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 .
Claims 1-11, 13-16, 18, 19, 21, 37, 47, 51, 56 and 62 are pending. Claims 21, 37, 51, 56 and 62 are withdrawn. Claims 1-11, 13-16, 18, 19 and 47 are currently under examination.
This office action is in response to the amendment filed on 4/6/2026.
All previous rejection not reiterated in this office action are withdrawn.
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 1-11, 13-16, 18, 19 and 47 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 1 recites the limitation "said heavy chain and light chain variable regions have 85%..." in line 5. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite any heavy chain or light chain variable regions prior to the wherein clause. In fact, the recitation of “wherein said antibody or antigen binding fragment comprises” is immediately followed by this “wherein said heavy chain and light chain,” which renders the claim indefinite because it is unclear what said antibody or antigen binding fragment actually comprise. As such, the metes and bounds of the claim cannot be established.
Dependent claims 2-11, 13-16, 18, 19 and 47 are rejected for same reason because they depend on claim 1 but do not remedy the indefiniteness.
The above is a new rejection necessitated by amendment.
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(s) 1-11, 13-16, 18, 19 and 47 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Kufe (US 10,059,775). This rejection is rewritten to address the amendment.
Amended claim 1 (and dependent claims thereof) is indefinite for reason discussed above. The following rejection is based on the interpretation that claim 1 is drawn to an antibody or antigen binding fragment thereof that selectively binds to MUC1-C extracellular domain (MUC1-C/ECD) defined by SEQ ID NO: 1.
Kufe teaches antibodies binding to MUC1-C/extracellular domain (MUC1-C/ECD) and methods of using such antibodies to treat cancer (abstract). Kufe teaches the antibody selectively binds to MUC1-C/ECD defined by SEQ ID NO: 2, which is an ECD fragment of SEQ ID NO: 1 of the present claim (col.2, lines 18-21). Therefore, the disclosure from Kufe anticipates the claimed invention of claim 1.
Regarding claims 2, 3 and 18, the wherein clause does not further limit claim 1 because it is unclear what the antibody and fragment encompasses. As such, the disclosure from Kufe anticipates the claimed invention of claim 2, 3 and 18.
Regarding claim 4, Kufe teaches the antibody may be a single chain antibody, a single domain antibody, a chimeric antibody (col.2, lines 51-52).
Regarding claim 5, Kufe teaches the antibody fragment may be a Fab fragment (col.2, line 52).
Regarding claim 6, Kufe teaches the antibody is a recombinant antibody having specificity for the MUC1-C/ECD and a distinct cancer cell surface antigen (col.3, lines 24-26).
Regarding claims 7-10, Kufe teaches the antibody is a murine antibody, an IgG, a humanized antibody or a humanized IgG (col.3, lines 26-27).
Regarding claim 11, Kufe teaches the antibody comprises a label (col.3, line 29).
Regarding claim 13-15, Kufe teaches the antibody further comprises an antitumor drug linked thereto, through a photolabile linker, an enzymatically cleavable linker (col.3, lines 31-33).
Regarding claim 16, Kufe teaches the antitumor drug is a toxin, a radioisotope, a cytokine or an enzyme (col.3, lines 34-36).
Regarding claim 19, Kufe teaches the antibody may be conjugated to a nanoparticle or a liposome (col.3, lines 36-37).
Regarding claim 47, Kufe pharmaceutical compositions comprising anti-MUC1-C antibodies and pharmaceutical acceptable carrier (col.48, lines 38-39, 55-62).
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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