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 .
Claim Status
The preliminary amendment filed 09/ 28/23 is acknowledged. Claims 1-17 are amended. Claim 18 is new. The response to the restriction requirement filed 04/24/26 is acknowledged. Applicant elects the antibody species comprising SEQ ID NOs: 104, 105, and 106 without traverse. Claims 1-18 are pending and under review.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [see p. 10, par. 3; see p.14, par. 3]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites “3 CDRs selected from the sequences shown in SEQ ID NOs: 44-133 sequence.” The second “sequence” is redundant. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: The claim recites “a method of diagnosing of diseases.” The second “of” is redundant. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: The claim recites “further composing one or more.” “Composing” is incorrect in this context. Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 and 4-18 are rejected under 35 U.S.C. 112(b) as being indefinite because independent claim 1 recites the phrase “three CDRs selected from SEQ ID NOs: 44-133,” which fails to particularly point out and distinctly claim the subject matter regarded as the invention. Specifically, the sequences comprise distinct CDR1, CDR2, and CDR3 sequences, and it is unclear whether the claims require one CDR1, one CDR2, and one CDR3, or whether any three CDR sequences, including multiple CDR1s or multiple CDR2s, satisfy the claim limitation. Accordingly, the metes and bounds of the claimed invention are not reasonably certain. To advance compact prosecution, the examiner is interpreting this claim such that a sequence selected from each of a CDR1, CDR2, and CDR3 are required. Claims 4-18 are included in this rejection because they explicitly or implicitly require the composition of claim 1 without correcting the indefiniteness.
Therefore, claims 1 and 4-18 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 2-5, 12, 13, and 17 are rejected under 35 U.S.C. 112(b) as being indefinite because it is unclear whether the limitations following the phrase “preferably” are part of the claimed invention. Descriptions of examples or preferences are properly set forth in the specification rather than the claims.
Therefore, claims 2-5, 12, 13, and 17 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 6 and 17 are rejected under 35 U.S.C. 112(b) as being indefinite because it is unclear what constitutes a “colored substance.” The claim does not define what characteristics distinguish a “colored substance” from other substances, such as the claimed “luminescent substance,” and the specification does not provide a definition or examples to establish the boundaries of this term. Accordingly, the scope of the claim cannot be determined with reasonable certainty.
Therefore, claims 6 and 17 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 11 is rejected under 35 U.S.C. 112(b) as being indefinite because it recites the limitation "culturing the host cells.” There is insufficient antecedent basis for this limitation as claim 1 does not recite host cells. To advance compact prosecution, the examiner is interpreting this limitation as “culturing host cells.”
Therefore, claim 11 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 14 and 18 are rejected under 35 U.S.C. 112(b) as being indefinite because it is unclear what constitutes a “a disease that specifically expresses NKp46.” NKp46 is a surface receptor that is expressed by certain cell types, such as NK cells, rather than by diseases themselves. Furthermore, the claim does not define what constitutes a disease expressing NKp46 and the specification does not provide a definition or examples to establish the boundaries of this limitation. Accordingly, it is unclear whether the claim is directed to diagnosing diseases involving NKp46 expressing cells, diseases associated with NKp46 expression, diseases associated with altered NKp46 expression, or some other category of diseases. Accordingly, one of ordinary skill in the art would not be able to determine the metes and bounds of the claimed invention with reasonable certainty.
Therefore, claims 14 and 18 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 112a – Written Description
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, 2, and 4-18 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.
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 MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), 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 MPEP 2163(II)(3)(a)(i)(C).
Independent claim 1 and dependent claim 2 recites an anti-NKp46 antibody or antigen binding domain comprising a heavy chain variable region comprising a CDR1 selected from SEQ ID NOs: 44, 47, 50, …, 131, the CDR2 is selected from SEQ ID NOs: 45, 48, 51, …, 132, and the CDR3 is selected from SEQ ID NOs: 46, 49, 52, …, 133. This language encompasses a large genus of potential sequence combinations. The specification, however, only describes 30 specific CDR combinations as enumerated in Table 3. As discussed above, the claims are not limited to those species, but also include many possible CDR sequence combinations, and crucially, protein chemistry is unpredictable and the art recognizes that even a single amino acid substitution can abolish protein activity [see Rudikoff et al., abstract]. Given that the specification fails to provide a representative number of species within the recited genus, adequate structure-function correlation, or other identifying characteristics of the genus as a whole, the disclosure does not reasonably convey possession of the full scope of possible CDR combinations.
Therefore, claims 1, 2, and 4-18 are rejected under 35 U.S.C. 112(a) for lack of written description.
Claims 1-18 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. Independent claim 1 recites an anti-NKp46 antibody, however the specification only discloses heavy chain binding domains without the corresponding light chains. As discussed above, protein chemistry is unpredictable and the art recognizes that even a single amino acid substitution can abolish protein activity. While it is clear that applicant is in possession of heavy chain only antibodies, such as camelid antibodies, and single chain antigen binding fragments thereof, combining the disclosed CDRs with any light chain CDRs known in the art would not reasonably be believed to produce a functioning antibody that comprises both a heavy and light chain. As such, the specification fails to provide a representative number of species within the recited genus, adequate structure-function correlation, or other identifying characteristics of the genus as a whole, and accordingly, the disclosure does not reasonably convey possession of the full scope of possible antibodies. Claims 2-18 are included in this rejection because the explicitly or implicitly require the composition of claim 1.
Therefore, claims 1-18 are rejected under 35 U.S.C. 112(a) for lack of written description.
Claims 5 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. Claim 5 recites the antibody or binding protein of claim 1 further comprising a heavy chain and/or light chain constant region. The term “and/or” introduces embodiments consisting of a heavy chain variable region and a light chain constant region. Although the specification discloses several heavy chain variable region embodiments as discussed above, it does not disclose antibodies consisting of a heavy chain variable region and a light chain constant region, nor a representative number of species showing that the disclosed heavy chain variable regions can be incorporated into the claimed antibody format. Accordingly, the disclosure does not reasonably convey possession of the full scope of possible antibodies encompassed by the claim.
Therefore, claim 5 is rejected under 35 U.S.C. 112(a) for lack of written description.
Claim Rejections - 35 USC § 112a - Enablement
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for cancer and infectious diseases, does not reasonably provide enablement for autoimmune diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Natural Killer (NK) cell activation via NKp46 is known in the art to produce positive outcomes in the treatment of cancer and infectious diseases, however, at the time of the invention, several lines of evidence indicated that overactivation of NK cells contributed to autoimmunity and induced organ damage [See French et al., line before conclusions], and NKp46 is a known method of inducing NK cell activation. As such, a person of ordinary skill in the art would have to engage in undue experimentation to determine how to use the NKp46 antibody, which activates NK cells, to treat a disease in which NK cell activation produces tissue damage.
Therefore, claim 13 is rejected under 35 U.S.C. 112(a) for lack of enablement.
Subject Matter Free of the Art
The prior art does not teach or suggest any of the possible combinations of HCDR 1, HCDR2, and HCDR3 as described in claim 2. However, claim 2 remains subject to outstanding rejections under 35 U.S.C. 112. Should applicant overcome the outstanding rejections and claim 2 be rewritten in independent form, including all limitations of the base claim and any intervening claims, this claim may be allowable.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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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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/TIRONE D. JOHNSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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