DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/25/2025 has been entered.
The rejection under section 103 is withdrawn in favor of the following new ground of rejection, which was necessitated by Applicant’s amendments:
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.
Claims 1, 13, 14, 16, 19 and 20 remain rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 20050089519 based on an application by Kipriyanov et al. (Kipriyanov) in view of:
Arruebo et al., Journal of Nanomaterials, Volume 2009, January 2009, Article No.: 37, pp 1–24, previously cited (Arruebo).
Kipriyanov teaches multivalent multimeric antibodies comprising at least two binding sites specific for the human B cell marker CD19 and human Fc gamma receptor III (CD16). Also described are polynucleotides encoding said antibodies as well as vectors comprising said polynucleotides, host cells transformed therewith and their use in the production of said antibodies. Finally, compositions are described comprising any of above mentioned antibodies, polynucleotides or vectors. The pharmaceutical compositions are useful for immunotherapy, preferably against B cell malignancies such as non-Hodgkin's lymphoma, see Abstract.
Kipriyanov may fail to explicitly teach conjugation to nanoparticles. However, the therapeutic benefits of conjugating antibodies to the recited nanoparticles were known, see Arruebo:
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In this way, those of ordinary skill could have applied anti-CD19/anti-CD18 antibodies to nanoparticles in the manner required and in a predictable fashion for the purposes of obtaining the recited conjugates. As outlined above, Kipriyanov teaches multivalent multimeric antibodies comprising at least two binding sites specific for the human B cell marker CD19 and human Fc gamma receptor III (CD16). Arruebo is added for the proposition that antibody-modified nanoparticles are applicable to these antibodies. Specifically, Arruebo teaches that the technique of conjugating multi-specific antibodies to nanoparticles was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to multispecific antibodies, such as anti-CD19/anti-CD18 antibody taught by Kipriyanov, would have yielded predictable results. Accordingly, conjugating anti-CD19/anti-CD18 antibodies to nanoparticles for the purposes of providing the instant conjugates would have been prima facie obvious.
Claims 15 and 18 remain rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2005089519 based on an application by Kipriyanov et al. (Kipriyanov) in view of:
Arruebo et al., Journal of Nanomaterials, Volume 2009, January 2009, Article No.: 37, pp 1–24, previously cited (Arruebo); in further view of:
“Chemotherapy of Neoplastic Diseases” in Goodmann & Gilman's Manual of Pharmacology and Therapeutics, 2008, McGraw-Hill Medical 2008, previously cited (Goodmann & Gilman's).
The primary and secondary references may fail to explicitly teach that the additional therapeutic agents. However, it is for that proposition that the examiner joins Goodmann & Gilman's, which teaches that anti-cancer regimens are optimized with combination therapies in order to avoid common mechanisms of resistance:
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In this way, those of ordinary skill could have applied combination therapy in a predictable fashion for the purposes of treating the recited cancers. Specifically, Goodman & Gilman’s teaches that the particular known technique of combination therapy was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to the recited conjugates would have yielded predictable results, see MPEP 2144 (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”). Accordingly, including the recited conjugates in combination therapy for the purpose of treating cancer would have been prima facie obvious.
Applicant has argued that the references do not teach nanoparticles conjugated with two different antibodies or fragments thereof, with one binding CD16 on NK cells and the other binding tumor cell. In the context of the above references, Applicant may argue that the bispecific anti-CD19/CD16 antibodies taught by Kipriyanov are not two different antibodies or fragments thereof, with one binding CD16 on NK cells and the other binding CD19 or CD 20 on a tumor cell. However, the claims only require that the first binding moiety is a first antibody or a fragment thereof and the second binding moiety is a second antibody or a fragment thereof, which does not exclude the bispecific anti-CD19/CD16 antibodies taught by Kipriyanov. Therefore, the claims remain rejected over the grounds of rejection outlined above.
The double patenting rejections remain outstanding:
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 13-16, 18-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-9 of U.S. Patent No. 11000603;
Claims 11-17 of U.S. Patent No. 11525009;
Claims 1-6 of U.S. Patent No. 10758625.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims also cover nanoparticle conjugates, wherein the conjugate comprises a first and second binding moieties connected by a nanomaterial which is a biodegradable nanomaterial. In this manner, the conflicting claims anticipate the scope of the instant claims.
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the instant conjugates with sufficient guidance and particularity, based on the structure of the recited bispecific antibody. In this manner, the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
In particular, the bispecific antibody conjugates of US 11525009 read on instant nanoparticle conjugates comprising a first and second binding moieties.
US 11525009:
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US 10758625:
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Janet Epps-Smith, can be reached at telephone number (571)272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646