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 the species of antibody clone 4C8, filed in the reply on 01/20/2026 is acknowledged. Claims 1, 3, 16-17, 27, 35-37, 39, 41-44, 46-56, 60, 62, 64, and 66 are cancelled. Claims 68-97 are added. Claims 68-97 are currently pending and under examination.
Priority
Acknowledgement is made of applicant’s claim for priority from provisional application 62/986,083 filed 03/06/2020. Priority date of 03/06/2020 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 93 and 94 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, namely a product of nature, without significantly more.
Claim 93 recites a 12-30 amino acid peptide comprising amino acids 4-13 of SEQ ID NO:165, which corresponds to a contiguous amino acid sequence of naturally occurring human CD44v6. The claimed peptide therefore constitutes a nature-based product. Under the broadest reasonable interpretation, the claim does not require any alteration of the recited amino acid sequence or any structural, functional, or other characteristic that is markedly different from the corresponding naturally occurring CD44v6 sequence. Mere isolation or preparation of the naturally occurring sequences does not, without more, provide a markedly different characteristic (MPEP 2106.04(c)).
Claim 94 further requires O-glycosylation at the threonine corresponding to position 5 and/or the serine corresponding to position 12 of SEQ ID NO:165. However, the Specification explains that the CD44v6 glycopeptide is glycosylated at these residues to mimic the glycosylation pattern of CD44v6 present on tumor cells (paragraph 0047, pg. 16). Thus, the recited glycosylation represents a naturally occurring characteristic of tumor-associated CD44v6 and does not impart a markedly different characteristic relative to its naturally occurring counterpart.
Therefore, the claims do not include additional elements that integrate the product of nature exception into a practical application or otherwise amount to significantly more than the judicial exception.
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 97 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 97 recites “administering to a subject the peptide of embodiment claim 97.” However, claim 97 is itself directed to a method of eliciting an immune response and does not define or recite any peptide. Thus, the reference to “the peptide of embodiment claim 97” is circular and fails to identify the peptide being administered with reasonable certainty. The Specification instead describes eliciting an immune response by administering the disclosed CD44v6 peptide, including the glycosylated peptide. Therefore, the metes and bounds of the claim are unascertainable.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 93-96 are rejected under 35 U.S.C. 103 as being unpatentable over Zarei et al. (Monoclonal Antibodies in Immunodiagnosis and Immunotherapy, 34(1):36-43, 2015) in view of Haylock et al. (Oncotarget, 8(39):65152-65170, 2017), and further in view of Steentoft et al. (Embo Journal, 32(10):1478-1488, 2013) and Campos et al. (Molecular and Cellular Proteomics, 14(6):1616-1629, 2015).
Zarei teaches a synthetic CD44v6 peptide containing the instant application’s claimed amino acids 4-13 of SEQ ID NO: 165 (Materials and Methods). They also teach conjugating this peptide to KLH and administering it with Freund’s adjuvant to mice to generate monoclonal antibodies against CDv6 (Materials and Methods). However, Zarei’s peptide is 43 amino acids long and therefore does not expressly meet the 12-30 amino acid limitation of claim 93.
Haylock teaches the use of shorter overlapping CD44v6 peptides, including approximately 20 amino acid peptides spanning the CD44v6 sequence, for identification and characterization of CD44v6 epitopes (Methods). Therefore, it would have been obvious to one of ordinary skill in the art to employ a shorter 12-30 amino acid portion of Zarei’s CD44v6 peptide while retaining the antigenic sequence of interest, as taught by Haylock, with a reasonable expectation that the resulting peptide would remain useful for CD44v6 epitope analysis and antibody generation. Accordingly, claim 94 is prima facie obvious.
Regarding claim 94, Steentoft teaches site-specific O-GalNAc glycosylation mapping of human proteins, with CD44 glycosylation at residues corresponding to T415 and S422, which correspond to the threonine and serine positions recited in claim 94 (Abstract). Campos further teaches that CD44 carries aberrant tumor associated O-glycans, including the STn glycoform, in cancer tissue (Abstract). Thus, one of ordinary skill would have been motivated to glycosylate the known CD44v6 peptide at the known O-glycosylation sites in order to provide a peptide more closely representative of the tumor associated glycoform of CD44, with a reasonable expectation of success using known peptide glycosylation techniques.
Regarding claim 96, Zarei further teaches administering the CD44v6 peptide immunogen to mice and recovering monoclonal antibodies reactive with CD44v6 (Abstract). In view of Steentoft and Campos’s teachings concerning tumor associated glycosylation of CD44, it would have been obvious to administer the glycosylated CD44v6 peptide of claim 94 using Zarei’s immunization method to generate antibodies directed against the tumor associated form of CD44v6.
Thus, the claimed subject matter represents the predictable use of known shortened CD44v6 peptide immunogens, known CD44 O-glycosylation sites, and conventional antibody generation methods for targeting a known tumor associated glycoform of CD44.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 68, and 71-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 18-22, 26-28, 31-35, and 37 of copending Application No. 18/548,772 (reference application ‘772), and, where necessary, in view of Baeuerle and Reinhardt (Cancer Research, 69(12):4941-4944, 2009) and Vermeulen et al. (Molecular Imaging and Biology, 15(3):290-298, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-6 of reference Application ‘772 are directed to humanized anti-glyco-CD44 antibodies derived from 4C8 and comprising corresponding 4C8 CDR sequence features and binding the same glycosylated CD44v6 target. Reference Application ‘772 claims 18-22, 26-28, 31-35, and 37 further recite the same conventional embodiments encompassed by present claims 75-79, 81-89, and 91, including an scFv, multispecific/bispecific antibody, fusion protein, CAR, ADC, nucleic acid, vector, host cell, pharmaceutical composition, cancer treatment method, and cancer detection method.
Regarding claim 80, reference claim 22 recites a bispecific antibody wherein the second epitope is a T cell epitope. Baeuerle teaches bispecific T cell engaging antibodies that target CD3 on T cells for redirecting T cell cytotoxicity against cancer cells. Therefore, it would have been obvious to select CD3, one of the alternatives recited in claim 80, as T cell epitope of reference claim 22.
Regarding claims 90 and 92, reference claims 35 and 37 broadly recite treatment and detection of cancer using the claimed 4C8 derived antibody. Vermeulen teaches that CD44v6 is frequently expressed in ductal carcinoma in situ and employs CD44v6 specific antibodies for detection of breast cancer lesions. Therefore, it would have been obvious to apply the reference application’s cancer treatment and cancer detection methods to breast cancer, which is expressly encompassed by present claims 90 and 92.
Accordingly, claims 68 and 71-92 are not patentably distinct from the claims of reference Application ‘772 either alone or in combination with the cited secondary prior art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
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Claims 68-92 are allowable over the prior art. The closest prior art of record that matches the VH of anti-glyco-CD44 antibody SEQ ID NO: 1 is VH of an anti-Mayaro virus (MAYV) antibody disclosed by Weiner et al. (WO2019075300) in SEQ ID NO: 9 with 86.8% query match.
The closest prior art that matches the VL of anti-glyco-CD44 antibody SEQ ID NO: 2 is VL of an amyloid-beta monoclonal antibody disclosed by Matsuoka and Kinoshita (WO2007022015) in SEQ ID NO: 41 with 93.7% query match.
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Claims 69 and 70 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (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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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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