DETAILED ACTION
Status of Claims
The amendments, and arguments, filed August 04, 2025 are acknowledged and have been fully considered. Claims 10-17 are pending and currently under consideration. Claims 1-9 were previously cancelled. 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 Office Action: Final
Maintained Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 10-17 are rejected under 35 U.S.C. § 103 as being unpatentable over KLOFTA (US 2003/0077307 A1, Publ. Apr. 24, 2003; on 07/09/2022 IDS; hereinafter, “Klofta”).
Klofta is directed to:
FILM-FORMING COMPOSITIONS FOR PROTECTING SKIN FROM BODY FLUIDS AND ARTICLES MADE THEREFROM
ABSTRACT
The present invention relates to a film-forming barrier composition useful for protecting the skin from body fluids, such as urine, feces, menses. The composition comprises a skin conditioning agent, a viscosity enhancing agent and an oleophilic film-forming agent. Optionally, the lotion may comprise skin care ingredients for treating or maintaining skin health. The composition may be applied to the skin by suitable delivery vehicles, such as absorbent articles or components thereof, sheet materials, pads, bandages, sponges, foam pads, pumps, sprays, depending on the viscosity of the composition.
Klofta, title & abstract. In this regard, Klofta teaches a claim embodiment directed to an anhydrous film-forming composition:
1. A substantially anhydrous film-forming composition comprising:
a. from about 1 % to about 90% a skin conditioning agent;
b. from about 15% to about 50% a viscosity enhancing agent;
c. from about 1 % to about 20% an oleophilic film-forming agent; and
d. optionally, from about 0.01 % to about 15% of a skin care ingredient.
Klofta, claim 1.
Regarding independent claim 10 and the requirements:
10. ([...]) A no-sting skin protectant film forming composition for peristomal skin, comprising:
at least one film forming polymer having both polar and nonpolar characteristics;
a solvent system, the solvent system being a no-sting and nonpolar solvent system; and
at least one skin health ingredient, wherein the at least one skin health ingredient is present in a concentration of about 0.01 percent to about 0.05 percent by weight of the composition;
wherein the no-sting skin protectant film forming composition is provided as a clear solution and configured to form a protective film on a skin surface after the solvent system evaporates, wherein the protective film is configured to provide a bonding surface for a skin barrier adhesive.
Klofta clearly teaches an anhydrous film-forming composition (Klofta, claim 1), whereby it is noted:
“c. from about 1 % to about 20% an oleophilic film-forming agent” (Klofta, claim 1) is broadly taught by Klofta (Klofta, par. [0068]-[0073]) as including “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), which is noted as “at least one film forming polymer having both polar and nonpolar characteristics” of claims 10-11:
“at least one film forming polymer having both polar and nonpolar characteristics” (claim 10), and
11. ([...]) The no-sting skin protectant film forming composition of claim 10, wherein the at least one film forming polymer comprises a vinylpyrrolidone-eicosene copolymer.
“a. from about 1 % to about 90% a skin conditioning agent” (Klofta, claim 1) is broadly taught by Klofta (Klofta, par. [0030]-[0053]) as including:
“C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), which is noted as:
encompassed by: “a solvent system, the solvent system being a no-sting and nonpolar solvent system” of claim 10, and
comprising C7-C8 isoparaffin of claim 12:
12. ([...]) The no-sting skin protectant film forming composition of claim 10, wherein the solvent system comprises C7-C8 isoparaffin.
ceramides (Klofta, par. [0040]-[0041]), which is noted as encompassed by “at least one skin health ingredient” of claims 10 and 13:
“at least one skin health ingredient” (claim 10), and
13. ([...]) The no-sting skin protectant film forming composition of claim 10, wherein the at least one skin health ingredient comprises ceramide.
However, Klofta DOES NOT EXPRESSLY TEACH a single exemplary embodiment containing “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), “C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), and ceramides (Klofta, par. [0040]-[0041]), which is well within the purview of the ordinarily skilled artisan in light of Klofta’s broader disclosure. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[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). “[W]hen 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 v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange Klofta’s anhydrous film-forming composition (Klofta, claim 1) according to Klofta’s broader disclosure (as discussed above) in order to contain “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), “C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), and ceramides (Klofta, par. [0040]-[0041]).
It is noted that the requirement of claim 10, “for peristomal skin,” is a recitation of intended use. In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art (If the prior art structure is capable of performing the intended use, then it reads on the claim, see MPEP § 2103 (I)(C)). Since it would be obvious to rearrange Klofta’s anhydrous film-forming composition (Klofta, claim 1) according to Klofta’s broader disclosure (as discussed above) in order to contain “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), “C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), and ceramides (Klofta, par. [0040]-[0041]), the resulting composition meets the structural requirements of claim 10, whereby it reasonably follows, the resulting composition would be suitable for “peristomal skin.”
With respect to the requirement of claim 10 for “provided as a clear solution,” rearranging Klofta’s anhydrous film-forming composition (Klofta, claim 1) per Klofta’s broader disclosure (as discussed above) to contain “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), “C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), and ceramides (Klofta, par. [0040]-[0041]), meets the structural requirements of the claims, and therefore, would reasonably expected to be clear. In this regard, it is noted that MPEP § 2112.01 states: “where the claimed and prior art products are identical or substantially identical in structure of composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP § 2112.01. Further, rearranging Klofta’s anhydrous film-forming composition with “a.” and “b.” of Klofta’s claim 1 formulation has one further required component, “b. from about 15% to about 50% a viscosity enhancing agent” (Klofta, claim 1), which would not be expected to be opaque and therefore, “provided as a clear solution” per the requirements of claim 10, absent evidence to the contrary.
It is noted that the requirement of claim 10 for “configured to form a protective film on a skin surface after the solvent system evaporates, wherein the protective film is configured to provide a bonding surface for a skin barrier adhesive” are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claims 10, which achieve the resulting film-forming and evaporation effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended film-forming and evaporation effect of a composition that meets the structural requirements discussed above. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claims 10 will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, Klofta renders claims 10-13 obvious.
Response to Arguments
Applicants’ arguments, filed on August 04, 2025 (hereinafter, referred to as “Remarks”), have been fully considered, but they are not persuasive.
Applicant argues:
As amended, claim 10 now recites, “A no-sting skin protectant film forming composition for peristomal skin, comprising: at least one film forming polymer having both polar and nonpolar characteristics; a solvent system, the solvent system being a no-sting and nonpolar solvent system; and at least one skin health ingredient, wherein the at least one skin health ingredient is present in a concentration of about 0.01 percent to about 0.05 percent by weight of the composition; wherein the no-sting skin protectant film forming composition is provided as a clear solution and configured to form a protective film on a skin surface after the solvent system evaporates, wherein the protective film is configured to provide a bonding surface for a skin barrier adhesive.” (Emphasis added.) Support for the amendments is found in the present application specification, See e.g., the present application specification, ¶¶ [0006], [0012] and [0015].[Remarks, p. 4, par. 4]
As explained in the present application, the claimed skin protectant film forming composition is configured for irritated or damaged peristomal skin to form a film having a sufficiently high surface energy for secure attachment of an ostomy skin barrier. See e.g., the present application specification, ¶[0006]. The present application teaches that ostomy skin barriers typically do not adhere well to nonpolar surfaces, and that a protectant film formed from a nonpolar polymer may degrade skin barrier adhesives to render the protectant film not suitable for ostomy applications. Id. The present application further states that after extensive research and development, it was discovered that copolymers having both polar and nonpolar characteristics and a sufficient solubility in a suitable nonpolar hydrocarbon solvent works well as a film forming polymer for the composition to provide a skin protectant film that has desirable characteristics including a good bonding surface for skin barrier adhesives. Id.[Remarks, p. 4, par. 5]
(Remarks, p. 4, par. 4-5), and further argues:
Further, the present application discloses some details of the research and development effort that went into developing the claimed composition in a clear solution form. Specifically, the present application states:
In preparing the exemplary composition, ceramide, cholesterol, and stearic acid were added to Isopar™C, and the suspension was stirred and heated to about 85°C. All of the solids dissolved to yield a clear solution. Upon cooling to room temperature, the solution became turbid as the solids precipitated. GanexTM V220F was added to the turbid suspension, stirred, and heated to 85°C, whereupon all of the solids dissolved to yield a clear solution. The solution remained clear with little or no evidence of precipitation after seven (7) days at room temperature. Subsequently, alpha-Tocopherol was added at room temperature and stirred, and the solution remained clear with little or no evidence of precipitation or phase separation. ¶[0021][Remarks, p. 5, par. 1]
Klofta does NOT disclose a film forming composition that is provided as a clear solution. Klofta also does NOT disclose a film forming composition formulated with a polymer having both polar and nonpolar characteristics dissolved in a no-sting and nonpolar solvent system, such that the composition can be applied to an irritated or damaged skin surface without producing stinging sensation and form a film that has sufficiently high surface energy for securing an ostomy skin barrier.[Remarks, p. 5, par. 2]
In rejecting claim 1, the Examiner conceded that Klofta does not disclose a single exemplary embodiment containing PVP/eicosene copolymer, isoparaffin and ceramides. However, the Examiner stated that it would have been well within the purview of the ordinary skill in the art in light of Klofta's broader disclosure to formulate such a composition. See, Office Action date 5/21/2025, page 5. The Examiner also stated that rearranging Klofta's film forming composition per its broader disclosure meets the structural requirement of the claims, and thus, would reasonably expected to be a clear solution. Id., at page 6. Applicant respectfully disagrees.[Remarks, p. 5, par. 3]
As noted by the Examiner, Klofta discloses film forming compositions comprising about 1% to about 90% of a skin conditioning agent, about 15% to about 50% of a viscosity enhancing agent, and about 1% to about 20% of an oleophilic film-forming agent. Klofta also discloses that preferred examples of the skin conditioning agent contained in its film compositions include petrolatum and mineral oil. A film formed from such compositions will be slippery and will not provide a sufficient bonding surface for a skin barrier adhesive.[Remarks, p. 5, par. 4]
Remarks, p. 5, par. 1-4.
In response: rearranging Klofta’s anhydrous film-forming composition (Klofta, claim 1) per Klofta’s broader disclosure (as discussed above) to contain “PVP/eicosene copolymers (GANEX® V-220 and V-220F)” (Klofta, par. [0071]), “C7-C40 branched hydrocarbons, such as ISOPAR® isoparaffins” (Klofta, par. [0046]), and ceramides (Klofta, par. [0040]-[0041]), meets the structural requirements of the claims, and therefore, would reasonably expected to be clear. In this regard, it is noted that MPEP § 2112.01 states: “where the claimed and prior art products are identical or substantially identical in structure of composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP § 2112.01. Further, rearranging Klofta’s anhydrous film-forming composition with “a.” and “b.” of Klofta’s claim 1 formulation has one further required component, “b. from about 15% to about 50% a viscosity enhancing agent” (Klofta, claim 1), which would not be expected to be opaque and therefore, “provided as a clear solution” per the requirements of claim 10, absent evidence to the contrary. A chemical composition and its properties are inseparable. See MPEP § 2112.01. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. It is noted that MPEP § 2112(I) states that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant argues:
Further, Klofta states that its compositions “contain viscosity enhancing agents that thickens, gels, or hardens the composition such that the composition is immobilized or locked at the location (e.g., on the surface or inside the cavity of the delivery vehicle) it is applied.” Klofta, at ¶[0055] (emphasis added). Klofta also states “[t]he compositions should preferably be solid or semi-solid at room temperature ... The compositions should also be at least partially transferable to the skin by contact, normal wear motions and/or body heat; therefore, the compositions are preferably plastic or fluid at skin temperature (i.e., about 34-36° C.) to facilitate the transfer to the skin. Further, the compositions should have storage stability ... Since the compositions are substantially immobilized and stable in storage, special barrier or wrapping materials may be unnecessary in packaging the treated absorbent articles useful in the present invention.” Id., at ¶[0026] (emphasis added).[Remarks, p. 5, par. 4, cont. on p. 6]
That is, Klofta's film forming compositions include the viscosity enhancing agent to provide a composition that is solid or semi-solid at room temperature. As quoted above, Klofta expressly explains the advantages achieved by providing its compositions in the solid or semi-solid form. Thus, Klofta does NOT disclose a film forming composition that is provided as a clear solution. In fact, Klofta teaches away from providing film forming compositions as a clear solution.[Remarks, p. 6, par. 1]
Therefore, Applicant respectfully submits that independent claim 10 and its dependent claims 11-17 are patentable over Klofta at least for the reasons discussed above. Reconsideration and indication of the allowability of claims 10-17 in view of foregoing amendments and remarks are respectfully solicited.[Remarks, p. 6, par. 2]
Remarks, p. 5, par. 4, cont. on p. 6, to p. 6, par. 2.
In response: it is noted that the criteria for establishing a case of prima facie obviousness is not whether the prior art exemplifies all the claimed limitations but whether the prior art suggests the claimed limitations. According to MPEP § 2123, “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or nonpreferred embodiment”. A reference is relevant as prior art for all that it contains.
Maintained Claim Rejections - Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 10-17 are rejected on the ground of nonstatutory double patenting over claims 1-6 and 8 of US Patent 11,986,574 B2 to Taylor, hereinafter “‘574 Patent,” matured from copending Application No. 17/295,800.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a no-sting skin protectant film forming composition, comprising: at least one film forming polymer having both polar and nonpolar characteristics; a solvent system, the solvent system being a no-sting and nonpolar solvent system; and at least one skin health ingredient.
Claim 10 is anticipated by claim 1 of the ‘574 Patent.
Claim 11 is anticipated by claim 2 of the ‘574 Patent.
Claim 12 is anticipated by claim 3 of the ‘574 Patent.
Claim 13 is anticipated by claims 4-6 of the ‘574 Patent.
Claim 14 is anticipated by claim 6 of the ‘574 Patent.
Claim 15 is anticipated by claim 1 of the ‘574 Patent.
Claim 16 is anticipated by claim 1 of the ‘574 Patent.
Claim 17 is anticipated by claim 8 of the ‘574 Patent.
Response to Arguments
Applicant’s arguments filed on August 04, 2025 have been fully considered, and it is acknowledged that applicants will take appropriate action in the event that the claims of one or both of the pending applications are allowed, or determined to have allowable subject matter therein. 01/20/2025 Remarks, p. 6, par. 3-4. Until such an appropriate event as noted by applicant is taken, the provisional double patenting rejection of record is maintained.
Summary/Conclusion
Claims 10-17 are rejected. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611