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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05 February 2026 has been entered.
Response to Amendment
The declaration under 37 CFR 1.132 filed 05 February 2026 is insufficient to overcome the rejection of claims 1, 8-11, 13-15, and 34 based upon Kasper in view of Nizzardo as applied under 35 U.S.C 103 as set forth in the last Office action because: It refers only to the system described in the above referenced application and not to the individual claims of the application. As such the declaration does not show that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
Election/Restrictions
Claims 16-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11 April 2025.
Claim Status
Claims 2-7, 12, and 23-33 were previously canceled, claim 1 was previously amended, claims 16-22 have been withdrawn, claims 1, 8-11, 13-15, and 34 have been considered on their merits.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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8-11, 13-15, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Kaspar et al. (US 2016/0038613, published 11 February 2016, of record) as evidenced by Michel et al. (GenBank: AY640632.1, submitted on 01 June 2005, of record), O'Conner et al. (GenBank: MK225671.1, submitted on 26 June 2019, of record), Hiramine et al. (GenBank: AB282594.1, submitted on 05 January 2008, of record), Strausberg et al. (GenBank: BC105090.1, submitted on 22 December 2006, of record), Scheller et al. (GenBank: MG437019.1, submitted on 28 August 2018, of record), and further in view of Nizzardo et al. (Gene Therapy, 2015, of record).
This rejection is substantially similar to the rejection of record as set forth in the Official action mailed 08 October 2025. A response to Applicant's traversal follows the rejection below.
Regarding claims 1 and 8, Kaspar teaches methods and materials useful for systemically delivering polynucleotides across the blood brain barrier (para. [0004]). Kaspar teaches employment of rAAV9 (claim 8) to deliver polynucleotides to nerve and glial cells wherein, systematic or intrathecal delivery methods are indicated for lower motor neuron diseases such as spinal muscular atrophy (SMA) (para. [0020]-[0021]). Kaspar teaches an exemplified rAAV comprising an AAV2 ITR, the chicken β-actin promoter with a cytomegalovirus enhancer, an SV40 intron, SMN coding cDNA, a polyadenylation signal sequence from bovine growth hormone and another AAV2 ITR (para. [0037]). Kaspar teaches sequences encoding other polypeptides may be substituted for the SMN DNA (para. [0037]). Kaspar teaches the ability of AAV9 to target and express protein in skeletal muscle in an in vivo model system wherein, intravenous administration of 1x1011 particles of scAAV9-GFP was performed in a total volume of 50 µl to postnatal day 1 mice and the extent of muscle transduction was evaluated (Example 1, para. [0081]). Kaspar teaches the rAAV GFP genome included in sequence an AAV2 ITR, the chicken β-actin promoter with a cytomegalovirus enhancer, an SV40 intron, the GFP DNA, a poly adenylation signal sequence from bovine growth hormone and another AAV2 ITR (Example 1, para. [0081]).
Nizzardo teaches delivery of a AAV9-IGHMBP2 to rescue the disease phenotype in the spinal muscular atrophy (SMA) with respiratory distress type 1 (SMARD1) mouse model (nmd) (Abstract). Nizzardo teaches a plasmid harboring a single-stranded AAV expression cassette carrying the wild-type human IGHMBP2 complementary DNA (cDNA) [National Center for Biotechnology Information (NCBI) accession number NM_002180] coding sequence under control of the cytomegalovirus (CMV) enhancer/chicken β-actin (CBA) promoter (regulatory control element) (pp. 7-8 1st para., AAV Vectors).
Therefore, it would have been obvious to one of ordinary skill in the art to utilize the vector of Kaspar to deliver the IGHMBP2 cDNA of Nizzardo with a reasonable expectation of success because Kaspar teach sequences encoding other polypeptides may be substituted for the SMN DNA. One would have been motivated to utilize the vector of Kaspar to deliver the IGHMBP2 cDNA of Nizzardo because Kaspar teach employment of rAAV9 to deliver polynucleotides to nerve and glial cells wherein, systematic or intrathecal delivery methods are indicated for lower motor neuron diseases such as SMA, which includes SMARD1 and Nizzardo provided proof-of-concept data demonstrating the high efficacy of IGHMBP2 gene therapy in the SMARD1 mouse model, which provided strong evidence for establishing a clinical trial of AAV9-mediated IGHMBP2 gene therapy (Nizzardo, Introduction). Additionally, both Kaspar and Nizzardo teach treatment of SMA, therefore, utilizing the vector backbone of Kaspar with the IGHMBP2 of Nizzardo to treat a subvariant of the same disease provides additional motivation to combine these references, absent evidence to the contrary.
Kaspar in view of Nizzardo are silent to the vector genome comprising human IGHMBP2 cDNA as required by nucleotides 1-4397 of SEQ ID NO: 7. This instant specification at Table 2 indicates nucleotides 1-4397 comprise the sequences of the AAV2 ITR (nucleotides 1-141), the chicken β-actin promoter (nucleotides 162-411) with a cytomegalovirus enhancer (nucleotides 448-717), the SV40 intron (nucleotides 783-842), the hIGHMBP2 cDNA (nucleotides 1021-4002), the poly adenylation signal sequence from bovine growth hormone (nucleotides 4041-4187), and the other AAV2 ITR (nucleotides 4257-4397).
However, the sequences of all of these elements are known in the art before the effective filing date of the instant application, as evidenced by the following:
Michel disclose in GenBank: AY640632.1, the nucleotide sequence for the AAV2 ITR, as disclosed in instant SEQ ID NO: 7, nucleotides 1-141 and 4257-4397 (instant Table 2), see alignment results below:
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147
692
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O’Connor disclose in GenBank: MK225671.1, the nucleotide sequence for the CMV enhancer with CBA promoter, as disclosed in instant SEQ ID NO: 7, nucleotides 448-717 (instant table 2), see alignment results below:
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153
713
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Hiramine disclose in GenBank AB282594.1, the nucleotide sequence for the modified SV40 intron, as disclosed in instant SEQ ID NO: 7, nucleotides 783-842 (instant Table 2), see alignment results below:
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151
834
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Strausberg disclose in GenBank: BC105090.1, the nucleotide sequence for the hIGHMBP2 cDNA, as disclosed in instant SEQ ID NO: 7, nucleotides 1021-4002 (instant Table 2), see alignment results below:
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179
1012
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Scheller disclose in GenBank: MG437019.1, the nucleotide sequence for the bGH Poly A as disclosed in instant SEQ ID NO: 7, nucleotides 4041-4187 (instant Table 2), see alignment below:
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149
686
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Therefore, the sequences of the disclosed components would have been suitable options in the vector of Kaspar to arrive at the claimed nucleotides 1-4397 of SEQ ID NO: 7 because all of the sequences were known in the art and Kaspar disclose all of the components of nucleotides 1-4397 of SEQ ID NO: 7.
Regarding claim 9, Kaspar teaches providing packaging cells that produce infectious rAAV. In one embodiment packaging cells may be stably transformed cancer cells such as HeLa cells, 293 cells and PerC.6 cells (para. [0035]). Kaspar teaches infectious encapsidated rAAV particles comprising a rAAV genome (para. [0036]).
Regarding claims 10, 13, and 34, Kaspar teaches the ability of AAV9 to target and express protein in skeletal muscle in an in vivo model system wherein, intravenous administration of 1x1011 particles of scAAV9-GFP was performed in a total volume of 50 µl to postnatal day 1 mice and the extent of muscle transduction was evaluated (Example 1, para. [0081]). Therefore, since the rAAV is injected it would necessarily be part of a composition (claims 10 and 34) used for IV delivery (claim 13).
Regarding claim 11, Kaspar teaches the rAAV may be purified by methods standard in the art such as by column chromatography or cesium chloride gradients (para. [0039]). The purification by cesium chloride gradient step reads as an agent to increase density of the composition.
Regarding claims 14 and 15, Kaspar teaches titers of the rAAV to be administered will vary depending on the particular rAAV, the mode of administration, the treatment goal, the individual, and the cell type being targeted, and may be determined by methods standard in the art (para. [0042]). Kaspar teaches the dosages of rAAV may range from about 1x1011 vg/kg to about 1x1016 vg/kg or more for an adult per kilogram body weight (para. [0042]). Kaspar teaches the ability of AAV9 to target and express protein in skeletal muscle in an in vivo model system wherein, intravenous administration of 1x1011 particles of scAAV9-GFP was performed in a total volume of 50 µl to postnatal day 1 mice and the extent of muscle transduction was evaluated (Example 1, para. [0081]). A P1 mouse weighs approximately 0.001 kg, therefore the dosage in vg/kg would be approximately 1x1013 vg/kg, therefore Kaspar teaches IV delivery comprising a dose of about 1x1013 vg/kg which falls in the range of about 1x1013 vg/kg to about 2x1014 vg/kg for IV delivery.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal
Applicant's arguments filed 05 February 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the rejection of claim 1, above, clearly identifies motivation to modify the AAV of Kaspar. In summary Kaspar teach employment of rAAV9 to deliver polynucleotides to nerve and glial cells to include methods for treating lower motor neuron diseases such as SMA, which includes SMARD1 and Nizzardo provided proof-of-concept data demonstrating the high efficacy of IGHMBP2 gene therapy in the SMARD1 mouse model, which provided strong evidence for establishing a clinical trial of AAV9-mediated IGHMBP2 gene therapy. Additionally, both Kaspar and Nizzardo teach treatment of SMA, therefore, utilizing the vector backbone of Kaspar with the IGHMBP2 of Nizzardo to treat a subvariant of the same disease provides additional motivation to combine these references, absent evidence to the contrary.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the particular order of elements in the rAAVs) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Even if this was a requirement of the claims, all of the sequences were known in the art and Kaspar discloses all of the components of nucleotides 1-4397 of SEQ ID NO: 7.
Regarding the statement, on page 3 of the remarks, that it is unknown whether a rAAV vector genome comprising multiple elements would be properly packaged into an infectious particle that effectively transduces the cell, this argument is merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration. Additionally, both Kaspar and Nizzardo teach treatment of SMA, therefore, utilizing the vector backbone of Kaspar with the IGHMBP2 of Nizzardo to treat a subvariant of the same disease provides additional motivation to combine these references, absent evidence to the contrary. Nothing in the prior art suggests combining the teachings of these references would not be predictable and determining the order of vector elements could be determined as a matter of routine experimentation/optimization.
In response to applicant's argument, found on page 4, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the rejection of record has not considered packaging efficacy issues) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s assertion of unexpected results on pages 4-6 of the remarks, although Applicant argues unexpected results, the claims are not commensurate in scope with the experimental results cited by the Applicant. MPEP 716.02(d) states that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983). In this case, the claims are directed to a vector assembly and composition comprising said assembly and the claims are not directed to a method of treating an IGHMBP2-related disease.
Additionally, the results provided in the declaration are regarding SEQ ID NO: 17, while the reference render obvious SEQ ID NO: 7. Furthermore, these results do not relate to assembling a vector. Both references, Kaspar and Nizzardo, teach vectors expressing a gene product and there is no reasonable explanation or evidence set forth to suggest this combination of vector backbone and gene product would not function together. The scope of the claims are directed to a vector assembly. The evidence and results presented do not suggest the combination of elements taught by Kaspar and Nizzardo could not be assembled. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this instance Kaspar and Nizzardo are both in the field of the inventor’s endeavor and are both reasonably pertinent to the particular problem with which the inventor was concerned.
While the evidence provided demonstrates the safety and tolerability of the vector described in SEQ ID NO: 17, there is no discussion of a control nor comparison of the disclosure to the prior art. MPEP 716.02(b) states the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Furthermore, the teachings of Kaspar in view of Nizzardo disclose the vector described in instant SEQ ID NO: 7, therefore, it is acknowledged that this vector would also be safe and tolerable if utilized in the same manner as the vector of instant SEQ ID NO: 17.
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, 8-11, 13-15, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of copending Application No. 19/119,574 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
This is a new rejection.
Regarding claims 1, 9-10, and 34, copending claims 17 and 33-35 recites a composition (claim 10) comprising rAAV or rAAV particle (claim 9 and 34) comprising nucleotide sequences SEQ ID NO: 8 or 17, which are identical to instant SEQ ID NO: 8 and 17 (claim 1).
Regarding claim 8, copending claims 17 and 33-35 recite a composition comprising rAAv comprising nucleotide sequences SEQ ID NO: 8 or 17, which are identical to instant SEQ ID NO: 8 and 17 and copending claims 21 and 37 recites wherein the rAAV are of the same serotypes as instant claim 8.
Regarding claim 11, copending claims 24 and 40 recites an rAAV in an aqueous composition comprising an agent that increases the viscosity or density of the formulation.
Regarding claim 13, copending claims 31 and 37 recites an rAAV formulated for direct injection into the cerebrospinal fluid, intracerebroventricular delivery, intrathecal delivery, or intravenous delivery.
Regarding claim 14, copending claims 47 which depends from any one of 33-35 recite a composition comprising a dose from about 7x1013 vg to about 9x1013 vg of the rAAV comprising nucleotide sequences SEQ ID NO: 8 or 17, which are identical to instant SEQ ID NO: 8 and 17 and copending claim 47 recites this composition is formulated for intrathecal delivery.
Regarding claim 15, copending claim 47 which depends from any one of 33-35 recite a composition comprising a dose from about 7x1013 vg to about 9x1013 vg of the rAAV comprising nucleotide sequences SEQ ID NO: 8 or 17, which are identical to instant SEQ ID NO: 8 and 17 and copending claim 47 recites this composition is formulated for intravenous delivery. Copending claim 47 does not specify the dosage amount, however, this could readily be calculatable based on the weight of the subject and the dose of the composition recited in copending claim 33.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vanoli et al., (J. Cell. Mol. Med. Vol 19, No 9, 2015 pp. 2058-2066)
Vanoli teaches gene therapy demonstrated effectiveness in SMA, being now at the stage of clinical trial in patients and therefore representing a possible treatment for SMARD1 as well. Vanoli teaches many studies have been made in mouse models of SMA, a similar genetic motor neuron disease caused by mutations in SMN1, encouraging a future application of gene therapy also in SMARD1. Vanoli teaches administration of AAV9 encoding wild-type SMN gene was able to rescue the phenotype of SMA mice when injected intravenously and the biodistribution of AAV in the CNS has been replicated also in larger animals, such as non-human primates. Vanoli teaches Ighmbp2 is mostly localized in the cytoplasm, in particular in the perinuclear cytoplasm, in the axon and in the growth cone and in the nmd mice it has been observed that the expression of the protein was extremely reduced in all those sites.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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