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 .
Priority
The present application, filed April 24, 2023, claims priority to foreign priority application KR10-2022-0053719, filed April 29, 2022.
Status of the Application
Claims 1-14 are pending and examined on the merits herein.
Claim Interpretation
The term “basic amino acid” recited in claim 4 is interpreted as any amino acid compound that includes a functional group capable of acting as a base.
In addition, the limitation that the composition is water-dispersable is interpreted as able to be dispersed with water. This limitation is not interpreted as requiring the composition to form a dispersion in water. The examiner believes this is consistent with the intended meaning of water-dispersable in this application, in view of the specification providing in Experimental Example 1 that the composition of example 5 maintained formulation stability without precipitation or discoloration (p. 9, Experimental Example 1 section, lines 8-11; data shown in Figure 2) (emphasis added).
Accordingly, compositions that may be washed away with water, including those compositions that may be dissolved in water, are interpreted herein as water-dispersable.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 4 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 4 depends from claim 1 requires the amino acid is a basic amino acid. However, amino acids by definition include an amino group, which is a basic group. Therefore, the amino acids of claim 1 would already satisfy the requirement of a basic amino acid, and thus claim 4 fails to further limit the subject matter of claim 1.
More generally, if claim 4 was intended to refer to those amino acids with basic side chains, the claim would be indefinite because the basicity of a functional group is dependent on pH. For example, the histidine side chain may act as a base at certain pH values, and even the aspartic acid side chain, often considered by those in the art as an acidic side chain, may act as a base in solution at a sufficiently low pH.
The examiner suggests amending claim 4 to recite the specific amino acids that Applicant intended to include in their group of basic amino acids.
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-8, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu (Publication No. CN 112494362 A; cited in PTO-892).
Lu was published in a language other than English. Both the original document and an English language machine translation are included with this Office action and cited in the PTO-892. Citations below refer to the English language translation document.
Lu teaches and claims a freeze-dried collagen mask which comprises, by weight, 0.05-1 parts of recombinant human collagen, 0.01-0.2 parts of sodium hyaluronate, 0.01-0.2 parts of betaine, 0.01-0.2 parts of hydroxyethyl cellulose, 1.2-6 parts of a first nutrient, 0.3-6 parts of a second nutrient, 1.92-21 parts of a third nutrient, 3-15 parts of a freeze-drying auxiliary agent, and the balance of deionized water (English translation, p. 1, claim 1). Lu further claims said second nutrient comprises cysteine 0.1-2 parts, tryptophan 0.1-2 parts, and methionine 0.1-2 parts (English translation, p. 1, claim 3), and the freeze-drying aid comprises 1 to 5 parts of trehalose, 1 to 5 parts of pullulan, and 1 to 5 parts of mannitol (English translation, p. 1, claim 5).
This collagen mask, with the second nutrient and freeze-drying aid as claimed by Lu, satisfies the requirements of present claim 1 wherein the composition comprises pullulan, mannitol, and the amino acids cysteine, tryptophan, and methionine. These are interpreted as basic amino acids as described in the above claim interpretation section.
Lu further teaches their invention has the benefit of providing a freeze-dried collagen mask, wherein hydroxyethyl urea, betaine and sodium hyaluronate have very strong water retention effects, hydroxyethyl cellulose is a macromolecular polysaccharide, and the moisturizing components and water can be networked together to form a moisturizing film to achieve a water locking effect for skin (English translation, p. 3, fourth paragraph, line 2). This is taken as teaching the composition of Lu is a film forming composition.
Finally, Lu teaches a specific example which includes, by weight, 0.05 parts of recombinant human-derived collagen, 0.01 parts of sodium hyaluronate, 0.01 parts of betaine, 0.01 parts of hydroxyethyl cellulose, 50.5 parts of vitamin B, 60.5 parts of vitamin B, 110.1 parts of vitamin B, 120.1 parts of vitamin B, 0.1 parts of cysteine, 0.1 parts of tryptophan, 0.1 parts of methionine, 0.02 parts of tetrahydro-methylpyrimidine carboxylic acid, 1 part of nicotinamide, 1 part of trehalose, 1 part of pullulan, 1 part of mannitol, and the balance of deionized water (English translation, p. 3, sixth paragraph, Example 1). This example includes less than 1% by weight of amino acids, as required by claim 7.
Regarding the requirement that the composition is water-dispersable, because Lu teaches that the composition is prepared by adding the components of the composition to deionized water in a specific order and then stirring (English translation, Example 1, preparation steps 1-4), this composition is interpreted as water-dispersable (i.e., able to be dispersed in water), absent evidence to the contrary.
This composition thus satisfies the limitations of present claims 1-4 and 7-8. In addition, because Lu does not teach the composition as including a silicone-containing component, the composition is interpreted as free of silicone, as required by claim 12. Finally, because Lu teaches this product is intended to form a moisturizing film for skin, it is considered as intended for external application to the skin, as recited in claim 14.
Thus Lu anticipates claims 1-4, 7-8, 12, and 14.
Claims 1, 3-5, 8, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feng (Publication No. CN 114159336 A; cited in PTO-892).
Feng was published in a language other than English. Both the original document and an English language machine translation are included with this Office action and cited in the PTO-892. Citations below refer to the English language translation document.
Feng teaches and claims a biological freeze-dried dressing stock solution capable of being rapidly dissolved comprising, by mass: 0.5-3% of pullulan polysaccharide, 0.1-1% of sodium alginate, 0.5-12% of mannitol, 0.01-10% of trehalose, 0.001-2% of recombinant human collagen, 5-30% of amino acid complex liquid and the balance of water, wherein the amino acid composite liquid comprises the following components in percentage by mass: 0.5 to 0.7 percent of sodium chloride, 0.05 to 0.15 percent of glucose, 0.08 to 0.2 percent of glycine, 0.08 to 0.2 percent of deoxyribonucleic acid, 0.02 to 0.04 percent of arginine, 0.02 to 0.04 percent of leucine, 0.02 to 0.04 percent of isoleucine, 0.01 to 0.02 percent of alanine, 0.01 to 0.02 percent of glutamic acid, 0.01 to 0.02 percent of serine, and the balance of water (English translation, p. 2, Claim 1).
This freeze-dried dressing stock satisfies the requirements of present claim 1 wherein the composition comprises pullulan, mannitol, and the amino acids listed above, including arginine.
In addition, Feng teaches and claims the method of making this freeze-dried dressing (English translation, p. 2, claim 5), and further claims the dressing may be placed in a forming mold in a film shape (English translation, p. 2, claim 6). This is interpreted as teaching the product of Feng may be molded to form a film, absent evidence to the contrary.
Regarding the requirement that the composition is water-dispersable, because Feng teaches that the dressing is prepared by adding the components of the composition to water with heating and homogenizing (English translation, p. 2, claim 5, step 1), this composition is interpreted as water-dispersable (i.e., able to be dispersed in water), absent evidence to the contrary.
This composition thus satisfies the limitations of present claims 1, 3-5, and 8. In addition, because Feng does not teach the composition as including a silicone-containing component, the composition is interpreted as free of silicone, as required by claim 12. Finally, because Feng teaches this dressing for reducing skin moisture loss (English translation, pp. 4-5, Test Example 2), it is interpreted as a composition for external application to the skin, as required by claim 14.
Thus Feng anticipates claims 1, 3-5, 8, 12, and 14.
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.
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, 3, 8, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Paufique (U.S. pre-grant publication no. US 20210022966 A1; cited in PTO-892), as evidenced by O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in PTO-892).
Paufique teaches and claims a method for a topical cosmetic treatment of healthy skin, the method comprising applying to the skin a dry and soluble film having a water activity of less than 0.6, wherein the dry and soluble film comprises: at least one mineral filler representing at least 5 wt. % of the dry film, at least one polymer of natural origin representing at least 15 wt. % of the dry film, at least one plasticizer representing at least 20 wt. % of the dry film, and at least one surfactant representing at least 0.1 wt. % of the dry film (p. 10, claim 1).
Paufique further teaches and claims the polymer of natural origin is chosen from a group that includes pullulan (p. 10, claim 18), and wherein the at least one plasticizing agent is selected from a group that includes sorbitol, amino acids, and mixtures thereof (p. 10, claim 20).
Paufique does not teach a specific embodiment that satisfies all requirements of present claim 1.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to prepare the composition of Paufique that includes a mixture of sorbitol and amino acid as the plasticizer and pullulan as the polymer of natural origin. One of ordinary skill in the art would have been motivated to prepare the composition of Paufique that includes a mixture of sorbitol and amino acid as the plasticizer and pullulan as the polymer of natural origin because each of these components are claimed by Paufique as potential components for the preparing their topical cosmetic treatment, and thus by following the method of Paufique, one of ordinary skill in the art would have contemplated a topical cosmetic that comprises, for example, pullulan, sorbitol and amino acid, with a reasonable expectation that this composition would be an effective topical cosmetic treatment for practicing the method of Paufique.
Regarding the requirement that the film be water-dispersable, Paufique teaches the film is a soluble film, which is interpreted as also being dispersable (i.e., able to be dispersed), absent evidence to the contrary. Although Paufique does not teach their film as water soluble, the examiner asserts that a film comprising pullulan would be water soluble. As evidence, O’Halloran teaches that Pullulan is amorphous, edible and naturally degradable, and is readily soluble in cold or warm water and forms clear, viscous solutions therewith (p. 2, [0027], lines 1-8). Accordingly, the examiner maintains that a film comprising pullulan would necessarily be water soluble, and thus also water dispersable, absent evidence to the contrary.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Feng (Publication No. CN 114159336 A; cited in PTO-892) in view of Sadiq (Sadiq, A.; et al. International Journal of Biosciences 2018, vol. 12, pp. 137-143; cited in PTO-892).
Feng teaches as described in the above rejection under 35 U.S.C. 102. In addition, Feng teaches their composition improves cell proliferation activity and has the effect of promoting barrier repair and shortening repair time in human tests (p. 1, Abstract, lines 8-10).
Feng does not teach the composition of claim 5, wherein the amino acid further comprises tryptophan.
Sadiq teaches a study to assess the role of tryptophan in post burn skin wound healing by using scald burn model (p. 137, Abstract, lines 1-3). Sadiq teaches that administration of tryptophan as topical cream formulation in a post burn wound model showed improved healing represented by smaller wound length, wound area and increased wound cellularity in tryptophan treated group as compared to the control (p. 137, Abstract, lines 3-5).
Sadiq concludes by stating that their study revealed tryptophan has potential to improve the burn skin wound healing, and thus tryptophan-based therapeutics can be a potential
candidate to investigate further about their mechanism of action for an improved wound healing process (p. 137, Abstract, lines 10-12).
It would have been prima facie obvious to modify the composition of Feng, which satisfies all limitations of claims 1 and 5, with tryptophan. One of ordinary skill in the art would have been motivated to modify the composition of Feng with tryptophan because Feng teaches their composition improves cell proliferation activity and improves barrier repair to promote wound healing, and because Sadiq teaches that tryptophan also improves wound healing by promoting cell proliferation. Therefore, one of ordinary skill in the art would have contemplated the addition of tryptophan to the composition of Feng because the addition of tryptophan may improve the cell proliferation and wound healing benefits of the composition taught by Feng.
MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same purpose, in order to form a third
composition to be used for the very same purpose.... [T]he idea of combining them flows
logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d
846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In this instance, because the composition of Feng promotes cell proliferation and improves, and because Sadiq teaches that topical tryptophan administration also improves wound healing by promoting cellular proliferation, the addition of tryptophan to the composition of Feng would have been obvious because each of the compositions taught by Feng and Sadiq promote skin cell proliferation and wound healing.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lu (Publication No. CN 112494362 A; cited in PTO-892) in view of Jarząbek-Perz (Jarząbek-Perz, S.; et al. Skin Research Technology 2021, vol. 27, pp. 925-930; cited in PTO-892).
Lu was published in a language other than English. Both the original document and an English language machine translation are included with this Office action and cited in the PTO-892. Citations below refer to the English language translation document.
Lu teaches as described in the above rejection under 35 U.S.C. 102.
Lu does not teach the composition of claim 1, further comprising gluconolactone, as recited in claim 10.
Jarząbek-Perz teaches a study to evaluate skin hydration after application of gluconolactone solutions (p. 925, Abstract, Background section, lines 4-5).
Jarząbek-Perz teaches in the sixteen healthy women part of their study, three
split face treatments were performed, with 10% and 30% gluconolactone solution applied to two sides of the face. Jarząbek-Perz teaches skin moisture was measured before each treatment and a week after the last treatment (p. 925, Abstract, Materials and Methods section, lines 1-4).
Jarząbek-Perz teaches that corneometric measurements of participants in their study showed a significant increase in facial skin hydration after gluconolactone treatment (p. 925, Abstract, Results section, lines 1-2), and concludes that gluconolactone is a moisturizing substance which works well in dry skin care (p. 925, Abstract, Conclusion section, lines 1-2).
It would have been prima facie obvious to modify the composition of Lu, which satisfies all limitations of claim 1, with gluconolactone. One of ordinary skill in the art would have been motivated to modify the composition of Lu with gluconolactone because Lu teaches their composition’s moisturizing components and water can be networked together to form a moisturizing film to achieve a water locking effect for skin, and because Jarząbek-Perz is a moisturizing substance that works well in dry skin care. Therefore, one of ordinary skill in the art would have contemplated the addition of gluconolactone to the composition of Lu, because the addition of gluconolactone may improve the moisturizing benefits achieved with the composition of Lu.
MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same purpose, in order to form a third
composition to be used for the very same purpose.... [T]he idea of combining them flows
logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d
846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In this instance, because the composition of Lu forms a moisturizing film on skin, and because Jarząbek-Perz teaches that gluconolactone has a hydrating effect on skin, the addition of gluconolactone to the composition of Lu would have been obvious because each of the compositions taught by Lu and Jarząbek-Perz provide a moisturizing effect on skin.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 3, 8, 9, and 12, are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Publication no. CN 107334750 A; cited in PTO-892) in view of Kulkarni (U.S. pre-grant publication no. US 20030211136 A1; cited in PTO-892).
Li was published in a language other than English. Both the original document and an English language machine translation are included with this Office action and cited in the PTO-892. Citations below refer to the English language translation document.
Li teaches an edible film that is particularly suitable for pets with poor oral
administration compliance. Li teaches that when this product is put into the pet's mouth, it will stick and dissolve quickly, releasing the active ingredients (English translation, document p. 5, [0008], lines 1-3).
As one example, Li teaches a pet oral care film that includes chlorhexidine (5 g), pullulan (16 g), polyvinyl alcohol (30 g), dextrin (4 g), citric acid (l g), glycerol (2 g), sucralose (1.6 g), and purified water as needed (English translation, document p. 9, [0024], lines 1-2).
Li further teaches and claims that the film includes a pharmaceutical active agent, a film-forming material, an adhesive material, a filler, and a plasticizer (English translation, document p. 13, claim 1), and that plasticizer is selected from one or a mixture of glycerin, propylene glycol, polyethylene glycol, and amino acids (English translation, document p. 15, claim 6).
Li does not teach an embodiment that includes an amino acid, as required by claim 1. In addition, Li does not teach an embodiment that includes a sugar alcohol, as required claim 1.
Kulkarni teaches fast dissolving orally consumable films for delivering one or more pharmaceutically active agents, more particularly to fast dissolving orally consumable films, containing a sweetener for improving the taste of the film (p. 1, [0001], lines 1-5).
Kulkarni teaches that conventional rapidly dissolving orally consumable films may have incorporated flavorants and/or sweetening agents to improve the taste of the film and/or its components, but the flavorants and/or sweetening agents used in these films generally provide limited taste improvement especially for films containing bitter tasting components. Kulkarni teaches there remains a need in the art to develop consumable thin films containing a sweetener, which at least substantially improves the taste of films and its components (p. 1, [0003], lines 1-10).
Finally, Kulkarni claims their film includes a taste masking effective amount of a sucralose (p. 12, claim 1), and further claims their film comprises a second sweetener selected from a group that includes xylitol (p. 12, claim 2).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the present application obvious to modify the oral film embodiment taught by Li and described above and include an amino acid plasticizer. One of ordinary skill in the art would have been motivated to modify the embodiment of an oral film taught by Li and include an amino acid plasticizer because Li suggests that either amino acid as an alternative plasticizer to glycerin. Therefore, one of ordinary skill in the art would have considered an alternative embodiment of the oral film of Li described above that includes amino acid in place of glycerin, and would have had a reasonably expectation of preparing an effective oral care film of Li because amino acids are suggested by Li as an alternative plasticizer to glycerin.
In addition, it would have been prima facie obvious to modify the oral film obvious over Li, as described above, and include a sugar alcohol, such as xylitol, as an additional sweetener. One of ordinary skill in the art would have been motivated to modify the oral film obvious over Li, as described above, and include a sugar alcohol, such as xylitol, as an additional sweetener, because Li teaches oral films that include sucralose as a sweetener, and Kulkarni teaches oral films with sucralose as a sweetener and further claims the films may include a second sweetener selected from a group that includes xylitol. In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because Li teaches oral film compositions that include sucralose as a sweetener, and because Kulkarni teaches oral films with a sweetener that includes sucralose and a second sweetener selected from a group that includes xylitol, one of ordinary skill in the art would have reasonably considered modifying the films disclosed by Li with a second sweetener, such as xylitol, because a second sweetener may make the films more palatable when administered to pets.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Feng (Publication No. CN 114159336 A; cited in PTO-892) in view of Zhao (Zhao, Z.; et al. Journal of the Science of Food and Agriculture 2019, vol. 99, pp. 4150-4157; cited in PTO-892), Cassanelli (Cassanelli, M.; et al. Food Biophysics 2018, vol. 13, pp. 304-315; cited in PTO-892) and Capra (Capra, P.; et al. International Journal of Cosmetic Science 2017, vol. 39, pp. 393-401; cited in PTO-892).
Claim 11 depends from claim 1 and requires composition has a static contact angle of 35 to 55 degrees.
Feng teaches as described in the above rejection under 35 U.S.C. 102.
Feng does not teach the static contact angle of their composition, as recited in claim 11.
Zhao teaches the contact angle of a pure pullulan film is 59 degrees (p. 4152, right column, Contact angle measurement, lines 4-5; p. 4153, Figure 3). In this instance, the contact angle taught by Zhao is interpreted as the same measurement as static contact angle recited in claim 11.
Cassanelli teaches the effect of mannitol and sucrose on polysaccharide freeze-dried gels made of gellan gum. Specifically, Cassanelli teaches that wettability of gels was assessed by measuring the static contact angle (p. 307, left column, first full paragraph, lines 1-4).
Cassanelli teaches that addition of sucrose and mannitol to gellan gum gels increases their wettability (p. 313, left column, first full paragraph lines 1-5) and reduces their contact angle in a concentration-dependent manner (p. 314, Table 1).
Capra teaches there is growing interest in assessing the wettability of the biosurfaces, such as skin, dentin, hair and nail. Capra teaches that skin is a living tissue and it is characterized from a superficial thick layer (stratum corneum) constituted of a complex of proteins, lipids and water-soluble components. Capra teaches the stratum corneum is considered the primary barrier to transdermal diffusion for most substances, and it is responsible for the physico-chemical properties of skin surface. Capra teaches the wettability properties of the skin influence the development of resident bacterial flora, the possible colonization of pathogenic bacteria, the control of triglyceride hydrolysis, skin pH, the water absorption in the process of desquamation and the mechanical behavior of skin (p. 394, right column, lines 1-12) (emphasis added). Capra further teaches that that the skin surface is mostly hydrophobic and becomes paradoxically more wettable by a lipid phase (p. 394, right column, lines 12-14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to optimize the static contact angle of the composition disclosed by Feng to achieve a desired wettability. One of ordinary skill in the art would have been motivated to optimize the static contact angle of the composition disclosed by Feng to be achieve a desired wettability because Zhao teaches the contact angle of a pure pullulan film is 59 degrees, Cassanelli teaches that addition of excipients, including mannitol, reduce the contact angle and increase the wettability of another polysaccharide composition, and because Capra teaches the wettability of skin impacts a number of different properties of said skin, including water absorption of the skin. Accordingly, in view of this prior art, one of ordinary skill in the art would have recognized that adjusting the concentration of components in the compositions disclosed by Feng, such as the concentration of mannitol, would be expected to increase the wettability and reduce the contact angle of the pullulan film, and accordingly, would have reasonably adjusted the amount of mannitol within the range suggested by Feng to achieve the desired wettability of the topical skin treatment taught by Feng.
MPEP 2144.05 II at A states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") (emphasis added). In this instance, because the contact angle of a film is a measure of the wettability of this film, and because the wettability of skin influences a number of different properties of that film, including water absorption, one of ordinary skill in the art would have optimized the specific topical composition, such as by optimizing the concentration of Mannitol, within the ranges described by Feng, to achieve a composition that forms a film with the desired wettability.
Regarding the specific static contact angle between 35 and 55 degrees, because Zhao teaches the contact angle of a pullulan film is 59 degrees, and because Cassanelli teaches addition of mannitol reduces the contact angle of a polysaccharide composition, one of ordinary skill in the art would have reasonably expected that optimization of wettability by adjusting the concentration of mannitol in the composition of Feng would have sampled compositions with contact angles between 35 and 55 degrees.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693