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Claims 79-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/23/2026. Applicant traversed the restriction stating that claims 90-95 are dependent on claim 76, and that should be included in Group I. Applicant’s assertion is correct and as such, claims 90-95 will be examined on the merits along with claims 76-78.
Response to Amendment
The amendment filed 2/23/2026 has been entered: Claims 76-95 remain pending in the present application. Claims 76-78 and 90-95 are examined on the merits.
Claim Rejections - 35 USC § 103
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 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.
Claims 76-78 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund (US 2019/0247222 A1), in view of Kendrick et al. (US 2021/0022908 A1).
Regarding claim 76, Ecklund teaches a urine collection device (Figs. 10A and 16A; Abstract), comprising:
a collection member extending from a proximal end to a distal end (collection member 1012, 1600), wherein the proximal end comprises an opening that provides access to an internal cavity of the collection member (¶s 155, 167, 184; aperture 1624), wherein the internal cavity comprises a first chamber in fluid communication with a second chamber (Fig. 10A shows how the walls create chambers 1038A and 1038B);
a spacer in the second chamber (spacer 1094 and 1694);
a first attachment member extending from a top wall of the collection member at the
proximal end (1096A, 1696A) wherein the first attachment member defines an aperture (attachment member 1626A is round and defines an opening; Fig. 10A shows how the opening and overlayed);
a second attachment member extending from a top wall of the collection member at
the proximal end (1096B and 1626B); and
an outlet for egressing urine from the internal cavity of the collection member, wherein the collection member is suitable to (i) direct urine from the first chamber to the second chamber and (ii) direct urine in the second chamber distally toward the outlet (outlet 1030, 1630 and port 1078; ¶s 155 and 192).
Ecklund does not explicitly teach a plurality of seams on opposing sides of the opening at the proximal end.
Kendrick teaches a urine collection bag (Fig. 1, collection bag 100; Abstract), thus being in the same field of endeavor, comprising a collection member (collection bag 100) wherein the proximal end comprises an opening that provides access to an internal cavity of the collection member (elongated portion 126 and opening 124) wherein the collection member comprises a plurality of seams on opposing sides of the opening at the proximal end (welds 140).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ecklund to comprise a plurality of seams on opposing sides of the opening, as taught by Kendrick. Doing so would be advantageous in creating a tapered profile for an increasingly tight fit with a user (¶ 108 of Kendrick).
Regarding claim 77, Kendrick further teaches the plurality of seams extend inwardly from a respective lateral edge of the collection member towards a middle portion of the collection member, and wherein the opening is at the middle portion between the plurality of seams (Fig. 1 of Kendrick shows how the welds 140 extend inwardly from lateral edges of the elongated portion 126, and having an opening between said welds allowing access into the bag).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ecklund to comprise a plurality of seams on opposing sides of the opening, as taught by Kendrick. Doing so with thus comprise the plurality of seams extend inwardly from a respective lateral edge of the collection member towards a middle portion of the collection member, and wherein the opening is at the middle portion between the plurality of seams . Doing so would be advantageous in creating a tapered profile for an increasingly tight fit with a user (¶ 108 of Kendrick).
Regarding claim 78, Ecklund further teaches the collection member comprises a first sheet of material coupled to a second sheet of material (top wall 1090A, 1690A and bottom wall 1090B, 1690B; ¶s 155-156 and 183).
Ecklund does not explicitly teach the first sheet of material is coupled to the second sheet of material at the plurality of seams.
Kendrick also teaches the collection member comprises a first and second sheet of material (first external layer 128 and second external layer 130) sealed together by welding (¶ 94) and wherein the first sheet of material is coupled to the second sheet of material at the plurality of seams (¶s 40 and 108 indicates welds 140 being between said first and second layers).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ecklund to comprise a plurality of seams on opposing sides of the opening, as taught by Kendrick. Doing so with thus comprise the first sheet of material is coupled to the second sheet of material at the plurality of seams. Doing so would be advantageous in creating a tapered profile for an increasingly tight fit with a user (¶ 108 of Kendrick).
Regarding claim 90, Ecklund further teaches the opening at the proximal end of the collection member has a central axis that is transverse to a center axis of the aperture defined by the first attachment member (the opening 1624 is directed in a transverse direction to the opening within the ring adhesive attachment member 1626A; also see Fig. 16C).
Claims 91-94 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund and Kendrick as applied to claim 76 above, and further in view of Martin (US 2026/0083584 A1).
Regarding claim 91, Ecklund further teaches wherein the outlet comprises a port (port 1078; Fig. 16A shows analogous construction).
Ecklund does not explicitly teach wherein the port is rotatable relative to the collection member.
Martin discloses a wearable fluid collection system (Figs. 2A-2B; Abstract) comprising a chamber (sump 204) and a rotatable port (outlet 216 and elements 226 and 228).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet port of Ecklund and Kendrick to be rotatable relative to the collection member, as taught by Martin. Doing so would be advantageous facilitating orientation of the outlet (e.g. for comfort or convenience when coupling to a conduit 230; ¶ 39).
Regarding claim 92, Martin further discloses a joint that is configured to allow a port to rotate about an axis relative to the collection member (outlet 216, conduit 230 and elements 226 and 228, where fluid outlet 216 and stationary element 226 comprise the port, and where stationary element 226 and rotating element 228 fit together to form a joint; ¶s 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the outlet port of Ecklund, Kendrick, and Martin to comprise the joint configured to allow the port to rotate about an axis relative to the collection member, as taught by Martin. Doing so would be advantageous facilitating orientation of the outlet (e.g. for comfort or convenience when coupling to a conduit 230; ¶ 39).
Regarding claims 93 and 94, the combination of Ecklund, Kendrick, and Martin does not explicitly disclose (claim 93) the port is rotatable by more than 360 degrees relative to the collection member, or (claim 94) wherein the port is limited to a range of rotation that is less than 360 degrees relative to the collection member.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Ecklund, Kendrick, and Martin to have made (claim 93) the port rotatable by more than 360 degrees relative to the collection member, or (claim 94) wherein the port is limited to a range of rotation that is less than 360 degrees relative to the collection member 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). In the instant case, the device of Ecklund, Kendrick, and Martin would not operate differently with the claimed rotation angles. Further, applicant places no criticality on the range claimed as Applicant indicates either configuration is suitable (i.e. more than 360 degrees or less than 360 degrees, which covers all possible configurations of rotation with the exception of exactly 360 degrees; ¶ 76 of Applicant’s specification).
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Ecklund, Kendrick, and Martin as applied to claim 91 above, and further in view of Perrenoud et al. (US 2016/0361488 A1).
Regarding claim 95, Ecklund, Kendrick, and Martin does not explicitly disclose the port being rotatable about a longitudinal axis of the port.
In addressing the same problem as Applicant, the problem being the rotation of port and tubing connections, Perrenoud teaches a port connection device (Figs. 1 and 6; Abstract), comprising a port that is rotatable about a longitudinal axis of the port (Fig. 6 shows how outlet 102 is rotatable about the axis; ¶ 96).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Ecklund, Kendrick, and Martin to be rotatable about a longitudinal axis of the port, as taught by Perrenoud. Doing so would be advantageous in preventing accidental disconnections and preventing torquing of elements connected to the port (¶s 78 and 97 of Perrenoud).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E 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.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781
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