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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al., WO2017/106911 [Tan]1.
Regarding claim 15, Tan discloses a method for making a customized ostomy baseplate, the method comprising:
via three-dimensional scanning operations, acquiring a peristomal contour map of at least part of a patient's stomal region, the peristomal contour map including raw contour map data [scanning the stoma and surrounding skin area using 3D-scanning techniques to create a point cloud of geometric samples of the stoma and surrounding skin surface, paragraphs 0016 and 0046];
generating filtered contour map data by computationally filtering the raw contour map data [using the point cloud to extrapolate the shape of the stoma and surrounding skin area, paragraphs 0016 and 0046];
generating a virtual customized ostomy template to fit the computationally filtered contour map data [converting the scan data to a stereolithography file, paragraphs 0017 and 0047];
three-dimensionally ("3D") printing and/or using laser subtraction to manufacture a customized ostomy template based on the virtual customized ostomy template [3D-printing a mold for a custom stoma insert, paragraphs 0035 and 0039]; and
applying the 3D printed customized ostomy template to an ostomy appliance to create the customized ostomy baseplate [using the 3D-printed mould to cast a custom stoma insert to be used for connecting to an ostomy bag, paragraphs 0044, 0045, 0048 and 0057].
Allowable Subject Matter
Claims 1-14 and 16-17 are allowed.
The following is an examiner’s statement of reasons for allowance:
Czaplewski et al., US Patent Application Publication no. 2024/0398606 discloses performing 3D scanning of a stoma and peristomal area and using the scan data to generate a 3D printed representation of the scanned stoma and peristomal area that is used for evaluating concepts for implementation in ostomy devices.
Wines, US Patent Application Publication no. 2024/0315865 discloses a stoma template that is used as a cutting guide for cutting ostomy skin material to match the shape of a patient stoma.
Otto, US Patent no. 6,659,989 discloses obtaining measurements of an outer contour of a patient stoma and using the measurements to two-dimensionally print a cutting guide pattern that is used to cover an ostomy wafer.
The prior art of record does not teach or suggest generating a customized ostomy, negative pressure vacuum or fistula management pouch baseplate by generating a customized template based on computationally filtered contour map data obtained by three-dimensionally scanning a patient stoma, wound or fistula and modifying an ostomy, negative pressure vacuum or fistula management pouch baseplate by using subtractive manufacturing to match the ostomy, negative pressure vacuum or fistula management pouch baseplate to the customized template.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/PAUL B YANCHUS III/Primary Examiner, Art Unit 2115 March 7, 2026
1 Tan was cited in the 4/22/24 IDS.