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Claims 8-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/7/2026.
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) 1-7 and 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharkar et al. (US 20240123134 A1, hereafter “Kharkar”) in view of Weedle (US 3931819 A).
Regarding claim 1, Kharkar discloses a fluid collection device (note that devices 100, 200, 400, 600, 700, 800, 1100, 1400, and 1700 are all substantially the same and are referenced interchangeably, para. [0130]), comprising:
a fluid impermeable barrier (890B and 890A, para. [0130]) having a first portion (890B), a second portion (890A), and a chamber (838) defined between the first portion and the second portion (figs. 8A and 8C), the first portion (890B) including an outer surface and an inner surface and defining an opening (836) sized to receive a penis therethrough (para. [0131]);
a fluid permeable body (890D) that is substantially planar (fig. 8A) and positioned at least partially within the chamber (para. [0131]); and
an attachment system (826A) secured to the outer surface of the fluid impermeable barrier (fig. 8A), the attachment system (826A) including:
one or more adhesive regions (826A, 1196A 1496A, para. [0126, 0170]) extending at least partially around the opening such that portions of the one or more adhesive regions are positioned on at least opposing sides of the opening (fig. 14A, para. [0170]), the one or more adhesive regions being configured to adhere to skin of a user (para [0100, 0170]).
However, Kharkar fails to disclose two adhesive covers removably secured to the one or more adhesive regions and positioned such that the opening is positioned between the two adhesives covers.
Weedle teaches a similar fluid collection device with two adhesive covers (26, column 3 lines 7-23) removably secured to the one or more adhesive regions and positioned such that the opening is positioned between the two adhesives covers (fig. 2, column 3 lines 7-23).
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 Kharkar and incorporate the adhesive covers of Weedle for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 2, the combination of Kharkar and Weedle discloses the device of claim 1. Kharkar discloses wherein the one or more adhesive regions with a first space (1736 in fig. 17A) positioned between a first set of terminating edges (A, annotated fig. 8A), but Kharkar fails to teach two adhesive regions and a second space is positioned between a second set of terminating edges of the two adhesive regions.
Kharkar discloses the claimed invention except for the second adhesive region, rather its adhesive region is one region that aligns with the opening/slit (fig. 17A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user.
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Regarding claim 3, the combination of Kharkar and Weedle discloses the device of claim 2. However, Kharkar fails to disclose wherein each of the two adhesive covers are substantially arc shaped.
Weedle teaches wherein each of the two adhesive covers are substantially arc shaped (fig. 2).
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 Kharkar and incorporate the adhesive covers of Weedle for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 4, the combination of Kharkar and Weedle discloses the device of claim 4. Kharkar further discloses wherein: the fluid impermeable barrier includes a proximal end region (1132), a distal end region (1134), and two side regions (side edges B, annotated fig. 11A) extending at least partially between the proximal end region and the distal end region (annotated fig. 11A); and the opening (see apertures corresponding which each layer fig. 14A) of the fluid impermeable barrier is positioned between the distal end region and the proximal region and between the two side regions (figs. 11A and 14A).
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Regarding claim 5, the combination of Kharkar and Weedle discloses the device of claim 4. Kharkar further discloses wherein the one or more adhesive regions are positioned between the opening (1124) and each of the two side portions (B). However, Kharkar fails to disclose each of the adhesive covers is at least partially positioned on the one or more adhesive regions between the opening and a different side portion of the two side portions.
Weedle teaches adhesive covers and 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 Kharkar and incorporate the adhesive covers of Weedle and align them accordingly with the adhesive region for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 6, the combination of Kharkar and Weedle discloses the device of claim 5. Kharkar discloses wherein the one or more adhesive regions (1196A) are positioned at least partially between the opening (1124) and the distal end region (1134, fig. 11A, para. [0153]).
However, Kharkar fails to teach adhesive covers.
Weedle teaches adhesive covers and 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 Kharkar and incorporate the adhesive covers of Weedle and align them accordingly with the adhesive region for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 7, the combination of Kharkar and Weedle discloses the device of claim 6. Kharkar’s adhesive region has a terminating edge (A) positioned between the opening and the distal end region (annotated fig. 8A), but fails to disclose adhesive covers.
Weedle teaches adhesive covers and 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 Kharkar and incorporate the adhesive covers of Weedle and align them accordingly with the adhesive region for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 13, the combination of Kharkar and Weedle discloses the device of claim 1. Kharkar discloses wherein the one or more adhesive (1196) is between the opening (1124) and the distal end region (1134, fig. 11A), but fails to disclose two adhesive regions.
Kharkar discloses the claimed invention except for the second adhesive region, rather its adhesive region is one region that aligns with the opening/slit (fig. 17A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user.
Regarding claim 14, the combination of Kharkar and Weedle discloses the device of claim 13 but fails to expressly disclose wherein the two adhesive covers each include a terminating edge spaced from one another between the opening and the two adhesive regions.
Kharkar’s adhesive region has a terminating edge (A) between the opening and the adhesive region, so upon duplication of the adhesive region, the terminating edges would also be duplicated because would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user.
Regarding claim 15, the combination of Kharkar and Weedle discloses the device of claim 13. Kharkar discloses wherein: at least a portion of the one or more adhesive regions (1196A) is positioned between the opening (1124) and the proximal end region (1132, fig. 11A) and also the adhesive region is positioned between the opening (1124) and the distal end region (1134, fig. 11A). However, Kharkar fails to disclose adhesive covers and a second adhesive region.
Kharkar discloses the claimed invention except for the second adhesive region, rather its adhesive region is one region that aligns with the opening/slit (fig. 17A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user.
Regarding claim 16, the combination of Kharkar and Weedle discloses the device of claim 15. However, Kharkar fails to disclose wherein each of the two adhesive covers are substantially arc shaped.
Weedle teaches wherein each of the two adhesive covers are substantially arc shaped (fig. 2).
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 Kharkar and incorporate the adhesive covers of Weedle for easy handling prior to placing the adhesive layer on the skin (column 3 lines 7-23).
Regarding claim 17, the combination of Kharkar and Weedle discloses the device of claim 1. Kharkar further discloses a tube (879) configured to provide fluid communication between the chamber and a vacuum source (para. [0137-0138]).
Regarding claim 18, the combination of Kharkar and Weedle discloses the device of claim 1. Kharkar further discloses wherein the fluid permeable body (1490D) includes a fluid permeable porous fiber structure and a wicking material (1490E) positioned to be proximate skin of the user and between the skin of the user and the fluid permeable porous fiber structure (para. [0132, 0170]).
Regarding claim 19, Kharkar discloses a method of collecting fluid, the method comprising:
positioning a penis of a user at least partially in a chamber (para. [0131]) defined by a fluid collection device (800) and through an opening (836) defined by a first portion (890B) of a fluid impermeable barrier (890B and 890C) of the fluid collection device, the fluid impermeable barrier having a second portion (890A, figs. 8A and 8C) and a chamber defined between the first portion and the second portion of the fluid impermeable barrier and the fluid collection device including a fluid permeable body (890D) that is substantially planar (fig .8A) and positioned at least partially within the chamber (para. [0131]);
removing a first adhesive cover from a first adhesive region secured to an outer surface of the first portion of the fluid impermeable barrier,
a first adhesive region (826A) extending at least partially around the opening (836) such that the first adhesive region is positioned at least partially between the opening and a first side portion (B) of the fluid impermeable barrier (annotated fig. 11A);
adhering the first adhesive region (826A) to at least one of pelvic, suprapubic, or abdominal skin of the user on a first side of the penis (fig. 3A, para. [0131]);
However, Kharkar fails to disclose:
removing a first adhesive cover from a first adhesive region secured to an outer surface of the first portion of the fluid impermeable barrier,
after adhering the first adhesive region to the at least one of pelvic, suprapubic, or abdominal skin of the user on the first side of the penis, removing a second adhesive cover from a second adhesive region secured to the outer surface of the first portion of the impermeable barrier,
the second adhesive region extending at least partially around the opening such that the second adhesive region is positioned at least partially between the opening and a second side portion of the fluid impermeable barrier opposite to the first side portion; and adhering the second adhesive region to at least one of pelvic, suprapubic, or abdominal skin of the user on a second side of the penis.
Firstly, Kharkar discloses the claimed method and invention except for the second adhesive region, rather its adhesive region is one region that aligns with the opening/slit (fig. 17A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user, and removing the adhesive cover is a necessary and inherent step in utilizing the device (column 3 lines 7-23).
Regarding claim 20, the combination of Kharkar and Weedle discloses the method of claim 19. Kharkar further discloses drawing fluid discharged in the chamber from the fluid collection device through a tube (879, para. [0137-0138]).
Regarding claim 21, the combination of Kharkar and Weedle discloses the method of claim 19. Kharkar discloses an adhesive region (1196A) secured to an outer surface of the first portion (890B) of the fluid impermeable barrier, the first adhesive region secured to the outer surface of the first portion of the fluid impermeable barrier between the opening (836) and the first side portion of the fluid impermeable barrier and also between the opening (836) and a distal end region (1134) of the fluid impermeable barrier (fig. 11A).
Firstly, Kharkar discloses the claimed method and invention except for the second adhesive region, rather its adhesive region is one region that aligns with the opening/slit (fig. 17A). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the opening/slit and repeat it on the opposite side of the arched adhesive region for increased flexibility and adjustability to better fit the user (para. [0185, 0189]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious for the adhesive covers of Weedle to correspond with the duplicated adhesive regions to adequately protect the adhesive until the device is ready to be adhered to the user, and removing the adhesive cover is a necessary and inherent step in utilizing the device (column 3 lines 7-23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 16 March 2026