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 with traverse of Group I and species of PAD4 in the reply filed on August 24, 2026, is acknowledged. The traversal is on the ground(s) that the Restriction Requirement did not “identify any particular document, or any passage of any document, and does not explain how the art bears on that feature.” P. 2 of the Response. While this has been fully considered, the argument is not persuasive because the ISR (International Search Report) submitted on 01/29/2024 cites only one prior art document. Applicant’s attention is directed to the document marked “X.” Next, since the prior art document, “X” document, has been cited against the first independent claim, this indicates that the unity of invention is not present, see 37 CFR 1.475(c).
2. Applicant further traverses the species election requirement on premises that, “the Office has not provided any list of species and, as such, cannot have provided any explanation in support of this requirement.” Applicant’s argument has been fully considered but found to be not persuasive because the list of species is clearly provided within claim 4, from which Applicant has elected PAD4 for examination. Applicant is reminded that if the generic claims are found to be allowable, all species would be examined.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 1-4, 9, 10 and 12 read on the elected invention.
4. Claims 5-8, 11 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 24, 2026.
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 1-4, 9, 10 and 12 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 term “suppresses” in claim 1 is a relative term which renders the claim indefinite. The term “to suppress” is not defined by the claim, 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 claim would obviate this ground of rejection.
7. Similarly, the term “inhibits” in claim 2 is a relative term which renders the claim indefinite. The term “to inhibit” is not defined by the claim, 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 claim would obviate this ground of rejection.
8. Claim 12 is indefinite wherein it recites functional language. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, the claim recites a product of claim 1 but then defines it —for use by placement in the distal vicinity of an injury site of a peripheral nerve— by functional language. While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by recitation of intended use of the product. Since the claim fails to meet the criteria set forth in MPEP 2173.05(g), then the claim is rejected as being indefinite.
9. Claims 3-4, 9 and 10 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.
10. Claims 1-4, 9 and 12 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 1-4, 9 and 12 encompass substances that suppress the formation of neutrophil extracellular traps (NETs) outside the parenchyma of an injured peripheral nerve, inhibit the accumulation of neutrophils, inhibit NETs formation by neutrophils, degrade NETs and specifically suppress the expression or inhibit the function of PAD4, wherein the substance is a nucleic acid that suppresses the expression of PAD4, an antibody against PAD4, an aptamer targeting PAD4 or a PAD4 inhibitor. The claims do not require that these substances possess any particular conserved structure, disclosed distinguishing feature or even belong to a particular chemical class. Thus, the claims are drawn to a genus of molecular embodiments that is defined strictly by their asserted intended function. However, the instant specification fails to describe the entire genus of molecules, 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).”
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 factors present in the claims are reference to the activity of the substances. There is not even identification of any particular portion of the structure that must be conserved. The specification does not provide a complete structure of those substances that suppress the formation of NETs outside the parenchyma of an injured peripheral nerve, inhibit the accumulation of neutrophils, inhibit NETs formation by neutrophils, degrade NETs, suppress the expression or inhibit the function of PAD4, nucleic acids that suppresses the expression of PAD4, antibodies against PAD4, aptamers targeting PAD4 or a PAD4 inhibitors, and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed 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 substances, 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.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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.
11. Claim(s) 1-4, 9, 10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0276206 published patent application.
Claims 1-4, 9, 10 and 12 encompass substances that are PAD4 inhibitors, and specifically C1-amidine. The ‘206 document teaches PAD4 inhibitors and Cl-amidine, see title, section Technical Filed of the Invention and p. 4 in particular; thus, fully anticipating the instant invention.
12. Claim(s) 1-4, 9, 10 and 12 is/are further rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knight et al., Arthritis and Rheumatol., 2014, 66(10):S281.
Claims 1-4, 9, 10 and 12 encompass substances that are PAD4 inhibitors, and specifically C1-amidine. The publication by Knight et al. discloses teaches PAD inhibitors and Cl-amidine specifically as pharmaceutical compositions. This meets the limitations of the claims.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
September 22, 2026
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