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 .
Acknowledgement of Receipt
Applicant’s Response, filed 5/26/2026, in reply to the Office Action mailed 2/23/2026, is acknowledged and has been entered. Claims 15-28 are pending, of which claims 16-18 and 20-26 are withdrawn from consideration at this time as being drawn to a non-elected invention. Claims 15, 19, 27 and 28 encompass the elected invention and are examined herein on the merits for patentability.
Response to Arguments
Any rejection not reiterated herein has been withdrawn. The Examiner’s response to Applicant’s arguments is incorporated herein.
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 15, 19, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/619,796 (reference application) in view of Mejia et al. (WO 18/187740), for reasons set forth in the previous Office Action.
Response to arguments
Applicant notes that because the rejection is provisional a response will be delayed until other issues have been resolved. The rejection is maintained at this time.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 19, 27 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that the claims indeed are not indefinite, and asserts that each of the variables X¹, X², X³, X⁴, X⁵, and R48 in Formula (1) is explicitly and specifically defined in the body of claim 15. Applicant contends that the definitions are closed Markush groups or otherwise precisely bounded. A POSITA presented with any candidate compound can readily and straightforwardly determine whether each structural variable falls within its defined group. Moreover, the provisos recited in claim 15: excluding combinations such as -O-O-, -O-N-, -C(O)-O-, N-N-, and -C(O)-C(O)- from adjacent atom sets, serve to further clarify and narrow the scope of the claim. The Examiner characterizes these provisos as a source of confusion, but this characterization is incorrect. Provisos by their nature define what is excluded, and a POSITA reading these limitations would understand with reasonable certainty what combinations are and are not claimed. The provisos increase definiteness; they do not diminish it.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted that the claim defines a chemical compound using one or more Markush groups, and that claim encompasses a massive number of distinct alternative members, which may render the claim indefinite under 35 U.S.C. 112(b), See MPEP 2173.05(h). In the instant case, the Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention. For example, if a claim defines a chemical compound using one or more Markush groups, and that claim encompasses a massive number of distinct alternative members, the claim may be indefinite under 35 U.S.C. 112(b) if one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group(s). In such a circumstance, a rejection of the claim for indefiniteness under 35 U.S.C. 112(b) is appropriate. In the instant case, it is considered that the structure presents a cyclooctene or heterocyclooctene with such a vast number of potential variations and provisos such that it renders the possible permutations of the claim unclear. The recitation of a label comprising a moiety comprising a radionuclide introduces an almost unlimited number of moieties, which are not identified, and further which may be present at almost any position on the molecule, as can many, many other moieties set forth in the independent claim. The compound features so many potential structural variations the metes and bounds of the claim are not clearly set forth. Applicant’s arguments have been fully considered but the rejection is maintained.
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.
Claim(s) 15, 19, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Mejia et al. (WO 18/187740), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that the fundamental function of the method is antibody-mediated targeting of the cyclooctene-radionuclide conjugate to a site of interest, followed by administration of the diene to cleave and clear the radionuclide label from the conjugate, for example at non-target sites, so as to achieve efficient clearance of the released label from circulation and other non-target tissues, and/or the body as a whole.
Applicant asserts that Mejia teaches a fundamentally and structurally different system. In Mejia, the targeting mechanism is a tetrazine-containing support composition, i.e., a biocompatible material physically placed at the target site (e.g., an implant, hydrogel, or locally injected material). The cyclooctene conjugate carrying a payload (D) is then subsequently administered systemically, and it reacts with the pre-placed tetrazine at the target site to release the payload at the site of the tetrazine-containing support composition. See Mejia, abstract; TT 0011-0012. The tetrazine, in Mejia, is not a subsequently-administered cleaving agent, instead it is the fixed targeting element that does not move. The cyclooctene is not conjugated to a targeting agent, instead targeting is achieved entirely by the physical placement of the tetrazine support, not by any recognition moiety on the cyclooctene. The roles of the tetrazine and cyclooctene in Mejia are thus the inverse of their roles in the instant claims. Applicant further argues that the Examiner's rejections are based on a misreading of paragraph 0239 of Mejia. In this regard, the Examiner relies on paragraph 0239 of Mejia for the proposition that the sequential administration requirement of the instant claims is met by Mejia's disclosure based on Paragraph 0239 which states that the compositions of Mejia's disclosure can be co-administered with "another active agent" sequentially in any order.
Applicant’s arguments have been fully considered but are not found to be persuasive. See for example, page 5+ of Meija, which teaches: a method of treating or preventing a condition or disorder comprising administering to a subject in need thereof, a therapeutically effective amount of a compound of formula (I) or (I-A), or a pharmaceutically acceptable salt or composition thereof, wherein D is a therapeutic agent; and a therapeutic support composition, the therapeutic support composition comprising a biocompatible support and a tetrazine-containing group. Accordingly, the formula 1 compound is administered prior to the diene compound. See MPEP 2144, Rationale different from Applicant’s is permissible. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
In In re Lintner, the claimed invention was a laundry composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering phosphate, and brightener in specified proportions. The claims were rejected over the combination of a primary reference which taught all the claim limitations except for the presence of sugar, and secondary references which taught the addition of sugar as a filler or weighting agent in compositions containing cationic fabric softeners. Appellant argued that in the claimed invention, the sugar is responsible for the compatibility of the cationic softener with the other detergent components. The court sustained the rejection, stating “The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references.” 173 USPQ at 562.
In In re Dillon, applicant claimed a composition comprising a hydrocarbon fuel and a sufficient amount of a tetra-orthoester of a specified formula to reduce the particulate emissions from the combustion of the fuel. The claims were rejected as obvious over a reference which taught hydrocarbon fuel compositions containing tri-orthoesters for dewatering fuels, in combination with a reference teaching the equivalence of tri-orthoesters and tetra-orthoesters as water scavengers in hydraulic (nonhydrocarbon) fluids. The Board affirmed the rejection finding “there was a ‘reasonable expectation’ that the tri- and tetra-orthoester fuel compositions would have similar properties based on ‘close structural and chemical similarity’ between the tri- and tetra-orthoesters and the fact that both the prior art and Dillon use these compounds ‘as fuel additives’.” 919 F.2d at 692, 16 USPQ2d at 1900. The court held “it is not necessary in order to establish a prima facie case of obviousness . . . that there be a suggestion or expectation from the prior art that the claimed [invention] will have the same or a similar utility as one newly discovered by applicant,” and concluded that here a prima facie case was established because “[t]he art provided the motivation to make the claimed compositions in the expectation that they would have similar properties.” 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in original). Applicant’s arguments have been fully considered but the rejection is maintained.
Conclusion
No claims are allowed at this time.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communication from the examiner should be directed to LEAH H SCHLIENTZ whose telephone number is (571)272-9928. The examiner can normally be reached Monday-Friday, 8:30am - 12:30pm EST.
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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.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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