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 . Claims included in the prosecution are claims 1 and 3-21.
Applicants' arguments, filed 06/26/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-21 are rejected under 35 U.S.C. 103 as being unpatentable over Niedermeyer (US 2017/0209490, Jul. 27, 2017).
Niedermeyer discloses a nanoparticle composition for treating onychomycosis including spherical-shaped nanoparticles and coral-shaped nanoparticles. The nanoparticle composition can be mixed with a carrier to provide or augment application of the nanoparticle composition to a target area (abstract). Suitable carriers include a penetrating solvent such as an alkane (i.e., hydrophobic component) (¶ [0041]). Onychomycosis is a fungal infection of the fingernail or toenail (¶ [0005]). The spherical-shaped nanoparticles and the coral-shaped nanoparticles are metal nanoparticles each comprising any desired metal, including silver or gold (¶ [0028]). In some embodiments, the spherical-shaped nanoparticles may be present in a range of between about 1 and about 15 ppm and the coral-shaped nanoparticles may be present in a range of between about 1 and about 5 ppm (¶ [0043]). In some embodiments, depending on the treatment site, the nature of the nanoparticles being added, and the type of penetrating solvent, stabilizing agent, and/or carrier being used, the nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight (¶ [0064]). Suitable carriers include topical sprays, emulsions, creams, gels, and pastes (¶ [0059]). Gels contain one or more liquid components together with known gelling agents (¶ [0063]). Liquid components include water (¶ [0061]). A nanoparticle composition may be prepared by adding to the carrier, (i) coral shaped Au nanoparticles and (ii) spherical Ag nanoparticles (¶ [0083]). One or more stabilizing agents may be included to reduce or eliminate agglomeration of the nanoparticles (¶ [0054]).
Niedermeyer differs from the instant claims insofar as not disclosing less than 850 ppb (0.85 ppm) of the spherical-shaped metal nanoparticles.
However, as discussed above, Niedermeyer discloses wherein depending on the treatment site, the nature of the nanoparticles being added, and the type of penetrating solvent, stabilizing agent, and/or carrier being used, the nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight. Thus, the amount of spherical-shaped particles may be, for example, 0.5 ppm (500 ppb) and the amount of coral-shaped nanoparticles may be, for example, 2 ppm for a total metal nanoparticles concentration of 2.5 ppm, which is within the range of about 0.5 ppm to about 100 ppm. As such, it would have been obvious to one of ordinary skill in the art that the amount of spherical-shaped nanoparticles may be less than 850 ppb (0.85).
In regards to instant claims 1,14 and 21 reciting dispersing coral-shaped metal nanoparticles throughout the carrier and forming a nanoparticle stabilizing matrix within the carrier and dispersing spherical-shaped metal nanoparticles to the carrier afterwards, this is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In the instant case, the product as claimed is the same as the product of the prior art since the product of the prior art comprises substantially the same components as the product as claimed. As such, the claim is unpatentable even though the prior product was made by a different process.
In regards to instant claims 1, 3, 4, 14 and 21 reciting wherein the weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles is greater than 1:1, as discussed above, Niedermeyer discloses wherein depending on the treatment site, the nature of the nanoparticles being added, and the type of penetrating solvent, stabilizing agent, and/or carrier being used, the nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight. Thus, the amount of spherical-shaped particles may be, for example, 0.5 ppm (500 ppb) and the amount of coral-shaped nanoparticles may be, for example, 2 ppm for a total metal nanoparticles concentration of 2.5 ppm, which is within the range of about 0.5 ppm to about 100 ppm. As such, it would have been obvious to one of ordinary skill in the art that the weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles may be greater than 1:1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claims 1, 14 and 21 reciting wherein a ratio greater than 1:1 in order to create the nanoparticle stabilizing matrix in the carrier that attracts and maintains the spherical-shaped metal nanoparticles in a dispersed, non-agglomerated, and stable condition, to provide hydrodynamic properties that permit the personal care composition to include more water while maintaining a desired viscosity or semi-solid nature, and to provide an antioxidant effect to preserve the color, stability, and aesthetic appearance of the personal care composition, as discussed above, Niedermeyer teaches a weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles greater than 1:1. Thus, the composition of Niedermeyer necessarily has the claimed properties. Applicant has not shown wherein the claimed ratio is unexpected or critical.
In regards to instant claims 1, 14 and 21 reciting wherein the composition includes an amount of spherical-shaped metal nanoparticles to act as a preservative to prevent or inhibit microbial growth and spoilage of the personal care composition without providing a therapeutic antimicrobial effect to treat infection when applied to tissue, this is merely a recitation of the intended use of the claimed amount. As discussed above, Niedermeyer discloses an amount of spherical-shaped nanoparticles overlapping the claimed amount. Therefore, the spherical-shaped nanoparticles of Niedermeyer are usable as a preservative to prevent or inhibit microbial growth and spoilage of the personal care composition without providing a therapeutic antimicrobial effect to treat infection when applied to tissue like the claimed invention.
In regards to instant 5 reciting wherein the spherical-shaped metal nanoparticles remain well-dispersed and non-agglomerated within the carrier for at least 12 months, since the composition of Niedermeyer comprises substantially the same components (e.g., spherical-shaped nanoparticles, coral-shaped nanoparticles, and carrier) as the claimed invention in substantially the same amount as the claimed invention, the spherical-shaped metal nanoparticles of Niedermeyer necessarily remain well-dispersed, and non-agglomerated within the carrier for at least 12 months like the claimed invention.
In regards to instant claim 15 reciting the term “consisting essentially of”, the instant specification does not provide a definition for the term “consisting essentially of.” Absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. See MPEP 2111.03(III).
In regards to instant claim 16 reciting dispersing the coral-shaped metal nanoparticles throughout the carrier before dispersing the spherical metal nanoparticles throughout the carrier, as discussed above, Niedermeyer does not disclose a specific order for adding the nanoparticles into the carrier; however, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04(IV)(C).
In regards to instant claim 21 reciting wherein the oil-based carrier omits water and polar solvents, Niedermeyer does not disclose wherein the penetrating solvent requires water or polar solvents. Niedermeyer discloses in paragraph [0053] wherein mixing the penetrating solvent with water or another organic solvent is optional. Thus, a carrier free of water and polar solvents would have been obvious.
Response to Arguments
Applicant argues that Niedermeyer does not teach or suggest a personal care composition that contains a carrier, coral-shaped metal nanoparticles, and spherical-shaped metal nanoparticles dispersed throughout the carrier and stabilized by the nanoparticle stabilizing matrix within the carrier formed by the coral-shaped metal nanoparticles and wherein the personal care composition has a weight ratio of the coral-shaped metal nanoparticles to the spherical-shaped metal nanoparticles of greater than 1:1 in order to create the nanoparticle stabilizing matrix in the carrier that attracts and maintains the spherical-shaped metal nanoparticle in a dispersed, non-agglomerated, and stable condition, to provide hydrodynamic properties that permit the personal care composition to include more water while maintaining a desired viscosity or semi-solid nature, and to provide an antioxidant effect to preserve the color, stability, and aesthetic appearance of the personal care composition.
The Examiner does not find Applicant’s argument to be persuasive. Niedermeyer teaches a personal care composition that contains a carrier, coral-shaped metal nanoparticles, and spherical-shaped metal nanoparticles in the abstract. In regards the claims reciting dispersing coral-shaped metal nanoparticles throughout the carrier and forming a nanoparticle stabilizing matrix within the carrier and dispersing spherical-shaped metal nanoparticles to the carrier afterwards, this is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In the instant case, the product as claimed is the same as the product of the prior art since the product of the prior art comprises substantially the same components as the product as claimed. Applicant has not shown wherein the order of dispersing is critical. In regards to the claims reciting wherein the weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles is greater than 1:1, as discussed above, Niedermeyer discloses wherein depending on the treatment site, the nature of the nanoparticles being added, and the type of penetrating solvent, stabilizing agent, and/or carrier being used, the nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight. Thus, the amount of spherical-shaped particles may be, for example, 0.5 ppm (500 ppb) and the amount of coral-shaped nanoparticles may be, for example, 2 ppm for a total metal nanoparticles concentration of 2.5 ppm, which is within the range of about 0.5 ppm to about 100 ppm. As such, it would have been obvious to one of ordinary skill in the art that the weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles may be greater than 1:1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. In regards to the claims reciting creating the nanoparticle stabilizing matrix in the carrier that attracts and maintains the spherical-shaped metal nanoparticles in a dispersed, non-agglomerated, and stable condition, to provide hydrodynamic properties that permit the personal care composition to include more water while maintaining a desired viscosity or semi-solid nature, and to provide an antioxidant effect to preserve the color, stability, and aesthetic appearance of the personal care composition, as discussed above, Niedermeyer teaches a weight ratio of coral-shaped metal nanoparticles to spherical-shaped metal nanoparticles greater than 1:1. Thus, the composition of Niedermeyer necessarily has the claimed properties. Applicant has not shown wherein the claimed ratio is unexpected or critical. As such, all the claim limitations appear to be obvious and Applicant’s argument is unpersuasive.
Applicant argues that the instability of the spherical-shaped metal nanoparticles in personal care products is shown in Comparative Examples 1 to 5, and the solution to such problems is shown in Examples 1 to 13.
The Examiner does not find Applicant’s argument to be persuasive. The claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). In the instant case, the comparative examples are not the closest prior art since the comparative examples do not comprise coral-shaped metal nanoparticles along with spherical-shaped metal nanoparticles, while the composition of Niedermeyer does. Applicant has not compared the claimed invention with the composition of Niedermeyer and shown wherein the claimed invention is unexpected. As such, Applicant’s argument is unpersuasive.
Applicant argues that Niedermeyer does not recognize stability problems associated with incorporating a gelling agent in water, hydrophobic oils blended with water, an oil carrier, or a semi-solid carrier and therefore cannot logically teach or suggest a solution to this problem. The solution, as later discovered and disclosed in the Application, is to form a stabilizing matrix of coral-shaped metal nanoparticles at a weight ratio greater than 1:1 relative to the spherical-shaped metal nanoparticles.
The Examiner does not find Applicant’s argument to be persuasive. Rationale different from Applicant’s is permissible. See MPE 2144(IV). Thus, the prior art does not need to teach the same advantage or result discovered by applicant. Also, Niedermeyer teaches coral-shaped metal nanoparticles. Applicant has not shown wherein the composition of Niedermeyer has stability problems. Applicant also has not shown wherein a weight ratio greater than 1:1 relative to the spherical-shaped metal nanoparticles is critical. As such, Applicant has not shown wherein the claimed invention is unexpected over Niedermeyer and Applicant’s argument is unpersuasive.
Applicant argues that as taught throughout the application, the coral-shaped metal nanoparticles are preferably added before adding the spherical-shaped silver nanoparticles to avoid premature agglomeration of the precipitation of the spherical-shaped silver nanoparticles. Once premature agglomeration of precipitation of the spherical-shaped silver nanoparticles occurs, adding coral-shaped metal nanoparticles after the fact would not break up the agglomerates and redisperse the spherical-shaped silver nanoparticles.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown with objective evidence wherein the claimed ratio is critical. There are no showings comparing the claimed ratio with a ratio outside of the claimed range. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227, 229 (C.C.P.A. 1978). As such, Applicant’s argument is unpersuasive.
Applicant argues that claim 16 requires a greater quantity by weight of the coral-shaped metal nanoparticles than the spherical-shaped metal nanoparticles. This is what creates the stabilizing matrix of coral-shaped metal nanoparticles.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Niedermeyer teaches an overlapping amount of coral-shaped metal nanoparticles and spherical-shaped metal nanoparticles compared to the claimed amount. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. Also, Applicant has not shown wherein the claimed range is responsible for creating a stabilizing matrix. As such, Applicant has not shown wherein the claimed range is critical and Applicant’s argument is unpersuasive.
Applicant argues that Niedermeyer requires a polar solvent such as DMSO that is capable of penetration into the toe nail and therefore teaches away from the personal care composition of claim 1.
The Examiner does not find Applicant’s argument to be persuasive. Claim 1 does not exclude polar solvents. It is only claim 21 that excludes polar solvents. Niedermeyer does not teach away from claim 21 since Niedermeyer discloses in paragraphs [0046]- [0051] wherein the penetrating solvent may be other solvents other than DMSO, for example, alkanes which are nonpolar. As such, Applicant’s argument is unpersuasive.
Applicant argues that because a critical feature of Niedermeyer is that that composition must be capable of killing the virus that causes onychomycosis, it would render Niedermeyer unsatisfactory for its intended purpose and render its composition inoperable if modified to act as a preservative to prevent or inhibit microbial growth without providing a therapeutic antimicrobial effect to treat infection when applied to tissue. Such a composition that does not provide a therapeutic antimicrobial effect would be incapable of treating onychomycosis.
The Examiner does not find Applicant’s argument to be persuasive. The claimed recitation of acting as a preservative to prevent or inhibit microbial growth without providing a therapeutic antimicrobial effect to treat infection when applied to tissue is merely a recitation of the intended use of the spherical-shaped metal nanoparticles. Applicant has not shown wherein the composition of Niedermeyer would be incapable of such use. Niedermeyer discloses in paragraph [0064] wherein depending on the treatment site, the nature of the nanoparticles being added, and the type of penetrating solvent, stabilizing agent, and/or carrier being used, the nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight. Instant claim 1 recites wherein less than 850 ppb spherical-shaped nanoparticles are needed for the composition to act as a preservative to prevent or inhibit microbial growth without provided a therapeutic antimicrobial effect to treat infection when applied to tissue. Therefore, since the composition of Niedermeyer may comprise 0.5 ppm (500 ppb) metal nanoparticles, which includes spherical-shaped nanoparticles, Niedermeyer teaches an amount of spherical-shaped metal nanoparticles this is less than 850 ppb that would allow the composition to act as a preservative to prevent or inhibit microbial growth without providing a therapeutic antimicrobial effect to treat infection when applied to tissue. Applicant has not shown wherein the amount of spherical-shaped nanoparticles taught by Niedermeyer would not enable such use. As such, Applicant’s argument is unpersuasive.
Applicant argues that the alleged overlap in concentration of spherical-shaped metal nanoparticles between Niedermeyer and the claims at issue is irrelevant because the type of spherical-shaped metal nanoparticles are not specified in either Niedermeyer or the claims at issue, and not every conceivable type of spherical-shaped metal nanoparticles inherently provides the exact same antimicrobial activity.
The Examiner does not find Applicant’s argument to be persuasive. Instant claim 11 specify wherein the spherical-shaped nanoparticles are silver nanoparticles. Niedermeyer discloses in paragraph [0028] wherein the metal nanoparticles may be silver. As such, Applicant’s argument that the type of spherical-shaped metal nanoparticles is not specified is not persuasive.
Response to Declaration
Declarant argues that where the concentration of silver nanoparticles is less than 1 ppm, such as less than 850 ppb by weight, the composition would be ineffective to treat onychomycosis.
The Examiner does not find Declarant’s argument to be persuasive. Declarant has not provided any objective evidence or scientific reasoning to support their allegation. Thus, Declarant’s argument is unpersuasive since it appears to merely be an opinion without scientific evidence. Also, Niedermeyer discloses in paragraph [0069] wherein the treatment composition may include spherical-shaped nanoparticles, coral-shaped nanoparticles, or both. Thus, the coral-shaped nanoparticles may alone treat onychomycosis since the composition isn’t required to comprise spherical-shaped nanoparticles. Therefore, Applicant’s argument is unpersuasive since the composition would not be ineffective to treat onychomycosis with less than 850 ppb of the spherical-shaped metal nanoparticles, since the coral-shaped metal nanoparticles would be able to treat onychomycosis. As such, Applicant’s argument is unpersuasive.
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 and 3-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,201,571. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite a specific type of personal care composition) and thus read on the instant claims.
Response to Arguments
The rejection is maintained since the claim amendments do not teach away from the patented claims as discussed above.
Conclusion
Claims 1 and 3-21 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights