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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 4-11, and 13-15 in the reply filed on July 8, 2026 is acknowledged.
Claims 17, 21, and 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US2022/028009, filed May 6, 2022. Applicant’s claim for the benefit of a prior-filed parent provisional applications 63/300,970 (Jan. 19, 2022); 63/191,571 (May 21, 2021); 63/187,765 (May 12, 2021); 63/186,626 (May 10, 2021); and 63/185,773 (May 7, 2021) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is May 7, 2021.
Information Disclosure Statement
The information disclosure statement filed Oct. 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
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.
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.
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.
Claim(s) 1, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fritscher et al. (WO2020/014479) in view of Innotherapy (KR-10-2167829), both cited in IDS filed on Oct 22, 2024.
The claims are directed to compositions including an adeno-associated virus (AAV) vector in a carrier including a zwitterionic surfactant and hydroxypropyl methylcellulose.
With respect to independent claim 1, Fritscher et al. teach a composition including an AAV vector in a carrier including hydroxypropyl methylcellulose (HPMC). (paras. [0004], [0024], [0138]).
Fritscher et al. does not teach that the carrier includes a zwitterionic surfactant.
Innotherapy teaches stabilizing AAVs in a carrier that includes a zwitterionic surfactant, as well as HPMC. (Abstract, paras. [0005], [0008], [0015]).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the AAV vector in a carrier including HPMC taught by Fritscher et al. to incorporate including a zwitterionic surfactant (as taught by Innotherapy) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results w11ith a reasonable expectation of success because both references are directed to carriers for stabilizers AAVs. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) See MPEP 2144.06 I.
With respect to claim 9, Innotherapy teach the zwitterionic surfactant is included at 0.005%-0.02%. (para. [0033]. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") See MPEP 2144.05 II.A.
With respect to claim 10, Innotherapy teach CHAPS as a specific zwitterionic surfactant. (para. [0033]). it would have been obvious to one of ordinary skill in the art at the time the invention was made to have used PMAL-C16, since the equivalence of PMAL-C16 and CHAPS was recognized for their use in the zwitterionic surfactant art and the selection of any of these known equivalents would be within the level of ordinary skill in the art. The motivation for making such an equivalent substitution would be to use a surfactant which has better compatibility with the other agents in the proposed formulation. It would have been obvious to further have used 1% PMAL-C16, since discovering the optimum value of a result effective variable involves only routine skill in the art. The motivation for doing so would be to provide a surfactant in an amount that is sufficient to help stabilize the composition.
With respect to claim 11, Fritscher et al. teach the composition has a pH within the claimed range of 7-9. (para. [0141]).
With respect to claim 13, Fritscher et al. teach the AAV composition are aqueous. (“liquid”). (para. [0154]).
With respect to claim 14, Fritscher et al. teach the AAV composition are lyophilized. (“solid”). (para. [0026]).
With respect to claim 15, Fritscher et al. teach AAV vectors generally, and specifically AAV9. (para. [0253]).
Claim(s) 2, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fritscher et al. (WO2020/014479) and Innotherapy (KR-10-2167829) as applied to claims 1, 9-11 and 13-15 above, and further in view of Ji et al. (U.S Patent App. No. 2008/0226724), all cited in IDS filed on Oct 22, 2024.
Fritscher et al., as modified by Innotherapy does not teach HPMC between 0.5% and 3.0%; that the HPMC that has a molecular weight (MW) that produces a viscosity that is less than 4000 cp at a concentration of 2% in water; or that the HPMC is A4M, F4M, A15C, A4C, K100LV, E4M, E6LV, or A15LV.
Ji et al. teach that HPMC is used at a concentration between 1% and 6% to produce a stable hydrogel, such that the hydrogel is autoclave sterilizable and can be stored for extended periods of time. (paras. [0001]) [0005]). Ji teaches HPMC that has a molecular weight (MW) that produces a viscosity that is less than 4000 cp at a concentration of 2% in water and that HPMC is A4M, F4M, A15C, A4C, K100LV, E4M, E6LV, or A15LV. (para. [0005]
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the AAV vector in a carrier including HPMC taught by Fritscher et al. to incorporate employing 0.5% - 3.0% HPMC (a range overlapping with that taught by Ji et al.) having a molecular weight (MW) that produces a viscosity that is less than 4000 cp at a concentration of 2% in water and using a HPMC is A4M, F4M, A15C, A4C, K100LV, E4M, E6LV, or A15LV because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because the HPMC is taught to be included to stabilize the AAV and Fritscher et al. further teach ranges at which that stabilization, in the form of a hydrogel, is suitable for long term storage.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") See MPEP 2144.05 II.A.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fritscher et al. (WO2020/014479) and Innotherapy (KR-10-2167829) as applied to claims 1, 9-11 and 13-15 above, and further in view of Marshall et al. (WO 2020/214929), all cited in IDS filed on Oct 22, 2024.
Fritscher et al., as modified by Innotherapy does not teach the inclusion of a sugar in the composition, such as 2% glycerol and/or 2% sorbitol.
Marshall et al. teach AAV formulation having sugars, specifically 0.1% and 5% glycerol and 1% sorbitol. (Abstract, paras. [0141], [0174]).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the AAV vector in a carrier including HPMC and a zwitterionic surfactant as taught by Fritscher et al. as modified by Innotherapy to incorporate adding a sugar, specifically 2.0% or either sorbitol or glycerol (as taught by Marshall et al.) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because Marshall et al. teach that adding sugars in the claimed range, and glycerol and/or sorbitol specifically helps achieve a desired viscosity and increases stability of the AAV vector.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") See MPEP 2144.05 II.A.
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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