DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/23/2026 has been entered.
3. Claims 25-53 are pending and under examination.
4. The rejection of claims 25-53 under 35 U.S.C. 102(a)(2) as being anticipated by US 20150023954 as is evidenced by the specification at Figs. 1 & 2 and Table 2 is hereby withdrawn in view of Applicant arguments that the codename "5B1" was used for many other antibodies that do not even bind sLea, including a monoclonal antibody targeting fucosyl-GM1 and a monoclonal antibody targeting 9-O-acetyl-GD3. As such, the use of codename "5B1" for antibodies in the cited references does not mean that these antibodies even necessarily have the same target as the "5B1" antibody described in Applicant's specification, much less include the same amino acid sequences of the present claims. Further, Applicant argues that the `954 publication does not establish any correspondence between the antibody codenames and target antigens.
5. 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.
6. 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 and 06/20/2025.
Applicant’s arguments, filed 02/23/2026, 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.
7. 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.
8. 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.
Further, 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).
Applicant’s arguments, filed 02/23/2026, have been fully considered, but have not been found convincing.
Applicant submits that neither Sawada I nor Sawada II discloses the claimed amino acid sequences, and the Office Action did not provide a proper rationale or evidence to show inherence as required by MPEP §2112(IV). With repect to antibodies disclosed therein, Sawada I provides , at best, (1) a codename; (2) the method by which antibodies were obtained;
(3) certain functional properties of the antibodies, and (4) certain germline sequences from which antibodies were derived. Sawada II discloses even less than Sawada I. Moreover, Sawada I states that multiple different antibodies with different mutations relative to the germline sequence were derived from the same germline sequence. The presently claimed sequences therefore do not necessarily flow from the teachings of Sawada I or Sawada II. Sakurai does not teach or suggest any antibodies at all, much less antibodies with sequences recited in the present claims.
This is not found persuasive. The Examiner’s position that the information about the CDRs sequences about mAb 5B1 and r5B1 antibody is not required to practice the claimed invention. Using the 5B1 antibody without knowing the CDRs sequences in the claimed method would result in the claimed method since the 5B1 antibody would inherently have the CDRs sequences. The Courts have held that there is no requirement that those of ordinary skill in the art know of the inherent property. See MPEP 2131.01(d) and MPEP 2112 - 2113. Sawada et al (A/I) teach that treatment of animals improved survival significantly: the median survival was doubled to 207 days in the group that received 4 doses of 5B1 and 2/5 animals survived until termination of the experiment after 301 days. The proportion of survivors further increased to 3/5 mice when 6 doses were administered (logrank test, p=0.0064; Hazard ratio = 6.375). The second study was terminated after 308 days and the surviving animals failed to reveal Colo205-luc tumors at the highest sensitivity of the imaging system (data not shown). These data demonstrate a significant survival benefit with 5B1 treatment. PK studies will be required to establish exposure levels and to further refine the dosing schedule (see page 8, 1st ¶). Applicant does not explain why one skilled in the art reading the relied upon references would have been have discouraged from using 5B1 antibody in the claimed methods.
The teachings of the well-known cloning techniques and method discussed in Sawada et al will enable the skill in the art to arrive to the claimed CDRs sequences of 5B1 as taught by Sawada et al (I) reference. Applicant does not dispute that the recombinant techniques taught by Sawada (I) are not enabled. Sawada et al (I) arrived to heavy and light chain variable regions of 5B1 antibody.
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].
Thus, 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.
Further, the mAb 5B1 inherently and intrinsically compresses the claimed CDR sequences present in SEQ ID NO: 2 and 4 as is evidenced by the specification on table 2 and Figs. 1&2. Applicant does not provide any supporting evidence to their assertion that the Sawada references do not teach antibodies as recited in the present claims. The claimed VH CDRs and VL CDRs are also obtained by sequencing the same prior art mAb 5B1 and were therefore anticipated by the prior art mAb 5B1 which necessarily possessed the same VH and VL sequences as the claimed polypeptides. The disclosure of the VH and VL of 5B1 mAb is only further characterization of otherwise old product. The VH and VL comprising identical sequences and therefore the claimed structural properties are inherent.
The issues presented herein are akin to the holding in In re Crish, 73 USPQ2d 1364 (CAFC 2004) where the Federal Circuit held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.”
The claimed sequences for the CDRs are intrinsic properties of the mAb 5B1 antibody. See In re Crish, 393 F.3d 1253 (Fed. Cir. 2004). The Federal Circuit affirmed the Board because “Just as the discovery of properties of a known material does not make it novel, the identification and characterization of [the sequence defining the structure] a prior art material does not make it novel.” Id. At 1258. As in Crish, the prior art of Sawada et al references actually disclosed a material that contains the claimed CDR sequences of mAb 5B1.
Applicant do not address Crish in their Remarks and the arguments they do advance fail to distinguish it from the present case. Like the references in Crish, Applicant’s prior art references in Sawada et al teaches a material containing the same sequence recited in the claims. The anti-sialyly-Lewisa antibody, 5B1 taught in Sawada et al references is the same antibody described in the specification and therefore necessarily contains the amino acid sequences recited in the claims, even if it was not until the present application that Applicant characterized mAb 5B1 by its amino acid sequences.
As Crish makes clear, “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Crish, 393 F.3d at 1258. There is “a long line of cases confirm that one cannot establish novelty by claiming a known material by its properties.” Id.
Like 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. That disclosure of the CDRs is anticipatory, even if it was not until the present application that Applicants characterized Mab 5B1 by its amino acid sequences.
9. Claims 25-53 stand rejected under 35 U.S.C. 103 as being unpatentable over US Pat. 8038994 (Quest Patent, IDS) in view of (I) Sawada et al (Mol Cancer Ther 2009;8(12 Suppl):B122, IDS) or (II) Sawada et al (Clin Cancer Res. 2011 Mar 1; 17(5): 1024–1032, IDS-C93) or (III) Sawada/Wu et al (Molecular Cancer Therapeutics (Nov. 2011) 10(11), suppl. 1 Abstract # C53, IDS) for the same reasons set forth in the previous Office Action mailed 06/20/2025.
Applicant’s arguments, filed 02/23/2026, have been fully considered, but have not been found convincing.
Applicant reiterates that the presently claimed sequences are not disclosed in and do not necessarily flow from the teachings of any of the Sawada References. Like Sawada II, Sawada
III is a poster presentation that disclose even less than Sawada I. Thus, none of Sawada I, Sawada II, or Sawada III discloses, either explicitly or inherently, the claimed amino acid sequences.
The Examiner rebuttal is the same above.
Applicant submits that 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.
Furthermore, Applicant submits that regarding the rationale for combining the references, the Office Action merely stated: "[T]hose of skill in the art would have had a reason to substitute the anti-Slea antibody taught by [the Quest Patent] with the 5B1 anti-Slea antibody taught by Sawada et al because 5B 1 is high affinity of mAb 5B 1 and potent effector functions support this translational potential" (at page 10). Applicant is perplexed by the Office Action's "rationale". Nonetheless, the Quest Patent discloses immunotherapeutic methods of treatment requiring use of xenotypic (i.e., non-human) antibodies, which trigger an immune response directed against the administered antibodies themselves. The present claims recite, in part, administering a therapeutic agent comprising human antibodies that bind to a specific target on cancer cells. Replacing a xenotypic antibody from the Quest Patent with a human anti-sLea antibody would render the methods of treatment disclosed in the Quest Patent unsatisfactory for their intended purpose.
However, the Examiner is confused by Applicant’s perplexity because given the known problem of xenotypic antibody in triggering an immune response directed against the administered antibodies themselves, per Applicant’s argument, in the face of having to solve the problem would have led one of ordinary skill in the art before the effective filing date the invention to use human antibody taught by the Sawada et al references to solve a well-known problem in the art. Those of skilled in the art would have been motivated to use human anti-SLea antibody, mAb 5B1 because it is much less likely to induce an immune response and thus reduce immunogenicity of the antibody. Importantly, the `994 patent teaches that Exemplary xenotypic monoclonal antibodies ("MAb") including humanized antibodies (see col., 2, lines 60+).
10. No claim is allowed.
11. 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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
May 3, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
Prosecution Insights