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 1-12, 16, 19-20, 43-44, 45, 48, and 51 are currently pending in this patent application..
The preliminary amendment filed on 10/16/2025, amending claims 1-12, 16, 19 and 20 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group II, Claims 19-20, 43 and 44, drawn to a recombinant adeno-associated virus (rAAV) having a genome comprising a polynucleotide sequence of claim 1, wherein the polynucleotide is in a single rAAV genome in the response filed on 10/16/2025 is acknowledged.
The traversal is on the ground(s) that NOW there is a unified technical feature between groups II and Group I concerning claim 1 of AAV genome of claim 1.
This is not found persuasive because, since applicants had received an action on the merits for the originally presented invention (previously version claims), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims [1-12, 16, 45, 48 and 51] are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 1-12, 16, 45, 48 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 request for rejoinder is noted. However, current claims of elected Group II are not allowable at this time. When Group II would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-20, 43 and 44 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.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 08/07/2024 and 12/13/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copies of 1449 are enclosed herewith.
Drawings objections-Non-Compliance of Sequence Rule
The disclosure is objected to because of the following informalities:
2422.01-.04 The Requirement for Exclusive Conformance; Sequences Presented
in the Drawing Figures (see, Fig. 2A----17M). 37 CFR 1.821(b) requires….Any sequence more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawings the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, Fig. 2A--- 17M in the Drawings). It should be noted, though, that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawing the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, Fig. 2A--- 17M in the Drawings in the Drawings). See particularly 37 CFR 1.821(d). Appropriate correction is required.
Claim Objections
Claim 19 is objected to as dependent from non-elected claim 1. Appropriate correction is required.
Claim 19 is objected to in the recitation “IRES”; as abbreviations should not be used without at least once fully setting forth what they are used for. Appropriate correction is required.
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.
Claims 19-20, and 44 are rejected 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).
The Broadest Reasonable Interpretation (BRI) of claim 19, which is drawn to a recombinant adeno-associated virus (rAAV) havinq a genome polynucleotide comprising a) a promoter element, b) a transgene, c) internal ribosomal entry site (IRES), and d) a nucleotide sequence encoding a muscle growth factor (synonym- insulin-like growth factor = IGF-1, fibroblast growth factor = FGFs, mechano growth factor = MCF, platelet-derived growth factor = PDGF and hepatocyte growth factor = HGF) or a muscle trans-differentiation factor in a single rAAV genome.
Regarding claims 19-20, and 44, 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).
Therefore, Gao et al. anticipate claims 19-20, and 44 of the instant application as written.
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 and 44 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) 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)
Regarding claims 19-20, and 44, Regarding claims 19-20, and 44, 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 serotype rAAVrh.74 AAV vector (for claim 43).
However, Chicoine et al. teach vascular Delivery of rAAVrh74.MCK.GALGT2 to the Gastrocnemius Muscle of the Rhesus Macaque, which Stimulates the Expression of Dystrophin and Laminin α2 Surrogates known to be therapeutic for several forms of muscular dystrophy, and using GALGT gene therapy for treating Muscular Dystrophy disease in large animal model Rhesus Macaque, and further teach recombinant adeno- associated virus, rhesus serotype 74 (rAAVrh74), was used to deliver GALGT2 via the femoral artery to the gastrocnemius muscle using an isolated focal limb perfusion method, wherein the GALGT2 expression averaged 44+-4% of myofibers after treatment in macaques with low preexisting anti-rAAVrh74 serum antibodies, and expression was reduced to 9+-4% of myofibers in macaques with high preexisting rAAVrh74 immunity (P < 0.001; n = 12 per group). This was the case regardless of the addition of immunosuppressants, including prednisolone, tacrolimus, and mycophenolate mofetil. Chicoine et al. also teach GALGT2-treated macaque muscles shows increased glycosylation of α dystroglycan and increased expression of dystrophin and laminin α2 surrogate proteins, including utrophin, plectin1, agrin, and laminin α5, wherein the experiments demonstrate successful transduction of rhesus macaque muscle with rAAVrh74.MCK.GALGT2 after vascular delivery and induction of molecular changes thought to be therapeutic in several forms of muscular dystrophy (see, Title 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. and Chicoine et al. to use 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 Chicoine 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 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 taught by Gao et al. and Chicoine et al. to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated using serotype rAAVrh.74 AAV vector 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 Chicoine 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 and 44 are rejected.
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.
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Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656