DETAILED ACTION
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 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 present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
The response filed 06/12/2026 is acknowledged.
Claims 1-2, 4-5, 8-9, and 11-19 are pending.
Claims 1, 9, 12, and 15 are independent.
Claims 12-19 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/2025.
Claims 1-2, 4-5, 8-9, and 11 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 06/11/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. Nos. 10470936, 11304854, 11304855, and 11826235 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn
The rejection of claim(s) 1-11 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-26 of US 10470936 in view of Stroebeck, US 20090171258 has been withdrawn because of the terminal disclaimer.
The rejection of claim(s) 1-11 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-12 of US 11304854 in view of Stroebeck, US 20090171258 has been withdrawn because of the terminal disclaimer.
The rejection of claim(s) 1-11 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of US 11304855 in view of Stroebeck, US 20090171258 has been withdrawn because of the terminal disclaimer.
The rejection of claim(s) 1-11 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of US 11826235 has been withdrawn because of the terminal disclaimer.
The rejection of claim(s) 2 and 11 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 pre-AIA the applicant regards as the invention has been withdrawn because of the amendment.
The rejection of claim(s) 2 and 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been withdrawn because of the amendment.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Applicant argues amended claim 1 now requires that the first barrier surface contain a water insoluble first adhesive that does not include a hydrocolloid. Applicant argues neither reference, alone or in combination, teaches or suggests an ostomy barrier where the inner adhesive layer-which contacts the peristomal skin-is specifically devoid of hydrocolloids combined with a second adhesive that includes a hydrocolloid.
This argument is unpersuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the first barrier surface contains a water insoluble first adhesive that does not include a hydrocolloid) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
There is nothing in claim 1 or claim 9 which excludes a hydrocolloid from the first adhesive.
Further, it is not clear where the specification supports a water insoluble first adhesive that does not include a hydrocolloid. To the extent that polyacrylic acid is a hydrocolloid (Specification, e.g., 0040-0041 and Taylor, e.g., 0036), it is noted that each of the adhesives exemplified containing a water insoluble adhesive (PIB, Styrene-isoprene-styrene copolymer, PE fibers) also includes polyacrylic acid and partially neutralized polyacrylic acid (Specification, e.g., Table 1).
Applicant argues Taylor teaches away from the use of conventional hydrocolloids such as pectin and CMC in the context of a polyacrylic acid buffer system, particularly when the goal is effective pH buffering in the presence of physiological fluids such as stomal effluent or wound exudate. Applicant argues the Examiner asserts that Taylor's teaching that pectin and CMC "function similarly to polyacrylates" (Taylor 0036) provides a reason to combine hydrocolloids with the polyacrylic acid buffer system. But a careful reading of Taylor reveals the opposite conclusion. Taylor's fundamental premise is that conventional hydrocolloid-based skin barriers have insufficient pH buffering capacity.
Applicant argues Taylor explicitly identifies the inadequacy of pectin and CMC as the problem to be solved, and proposes the use of high molecular weight non-neutralized and partially neutralized polyacrylic acids as the solution precisely instead of those hydrocolloids. Applicant argues Taylor further demonstrates that citric acid, a low molecular weight buffer, is also unsuitable, as it caused punctate ulcers in human subjects. (Taylor 0058-0061.) The inventors of Taylor developed the claimed system specifically because existing hydrocolloid-based approaches failed.
This argument is unpersuasive.
It is agreed that Taylor expressly teaches non-neutralized and partially neutralized polyacrylic acids may be used as hydrocolloids in place of pectin and CMC because they absorb and swell and form viscous solutions that provide mucoadhesion against a wearer’s skin just like CMC and pectin (Taylor, e.g., 0036). The difference is non-neutralized and partially neutralized polyacrylic acids additionally provide independent modification of the extent of absorption and of pH control which are highly desirable qualities in an adhesive composition for a medical device to be attached to a patient’s skin such as a wound dressing or an ostonomy skin barrier (Taylor, e.g., 0027-0030).
Applicant’s argument that Taylor, 0036, explains that the polyacrylic acid buffer system can replace conventional hydrocolloids, not that one of ordinary skill would be motivated to add conventional hydrocolloids to a polyacrylic acid buffer is unclear. The rejection does not rely on adding conventional hydrocolloids to a polyacrylic acid buffer. Even if, arguendo, the rejection relied upon combining polyacrylic acid buffer with hydrocolloids, Taylor expressly teaches this combination (Taylor, e.g., 0062). Further, arguendo, if the claims were amended to exclude a hydrocolloid from the first adhesive, Taylor, 0036, provides motivation to substitute non-neutralized and partially neutralized polyacrylic acids for CMC and/or pectin in Stroebeck since the non-neutralized and partially neutralized polyacrylic acids absorb fluids, swell, and form viscous solutions that provide adhesion against a wearer’s skin like CMC and pectin (Taylor, e.g., 0036). In terms of adhesion, they are equally effective.
Applicant’s argument that Taylor explicitly criticizes the pH buffering performance of pectin- and CMC-based barriers, which are the very hydrocolloids that Stroebeck relies upon, and a person of ordinary skill reading Taylor would understand that combining Stroebeck's hydrocolloid-heavy adhesive system with Taylor's polyacrylic acid buffer system would undermine the buffering efficacy that Taylor is not persuasive. Taylor does not criticize pectin and CMC based barriers. Tylor criticizes citrate buffers in barrier compositions. Taylor points out that barrier compositions which contain a citrate buffer in combination with pectin and CMC shows citrate caused irritation accompanied by focal erosions (Taylor, e.g., 0061). The pectin/CMC adhesive is still effective as an adhesive and the irritation is not attributed to either pectin or CMC. Since Taylor expressly teaches combining polyacrylic acid buffer with hydrocolloids (Taylor, e.g., 0062) the skilled artisan would conclude that the buffering efficacy of Taylor's polyacrylic acids would be effective when included in a hydrocolloid containing adhesive system.
Applicant’s argument that Stroebeck does not recognize a pH problem or suggest any need for a polymeric buffer system and a motivation to combine cannot rest on a problem that the primary reference does not recognize (citing Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012)) is unpersuasive. Applicant has not explained how the facts in this case relate to the facts in the cited case. The motivation to combine does not rest on a problem that the primary reference does not recognize. The rejection rationale has been applied using either Stroebeck or Taylor as the primary reference. In the case where Stroebeck is considered the primary reference Stroebeck, did identify a need for a polymeric system including hydrocolloids which absorb fluid and provide mucoadhesion, e.g., CMC and pectin for adhesion and fluid absorption. Taylor’s solution is not limited to replacing conventional hydrocolloids with the polyacrylic acid buffer since Taylor expressly teaches combining polyacrylic acid buffer with hydrocolloids in an adhesive (Taylor, e.g., 0062). Applicant’s argument that Taylor’s core teaching rest on identifying hydrocolloids as the root of the buffering problem is not persuasive since Taylor identifies the hydrocolloid system of non-neutralized and partially neutralized polyacrylic acids as a more effective buffer than CMC and pectin (Taylor, e.g., 0014 pectin and CMC have only limited pH buffering capacity).
Rejections Addressing Applicant’s Amendment
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 61604663, 13778538, and 15680524, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The parent applications do not support the limitations of a first and second adhesive as presently claimed. The parent applications do not support the limitations of a first barrier surface containing a water insoluble first adhesive and a second barrier surface containing a water insoluble second adhesive that includes a hydrocolloid.
The earliest support for these limitations appears to be found in 15813615 having a filing date of 08/18/2017.
Each of the examined claims in the present application have a filing date of 08/18/2017.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-2, 4-5, 8-9, and 11 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stroebeck, US 20090171258 and Taylor, US 20130231600.
Stroebeck teaches an ostomy barrier and wound care device (Stroebeck, e.g., 0001, 0004, 0042-0043), comprising a hydrocolloid adhesive composition (Stroebeck, e.g., Abstract, examples, claims, e.g., 0038-0051, and examples 1-2). The devices comprise a flexible backing layer (Stroebeck, e.g., 0052-0056) which corresponds to a barrier surface and flexible outer layer as claimed. The layers comprise first and second adhesive compositions (Stroebeck, e.g., 0057-0064 and claims 1-12). Layers may be applied coextensively, i.e., two adhesive layers may have the same area and shape (Stroebeck, e.g., 0061), or the two adhesives may be applied to different surfaces, i.e., one layer extends beyond the peripheral edge of the other layer (Stroebeck, e.g., 0061).
Applicable to the limitation of wherein the second adhesive has a lower absorptive capacity than the first adhesive: The adhesives differ in absorbent properties and composition (Stroebeck, e.g., 0051 and Examples 1-2).
Applicable to the limitation of wherein the first barrier surface is an inner layer formed from the first adhesive and the second barrier surface is a backing layer formed from the second adhesive and wherein the backing layer extends over and beyond the inner layer to form an edge portion of the barrier: Stroebeck teaches first and second adhesives in a layered configuration wherein the first layer is disposed on the second layer, and wherein the second layer extends beyond the peripheral edge of the first adhesive layer (Stroebeck, e.g., 0018 and 0061). Thus, Stroebeck teaches the first and second adhesive layers arranged as claimed.
Since Stroebeck teaches an ostomy barrier and wound care device wherein the first barrier surface is an inner layer formed from the first adhesive, Stroebeck teaches the first barrier surface is configured to contact a peristomal area that is immediately adjacent to a wearer's stoma as claimed.
Applicable to claims 2 and 11: Adhesive compositions may comprise zinc oxide, emollients, disinfecting agents, and/or bactericidal agents (Stroebeck, e.g., 0042-0043).
Applicable to claim 8: Stroebeck teaches the adhesives comprising a release liner (Stroebeck, e.g., 0071).
Applicable to claims 1, 4, 9: Adhesives include hydrocolloids and water insoluble adhesives, e.g., polyisobutylene and/or styrene polymers (Stroebeck, e.g., 0041, 0044, 0047-0049).
Strobeck teaches modifying ostomy barrier devices and wound dressings with first and second adhesives enables optimizing the properties of each adhesive to result in an improved adhesive system, e.g., the first adhesive has a composition optimized for good skin adhesion, moisture handling properties and skin compatibility (Stroebeck, e.g., 0020), while the second adhesive composition is optimized for cohesive strength to avoid breakage or flow, and to help the first adhesive to be removed from the skin in one piece (Stroebeck, e.g., 0021).
Stroebeck does not expressly teach the devices comprising a buffer composition that includes a non-neutralized cross linked polyacrylic acid and a partially neutralized cross-linked polyacrylic acid.
Taylor teaches an ostomy skin barrier and wound dressing (Taylor, e.g., abstract) and teaches that known hydrocolloid adhesives for use therein have non optimal buffering properties (Taylor, e.g., 0005 and 0014). Taylor’s solution to the problem is to use a combination of non-neutralized and partially neutralized polymers rich in acidic sites (Taylor, e.g., 0030) such as polyacrylic acids (Taylor, e.g., 0037) with the adhesive (Taylor, e.g., 0036 and examples). The polymeric buffer improves ostomy skin barrier and wound dressing devices by maintaining the normal pH of the skin under the device without being inherently irritating to the user’s skin (Taylor, e.g., 0014, 0015, 0065). Applicable to claim 9: Taylor teaches adhesives further comprising polyethylene fibers, e.g., PIB and polyethylene fibers (Taylor, e.g., claims 4, 5, 12, and example 1, 0054, and example 2 comprises polyethylene fibers, carboxymethyl cellulose hydrocolloid and PIB). Applicable to claims 4-5: Taylor teaches adhesives including polyisobutylene (PIB), styrene-isoprene-styrene copolymer, polyethylene fibers (Taylor, e.g., Example 1, table 1, claim 12). Taylor teaches adhesives further comprising known hydrocolloids such as pectin and/or CMC (Taylor, e.g., 0005, 0014, 0062), as pectin and CMC function similarly to polyacrylates in that they absorb fluids, swell and provide mucoadhesion to the skin, thus combinations of hydrocolloids were known and used in wound dressings and ostomy barrier adhesives for desired fluid handling demands depending on the application (Taylor, e.g., 0036). Applicable to claim 8: Taylor teaches the adhesives on a release layer (Taylor, e.g., 0044).
Taylor does not expressly teach a single device comprising first and second adhesive compositions. Taylor does not expressly teach the limitations of a first barrier surface containing a water insoluble first adhesive and a second barrier surface containing a water insoluble second adhesive that includes a hydrocolloid.
It would have been obvious before the presently claimed invention was made to combine the teachings of Stroebeck and Taylor to arrive at the presently claimed ostomy barrier device and wound dressing device with a reasonable expectation of success.
Starting from Stroebeck, the skilled artisan would have been motivated to modify Stroebeck’s devices with a buffer composition that includes a non-neutralized cross linked polyacrylic acid and a partially neutralized cross-linked polyacrylic acid as known from Taylor for benefits including maintaining the normal pH of the skin under the device thereby reducing skin irritation from the adhesives required to adhere the device to the location of interest on the user’s skin. The skilled artisan would have seen this modification as the use of known techniques to improve similar adhesive devices in the same way. The skilled artisan would have had a reasonable expectation of success because Stroebeck suggests the adhesive devices may be modified to be skin friendly.
Starting from Taylor, the skilled artisan would have been motivated to modify Taylors ostomy barrier and wound dressing devices with a first and second adhesives arranged according to Stoebeck to improve skin adhesion, moisture handling properties and skin compatibility in combination with optimal cohesive strength to avoid breakage or flow, and to removal of the adhesive from the skin when removing the device. The skilled artisan would have seen this modification as the use of known techniques to improve similar adhesive devices in the same way. The skilled artisan would have had a reasonable expectation of success since Taylor demonstrates the polymeric buffer improves devices addressed by Stroebeck which contain the same hydrocolloid adhesives, and since both references teach improvements for adhesive ostomy barriers and wound dressings.
Accordingly, the subject matter of claims 1-2, 4-5, 8-9, and 11 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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