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 .
Priority
This application is a national stage entry of 35 U.S.C. 371 of PCT/US2022/078984 (filed on 10/31/2022), which claims benefit to US provisional 63/285,988 (filed on 12/03/2021), and claims benefit of US provisional 63/274,037 (filed on 11/01/2021).
Election/Restrictions
Applicants’ election without traverse of invention group II filed on 07/07/2026 is acknowledged. Claims 1-4,8,10, and 43-45 read on the elected invention.
Claims Status
Claims 1-4,8,10,13-14,17,22-23,26,29,34,36,40-41,43-45 are pending.
Claims 13-14,17,22-23,26,29,34,36, and 40-41 have been withdrawn per election of invention group.
Claims 1-4, 8, 10 and 43-45 have been examined on the merits.
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.
Claims 1-4,10, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al (WO 2021/050991 A1; as cited in IDS filed on 11/08/2024) and in view of Rojas et al (Journal of personalized medicine, 2021) and Wu et al (PLoS One, 2013).
Rodriguez et al disclose compositions for the treatment of Friedreich’s Ataxia (FA), including nucleic acid constructs and recombinant vectors comprising a human frataxin 5’ untranslated region (5’ UTR FXN) and human frataxin (FXN) (See, Abstract).
Regarding claim 1, Rodriguez et al disclosed a method includes administering to a subject (a mammal, human or primate) having FA, a therapeutically effective amount of any of the recombinant AAV (rAAV) particles described in disclosure (See, ¶0185-0186). Rodriguez et al disclosed a recombinant AAV vector expressing human frataxin (FXN) (See, ¶0152). This reads on, a method comprising administering…to a mammalian subject a recombinant AAV (rAAV) particle comprising an rAAV vector that comprises heterologous nucleic acid encoding human FXN.
Rodriguez et al does not disclose nor teach administering the rAAV particles to one or both eyes of a mammalian subject.
Rojas et al teaches that 73% of FA patients present with clinical neuro-ophthalmological alterations and progressive degeneration of the optic nerve (See, p3-4). Figure 1 of Rojas et al also teaches that in the retina there is decrease in the ganglion cell complex (See, p 4). Thus, Rojas et al is considered to evidence that FA presents with pathology in the eye, specifically in the retina.
Wu et al teaches rAAV vectors are a powerful vehicle for in vitro and in vivo gene delivery in the retina (See, Abstract). Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3). Wu et al teach integration of the GFP in the retina after administration (See, p3 and Figure 1). Thus injection of AAVs into the intravitreal space is a suitable way to deliver the nucleic acids of the AAVs into retinas of a mammalian subject.
Given that Rodriguez et al is treating FA, and given that FA has pathology in the eye, particularly the retina, one would have been motivated to deliver the therapeutic rAAV particles of Rodriguez et al directly to the retinal cells of the subject in need of treatment. It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by Rodriguez et al such that the rAAV is administered to the eye of the subject. Delivery of rAAV to the eye of a subject was taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al and the integration of the GFP in the retina after administration (See, p3 and Figure 1).
Regarding claim 2, following the discussion above, Rodriguez et al disclosed in Figure 10 vector maps used for the rAAV, Figure 10E shows a map of LP1049 AAV vector with a CBA promoter, 3’ UTR, and a codon optimized sequence encoding human FXN (See, ¶0036, ¶0068, Figure 10E). This reads on, wherein the rAAV vector further comprising a 3’ UTR comprising one or more axon targeting motifs (ATM), because as the Specification of the instant application states that human FXN 3’ UTR is an ATM (See, instant SPEC p19).
Regarding claim 3, following the discussion above, Rodriguez et al disclosed that the subject that is administered the rAAV is a mammal and preferably a human (See, ¶0185-0186). This reads on, wherein the subject is human.
Regarding claim 4, following the discussion above, Rodriguez et al disclosed the compositions can be administered as a local or systemic treatment, such as intravenously or intracisternal (See, ¶0196).
Rodriguez et al does not teach administering intravitreal, subretinal or subILM.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by Rodriguez et al such that the rAAV is administered to the eye of the subject intravitreally, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al.
Regarding claim 10, following the discussion above, Rodriguez et al disclosed that the method provided can further include administering a second therapeutic agent to the subject (See, ¶0195). This can include a second rAAV particle comprising a second rAAV vector comprising human FXN coding sequence. Rodriguez et al disclosed 4 versions of plasmid vector encoding recombinant AAV vector with codon optimized human FXN in example 1 (See, ¶0207). Therefore, it would have been obvious to choose one of the 4 vectors of Rodriguez et al to provide a second administration to a subject.
Regarding claim 43, following the discussion above, Rodriguez et al disclosed a method an rAAV with human FXN and 3’ UTR with one or more ATMs. Rodriguez et al also disclosed a pharmaceutical composition including rAAV particles and pharmaceutically acceptable carriers (See, ¶0173-0174). This all reads on, … method comprising administering… of a mammal the composition comprising a plurality of the rAAV particle comprising the rAAV nucleic acid vector encoding human FXN and 3’ UTR that comprises one or more ATMs of claim 43. Rodriguez et al does not disclose administering to one or both eyes of the subject the composition, but as discussed above, Wu et al teaches administering rAAV particles intravitreally in subject.
Rodriguez et al does not disclose that the method transduces a mammalian photoreceptor or RGC.
Wu et al teaches injecting motif targeted rAAAV2 vectors carrying ChR2-GFP into the retina of the subjects. Wu et al teaches that the retinas that were inject by all motifs express GFP in various targeted regions of the retina (See, p3 col 1 paragraph 1-2, Figure 1). Figure 1 of Wu et al teaches that the injected rAAV2 particles show GFP expression in the RGC of the retinas (See, p4 Figure 1). Therefore, the RGCs were transduced.
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by Rodriguez et al such that the rAAV is administered to the eye of the subject intravitreally and that it transduces the RGCs in the retina, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA that include ganglion cell deficiencies, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al.
Regarding claim 44, following the discussion above, , Rodriguez et al disclosed a method an rAAV with human FXN and 3’ UTR with one or more ATMs in subjects with FA. Rodriguez et al also disclosed a pharmaceutical composition including rAAV particles and pharmaceutically acceptable carriers (See, ¶0173-0174). Wu et al taught administering the rAAV to both eyes of the mammal. This reads on, a method for treating FA in mammal, the method comprising administering to both eyes of the mammal the composition comprising a plurality of the rAAV particle comprising the rAAV nucleic acid vector encoding human FXN and 3’ UTR that comprises one or more ATMs of claim 44.
Rodriguez et al disclosed the compositions of rAAV virions can be administered at a dosage commeasured to the subjects’ species, age, body-weight, general health, sex and diet, and can be modified by those skilled in the art (See, ¶0192-0194). This reads on, ..in an amount sufficient to treat or ameliorate one or more symptoms of the ataxia of the mammal.
Regarding claim 45, following the discussion above, Rodriguez et al does not teach intravitreal administration but Wu et al does teach intravitreal administration of rAAV in both eyes of the mammalian subject and it has been obviated for the method of Rodriguez et al.
Therefore, claims 1-4, 10, and 43-45 are rendered obvious over Rodriguez et al in view of Wu et al and evidenced by Rojas et al.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al (WO 2021/050991 A1; as cited in IDS filed on 11/08/2024), in view of Rojas et al (Journal of personalized medicine, 2021) and Wu et al (PLoS One, 2013) as applied to claims 1-4, 10, and 43-45 above, and further in view of Schauer et al (US 11,116,852 B2).
The teachings of Rodriguez et al, Rojas et al, and Wu et al are set forth above.
Regarding claim 8, following the discussion above, Rodriguez et al does not wherein the rAAV vector comprises a nucleotide sequence of any SEQ ID NOS: 8, 18, and 24-27.
Schauer et al discloses invention that includes polynucleotides, vectors and viruses expressing frataxin and methods of treating FA (See, Abstract).
Schauer et al discloses SEQ ID NO: 2, which correlates to nucleic acids encoding the frataxin protein (See, col 22 lines 26-29). SEQ ID NO: 2 of Schauer et al is a 99.7% query match for instant SEQ ID NO: 18 ( FXN heterologous nucleic acid sequence, See, instant SPEC ¶0017).
Given the Rodriguez et al and Schauer et al both disclose methods of treating FA, it would have been prima facie obvious to a person having ordinary skill in the art before the effect filing date of the claimed invention to substitute the vector sequence of the rAAV of Rodriguez et al to have the sequence provided in Schauer et al for human FXN, as taught for a similar purpose to administer to a subject with FA.
Both Rodriguez et al and Schauer et al teach methods for treating subjects with FA. The use of nucleic acid sequence for human FXN is a predictable use of prior art elements according to their established functions, leading to predictable result of treating FA. This rationale aligns with the principle of KSR for a simple substitution of one known element for another to obtain predictable results (See, MPEP 2143).
Therefore, claim 8 is rendered obvious over Rodriguez et al and Wu et al, in further view of Schauer et al.
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 1-2, 4 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,617,770 B2 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
The teachings of Wu et al and Rojas et al are set forth above.
Regarding claim 1, reference patent claim 14 recites a method of treating Friedreich's ataxia , the method comprising : administering a therapeutically effective amount of the rAAV particle of claim 12 or the composition of claim 12 to a subject having Friedreich's ataxia; claims 1-10 recite limitations for the nucleic acid expression construct of the rAAV, wherein the nucleic acid construct has human FXN coding sequence, truncated human FXN 3’ UTR, and ITR in each flank. This reads on the method of instant claim 1, as the scope of the claim is a method administering to a subject rAAV comprising an rAAV vector that comprises a heterologous nucleic acid encoding human FXN. The reference claim does not teach the administration of the rAAV particle into one or both eyes of a mammalian subject.
Reference claim 18 recites a method of treating Friedreich's ataxia , the method comprising : administering a therapeutically effective amount of a recombinant adeno - associated virus ( rAAV ) particle to a subject having Friedreich's ataxia , wherein the rAAV particle comprises a rAAV vector encoded by a nucleic acid comprising an expression construct , the expression construct comprising : a human frataxin (FXN) coding sequence and a truncated human FXN 3 ' untranslated region (UTR) , a promoter operably linked to the human FXN coding sequence and truncated human FXN 3'UTR , wherein the expression construct is flanked on each side by an inverted terminal repeat sequence ; and wherein the rAAV particle is administered by intravenous injection , and further rAAV particles are administered by intrathecal or intracisternal injection , wherein the ratio of rAAV particles administered to the subject via intravenous injection to rAAV particles administered to the subject via intrathecal or via intracisternal injection is 1:10. This reads on the method of instant claim 1, as the scope of the claim is a method administering to a subject rAAV comprising an rAAV vector that comprises a heterologous nucleic acid encoding human FXN. The reference claim does not teach the administration of the rAAV particle into one or both eyes of a mammalian subject.
Reference claim 20 recites a method of treating Friedreich's ataxia , the method comprising : administering a therapeutically effective amount of a composition comprising a plurality of rAAV particles to a subject having Friedrich's ataxia , wherein the PAAV particles comprise : a nucleic acid comprising rAAV vector comprising an expression construct comprising a human frataxin ( FXN ) coding sequence and a truncated human FXN 3 ' untranslated region ( UTR ) operably linked to a promoter , and wherein the expression construct is flanked on each side by an inverted terminal repeat sequence , wherein the amount of the composition is administered by intravenous injection , and a further amount of the composition is administered by intrathecal or intracisternal injection, wherein the ratio of rAAV particles within the composition administered to the subject via intravenous injection to the rAAV particles within the composition administered to the subject via intrathecal or via intracisternal injection is 1:10 . This reads on the method of instant claim 1, as the scope of the claim is a method administering to a subject rAAV comprising an rAAV vector that comprises a heterologous nucleic acid encoding human FXN. The reference claim does not teach the administration of the rAAV particle into one or both eyes of a mammalian subject.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al and the integration of the GFP in the retina after administration (See, p3 and Figure 1).
Regarding claim 2, following the discussion above, reference claims 14, 18 and 20 recite limitations that the rAAV comprises human FXN 3’ UTR, which has been established to have ATMs. Therefore, this reads on instant claim 2.
Regarding claim 4, following the discussion above, reference claims 15-18, and 20 recite administering the rAAV particles intravenously, intrathecally, or intracisternally but not intravitreally.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject intravitreally, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al.
Regarding claim 44, following the discussion above, reference claims 14, 18 and 20 recite limitations to a method of treating FA by administering rAAV particle to a subject in a sufficient amount, with the composition having a pharmaceutically acceptable carrier. This reads on the scope of instant claim 44 to treat FA with a composition with a pharmaceutically acceptable excipients, with rAAV with nucleic acid encoding human FXN and 3’ UTR with one or more ATM.
Therefore, claims 1-2, 4 and 44 are rendered obvious by U.S. Patent No. 10,617,770 B2 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
Claims 1-2, 4 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-17 of U.S. Patent No. 11,446,395 B2 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
The teachings of Wu et al and Rojas et al are set forth above.
Regarding claim 1, reference claim 16 recites limitations that include those of reference claims 10,11, and 14. Reference claim 16 recites, a method of treating FA, the method comprising administering a therapeutically effective amount of the rAAV particle with nucleic acid construct with human FXN coding sequence, truncated human FXN 3’ UTR, operably linked promoter, and flanked by ITR, by injecting a subject via intrathecal injection at 1:10. This reads on the method of instant claim 1, as the scope of the claim is a method administering to a subject rAAV comprising an rAAV vector that comprises a heterologous nucleic acid encoding human FXN. The reference claim does not teach the administration of the rAAV particle into one or both eyes of a mammalian subject.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al and the integration of the GFP in the retina after administration (See, p3 and Figure 1).
Regarding claim 2, following the discussion above, reference claims 10,16, and 17 recite limitations that the rAAV comprises human FXN 3’ UTR, which has been established to have ATMs. Therefore, this reads on instant claim 2.
Regarding claim 4, following the discussion above, the reference claims 11-17 teach administering the rAAV intravenous, intrathecal, intracisternal injection but not intravitreally.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject intravitreally, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al.
Regarding claim 44, following the discussion above, reference claims 10,11,16, and 17 recite limitations to a method of treating FA by administering rAAV particle to a subject in a sufficient amount, with the composition at a therapeutically effective amount. Reference claims are silent on pharmaceutically acceptable carrier, but it would have been obvious to include a pharmaceutically acceptable carrier when administering an rAAV to a subject, as is standard in the art, evidenced by US Patent 10,617,770 B2. This reads on the scope of instant claim 44 to treat FA with a composition with a pharmaceutically acceptable excipients, with rAAV with nucleic acid encoding human FXN and 3’ UTR with one or more ATM.
Therefore, claims 1-2, 4 and 44 are rendered obvious by U.S. Patent No. 11,446,395 B2 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
Claims 1,3, and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28 and 36 of copending Application No. 18/270,498 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
The teachings of Wu et al and Rojas et al are set forth above.
Regarding claim 1, reference claim 28 recites a method of treating Friedreich's Ataxia in a subject in need thereof, comprising: administering to the subject a first dose of an rAAV vector encoding codon optimized human frataxin, wherein the codon optimized human frataxin comprises a DNA sequence that has been codon optimized for enhanced expression and/or function in human cells comprising a sequence that comprises at least 99%, or more sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2, wherein the first administration is intravenous, and administering to the subject a second dose of the rAAV vector encoding the codon optimized human frataxin, and wherein the second administration is to the cerebrospinal fluid.
This reads on instant claim 1 as, as the scope of the claim is a method administering to a subject rAAV comprising an rAAV vector that comprises a heterologous nucleic acid encoding human FXN. The reference claim does not teach the administration of the rAAV particle into one or both eyes of a mammalian subject.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al and the integration of the GFP in the retina after administration (See, p3 and Figure 1).
Regarding claim 3, following the discussion above, reference claim 36 recites, wherein the subject is human. This reads on instant claim 3, as the subject being injecting the rAAV for FA to a human subject.
Regarding claim 4, following the discussion above, the reference claim 28 teach administering the rAAV intravenous injection but not intravitreally.
Wu et al teaches a method of injecting intravitreal space of each eye of the mice in the study rAAV2 vectors with specific motifs and GFP (See, p2 col 1 paragraphs 2-3).
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of administering to a subject having FA an rAAV with human FXN as taught by reference claims such that the rAAV is administered to the eye of the subject intravitreally, as taught by Wu et al. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification to treat FA and ophthalmic abnormalities associated with FA, evidenced by Rojas et al. One would have had a reasonable expectation of success evidenced by Wu et al.
Therefore, claims 1,3 and 4 are rendered obvious by co-pending application 18/270,498 in view of Wu et al (PLoS One, 2013) and evidenced by Rojas et al (Journal of personalized medicine, 2021).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
APPENDIX:
Sequence Alignment
RE: US 11,116,852 B2 for instant claim 8
Query (instant SEQ ID NO: 18) vs Subject (referenced SEQ ID NO: 2)
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Prosecution Insights