the limitation of “SEQ. ID NO.” should be changed exactly to “SEQ ID NO:”. Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Remer (WO 2018209415 A1) in view of Fiedler (J Syst Integr Neurosci., 2017 May, 3(3), 1-12), Gauntt (Frontiers in Bioscience, 1 Jan 2003, 8, e23-35), Adedayo (West Indian Med J., 2011, 60(2), 217-219) and Ristic (Heart Fail Rev., 2013, 18, 345-353).
Remer teaches a method of treating multiple sclerosis by administering NFKF [see Example 13].
Remer further teaches peptide sequences, viz., NFKF and NFKL, and their use in treating inflammatory disorders, pain [see Abstract, paragraph 0315 and claim 4].
Remer still further teaches that the response time profile of NFKF-treated transgenic animals (Figure 25), are consistent with effects on the immune response and / or anti-inflammatory effect or compound of the invention. In this context, it is known that the cannabinoid system is involved in a variety of immune cells whose activation through receptors triggers a series of signal transductions that affect the transcription and production of cytokines and chemokines. Further states that the compound of the invention, having been shown to modulate the cannabinol system, may interfere with this system and is potentially useful in a variety of inflammatory, immune, autoimmune conditions. [see 0315].
Though Remer teaches the peptides NFKF and NFKL, and their utilities in treating inflammatory conditions, but silent on treating applicants cited disorders or diseases (claims require at least one), and claimed lowering levels of cytokines. This can be cured by the following reasoning and from the known art, see below.
First, increase in the levels of cytokines are expected in the recited disorders or conditions since these are associated with inflammation, absent evidence to the contrary. Therefore, a skilled person in the art would be motivated to extrapolate the advantages of NFKF and NFKL to other inflammatory disorders. There is a reasonable expectation of success in light of guidance provided by the Remer in its disclosure.
Second, the following art teaches increase in levels of cytokines are associated with inflammation and corresponding disorders or diseases:
Fiedler teaches increase in levels of IL-6, IL-1beta and TNF-alpha multiple sclerosis patients [see title, abstract, page 5 and Fig.1-3].
Gauntt teaches cytokines, viz., IL-6, IL-1beta and TNF-alpha, in involvement in CVB3-induced myocarditis [see page 29].
Adedayo teaches that the mechanism of viral myocarditis may include viral induced cell mediated cytotoxicity or myocardial damage by pro-inflammatory cytokines. Acute influenza virus is associated with release of cytokines which includes pro inflammatory cytokines as IL-1beta, IL-6, IL-18 and tumour necrosis factor alpha [see 4th paragraph in right column in page 218].
Ristic identified various cytokines, such as IL-6, TNF-alpha etc., in patients with pericarditis [see Abstract and Introduction].
Based on the above teachings it is clear that the above cytokines are common in at least multiple sclerosis, myocarditis and pericarditis. Therefore, NFKF and NFKL expect to treat myocarditis and pericarditis or diseases or disorders show elevated levels of cytokines.
Please note that claims require at least one disorder or condition, and the above showed two evidences.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants peptide and its use in treating inflammatory disorders, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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