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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated April 29, 2026, has been received. By way of this submission, Applicant has elected, without traverse, Group I: claims 1-10, 16-17, 19-21, 23, and 25-26, drawn to methods for treating a skeletal muscle disease in a subject in need thereof, and the species of dystrophic genetic myopathy, intravenous administration, and dystrophin.
Claims 1-10, 16-17, 19-21, 23, 25-26, 62, and 85 are pending in the application. Claims 4, 16-17, 62, and 85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (62 and 85) or species (4 and 16-17), there being no allowable generic or linking claim.
Claims 1-3, 5-10, 19-21, 23, and 25-26 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 14. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation of "the skeletal muscle polypeptide" of claim 1. There is insufficient antecedent basis for this claim limitation, as claim 1 recites "therapeutic mRNA polynucleotide encoding a skeletal muscle protein". Clarification is required.
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.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-6, 19-21, and 23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Weisbart (US20080292618A1).
Weisbart teaches a method of treating a genetic disorder, comprising administering a substate and an agent for treating the disorder, and the disease or disorder involves skeletal muscle and the conjugate is transported into the skeletal muscle cells, thereby delivering the active agent (para. 0011). Weisbart further teaches that the substrate may be the antibody 3E10 (para. 0044). Weisbart further teaches that the agent may be an RNA (para. 0041), and may be dystrophin (para. 0042).
Weisbart further teaches that the heavy chain of the antibody has a sequence of SEQ ID NO: 6, which is 100% identical to Applicant's SEQ ID NO: 2, and that the light chain of the antibody has a sequence of SEQ ID NO: 8, which is 98.5% identical to Applicant's SEQ ID NO: 8 (para. 0054), which is pertinent to claims 1, 3, 21, and 23.
Weisbart further teaches that the disorder to be treated may be Duchenne muscular dystrophy (para. 0129). According to Applicant's specification at page 136, Duchenne muscular dystrophy is an x-linked myopathy caused by loss-of-function mutations in the dystrophin (DMD) gene. Therefore, Weisbart inherently teaches the subject matter of claims 2, 5, and 19.
Weisbart further teaches that the treatment may be administered intravenously (para. 0167), which is pertinent to claim 6.
Claim Rejections - 35 USC § 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 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 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Weisbart as applied to claim 1 above, and further in view of Armstrong (US20180127509A1).
The teachings of Weisbart have been discussed supra. However, Weisbart does not teach the claimed arrangement of heavy and light chain domains.
Armstrong teaches that the antibody 3E10 may have heavy chain domains of CH1-hinge-CH2-CH3, and a light chain constant region CL attached to the heavy and light variable regions, respectively (para. 0062).
Armstrong further teaches that 3E10 may have the IgG1, IgG2, or IgG4 isotype (para. 0164).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Weisbart and Armstrong to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Weisbart and Armstrong are concerned with the 3E10 antibody. As stated above, methods of treating genetic skeletal muscle disease by administering a 3E10 antibody and a therapeutic polynucleotide were taught in the art by Weisbart. Armstrong teaches conventional arrangements of constant regions of the heavy and light chains. One of ordinary skill in the art of antibody design would recognize that a 3E10 antibody with the constant regions taught by Armstrong could be used in the method of Weisbart, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Allowable Subject Matter
Claims 7-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hildyard (Biomedicines. 2023 Jul 24;11(7):2082) teaches that the gene for dystrophin is 2.3 million nucleotides in length (abstract).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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