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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 11/06/2023, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 1-11 and newly added claims 17-19, in the reply filed on 05/18/2026 is acknowledged.
Newly added claims 20-21 are drawn to different invention, which is distinct from the subject matter of claim 1. Similarly, newly added claim 22 is drawn to manufacture of a cosmetic pharmaceutical composition, and newly added claims 23-24 are drawn to cosmetic pharmaceutical composition, both are patentably distinct from claims of group I.
Accordingly, claims 20-24 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 1-11 and 17-19 are examined on merits in this office action.
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 1-11 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Naider (The Journal of Biological Chemistry, 1974, vol.249, issue of Jan 10, pp.9-20) in view of Baldys (WO2016/204841A1) and Fournial (WO2010/082175A2).
For claims 1-3:
Naider teaches purification of methionine and glycine containing tri- and tetrapeptides, such as Met-Met-Gly-Gly, Met-Met-Gly and Met-Gly-Gly etc. Naider exemplify the purification of Met-Met-Gly, comprises dissolving Boc-(Met)2-Gly in anhydrous acetic acid and solution left at room temperature for 1 hour. Anhydrous diethyl ether was then added causing the precipitation of the tripeptide hydrochloride. The precipitate was recovered by filtration and washed twice with diethyl ether. [See pages 12-13].
Difference is that Naider is silent on (i) applicants tripeptide of the formula (I) with the recited limitations and (ii) its purification.
With regard to (i) of above, the following art and the reasoning cures the deficiency:
Baldys teach MVV as an active agent for their topical composition [see SEQ ID NO:369 in Table 2]. It appears that methionine is not in the oxidized form. However, oxidized methionine in peptides are known topical formulations in the art, specifically in cosmetic skin applications, wherein oxidized peptides show enhanced properties over their corresponding non-oxidized peptides. For example, Fournial teach cosmetic compositions, wherein dioxidized methionine in 3-mer show several fold higher collagen I in the dermis than non-oxidized methionine [see Table 1 in Example 3]. So, it oxidized form shows higher activity than non-oxidized form. Therefore, one would be motivated to oxidize methionine of MVV in Baldys in light of its advantages as evidenced from the teachings of Fournial. Accordingly, applicants compound is obvious over the art.
With regard to (ii) of above, Naider fairy suggests applicants solvents in the purification of tripeptides comprises methionine and it is expected to work for the purification of applicants compound, absent evidence to the contrary. Moreover, ether precipitation of peptides is well established in the art.
For claims 4-5:
MPEP 2144.05 II A states “Generally, differences in concentration or temperatures will not support the patentability of subject matter encompassing by the prior art unless there is evidence indicating such concentration or temperature is critical”.
Merely modifying the process conditions such as temperature and concentration is not a patentable modification absent a showing of criticality. In re Aller, 220 F.2d 454, 105 U.S.P.Q. 233 (C.C.P.A. 1955).
For claims 6-7:
See For claims 1-3 above.
For claims 8:
Naider teaches diethyl ether, whereas claim requires methyl tert-butyl ether. Difference is in the size of alkyl groups. This difference is interpreted as replacing H with methyl groups and vice versa.
However, the issue of patentability over the replacement of alkyl groups for hydrogen and vice versa has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that "one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious - at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound - at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results - at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds could be prepared by the same method as taught by the prior art and have the same utility as the compounds taught by the prior art.
MPEP 2144.09 (VII) states "A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)".
For claim 9:
See For claims 1-3 above.
For claims 10-11 and 17-19:
See For claims 4-5.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants claimed solvents in purification of tripeptides and applicants tripeptide of formula (I), 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 can 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.
A combination of prior art references is only proper if a person of ordinary skill in the art at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
The strongest rationale for modifying or combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
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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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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