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 24 May 2024 and is the national stage entry of PCT/US2022/080292 filed 22 November 2022. Therefore, the effective filing date of the instant application is 22 November 2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 24 April 2026 is acknowledged.
Claims 8-10 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 April 2026.
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 1 and 7 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.
Claim 1 recites “a particle size of about 15 µm to about 40 µm (D50)” and claim 7 recites “a particle size of between about 15 µm to about 25 µm (D50).” The parenthetical recitation “(D50)” renders these claims indefinite because D50 is not the same as or an abbreviation for “particle size.” The claims recite “a particle size,” instead of, for example, “an average particle size.”
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, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albayrak (US 2017/0231957 A1).
Regarding claim 1, Albayrak teaches microspheres (para. 35) comprising asenapine or a salt of asenapine (abs, entire teaching) and a biodegradable polymer, such as a polylactide polymer (abs). The amount of asenapine may be at least 15% (para. 21) and the particle size of the microspheres may be below 100 microns or 1-125 microns (para. 34).
Regarding claim 2, Albayrak teaches microspheres (para. 35) comprising asenapine or a salt of asenapine (abs).
Regarding claim 6, the amount of asenapine may be at least 15% (para. 21).
Regarding claim 7, the particle size of the microspheres may be below 100 microns or 1-125 microns (para. 34).
Albayrak does not teach an exact combination of a polymer microsphere comprising asenapine, a biodegradable polymer, at least 15% by weight of asenapine, and a particle size of 15-40 microns for the microspheres, as recited in instant claim 1.
In regards to selecting the combination of a polymer microsphere comprising asenapine, a biodegradable polymer, at least 15% by weight of asenapine, and a particle size of 15-40 microns for the microspheres, as recited in instant claim 1, “[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.”
Albayrak teaches compositions comprising asenapine microspheres and polylactide polymers, 15% of asenapine, and a particle size of 1-125 microns, whereas the claimed invention is directed towards a polymer microsphere formulation comprising asenapine, a biodegradable polymer, a drug load of 15% of asenapine, and a particle size of about 15-40 microns. Since Albayrak 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.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albayrak (US 2017/0231957 A1), as applied to claims 1, 2, 6, and 7 above, in view of Wang (Encapsulation and release of doxycycline from electrospray-generated PLGA microspheres: Effect of polymer end groups, International Journal of Pharmaceutics, 2019).
In regards to claim(s) 1, 2, 6, and 7, Albayrak, as applied supra, is herein applied in its entirety for its teachings of asenapine microspheres and a biodegradable polymer, such as polylactide polymers.
Regarding claims 3-5, Albayrak teaches an inherent viscosity in the range of 0.1-3 dL/g (para. 29).
Albayrak does not teach an acid-terminated PLA polymer, as recited in instant claims 3-5.
Wang teaches that acid-terminated polymers are more hydrophilic and offer slower release or drugs, higher encapsulation efficiency, and better stability in emulsions (pgs. 1-2).
Since Albayrak teaches a biodegradable polymer, such as polylactide polymers, in their asenapine microsphere formulation wherein the polymers may have an inherent viscosity of 0.1-3 dL/g, but does not specify that the PLA polymer is acid-terminated in instant claims 3-5, one of ordinary skill in the art would have been motivated to use Wang’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the benefit of incorporating acid-terminated PLA to achieve an improved product with better encapsulation efficiency and stability.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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