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
Claims 1-7 are pending in the instant application.
Election/Restrictions
Applicant's election with traverse of Group I,
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in the reply filed on June 5, 2025 is acknowledged. The traversal is on the ground(s) that the claims of the instant application do not present a serious burden on the Examiner. This is not found persuasive because separate search considerations are involved for each of the groups identified in the Restriction Requirement of April 28, 2025. For example, various chemical structure searches {see formula (5), formula (4), etc. in instant claim 1} are required for elected Group I but are not required for non-elected Group II. Therefore, it would impose an undue burden on the Examiner and the U.S. Patent and Trademark Office’s resources if the Restriction were withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 5, 2025.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on May 2, 2018. It is noted, however, that applicant has not filed a certified copy of the Indian application as required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on October 24, 2022, November 11, 2022, April 24, 2023, August 26, 2023 (Third Party Submission) and October 12, 2023. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
in claim 1, the phrase “a suitable solvents” should be changed to “a suitable solvent” (line 9 of the page 16);
in claim 1, the phrase “a suitable solvents” should be changed to “a suitable solvent” (the last line of the claim);
in claim 7, the phrase “wherein preparation of formula (3) comprises” should be changed to “wherein E-N-((2E,4E)-5-(phenyl amino) penta-2,4-dienylidene) aniline hydrochloride of formula (3) is prepared comprising” (line 1 of the claim).
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.
Claims 1-3 and 7 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 1 is confusing because of the product recited in step c) and the product being purified in step d). Step c) states the following:
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However, formula (1) is the Indocyanine Green and not the compound recited in step c) and step d). Therefore, claim 1 is indefinite. Correction is required.
Claims dependent on claim 1 which do not resolve the problem in claim 1 are also indefinite.
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 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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. {CN 106631979 A}. A machine generated English translation of the CN document has been provided with this Office Action and will be referred to hereinafter.
Wang et al. disclose a process for preparing Indocyanine green (ICG) by the following process on pages 2-4, 6 and 7 of the provided English translation,
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Wang et al. disclose the same reactants as instantly claimed, the same process steps as instantly claimed, the same base as instantly claimed and the same solvents as instantly claimed in his process for preparing Indocyanine green. Therefore, Wang et al. anticipate the instant claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. {Zhongguo Yiyao Gongye Zazhi (2006), 37(9), 584-585}. An English translation of Wang et al. was cited on the IDS filed October 12, 2023 and will be referred to hereinafter.
Wang et al. (2006) disclose the process for preparing Indocyanine Green by the following process on page 2 of the English translation,
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Wang et al. (2006) disclose the same reactants as instantly claimed, the same process steps as instantly claimed, the same base as instantly claimed and the same solvents as instantly claimed in his process for preparing Indocyanine green. Therefore, Wang et al. anticipate the instant claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jia et al. {CN 104130178 A}. A machine generated English translation of the CN document has been provided with this Office Action and will be referred to hereinafter.
Jia et al. disclose a process for preparing a pharmaceutical Indocyanine Green by the following process on pages 4-6 of the provided English translation:
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Jia et al. disclose the same reactants as instantly claimed, the same process steps as instantly claimed, the same base as instantly claimed and the same solvents as instantly claimed in his process for preparing Indocyanine green. Therefore, Jia et al. anticipate the instant claimed invention.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. {CN 106631979 A}, Wang et al. {Zhongguo Yiyao Gongye Zazhi (2006), 37(9), 584-585} and Jia et al. {CN 104130178 A}, each taken alone, and each in further view of the teachings in Telfer et al. {U.S. Patent 5,262,549} and Kim et al. {Spectrochimica Acta, Part A: Molecular and Biomolecular Spectroscopy (2018), 192, 378-383}. Machine generated English translations of CN 106631979 A and CN 104130178 A have been provided with this Office Action and will be referred to hereinafter.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant claims a process for preparing Indocyanine green of formula (1),
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Wang et al. disclose a process for preparing Indocyanine green (ICG) by the following process on pages 2-4, 6 and 7 of the provided English translation,
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Wang et al. (2006) disclose the process for preparing Indocyanine Green by the following process on page 2 of the English translation,
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Jia et al. disclose a process for preparing a pharmaceutical Indocyanine Green by the following process on pages 4-6 of the provided English translation:
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Both Wang et al. references and the Jia et al. reference disclose the same reactants as instantly claimed, the same process steps as instantly claimed, the same base as instantly claimed and the same solvents as instantly claimed in claims 1-3 in their processes for preparing Indocyanine green.
Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
Neither of the Wang et al. references or the Jia et al. reference teach the process of preparing E-N-((2E,4E)-5-(phenyl amino) penta-2,4-dienylidene) aniline hydrochloride of instant formula (3) as claimed in instant dependent claim 7.
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
However, Telfer et al. and Kim et al. each teach a process for preparing E-N-((2E,4E)-5-(phenyl amino) penta-2,4-dienylidene) aniline hydrochloride of instant formula (3) as claimed in instant claim 7. See the process for preparing Compound (X) in Figure 3 and in column 14 of Telfer et al.,
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See also the process of making compound (GAD) in Figure 1 on page 379 of Kim et al.,
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The claimed process is no more than a selective combination of prior art teachings done in a manner obvious to one of ordinary skill in the art since each step of the process appears to be relatively complete in itself and there is no indication of an interaction between steps of such a type that would lead one of ordinary skill in the art to doubt that a substitution of alternative steps known to the art could be made. In re Mostovych, 144 USPQ 38 (C.C.P.A. 1964). The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Reminder to Applicant
As a gentle reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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,
Joseph K. McKane can be reached on 571/272-0699. 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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
June 27, 2025
Book XXV, page 89