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 instant application was filed 19 April 2024. The Applicant claims priority to provisional application 63/497,525 filed 21 April 2023. The effective filing date of the instant application is 21 April 2023.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 14-42 and 50-64) in the reply filed on 27 April 2026 is acknowledged.
Claims 1-13 and 43-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 April 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28, 36, 54, and 60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 28 and 36 recite “minerals (Zn)” with “Zn” in parenthesis. The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. See MPEP 2173.05(d).
Claims 54 and 60 recite “polyethylene glycol (PEG-20 and more)” with “PEG-20 and more” in parenthesis. The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. See MPEP 2173.05(d).
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.
Claim(s) 14-42 and 50-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (WO 2022236151 A2).
Regarding claim 14, Knight teaches a skin cleansing article for delivery of cosmetics or therapeutics to the skin (abs, entire teaching). The cleansing article includes a core substrate comprising a resin. The core substrate contains an active agent and is water-soluble or water-dispersible in water with a temperature greater than 10 °C, according to MSTM-205, to release the active formulation (abs). A binder solution may be used with the resin to help form the substrate (para. 184).
Regarding claim 15, the nonwoven substrates may include modified starch (para. 56), which is an example of an absorbent powder (instant specification, para. 47). The limitation of “configured to absorb the active agent to form an active mixture” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding claim 16, the substrate may include ethylcellulose (para. 92), which is used for encapsulation (para. 92).
Regarding claim 17, the active agent may be in the form of a solid (para. 40). The composition may include cross-linking agents (para. 74), which is interpreted as capable of chemical modification.
Regarding claim 18, the formulation may have a moisture content of less than 10% (claim 20).
Regarding claim 19, the core substrate is contacted with water with a temperature of greater than 10 °C for a period of time of 30-300 seconds (para. 16).
Regarding claim 20, the core substrate is contacted with water with a temperature of 30-40 °C, leading to a dissolution time of 30-300 seconds, according to MSTM-205 (paras. 16, 18).
Regarding claim 21, the core substrate is planar and formable to the contour of the skin (para. 21).
Regarding claim 22, the article comprises a nonwoven substrate (para. 16) with a water-dispersible resin, such as polyvinyl alcohol (PVA) (para. 18).
Regarding claim 23, the resin is a polyvinyl alcohol polymer (para. 18).
Regarding claim 24, the resin is a polyvinyl alcohol copolymer (para. 18).
Regarding claim 25, the polyvinyl alcohol copolymer is a copolymer of vinyl acetate and vinyl alcohol (para. 18).
Regarding claim 26, the polyvinyl alcohol copolymer comprises an anionically modified copolymer (para. 18).
Regarding claim 27, the anionically modified copolymer comprises a carboxylate or sulfonate (para. 18).
Regarding claim 28, the formulation may comprise hyaluronic acid (para. 25).
Regarding claim 29, the formulation is disposed on the surface of the core substrate (para. 25).
Regarding claim 30, the core substrate is coated with the formulation (para. 40).
Regarding claim 31, Knight teaches a facial mask (para. 3) to deliver cosmetics or therapeutics (abs) comprising a water-soluble nonwoven substrate (para. 16) with a water-soluble resin (para. 16). Modified starch (para. 56) may be included in the formulation, which is an absorbent powder (instant specification, para. 47). The limitation of “configured to absorb the active agent to form an active mixture” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Additionally, the nonwoven substrate is soluble upon contact with water with a temperature of 10 °C for 30-300 seconds, according to MSTM-205, to release the active treatment formulation (abs, para. 18).
Regarding claim 32, the nonwoven substrate may be soluble in water with a temperature of 30-40 °C for 30-300 seconds, according to MSTM-205 (abs, para. 16)
Regarding claim 33, the formulation may have a moisture content of less than 10% (claim 20).
Regarding claim 34, the core substrate is planar and formable to the contour of the skin (para. 21).
Regarding claim 35, the active agent may be in the form of a solid (para. 40). The composition may include cross-linking agents (para. 74), which is interpreted as capable of chemical modification.
Regarding claim 36, the formulation may comprise hyaluronic acid (para. 25).
Regarding claim 37, the substrate is saturated with the formulation (para. 40).
Regarding claim 38, the formulation is disposed on the substrate (para. 25).
Regarding claim 39, the core substrate comprises a resin, such as a polyvinyl alcohol (PVA) copolymer (para. 18).
Regarding claim 40, the degree of hydrolysis of polyvinyl alcohol copolymers is about 90-99% (para. 65).
Regarding claim 41, the degree of hydrolysis of polyvinyl alcohol copolymers is about 75-89% (para. 65).
Regarding claim 42, the substrate is made of biodegradable PVA (para. 70).
Regarding claim 50, Knight teaches a skin cleansing article for delivery of cosmetics or therapeutics to the skin (abs, entire teaching). The cleansing article includes a core substrate comprising a resin. The core substrate contains an active agent and the article is substantially dry or solid and is water-dispersible or water-soluble (abs). The nonwoven substrates may include modified starch (para. 56), which is an example of an absorbent powder (instant specification, para. 47). The limitation of “configured to bind the active treatment formulation to a surface of the substrate without dissolving the substrate” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding claim 51, the core substrate is dispersible or soluble in water with a temperature of greater than 10 °C, according to MSTM-205, where the core substrate releases the first or second active formulations (abs).
Regarding claim 52, the formulation comprises modified starch (para. 56).
Regarding claim 53, the formulation may comprise hyaluronic acid (para. 25).
Regarding claim 54, the formulation may comprise PEG (100-1000 MW) (para. 156) as an auxiliary agent.
Regarding claim 55, the formulation may have a moisture content of less than 10% (claim 20).
Regarding claim 56, Knight teaches a skin cleansing article to deliver cosmetics or therapeutics (abs) comprising at least one nonwoven substrate (para. 18). The nonwoven substrate or core substrate has a first region (abs) and plurality of fibers made of resin (para. 18). A second nonwoven substrate may be coupled to the first nonwoven substrate (para. 45) and contained in a second region (abs). The nonwoven substrates may include modified starch (para. 56), which is an example of an absorbent powder (instant specification, para. 47). The active agents (para. 74) and the modified starch (para. 56) in the substrate material is interpreted as an active mixture. The limitation of “configured to bind the active treatment formulation to a surface of the substrate without dissolving the substrate” is interpreted as a functional limitation. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding claim 57, the core substrate is dispersible or soluble in water with a temperature of greater than 10 °C for 30-300 seconds (para. 16), according to MSTM-205.
Regarding claim 58, the formulation comprises modified starch (para. 56).
Regarding claim 59, the formulation may comprise hyaluronic acid (para. 25).
Regarding claim 60, the formulation may comprise PEG (100-1000 MW) (para. 156) as an auxiliary agent.
Regarding claim 61, the formulation may have a moisture content of less than 10% (claim 20).
Regarding claim 62, the first nonwoven substrate includes a plurality of fibers comprising a water-soluble resin (para. 45). The second nonwoven substrate includes a plurality of fibers comprising a water-dispersible resin (para. 45). The second nonwoven substrate is contacted with water having a temperature greater than 10 °C for 300 seconds or less, according to MSTM-205 to release the second active treatment formulation (para. 45).
Regarding claim 63, the first nonwoven substrate includes a plurality of fibers comprising a water-soluble resin (para. 45). The second nonwoven substrate includes a plurality of fibers comprising a water-soluble resin (para. 45). The second nonwoven substrate is contacted with water having a temperature greater than 10 °C for 300 seconds or less, according to MSTM-205 to release the second active treatment formulation (para. 45).
Regarding claim 64, a water-soluble or water-dispersible film may be coupled to the nonwoven substrate (para. 45).
Knight does not teach an exact combination of a core substrate comprising a resin, an active agent, and a water-soluble binder in at least claim 14.
In regards to selecting the combination of a core substrate comprising a resin, an active agent, and a water-soluble binder, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Knight teaches a skin cleansing article for delivery of cosmetics or therapeutics to the skin comprising a core substrate with a resin. The core substrate contains an active agent and is water-soluble or water-dispersible in water with a temperature greater than 10 °C, according to MSTM-205, to release the active formulation. A binder solution may be used with the resin to help form the substrate. However, the claimed invention is directed towards a skin treatment article comprising a core substrate with a resin, an active agent, and a water-soluble binder mixed with the active agent. Since Knight teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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