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 1-20.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/05/2026 has been entered.
Applicants' arguments, filed 01/05/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
Claim 1 and 14 recite wherein the personal care composition has greater semi-solid nature compared to the same composition devoid of the coral-shaped metal nanoparticles. The claim fails to comply with the written description requirement since this limitation is not supported in the specification. At best, the specification discloses in paragraph [0075] wherein semi-solid nature is maintained.
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 14 recite wherein the personal care composition has greater semi-solid nature. The claim is indefinite since a composition is either semi-solid or not. It is not clear how a composition can be more semi-solid than another semi-solid composition.
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 1-20 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). 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 and 14 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 and 14 reciting wherein the coral-shaped metal nanoparticles hydrodynamically interact with water, since the nanoparticle composition comprising coral-shaped nanoparticles is mixed with a carrier comprising water, the coral-shaped nanoparticles and water would hydrodynamically interact.
In regards to instant claims 1 and 14 reciting a greater stability, viscosity, or semi-solid nature compared to the same composition devoid of the coral-shaped metal nanoparticles, since the composition of Niedermeyer comprises coral-shaped metal nanoparticles, the composition of Niedermeyer necessarily has greater stability, viscosity, or semi-solid nature like the claimed invention compared to the same composition devoid of the coral-shaped metal nanoparticles.
In regards to instant claims 1 and 14 reciting wherein the composition includes an amount of spherical-shaped metal nanoparticles to act as a preservative to prevent or inhibit microbial growth 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 without providing a significant therapeutic antimicrobial effect to treat infection when applied to tissue like the claimed invention.
In regards to instant claims 2-4 and 14 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 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).
Response to Arguments
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.
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.
Applicant argues that the maximum concentration of spherical shaped metal nanoparticles is outside the minimum amount of about 1 ppm required by Niedermeyer.
The Examiner does not find Applicant’s argument to be persuasive. Niedermeyer discloses in paragraph [0043] wherein in some embodiments the spherical-shaped nanoparticles are between about 1 and about 15 ppm. Thus, the amount of spherical-shaped nanoparticles do not need to be at least about 1 ppm since this is only in some embodiments and not all embodiments. Furthermore, Niedermeyer discloses in paragraph [0064] wherein the amount of metal nanoparticles may be as low as about 0.5 ppm, which is within the claimed range. As such, Applicant’s argument is unpersuasive.
Applicant argues that in Niedermeyer the examples that actually worked to treat onychomycosis all contained 1 ppm or more of spherical shaped metal nanoparticles and in every example the concentration of spherical-shaped metal nanoparticles is greater than that of the coral-shaped metal nanoparticles.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to working examples.
Applicant argues that the application explains that forming the stabilizing matrix of coral-shaped metal nanoparticles prior to adding a spherical-shaped metal nanoparticles yield a more stable composition. This is a new result that is not known from the prior art.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not stated where in the application it says this. Also, even if it did, Applicant’s argument would still be unpersuasive since it’ll be a conclusory statement, which bears no patentable weight. 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 1-20 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 1-20 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614