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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/5/2026 has been entered.
Claim 1 has been amended.
In view of Applicant’s amendments to claim 1, limiting the treatment to a retinal disease, the 103 rejections of record have been amended.
Claims 1-3, 5 and 7-9 are examined in the instant application.
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, 8 and 9s is/are rejected under 35 U.S.C. 103 as being unpatentable over Behar-Cohen et al. (US 2014/0309613 A1) in view of Beranek et al. (2002, Am. J. Med. Genetics, Vol. 109, pgs. 278-283).
Regarding claim 1, Behar-Cohen et al. teach an engineered vector comprising a retina-specific promoter operably linked to a nucleic acid sequence encoding a TGF-β polypeptide (parags. 4, 6, 20 and 28).
Regarding a regulatory element, Behar-Cohen teach that their engineered vector can comprise a variety of regulatory elements (parag. 20).
Regarding claim 2, Behar-Cohen teaches that the vector can be an AAV (parags. 3 and 111).
Regarding claims 8 and 9, Behar-Cohen teaches that their engineered vector can be formulated in a pharmaceutical composition for treatment of an ocular disease (parags. 1, 8 and 35).
Behar-Cohen does not teach:
TGF-β1 polypeptide.
While Behar-Cohen does not explicitly teach using the β1 isoform of TGF-β, it would have been obvious to use TGF-β1 operably linked to a retina-specific promoter. For example, Beranek et al. teach that polymorphisms in the TGF-β1 gene could be regarded as a strong genetic risk factor for proliferative diabetic retinopathy (PDR) (see Abstract). Specifically, Beranek teaches that “our results show that the two majority alleles—10L and especially 25R—in the TGF-β1 gene exhibit a highly significant association with the presence of proliferative diabetic retinopathy in NIDDM subjects. Diabetes duration, age, and R25P genotype were proved to significantly predict PDR occurrence.” (pg. 282 col. 1 last two lines bridge col. 2 lines 1-4).
Thus, at the time of filing the ordinary artisan would have found it prima facie obvious to substitute TGF-β1 taught by Beranek for the TGF-β in the engineered vector of Behar-Cohen to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Beranek teaches that polymorphisms in TGF-β1 are a strong genetic risk factor for significant predicter for PDR occurrence.
There would have been a reasonable expectation of success that that the TGF-β1 of Beranek could be substituted for the TGF-β of Behar-Cohen, since TGF-β1 is one of the three isoforms of TGF-β.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Response to Arguments
While Applicant’s arguments have been fully considered they are not found persuasive. As set forth above the teachings of Lee are no longer relied upon in view of Applicant’s amendments to claim 1 limiting the treatment to a retinal disease. In this regard, the teachings of Beranek are relied upon that polymorphisms in TGF-β1 are a strong genetic risk factor for significant predicter for PDR occurrence.
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behar-Cohen et al. (US 2014/0309613 A1) in view of Beranek et al. (2002, Am. J. Med. Genetics, Vol. 109, pgs. 278-283) as applied to claims 1, 2, 8 and 9 above, and further in view of Patricio et al. (2017, Molecular Therapy: Nucleic Acids, Vol. 6, pgs. 198-208).
Behar-Cohen and Beranek are relied upon above in teaching an engineered vector comprising a retina-specific promoter operably linked to a nucleic acid sequence encoding TGF-β1.
Behar-Cohen and Beranek do not teach:
AAV2 and WPRE.
Regarding AAV2 AND WPRE in claims 3 and 5, Patricio et al. teach that the addition of a WPRE in an AAV2 vector enhances transduction of mouse retina (see Abstract). Specifically, Patricio teaches “Altogether, our data show that the inclusion of a WPRE sequence within an AAV2 expression cassette significantly enhances expression of target protein in the retina.” (pg. 205, col. 1 parag. 4 lines 1-3).
Thus, at the time of filing the ordinary artisan would have found it prima facie obvious to modify the engineered vector of Behar-Cohen to comprise the AAV2 and WPRE of Patricio to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Patrcio teaches that the combination of AAV2 and WPRE significantly enhances expression of a target protein in the retina.
There would have been a reasonable expectation of success that that the AAV2 AND WPRE would work in the engineered vector of Behar-Cohen since Patricio teaches success expression of a target protein in the retina using AAV2 and WPRE.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behar-Cohen et al. (US 2014/0309613 A1) in view of Beranek et al. (2002, Am. J. Med. Genetics, Vol. 109, pgs. 278-283) as applied to claims 1, 2, 8 and 9 above, and further in view of Li et al. (2008, Vision Res., Vol. 48, pgs. 332-338).
Behar-Cohen and Beranek are relied upon above in teaching an engineered vector comprising a retina-specific promoter operably linked to a nucleic acid sequence encoding TGF-β1.
Behar-Cohen and Beranek do not teach:
Red opsin promoter
(i) Regarding using the red opsin promoter, Li et al. teach that the red opsin promoter can promote cone-specific expression in the eye when used in an AAV vector (see Abstract). Li continues to teach “we have shown that cone photoreceptor cells can be specifically targeted at high efficiency by using a human promoter of the red/green pigment genes mediated by rAAV and delivered via subretinal injections. This has significant implications for the therapy of retinal degenerations that primarily affect cone photoreceptors.” (pg. 337 col. 2 parag. 1 lines 1-6).
Thus, at the time of filing the ordinary artisan would have found it prima facie obvious to modify the engineered vector of Behar-Cohen to comprise the red opsin promoter of Li to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a modification since Li teaches that the red opsin promoter leads to high targeting efficiency when used in an engineered AAV (rAAV).
There would have been a reasonable expectation of success that that the red opsin promoter could be used in the engineered AAV of Behar-Cohen since Li teaches successful use of the red-opsin promoter in an engineered AAV.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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