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 07/09/2026.
Claims 4, 6, 11, 15-20 have been amended.
Claims 1-20 are pending in the instant application.
Claims 1-3, 5, 7-10, 12-14 are withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Election/Restrictions
Amended claims 4, 6, 11, 15-19 are now dependent on the elected composition invention of claim 20 and are rejoined.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 4, 20 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.
Claim 4 does not recited units for “58,000, 60,000 and 3,200”.
Claim 20 recites “polyactic acid”. It’s unclear what compound is “polyactic acid”. Is this a typographical error for polylactic acid?
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) 6, 11, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over POUL et al (US 2016/0136304).
POUL teaches a composition for diagnostic monitoring of oncology patients (see abstract) comprised of: inorganic nanoparticles (see abstract), such as tantalum (see [0043]); and “covered with a biocompatible coating” (see abstract), such as chitosan and polyvinylpyrrolidone (see [0061]). Additional disclosures include: nanoparticle size of about 150 nm (see [0028])
Note, claims 11, 15-19 are drawn to product-by-process claims, wherein Applicant’s claims are directed to a composition. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this instance, the prior art’s composition has the same ingredients as claimed by Applicant.
Claim(s) 6, 11, 15--20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CHAKRAVARTY et al (US 2022/0048788).
CHAKRAVARTY teaches a composition comprised of: tantalum nanoparticle (see title and abstract); coated with poly(vinylpyrrolidone) (see [0112]), chitosan or polylactic acid (see [0118]), wherein the nanoparticle has a diameter of about 100nm (see [0113]).
Note, claims 11, 15-19 are drawn to product-by-process claims, wherein Applicant’s claims are directed to a composition. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this instance, the prior art’s composition has the same ingredients as claimed by Applicant.
Response to Arguments
Applicant argues that Poul exemplifies only one kind of nanoparticles, namely biocompatible hafnium oxide (Hf02) nanoparticles or nanoparticle aggregates with sodium hexametaphosphate as the coating agent. In addition to the only one type of Hf02 nanoparticle mentioned above, Poul does not provide any experimental data to prove which inorganic materials such as metal elements, metal oxides or sulfide can form stable structures with which biocompatible materials such as agents displaying a steric group or agents allowing interaction with a biological target, and achieve the functions described in Poul. While Poul mentions irradiating said nanoparticles or nanoparticles aggregates using ionizing radiation beam(s), thereby treating the subject, there is no supporting data or other evidence regarding such an irradiation. None of polyvinylpyrrolidone (PVP), tween 20, polylactic acid, or chitosan are disclosed in Poul as a biocompatible coating. Poul describes the use of PVP to form a biocompatible gel matrix. Therefore, Poul fails to teach or suggest a nanoparticle or nanoparticle aggregate covered with a biocompatible coating, wherein the nanoparticle is pure tantalum and a biosurfactant coating comprising one or more of polyvinyl pyrrolidone, tween 20, polyactic acid, and chitosan. Accordingly, Poul does not teach or suggest to a person of skill in the art to select an easily oxidized elemental metal (Ta) and a non-disclosed bio-surfactant (polyvinylpyrrolidone, tween 20, polyactic acid, and chitosan) and arrive at the claimed invention.
The Examiner finds this argument unpersuasive, because the teaching of POUL is not limited to the examples, similar to Applicant’s claims are not limited to Applicant’s examples.
Applicant argues that Poul discloses the use of sodium hexametaphospate as the only coating agent for its biocompatible hafnium oxide (HfO2) nanoparticles or nanoparticle aggregates. This coating relates to coordination chemical adsorption. The tantalum nanocomposite of amended claim 20 is prepared through physisorption, i.e., a wet-process ball milling in-situ coating modification (see paragraphs [0059]-[0062] of the specification). Therefore, the coating method of Poul is different from the present invention.
The Examiner finds this argument unpersuasive, because Applicant’s claims are directed to a composition, wherein claim 20 does not recite any method steps. Additionally, as discussed in the rejection, claims 11, 15-19 are drawn to product-by-process claims, wherein Applicant’s claims are directed to a composition. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this instance, the prior art’s composition has the same ingredients as claimed by Applicant.
Applicant argues that the biocompatible gel of Poul comprises nanoparticles and/or nanoparticles aggregates covered with a biocompatible coating that is for use in medical diagnostic and patient monitoring and allows for improved post-surgery tumor bed delineation. Poul does not teach or suggest that its nanoparticles and/or nanoparticles aggregates covered with a biocompatible coating drain through the interstitium into regional lymphatic vessels and lymph nodes. Poul does not teach or suggest to a person of skill in the art to use its nanoparticles and/or nanoparticles aggregates covered with a biocompatible coating as lymph tracers. Poul also does not provide clonogenic assay to verify sensitizing effects of its nanoparticles and/or nanoparticles aggregates covered with a biocompatible coating. Therefore, Poul does not teach or suggest to a person of skill in the art to use its nanoparticles and/or nanoparticles aggregates covered with a biocompatible coating as radiosensitizers. In contrast, the tantalum nanocomposite of amended claim 20 is used as a lymph tracer and/or a radiosensitizer. As discussed above, the claimed lymph tracer and/or radiosensitizer shows a significant technical effect that is not taught or suggested by Poul.
The Examiner finds this argument unpersuasive, because Applicant’s claims are directed to a composition, not a method of use. Additionally, POUL’s composition would be capable of the same intended use, because POUL’s composition has the same ingredients as claimed by Applicant.
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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