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 .
Applicant’s amendment and reply filed March 2, 2026 have been received and entered into the case. Claims 5 – 6 and 11 – 12 are canceled; claims 1 – 4 and 10 are pending; claims 1 – 3 and 10 are withdrawn; claim 4 has been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim is drawn to a method for ameliorating a neuromuscular disease comprising administering an effective amount of a PRMT1 protein or a gene encoding the same to a subject in need, wherein treatment results from “protection of motor neuron cells against damage caused by oxidative stress and inflammatory stress” and wherein the subject as amyotrophic lateral sclerosis (ALS), progressive bulbar palsy, pseudobulbar palsy, progressive lateral sclerosis (PLS), or Huntington's disease. The phrase “results in protection from” is interpreted as preventing damage.
The claim is considered genus claim that encompass a wide array of proteins or genes encoding the proteins. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of proteins and genes, particularly proteins or genes encoding the same that result in protecting cells from, or preventing, oxidative stress and inflammation. As expressly acknowledged by applicant in the reply filed 03.02.2026 beginning on page 9, proteins within the PRMT1 family exhibit differences in amino acid sequence, number of amino acids and molecular weight that results in structural differences of active sites, binding affinity, reaction rate and pharmacological effect. These differences may result in variation of protein folding and genes that encoding the proteins, for example a wild type PRMT1 and PRMT1 variations in the art such as PRMT1 11.44 (CN 1339592A, IDS 01.26.2025, FPD #1). Moreover, while the specification demonstrates a link between PRMT1 expression and oxidative and inflammatory stress markers, the specification fails to demonstrate preventing damage in motor neuron cells as claimed in subject with the claimed neuromuscular diseases. Nor does the specification set forth any specific structure of the PRMT1 proteins that might result in the claimed function or method.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all proteins and genes that fall under the umbrella term “PRMT1.” The instant disclosure fails to identify a single protein or gene that successfully protects motor neurons from oxidative stress or inflammatory stress. The possible variations of proteins within the PRMT1 family are limitless with potentially millions of types of proteins and variant let alone any gene encoding the same.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of proteins to reflect this variance in the genus since the specification does not provide any examples of such a genus of PRMT1 proteins or genes encoding the same. Accordingly, the specification fails to provide adequate written description for the genus of a “PRMT1 protein or a gene encoding the same” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these proteins and genes, the specification does not describe the claimed in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these proteins and genes at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 4 remains 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 4 is drawn to a method for ameliorating a neuromuscular disease however remains indefinite for reciting “results from protection” because it remains unclear what the term “protection” requires. For example, it is unclear if protection requires prevention to or a reduction in damage to motor neurons caused by oxidative or inflammatory stress. Further, the phrase remains indefinite in conjunction with “pharmaceutically effective amount” because it is unclear what effect must be achieved, e.g., reduced damage or no damage.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 as being anticipated by CN 1339592A (IDS 01.26.2025, FPD #1) are withdrawn due to the amendment limiting the neuromuscular disease to one of amyotrophic lateral sclerosis (ALS), progressive bulbar palsy, pseudobulbar palsy, progressive lateral sclerosis (PLS) or Huntington's disease.
Claim Rejections - 35 USC § 103
Previous rejections under 35 U.S.C. 103 as being unpatentable over CN 1339592A (IDS 01.26.2025, FPD #1) in view of Kang (IDS 01.26.2025, NPL #4) OR Choi et al. (IDS 01.26.2025, NPL #1) are withdrawn due to the amendment limiting the neuromuscular disease to one of amyotrophic lateral sclerosis (ALS), progressive bulbar palsy, pseudobulbar palsy, progressive lateral sclerosis (PLS) or Huntington's disease.
Response to Arguments
Applicant argues that the prior art does not motivate one to combine the teachings of the references to provide a reasonable expectation for successfully ameliorating the claimed neuromuscular diseases. This argument is persuasive.
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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