DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 12 March 2026, is acknowledged.
Claims 1, 5, 10, 12-16, and 18-19 have been amended.
Claims 2-3, 11, and 17 have been cancelled.
Claims 1, 4-10, 12-16, and 18-19 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the specific carbon nanoparticles are carbon quantum dots;
the specific suspending agent is poloxamer (a poly(propylene oxide) and poly(ethylene oxide) triblock copolymer with formula PEOxPPOyPEOz);
the specific pH adjuster is sodium acetate; and
the specific ferric salt is ferrous sulfate (FeSO4).
Objections Withdrawn
Objections to Claims
Applicant’s amendment to claims 1 and 16, submitted on 12 March 2026, has overcome the objection to the claims set forth in the Office Action mailed on 12 December 2025. Accordingly, the relevant objections are withdrawn. The cancellation of claims 2, 11, and 17 have rendered moot the objections to the claims set forth in the Office Action mailed on 12 December 2025.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejections of claims 5, 7, 10, 12-16, and 18-19 under 35 U.S.C. § 112 is withdrawn in view of Applicant’s amendments to the claims. The cancellation of claims 11 and 17 have rendered moot the rejections of the claims under 35 U.S.C. § 112.
Maintained Rejections
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.
Claim 5 is 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 5 recites the limitation "the heating time" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 5 does not recite a heating time. Claim 2, from which claim 5 depends, has been cancelled and for the purposes of examination claim 5 is interpreted as depending from claim 1. Claim 1 also does not recite a heating time.
Response to Amendments
Claim 5 was amended to further limit use of the claimed invention to “heating the tissue using near-infrared light”. However, as stated in the Office Action mailed on 12 December 2025, claim 5 was rejected under 35 U.S.C. § 112(b) for lacking antecedent basis for the limitation “the heating time” because neither claim 5 nor the claim from which it depended (claim 2 in the claims filed on 30 September 2025) recited “a heating time”. The amendments submitted on 12 March 2026, do not overcome this rejection because claim 5 still does not recite a heating time and claims 1 and 4, the only preceding claims from which claim 5 could depend, also do not recite a heating time.
Claim Rejections - 35 USC § 103
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 1, 4-10, 12-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chongqing Lummy Pharmaceutical Co., LTD (WIPO International Publication No. WO 2018/137708 A1, published on 2 August 2018, provided by Applicant in the IDS filed on 27 March 2023, references to English translation, hereafter referred to as CL Pharma) as evidenced by Liu et al. (Sci. Prog. 2023, 106 (2), 1.) in view of Moghimi et al. (Trends Biotechnol. 2000, 18, 412., hereafter referred to as Moghimi), Napaporn et al. (Pharma. Dev. Technol. 2000, 5 (1), 123., hereafter referred to as Napaporn), and Zhang et al. (Carbon 2017, 118, 752., hereafter referred to as Zhang).
CL Pharma teaches a nanocarbon-iron composite system comprising ferrous iron salts in a suspension liquid for injection, preparation methods of the system, and use of the system to treat cancer (Abstract). The system contains an iron salt, which may be ferrous sulfate (claim 4), at a concentration from 1.36-13.6 mg/mL (claim 2). In a 1,000 mL solution, as recited in instant claim 1, this would be 1.36-13.6 g of ferrous sulfate. CL Pharma further teaches that the ratio of nanocarbon to iron salt is 40:1 to 3:1 (claim 5), resulting in a 1,000 mL solution containing ~4-544 g of nanocarbon, which contains the ratio and quantity of carbon nanoparticles recited in instant claim 1. In one embodiment, the nanocarbon is carbon quantum dots (claim 7).
The system is further taught to comprise a suspending agent to increase the viscosity of the dispersion medium at a concentration of 10-40 mg/mL, which would be 10-40 g in a 1,000 mL sample and therefore encompasses the range recited in instant claim 1 (pg. 4, lines 22-25 and claims 12-13). CL Pharma also teach the inclusion of sodium citrate as a pH adjuster in a ratio with the iron salt of 0.1-3, which results in ~0.14-41 g in a 1,000 mL sample, to adjust the pH to 6.8-7.2 (pg. 4, lines 28-29 and claim 10). Further, CL Pharma teaches the suspension liquid to be “physiological saline”, which is a solution of 0.9% sodium chloride in water, as evidenced by Liu et al. (pg. 4, lines 28-29 and claim 15). The molar mass of NaCl is 58.44 g/mol, therefore a 1,000 mL of a 0.9% NaCl solution would contain 9 g of NaCl, which falls within the range cited in instant claim 1. Finally, the solution is taught to be lyophilized prior to injection, which is interpreted as containing a “lyophilized powder of ferrous sulfate for injection” as recited in claim 10 (pg. 4, line 38 and claim 16).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the ratios and quantities of the iron salt, carbon nanoparticle, suspending agent, NaCl, and pH adjuster. In each instance, the recited ratio and/or ranges either fall within or significantly overlap with the ratio and/or ranges taught by CL Pharma.
CL Pharma does not teach the suspending agent to be a poloxamer, the pH adjuster to be sodium acetate, nor use of their composition in combination with near-IR light for the treatment of cancer. These deficiencies are offset by the teachings of Moghimi, Napaporn, and Zhang.
Moghimi teaches the applications of poloxamers and poloxamine nonionic surfactants in biomedical fields (Abstract). Poloxamers, block polymers of PEO and PPO, are taught to be nonionic and to “adsorb strongly onto the surface of hydrophobic nanospheres”, which includes carbon quantum dots (pg. 412, para. 1 - pg. 413, left column, para. 1). This adsorption is taught to “provide stability to the particle suspension” and the nanoparticles subsequently exhibit reduced adsorption of biomolecules such as proteins, which can lead to ingestion by scavenger cells (pg. 413, Long circulating particles, para. 1-2). Poloxamers are taught to possess other advantages following intravenous injection, including increased systemic circulation, improving drug delivery, improved targeting, and improved medical imaging (pg. 414, left column, para. 1 - right column, para. 4 and Table 1). Moghimi also teaches examples in which poloxamers increase immunological activity (pg. 415, left column, final para.), inhibit multidrug resistance (pg. 416, Inhibition of multidrug resistance), and reduces blood viscosity via lubricating cell surfaces (pg. 416, Applications in vascular medicine).
Napaporn teaches an assessment of the myotoxicity of acetate, succinate, and citrate pharmaceutical buffers (Abstract). Typical pharmaceutical formulations are taught to use acetate, succinate, citrate, and phosphate buffer systems to reduce discomfort to patients, ensure formulation stability and solubility, and to control therapeutic activity of APIs (pg. 124, left column, para. 2). Napaporn teaches that citrate buffers have been noted in particular to cause pain to patients and that buffers containing the conjugate bases of carboxylic acids, acetate, succinate, and citrate, have been observed to “cause red blood cell agglutination and/or hemolysis” (pg. 124, left column, para. 2). Napaporn established a study to investigate the toxicity to skeletal muscle (myotoxicity) of acetate, succinate, and citrate buffers as a function of pH, buffering capacity, tonicity, and buffer type (pg. 124, right column, para. 2).
Citrate buffers were taught to possess myotoxicity that “was greater than those of acetate and succinate buffers” (pg. 126, right column, para. 4). When buffer solutions were made isotonic with NaCl or trehalose, that is equal osmolality to biological conditions, the toxicity was greatly reduced as compared to the buffers alone in solution, which are hypertonic with respect to biological conditions (pg. 127, Buffer Tonicity Studies). In particular, the citrate buffer had the highest toxicity again when in solution with NaCl, with acetate or succinate having the lowest depending on the concentration of the carboxylic acid (Fig. 4 and 5). Napaporn notes that the lower succinate toxicity “may have been dependent upon muscle weight of rats used in the study” as subjects, that the animal size and age had substantial effects on data, and that “the succinate data may have been confounded by these parameters” (pg. 129, left column, final para.).
Zhang teaches the use of functionalized carbon quantum dots for simultaneous photothermal therapy (PTT) and photodynamic therapy (PDT) following irradiation with near-IR (NIR) light (Abstract). PDT is taught to be non-invasive cancer treatment method that utilizes a photosensitzer to kill targeted tissue, such as a tumor, following irradiation, and PTT is similarly taught to be highly selective and minimally invasive, as well as utilizing NIR radiation (pg. 752, right column, final para. - pg. 753, left column, para. 1). The use of PDT or PTT alone is taught to have drawbacks, but combining the techniques to be used with nanoparticles, in particular quantum dots, is taught to be worth investigation (pg. 753, left column, para. 1). Carbon quantum dots are taught to be capable of anticancer activity following NIR irradiation, “which offers greatly improved tissue penetration” (pg. 753, left column, para. 2). Zhang concludes that the NIR activated functionalized quantum dots have “great potential for the clinical applications in treating patients with gastric cancer or other tumors in the future” (pg. 762, Conclusion).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention of CL Pharma with the teachings of Moghimi, Napaporn, and Zhang to arrive at the claimed invention because simple substitution of one element known in the art for another to impart known benefits produces predictable results. A person of ordinary skill would have been motivated to use a poloxamer as a suspending agent in view of the teachings of Moghimi because Moghimi teaches the triblock polymers to provide stability to hydrophobic nanoparticle suspensions and to reduce undesirable adsorption of biomolecules to the nanoparticles, alongside other benefits, which an ordinary artisan would desire in a solution containing hydrophobic carbon nanoparticles such as quantum dots that will be injected into a patient. The ordinary artisan would further be motivated to try using sodium acetate as the pH adjuster rather than sodium citrate in view of the teachings of Napaporn because Napaporn teaches that citrate buffers may have higher toxicity than acetate buffers following administration. One of ordinary skill would desire their injectable solution to have lower toxicity to the patient and would therefore be motivated to try using pH adjusters that possess lower toxicity. Finally, an ordinary artisan would be motivated to use the above composition in combination with near-IR light for the treatment of cancer because CL Pharma teaches that a composition containing carbon quantum dots, ferrous sulfate, sodium chloride, and water is useful for treating cancer and Zhang teaches that near-IR light is a preferable wavelength range to be used in cancer treatment, due to PTT activity and greater tissue penetration, as well as teaching that quantum dots may absorb in the near-IR range. The ordinary artisan would be motivated to try using the above composition in combination with near-IR light to meet the therapeutic need taught by Zhang.
With respect to claims 4-5, the limitations regarding the irradiation with near-infrared light is interpreted as intended use. The use of a material known in the art based upon its suitability for a particular use has previously supported determinations of prima facie obviousness. See MPEP § 2144.07, Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). The use of a composition comprising carbon quantum dots, ferrous sulfate, a suspending agent, a pH adjuster, sodium chloride, and water for the treatment of cancer is known in the art, as evidenced by the CL Pharma reference. Therefore, the intended use in claims 4-5 is prima facie obvious.
With respect to claims 10, 12-15, and 18-19, the claims are interpreted as product-by process claims where the patentability is based on the product and are not limited to the manipulations of the recited steps. “[E]ven 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). As a result, there is a reasonable expectation of success in arriving at the invention of claims 1, 4-10, 12-16, and 18-19 in view of the teachings of CL Pharma, Moghimi, Napaporn, and Zhang.
Response to Arguments
The Applicant’s arguments, filed on 12 March 2026, have been fully considered but are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In para. 1-2 of the section titled “35 U.S.C. 103” on pg. 7, Applicant argues that “Reference Document 1”, which is interpreted as equivalent to CL Pharma above, does not disclose the use of CNSI-Fe with near-IR light nor mention “the concept of mild hyperthermia”. This argument is directed to the intended use of the CNSI-Fe mixture while the instant claims are drawn to the mixture itself. As stated in the Office Action mailed on 12 December 2025, the limitations regarding the irradiation with near-infrared light are interpreted as intended use and do not have patentable weight. See MPEP § 2111.02. In brief, the use of a material known in the art based upon its suitability for a particular use has previously supported determinations of prima facie obviousness. A composition comprising carbon quantum dots, ferrous sulfate, a suspending agent, a pH adjuster, sodium chloride, and water has been rendered prima facie obvious (vide supra) and its use in the treatment of cancer is therefore also prima facie obvious regardless of teaching the use of near-IR light or mild hyperthermia.
In para. 2 of the section titled “35 U.S.C. 103” on pg. 7, Applicant states that their invention “discovers a new use of CNSI-Fe in combination with near-infrared light for tumor hyperthermia” (bold added for emphasis). As stated above and restated here for convenience, the limitations regarding the irradiation with near-infrared light are interpreted as intended use, which do not have patentable weight when the claims are drawn to the CNSI-Fe mixture. See MPEP § 2144.07, Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). To the extent that Applicant is claiming new properties of the claimed mixture, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112(I).
In the penultimate para. of pg. 7 and para. that spans pg. 7 and 8, Applicant argues that none of the references cited in the rejection under 35 U.S.C. § 103 disclose a “synergistic effect”. As stated above, this argument is drawn to an intended use of the CNSI-Fe mixture while the claims are drawn to the mixture itself. The prior art has rendered the CNSI-Fe mixture prima facie obvious and does not have to teach its intended use nor its synergy when used with near-IR light to render the mixture obvious under 35 U.S.C. § 103. See MPEP § 2144.07.
To the extent that Applicant is arguing a property or advantage of the CNSI-Fe mixture when used in combination with near-IR light, the “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). See MPEP § 2145.II. In addition, because the mixture of carbon quantum dots, ferrous sulfate, a suspending agent, a pH adjuster, sodium chloride, and water has been rendered prima facie obvious (vide supra), any synergy between the mixture and near-IR light would necessarily be present. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP § 2112.01.II.
From para. 2 of pg. 8 to para. 2 of pg. 9, Applicant discusses the mechanism of their invention and compares it to treatment without iron or near-IR irradiation and to the absence of treatment. This is acknowledged, but as stated above the instant claims are drawn to the CNSI-Fe mixture itself and not its intended use, i.e., applicant are not claiming a method. The mixture has been rendered prima facie obvious and the prior art does not need to teach its mechanism of action nor its synergy with near-IR light to show this obviousness, therefore the argument is not found persuasive. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). It should also be noted that the document titled “Comparative Document 1” Applicant cites is not in the specification nor was it cited in the previous Office Action, so its relevance cannot be determined. In addition, “Table 21” referenced in para. 3 of pg. 8 is not able to be identified.
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 1, 4-10, 12-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting (NSDP) as being unpatentable over claim 1-6 of copending Application No. 18/970,315 in view of Napaporn (Pharma. Dev. Technol. 2000, 5 (1), 123.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/970,315 recites a mixture of carbon nanoparticle suspension injection and iron, in which iron is ferrous sulfate, and the concentration in the mixture is 20-100 mg/mL carbon nanoparticle suspension and 0.5-60 mg/mL ferrous sulfate (claims 1-2). In a 1,000 mL sample, this results in concentrations of 20-100 g of carbon nanoparticles and 0.5-60 g ferrous sulfate, and a carbon nanoparticle: ferrous sulfate ratio of 3.3-400: 16.7-2000, which encompasses the ranges recited in instant claim 1 (claim 4). The 1,000 mL sample is further recited to comprise 17-30 g of poloxamer, 2-4 g of sodium citrate, 8-10 g of sodium chloride, and “the balance water for injection” (claims 4-5). Finally, Application ‘315 recites the mixture to have a pH between 2.8-6.0 (claim 3) and the ferrous sulfate to be freeze-dried, which is equivalent to lyophilization (claim 6).
Copending Application No. 18/970,315 does not recite the pH adjuster to be sodium acetate. These deficiencies are offset by the teachings of Napaporn.
Napaporn has been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention claimed by copending Application No. 18/970,315 in view of the teachings of teachings of Napaporn to arrive at the claimed invention because simple substitution of one element known in the art for another to impart known benefits produces predictable results. A person of ordinary skill would have been motivated to try using sodium acetate as the pH adjuster rather than sodium citrate in view of the teachings of Napaporn because Napaporn teaches that citrate buffers may have higher toxicity than acetate buffers following administration. One of ordinary skill would desire their injectable solution to have lower toxicity to the patient and would therefore be motivated to try using pH adjusters that possess lower toxicity.
With respect to claims 4-5, the limitations regarding the use of near-infrared light for the treatment of cancer is interpreted as intended use. The use of a material known in the art based upon its suitability for a particular use has previously supported determinations of prima facie obviousness. See MPEP § 2144.07, Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). The use of a composition comprising carbon quantum dots, ferrous sulfate, a suspending agent, a pH adjuster, sodium chloride, and water for the treatment of cancer is known in the art, as evidenced by the CL Pharma reference and claims 9, 11, and 13 of copending Application ‘315. Therefore, the intended use in claims 4-5 is prima facie obvious.
With respect to claims 10, 12-15, and 18-19, the claims are interpreted as product-by process claims where the patentability is based on the product and are not limited to the manipulations of the recited steps. “[E]ven 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). As a result, there is a reasonable expectation of success in arriving at the invention of claims 1, 4-10, 12-16, and 18-19 in view of the invention recited in claims 1-6 of copending Application No. 18/970,315 and in view of the teachings of Napaporn.
Claims 1, 4-10, 12-16, and 18-19 are directed to an invention not patentably distinct from claims 1-5 of commonly assigned copending Application No. 18/970,315 in view of Napaporn. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 18/970,315, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant attempted to file a Terminal Disclaimer on 12 March 2026, but it has been disapproved due to incorrect information and form usage, see comments on the Terminal Disclaimer review decision dated 26 March 2026. As a result, the NSDP rejection is maintained.
From the penultimate para. of pg. 9 to para. 2 of pg. 10, Applicant states that they have amended claims 7 and 9 to include nonelected species to preserve the right to seek rejoinder in the event that claims are found allowable. This is acknowledged.
In para. 3 of pg. 10, Applicant restates the mechanism and usefulness of their invention. This is also acknowledged, but does not present an argument against the NSDP rejection presented in the Office Action mailed on 12 December 2025, and is therefore not found persuasive.
New Grounds of Objection
Claim Objections
Claim 13 is objected to because it has been amended to recite “nanoparticles ,and thenby ethyl acetate” in lines 3-5. The comma should precede the space between “nanoparticles” and “and” and a space should separate the words “then” and “by”, so the resulting phrase reads “nanoparticles, and then by ethyl acetate” (bold added for emphasis).
Appropriate correction is required.
New Grounds of Rejection
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 4-5 and 13 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.
Claims 4-5 depend from claim 2, which has been cancelled, and the claims are therefore indefinite for being incomplete. Applicant may overcome this rejection by amending the claims to depend from claim 1. For purposes of examination, claims 4-5 are interpreted as depending from claim 1.
Claim 13 has been amended to recite “degreasing the carbon nanoparticles ,and thenby ethyl acetate using a 8-15%v/v HNO3 aqueous solution” in lines 3-5. It is unclear if ethyl acetate is used to degrease the carbon nanoparticles, if ethyl acetate washing follows a separate degreasing step using the HNO3 solution, or if three separate steps of washing are being performed.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard, can be reached at (571) 272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619