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 .
DETAILED ACTION
This office action is in reply to Applicant’s Amendments/Arguments/Remarks filed 17 April 2026. Claims 1 and 3-6 are canceled. Claim 2 is amended. Claim 7 is new. Currently, claims 2 and 7 are pending.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous office action is set out below.
35 U.S.C. 102, 103, Double Patenting
Applicant’s amendment to claim 2, further limiting the claim to a single known impurity, listing several within the claim, utilizing a HPLC method also outlined within the claim, is sufficient to overcome this rejection.
Response to Arguments
The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below.
Applicant’s arguments, see pg. 1 – Objection to the Specification, filed 17 April 2026, with respect to the abstract have been fully considered and are persuasive. The objection of abstract has been withdrawn.
Applicant’s arguments, see pgs. 1-2 – Rejection under 35 U.S.C §§ 102(a)(1) and 102(a)(2), filed 17 April 2026, with respect to claims 2 and 6 (now claim 7) have been fully considered and are persuasive. The rejections of claims 2 and 6 (now claim 7) have been withdrawn.
Claim Objections
Claims 2 and 7 are objected to because of the following informalities: the structures of the impurities in claim 2 and reactive intermediates of claim 7 are not well resolved (i.e. too blurry). Appropriate correction is required.
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.
As a product-by-process claim, the 112(b) issue is that “obtainable” doesn’t require that the product is made by the particular method, thus, it is unclear what method is required to obtain the claimed product. The amendment, as suggested below, clearly delineates the method steps of the product-by-method limitations that are necessary to obtain the claimed product. Consequently, the public will be able to understand the metes and bounds of this claim and know what they can or can’t do regarding the infringement of this claim, should it issue in a US patent. Claim 7 should be amended in part to read “A composition comprising indocyanine green of formula (I) according to claim 2 obtained by a process comprising…”.
Allowable Subject Matter
Claims 2 and 7 are allowable.
Reasons For Allowance
The following is an examiner’s statement of reasons for allowance: the limitations amended into claim 2 including the listed impurities, range of impurities, and listed HPLC methodology is not taught in the prior art in a 100% embodiment. The closest match is disclosed by Pullagurla et al. (Process for the preparation of sodium 4-(2-((1E,3E,5E,7Z)-7-(1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[E]indol-2(3H)-ylidene)Hepta-1,3,5-trienyl)-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate (indocyanine green), US 2019/0337896, 2019; entered into the IDS on 18 August 2023) who discloses chromatographic conditions for the purification of Indocyanine Green, but does not list conditions to the specificity to read upon the claim, nor do they identify any impurities found during the purification process (para. 0078-0079 – Example 7). Pullagurla is also a close match for claim 7, who discloses a scheme for the synthesis of Indocyanine Green (pg. 6 - Scheme 1). Step b does not utilize sodium acetate (para. 0041-0042), nor do they specify isopropanol/water as solvents to be used in the purification process in any specific ratios. Fang et al. (One-step condensation synthesis and characterizations of indocyanine green, Results in Chemistry 2021, 3, 196092; entered in the IDS on 18 August 2023) also teaches synthesis of Indocyanine Green though the method differs where compound IV is reacted neat, sodium acetate is used in the reaction of compound IV and V, acetonitrile is not, and the final product is not purified through crystallization. A SciFinder search reveals several syntheses in the prior art but none that read exactly on the limitations of claim 7.
Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed invention and therefore, the claimed invention is deemed novel and unobvious over the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Summary
Claims 2 and 7 are objected to. Claim 7 is rejected under 35 U.S.C. 112(b).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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, James H Alstrum-Acevedo can be reached at 571-272-5548. 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.
/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights