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 .
1. Claims 3, 5, 7-29, 31-34, 37-47, 49-55, and 57-65 were cancelled. Claims 6, 30, 35, 48, 56, 66, and 67 have been amended.
Claims 1, 2, 4, 6, 30, 35, 36, 48, 56, 66, and 67 are pending and under examination.
Claim Objections
2. Claim 1 is objected to because of the recitation “a quantity” in step c). Correction “the quantity” is required.
3. Claim 35 is objected to because of the recitation “a polynucleotide”. Correction “the polynucleotide” is required.
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1, 2, 4, 6, 30, 35, 36, 48, 56, 66, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Drouin et al. (WO 19/210137), in view of both Duong et al. (J. Neuromusc. Dis., online September 2020, 8: 63-77) and Laporte et al. (WO 2019/007991), as evidenced by both Perez et al. (WO 22/192622) and Shieh et al. (Neurology, 2020, 94, 15_Supplement, Abstract).
Drouin et al. teach that AADC-encoding AAV is useful for AADC delivery to subjects affected by a disease associated with AADC loss-of-function (see [0004]; [0008]; [0205]-[0207]). Drouin et al. teach a method for determining the efficacy of an AAV encoding L-amino acid decarboxylase (AADC), the method comprising: contacting permissive cells with the AAV; lysing the cells; adding L-DOPA substrate to the cell lysate; measuring the amount of dopamine produced in the cell lysate via chromatography; determining relative efficacy by comparing the result to a reference AAV; selecting the AAV having the desired efficiency for gene therapy and aliquoting into a container (i.e., releasing the selected AADC-encoding AAV for treating the disease) (claims 1, 2, and 6) (see [0004]; [0015]-[0018]; [0031]; [0273]; [0290]-[0291]).
Drouin et al. do not teach an AAV encoding MTM1 from the desmin promoter (claims 30, 35, and 36). However, one of skill in the art would have reasonably concluded that the method of Drouin et al. could be applied to assess and select other AAVs for therapy.
Duong et al. teach clinical trial NCT03199469 for treating XLMTM by administering resamirigene bilparvovec (or AT132; an MTM1-expressing AAV) (see Abstract; p. 65, column 2). As evidenced by Perez et al., resamirigene bilparvovec is an AAV whose genome has the sequence set forth by SEQ ID NO: 5, which comprises a nucleic acid encoding human MTM1 operably linked to the desmin promoter and which is identical to the claimed SEQ ID NO: 2 (claim 48) (see p. 25, Table 1; see the attached Sequence Alignment). As evidenced by Shieh et al., NCT03199469 used doses of 1x1014 vg/kg and 3x1014 vg/kg (claim 56 and 66) (see Abstract).
One of skill in the art would have found obvious to extrapolate the method of Drouin et al. to AT132 and further administering the selected AT132 to XLMTM patients, with the reasonable expectation that doing so would result in optimal therapeutic effect. Since the cleavable substrate phosphoinositide was routinely used in the prior art to assess MTM1 activity (see Laporte et al., p. 15, lines 1-5; p. 23, lines 24-30), one of skill in the art would have also found obvious to use phosphoinositide as the substrate, to achieve the predictable result of assessing AT132 efficiency.
By doing so, one of skill in the art would have practiced a method as recited in claims 1, 2, 4, 56, and 66.
With respect to claim 67, the limitation of instructions only represents printed matter that is not related to the AAV or the method for determining efficiency, and thus, it is not patentably significant. MPEP 2111.05 I A/B states:
“To be given patentable weight, the printed matter and associated product must be in a functional relationship.
Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339.”
Furthermore, kits have been routinely used in the prior art. One of skill in the art would have been motivated to assemble a kit, i.e., put the reagents in a box containing instructions how to use the reagents, because they are convenient to use and save time.
Thus, the claimed invention was prima facie obvious at the time of its effective filling date.
6. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/ Primary Examiner, Art Unit 1633
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