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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 2 of copending Application No. 18849214 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they essentially recite the same subject matter except for the further specifying the characteristics of the convexity to be slope or compressibility. These two factors would inherently affect the convexity as they would alter the shape.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No 11833073. Although the claims at issue are not identical, they are not patentably distinct from each other. US patent 11833073 generally fulfills the limitations of the instant claims even though there is a specific recitation of using a bladder for changing the convexity, while the instant claim is broader in claim one and simply recites a convexity adjusting device, as such the species of bladder anticipates the broader genus of device.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ekfeldt et al. 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; [0011 and 0131-0132]; Abstract), comprising: a skin barrier comprising an adhesive (adhesive wafer 227 has adhesive 225; Figure 13; [0132]); an inlet opening defined in the skin barrier for receiving the stoma (through-going holes 226 receives the stoma; Figure 13; [0132]); and a convexity adjusting device (supporting device 220; [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; [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 which includes compressibility or slope (supporting device provides a localized and customized adjustment of the characteristic of the convexity; [0130]; Figure 11).
Regarding claim 2, Ekfeldt 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; [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; [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; [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; [0130]).
Regarding claim 3, Ekfeldt discloses wherein the plurality of radially extending members comprise eight radially extending members ([0131]).
Regarding claim 14, Ekfeldt discloses wherein the plurality of adjusting members are attached to an adjusting member base (or annular ring, 223) and formed as a single-piece device (fig 12), wherein the adjusting member base forms a first end of each of the plurality of adjusting members and adjacent adjusting members are connected via the adjusting member base (fig 12, [0131]).
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 is rejected under 35 U.S.C. 103 as being unpatentable over Ekfeldt et al. US 2014/0316360 A1.
Regarding claim 4, Ekfeldt fails to disclose wherein the plurality of radially extending members comprises sixteen radially extending members per claim 14.
It would have been obvious to one ordinary skill in the art to have duplicated the number of radially extending members as Ekfeldt teaches 2 and then later eight for further improved stability therefore additional duplication will only provide greater stability and more precise adjustability [0131]. (MPEP 2144.04. VI. B.)
Allowable Subject Matter
Claims 5-13 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record are:
Ekfeldt et al. US 2014/0316360 A1 discloses multiple adjustable springs to adjust the convexity but fails to teach respectively a clip that keeps the member stable for claim 5 and a tab and lip combination for holding the extending the members in place per claim 7.
Czaplewski US 11833073 B1 discloses multiple bladders to adjust the convexity locally but again fails to teach respectively a clip that keeps the member stable for claim 5 and a tab and lip combination for holding the extending the members in place per claim 7.
Leise US 20030171737 discloses a per molded convex ostomy ring to solve a similar problem of irregularities around the peristomal site but it is premolded and not adjustable.
No other prior art was found that was able to selectively adjust the convexity of the stomal ring using individually spaced adjustment a clip that keeps the member stable for claim 5 and a tab and lip combination for holding the extending the members in place per claim 7.
While clips and locking tabs are known applying them to an ostomy ring to alter the convexity regionally around the stoma as needed would not have been obvious to one ordinary skill in the art without improper hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
