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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 05/18/2026; and IDS filed on 08/08/2025 and 06/15/2023.
Claims 2 and 4 are drawn to non-elected species
Claims 1-10, 13-18 are pending in the instant application.
Claims 2, 4-10, 13-18 are withdrawn from further consideration.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-4) and specie election of Formula (Ib) (claim 3) in the reply filed on 05/18/2026 is acknowledged. The traversal is on the ground(s) that Groups I-VIII do in fact share a special technical feature. For instance, Wycisk fails to disclose the compound of formula (I) recited in claims 1-4 of Group I, including that "both R1 together with R2 and R3 together with R4, respectively and with the atoms to which they are bonded, form two aryl rings." Claims 5-8 of Group II share the structure of formula (I), and are additionally conjugated to a targeting moiety ("wherein at least one group -CONH-(S)mT is present in R9 or RIO"). The remaining claims of Groups III-VIII depend from and include all of the limitations of claim I or claim 5. Applicant respectfully notes that "[i]f. .. there is a single general inventive concept that appears novel and involves inventive step, then there is unity of invention and an objection of lack of unity does not arise ... the benefit of any doubt being given to the applicant." M.P.E.P. § 1850. For at least these reasons, Applicant respectfully asserts that a special technical feature exists and requests withdrawal of the restriction requirement between Groups I-VIII.
This is not found persuasive because WYCISK does teach claim 1, as discussed below in the 102 rejection.
The requirement is still deemed proper and is therefore made FINAL.
Note, claims 2 and 4 are drawn to non-elected species.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WYCISK et al (Responsive Contrast Agents: Synthesis and Characterization of a Tunable Series of pH-Sensitive Near-Infrared Pentamethines. ACS Omega 2016, 1, 808−817).
WYCISK teaches near-infrared (see title) compound 6 (see pg. 810, Scheme 1, which is provided below), wherein W is C(Cl), R1 is COOH and R3 is SO3, R2 and R4 are hydrogens, and R5 is an alkyl optionally substituted by SO3H.
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Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YI et al (CN105693590).
YI teaches near-infrared compound (see pg. 6; as provided below).
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Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over ACHILEFU et al (WO 02/32465; see IDS filed on 08/04/2025).
ACHILEFU teaches a near infrared compound (see pg. 7, line 4), such as Example 5 (see pg. 30, which is provided below), the Z6 position can be the alkyl optionally substituted COOH as shown below or a hydrogen (see pg. 16, line 4).
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Claim Rejections - 35 USC § 103
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 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.
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 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over
LEE et al (Near-Infrared pH-Activatable Fluorescent Probes for Imaging Primary and Metastatic Breast Tumors. Bioconjugate Chem. 2011, 22, 777–784) in view of WYCISK et al (Responsive Contrast Agents: Synthesis and Characterization of a Tunable Series of pH-Sensitive Near-Infrared Pentamethines. ACS Omega 2016, 1, 808−817).
LEE teaches near-infrared pH-activable (see abstract) compounds, such as Compound 1 and 1’ (see pg. 779 at Fig 2a, which is also provided below).
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LEE does not teach R5 is an alkyl optionally substitued by a group selected from SO3H, COOH and CONH2.
WYCISK teaches a similar near-infrared (see title) compound 6 (see pg. 810, Scheme 1, which is provided below).
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Wherein R5 is an alkyl optionally substituted by SO3H at the R5 position.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate R5 is an alkyl optionally substituted by a group selected from SO3H. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because alkyl optionally substituted by a group selected from SO3H have been used in the prior art for near-infrared compounds.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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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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/JAKE M VU/Primary Examiner, Art Unit 1618
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