DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-18 are pending in this application.
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 .
Priority
This application is a 35 USC 111(a) filing that claims benefit under 35 USC 119(a)-(d) to foreign application Nos. CHINA 202410088799.8 filed on 23 Jan. 2024 and PCT CN 2024075483 filed on 2 Feb. 2024.
Claim Objections
Claims 1-6 objected to because of the following informalities: in claims “represent” and/or “represents” should be replaced with the corresponding “is” or “are”. 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 1-8, 11-12, and 16 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.
Instant claims 1, 5, and 11 are directed to methods that merely use a second near-infrared organic fluorescent compound having a structure represented by formula I without requiring any method steps. Claims that provide for the use but do not set forth any steps involved in the method/process are indefinite because it is unclear what methods/processes applicant are intending to encompass. A claim is indefinite where it merely recites a use, without any active, positive steps delimiting how this is actually practiced. See Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Claims 2-4, 12, and 16 depend to one of those claims and fall therewith.
In claim 6, the recitation of “(NIR-II)” is indefinite because it is not clear if the recitation is an example, an abbreviation, or a required limitation.
Claim 7 contains the trademark/trade name Pluronic® F-127. 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 polyoxyalkylene ether of high molecular weight and, accordingly, the identification/description is indefinite.
Claim 8 recites subjecting a resulting mixture to ultrasonic assembly and it is not clear if the “a resulting mixture” refers to the mixture of the mixed solution with water or some other resulting mixture.
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 (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 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.
Claim(s) 1-6, 8-11, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Adv. Mat.; published 27 Oct. 2022; see IDS filed on 23 Jul. 2024).
Regarding claims 1-4, 6, 8-10, and 14-15, Li et al. teach a nanoimaging agent (FY6-NPs) comprising FY6 (second near-infrared organic fluorescent compound, NIR-II)
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and 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)] (DSPE-mPEG; organic encapsulation matrix; Fig. 1, pg. 3). FY6 reads on a compound of formula I wherein R1=undecyl (linear alkyl); R2=2-ethylhexyl (branched alkyl); and R3=
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, 2X=H, and 2X=F. The nanoimaging agent was prepared by a well established nanoprecipitation method. Compounds and DSPE-PEG2000 (ratio 3:1) were dissolved in THF and mixed homogeneously. The mixed solution was injected once into 9mL of double distilled water under ultrasonic conditions for 5 min, then transferred to a dialysis bag (MWCO=3600) and dialyzed against deionized water for 24 h. The as prepared NPs were concentrated and calibrated before use (see S2). (reads on a method for preparing a bioimaging contrast agent comprising using a second near-infrared organic fluorescent compound having the structure represented by formulas I and I-b. The method comprises the steps of mixing the organic encapsulation matrix (DSPE-PEG2000), the FY6, and an organic solvent to obtain a mixed solution, mixing the solution with water and subjecting a resulting mixture to ultrasonic assembly, to obtain an assembly liquid; introducing the assembly liquid into a dialysis bag and performing dialysis to obtain a purified assembly material and concentrating the purified assembly material to obtain a solution of the nanoimaging agent and wherein the mass ratio of the DSPE-PEG2000 and FY6 is 3:1 and the dialysis bag has a MWCO of 3500.) Claims 8-10, and 13-15 are product by process claims. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In this case, the FY6 nanoimaging agent described by Li et al. is structurally the same as the nanoimaging agent prepared by the method steps of claims 8-10 and 13-15 because the FY6 nanoimaging agent is a spherical nanoimaging agent having a hydrodynamic diameter of 150 nm that is prepared using a nearly identical method. Regarding claims 5, 11, and 16, Li et al. teach a in vivo NIR-II fluorescence imaging of blood vessels wherein after tail vein injection of 100 µL FY6-NPs (100 µM), the in vivo NIR-II fluorescence of blood vessels in the belly was imaged by the NIR-II fluorescent imaging instrument (NIR-30F) utilizing 1095 nm LP filter at predetermine time points (1 min, 5 min, 10 min, 20 min, 30 min, and 60 min) (pg. S4). Li et al. teach intravenous injection of FY6-NPs (500 µM, 100 µL) and imaging were collected at different post-injection times (S5). Reads on a method for providing vascular fluorescence imaging comprising using a second near-infrared organic fluorescent compound having a structure represented by formula I wherein the vascular fluorescence imaging is in vivo imaging wherein the method comprises injecting the nanoimaging agent into a subject through a vein and performing fluorescence imaging and wherein the nanoimaging agent injected into the subject during the vascular fluorescence imaging has an effective concentration of not less than 300 µmol L-1, and a volume of not less than 100 µL.
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 (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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Adv. Mat.; published 27 Oct. 2022; see IDS filed on 23 Jul. 2024), in view of Fengler et al. (US 2017/0209050 A1; published 27 Jul. 2017; see attached 892) and Chen et al. (Chem. Sci.; published 2021; see attached 892).
Li et al. teach as discussed above.
Li et al. do not expressly teach a method of providing vascular fluorescence imaging provided under excitation of white light, the white light having a wavelength of 400-800 nm. Li et al. do not further expressly teach 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-poly(ethylene glycol).
Fengler et al. teach configurable platform. Fengler et al. teach that systems and methods that provide fluorescence imaging across a broad range of surgical applications is desirable ([0006]). Fengler et al. teach an imaging system that includes a white light provide that emits white light ([0007]). At least one of the excitation bands may be centered on about 405 nm, about 470-480 nm, about 660 nm, and about 760-780 nm ([0008], [0023]). Fengler et al. teach detecting light in the NIR-II waveband ([0101]-[0110]).
Chen et al. teach expanded porphyrins: functional photoacoustic imaging agents that operate in the NIR-II region (see title). Chen et al. teach that octaphyrin (4) was successfully encapsulated into 1,2-distearoyl-sn-glucero-3-phosphoethanolamine-poly(ethylene glycol) nanoparticles to afford OctaNPs (see abstract; fig. 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Li et al. (method of providing in vivo vascular imaging wherein the method uses the FY6 nanoimaging agent and wherein the method comprises injecting the nanoimaging agent into a subject through a vein and performing fluorescence imaging) so that the fluorescence imaging is provided under wight light, the white light having a wavelength of 400-800 nm as taught by Fengler et al. because the white light would have been expected to advantageously enable the use of imaging system having a broad range of medical applications. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Li et al. so that the DSPE-mPEG is a DSPE-PEG as taught by Chen et al. because the DSPE-PEG would have been expected to provide an equivalent organic encapsulation matrix suitable for the formation of nanoimaging agents. Generally differences in concentration will not support patentability of subject matter encompassed by the prior art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, a person of ordinary skill in the art would have arrived at a method wherein the nanoimaging agent injected into the subject during the vascular fluorescence imaging has an effective concentration of not less than 300 µmol L-1 in order to arrive at an imaging method that uses an effective concentration of the nanoimaging agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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