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
Filed information disclosure statements (IDS) 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 1-7 and 14-21, without traverse, in the reply filed on 05/11/2026 is acknowledged.
Claims 8 and 10-13 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-7 and 14-21 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 1-7 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mezo (US2016/0368960A1) in view of Avanti [Innovative Strategies for Stabilization of Therapeutic Peptides in Aqueous Formulations, 1 Jan 2012; see applicants filed IDS dated 05/11/2016].
For claims 1-3:
Mezo teaches the following compound and its pharmaceutical composition:
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[see page 11, Example 2 and SEQ ID NO:6; see paragraphs 0067-0068, 0149-0150, and claims 12-13].
The above chemical formula is identical to applicants chemical formula of OXM3.
Mezo teaches 10 mM Tris (aka tromethamine) and 3 mg/mL m-cresol in testing the solubility of 10 mg/mL peptide [0212-0217 and Table 2(b)], which is interpreted as compositions.
Mezo further teaches that water as a suitable carrier and mannitol or sorbitol as suitable excipients for their pharmaceutical composition [see 0150].
In the above, 05-5 mg/mL TRIS equals to ~4 mM to 41 mM of TRIS, wherein mol wt of TRIS is 121.14. So, 10 mM of TRIS from Mezo falls within the claimed range. Also, water is interpreted as applicants solvent, and mannitol is interpreted as applicants stabilizer.
Difference is that Mezo silent on (i) chelating agent and (ii) specific concentration ranges of stabilizer and chelating agent.
With regard to (i) of above, chelating agents, such as EDTA or its sodium salt, are well known in the art in protein formulations. For example, Avanti teaches strategies to improve peptide stability in aqueous formulations and mentioned that chelating agents, viz., EDTA, citric acid, and tartaric acid etc., one of the component since it lowers the risk of free radical oxidation [see page 26 in section 3]. Therefore, one would be motivated to incorporate EDTA or its salt form to avoid free radical oxidation.
With regard to (ii) of above, generally, concentrations of components for a given process is considered as result effective variables, and the differences in their amounts will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such differences in result-effective variables are critical. "Where 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, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
For claim 4:
Mezo further teaches tween-20 in solubility testing of their peptides [see 0215], which is interpreted as formulation comprising surfactant, viz., tween-20.
For claim 5:
Mezo teaches 10 mg/mL of peptide [0217].
For claim 6:
Mezo teaches pH 7.4 and 8 [see Table 2(b)].
For claims 7 and 14:
As explained under For claims 1-3 above, Mezo teaches applicants OXM3, Tris, mannitol, water as a solvent etc., but silent on EDTA and propylene glycol in their compositions. However, Avanti cures this deficiency. Avanti in “strategies to improve peptide stability in aqueous formulations” teaches EDTA as a chelating agent and its advantages [see section 3.2.4] and co-solvents such as low molecular weight PEG were shown reduce the aggregation of several peptides, and further teaches propylene glycol as one of the polyol for stabilizing peptides [see section 3.1.3]. Therefore, one would be motivated to incorporate EDTA or its salt form and propylene glycol or its equivalents as a co-solvent in the formulation to avoid aggregation and stabilize peptide.
With regard to concentrations and pH see the provided reasoning for concentrations in For claims 1-3 and for pH in For claim 6.
For claim 15-16:
Mezo teaches 10 mg/mL of peptide [0217], which falls within the claimed ranges.
For claims 17-18:
As explained under For claims 1-3 above, Mezo teaches applicants OXM3, Tris, mannitol, water as a solvent etc., but silent on EDTA and propylene glycol in their compositions. However, Avanti cures this deficiency. Avanti in “strategies to improve peptide stability in aqueous formulations” teaches EDTA as a chelating agent and its advantages [see section 3.2.4] and co-solvents such as low molecular weight PEG were shown reduce the aggregation of several peptides, and further teaches propylene glycol as one of the polyol for stabilizing peptides [see section 3.1.3]. Therefore, one would be motivated to incorporate EDTA or its salt form and propylene glycol or its equivalents as a co-solvent in the formulation to avoid aggregation and stabilize peptide.
With regard to concentrations see the provided reasoning in For claims 1-3.
For claim 19:
See For claim 4 above.
For claim 20:
Mezo teaches pH 7.4 and 8 [see Table 2(b)].
For claim 21:
See For claims 7 and 14 above.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their advantages in peptide formulations, 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 teachings of 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.
The strongest rationale for 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
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