DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 9/4/26, are acknowledged.
Claims 1, 4, 6, 11, 13, 21-23, 29, 32, 36, 44 have been amended.
Claims 56-57 have been added.
Claims 1, 4-7, 11, 13, 15, 17, 20-23, 29, 32, 36, 44, 56-57 are pending and are under examination.
In view of Applicant’s claim amendments, only the following rejections remain.
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 7 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 7 is indefinite since it recites that the antibody is a “human” antibody. The VH and VL of SEQ ID NO; 1 and 5 are murine, and it is unclear how an antibody requiring murine CDRs could be considered a “human” antibody.
Applicant’s arguments filed 9/4/26 have been fully considered, but they are not persuasive.
Applicant argues that that the amendment overcomes the rejection, since one could include the claim CDR sequences in a human antibody.
The claimed CDR sequences are from a mouse antibody. One could include them in a human antibody framework (i.e. replace the human CDRs with the claimed mouse CDRs), but this would result in a humanized antibody. A human antibody would normally be understood to have human derived CDRs. See for example, page 10 of the instant specification which defines a human antibody as including sequences from the human genome and does not include sequences from another species. It is unclear how an antibody requiring murine CDRs could be considered a “human” antibody and the scope of the claim is unclear and indefinite.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
Claim 23 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 23 is directed to a method for reducing T cell exhaustion, reducing lactic acid uptake by an exhausted T cell, or increasing effector function of a T cell comprising “expressing a nucleic acid molecule or a vector encoding the monoclonal antibody”. The claim does not specify where the nucleic acid is expressed. For example, do the claims require expressing the nucleic acid in the exhausted T cell or T cell? If it could be expressed somewhere else (in a different cell type, for example), how would it reduce T cell exhaustion? The scope of the claimed method is unclear and indefinite. It is suggested to amend the claim to recite that it is expressed “in the exhausted T cell or T cell”.
Claims 1, 4-6, 11, 13, 15, 17, 20-22, 29, 32, 36, 44, 56-57 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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