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 .
The preliminary amendments of 06/02/2023 have been entered in full. Claims 1-18, 20, and 22 are pending.
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.
Claims 1-18, 20, and 22 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.
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 1 recites the broad recitation “substitutions”, and the claim also recites “preferably, the substitution is a conservative amino acid substitution”, 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.
All claims are indefinite as they depend from claim 1. Lack of clarity is compounded by each instance of the term “preferably”, which appears in at least in claims 5, 8-10, 12, 15, 18, and 20. Each of these claims sets forth a broad limitation and then recites a preference for a narrower range.
Further regarding claim 8, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the nanobody of claim 1, wherein the nanobody is fully human. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The accepted meaning the term “nanobody” is a type of antibody produced by certain camelids or fish; humans do not make nanobodies. (See Konning et al., Curr. Opin. Structural Biol. 45:10-16, 2017). Therefore, recitation of a fully human nanobody is contrary to the ordinary meaning of “nanobody”. The term is indefinite because the specification does not clearly redefine the term.
Regarding claim 3, it is agreed that the expression “the sequence shown above” can be readily interpreted as referring to the SEQ ID NO recited earlier in the section in which it appears. However, in all but the first instance, “the sequence shown above” could also be construed as referring to any SEQ ID NO recited earlier in the claim. The claim would be clarified by reciting percent identity to specific SEQ ID NO’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.
Claims 1-18, 20, and 22 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.
Claim 1 is drawn to a nanobody has 1, 2, or 3 amino acid insertions, deletions, and/or substitutions compared to the CDRs listed in the table of claim 1. Claim 4 is drawn to nanobodies that have a KD less than 50nM.
At the time the invention was made, the art teaches that there is an interest in optimizing natural properties (affinity, specificity, stability, solubility, and effector function) in antibodies. A common challenge during antibody optimization is that improvements in one property (e.g. affinity) can lead to deficits in other properties (e.g. stability) (Rabia et al., Biochem Eng J. 2018 Jun 5;137:365–374, abstract). Rabia et al. teach that the most important antibody properties are mediated by their complementary-determining regions (CDRs) within the variable heavy and light regions (Rabia et al., under Introduction).
As this applies to claim 1 and all claims dependent therefrom, the specification does not teach what amino acids in the CDRs can be inserted, deleted, and/or substituted, nor the spec teach how to predictably make changes in the CDR sequences and still have the nanobody bind to CD40. As the issue applies to claim 4, the specification does not provide guidance as to what residues in the CDRs can be changed and have the nanobody still have a KD less than 50nM.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W 9:00 am-5:30pm, EST. Please note the examiner’s part-time schedule. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647