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
Applicant’s response dated 19 August 2025 to the previous Office action dated 19 May 2025 is acknowledged. Pursuant to amendments therein, claims 16-20 and 22-29 are pending in the application.
The rejection under 35 U.S.C. 112 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new (modified) rejection under 35 U.S.C. 103 is made herein in view of applicant’s claim amendments.
Information Disclosure Statement
The information disclosure statement filed 19 August 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been fully considered. In particular, the first two Non-Patent Literature Documents have not been considered as copies of such references were not provided, only title sheets were provided.
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.
Claims 16-20 and 22-29 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 16 and 27 recite that the first skin-facing adhesive layer is moisture impermeable, but also recite that such first skin-facing adhesive layer comprises hydrocolloid particles. However, the specification teaches that such hydrocolloid particles are moisture permeable, whereas the sticky polymer matrix of the first skin-facing adhesive layer is impermeable to moisture (specification page 4 lines 19-20). It is not possible for the first skin-facing adhesive layer to be moisture impermeable as claimed (as opposed to the sticky polymer matrix of the first skin-facing adhesive layer) since it contains moisture permeable hydrocolloid particles. Moreover, claims 20 and 27 recite water transport through the first skin-facing adhesive layer, which cannot be possible if the first skin-facing adhesive layer is moisture impermeable. (Perhaps applicant meant to recite “moisture vapor impermeable”?) Thus, the claims are contradictory and therefore indefinite. Dependent claims 17-20, 22-26, and 28-29 are rejected as depending upon claims 16 or 27 without remedying such deficiency.
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.
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.
Claim(s) 16-20 and 22-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bach et al. (US 2010/0191204 A1; published 29 July 2010; of record) as evidenced by Lipman (US 6,710,100 B1; issued 23 March 2004; of record).
Bach et al. discloses an adhesive composite comprising at least three layers (i.e., a laminate), a backing layer, a moisture absorbing layer, and a thin layer of vapour permeable, low-absorbing adhesive layer (abstract) wherein small amounts of absorbing particles may be dispersed in the skin-facing adhesive (paragraph [0031]) wherein absorbent particles may be hydrocolloids (paragraph [0063]) wherein preferred particle size is 10-300 µm (paragraph [0064]) wherein the absorbing layer may comprise 1-40% w/w hydrocolloid particles (paragraph [0066]) wherein the water absorption capacity of the skin facing layer should be less than 20% of the absorbing layer (i.e., less than 20% of 1-40% w/w hydrocolloid particles, or less than 8% w/w hydrocolloid particles) (paragraph [0031]) wherein the absorbing layer and adhesive layer may both comprise identical polymeric matrix (paragraphs [0072]-[0073]) wherein the layer of absorbing material may be an absorbing adhesive layer (paragraph [0053]) wherein the skin-facing layer may be 20-500 µm thick (paragraph [0038]) wherein the absorbing layer can be 300 µm thick (paragraph [0064]) wherein the hydrocolloid may be AQUASORB A500 (paragraphs [0104], [0106]) wherein the adhesive attaches a collecting device such as an ostomy device to human skin (paragraph [0001]) wherein various adhesives, oils, and tackifiers can be used therein to adjust the adhesive properties of the skin-facing layer (paragraph [0039]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bach et al. as discussed above and to make an ostomy device for attaching to human skin comprising a backing layer, a 300 µm thick moisture absorbing layer, and a 20-500 µm thick adhesive layer, wherein the adhesive layer comprises less than 8% w/w AQUASORB A500 hydrocolloid particles of size 10-300 µm, with a reasonable expectation of success.
Regarding the claimed recitation of a D90 cumulative particle size distribution of less than 290 µm, the hydrocolloid particles of Bach et al. have size 10-300 µm, which overlaps the claimed range, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding the claimed ratio between first thickness L and the D90 cumulative particle size distribution of 0.6-1.2, Bach et al. discloses thickness of 20-500 µm and particle size of 10-300 µm, resulting in a ratio of 20-500 : 10-300, or 20/300 to 500/10, or 0.07-50, which overlaps the claimed range, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding the claimed recitation of the adhesive layer being moisture impermeable, given that such recitation is contradictory to the other language of the claims as discussed above and thus the meaning of such recitation in the context of the claims is unclear and indefinite, such claimed property is presumed to be inherent per MPEP 2112(V) and 2112.01(I) in the adhesive layer of Bach et al. as discussed above given that such layer of Bach et al. as discussed above and the claimed adhesive layer are at least otherwise substantially identical, and given that identical compositions must have the same properties per MPEP 2112.01(II).
Regarding claim 17, Lipman discloses that AQUASORB A500 is carboxymethyl cellulose (column 12 lines 16-18).
Regarding claim 18, Bach et al. discloses a particle size of 10-300 µm, which overlaps the claimed range of 5-200 µm, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding claim 19, Bach et al. discloses a thickness of 20-500 µm, which overlaps the claimed range of below 350 µm, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding claims 20 and 27, Bach et al. discloses a concentration of less than 8% w/w hydrocolloid particles, which overlaps the claimed range of 5-20% w/w, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding claim 22, Bach et al. discloses an adhesive layer thickness of 20-500 µm and an absorbing layer thickness of 300 µm, which results in a range that includes an adhesive layer thinner than the absorbing layer, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding claims 23 and 28, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bach et al. as discussed above and to make the absorbing layer an adhesive layer with hydrocolloid particles therein, with a reasonable expectation of success.
Regarding claims 24 and 27, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bach et al. as discussed above and to make the absorbing layer comprise 1-40% w/w hydrocolloid particles, with a reasonable expectation of success. Such range overlaps the claimed range of 20-45% w/w, and a prima facie case of obviousness exists where prior art and clamed ranges overlap per MPEP 2144.05(I).
Regarding claim 29, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize adhesive performance of the adhesive layer of Bach et al. by varying adhesives/oils/tackifiers therein thereby varying the perspiration peel force thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Bach et al. teaches such adjustment of adhesive properties.
Response to Arguments
Applicant's arguments regarding obviousness filed 19 August 2025 have been fully considered but they are not persuasive.
Applicant argues that Bach et al. discloses a skin-facing adhesive layer that is moisture permeable whereas the claimed skin-facing adhesive layer is moisture impermeable (remarks pages 5-6). In response, regarding the claimed recitation of the adhesive layer being moisture impermeable, given that such recitation is contradictory to the other language of the claims as discussed above and thus the meaning of such recitation in the context of the claims is unclear and indefinite, such claimed property is presumed to be inherent per MPEP 2112(V) and 2112.01(I) in the adhesive layer of Bach et al. as discussed above given that such layer of Bach et al. as discussed above and the claimed adhesive layer are at least otherwise substantially identical, and given that identical compositions must have the same properties per MPEP 2112.01(II).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617