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
The instant application was filed 16 December 2023 and is the national stage entry of PCT/CN2022/140816 filed 21 December 2022. The Applicant claims priority to foreign application CN202210682418.X filed 16 June 2022. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 21 December 2022.
Election/Restrictions
Claim10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 25 November 2025.
Applicant's election with traverse of Group I in the reply filed on 25 November 2025 is acknowledged. The traversal is on the ground(s) that amended claim 1 involves an inventive step. This is not found persuasive because Okaji et al. (JP 2013253038 A) teaches an oral film comprising brexpiprazole with a particle size of 5-60 microns, a PEG plasticizer, and 10-98% of hydroxypropylcellulose (abs; pg. 2, para. 6; pg. 3, para. 5). Ni et al. (CN 114767663 A) teaches an oral film with 4-20% of plasticizer (abs). Therefore, a skilled artisan would have been led to the ratios in claim 1 and the claim does not involve an inventive step.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 9 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.
Claim 9 recites the limitation "the pharmaceutical suspension" in line 2 of claim 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “or be prepared by the pharmaceutical suspension according to claim 1 as a raw material.” This limitation is unclear; the Applicant is recommended to amend the language for clarification purposes.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1, 2, 4-6, 8, 9, 12, 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okaji et al. (JP 2013253038 A; machine translation cited) and Ni et al. (CN 114767663 A; machine translation cited), as evidenced by clinpgx.org, cambridge.org, and Krekeler (US 2017/0182105 A1).
Okaji teaches an oral film comprising 1-50% (pg. 6, para. 2; entire teaching) of a drug compound 7-[4-(4-benzo[b]thiophene-4-yl-piperazine-1-yl)butoxy]-1H-quinoline-2-one (common name: brexpiprazole; evidenced by clinpgx.org, pg. 1) with a particle size of 5-60 microns (abs; entire teaching; pg. 2, para. 6). The composition may further comprise PEG as a plasticizer (pg. 3, para. 6) and hydroxypropyl cellulose as a water-soluble polymer (pg. 3, para. 4) in an amount of 10-98% (pg. 3, para. 5), addressing claims 2 and 9, and partially addressing claim 1. Water may be used as a solvent (pg. 4, para. 4), addressing claim 6. The pharmaceutical suspension in claim 6 is interpreted as the starting component before the film is made (evidenced by Krekeler, para. 106). Therefore, the liquid state of the composition during the processing steps in Okaji’s teaching (Example 1) is interpreted as the suspension component prior to obtaining the film.
Okaji does not specifically teach an amount of plasticizer or the ratios in claims 1, 4, 5, 8, 12, and 15. Okaji also does not teach an exact combination of the components in claim 1.
Ni teaches an oral film comprising aripiprazole, a film-forming agent, and a plasticizer (abs), where brexpiprazole and aripiprazole are both dopamine multifunctional agents used to treat schizophrenia (evidenced by cambridge.org, pgs. 1-2).
In regards to selecting the combination of brexpiprazole, a plasticizer, and a film-forming agent, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Okaji teaches compositions and methods for an oral film comprising brexpiprazole with a particle size of 5-60 microns, whereas the claimed invention is directed towards a composition comprising brexpiprazole with a diameter between 30 and 50 microns, a plasticizer, and a film-forming material. Since Okaji teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the amounts of components and ratios in claims 1, 4, 5, 8, 12, and 15, Ni teaches plasticizers in an amount of 4-20% (abs). Therefore, 1-50% of brexpiprazole, 10-98% of a film-forming agent, and 4-20% of a plasticizer could result in ratios for brexpiprazole:(film-forming agent and plasticizer) and film-forming agent:plasticizer that is within the ranges of claims 1 and 4. Similarly, Okaji provides an example with 0.5 parts by mass of brexpiprazole and 7.6 parts by mass of the film-forming agent (Example 1).That being said and in lieu of objective evidence of unexpected results, the amounts of components in claims 1, 4, 5, 8, 12, and 15 can be viewed as a variable that achieves the recognized result of successfully making the brexpiprazole composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of amounts and ratios can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of structural units of formula (I) as nonobvious.
Claim(s) 1, 2, 4-9, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okaji et al. (JP 2013253038 A), Ni et al. (CN 114767663 A), and Krekeler (US 2017/0182105 A1), as evidenced by clinpgx.org, Cambridge.org, and Krekeler (US 2017/0182105 A1).
In regards to claim(s) 1, 2, 4-6, 8, 9, 12, 14, 15, Okaji and Ni, as applied supra, is herein applied in its entirety for its teachings of an oral film comprising brexpiprazole.
Okaji does not specifically teach a viscosity of larger than 3,500 mPas for the composition in claims 7 and 13.
Krekeler teaches that a high viscosity for the suspension is preferable to obtain a stable suspension with a preferred viscosity of 1,000-5,000 mPas (para. 114; entire teaching) for orodispersible films.
Since Okaji does not specifically teach a viscosity of larger than 3,500 mPas for the composition in claims 7 and 13, one of ordinary skill in the art would have been motivated to use Krekeler’s teaching of a preferred viscosity of 1,000-5,000 mPas for oral films. A skilled artisan would have recognized the added benefit of utilizing a high suspension in order to obtain a stable suspension and better product, as a result of combining the teachings. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613