Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 09/22/2025.
Claims 40-52 are pending in the instant application.
Claims 43, 47-50 are drawn to non-elected species.
Claims 43, 47-50 are withdrawn from further consideration.
Election/Restrictions
Applicant's election with traverse of “tumor” (claim 41), “manufacturing the nanoparticles based on the one or more parameters” (claim 45) in the reply filed on 09/22/2025 is acknowledged. The traversal is on the ground(s) that the requirement of electing a species of "further comprising" at least because the steps recited in claims 45 and 47-49 are essential for enabling the method of independent claim 40 to function. Thus, the steps of claims 45 and 47-49 are not patentably distinct species. First, one must generate the nanoparticles of claim 40 to practice the method of administering a photothermal therapy by direct injection of nanoparticles into a tissue. Second, the method of claim 40 involves controlling the emitted light energy within the tissue to ultimately emit heat energy, thereby resulting in "cellular death of cells of the tissue." Third, the method of claim 40 involves "determining an output power of the laser based at least in part upon one of heat dissipation and conductivity values within the tissue or shape factor values of the tissue; and emitting the light energy at the determined output power" as recited in claim 48. Lastly, emitting light energy involves "determining a time of exposure of the light energy on the tissue; and emitting the light energy for the determined time" as recited in claim 49 to achieve the method of claim 40.
This is not found persuasive because if the steps recited in claims 45 and 47-49 are essential for enabling the method of independent claim 40 to function, then these steps are required to be in independent claim 40, because independent claim 40 would lack the essential steps for enabling Applicant’s invention as argued by Applicant, which is a 112 issue. Applicant is entitled to amend these dependent claims of essential steps to independent claim 40 to avoid 112 issues as argued by Applicant. However, as currently recited by Applicant, these claims require different further comprising steps and would be a burden on the Office.
The requirement is still deemed proper and is therefore made FINAL.
Note, claims 43, 47-50 are drawn to non-elected species.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 40-42,44-46 and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/092,825 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-application recites a method of inducing malignant tumor regression in an organism having a malignant tumor, the method comprising: a) intravenously delivering to the organism having a malignant tumor a plurality of photothermal gold nanorods, each photothermal gold nanorod comprising a coating of a biocompatible molecular layer comprising thiol-terminated methoxy-poly-ethylene glycol to which was covalently conjugated an antibody that selectively targets malignant tumor cells, wherein the thiol is covalently bonded to external surfaces of the gold nanorods and the antibody is labeled with a near infrared (NIR) fluorescent dye, and wherein the photothermal gold nanorods attach to the malignant tumor cells; b) fluorescence imaging of the malignant tumor to indicate accumulation of the photothermal gold nanorods in the malignant tumor and an initial tumor size; c) applying a NIR laser that emits light energy to a region of the organism that contains the malignant tumor and the attached photothermal gold nanorods such that the photothermal gold nanorods absorb the light energy and emit heat energy that causes death of malignant tumor cells and reduction of tumor size; and d) fluorescence imaging of the malignant tumor to show tumor size after application of the NIR laser, wherein a decreased tumor size after application of the NIR laser shows tumor regression (see claims 53 and 59).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Note, Applicant’s recitation of “determining” are mental steps and are not active steps.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 42 and 52 recite the limitation "the molecular layer" in claim 40. There is insufficient antecedent basis for this limitation in the claims.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 40-42, 44-46, 51-52 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over HUANG et al (Plasmonic photothermal therapy (PPTT) using gold nanoparticles. Lasers Med Sci (2008) 23:217–228).
Regarding claims 40 and 41, HUANG teaches photothermal therapy using gold nanoparticles (see title) for treating tumors (see abstract) comprised of: injecting directly or intravenously PEGylated gold nanoshells to the tumor region (see abstract; pg. 224, 2nd col. – pg. 225 1st col.), which is the same nanoparticles used by Applicant and reads on “injecting a photothermal nanoparticle device directly into a tissue in an organism, the photothermal nanoparticle device comprising the determined concentration of nanostructures, each of the nanostructures configured to absorb light energy at the light energy absorption wavelength to produce a plasmon resonance effect that causes that nanostructure to emit heat energy”; using light from a laser to produce heat energy to treat cancer, wherein “hot electron temperatures of several thousand kelvins are easily reached in the nanoparticles even with laser excitation powers as low as 100 nJ
and the lattice temperature on the order of a few tens of degrees can be achieved (see abstract; and pg. 220, 2nd col), which reads on “emitting, via the laser, light energy, at the determined output parameters, and at a region of the organism that contains the tissue, wherein the heat energy causes cellular death of cells of the tissue”.
Regarding claims 42, 51 and 52, HUANG teaches “PEG is used to increase the biocompatibility and biostability of nanoparticles and impart them an increased blood retention time… PEGylated nanospheres and nanorods can be readily made by the conjugation of thiol-functionalized PEG with the gold nanoparticles. In case of in vivo applications, PEGylated nanoparticles are preferentially accumulated into tumor tissues due to the enhanced permeability and retention effect, known as the “golden standard” for drug design (see pg. 221, 1st col), which reads on “the nanostructures has a molecular layer functionalized onto an external surface of that nanostructure” and “the molecular layer comprises polyethylene glycol”;
Regarding claims 44-46, HUANG teaches “by adjusting the particle number, size, and laser energy, the researchers were able to selectively induce cell death or transiently modify cellular functions without causing cell destruction (see pg. 222, 1st col), which reads on “the one or more parameters of the nanoparticle comprise: a type of the nanoparticles, a shape of the nanoparticles, a size of the nanoparticles, a material of the nanoparticles, an aspect ratio of the nanoparticles, or a value of cross-section of absorption of the nanoparticles” and “manufacturing the nanoparticles based on the one or more parameters” and “determining the one or more parameters of the nanoparticles comprises determining the one or more parameters to have a plasmon resonance absorption to overlap with the light energy absorption wavelength”.
The reference does not specifically teach functionalizing the PEG molecular layer in the concentration range amounts as claimed by Applicant. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as increase the biocompatibility and biostability of nanoparticles, accumulation into tumor tissues due to the enhanced permeability and retention effect. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Note, Applicant’s recitation of “determining” are mental steps and are not active steps.
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