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 .
DETAILED ACTION
Restriction/Election
Applicant’s election without traverse of Invention Group I (claims 1-3, 10-13, 15, and 19-20) in the reply filed on 12/30/2025 is acknowledged. In response to species election requirement, Applicant elected an antibody comprising a heavy chain variable sequence of SEQ ID NO: 9 and a light chain variable sequence of SEQ ID NO: 10.
2. Claims 1-3, 10-13, 15, 19-20, 23-29, 31, and 33 are pending. Claims 1-3, 10-13, 15, and 19-20 are currently under consideration. Claims 23-29, 31, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 09/11/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 11/28/2022 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 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.
6. Claims 1-3, 10-13, 15, and 19-20 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 1 is drawn to a method of treating or reducing the progression of osteoarthritis (OA) comprising administering to a mammalian subject having OA an effective amount of a composition comprising an antibody or binding fragment thereof that binds leucine-rich repeat-containing protein 15 (LRRC15) in an amount sufficient to inhibit or suppress the activity of LRRC 15. Claims 3, 10-13, 15, and 19 depend from claim 1. Claim 20 is drawn to a method of treating an arthritic joint comprising injecting into the joint of a mammalian subject having symptoms of fibrosis or osteoarthritis an effective amount of a composition comprising an antibody or binding fragment thereof that binds leucine-rich repeat-containing protein 15 (LRRC15) in an amount sufficient to inhibit or suppresses the activity of LRRC 15. The claims do not require that the anti-LRRC15 antibodies possess any particular conserved structure nor other disclosed distinguishing feature. Thus, the claims encompass a genus of anti- anti-LRRC15 antibodies without any structural features. Claim 3 recites a random combination of heavy chain variable regions/light chain variable regions as recited in the claim.
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses a number of anti-LRRC15 antibodies (page 12), which are known in the art. All these anti-LRRC15 antibodies comprise a particular pair of VH chain and VL chain. The instant disclosure is insufficient to support the broad genus of anti-LRRC15 antibodies.
It is well established in the art that the formation of an intact antigen binding site of an antibody routinely requires the association of the complete heavy/light chain variable regions of a given antibody. It is expected that proper association of heavy/light chain variable regions is required in order to form a functional antigen binding site (Paul, Fundamental Immunology, 3rd Edition, 1993, pages 292-295; in particular page 293, column 1, lines 3-8; column 1, line 31 to column 2, line 9; column 2, lines 27-30). Vajdos et al. teach that amino acid sequence and conformation of each of the CDRs of the heavy and light chains is critical for maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (J. Mal. Biol. 320:415-428, 2002; in particular page 416).
Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other anti-LRRC15 antibodies might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of anti-LRRC15 antibodies.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
7. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
8. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 2 recites the broad recitation “wherein said composition further comprises a pharmaceutically acceptable excipient or carrier”, and the claim also recites “optionally a nanocarrier or nanoparticle suitable for direct injection into a joint”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
9. Claims 12 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 12 recites “wherein said composition comprises one or more different said antibodies or fragments thereof”. However, the claim does not identify the antibodies or fragments thereof, rendering the claims indefinite.
Claim 19 is indefinite because it recites “a dose ranging from about 0.01 mg/kg to about 6 mg/kg”. The use of the word “about” in the context does not unambiguously define the borderline, rendering the claim indefinite.
Claim Objection
10. Claim 3 is objected to because it recites non-elected subject matter (non-elected antibodies).
Conclusion
11. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
March 2, 2026