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 Application
Receipt of Applicants’ Arguments, Remarks and amended claims filed on 0731/2025 is acknowledged.
Claims 1, 3-14, 17-21, 28 and 29 are pending.
Claims 2, 15, 16, 22-27, have been have been cancelled.
Claim 1, have been amended.
Claims 1, 3-14, 17-21, 28 and 29 are pending and under examination in this application.
Maintained Rejections
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, 3-14, 17-21, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Wibaux et al. (US 2010/0322996) hereinafter the reference is referred as Wibaux in view of Jensen (US 2005/0277860 A1) (reference cited in IDS filed 7/16/2021), Truelsen et al. (WO 2006/018026 A1) hereinafter the reference is referred as Truelsen and further in view of Smith et al. (WO 03/086234 A2) hereinafter the reference is referred as Smith.
Wibaux teaches an adhesive composite having superior skin adhesion,
breathability and fluid handling capacity comprising: (i) a polymeric backing layer; and (ii) a fluid absorbing adhesive layer comprising (a) 20-80% by weight of a solvent-based acrylic pressure sensitive adhesive and (b) 20-80% by weight of at least one super-absorbent polymer or hydrocolloid having an average particle size of less than 150 μm, wherein the thickness of the adhesive layer is about 40 μm to about 300 μm, and the overall adhesive composite has a fluid handling capacity of at least 2000 g/m2/24 hours and a moisture vapor transmission rate of at least 1100 g/m2 /24 hours (¶ 0004).
Regarding claims 1 and 18, Wibaux teaches wound dressing (abstract) comprising: acrylic adhesive (¶ 0004), thermoplastic absorbent polymer polyurethane elastomeric polyester, blends of polyurethane and polyester (¶ 0030), gelling agent sodium carboxymethyl cellulose (¶ 0028); it is noted in specification (page 4, line 5) defines the gelling agent is carboxymethylcellulose, .
Regarding absorption capacity, Wibaux teaches fluid handling capacity (FHC) of at least 2000 g/m2 24 hours (¶ 0004, claim 1) to at least 4000 g/m2 24 hours (¶ 0006, claim 11); it is noted fluid handling capacity is a measure of the combined ability of the article to take up moisture and to evaporate it to the environment, and the fluid handling capacity in one embodiment is at least about 2500 g/m2 24 hours, or at least about 3500 g/m2 24 hours at an adhesive layer thickness of about 80 µm to about 300 µm (¶s 0015 and 0045), and therefore FHC reads on the limitation of absorption capacity. Therefore, the above absorption capacity overlaps with instant range of 2 g/m2 24 hours to about 5 g/m2 24 hours. Wibaux disclose that the FHC is measured using a Paddington cup (¶ 0045) and in (specification, page 24, lines 3-19) the ISO 13726 is used to measure the FHC, which is the sum of the absorption and moisture vapor transmission rate, and the Paddington cup method is included. Therefore, the limitation of absorption capacity as measured in accordance with ISO 13726 is taught. The units for measuring absorption capacity can be expressed in terms of mass of the absorbed substance per mass or volume of the absorber, and therefore, a person having ordinary skill in the art would be able to convert the units g/m2/ 24 hours to g/cm2/24 hours, and thus the absorption capacity is taught.
Regarding moisture vapor transmission rate (MVTR), Wibaux teaches MVTR in pages 5-6, Tables 1-3, in the ranges of 300 g/m2 24 hours to 1395 g/m2 24 hours; and the tack value. Therefore, the above MVTR overlaps with instant MVTR range of 700 g/m2 24 hours to 1000 g/m2 24 hours. Therefore, the limitation of absorption capacity as measured in accordance with ISO 13726 is taught. Same rational as above, a person having ordinary skill in the art would be able to convert the units g/m2/ 24 hours to g/cm2/24 hours, and thus the MVTR is taught.
Regarding tack value, Wibaux teaches within the adhesive material, in one embodiment, the weight ratio of solid rubber to liquid rubber is in the range from about 100:1 to about 1:2, and is varied in order to obtain the desired degree of adhesiveness and tackiness (¶ 0040). Therefore, the degree of tackiness is taught and it would have been obvious to a person having ordinary skill in the art (PHOSITA) to measure the tack value (specification page 6, lines 24-27) to obtain the desired instant range of 120 to about 190 (g).
Regarding peel value, Wibaux teaches determination of skin adhesion, wherein each strip was removed after a defined wear time at a 90° angle using an Instron adhesion tester at a speed of 300 mm/min, and the peel force of each example was measured after 24 hours (Table 4a) of wear time and after 48 hours of wear time is exemplified in (Table 4b) (¶ 0055). Therefore, the peel force is taught and it would have been obvious to a person having ordinary skill in the art (PHOSITA) to measure the peel value to obtain the desired instant range of 2 to about 3 (N), and use the technique as defined in (specification page 7, lines 4-6) with a stainless steel 304 test panel at a 90° angle at a standard rate of 5.0 mm/s, in accordance with ASTM A 666.
Regarding claims 3-7, as noted above, Wibaux teaches acrylic adhesive 20-80 % (¶ 0004 and 0006); thermoplastic polymer that is polyurethane elastomeric polyester (¶ 0030) and the super absorbing polymer content of adhesive layer may be in the range of about 20 % to about 80 % by weight (¶ 0034); and the gelling agent sodium carboxymethylcellulose is 40 % (example 6), and at least 20 - 80 % hydrocolloid (claims 1, 11 and 19). Therefore, the contents of acrylic adhesive, thermoplastic absorbent polymer and gelling agent are taught and overlaps with instant ranges and it would have been obvious to a person having ordinary skill in the art (PHOSITA) to optimize these components in order to obtain the desired absorption capacity, MVTR, tackiness and adhesiveness.
Regarding claims 12-13, Wibaux teaches superabsorbent polymer and hydrocolloid sodium carboxymethyl cellulose (¶s 0025 and 0028).
Regarding claim 14, Wibaux teaches pharmaceutically active components, for example antimicrobials, anti-inflammatory agents, analgesic agents, anesthetics, or other pharmaceutically acceptable compounds can be included in the adhesive layer (¶ 0021).
Regarding claim 17, Wibaux teaches the adhesive composition is in the form of a layer wherein the thickness is about 40 µm to about 300 µm (¶ 0004, claim 11). Therefore, overlaps with instant range of thickness from about 100 µm to about 2000 µm.
Regarding claims 19-20, Wibaux teaches breathable backing layer and is a polyurethane elastomeric polyester, polyurethane film (¶ 0030 and 0034).
Regarding claim 21, Wibaux teaches method of preparation of the adhesive composition comprising acrylic adhesive (¶ 0004), thermoplastic absorbent polymer polyurethane elastomeric polyester, blends of polyurethane and polyester (¶ 0030), and gelling agent sodium carboxymethyl cellulose (¶ 0028) in Examples 2-4 (¶ 0048-0049, 0050-0051).
Regarding claim 28, Wibaux teaches sodium carboxymethylcellulose (¶ 0028).
Regarding claim 29, Wibaux teaches thickness layer ranging of about 80 to about 400 µm (¶ 0034).
Wibaux fails to specifically teach hot-melt acrylic adhesive.
Jensen teaches a wound dressing comprising a highly water-absorbable material (e.g., hydrocolloid), an acrylic adhesive and a tackifier wherein the composition provides extended stay-on capabilities, and the composition also provides adhesive that is removed from the skin with little pain (abstract). Notably, Jensen disclose the dressing comprises a formulation that combines a hydrocolloid adhesive with acrylic to advantageously provide extended stay-on without the pain and irritation typically experienced with strong adhesives such as pure acrylic adhesives (¶ 0009).
Regarding claims 1, 3, 4, Jensen teaches a composition comprising acrylic adhesive (¶s 0009, 0013), wherein the acrylic adhesive is hot melt acrylic adhesive (¶s 0013, 0016, and claim 1) comprising of 5-60 % by weight (¶ 0016) and carboxymethylcellulose comprising 38 % or 50.5 % (¶ 0023, claims 9, 10). It is noted the gelling agent is carboxymethylcellulose (Specification, page 4, line 5). The amended limitation comprises of requiring at least 60% of the acrylic hot melt adhesive is met.
Notably, Jensen teaches the highly water-absorbable material may be a hydrocolloid material in which carboxymethylcellulose is one example (¶ 0020). The component (carboxymethylcellulose) is defined as gelling agent in specification throughout. Therefore, the limitation of hot melt acrylic adhesive and gelling agent and its percentages overlaps with instant percentages of at least 60 wt% of a hot melt acrylic adhesive and at least about 1 wt% of a gelling agent, up to about 50 wt% of a gelling agent.
Regarding claim 5, as noted above, Jensen teaches 5-60% by weight hot melt acrylic adhesive (¶ 0016). The newly amended limitation to increase the hot melt acrylic adhesive to 80 % would have been obvious to one of ordinary skill in the art to optimize in order to achieve the desired tackiness and adhesiveness.
Regarding claim 7, as noted above, Jensen teaches gelling agent carboxymethylcellulose at 38% (¶s 0028, and claims 10, 30). Therefore, it would have been obvious to one of ordinary skill in the art to optimize to the instant range of about 15 wt% to about 30 wt% of a gelling agent in order to achieve the desired dissolving in the liquid phase in forming a gel or colloid mixture.
Regarding claim 12, Jensen teaches highly water-absorbable material hydrocolloid (¶ 0020, claim 2).
Regarding claim 13, Jensen teaches calcium carboxymethylcellulose (CMC) (¶ 0020). It would have been obvious to a person having ordinary skill in the art (PHOSITA) to substitute calcium carboxymethylcellulose (CMC) for sodium carboxymethylcellulose (CMC) because both are highly water-absorbable hydrocolloid materials.
Regarding claims 14 and 18, Jensen teaches the composition would be desirable to have a dressing that may be used on the human skin for treating or preventing the formation of blisters, corns, warts, calluses, and any cut or wound that may be worn for an extended period of time, even withstanding patient mobility, without causing pain and discomfort during removal (¶ 0004) and wound dressing (¶ 0010, 0011). Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) to envisage a particular active (therapeutic agent) in treating or preventing the above conditions to be included in the wound dressing composition.
Jensen fails to specifically teach thermoplastic absorbent polymer.
Truelsen teaches an absorbent fibrous material comprising fibers prepared by melt spinning, solvent spinning, dry spinning or electro spinning of a polymer composition having a water absorption capacity of at least 10g/g polymer, and the composition comprises a thermoplastic hydrophilic block copolymer as well as wound dressing with absorbent fibrous material (abstract). Furthermore, Truelsen disclose fibrous materials are widely used as wound dressings or as absorbent elements in wound dressings wherein these fibrous materials are water absorbent and gelling in order to be able to absorb and retain wound fluid without adhering to the skin, as well as being comfortable and flexible (page 1, lines 19-24).
Regarding claim 6, Truelsen teaches thermoplastic absorbent hydrophilic block copolymer comprises at least 20% w/w. Therefore, overlaps with instant composition from about 1 wt% to about 10 wt% of a thermoplastic absorbent polymer.
Regarding claims 1, 8 and 11, Truelsen teaches the hydrophilic block copolymer is thermoplastic hydrophilic or amphiphilic polyurethane (page 5, lines 22-23) and useful thermoplastic hydrophilic polyurethanes may be selected from Tecogel TG 2000 (water absorption capacity: 13g/g), Tecophilic (page 5, line 30) wherein Tecophilic fibrous materials obtained have a water absorption capacity of about 500% (page 3, line 2-4). Therefore, the limitation and structural features overlaps the instant thermoplastic absorbent polymer absorbs water in an amount of at least about 100% of its own weight is taught.
Regarding claims 9 and 10, Truelsen teaches the polymer composition is heated to a temperature above it melting temperature/glass transition temperature (page 12, lines 5-6). As noted above, Truelsen teaches the identical thermoplastic absorbent polymer (polyurethane polymer) as instant claims and thus, it would have be obvious to a person having ordinary skill in the art (PHOSITA) to reasonably expect the properties of a glass transition temperature equal to or less than about 0°C and melting temperature equal to or less than about 120 0°C would be in similar range.
Regarding claim 14, Truelsen teaches fibres and pharmacologically or biologically active compounds (page 14, lines 10-14).
Truelsen specifically fails to disclose composition thickness, breathable film.
Smith teaches a non-woven fiber assembly comprises one or more fibers containing an adhesive component, an elastomeric component, and a hydrophilic component and a method of making a non-woven fiber assembly (abstract). Notably, Smith disclose a medical dressing or other non-woven mat or membrane that is capable of adhering to a dry substrate such as undamaged skin but will not adhere to a wet substrate such as the surface of a wound or tot wet tissues that form in the early stages of wound healing (page 5, lines 22-25).
Regarding claim 17, Smith teaches medical dressing is a thin but effective barrier to contaminants, and the appropriate thickness of the fibers of the dressing depends on factors such as fiber forming materials used the diameter of the fibers as well as the desired degree of air permeability and protection from contaminants (page 8, lines 26-30), and one of the major advantages of using electrospun fibers in wound dressing, is that very thin fibers can be produced having diameters of about 50 nanometers to about 25 microns, and 50 nanometers to about 5 microns, and these fibers can be collected and formed into non-woven mats of any desired shape and thickness (page 2, lines 1-6). Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) to create the desired thickness of the wound dressing composition ranging from about 100 µm to about 2000 µm.
Regarding claim 19, Smith teaches the non-woven fiber assembly forms a medical dressing, is microporous and breathable (page 8, lines 7-9). Therefore, the limitation of a wound dressing with breathable characteristic is taught.
Regarding claim 21, Smith teaches a method of making a non-woven fiber assembly comprising the forming of at least one fiber, containing an adhesive component, an elastomeric component and a hydrophilic component (page 7, lines 14-16). Furthermore, Smith teaches acrylate copolymers, Tecophilic polyether-based polyurethane, (page 18, lines 1-5) and carboxymethyl cellulose as the water absorbing gel (page 12, line 4-5). Therefore, the limitation and structural features of a method of making the composition comprising mixing the acrylic adhesive, the thermoplastic absorbent polymer and the gelling agent is taught.
It would have been prima facie obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to produce the adhesive composition with acrylic adhesive, thermoplastic absorbent polymer with blends of polyurethane and polyester, and gelling agents and optimize the contents in order to achieve the desired absorption capacity, moisture vapor transmission rate, tack value and peel value as taught by Wibaux, Jensen, Truelsen and Smith. One of ordinary skill in the art would have been motivated to incorporate thermoplastic absorbent polymer because the (polyurethane polymer) materials are widely used in wound dressings or as absorbent elements in wound dressings, and these materials are water absorbent and gelling in order to be able to absorb and retain wound fluid without adhering to the skin, as well as being comfortable and flexible. One of ordinary skill in the art would have been motivated to do this because all references are drawn to components used in medical wound dressing and the components of acrylic adhesive, a thermoplastic absorbent polymer and a gelling agent are all taught in the prior art. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to include the components.
From the combine teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Response to Arguments
Examiner fully considered the arguments and respectfully disagree and found the argument not persuasive.
Applicant amended claim 1 to recite “repositionable” as a required feature of the wound dressing adhesive composition, and asserts that prior art of record Wibaux fails to mention the attributes of highly absorbent, with good moisture vapor transmission rate, and are adhesive to skin, all the while provide repositionability and reduced pain upon removal. Additionally, Applicant asserts that Wibaux is solely focused on superior skin adhesion and fails to teach or suggest claimed tack range (120 to about 190 (g) and peel value.
Wibaux teaches wound dressing comprising: acrylic adhesive, thermoplastic absorbent polymer polyurethane elastomeric polyester, blends of polyurethane and polyester, gelling agent sodium carboxymethyl cellulose, absorption capacity that overlaps with instant range of 2 g/m2 24 hours to about 5 g/m2 24 hours, MVTR that overlaps with instant MVTR range of 700 g/m2 24 hours to 1000 g/m2 24 hours, and within the adhesive material, in one embodiment, the weight ratio of solid rubber to liquid rubber is in the range from about 100:1 to about 1:2, and is varied in order to obtain the desired degree of adhesiveness and tackiness (¶ 0040) and teaches determination of skin adhesion, wherein each strip was removed after a defined wear time at a 90° angle using an Instron adhesion tester at a speed of 300 mm/min, and the peel force of each example was measured after 24 hours (Table 4a) of wear time and after 48 hours of wear time is exemplified in (Table 4b) (¶ 0055). Therefore, the peel force is taught. Therefore Wibaux’s wound dressing composition overlaps in components and properties of instant claims in spirit, scope and subject matter. Given these similar components, overlaps in range amounts, shared properties that are known in the art of wound dressing adhesive, it would have been obvious to a person skilled in the art to reasonably surmise that the tack value (120 to about 190 (g)) and peel value about 2 to about 3 (N)) would exists and overlaps in the composition.
Regarding the “repositionable” feature of the wound dressing adhesive, it would have been obvious to one skilled in the art to reasonably expect this feature to exists in Wibaux’s composition because of the mentioned common components, properties and overlaps in amount ranges and as stated in the MPEP 2112.01 "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), “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.". Additionally, why would such adhesive composition would not be able to be repositioned when using shared components, and overlaps of amount ranges? The prior art of record are directed to components used in medical wound dressing comprising components of acrylic adhesive, a thermoplastic absorbent polymer, a gelling agent and one skilled in the art would be able to optimize the contents in order to achieve the desired absorption capacity, moisture vapor transmission rate, tack value and peel value as taught by Wibaux in view of Jensen, Truelsen and further in view of Smith. Therefore, from the combine teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
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 ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615