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
Application Status
This application is a 371 of PCT/US2020/066477, filed on 06/17/2022.
Claims 19-20, 43-44, 45, 48, 51 and 52-59 are currently pending in this patent application..
In response to a previous Office action, a Non-Final Rejection Office action (mailed on 01/22/2026), Applicants filed a response and an amendment on May 20, 2026, amending claims 19 and canceling claims 1-18, 46-47, 49-50, and adding new claims 52-59 is acknowledged.
Claims 45, 48 and 51 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants' arguments filed on May 20, 2026, have been fully considered and are deemed persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 19-20, 43-44 and 52-59 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of International patent application PCT/US2020/066477, filed on12/21/2020, and US Provisional application 62/951,564, filed on 12/20/2019.
Withdrawn-Drawings Objections
The previous objection of the Drawings for reciting incorrect Drawings not following Sequence Rules, is withdrawn in view of Applicant’s amendment to the Drawings and persuasive arguments. See particularly 37 CFR 1.821(d).
Withdrawn-Claim Objections
The previous objection of Claim 19, is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
Withdrawn-Claim Rejections - 35 USC § 102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 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.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
The previous rejection of Claims 19-20, and 44 under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Gao et al. (Dual recombinant gene therapy compositions and methods of use. WO2002/02148 A2, publication 01/10/2002, see IDS), is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
Withdrawn-Claim Rejections - 35 U.S.C. § 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.
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.
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
The previous rejection of Claims 19-20, 43 and 44 under 35 U.S.C. 103 as being unpatentable over Gao et al. (Dual recombinant gene therapy compositions and methods of use. WO2002/02148 A2, publication 01/10/2002, see IDS) as applied to claims 19-20 and 44 above and further in view of Chicoine et al. (Vascular Delivery of rAAVrh74.MCK.GALGT2 to the Gastrocnemius Muscle of the Rhesus Macaque Stimulates the Expression of Dystrophin and Laminin α2 Surrogates. Molecular Therapy (2014), 22(4):713-724), is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
New-Claim Rejections - 35 U.S.C. § 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.
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.
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claims 19-20, 43-44 and 52-59 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (Dual recombinant gene therapy compositions and methods of use. WO2002/02148 A2, publication 01/10/2002, see IDS) in view of Paul T. Martin (Translation studies of GALGT2 gene therapy for Duchenne Muscular Dystrophy. US Army Research Grant, 2014).
The Broadest Reasonable Interpretation (BRI) of claim 19, which is drawn to a recombinant adeno-associated virus (rAAV) having a genome comprising a) one or more promoter elements, b) a transgene comprising a GNE cDNA sequence or a GALGT2 cDNA sequence, c) an internal ribosomal entry site (IRES), and d) a nucleotide sequence encoding a muscle growth factor or a muscle trans-differentiation factor, wherein the promoter elements, the transgene, the IRES, and the nucleotide sequence encoding a muscle growth factor or a muscle trans-differentiation factor are in a single rAAV genome.
Gao et al. teach a single AAV gene delivery vector (see, abstract) comprising a genome of AAV construct comprising a nucleic acid molecule comprising a CMV promoter that comprises mini-CMV promoter, a FGF (fibroblast growth factor, a muscle growth factor), an IRES (Internal Ribosome Entry Site), and VEGF promoter, FGF (fibroblast growth factor, a muscle growth factor), an IRES and VEGF, wherein both FGF and VEGF (muscle growth factors as well as regarded as transgene) are involved in muscle growth and regeneration acts as transgene as claimed. Gao et al. also teach insulin-like growth factor 1 (IGF-1, a muscle growth factor), wherein said recombinant AAV vector can produce AAV virus particles, when a host cells are transformed or by administered or delivered with this recombinant AAV vector. Since, Gao et al. teach host cells, mammalian cells, rAAV vector would inherently produce AAV virus particles (see, abstract, pg9-10, pg36, 1-4, pg42, para 3, pg58, para 2-5, Example 4, and claims 35, 40, 44, 48-51, 54, 58, 61-64, and 67).
Gao et al. do not teach using a GALGT2 gene (cDNA) or a GNE cDNA in the rAAV genome vector and for treating muscular dystrophy disease and using rAAV, which is of serotype rAAVrh.74 (for claim 19, 20 and 44).
However, Martin et al. teach translation studies of GALGT2 gene (cDNA) therapy for Duchenne Muscular Dystrophy in an animal model, and further teach a single rAAV (recombinant Adeno-associated virus) gene delivery vector (see, abstract) comprising a vector genome (vg) of AAV construct comprising a nucleic acid molecule comprising a MCK or MHCK7 promoter that comprises rAAV genome vector under said promoter, in wild type or WT, Cmah-/-, mdx and Cmah-/-mdx mice via intramuscular injection with the two therapeutic gene therapy vectors to be tested (AAVrh74.MCK.GALGT2 and AAVrh74.MHCK7.GALGT2), wherein said AAVrh74.MCK.GALGT2 and AAVrh74.MHCK7.GALGT2) uses the AAVrh74 serotype as its delivery platform (see, evidential reference- Xu et al. rAAVrh74.MCK.GALGT2 Protects against Loss of Hemodynamic Function in the Aging mdx Mouse Heart. Molecular Therapy (2019), 27(30, 636-649), wherein the research work demonstrates that Cmah-/- animals have more expression from rAAVrh74.(MCK or MHCK7).GALGT2 injection at the same dose compared to WT and that the human GALGT2 gene may show greater potency in DMD patients than its does in mdx mice due to the altered sialic acid repertoire that exists in humans, and in addition, the result shows loss of GALGT2 expression in mdx muscles when injected at 2 weeks of age, and the result of muscle damage prior to when GALGT2 expression would allow therapeutic effects, which stands previous studies showing robust inhibition of muscle damage when this vector is injected into adult mdx animals (see, abstract).
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole before the effective filing date of the invention was made by combining the teachings of Gao et al. Martin et al. to use a GALGT2 gene (cDNA) or a GNE cDNA in the rAAV genome vector and for treating muscular dystrophy disease a GALGT2 gene (cDNA) or a GNE cDNA in the rAAV genome vector for treating muscular dystrophy disease and using the serotype rAAVrh.74 rAAV vector for treating muscle specific disease including Muscular Dystrophy in large animal model for vascular Delivery of rAAVrh74.MCK.GALGT2 to the Gastrocnemius Muscle of the Rhesus Macaque as taught by Martin et al. and modify Gao et al. to use a single AAV gene delivery vector (see, abstract) comprising a genome of AAV construct comprising a nucleic acid molecule comprising a CMV promoter that comprises mini-CMV promoter, a FGF (fibroblast growth factor, a muscle growth factor), an IGF (insulin-like growth factor, a muscle growth factor, and an IRES (Internal Ribosome Entry Site), and VEGF promoter, FGF (fibroblast growth factor, a muscle growth factor), an IRES and VEGF, wherein FGF, VEGF, and IGF (muscle growth factors as well as regarded as transgene) are involved in muscle growth and regeneration acts as transgene as taught by Gao et al. and Martin et al. to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated using a GNE cDNA and GALGT2 gene (cDNA) in rAAVrh.74 AAV vector and using serotype rAAVrh.74 for the purpose of gene therapy of various disease prone genes causing genetic diseases in huma, animals like Cow or pigs, which is therapeutically, clinically, pharmaceutically and financially beneficial.
One of ordinary skilled in the art would have a reasonable expectation of success because Gao et al. and Martin et al.et al. could successfully use recombinant AAV viral vector for treating genetical diseases.
Thus, the above references render the claims prima facie obvious to one of ordinary skill in the art.
Conclusion
Status of the claims:
Claims 19-20, 43-44 and 52-59 are rejected.
Applicant's amendment to the claim (see, claim 19, and new claims 52-59) necessitated the new ground(s) of rejection presented in this Office action.
Applicants must respond to the objections/rejections in each of the sections in this Office action to be fully responsive in prosecution. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee pursuant to 37 C.F.R. § 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 IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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