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 .
Applicants' arguments, filed January 9, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (New Rejections)
1) Claims 1, 3-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 106176287) in view of Curutcharry (FR 2479002).
Li et al. disclose a stoma special skin powder and preparation method and application thereof, composed of gum karaya, chitosan and guar gum. The weight ratio is: karaya 10 %-60 %, chitosan 5 %-40 % and guar gum 5 %-45 %. The powder uses medical grade absorbent polymer materials, has a grain size ranging from 5-20 microns, good dispersibility, easy spraying; and at the same time, has good absorption capacity and can often keep the skin dry around the stoma (Abstract).
The powders are used for ostomy patients to absorb exudates and to keep skin dry. The powders are so there are no leaks that lead to pain and inflammation. This would meet the limitation of identifying a stoma and one or more of a leak that originate from the stoma.
Li et al. differ from the instant claims insofar as it does not disclose bentonite.
Curutcharry disclose a composition comprising at least one pressure sensitive adhesive, at least one hydrocolloid and optionally a reinforcing substance containing at least one hydrated aluminum silicate. The preferred silicate is a bentonite or a montmorillonite. The amount of silicate is 15-50%. The adhesive is used in stoma and fistula and used on strips on the abdominal wall. The replacement of part of the hydrocolloid/adhesive by the silicate reduces the cost, and makes the adhesive more flexible and resistance to putrescence (Abstract). Hydrocolloids include guar gum. The hydrocolloid may comprise 20 to 35% by weight of the adhesive gum. The silicate reinforces adhesion in the presence of moisture.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added bentonite to the composition of Li et al. motivated by the desire to add an absorbent that reinforces adhesion in the presence of moisture, such as exudate from the stoma. This would lead to the absorption of exudate and help maintain the powder to the site for a longer period of time.
The powder absorbs the exudate and therefore would prevent the flow of the leak.
In regards to claims 3 and 12, the silicate may be used in an amount from 15 to 50% and guar gum may be used in an amount of 5 to 45%. Therefore it would have been obvious to have used bentonite in a higher amount than guar gum. Further the bentonite and guar gum are result effective variables and affect the adhesiveness of the composition. Therefore it would have taken no more than the relative skill of one of ordinary skill in the art through routine experimentation to have adjusted the amount of guar gum and bentonite to achieve the desired adhesiveness. See MPEP 2144.05.
In regards to claim 4, the components of the composition are added together to form a powder and the powder is applied to the site. Therefore this would meet the limitation of instant claim 4.
In regards to applying the adhesive at different intervals, the composition is to be applied to the stoma site. It would have been obvious to one of ordinary skill in the art to check the integrity of the powder at different intervals and apply the powder as needed to areas of possible leakage or leakage to insure that any leakage from the bag to the skin was absorbed.
In regards to one or more patients, the powders are used for ostomy patients in general and therefore encompass more than one patient.
2) Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 106176287) in view of Curutcharry (FR 2479002) in further view of Bluhm (US 4083965).
Li et al. in view of Curutcharry is discussed above and differs from the instant claims insofar as it does not disclose arrowroot powder.
Bluhm discloses a topical composition for relieving itch, pain, and swelling comprises at least either arrowroot, a calcium phosphate or a combination of both, as an active absorbent ingredient and a carrier suitable for topical application to human skin. It is believed that the active absorbent ingredient operates to draw the acids, mucoids, poisons, and debris from the site or area of skin contacted. These acids, mucoids, poisons, and debris are then absorbed, neutralized and diluted in the composition and are later rinsed away with the composition.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added arrowroot powder as an absorbent to the powder composition of Li et al. and Curutcharry to stop leakage from a stoma because leakage of stool from the stoma causes irritation and pain, and arrowroot powder helps relieve itch and pain caused by irritants on the skin, as disclosed by Bluhm.
In regards to assigning a ratio, it would have been obvious to determine the amount of each component of bentonite and arrowroot powder motivated by the desire to get the desired therapeutic effect of relieving or preventing pain due to leakage.
Response to Declaration
The Examiner has considered the Declaration by Jasmine Rowan Sturr. Due to the amendments, new rejections have been set forth. Declarant asserts that the stoma of the instant claims refer to a feeding tube. However the claims recite stoma in general. Therefore the claims encompass a colostomy stoma.
Conclusion
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.
Claims 1-14 are rejected.
Claims 15-20 are withdrawn.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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