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 of the Application
1. Claims 1-15-16, 18-22, and 24 are pending and subject to examination on the merits. Claims 16, 18-22, and 24 are withdrawn from consideration as being drawn to non-elected subject matter.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 06 March 2026 is acknowledged.
Priority
2. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 63/208,247 filed 08 June 2021.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 09 May 2024 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Objections
4. Claim 6 is objected to because of the following informalities: Lactobacillus, Lactobacillus plantarum, and Bifidobacteria should all be italicized (Lactobacillus, Lactobacillus plantarum, and Bifidobacteria). Appropriate correction is required.
5. Claim 7 is objected to because of the following informalities: Saccharomyces cerivisae, Clorella, Spirulina, and Archaebacteria should all be italicized (Saccharomyces cerivisae, Clorella, Spirulina, and Archaebacteria). Appropriate correction is required.
6. Claim 10 is objected to because of the following informalities: “wherein ostomy” should be amended to “wherein the ostomy” to correct an apparent typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 6-7 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.
9. Claim 6 is rejected for reciting “selected from a group consisting of,” since “a” is defined in the specification at paragraph 0040 as both singular and plural. Therefore, it is unclear whether the group recited after “a” is singular or plural. The phrase should be amended to “selected from the group consisting of” to mitigate this issue.
10. Claim 7 is rejected for reciting “selected from a group consisting of,” since “a” is defined in the specification at paragraph 0040 as both singular and plural. Therefore, it is unclear whether the group recited after “a” is singular or plural. The phrase should be amended to “selected from the group consisting of” to mitigate this issue.
Claim Rejections - 35 USC § 103
11. 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.
12. Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Desroche et al (Desroche et al., 2015, US 20150366920 A1—cited herein), Steinhagen et al (Steinhagen et al., 2017, Clin Colon Rectal Surg—cited herein), and Forget (Forget, 2021, US 20210113454 A1—cited herein). Regarding claims 1 and 15, drawn to an ostomy appliance comprising a skin barrier material and a population of non-pathogenic bacteria, fungi, algae, yeast, or their lysates (“the population”), wherein the population is configured to limit proliferation of pathogenic organisms in a peristomal skin environment and wherein the ostomy appliance is an ostomy pouch system including an ostomy pouch formed from a polymeric film comprising the population, Desroche et al. teaches care products containing one or more non-pathogenic antagonistic strains with respect to S. aureus, P. aeruginosa, S. pyrogenes, E. faecium, E. cloacae, P. mirabilis, B. fragilis, S. epidermidis, P. acnes, C. albicans, and/or M. furfur intended to prevent infections or colonization on skin (abstract), wherein the bacterium according the invention can be incorporated into a composition, such as a medical device, i.e. an ostomy bag (paragraph 0060), and further, the composition has a layer or surface that comes in contact with the wound consisting of a material or combinations of layers, such as an adhesive material (paragraph 0074). Regarding claim 2, drawn to the population being incorporated into the skin barrier material, Desroche et al. teaches that the bacterium may be deposited on the surface intended to come into contact with the wound (paragraph 0070). Regarding claim 5, drawn to the skin barrier material formed from a skin barrier formulation incorporating the population, wherein the population migrates to a skin facing surface, Desroche et al. teaches a hydrogel for controlled release (paragraph 0064). Regarding claim 6, drawn to the population being selected from Lactobacillus or Lactobacillus plantarum, Desroche et al. teaches the bacterium may be strains of Lactobacillus saniviri, Lactobacillus salivarius, or Lactobacillus plantarum (paragraph 0051).
Desroche et al. does not teach the ostomy appliance with an ostomy skin barrier (claim 1), a release liner, where the release liner is laminated to the skin barrier (claim 4), an air-tight peristomal area for an anaerobic environment (claim 8), a re-sealable opening or port allowing oxygen to produce an aerobic environment (claims 9 and 11), the control of humidity, or an ostomy ring (claim 14). Steinhagen et al. teaches an ostomy pouching system consisting of the odor proof pouch, skin barrier, and water resistant tape (p. 185, lines 1-4 and 13-15,“Basic Stoma Care”). Steinhagen et al. teaches the moist environment under the adhesive as a hospitable environment to fungal infections, where a properly fitted skin barrier and powder can be utilized to treat in the moist environment (p. 191, first paragraph). Steinhagen et al. continues to teach an integrated closure built onto the bottom of the pouch, and a skin barrier ring used to enhance the seal around the stoma (p. 185, lines 1-4 and 13-15,“Basic Stoma Care”).
Desroche et al. and Steinhagen et al. do not teach a nutritional medium configured to selectively promote the growth of the population, while suppressing the growth of the pathogenic organisms (claim 3), the population being selected from a group consisting of Saccharomyces cerivisae, Clorella, Spirulin, Archaebacteria, an lysates thereof (claim 7), an ostomy device configured to maintain a peristomal skin temperature between about 38-48oC (claim 10), and the control of the pH level of the peristomal skin area (claim 13). Forget teaches a topical composition comprising a biocompatible mixture of probiotics and nutrients for topical composition (abstract), where the composition further comprises nutrient sources in the topical ointment for improving the efficacy of the ointment (paragraph 0124). Forget et al. continues to teach the utilization of the probiotic S. cervisae in the ointment or topical composition (paragraph 0006). Forget further teaches an increase in skin temperature by the utilization of an infrared light to create a more favorable environment for the microorganisms (paragraph 0119), where the temperatures of 38-48oC could be envisaged as they are above body temperature. Last, Forget teaches ointment pH increases during treatment, where the pH may be between pH 6-7.5 (Example 13).
Therefore, it 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 combine the teachings of Desroche et al., Steinhagen et al., and Forget to make an ostomy appliance with a probiotic solution to prevent site infections because irritant contact dermatitis and other peristomal skin conditions are common complications for ostomates as taught by Steinhagen et al (abstract). One would be motivated to combine these teachings to arrive at the instant claims to utilize an ostomy appliance with a probiotic topical solution to prevent and/or treat pathogenic infections as taught by Desroche et al (paragraph 0002). There would be reasonable expectation of success, yielding no surprising results when combining the teachings of Desroche et al., Steinhagen et al., and Forget to make an ostomy appliance with a probiotic solution, since Desroche et al. teaches the utilization of topical probiotics in medical devices, such as ostomy bags, as taught above.
Conclusion
13. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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