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 12/22/2025 is acknowledged.
Claims 1-19 are pending.
Claims 1, 9, 12, and 15 are independent.
Applicant's election with traverse of Group I, claims 1-8 in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground(s) that all claim sets include a buffer composition that includes a non-neutralized cross-linked polyacrylic acid and a partially neutralized cross-linked polyacrylic acid. Applicant further argues the claim sets are for a buffer composition, a wound dressing incorporating the buffer composition and methods related to a buffer composition. Applicant further argues there is no search burden or any other justification for the election.
These arguments are not found persuasive because search burden was enumerated in the restriction, pg. 5, ¶ 2. There are no claims to a buffer composition. The claim sets are directed to an ostomy skin barrier (claims 1-8), a wound dressing (claims 9-11), a method of manufacturing an ostomy barrier (claims 12-14), and a method for securing a medical product to a skin area (claims 15-19). The ostomy skin barrier as claimed has a materially different design from the wound dressing as claimed as evident from the different structural features claimed. For example, the ostomy skin barrier has a first and second surface containing a first and second adhesive. In contrast the wound dressing has both adhesives applied to the same surface (a side of the flexible outer layer). Further still, these distinct devices have different functions and effects. Applicant has not stated on the record that the ostomy skin barrier and the wound dressing as claimed are obvious variants.
After search and consideration of the prior art, the restriction between Group I and Group II has been withdrawn, while the restriction requirement for Groups III and IV is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/2025.
Claims 1-11 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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 2 and 11 include the limitation of “further comprising an optional ingredient.” It is contradictory to consider an optional ingredient a required limitation. Therefore, the skilled artisan cannot understand what is required by claims 2 and 11. If the additional ingredients are optional, then claims 2 and 11 would fail to further limit the subject matter of claims 1 and 9. As written the skilled artisan cannot understand the metes and bounds for which applicant is claiming protection.
Clarification is required.
Claim 2 and 11 are rejected 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.
Claims 2 and 11 include the limitation of “further comprising an optional ingredient.” It is contradictory to consider an optional ingredient a required limitation. To the extent that claims 2 and 11 do not require any additional limitations since the ingredients are optional, claims 2 and 11 fail to further limit claims 1 and 9 from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-11 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 claims 2 and 11: Adhesive compositions may comprise zinc oxide, emollients, disinfecting agents, and/or bactericidal agents (Stroebeck, e.g., 0042-0043).
Applicable to claims 3 and 10: The adhesives differ in absorbent properties and composition (Stroebeck, e.g., 0051 and Examples 1-2).
Applicable to claim 6: 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 recited in claim 6.
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 1-11 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-26 of US 10470936 in view of Stroebeck, US 20090171258.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach an ostomy barrier device and a wound dressing device comprising first and second adhesives applied to a surface of the device, e.g., wherein the first and second adhesives are applied to a side of the flexible outer layer (Claim 14). The wound dressing claims 14-23 anticipate the subject matter of instant claims 9-10.
The reference claims do not generically recite 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 as found in claim 1. However, the reference claims teach a specific arrangement which is within the scope of the arrangement generically recited in claim 1. For example, reference claim 10 refers to an ostomy skin barrier of claim 9, 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, wherein the backing layer extends over and beyond the inner layer to form an edge portion of the barrier. This is the same arrangement recited in present claim 6. Thus, the specific limitations of the reference claims anticipate the subject matter of instant claims 1 and 3-8.
The reference claims do not expressly teach the optional ingredients of claims 2 and 11. However, to the extent that the ingredients are optional and not required, the reference claims meet these limitations. To the extent that the ingredients are required, Stroebeck teaches adhesive compositions may comprise zinc oxide, emollients, disinfecting agents, and/or bactericidal agents (Stroebeck, e.g., 0042-0043).
It would have been obvious before the presently claimed invention was made to modify adhesive compositions of the reference claims by incorporating zinc oxide, emollients, disinfecting agents, and/or bactericidal agents as taught by Stroebeck with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known technique to improve similar devices in the same way. The skilled artisan would have been motivated to make this modification for improved skin compatibility and/or reduced incidence of infection. The skilled artisan would have had a reasonable expectation of success because Stroebeck teaches this modification for the devices claimed by the reference patent.
Accordingly, the subject matter of claims 1-11 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claim(s) 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-12 of US 11304854 in view of Stroebeck, US 20090171258.
The reference claims teach an ostomy barrier device and a wound dressing device comprising first and second adhesives applied to a surface of the device, e.g., wherein the first and second adhesives are applied to a side of the flexible outer layer (Claim 9). The wound dressing claims 9-12 anticipate the subject matter of instant claims 9-10. The ostomy device comprises a first barrier surface having a first adhesive that includes a polymeric buffer composition; and a second barrier surface having a second adhesive includes a hydrocolloid; and wherein the first adhesive includes 40 wt. % of polyisobutylene, 16 wt. % of styrene-isoprene-styrene copolymer, 5 wt. % of liquid PIB, 4 wt. % of polyethylene fibers, 20 wt. % of cross linked polyacrylic acid, and 15 wt. % of cross linked partially neutralized polyacrylic acid. This meets the limitations of claim 1.
The difference is that the reference claims are more specific than the present claims. However, the specific adhesives claimed by the reference patent are within the scope of the presently claimed adhesives.
The reference claims do not expressly teach the optional ingredients of claims 2 and 11. However, to the extent that the ingredients are optional and not required, the reference claims meet these limitations. To the extent that the ingredients are required, Stroebeck teaches adhesive compositions may comprise zinc oxide, emollients, disinfecting agents, and/or bactericidal agents (Stroebeck, e.g., 0042-0043).
It would have been obvious before the presently claimed invention was made to modify adhesive compositions of the reference claims by incorporating zinc oxide, emollients, disinfecting agents, and/or bactericidal agents as taught by Stroebeck with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known technique to improve similar devices in the same way. The skilled artisan would have been motivated to make this modification for improved skin compatibility and/or reduced incidence of infection. The skilled artisan would have had a reasonable expectation of success because Stroebeck teaches this modification for the devices claimed by the reference patent.
Accordingly, the subject matter of claims 1-11 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claim(s) 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of US 11304855 in view of Stroebeck, US 20090171258.
The reference claims teach an ostomy barrier device and a wound dressing device comprising first and second adhesives applied to a surface of the device, e.g., wherein the first and second adhesives are applied to a side of the flexible outer layer (Claim 9). The wound dressing claims 9-12 anticipate the subject matter of instant claims 9-10. The ostomy device comprises a first barrier surface having a first adhesive that includes a polymeric buffer composition; and a second barrier surface having a second adhesive includes a hydrocolloid (Claims 1-3). This meets the limitations of claim 1.
The reference claims do not expressly teach the optional ingredients of claims 2 and 11. However, to the extent that the ingredients are optional and not required, the reference claims meet these limitations. To the extent that the ingredients are required, Stroebeck teaches adhesive compositions may comprise zinc oxide, emollients, disinfecting agents, and/or bactericidal agents (Stroebeck, e.g., 0042-0043).
It would have been obvious before the presently claimed invention was made to modify adhesive compositions of the reference claims by incorporating zinc oxide, emollients, disinfecting agents, and/or bactericidal agents as taught by Stroebeck with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known technique to improve similar devices in the same way. The skilled artisan would have been motivated to make this modification for improved skin compatibility and/or reduced incidence of infection. The skilled artisan would have had a reasonable expectation of success because Stroebeck teaches this modification for the devices claimed by the reference patent.
Accordingly, the subject matter of claims 1-11 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claim(s) 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of US 11826235.
The reference claims teach an ostomy skin barrier comprising: a first barrier surface containing a water insoluble first adhesive; a second barrier surface containing a water insoluble second adhesive that includes a hydrocolloid; a buffer composition that includes a non-neutralized cross-linked polyacrylic acid and a partially neutralized cross-linked polyacrylic acid, and an optional ingredient that includes an antioxidant, an antibiotic, an antimicrobial agent, an anti-inflammatory agent, a skin protective agent, and/or an active ingredient; wherein the polyacrylic acids are dispersed as particles in the first adhesive and the first adhesive includes polyisobutylene, a styrene-isoprene-styrene copolymer, and polyethylene fibers; wherein the second adhesive includes polyisobutylene, a styrene-isoprene-styrene copolymer, polyethylene fibers, pectin, and CMC (claim 1). The reference claims teach a wound dressing comprising: a flexible outer layer; a first adhesive that includes polyisobutylene and polyethylene fibers; a second adhesive that includes a hydrocolloid; a buffer composition that includes a cross-linked non-neutralized polyacrylic acid and a cross-linked partially neutralized polyacrylic acid, the polyacrylic acids being dispersed as particles in the first adhesive; and an optional ingredient that includes an antioxidant, an antibiotic, an antimicrobial agent, an anti-inflammatory agent, a skin protective agent, or an active ingredient; wherein the first and second adhesives are applied to a side of the flexible outer layer; wherein first adhesive includes polyisobutylene, a styrene-isoprene-styrene copolymer, and polyethylene fibers; wherein the second adhesive includes polyisobutylene, a styrene-isoprene-styrene copolymer, polyethylene fibers, pectin, and CMC.
The reference claims are more specific than the presently claimed invention in terms of the composition of the first and second adhesives, but are within the scope of the presently claimed invention.
The skilled artisan would consider the presently claimed invention to be an obvious variant of the devices covered by the reference claims.
Conclusion
No claim is allowed.
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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