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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/23/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 03/23/2026 has been fully considered. Claims 1-18, 20-21, 23-26, 30-37, and 40-47 are pending. Claim 17 is amended. Claims 1-16, 23, 26, and 30-37 has been withdrawn. Claims 19, 22, 27-29, and 38-39 are cancelled. Claims 46-47 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claim(s) 17 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.
Though some of the same prior art reference is re-used herein, amended claim 17 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection. More specifically, the amended claim limitation “…the fluid permeable body exhibiting substantially no absorption…” changes the scope of the claimed invention.
The newly added claims 46-47 will be addressed in the rejection below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17, 24, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Block (Patent No. US 5,632,736 A) in view of Newton (Publication No. US 2018/0049910 A1).
Regarding claim 17, Block teaches a fluid collection device (urine voiding apparatus 220; Figure 9; Abstract; Column 6, lines 25-30), comprising: a fluid impermeable barrier having a concave inner surface at least partially defining a chamber (container 22/222 is made of fluid impermeable plastic, rubber, or latex and is concaved to define a reservoir 30, Figure 2 and 9, Column 3, lines 20-22 and Column 3, lines 39-43, Column 6, lines 25-30), a first end region defining an aperture extending therethrough and including a first outer surface portion (see annotated Figure 9 below), and a second end region distal to the first end region (see annotated Figure 9 below), the fluid impermeable barrier also defining an opening to the chamber (container 222 has an opening with sides 238/240/244/246 that opens to the reservoir; Figure 9), the opening extending longitudinally along the chamber (Figure 9), wherein a perimeter of the opening defines an oblong shape (sides 238/240/244/246 is the perimeter that is an oblong shape; Figure 9; Column 6, lines 29-38), wherein the oblong shape has a first width proximate the first end region and a second width greater than the first width proximate the second end region (second width of second end region is greater than first with of the first end region; annotated Figure 9 below), wherein the concave inner surface is configured to curve around a wearer's pubic area where the fluid impermeable barrier extends from proximate the wearer's pubic bone to proximate the wearer's perineum when the fluid collection device is placed in contact with the wearer (top end of container is aligned with mons Veneris, which overlies the pubic bone, and bottom end is proximate to the perineum when container 222 is attached to the user and curves with the shape of the user; Column 6, lines 29-38; annotated Figure 9 below); a liner disposed along an entirety of the perimeter of the opening (resilient material 226 is disposed around the entirety of the perimeter; Figure 9; Column 6, lines 38-44). Block does not teach a fluid permeable body disposed within the chamber adjacent to the concave inner surface and spaced apart from the wearer's urethra when the fluid collection device is placed in contact with the wearer, the fluid permeable body disposed adjacent to substantially all of the concave inner surface.
However, Newton teaches a fluid permeable body disposed within the chamber adjacent to the concave inner surface and spaced apart from the wearer's urethra when the fluid collection device is placed in contact with the wearer (porous material 12 made of polyester is within the volume of the device 10 along the concave inner surface and is spaced apart from the wearer’s urethra when device is worn by user; Paragraph 0009-0012; Figure 2), the fluid permeable body disposed adjacent to substantially all of the concave inner surface (porous material 12 is adjacent to substantially all of the concave inner surface; Figure 2; Paragraph 0009-0013), the fluid permeable body exhibiting substantially no absorption (polyester porous material is not water absorbent; Paragraph 0013; Figure 2).
Block and Newton are considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block to incorporate the teachings of Newton to have the fluid permeable body of Newton in the chamber and adjacent to the concave inner surface of Block. This would allow for the urine to be wicked away from the user and towards the receiving tube 22 when vacuum is applied (Newton; Paragraph 0009-0013).
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Annotated Figure 9
Regarding claim 24, Block in view of Newton teaches the device of claim 17. Block further teaches wherein the liner comprises a hydrophobic material (resilient material 26/226 made of non-absorbent material such as rubber or plastic, obvious that non-absorbent material is hydrophobic; Column 4, lines 32-36).
Regarding claim 40, Block in view of Newton teaches the device of claim 17. Block further teaches wherein the oblong shape comprises a rounded teardrop shape or pear-like shape (rounded tear-drop shape with a pointed first end region and a rounded second end region; Figure 9).
Furthermore, the shape of the perimeter of the opening of the urinary collection device is a matter of choice which a person of ordinary skill in the art would have found obvious as there is no evidence that the rounded teardrop or pear-like shape is significant to the functioning of the opening of the device, i.e., the perimeter of the opening of the device can be a variety of shapes and perform the same function. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the perimeter of Block in view of Newton to have a pear-like shape, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (MPEP 2144.04 (IV)(B)).
Regarding claim 41, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton further teaches wherein a portion of the concave inner surface proximal to the aperture and the fluid permeable body define a reservoir (concave inner surface of Block and fluid permeable body of Block that is proximal to the aperture forms a volume/reservoir for urine to travel to for storage and draining; see rejection of claim 17 above).
Claim(s) 18, 20-21, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Block (Patent No. US 5,632,736 A) in view of Newton (Publication No. US 2018/0049910 A1), as applied to claim 17, and further in view of Davis et al. (Publication No. US 2018/0228642 A1) and Greener (Publication No. US 2011/0319804 A1).
Regarding claim 18, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton does not teach wherein the fluid permeable body comprises a plurality of blocks, wherein individual ones of the plurality of blocks are configured to be selectively removed to accommodate the wearer's anatomy.
However, Davis teaches that a collection layer 40 is made of a polyurethane foam having open cell that is high density, thus not water absorbent (Paragraph 0057; Figures 9A-9C).
Block in view of Newton and Davis are considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Davis to have the fluid permeable body of Block in view of Newton be made of a polyurethane open cell foam with high density, as taught by Davis. This would allow for the enhanced moisture wicking of urine away from the user (Davis; Paragraph 0057). The combination of Block in view of Newton and Davis does not teach wherein the fluid permeable body comprises a plurality of blocks, wherein individual ones of the plurality of blocks are configured to be selectively removed to accommodate the wearer's anatomy.
However, Greener teaches wherein the fluid permeable body comprises a plurality of blocks (body 10 has cubic portions 12; Figure 1; Paragraph 0073-0076), wherein individual ones of the plurality of blocks are configured to be selectively removed to accommodate the wearer's anatomy (portions 12 can be removed by hand to shape the body 10 to fit the patient; Paragraph 0076; Figure 1).
Block in view of Newton and Davis and Greener are considered to be analogous to the claimed invention because they are in the same field of fluid absorbents. 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 Block in view of Newton and Davis to incorporate the teachings of Greener to have the fluid permeable body made of high density open cell polyurethane foam of Block in view of Newton and Davis to be formed of frangible plurality of blocks, as taught by Greener, and fits the volume of the chamber of Block in view of Newton and Davis. This would allow for the body to be sized to fit the desired volume while retaining its structural integrity (Greener; Paragraph 0076 and 0078).
Regarding claim 20, Block in view of Newton, Davis, and Greener teaches the device of claim 18. The combination of Block in view of Newton, Davis, and Greener further teaches wherein the plurality of blocks comprise an open cell foam (Davis; collection layer 40 is made of a polyurethane foam having open cell that is high density; Paragraph 0057; Figures 9A-9C).
Regarding claim 21, Block in view of Newton, Davis, and Greener teaches the device of claim 20. The combination of Block in view of Newton, Davis, and Greener further teaches wherein the open cell foam includes polyurethane (Davis; collection layer 40 is made of a polyurethane foam having open cell that is high density; Paragraph 0057; Figures 9A-9C).
Regarding claim 45, Block in view of Newton, Davis, and Greener teaches the device of claim 18. The combination of Block in view of Newton, Davis, and Greener further teaches wherein the plurality of blocks are configured to increase a volume of unoccupied space in the chamber when selectively removed (when blocks 12 of Greener are removed, the volume of unoccupied space in the chamber of Block increases; see rejection of claim 18 above).
Regarding claim 46, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton does not each wherein the fluid permeable body occupies substantially all of a volume of the chamber.
However, Davis teaches that a collection layer 40 is made of a polyurethane foam having open cell that is high density, thus not water absorbent (Paragraph 0057; Figures 9A-9C).
Block in view of Newton and Davis are considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Davis to have the fluid permeable body of Block in view of Newton be made of a polyurethane open cell foam with high density, as taught by Davis. This would allow for the enhanced moisture wicking of urine away from the user (Davis; Paragraph 0057). The combination of Block in view of Newton and Davis does not teach wherein the fluid permeable body occupies substantially all of a volume of the chamber.
However, Greener teaches wherein the fluid permeable body comprises a plurality of blocks (body 10 has cubic portions 12; Figure 1; Paragraph 0073-0076), wherein individual ones of the plurality of blocks are configured to be selectively removed to accommodate the wearer's anatomy (portions 12 can be removed by hand to shape the body 10 to fit the patient; Paragraph 0076; Figure 1).
Block in view of Newton and Davis and Greener are considered to be analogous to the claimed invention because they are in the same field of fluid absorbents. 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 Block in view of Newton and Davis to incorporate the teachings of Greener to have the fluid permeable body made of high density open cell polyurethane foam of Block in view of Newton and Davis to be formed of frangible plurality of blocks, as taught by Greener, and fits the volume of the chamber of Block in view of Newton and Davis. This would allow for the body to be sized to fit the desired volume while retaining its structural integrity (Greener; Paragraph 0076 and 0078). The combination of Block in view of Newton, Davis, and Greener further teaches wherein the fluid permeable body occupies substantially all of a volume of the chamber (blocks 12 of Greener occupy a volume of the chamber of Block; see combination above).
Regarding claim 47, Block in view of Newton, Davis, and Greener teaches the device of claim 18. The combination of Block in view of Newton, Davis, and Greener further teaches wherein the fluid impermeable barrier is configured to maintain a volume of the chamber unchanged when one or more of the plurality of blocks are selectively removed (fluid impermeable barrier of Block maintains a volume of the chamber that is unchanged when blocks 12 of Greener is removed; see rejection of claim 18 above).
Claim(s) 25 and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Block (Patent No. US 5,632,736 A) in view of Newton (Publication No. US 2018/0049910 A1), as applied to claim 17, and further in view of Conkling et al. (Patent No. US 5,002,541 A).
Regarding claim 25, Block in view of Newton teaches the fluid collection device of 17. The combination of Block in view of Newton teaches wherein the liner comprises a foam (Block; Column 4, lines 28-33). The combination of Block in view of Newton does not teach wherein the liner comprises an open cell foam.
However, Conkling teaches wherein the liner comprises an open cell foam (pad 166 is made of open-cell foam and is a ring on opening of device; Figure 13; Column 7, lines 1-32).
Conkling and Block in view of Newton are both considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Conkling to have the liner of Block in view of Newton to be an open-cell foam, as taught by Conkling. This would allow for the device to be air permeable and suction reducing at its opening while preventing the leaking of urine and providing user comfort (Conkling; Column 7, lines 1-32). Since the prior art of Conkling recognizes the equivalency of having a foam liner made from the material of open-celled foam in the field of external urinary collection devices, it would have been obvious to a person having ordinary skill in the art to substitute the foam of Block in view of Newton with the open-celled foam of Conkling since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claim 43, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton teaches wherein the liner comprises a foam (Block; Column 4, lines 28-33). The combination of Block in view of Newton does not teach wherein the liner comprises an open cell foam and is attached to a body-facing surface of the fluid impermeable barrier.
However, Conkling teaches wherein the liner comprises an open cell foam (pad 166 is made of open-cell foam and is a ring on opening of device; Figure 13; Column 7, lines 1-32) and is attached to a body-facing surface of the fluid impermeable barrier (pad 166 is on top of the body-facing surface of the vessel 160; Figure 13; Column 7, lines 18-32).
Conkling and Block in view of Newton are both considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Conkling to have the liner of Block in view of Newton to be an open-cell foam and placed on the body-facing surface of the fluid impermeable barrier, as taught by Conkling. This would allow for the device to be air permeable and suction reducing at its opening while preventing the leaking of urine, and providing user comfort, and fit tightly against the female’s genital region (Conkling; Column 7, lines 1-32). Since the prior art of Conkling recognizes the equivalency of having a foam liner made from the material of open-celled foam in the field of external urinary collection devices, it would have been obvious to a person having ordinary skill in the art to substitute the foam of Block in view of Newton with the open-celled foam of Conkling since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claim 44, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton teaches wherein the liner comprises a foam (Block; Column 4, lines 28-33). The combination of Block in view of Newton does not teach wherein the liner comprises an open cell foam and directly defines the opening.
However, Conkling teaches wherein the liner comprises an open cell foam (pad 166 is made of open-cell foam and is a ring on opening of device; Figure 13; Column 7, lines 1-32) and directly defines the opening (pad 166 is on top of the body-facing surface of the vessel 160 to define the opening of the device; Figure 13; Column 7, lines 18-32).
Conkling and Block in view of Newton are both considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Conkling to have the liner of Block in view of Newton to be an open-cell foam and placed on the body-facing surface of the fluid impermeable barrier, as taught by Conkling. This would allow for the device to be air permeable and suction reducing at its opening while preventing the leaking of urine, and providing user comfort, and fit tightly against the female’s genital region (Conkling; Column 7, lines 1-32). Since the prior art of Conkling recognizes the equivalency of having a foam liner made from the material of open-celled foam in the field of external urinary collection devices, it would have been obvious to a person having ordinary skill in the art to substitute the foam of Block in view of Newton with the open-celled foam of Conkling since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over Block (Patent No. US 5,632,736 A) in view Newton (Publication No. US 2018/0049910 A1), as applied to claim 17 above, and further in view of Cross et al. (Patent No. US 4,936,838 A).
Regarding claim 42, Block in view of Newton teaches the device of claim 17. The combination of Block in view of Newton does not teach wherein the fluid permeable body extends out of the chamber beyond the liner.
However, Cross teaches wherein the fluid permeable body extends out of the chamber beyond the liner (absorbent foam insert 3 has annular wall 34 that protrude out the chamber 30 and past the liner 14; Figure 2; Column 2, line 54 to Column 3, line 4).
Cross and Block in view of Newton are both considered to be analogous to the claimed invention because they are in the same field of external urinary 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 Block in view of Newton to incorporate the teachings of Cross to have the fluid permeable body of Block in view of Newton shaped with the annular wall of Cross. This would allow for the device to be secured against lateral movement and twisting and prevent urine leakage (Cross; Column 3, lines 15-32).
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.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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