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 .
Status of the claims
Claims 1, 2-23, 25-38, 40-68, 73-75, 82-83, and 94-98 were cancelled in a previous communication. Claim 71 has been cancelled.
Claims 24, 39, 69-70, 72, 76-81 and 84-93 are pending and currently under examination.
The claims are examined in view of the following species elections: skin folds as the species of skin conditions.
All rejections not reiterated have been withdrawn.
Examiner’s notes
The examiner points out that the search was extended to skin folds and wrinkles. Skin folds and wrinkles are not patentably distinct species. The remaining species however remain withdrawn. Skin folds and wrinkles were examined together because the examiner is defining wrinkles as a type of skin fold. Manriquez et al. (BMJ Clin Evid., Published 2014 Dec 22; 2014:1711) defines wrinkles as visible creases or folds in the skin (page 2, first paragraph).
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. Applicants are 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 24, 39, 69-70, 72, 76-81 and 85-93 are rejected under 35 U.S.C. 103 as being unpatentable over Key (US20070065515A1, Published 03/22/2007) in view of Villani (US20100080853A1, Published 04/01/2010; cited in the IDS filed 03/15/2022) as evidenced by Choudhary (Pharmaceutical guidelines, Published 09/22/2015, https://www.pharmaguideline.com/2015/09/mesh-sizes-used-in-pharmaceuticals-and-its-conversion.html).
The claims are examined in view of the following species elections: skin folds as the species of skin conditions.
Applicant’s invention
Applicants claims are drawn to a method for administering a dermal filler into the skin of a subject, comprising applying to the skin of the subject a first composition comprising Spongilla spicules having an average length of about 200 µm to about 350 µm, and an average diameter of about 5 µm to about 20 µm, wherein the Spongilla spicules are manufactured from Spongilla lacustris, and a second composition comprising an effective amount of a dermal filler comprising a polymer or co-polymer selected from hyaluronic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, and poly-L- lactic acid; or a topical dermal filler comprising glycerin, peptides derived from collagen, alguronic acid, sodium acetylated hyaluronate, glycolic acid, lactic acid, L-lactic acid, amino acids, nicotinate ester, deoxycholic acid or an acetyl peptide.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 24, 39, and 69 Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract). Key also teaches that these methods lead to significant improvement in the treatment of skin aging (abstract). Key further teaches that the method can reduce the appearance of skin changes associated aging, visibly reduce human skin wrinkles and improve the textural quality of skin (page 1, paragraph [0008]). Key continues to teach hyaluronic acid for use in the methods described herein is generally in a form suitable for topical administration to the skin (page 3, paragraph [0039]). Key teaches a method of applying a pre-wetting agent such as hyaluronic acid, or collagen (page 1, paragraph [0008]), wherein collagen is a polypeptide (i.e., peptides derived from collagen) (page 4, page [0043]). Key also teaches hyaluronic acid for use in the methods described herein is generally in a form suitable for topical administration to the skin includes fragments (i.e., low molecular weight hyaluronic acid)(page 3, paragraph [0039]).
Regarding claim 85, Key teaches the pre-wetting agent (i.e., hyaluronic acid) is applied immediately prior to dermabrasion (page 3, paragraph [0036]), but any order of steps is prima facie obvious. See MPEP 2144.04 (IV)(C). The examiner points out that as long as the dermabrasion step and the dermal filler applications step have the effect they are intended to have, any order of steps is prima facie obvious.
Regarding claim 86, Key teaches the pre-wetting agent can be applied to the skin surface about 120 minutes prior to dermabrasion (i.e., permitted to dry)(page 3, paragraph [0037]), but any order of steps is prima facie obvious. See MPEP 2144.04 (IV)(C). The examiner points out that as long as the dermabrasion step and the dermal filler applications step have the effect they are intended to have, any order of steps is prima facie obvious.
Regarding claim 87, Key teaches the abrasive components (i.e., first composition) can be water soluble, and therefore can be dissolved and rinsed away so as to prevent leaving any abrasive particulate or particulate residue on the treated skin following dermabrasion (page 6, paragraph [0063]).
Regarding claim 88, Key teaches the two compositions of a pre-wetting agent (i.e., second composition) and the abrasive composition (i.e., first composition) can be formulated into one composition for simultaneous application (page 4, paragraph [0049]).
Regarding claim 89, Key teaches the method is performed monthly (page 7, paragraph [0073]).
Regarding claim 90, this claim reads on performing the method one time.
Regarding claims 91 and 92, Key teaches following a treatment, the compositions can be rinsed away from the skin with ordinary tap water(page 6, paragraph [0063]).
Regarding claim 93, Key teaches the pre-wetting agent can be in the form of a gel (page 2, paragraph [0032]). The examiner notes that the instant specification on page 2, paragraph [0004] discloses that the dermal fillers, such as a hydrogel is composed of polymers (i.e., hyaluronic acid).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Key does not teach wherein the first composition comprises Spongilla spicules having an average length of about 200 µm to about 350 µm, and an average diameter of about 5 µm to about 20 µm wherein the Spongilla spicules are manufactured from Spongilla lacustris, (instant claims 24, 39, 69); wherein the Spongilla is in the form of a powder (instant claim 70); wherein not less than 50% of the particles comprising Spongilla powder pass through a US 70-mesh screen (instant claim 72); wherein the first composition has a residual moisture content of not more than about 10% (instant claim 76); wherein the amount of the first composition comprising Spongilla is from about 0.5 grams to about 50 grams (instant claim 77); wherein the first composition is applied to the skin of the subject in the form of a paste (instant claim 78); wherein the paste further comprises water or saline or hydrogen peroxide (instant claim 79); wherein the paste is prepared by mixing a powder comprising Spongilla and water or saline or hydrogen peroxide (instant claim 80); and wherein applying the first composition comprises massaging the paste onto a region of the skin of a subject (instant claim 81). However, these deficiencies are cured by Villani.
In the analogous art of dermabrasion Villani teaches dermabrasive compositions suitable for treating skin disease wherein the compositions are applied topically for the treatment of various skin disorders and diseases (page 1, paragraph [00002]). Villani also teaches upon massaging substantially pure Spongilla powder into the skin, spicules penetrate epidermis creating controlled microscopic injuries to the skin. By doing so, they activate a wound healing responses which are normally take place in a natural restorative response to tissue injury (page 4, paragraph [0031]). Wound healing responses stimulate new cell growth, elastin and collagen production and improve skin tone and texture (page 4, paragraph [0032]). Penetrating spicules additionally aid in the delivery of bioactive compounds to the dermis. Furthermore, spicules open pores and prevent future occlusion and consequent formation of comedones (page 4, paragraph [0033]). Spongilla spicules can be used as a resurfacing modality that rejuvenates the skin, removes old, debilitated or dead cells from the skin's outer layer without harming the younger, living cells and result in softer, smoother skin (page 4, paragraph [0034]). Villani also teaches in an exemplary embodiment of the present invention the Porifera is used to prepare topical dermabrasives is Spongilla lacustris (paragraph [0020]), wherein Spongilla lacustris is generally preferred for making the compositions of the present invention because this sponge genus is highly tolerate of natural environmental variation and grows extremely well in a wide range of habitats (paragraph [0021]). Villani further teaches the dermabrasive composition comprises from 0.1% to 100% substantially pure Spongilla powder (page 1, paragraph [0007]). Villani continues to teach dried sponge material is further purified, refined and processed to a standard particle size using sieves (i.e., substantially uniform in size) (page 3, paragraph [0026]). Villani also teaches the particles are ground and sieved to reduce particle size to no more than 0.2mm (page 3, paragraph [0026]). Villani further teaches the sponge (i.e., first composition) mass is dried until residual moisture content is less than 10% (page 3, paragraph [0026]). Villani also teaches the invention generally comprise from 0.8 to 1.5 grams of substantially pure Spongilla powder (page 3, paragraph [0030]). Villani continues to teach a sufficient amount of substantially pure Spongilla powder for application of the treatment for the skin was mixed with a carrier wherein the carriers can be water or hydrogen peroxide, the resulted mixture forms a paste (page 4, paragraph [0036]). Villani further teaches wherein an amount of the paste (mask) was applied to the mid-forehead by massaging in circular motions. The mask should be massaged into the skin before it dries to optimize penetration of the spicules into the skin (page 4, paragraph [0037]). Villani also teaches over the next 2-4 days the microscopic spicules slowly separate old cells from underlying new dermal cells thereby increasing stratum corneum sloughing action. On the fifth day, the ready to shed cells are exfoliated (page 4, paragraph [0042]). Villani further teaches after the treatment is complete, the dried dermabrasive composition is rinsed from the skin with cold or warm water (page 4, paragraph [0039]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have Spongilla in Key’s method of treating aging skin using a hyaluronic acid and an abrasive agent. Key teaches that the method of using a pre-wetting agent in conjunction with dermabrasion treatment can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles (page 1, paragraph [0008]). Key also teaches that the “abrasive agent” is intended as an agent capable of being used in a dermabrasion treatment (page 2, paragraph [0034]). One would have understood in view of Villani that upon massaging substantially pure Spongilla powder into the skin, spicules penetrate epidermis creating controlled microscopical injuries to the skin. By doing so, they activate a wound healing responses which are normally take place in a natural restorative response to tissue injury (page 4, paragraph [0031]). Wound healing responses stimulate new cell growth, elastin and collagen production and improve skin tone and texture (page 4, paragraph [0032]). Penetrating spicules additionally aid in the delivery of bioactive compounds to the dermis. Furthermore, spicules open pores and prevent future occlusion and consequent formation of comedones (page 4, paragraph [0033]). Spongilla spicules can be used as a resurfacing modality that rejuvenates the skin, removes old, debilitated or dead cells from the skin's outer layer without harming the younger, living cells and result in softer, smoother skin (page 4, paragraph [0034]). It would have been obvious to one of ordinary skill to have Spongilla in Key’s method of treating aging skin using a hyaluronic acid and an abrasive agent because Villani teaches Spongilla spicules provide a natural alternative approach to microdermabrasion and dermabrasion (page 1, paragraph [0012]). Therefore, one of ordinary skill would have recognized Spongilla as suitable for the purpose of dermabrasion. See MPEP 2144.07.
With regards to instant claims 24, 39, and 69 wherein the particles comprising the Spongilla spicules have an average length of from about 200 µm to about 350 µm and an average diameter of from about 5 µm to about 20 µm, it would have been obvious to one of ordinary skill in the art to optimize the length and diameter of Spongilla spicules. One would have understood in view of Villani that the several grinding and sieving steps are performed to reduce average particle size to no more than 0.2 mm of the Spongilla powder (page 3, paragraph [0026]). Therefore, it would have been obvious to one of ordinary skill in the art to optimize the length and diameter of Spongilla spicules in Villani to achieve desired results by routine experimentation. Determining optimal concentrations is routine experimentation and is practiced by one of ordinary skill. [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). See MPEP 2144.05 (II).
With regards to instant claim 69, wherein a method for enhancing skin permeation of a topically applied dermal filler composition in a skin of a subject comprising applying to the skin a first composition comprising Spongilla, followed by applying a second composition comprising an effective amount of a dermal filler, Key teaches that hyaluronic acid for use described herein is generally in a form suitable for topical administration to the skin (page 4, paragraph [0039]). One would have understood in view of Villani that upon massaging Spongilla spicules into the skin, the spicules mechanically separate the epidermal layers and reduce keratinocyte cohesion, thereby increasing stratum corneum sloughing and sebum plug and loose keratinocyte removal (page 1, paragraph [0012]). Therefore, enhancing skin permeation is inherent because Villani teaches that Spongilla causes skin permeation when massaged onto the skin. This provides further motivation to also or alternatively add the hyaluronic acid or collagen to the skin after the dermabrasion step.
With regards to instant claim 72, wherein not less than 50% of the particles comprising Spongilla powder pass through a US 70-mesh screen, it would have been obvious to one of ordinary skill in the art to have particles comprising Spongilla powder pass through a US 70-mesh screen because Villani teaches that the several grinding and sieving steeps are performed to reduce average particle size to no more than 0.2 mm (page 3, paragraph [0026]). As evidenced by Choudhary’s conversion table, the size of a particle which passes through a US 70-mesh is .210 mm (page 2, conversion table). Therefore, the size of a particle that comprises Spongilla would inherently be the size of a particle that passes through a US 70-mesh screen.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Key (US20070065515A1, Published 03/22/2007) in view of Villani (US20100080853A1, Published 04/01/2010; cited in the IDS filed 03/15/2022) as evidenced by Choudhary (Pharmaceutical guidelines, Published 09/22/2015, https://www.pharmaguideline.com/2015/09/mesh-sizes-used-in-pharmaceuticals-and-its-conversion.html) as applied to claims 24, 39, 69-83 and 85-93 above in further view of Crandall (US6316428B1, Published 11/13/2001).
Applicant’s invention
Key and Villani renders obvious all the limitations of instant claim 24. Applicants claim 84 further adds the limitation wherein the second composition comprises deoxycholic acid.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 84, Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler) (i.e., second composition), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract). Key also teaches the method can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles, and improve the textural quality of skin (page 1, paragraph [0008]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Key and Villani do not teach deoxycholic acid. However, this deficiency is cured Crandall.
In the analogous art of topically treating keratinous structures of humans including skin, Crandall teaches with increasing age, the skin gradually loses ceramides and water and becomes drier, less flexible and supple, more wrinkled, and scaly in appearance (column 1, lines 49-51). Crandall also teaches that the use of their process and composition increases the moisture content of the skin, reduces wrinkling, and provides a rejuvenated appearance to the skin (column 3, lines 5-7). Crandall further teaches it is understood that the present invention also encompasses a method and composition for delivery of molecules into the skin. These molecules include collagen, hyaluronic acid, deoxycholic acid, etc. (column 8, lines 3-11).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have deoxycholic acid in Key’s composition comprising hyaluronic acid (i.e., dermal filler). Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler) (i.e., second composition), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract) wherein the method can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles, and improve the textural quality of skin (page 1, paragraph [0008]). One would have understood in view of Crandall that the use of this process reduces wrinkles and encompasses a method for delivery of molecules into the skin such as deoxycholic acid, hyaluronic acid, and collagen. It would have been obvious to one of ordinary skill in the art to have deoxycholic acid in Key’s composition comprising hyaluronic acid because Crandall teaches that deoxycholic acid is a molecule that can be delivered into the skin and that the composition reduces wrinkles, therefore making deoxycholic acid taught for the same purpose of reducing wrinkles. See MPEP 2144.06 (I).
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 24, 39, 69-70, 72, 76-81 and 85-93 are rejected under 35 U.S.C. 103 as being unpatentable over Key (US20070065515A1, Published 03/22/2007) in view of Villani (US20100080853A1, Published 04/01/2010; cited in the IDS filed 03/15/2022) as evidenced by Choudhary (Pharmaceutical guidelines, Published 09/22/2015, https://www.pharmaguideline.com/2015/09/mesh-sizes-used-in-pharmaceuticals-and-its-conversion.html) further in view of Udompataikul (J Med Assoc Thai. 2012 Dec; 95 Suppl 12:S15-20. PMID: 23513460).
The claims are examined in view of the following species elections: skin folds as the species of skin conditions.
Applicant’s invention
Applicants claims are drawn to a method for administering a dermal filler into the skin of a subject, comprising applying to the skin of the subject a first composition comprising Spongilla spicules having an average length of about 200 µm to about 350 µm, and an average diameter of about 5 µm to about 20 µm, wherein the Spongilla spicules are manufactured from Spongilla lacustris, and a second composition comprising an effective amount of a dermal filler comprising a polymer or co-polymer selected from hyaluronic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, and poly-L- lactic acid; or a topical dermal filler comprising glycerin, peptides derived from collagen, alguronic acid, sodium acetylated hyaluronate, glycolic acid, lactic acid, L-lactic acid, amino acids, nicotinate ester, deoxycholic acid or an acetyl peptide.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 24, 39, and 69 Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract). Key also teaches that these methods lead to significant improvement in the treatment of skin aging (abstract). Key further teaches that the method can reduce the appearance of skin changes associated aging, visibly reduce human skin wrinkles and improve the textural quality of skin (page 1, paragraph [0008]). Key continues to teach hyaluronic acid for use in the methods described herein is generally in a form suitable for topical administration to the skin (page 3, paragraph [0039]). Key teaches a method of applying a pre-wetting agent such as hyaluronic acid, or collagen (page 1, paragraph [0008]), wherein collagen is a polypeptide (i.e., peptides derived from collagen) (page 4, page [0043]). Key also teaches hyaluronic acid for use in the methods described herein is generally in a form suitable for topical administration to the skin includes fragments (i.e., low molecular weight hyaluronic acid)(page 3, paragraph [0039]).
Regarding claim 85, Key teaches the pre-wetting agent (i.e., hyaluronic acid) is applied immediately prior to dermabrasion (page 3, paragraph [0036]), but any order of steps is prima facie obvious. See MPEP 2144.04 (IV)(C). The examiner points out that as long as the dermabrasion step and the dermal filler applications step have the effect they are intended to have, any order of steps is prima facie obvious.
Regarding claim 86, Key teaches the pre-wetting agent can be applied to the skin surface about 120 minutes prior to dermabrasion (i.e., permitted to dry)(page 3, paragraph [0037]), but any order of steps is prima facie obvious. See MPEP 2144.04 (IV)(C). The examiner points out that as long as the dermabrasion step and the dermal filler applications step have the effect they are intended to have, any order of steps is prima facie obvious.
Regarding claim 87, Key teaches the abrasive components (i.e., first composition) can be water soluble, and therefore can be dissolved and rinsed away so as to prevent leaving any abrasive particulate or particulate residue on the treated skin following dermabrasion (page 6, paragraph [0063]).
Regarding claim 88, Key teaches the two compositions of a pre-wetting agent (i.e., second composition) and the abrasive composition (i.e., first composition) can be formulated into one composition for simultaneous application (page 4, paragraph [0049]).
Regarding claim 89, Key teaches the method is performed monthly (page 7, paragraph [0073]).
Regarding claim 90, this claim reads on performing the method one time.
Regarding claims 91 and 92, Key teaches following a treatment, the compositions can be rinsed away from the skin with ordinary tap water(page 6, paragraph [0063]).
Regarding claim 93, Key teaches the pre-wetting agent can be in the form of a gel (page 2, paragraph [0032]). The examiner notes that the instant specification on page 2, paragraph [0004] discloses that the dermal fillers, such as a hydrogel is composed of polymers (i.e., hyaluronic acid).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Key does not teach wherein the first composition comprises Spongilla spicules having an average length of about 200 µm to about 350 µm, and an average diameter of about 5 µm to about 20 µm wherein the Spongilla spicules are manufactured from Spongilla lacustris, (instant claims 24, 39, 69); wherein the Spongilla is in the form of a powder (instant claim 70); wherein not less than 50% of the particles comprising Spongilla powder pass through a US 70-mesh screen (instant claim 72); wherein the first composition has a residual moisture content of not more than about 10% (instant claim 76); wherein the amount of the first composition comprising Spongilla is from about 0.5 grams to about 50 grams (instant claim 77); wherein the first composition is applied to the skin of the subject in the form of a paste (instant claim 78); wherein the paste further comprises water or saline or hydrogen peroxide (instant claim 79); wherein the paste is prepared by mixing a powder comprising Spongilla and water or saline or hydrogen peroxide (instant claim 80); and wherein applying the first composition comprises massaging the paste onto a region of the skin of a subject (instant claim 81). However, these deficiencies are cured by Villani and Udompataikul.
In the analogous art of dermabrasion Villani teaches dermabrasive compositions suitable for treating skin disease wherein the compositions are applied topically for the treatment of various skin disorders and diseases (page 1, paragraph [00002]). Villani also teaches upon massaging substantially pure Spongilla powder into the skin, spicules penetrate epidermis creating controlled microscopic injuries to the skin. By doing so, they activate a wound healing responses which are normally take place in a natural restorative response to tissue injury (page 4, paragraph [0031]). Wound healing responses stimulate new cell growth, elastin and collagen production and improve skin tone and texture (page 4, paragraph [0032]). Penetrating spicules additionally aid in the delivery of bioactive compounds to the dermis. Furthermore, spicules open pores and prevent future occlusion and consequent formation of comedones (page 4, paragraph [0033]). Spongilla spicules can be used as a resurfacing modality that rejuvenates the skin, removes old, debilitated or dead cells from the skin's outer layer without harming the younger, living cells and result in softer, smoother skin (page 4, paragraph [0034]). Villani also teaches in an exemplary embodiment of the present invention the Porifera is used to prepare topical dermabrasives is Spongilla lacustris (paragraph [0020]), wherein Spongilla lacustris is generally preferred for making the compositions of the present invention because this sponge genus is highly tolerate of natural environmental variation and grows extremely well in a wide range of habitats (paragraph [0021]). Villani further teaches the dermabrasive composition comprises from 0.1% to 100% substantially pure Spongilla powder (page 1, paragraph [0007]). Villani continues to teach dried sponge material is further purified, refined and processed to a standard particle size using sieves (i.e., substantially uniform in size) (page 3, paragraph [0026]). Villani also teaches the particles are ground and sieved to reduce particle size to no more than 0.2mm (page 3, paragraph [0026]). Villani further teaches the sponge (i.e., first composition) mass is dried until residual moisture content is less than 10% (page 3, paragraph [0026]). Villani also teaches the invention generally comprise from 0.8 to 1.5 grams of substantially pure Spongilla powder (page 3, paragraph [0030]). Villani continues to teach a sufficient amount of substantially pure Spongilla powder for application of the treatment for the skin was mixed with a carrier wherein the carriers can be water or hydrogen peroxide, the resulted mixture forms a paste (page 4, paragraph [0036]). Villani further teaches wherein an amount of the paste (mask) was applied to the mid-forehead by massaging in circular motions. The mask should be massaged into the skin before it dries to optimize penetration of the spicules into the skin (page 4, paragraph [0037]). Villani also teaches over the next 2-4 days the microscopic spicules slowly separate old cells from underlying new dermal cells thereby increasing stratum corneum sloughing action. On the fifth day, the ready to shed cells are exfoliated (page 4, paragraph [0042]). Villani further teaches after the treatment is complete, the dried dermabrasive composition is rinsed from the skin with cold or warm water (page 4, paragraph [0039]).
In the analogous art of Spongilla spicules, Udompataikul teaches Spongilla lacustris (SL) in 3% hydrogen peroxide (H2O2) on rat skin, wherein under electron microscopic examination, SL was demonstrated as spicule which was sharp-edged, rod-shaped and smooth surface with approximate 150-300 microns in length and 10-20 microns in diameter. The authors hypothesized that the spicule causes puncture that enhances H2 O2 penetration into the skin (abstract). Udompataikul also teaches that the spicules with this length and diameter pierced into stratum basalis but not into the dermis wherein this may be according to the application pressure of the author on the rat skin. Mild pressure may contribute to the fact that the spicules were only be detected deep into stratum basalis and if more pressure was applied they may be found deeper into the dermis (page S18, first paragraph).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have Spongilla in Key’s method of treating aging skin using a hyaluronic acid and an abrasive agent. Key teaches that the method of using a pre-wetting agent in conjunction with dermabrasion treatment can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles (page 1, paragraph [0008]). Key also teaches that the “abrasive agent” is intended as an agent capable of being used in a dermabrasion treatment (page 2, paragraph [0034]). One would have understood in view of Villani that upon massaging substantially pure Spongilla powder into the skin, spicules penetrate epidermis creating controlled microscopical injuries to the skin. By doing so, they activate a wound healing responses which are normally take place in a natural restorative response to tissue injury (page 4, paragraph [0031]). Wound healing responses stimulate new cell growth, elastin and collagen production and improve skin tone and texture (page 4, paragraph [0032]). Penetrating spicules additionally aid in the delivery of bioactive compounds to the dermis. Furthermore, spicules open pores and prevent future occlusion and consequent formation of comedones (page 4, paragraph [0033]). Spongilla spicules can be used as a resurfacing modality that rejuvenates the skin, removes old, debilitated or dead cells from the skin's outer layer without harming the younger, living cells and result in softer, smoother skin (page 4, paragraph [0034]). It would have been obvious to one of ordinary skill to have Spongilla in Key’s method of treating aging skin using a hyaluronic acid and an abrasive agent because Villani teaches Spongilla spicules provide a natural alternative approach to microdermabrasion and dermabrasion (page 1, paragraph [0012]). Therefore, one of ordinary skill would have recognized Spongilla as suitable for the purpose of dermabrasion. See MPEP 2144.07.
With regards to instant claims 24, 39, and 69 wherein the particles comprising the Spongilla spicules have an average length of from about 175 µm to about 350 µm and an average diameter of from about 5 µm to about 20 µm, it would have been prima facie obvious to use Spongilla spicules with an average length of from about 175 µm to about 350 µm and an average diameter of from about 5 µm to about 20 µm as Villani’s Spongilla spicules. The artisan of ordinary skill would have been motivated to do so because Udompataikul teaches that the spicules with approximate 150-300 microns in length and 10-20 microns in diameter pierced into stratum basalis but not into the dermis wherein this may be according to the application pressure of the author on the rat skin. Mild pressure may contribute to the fact that the spicules were only be detected deep into stratum basalis and if more pressure was applied they may be found deeper into the dermis (page S18, first paragraph). The skilled artisan would have had a reasonable expectation of success because Villani teaches upon massaging substantially pure Spongilla powder into the skin, spicules penetrate epidermis creating controlled microscopic injuries to the skin. By doing so, they activate a wound healing responses which are normally take place in a natural restorative response to tissue injury (page 4, paragraph [0031]). Wound healing responses stimulate new cell growth, elastin and collagen production and improve skin tone and texture (page 4, paragraph [0032]). Penetrating spicules additionally aid in the delivery of bioactive compounds to the dermis. Furthermore, spicules open pores and prevent future occlusion and consequent formation of comedones (page 4, paragraph [0033]).
With regards to instant claim 69, wherein a method for enhancing skin permeation of a topically applied dermal filler composition in a skin of a subject comprising applying to the skin a first composition comprising Spongilla, followed by applying a second composition comprising an effective amount of a dermal filler, Key teaches that hyaluronic acid for use described herein is generally in a form suitable for topical administration to the skin (page 4, paragraph [0039]). One would have understood in view of Villani that upon massaging Spongilla spicules into the skin, the spicules mechanically separate the epidermal layers and reduce keratinocyte cohesion, thereby increasing stratum corneum sloughing and sebum plug and loose keratinocyte removal (page 1, paragraph [0012]). Therefore, enhancing skin permeation is inherent because Villani teaches that Spongilla causes skin permeation when massaged onto the skin. This provides further motivation to also or alternatively add the hyaluronic acid or collagen to the skin after the dermabrasion step.
With regards to instant claim 72, wherein not less than 50% of the particles comprising Spongilla powder pass through a US 70-mesh screen, it would have been obvious to one of ordinary skill in the art to have particles comprising Spongilla powder pass through a US 70-mesh screen because Villani teaches that the several grinding and sieving steeps are performed to reduce average particle size to no more than 0.2 mm (page 3, paragraph [0026]). As evidenced by Choudhary’s conversion table, the size of a particle which passes through a US 70-mesh is .210 mm (page 2, conversion table). Therefore, the size of a particle that comprises Spongilla would inherently be the size of a particle that passes through a US 70-mesh screen.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Key (US20070065515A1, Published 03/22/2007) in view of Villani (US20100080853A1, Published 04/01/2010; cited in the IDS filed 03/15/2022) as evidenced by Choudhary (Pharmaceutical guidelines, Published 09/22/2015, https://www.pharmaguideline.com/2015/09/mesh-sizes-used-in-pharmaceuticals-and-its-conversion.html) further in view of Udompataikul (J Med Assoc Thai. 2012 Dec; 95 Suppl 12:S15-20. PMID: 23513460) further view of Crandall (US6316428B1, Published 11/13/2001).
Applicant’s invention
Key, Villani, and Udompataikul renders obvious all the limitations of instant claim 24. Applicants claim 84 further adds the limitation wherein the second composition comprises deoxycholic acid.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 84, Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler) (i.e., second composition), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract). Key also teaches the method can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles, and improve the textural quality of skin (page 1, paragraph [0008]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Key, Villani, and Udompataikul do not teach deoxycholic acid. However, this deficiency is cured Crandall.
In the analogous art of topically treating keratinous structures of humans including skin, Crandall teaches with increasing age, the skin gradually loses ceramides and water and becomes drier, less flexible and supple, more wrinkled, and scaly in appearance (column 1, lines 49-51). Crandall also teaches that the use of their process and composition increases the moisture content of the skin, reduces wrinkling, and provides a rejuvenated appearance to the skin (column 3, lines 5-7). Crandall further teaches it is understood that the present invention also encompasses a method and composition for delivery of molecules into the skin. These molecules include collagen, hyaluronic acid, deoxycholic acid, etc. (column 8, lines 3-11).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have deoxycholic acid in Key’s composition comprising hyaluronic acid (i.e., dermal filler). Key teaches the method of applying a solution of about 20-30% pre-wetting agent such as hyaluronic acid (i.e., dermal filler) (i.e., second composition), to a skin surface with concurrent dermabrasion treatment using an abrasive agent (abstract) wherein the method can reduce the appearance of skin changes associated with aging, visibly reduce human skin wrinkles, and improve the textural quality of skin (page 1, paragraph [0008]). One would have understood in view of Crandall that the use of this process reduces wrinkles and encompasses a method for delivery of molecules into the skin such as deoxycholic acid, hyaluronic acid, and collagen. It would have been obvious to one of ordinary skill in the art to have deoxycholic acid in Key’s composition comprising hyaluronic acid because Crandall teaches that deoxycholic acid is a molecule that can be delivered into the skin and that the composition reduces wrinkles, therefore making deoxycholic acid taught for the same purpose of reducing wrinkles. See MPEP 2144.06 (I).
Response to Arguments
Applicants arguments filed 01/15/2026 have been fully considered but they are not persuasive.
On pages 7-8 of Applicants remarks, Applicants argue that the references, alone or combined fail to teach, suggest or in any way make obvious the recited Spongilla spicules having an average length of about 200 µm to about 350 µm, and an average diameter of about 5 µm to about 20 µm in combination with the recited dermal fillers, including use of the same in the recited methods. As Key does not teach or suggest Spongilla in any form and Villani does not teach the recited parameters of Spongilla. Villani states that it sought to have an “average particle size to no more than 0.2 mm”. 0.2mm is equal to 200 µm, the shortest extreme of the claimed range of 200 µm to 350 µm. Thus, Villani taught to avoid the spicules as claimed here. Villani would not create large enough microchannels in the skin that would allow dermal fillers to penetrate the skin. Applicants further argue that through extensive inventive, discovery work, Applicants unexpectedly found that the claimed characteristics and size parameters work surprisingly better than any other size of Spongilla spicule for facilitating topical application of dermal fillers. Therefore, Villani teaches away from Spongilla spicules of the claimed size parameters and would not have made obvious their use.
These arguments are not persuasive. The examiner points out that Villani teaches average particle size to no more than 0.2 mm and instant claims 24, 39, and 69 recite the range of about 200 µm to about 350 µm, therefore, the teaching of Villani of no more than 0.2 mm still overlaps with the instantly claimed range of about 200 µm at the low end of the instantly claimed range with the high end of Villani. Therefore, Villani is not teaching away from Spongilla spicules of the claimed size parameters and would not have made obvious their use as there is an overlap in the range taught by Villani. 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). See MPEP 2144.05(I).
Applicants’ assertion of unexpected results is merely Attorney argument and for Applicants arguments of unexpected results to be fully considered data needs to be presented in an Affidavit. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims. The Examiner points out that Applicants are arguing an unexpected result or a criticality of the claimed length and diameter of the Spongilla spicules, but Applicants have not provided comparative data to suggest that the claimed length and diameter are critical and other lengths and diameters outside the claimed range would achieve the same results. Absent evidence of criticality of the claimed range is not a patentable distinction over the prior art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See MPEP 2144.05(I).
On page 8-9 of Applicants remarks, Applicants argue that Villani does not teach or suggest combining the Spongilla particles of the claimed size with any of the dermal fillers recited in the present claims. Applicants further argue that Udompataikul does not correct this deficiency because Udompataikul does not teach or suggest any of the recited dermal fillers. Applicants continue to argue that Choudhary does not correct any of the above noted deficiencies because Choudhary does not teach or suggest Spongilla; and Crandall is only cited with respect to dependent claim 84, and does not teach or suggest Spongilla. Applicants also argue that there are no other products on the market that deliver dermal fillers topically.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner points out that Key was relied on for the teaching of dermal fillers, Villani and Udompataikul were relied on for the teachings of Spongilla and Crandall was relied on for the teaching of deoxycholic acid, therefore it is the combination of the references to show obviousness.
With regards to Applicants argument that there are no other products on the market that deliver dermal fillers topically, the Examiner points out that being on the market is not a standard by which one determines if a product is inventive and nonobvious.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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