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
Applicant’s communication, received April 27, 2026, wherein claims 1-3 and 6-14 are amended, claims 4-5 are canceled, and new claims 15-17 are added, is acknowledged.
Claims 1-3 and 6-17 are pending and examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claim 4 under 35 USC § 112(d) for failing to further limit the subject matter of the claim upon which it depends, has been fully considered and found to be persuasive to remove the rejection because claim 4 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1-4, 7-8, 12, and 14 under 35 USC § 102 as anticipated by Lu, has been fully considered and found to be persuasive to remove the rejection because claim 4 is canceled and independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by Lu. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1, 3-5, 8, 12, and 14 under 35 USC § 102 as anticipated by Feng, has been fully considered and found to be persuasive to remove the rejection because claim 4 is canceled and independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by Feng. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1, 3, 8, and 12-14 under 35 USC § 103 as unpatentable over Paufique, as evidenced by O’Halloran, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by Paufique. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1, 5, and 6 under 35 USC § 103 as unpatentable over Feng in view of Sadiq, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by the combination of Feng and Sadiq. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1, 5, and 6 under 35 USC § 103 as unpatentable over Lu in view of Jarząbek-Perz, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by the combination of Lu and Jarząbek-Perz. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1, 3, 8, 9, and 12 under 35 USC § 103 as unpatentable over Li in view of Kulkarni, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by the combination of Li and Kulkarni. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 27, 2026, with respect to the rejection of claims 1 and 11 under 35 USC § 103 as unpatentable over Feng in view of Zhao, Cassanelli, and Capra, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to claim a method for forming a film on a skin surface, which is not taught by the combination of Feng, Zhao, Cassanelli, and Capra. Therefore the rejection is withdrawn.
The following are new and/or modified grounds of rejection, necessitated by Applicant’s amendment received April 27, 2026. Applicant’s arguments are addressed following the rejections below.
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 1-3, 7, 8, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in previous office action) in view of Feng (Publication No. CN 114159336 A; cited in previous office action), Coltelli (Coltelli, M.-B.; et al. Journal of Functional Biomaterials 2020, vol. 11, article 20; cited in PTO-892) and Haniffa (Haniffa, et al. Polymers 2016, vol. 8, article 246; cited in PTO-892).
Feng was published in a language other than English. Both the original document and an English language machine translation were included with the previous Office action and cited in the PTO-892. Citations below refer to the English language translation document.
O’Halloran teaches compositions for forming a visible and distinctive cosmetic
film on the skin of a subject that contain 3 to 15 wt. % pullulan (cover page, Abstract, lines 1-3).
O’Halloran teaches that cosmetic films are conventionally used to produce
a variety of favorable results for the user and require that a coating be formed over the contours of the skin to which it is applied, typically on the face (p. 1, [0003], lines 1-6). O’Halloran teaches that the major function of most conventional, cosmetic films is to deep clean facial skin by removing dead skin cells, and that cosmetic films are believed to improve capillary blood circulation, cleanse, retexturize, firm and moisturize as well as stimulate the skin and increase
cell regeneration (p. 1, [0004], lines 1-5).
O’Halloran teaches compositions for forming a cosmetic film on the skin of a subject contain 3 to 15 wt. % pullulan (p. 1, [0005], lines 1-4). O’Halloran teaches the compositions of the present invention are cosmetically elegant in nature, spread easily onto the skin, and are non-sticky (p. 1, [0005], lines 8-10). O’Halloran teaches the compositions, when applied to the skin of a subject, form into a visible and distinctive film on the skin as the volatile components of the compositions evaporate. O’Halloran teaches the resultant film is comfortable and can preferably be worn on the skin of the subject for a period of 20 minutes to several hours, and after the composition dries into a film, it may be rinsed off the skin of the subject (p. 2, [0024], lines 6-13).
O’Halloran teaches that formulations which contain less than around 3 wt. % pullulan fail to produce an acceptable visible and distinctive cosmetic film, and formulations containing greater than about 15 wt. % pullulan are very thick and sticky and are difficult to spread onto the skin (p. 2, [0025], lines 6-11).
O’Halloran teaches examples of aqueous compositions comprising pullulan that may be used in their invention (p. 4, [0043], Table 1; pp. 4-5, [0055], Table 2). Therefore, the method of O’Halloran is intended to be practiced with aqueous compositions.
Finally, O’Halloran teaches and claims a method for forming a cosmetic film on the skin of a subject, comprising applying to the skin of the subject a composition comprising: 3 to 15 wt. % pullulan (p. 6, claim 23), and further claims this method, wherein the composition comprises additional components, such as active agents and humectants (p. 6, claim 24). Therefore, in view of O’Halloran, one of ordinary skill in the art would have recognized that the method of O’Halloran is intended to be practiced with a composition that includes other components, not solely pullulan.
O’Halloran does not teach a composition comprising a sugar alcohol and the amino acid arginine, and wherein the film is transparent and flexible, as required by claim 1.
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) (emphasis added).
This freeze-dried dressing stock 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.
Feng teaches this dressing needs to have the functions of reducing the wound repair time, preventing infection and repairing the skin percutaneous water loss barrier (TEWL), and that their dressing can effectively promote epidermis reconstruction, reduce wound repair time and repair skin TEWL value (p. 2, Description, Background section, paragraph 3; Disclosure of Invention section, paragraph 1), and affects the repair of skin moisture loss (p. 3, eighteenth paragraph, line 4).
Regarding the requirement that the composition is an aqueous dispersion, 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-dispersible (i.e., able to be dispersed in water).
Finally, Feng does not teach the composition as including a silicone-containing component or an oil, and thus the composition is interpreted as free of silicone and oil.
Coltelli teaches pullulan used in applications relating to sustainable body and skin-contact (p. 1, Title). Coltelli teaches that the alpha linkages give pullulan physical properties such as water solubility and fiber flexibility, enabling its capacity of forming fibers and films (p. 2, lines 1-2), and teaches pullulan can be processed into a transparent and edible film (p. 2, lines 3-5) (emphasis added). Therefore, one of ordinary skill in the art would have reasonably expected a pullulan film to be transparent.
Haniffa reviews bionanocomposite coating films and their applications (p. 1, Title), including pullulan (pp. 6-8). Haniffa teaches the unique pattern of the α-(1→6) linkages among the maltotriose subunits in pullulan provides distinctive physical properties of pullulan including high water solubility and structural flexibility, and these properties endow the pullulan with physical traits, along with adhesive properties, and enable its capacity for compression, thereby molding strong, oxygen-impermeable films and forming fibers (p. 7, first paragraph, lines 1-5) (emphasis added). Therefore, in view of Haniffa, one of ordinary skill in the art would have recognized pullulan may form films and exhibit structural flexibility, and accordingly, would have reasonably expected a film to exhibit such flexibility.
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 form a film on skin using the method taught by O’Halloran and the composition taught by Feng. One of ordinary skill in the art would have been motivated to form a film on skin using the method taught by O’Halloran and the composition taught by Feng because O’Halloran teaches cosmetic films are believed to improve capillary blood circulation, cleanse, retexturize, firm and moisturize as well as stimulate the skin and increase cell regeneration, and further teaches a method of forming a pullulan-based film which is comfortable and can preferably be worn on the skin of the subject for long periods of time by administering an aqueous composition to the skin, and because Feng teaches a composition comprising pullulan that can effectively promote epidermis reconstruction, reduce wound repair time, repair skin TEWL value and skin moisture loss. Accordingly, one of ordinary skill in the art would have contemplated applying the method of O’Halloran for forming a pullulan-based film on the skin surface using the composition taught by Feng, because the resulting method would have reasonably produced a comfortable skin film capable of promoting wound healing and repairing skin moisture loss, as taught for the composition of Feng.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because O’Halloran teaches a method of forming a pullulan film on skin by applying an aqueous composition, and because Feng teaches a dressing that may be dispersed in water and used for the purposes of promoting skin repair, one of ordinary skill in the art would have contemplated practicing the method of O’Halloran using a composition suggested by Feng, because such a composition may be effective for promoting wound repair and repairing skin moisture loss.
Regarding the film as transparent and flexible, because Coltelli teaches pullulan films as transparent and Coltelli and Haniffa teach the structural flexibility of pullulan, one of ordinary skill in the art would have reasonably expected the film produced when practicing the method obvious over O’Halloran in view of Feng to produce a transparent and flexible film. Moreover, because O’Halloran teaches that films require that a coating be formed over the contours of the skin to which it is applied, typically on the face, one of ordinary skill in the art would have recognized the film of O’Halloran to exhibit flexibility.
Regarding the weight ratio of pullulan and the sugar alcohol of claim 2, Feng teaches their composition as including 0.5-3% of pullulan polysaccharide and 0.5-12% of mannitol. Following the guidance of O’Halloran and using 3% pullulan to enable a film to form, quantities of 1.5 to 6% mannitol would satisfy the requirements of claim 2, requiring pullulan and the sugar alcohol are comprised in a weight ratio of 1:2 to 2:1. MPEP 2144.05 at I states: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” In addition, “"[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).” Therefore, in this instance, because Feng discloses a range encompassing the somewhat narrower claimed range, the weight ratio of claim 2 is also obvious, absent a showing of the criticality of this weight ratio.
Regarding the quantity of amino acid in the composition as less than 1% by weight as recited in claims 7 and 17, Feng teaches their composition as having 5-30% of amino acid complex liquid. Feng teaches the amino acid complex liquid includes, as amino acids, 0.08 to 0.2 percent of glycine, 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. Considering only the upper recommended amount, the total amount of amino acids would be approximately 0.38% by mass. Therefore, even if 30% of the composition is the amino acid complex mixture, the total amino acids in the composition would be approximately about 0.11% by mass, and thus would satisfy the requirements of claims 7 and 17.
Regarding the limitation of claim 1 requiring an aqueous dispersion, because Feng teaches their composition as being able to be dispersed in water and O’Halloran requiring applying an aqueous composition to skin to form the pullulan film, the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa, requiring the composition of Feng as dispersed in water, would include an aqueous dispersion formulation.
Therefore the invention taken as a whole is prima facie obvious.
Claim 6 is rejected under 35 U.S.C. 103 as being over O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in previous office action) in view of Feng (Publication No. CN 114159336 A; cited in previous office action), Coltelli (Coltelli, M.-B.; et al. Journal of Functional Biomaterials 2020, vol. 11, article 20; cited in PTO-892) and Haniffa (Haniffa, et al. Polymers 2016, vol. 8, article 246; cited in PTO-892) as applied to claim 1 above, and further in view of Sadiq (Sadiq, A.; et al. International Journal of Biosciences 2018, vol. 12, pp. 137-143; cited in previous office action).
O’Halloran, Feng, Coltelli, and Haniffa teach as described in the above rejection under 35 U.S.C. 103.
O’Halloran, Feng, Coltelli, and Haniffa do not teach the method of claim 1, 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 a 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 one of ordinary skill in the art before the effective filing date of the present application to modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include tryptophan in the composition used to form a film over skin. One of ordinary skill in the art would have been motivated to modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include tryptophan in the composition used to form a film over skin 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 used in the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa, because the addition of tryptophan may improve the cell proliferation and wound healing benefits of said method.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa may be reasonably applied to promote skin wound healing, and because Sadiq teaches the benefits of tryptophan for promoting skin wound healing, including tryptophan in the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa may provide superior wound healing activity than the equivalent method lacking tryptophan.
Therefore the invention taken as a whole is prima facie obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in previous office action) in view of Feng (Publication No. CN 114159336 A; cited in previous office action), Coltelli (Coltelli, M.-B.; et al. Journal of Functional Biomaterials 2020, vol. 11, article 20; cited in PTO-892) and Haniffa (Haniffa, et al. Polymers 2016, vol. 8, article 246; cited in PTO-892) as applied to claim 1 above, and further in view of Tokuyama (Publication no. US 20110213033 A1; cited in PTO-892).
O’Halloran, Feng, Coltelli, and Haniffa teach as described in the above rejection under 35 U.S.C. 103.
O’Halloran, Feng, Coltelli, and Haniffa do not teach the method of claim 1, wherein the composition further comprises dextrin, as required by claim 9.
Tokuyama teaches a skin conditioner that is effective as an agent for the prevention and treatment of atopic dermatitis and as a skin moisture retention agent (cover page, Abstract, lines 11-14). Tokuyama teaches a method of improving moisture retention ability of skin and/or treating or processing skin for another purpose, comprising applying to skin a composition as claimed (pp. 18-19, claim 1), wherein the method further includes a moisture retention agent (p. 19, claim 16), and wherein the moisture retention agent contains one or more substances selected from a group that includes dextrin (p. 19, claim 17). Therefore, dextrin is recognized by Tokuyama as a moisture retention agent that may be used in a method of improving moisture retention ability of skin.
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 modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include dextrin in the composition used to form a film over skin. One of ordinary skill in the art would have been motivated to modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include dextrin in the composition used to form a film over skin because Feng teaches their composition improves barrier repair to promote wound healing, repair skin TEWL value, and repair skin moisture loss, and because Tokuyama teaches dextrin is a moisture retention agent that may be used for improving the moisture retention ability of the skin. Therefore, one of ordinary skill in the art would have contemplated the addition of dextrin to the composition used in the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa because the addition of dextrin, a moisture retention agent, may reasonably promote repair of skin TEWL value and skin moisture loss more effectively than the equivalent method that lacks dextrin.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa may be reasonably applied to promote repair of skin TEWL value and repair of skin moisture loss, and because Tokuyama teaches the benefits of dextrin as a moisture retention agent that may be used for improving the moisture retention ability of the skin, including dextrin in the method obvious over O’Halloran, Feng, Coltelli, and Haniffa may more effectively promote repair of skin TEWL value and skin moisture loss than the equivalent composition that lacks dextrin.
Therefore the invention taken as a whole is prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in previous office action) in view of Feng (Publication No. CN 114159336 A; cited in previous office action), Coltelli (Coltelli, M.-B.; et al. Journal of Functional Biomaterials 2020, vol. 11, article 20; cited in PTO-892) and Haniffa (Haniffa, et al. Polymers 2016, vol. 8, article 246; cited in PTO-892) as applied to claim 1 above, and further in view of Jarząbek-Perz (Jarząbek-Perz, S.; et al. Skin Research Technology 2021, vol. 27, pp. 925-930; cited in previous office action).
O’Halloran, Feng, Coltelli, and Haniffa teach as described in the above rejection under 35 U.S.C. 103.
O’Halloran, Feng, Coltelli, and Haniffa do not teach the method of claim 1, wherein the composition further comprises gluconolactone, as required by 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 that were 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 one of ordinary skill in the art before the effective filing date of the present application to modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include gluconolactone in the composition used to form a film over skin. One of ordinary skill in the art would have been motivated to modify the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa and include gluconolactone in the composition used to form a film over skin because Feng teaches their composition improves cell improves barrier repair to promote wound healing, repair skin TEWL value, and repair skin moisture loss, and because Jarząbek-Perz teaches gluconolactone is a moisturizing substance which works well in dry skin care. Therefore, one of ordinary skill in the art would have contemplated the addition of gluconolactone to the composition used in the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa because the addition of gluconolactone, a moisturizing substance, may reasonably repair skin TEWL value and skin moisture loss more effectively than the equivalent composition that lacks gluconolactone.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa may be reasonably applied to repair skin TEWL value and repair skin moisture loss, and because Jarząbek-Perz teaches the benefits of gluconolactone as skin moisturizing agent, including gluconolactone in the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa may provide may more effectively repair skin TEWL value and skin moisture loss than the equivalent method that lacks gluconolactone.
Therefore the invention taken as a whole is prima facie obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran (U.S. pre-grant publication no. US 20030082221 Al; cited in previous office action) in view of Feng (Publication No. CN 114159336 A; cited in previous office action), Coltelli (Coltelli, M.-B.; et al. Journal of Functional Biomaterials 2020, vol. 11, article 20; cited in PTO-892) and Haniffa (Haniffa, et al. Polymers 2016, vol. 8, article 246; cited in PTO-892) as applied to claim 1 above, and further in view of Zhao (Zhao, Z.; et al. Journal of the Science of Food and Agriculture 2019, vol. 99, pp. 4150-4157; cited in previous office action), Cassanelli (Cassanelli, M.; et al. Food Biophysics 2018, vol. 13, pp. 304-315; cited in previous office action) and Capra (Capra, P.; et al. International Journal of Cosmetic Science 2017, vol. 39, pp. 393-401; cited in previous office action).
O’Halloran, Feng, Coltelli, and Haniffa teach as described in the above rejection under 35 U.S.C. 103.
O’Halloran, Feng, Coltelli, and Haniffa do not teach the method of claim 1, wherein the composition has a static contact angle of 35 to 55 degrees, 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 film produced by the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa to achieve a desired wettability. One of ordinary skill in the art would have been motivated to optimize the static contact angle of the film produced by the method obvious over O’Halloran in view of Feng, Coltelli, and Haniffa to 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 a pullulan film formed from said composition, and accordingly, would have reasonably adjusted the amount of mannitol within the range suggested by Feng to achieve a desired wettability.
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.
Response to Applicant’s arguments: Applicant’s arguments relating to references used in in the above rejections are summarized below. Arguments relating to references not used in the current rejections are considered moot.
Regarding the previous claim interpretation section, Applicant’s discussion of the meaning of water-dispersible and the new limitation of an aqueous dispersion is acknowledged. In this instance, as stated above, because Feng teaches their composition may be dispersed in water and O’Halloran teaches an aqueous composition for use in their method, such a composition used in the method obvious over O’Halloran, Feng, Coltelli, and Haniffa would have reasonably been considered an aqueous dispersion formulation. Moreover, because the composition of Feng includes, for example, pullulan, mannitol, and arginine, the same components shown in Example 1 of the instant application, if the method of Example 1 were to form an aqueous dispersion, the composition of Feng would also be expected to form an aqueous dispersion, absent evidence to the contrary.
Regarding the previous rejection of claims 1, 3-5, 8, 12, and 14 under 35 U.S.C. 102 as anticipated by Feng, Applicant argues that Feng neither discloses nor suggests a method for forming a film on the skin's surface as recited in claim 1, and it would not have been obvious to derive from Feng a technical configuration for forming a transparent and flexible film closely adhering to the skin like a coating layer. Further, although Claim 6 of Feng recites a film shape, this merely refers to the shape of a molding die and is clearly distinguishable from the skin-adhering film of the present invention.
Insofar as Applicant’s arguments are relevant to the present rejections, the arguments have been fully considered but are not found persuasive.
Regarding the previous rejection over Feng, the Office acknowledges that Feng no longer anticipates the present claim 1. However, as described in the above rejection under 35 U.S.C. 103, claim 1 is rendered obvious over O’Halloran in view of Feng, Coltelli, and Haniffa. O’Halloran teaches a process of forming films on skin using aqueous compositions of pullulan, and one of ordinary skill in the art would be reasonably considered practicing the method of O’Halloran with the composition disclosed by Feng comprising pullulan, arginine, and a sugar alcohol, as described in the above rejection. The pullulan films taught by O’Halloran form a skin-adhering film like the present invention.
Regarding the previous rejection of claims 1, 5, and 6 under 35 U.S.C. 103 as unpatentable over Feng in view of Sadiq, Applicant argues that Feng neither discloses nor suggests a method for forming a film on the skin surface, and it would not have been easy to derive from Feng a technical configuration for forming a transparent and flexible film closely adhering to the skin like a coating layer. Further, although Claim 6 of Feng recites a film shape, this merely refers to the shape of a molding die and is clearly distinguishable from the skin-adhering film of the present invention. Sadiq fails to remedy the deficiencies of Feng. Sadiq relates to the skin wound healing effects of tryptophan and fails to disclose or suggest a method for forming a film on the skin surface, nor the specific combination of pullulan, sugar alcohol, and arginine as recited in amended claim 1.
Moreover, Applicant argues that Examples 1 to 5 containing pullulan, sugar alcohol, and an amino acid including arginine primarily provided a fresh feel similar to water upon use, while also providing a natural film feel without a foreign-body sensation, which is superior to the feel of Comparative Examples 1, 2, 4, and 5. In addition, Applicant argues that comparative Example 5 (lysine) and Comparative Example 6 (glycine) both contain amino acids but fail to exhibit the same effects as the Examples. Applicant asserts that this indicates the effects of the present invention are not achieved merely by the presence or absence of an added amino acid, but that, among amino acids combined with pullulan and sugar alcohol, the selection of arginine in particular is important for achieving a natural film feel and excellent usability. Therefore, such effects would not have been predictable by a person having ordinary skill in the art from the cited references.
Insofar as Applicant’s arguments are relevant to the present rejection, the arguments have been fully considered but are not found persuasive. Claim 1 is rejected as obvious over O’Halloran in view of Feng, Coltelli, and Haniffa for reasons described in the above rejection and in the above response to Applicant’s arguments. Sadiq provides motivation to supplement the composition used in the method obvious over Feng in view of O’Halloran, Coltelli, and Haniffa with tryptophan, because it may improve the skin healing benefits of said method.
Regarding Applicant’s remarks concerning the Examples and Comparative Examples of the present application, because Feng teaches a composition comprising each of pullulan, sugar alcohol, and arginine, the benefits associated with this combination described in the present application would also be expected to be present when practicing the method of forming a film on a skin using the composition taught by Feng, obvious over O’Halloran, Feng, Coltelli, and Haniffa.
Applicant’s arguments regarding rejections over Jarzabek-Perz, Zhao, Cassanelli, and Capra assert that these references neither disclose nor suggest the claimed method for forming a film on the skin surface, nor the specific combination of pullulan, sugar alcohol, and arginine. These secondary references are used herein to motivate supplementing gluconolactone in the composition used in the method obvious over O’Halloran, Feng, Coltelli, and Haniffa, and to motivate optimizing the static contact angle of the film formed in the method obvious over O’Halloran, Feng, Coltelli, and Haniffa. Therefore, for the reasons described above, the rejections that include Jarzabek-Perz, Zhao, Cassanelli, and Capra as references are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN BRANDSEN whose telephone number is (703)756-4780. The examiner can normally be reached Monday - Friday from 9:00 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.M.B./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
Prosecution Insights