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 .
Claim Objections
Claim 2 is objected to because of the following informalities: for grammatical reasons, the indefinite article a should appear before the adjective “…polymeric…”.
Appropriate correction is required.
Claims 8 and 12 are objected to because of the following informalities: for grammatical reasons, the preposition of should appear before the term “…claim 1…”.
Appropriate correction is required.
Claims 15 and 18 are objected to because of the following informalities: for grammatical reasons, the phrase “…any one of…” should be deleted.
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor grammatical and/or spelling errors which may be present in the claim set.
Claim Rejections - 35 USC § 112
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 5, 10 and 11 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). Claim 5, for instance, recites the broad recitation “…in the range of 40,000-250,000 g/mol…”, and the claim also recites “…preferably [emphasis added] 80,000-150,000 g/mol…” which is the narrower statement of the range/limitation. Analysis of the “preferably” and “more preferably” limitations of claims 10 and 11 is similar.
The claims 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.
Claims 6, 9, 11-14, 16, 17, 19 and 20 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.
The phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 is 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.
There is insufficient antecedent basis for the limitation “…the dry weight ratio of disintegrant…” in the claim.
Claim 18 is also 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.
The claim depends from an indefinite claim but does not relieve the indefiniteness. Dependent claim 18 is also, therefore, indefinite.
Allowable Subject Matter
Claims 1 and 7 are allowed. Claims 3 and 4 are objected to as being dependent upon a base claim which has also been objected to, but are otherwise allowable. The subject matter of the remaining claims would be allowable once the objections and 112 rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
Amorphous X842 is the key to the instant invention. US 2022/0002297 A1 (which claims priority to US 63/047,607 filed 7/2/2020), cited in the IDS, appears to be the closest prior art. The reference teaches polymorphs A and B of X842 utilized in pharmaceutical compositions for treating and preventing a gastrointestinal inflammatory disease or a gastric acid related disease (abstract; page 1, column 1, [0002]; page 1, column 2, [0016]ff). The reference explicitly teaches away, in fact, from amorphous forms of X842 due to several undesirable characteristics of non-crystalline forms (page 1, column 1, [0005]). One of ordinary skill in the art, before the effective filing date of the instant invention, would have had no motivation to formulate the instant amorphous form of X842, given the teaching the cited art, in order to arrive at the amorphous X842 formulation and dispersion of the instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/25/2026
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