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 .
Claims 1-11 are under consideration in the instant Office Action.
Withdrawn Objections and Rejections
The objection of nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d) is withdrawn in view of the amendments submitted on 1/28/2026.
The objection of claims 10 and 11 is withdrawn in view of the newly amended claims.
The rejection of claim 7 is withdrawn in view of the newly amended claims.
Modified Rejections Necessitated by Amendment
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.
Claims 1-3 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1 F4 in Patients with AL Amyloidosis, ClinicalTrials.gov, identifier: NCT02245867” (first published in 2014, 7/29/2025 PTO-892), as evidenced by Langer et al. (Blood, 2015, 7/29/2025 PTO-892), NIH grant # 2015 R01 FD to Suzanne Lentzsch of Columbia University (“Grantome.com”; 7/29/2025 PTO-892).
Note that the Cinicaltrials.gov study is the same clinical study of the Langer et al. reference, NTC02245867, and the Grantome.com citation refers to the NIH grant that funded the clinical study. Note also that a 35 U.S.C. 102 rejection over multiple references is proper when the additional references are cited to show that a characteristic not disclosed in the reference is inherent. See MPEP § 2131.01 (III).
Langer et al. disclose the results of a clinical study that comprised administering chimeric 11-1F4 monoclonal antibody (mAb) to human patients having relapsed or refractory AL amyloidosis (see under Methods). The abstract for the NIH grant funding this study (see Grantome.com), which was awarded to the applicant of the instant invention (Columbia University in the City of New York) indicates that the chimeric 11-1F4 antibody that was developed by Dr. Solomon’s group was used in the clinical trial. Thus, the chimeric mAb 11-1F4 used by Langer would inherently comprise the VK region of SEQ D NO: 54 and the VH region of SEQ ID NO: 48, as evidenced by the instant specification which teaches the same chimeric mAb 11-1F4 comprising these sequence identifiers (see pp.7-8, [0027]-[0028]). Since the Clinical trial study teaches the same chimeric mouse-human antibody 11-1F4 of the instant specification, the study inherently teaches that the antibody comprises the VK region of SEQ ID NO: 54 and the VH region of SEQ ID NO: 48 and that it has the functional requirements of claim 2, thus meeting the limitations of claims 1, 2 and 10-11. The clinical trial administered the antibody in a pharmaceutically acceptable carrier, thus meeting the limitations of claim 3. Note that claims 8-9 are “product-by-process” claims. Thus, the patentability of the product is based on the product itself and does not depend on its method of isolation (see MPEP §2113).
Claim Rejections - 35 USC § 103
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.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over “Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1 F4 in Patients with AL Amyloidosis, ClinicalTrials.gov, identifier: NCT02245867” (7/29/2025 PTO-892), as evidenced by Langer et al. (Blood, 2015, 7/29/2025 PTO-892), NIH grant # 2015 R01 FD to Suzanne Lentzsch of Columbia University (“Grantome.com”; 7/29/2025 PTO-892) in view of O’Brian et al., 2009 (7/29/2025 PTO-892).
The Langer et al., and clinical trial teaches the instantly claimed chimeric mouse-human antibody 11-1F4 but does not specifically disclose that vectors the produce this antibody.
The chimeric mouse-human antibody 11-1F4 of the instant specification and the cited prior art clinical trial study is produced through the vectors of claims 4-7 ( see the instant specification at p.7-8 [0027]).
O’Brian teaches a method making humanized monoclonal antibodies expressed as whole chimeric IgG1K antibody (see page 2247, 2nd column). O’Brian teaches using expression vectors pG1D200 for g-1constant region and pKN100 for human kappa constant domain (see page 2247, 2nd column) which are the same expression vectors of the instant claims 4-7. O’Brian does not teach the chimeric mouse-human antibody 11-1F4.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Langer et al., and O’Brian. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because it is a well-known practice of using different vectors to express the chosen proteins and antibodies and produce different effects such as stable or transient transfection in antibody production. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
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 1-3 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/665,664. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the same chimeric mouse-human monoclonal antibody 11-1F4 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1-25 of copending Application No. 18/665,664 in view of O’Brian et al., 2009 (7/29/2025 PTO-892). While ‘664 teaches the same chimeric mouse-human monoclonal antibody 11-1F4 , ‘664 does not teach the claimed antibody in vectors. O’Brian teaches using expression vectors pG1D200 for g-1constant region and pKN100 for human kappa constant domain (see page 2247, 2nd column) which are the same expression vectors of the instant claims 4-7. O’Brian does not teach the chimeric mouse-human antibody 11-1F4.The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because it is a well-known practice of using different vectors to express the chosen proteins and antibodies and produce different effects such as stable or transient transfection in antibody production. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 17/862,626. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the same chimeric mouse-human monoclonal antibody 11-1F4 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1-6 of copending Application No. 17/862,626 in view of O’Brian et al., 2009 (7/29/2025 PTO-892). While ‘626 teaches the same chimeric mouse-human monoclonal antibody 11-1F4 , ‘626 does not teach the claimed antibody in vectors. O’Brian teaches using expression vectors pG1D200 for g-1constant region and pKN100 for human kappa constant domain (see page 2247, 2nd column) which are the same expression vectors of the instant claims 4-7. O’Brian does not teach the chimeric mouse-human antibody 11-1F4. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because it is a well-known practice of using different vectors to express the chosen proteins and antibodies and produce different effects such as stable or transient transfection in antibody production. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references. This is a provisional nonstatutory double patenting rejection.
Claims 1-3 and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-88 of U.S. Patent No. 11,382,974. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the same chimeric mouse-human monoclonal antibody 11-1F4.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-88 of U.S. Patent No. 11,382,974 in view of O’Brian et al., 2009 (7/29/2025 PTO-892). While ‘974 teaches the same chimeric mouse-human monoclonal antibody 11-1F4 , ‘974 does not teach the claimed antibody in vectors. O’Brian teaches using expression vectors pG1D200 for g-1constant region and pKN100 for human kappa constant domain (see page 2247, 2nd column) which are the same expression vectors of the instant claims 4-7. O’Brian does not teach the chimeric mouse-human antibody 11-1F4. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because it is a well-known practice of using different vectors to express the chosen proteins and antibodies and produce different effects such as stable or transient transfection in antibody production. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,018,069. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the same chimeric mouse-human monoclonal antibody 11-1F4. Further, the ‘069 discloses that the mouse-human monoclonal antibody 11-1F4 hybridomas which are produced via vectors like pKN100 and pG1D200 (see figures 4-5) and therefore, inherently reads on the vectors of the instant claims.
Claims 1-3 and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,530,257. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the same chimeric mouse-human monoclonal antibody 11-1F4.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,530,257 in view of O’Brian et al., 2009 (7/29/2025 PTO-892). While ‘257 teaches the same chimeric mouse-human monoclonal antibody 11-1F4 , ‘257 does not teach the claimed antibody in vectors. O’Brian teaches using expression vectors pG1D200 for g-1constant region and pKN100 for human kappa constant domain (see page 2247, 2nd column) which are the same expression vectors of the instant claims 4-7. O’Brian does not teach the chimeric mouse-human antibody 11-1F4. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because it is a well-known practice of using different vectors to express the chosen proteins and antibodies and produce different effects such as stable or transient transfection in antibody production. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive. Applicant argues that the NCT02245867” (7/29/2025 PTO-892), as evidenced by Langer et al. (Blood, 2015, 7/29/2025 PTO-892), NIH grant # 2015 R01 FD to Suzanne Lentzsch of Columbia University (“Grantome.com”; 7/29/2025 PTO-892) does not specifically call out the specific sequences as in the instant claims and argue that the prior art does not inherently teach the instantly claimed antibody.
It is noted that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III). In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V). Where the claimed and prior art products are identical or substantially identical in structure, a prima facie case of either anticipation or obviousness has been established and the burden of proof rests upon the Applicant to demonstrate that the prior art does not necessarily or inherently possess the characteristics of Applicant’s claimed product. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
While the reference, NCT02245867, does not explicitly call out the sequences for the chimeric mouse-human 11-1F4 antibody, it is clear that the same antibody, with the same identifier, same epitopes and same mouse-human chimeric structure would have the same characteristics as the instantly claimed composition since there is no evidence to the contrary. Note that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III). In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V).
Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to applicant to show an unobvious difference (see MPEP §2112 (V)). The USPTO does not have the resources or facilities to determine if the prior art antibody is indeed distinct from the claimed antibody. The examiner has set forth a prima facie case of inherency, and has provided sound scientific reasoning and evidence as to why the antibody of the prior art is not distinct from the antibody of the claims. After setting forth a prima facie case of inherency, the burden shifts to applicant to provide evidence that the products now claimed are patentably distinct from those in the prior art; see MPEP § 2112(V). Applicants' allegations do not provide the requisite evidence to overcome the rejection.
It is also noted that the parent application case, 16/626,613 and now issued US patent 11382974, supports that the antibody disclosed in the NCT02245867 reference of record is the same antibody of the instant claims.
Finally, Applicant's arguments filed 1/26/2026 over the double patenting rejections have been fully considered but they are not persuasive. Applicant requests to hold the provisional double patenting rejection in abeyance until the determination of patentable subject matter, at which time they will consider responding is not appropriate. Since applicant has not provided any objections or arguments for the double patenting rejections of record, the above double patenting rejections are maintained.
Conclusion
Claims are not allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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