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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 2/8/2022 wherein the specification and claims 11-10 and 12 were amended and claims 14-17 were added.
Note(s): Claims 1-17 are pending.
Priority
This application is a 371 of PCT/EP2020/071865 filed 8/4/2020 and claims benefit to EPO EP19315089.3 filed 8/8/2019.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy was filed in the pending application on 2/28/2022.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to prove the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 8/4/2020 because support for the pending invention is provided therein. In addition, it is noted that the priority document is not in English and it is unclear whether or not the pending invention is supported therein.
Claim Interpretation
Independent claim 1 is directed to a method of imaging using the fluorophore,
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, at a wavelength of 1000 nm – 1700 nm and wherein the variables are as set forth in the claim.
Claim 6 is directed to the fluorophore
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Claim 8 is directed to a composition comprising a fluorophore compound having formula
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Claim 11 is directed to a kit comprising an injection system and the fluorophore
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or
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Claim 12 is directed to a method of in vitro identification of a biological target wherein the fluorophore used is
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or
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.
Information Disclosure Statement
The information disclosure statement filed 2/8/2022 and 3/1/2022 was considered.
Specification
The disclosure is objected to because of the following informalities: it is difficult to read some of the structures (e.g., atoms, charges, and/or subscripts). See page 16, lines 1 and 5; page 18, line 10; page 20, lines 1-3; page 27, line 4; page 28, line 14; page 29, line 11; page 30, line 12; page 31, line 6; page 32, line 9; page 33, line 7; and page 37, line 9.
Appropriate correction is required.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 8, 9, 15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 7,897,786. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to overlapping fluorophore compounds. However, while the patented invention does not specify the wavelength as being 1000 – 1700 nm, according to MPEP 2112.01, if the compositions are physically the same, then they have the same properties. As a result, the skilled artisan would recognize that both fluorophore would be capable of being excited in the wavelength of 1000 -1700 nm. In addition, the skilled artisan would recognize that since the purpose of generating fluorophores is for imaging purposes, then it would have been obvious to a skilled artisan to use the fluorophore in a method of imaging. Thus, the inventions disclose overlapping subject matter.
112 Second Paragraph Rejections
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 1-17 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.
Claims 1-11 and 13-17: Independent claim 1 is ambiguous for the following reasons:
(1) It is unclear for what purpose imaging is being performed (see line 1) in independent claim 1.
(2) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 (line 13) recites the broad recitation “chalcogen”, and the claim also recites “SePh and TePh” (line 13) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
(3) Claim 1, lines 22-24 and lines 27-29 are duplicates. Did Applicant intend to delete some of the text or is text missing?
(4) The claim is ambiguous because it is unclear what metal complex(es) Applicant is referring to that are considered effective for therapeutic purposes, especially because the purpose for which the method of performing the imaging is not identified in the claim.
(5) Claim 1, line 42, is ambiguous because it is unclear what molecule(s) Applicant is referring to with a diameter of less than 10 nm that is/are compatible for imaging with
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(6) Claim 1, line 46, is ambiguous because of the phrase ‘caffeine derivative’. Specifically, it is unclear what portion of the parent structure must be present in the derivative such that the derivative is compatible for imaging with
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For the reasons above, claims 2-11 and 13-17 which depend upon independent claim 1 for clarity are also vague and indefinite.
Claim 5: The claim is ambiguous because it is difficult to read some of the charges because they overlap some of the bonds and atoms of the structures they are a part of. In addition, it is unclear what is the value of the variable range for “n” in some of the structures (see line 5, last structure and line 11).
Claim 5, line 14: For the variable X (line 13), it is unclear if X is all of the things listed thereafter because X = NH2 appears in 14 and 21 and the phrase ‘from the groups comprising a biological vector” with various substances listed thereafter. Hence, it is unclear what is the actual value of X. Applicant should consider replacing “X=” with “wherein X is selected from” and list the options thereafter in an appropriate Markush format. Also, for the reference for the reference to a biological vector, Applicant should clarify the claim by indicating that the biological vector is ‘selected from’ and listing the options in a proper Markush format (see line 21).
Claim 5, lines 24-28. The claim is confusing because of the ‘from’ in front of some of the terms as well as simply not knowing what the lines are referring to. In addition, the claims include reference to sequences which do not contain a sequence identification number (see line 26).
Claim 6: The claim is confusing as it is unclear if Applicant is referring to the definitions of Ra, Rb, Rc, and Rd is that of claim 1 or if reference is to claims 3-5 which also contain the variables Ra, Rb, Rc, and Rd. In addition, in the reference to Re and Rf, the phrase ‘at least one group’ is confusing. Did Applicant something similar to ‘Re and Rf are independently selected from hydrogen, a halogen, NRcRd, -ORd, hydrazine, -CF3, and -CN’. According to MPEP 2173.05(s), where possible claims are to be complete in themselves. Thus, Applicant should consider defining the variables in claim 6 as it is directed to a particular structure having a limited number of variables attached thereto. As a result, there does not exist and exceptional circumstance wherein the information cannot be duplicated in the claim.
Claim 11: The claim is ambiguous because it is unclear what apparatus Applicant is referring to as an injection system.
Claims 11 and 12: The claims references formulae I and II and generally states that the formula are as defined above. According to MPEP 2173.05(s), where possible claims are to be complete in themselves. Thus, it is respectfully requested that Applicant incorporated Formula I and II into the claim as well as definitions thereof. There does not exist and exceptional circumstance wherein the information cannot be incorporated in the independent claims.
Essential Steps Missing
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are those which enable one to identify the target cells.
103 Rejection
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.
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.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bai et al (Chem. Commun., 2019, Vol. 55, pages 10920-10923).
Independent claim 1 is directed to a method of imaging using the fluorophore,
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, at a wavelength of 1000 nm – 1700 nm and wherein the variables are as set forth in the claim. Claims 2-5, 7, 13, and 14 are directed to various variable definitions that are present in independent claim 1. Claim 17 is directed to the presence of a pharmaceutically acceptable excipient and/or solvent.
Bai et al is directed to aza-BODIPY NIR-II fluorophores that are used for in vivo imaging. In particular, it is disclosed that biological imaging in the second near infrared (NIR-II, 1000-1700nm) has advantages such as deep tissue penetration, high signal to background ratio, and high maximum permissible exposure to lasers. In Figure 1, Bai et al disclose structures which are encompassed by pending claims 1-5, 7, 13, and 14. The compounds are NJ960,
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; NJ1030,
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; and NJ1060
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which had emissions at 960 nm, 1030 nm, and 1060 nm, respectively. NJ960, NJ1030, and NJ1060 were evaluated in a PBS solution (pH = 7.4) containing 20% DMSO as a co-solvent. In vivo imaging was performed using the fluorophores (see entire document, especially, abstract; page 10920, left and right columns, bridging paragraph; page 10920, Figure 1; page 10921, left and right columns, bridging paragraph; page 10921, Figure 2; page 10922, left and right columns, bridging paragraph; page 10922, Figure 4; pages 10922-10923, bridging paragraph). The fluorophores meet the requirements of the pending claims at the following conditions: NJ960: R1 and R2 = C6 aryl group with NRcRd; R3 and R4 = C6 aryl substituted with ORd; and R5 and R6 = hydrogen; and NJ1030 and NJ1060: R1 and R2 = heteroaryl group; R5 and R6 = hydrogen; R3 and R4 = C6 aryl substitute with ORd. Thus, the limitations of claims 1-5, 7, 13, 4, and 17 are met.
Claim 6 is directed to the fluorophore
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As disclosed supra for independent claim 1, Bai et al disclose the fluorophore of pending claim 6. For NJ960 of Bai et al, Applicants Re and Rf variables are both ORd. Thus, the claim limitations are met.
Claim 8 is directed to a composition comprising a fluorophore compound having formula
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. Claim 9 is directed to the composition of claim 8 wherein the pH is from 4-10. Claim 15 is directed to the composition of claim 8 having a pH in the range of 6-8.
As disclosed supra for independent claim 1, Bai et al disclose the fluorophore of claim 8. In addition, it is disclosed that the pH = 7.4. Thus, the limitations of claims 8, 9, and 15 are met.
Claim 10 is directed to an encapsulated fluorophore compound.
In the abstract, Bai et al disclose that the fluorophores give bright fluorescence as nanoparticles in an aqueous solution. In addition, it is disclose that for NJ1060, for example, nanoparticles were prepared for in vivo NIR-II imaging using sonication to encapsulate them into a Pluronic F-127 matrix. Thus, the claim limitation is met.
Claim 11 is directed to a kit comprising an injection system and the fluorophore
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or
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As set forth supra for independent claim 1, Bai et al encompasses the species present in pending claim 11. In addition, Bai et al disclose that before in vivo imaging studies were conducted, the NIR-II imaging depth was investigated by imaging a capillary tube filled with the fluorophore (NJ1060) nanoparticles solution with biological tissue (chicken meat) at various depths (page 10922, left and right columns, bridging paragraph). Thus, the limitation of claim 11 is met. Specifically, since there are no particular regarding what is an injection system and a kit in general is equipment used for a particular purpose.
Claim 12 is directed to a method of in vitro identification of a biological target wherein the fluorophore used is
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As set forth supra for independent claim 1, Bai et al disclose the species disclosed in claim 12. Also, Bai et al is directed to in vitro identification (images) of subjects administered the NIR-II compositions (e.g., NJ1060, see page 10922, Figure 4). In addition, as set forth supra for claim 11, Bai et al conducted in vitro identification studies with a capillary tube and chicken meat prior to conducting in vivo imaging studies. Thus, the limitation of claim 12 is met.
Claim 16 is directed to measuring fluorescence via microscopy, flow cytometry, optical imaging with fluorescence reflection, or optical probe.
As discussed supra, Bai et al disclose various methods of imaging for optically imaging using the NIR-II fluorophores (see entire document, especially, page 10921, Figure 2; page 10922, Figure 4). Thus, the limitations of claim 16 is met.
Comments/Notes
Applicant is respectfully requested to incorporate the SEQ ID Nos into the appropriate claims (e.g., claim 5).
According to 37 CFR 1.75(i), where a claim sets forth a plurality of elements or steps, each element or step should be separated by a line indentation. Thus, Applicant is respectfully requested to review all the claims (e.g., claim 1) and remove the hyphens, bullets, and any other markings not recommended by the Manual of Patent Examining Procedure (MPEP).
It is respectfully suggested that in claim 5, lines 4 and 12, the phrase ‘ of the following formulae’ be replaced with ‘selected from’.
Conclusion
Claims 1-17 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. 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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 14, 2025
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