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 .
Applicant’s amendment and response filed on 7/9/2026 has been received and entered into the case.
Claims 1-25 have been canceled, and claims 26-39 have been considered on the merits. All arguments have been considered.
Claim Rejections - 35 USC § 102 (maintained)
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(s) 26-28 and 33-35 stand rejected under 35 U.S.C. 102(a)(2) as being anticipated by Simons et al. (US2020/0390905 A1; of record) for the reason set forth in the OA mailed on 2/13/2026.
Claim Rejections - 35 USC § 103
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(s) 26-30 and 33-36 stand rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. (US 2020/0155705; of record) in view of Simons et al. (US2020/0390905; earliest filing date of 2/22/2018) for the reason set forth in the OA mailed on 2/13/2026.
Claim(s) 31 stands rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Simons et al. as applied to claims 26-30 and 33-36 above, and further in view of Petrs-Silva et al. (2011, Molecular Therapy; IDS ref. filed 10/15/2021) for the reason set forth in the OA mailed on 2/13/2026.
Claim(s) 32 and 37-38 stand rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Simons et al. as applied to claims 26-30 and 33-36 above, and further in view of Marlin et al. (of record) and Pangrsic et al. (of record) for the reason set forth in the OA mailed on 2/13/2026.
Claim(s) 39 stand rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Simons et al. as applied to claims 26-30 and 33-36 above, and further in view of Petit et al. (US2018/0055908 A1) for the reason set forth in the OA mailed on 2/13/2026.
Response to Arguments
The declaration under 37 CFR 1.132 by Natalie Loundon filed 7/9/2026 is insufficient to overcome the rejection of claims 26-36 based upon Burns et al. in view of Simons et al.
The declaration pointed out the differences in the timeline of auditory development between mice and humans and for assessing the effect of a gene therapy on a developed and mature auditory system requires administering the gene therapy to mice older than P20, and the declaration presented the teachings of Wang et al. and Zhang et al. The declaration concluded that mice younger than P20 did not have a developed and mature auditory system. This is the consistent conclusion from the previous declaration filed on 9/11/2025, and the Examiner does not dispute that P20 mice would not have developed and mature auditory system. The declaration further stated that the examples shown in the instant application utilized OTOF-/- mice aged P30 resulted in expression of Otoferlin in inner ear cells and in auditory function comparable to that of control WT mice.
The declaration alleged that Simons et al. do not teach treating human patients such as newborn babies and older patients up to 6-year-old. This is incorrect analysis. As discussed in the 102 rejection, Simons et al. clearly teach that the method is for human subjects and the human subject can be a child, a toddler, an infant or a newborn (para. 400). As Simons et al. teach the method of treating a human subject suffering from non-age-associated hearing impairment by administering the AAV vectors identical to the claimed invention. Thus, one skilled in the art would expect that the method of Simons et al. is effective in treating hearing impairment by using the gene therapy in the subject as claimed because they teach the identical method as claimed.
The declaration alleged that para. 400 of Simons et al. or anywhere else in Simons et al. provide any information that allow the skilled artisan to ascertain the effectiveness of the method. The prior art does not require evidence to show the therapeutic effect of the method of treating as claimed. Rather the patentability of the claimed method is based on the prior art’s teaching of the identical method steps. It is the Examiner’s position that Simons et al. teach the identical method steps as claimed including the same vectors and the same patient group. The identical method steps taught by Simons et al. are expected inherently produce the identical outcome as claimed invention.
M.P.E.P. §2112 states that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). >In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Therefore, a holding of anticipation is clearly required.
The declaration asserted that Simons et al. do not provide any example that the method would be effective to subjects or mammals disclosed in para. 400. It is acknowledged that Simons et al. do not particularly show that the method would be effective in the human at the claimed ages. As discussed above, there is no requirement that the prior art should present any evidence showing the effect or results of the disclosed method. What matters is that Simons et al. teach the gene therapy for the hearing loss in the human patient at the age as claimed, and without any evidence to the contrary, the disclosure of Simons et al. would be considered enabled. MPEP2121 states that efficacy is not a requirement for prior art enablement for purposes of anticipation. This is also true for the obviousness rejection of Burns et al. in view of Simons et al. While obviousness rejection requires a reasonable expectation of success but conclusive proof of efficacy is not required to show a reasonable expectation of success (MPEP2143.02).
Thus, it is the Examiner’s position that in the absence of any evidence that the teaching of Simons et al. is not enabled, the disclosure of Simons et al. is considered enabled and thus, the teaching of Simons et al. would anticipate the claimed subject matter as shown below (102 rejection), and at the same time, based on the teaching of Simons et al. with regard to the method of treating hearing loss in the human subject being a child, a toddler, an infant or a newborn, there would be a reasonable expectation of success to use the method of Burns et al. to treat hearing loss in a newborn baby, an infant or a toddler as claimed in the absence of any evidence to the contrary.
Applicant's arguments filed 7/9/2026 have been fully considered but they are not persuasive. Applicant’s arguments are directed to the declaration filed and the declaration has been addressed as above.
Applicant alleged that the Examiner does not indicate where Simons et al. discloses that the vector system is “administered after cochlear maturation” and that “the administration restores hearing capacity when hearing loss has already occurred”. The 102 rejection does not point out the explicit teaching of the identified limitation by Simons et al. However, the rejection is based on inherency such that the human subject at a certain age, the claimed limitation would be inherently met. The claimed age of up to 6 years would clearly meet the “cochlear maturation” or “hearing loss has already occurred”, and Simons et al. teach the age of human including as claimed but also adults. Thus, it is the Examiner’s position that Simons et al. anticipate the claimed limitations.
Applicant further asserted that the examiner cannot pick and choose among the individual elements of assorted prior art to recreate the claimed invention, and the examiner cannot use hindsight reconstruction. The teaching of Simons et al. under 102 does not recreate pick and choose the individual elements to recreate the claimed invention. The teaching of Simons et al. as discussed in the claim rejection above discloses the identical method for the identical subject using the identical materials. With regard to the age of the human subject, Simons et al. disclose broad scope and exemplified the age indicating that a human subject at any age would be treated with the method.
In the absence of any evidence to the contrary, it is the examiner’s position that the disclosure of Simons et al. is considered enabled and thus, the teaching of Simons et al. anticipates the claimed method.
Regarding the 103 rejection, applicant’s arguments directed to the declaration, and the arguments/discussion of the declaration have been addressed above. The applicant’s argument further mentioned the declaration by Saaid Safieddine filed on 9/11/2025, and the examiner has addressed the declaration in the OA mailed on 2/13/2026.
As Simons et al. teach the human subject being treated for hearing loss by the gene therapy includes those at the claimed age, it is the Examiner’s position that the disclosure of Simons et al. anticipate the claimed method as discussed in the claim rejection. It is the Examiner’s position that Simons et al. do not need to provide experimental evidence and data showing that the embodiment of Simons et al. are in fact enabled. The anticipation is based on the disclosure of the cited reference. As discussed above, while Simons et al. do not disclose the claimed limitation verbatim (i.e. a patient has a developed and mature auditory system or hearing loss has already occurred), however, the patient with the specific age (i.e. new born and/or up to 6-year-old) would inherently meet the limitation and Simons et al. teach the claimed age and thus, would meet the limitations.
Based on the above discussion, it is the Examiner’s position that the cited reference anticipates and render the claimed invention obvious.
Conclusion
No claims are 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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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