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 .
Summary
Receipt of Applicants election of claims 1-16 without traverse filed on 07/20/2026 is acknowledged. Claims 17-20 and 24 are canceled as filed in Preliminary Amendment dated 03/27/2024. Claims 1-16, 21-23 and 25 are pending.
Election/Restrictions
Applicant elects Group I, claims 1-16, without traverse is acknowledged. Group II, claims 21-23 and 25, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-16 are pending and under examination in this application.
Priority
The current application filed on 03/27/2024 is a 371 of PCT/EP2022/077221 filed 09/29/2022, which in turn claims priority to patent application GB2113926.6 filed on 09/29/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/26/2024 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
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.
Claims 7, 8, 9, 10, 11, 12,13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7-8, both claims recite that the w/w ratio "may be from" specified ranges. Under USPTO practice (MPEP 2173.05(r)), using permissive language such as "may be" renders the feature optional and introduces ambiguity as to whether the numerical ranges are mandatory limitations or merely preferred embodiments.
Regarding claim 9, the claim recites that the material “is configured to substantially retain its shape on a mounting surface when exposed to a wetting agent but disintegrate under mechanical agitation to form a cream or gel". This relies on broad functional outcome language without providing requisite structural limits, and "substantially" acts as a vague term of degree in this context. The two terms (configured to substantially) are functional claiming terms without structural boundaries, especially coupled with the term of degree "substantially." The functional "configured to" clause cannot impart novelty to an otherwise identical structural material (MPEP 2112).
Regarding claims 11-12, both claims state that the polymer is "optionally selected from...". Language stating that a species is "optionally selected" renders the listed species non-binding for patentability. Moreover, claim 12 recites "said proteins optionally selected from... sodium alginate (SA)". Sodium alginate is a polysaccharide/carbohydrate, not a protein, and recites "said carbohydrates optionally selected from collagen...". Collagen is a structural protein, not a carbohydrate. Therefore, this is scientifically inaccurate.
Regarding claim 13, the claim recites an average thickness of "around 20nm to 100μm". The term "around" is a term of degree that lacks clear boundaries.
Claims 8 and 16 recites the limitation "the total oil content" in claim 8 line 1; and in claim 16 recites "wherein said topical delivery system is for delivery to the skin or to the mucous membranes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. If claim 8 depends from claim 6 (which depends from claim 1) without depending through claim 4, there is no proper antecedent basis for "the total oil content" because claim 1 refers broadly to "oil(s)" rather than defining a "total oil content". There is insufficient antecedent basis for this limitation in the claim; and claim 16 depends from any of claims 1–15 (which are directed exclusively to a "dry cream"), "said topical delivery system" lacks antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites "The dry cream or topical delivery system according to any one of claims 1 to 9...". Claims 1–8 define a "dry cream," while claim 9 defines a "topical delivery system". Referencing "The dry cream" when depending from claim 9, or "topical delivery system" when depending from claims 1–8, creates improper hybrid dependency. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tojo et al., (US 2013/0125912 A1 hereinafter “Tojo”) in view of Hamersky et al., (US 2019/0350819 A1 hereinafter “Hamersky”); and Stachewicz et al., (Pore shape and size dependence on cell growth into electrospun fiber scaffolds for tissue engineering: 2D and 3D analyses using SEM and FIB-SEM tomography, hereinafter “Stachewicz”); and Krysiak et al., (Nano- and Microfiber PVB Patches as Natural Oil Carriers for Atopic Skin Treatment, hereinafter “Krysiak”); and further in view of Rahmani et al., (Electrospun PVP/PVA Nanofiber Mat as a Novel Potential Transdermal Drug-Delivery System for Buprenorphine: A Solution Needed for Pain Management, hereinafter “Rahmani”).
Tojo teaches a nanofiber made from a water soluble polymer, having a cavity, and containing an oily component in the cavity (Abstract; [0007]), produced by electrospinning an O/W emulsion having the water soluble polymer dissolved in the aqueous phase and the oily component contained in the oily phase ([0008], [0020]-[0059]). Tojo teaches that the nanofiber has a thickness usually of 10 to 3000 nm, preferably 100 to 2000 nm, more preferably 200 to 1500 nm, in terms of circle equivalent diameter ([0026]). Tojo teaches that the water soluble polymer may be a naturally occurring polymer (e.g., pullulan, hyaluronic acid, chondroitin sulfate, cellulose, pectin, xylan, modified corn starch, and the like) or a synthetic polymer (e.g., partially saponified polyvinyl alcohol, low-saponified polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, sodium polyacrylate) ([0027]). Tojo teaches that the oily component is preferably present in a ratio of 0.5% to 95%, more preferably 10% to 90%, even more preferably 20% to 90%, by mass, and that the water soluble polymer is preferably present in a ratio of 5% to 99.5%, more preferably 10% to 90%, even more preferably 10% to 80%, by mass ([0035]). Tojo further teaches specific worked examples in which the resulting dry nanofiber sheet contains 75.82% pullulan / 24.11% oil (Examples 1-2), 65.3% pullulan / 34.58% oil (Example 3), and 80% pullulan / 20% oil (Example 4), with corresponding fiber diameters of 504 nm, 490 nm, 270 nm, and 1312 nm, respectively ([0073], [0079], [0082], [0084]). Tojo teaches use of a nonionic surfactant (e.g., polyoxyethylene hydrogenated castor oil) as an emulsifier for preparing the O/W emulsion ([0054], Example 1). Tojo further teaches that the nanofiber sheet may be attached to human skin, wherein wetting the sheet with water dissolves the water soluble polymer, destroying the cavity and releasing the oily component onto and into the skin ([0046]).
Hamersky teaches dissolvable fibrous elements/filaments for conditioning/topical compositions that are explicitly spinnable by “meltblowing, spunbonding, electro-spinning, and/or rotary spinning” (¶[0036]), confirming electrospinning as an art-recognized method for forming this class of water-soluble-polymer fiber structures. Hamersky's claim 2 recites less than 7% water content on a dry filament basis, and the specification frames residual water as a controlled/minimized parameter. Hamersky teaches a Hand Dissolution Test in which the fibrous structure is wet with water for 5-10 seconds (without necessarily fully collapsing the structure), then rubbed/agitated to dissolve/disperse the structure into a lamellar, cream/gel-like composition. Hamersky further teaches inclusion of a cationic surfactant, and delivery of the composition to the scalp and hair.
Stachewicz teaches electrospun polymeric nanofiber scaffolds in which the average apparent pore diameter, measured by 2D SEM analysis and confirmed by 3D FIB-SEM tomography, ranges from 0.92 ± 0.57 μm to 1.92 ± 1.32 μm depending on fiber arrangement (aligned vs. random) and cell seeding condition (Table 1, p. 407).
Krysiak teaches electrospun poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate) (PVB) nano- and microfiber mats used as natural oil carriers for topical skin treatment, in which fiber diameter directly governs oil wetting and penetration behavior. Krysiak’s cryo-SEM analysis demonstrates that for nanofiber mats (average fiber diameter ~335 nm), borage oil penetrated the fiber network evenly, with individual fibers wetted and covered in oil throughout the mat (§3.4, Fig. 5A). By contrast, for microfiber mats (average fiber diameter ~966 nm), oil wetted only the outermost fiber layers, with sharp-edged oil droplets observed and no penetration or leakage into the underlying fiber network (§3.4, Fig. 5A-D). Krysiak confirms this fiber-diameter-dependent wetting/penetration behavior — governed by the resulting pore size/spacing between fibers — across all three tested oils of varying viscosity (borage, black cumin seed, evening primrose oil).
Rahmani teaches a novel nanofibrous transdermal drug-delivery system to treat pain, the nanofiber mats of buprenorphine-loaded poly (vinyl pyrrolidone) (Bup/PVP) and buprenorphine-loaded poly(vinyl alcohol)/poly(vinyl pyrrolidone) (Bup/PVP/PVA) were successfully fabricated by the electrospinning process for transdermal drug delivery (abstract).
Regarding claim 1, the combination of Tojo and Hamersky teaches a dry cream / topical delivery system comprising a mat of electrospun hydrophilic polymeric fibers containing oil(s), as set forth above. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form Hamersky's dissolvable water-soluble-polymer fiber structure using Tojo's electrospun oil-containing nanofiber technique, since both references are directed to water-soluble polymeric fiber structures for topical/cosmetic delivery, and Tojo teaches that its electrospinning technique and cavity-retained oil structure yields a nanofiber that feels less sticky and exhibits improved storage stability relative to conventional oil-loaded fiber structures ([0006]-[0007], [0016]), providing an art-recognized motivation to combine.
Regarding claim 2, Hamersky's claim 2 recites a water content of less than 7% on a dry filament basis, overlapping the claimed range of less than 2.0 wt% and its recited sub-ranges. It would have been obvious to a person having ordinary skill in the art to further optimize/minimize the water content down through the claimed sub-2% thresholds as a routine result-effective variable, motivated by the shared goal (evident in both Hamersky and Tojo, see Tojo ¶[0016]) of improving storage stability and shelf life through minimizing residual water content. See In re Aller, 220 F.2d 454 (CCPA 1955).
Regarding claim 3, Tojo's disclosed water soluble polymer ratio of 5% to 99.5%, preferably 10% to 90% ([0035]), overlaps the claimed range of 40-99 wt%. Tojo's specific worked examples (75.82%, 65.3%, and 80% polymer, Examples 1-4) each fall within the claimed range. See In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)
Regarding claim 4, Tojo's disclosed oily component ratio of 0.5% to 95%, preferably 10% to 90%, more preferably 20% to 90% ([0035]), overlaps the claimed range of 1-35 wt%. Tojo's specific worked examples (24.11%, 34.58%, and 20% oil, Examples 1-4) each fall within the claimed range.
Regarding claim 5, Tojo teaches that the oily component is preferably present in a ratio of 0.5% to 95% by mass and the water soluble polymer is present in a ratio of 5% to 99.5% by mass ([0035]). These disclosed ranges overlap the claimed w/w ratio of about 1:5 to about 1:50 at their low-oil, high-polymer ends (e.g., an oil loading toward the low end of 0.5 – 95 % combined with a polymer loading toward the high end of 5 -99.5 % necessarily yields ratios within the claimed ranges (ratios of approximately 1:1.9 to 1:4), this confirms that the relative proportion of oil to polymer is a result-effective variable within Tojo’s disclosed formulation space, one which a person having ordinary skill in the art would have optimized, including toward more dilute, lower-oil formulations within the claimed 1:5 to 1:50 range to balance oil delivery against fiber-forming capability and mat integrity, absent a showing of unexpected results. See MPEP § 2144.05 and In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955).
Regarding claim 6, Tojo teaches use of a nonionic surfactant (polyoxyethylene hydrogenated castor oil) as an emulsifier in forming the O/W emulsion ([0054]), and Hamersky further teaches inclusion of a cationic surfactant, together teaching that the dry cream/topical delivery system comprises one or more surfactant(s).
Regarding claims 7-8, both claims depend from claim 6 and further recite that the w/w ratio of polymeric fiber content to surfactant content, and of oil content to surfactant content, respectively, “may be from” specified ranges. As discussed in the §112(b) rejection above, this permissive “may be” language renders the recited ratio non-limiting under broadest reasonable interpretation. Accordingly, the base surfactant limitation of claim 6, met by Tojo's nonionic surfactant emulsifier as discussed above, satisfies claims 7 and 8 as currently written.
Regarding claim 9, Hamersky teaches a Hand Dissolution Test in which the fibrous structure is wet with water for 5-10 seconds without necessarily fully collapsing the structure (¶[0206]), then rubbed/agitated in circular strokes to dissolve/disperse the structure (¶[0207]), corresponding to the claimed configuration to substantially retain shape on a mounting surface when exposed to a wetting agent but disintegrate under mechanical agitation. Hamersky further teaches, as a general characteristic of the dissolvable solid structure, that it forms a lamellar structure upon wetting and yields a cream/gel-like composition upon dissolution (¶[0004]; ¶[0177]), consistent with the claimed formation of “a cream or gel.” Examiner notes that Tojo’s own disclosed mechanism (full dissolution of the water-soluble polymer upon wetting to release the oily component, [0046]) is not relied upon for this limitation and is not read onto claim 9; Hamersky alone is relied upon for this teaching.
Regarding claim 10, Tojo and Hamersky each teach that the fiber-forming polymer may comprise a synthetic polymer, a natural polymer, or a combination thereof ([0027]).
Regarding claim 11, Tojo's disclosed list of synthetic water soluble polymers — partially saponified polyvinyl alcohol, low-saponified polyvinyl alcohol, polyvinylpyrrolidone, and polyethylene oxide ([0027]) — substantially corresponds to the claimed list of synthetic polymers.
Regarding claim 12, Tojo's disclosed list of naturally occurring polymers — including pullulan, hyaluronic acid, chondroitin sulfate, cellulose, pectin, xylan, and modified corn starch ([0027]) — substantially corresponds to the claimed list of natural (protein and carbohydrate) polymer species. Examiner notes claim 12 appears to mis-assign “sodium alginate” to the recited “proteins” subgroup and “collagen” to the recited “carbohydrates” subgroup, addressed under the §112(b) rejection above; this mapping addresses the listed species without regard to the mis-assigned category label and is without prejudice to that rejection.
Regarding claim 13, Tojo teaches a nanofiber thickness of 10 to 3000 nm, preferably 100 to 2000 nm, more preferably 200 to 1500 nm ([0026]), and its worked examples report measured diameters of 504 nm, 490 nm, 270 nm, and 1312 nm ([0073], [0079], [0082], [0084]), each of which falls within one or more of the claimed nested sub-ranges (e.g., about 150nm to about 900nm; about 150nm to about 2μm; about 20nm to about 100μm).
Regarding claim 14, Krysiak teaches that fiber diameter in electrospun fiber mats directly governs oil penetration behavior: for nanofibers (smaller fiber diameter, ~300 nm), borage oil penetrated the fiber network evenly with individual fibers wetted throughout the mat, while for microfibers (larger fiber diameter, ~1 μm), oil wetted only the outermost fiber layers with no penetration into the underlying network (§3.4, Fig. 5A, 5D). Krysiak further confirms this fiber-diameter-dependent wetting/penetration behavior across all three tested oils, establishing that controlling fiber diameter — and by direct structural consequence, the pore size defined by the spacing between fibers — is a functionally significant parameter for achieving oil uptake into (rather than mere retention on the surface of) an electrospun oil-carrying fiber mat. This provides an art-recognized motivation for a person having ordinary skill in the art to specifically select and control pore size when constructing the Tojo/Hamersky electrospun oil-containing fiber mat, in order to achieve oil penetration into the fiber network rather than surface-only retention.
Stachewicz teaches electrospun polymeric nanofiber scaffolds in which the average apparent pore diameter, measured by 2D SEM analysis and confirmed by 3D FIB-SEM tomography, ranges from 0.92 ± 0.57 μm to 1.92 ± 1.32 μm depending on fiber arrangement (aligned vs. random) and cell seeding condition (Table 1, p. 407), with the text further confirming that fiber and pore diameters in seeded samples fell within the range of 0.5 μm to 1.5 μm (§3.1, p. 403). These disclosed pore size values fall squarely within each of the claimed ranges of about 0.1 μm to about 2 μm, about 0.2 μm to about 1.5 μm, and about 0.5 μm to about 1 μm. Stachewicz further confirms that pore size in electrospun fiber mats is directly governed by fiber diameter and fiber spacing/arrangement — an inherent structural relationship of electrospun mat construction generally, consistent with Krysiak’s demonstration that this same structural parameter controls oil penetration/uptake behavior specifically. It would have been obvious to a person having ordinary skill in the art before the effective filing date to select a pore size within the disclosed and overlapping range of about 0.1 μm to about 2 μm when constructing the Tojo/Hamersky electrospun oil-carrying fiber mat, since pore size is a result-effective variable governed by routinely-adjustable electrospinning parameters (fiber diameter, solution concentration, voltage, collector arrangement) — motivated, per Krysiak, by the goal of achieving oil penetration into the fiber network — and Stachewicz demonstrates that the claimed pore size range is readily achievable and commonly reported for electrospun nanofiber scaffolds. See In re Aller, 220 F.2d 454 (CCPA 1955); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).
Regarding claim 15, Rahmani teaches an electrospun PVP/PVA nanofiber mat — the same preferred synthetic polymer blend disclosed in the instant specification — having a BJH-adsorption cumulative pore volume of 0.031125 cm³/g in its non-cross-linked form (p. 16, §4). Rahmani further teaches that this pore volume increases nearly three-fold, to 0.089977 cm³/g, upon cross-linking the same PVP/PVA nanofiber mat with glutaraldehyde (GTA), while the fibrous, porous nanostructure of the mat is expressly maintained throughout (p. 16, “maintaining the integrity and porosity of nanofibers”). Rahmani thus establishes pore volume as a result-effective variable in electrospun PVP/PVA mats that is directly and predictably increased through the degree/extent of cross-linking treatment, with the disclosed data demonstrating this relationship across at least two data points (0.031 cm³/g uncross-linked to 0.090 cm³/g cross-linked). It would have been obvious to a person having ordinary skill in the art before the effective filing date to further extend or optimize the cross-linking treatment of the Tojo/Hamersky/Krysiak electrospun oil-carrying fiber mat — a technique of general applicability to hydrophilic polymeric nanofiber mats, consistent with Hamersky’s own disclosure of controlled water-content parameters for this class of materials — through routine experimentation (e.g., increased cross-linker concentration or immersion time) to reach or exceed the claimed pore volume of about 0.1 cc/g, since Rahmani’s data demonstrates that this parameter responds predictably and substantially to a single, routinely-adjustable processing variable, and no unpredictable result or unexpected difficulty in extending this established trend has been shown. See In re Aller, 220 F.2d 454 (CCPA 1955) (routine optimization of a result-effective variable through ordinary experimentation).
Regarding claim 16, the recitation that the topical delivery system “is for delivery to the skin or to the mucous membranes” is directed to an intended use of the claimed composition and is given little patentable weight, as it does not further structurally limit the claimed dry cream/topical delivery system over the prior art. See MPEP § 2111.02. Notwithstanding, Tojo and Hamersky’s teachings are provided below for compact prosecution purposes. Tojo teaches that the nanofiber sheet is suitable for attachment to human skin as a moisturizing, cosmetic, or medical sheet (¶ [0046]). Hamersky further teaches delivery of the composition to the hair (¶ [0172]: detangling, reduced breakage, reduced frizz/static, smoothness/shine), and that the filament-forming polymer should be physiologically compatible with the skin, mucous membranes, hair, and/or scalp (¶ [0069]), together with Tojo teaching delivery to the skin and mucous membranes as claimed. This mapping is provided without prejudice to the §112(b) antecedent-basis rejection of claim 16 set forth above, which rests on an independent ground.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to adjust and optimize the relative proportions/ratios of oil to polymer matrix within the broad ranges taught by Tojo to achieve optimum fiber formation, structural integrity, and oil loading capacity. Modifying component ratios within an art-disclosed range represents the routine optimization of result-effective variables (MPEP § 2144.05; In re Aller, 220 F.2d 454; In re Peterson, 315 F.3d 1325).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0323. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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