RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 08/06/2026, is acknowledged.
2. Claims 25-53 are pending and under examination.
3. In view of the amendment filed on 08/06/2026, only the following rejections remained.
4. 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.
5. Claims 25-53 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 of U.S. Patent No.9475874 for the same reasons set forth in the previous Office Action mailed 12/31/2025, 06/20/2025 and 05/06/2026.
Applicant’s arguments, filed 08/06/2026, have been fully considered, but have not been found convincing.
Applicant requests the rejection be held in abeyance until such time that the pending claims are otherwise allowable.
The rejection is maintained until the rejection is fully addressed.
6. 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.
7. Claims 25-53 stand rejected under 35 U.S.C. 103 as being unpatentable over Sawada et al (Clin Cancer Res. 2011 March 1; 17(5): 1024–1032 (A), IDS) or Sawada et al (Mol Cancer Ther (2011) 10 (11_Supplement): C53 (B)), each in view of Sakurai et al (Gan to Kagaku ryoho Cancer & Chemotherapy, 01 Jul 2010, 37(7):1333-1335, English abstract) as is evidenced by the specification at Figs. 1 & 2 and Table 2 for the same reasons set forth in the previous Office Action mailed 06/20/2025 and 05/06/2026.
Applicant’s arguments, filed 08/06/2026, have been fully considered, but have not been found convincing.
Regarding the 5B 1 antibody would inherently have the CDRs sequences, Applicant submits that to properly rely on inherency, the Office is required to provide evidence or a proper rationale for inherent disclosure of such a claim feature in the cited references. MPEP § 2112(IV). The Office Action has not provided such evidence. Rather, as discussed in Applicant's previous responses, the Office has repeatedly relied on mere speculation to assume that any antibody referred to by a codename "5B1" is necessarily the same as the "5B1" antibody described in Applicant's specification. Further, as discussed below, the Office Action has not given proper consideration to evidence that rebuts such speculation - evidence put forth by Applicant in the form of a Declaration under 37 C.F.R. § 1.132 by Dr. Ursula Ellinghaus filed November 29, 2024 in the present application (the "Ellinghaus Declaration"; attached as Appendix A).
The Ellinghaus Declaration under 1.132, filed 11/29/2024 was fully addressed in the office action mailed 12/31/2024 and 06/20/25, and adapted the herein.
Applicant submits that the Office Action cited In re Crish, 393 F.3d 1253 (Fed. Cir.
2004) (hereinafter "Crish") as controlling law, noting that, in Crish, claims reciting the sequence of purified DNA molecules having promoter activity for the human involucrin gene (hINV) were held to be anticipated by prior art disclosure of a plasmid having the same sequence. The Office Action states, "[l]ike the references in Crish, the prior art of Sawada et al references disclose a material containing the same sequence recited in the claims. It is undisputed that Sawada references disclose an antibody that contains the amino acids recited in Applicant's claims" (Office Action, page 6). Applicant respectfully disagrees.
Applicant further submits that the Office Action has overlooked key distinctions between Crish and the present case. First, as noted by the Federal Circuit, "Crish's application disclosed that SEQ ID NO:1 was obtained by sequencing the same plasmid disclosed in the cited prior art references", and specifically stated that "both the application and the publication refer to the same source for plasmid pSP64Mi-3 H6B, a publication by Eckert et al." (emphases added). Thus, the plasmid at issue in Crish, which included the hINV gene and its promoter, was specifically identified by the Applicant as having been sourced from a prior art publication, which was publicly known and available.
In contrast, Applicant's specification does not include any statement or reference to the Sawada References that would lead to the conclusion that Applicant's recited sequences were obtained by sequencing a "5B1" antibody disclosed by the Sawada References.
This is not found persuasive because Sawada et al (A/I) and (B/II) teach mAb 5B1 and r5B1 and the instant specification at Fig. 1 which discloses the amino acid sequence of the variable heavy (VH) chain domain of clone 5B1 and a leader sequence that can be used for recombinant expression. Fig. 1/2 shows VH/VL and amino acid sequence of SEQ ID NO: 2/4. The three complementarity determining regions (CDR1, CDR2 and CDR3) are also identified (see Table 2). Sawada I provides method of producing recombinant antibody by immunoglobulin cDNA cloning and expression. Variable region of human mAb heavy and light chain cDNA was recovered by RT-PCR from the individual hybridoma cell line and subcloned into IgG1 or IgM heavy chain or IgK or IgL light chain expression vector. High anti-sLea antibody-producing clones were selected by measuring the antibody levels in supernatants in a sLea -specific ELISA assay and expanded for large-scale mAb production (see page 1025, bridging ¶). The instant specification discloses identical method to obtain the claimed sequences described before Sawada-Hirai et al., J. Immune Based Ther. Vaccines, 2:5 (2004) [00152] and [00162].
Applicant submits that unlike Crish, antibodies described in the Sawada References were not
publicly available. Applicant submits herewith evidence in the form of a Declaration under 37 C.F.R. § 1.132 by J. David Hansen2 (the "Hansen Declaration"; attached as Appendix B), in which Mr. Hansen stated that "the Sawada Antibodies were not publicly available prior to the filing of the MabVax Provisional Application". See Hansen Declaration,
The Hansen Declaration filed, 08/06/2026, under 37 CFR §1.132 is insufficient to overcome the 103 rejection for the following reasons.
The Hansen Declaration was filed in the parent application 15275174 because the Examiner provides the editorial policies of AACR Journal (Sawada et al (Clinical cancer Research 2011, 10(11), 17(5):1024-1032) which requires authors’ certification that all materials, data, and protocols described in the manuscript will be made available upon request, if the request is made within six years of publication. Restrictions on availability of any of the components of a manuscript must be disclosed in the cover letter at initial submission. Unique materials such as antibodies that were used in the research reported and that are not available from commercial suppliers must be made available. According to the instructions to authors, the claimed anti-sLea antibody, 5B1 must be made available to the public upon request.
The Hansen Declaration at ¶5 states that “I hereby declare that the Sawada Antibodies were, at the time of both Sawada II and the MabVax filings, solely owned by MabVax”. The Hansen Declaration at 6¶ states that the Sawada Antibodies were not required to be, and in fact were not, distributed to any third party without confidentiality restrictions prior to the filing of the MabVax Provisional Application. In fact to the best of my knowledge, the only third parties to whom the Sawada Antibodies were distributed prior to the filing of the MabVax Provisional Application were the Sloan-Kettering Institute for Cancer Research (and specifically to the authors of Sawada II), and to one other not-for-profit research institution, in each case according to an agreement that (i) restricted use of provided antibodies to specific agreed studies; (ii) prohibited further transfer of the antibodies; and (iii) required confidentiality be maintained for a period of time that extended past the filing of the MabVax Provisional Application. The declaration, at ¶7 states that “I can confidently confirm that the Sawada Antibodies were not publicly available prior to the filing of the MabVax Provisional Application”.
However, the antibodies 5B1 of Sawada et al reference is enabled because 5B1and r5B1 were “otherwise available to the public” since Applicant agreed to provide to the public access to 5B1. The Sawada et al reference discloses no restrictions to the availability of the 5B1 and r5B1 antibodies. Thus, the 5B1 itself is otherwise available to the public. Sawada et al made the 5B1 and r5B1 antibodies otherwise available to the public by publishing under the constraint that the antibody would be distributed upon request. Applicants agree to provide access to the public the 5B1 and r5B1 antibodies (see AACR Editorial policies Submission Guidelines). Moreover, the mAb 5B1 and r5B1 antibodies were made available to co-authors of Sawada et al reference who are non-named inventors. The declaration does not account for the other authors listed in the Sawada et al reference. No statement of confidentiality or control is provided. Further, there is no evidence on the records that the inventors refused to cooperate with the AACR Editorial policies such that a request was made and was refused. While the declaration states the 5B1 and/or r5B1 antibodies were given to two parties “according to an agreement that (i) restricted use of provided antibodies to specific agreed studies; (ii) prohibited further transfer of the antibodies; and (iii) required confidentiality be maintained for a period of time”, however such restriction were not made in the AACR Editorial policies since the Editorial policies states “Restrictions on availability of any of the components of a manuscript must be disclosed in the cover letter at initial submission”. Further, Unique materials such as antibodies that were used in the research reported and that are not available from commercial suppliers must be made available.
Applicant notes that the Crish court distinguished its holding from that in Glaxo Inc. v Novopharm Ltd., 52 F.3d 1043 (Fed. Cir. 1993), where the court held that claims were not inherently anticipated by description of a prior art process that did not always yield the claimed material. The present case is closer to Glaxo than to Crish. Sawada I describes (i) obtaining antibodies from immunized humans, (ii) verifying that the antibodies bind (a) to sLea- HSA conjugates and (b) to native antigen without binding detectably to certain control carbohydrates, and (iii) expressing the antibodies as human recombinant antibodies in CHO cells. Sawada II describes even less. Nothing in the descriptions of Sawada I or Sawada II necessarily describes antibodies recited in the present claims (i.e., having the specified CDR sequences). Indeed, both references report that multiple different antibodies were obtained following the described process. For at least these reasons, the rejection should be removed.
This is not found persuasive. Although the Sawada et al references do not teach the sequences for the CDRs from the 5B1 monoclonal antibody, these are intrinsic properties of the 5B1 antibody. Also, it is an inherent property of the 5B1 immunoglobulin light and heavy chains to bind to the same antigen as the original antibody. Therefore, the light and heavy chain CDRs instantly claimed are unpatentable over the prior art as the sequences are intrinsic properties of the antibody.
Applicant submits that the Sawada References do not contain sufficient description to enable one of ordinary skill in the art to make and use any particular antibody having a particular set of CDRs, let alone antibodies recited in the present claims. Based on the Hansen Declaration (discussed above), the antibodies of Sawada References were not publicly available. As such, one of ordinary skill in the art could not "have combined the publication's description of the invention with his own knowledge to make the claimed invention".
This is not found persuasive. The Hansen Declaration was addressed above and the Examiner adapted the same rebuttal herein. The instant specification discloses identical method to obtain the claimed sequences described before Sawada-Hirai et al., J. Immune Based Ther. Vaccines, 2:5 (2004) [00152] and [00162].
The Examiner’s position remains that Applicant cannot represent to the public that their claimed antibody sequences can be derived and isolated by standard biochemical methods discussed in a well-known reference on cloning techniques, while at the same time discounting the relevance of that very references to the obviousness of their claims. Applicant employed conventional methods, such as those outlined in Sawada-Hirai et al to isolate a cDNA encoding 5B1 and determine the CDR sequence (set forth in SEQ NOS: 2 & 4).
Here, Sawada references are enabling in the sense that it describes the claimed invention sufficiently to enable a person of ordinary skill in the art to make and use the claimed anti-sLea antibody, 5B1. Essentially, applicants are applying a higher standard of enablement to the obviousness references than is warranted.
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his own knowledge to make the claimed in invention." In re Donohue, 766 F.2d 531,226 USPQ 619 (Fed. Cir. 1985). See MPEP 2121.01.
A reference is presumed operable until applicant provides facts rebutting the presumption of operability. In re Sasse, 207 USPQ 107 (CCPA 1980). See MPEP 2121, 2121.02.
Il. The Office Action relied on case law inapplicable in the present case.
Applicant continue to argue and points to Ellinghaus Declaration, disclosure of specific sequences, and in particular, CDR sequences, would be required in order to produce an antibody with such CDRs given the disclosure of the Sawada References. See, e.g., Ellinghaus Declaration, 7. Given that "5B1" antibodies of the Sawada References were not publicly available, no "starting material" was available from which one of ordinary skill in the art could obtain sequences of the "5B 1" antibodies mentioned only by codename in the Sawada References. As such, the Sawada References fail to disclose the sequences of the present claims, expressly or inherently. Neither Sakurai nor the Quest Patent makes up for this deficiency. Sakurai does not teach or suggest any antibodies at all, much less antibodies with sequences recited in the present claims. Nor does the Quest Patent disclose antibodies with the claimed amino acid sequences, as has previously been acknowledged. See, e.g., Non-Final Office Action mailed June 20, 2025, page 18, last paragraph. Accordingly, the cited references do not disclose all elements of the present claims.
This is not found persuasive because the 5B1 and r5B1 antibodies recited in Sawad I and II, inherently and intrinsic properties of the 5B1 antibody as discussed, above.
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. 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 extension fee 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 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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September 21, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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