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 .
Receipt is acknowledged of Applicant’s Request for Continued Examination and Amendment filed on 02/18/2026.
Claim 1 has been amended.
Claims 9-12 has been added.
Claims 1-12 are pending in the instant application.
Claims 5-6 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/18/2026 has been entered.
Claim Rejections - 35 USC § 102/103
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 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) 1-4, 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over VASHIST et al (Development of Multifunctional Biopolymeric Auto-Fluorescent Micro- and Nanogels as a Platform for Biomedical Applications. Frontiers in Bioengineering and Biotechnology. 8(315). 1-16, April 2020).
VASHIST teaches image-guided therapy (see abstract), such as diversely used in therapeutics and diagnostics in cancer (see pg. 6, 1st col), which reads on imaging a tumor, comprised of: fluorescence-based hydrogels for sensing and tracking the bio-actives and therapeutics in vitro and in vivo (see pg. 2, 1st col), which reads on introducing into the environment of said tumor associated macrophages, size-controlled (micro-to-nano) auto-fluorescent biopolymeric hydrogel particles of chitosan and hydroxyethyl cellulose (see abstract) and linseed oil-based polyol (see abstract) at wavelengths 450–780 nm (see abstract). Additional disclosures include: linseed polyol contributed largely to the fluorescing capacity (see pg. 7, 1st col); the developed bio-polymeric fluorescent micro- and nano- gels as a potential theranostic tool for central nervous system (CNS) drug delivery and image-guided therapy (see abstract), wherein it would have been obvious that the hydrogel particle can be used for only diagnostic/imaging if the person skilled in the art desire to only image for the cancer; (v) the biomaterials can be detected in vitro and in vivo; and (vi) the cellular uptake and the monitoring or tracking of the carrier for release and degradability should be feasible (see pg. 2, 1st col); literature reveals both micro and nano range is preferred for various cancer therapies and other biomedical applications (see pg. 2, 1st col).
Note, VASHIST teaches the hydrogel nanoparticles were made using a water-in-oil emulsion polymerization method, wherein the linseed oil-based polyol was used as a hydrophobic modifier (see pg. 3, 1st col, under Synthesis of Micro/Nano Hydrophobically Modified Chitosan-Hydroxyethyl Cellulose), which uses the same ingredients and method as disclosed by Applicant (see Applicant’s specification at [0128]). Thus, the prior art’s hydrogel nanoparticles would have result in the same “vegetable oil-derived polyol(s) not forming a component of hydrogel nanoparticles and/or microparticles” as claimed by Applicant, unless proven otherwise.
Note, Applicant’s recitation of “evaluating” appears to be a mental step, and not an active step.
VASHIST conducted experiments on in-vitro cells, such as PBMCs and CHME5; however, it would have been obvious to introduce the hydrogel particles into cancer/tumor cells, because as discussed above, VASHIST teaches the hydrogel particles can be diversely used in therapeutics and diagnostics in cancer (see pg. 6, 1st col).
Regarding claim 12, VASHIST teaches the same vegetable (linseed) oil-derived polyol comprising a compound of the formula (I) as claimed by Applicant (see pg. 7, Figure 1, wherein the figure is also provided below).
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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.
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) 1-4, 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over VASHIST et al (US 10,344,100) in view of TOY et al (Targeted Nanotechnology for Cancer Imaging. Adv Drug Deliv Rev. 2014 September 30; pg. 1-47).
VASHIST teaches an auto-fluorescent imaging particle (see claim 1 and 10) comprised of: chitosan and hydroxyethyl cellulose (see claim 1); and linseed oil polyol (see claim 1), wherein the imaging was conducted at 505-560 nm (see col. 5, line 55-56). Additional disclosures include: linseed polyol contributed largely to the fluorescing capacity (see pg. 7, 1st col); in vivo drug monitoring (see col. 4), wherein these hydrogel nanoparticles are tagged with antigen/antibody for specificity for a disease of interest (see col. 4, line 16-20); uptake in peripheral blood mononuclear cells (PBMCs; see col. 2, line 40-41) and CMHE5 cells (see col. 2, line 44-45).
Regarding claim 12, VASHIST teaches the same vegetable (linseed) oil-derived polyol comprising a compound of the formula (I) as claimed by Applicant (see pg. 7, Figure 1, wherein the figure is also provided below).
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Note, VASHIST teaches the hydrogel nanoparticles were made using a water-in-oil emulsion polymerization method, wherein the linseed oil-based polyol was used as a hydrophobic modifier (see col. 4, line 45-55), which uses the same ingredients and method as disclosed by Applicant (see Applicant’s specification at [0128]). Thus, the prior art’s hydrogel nanoparticles would have result in the same “vegetable oil-derived polyol(s) not forming a component of hydrogel nanoparticles and/or microparticles” as claimed by Applicant, unless proven otherwise.
VASHIST does not explicitly teach using the auto-fluorescent imaging particle for imaging a tumor; or the mental step of evaluating cell death of tumor cells.
TOY teaches the prior art had known of using nanoparticles labeled by fluorescent agents (see title and pg. 14) for cancer imaging (see title) and imaging of tumor associated macrophages (see pg. 16). Additional disclosures include: antibody targeting (see pg. 16); administered (see pg. 5); “treatment monitoring at the molecular/cellular level” and “treatment follow up” (see pg. 10), which both reads on evaluating cell death of tumor cells.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the auto-fluorescent imaging particle for imaging a tumor by administering to cancer patients and monitoring/evaluating cell death of tumor cells. The person of ordinary skill in the art would have been motivated to make those modifications, because the particle would allow imaging of the cancer in patients for successful treatment and diagnostic, and reasonably would have expected success because the prior art had known of using nanoparticles for cancer imaging and monitoring.
Response to Arguments
Applicant argues that Vashist et al. teach that "[e]mphasis was given on obtaining both micro and nanoparticles with unique characteristic properties, which can be diversely used as a carrier for therapeutics in cancer" (see, page 6, 1st column). Such teaching of Vashist et al. does not disclose the use of micro/nanoparticles for imaging a tumor, but as a carrier for therapeutics for cancer treatment. Vashist et al. do not teach that their micro and nanoparticles can selectively induce apoptosis and/or programmed cell death of cancer cells in the absence of any anti-cancer agents; nor do Vashist et al. teach a step of evaluating cell death of tumor cell and/or TAMs. Vashist et al. conducted experiments in vitro on cells, such as peripheral blood mononuclear cells (PBMCs) and microglial cell lines (CHME5), which are not related to cancer or tumors. Thus, Vashist et al. do not teach the use of their micro and nanoparticles for selectively imaging a tumor and/or TAMs by introducing into the environment of the tumor and/or TAMs an effective amount of micro and nanoparticles, visualizing the tumor and/or TAMs, and evaluating cell death of tumor cells and/or TAMs. The Vashist et al. reference does not disclose within its four comers, each and every element of the claimed invention and, therefore, fails to anticipate the claimed method. Moreover, Vashist et al. do not make the claimed method obvious. An obviousness rejection requires a teaching or suggestion of all claim limitations. CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). As noted above, Vashist et al.' s micro and nanoparticles are used in cancer therapy as a earner. The teaching of Vashist et al. does not teach or suggest that their micro and nanoparticles can be used as a cancer treatment. Thus, even if one skilled in the art is to image tumor and/or TAMs using Vashist et al.'s micro and nanoparticles, one skilled in the art would not have been motivated to evaluate cell death of tumor cells and/or T AMs after the treatment of Vashist et al.' s micro and nanoparticles. In summary, Vashist et al. do not teach or suggest the claimed invention because Vashist et al. fail to teach or suggest all claim limitation, and lack any reason, and suggestion or motivation that would lead an ordinarily skilled artisan to modify their teachings to arrive at the claimed method. Therefore, the claimed method is not obvious.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, VASHIST conducted experiments on in-vitro cells, such as PBMCs and CHME5; however, it would have been obvious to introduce the hydrogel particles into cancer/tumor cells, because as discussed above, VASHIST teaches the hydrogel particles can be diversely used in therapeutics and diagnostics in cancer (see pg. 6, 1st col).
Applicant argues that Vashist et al. do not teach that the linseed oil-based polyol alone can be used to selectively image a tumor and/or TAMs. Thus, the Vashist et al. reference does not disclose within its four corners, each and every element of the claimed invention and, therefore, fails to anticipate the claimed method of claims 9-12. Vashist et al. further do not suggest that the linseed oil-based polyol alone can be used to selectively image a tumor and/or TAMs. Because the linseed oil-based polyol is introduced as an element of hydrophobicity, one skilled in the art would have no reason to believe that the linseed oil-based polyol alone can be used to selectively image a tumor and/or TAMs. Thus, Vashist et al. do not teach or suggest the claimed method for selectively imaging a tumor and/or TAMs by using an effective amount of a vegetable oil-derived polyol. Therefore, claims 9-12 are not obvious.
The Examiner finds this argument unpersuasive, because Applicant’s claims recite “comprising”, which is open language and would encompass other ingredients.
Applicant argues that Vashist et al. do not teach or suggest that their auto-fluorescent imaging particles have any anti-tumor effect. Nor do Vashist et al. teach or suggest a step of evaluating cell death of tumor cells and/or TAMs. In the absence of such teachings, the skilled artisan would have been motivated to evaluate cell death of tumor cells and/or TAMs after the treatment of Vashist et al.'s particles. Thus, even if a skilled artisan is to incorporate the auto-fluorescent imaging particle of Vashist et al. for cancer imaging as disclosed by Toy et al., the skilled artisan would still fail to arrive at the claimed invention.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, VASHIST conducted experiments on in-vitro cells, such as PBMCs and CHME5; however, it would have been obvious to introduce the hydrogel particles into cancer/tumor cells, because as discussed above, VASHIST teaches the hydrogel particles can be diversely used in therapeutics and diagnostics in cancer (see pg. 6, 1st col). Note, evaluating is a mental step and not an active step.
Applicant argues that Vashist et al. do not teach or suggest that the linseed oil-based polyol alone can be used to selectively image a tumor and/or TAMs. Because the linseed oil-based polyol is introduced as an element of hydrophobicity, one skilled in the art would have no reason to believe that the linseed oil-based polyol alone can be used to selectively image a tumor and/or TAMs.
The Examiner finds this argument unpersuasive, because VASHIST explicitly states that “linseed polyol contributed largely to the fluorescing capacity (see pg. 7, 1st col).
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618