DETAILED ACTION
Applicants' arguments, filed 08/08/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-2, 4-5, 7, and 9-22 are pending in the instant application.
Priority
The instant application is a 371 of PCT/IB2018/055337 filed on 07/18/2018, which claims domestic priority to provisional application 62/534,751 filed on 07/20/2017.
Claim Interpretation
The term “for use as a” in claims 10-12 are interpreted as an intended use it does not appear to result in a structural difference to the instantly claimed formulation.
The term “formulated as a personal hygiene product” is interpreted as an intended use as it does not appear to result in a structural difference to the instantly claimed formulation. The instant specification recites “the product can be formulated as a personal hygiene product to be applied on the skin, hair, nails and other external tissues to eliminate microbial agents and prevent infections” with no further descriptor of structural differences to the composition or formulation, therefore the formulation as described in claim 1 will constitute a personal hygiene product.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 9-13, 16, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Prevo et al (US Patent Application Publication 20160319160A1).
Prevo teaches the use of sol-gels (Prevo at [0035-0076]), and further teaches that they can include silica, alumina, ceria, molybdenum oxide, titania, zirconia, zinc oxide, iron oxides, including but not limited to magnetite (Fe3O4) and various forms of Fe2O3, niobium oxide, vanadium oxide, tungsten oxide, tin oxide, barium oxide, calcium oxide, magnesium oxide, strontium oxide, phosphorous oxides, mixtures of any of these, or mixed oxides of any two or more of these (Prevo at [0035]). Prevo teaches that the sol-gel may be treated with phosphates (Prevo at [0045]). Prevo teaches the sol-gel may be used in a liquid to form a slurry (Prevo at [0119]).
Prevo differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Prevo teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Prevo to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Claims 2, 4, 7, 14-15, 17, 19-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Prevo et al (US Patent Application Publication 20160319160A1).as applied to claims 1, 5, 10-13, 16, 18, and 21 above, and further in view of Asgari (US Patent Application Publication 20080195170 A1).
The teachings of Prevo are discussed above.
The teachings of Prevo differ from the instant claims insofar as they do not specify the use of copper and palladium as metal ions in a sol-gel.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the iron ions of Prevo with the metal ions iron, copper, and palladium as they are taught to be preferable metals in the use of sol-gels as taught by Asgari. See MPEP 2144.06(I). See MPEP 2143(I).
Asgari teaches the use of sol-gels (Asgari at [0076 -0099]). Asgari teaches the sol/gel forming components in the exemplary embodiment of the process according to the present invention may be selected from alkoxides, oxides, acetates, nitrates of various metals, e.g. silicon, aluminum, boron, magnesium, zirconium, titanium, alkaline metals, alkaline earth metals, or transition metals, preferably from platinum, molybdenum, iridium, tantalum, bismuth, tungsten, vanadium, cobalt, hafnium, niobium, chromium, manganese, rhenium, iron, gold, silver, copper, ruthenium, rhodium, palladium, osmium, lanthanum and lanthanides, as well as combinations thereof. Asgari teaches the sol-gel is a gel that is then cured or dried to form a solid (Asgari at [0076-0078], [0093-0099].
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, 4-5, 7 and 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-8, 10, 12-16, and 26 of copending Application No. 16/632,843 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a nanostructured, biocompatible and biocatalytic irreversible inorganic network gel comprising (i) mixed oxides of silica and titania (TiO2SiO2), (ii) one or more functional groups selected from the group consisting of a sulfate, an amine and a phosphate, and (iii) one or more coordinated metallic atoms selected from the group consisting of copper, silver, gold, iron, ruthenium, rhodium, cobalt, zinc, palladium, manganese, iridium and platinum.
The instant application recites a nanostructured, biocompatible and biocatalytic irreversible inorganic network gel comprising (i) mixed oxides of silica and titania (TiO2-SiO2), (ii) one or more functional groups selected from the group consisting of a polyurethane, a sulfate, an amine and a phosphate, and (iii) one or more coordinated metallic atom selected from the group consisting of copper, silver, gold, iron, ruthenium, rhodium, cobalt, zinc, palladium, manganese, iridium and platinum metals (instant invention at claim 1).
The reference application ‘843 recites a nanostructured, biocompatible and biocatalytic irreversible inorganic network gel comprising (i) mixed oxides of silica and titania (TiO2SiO2), (ii) one or more functional groups selected from the group consisting of a sulfate, an amine and a phosphate, and (iii) one or more coordinated metallic atoms selected from the group consisting of copper, silver, gold, iron, ruthenium, rhodium, cobalt, zinc, palladium, manganese, iridium and platinum (‘843 at claim 6).
The claims are not considered statutory because the reference application teaches a method of treating wounds which is not required by the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting Remarks
Applicant states in the remarks filed 08/08/2025, in view of the submission of the Terminal Disclaimer, reconsideration and withdrawal of the rejection is respectfully requested.
There is currently no terminal disclaimer filed for reference Application No. 16/632,843 in this case. Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejection is maintained.
Conclusion
No claims are presently allowable.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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, Frederick Krass can be reached on (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600