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 .
Applicant’s arguments and amendments filed on 3/20/2026 have been entered.
Claims 1, 17 and 20 have been amended.
Claims 12-16 have been cancelled.
In view of Applicant’s amendments to the claims the 102 and 103 rejections have been withdrawn. While the allowability of claim 16 was previously noted and its limitations (SEQ ID NOs: 8 and 9) have now been incorporated into claim 1, upon further search the teachings of Beales et al. would obviate the sequences set forth in SEQ ID NOs: 8 and 9.
Claims 1, 3-8, 17, 20, 23 and 24 are examined in the instant application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 7, 17, 20 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beales et al. (WO 2018/203092 A1).
Regarding claims 1, 5, 7, 17, 20 and 24, Beales et al. a pharmaceutical composition comprising an AAV 2/8 or AAV9 vector for treating retinal degeneration associated with BBS, wherein the vector comprises a promoter operably linked to a BBS1 gene comprising the nucleotide sequence of SEQ ID NOs: 8 or 9, wherein the promoter is either the CMV or CAG promoter (see Abstract, claims 1-6, 10 and 23 and Fig. 3).
Regarding SEQ ID NO: 8, Beale teaches SEQ ID NO: 11, which is 100% identical to instant SEQ ID NO: 8.
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Regarding SEQ ID NO: 9, Beale teaches SEQ ID NO: 12, which is 100% identical to instant SEQ ID NO: 9.
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Thus, Beale clearly anticipate the invention of claims 1, 5, 7, 17, 20 and 24.
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, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Beales et al. (WO 2018/203092 A1) in view of Kirin et al. (WO 2017 /197355-A2, cited on IDS filed on 9/4/2024) and evidenced by the teachings of Young et al. (2003, Ophthalmol. Vis. Sci. 44, pgs. 4076-4085).
Regarding claim 1, Beales et al. a pharmaceutical composition comprising an AAV 2/8 or AAV9 vector for treating retinal degeneration associated with BBS, wherein the vector comprises a promoter operably linked to a BBS1 gene comprising the nucleotide sequence of SEQ ID NOs: 8 or 9, wherein the promoter is either the CMV or CAG promoter (see Abstract, claims 1-6, 10 and 23 and Fig. 3).
Regarding SEQ ID NO: 8, Beale teaches SEQ ID NO: 11, which is 100% identical to instant SEQ ID NO: 8.
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Regarding SEQ ID NO: 9, Beale teaches SEQ ID NO: 12, which is 100% identical to instant SEQ ID NO: 9.
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Beales does not teach:
a human RK promoter.
Regarding a human RK promoter in claim 3, Kirin et al. teach an AAV9 vector for treating retinal degeneration associated with BBS, wherein the vector comprises an RK promoter operably linked to a BBS1 gene (parags. 81, 162, 172 and 179).
While Kirin does not explicitly state that the RK promoter is human, Kirin cites, when discussing the RK promoter, Young et al. (2003) Ophthalmol. Vis. Sci. 44, pgs. 4076-4085), which teaches the human RK promoter.
Regarding claim 4, as Kirin cites Young et al. for the human RK promoter, Young also teaches a nucleotide sequence for the human RK promoter which is 100% identical to instant SEQ ID NO: 7.
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Thus, at the time of filing it would have been prima facie obvious to the ordinary artisan to combine the teachings of Beale regarding a vector for treating retinal degeneration associated with BBS with the teachings of Kirin regarding a vector for treating retinal degeneration associated with BBS, wherein the vector comprises a human RK promoter to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since the nucleotide sequence for the RK promoter set forth in instant SEQ ID NO: 7 was known and used in the art as demonstrated by Kirrin.
There would have been a reasonable expectation of success that the nucleotide sequence of Kirrin would work in the vector of Beale since Kirrin teaches that their nucleotide sequence was for the RK promoter.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 1, 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beales et al. (WO 2018/203092 A1) in view of Kirin et al. (WO 2017 /197355-A2, cited on IDS filed on 9/4/2024) and evidenced by the teachings of Young et al. (2003, Ophthalmol. Vis. Sci. 44, pgs. 4076-4085) as applied to claims 1, 3 and 4 above, and further in view of Zhang et al. (1991, Virology, Vol. 182, pgs. 865-869).
Beale is relied upon above in teaching an AAV 2/8 or AAV9 vector for treating retinal degeneration associated with BBS, wherein the vector comprises a promoter operably linked to a BBS1 gene comprising the nucleotide sequence of SEQ ID NOs: 8 or 9, wherein the promoter is the CMV promoter.
Beale does not teach:
a CMV promoter having a sequence set forth in SEQ ID NO: 5.
Regarding claim 6 and a CMV promoter having a sequence set forth in SEQ ID
NO: 5, Zhang et al. teach using the CMV promoter, which is 100% identical to the sequence set forth in instant SEQ ID NO: 5, to drive expression of the CAT gene (see Abstract and pgs. 865 and 868).
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Thus, at the time of filing it would have been prima facie obvious to the ordinary artisan to combine the teachings of Beale regarding a vector for treating retinal degeneration associated with BBS, wherein the vector comprises a CMV promoter with the teachings of Zhang regarding the nucleotide sequence for the CMV promoter to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since the nucleotide sequence for the CMV promoter set forth in instant SEQ ID NO: 6 was known and used in the art as demonstrated by Zhang.
There would have been a reasonable expectation of success that the nucleotide sequence of Zhang would work in the vector of Beale since Zhang teaches that their nucleotide sequence was for the CMV promoter.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 1, 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beales et al. (WO 2018/203092 A1) in view of Kirin et al. (WO 2017 /197355-A2, cited on IDS filed on 9/4/2024) and evidenced by the teachings of Young et al. (2003, Ophthalmol. Vis. Sci. 44, pgs. 4076-4085) as applied to claims 1, 3 and 4 above, and further in view of Wickersham et al. (2010, Nature Protocols, Vol. 5(3), pgs. 595-606).
Beale is relied upon above in teaching an AAV 2/8 or AAV9 vector for treating retinal degeneration associated with BBS, wherein the vector comprises a promoter operably linked to a BBS1 gene comprising the nucleotide sequence of SEQ ID NOs: 8 or 9, wherein the promoter is the CAG promoter.
Beale does not teach:
a CAG promoter having a sequence set forth in SEQ ID NO: 3.
Regarding claim 8 and a CAG promoter having a sequence set forth in SEQ ID
NO: 3, Wickersham et al. teach using the CAG promoter, which is 100% identical to the sequence set forth in instant SEQ ID NO: 3, to drive expression of transgenes in a replication-deficient rabies virus (see Abstract, Introduction and pg. 599).
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Thus, at the time of filing it would have been prima facie obvious to the ordinary artisan to combine the teachings of Beale regarding a vector for treating retinal degeneration associated with BBS, wherein the vector comprises a CAG promoter with the teachings of Wickersham regarding the nucleotide sequence for the CAG promoter to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since the nucleotide sequence for the CAG promoter set forth in instant SEQ ID NO: 3 was known and used in the art as demonstrated by Wickersham.
There would have been a reasonable expectation of success that the nucleotide sequence of Wickersham would work in the vector of Beale since Wickersham teaches that their nucleotide sequence was for the CAG promoter.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beales et al. (WO 2018/203092 A1) in view of Kirin et al. (WO 2017 /197355-A2, cited on IDS filed on 9/4/2024) and evidenced by the teachings of Young et al. (2003, Ophthalmol. Vis. Sci. 44, pgs. 4076-4085) as applied to claims 1, 3 and 4 above, and further in view of Sahel et al. (2015, Cold Spring Harbor Perspectives in Medicine, pgs. 1-25).
Beale is relied upon above in teaching an AAV 2/8 vector for treating retinal degeneration associated with BBS, wherein the vector comprises a promoter operably linked to a BBS1 gene comprising the nucleotide sequence of SEQ ID NOs: 8 or 9, wherein the promoter is the CMV promoter.
Beale does not teach:
Using AAV2/7m8.
Regarding claim 23 and AAV2/7m8, Sahel et al. teach that the 7m8 variant of
AAV mediates efficient panretinal delivery of the therapeutic gene from the vitreous and that “The 7m8 vector enabled noninvasive, long-term histological and functional rescue of these disease phenotypes across the entire retina, offering clinically relevant implications for further gene therapy development.” (pg. 12 col. 2 last 11 lines).
Sahel continues to teach that gene therapy has had success in treating inherited retinal disorders such as Bardet-Biedl (pgs. 6 and 12-14).
Thus, at the time of filing it would have been prima facie obvious to the ordinary artisan to modify the teachings of Beale regarding an AAV 2/8 vector for treating retinal degeneration associated with BBS, wherein the vector encodes BBS1 with the teachings of Saleh regarding the 7m8 variant of AAV to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a modification since Saleh teaches that 7m8 variant of AAV has exhibited success in delivery therapeutic genes to the retina. Further motivation is provided by Beale that AAV vectors such as AAV2 can be used in their vector expressing a BBS1 gene.
There would have been a reasonable expectation of success that AAV vector of Beale could be modified to be an AAV2/7m8 variant since Saleh teaches success using 2/7m8 to deliver a gene to the retina of the eye.
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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