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 .
According to a preliminary amendment filed on Oct. 2, 2023, the applicants have amended claims 4, 7-9, 12-15 and 17.
Claims 1-17 are pending in the application.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 5, 10 and 12-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation between 0.5 and 2 weight ratio, and the claim also recites preferably between 0.54 and 1.57, more preferably 1 or 1.28 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 recites the broad recitation for density between 20 and 100 mg/cm2, and the claim also recites preferably between 25 and 80 mg/cm2 which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation comprising 18%, 28% or 40%, and the claim also recites preferably 40% which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation molecular weight between 1500 and 8000 g/mol, and the claim also recites between 2000 and 6000 g/mol, more preferably 4000 g/mol which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation between 35 and 55%, and the claim also recites preferably 35% which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation between 10 and 30%, and the claim also recites preferably 20% which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation between 30 and 55%, and the claim also recites preferably between 35 and 55%, more preferably 45% which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation between 35 and 55%, and the claim also recites preferably 50% which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation between 30 and 55%, and the claim also recites preferably between 35 and 55%, more preferably 50% which is the narrower statement of the range/limitation.
Claim 14 recites the broad recitation veterinary composition, and the claim also recites preferably bovine, a caprine, a sheep and a pig, preferably a bovine which is the narrower statement of the range/limitation.
Claim 15 recites the broad recitation non-human animals, and the claim also recites preferably bovines, caprines, sheep and pigs, which is the narrower statement of the range/limitation.
Claim 16 recites the broad recitation mucosally, and the claim also recites preferably nasally or intravaginally, which is the narrower statement of the range/limitation.
Claim 17 recites the broad recitation device, and the claim also recites preferably a nasal or intravaginal device, which is the narrower statement of the range/limitation.
Claims 15 and 16 are directed to use of composition. However, it is not clear who is being administered and furthermore, the steps of administration are also missing in the claims.
Claim Rejections - 35 USC § 103
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.
8. 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.
9. Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson (US 2019/0290474 A1, cited on applicant’s form 1449).
Simpson discloses drug release device and use. The composition comprising progesterone and EVA (see example 7 on page 22), thermoplastic polymer , ASTM D2240, melting point between 40 and 200 degree (see paragraph 0011 on page 1) and a device for synchronizing estrous in animals (see paragraphs 0013-0020 and paragraphs 0025-0029 on page 2) as well as claims 114 and 130-133 disclosed by Simpson meet all the limitations of instant claims except that Simpson does not teach percentages 35%-55% of polymer matrix and 30%-50% of progesterone in the composition. However, Simpson teaches all the ingredients including progesterone, thermoplastic polymer, device comprising composition for synchronizing the estrous in animals. Therefore, it would have been obvious to one skilled in the art to select percentages of progesterone and polymer matrix in the composition and its use in a device for synchronizing the estrous in animals with reasonable expectation of success unless applicants provide unexpected results of superior activity of their composition over the composition disclosed by Simpson.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621