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 .
Election/Restrictions
Applicants’ election without traverse of Group I and species a.ii of the R1 through R4 groups being not linked of claims 2-4, 7-13 and 15, in the reply filed on 09/01/2026 is acknowledged.
Claims 5, 6 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/01/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 15 is objected to because of the following informalities:
In claim 15, the phrase “exposing a stable formulation comprising a dye of formula (I)…which is dissolved in a Good’s buffer and contained in a primary packaging for fluorescence detection to an excitation source of the fluorescence system” is objected to grammatically. The objection can be overcome by changing the phrase to “exposing a stable formulation contained in a primary packaging for fluorescence detection to an excitation source of the fluorescence imaging apparatus, wherein the stable formulation comprises a dye of formula (I) dissolved in a Good’s buffer…” which is how the claim will be interpreted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 2-4, 7-13 and 15 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 claim 15 on line 17, the phrase “the fluorescence system” lacks antecedent basis in the claim. The rejection can be overcome by changing the phrase to “the fluorescence imaging apparatus” which is how the claim will be interpreted.
In claims 15 and 2, the phrase “bivalent alkyl substituted by…at least two hydroxyl groups” renders the claim indefinite because a bivalent substituent has two hydrogens removed from an alkyl group, wherein one of the binding sites would be at the point where the ‘Y’ attaches to the rest of the substituent. For purposes of examination, the alkyl will be treated as being able to be substituted by the SO3H or two hydroxyl groups.
In claims 4 and 11, the dyes names of claim 4 and the compound names “Tween 20”, “Tween 80”, “Triton X-100” and “NP-40” in claim 11, are all trademarked/trade named compounds. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe certain surfactants and, accordingly, the identification/description is indefinite. The rejection to claim 4 can be overcome by claiming the specific CAS numbers disclosed, which is how the claim will be interpreted.
Claim Rejections - 35 USC § 102
Claims 2-4, 7-9 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hernandez et al. (WO 2016/111797) as evidenced by “Tecan Infinite 200 Pro” (https://www.cambridgescientific.com/product/tecan-infinite-200-pro-multimode-microplate-reader).
With regard to claims 2-4, 7-9 and 15, Hernandez et al. teach investigating the fluorescence of IRdye 800CW, which reads on applicants’ dye of formula (I) and (Ia), in the buffer’s HEPES or MES, which read on applicants’ Good’s buffer [0477]. Hernandez et al. state that the “800CW fluorescence under different pH was determined as described above” [0477], which is referring to the manner of making fluorescence readings in [0476]. In this paragraph, the samples are placed into a Costar flat bottom 96 well plate, which reads on applicants’ primary packaging, and the excitation and emission spectra are collected at 740 nm and 796 nm, respectively, by an Infinite 200 Pro machine, which reads on the collecting the fluorescence emission [0476]. As evidenced by, “Tecan Infinite 200 Pro” the machine includes software, which means it will necessarily be recording the fluorescence data with a computerized system (pg. 2).
Lastly, the Examiner is interpreting the preamble limitations of the method “of calibrating a fluorescence imaging apparatus” as a statement or purpose of intended use and does not result in a manipulative difference between the claimed invention and the prior art; further, the body of the claim sets forth all of the limitations of the claimed invention, see MPEP 2111.02. The prior art method reads on applicants’ intended use of calibrating as the results from the method limitations in the prior art can be used to check the instrument to see if it is accurate.
Potential Allowable Subject Matter
Claims 10-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
There is no teaching in the prior art of this combination of materials being used in a method of calibrating a fluorescence imaging apparatus including the steps of exposing the stable formula to an excitation source of a fluorescence imaging apparatus, collecting the fluorescence imaging with a detection system and recording the fluorescence data with a computerized system in combination with the rest of the limitations claimed. There is no reason to include an antimicrobial compound or an organic solvent as there are no organic compounds that can develop bacteria in the test samples of Hernandez et al. and the samples are aqueous solutions, wherein adding an organic solvent would be improper hindsight.
The closest prior art to claims 10 and 11 is Kundu et al. (US 2014/0213473), but there is no rationale to make the testing samples of Hernandez et al. have a surfactant as it is not being used for enteral administration.
The closest prior art to claims 10 and 13 is Dacosta et al. (US 2022/0082500), but there is no rationale save improper hindsight to have made the buffer of Dacosta et al. a Good’s buffer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERARD T HIGGINS whose telephone number is (571)270-3467. The examiner can normally be reached M-F 9:30-6pm.
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, Mark Ruthkosky can be reached at (571) 272-1291. 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.
/Gerard Higgins/Primary Examiner, Art Unit 1785
