DETAILED ACTION
Notice of Pre-AIA or AIA Status
This office action is intended to supersede the Office Action previously issued on 02 February 2026.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application was filed 16 August 2023 and is the national stage entry of PCT/US22/16553 filed 16 February 2022. The Applicant claims priority to provisional application 63/150,386 filed 17 February 2021. Therefore, the effective filing date of the instant application is 17 February 2021.
Election/Restrictions
Claims 59-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 November 2025.
Applicant’s election without traverse of Group I (claims 1, 2, 7, 17, 19, 20, 22, 23, 27, 32, 33, 39, and 40) in the reply filed on 24 November 2025 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 7, 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more. The claim(s) recite(s) a composition comprising an activated metal and water, saline, and/or a solvent. This judicial exception is not integrated into a practical application because the claims do not recite anything more than an activated metal and a solvent. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the activated metals taught by the Applicant are found in nature.
Step 1
Claims 1, 2, 7, and 19 are interpreted as a composition comprising an activated metal, such as Manganese (para. 48 of the instant specification), and a solvent, such as water. Therefore, claims 1, 2, 7, and 19 fall under one of the four eligible statutory categories for patentability.
Step 2A1
Claims 1, 2, 7, and 19 are directed to products of nature. The claims recite an activated metal, such as Manganese (para. 48 of the instant specification), and a solvent, such as water. The Toxicological Profile for Manganese document teaches that the natural concentrations of manganese in seawater ranges from 0.4 to 10 mcg/L (EPA 1984, pg. 383), which is roughly at most 0.000001%.
Step 2A2
Claims 1, 2, 7, 19 are do not recite additional elements other than the judicial exception. Claims 1 and 2 do not recite any more than 0.000000001% to 5% or 0.00001% to 5% of an activated metal and a solvent. Claim 7 does not recite any more than 0.0001% to 0.001% of an activated metal. Claim 19 does not recite any more than an activated metal, such as Manganese. Therefore, claims 1, 2, 7, and 19 do not recite any elements that integrate the judicial exception into a practical application and are rejected under 35 U.S.C. 101.
Step 2B
Claims 1, 2, 7, and 19 do not recite additional elements that add significantly more than the judicial exception. Claims 1, 2, 7, and 19 only recite naturally-occurring products in the composition. Since these claims do not recite additional elements that amount to significantly more than the judicial exception, claims 1, 2, 7, and 19 are rejected under 35 U.S.C. 101.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banowski et al. (DE 102007024377 A1; machine translation cited).
Banowski teaches an antiseptic cosmetic cleansing composition with a photoactivated metal oxide (abs; entire teaching) particles, such as titanium or zinc oxide (pg. 3, para. 1) in an amount of 0.01-20% (pg. 2, bottom page). The composition may be a watery product (pg. 3, para. 2). In the examples, water and 0.30% of titanium dioxide is used (Examples, pg. 36), addressing claims 1 and 2.
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.
Claim(s) 1, 2, 7, 19, 23, 27, 32, 33, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banowski et al. (DE 102007024377 A1; machine translation cited).
Banowski teaches an antiseptic cosmetic cleansing composition with a photoactivated metal oxide (abs; entire teaching) particles, such as titanium or zinc oxide (pg. 3, para. 1) in an amount of 0.01-20% (pg. 2, bottom page). The composition may be a watery product (pg. 3, para. 2), thus far addressing claims 1, 2, and 19. In the examples, water and 0.30% of titanium dioxide is used (Examples, pg. 36). The pH of the composition may range from 2.5-11 (pg. 28, last paragraph), addressing claims 23 and 27. The metal oxide particles may have a particle size in the range from 2-600 nm (claim 5), addressing claims 32, 33, 39, and 40. The microparticle and nanoparticle limitations in claims 32, 33, 39, and 40 are addressed by the size range of 2-600 nm.
Banowski does not specifically teach 0.00001-0.001% of active component in claim 7.
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would be obvious to adjust the percentage by weight of particles in claim 7 in order to improve or maintain a stable composition for the intended purpose, e.g. for use as a therapeutic or medical product.
Claim(s) 1, 2, 7, 17, 19, 20, 22, 23, 27, 32, 33, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banowski et al. (DE 102007024377 A1; machine translation cited) and Janani et al. (Selectivity and sensitivity of molybdenum oxide-polycaprolactone nanofiber composites on skin cancer: Preliminary in-vitro and in-vivo implications, Journal of Trace Elements in Medicine and Biology, 2018).
In regards to claim(s) 1, 2, 7, 19, 23, 27, 32, 33, 39, and 40, Banowski, as applied supra, is herein applied in its entirety for its teachings of an antiseptic cosmetic cleansing composition with a photoactivated metal oxide particles and water.
Banowski does not specifically teach Molybdenum as the activated metal in claims 17, 20, and 22.
Janani et al. teach molybdenum trioxide nanoparticles for use as antimicrobial agents (pg. 61, introduction). Molybdenum trioxide nanoparticles are less toxic and have a wide range of therapeutic applications (pg. 61, introduction). The nanofibers with molybdenum nanoparticles (dispersed in deionized water, pg. 61, 2.2) may be used to target skin cancer and applied topically (abs). the molybdenum trioxide nanoparticles are orthorhombic in shape (pg. 65).
Since Banowski does not specifically teach Molybdenum as the activated metal in claims 17, 20, and 22, one of ordinary skill in the art would have been motivated to use Janani’s teaching of molybdenum trioxide nanoparticles for use on the skin with a reasonable expectation of success. Janani teaches molybdenum trioxide nanoparticles as an antimicrobial agent that may be applied topically to target skin cancer. A skilled artisan would have recognized the benefit of combining the teachings of Janani and Banowski to improve Banowski’s skin composition comprising activated metal oxide particles.
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, 2, 17, 19, 20, 22, 32, 33, 39, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6 of U.S. Patent No. 12201115. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference patent recites an antipathogenic solid composition comprising 0.01-5% of a metal oxide (molybdenum) with a polymer, and a particle size of larger than 100 nm and smaller than 100 microns, which corresponds to instant claims 1, 2, 17, 19, 20, 22, 32, 33, 39, and 40. In the reference patent, the composition itself is liquid (abs), but the solid composition is from the polymer surface. It would have been obvious to a skilled artisan to apply the liquid composition from the instant claims to a polymeric surface, such as for wound treatment. Claim 2 of the reference patent recites molybdenum as the metal oxide, correspond to instant claims 17, 19, and 20. Claim 4 of the reference patent recites a particle size of 1-1000 nm, which corresponds to instant claims 39 and 40. Claim 5 of the reference patent recites a particle size of 40-50 microns, corresponding to instant claims 32 and 33. Claim 6 of the reference patent recites a metal oxide selected from several different metals, corresponding to instant claim 19.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613