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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, and the following species: the CDRs of SEQ ID NOs: 1, 4, 11, 15, 18 and 22, respectively for the 1H7 antibodies; SEQ ID NO: 27; SEQ ID NO: 35; for SEQ ID NO: 25, I at position 48, K at position 74, and A at position 79 (designated SEQ ID NO: 56); for SEQ ID NO: 27, R at position 67, L at position 70, and V at position 72 (designated SEQ ID NO: 57); for SEQ ID NO: 32, N at position 73 and L at position 83 (designated SEQ ID NO: 58); for SEQ ID NO: 35, the amino acids Y at position 72 and M at position 79 (designated SEQ ID NO: 59); for SEQ ID NO: 39, S at position 50, R at position 62, and G at position 82 (designated SEQ ID NO: 60); antibody isotype: the IgG1 isotype. type of antibody: humanized antibody; additional component in pharmaceutical composition is the anti-inflammatory agent; type of disease: inflammatory disease; type of inflammatory disease: rheumatoid arthritis; type of cancer: non-small cell lung cancer in the reply filed 12/03/2025 is acknowledged.
Upon further consideration, the examiner is rejoining Group II, claims 14-18.
Claims 1-18 are now under consideration in the instant Office Action.
Specification
The disclosure is objected to because of the following informalities: the typeface of the specification is blurry and at times illegible. Applicant is encouraged to submit a new copy where the print is a higher resolution and legible.
Appropriate correction is required.
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 2-4 and 6 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.
Instant claims 2-4 recite percent identities of the heavy and light chain CDR and variable region sequences containing amino acid substitutions at specifically defined positions. These substitutions occur within wild card slots included in the recited amino acid sequence. The instant specification provides completed sequence identity numbers that include all the permutations of amino acids substitutions listed in the claims, but the instant claims as recited do not describe this feature. As such, it is unclear how the claims are reciting the identities of the complete sequences with the substituted amino acids. Applicant correctly identifies SEQ ID NO: 25 with the amino acid substitutions of I, K, and A at positions 48, 74, and 79, respectively as “SEQ ID NO: 57” in the election of species response. To overcome this rejection and improve the clarity of the claims, Applicant is invited to amend the claims to include the sequence identity of the sequences with the claimed amino acid substitutions alongside their description to avoid confusion when claiming the sequences that comprise the antibody.
Instant claim 6 uses the transitional term “having the amino acid sequence”. This term is problematic because the recitation of these terms in instant claim 6 renders the claim unclear by what not defining what is encompassed by “having” the sequences. Applicant has not conveyed that they are in possession of all the antibodies that are included in the broad term “having the sequence”. It is not immediately clear whether open or closed claim language is intended, Crystal Semiconductor Corp. v. Trilech Microelectronics Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, 1959 (Fed. Cir. 2001) (term “having” in transitional phrase "does not create a presumption that the body of the claim is open"); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d 1398, 1410 (Fed. Cir. 1997) (in the context of a cDNA having a sequence coding for human PI, the term “having” still permitted inclusion of other moieties), see MPEP 2111.03. Applicant is encouraged to use transitional phrases “comprising of” or “consisting of” to define the scope of a claim with respect to what unrecited additional components, if any, are excluded from the scope of the claims.
Allowable Subject Matter
Claims 1, 5, and 7-18 are allowed. Claims that encompass SEQ ID NOs: 11, 15, 18, 22, 57, and 59 are free of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675