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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on May 28, 2026 is acknowledged.
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.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (The Journal of Nuclear Medicine, 2016; cited on IDS filed January 25, 2024) in view of Mahler et al. (US 2005 0175611; cited on IDS filed January 25, 2024).
Regarding claims 1-3, Song discloses a method of preparing immunoconjugate (intermediate of radiopharmaceutical composition) comprising a PCTA (3,6,9,15-tetraazabicyclo[9.3.1]pentadeca- 1(15),11,13-triene-3,6,9-triacetic acid) and a cetuximab (anti-epidermal growth factor receptor (EGFR) antibody) (page 1106, column 1, ¶ 4). Song discloses that the immunoconjugate can be finally concentrated in 20 mM sodium acetate buffer (page 1106, column 1, ¶ 4). Song does not disclose a storage of the intermediate (immunoconjugate, PCTA-Cetuximab) but Song discloses that the radioimmunoconjugates (64Cu- or 177Lu-PCTA-Cetuximab) show high stabilities in serum at 37°C for 24 hours (90.1% ± 0.6%) and 7 days (90.6% ± 0.4%) (page 1107, column 1, ¶ 5).
Song does not disclose that the intermediate being stored for a storage period of not less than 24 hours and that the acetate buffer contains at least one type of neutral amino acid and at least one type of polysorbate.
Mahler discloses an aqueous pharmaceutical preparation comprising an anti-EGFR antibody (abstract). Mahler discloses that the aqueous preparation can comprise a buffer consists of acetate salt, neutral amino acid such as glycine, and a surfactant such as polysorbate 90 (claim 1; claim 4; ¶ 26; ¶16). Mahler discloses that glycine and polysorbate 80 can be used for the stabilization of an aqueous solution of immunoglobulin G (¶ 16). Mahler discloses that the preparation can be stable on storage over period of at least 3 months to a period of 4 years at refrigerator temperature (2-8°C), and also stable on storage over a period of up to 2 years at elevated temperatures and higher atmospheric humidity levels, for example at a temperature of 25°C and 60% relative atmospheric humidity, or over a period of 3 months at a temperature of 40°C and 75% relative atmospheric humidity (¶ 25).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the acetate buffer of Song by adding a neutral amino acid and a polysorbate to stabilize the intermediate for a longer storage period of not less than 24 hours. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Mahler teaches that a neutral amino acid such as glycine and polysorbate 80 can be used to stabilize an aqueous solution comprising antibody, allowing the aqueous solution to be stored for not less than 24 hours. Further, a person of ordinary skill in the art would have been motivated to utilize stabilizer such as a neutral amino acid and a polysorbate to stabilize therapeutic proteins or monoclonal antibodies by preventing aggregation and interfacial stress, thereby ensuring the intermediate of radiopharmaceutical composition remains stable for not less than 24 hours before radiolabeling. Accordingly, applying the teachings of Mahler to the method of Song constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 9 of copending Application No. 19/110,632. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, claim 1 of the ‘632 recites a method for producing an intermediate of a radiopharmaceutical composition in an acetate buffer, wherein the intermediate is a complex of a PCTA and an anti-EGFR antibody. Claims 9 of the ‘632 recites that a storage step of storing the elution containing the intermediate can be for not less than 24 hours.
Regarding claim 2, claims 1 and 2 of the ‘632 recite that the acetate buffer can contain at least one type of neutral amino acid and at least one type of polysorbate as stabilizer.
Regarding claim 3, claim 7 of the ‘632 recites that the anti-EGFR antibody is cetuximab.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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