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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I and species of MuSK MR antibodies in the reply filed on October 10, 2025 is acknowledged.
Claims that read on the elected invention are 1-5, 7 and 9-14.
2. Claims 6, 8 and 15-85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 10, 2025.
3. Claims 1-5, 7 and 9-14 are under examination.
Claim Objections
4. Claims 1-5, 7 and 9-11 are objected to because of the following informalities:
The claims recite “MuSK” and “BMP-MuSK” without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for. Appropriate correction is suggested.
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.
5. Claims 1-5, 7 and 9-14 are 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.
6. The terms “increasing” and “decreasing” in claims 1-3 are relative term which render the claims indefinite. These terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claims would obviate this ground of rejection.
7. Further, claims 1-3 are vague and indefinite for missing active, meaningful physical steps that support limitation “increasing (or reducing) levels or activity”. While a skilled practitioner readily appreciates what stands for administering to a subject a pharmaceutical composition,” claim 4, for example, one has not idea what physical steps are intended to meet the limitations of increasing or reducing levels or activity of a polypeptide or its complex.
8. Finally, claims 1-3 are indefinite insofar as they employ the term “activity of MuSK polypeptide lacking a functional Ig3 domain” or “activity of a BMP-MuSK polypeptide complex” as limitations. These terms are not known in the relevant prior art of record as being associated with well-defined genus of activities or functions. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of “activity of MuSK polypeptide lacking a functional Ig3 domain” or “activity of a BMP-MuSK polypeptide complex,” an artisan cannot determine if an activity which meets all of the other limitations of the claims would then be included or excluded from the claimed subject matter by the presence of this limitation.
9. Claim 11 recites a modal verb “may,” which is interpreted as possibility or permission, thus rendering the claimed subject matter indefinite as being at least subjective.
10. Claims 4, 5, 7, 9, 10 and 12-14 are indefinite for being dependent from indefinite claim(s).
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.
11. Claims 1-5, 7 and 9-14 are 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.
Claims 1-5, 7 and 9-14 specifically require possession of MuSK muscle regeneration (MR) agonizing agents, which include antibodies that bind to MuSK polypeptide, specifically to the Ig3 domain of MuSK polypeptide, target the Ig3 domain of MuSK protein and may bind specifically to the Ig3 domain relative to the Ig1 or Ig2 domains of MuSK, wherein the agents downregulate the MuSK Ig3 domain protein expression, MuSK Ig3 domain gene expression, MuSK Ig3 activation of BMP signaling and prevent or reduce the accumulation of extracellular matrix within the extracellular space of the muscle. The claims do not require that these agents or antibodies possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of molecular embodiments that is defined only by reference to their desired function. However, the instant specification fails to describe the entire genus of agents, which are encompassed by these claims.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. From the specification, and with respect to the instantly elected MuSK MR antibody, it is clear that Applicant is not in possession of even one embodiment that satisfies the claims limitations.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claims is a requirement to meet all the functional limitations of the claims, such as being useful for certain desired effects upon clinical administration, see claim 5, for example. There is not even identification of any particular portion of the structure of the MuSK MR agonizing agent or description of at least one antibody that satisfies the claims, as written. The specification does not provide a complete structure of those MuSK muscle regeneration (MR) agonizing agents, which include antibodies that bind to MuSK polypeptide, specifically to the Ig3 domain of MuSK polypeptide, target the Ig3 domain of MuSK protein and may bind specifically to the Ig3 domain relative to the Ig1 or Ig2 domains of MuSK, wherein the agents downregulate the MuSK Ig3 domain protein expression, MuSK Ig3 domain gene expression, MuSK Ig3 activation of BMP signaling and prevent or reduce the accumulation of extracellular matrix within the extracellular space of the muscle, and fails to provide a representative number of species for the recited genus of agents and antibodies. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of molecular embodiments termed agents or specifically functional antibodies all suitable for clinical administration, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Further, the instant claims encompass a method of treating a subject suffering from neuromuscular dysfunction, muscular dystrophy, for increasing muscle regeneration and muscle growth and for treatment of muscle fibrosis by administering a MuSK MR agent, or specifically an antibody to MuSK. However, the instant specification is devoid of any evidence that Applicant was in possession of even a single operable embodiment of the claimed method.
As stated in M.P.E.P. § 2163(II)(A)(3), a specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves).
Whereas a reduction to practice of an uncomplicated invention such as a simple mechanical or electrical device can be achieved by merely providing a diagram of the device wherein one skilled in the relevant art can predict the likely operability of the device by reviewing the diagram, the operability of the claimed invention cannot be predicted by merely reviewing diagrams or illustrations. To demonstrate the reduction to practice of a method of treating a specific pathological condition requires either a working embodiment, a demonstration of operability of the clinical method when applied to an art accepted animal model of the condition to be treated wherein that animal model has been shown to be reliably predictive of efficacy in the treatment of the condition, or a demonstration that the parameter employed therein reasonably correlates with the presence of the condition being treated. In the instant case, Applicant has provided none of these. Consequently, Applicant has failed to demonstrate possession of the claimed methods as of the earliest effective filing date of the instant application.
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 (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 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.
12. Claim(s) 1-4, 7 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0050289, the ‘289 document hence forward, reference 6 of IDS filed on 12/07/2022.
By broadest reasonable interpretation and consistent with the specification as filed, claims 1-4, 7 and 12 encompass methods of treatment of neuromuscular dysfunction, increasing muscle growth and prevention and treatment of muscular fibrosis by administration of an antibody that binds to MuSK. The ‘289 published document teaches treatment of motor dysfunction and ALS, the pathology that is characterized by muscle fibrosis, by administration of an antibody that binds to MuSK and increases MuSK activity, see the whole text of the document and especially claims 1-11. By practicing the step of clinical administration of the anti-MuSK antibody, increase in muscle growth is reasonably expected. Thus, the ‘289 document fully anticipates the invention of at least claims 1-4, 7 and 12.
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
December 16, 2025