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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered. Applicant indicates on the Request for Continued Examination (RCE) Transmittal, 1/26/2026, that the response of 12/23/2025 be considered.
Claim status
Applicant has amended Claim 181.
Claims 169-180, 186-201 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 181-182, 185, and 202-204 are under consideration.
New Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 181-182, 185, and 202-204 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to Claim 181, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The phrase “wild-type AAV6” in claim 181 is used by the claim to mean an AAV6 vector comprising wild-type AAV6 ITRs and wild-type AAV6 capsid protein, while the accepted meaning of a “wild-type AAV6” is a strain which is found in nature. Dependent claims 182, 185, and 202-204 are included in the basis of this rejection because they do not clarify the meaning of “wild-type AAV6”.
In addition, in regard to Claims 182, 203, and 204 recites the limitation "the protein" in regard to Claim 181. There is insufficient antecedent basis for this limitation in the claim because Claim 181 is silent to a protein. For the sake of compact prosecution, “the protein” is being interpreted as the target gene product.
Appropriate correction is required.
Withdrawn 35 USC § 102
The prior rejection of Claim 181 under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al., (Brain Res Bull, 2010, 81:273) is withdrawn in light of Applicant’s amendment of Claim 181 to limit the composition to a wild-type AAV6 vector, which is a limitation Sharma does not anticipate. Specifically, Sharma is directed to a chimeric AAV2/6 vector.
Withdrawn 35 USC § 103
The prior rejection of Claim 203 under 35 U.S.C. 103 as being unpatentable over Sharma et al., (Brain Res Bull, 2010, 81:273, prior art of record), in view of Wang et al., (Nat Biotech, 2005, 23:321-328) is withdrawn in light of Applicant’s amendment of Claim 181 to limit the composition to a wild-type AAV6 vector, which is a limitation neither Sharma nor Wang make obvious.
The prior rejection of Claims 181-182, 185, and 202-203 under 35 U.S.C. 103 as being unpatentable over Dion et al., (US 2019/0167814, filed 4/13/2017, published 6/06/2019), in view of Song et al. (Gene Ther, 2018, 25:402-414) is withdrawn in light of Applicant’s amendment of Claim 181 to limit the composition to a wild-type AAV6 vector, which is a limitation neither Dion nor Song make obvious. Specifically, Song is directed to a chimeric AAV2/6 vector.
The prior rejection of Claims 203-204 under 35 U.S.C. 103 as being unpatentable over Dion et al., (US 2019/0167814, filed 4/13/2017, published 6/06/2019) in view of Song et al. (Gene Ther, 2018, 25:402-414), as applied to claim 181, in further view of Burns et al. (US2019/0142972, filed 4/21/2017, published 5/16/2019) is withdrawn in light of Applicant’s amendment of Claim 181.
New Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 181-182, 185, and 202-204 are rejected under 35 U.S.C. 103 as being unpatentable over Dion et al., (US 2019/0167814, filed 4/13/2017, published 6/06/2019, prior art of record), in view of Rutledge et al. (J Virol, 1998, (72):309-319), as evidenced by Burns et al. (US2019/0142972, filed 4/21/2017, published 5/16/2019, prior art of record)
With respect to claim 181, Dion claims a composition comprising (a) an AAV vector, and (b) a nucleotide sequence that encodes a Cas9 protein, and a nucleic acid sequence that encodes a sgRNA capable of down-regulating gene expression of a mutant allele of target gene that causes Fuch’s endothelial corneal dystrophy (see Claims 1-12 of Dion). Specifically, in regard to the AAV vector, Dion teaches the AAV vector serotype is AAV6 [0055].
However, Dion is silent to a wildtype AAV6.
Nevertheless, the wildtype AAV6 for gene therapy purposes was well known, and Rutledge provides the sequences and enabling disclosure for making and using a wildtype AAV6 vector encoding a transgene.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have prepared the AAV6 composition as suggested by Dion and choose a wildtype AAV6 vector as taught by Rutledge with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so not only because Dion suggests the AAV6 vector and the wildtype is an obvious member of a limited genus of AAV6 vectors, but also because Rutledge teaches that the wildtype AAV6 vector is resistance to neutralizing antibodies against AAV2, and that this could be especially important for gene therapy, as significant immunity against AAV2 exists in human populations (Abstract).
In regard to claims 182, 185 and 202-204, Dion teaches the target gene that causes Fuchs’ endothelial corneal dystrophy to which the sgRNA binds encodes the transcription factor protein TCF4 ([0058, 0150] see Tables 1 and 8). In regard to claims 182 and 185 reciting the wherein clauses directed to the preferential expression of the TCF4 target gene, and protein product thereof, in the cornea and/or anterior portion of the eye, this was a well-known expression pattern for TCF4 and reflects an inherent proper of this particular target gene as evidenced by Burns et al. ([0005, 0175]). Moreover, the phrase “preferentially expressed” is not defined by the claim, nor the specification. Thus, the fact that TCF4 causes Fuchs endothelial corneal dystrophy, by preferentially affecting the corneal endothelium compared to other cells evidences that the TCF4 target gene and protein fulfill this limitation. Furthermore, in regard to the contingent clause of Claim 185 directed to TCF4 gene expression “after intracameral (IC) injection” is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the fact that Dion discloses a sgRNA that down-regulates the TCF4 target gene, and the TCF4 target gene is naturally preferentially expressed in the cornea of the eye, the AAV based composition possesses the structure capable of performing the intended use.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 12/23/2025 are acknowledged.
Applicant argues that the cited prior art is silent to a wild-type AAV vector.
Furthermore, Applicant argues that Dion does not teach a AAV6 vector in context of treating Fuchs.
Finally, Applicant argues that the prior art of Wang et al. teaches it is advantageous to use an AAV2/6 chimeric vector.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's first argument, a 35 U.S.C. § 103(a) based test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In instant case, the primary reference of Dion teaches a generic AAV6 vector, while the secondary reference of Rutledge makes it predictably obvious to choose a wild-type AAV6 vector because of its advantages for gene therapy.
In response to Applicant’s second argument, although Dion does not provide a preferred embodiment of using an AAV6 vector for treating Fuchs, the MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. In instant case, the AAV6 vector to be included in the composition claimed by Dion was a typical agent found in the gene therapy art.
In response to Applicant’s third argument, it must be noted that Wang et al. are no longer part of the pending rejection. Furthermore, the purported advantages for an AAV2 vector components are not directed to the ITRs, but the AAV2 rep gene, which is not part of the claimed AAV vector composition. In other words, Wang does not criticize, discredit, or otherwise discourage the use of an AAV6 vector comprising AAV6 ITRs and an AAV6 capsid.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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