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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated December 23, 2024 is acknowledged.
Claims 1-18, 20 and 21 are pending.
Claim 19 is cancelled.
Claims 1, 4-7, 10, 13-16 and 20 are currently amended.
Claim 21 is new.
Claims 10-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-9, 20 and 21 as filed on December 23, 2024 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all of the claim objections are withdrawn, some of the claim rejections under 35 USC 112(b) are withdrawn, some of the claim rejections under 35 USC 112(d) are withdrawn, and all of the claim rejections under 35 USC 103 are withdrawn.
In view of the Notice of Abandonment mailed October 16, 2024 in Application No. 18/394,798, the provisional double patenting rejection thereover is withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities: “interfaces” should presumably recite “the interfaces” consistent with paragraph [0030] of the specification and because antecedent basis is implicit. Appropriate correction is required.
Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
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 6, 8, 9 and 20 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the polymeric matrix material is selected from the (closed) group inclusive of inter alia acrylate resins or polyester, however, claim 1 from which claim 6 depends recites the polymeric matrix material comprises a polymer precursor component. Because claim 6 appears to be drawn to different polymeric matrix material than that of claim 1, it is unclear what polymeric matrix material is claimed.
Claim 8 recites the polymeric matrix material is a curable resin material, however, claim 1 from which claim 8 depends recites the polymeric matrix material comprises a polymer precursor component. Because claim 8 appears to be drawn to different polymeric matrix material than that of claim 1, it is unclear what polymeric matrix material is claimed. Claim 9 is included in this rejection because it depends from claim 8 and also because it compounds the ambiguity as the materials of claim 9 not understood to be polymer precursor components.
Claim 20 (c) recites the polymeric matrix material is selected from the (closed) group inclusive of inter alia acrylate resins or polyester, however, claim 20 earlier recites the polymeric matrix material comprises a polymer precursor component. Because claim 20 appears to recite different polymeric matrix materials, it is unclear what polymeric matrix material is claimed.
Response to Arguments: Claim Rejections - 35 USC § 112(b)
Applicant’s argument at page 8 that Applicant fails to see the conflict between the claims has been fully considered but is not persuasive. A polymer precursor component, while not defined in the instant specification, is understood as a component which is specifically not a polymer. Therefore, the rejections are properly maintained.
Claim Rejections - 35 USC § 112(d)
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.
Claim 6 is 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 6 recites the polymeric matrix material is inter alia acrylate resins or polyester, however, claim 1 from which claim 6 depends recites the polymeric matrix material comprises a polymer precursor component. Because inter alia acrylate resins or polyester are polymers per se, the recitation of group of polymers in claim 6 omits the precursor components of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments: Claim Rejections - 35 USC § 112(d)
Applicant’s argument at pages 8-9 that Applicant fails to see the conflict between the claims has been fully considered but is not persuasive. A polymer precursor component, while not defined in the instant specification, is understood as a component which is specifically not a polymer. Claim 6 only allows for circumscribed polymers / resins, copolymers and mixtures thereof. Therefore, the rejection is properly maintained.
New Grounds of Rejection Necessitated by Amendment
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-9, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (WO 2018/114351, published June 28, 2018, as evidenced by English equivalent US 2019/0381482, of record) in view of Wu et al. “Fabrication and evaluation of light-curing nanocomposite resins filled with surface-modified TiO2 nanoparticles for dental application,” Iran Polymer Journal 23:513-524, 2014; Kleine et al. (US 2011/0311601, published December 22, 2011, of record); and Heyer et al. (US 2012/0010707, January 12, 2012).
Mueller teach doped nanoparticles, particularly N-doped nanoparticles, particularly N-doped TiO2 nanoparticles (title; abstract; claims; paragraphs [0011], [0028], [0046], [0052]-[0055], [0087], [0131]; Examples), as required by instant claim 2. The nanoparticles can be surface modified with compounds which have one or more groups inclusive of bifunctional surface modifiers inclusive of silanes (paragraphs [0059], [0065], [0068]-[0069]), as required by instant claim 3. The nanoparticles can also be coated with proteins (paragraphs [0077], [0067]). Compositions which contain the nanoparticles include coatings comprising monomers, oligomers or polymers as organic matrix-forming materials (curable) (paragraphs [0078]-[0080]), as required by instant claim 8. The compositions may also contain polymerization and polycondensation catalysts (curable) (paragraph [0079]), as required by instant claim 8. A field of use includes sterilization or protection of instruments inclusive of medical instruments inclusive of dental (paragraph [0087]). Regarding the dental materials of the group as required by instant claim 9, such recitations of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Mueller do not teach proteins linked to the nanoparticles via bifunctional linkers, wherein the proteins bind to interfaces between the nanoparticles and the polymer matrix as required by claims 1, 20.
Mueller do not teach a silane selected from the group of claims 4, 20 inclusive of aminopropyltrimethoxysilane.
Mueller do not teach a protein is selected from the group of claim 5 inclusive of osteopontin.
Mueller do not teach a matrix selected from the group of claims 6, 20 inclusive of acrylate resin.
Mueller do not teach a monomer selected from the group of claims 7, 20 inclusive of acrylate.
Mueller do not teach a monomer selected from the group of claim 21 inclusive of bisphenol A glycidyl methacrylate.
These deficiencies are made up for in the teachings of Wu, Kleine and Heyer.
Wu teach light-curing nanocomposite resins filled with surface-modified TiO2 nanoparticles (title; abstract; claims). Introduction of functional groups onto the nano-filler surface to participate in the reaction of resin monomer improves the interfacial adhesion and the resultant miscibility between nano-filler and resin matrix (abstract). The nanoparticles were first conjugated with glycidyl methylmethacrylate via aminopropyl triethoxysilane as coupling agent, and then blended with the monomers of bisphenol-A glycidyl methacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEG-DMA) to produce a precursor of light-cured nanocomposite (page 514, paragraph bridging columns; Scheme 1; Table 2), as required by instant claims 6, 7, 21. Unreacted monomers remain in the nanocomposite (Table 2; page 519, rhc, last full paragraph).
Kleine teach antimicrobial medical devices having a silane surface comprising an antimicrobial peptide; the peptide is reversibly attached to the silane and inhibits or/and kills pathogenic microorganisms under physiological conditions (title; abstract; claims; paragraphs [0005], [0049], [0054], [0075]). The silane is attached to the device (claim 3). The silane is a methoxysilane such as 3-aminopropyl-trimethoxysilane (claims 12, 13; paragraphs [0074], [0091]; Examples), as required by instant claim 4. The devices comprise titanium inclusive of oxidized titanium TiO2 (paragraphs [0005], [0049], [0053], [0089]-[0090]; Examples). The devices include implants such as dental implants and instruments such as surgical instruments (paragraph [0049]).
Heyer teach biomolecule-containing coatings comprising a synthetic polymer including a reactive group and a biomolecule attached to the reactive group; the coatings are biocompatible and are suitable for medical devices such as surgical instruments and dental devices (title; abstract; claims; paragraphs [0002], [0017], [0036], [0044], [0046]). Biomolecules include peptides or proteins inclusive of osteopontin (paragraphs [0092], [0107]), as required by instant claim 5. Synthetic polymers can be acrylated or amine-containing (abstract; claims), as required by instant claim 6. Polymers can be formed by copolymerizing an acrylate monomer with a monomer comprising a first reactive group (paragraphs [0025], [0057]-[0058]), as required by instant claim 7. In some embodiments, one or more bioactive agents can optionally be included in the coating; the bioactive agents can be controllably released (paragraphs [0114], [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bifunctional silane surface modified N-doped TiO2 nanoparticles of Mueller to further comprise antimicrobial peptides reversibly attached to the silane as taught by Kleine in order to inhibit or/and kill pathogenic microorganisms under physiological conditions. There would be a reasonable expectation of success because the nanoparticles of Mueller may further be coated with proteins. One would have been motivated to do so because the compositions of Mueller may be used for sterilization or protection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating compositions of Mueller comprising the antimicrobial peptide surface modified N-doped TiO2 nanoparticles of Muller in view of Kleine to further comprise synthetic polymers inclusive of acrylated polymers comprising a reactive group as taught by Heyer so that at least some of the antimicrobial peptides attach to the reactive group in order to improve the interfacial adhesion and the miscibility of the antimicrobial peptide surface modified N-doped TiO2 nanoparticles of Muller and Kleine with the polymer coating as taught by Wu leaving at least some of the antimicrobial peptides unreacted in order to inhibit or/and kill pathogenic microorganisms under physiological conditions. There would be a reasonable expectation of success because the coating compositions of Mueller comprise monomers, oligomers or polymers as organic matrix-forming materials.
Regarding claims 4, 20, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the silanes as taught by Kleine inclusive of 3-aminopropyl-trimethoxysilane for the bifunctional silane surface modifiers of Mueller because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. One would have been motivated to do so because Kleine expressly teach the silanes thereof allow for the reversible attachment of antimicrobial peptides and release under physiological conditions and because the silanes thereof are suitable for attaching to titania.
Regarding claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute any biomolecule inclusive of proteins inclusive of osteopontin as taught by Heyer for the antimicrobial peptide in the coating compositions Mueller in view of Kleine, Wu and Heyer because Heyer teach any biomolecule introduced into polymer coatings and attached to the polymer therein improves biocompatibility. When antimicrobial peptide release is desired, it would have been obvious to modify the coating compositions to comprise such because Heyer teach an embodiment wherein bioactive agents may optionally be included within the coating for purposes of controlled release.
Regarding claims 7, 20, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that polymers inclusive of acrylated polymers can be formed by copolymerizing monomers inclusive of acrylate monomers because Heyer expressly teach such.
Regarding claim 21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute monomers inclusive of bisphenol-A glycidyl methacrylate as taught by Wu for the acrylate monomers of the acrylated polymers of the coating compositions of Mueller in view of Kleine, Wu and Heyer because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant's arguments have been considered but are moot in light of the new grounds of rejection necessitated by amendment.
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 1-9, 20 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,857,651 (Application No. 16/467,387) in view of Mueller et al. (WO 2018/114351, published June 28, 2018, as evidenced by English equivalent US 2019/0381482, of record); Wu et al. “Fabrication and evaluation of light-curing nanocomposite resins filled with surface-modified TiO2 nanoparticles for dental application,” Iran Polymer Journal 23:513-524, 2014; Kleine et al. (US 2011/0311601, published December 22, 2011, of record); and Heyer et al. (US 2012/0010707, January 12, 2012).
The instant claims are drawn to a composition comprising (a) doped TiO2 nanoparticles surface modified with a plurality of bifunctional linker molecules attached to a plurality of protein molecules and (b) a curable resin material comprising a polymer precursor component, wherein the proteins bind to interfaces between the nanoparticles and the polymer matrix. The dopants are selected from N, Ag, F, P and PO4. The linker may be a silane such as aminopropyltrimethoxysilane. The protein may be osteopontin. The polymer matrix may be an acrylate resin or a curable resin material such as an acrylic resin. The polymer precursor component may be a monomer selected from inter alia acylates, may be selected from inter alia ethylenedimethacrylate (EDMA). The composition may be used as inter alia dental resins.
The patented claims are drawn to a dental composition comprising nitrogen-doped TiO2 nanoparticles and a curable resin material comprising a polymer precursor component. The nitrogen-doped TiO2 nanoparticles may further comprise dopants selected from Ag, F, P and PO4. The polymer precursor component may be photocurable, may be selected from inter alia acylates, may be selected from inter alia ethylenedimethacrylate (EDMA). The composition may be used as inter alia dental resins or may comprise a filler.
The instant claims differ from the patented claims with respect to the linker / aminopropyltrimethoxysilane, the protein / osteopontin and the acrylate resin matrix. However, these differences are obvious in view of the prior art as elaborated supra. In view of Mueller, Wu, and Kleine, it would have been obvious to surface modify the nanoparticles of the patented claims with bifunctional linkers inclusive of silanes such as 3-aminopropyl-trimethoxysilane in order to reversibly attach antimicrobial peptides. In view of Wu and Heyer, it would have been obvious to modify the nanoparticles of the patented claims to comprise any biomolecule inclusive of proteins inclusive of osteopontin via the bifunctional linker so that the functional groups of the biomolecule react with the curable resin acrylate material in order to improve interfacial adhesion and the resultant miscibility between the nanoparticles and the resin matrix. In view of Wu and Heyer, it would have been obvious that photocuring the acrylate polymer precursors of the patented claims would result in acrylate resins and that during photocuring both precursors and resins would be simultaneously present.
Claims 1-9, 20 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/394,850 in view of Mueller et al. (WO 2018/114351, published June 28, 2018, as evidenced by English equivalent US 2019/0381482, of record); Wu et al. “Fabrication and evaluation of light-curing nanocomposite resins filled with surface-modified TiO2 nanoparticles for dental application,” Iran Polymer Journal 23:513-524, 2014; Kleine et al. (US 2011/0311601, published December 22, 2011, of record); and Heyer et al. (US 2012/0010707, January 12, 2012).
The instant claims have been described supra.
The copending ‘850 claims are also drawn to a dental composition and to a hardened article comprising nitrogen-doped TiO2 nanoparticles and a curable resin material comprising a polymer precursor component. The nitrogen-doped TiO2 nanoparticles may further comprise dopants selected from Ag, F, P and PO4. The polymer precursor component may be photocurable, may be selected from inter alia acylates, may be selected from inter alia ethylenedimethacrylate (EDMA). The composition may be used as inter alia dental resins or may comprise a filler.
The instant claims differ from the conflicting, copending claims with respect to the linker / aminopropyltrimethoxysilane, the protein / osteopontin and the acrylate resin matrix. However, these differences are obvious in view of the prior art as elaborated supra. In view of Mueller, Wu and Kleine, it would have been obvious to surface modify the nanoparticles of the copending claims with bifunctional linkers inclusive of silanes such as 3-aminopropyl-trimethoxysilane in order to reversibly attach antimicrobial peptides. In view of Wu and Heyer, it would have been obvious to modify the nanoparticles of the patented claims to comprise any biomolecule inclusive of proteins inclusive of osteopontin via the bifunctional linker so that the functional groups of the biomolecule react with the curable resin acrylate material in order to improve interfacial adhesion and the resultant miscibility between the nanoparticles and the resin matrix. In view of Wu and Heyer, it would have been obvious that photocuring the acrylate polymer precursors of the copending claims would result in acrylate resins and that during photocuring both precursors and resins would be simultaneously present.
Response to Arguments: Double Patenting
Applicant's arguments have been considered but are moot in light of the new grounds of rejection necessitated by amendment.
Conclusion
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (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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/ALISSA PROSSER/
Examiner, Art Unit 1619
/ILEANA POPA/Primary Examiner, Art Unit 1633
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