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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See Example 1 on page 56.
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 50, 53-59 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.
Claim 50 is drawn to a polynucleotide sequence encoding “at least one sequence of a heavy chain or a light chain region of an antibody or antibody fragment of claim 41.” The limitation “at least one sequence of a heavy chain or a light chain region” makes unclear whether claim 50 requires a polynucleotide encoding any of the CDRs recited in claim 41. For example, claim 41 recites an anti-CD112R antibody that “comprises” a set of six CDRs recited by SEQ ID NO. The antibody of claim 41 could comprise other sequences not defined by SEQ ID NO in claim 41, such an Fc region and framework regions. The limitation “one sequence of a heavy chain or a light chain region” in claim 50 appears to encompass polynucleotides encoding subsequences or subregions within a heavy or light chain and does not appear to require the entirety of heavy or light chain, nor the entirety of a heavy or light chain variable region which comprise the CDRs of claim 41. Thus, it is unclear what polynucleotide sequence is needed to meet claim 50. Claim 53 references claim 50 while failing to remedy the indefiniteness of claim 50. Therefore, claim 53 is also rejected. For the purpose of compact prosecution, claim 50 is interpreted as requiring a polynucleotide encoding an antibody heavy or light chain variable region which comprises the heavy or light chain CDRs recited in claim 41.
Claim 54 recites a pharmaceutical composition comprising as an active ingredient at least one antibody or antibody fragment according to claim 51. However, claim 51 does not recite an antibody or antibody fragment. Rather, claim 51 is drawn to a polynucleotide sequence encoding an antibody heavy chain variable region comprising SEQ ID NOs: 16, 20, or 24. It is unclear whether the pharmaceutical composition of claim 54 requires an amino acid sequence or a poly nucleotide sequence encoding an antibody. Claims 55-59 recite methods comprising administering the pharmaceutical composition of claim 54 and are further rejected for failing to remedy the indefiniteness. For the purpose of compact prosecution, claim 54 is interpreted as referencing the antibody or antibody fragment of claim 41. As such, claims 54-59 are interpreted as requiring a pharmaceutical composition and a method of treating comprising administering the pharmaceutical composition, wherein the pharmaceutical composition comprises an anti-CD112R antibody comprising a set of six CDRs as recited in claim 41. It is noted that should claim 54 be amended to only define the sequence of the heavy chain variable region without constraint by a set of six CDRs, the method of claims 55-59 would not be enabled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 50 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Watkins et al. (WO 2003/046204 A2; Published: June 5, 2003).
Claim 50 recites a polynucleotide sequence encoding at least one sequence of a heavy chain or light chain region of an antibody or antibody fragment according to claim 41. Claim 50 is indefinite and interpreted as requiring a polynucleotide encoding an antibody heavy or light chain variable region which comprises the heavy or light chain CDRs recited in claim 41. Claim 41 recites light chain CDRs of instant SEQ ID NOs: 4, 5, and 6.
Watkins et al. teaches humanized collagen antibodies with clone HUIV26 comprising the light chain CDRs of SEQ ID NOs: 20, 22, and 24 which are 100% identical to instant SEQ ID NOs: 4, 5, and 6 when X is N; see claim 1 and page 21 lines 2-6. Further, Watkins et al. teaches that the nucleic acid encoding the light chain variable region was cloned independent of the nucleic acid encoding the heavy chain variable region; page 79 lines 9-17.
Thus, Watkins et al. anticipates the polynucleotide of claim 50 by teaching a nucleic acid encoding a light chain variable region which comprises the same light chain CDRs recited in claim 41.
Allowable Subject Matter
Claims 51 and 52 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 41-49 and 60 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the antibody targeting CD112R, also known as PVRIG, comprising a set of 6 CDRs encompassed in claim 41 is novel and nonobvious. The closest prior art is Mandelboim et al. (US 2020/0040092 A1; Published: February 6, 2020) which teaches anti-CD112R antibodies with similar, but not identical CDRs, and no teaching or suggestion to modify the CDRs to arrive at the instant CDRs of claim 41. Additionally, the polynucleotide sequences of the heavy chain recited in claim 51 and heavy chain sequences recited in claims 46 and 47 are also novel and nonobvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm MT.
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/KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646
/JULIET C SWITZER/Primary Examiner, Art Unit 1682