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 .
Notes and Comments
No prior art against the invention was found. The closest prior art is WO 2012/047354 to Reshetnyak (IDS filed 3/21/2025). Although Reshetnyak teaches peptide fluorophore conjugates for imaging of a patient, such as SEQ ID NO:40 of sequence ACDDQNPWRAYLDLLFPTDTLLLDLLW (abstract; summary of the Invention, table at page 33), it fails to teach or fairly suggest the peptide fluorophore conjugate required by present claims 45 and 57, and further fails to teach the use of the present peptide fluorophore conjugate in a method for detecting movement of a bodily fluid in a subject and in a method for detecting a fluorophore in a biological sample ex vivo.
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 49 and 58 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.
Claim 49 recites the method of claim 40, but claim 40 is cancelled. As a claim cannot properly depend from a cancelled claim, it’s unclear what the scope of claim 49 is. Further, it’s unclear why “intravesical” is misspelled “intravesical.” Appropriate correction is required.
Claim 58 is indefinite since the claim depends on claim 58.
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.
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Claims 45-49 and 55-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending U.S. Patent Application No No.19199071. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to a compound pHLIP-fluorophore compound comprising a pH-triggered pHLIP and a fluorophore (claim 1) , wherein the compound may be SEQ ID NO 4 (claim 2), and a method of using the compound in a method of detecting diseased or damaged tissue in subject, comprising (a) administering the compound of claim 1 to the subject; (b) contacting the subject with electromagnetic radiation comprising an excitation wavelength of the fluorophore; and (c) detecting electromagnetic radiation emitted from the compound, wherein detection of the radiation indicates the presence of the diseased tissue. As the composition is administered intravenously into the blood serum (a bodily fluid), detecting the electromagnetic radiation is detecting the movement of blood serum (a bodily fluid). The patent claims further teach a method for detecting a fluorophore in a biological sample ex vivo,(a) contacting a biological sample from a subject with the compound of claim 1; (b) contacting the biological sample with electromagnetic radiation comprising an excitation wavelength of the fluorophore; and (c) detecting electromagnetic radiation emitted from the fluorophore (claim 57). The difference between the present claims and the copending claims is that in the copending claims SEQ ID NO 4 needs to be chosen for the pHLIP-fluorophore compound to meet the present claims. However, as SEQ ID No 4 is taught in claim 2 as an embodiment of the claimed invention as a preferred fluorophore, it would have been obvious to choose SEQ ID NO4 out of the limited number of choices in the copending claims.
Claims 45-49 and 55-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12290575. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a method for removing diseased or damaged tissue in a subject, wherein the method comprises intravenously administering a pH-triggered polypeptide fluorophore compound containing SEQ ID NO:4 (corresponding to the fluorophore compound of the present invention), contacting the subject with electromagnetic radiation comprising an excitation wavelength of the fluorophore, and detecting electromagnetic radiation emitted from the compound. As the composition is administered intravenously into the blood serum (a bodily fluid), detecting the electromagnetic radiation is detecting the movement of blood serum (a bodily fluid). The claims further teach “wherein the surface comprises a site within the body of the subject that is accessed via surgery” (claim 5), “wherein electromagnetic radiation emitted from the compound is detected in vivo, and “wherein electromagnetic radiation emitted from the compound is detected ex vivo” (claim 7), which is a method of detecting a fluorophore in a biological sample ex vivo comprising contacting a biological sample with the fluorophore composition, which anticipates the present claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 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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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
January 13, 2026