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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-10 and 21-27) in the reply filed on 11/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Specifically, Applicant has not clarified whether the restriction is made with or without traverse.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Priority
The present application is a CIP of application PCT/IB22/54627 filed 05/18/2022, which claims the benefit of Foreign application GB2107130.3 filed 05/19/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 11/20/2023, in the matter of Application N° 18/513,764. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-10 and 18-27 are pending.
Claims 18-20 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-10 and 21-27 are presented for examination and rejected as set forth below.
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 3-4, 8-9, 21-25, and 26-27 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 3, 8, 23-25, and 27 recite “selected from a group comprising” (about 8 times total; also check for this in the method claims) which is an improper Markush grouping and indefinite. See MPEP 2173.05(h).
Claim 4 recites “at least one, at least two, or at least three” which is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest range is used (i.e., “at least one”).
Claim 9 recites the term “about” to describe numerical values, which is indefinite because it is an imprecise definition of a value. The Examiner suggests “about” should be removed and considers the claim values as if the term “about” was not present. See MPEP 2173.05(b)(i).
Claims 21-22, and 26 recite broad and narrow ranges. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest range is used.
Claim 27 recites the active agent is selected “to improve appearance of the skin” or “optionally providing at least one of an anti-acne…” or “each active agent being a polar-carrier-insoluble active agent selected from the group comprising albendazole…” It is unclear how the claim is further limiting claim 7 due to the broad alternatives, as presented. From one perspective, when the active agent is interpreted as “optionally providing at least one of an anti-acne…” there is no further limiting of claim 7, if the active agent “optionally” does not provide one of the listed functions.
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 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Handjani (US 2001/0010824A1), and in further view of 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 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 200 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 properties of the CSSCs and/or 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 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 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. Furthermore, CSSC is a recognized term of the Art, per a literature search. The specification lists several compound examples of CSSC, such as PCL and PLGA (on pg 10-11, 31-32, and pg 67-68, Table 1 of Applicant’s specification), with particular attention paid to polycaprolactone (PCL) of different molecular weights (e.g., PCL-14) used in Table 6 (pg 90) of Applicant’s specification, as a non-limiting example to demonstrate the invention’s effect on wrinkles.
Also, note that the viscosity limitation of claim 1 does not apply to the composition, but to the “CSSC(s)” or “nano-element” thus making the characterization with dynamic viscosity units unclear; however, it is understood that the “CSSC(s)” or “nano-element” can be associated with liquid, as shown in claim 2, where Art is found to read on the dynamic viscosity values. Further note that the vapor pressure of the nano-element constituents of claim 9 is also inherent to the ingredient, because an ingredient and its properties are inseparable (when the specific ingredient is taught by the Prior Art).
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. The term “active agent” of claims 7 and 26 has no particular additional limitation, with respect to the definition of “active agents” as known in the cosmetic Prior 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 may 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’s composition is capable of use topically (abstract).
Regarding claim 27: 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 viscosity of the CSSC or nanoelements (claim 1) or the molecular weight range (claim 1, 4, and 21), or solubility limitations (instant claim 26).
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, and 21) (pg 75, paragraph 1) in terms of microspheres, nanoparticles, etc. that can be used in drug-delivery systems (e.g., topically, etc.) (abstract).
Regarding claim 26 (including the solubility properties associated with the instant CSSC and “active agent”): Handjani and Azimi teach the obviousness of PCL-14 (i.e., 14 kDa PCL, where the 14 kDa MW is within Azimi’s 3-80 kDa range) in topical cosmetic compositions (where PCL-14 is exemplified in Applicant’s specification), and Handjani teaches “active agents” such as anti-inflammatories, vitamins, depigmenting agents, etc. [0017]. A PHOSITA would optimize the solubility of the ingredients in the formulation to ensure that the composition matches the product type desired by the artisan (i.e., dispersion or solution, as described by [0018-0023] in Handjani), where Azimi teaches tactics to alter solubility such as blending or copolymerizing (pg 75, paragraph 2). Thus, the PCL taught as obvious by Handjani and Azimi is expected to exhibit the solubility properties taught by Applicant in claim 26, with rationale provided for optimizing solubility of PCL and/or “active agents”. Furthermore, a compound and its properties are inseparable, and certain specific ingredients (e.g., PCL-14 or the anti-inflammatory) cannot have solubilities that are separated from their 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 compositions by specifying the molecular weight of the polymer, as taught by Azimi, because Azimi teaches 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 materials/”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.
Claims 1-10 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Handjani (US 2001/0010824A1), Azimi (Journal of Engineered Fibers and Fabrics, 2014) and Hougaz (US20090061001A1), as applied to 1-2, 4-10, 21-22, 24, and 26-27, 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 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 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Handjani (US 2001/0010824A1), 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 teaches the obviousness of solid nanoparticles and core-shell nanoparticles loaded with active agents [0003], 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 2/4/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614