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 05/12/2023, 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 19-28, with traverse, in the reply filed on 07/08/2026 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing a single species for the claimed composition.
Applicants traversal of restriction and election of species is on the grounds that restriction requirement has not provided sufficient evidence to establish lack of novelty or lack of inventive step, since CN11151135 does not disclose a solid form. Furthermore, there is no serious burden in searching the Groups together, given especially the related nature of the claims.
Independent claim does not require any specific form and so, cited document reads claim 1. Solid form is elected species. Still cited art in combination with known art, which teaches solid form, reads elected species, which breaks the unity.
The search strategy for product/composition is different from that of method claims. The product search is based on the on the registry numbers or structure or names of the compounds in a given formulation, whereas the search of method claims requires additional key words or subject matter, which is a serious burden. Even if the product is allowable, the method claims are not necessarily be allowable, because the method claims will be analyzed in view of 112 issues, which requires an additional search.
Claims 29-39 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 19-28 are examined, in light of elected species, 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 19-28 are rejected under 35 U.S.C. 103 as being unpatentable over CN 111511351 A (herein after CN111) in view of Lajoinie (Br.J.Clin.Pharmacol, 2014, 78:5, 1080-1089), Basit (US 2007/0243253 A1) and Feng (BioMol Concepts, 2016, 7(3), 179-187).
For claim 1:
CN111 teaches an aqueous solution composition comprising peptide therapeutic agent and one or more buffering agents, wherein peptide therapeutic agent is oxytocin and buffering agent is arginine [see claims 1-2 and 4-5].
Difference is that CN111 is silent on applicants elected solid pharmaceutical composition.
However, solid form has advantage over liquid form, see the reasoning below:
There are several key differences between solid and liquid dose drug manufacturing techniques that may make one or the other more advantageous for a particular product or process. Solid dose production typically uses less active pharmaceutical ingredients (API) and involves fewer processing steps than liquid dose production. This can lead to reduced costs and shorter production timelines. Solid dose drugs are also easier to store and transport than liquids, making them more convenient for patients.
In addition, Lajoinie teaches numerous advantages of solid forms compared with liquid forms [see whole document].
Therefore, one would be motivated to make solid form of pharmaceutical composition, and so, it is obvious limitation.
For claim 20:
CN111 teaches oxytocin, which is a cyclic peptide.
For claims 21-22:
Generally solid forms, such as tablets are suitable for oral administration.
With regard to enteric coating see For claims 24-27 below.
For claim 23:
The recited limitation is intended use and it does not have any weight, since it does not add any structural limitation to the claimed composition. Therefore, this part of the claim is not given patentable weight. See MPEP 2111.02(11).
For claims 24-27:
CN111 is silent on solid form, as explained above, and so, it is also silent on a solid dosage form with a core and a coating for the core with the recited limitations. This deficiency can be cured with the teachings of Basit, see below.
Basit teaches a delayed release coating comprising a mixture of a first material selected from starch, amylose, amylopectin, chitosan, chondroitin sulfate, cyclodextrin, dextran, pullulan, carrageenan, scleroglucan, chitin, curdulan and levan, and second material is a film-forming polymeric material, which is acrylate polymer or cellulose polymer or polyvinyl-based polymer, wherein cellulose polymer is cellulose acetate phthalate [see claims 1-15].
So, light of teachings of Basit, a skilled person in the art can make a solid form of a pharmaceutical composition.
For claim 28:
CN111 silent on D-amino acids in the peptide.
Advantages of D-amino acids in the peptides are well known in the art. For example, Feng teaches D-amino acids containing peptides and their advantages [see whole document]. Therefore, a skilled person in the art would be motivated to incorporate one or more D-amino acids in the peptide.
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 scope, 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 composition 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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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