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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21 April 2026 has been entered.
Status
Applicant’s response dated 21 April 2026 to the previous Office action dated 01 December 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The rejection under 35 U.S.C. 112 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but new rejections under 35 U.S.C. 112 are made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new (modified) rejection under 35 U.S.C. 103 is made herein in view of applicant’s claim amendments.
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 20 and 27-29 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.
Claim 20 recites the limitation "the moisture impermeable first skin-facing adhesive layer" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the moisture impermeable first skin-facing adhesive layer" in lines 16-17. There is insufficient antecedent basis for this limitation in the claim. Claims 28-29 are rejected as depending upon claim 27 without remedying such deficiency.
Claims 20 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. Thus, the claims are contradictory and therefore indefinite. Dependent claims 28-29 are rejected as depending upon claim 27 without remedying such deficiency.
Claim 27 recites a ratio between a first thickness L and a D90 cumulative particle size distribution, but fail to indicate units for the D90 cumulative particle size distribution, and thus such ratio is unclear and non-limiting as it may be any number based on merely calculating it using different units, thereby rendering the claims indefinite. Dependent claims 28-29 are rejected as depending upon claim 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) 27-29 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).
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 D90 cumulative particle size distribution, the hydrocolloid particles of Bach et al. necessarily have a D90 cumulative particle size distribution, and no particular range is claimed, and the moisture absorbing layer of Bach et al. is designed to absorb moisture from the adhesive layer via the hydrocolloid particles therein (i.e., where the hydrocolloid particles therein bridge over the thickness of the skin-facing adhesive layer to transport water therethrough to the moisture absorbing layer).
Regarding the claimed ratio between a first thickness L and a D90 cumulative particle size distribution, but fail to indicate units for the D90 cumulative particle size distribution, and thus such ratio is unclear and non-limiting as it may be any number based on merely calculating it using different units, thereby rendering the claims indefinite.
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 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 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 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 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, see remarks pages 6-7, filed 21 April 2026, with respect to nonobviousness of claims 16 and claims dependent thereupon, have been fully considered and are persuasive, in that Bach et al. does not disclose a D90 particle size distribution as claimed. The obviousness rejection of claims 16-20 and 22-26 has been withdrawn.
Applicant's arguments regarding nonobviousness of claim 27 and claims dependent thereupon filed 21 April 2026 have been fully considered but they are not persuasive, in that such claims do not require any particular D90 particle size distribution as claimed as discussed above.
Allowable Subject Matter
Claims 16-19 and 22-26 are allowed.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
Prosecution Insights