DETAILED ACTION
This is a First-Action Final Rejection for Application 17/282,443 filed April 02, 2021. Priority to Foreign Application EP18198982.3 filed October 5, 2018 is acknowledged. Claims 1, 3-9 and 11-12 are currently pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 31, 2026 has been entered.
Response to Arguments
Applicant's arguments filed March 31, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments are directed to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over US 2009/0216168 (Eckstein) in view of US 2016/0355633 (Honcoop et al.), WO 90/14109 (Miller) and KR 101202875 (Kim et al.).
Applicant first argues that there is no teaching in Eckstein that the hydrophilic polyurethane elastomers disclosed therein can achieve a peel adhesion of 0 N. Further, the skilled person would not be motivated to modify or replace the hydrophilic layer of the wound dressing disclosed in Eckstein with a hydrophobic polyurethane, for example as taught in Honcoop.
As addressed in the Final Rejection filed December 9, 2025, Eckstein does not disclose wherein the polyurethane formulation has a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1, however Eckstein does disclose that the hydrophilic polyurethane elastomer is a non-wound-adhering wound contact layer. See [0011]. While Eckstein has a weak adhesion to human skin or tissue, non-wound adherence is a desired feature. Honcoop discloses a polyurethane elastomer that is solid, non-adhesive, and has no adherent properties. See [0128] of Honcoop. Both Eckstein and Honcoop disclose an embodiment comprising hexanediol as the polyol and MDI as the isocyanate. In Eckstein, hexanediol is listed as a suitable diol ([0022]) and MDI is listed as a suitable isocyanate ([0013]). In Honcoop, the polyol may comprise up to 50 wt % non-dimeric, non-FDCA diacid and lists hexanediol as a suitable diol ([0081]-[0084]) and the isocyanate is preferably MDI ([0133]). Therefore, since both polyurethane elastomers comprise hexanediol and MDI in an embodiment, modifying the polyurethane elastomer of Eckstein to have the non-adherence property of the polyurethane elastomer of Honcoop would be obvious. As previously stated, the lack of adhesion may be desirable in a polyurethane elastomer so that it does not stick to other parts of an object in which it is contained. Applicant also points out that the modification would improve the polyurethane elastomer’s chemical and hydrolysis resistance. In response to applicant's argument that Honcoop is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Honcoop is reasonably pertinent to the particular problem of using polyurethane elastomers and achieving desirable properties thereof.
Applicant further argues that there is no disclosure or suggestion in Miller of applying a polyurethane formulation coating directly onto a foam dressing, as required by claim 1, let alone using one of the specific printing techniques claimed to form the wound contact surface of such a dressing.
Miller discloses a hypoadherent wound dressing comprising a polymeric coating made of polyurethane elastomer. See the abstract and Pg. 6, Par. 1 of Miller. Miller further discloses applying the coating by screen printing. See Pg. 14, Par. 2 of Miller. This allows the coating to be applied in patterns. A skilled artisan would have been motivated to modify Eckstein because Miller teaches that the polyurethane elastomer coating is applied by screen printing which allows for the coating to be applied in pattern based on patterns in the screen (Pg. 14, Par 2-3). Miller does not need to teach a foam dressing as this feature is taught in Eckstein. Miller teaches coating a polyurethane elastomer by screen printing on a wound dressing, so it would be obvious for the polyurethane coating of Eckstein to be applied using the same technique as it is known in the art and performed on wound dressings.
Applicant further argues that Kim is not analogous to the dressing of Eckstein, and the skilled person would not have looked to Kim if seeking to modify Eckstein.
In response to applicant's argument that Kim is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Kim is drawn to a wound dressing with a polyurethane film layer cured thereon which is in the field of the inventor’s endeavor. Kim is not being used to teach any of the limitations beyond the curing step in claim 1. 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).
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.
Claims 1, 3-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0216168 (Eckstein) in view of US 2016/0355633 (Honcoop et al.), WO 90/14109 (Miller) and KR 101202875 (Kim et al.). Miller was provided in the IDS filed 02/07/2022 and Kim, with the translation, was provided by the examiner on 06/12/2023.
Regarding claim 1, Eckstein discloses a method of preparing a wound contact surface for a wound dressing (Eckstein discloses a multi-layer wound dressing comprising a carrier layer, an absorbing layer, and a hydrophilic wound contact layer. Eckstein further discloses how the hydrophilic wound contact layer is prepared for use in a wound dressing. See the Abstract and Fig. 1.), the method comprising:
coating a polyurethane formulation onto a wound dressing to form a wound contact surface (The abstract states that “the wound contact layer comprises a hydrophilic polyurethane elastomer,” which is interpreted as a polyurethane formulation.),
wherein the coating is applied in a predetermined pattern providing a continuous or non-continuous surface configuration ([0036] discloses that the “wound contact layer can be fully contiguous with respect to the absorbent layer and or feature a uniform or profiled layer thickness and/or feature a regular or an irregular pattern.”); and
wherein the wound dressing is a foam dressing ([0044] discloses that “the wound dressing comprises as its absorbent layer a hydrophilic polymer foam.”), and
wherein the wound contact surface is the polyurethane formulation (The abstract states that “the wound contact layer comprises a hydrophilic polyurethane elastomer.”).
Eckstein does not disclose wherein the polyurethane formulation has a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1; wherein the coating is performed by printing the polyurethane formulation directly onto the wound dressing by a printing technique selected from the group consisting of screen printing, rotary screen printing, flexo printing, gravure printing, and inkjet printing, and wherein, after printing, the polyurethane formulation is cured under conditions effective to provide a fully cross-linked, non-tacky surface.
However, Eckstein does disclose that the hydrophilic polyurethane elastomer is a non-wound-adhering wound contact layer. See [0011]. While being non-wound-adhering does not inherently indicate that the material has a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1, it does indicate that the material is intended to have a low or no adhesion in order to prevent adhesion to a wound. Honcoop discloses a polyurethane elastomer that is solid, non-adhesive, and has no adherent properties. See [0128] of Honcoop. This is so that the polyurethane elastomer does not stick to other parts of an object in which it is contained. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the polyurethane formulation to have a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1 as taught by Honcoop. A skilled artisan would have been motivated to do so because Honcoop teaches that polyurethane elastomer can be made to be solid, non-adhesive, and have no adherent properties such that the polyurethane elastomer does not stick to other parts of an object in which it is contained ([0128]). Since the polyurethane elastomer has no adherent properties, it would inherently have a peel adhesion of 0 N when measured in accordance with ISO 29862-2018 method 1. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to polyurethane elastomers.
Additionally, Miller discloses a hypoadherent wound dressing comprising a polymeric coating made of polyurethane elastomer. See the abstract and Pg. 6, Par. 1 of Miller. Miller further discloses applying the coating by screen printing. See Pg. 14, Par. 2 of Miller. This allows the coating to be applied in patterns. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the coating to be performed by printing the polyurethane formulation directly onto the wound dressing by a printing technique selected from the group consisting of screen printing, rotary screen printing, flexo printing, gravure printing, and inkjet printing as taught by Miller. A skilled artisan would have been motivated to do so because Miller teaches that the polyurethane elastomer coating is applied by screen printing which allows for the coating to be applied in pattern based on patterns in the screen (Pg. 14, Par 2-3). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings with a layer of polyurethane formulations.
Finally, Kim discloses a wound dressing with a polyurethane film layer that is cured. The curing process occurs between 30-100 °C for a varying amount of time adjustable by one skilled in the art. One example uses 5 minutes. See Pg. 8 of the translation provided on June 12, 2023 of Kim. The dressing of Kim is analogous to the dressing of Eckstein in that both dressings comprise a polyurethane foam layer with a polyurethane coating formulation. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for, after printing, the polyurethane formulation to be cured under conditions effective to provide a fully cross-linked, non-tacky surface as taught by Kim. A skilled artisan would have been motivated to do so because Kim teaches that the polyurethane film layer is cured to produce the finished product (Pg. 8 of the translation provided on June 12, 2023 of Kim). Applicant’s specification discloses that the conditions effective to provide a fully cross-linked, non-tacky surface are a temperature between 75 °C and 130 °C and a period of time from 3 minutes to 20 minutes, which are met by Kim since the curing process occurs between 30-100 °C and a varying amount of time, preferably 5 minutes. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising polyurethane formulations.
Regarding claim 3, Eckstein in view of Honcoop, Miller and Kim discloses the method of preparing a wound contact surface as claimed in claim 1, wherein the foam dressing is a polyurethane foam ([0044] discloses that “the wound dressing comprises as its absorbent layer a hydrophilic polymer foam.” [0045] discloses “Hydrophilic polyurethane foams are especially suited as polymer foams.”).
Regarding claim 4, Eckstein in view of Honcoop, Miller and Kim discloses the method of preparing a wound contact surface as claimed in claim 1, comprising: after coating the polyurethane formulation onto the wound dressing to form the wound contact surface thereon; allowing the wound dressing surface to cure (In view of Kim, after coating the polyurethane formulation onto the wound dressing to form the wound contact surface thereon, the wound dressing of Eckstein is cured.).
Regarding claim 5, Eckstein in view of Honcoop, Miller and Kim discloses the method of preparing a wound contact surface as claimed in claim 4, wherein curing takes place at a temperature of from 75°C to 130 °C for 3 minutes to 30 minutes or under infrared (I.R.) light for 30 seconds to 15 minutes (In view of Kim, the curing of the polyurethane formulation to the polyurethane foam layer takes place at a temperature of 30-100 °C and a varying amount of time, preferably 5 minutes. However, it has been held that where 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). Therefore, it would be obvious for the curing to take place at a temperature of from 75°C to 130 °C for 3 minutes to 30 minutes.)
Regarding claim 6, Eckstein in view of Honcoop, Miller and Kim discloses the method of preparing a wound contact surface as claimed in claim 1, wherein the polyurethane formulation having a peel adhesion of 0 N is prepared by controlling the ratios of the constituent groups of the polyurethane (The hydrophilic polyurethane elastomer of Eckstein inherently has a controlled ratio of constituent groups because otherwise, the product would not necessarily be functional. Honcoop also discloses changing the ratio of constituents of the polyol to affect the properties of the resultant polyurethane. See [0075] of Honcoop. A material is inherently prepared by controlling the ratios of the constituent groups as different ratios result in different properties.).
Regarding claim 7, Eckstein in view of Honcoop, Miller and Kim discloses the method of preparing a wound contact surface as claimed in claim 1, wherein the polyurethane formulation is a polyether-based polyurethane ([0019] discloses “Polyether polyols with molecular weights between about 600 and about 12,000 are preferred”; and “Aliphatic polyether polyols are preferred today for use in medicine”).
Regarding claim 8, Eckstein discloses a wound dressing comprising a wound contact surface (Eckstein discloses a multi-layer wound dressing comprising a carrier layer, an absorbing layer, and a hydrophilic wound contact layer. See the Abstract and Fig. 1.),
wherein the wound contact surface is a continuous or non-continuous surface of a polyurethane formulation (The abstract states that “the wound contact layer comprises a hydrophilic polyurethane elastomer,” which is interpreted as a polyurethane formulation.),
wherein the polyurethane formulation is applied in a predetermined pattern providing a continuous or non-continuous surface configuration ([0036] discloses that the “wound contact layer can be fully contiguous with respect to the absorbent layer and or feature a uniform or profiled layer thickness and/or feature a regular or an irregular pattern.”); and
wherein the wound dressing is a foam dressing ([0044] discloses that “the wound dressing comprises as its absorbent layer a hydrophilic polymer foam.”).
Eckstein does not disclose having a peel adhesion of 0 N when measured in accordance with ISO 29862-2018 method 1, wherein the wound contact surface is a surface of the wound dressing itself onto which the polyurethane formulation has been directly printed, by a printing technique selected from the group consisting of screen printing, rotary screen printing, flexo printing, gravure printing, and inkjet printing, and wherein, after printing, the polyurethane formulation is cured under conditions effective to provide a fully cross-linked, non-tacky surface, and
However, Eckstein does disclose that the hydrophilic polyurethane elastomer is a non-wound-adhering wound contact layer. See [0011]. While being non-wound-adhering does not inherently indicate that the material has a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1, it does indicate that the material is intended to have a low or no adhesion. Honcoop discloses a polyurethane elastomer that is solid, non-adhesive, and has no adherent properties. See [0128] of Honcoop. This is so that the polyurethane elastomer does not stick to other parts of an object in which it is contained. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the polyurethane formulation to have a peel adhesion of 0 N measured in accordance with ISO 29862-2018 method 1 as taught by Honcoop. A skilled artisan would have been motivated to do so because Honcoop teaches that polyurethane elastomer can be made to be solid, non-adhesive, and have no adherent properties such that the polyurethane elastomer does not stick to other parts of an object in which it is contained ([0128]). Since the polyurethane elastomer has no adherent properties, it would inherently have a peel adhesion of 0 N when measured in accordance with ISO 29862-2018 method 1. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to polyurethane elastomers.
Additionally, Miller discloses a hypoadherent wound dressing comprising a polymeric coating made of polyurethane elastomer. See the abstract and Pg. 6, Par. 1 of Miller. Miller further discloses applying the coating by screen printing. See Pg. 14, Par. 2 of Miller. This allows the coating to be applied in patterns. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the wound contact surface to be a surface of the wound dressing itself onto which the polyurethane formulation has been directly printed, by a printing technique selected from the group consisting of screen printing, rotary screen printing, flexo printing, gravure printing, and inkjet printing as taught by Miller. A skilled artisan would have been motivated to do so because Miller teaches that the polyurethane elastomer coating is applied by screen printing which allows for the coating to be applied in pattern based on patterns in the screen (Pg. 14, Par 2-3). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings with a layer of polyurethane formulations.
Finally, Kim discloses a wound dressing with a polyurethane film layer that is cured. The curing process occurs between 30-100 °C for a varying amount of time adjustable by one skilled in the art. One example uses 5 minutes. See Pg. 8 of the translation provided on June 12, 2023 of Kim. The dressing of Kim is analogous to the dressing of Eckstein in that both dressings comprise a polyurethane foam layer with a polyurethane coating formulation. Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for, after printing, the polyurethane formulation to be cured under conditions effective to provide a fully cross-linked, non-tacky surface as taught by Kim. A skilled artisan would have been motivated to do so because Kim teaches that the polyurethane film layer is cured to produce the finished product (Pg. 8 of the translation provided on June 12, 2023 of Kim). Applicant’s specification discloses that the conditions effective to provide a fully cross-linked, non-tacky surface are a temperature between 75 °C and 130 °C and a period of time from 3 minutes to 20 minutes, which are met by Kim since the curing process occurs between 30-100 °C and a varying amount of time, preferably 5 minutes. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to wound dressings comprising polyurethane formulations.
Regarding claim 9, Eckstein in view of Honcoop, Miller and Kim discloses the wound dressing as claimed in claim 8, wherein the polyurethane formulation is a polyether-based polyurethane ([0019] discloses “Polyether polyols with molecular weights between about 600 and about 12,000 are preferred”; and “Aliphatic polyether polyols are preferred today for use in medicine”).
Regarding claim 11, Eckstein in view of Honcoop, Miller and Kim discloses the wound dressing as claimed in claim 8 where the foam dressing comprises a polyurethane foam ([0044] discloses that “the wound dressing comprises as its absorbent layer a hydrophilic polymer foam.” [0045] discloses “Hydrophilic polyurethane foams are especially suited as polymer foams.”).
Regarding claim 12, Eckstein in view of Honcoop, Miller and Kim discloses the wound dressing as claimed in claim 11, wherein the polyurethane foam is an aliphatic polyurethane foam or an aromatic polyurethane foam ([0019] discloses “Polyether polyols with molecular weights between about 600 and about 12,000 are preferred”; and “Aliphatic polyether polyols are preferred today for use in medicine”).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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