DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/29/2026 has been entered.
Status of the Claims
Claims 1, 5-7, and 9-13 are pending and under current examination.
Withdrawn Objections and Rejections
The rejection to the specification is withdrawn in view of the amendment to the abstract filed 1/29/2026.
All rejections not reiterated have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the limitation “one or more mesh materials selected from the group consisting of non-woven fabric (NWF), fabrics, paper or cellulose, and a combination of one or more mesh materials with adhesives”. This is an improper Markush grouping. Please refer to MPEP 2173.05(h):
“When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.”
This objection may be obviated by amending the claim to read “one or more mesh materials selected from the group consisting of non-woven fabric (NWF), fabrics, paper, cellulose, and a combination of one or more mesh materials with adhesives”.
Appropriate correction is required.
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 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “one or more mesh materials selected from the group consisting of non-woven fabric (NWF), fabrics, paper or cellulose, and a combination of one or more mesh materials with adhesives”. This renders the claim indefinite because it is not clear if the limitation “a combination of one or more mesh materials with adhesives” is limited to the species identified in the Markush grouping or if it encompasses mesh materials not specified in the claim. Furthermore, it is not clear if the limitation “said one or more mesh materials are impregnated, extruded,” refers to the mesh materials specified in the Markush grouping, the mesh materials specified by the phrase “a combination of one or more mesh materials with adhesives”, or both.
Claim 1 recites the limitation “radomyl-beta-cyclodextrin”. This renders the claim indefinite because the specification provides no definition for the term and a search of the prior art provides no definition or guidance as to what the term “radomyl-beta-cyclodextrin” may refer.
Claim 5 recites the limitation “impregnated with at least 0.02% by mass of chlorhexidine”. This renders the claim indefinite because there is no upper limit to the weight percentage of chlorhexidine that may be impregnated in the mesh material, it is therefore impossible to discern the metes and bounds of the claim.
Regarding claims 6-7 and 9-13, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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, 6, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023) in view of Denadai et. al. (Carbohydrate Research, pg. 2286-2296, publication year: 2007), as evidenced by Deshwal et. al. (Journal of Food Science Technology, pg. 4391-4403, publication year: 2019).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Lavoine discloses cellulosic paper substrates (pg. 197, 2.1 Materials) that are coated with a chlorhexidine: beta-cyclodextrin inclusion complex (pg. 198, 2.2.3 Coating mixtures). The chlorhexidine and beta-cyclodextrin are mixed in a ratio of 67/33, which is a ratio of about 2:1 (pg. 198, 2.2.3 Coating mixtures). Lavoine also teaches that beta-cyclodextrins provide reservoir systems for chlorhexidine molecules. Chlorhexidine molecules not included into beta-cyclodextrins still remain homogenously distributed within the paper matrix and can thus be considered a monolithic system. The chlorhexidine: beta-cyclodextrin coated sample therefore involved two release mechanisms: the reservoir and monolithic systems. The use of beta-cyclodextrin induces a “lag-time effect” because the chlorhexidine takes time to diffuse into the beta-cyclodextrins and paper substrate and cross it (pg. 201, 3.2.1 CHX release in aqueous medium). After 10 hours of release, 5mg/g chlorhexidine is released from the chlorhexidine: beta-cyclodextrin coated sample (pg. 201, 3.2.1 CHX release in aqueous medium).
Regarding claim 5, Lavoine discloses that the chlorhexidine was diluted to 2% by weight (pg. 197, 2.1 Materials and 2.2.3 Coating Mixtures).
Regarding claim 6, Lavoine discloses that the coated paper may be prepared by first mixing chlorhexidine and beta-cyclodextrin in distilled water (pg. 198, 2.2.3 Coating Mixtures). The samples are prepared by the coating of the base paper with the solution with a bar-coating process. The bar-coating process occurred at a speed of 5cm/s (pg. 197, 2.2.2 Coating Process) and the paper samples had a size of 10x10cm2 (pg. 198, 2.2.4 Determination of CHX amount introduced in paper samples). Five successive layers of the solutions are coated onto the untreated paper surface (pg. 197, 2.2.2 Coating Process); therefore the paper samples are coating for a 2s/layer and a total of 10s/5 layers. The paper samples are dried at 105oC between each layer and after the final layer (pg. 197, 2.2.2 Coating Process). The instant specification details a saturation process to include dripping a paper sample and subsequent spreading with a steel rod [0085 of instant specification]. The Examiner therefore considers the coating process disclosed by Lavoine to read on the “saturation” limitation of the instant claim 6.
Regarding claim 10, Lavoine discloses that the paper samples have an initial use for food packaging (pg. 197, 2.1 Materials). The chlorhexidine: beta-cyclodextrin inclusion complex is released after 24 hours (pg. 204, Results and Discussion). Deshwal teaches that paper food packaging is disposable by incineration, landfilling, pyrolysis and composting (pg. 4391, Abstract).
Regarding claim 12, Lavoine discloses that the paper samples have an initial use for food packaging (pg. 197, 2.1 Materials). The chlorhexidine: beta-cyclodextrin inclusion complex is released after 24 hours (pg. 204, Results and Discussion).
Regarding claims 10 and 12, the claims recite the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated paper samples embraced by Lavoine reads on the instant claims. See MPEP 2112.01 (II).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, Lavoine does not teach a molar ratio of chlorhexidine to cyclodextrin or a release range within the range embraced by the instant claims. However this deficiency is cured by Denadai.
Denadai teaches that a 1:4 molar ratio of chlorhexidine to beta-cyclodextrin can increase the concentration of the active component and that the activity of the formulations is molar ratio dependent (pg. 2294, 2.4 Antimicrobial evaluation).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding the molar ratio of chlorhexidine to cyclodextrin as specified in claim 1, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Furthermore, Denadai teaches that the antimicrobial activity of a chlorhexidine: beta-cyclodextrin inclusion complex is molar ratio dependent (pg. 2294, 2.4 Antimicrobial evaluation). The Applicants' specification provides no evidence that the selected molar ratios in claim 1 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the direct effect that the molar ratio of chlorhexidine: beta-cyclodextrin has on the antimicrobial activity of a formulation, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the molar ratio. One of ordinary skill in the art would have been motivated to change the molar ratio as this could be expected to be advantageous for optimizing the antimicrobial activity of the composition.
Regarding the release rate of chlorhexidine as specified in claim 1, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Furthermore, Lavoine teaches that beta-cyclodextrin forms reservoirs for chlorhexidine that slow the diffusion of chlorhexidine through the paper substrate. The Applicants' specification provides no evidence that the selected release rate in claim 1 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the direct effect that beta-cyclodextrin has on the release rate of chlorhexidine from the paper substrate, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the release rate. One of ordinary skill in the art would have been motivated to change the release as this could be expected to be advantageous for the prolonged antimicrobial activity of the paper substrate.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Davenport (U.S. Patent No. 8,062,415, issue date: 11/22/2011), as evidenced by Werner Mathis (Coating of a Wide Range of Materials, available 2017).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Lavoine teaches the relevant limitations as described above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Lavoine does not teach the inclusion of a varnish or dye in the aqueous solution. However, this deficiency is cured by Davenport.
Davenport teaches an aqueous solution that may contain an organic coloring pigment and an anionic direct dye (col. 1 lines 40-53). The solutions may be utilized in a bath that is added to a Werner Mathis size press through which a paper sample is passed through (col. 3 lines 55-57). Werner Mathis teaches that a size press is used for coating paper samples (pg. 8, Sizepress type SP).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to include a dye or varnish in the aqueous solution used to coat the paper disclosed by Lavoine. One would have understood in view of Davenport that an organic pigment or anionic dye may be included in an aqueous solution that is to be applied to paper via a size press. It would have been obvious that the aqueous solution taught by Lavoine that is applied to paper via spreading may also include a dye. One of ordinary skill in the art of filing would have been motivated to include a dye in the aqueous solution in order to impart a desired color to the paper. The artisan of ordinary skill in the art would have had reasonable expectation of success because Davenport teaches that an aqueous solution comprising an organic pigment or dye may be used to dye a paper substrate via a coating process.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Williams (U.S. Patent Application No. 2020/0230539, publication year: 2020).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Lavoine teaches the relevant limitations as described above. Lavoine also teaches that the cellulose fibers of the paper are linked to the chlorhexidine: beta-cyclodextrin by both the chlorhexidine and cyclodextrin molecules, which facilitates the release of the entire complex over a longer period of time (pg. 203, 3.2.2 CHX/βCD-coated samples and Figure 6). Lavoine also teaches that the chlorhexidine: cyclodextrin inclusion complexes have a positive charge that enable association with the negatively charged cellulose fibers (Figure 6).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Lavoine does not teach an air conditioning filter comprising a mesh material coated with a chlorhexidine and cyclodextrin inclusion complex. However, this deficiency is cured by Williams.
Williams teaches a heating, ventilation, and air conditioning home air filter comprising paper, foam, cotton, spun fiberglass, or other known filter materials and may be woven or non-woven [0009]. An electrostatic portion of the filter medium comprises at least some fibers that are treated with a coating of antimicrobial molecules configured to destroy microbes. The antimicrobial molecules comprise positively charged molecules distributed around a circumference of each of the at least some fibers [0012].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the antimicrobial coating of Williams and the chlorhexidine: beta-cyclodextrin inclusion complex coating of Lavoine for the purpose of imparting antimicrobial activity to a negatively charged mesh material). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated air filters embraced by Lavoine in view of Williams reads on the instant claims. See MPEP 2112.01 (II).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Fox, Jr. (U.S. Patent No. 5,616,338).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Lavoine teaches the relevant limitations as described above. Lavoine also teaches that the cellulose fibers of the paper are linked to the chlorhexidine: beta-cyclodextrin by both the chlorhexidine and cyclodextrin molecules, which facilitates the release of the entire complex over a longer period of time (pg. 203, 3.2.2 CHX/βCD-coated samples and Figure 6). Lavoine also teaches that the chlorhexidine: cyclodextrin inclusion complexes have a positive charge that enable association with the negatively charged cellulose fibers (Figure 6).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Lavoine does not teach a personal protection equipment comprising a mesh material coated with a chlorhexidine and cyclodextrin inclusion complex. However, this deficiency is cured by Fox, Jr..
Fox, Jr. teaches a polymeric coating agent that enables the antimicrobial agent to be retained and released in an active state on the coated medical device over an appreciable period of time, from about 12 to in excess of 21 days (col. 3 line 65- col. 4 line 2). The antimicrobial agent includes chlorhexidine (col. 2 line 33). Surfaces which may embody the present invention include surgical and examination gloves (col. 3 lines 12-13).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the coating composition of Fox, Jr. and the chlorhexidine: beta-cyclodextrin inclusion complex coating of Lavoine for the purpose of imparting controlled release of chlorhexidine). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated personal protective equipment embraced by Lavoine in view of Fox, Jr. reads on the instant claims. See MPEP 2112.01 (II).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Conolly (U.S. Patent Application No. 2020/0216948, publication date: 7/9/2020), as evidenced by Cotton Incorporated (Cotton Morphology and Chemistry, available 4/2/2019).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Lavoine teaches the relevant limitations as described above. Lavoine also teaches that the cellulose fibers of the paper are linked to the chlorhexidine: beta-cyclodextrin by both the chlorhexidine and cyclodextrin molecules, which facilitates the release of the entire complex over a longer period of time (pg. 203, 3.2.2 CHX/βCD-coated samples and Figure 6). Lavoine also teaches that the chlorhexidine: cyclodextrin inclusion complexes have a positive charge that enable association with the negatively charged cellulose fibers (Figure 6).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Lavoine does not teach a clothing comprising a mesh material coated with a chlorhexidine and cyclodextrin inclusion complex. However, this deficiency is cured by Conolly.
Conolly teaches composite materials for use in garments or footwear [0003]. The garment may utilize cotton fibers [0040]. At least one textile fabric such as woven, non-woven, or knitted fabric is applied to a substrate after coating with an organic or in-organic layer [0271]. The organic or in-organic coatings include functional components such as antimicrobial coatings form encapsulated antimicrobial agents, including chlorinated aromatic compounds [0272]. Cotton Incorporated teaches that after scouring and bleaching, cotton is 99% cellulose (pg. 16, Cellulose Chemistry).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the antibacterial coating of Conolly and the chlorhexidine: beta-cyclodextrin inclusion complex coating of Lavoine for the purpose of imparting antimicrobial activity to a cellulose material). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated personal protective equipment embraced by Lavoine in view of Conolly reads on the instant claims. See MPEP 2112.01 (II).
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 1, 5-7, and 9-13 under 35 U.S.C. 103 over Weltrowski, Davis, Reuscher, Inoue, Yoon, and Teixeira have been considered but are moot because the new grounds of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 9, Applicant argues that, in view of the declaration, the claimed mesh material has a 99.99% virucidal activity for at least 30 days, and up to 60 days while remaining structurally intact and therefore overcoming the rejections of record. This is not found persuasive. Please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: The unexpected results amount to a long-lasting virucidal effect of 30 days rendered by the mesh materials of the instant invention. However, as described in the obviousness rejection above, it would have been a matter of routine optimization to adjust the release rate of chlorhexidine from the paper substrate of Lavoine. Lavoine teaches that the beta-cyclodextrin acts a reservoir for chlorhexidine and the use of beta-cyclodextrin induces a “lag-time effect” because the chlorhexidine takes time to diffuse into the beta-cyclodextrins and paper substrate and cross it (pg. 201, 3.2.1 CHX release in aqueous medium). It would therefore have been matter of routine optimization to adjust the release rate of chlorhexidine from the paper substrate of Lavoine by adjusting the amount of beta-cyclodextrin present in the coating composition. Furthermore, there is no explanation as to what “Masking Tape 17” and Masking Tape 19” are, it is therefore impossible to discern what composition is compared to the masking tape of the instant invention, “Masking Table 22”. Therefore, the evidence of unexpected results is not unexpected or unobvious.
Differences are of both practical and statistical significance: The differences in unexpected results amount to long-term virucidal activity of the mesh material of the instant invention, therefore the differences are of practical significance. However, there is no statistical analysis present in the data, therefore the differences are not of statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The evidence of unexpected results is in commensurate scope with the claims.
Additionally, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
Response to Declaration
Applicant’s arguments with respect to the teachings of Teixeira and Davis have been considered but are moot because the new grounds of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 2, Applicant argues that the evidence presented in an independent laboratory test represents an order of magnitude improvement over the prior art and constitutes an unexpected technical effect. This is not found persuasive. As described in the response to arguments above, the evidence of unexpected results is not unexpected or unobvious because Lavoine teaches that beta-cyclodextrin has a lag-time effect on the release of chlorhexidine from a paper substrate. It therefore would be a matter of routine optimization to adjust the release rate of chlorhexidine from the paper substrate of Lavoine to lie with the range of the instant claims. There is no explanation as to what samples “Masking Tape 17” and “Masking Tape 19” are and no statistical analysis of the data presented. Additionally, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Therefore, the declaration is not 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, 5, 6, 10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of copending application no. 18/833,966,
and claims 1-15 of copending application no 18/995,974;
in view of Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘966 and ‘974 applications embrace an antimicrobial composition comprising chlorhexidine encapsulated in beta-cyclodextrin. The chlorhexidine is in a molar ratio with cyclodextrin within a range embraced by the instant claims. The claims of the ‘966 and ‘974 applications also embrace a use of the antimicrobial composition to be used in the production of formulations for environmental treatment and surface disinfection.
The claims of the ‘966 and ‘974 applications do not teach a mesh material, a weight percentage of chlorhexidine, or a process for obtaining a mesh material. However, these deficiencies are cured by Lavoine. Lavoine discloses cellulosic paper substrates (pg. 197, 2.1 Materials) that are coated with a chlorhexidine: beta-cyclodextrin inclusion complex (pg. 198, 2.2.3 Coating mixtures). The chlorhexidine and beta-cyclodextrin are mixed in a ratio of 67/33, which is a ratio of about 2:1 (pg. 198, 2.2.3 Coating mixtures). With regards to the “at least 30 days” limitations of instant claim 1, the prior art teaches the same coated mesh substrate as claimed and therefore, the controlled release properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” Lavoine also discloses that the chlorhexidine was diluted to 2% by weight (pg. 197, 2.1 Materials and 2.2.3 Coating Mixtures). The coated paper may be prepared by first mixing chlorhexidine and beta-cyclodextrin in distilled water (pg. 198, 2.2.3 Coating Mixtures). The samples are prepared by the coating of the base paper with the solution with a bar-coating process. The bar-coating process occurred at a speed of 5cm/s (pg. 197, 2.2.2 Coating Process) and the paper samples had a size of 10x10cm2 (pg. 198, 2.2.4 Determination of CHX amount introduced in paper samples). Five successive layers of the solutions are coated onto the untreated paper surface (pg. 197, 2.2.2 Coating Process); therefore the paper samples are coating for a 2s/layer and a total of 10s/5 layers. The paper samples are dried at 105oC between each layer and after the final layer (pg. 197, 2.2.2 Coating Process). The paper samples have an initial use for food packaging (pg. 197, 2.1 Materials). The chlorhexidine: beta-cyclodextrin inclusion complex is released after 24 hours (pg. 204, Results and Discussion).
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the antimicrobial composition embraced by the claims of the ‘966 and ‘974 applications to coat a mesh material. One would have understood in view of Lavoine that an identical antimicrobial composition may be used to coat a cellulosic mesh material. It would have been obvious that the antimicrobial composition embraced by the claims of the ‘966 and ‘974 applications may also be used to coat a cellulosic mesh material in the manner described by Lavoine. One of ordinary skill in the art of filing would have been motivated to utilize the composition embraced by the claims of the ‘966 and ‘974 applications to coat a cellulosic mesh material in order to impart it’s long-lasting antimicrobial properties to the substrate. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Lavoine teaches that an identical composition may be applied to a mesh material. See MPEP 2144.07.
Regarding the weight percentage of chlorhexidine as specified in instant claim 5, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Furthermore, Lavoine teaches that an antimicrobial composition to coat a cellulosic mesh material may include chlorhexidine at 2% by weight (pg. 197, 2.1 Materials and 2.2.3 Coating Mixtures). The Applicants' specification provides no evidence that the selected weight percentage in claim 5 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the antimicrobial and controlled release properties of the antimicrobial composition, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the weight percentage of chlorhexidine. One of ordinary skill in the art would have been motivated to change the weight percentage as this could be expected to be advantageous for achieving the desired antimicrobial and controlled release effects.
The claims recite the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated paper samples embraced by Lavoine reads on the instant claims. See MPEP 2112.01 (II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of copending application no. 18/833,966,
and claims 1-15 of copending application no 18/995,974;
in view of Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Davenport (U.S. Patent No. 8,062,415, issue date: 11/22/2011), as evidenced by Werner Mathis (Coating of a Wide Range of Materials, available 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘966 and ‘974 applications embrace the relevant limitations as described above. The claims of the claims of the ‘966 and ‘974 applications do not embrace the inclusion of a dye or varnish. However, this deficiency is cured by Davenport. Davenport teaches an aqueous solution that may contain an organic coloring pigment and an anionic direct dye (col. 1 lines 40-53). The solutions may be utilized in a bath that is added to a Werner Mathis size press through which a paper sample is passed through (col. 3 lines 55-57). Werner Mathis teaches that a size press is used for coating paper samples (pg. 8, Sizepress type SP).
It would have been prima facie obvious to one of ordinary skill in the art of filing to include a dye or varnish in the aqueous solution used to coat the paper disclosed by Lavoine. One would have understood in view of Davenport that an organic pigment or anionic dye may be included in an aqueous solution that is to be applied to paper via a size press. It would have been obvious that the aqueous solution taught by Lavoine that is applied to paper via spreading may also include a dye. One of ordinary skill in the art of filing would have been motivated to include a dye in the aqueous solution in order to impart a desired color to the paper. The artisan of ordinary skill in the art would have had reasonable expectation of success because Davenport teaches that an aqueous solution comprising an organic pigment or dye may be used to dye a paper substrate via a coating process.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of copending application no. 18/833,966,
and claims 1-15 of copending application no 18/995,974;
in view of Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Williams (U.S. Patent Application No. 2020/0230539, publication year: 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘966 and ‘974 applications embrace the relevant limitations as described above. The claims of the claims of the ‘966 and ‘974 applications do not embrace an air conditioning filter. However, this deficiency is cured by Williams. Williams teaches a heating, ventilation, and air conditioning home air filter comprising paper, foam, cotton, spun fiberglass, or other known filter materials and may be woven or non-woven [0009]. An electrostatic portion of the filter medium comprises at least some fibers that are treated with a coating of antimicrobial molecules configured to destroy microbes. The antimicrobial molecules comprise positively charged molecules distributed around a circumference of each of the at least some fibers [0012].
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the antimicrobial coating of Williams and the antimicrobial composition embraced by the claims of the ‘966 and ‘974 applications for the production of formulation for environmental treatment and surface disinfection). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated air filters embraced by the claims of the ‘966 and ‘974 applications in view of Williams reads on the instant claims. See MPEP 2112.01 (II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of copending application no. 18/833,966,
and claims 1-15 of copending application no 18/995,974;
in view of Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Fox, Jr. (U.S. Patent No. 5,616,338).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘966 and ‘974 applications embrace the relevant limitations as described above. The claims of the ‘966 and ‘974 applications do not embrace a personal protective equipment. However, this deficiency is cured by Fox, Jr.. Fox, Jr. teaches a polymeric coating agent that enables the antimicrobial agent to be retained and released in an active state on the coated medical device over an appreciable period of time, from about 12 to in excess of 21 days (col. 3 line 65- col. 4 line 2). The antimicrobial agent includes chlorhexidine (col. 2 line 33). Surfaces which may embody the present invention include surgical and examination gloves (col. 3 lines 12-13).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the antimicrobial coating of Fox, Jr. and the antimicrobial composition embraced by the claims of the ‘966 and ‘974 applications for the production of formulation for environmental treatment and surface disinfection). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated personal protective equipment embraced by the claims of the ‘966 and ‘974 applications in view of Fox, Jr. reads on the instant claims. See MPEP 2112.01 (II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of copending application no. 18/833,966,
and claims 1-15 of copending application no 18/995,974;
in view of Lavoine et. al. (Colloids and Surfaces B: Biointerfaces, pg. 196-205, publication year: 2014, cited in the IDS filed 2/17/2023), as applied to claims 1, 5, 6, 10, and 12 above, and further in view of Conolly (U.S. Patent Application No. 2020/0216948, publication date: 7/9/2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘966 and ‘974 applications embrace the relevant limitations as described above. The claims of the ‘966 and ‘974 applications do not embrace a clothing. However, this deficiency is cured by Conolly. Conolly teaches composite materials for use in garments or footwear [0003]. The garment may utilize cotton fibers [0040]. At least one textile fabric such as woven, non-woven, or knitted fabric is applied to a substrate after coating with an organic or in-organic layer [0271]. The organic or in-organic coatings include functional components such as antimicrobial coatings form encapsulated antimicrobial agents, including chlorinated aromatic compounds [0272].
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the antibacterial coating of Conolly and the antimicrobial composition embraced by the claims of the ‘966 and ‘974 applications for the production of formulation for environmental treatment and surface disinfection). See MPEP 2144.06 (II).
The claim recites the limitation “including against coronaviruses”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the coated personal protective equipment embraced by the claims of the ‘966 and ‘974 applications in view of Conolly reads on the instant claims. See MPEP 2112.01 (II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617