DETAILED ACTION
Notice of Pre-AIA or AIA Status
This Office action details a first action on merits for the above referenced application No. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/15/2024 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 07/18/2024. These drawings are acknowledged.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-15, drawn to a compound of Formula (I) and pharmaceutical composition comprising the compound of formula (I).
Group II, claim(s) 16-20, drawn to a method of imaging a cancerous tumor in a subject as recited in claim 16.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
The species are as follow: those species as described by general compound of formula (I).
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The technical feature linking the claims is a formula (I) derivative. Prior art exists which causes the compound of formula (I) in the current application to lack a special technical feature. Hershberger et al. (WO 2021/026402) discloses compound
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used to detect the presence of an analyte in a biological sample (Page 85, example 43).
As result, no technical feature exists among the different groups because the inventions in Groups I and II fail to make a contribution over the prior art and are therefore not “special.”
During a telephone conversation with Craig Boyle on 09/08/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Applicants also elected species
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without traverse. Affirmation of this election must be made by applicant in replying to this Office action. A prior art search for Applicants’ elected species did not retrieve applicable art. Therefore, the search was extended to general compound of formula (I), which retrieved applicable prior art. Accordingly, claims 1-4, 7-9, and 11-15 are pending in this application. Claims 5, 6, 10, and 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9, 11 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hershberger et al. (WO 2021/026402).
Hershberger discloses compounds, conjugates, and method that used to detect the presence of an analyte in a biological sample (abstract). In one embodiment, discloses a compound
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(reads on compound of formula (I) (page 85, example 43). Additional disclosure includes kits that includes reagents for labeling the specific binding members/or for labeling the analytes and other reagents required to conduct a diagnostic assay or facilitate quality control evaluations, such as buffers, salts, enzymes, enzyme co-factors, substrates, detection reagents, and the like.
Claim(s) 1-4, 7-9, and 11-15 are rejected under 35 U.S.C. 102(a)(I) as being anticipated by Cai et al. (CN 105503831, English Translation, Published on 04/20/2016).
Cai discloses infrared fluorescent compound of formula (I)
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(abstract). In formula (I), X= -C(CH3)2, Z is radical, R1 and R2 independently selected from H atom, C1-8 alkyl group, R3 and R4 independently selected from C1-8 alkyl or benzyl, Y is F, Cl, Br or I. Cai discloses that the near infrared fluorescent probe is suitable for carrying out detection for the low pH environment acid, overcomes the defect of the existing technique of fluorescence probe and in preparing medicine for detecting early tumour, diagnosis, treatment or diagnosis and treatment.
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
Claim(s) 1-4, 7-9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hershberger et al. (WO 2021/026402) in view of Nagano et al. (US 2010/0285515).
Hershberger discloses compounds, conjugates, and method that used to detect the presence of an analyte in a biological sample (abstract). In one embodiment, discloses a compound
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(reads on compound of formula (I) (page 85, example 43). Additional disclosure includes kits containing reagents for labeling the specific binding members/or for labeling the analytes and other reagents required to conduct a diagnostic assay or facilitate quality control evaluations, such as buffers, salts, enzymes, enzyme co-factors, substrates, detection reagents, and the like.
Hershberger does not disclose compound of formula
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in the composition.
Yang discloses a fluorescent compound and synthesis from piperazine and Cy.7
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(page 334, Scheme 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the compound disclosed by Hershberger, in order to provide a compound wherein, R3 and R4 together with N atom to which they are attached form a piperazine ring. Further, both Hershberger and Yang disclose the compounds having similar structure and comprising piperazine linker, and where compounds are designed as fluorophores for use in aqueous solution. The modification of Hershberger compound having for R3 and R4 each independently a hydrogen and C1-8 alkyl or at least one of R3 and R4 is other than H, for providing for piperazine ring linker would provide the benefit in triggering an increase in the fluorescence emission and a distinguished color change from dark blue to light blue, which makes to be a new turn-on fluorescent probe for S2-.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9525. The examiner can normally be reached Monday-Friday 9am-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, Hartley G Michael 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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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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