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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/21/2025 is acknowledged.
Accordingly, claims 21, 37, 51, 56 and 62 are withdrawn from consideration for being directed to non-elected subject matter. Claims 1-11, 13-19 and 47 are currently under examination.
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, 13-19 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.
Regarding claim 1, the recitation of “an antibody or fragment thereof…wherein said antibody comprises a variable heaving chain comprising CDR2, CDR2 and CDR3 regions of SEQ ID NO: 3, 4, 5…respectively” renders the claim indefinite because it is unclear whether the fragment also comprises said SEQ IDs or only a fragment of said SEQ IDs. The claim is interpreted as the fragment thereof comprises fragment(s) of SEQ IDs for the art rejection discussed below.
Dependent claims 2-11, 13-19 and 47 are rejected for same reason because they depend on claim 1 and does not remedy the indefiniteness.
Regarding claim 15, the recitation of “wherein said antitumor drug is linked to said antibody or fragment thereof through an enzymatically cleaved linker” renders the claim indefinite because it is unclear how an already cleaved linker can provide linkage to drug and antibody. It would be remedial to amend it to “cleavable linker.”
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, 13-17 and 47 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Kufe (US 10,059,775).
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, lines18-21). Kufe teaches the antibody comprises a variable heavy chain comprising CDR1, CDR2 and CDR3 regions of SEQ ID NO: 3, 4, 5 (SEQ ID NO:3 is 100% identical to aa 6-10 of SEQ ID NO: 42 (SYWMH) of ‘775 patent, SEQ ID NO: 4 is 100% identical to SEQ ID NO: 43 (EINPSNGRTYYNENFKT) of ‘775 patent, and SEQ ID NO: 5 is 100% identical to SEQ ID NO: 44 (DGDYVSGFAY) of ‘775 patent) (col.2, lines 25-28, and sequence listing col.113, and Table 1). Kufe teaches said antibodies comprises a variable light chain comprising CDR1, CDR2 and CDR3 region comprising SEQ ID NO: 9, 10 and 11 (SEQ ID NO: 9 is 100% identical to aa 2-12 of SEQ ID NO: 57 (KASENVGTYVS) of ‘775 patent, SEQ ID NO: 10 is 100% identical to SEQ ID NO: 58 (GASNRYT) of ’775 patent, SEQ ID NO: 11 is 100% identical to SEQ ID NO: 59 (GQSYSYPWT) of ‘775 patent) (col.2, line 33, and col.117, sequence listing, and Table 1). Therefore, the disclosure from Kufe anticipates the claimed invention of claim 1.
Regarding claims 2 and 17, Kufe teaches the antibody that comprises a variable heavy chain having 86.8% homology o SEQ ID NO: 15 (SEQ ID NO:68 of ’755 patent, see alignment), and a variable light chain having 84.7% sequence homology with SEQ ID NO: 16 (SEQ ID NO: 62 of ‘775 patent, see alignment). Although SEQ ID NO:16 has 84.7% homology with full length SEQ ID NO: 62 of ‘775 patent, the best local similarity is 100%. Since the claim recites “fragment thereof,” the antibody fragment meets the claim limitation.
Regarding claims 3 and 18, Kufe teaches the antibody comprises a variable heavy chain encoded by a nucleic acid having 86.2% homology with SEQ ID NO: 21 (SEQ ID NO: 69 of ‘775 patent, see alignment), and a variable light chain having 99.5% sequence homology with SEQ ID NO:24 (SEQ ID NO: 71 of ’775 patent, see alignment).
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).
No claims are allowed.
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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/CELINE X QIAN/Primary Examiner, Art Unit 1637