DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Status
Claims 1-14, 16, 19-25, 31-35, 37-41, 44-45, and 49 were previously pending.
Receipt is acknowledged of the amendments to the claims submitted on 11 March, 2026. Claims 5-9, 13-14, 16, 23, and 40 are cancelled. Claims 1-2, 10-11, and 24-25 are amended.
Applicant’s election without traverse of the invention of Group I, drawn to a method of treating Parkinson’s disease in the reply filed on 20 November, 2025 was previously acknowledged.
Claims 10-12 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1-4, 19-22, 24-25, 31-35, 37-39, 41, 44-45, and 49 are pending and under examination in the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/045447, filed 10 August, 2021, which claims priority to United States Provisional Application No. 63/063,851, filed 10 August, 2020. Acknowledgment is made of applicant’s claim for priority.
The earliest possible priority for the instant application is 10 August, 2020.
Drawings
The Drawings submitted on 09 February, 2023 are accepted by the Examiner.
Withdrawn Objections/Rejections in view of Applicant’s Amendments/Arguments
Claim Objections
The objection to claim 25 is withdrawn in view of Applicant’s amendments to the claims. Applicant has spelled out “TRY”.
Claim Rejections - 35 USC § 112, first paragraph
The rejection of claims 1-4, 9, 19-25, 31-35, 37-39, 41, 44-45, and 49 under 35 U.S.C. 112, first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims is withdrawn in view of Applicant’s amendments and arguments.
Applicant has amended the claims to comply significantly with the identified enabled claim scope in the non-final rejection mailed 06 January, 2026. In addition, Applicant has argued that the clinical history of the PROPEL trial (see, NCT04127578; https://clinicaltrials.gov/study/NCTO4127578?intr=PR001 &rank=3) refutes the Examiner’s assertion that a clinical trial does not appear to have been performed to test Applicant’s hypothesis (Remarks, page 11). This argument has been fully considered and has been found persuasive because the PROPEL trial evidences predictability with regard to the combination of immunosuppressants and the rAAV therapeutic claimed. A skilled artisan would not be subjected to undue experimentation with regard to combining an immunosuppressant with the rAAV therapeutic claimed because they would know from the PROPEL trial to do so.
Maintained Rejections in view of Applicant’s Amendments/Arguments
Double Patenting
Claims 1-4, 19-22, 24-25, 31-35, 37-39, 41, 44-45, and 49 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-24 of U.S. Patent No. 11,903,985. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘985 is drawn to methods of treating a subject having Parkinson’s disease comprising administering an rAAV comprising SEQ ID NO: 15 just like the instant claims. This rejection has been modified for clarity as necessitated by Applicant’s amendments to the claims.
Claim 1 of the reference patent reads: “A method for treating a subject having Type 2 Gaucher disease or Type 3 Gaucher disease, the method comprising administering to the subject a recombinant adeno-associated virus (rAAV) comprising: (i) a rAAV vector comprising a nucleic acid comprising an expression construct comprising a promoter operably linked to a transgene insert encoding a glucocerebrosidase (Gcase) protein, wherein the transgene insert comprises the nucleotide sequence of SEQ ID NO: 15; and (ii) an AAV9 capsid protein; wherein the rAAV is administered to the subject at a dose ranging from about 5×10.sup.10 vg/g brain to about 5×10.sup.11 vg/g brain.”
Amended claim 1 of the instant Application reads: “A method for treating a subject having Parkinson's disease with a glucocerebrosidase-1 (GBA1) mutation, the method comprising administering to the subject:a recombinant adeno-associated virus (rAAV) comprising:(i) a rAAV vector comprising: (a) a nucleic acid comprising an expression construct comprising a promoter operably linked to a transgene insert encoding a glucocerebrosidase (Gcase) protein, wherein the transgene insert comprises the nucleotide sequence of SEQ ID NO: 15; and (b) two adeno-associated virus inverted terminal repeats (ITR) sequences flanking the expression construct, wherein the first ITR sequence is a 5' ITR, and the second ITR sequence is a 3' ITR; and (ii) an adeno-associated virus (AAV) 9 capsid protein; and one or more of the following:(A) sirolimus;(B) methylprednisolone;(C) rituximab; and(D) prednisone. wherein the rAAV is administered directly to the central nervous system (CNS) of the subject.”
Note that MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for ODP rejections.
In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. The court in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The instant claims are narrower than the patented claims insofar as they require one or more of sirolimus, methylprednisolone, rituximab, and prednisone. However, the ‘985 patent specifically discloses that an immunosuppressant can be administered to the subject as well and specifically mentions prednisone (paragraph (170)). Thus, the instantly claimed species are an obvious variant of the patented claims in view of the species of methods including administration of prednisone disclosed in the reference patent’s supporting disclosure.
Response to Arguments
Applicant argues against the above-double patenting rejection on the grounds that (1) no claim in the reference patent requires co-administration of any immunosuppressant (Remarks, page 15), (2) a single mention of prednisone does not render obvious the “claimed four-agent immunosuppression regimen” (remarks, page 15), (3) the amended claims “recite a specific combination selected from sirolimus, methylprednisolone, rituximab and prednisone” and the dependent claims 32-34, 39, and 41 specify “with precision” the dose, route, and timing of administration (Remarks, page 16), and (4) the clinical history of the PROPEL trial demonstrates that the immunosuppression regimen was not obvious (Remarks, page16). These arguments have been fully considered but have not been found persuasive for the following reasons.
First, the claims of the reference patent do not need to recite immunosuppression for the disclosure to be relevant in a determination of obviousness in the instant case. The reference patent recites a genus of methods with a supporting disclosure that teaches various species of that genus. Including an immunosuppressant, more specifically prednisone, is suggested in that disclosure as a species of the method claimed in the reference patent. Therefore, the instant claims are an obvious variant of the reference claims. Applicant’s attempt to claim the species in this patent application would improperly give the patentee an extended patent term by allowing them to monopolize an obvious variant of an invention they had already disclosed to the public in the reference patent.
Second (and third), Applicant is claiming “one or more of” sirolimus, methylprednisolone, rituximab, and prednisone, not any specific four-agent immunosuppressant regimen as they argue here. Where Applicant specifies dosages, routes, and timing in the dependent claims, they all depend directly from claim 1 which claims the immunosuppressants in the alternative. Thus, the dependent claims, to the extent they are more specific, still do not require any specific four-agent regimen as Applicant argues. In addition, “where 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the reference patent suggests to include an immunosuppressant and specifically suggests prednisone in a species of the methods claimed therein, the precise immunosuppressant used and the amount and timing of that immunosuppressant would have been a matter of optimization by routine experimentation to a person having ordinary skill in the art.
Lastly, Applicant’s argument that the clinical history of the PROPEL trial demonstrates that the immunosuppression regimen was not obvious appears to assert that no manner of improvement or combination of methods with that of the reference patent would have been obvious if Applicant’s themselves did not make such an improvement or combination. This argument is unpersuasive on its face because of the circular logic required to get to the conclusion of nonobviousness and because it ignores the fact that obviousness is determined from the perspective of a person having ordinary skill in the art. Further, the reference patent specifically suggests to include an immunosuppressant, specifically describes the classes of immunosuppressants Applicant is claiming, and specifically names some of the immunosuppressants claimed here (“(170) In some embodiments, a subject is administered an immunosuppressant prior to (e.g., between 1 month and 1 minute prior to) or at the same time as a composition as described herein. In some embodiments, the immunosuppressant is a corticosteroid (e.g., prednisone, budesonide, etc.), an mTOR inhibitor (e.g., sirolimus, everolimus, etc.), an antibody (e.g., adalimumab, etanercept, natalizumab, etc.), or methotrexate.”, Reference patent, (170)). It is disingenuous to assert that doing so would not have been obvious when, as here, the Applicant is the source of the teachings to do so. Still further, Applicant argued against the rejection under 35 U.S.C. 112(a) above with the following: “The PROPEL trial was initiated in January 2020. The first enrolled participant experienced an adverse event about three months after intracisternal magna (ICM) injection of PRO01 (i.e., a rAAV comprising SEQ ID NO:15), which was attributed to an immune response to the AAV9 vector. That immune response was resolved with immunosuppressive treatment. Following this clinical course, Prevail Therapeutics amended the PROPEL protocol to require concomitant administration of immunosuppressants alongside PRO01 for all subsequently enrolled participants” (Remarks, page 12). The effective filing date of the reference patent correlates with “about three months after” January 2020 (10 April, 2020). Thus, it appears at least supported by Applicant’s timeline and the effective filing date of the reference patent that Applicant was aware of the desire to co-administer an immunosuppressant and had actually done so when they included the teachings of paragraph 170 in the reference patent. Any assertion that the instant claims are not obvious variants in view of the reference patent claims and disclosure because Applicant’s hadn’t actually made the suggested change to the protocol to add an immunosuppressant is unpersuasive on its face and contradicts Applicant’s timeline of events asserted in the same remarks. Accordingly, the arguments have been fully considered but have not been found persuasive.
Examiner’s Comment
Claims 1-17 of U.S. Patent No. 10,837,028, claims 1-15 of U.S. Patent No. 11,060,113, and claims 1-44 of U.S. Patent No. 11,802,294 are all commonly invented and drawn to related inventions to that instantly claimed. However, none of these patents teach or suggest use with immune suppression which is why they are not being applied under non-statutory double patenting.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached on Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached on 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634 /MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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