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 .
Election/Restrictions
Claims 6-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species I-VII, VIV, and X, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/29/2026.
Applicant’s election without traverse of Species VIII, claims 1-5 and 22 in the reply filed on 07/29/2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 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(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ekfeldt et al. (Publication No. US 2014/0316360 A1).
Regarding claim 1, Ekfeldt discloses a convex ostomy barrier assembly for attaching an ostomy appliance to a peristomal skin surrounding a stoma (convex ostomy barrier 220 with adhesive wafer 227 is an assembly that holds an ostomy device to the peristomal skin surround a stoma; Figure 12-14; Paragraph 0011 and 0131-0132; Abstract), comprising:
a skin barrier comprising an adhesive (adhesive wafer 227 has adhesive 225; Figure 13; Paragraph 0132);
an inlet opening defined in the skin barrier for receiving the stoma (through-going holes 226 receives the stoma; Figure 13; Paragraph 0132); and
a convexity adjusting device (supporting device 220; Paragraph 0132; Figures 12-14), wherein the convexity adjusting device is configured to provide a convexity to the skin barrier and to adjust the convexity according to a topography of user's peristomal skin as the convex ostomy barrier assembly is applied to a user (device 220 provides a convexity to the adhesive wafer 227 following the shape of the user’s peristomal skin when the assembly 220/227 is applied to the user; Figure 11-14; Paragraph 0130-0132), and wherein the convexity adjusting device is configured to provide a localized and customized adjustment of at least one characteristic of the convexity (supporting device provides a localized and customized adjustment of the characteristic of the convexity; Paragraph 0130; Figure 11).
Regarding claim 2, Ekfeldt discloses the convex ostomy barrier assembly of claim 1. Ekfeldt further discloses wherein the convexity adjusting device comprises a plurality of radially extending members configured to define and support the convexity (spring members 224 extend radially and defines and supports the convexity; Figures 12-14; Paragraph 0131-0132), wherein each of the plurality of radially extending members is separated from an adjacent radially extending member by a gap (each spring member 224 is separated from an adjacent spring member 224 by a gap; Figures 12-14; Paragraph 0131-0132), wherein each of the radially extending members is configured to be flexed independently according a force applied to each of the radially extending member as the skin barrier is pressed against the user's peristomal skin (spring member 204/224 can be flexed independently according to a force applied to the spring member 204/224 when the device 220 is applied to the skin; Figure 11; Paragraph 0130-0132), and wherein each of the radially extending members is configured to provide an automatic and localized adjustment of at least one of a slope, a depth, and/or a tension location of the convexity (each spring member 204/224 has an automatic and localized adjustment of the slope, depth, and tension location of convexity, such as one spring element is flexing while the other spring element is folding when the peristomal skin is sloped unevenly; Figure 11; Paragraph 0130).
Regarding claim 3, Ekfeldt discloses the convex ostomy barrier assembly of claim 2. Ekfeldt further discloses wherein the convexity adjusting device comprises a dome (dome shape formed by spring members 224; Figure 12), a base (distal annular ring 223; Paragraph 0131; Figure 12), and a middle portion connecting the dome and the base, wherein the dome is formed by the plurality of radially extending members.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ekfeldt et al. (Publication No. US 2014/0316360 A1) in view of Czaplewski et al. (Publication No. US 2019/0231580 A1), hereby referred to as “Czaplewski ‘580”, and Czaplewski et al. (Publication No. US 2019/0254864 A1), hereby referred to as “Czaplewski ‘864”.
Regarding claim 4, Ekfeldt discloses the convex ostomy barrier assembly of claim 3. Ekfeldt does not teach wherein the convexity adjusting device has a depth of about 7mm, a slope of about 55° and comprises 12 radially extending members.
However, Czaplewski ‘580 teaches wherein the convexity adjusting device has a depth of about 7mm, a slope of about 55° (depth is about 0 mm to about 15 mm and a slope/convexity angle of about 0 to 60 degrees; Paragraph 0066; Figures 13A-13B; Claims 20-21).
Ekfeldt and Czaplewski ‘580 are considered to be analogous to the claimed invention because they are in the same field of ostomy barriers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ekfeldt to incorporate the teachings of Czaplewski ‘580 and have the convexity adjusting device of Ekfeldt to be the depth and slope of Czaplewski ‘580. This allows for the ostomy barrier to fit the convexity of the peristomal skin and adds pressure to the peristomal area for adherence, seal, and comfort (Czaplewski ’580; Paragraph 0017, 0042, and 0066).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the convexity adjusting device of Ekfeldt to have a depth of about 7mm and a slope of about 55° since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the device would not operate differently with the slope and depth and the ostomy barrier of Ekfeldt has similar components and structure resembling the claimed invention and is intended to prevent fluid from leaking and to hold the ostomy bag in place against the peristomal skin of the user. Further, applicant places no criticality on the range of the depth and slope claimed, since the applicant recites that the depth and the slope “may be” and “about” the claimed ranges (specification of instant application; Paragraph 0064-0066).
The combination of Ekfeldt in view of Czaplewski ‘580 does not teach wherein the convexity adjusting device comprises 12 radially extending members.
However, Czaplewski ‘864 teaches wherein the convexity adjusting device can comprise 2 to 50 radially extending members (Paragraph 0046).
Therefore, when there is a finite number of identified, predictable solutions, i.e. to have 2 to 50 members, and more specifically 12 members, a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, i.e. provide an ostomy barrier for the protection against leakage and to hold an ostomy bag, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance, the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103 (KSR Int' l Co. v. Teleflex Incl, 127 S. Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)). See MPEP 2143(I)(E).
The combination of Ekfeldt in view of Czaplewski ‘580 and Czaplewski ‘864 further teaches wherein the convexity adjusting device comprises 12 radially extending members (see combination above).
Regarding claim 5, Ekfeldt discloses the convex ostomy barrier assembly of claim 3. Ekfeldt does not teach wherein the convexity adjusting device has a depth of about 7mm to about 9mm, a slope of about 55° to about 62°, and comprises 16 radially extending members.
However, Czaplewski ‘580 teaches wherein the convexity adjusting device has a depth of about 7mm to about 9mm, a slope of about 55° to about 62° (depth is about 0 mm to about 15 mm and a slope/convexity angle of about 0 to 60 degrees; Paragraph 0066; Figures 13A-13B; Claims 20-21).
Ekfeldt and Czaplewski ‘580 are considered to be analogous to the claimed invention because they are in the same field of ostomy barriers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ekfeldt to incorporate the teachings of Czaplewski ‘580 and have the convexity adjusting device of Ekfeldt to be the depth and slope of Czaplewski ‘580. This allows for the ostomy barrier to fit the convexity of the peristomal skin and adds pressure to the peristomal area for adherence, seal, and comfort (Czaplewski ’580; Paragraph 0017, 0042, and 0066).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the convexity adjusting device of Ekfeldt to have a depth of about 7mm to about 9mm, a slope of about 55° to about 62° since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the device would not operate differently with the slope and depth and the ostomy barrier of Ekfeldt has similar components and structure resembling the claimed invention and is intended to prevent fluid from leaking and to hold the ostomy bag in place against the peristomal skin of the user. Further, applicant places no criticality on the range of the depth and slope claimed, since the applicant recites that the depth and the slope “may be” and “about” the claimed ranges (specification of instant application; Paragraph 0064-0066).
The combination of Ekfeldt in view of Czaplewski ‘580 does not teach wherein the convexity adjusting device comprises 16 radially extending members.
However, Czaplewski ‘864 teaches wherein the convexity adjusting device can comprise 2 to 50 radially extending members (Paragraph 0046).
Therefore, when there is a finite number of identified, predictable solutions, i.e. to have 2 to 50 members, and more specifically 16 members, a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, i.e. provide an ostomy barrier for the protection against leakage and to hold an ostomy bag, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance, the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103 (KSR Int' l Co. v. Teleflex Incl, 127 S. Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)). See MPEP 2143(I)(E).
The combination of Ekfeldt in view of Czaplewski ‘580 and Czaplewski ‘864 further teaches wherein the convexity adjusting device comprises 16 radially extending members (see combination above).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ekfeldt et al. (Publication No. US 2014/0316360 A1) in view of Czaplewski et al. (Publication No. US 2019/0231580 A1).
Regarding claim 22, Ekfeldt discloses the convex ostomy barrier assembly of claim 1. Ekfeldt does not teach wherein the convexity adjusting device is configured to provide the convexity having a depth of about 3 mm to about 15 mm, a slope of about 15° to about 80°, and a tension location at about 1 mm to about 50 mm radially spaced from the stoma.
However, Czaplewski ‘580 teaches wherein the convexity adjusting device is configured to provide the convexity having a depth of about 3 mm to about 15 mm, a slope of about 15° to about 80° (depth is about 0 mm to about 15 mm and a slope/convexity angle of about 0 to 60 degrees; Paragraph 0066; Figures 13A-13B; Claims 20-21).
Ekfeldt and Czaplewski ‘580 are considered to be analogous to the claimed invention because they are in the same field of ostomy barriers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ekfeldt to incorporate the teachings of Czaplewski ‘580 and have the convexity adjusting device of Ekfeldt to be the depth and slope of Czaplewski ‘580. This allows for the ostomy barrier to fit the convexity of the peristomal skin and adds pressure to the peristomal area for adherence, seal, and comfort (Czaplewski ’580; Paragraph 0017, 0042, and 0066).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the convexity adjusting device of Ekfeldt to have a depth of about 3 mm to about 15 mm, a slope of about 15° to about 80° since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the device would not operate differently with the slope and depth and the ostomy barrier of Ekfeldt has similar components and structure resembling the claimed invention and is intended to prevent fluid from leaking and to hold the ostomy bag in place against the peristomal skin of the user. Further, applicant places no criticality on the range of the depth and slope claimed, since the applicant recites that the depth and the slope “may be” and “about” the claimed ranges (specification of instant application; Paragraph 0064-0066, 0077, 0080, and 0082).
The combination of Ekfeldt in view of Czaplewski ‘580 does not teach a tension location at about 1 mm to about 50 mm radially spaced from the stoma.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a tension location at about 1 mm to about 50 mm radially spaced from the stoma since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the device would not operate differently with the tension location range and the device of Ekfeldt in view of Czaplewski ‘580 has similar components and structure resembling the claimed invention and is intended to prevent fluid from leaking and to hold the ostomy bag in place against the peristomal skin of the user. Further, applicant places no criticality on the range of the tension location claimed, since the applicant recites that the tension location may be “about” the claimed ranges (specification of instant application; Paragraph 0077, 0080, and 0082).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
Prosecution Insights