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 19 February 2026, is acknowledged.
Claims 1-4, 8, 12, and 49 have been amended.
Claims 9-11 have been cancelled.
New claim 51 has been added.
Claims 16-48 were previously withdrawn from consideration in the Office Action mailed on 19 August 2025, as being drawn to a nonelected invention.
Claims 1-8, 12-14, and 49-51 are pending and under consideration in the instant Office Action, to the extent of the previously elected species silver and water.
Objections Withdrawn
Objections to Specification
Applicant’s newly submitted drawings, submitted on 19 February 2026, have overcome the objection to the drawings set forth in the Office Action mailed on 19 August 2025. Accordingly, the relevant objections are withdrawn.
Objections to Claims
Applicant’s amendment to claim 1, submitted on 19 February 2026, has overcome the objection to the claim set forth in the Office Action mailed on 19 August 2025. Accordingly, the relevant objection is withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claims 1-8 and 12-14 under 35 U.S.C. § 112(a) is withdrawn in view of Applicant’s amendment to claim 1. The rejections of claims 9-11 under 35 U.S.C. § 112(a) and 112(b) and claims 9-10 under 35 U.S.C. § 112(d) have been rendered moot in view of Applicant’s cancellation of the claims.
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 9-11 under 35 U.S.C. § 103 has been rendered moot in view of Applicant’s cancellation of the claims. The rejection of claims 1-8, 12-14, and 49-50 under 35 U.S.C § 103 is withdrawn in view of Applicant’s amendments to the claims and in favor of the new grounds of rejection below.
Double Patenting Rejections
The nonstatutory double patenting (NSDP) rejection of claims 9-11 has been rendered moot in view of Applicant’s cancellation of the claims. The NSDP rejection of claims 1-8, 12-14, and 49-50 has been made anew in view of Applicant’s amendments to the claims and submission of new claim 51.
Maintained Objections
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. On pg. 37, references 1-4, and on pg. 38, references 6-7, contain hyperlinks. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Response to Remarks
The Applicant’s remarks, filed on 19 February 2026, regarding the embedded hyperlinks in the instant specification are acknowledged. Applicant’s amendments to the above sections of the instant specification do not remove the embedded hyperlinks and/or other forms of browser-executable code and therefore remain objectionable. Applicant is advised that the references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code.
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.
Claims 1-8 and 12-14 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 “a first range from 20 nm to 24 nm and a second range from 3 nm to 5 nm” in lines 5-6. It is unclear whether the diameter is limited to one of the ranges, may fall within either, or if the diameter is required to fall within both ranges simultaneously. Claims 2-8 and 12-14 depend from claim 1 and necessarily incorporate the indefinite limitations of claim 1, and therefore are also rejected as being indefinite. Claim 1 has been amended to recite the mCNPs may be in the shape of a rod, star, or other polygon, which do not all possess diameters and also render the limitation unclear. This rejection may be overcome by amending claim 1 to limit the diameter to one of the two ranges, to recite the two ranges in the alternative, or to specify the relationship of the ranges to the Janus-type two phase construct.
Response to Arguments
The Applicant’s amendments, filed on 19 February 2026, have been fully considered but do not overcome the rejection above. Applicant amended instant claim 1 to remove the phrase “at least a portion of”, but the relationship between the two ranges, which may both be required, and the shape of the metal-associated cerium oxide nanoparticles is still not clear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 depends from claim 2, which recites a Markush group consisting of 11 metals. Claim 3 recites the metal to comprise “metallic silver”, which is not one of the 11 metals in the Markush group recited in claim 2. As a result, claim 3 fails to incorporate all of the limitations of the claim upon which it depends.
Claim 8 depends from claim 1, which recites an average diameter that is 20-24 nm and 3-5 nm. Claim 8 recites a series of dimensions in the alternative, including “less than 15 nm or less than 10 nm”. Neither of these ranges include the range of 20-24 nm as recited in claim 1 and therefore claim 8 fails to incorporate all of the limitations of the claim upon which it depends.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Response to Amendments
The Applicant’s amendments, filed on 19 February 2026, have been fully considered but do not overcome the rejection above. Applicant has amended claim 3 to remove the words “a stable”, but it still recites “metallic silver” which is not one of the 11 metals in the Markush group recited in claim 2.
Additionally, the amendment to claim 8 has removed the limitation “less than 100 nm, less than 50 nm”, but does not address the issue of indefiniteness presented in the Office Action mailed on 19 August 2025. In brief, instant claim 8 still recites “less than 25 nm”, which encompasses all values between 0-25 nm, and depends from claim 1 which recites the specific ranges 20-24 nm and 3-5 nm. Claim 8 therefore includes ranges from 24-25 nm, 5-20 nm, and <3 nm, which are not recited in claim 1, and the issue remains regarding failure to incorporate all of the limitations of the claim upon which it depends. Similar issues persist with the limitations “less than 15 nm or less than 10 nm” with respect to claim 1 reciting “3 nm to 5 nm”.
New Grounds of Objection
Claim Objections
Amended claims 1, 12, 49, and 51 are objected to because of the following informalities:
Claim 1 was amended to recite “the…nanoparticles is at least” in line 4 (bold added for emphasis). The noun “nanoparticles” is plural and the bolded word should be changed to “are” so the resulting phrase reads “the…nanoparticles are at least” (bold added for emphasis).
Claim 12 was amended to recite “the mCNPs omprise both” in lines 1-2. The letter “c” appears to have been inadvertently deleted from the word “comprise” and should be added.
Claim 49 was amended to recite a composition “comprising a silver-associated cerium oxide nanoparticles” in lines 1-2 (bold added for emphasis). The noun “nanoparticles” is plural and the bolded word should be removed so the resulting phrase reads “comprising silver-associated cerium oxide nanoparticles”. Claim 49 also was amended to recite “construct and and an aqueous excipient” in lines 3-4 (bold added for emphasis). The extraneous “and” bolded above should be removed.
New claim 51 recites “the composition is antimicrobial composition”. The word “an” should be inserted so the phrase reads “the composition is an antimicrobial composition” (bold added for emphasis).
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.
Claim 4 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 4 was amended to recite the concentration of silver in the composition to be “about 6% to 10%” in line 2, but also recites “or less” which includes values below 6%. The claim is considered indefinite because there is a question or doubt as to whether the limitation is 6-10% w/w or ≤10% w/w. Applicant may overcome this rejection by amending the claim to only recite “6 to 10% by weight” or “10% or less by weight”.
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 1-8, 12-14, and 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over Baker (WIPO International Patent Publication No. WO 2016/011328 A1, published on 21 January 2016, provided by Applicant in IDS) in view of Das (Nanomed. J. 2013, 8 (9), 1483., provided by Applicant in IDS filed on 24 January 2023), Wu et al. (Nano Today 2018, 22, 62., hereafter referred to as Wu), and Chang (J. Catal. 2012, 293, 195.,).
Baker teaches cerium oxide nanoparticles and a method of using the nanoparticles to treat cancer (Abstract). The cerium oxide nanoparticles are taught, in one embodiment, to be in a composition which also comprises a pharmaceutical carrier and may be administered to patients topically (para. [0034-0035]). Baker defines the “pharmaceutical carrier” of their invention to include antibacterial agents and the composition is therefore considered to be an antibacterial composition (para. [0094]). Under the definition of “dispense” provided in the instant specification on pg. 5, lines 3-12, the composition described above is interpreted as a dispensable composition. Baker further teaches the nanoparticles to have a “size dimension” that may be 1-20 nm (claim 11) or 3-50 nm (para. [00103]). The cerium oxide nanoparticles are also taught to be doped with metal ions, including silver, and anions including fluorine (para. [00104]). The pharmaceutical carrier, in some embodiments, is taught to comprise water (para. [0035], [00277], [00286], and claim 18).
The cerium atoms in the nanoparticles are taught to be in the 3+ or 4+ valence state, which can vary depending on redox conditions and other factors (para. [0098]). The predominant valence state of the cerium ions is taught to change with pH conditions, shifting the ratio towards Ce3+ in alkaline conditions (pH >6.5) and toward Ce4+ in acidic conditions (pH <6.5) (para. [0105]). In Table 3, Baker teaches 9 example compositions with pH values that are both above and below 6.5, resulting in compositions that are predominantly Ce4+ and compositions that are predominantly Ce3+.
Baker does not teach the shape of the cerium oxide nanoparticles, removal of the unassociated silver ions, the amount of silver in the nanoparticles, the nanoparticles to form a Janus-type two phase construct, nor the nanoparticles to possess catalase and/or superoxide dismutase-like enzyme-mimetic activity. These deficiencies are offset by the teachings of Das, Wu, and Chang.
Das teaches the use of cerium oxide nanoparticles in biological systems to scavenge reactive oxygen and nitrogen species and protect against chronic oxidative stress and inflammation (Abstract). Cerium oxide nanoparticles (CNPs) are taught to have gained interest due to their regenerative antioxidant property, finding use in industries such as toxic gas removal, solid oxide fuel cells, and catalysis, as well as biotechnology and medicine (pg. 1483, right column, final para. - pg. 1484, left column, para. 2). When used in biological contexts, Das teaches that morphology is an important physical property because some shapes, such as polygonal, cube, or rod shapes, have sharp edges that could cause cellular damage (pg. 1485, left column, para. 2). Das concludes that spherical or near spherical particle shapes do not have sharp edges and that these shapes may be manufactured using room temperature, wet chemical methods (pg. 1485, left column, para. 2).
Das further teaches that CNPs display activity similar to that of superoxide dismutase (SOD), referred to as an “SOD mimic”, as well as peroxide protection activity, which has been described as “catalase mimetic activity” (pg. 1487, SOD mimetic activity and Catalase mimetic activity). Das correlates the above activities with the predominant oxidation state on the surface of the CNP and teaches that predominantly Ce3+ leads to SOD mimetic activity, while predominantly Ce4+ leads to catalase mimetic activity (pg. 1488, Antioxidant activity & correlation with physiochemical properties and Table 2). Finally, Das teaches a correlation of nanoparticle size with antioxidant activity, demonstrating SOD mimetic CNPs with sizes of 3-5 nm and catalase mimetic CNPs with sizes of 16 or 8-10 nm (Table 2).
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 size of the CNPs; in each instance, the ranges taught by Baker and Das encompass or fall within the ranges recited in instant claims 1 and 8 and the ranges are therefore prima facie obvious.
Wu teaches the nanostructure class of Janus nanoarchitectures and their applications in various fields including emulsion stabilizers, catalysis, and drug delivery (Abstract). Wu teaches that Janus nanomaterials are those with an asymmetric, heterostructural junction which can have separate portions with different surface modifications, reactivity, catalytic properties, etc. (pg. 63, left column, para. 1-2). Janus composite nanoparticles are taught, in combination with rational design, to have the potential to contain “an interesting combination of different or opposite properties in single particles [that] can achieve some extraordinary synergic properties for some specific applications” (pg. 63, left column, para. 2). In Figure 1, Wu teaches that spherical nanoparticles or “Snow-man” type nanoparticles, which have a semi-sphere attached to a larger semi-sphere, are possible Janus structures.
Chang teaches the structure and catalytic activities in CO oxidation of Ag/CeO2 nanoparticles (Abstract). CNPs with 1% and 3% by weight of Ag were synthesized and characterized using X-ray photoelectron spectroscopy (XPS) and X-ray absorption spectroscopy (XAS) measurements (2. Experimental section, 2.2. Structural characterization). Data from these measurements indicated that the silver species present in the Ag/CeO2 are nanoparticles and either metallic atomic silver or ionized Ag+, with the dominant silver species varying based upon loading (pg. 198, left column, para. 2). XPS, XAS, and X-ray absorption near-edge structures (XANES) indicated that the metallic atomic silver species dominates in the 3% Ag/CeO2 nanoparticles and the proportion of silver species shifts toward metallic nanoparticles as the loading increases (pg. 198, left column, para. 2 - right column, para. 2).
Chang further teaches that “oxygen vacancies play a decisive role in the surface reactivity and catalytic performance of CeO2 nanoparticles” and that metallic Ag nanoparticles are “much more capable of creating oxygen vacancies in CeO2” (pg. 202, left column, para. 1-2). This is supported by the teachings that the CNPs with metallic Ag nanoparticles have greater catalytic activity and turnover frequency than those with Ag+ (pg. 202, left column, final para. and Fig. 11). Chang concludes that metallic Ag nanoparticles are much more capable of enhancing CeO2 activity than Ag+ and that Ag-loaded CNPs can display high catalytic activity even with a relatively low silver loading (pg. 203, 4. Conclusions).
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 concentration of silver loaded onto the CNPs. Instant claim 4 was amended to recite a concentration of silver that is “about 6% to 10% or less by weight”, which encompasses values between 0-10% by weight. The values taught by Chang fall within the range recited in instant claim 4 and the range is therefore prima facie obvious.
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 combine the teachings of Baker, Das, Wu, and Chang to arrive at the claimed invention because combining prior art elements according to known methods yields predictable results. Baker teaches cerium oxide nanoparticles that may contain silver and/or fluorine, with a size from 1-20 nm or 3-50 nm, in a composition that may be dispensed and in some embodiments contains water. In view of the teachings of Das, an ordinary artisan would be motivated to make the nanoparticle spherical because Das teaches the shape to reduce cellular damage due to sharp edges, which the artisan would desire in a composition that is intended to be used by a patient. One of ordinary skill would further be motivated to manipulate the ratio of Ce3+: Ce4+ ions on the surface of the CNPs to modulate SOD and/or catalase mimetic activity because Das teaches CNPs to have this capability and the utility of its use in biological applications, such as patient treatment as taught by Baker.
The ordinary artisan would be motivated to modify the above invention to have a Janus-type two phase architecture because Wu teaches that Janus-type nanoarchitectures can enable different properties on different portions of the same nanoparticle. Das taught that CNPs can exhibit both SOD and catalase mimetic activity based upon the predominant oxidation state of Ce in the nanoparticles. In view of the teachings of Wu, the person of ordinary skill would be motivated to develop a Janus-type CNP with predominantly Ce3+ on one portion, which would enable SOD-like activity, and predominantly Ce4+ on another portion, which would enable catalase-like activity on a separation portion of the same nanoparticle. Because Das teaches the catalase-activity possessing diameter to be larger, the number of Ce ions with a 4+ charge would be greater and therefore the predominant surface charge would necessarily be 4+. Finally, in view of the teachings of Chang the ordinary artisan would be motivated to load the CNPs with ~3% Ag because Chang teaches this concentration to have higher surface activity than 1% Ag, which would be desirable for CNPs that are intended to treat patients and exhibit SOD and/or catalase mimetic activity. Further, one of ordinary skill would be motivated to remove any ionized silver from the surface of the Ag-CNPs because Chang teaches the ionized metal to have lower activity than metallic silver nanoparticles and it would be obvious to an artisan that ions exhibiting low activity on the surface of nanoparticles are unwanted.
Claims 13-14 and 50 are interpreted as product-by-process claims. While the claims recite the steps of a method of producing Ag-CNPs, the patentability is based upon the product, that is Ag-CNPs, and the claims are therefore not limited to the manipulations of the recited steps of the method, only the structure implied by the steps. See MPEP § 2113. "[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). Because the dispensable compositions comprising Ag-CNPs recited in instant claims 1-8, 12, 49, and 51 are obvious in view of the teachings of Baker, Das, Wu, and Chang, claims 13-14 and 50 are unpatentable even if the Ag-CNPs were made via a different process. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-8, 12-14, and 49-51 in view of the teachings of Baker, Das, Wu, and Chang.
Response to Arguments
The Applicant’s arguments, filed on 19 February 2026, have been fully considered but are not persuasive.
In response to applicant's arguments against the references individually from the final para. of pg. 3 to para. 4 of pg. 4, 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 of pg. 4 Applicant argues that the Baker reference does not teach cerium oxide “with a predominantly 4+ surface discharge and does not form a Janus-type two phase construct”. This has been addressed in the new ground of rejection of claim 1 under 35 U.S.C. § 103 presented above, which now includes the teachings of the Wu reference regarding Janus-type constructs that were previously cited in the rejection of claim 11 in the Office Action mailed on 19 August 2025. Therefore, Applicant’s argument is found unpersuasive.
In para. 2 of pg. 4 Applicant argues that the Das reference does not teach “mCNPs that comprise a predominantly 4+ surface discharge and form a Janus-type two phase construct”. This argument was also not made in the Office Action mailed on 19 August 2025, nor is it made above, and the Applicant’s argument is therefore considered moot.
Finally, in para. 3-4 of pg. 4 Applicant argues that Chang “does not teach mCNPs that comprise a predominantly 4+ surface discharge and form a Janus-type two phase construct”. As stated above, this argument was not made in the Office Action mailed on 19 August 2025, nor is it made above, and the Applicant’s argument is therefore considered moot. In each instance, the limitations recited in the instant claims are rendered obvious by the combination of teachings from the references above. As a result, Applicant’s arguments are not found to be persuasive.
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 1-8, 12-14 and 49-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 17/973,769 in view of Das et al. (Nanomed. J. 2013, 8 (9), 1483., provided by Applicant in IDS filed on 24 January 2023, hereafter referred to as Das), Chang et al. (J. Catal. 2012, 293, 195., hereafter referred to as Chang), and Baker (WIPO International Patent Publication No. WO 2016/011328 A1, published on 21 January 2016, provided by Applicant in IDS).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 17/973,769 recites a fibrous therapeutic material that has been treated with a mixture comprising metal-modified cerium oxide nanoparticles with a predominantly 3+ surface charge, a size in the range of 3-35 nm, one or more polymeric binders, one or more dispersants, and one or more stabilizers (claim 1). The metal in the cerium oxide nanoparticles is recited to be metallic silver and the particles are a “Janus-type two-phase construct” (claim 2).
Copending Application No. 17/973,769 does not recite the nanoparticles of the invention to be spherical, the concentration of silver in the nanoparticles, the mixture to comprise water, the nanoparticles to be doped with fluorine, nor the nanoparticles to possess catalase and/or superoxide dismutase-like enzyme-mimetic activity. These deficiencies are offset by the teachings of Das, Chang, and Baker.
Das, Chang, and Baker are described in the rejection under 35 U.S.C. § 103.
Instant claims 1-8, 12-14 and 49-51 are obvious variations of copending Application No. 17/973,769 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to use silver- and fluorine-doped cerium oxide nanoparticles in a dispensable antibacterial composition in view of the teachings of Das, Chang, and Baker. Copending Application No. 17/973,769 recites a mixture comprising AgCNPs with a predominantly 3+ surface charge, in the size range of 3-35 nm, with the silver present as metallic silver, and in a Janus-type two-phase construct. In view of the teachings of Das, the ordinary artisan would be motivated to make the nanoparticles spherical because ‘769 does not recite a shape and Das teaches spherical shapes to cause less cellular damage than other shapes, which the artisan would recognize as desirable in a therapeutic composition. The person of ordinary skill would also recognize the 3+ surface charge of the CNPs would enable SOD-like mimetic activity in view of the teachings of Das, which the reference teaches as useful in therapeutic applications. In view of the teachings of Das and Baker, the ordinary artisan would be motivated to modulate the pH of the composition to shift the predominant Ce surface charge to 4+ to achieve both catalase and superoxide dismutase-like enzyme-mimetic activity because additional surface activity is desirable in a therapeutic composition. Das teaches that the catalase-activity possessing diameter of the two-phase Janus-type construct should be larger, therefore the number of Ce ions with a 4+ charge would subsequently be greater and the predominant surface charge would necessarily be 4+.
In view of the teachings of Chang, one of ordinary skill would be motivated to use a concentration of ~3% Ag in the Ag-CNPs because Application ‘769 does not recite a concentration and Change teaches this concentration to provide enhanced surface activity as compared to lower concentrations. Finally, in view of the teachings of Baker, a person of ordinary skill would be motivated to use the nanoparticle mixture recited by ‘769 as part of a dispensable composition because Baker teaches such a composition, comprising CNPs, to be effective in therapeutic cancer treatment and antibacterial treatments, which the artisan would recognize as desirable. Baker further teaches that such a composition, comprising the CNPs, one or more surfactants, and water, and can be applied topically. The person of ordinary skill would further be motivated to use CNPs doped with both silver and fluorine because Baker teaches both dopants to be effective in CNP-containing therapeutic compositions. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-8, 12-14 and 49-51 in view of the invention recited by copending Application No. 17/973,769 and further in view of the teachings of Das, Chang, and Baker.
Claims 1-8, 12-14 and 49-51 are directed to an invention not patentably distinct from claims 1-2 of commonly assigned copending Application No 17/973,769 in view of the teachings of Das, Chang, and Baker. 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. 17/973,769, 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
The Applicant’s arguments, filed on 19 February 2026, have been fully considered but are not persuasive. In the final para. of pg. 5 of the remarks, Applicants “respectfully request the Examiner to hold this rejection in abeyance until the claims in the cited application has issued as a patent”. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by the Applicant showing that the claims subject to the restriction are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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