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 filed a response to the Non-Final action of 7/23/2025 on 10/22/2025. Claims 1-110, 118-119, 143 are canceled. Claims 111-117, 120-128, 131-134, 137, 138, 140-142 are amended. Claims 116-117, 120, 124-127, 130, 142 are withdrawn. Claims 145-163 are new.
Claims 111-115, 121-123, 128,129,131-141, 144-163 are under consideration.
Maintained Objections
Specification/Sequences
Regarding the issue that Figs. 2A and 2B comprise sequences and SEQ ID NOs: need to be assigned to them, applicant has not complied with this issue. SEQ ID NOs: need to be assigned to the sequences in Figs. 2A and 2B. The SEQ ID NOs: can be written in the figures themselves or as part of the Brief Description of the Drawings/Figures (see for example, Figures 4A and 4B). Upon assignment of SEQ ID NOs: to these sequences, the sequence listing must be updated. Thus, the objection regarding this issue remains.
Regarding the objection to the specification regarding sequences issues (SEQ ID NO: 45 was not included in the CRF, SEQ ID NO: 206 was duplicated in the CRF, SEQ ID NO: 168 may be a duplicate of SEQ ID NO: 169), the examiner has not verified that these issues were fixed as the sequence listing filed 10/22/2025 is defective. The sequence listing has not been entered as applicant filed an ST.26 version of the sequence, rather than an ST.25 version, see printout attachment. Thus, the objection regarding this issue remains.
Withdrawn Objections/Rejections
Specification
Regarding the objection to Table 17, wherein “huEpCAM23 Gv4.2-1565T” was present twice, applicant has amended the specification. The objection as it applies to this issue is withdrawn.
Claims
Claim 123 was objected to for reciting “antibdoy.” Applicant has amended the claim. The objection to claim 123 has been withdrawn.
Claim 142 was objected to for missing “(A)” to indicate the first item of a list. Applicant has amended the claims to “(i),” “(ii),” and “(iii)).” The objection to claim 142 has been withdrawn.
112b
Claim 144 was rejected for indicating that the cleavable sequence is ISSGLLSGRSDNI (SEQ ID NO: 169), wherein the confusion was a result of the sequence listing. Applicant indicates that SEQ ID NO: 169 is the cleavable sequence and should be consistent with the updated sequence listing. The rejection as it applies to this issue is withdrawn.
112a
Claims 109-111, 113-116, 118-141 were rejected under 112a, written description. The claims were drawn to antibodies with wild card amino acids in the CDR regions of the antibody. Applicant amended the claims to specifically claim antibodies with specific CDRs. The rejection as it applies to this issue is withdrawn.
New Rejection
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.
Claim 121 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 121 recites that the antibodies are “non-human mammal” or “human.” This would imply that the antibodies (with the CDRs recited in claims 111 and 112) are obtained from a non-human mammal or human. However, while the antibodies were obtained from mice, and then modified with a human framework region of an antibody, no antibodies were obtained from another species of mammal or from a human.
Rejoinder/Allowable Subject Matter
Applicant has amended claims to allowable subject matter. Subsequently, withdrawn claims 116-117, 120, 124-127, 130, 142 are now rejoined.
Claim 121 is rejected.
Claims 111-117, 120, 122-142, 144-163 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE HAMA whose telephone number is (571)272-2911. The examiner can normally be reached Monday-Thursday 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bonnie Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
Prosecution Insights