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 2026 March 9 is acknowledged. Claims 1-16 are examined on the merits.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 March 9.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2024 October 8 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. No citations were present in the IDS.
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 1-16 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.
In claims 1-16, what are the structural metes and bounds of variable T, a protease targeting element that comprises a dark quencher? The claims provide no guidance to the metes and bounds of the protease targeting element and the dark quencher aspect. The specification discusses what constitutes a dark quencher (page 32, lines 6-16). Various examples from US patents and a WIPO document are referred to, but do not limit the claims as written. A protease targeting element is discussed but these limitations do not limit the broadest reasonable interpretation of claim 1 (specification, page 34, paragraph [0128] to page 35, paragraph [0135]). Protease targeting element of claim 6 is discussed in paragraph [0131] of the specification.
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Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the boundaries of group L0-D are unclear. In this group, where does the linkers L0 end and detectable element D begin? Claims 1-16 do not define the limits of each group.
OFORI (ACS Chemical Biology, 2015, 10, 1977-1988) is used as one example. Ofori describes compound 8 (page 1978, figure 1; page 1982, figure 5A) a compound in which the following definitions apply: T is a protease targeting element of claim 6 in which variable AA1 is butylene-NH-C in which C is DyLight780-B1, AA2 is benzyl, U is O, R is benzyl and L0-D is hexylene-NH-R2 in which R2 is Q, IRDye QC-1. Compositions are described (page 1986, column 2, paragraph 1).
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In claims 1-16 detectable element D does not have clear metes and bounds with respect to what else is present beside a benzoindole dye. As shown by Ofori, a detectable element comprising a benzoindole dye contains functional groups in addition to a benzoindole ring.
Claims 6-15 recites that variable T is a group shown below. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite clear metes and bounds to what a protease targeting element is. Additionally, which part of this group is a dark quencher attached to? Claims 6-8 and 15 do not show which part of this moiety a dark quencher is attached to.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by OFORI (ACS Chemical Biology, 2015, 10, 1977-1988). Ofori describes compound 8 (page 1982, figure 5A). In this compound the following definitions apply: T is a protease targeting element of claim 6 in which variable AA1 is butylene-NH-C in which C is DyLight780-B1, AA2 is benzyl, U is O, R is benzyl and L0-D is hexylene-NH-R2 in which R2 is Q, IRDye QC-1. Compositions are described (page 1986, column 2, paragraph 1).
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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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11828572. Although the claims at issue are not identical, they are not patentably distinct from each other because a compound of claim 13 is encompassed by the specified claims of the examined application for the following reasons: R is benzyl; U is O; AA2 is benzyl; AA1 is butylene-NH(CO)-pentylene-benzoindole; L0 is hexylene-NH-C(O)-pentylene-benzoindole.
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Conclusion
Claims 1-16 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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