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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/21/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 04/21/2026 has been fully considered. Claims 1-14, 19, and 26-29 are pending. Claims 1, 26, and 28 are amended. Claims 15-18, 20-25, and 30-32 are cancelled.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1 and 26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the amendment to independent claims 1 and 26 now require the adhesive arms mounted on the ring, wherein the ring is movable with the arms on the fluid impermeable barrier, which further limits the scope of the claimed invention. The independent claims 1 and 26 is now rejected with the U.S.C. 103 prior art combination rejection of Davis in view of Brenikov (see rejection of claim 1 and 26 below). Davis teaches the fluid collection device but does not teach a ring that is moveable along the fluid impermeable barrier. However, Brenikov teaches a portion 3/ring that is used to adjustably hold a tube (Figure 1; Abstract; Claim 1). Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical device attachments. Brenikov further addresses the solution to the pertinent problem faced by the inventor in this instant application, which is to adjustably place the ring of the adhesive attachment along the length of the device/tube for holding the device/tube in place (Brenikov; Claim 1 and 9; Page 3, lines 14-25 and Page 5, lines 6-14; specification of instant application; Paragraphs 0060-0061). 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 Davis to incorporate the teachings of Brenikov and have the attachment device of Brenikov be sized to fit around the fluid impermeable barrier of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to be adjustably attached onto the tube (Brenikov; Claim 1 and 9; Page 3, lines 14-25 and Page 5, lines 6-14), prevent any movement between the tubular structure and the user during use (Brenikov; Page 1, lines 18-21, and preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6).
Though some of the same prior art reference is re-used herein, amended claims 1 and 26 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection.
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.
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) 1-14, 19, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1) in view of Brenikov (Publication No. GB 2507318 A).
Regarding claim 1, Davis teaches a fluid collection device (device 10; Figure 1-7 is the first embodiment; Paragraph 0052 and 0086), comprising:
a fluid impermeable barrier that is generally cylindrical and at least partially defines a chamber (covering 20 is a fluid impermeable barrier and defines a chamber within it; Paragraph 0052; Figure 1), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned at least proximate to a urethra of a user (fenestration 30 is aligned to user’s urethral opening to collect urine; Figure 1; Paragraph 0052), and an aperture configured to receive a conduit therethrough (open first end 33 to receive tube 32; Figure 1 and 4; Paragraph 0060);
a fluid permeable body positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening (outer collection layer 40 is a fluid permeable material that extends across fenestration 30 to wick fluid away from user; Paragraph 0056-0057; Figure 7); and
one or more arms including an adhesive surface oriented towards the fluid impermeable barrier (anchor 50 has two arms and an adhesive surface that faces towards the covering 20 of the device to be secured to the device 10; Paragraph 0091 and Figure 6), wherein the one or more arms are positioned to attach to at least one of an abdominal region, a pubic region, or a pelvic region of the user when the opening of the fluid impermeable barrier is positioned at least proximate to the urethra of the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061). Davis does not teach a ring movable on the fluid impermeable barrier and configured to friction fit around the fluid impermeable barrier that is generally cylindrical; the one or more arms being secured to the ring and moveable with the ring on the fluid impermeable barrier, with the ring being configured to enable a user or a caregiver to position the ring and the one or more arms on the fluid impermeable barrier in a position on the fluid impermeable barrier selected by the user or the caregiver.
However, Brenikov teaches a ring movable on the fluid impermeable barrier and configured to friction fit around the fluid impermeable barrier that is generally cylindrical (tube receiving portion 3 that is moveable on a tube and configured to friction fit around the tube that is cylindrical; Figure 1; Page 3, lines 14-25 and Page 5, lines 6-14; Claim 1); the one or more arms being secured to the ring and moveable with the ring on the fluid impermeable barrier (base 2 with adhesive is attached/molded to tube receiving portion 3 and moveable with portion 3 on the tube; Figure 1; Page 5, lines 6-14; Claim 1; Abstract), with the ring being configured to enable a user or a caregiver to position the ring and the one or more arms on the fluid impermeable barrier in a position on the fluid impermeable barrier selected by the user or the caregiver (portion 3 is configured to allow for the user to position the portion 3 and base 2 on the tube; Page 5, lines 6-14; Figure 1; Claim 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical device attachments. 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 Davis to incorporate the teachings of Brenikov and have the attachment device of Brenikov be sized to fit around the fluid impermeable barrier of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to be adjustably attached onto the tube (Brenikov; Claim 1 and 9; Page 3, lines 14-25 and Page 5, lines 6-14), prevent any movement between the tubular structure and the user during use (Brenikov; Page 1, lines 18-21, and preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6).
Regarding claim 2, Davis in view of Brenikov teaches the device of claim 1. Davis further teaches wherein the one or more arms include two arms aligned laterally (wings of anchor 50 are aligned laterally; Figure 1-7; Paragraph 0086).
Regarding claim 3, Davis in view of Brenikov teaches the device of claim 2. Davis further teaches wherein the two arms are connected to one another (wings of anchor 50 are connected to one another; Paragraph 0086; Figure 1-7).
Regarding claim 4, Davis in view of Brenikov teaches the device of claim 2. The embodiment of Davis in Figures 1-7 does not teach wherein each of the two arms include a width of at least about 2.5 cm.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms include a width of at least about 2.5 cm (second to fourth sizes of the anchor has an anchor 50 with each arm having a width that ranges from approximately 2 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis in view of Brenikov to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 5, Davis in view of Brenikov teaches the device of claim 2. The embodiment of Davis in Figures 1-7 does not teach wherein each of the two arms include a width of at least about 5.1 cm.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms include a width of at least about 2.5 cm (third to fourth sizes of the anchor has an anchor 50 with each arm having a width that ranges from approximately 6 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis in view of Brenikov to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 6, Davis in view of Brenikov teaches the device of claim 4. The combination of Davis in view of Brenikov further teaches wherein the width of each of the two arms tapers towards the fluid collection device or the conduit (Davis; Figure 23A-B; Paragraph 0086; see rejection of claim 4 above).
Regarding claim 7, Davis in view of Brenikov teaches the device of claim 2. Davis further teaches wherein each of the two arms includes a non-adhesive surface opposite to the adhesive surface (adhesive surface is only on side that attaches to skin of user; Paragraph 0088 and 0090).
Regarding claim 8, Davis in view of Brenikov teaches the device of claim 7. Davis further teaches further comprising a removable cover on the adhesive surface of each of the two arms (Paragraph 0088).
Regarding claim 9, Davis in view of Brenikov teaches the device of claim 2. Davis further teaches wherein the two arms are detachably secured or securable to the fluid impermeable barrier in a position selected by the user or the caregiver (Paragraph 0091-0092).
Regarding claim 10, Davis in view of Brenikov teaches the device of claim 9. The embodiment of Figures 1-7 of Davis does not teach wherein each of the two arms extend at least about 2.5 cm from the fluid impermeable barrier.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 2.5 cm from the fluid impermeable barrier (second to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the cover 20/fluid impermeable barrier of the device 10 that ranges from approximately 2 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis in view of Brenikov to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 11, Davis in view of Brenikov teaches the device of claim 9. The embodiment of Figures 1-7 of Davis does not teach wherein each of the two arms extend at least about 5.1 cm from the fluid impermeable barrier.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 5.1 cm from the fluid impermeable barrier (third to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the cover 20/fluid impermeable barrier of the device 10 that ranges from approximately 6 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis in view of Brenikov to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 12, Davis in view of Brenikov teaches the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 7.6 cm from the aperture on the fluid impermeable barrier.
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 the two arms of Davis to be positioned less than about 7.6 cm from the aperture on the fluid impermeable barrier 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 arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis in view of Brenikov has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 13, Davis in view of Brenikov teaches the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 5.1 cm from the aperture on the fluid impermeable barrier.
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 the two arms of Davis to be positioned less than about 5.1 cm from the aperture on the fluid impermeable barrier 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 arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis in view of Brenikov has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 14, Davis in view of Brenikov teaches the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 2.5 cm from the aperture on the fluid impermeable barrier.
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 the two arms of Davis to be positioned less than about 2.5 cm from the aperture on the fluid impermeable barrier 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 arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis in view of Brenikov has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 19, Davis in view of Brenikov teaches the device of claim 2. Davis further teaches further comprising the conduit extending through the aperture such that a first portion of the conduit is disposed within the chamber and a second portion of the conduit is disposed outside the chamber (conduit 32 extends through open first end 22 – where first portion of conduit 32 is inside of the chamber of device 10 and second portion of conduit 32 is outside of first end 22 of device 10; Figure 4, Paragraph 0091-0092).
Regarding claim 26, Davis teaches a method of collecting fluids from a user (Abstract; Paragraph 0052), the method comprising:
positioning a fluid permeable body of a fluid collection device to cover a urethra of a user (fenestration 30 is aligned to user’s urethral opening to collect urine – device 10 has outer collection layer 40 that is a permeable material that extends across fenestration to wick fluid away from user; Figure 1 and 7; Paragraph 0052 and 0056-0057), the fluid collection device having a fluid impermeable barrier that is generally cylindrical and at least partially defines a chamber (covering 20 is a fluid impermeable barrier and defines a chamber within it; Paragraph 0052; Figure 1) having the fluid permeable body positioned at least partially therein (outer collection layer 40 is a fluid permeable material within the covering 20 that extends across fenestration 30 to wick fluid away from user; Paragraph 0056-0057; Figure 7), an opening extending longitudinally along the fluid impermeable barrier and positioned at least proximate to a urethra of a user (fenestration 30 is aligned to user’s urethral opening to collect urine; Figure 1; Paragraph 0052), and an aperture having a conduit extending therethrough (open first end 33 to receive tube 32; Figure 1 and 4; Paragraph 0060);
applying one or more adhesive arms to at least one of a pubic region, a pelvic region, or an abdominal region of the user effective to secure the fluid collection device to the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061); and
receiving fluids discharged from the urethra into a chamber of the fluid collection device (covering 20 of device 10 forms a chamber for urine collection; Figure 1; Paragraph 0052). Davis does not teach the one or more adhesive arms being secured to a ring detachably secured with a friction fit to the fluid impermeable barrier of the fluid collection device in a position selected by the user or a caregiver, the ring being movable with the one or more arms on the fluid impermeable barrier.
However, Brenikov teaches the one or more adhesive arms being secured to a ring (base 2 with adhesive is attached/molded to tube receiving portion 3 and moveable with portion 3 on the tube; Figure 1; Page 3, lines 14-25 and Page 5, lines 6-14; Claim 1; Abstract) detachably secured with a friction fit to the fluid impermeable barrier of the fluid collection device in a position selected by the user or a caregiver (portion 3 is configured to allow for the user to position the portion 3 and base 2 on the tube; Page 5, lines 6-14; Figure 1; Claim 1), the ring being movable with the one or more arms on the fluid impermeable barrier (tube receiving portion 3 that is moveable on a tube and configured to friction fit around the tube that is cylindrical; Figure 1; Page 5, lines 6-14; Claim 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical device attachments. 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 Davis to incorporate the teachings of Brenikov and have the attachment device of Brenikov be sized to fit around the fluid impermeable barrier of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to be adjustably attached onto the tube (Brenikov; Claim 1 and 9; Page 3, lines 14-25 and Page 5, lines 6-14), prevent any movement between the tubular structure and the user during use (Brenikov; Page 1, lines 18-21, and preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6).
Regarding claim 27, Davis in view of Brenikov teaches the method of claim 26. The combination of Davis in view of Brenikov further teaches wherein applying one or more adhesive arms to at least one of a pubic region, a pelvic region, or an abdominal region of the user effective to secure the fluid collection device to the user includes applying the one or more adhesive arms to the pelvic region of the user (Davis; anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061), the one or more adhesive arms being secured to the fluid impermeable barrier distal to an opening in the fluid impermeable barrier through which the fluids are collected from the urethra (anchor of Davis is secured to ring of Brenikov that is on the fluid impermeable barrier of Davis distal to the opening where the fluids are collected from the urethra of the device of Davis; see rejection of claim 26 above). Regarding claim 28, Davis in view of Brenikov teaches the method of claim 27. The combination of Davis in view of Brenikov further comprising moving the ring and the one or more adhesive arms to a selected location on the fluid impermeable barrier (ring 3 of Brenikov with arm of Davis is moveable on the fluid impermeable barrier of Davis; see rejection of claim 26 above).
Regarding claim 29, Davis in view of Brenikov teaches the method of claim 28. The combination of Davis in view of Brenikov further comprising wherein securing the one or more arms to the fluid impermeable barrier includes friction fitting the ring on the fluid impermeable barrier that is generally cylindrical (Brenikov; tube receiving portion 3 that is moveable on a tube and configured to friction fit around the tube that is cylindrical; Figure 1; Page 3, lines 14-25 and Page 5, lines 6-14; Claim 1), the one or more arms being secured to the ring (arms of Davis is secured to ring of Brenikov; see rejection of claim 26 above).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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