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
Applicant’s election without traverse of Group I in the reply filed on 11/20/2025 is acknowledged.
Applicant's election with traverse of Species of disease or condition which is inflammatory pain in the reply filed on 11/20/2025 is acknowledged. The traversal is on the ground(s) that as amended, claim 17 has been limited to a disease or condition to be treated caused by increased expression of or sensitivity to NGF, and that pain-related diseases or conditions are now listed. Applicant further notes documents that support the basis for a common pain mechanism of these diseases/conditions. Applicant’s arguments are persuasive and the requirement for election of species of disease or condition for claim 17 as amended is withdrawn.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities: In [0001], the name and size of the Sequence Listing is incorrect. Pleases refer to the information below reproduced from the Electronic Acknowledgement Receipt. Note the size of the Sequence Listing must be specified in “bytes” rather than kilobytes (KB): see 37 CFR 1.52(e)(5) and MPEP 2322.03(a).
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The disclosure is objected to also because of the following informalities: In the Abstract, “recognizing” should be --recognizes--. In [00198] and [00199], respectively, “sub cloned” and “sub clones” should be one word. In [00330], “At24h” should be --At 24h--.
Appropriate correction is required.
Claim Objections
Claim 17 is objected to because of the following informalities: “post-hepatic neuralgia” is repeated (third to last and last line). Appropriate correction is required.
Information Requirement
The following information is required under 37 CFR 1.105 in order to fully examine the application: what type of yeast surface display “company library” was used for selection of anti-NGF scFv antibodies, e.g., human, mouse, etc. (see paragraphs [0296] of the specification). The reasons this is important is that claim 10 recites the antibody of claim 1 is chimeric, human or humanized. The antibody cannot be all of these, and which it can be classified as depends on the origin of scFv variable heavy and light chain sequences. See rejection under 35 USC 112(a) below for a full explanation.
Claim Rejections - 35 USC § 112(a)
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 10 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 source of the antibody heavy and light chain variable region CDRs is disclosed only as from a company yeast display scFv library ([00296[). As a result, a requirement for information under 37 CFR 1.105 has been made (see above). It is not clear if the variable regions originate from human or other species. This is important for claim 10, which is drawn to the anti-NGF antibody of claim 1 which is chimeric, human or humanized. As defined in [0043] and [0047], a humanized antibody has nonhuman hypervariable regions (HVRs or CDRs), which is distinct from a chimeric antibody which could have the human variable domains and constant regions from a different species (or vice versa). While a chimeric antibody may have human variable heavy and light chain regions, a humanized antibody cannot. Therefore, if the library used to obtain the scFv antibody comprising the CDRs of claim 1 was composed of human antibody variable region sequences, then there is no written description for a humanized antibody. On the other hand, if the library had nonhuman NGF-binding sequences, e.g., from mouse, then the antibody of claim 10 cannot be a human antibody. The skilled artisan cannot readily envision a representative number of antibodies meeting the inherent limitations of each antibody type of the claim. Therefore, at least one type of antibody of claim 10 does not meet the written description provision under 35 USC 112(a).
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 97 USPQ2d 1870 at 1875 (Fed. Cir. 2011) set forth that, (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity. Aa mouse and human antibody, for example, would not reasonably be expected to share full heavy and light chain variable regions. As a result, while a mouse or human antibody could be a chimeric antibody, an antibody having human variable regions cannot be a “humanized” antibody and an antibody having mouse variable regions cannot be a “human” antibody.
Claim Rejections - 35 USC § 112(b)
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 11 is 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 11 recites a number of antibody fragments, including a “linear antibody”. The claim is indefinite because it is not clear what is meant by that term and it is not defined in the specification. If “linear antibody” is intended to mean an antibody fragment that binds a linear epitope, then it is unclear what distinguishes it from the other antibody fragment types listed. Clarification is required.
Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
Denk et al. (Ann Rev. Neurosci. 40:307-325, 2017) reviews the mechanisms of pain related to nerve growth factor. It also reviews therapeutic targeting of NGF for pain relief. This reference is cited to show the state of the art for the understanding of the role of NGF in pain and preclinical and clinical studies supporting the use of antibodies against NGF in the treatment of pain.
Jaffal et al. (Korean J. Pain, 37(4):288-298, 2024) is a post-filing reference cited to show further clinically suggested and/or supported pain types for NGF-targeted therapies.
The WIPO and CN patent documents, as well as US Patent application publications, cited in the IDSs filed 11/28/2022 and 12/26/2024 disclose anti-NGF antibodies, and most disclosed methods of treating pain using the antibodies. However, none disclose or make obvious an antibody having the heavy and light variable region CDR1-3 of instant independent claim 1.
Allowable Subject Matter
Claims 1, 3, 5, 7, 8, 9, 16 and 17 are allowed. However, note that claim 17 is objected to above.
As allowable subject matter has been indicated, Applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
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Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
February 26, 2026