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 .
Response to Amendment
The Amendment filed 05/20/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 02/20/2026. Applicant’s claims have been amended in the following manner: the claim set has been modified according the 112(b) language of the previous action, with further clarifying or small changes. Furthermore, introduction of the term “mono-phasic” and changing the average diameter (Dv50) of 175 nm or less has prompted a new ground of rejection (specifically, Benita has been incorporated into the 103 rejection to address Applicant’s amendments). Some clarifying edits were incorporated into the 103 rejection to specifically address Applicant’s arguments in relation to the Art. Additionally, new claims 27-30 have been entered to draw a new ground of rejection.
The following objections/rejections are withdrawn: 112b (for amendments made).
The Examiner further acknowledges the following:
Claims 1-10 and 21-30 are pending.
No claims are withdrawn, although a restriction requirement (filed 09/30/2025) remains in place.
Claims 1-10 and 21-30 are presented for examination and rejected as set forth below.
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 1-2, 4-10, 21-22, 24, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Handjani (US 2001/0010824A1), and in further view of Benita (US20140079642A1), Azimi (Journal of Engineered Fibers and Fabrics, 2014) and Hougaz (US20090061001A1).
Applicant’s claims (particularly instant independent claim 1) are directed to a composition comprising “mono-phasic” nano-elements of at least one water-insoluble collagen-synthesis stimulating compound (CSSC) having a molecular weight of 0.6 kilodalton (kDa) or more, the nano-elements being dispersed in a polar carrier; wherein at least 50% of the total volume of the nano-elements have an average diameter (Dv50) of 175 nm or less; and wherein the CSSC(s) or the nano-elements made therefrom have a viscosity of 107 mPa-s or less, as measured at least one temperature between 20°C and 80°C, and at a shear rate of 10 s-1. With respect to the viscosity, vapor pressure, and/or solubility properties nano-elements, the Specification recites CSSC ingredients (see pg 10-12, pg 30-33, pg 67-68) that have suitable properties (pg 33-35), and Art teaching those components as obvious is presumed to reflect those properties. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant defines a “nano-element” (e.g., claim 1, etc.) by non-limiting example as a nano-particle or nano-droplet (Specification on pg 5, lines 18-22), which in this case, comprises a CSSC, such that a “nano-sized” structural component is invoked, and there is no particularly defined shape named by the claim scope. Furthermore, CSSC is a recognized term of the Art, per a literature search.
The term “plasticized” (or “swelled”, as stated in the Specification) in claims 2 and 4, does not impact the actual content of the composition, except for that the term describes a mixing of the polymer and non-volatile liquid. Because “polar carrier” (e.g., claim 1, etc.) is not defined in the instant claim set, the Examiner refers to page 12, lines 16-23 of the Specification, where the polar carrier is identified, by example, as water, glycols, glycerol, etc., but could be further extended to polar carriers of the Art.
Handjani teaches a composition comprising biodegradable polymer (i.e., PCL, PLGA, etc.) nanoparticles comprising an active for topical application (abstract, [0001], Handjani – claim 1, [0013,0014]).
Regarding claim 1, 4-6, 8, 22, and 24: Handjani teaches a nanoparticle made from 125 mg polycaprolactone (PCL), 500 mg a-tocopherol [0015] (reads on the active agent of claim 8), 250 mg Pluronic F68, and water (reads on the polar carrier, which is named as water in the Specification (pg 12, lines 16-23), and the aqueous dispersion can be used as is (in Example 22 [0214-0218]. Handjani teaches nanoparticles that are between 10-1000 nm (Handjani – claim 2, [0003]), especially between 50-500 nm [0011]. Note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
The nanoparticles can be formulated as fluids, lotions, gels, emulsions or dispersion [0020]. Furthermore, Handjani teaches additional polymers such as co-poly(DL-lactides/glycolides) (PLGA) [0014], wherein PLGA and PCL are biodegradable.
Regarding claims 2: Handjani teaches “inactive carrier oils”, including triglycerides (reads on non-volatile liquids) (Handjani – claims 1 and 7).
Regarding claim 7: Handjani teaches incorporation of surfactants [0030].
Regarding claim 9: By lower vapor pressure, Applicant explains that is meant by less than 40 Pa (see Specification page 6, paragraph 1). Nanoparticles made of heavy polymers (i.e., PCL or PLGA) are not expected to have significant vapor pressure because they are solid particles with high molecular weights and are generally not considered volatile (claim 9a). Furthermore, because the prior Art teaches the polymers of the instant claims, the vapor pressure of those polymers is inherent to the species. Finally, there is no requirement to incorporate volatile organic compounds into the polymers taught by Handjani (claim 9b).
Regarding claim 10: Handjani teaches compositions capable of use topically (abstract).
Regarding claim 27-29: Handjani teaches “active agents” capable of cosmetic or therapeutic activity such as anti-inflammatories, vitamins, depigmenting agents, etc. [0017].
In summary, Handjani teaches PCL and PLGA nanoparticles in cosmetic compositions for topical use. Handjani uses polycaprolactone marketed by Aldrich [0216], similarly to the polycaprolactone of the Applicant’s Specification of Table 1. However, Handjani does not teach the “mono-phasic” aspect of PCL particles (claim 1), viscosity of the CSSC or nanoelements (claim 1) or the molecular weight range (claim 1, 4, 21, and 30), or solubility limitations (instant claim 26).
Benita teaches biodegradable polymers including PCL and/or PLGA as drug delivery materials [0010] in a carrier [0100, 0103], for dermal therapy [0001-0002], whereby encapsulation of actives is an obvious variant [0003], but additionally the use of solid polymeric nanoparticles is suitable (reads on “mono-phasic”) [0077] in homogeneous form [0069, 0218] not featuring a core/shell structure [0063, 0064]. Furthermore, Benita teaches a nanoparticle of 50-75 nm (reads on 175 nm or less) (Benita – claim 97) and/or 2-20 kDa (Benita claim 95) or 4-5 kDa (Benita – claim 96).
Azimi teaches the average molecular weight of PCL samples vary from 3000 to 80000 g/mol (i.e., 3 kDa to 80 kDa, which overlaps with claims 1, 4, 21, and 30) (pg 75, paragraph 1) in terms of microspheres, nanoparticles, etc. that can be used in drug-delivery systems (e.g., topically, etc.) (abstract).
Regarding the instant properties of claims 1, 9, and 26 (i.e., viscosity, vapor pressure, and solubility of the “nano-elements”): Handjani, Benita, and Azimi teach the obviousness of PCL-14 (i.e., 14 kDa PCL, where the 14 kDa MW is within Benita’s 2-20 kDa range and Azimi’s 3-80 kDa range) in topical cosmetic compositions (where PCL-14 among other “CSSCs” is exemplified in Applicant’s specification as suitable for use; see Table 1 of Applicant’s Specification). Note that, a compound and its properties are inseparable, and certain specific ingredients (e.g., PCL-14) cannot have a viscosity, vapor pressure, and/or solubility that is separate from its identity. Finally, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Hougaz teaches cosmetics with viscosities in ranges (10 cps to 500000 cps; where 1 cps = 1 mPa⋅s), ranging from gelatinous to thin [0022] for emulsions and suspensions [0019], where viscosity is important for formulation delivery method [0047]. Thus, the instant range (<10,000,000 mPa⋅s of instant claim 1) is obvious based on the dynamic viscosity that finds use in the cosmetic field. Regarding the shear rate, further note, that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Handjani’s polymeric (encapsulated nanoparticle) compositions by making a topical composition comprising non-encapsulated nanoparticle, as taught by Benita, because Benita demonstrates the benefits of non-encapsulated nanoparticle, because compositions comprising non-encapsulated nanoparticle, have the ability to penetrate the skin and induce a therapeutic effect [0035], whereby Benita establishes the use of solid polymeric nanoparticles is suitable [0077] in homogeneous form [0069, 0218] not featuring a core/shell structure [0063, 0064], as an alternative to encapsulated forms [0003], which are the focus of Handjani’s disclosure.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Handjani’s polymeric compositions by specifying the molecular weight of the polymer, as taught by Benita and Azimi, because Azimi and Benita teach the MW size of PCL polymers used in cosmetics to overlap with the instant range. The selection of a known material (e.g., PCL with MW range inside of 3-80 kDa) based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Handjani by specifying the viscosity of the ”nano-elements”, as taught by Hougaz, because Hougaz teaches viscosity of the formulation to affect the final product and method of delivery being used (i.e., gel, thin, spray, etc. [0022, 0047]), where Handjani teaches generally that the nanoparticles can be formulated as fluids, lotions, gels, emulsions or dispersion [0020]. Thus, adjusting viscosity values with the ranges of Hougaz would be important in obtaining the desired formulations disclosed by Handjani.
Furthermore, the Art teaches the obviousness of “nano-elements” such as PCL-14 (i.e., considered suitable for use by Applicant, as shown in Table 1 of Applicant’s Specification) as obvious, and would therefore, the Prior Art ingredients would be expected to have the same properties (i.e., viscosity, vapor pressure, and/or solubility) as claimed.
Claims 1-10 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Handjani (US 2001/0010824A1), Benita (US20140079642A1), Azimi (Journal of Engineered Fibers and Fabrics, 2014) and Hougaz (US20090061001A1), as applied to 1-2, 4-10, 21-22, 24, and 26-30, and in further view of Baldo (US20070248633A1), Singh (US20100172993A1), and Massey (Carbohydrate Polymers, 2017).
As discussed above, the combined Prior Art teaches a topical composition comprising polymeric nanoparticles (e.g., PCL, PLGA) of specified size, molecular weight, and viscosity. Handjani teaches “inactive carrier oils” (reads on non-volatile liquids) (Handjani – claims 1 and 7). However, the Prior Art does not teach the specific non-volatile liquids (instant claim 3 and 23) or the other specific natural polymer ingredients (claim 25).
Baldo teaches compositions such as cream, ointments, etc. [0187] for topical application to skin (abstract) comprising nanoparticles of polycaprolactone or PLGA (Baldo – claim 14, [0129]), wherein oils such as triglycerides of octanoic acids (but not limited to) can be used [0189] (reads on glyceryl trioctanoate of instant claim 23). Baldo also teaches the instant ingredients (instant claim 23) dicaprylyl carbonate [0066, 0223], isopropyl myristate [0189], stearic acid, lauric acid, palmitic acid and oleic acid [0199], linoleic acid [0230], eugenol [0326], farnesol [0381], propylene glycol monolaurate [0398], etc.
Singh teaches release rate modulating agents suitable for incorporation into microparticles intended for topical cosmetic application (abstract, Singh – claim 1). Non-limiting suitable release rate modulating agents include natural, semi-synthetic, synthetic (including polylactide copolymers (Singh – claim 7)) polymers such as shellac derivatives, natural/synthetic gums (including “gum acacia” [0068, 0128]), cationic guar, various cationic polymers, etc. (Singh – claims 1-2 and 6-7, [0065-0068]).
Massey teaches Acacia nilotica is merely the species name from which “gum Acacia” can be derived, and finds use in the cosmetic industry (pg 207, abstract and introduction).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Prior Art by specifying the carrier oil any of the ingredients as taught by Baldo as suitable for incorporation, because Baldo teaches these ingredients to be suitably compatible for topical compositions comprising PLGA or PCL nanoparticles for skin benefit, and Handjani teaches “inactive carrier oils” in similar cosmetic topical compositions. Further note, the wide variety of suitable oils taught by Baldo [0198-0199], when Handjani generically teaches any inactive carrier oil in the topical composition [0016-0017].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Prior Art by incorporating gum acacia of the Acacia nilotica variety into the “nano-element”, as taught by Singh and Massey, because gum acacia (among many non-limiting examples of natural/synthetic ingredients) serves a rate release modulating function for nanoparticle-based topical cosmetics, where Handjani discusses delivery of active ingredients into the upper epidermis (abstract) and efficacy [0002] and active release rate [0008].
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 1-10 and 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Handjani (US 2001/0010824A1), Benita (US20140079642A1), Azimi (Journal of Engineered Fibers and Fabrics, 2014) and Araujo (Colloids and Surfaces B: Biointerfaces, 2009), Singh (US20100172993A1), Baldo (US20070248633A1), and Massey (Carbohydrate Polymers, 2017).
claims 1-20 of copending Application No. 18/513,686 (reference application)
claims 1-20 of copending Application No. 19/012,942 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach a composition comprising nanoelements of at least one water-insoluble collage-synthesis stimulating compound (CSSC), bearing similar limitations.
It is unclear from the independent claim set of ‘686 what the specific differences are except for the dependent limitations and claim numbering. Application ‘942 appears to focus on a core-shell element, where Handjani [0003] and Benita [0010, 0001-0003, 0010, 0063-0064, 0069, 0077, 0218] teach the obviousness of core-shell nanoparticles in relation to “mono-phasic” nanoparticles, as does Baldo in terms of nanospheres and nanocapsules [0121].
Nevertheless, the differences are remedied by the Prior Art above, who teach elements of topical polymeric nanoparticle formulations for skin use, applied and rationalized in a similar way to the 103 rejection discussed above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants arguments, see pg 9-17, filed 05/20/2026, with respect to the 103 rejection of claims 1-10 and 21-27 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claims (especially the inclusion of Benita (US20140079642A1) into the 103 rejection). Note that, arguments made based on amended limitations are considered moot, but will be addressed based on the new ground of rejection.
On page 9, Applicant discusses amendments made in response to the 112(b) rejections which are found acceptable.
On page 9-10, Applicant prefaces the remarks by suggesting that the Office did not establish obviousness of the claim set, and that there was no reasonable expectation of success at the time of filing. With regard to reasonable expectation of success: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Thus, the previous 103 rejection provided appropriate rationale for the previous claim set (i.e., additionally, the current 103 rejection above establishes rationale for the obviousness of the newly amended claim set). Furthermore, Applicant has not provided evidence that unpredictability of the art to challenge the obviousness of the modification.
With regard to the arguments concerning (1) different ingredient proportions, (2) method of preparation resulting in different characteristics (3) “some” CSSCs are proteins with molecular weights impacting characteristics (i.e., note that the instant CSSCs as claimed are not limited to proteins alone), Applicant has provided no specific objective evidence in support of these claims, that can be responded to. Furthermore, the Examiner has provided rationale for the obviousness of the ingredients, method preparation, and proteins of various molecular weights in the 103 rejection above.
On page 10, Applicant argues that a person preparing nano-elements would be able to measure their viscosity, which is not an argument that pertains to patentability of the claim scope. Furthermore, the Examiner reiterates the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, the Office’s position is not whether one would be capable of making a measurement, but the Office is not afforded the time and/or capability to make any measurements. Furthermore, the Examiner has demonstrated the obviousness of the instant viscosity values of the claims, by demonstrating the general viscosity of topical cosmetics and also demonstrating the obviousness of ingredients such as PCL-14 (i.e., Applicant demonstrates PCL-14 as an ingredients suitable for the invention in Table 1, and an ingredient and its properties are inseparable).
On page 10-11, Applicant focuses an argument on “plasticized” meaning a mixture of CSSC and a non-volatile liquid. This particular mixture is made obvious by the 103 rejection above, and thus reads on characterizations of the compositions, as a “mixture”, “swelled”, “plasticized”, and/or a “composition.” The point being that “plasticized” does not provide any structural element that differs from the mixing of the ingredients. Therefore, this argument is unpersuasive including the amendment made by Applicant to clarify this position. Applicant has not made a specific argument (or provided evidence) that is persuasive in attributing more structural meaning to the term “plasticized” that is not already covered by the mixtures and compositions of the Prior Art.
On page 11, Applicant begins attacking individual references, because they are not analogous to the instant application and/or do not teach the required elements, based on specific teachings and/or embodiments. Applicant is reminded at the outset: (1) Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). (2) One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually.
On page 11-13, Applicant attacks Handjani, because Handjani does not teach the new limitation whereby “mono-phasic” characterizes the nano-elements. In response to the now-amended incorporation of ”mono-phasic”, this argument is now moot. However, the 103 rejection has been amended to incorporate Benita, where Benita teaches biodegradable polymers including PCL and/or PLGA as drug delivery materials [0010], for dermal therapy [0001-0002], whereby encapsulation of actives is obvious [0003], but also the use of solid polymeric nanoparticles is suitable [0077] in homogeneous form [0069, 0218] not featuring a core/shell structure [0063, 0064]. Thus, functionally equivalent drug delivery approach of encapsulating an active within a nanomaterial, or alternatively, distributing an active homogeneously within a solid nanomaterial is made obvious by Benita. Additionally, Azimi’s polymers (i.e., suitable for topical cosmetic application) would be considered mono-phasic, and there is no particular limitation for the “nano-element” shape in instant claim 1.
Furthermore, with respect to the particle size argument against Handjani by pointing to embodiments (i.e., “in practice”) of the Specification: Note that specific embodiments do not define the teachings: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Thus, Handjani explicitly teaches nanoparticles that are between 10-1000 nm (Handjani – claim 2, [0003]), especially between 50-500 nm [0011], covering the instant “average diameter (Dv50) of 175 nm or less”.
With regard to the “in practice” argument pertaining to particle size, Applicant has additionally provided no objective data that Handjani is incapable of making nanoparticles that have an average diameter of 175 nm or less (i.e., other than only pointing to specific embodiments of Handjani).
Additionally, Benita teaches a “mono-phasic” nanoparticle (see 103 rejection) of 50-75 nm (Benita – claim 97) and/or 2-20 kDa (Benita claim 95) or 4-5 kDa (Benita – claim 96). Therefore, the arguments made against Handjani are additionally covered by the teachings of Benita.
On page 13, Applicant argues that the instant invention is advantageously devoid of VOCs compared to Handjani. First, the trace VOC of the Specification (pg 63, line 7) is not a required limitation of the claims (as found in the alternative of instant claim 9). Second, there is no objective data that demonstrates high amounts of VOCs in Handjani, when Handjani is silent on VOC levels. Third, objective data has not been provided demonstrating low VOC in the embodiments of Applicant’s compositions. Fourth, to demonstrate non-obviousness, the argument should consider the teachings of the combined Prior Art, whereby Benita additionally teaches solid polymeric nanoparticles (i.e., Benita’s introduction is prompted by amendment) and Azimi teaches polymeric materials suitable for topical cosmetic application.
On page 13-14, Applicant argues against Azimi for focusing on fibers of PCL vs. the microspheres that are also taught by Azimi. Note that the claims do not restrict “nano-element” (i.e., devoid of shape) shape to a sphere (see instant claim 1, or “nano-materials” including “nano-fibers” of pg 2 of the Specification). Furthermore, when Azimi teaches all shapes (including a sphere) as obvious, the information found for the molecular weight property of PCL fibers would also be considered obvious for the other shapes (e.g., a fiber can be modeled into a sphere). Note that Azimi explicitly states: “various polymeric devices like microspheres, microcapsules, nanoparticles, pellets, implants, and films have been fabricated using this polymer” in the abstract. Finally, Applicant has not provided objective evidence to invalidate the Examiner’s proposed combination, but only relies on focusing on a specific embodiment of the Azimi reference.
Further note, Benita teaches biodegradable polymers including PCL and/or PLGA as drug delivery materials [0010], for dermal therapy [0001-0002], in the form of a spherical [0043] nanoparticle of 50-75 nm (Benita – claim 97) and/or 2-20 kDa (Benita claim 95) or 4-5 kDa (Benita – claim 96) (i.e., it is the combined teaching of the Art that is used in an obviousness analysis of the 103 above).
On page 14-15, Applicant argues that Hougaz teaches the viscosity of whole formulations vs. the viscosity of the nano-elements. Note that the final viscosity of full formulations is based on the viscosity of its constituent parts. Thus, when the viscosity of a formulation encompasses the viscosity of the constituent parts, then viscosities of the parts are obvious. Applicant has provided no objective evidence to contradict this rationale. Additionally, the Examiner will repeat that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, the Art teaches the obviousness of “nano-elements” such as PCL-14 (i.e., considered suitable for use by Applicant, as shown in Table 1 of Applicant’s Specification) as obvious, and would therefore, the Prior Art ingredients would be expected to have the same properties (i.e., viscosity, vapor pressure, and/or solubility) as found in instant claims 1, 9, and 26. Applicant has provided no objective evidence to demonstrate that the ingredients of the Art do not have the property values of the instant claims.
On page 15, Applicant argues that Hougaz teaches away from the instant viscosities because Hougaz’s sunscreen agents are to remain on top of the skin, and Hougaz would “hypothetically” point to ranges preventing skin penetration. These are per se arguments that are not based on any factual evidence. Applicant has provided no evidence that sunscreen agents do not penetrate skin.
Moreover, Hougaz does not explicitly criticize the proposed modification made by the 103 rejection (i.e., formation of topical compositions of certain viscosities, based on ingredients that contribute to a final viscosity). In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The art does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner.
Furthermore, Handjani (Example 3) and Benita [0001-0035] teach the skin penetration of polymeric nanoparticles, as an expected result of their structural and compositional makeup, regardless of the viscosity of the final composition.
On page 15-16, Applicant argues that Baldo, Singh, and Massey do not correct the deficiencies, however Applicant’s arguments against Handjani and Azimi have been addressed, and Baldo, Singh, and Massey are used to teach other elements of the claims. Therefore, the 103 rejection, as modified due to Applicant’s amendments, stands.
On page 16-17, Applicant argues for withdrawal of the double patenting rejections. However, the double patenting rejections remain on the basis of the modified 103 rejection rationale that has been prompted by Applicant’s amendments.
Correspondence
Applicant's amendment necessitated the new ground 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/R.P./Examiner, Art Unit 1614 6/29/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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