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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 1/14/2026 is acknowledged. The traversal is on the ground(s) that there would be no undue search burden to examine the groups together. This is not found persuasive because there would be an undue search burden to examine the groups together for the reasons set forth in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
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 78-100 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 1 recites “administering a payload comprising first high z nanoparticles (NPs) and second semiconductor NPs to a tissue site of a subject.” If the payload comprises high z nanoparticles and semiconductor NPs, it’s unclear in what way “first” and “second” limit the claim and in what way the payload comprises first high z nanoparticles and second semiconductor NPs in that order if both NPs are present in the payload. Further regarding “high z NPs” is a relative term which renders the claim indefinite. The term “”high z NP” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the claims recite “wherein the first high z NPs includes NPs comprising an element having an atomic number of at least 26,” this is not a definition of “high z NPs,” but a statement that the first high z NPs includes NPs comprising an element having an atomic number of at least 26, but is open to have further high z NPs that may be out of range, provided it comprises at least one element having an atomic number of at least 26. As there is no art-recognized definition of how high z must be in order to be considered a high z, it is unclear what high z NPs are encompassed by the present invention.
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.
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 78-79 and 81-100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kotagiri (Nat. Nanotechnol, 2015). Kotagiri teaches a radiation therapy method comprising: administering a 64Cu PET radionuclide (applicant's 'first NPs'; radioisotope) and coated TiO2 nanoparticles (applicant's 'second NPs'; titanium has an atomic number of 47 (at least 26; between 26 and 79; titanium oxide is an image contrast agent; an agent that emits electrons via photoelectric interaction under radiation) to a tumor-bearing mouse, either intravenous or intratumoral injection; and applying radiation to the mouse, wherein Cerenkov radiation is generated via the PET radionuclide and radical species are generated via the Cerenkov radiation, and wherein the radical species treat the tumor (abstract; p 370, right col; Fig. 1-6; Table 1). This is radiation therapy method comprising: administering a payload comprising first high Z nanoparticles (NPs) and second semiconductor NPs to a tissue site of a subject; and applying an ionizing first radiation directed at the site at which the payload was administered; wherein a second radiation is generated via interaction of the first high Z NPs with the first radiation; wherein chemical species are generated via interaction of the second semiconductor NPs with the second radiation; wherein the chemical species are damaging to one or more cells at the tissue site, and wherein the first high Z NPs include NPs comprising an element having an atomic number of at least 26. Exemplified TiO2 coatings include transferrin (applicant's 'immunologic adjuvant') (Fig. 1). The radionuclide and nanoparticles may be administered in Matrigel (RT device) (p 372, left col). The payload is administered via injection (abstract).
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.
Claims 78-100 are rejected under 35 U.S.C. 103 as being unpatentable over Kotagiri (Nat. Nanotechnol., 2015) in view of Hu (Biomaterials, 2014). The relevant portions of Kotagiri are given above.
Kotagiri fails to teach wherein the first high z NPs comprise at least one of gold NPs, gadolium NPs, or iron oxide NPs.
Hu teaches 64Cu-doped gold nanoclusters (AuNCs) useful for PET and NIR fluorescence imaging based on Cerenkov resonance energy transfer (Abstract; p 9868; Scheme 1). The AuNCs provide excellent biocompatibility, water solubility, and help avoid undesired or nonspecific binding (p 9869, left col).
It would have been obvious to a person of ordinary skill in the art at the time the invention was filed to use the 64Cu-doped AuNCs of Hu as the PET radionuclide composition species in the in vivo method of Kotagiri. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because the 64Cu-doped AuNCs would provide the advantages of biocompatibility, water solubility, and help to avoid undesired or nonspecific binding, as suggested by Hu.
Double Patenting
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 78-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1- 22 of US 11351258. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patent claims are directed to adiation therapy method comprising: administering a payload comprising first high z nanoparticles (NPs) and second semiconductor NPs to a tissue site of a subject; and applying an ionizing first radiation directed at the site at which the payload was administered; wherein a second radiation is generated via interaction of the first high z NPs with the first radiation; wherein chemical species are generated via interaction of the second semiconductor NPs with the second radiation; wherein the chemical species are damaging to one or more cells at the tissue site, and wherein the first high z NPs include NPs selected from the group consisting of gold NPs, gadolinium NPs, and iron oxide NPs (patent claim 1), further wherein the second semiconductor NPs are metal oxide NPs (patent claim 2), further wherein the second semiconductor NPs include NPs selected from the group consisting of titanium oxide and zinc oxide (patent claim 3), further wherein the second semiconductor NPs are doped with an image contrast agent (patent claim 4), further wherein the first high z NPs emit electrons via photoelectric interaction with the first radiation (patent claim five), further wherein the electrons are damaging to one or more cells at the site (patent claim 6), further wherein the first radiation is x-radiation (patent claim 7, further wherein the first high z NPs emit electrons via photoelectric interaction with the first radiation, and wherein the Cerenkov radiation is generated via interaction of the electrons with tissue of the subject (patent claim 8). This anticipates the present claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
April 17, 2026
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