DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 1-13 are pending and under current examination in this application. Amendment to the claims, filed 23 May 2023, are acknowledged and are supported by the originally-filed disclosure.
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 Applicant regards as his invention.
Claims 1-13 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, regards as the invention.
Claims 1, 9, and 10 are indefinite because the mathematical expression: (average fiber diameter)² / (fiber content) (μm²/mass%) is ambiguous because mass % is dimensionless, thus the mixture of dimensional and nondimensional units results in an unclear physical meaning. It is also unclear whether “mass %” refers to mass fraction, weight percent, mass per unit volume, or another metric. Thus, the metes and bounds of the claims cannot be determined with reasonable certainty.
The expression would be more clearly expressed, for example as:
F=(d2/c)
where: F= cumulative fiber length indicator (μm2/mass %), d=average fiber diameter (μm), and c= fiber content weight percent (mass %), wherein the F value ranges from 0.005-7 μm2/mass %.
Appropriate correction is required to resolve the ambiguity. Dependent claims 2-8 and 11-13 are included in this rejection because they do not cure the defect noted above.
By contrast with this understanding, the specification paragraph [0009] indicates that the nonvolatile oil may be only the oil-soluble ultraviolet absorber in a liquid state at 25°C and 1 atm, thus specifying that the ultraviolet absorber feature may be the nonvolatile oil feature (i.e., one chemical entity in the composition). Thus, clarification of the wording is required as to what particular meaning is intended (e.g., “A film-forming composition comprising components (a) and (b): (a) an ultraviolet absorbing oil mixture, wherein the ultraviolet absorbing oil mixture contains an oil-soluble ultraviolet absorber dissolved in a nonvolatile liquid oil; and (b) a fiber…”). Dependent claims 2-13 are included in this rejection because they do not cure the defect noted above.
Claims 12 and 13 are also is rejected as indefinite. Claim 12 recites a method of "manufacturing a film" by "applying the ... composition." This is indefinite because it fails to specify any steps that result in the formation of a distinct "film." Mere application does not necessarily manufacture a film; the claim lacks any limitations regarding drying, setting, curing, or any other process step that transforms the applied composition into a "film." Appropriate correction of claims 12 and 13 is required.
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.
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.
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.
Claims 1-13 are rejected under 35 U.S.C. § 103 as being unpatentable over Sano et al. (JP2020105119A; published 09 July 2020; the English translated version, EP3903886A has been published after the priority date of the present application and is only cited as a faithful translation of the prior art JP2020105119A, hereinafter referred to as “Sano”).
Sano teaches a skin cosmetic comprising a thickening stabilizer and cellulose nanofibers having an average fiber diameter of 10 to 1000 nm (0.01-1 µm; claim 1), a preferably 0.1-5 mass % (¶[0057]) or 0.01-3 mass% (¶[0059] and claim 4) and an average fiber length of 0.3-200 µm (¶[0038]), manufacturing a non-sticky, flexible, film on skin surface after application of the film-forming composition (¶[0007], ¶[0019] and ¶[0099]), that may be dispersed in an oil component ([¶0057]) preferably with a 1-50 mass % (¶[0064]), which may include a nonvolatile oil (i.e., all listed oils in ¶[0063] with the explicit exception of the cyclomethicones decamethylcyclopentasiloxane and octamethylcyclotetrasiloxane) and may comprise oil-soluble ultraviolet absorbers (¶[0062], ¶[0073] and ¶[0075]), preferably with a content mass 1-40 mass % (¶[0078]), wherein the ultraviolet protector is used to protect skin or the cosmetics per se against ultraviolet rays [expected technical effect sunscreen] (¶[0073]).
The average fiber diameter taught by Sano (i.e., 0.01-1 µm; claim 1) overlaps with the instant claim range of 0.1-7 μm and is taught by Sano to be a factor that may be adjusted by selection, pretreatment, or defibration (¶[0035]). In the discussion section, Sano notes that using an average fiber diameter that is too small results in skin tightness and poor film flexibility of the composition (¶[0107]) as presented by the use of CNF-C in Comparative Example 4 which was not an issue using the in higher diameter fibers in Example 1 of CNF-A, in Example 2 of CNF-B, and in Comparative Example 6 of MFC Table 4 (page 15). Thus, Sano provides motivation to increase the average fiber diameter range claimed as 0.01-1 µm (claim 1) to adjust to that of a higher average fiber diameter as in the instant claimed range of 0.1-7 μm.
The fiber mass % in the film-forming composition of Sano (i.e., 0.01-5 mass %; ¶[0057], ¶[0059] and claim 4) overlaps with the instant claimed mass % range of 0.5-10. Sano teaches that the fiber mass % can be adjusted by adding a solvent (¶[0057]), wherein a content too low can cause poor skin resilience and film-forming function and a content too high can result in poor spreadability of the composition and low film flexibility (¶[0059]). Thus, Sano provides motivation to increase the fiber mass % by adjusting it from the 0.01-5 mass % taught (¶[0057], ¶[0059] and claim 4) to that of a higher fiber mass % such as the 0.5-10 mass % of the instant claimed range, given that Examples 1 and 2 using the CNF-A and CNF-B, respectively, in Table 3 (page 13) had room for further improvement of skin resilience.
Sano does not explicitly disclose numerically, F=(d2/c), where: F= cumulative fiber length indicator (μm2/mass %), d=average fiber diameter (μm), and c= fiber content weight percent (mass %), wherein the exact numerical F value ranges from 0.005-7 μm2/mass %, however the claimed mathematical relationship (F) is a readily calculated mathematical consequence resulting from selecting the fiber diameter and mass % content ranges taught by Sano. The average fiber diameter taught by Sano (i.e., 0.01-1 µm; claim 1) and the fiber 0.01-5 mass % (¶[0057], ¶[0059] and claim 4) provides an F parameter that can range from 0.00002-100 μm2/mass %. The instant claim 1 selected range is a narrower range encompassed within the range that would result from the diameter and fiber content ranges taught by Sano.
In the example section Table 2 (page 14), Sano teaches using 0.5 mass % CNF-A fibers (used in inventive Example 1) with an average fiber width of 0.0508 μm calculated to yield an F value of 0.00516 μm2/mass %, CNF-B fibers (used in inventive Example 2) with an average fiber width of 0.2857 μm calculated to yield an F value of 0.163 μm2/mass %, MFC fibers (used in Comparative Example 6) with an average fiber width of 16.2 μm calculated to yield an F value of 524.88 μm2/mass %, and CNF-C fibers (used in Comparative Example 4) with an average fiber width of 0.003-0.01 μm calculated to yield an F value of 0.000018-0.0002 μm2/mass %. Wherein, for characterizing cellulose fibers, one skilled in the art would recognize the terms average cellulose fiber width and diameter are often used interchangeably in the art for ease since the diameter reflects the average width along the length of the fiber (although the cellulose fibers are not perfectly cylindrical/are irregular).
Thus, the calculated F parameter from the inventive Examples 1 and 2 are encompassed within the instant claim 1 range of 0.005-7 μm2/mass % and the calculated F value for inventive Example 2 using the CNF-B fibers (i.e., 0.163 μm2/mass %) is encompassed within the range of instant claims 9 and 10. Further, Sano expressly teaches adjustment of the average fiber diameter/width, and mass % to optimize the composition properties to achieve desired film properties as discussed above, motivating such selection of the specific instant claimed range of 0.005-7 μm2/mass %. More so, as the inventive examples (Example 1 and 2) falling within the instant claimed F value range provided the best overall balance performance results and (see page 15, Tables 3 and 4), whereas F values below 0.0002 μm2/mass % (CNF-C fibers; Comparative Example 4) and above 524.88 μm2/mass % (MFC fibers; Comparative Example 6) resulted in performance benefit tradeoffs (see page 15, Table 3 and 4). Thus, it would be a matter of routine experimental optimization from overlapping known fiber diameters and loadings taught by Sano, when applying the optimization principles also taught by Sano, to arrive at the narrower F value of the instant claimed ranges.
Sano teaches that the average fiber length can be adjusted by selection, pretreatment, or defibration (¶[0040]). The average fiber length range of 0.3-200 µm taught by Santo (¶[0038]) strongly overlaps with the instant claimed average fiber length of 20-300 μm. Santo teaches that lower average fiber lengths may result in poor film function and skin resilience (¶[0038]) and average fiber lengths above 200 µm may result in fiber entanglement and aggregation issues leading to a rough texture of the composition and the formation of eraser-like crumbs (¶[0039]).
The example embodiments in the instant specification Table 2, 3, and 4 all use an average fiber length of 50 μm (instant specification ¶[0145]), or 3 μm in Example 5A and 5 μm in Example 6A (instant specification Table 5, ¶[0160]). In the absence of any examples in the instant specification testing the higher limit of the instant claimed range of 200-300 μm with unexpected results, any relationship demonstrating the criticality of this higher limit, or evidence of a linkage of the higher limit of the instant claimed range to a particular effect, and given the instant specification notes 150 μm or less is particularly preferably to mitigate aggregation and a range of 40-150 μm is particularly preferably for a smooth even, uniform film formation, adhesion and durability (instant specification ¶[0060]), arriving at the instant claimed range is a matter of routine experimental optimization from that of the range taught by Sano.
While Sano does not explicitly specify the fiber of the component having an aspect ratio (average fiber length/average fiber diameter) of 15 or more, the average fiber length range of 0.3-200 µm taught by Santo (¶[0038]) and the average fiber diameter taught by Sano (i.e., 0.01-1 µm; claim 1) yield an aspect ratio range from 0.3-20,000, which encompasses the instant claimed range of 15 or more. Furthermore, Sano teaches both average fiber length and average fiber diameter may be adjusted by fiber selection, pretreatment, or defibration (¶[0035] and ¶[0040]). Selection within the calculated aspect ratio range taught by Sano of 15-20,000 would be a matter of routine experimental optimization.
Sano teaches a nonvolatile oil composition component ([¶0057] and ¶[0063]) containing an ultraviolet absorber (¶[0062], ¶[0073] and ¶[0075]) preferably with a 1-50 mass %, wherein adjusting the oil component below 1 mass% may result in poor flexibility of the composition film and a content of the oil component above 50 mass % may have a stickier texture and lower skin resilience (¶[0064]). Sano specifically teaches in the examples of Table 1, the use of the nonvolatile oils 3% diisostearyl malate, 20% ethylhexyl palmitate, and 2% dimethicone/vinyldimethicone crosspolymer dimethicone KSG-16 (Shin-etsu Chemical Co., Ltd.) totaling 25% total nonvolatile oil content and 8% ultraviolet absorber hydrogen dimethicone-treated fine particle titanium oxide (¶[0101], page 12) for a total of 33 mass %, which is encompassed in the instant claimed range of 0.5-90 mass % for component (a).
In the absence of any examples in the instant specification testing the higher limit of the instant claimed range of 50-90 mass % or the lower limit of 0.5-1 mass % showing unexpected results, any relationship demonstrating the criticality of this higher or lower limit, or evidence of a linkage of the higher or lower limit of the instant claimed range to a particular effect, and given the instant specification teaches an oil component content of 10-40 mass % is particularly preferably for film uniformity and desirable use impression (no oily and sticky feelings) (instant specification ¶[0024]), arriving at the instant claimed range is a matter of routine experimental optimization from that of the range taught by Sano.
The mass ratio of the ultraviolet absorber to a total of the nonvolatile oil calculated from the examples in Table 1 of Santo, totaling 25% total nonvolatile oil content and 8% ultraviolet absorber (¶[0101], page 12; encompassing the ultraviolet absorber range limitations of instant claims 8 and 9) is 0.32 for all examples, which is encompassed within the instant claim 2 range of 0.1-1. Santo also teaches adjustable nonvolatile oil composition components ([¶0057] and ¶[0063]), preferably with a 1-50 mass % (¶[0064]) and ultraviolet absorbers, preferably with a content mass 1-40 mass % (¶[0078]), thus resulting a calculated mass ratio of the ultraviolet absorber to a total of the nonvolatile oil ranging from 0.02-1, which encompasses the instant claim 2 and 10 range.
Sano teaches a particularly preferably 5-25 mass % of ultraviolet protector, and that lower ultraviolet protector levels can be insufficient providing the protective effect from ultraviolet and a content above 40 mass % may impair the spreadability of the composition (¶[0078]). One of skill in the art specifically seeking to formulate a composition with the objective of providing a primary ultraviolet ray sunscreen film protection attribute would be motivated to choose a higher ultraviolet absorber mass % from the teachings of Sano to ensure the ultraviolet absorber concentration is high enough to provide adequate desired protection, along with optimization of the nonvolatile oil content to balance the higher ultraviolet absorber concentration for optimal film properties while maintain desirable spreadability and formulation stability. Thus, adjusting the mass ratio of the ultraviolet absorber to total nonvolatile oil from the teachings of Sano to that of the instant claim 2 and 10 ranges is a matter of routine experimental optimization for a skilled formulator in the art that would yield predictable results with a reasonable expectation of success.
Sano discloses fibers treated with film-forming polymer emulsion (aqueous dispersion of a water-insoluble polymer) selected from the water-insoluble polymer (meth)acrylic resins alkyl acrylate copolymer emulsion and alkyl methacrylate copolymer emulsion (¶[0083]). In addition, powders may be used in the embodiment of the invention including the classic (meth)acrylic resin polymethylmethacrylate (PMMA; ¶[0067]). Sano also teaches that the water retention of the fibers may be adjusted by pretreatment or defibration of the raw fiber material pulp (¶[0046]) and that aqueous dispersion slurry of cellulose nanofibers may be used (¶[0037]). Further, cellulose fibers CNF-C, Rheocrysta™ (DKS Co., Ltd.; a cellulose nanofibril suspension treated to become compatible with hydrophobic materials, wherein the CNFs are integrated within a water-insoluble polymer matrix) was used as a raw material for testing in the specification (¶[0100]). Thus, embodiments of the invention integrating (meth)acrylic resins alkyl acrylate copolymer, alkyl methacrylate copolymer or polymethylmethacrylate into the cellulose fibers are taught by Sano.
In summary, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to adjust fiber diameter, fiber mass % concentration, fiber length as well as the mass % concentration of the ultraviolet absorber and nonvolatile oil components of the fiber-reinforced film-forming systems containing ultraviolet absorbers in nonvolatile oils taught by Sano, as Sano expressly teaches adjusting these parameters to achieve desired film properties (e.g., lack of sticky texture, skin resilience, smoothness of finish, lack of skin tightness, film flexibility and skin texture), motivating such selection of parameter optimization. One of skill in the art would have a reasonable expectation of success in making these routine optimization changes to arrive at the predictable effective concentration or ratio ranges of the instant claimed invention, given these parameters are directly or indirectly taught as result-effective variables by Sano.
Claims 1-5 are rejected under 35 U.S.C. § 103 as being unpatentable over Sano et al. (JP2020105119A; published 09 July 2020; the English translated version, EP3903886A has been published after the priority date of the present application and is only cited as a faithful translation of the prior art JP2020105119A, hereinafter referred to as “Sano”), in view of Sasaoka et al. (JP2020090487A; published 11 June 2020, hereinafter referred to as “Sasaoka”).
Sano renders the limitations of instant claims 1-3 obvious, as described above, from which instant claims 4 and 5 depend. Said claims 4 and 5 are also considered obvious under 35 USC § 103(a) over Sano for the reasons set forth above, however, alternatively, by way of differing interpretation of Sano, the specific limitations of instant claims 4 and 5, wherein the fibers more explicitly comprise water-insoluble (meth)acrylic resin polymer, is taught by Sano in view of Sasaoka.
Sasaoka teaches a cosmetic composition for forming fibers of a water-insoluble polymer (claim 1), as a polyester or an acrylic resin such as PMAA resin (¶[0028]-[0029]), with an average fiber diameter of 50 to 10,000 nm (0.05-10 µm; claim 1), and length of 10-100 μm or more (¶[0035]) having skin film-forming capability (claim 9) dispersed in a liquid preparation containing a liquid oil and polyol between and on the surface of the fibers (claim 1).
On this basis, it would have been prima facie obvious to one of ordinary skill in the art prior, to the instant effective filing date, to readily conceive substituting the use of a polyester or an PMAA resin fiber as taught by Sasaoka for the cellulose fiber material disclosed in the invention of Sano. One would have a reasonable expectation of success in making the change, since both fiber types were known for the same purpose of use in film forming of cosmetic compositions. One would be motivated to tailor the fiber composite formulation by modifying or replacing cellulose fibers, which are hydrophilic in an unmodified state, with PMAA resin fibers to achieve the expected technical effect of increased interfacial compatibility with hydrophobic components resulting in better ingredient dispersion and increased product stability via the prevention of phase separation, as well as enhanced film formation and durability via the more tightly interconnected fiber network compared to a simple unmodified cellulose fiber. Substituting cellulose fibers taught by Sano with PMAA resin modified cellulose fibers or replacing them with PMAA resin fibers, taught by the invention of Sasaoka, represents predictable optimization to enhance film forming strength and performance characteristics and product properties, such as better compatibility and stability with hydrophobic composition components.
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615