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 .
Applicant’s preliminary amendment filed 6/22/2023, are acknowledged. Claims 1-12 are pending.
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 1-5 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 “including tumor cells that naturally express the processed target protein and mammalian transformed and tumor cells, insect cells, yeast cells, bacterial cells, that have been transfected with vectors that express the target protein and fragments thereof, also as fusion proteins with other sequences.” The language is objectionable on various grounds. First, “mammalian transformed” appears to be an incomplete thought. It is unclear what is being claimed. Second, the use of the term “including” precedes various narrow embodiments which raises a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Third, the language “also as fusion proteins with other sequences” appear to be another incomplete thought. Again, it is unclear what is being claimed. Given the level of indefiniteness, it is unclear how to intepretate the step of the claim and thus the claim as a whole cannot be examined further on the merits.
Likewise with respect to claim 4, the use of the term “preferably” renders the claim indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-5 are rendered indefinite because they depend from claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et al. (EP2573120A1).
Nakamura et al. discloses (see references in the search report and citations here below): an antibody specific for Trop-2 protein expressed in local or metastatic tumor, wherein said antibody binds to a non-linear epitope on Trop-2 comprised between glycosylated residues N120 and N208, wherein said epitope is on Trop-2 protein cleaved between R87 and T88, wherein the residue numbering is according to SEQ ID NO. 1; wherein the non-linear epitope is selected in the group comprising: a peptide consisting of the extra-cellular portion of Trop-2, AA 31-274 of SEQ ID NO: 1, a peptide consisting of the globular domain of Trop-2, AA 31-145 of SEQ ID NO: 1, a peptide consisting of the "stem" domain of Trop-2, AA 146-274 of SEQ ID NO: 1. D4 further discloses a pharmaceutical composition comprising at least one antibody according to one of the claims 6-12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614