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
The amended claims filed on September 11, 2025, have been acknowledged. Claims 1-31 were cancelled. Claims 32-51 are new. Claims 32-51 are pending and examined on the merits.
Priority
The applicant claims foreign priority from EP15305270.9 filed on February 20,2015. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received August 15, 2017 in Application No. 15551096. Claims 32-51 find support in foreign application EP15305270.9 filed on February 20,2015.
Information Disclosure Statement
The information disclosure statements (IDS) filed on May 5, 2023, have been considered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 32-33, 37-38, and 42-43 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by World Intellectual Property Organization Patent Application No. 2011075838 (Bance; referenced in IDS).
Bance teaches a method of treating hereditary hearing loss in a subject, the method comprising: contacting the round window membrane of the subject with a adeno-associated viral (AAV) expression vector expressing a gene responsible for hereditary hearing loss, the gene responsible for hereditary hearing loss being positioned in the mutated tyrosine adeno-associated expression vector for expression in an inner ear organ of the subject so as to treat or prevent the hearing loss (page 4, lines 10-17 and claim 44).
Bance teaches that the gene expressed by the AAV vector can be the DFNB59 gene (also known as pejvakin) (page 7, lines 22-26 and page 12, lines 27-32 and claims 44 and 57).
Regarding the limitation in claim 1 “a viral vector for transduction of inner hair cells,” this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. Nevertheless, Bance does disclose using their viral vectors can be used to transduce inner hair cells (page 34, lines 8-23 and Figure 15).
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.
The factual inquiries 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 32-36, 39-41, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over World Intellectual Property Organization Patent Application No. 2011075838 (Bance) as applied to claims 32-33 above, and further in view of Delmaghani et al. (Nature Genetics 38: 770-778. 2006; referenced in IDS).
The teachings of Bance are as discussed above.
Bance is silent as to the sequence of the pejvakin gene in the AAV vector.
However, Delmaghani teaches that the wildtype human pejvakin protein sequence (Figure 4) is 100% identical to SEQ ID NO: 1 of the instant application.
It would have been obvious that this sequence could have been used as the sequence for the DFNB59 gene to treat genetic hearing loss caused by mutations in the DFNB59 gene as SEQ ID NO: 1 corresponds to the wildtype DFNB59 amino acid sequence in humans, as identified by Delmaghani. Furthermore, the successful cloning and sequencing of a DNA encoding a known gene and making an amino acid sequence is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the DNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 32-33, 37-38, 42-43, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over World Intellectual Property Organization Patent Application No. 2011075838 (Bance) as applied to claims 32-33, 37-38, and 42-43 above, and further in view of Meyer et al. (Otolaryngology–Head and Neck Surgery. 149(2_suppl):P102. 2013).
The teachings of Bance are as discussed above. As stated supra, Bance teaches that their method targets inner ear cells (page 4, lines 10-17 and claim 44), Bance teaches that the AAV vector can be a modified AAV2 vector (page 11, lines 25-31).
Bance does not teach wherein the AAV vector is an AAV2/8 vector.
However, Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness (Results and Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an AAV2/8 vector as part of the in vivo method of treating hereditary hearing loss in a subject of Bance to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use an AAV2/8 vector with a reasonable expectation of success because Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness. Therefore, it was well understood that AAV2/8 vectors were highly efficient at delivering transgenes to inner hair cells. As such, it would have been obvious that one could use this vector for in vivo gene transfer to treat genetic deafness (the stated goal of Bance) as it was directly contemplated by Meyer and its high efficiency would make it an obvious choice. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 32-36, 39-41, 44-46, and 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over World Intellectual Property Organization Patent Application No. 2011075838 (Bance) and Delmaghani et al. (Nature Genetics 38: 770-778. 2006) as applied to claims 32-46 above, and further in view of Meyer et al. (Otolaryngology–Head and Neck Surgery. 149(2_suppl):P102. 2013).
Bance and Delmaghani do not teach wherein the AAV vector is an AAV2/8 vector.
However, Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness (Results and Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an AAV2/8 vector as part of the in vivo method of treating hereditary hearing loss in a subject of the combined teachings of Bance and Delmaghani to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use an AAV2/8 vector with a reasonable expectation of success because Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness. Therefore, it was well understood that AAV2/8 vectors were highly efficient at delivering transgenes to inner hair cells. As such, it would have been obvious that one could use this vector for in vivo gene transfer to treat genetic deafness (the stated goal of Bance) as it was directly contemplated by Meyer and its high efficiency would make it an obvious choice. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 32-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10751385 in view of Meyer et al. (Otolaryngology–Head and Neck Surgery. 149(2_suppl):P102. 2013), as evidenced by Tran et al. (Pediatric Neurology 51: 262-265. 2014; referenced in IDS).
‘085 claims a method of administering a vector encoding Pejvakin of SEQ ID NO:1 (which has 100% sequence identity to SEQ ID NO: 1 of the instant application) to a patient suffering from a peroxisomal disorder leading to ROS production (claims 1 and 4).
Tran evidences that Zellweger syndrome is a is an autosomal recessively inherited multisystem disorder caused by one of the 13 different PEX gene defects resulting in defective peroxisomal assembly and multiple peroxisomal enzyme deficiencies and can lead to sensorineural hearing loss from PEX6 mutations (abstract). Although Tran does not identify that Zellweger syndrome is associated with reactive oxygen species production, reactive oxygen species production is a natural part of cell biology and would occur in patients suffering from Zellweger syndrome, and the instant specification identifies Zellweger syndrome as being a peroxisomal disorder that leads to reactive oxygen species production (page 18, line 9-page 19, line 2).
‘085 is silent as to the vector used to treat the peroxisomal disorder.
However, Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness (Results and Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an AAV2/8 vector as part of the in vivo method of treating a peroxisomal disorder in a subject using a vector encoding Pejvakin of ‘085 to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use an AAV2/8 vector with a reasonable expectation of success because Meyer teaches that AAV2/8 vectors transduced cochlear inner hair cells with high efficiency (80%) and that these vectors may be useful for AAV gene transfer into the cochlea to treat genetic deafness. Therefore, it was well understood that AAV2/8 vectors were highly efficient at delivering transgenes to inner hair cells. As such, it would have been obvious that one could use this vector for in vivo gene transfer to treat a peroxisomal disorder that causes genetic deafness as it was directly contemplated by Meyer and its high efficiency would make it an obvious choice. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
As such, the combined method of ‘085 and Meyer would teach the viral vector of the instant claims.
Conclusion
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/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631