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 .
Applicants' arguments, filed April 23, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claims 8 and 10 remain withdrawn from consideration as no targeting agent was present in the elected species that terminates in a dienophile that is capable of being linked to a targeting agent and not actually linked to a targeting agent.
Specification
The disclosure is objected to because of the following informalities: trade names or marks used in commerce are present but not properly formatted.
At least the terms AFFIBODY®, UNIBODY® and NANOBODY®, which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required and this may not be an exhaustive list of all trade names or marks used in commerce that are not properly formatted.
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.
Claim(s) 1, 3, 4, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dudkin et al. (WO 2019/125982; cited on IDS filed July 13, 2023) in view of Lewis et al. (Bioconjugate Chem, 1994). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 28, 2026 and those set forth herein.
The DOTAGA-DBCO (2,2′,2′′,2′′′-(1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetrayl)tetraacetic acid-dibenzocyclooctyne) group of the elected species is when R15 represents a reactive atomic group to be linked to a targeting agent that includes a dienophile, R14 represents a hydrogen atom and each of R11, R12 and R13 are -CH2-COOH groups. The pH range in claim 1 was previously presented in claim 2 that was rejected over Dudkin et al. in view of Lewis et al.
The newly added temperature range in claim 1 of 50 – 80°C is narrower than that previously presented in now cancelled claim 5. Dudkin carried out reactions at 80°C (p 46, ln 8) or 60°C (p 46, ln 15) by placing the vials on a shake block at the respective temperature, which applies heat from outside the system, although with other isotopes than the 90°C used for the 89Zr-DOTA-GA-DBCO on p 47. Lewis et al. studied a range of 25°C to 43°C. As discussed in MPEP 2144.05(I), a range can be established not only from a single reference but also from multiple references and there is no evidence of criticality of the claimed range of 30 – 50°C.
Applicants traverse this rejection on the grounds that Dudkin et al. does not explicitly disclose radioactive zirconium ion complexation under acidic conditions as the synthesis reaction takes place at pH 7.5. Applicant does not agree that optimization of reaction pH would have been obvious in view of Lewis. Lewis does not disclose complexation reactions with radioactive zirconium, which is tetravalent, but rather two trivalent cations – 90Y3+ and 111In3+. A person skilled in the art would understand that the reaction conditions in Lewis cannot be applied to zirconium complexation reactions given the different in the reactivity of the radioactive metal ions and therefore not obvious to modify the reaction conditions in Dudkin et al. in view of Lewis et al. Both references fail to disclose the temperature range of 50 – 80°C with Dudkin using a higher temperature (90°C) and Lewis et al. lower temperatures (25°C or 43°C) so the proposed combination would not lead to all the features recited in claim 1.
These arguments are unpersuasive. Nothing in Dudkin et al. limits the chelation reactions to tetravalent ions and on p 9, line 14 two of the three exemplary (e.g.) radiometals ions are trivalent (225Ac and 111In) along with tetravalent 89Zr are explicitly disclosed. All of the complexation reactions in both references are with the same DOTA chelator ring. Based on the knowledge of one of one ordinary skill in the art and the explicit, implicit and inherent teachings of the prior art, complexation reaction conditions such as pH and temperature would be understood as results effective variables that would be reasonably expected to alter the reaction kinetics, rendering pH and temperature results effective parameters that one of ordinary skill in the art would routinely optimize. There is no evidence of record as to the criticality of the claimed parameters.
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, 4, 7 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12 and 16 - 28 of copending Application No. 17/769,657 in view of Dudkin et al. (WO 2019/125982; cited on IDS filed July 13, 2023) in view of Lewis et al. (Bioconjugate Chem, 1994). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 28, 2026 and those set forth herein.
Applicants traverse this rejection on the grounds that discussed above that the claimed complexation reaction is not obvious.
As discussed in greater detail above, those arguments are unpersuasive.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 4, 7 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of copending Application No. 18/249,753 (reference application). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 28, 2026 and those set forth herein.
Applicants request that this rejection be held abeyance until the claims are deemed to be otherwise in condition for allowance.
As the claims are not otherwise in condition for allowance, this rejection is maintained for the reasons of record.
This is a provisional nonstatutory double patenting rejection because the
patentably indistinct claims have not in fact been patented.
Claims 1, 3, 4, 7 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 9 of copending Application No. 18/714,548 in view of Dudkin et al. (WO 2019/125982; cited on IDS filed July 13, 2023) in view of Lewis et al. (Bioconjugate Chem, 1994). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 28, 2026 and those set forth herein.
Applicants traverse this rejection on the grounds that discussed above that the claimed complexation reaction is not obvious.
As discussed in greater detail above, those arguments are unpersuasive.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 4, 7 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, 9 and 12 - 17 of copending Application No. 18/859,659 (reference application). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 28, 2026 and those set forth herein.
Applicants traverse this rejection on the grounds that the process in ‘659 heats the material by irradiation with microwaves which means the heat is generated inside the reaction vessel. In contrast, ¶ [0040] of the specification as filed mentions that heating means applying heat from outside of the reaction system which is not part of the instant claimed process.
These arguments are unpersuasive. "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference .... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413,425 (CCPA 1981) MPEP 2145(III) Microwave irradiation and other heating means from an external source all result in raising of the temperature of the material being heated and are means known to those of ordinary skill in the art and can be used interchangeably based on, for example, the equipment available for use at the time of the complexation reaction. There is no evidence of record as to the criticality of the heating coming from an external source rather than from microwave irradiation and therefore the instant claims are not patentably distinguished over those of US’659.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
Prosecution Insights