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 Amendment filed on 06/09/2026.
Claims 1, 9 have been amended.
Claims 1-12 are pending in the instant application.
Claims 5-6 have been withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112, 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for linseed oil-derived polyol, does not reasonably provide enablement for the genus of vegetable oil-derived polyol. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to these claims, with the most relevant factors discussed below:
1) The breadth of claims: The instant claims are directed to a method of imaging tumor using any vegetable oil-derived polyol. This is a very broad claim, one that is not supported by the instant specification, because the instant specification only teaches linseed oil-derived polyol to be auto-fluorescence and is capable of being visualized at 450-810 nm.
2) The nature of the invention: The nature of the invention is a method of imaging tumor using any vegetable oil-derived polyol at 450-810nml. However, Applicant only showed linseed oil-derived polyol is auto-fluorescent and is capable of imaging tumors at 450-810 nm. Other vegetable oil-derived polyols, such as the commercially available Lopiodol® (poppy seed oil), is currently used to image tumors at X-ray wavelengths (0.01-10 nm), which is not auto-fluorescence and is incapable of imaging at the range of 450-810 nm as claimed by Applicant.
3) The state of the prior art: The state of the art shows vegetable oil-derived polyols, such as the commercial available Lopiodol (poppy seed oil), is currently used to image tumors at X-ray wavelengths (0.01-10 nm), because poppy seed oil is incapable of imaging tumors at the range of 450-810 nm. There is no evidence in the prior art that all vegetable oil-derived polyols are capable of being auto-fluorescent like linseed oil-derived polyol.
4) The amount of direction provided by the inventor: Applicant only showed linseed oil-derived polyol is capable of imaging tumors at 450-810 nm. There is no other evidence that other vegetable oil-derived polyols are auto-fluorescent like linseed-oil derived polyols in the specification. Thus, a burdensome amount of research would be required by one of ordinary skill in the art to test for auto-fluorescent in other vegetable oil-derived polyols.
5) The presence or absence of working examples: Applicant only showed linseed oil-derived polyol is capable of imaging tumors at 450-810 nm. There is no other evidence that other vegetable oil-derived polyols are auto-fluorescent like linseed-oil derived polyols in the specification. Therefore, the practitioner would turn to trial and error experimentations to make/use the instant compositions for every vegetable oil.
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, 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable 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) in view of MIRAYANS et al (Viability Assessment Following Anticancer Treatment Requires Single-Cell Visualization. Cancers 2018, 10, 255; pg.1-11).
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 treating and 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); (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).
VASHIST further 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]). VASHIST teaches the same vegetable (linseed) oil-derived polyol comprising a compound of the formula (I) as claimed and disclosed by Applicant (see pg. 7, Figure 1, wherein the figure is also provided below).
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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 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).
VASHIST does not teach detecting viability cell death of tumor cells using viability assay.
MIRAYANS teaches the prior art had known of using viability assessment following anticancer treatment (see title), such as MTT viability assay (see pg. 7) and XTT (see pg. 4), because dormant cancer cells might be scored as “dead” in conventional preclinical assays, they remain viable, secrete growth-promoting factors, and can give rise to progeny with stem cell-like properties (see abstract), wherein these assays will be useful in identifying pharmacological agents capable of killing highly enlarged (e.g., polyploid/multinucleated) cancer cells before they will have the opportunity to enter the STAR cycle to promote tumor repopulation following anticancer treatment (see pg. 8 at Conclusion).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate detecting viability cell death of tumor cells using viability assay when using VASHIST composition for treating and diagnosing cancer. The person of ordinary skill in the art would have been motivated to make those modifications, because these assays will be useful in identifying pharmacological agents capable of killing highly enlarged cancer cells before they will have the opportunity to promote tumor repopulation following anticancer treatment, and reasonably would have expected success because both references dealt in the same field of endeavor, such as cancer treatment.
Allowable Subject Matter
Claims 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Michael 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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/JAKE M VU/Primary Examiner, Art Unit 1618
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