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 in the reply filed on February 18, 2026 is acknowledged. The traversal is on the ground(s) that “Groups I-III are linked by a single inventive concept,” p. 6 of the Response. This is not found persuasive because the instant patent application is a national stage application, wherein a single inventive concept is defined by unity of invention. Because the first independent claim lacks novelty, the claims lack unity of invention and Groups II-III represent distinct inventions.
The requirement is still deemed proper and is therefore made FINAL.
2. Claims 95-97 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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 February 18, 2026.
3. Clams 78-94 are under examination.
Claim Objections
4. Claim 78, 79, 83, 85-92 are objected to because of the following informalities:
The claims recite acronyms 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 78-94 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. Claim 78 is vague and ambiguous in section c, which reads “identifying or capturing the EV bound to the affinity molecules.” Specifically, while it is clear what stands for step b, wherein the step recites an active physical step of contacting the sample with affinity molecules, it is not obvious what active, physical and repeatable steps support identifying or capturing. This renders the claim indefinite.
7. Next, claim 78 specifically states capturing neuron-derived EV, and it is not obvious whether the last step leads to achieving the goal by identifying of neuron-derived EV or to identifying any EV, thus making the claimed subject matter vague and ambiguous.
8. Further, the term “capable of” renders claim 78 indefinite because it is unclear whether the encompassed “capability” is part of the claimed invention.
9. Finally, claim 78 is rendered indefinite and ambiguous in the recitation of binding “under conditions enabling specific binding of the affinity molecules to their corresponding target molecules” as this phrase is unclear absent a statement of the conditions under which the specific binding reaction is performed. Affinity molecules that will bind under some conditions will not necessarily bind under different conditions. Without providing a precise set of conditions enabling specific binding, in the claim or the specification, the metes and bounds of the claimed subject matter cannot be defined.
10. Claim 81 is indefinite for reciting limitation “predetermined amount of particles.” The metes and bounds of the particles cannot be determined from the claim or the specification as filed.
11. Claim 85 recites the limitation "neuron-specific" and “non-neuron-specific” markers in claim 78. There is insufficient antecedent basis for this limitation in the claim.
12. Claim 86 recites the limitation "one or more biomarkers in the EV" in claim 78. There is insufficient antecedent basis for this limitation in the claim.
13. Claims 79, 80, 82-84, 87-92, 93 and 94 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.
14. Claims 78-92 and 94 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 78-92 and 94 specifically require possession of affinity molecules capable of binding, under conditions enabling specific binding, to target molecules NLGN3 and GAP43. The claims do not require that these affinity molecules 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 binding capability to the target molecules. However, the instant specification fails to describe the entire genus of affinity 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 factor present in the claim is a reference to the binding target. There is no identification of any particular chemical class of the molecules or a portion of the structure that must be conserved to provide for the capability of binding. The specification does not provide a complete structure of those affinity molecules capable of binding, under conditions enabling specific binding, to target molecules NLGN3 and GAP43, and fails to provide a representative number of species for the recited genus. 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 affinity molecules, 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).
Conclusion
15. 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
May 5, 2026
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