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 .
Response to Amendment
Applicant’s amendments filed 07/29/2026 have been fully considered. Claims 1-4, 7-11, 14-19, 22-26, 29-30, 32-34, 38-39, 41, and 44 are pending in this application. Claims 5-6, 12-13, 20-21, 27-28, 31, 35-37, 40, and 42-43 are cancelled. Claims 1, 10, 15, 19, 24, and 32 are amended. Claim 44 is newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claim(s) 1 and 32 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 overall some of the same prior art references are used herein, the applicant’s submission of amended claims 1 and 32 and newly added claim 44 required a change in the grounds of rejection 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.
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) 1-4, 7, 9-11, 14, 32-34, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Publication No. US 2016/0374848 A1) in view of SanAntonio (Publication No. US 2017/0196726 A1).
Regarding claim 1, Sanchez teaches a fluid collection system (Abstract), comprising: a fluid collection device (assembly 1602; Paragraph 0119; Figure 32) including: a fluid impermeable barrier at least partially defining a chamber (impermeable casing 1604 forming a volume or chamber; Figure 32; Paragraph 0119), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a urethra of a user (elongated opening 1604A extends longitudinally along the impermeable casing 1604 and placed adjacent to the user’s urethra for urine collection; Paragraph 0119-120; Figure 32-33), and an aperture configured to receive a conduit therethrough (outlet 1620 has an aperture to receive a tube 1621; Figure 32; Paragraph 0119), wherein the fluid impermeable barrier is substantially cylindrical (impermeable casing 1604 is cylindrical; Paragraph 0119; Figure 32-33) and includes a first region defining the opening (top portion of the impermeable casing 1604 has the opening 1604A; Figure 32), a second region generally opposite to the first region (bottom portion of the impermeable casing 1604 is the opposite of the top portion; Figure 32), a proximal end region defining the aperture and extending proximally from the opening (proximal end having the aperture of outlet 1620 and extends proximally from opening 1604A; Figure 32), and a distal end region extending distally from the opening and at least partially defining a reservoir configured to store fluid therein (distal end region has reservoir 1610 to store fluid and extends distally from opening 1604A; Figure 32; Paragraph 0119); and 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 (permeable membrane 1630 is positioned within the chamber and extends across the opening 1604A for the wicking of urine away from opening 1604A and into reservoir 1610; Paragraph 0119; Figure 32). Sanchez does not teach one or more straps configured to wrap around the user to secure the fluid collection device adjacent to the urethra of the user, wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier that at least partially defines the reservoir configured to store fluid therein with at least a portion of the distal end region extending distally beyond where the one or more straps are fixedly or releasably secured to the fluid impermeable barrier.
However, SanAntonio teaches one or more straps configured to wrap around the user to secure the fluid collection device adjacent to the urethra of the user (straps 120a-120d is configured to wrap around the user to secure apparatus 102 adjacent to urethra of user; Figure 4; Paragraph 0035), wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier with at least a portion of the distal end region extending distally beyond where the one or more straps are fixedly or releasably secured to the fluid impermeable barrier (straps 120a and 120b are secured to the distal end region of the outer impermeable layer of the apparatus 102 through the loops 118, where a portion of the distal end region extends distally beyond where straps 120a-120b are secured to the loops 118 of the outer impermeable layer of the apparatus 102; Figure 2 and 4; Paragraph 0036 and 0044).
SanAntonio and Sanchez 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 Sanchez to incorporate the teachings of SanAntonio to have the waist strap of SanAntonio be attached to the proximal end region between the opening and aperture of Sanchez and the buttock straps of SanAntonio be attached to the distal end region of the fluid impermeable barrier of Sanchez. This would allow for the device to adjustably fit onto the anatomy of the groin of the user (SanAntonio; Paragraph 0042-0044). The modification of Sanchez with the teaching of SanAntonio is further supported with the discussion of Sanchez of having a stabilizer (154) that is attached to the fluid impermeable barrier to secure the device to the user’s body (Paragraph 0070).
The combination of Sanchez in view of SanAntonio further teaches wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier that at least partially defines the reservoir configured to store fluid therein (straps 120a and 120b of SanAntonio are attached to the distal end region of the fluid impermeable barrier that defines the reservoir of Sanchez; see the combination above).
Regarding claim 2, Sanchez in view of SanAntonio teaches the system of claim 1. The combination of Sanchez in view of SanAntonio further teaches wherein the one or more straps include at least a waist strap secured to the fluid impermeable barrier and configured to wrap around a waist of the user (straps 120c and 120d of SanAntonio is a waist strap connected to belt 138 that is secured to the fluid impermeable barrier of Sanchez and wraps around waist of the user; SanAntonio; Figure 2 and 4; Paragraph 0042).
Regarding claim 3, Sanchez in view of SanAntonio teaches the system of claim 2. The combination of Sanchez in view of SanAntonio further teaches wherein the waist strap is secured or securable to the fluid impermeable barrier at the proximal end region of the fluid collection device between the aperture and the opening (straps 120c and 120d/waist straps of SanAntonio on the proximal end region of the fluid impermeable barrier between the aperture and the opening of the device of Sanchez; see rejection of claim 1 above).
Regarding claim 4, Sanchez in view of SanAntonio teaches the system of claim 2. The combination of Sanchez in view of SanAntonio does not teach wherein the waist strap is secured or securable to the second region of the fluid impermeable barrier of the fluid collection device opposite to a portion of the opening.
However, it would have been obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the location of the connection of the waist strap connected to the fluid impermeable barrier to be coupled to the second region of the fluid impermeable barrier. The strap will perform the same function of fixing the device around the waist of the user, whether on the first region or the second region. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The modified combination of Sanchez in view of SanAntonio further teaches wherein the waist strap is secured or securable to the second region of the fluid impermeable barrier of the fluid collection device opposite to a portion of the opening (straps 120c and 120d of SanAntonio is a waist strap connected to belt 138 that is secured to the fluid impermeable barrier at the second region of Sanchez, opposite side from the portion of elongated opening 1604A of Sanchez, and wraps around waist of the user; SanAntonio; Figure 2 and 4; Paragraph 0042; see combination above).
Regarding claim 7, Sanchez in view of SanAntonio teaches the system of claim 2. The combination of Sanchez in view of SanAntonio further teaches wherein the waist strap is releasably secured or securable to the fluid collection device (SanAntonio; waist straps 120c and 120d with belt 138 are releasably secured to apparatus 102 through male-female connectors 126, such as hook-and-loop or snaps; Figure 2-4; Paragraph 0036-0037 and 0039-0040).
Regarding claim 9, Sanchez in view of SanAntonio teaches the system of claim 2. The combination of Sanchez in view of SanAntonio further teaches wherein the fluid collection device includes one or more buttocks straps secured or securable to the distal end region of the fluid impermeable barrier and the waist strap (SanAntonio; buttock straps 120a and 120b are secured to the distal end region of the fluid impermeable barrier of Sanchez and straps 120a-120b are attachable to belt 138; Figure 4; Paragraph 0044).
Regarding claim 10, Sanchez in view of SanAntonio teaches the system of claim 9. The combination of Sanchez in view of SanAntonio further teaches wherein the one or more buttocks straps include a strap configured to position between the buttocks of the user when secured to the distal end region and the waist strap.
However, it would have been obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the location of the connection of the strap 120a of SanAntonio connected to the fluid impermeable barrier of Sanchez to be coupled to the second region of the fluid impermeable barrier. The strap will perform the same function of fixing the device around the buttocks of the user, whether on the first region or the second region. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The modified combination of Sanchez in view of SanAntonio further teaches wherein the one or more buttocks straps include a strap configured to position between the buttocks of the user when secured to the distal end region and the waist strap (strap 120a of SanAntonio is placed between the buttocks of the user; see combination above).
Regarding claim 11, Sanchez in view of SanAntonio teaches the system of claim 9. The combination of Sanchez in view of SanAntonio further teaches wherein the one or more buttocks straps include two buttocks straps each configured to position over or around a different buttock of the user (SanAntonio; buttock straps 120a and 120b each go over a different buttock of the user; Figure 4; Paragraph 0044).
Regarding claim 14, Sanchez in view of SanAntonio teaches the system of claim 9. The combination of Sanchez in view of SanAntonio further teaches wherein each of the one or more buttocks straps is releasably secured or securable to at least one of the fluid collection device or the waist strap (SanAntonio; buttock straps 120a and 120b are releasably secured to apparatus 102 through male-female connectors 126, such as hook-and-loop or snaps; Figure 2-4; Paragraph 0036-0037 and 0039-0040).
Regarding claim 32, Sanchez teaches a method of collecting fluid (Abstract), the method comprising: providing fluid collection device (assembly 1602; Paragraph 0119; Figure 32) comprising
a fluid impermeable barrier at least partially defining a chamber (impermeable casing 1604 forming a volume or chamber; Figure 32; Paragraph 0119), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a urethra of a user (elongated opening 1604A extends longitudinally along the impermeable casing 1604 and placed adjacent to the user’s urethra for urine collection; Paragraph 0119-120; Figure 32-33), and an aperture configured to receive a conduit therethrough (outlet 1620 has an aperture to receive a tube 1621; Figure 32; Paragraph 0119), wherein the fluid impermeable barrier is substantially cylindrical (impermeable casing 1604 is cylindrical; Paragraph 0119; Figure 32-33) and includes a first region defining the opening (top portion of the impermeable casing 1604 has the opening 1604A; Figure 32), a second region generally opposite to the first region (bottom portion of the impermeable casing 1604 is the opposite of the top portion; Figure 32), a proximal end region defining the aperture and extending proximally from the opening (proximal end having the aperture of outlet 1620 and extends proximally from opening 1604A; Figure 32), and a distal end region extending distally from the opening and at least partially defining a reservoir configured to store fluid therein (distal end region has reservoir 1610 to store fluid and extends distally from opening 1604A; Figure 32; Paragraph 0119); and
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 (permeable membrane 1630 is positioned within the chamber and extends across the opening 1604A for the wicking of urine away from opening 1604A and into reservoir 1610; Paragraph 0119; Figure 32); positioning the fluid permeable body of the fluid collection device to cover the urethra of the user (permeable membrane 1630 is positioned to extend across the opening 1604A which covers the urethra of the user; Figures 32-33; Paragraph 0119-0120), and receiving fluids discharged from the urethra into the chamber of the fluid collection device (Paragraph 0120). Sanchez does not teach positioning one or more straps around the user, wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier that at least partially defines the reservoir configured to store fluid therein with at least a portion of the distal end region extending distally beyond where the one or more straps are fixedly or releasably secured to the fluid impermeable barrier; the one or more straps hold the fluid collection device in place with the fluid permeable body covering the urethra of the user.
However, SanAntonio teaches positioning one or more straps around the user (straps 120a-120d are positioned around the user; Figure 4; Paragraphs 0041-0044), wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier with at least a portion of the distal end region extending distally beyond where the one or more straps are fixedly or releasably secured to the fluid impermeable barrier (straps 120a and 120b are secured to the distal end region of the outer impermeable layer of the apparatus 102 through the loops 118, where a portion of the distal end region extends distally beyond where straps 120a-120b are secured to the loops 118 of the outer impermeable layer of the apparatus 102; Figure 2 and 4; Paragraph 0036 and 0044).
SanAntonio and Sanchez 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 Sanchez to incorporate the teachings of SanAntonio to have the waist strap of SanAntonio be attached to the proximal end region between the opening and aperture of Sanchez and the buttock straps of SanAntonio be attached to the distal end region of the fluid impermeable barrier of Sanchez. This would allow for the device to adjustably fit onto the anatomy of the groin of the user (SanAntonio; Paragraph 0042-0044). The modification of Sanchez with the teaching of SanAntonio is further supported with the discussion of Sanchez of having a stabilizer (154) that is attached to the fluid impermeable barrier to secure the device to the user’s body (Paragraph 0070).
The combination of Sanchez in view of SanAntonio further teaches wherein the one or more straps are fixedly or releasably secured or securable to at least the distal end region of the fluid impermeable barrier further teaches that at least partially defines the reservoir configured to store fluid therein (straps 120a and 120b of SanAntonio are attached to the distal end region of the fluid impermeable barrier that defines the reservoir of Sanchez; see the combination above), the one or more straps hold the fluid collection device in place with the fluid permeable body covering the urethra of the user (straps 120a-120d of SanAntonio hold the fluid collection device with the fluid permeable body of Sanchez covering the urethra of the user; see combination above).
Regarding claim 33, Sanchez in view of SanAntonio teaches the method of claim 32. The combination of Sanchez in view of SanAntonio further teaches further comprising securing the one or more straps to the fluid impermeable barrier of the fluid collection device (straps 120a-120d of SanAntonio are secured to the fluid impermeable barrier of fluid collection device of Sanchez; see rejection of claim 32 above; SanAntonio; Figure 4; Paragraphs 0035-0037 and 0039-0040).
Regarding claim 34, Sanchez in view of SanAntonio teaches the method of claim 32. The combination of Sanchez in view of SanAntonio further teaches wherein positioning one or more straps around the user includes fastening two ends of at least a waist strap together such that the waist strap is positioned around a waist of the user (SanAntonio; waist straps 120c and 120d with belt 138 have two ends fixed together at 140 so that waist straps are positioned around waist of the user; Paragraph 0042-0043; Figure 4).
Regarding claim 44, Sanchez teaches a fluid collection system (Abstract), comprising: a fluid collection device (assembly 1602; Paragraph 0119; Figure 32) including:
a fluid impermeable barrier at least partially defining a chamber (impermeable casing 1604 forming a volume or chamber; Figure 32; Paragraph 0119), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a urethra of a user (elongated opening 1604A extends longitudinally along the impermeable casing 1604 and placed adjacent to the user’s urethra for urine collection; Paragraph 0119-120; Figure 32-33), and an aperture (outlet 1620 has an aperture to receive a tube 1621; Figure 32; Paragraph 0119), wherein the fluid impermeable barrier is substantially cylindrical (impermeable casing 1604 is cylindrical; Paragraph 0119; Figure 32-33) and includes a first region defining the opening (top portion of the impermeable casing 1604 has the opening 1604A; Figure 32), a second region generally opposite to the first region (bottom portion of the impermeable casing 1604 is the opposite of the top portion; Figure 32), a proximal end region defining the aperture and extending proximally from the opening (proximal end having the aperture of outlet 1620 and extends proximally from opening 1604A; Figure 32), and a distal end region extending distally from the opening and at least partially defining a reservoir configured to store fluid therein (distal end region has reservoir 1610 to store fluid and extends distally from opening 1604A; Figure 32; Paragraph 0119); and
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 (permeable membrane 1630 is positioned within the chamber and extends across the opening 1604A for the wicking of urine away from opening 1604A and into reservoir 1610; Paragraph 0119; Figure 32);
a conduit extending proximally through the aperture at the proximal end region (tube 1621 extending proximally through aperture 1620 at the proximal end region; Figure 32-33; Paragraph 0119-0120).
Sanchez does not teach one or more straps configured to wrap around the user to secure the fluid collection device adjacent to the urethra of the user, wherein the one or more straps are secured or securable to the fluid impermeable barrier between the aperture and the opening.
However, SanAntonio teaches one or more straps configured to wrap around the user to secure the fluid collection device adjacent to the urethra of the user (straps 120a-120d is configured to wrap around the user to secure apparatus 102 adjacent to urethra of user; Figure 4; Paragraph 0035).
SanAntonio and Sanchez 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 Sanchez to incorporate the teachings of SanAntonio to have the waist strap of SanAntonio be attached to the proximal end region between the opening and aperture of Sanchez and the buttock straps of SanAntonio be attached to the distal end region of the fluid impermeable barrier of Sanchez. This would allow for the device to adjustably fit onto the anatomy of the groin of the user (SanAntonio; Paragraph 0042-0044). The modification of Sanchez with the teaching of SanAntonio is further supported with the discussion of Sanchez of having a stabilizer (154) that is attached to the fluid impermeable barrier to secure the device to the user’s body (Paragraph 0070).
The combination of Sanchez in view of SanAntonio further teaches wherein the one or more straps are secured or securable to the fluid impermeable barrier between the aperture and the opening (see combination above) with the aperture and the conduit (1) proximal of where the one or more straps are secured or securable to the fluid impermeable barrier at the proximal end region and (2) proximal of where the one or more straps are secured or securable to the fluid impermeable barrier at the distal end region (aperture 1620 and tube 1621 are located at the proximal most end of the fluid collection device of Sanchez and proximal to the straps 120a-d of SanAntonio, located at the distal and proximal end region of the fluid collection device of Sanchez; see combination above; Sanchez; Figures 32-33; Paragraphs 0119-0120; SanAntonio; Figure 4; Paragraph 0035-0036).
Claim(s) 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Publication No. US 2016/0374848 A1) in view of SanAntonio (Publication No. US 2017/0196726 A1), as applied to claim 1 above, and further in view of Walsh (Patent No. US 4,994,051 A).
Regarding claim 8, Sanchez in view of SanAntonio teaches the system of claim 2. The combination of Sanchez in view of SanAntonio does not teach wherein the waist strap is fixedly secured to the fluid collection device.
However, Walter teaches wherein the waist strap is fixedly secured to the fluid collection device (straps 62 are fixedly attached to the fluid collection device; Figure 6; Column 5, lines 6-25).
Sanchez in view of SanAntonio and Walter 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 Sanchez in view of SanAntonio to incorporate the teachings of Walter to have the waist strap of Sanchez in view of SanAntonio to be fixedly secured to the fluid collection device, as taught by Walter. This would allow for the user to adjustably attach the straps onto the waist belt at the fastener end of the straps, opposite to the fixed end of the strap to wear the fluid collection device (Walter; Column 5, lines 6-25).
Regarding claim 15, Sanchez in view of SanAntonio teaches the system of claim 9. The combination of Sanchez in view of SanAntonio does not teach wherein each of the one or more buttocks straps is fixedly secured to the fluid collection device.
However, Walter teaches wherein each of the one or more buttocks straps is fixedly secured to the fluid collection device (straps 63 are fixedly secured to fluid collection device; Figure 6; Column 5, lines 6-25).
Sanchez in view of SanAntonio and Walter 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 Sanchez in view of SanAntonio to incorporate the teachings of Walter to have the buttocks strap of Sanchez in view of SanAntonio to be fixedly secured to the fluid collection device, as taught by Walter. This would allow for the user to adjustably attach the straps onto the waist belt at the fastener end of the straps, opposite to the fixed end of the strap to wear the fluid collection device (Walter; Column 5, lines 6-25).
Claim(s) 16-19, 22-26, 29-30, 38-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Publication No. US 2016/0374848 A1) in view of SanAntonio (Publication No. US 2017/0196726 A1), as applied to the rejection of claims 1 and 32 above, and further in view of Walters (Publication No. US 2008/0183157 A1).
Regarding claim 16, Sanchez in view of SanAntonio teaches the system of claim 1. The combination of Sanchez in view of SanAntonio does not teach wherein the one or more straps include at least one or more thigh straps.
However, Walters teaches wherein the one or more straps include at least one or more thigh straps (straps 551 and 553 are straps to go around the thighs; Paragraph 0042; Figure 5).
Sanchez in view of SanAntonio and Walters 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 Sanchez in view of SanAntonio to incorporate the teachings of Walters to have the thigh straps of Walters connected to the attachment loop of SanAntonio. This would allow for the additional security of the device onto the thighs of the user and reduce potential movement of the device from the body (Walters; Paragraph 0030 and 0042). The combination of Sanchez in view of SanAntonio and Walters teaches where the first strap 551 of Walters would be attached to loops 118 on the left side of the device of SanAntonio and the second strap 553 of Walters would be attached to loops 118 on the right side of the device of SanAntonio.
Regarding claim 17, Sanchez in view of SanAntonio and Walters teaches the system of claim 16. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the one or more thigh straps include a single thigh strap configured to wrap around the thighs of the user (Walters; strap 551; Figure 5; Paragraph 0042).
Regarding claim 18, Sanchez in view of SanAntonio and Walters teaches the system of claim 17. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the single thigh strap is secured or securable to the fluid impermeable barrier at the proximal end region of the fluid collection device proximate to the aperture (strap 551 of Walters is securable to loop 118 on the proximal end region of Sanchez in view of SanAntonio; Figure 18; see rejection of claim 16 above).
Regarding claim 19, Sanchez in view of SanAntonio and Walters teaches the system of claim 17. The combination of Sanchez in view of SanAntonio and Walters does not teach wherein the single thigh strap is secured or securable to the second region of the fluid impermeable barrier opposite to a portion of the opening.
However, it would have been obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the location of the connection of the single thigh strap connected to the fluid impermeable barrier to be coupled to the second region of the fluid impermeable barrier. The strap will perform the same function of fixing the device around the thigh of the user, whether on the first region or the second region. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.). The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the single thigh strap is secured or securable to the second region of the fluid impermeable barrier opposite to a portion of the opening (strap 551 of Walters is securable to the loops 118 located on the second region of the fluid impermeable barrier of Sanchez and opposite to a portion of the opening of Sanchez; Walters; Column 4, lines 62-65; Figure 18; see combination above).
Regarding claim 22, Sanchez in view of SanAntonio and Walters teaches the system of claim 17. The combination of Sanchez in view of SanAntonio and Walters does not teach wherein the single thigh strap is releasably secured or securable to the fluid impermeable barrier.
However, Walters teaches wherein the strap is securable to the fluid collection device by fastening devices such as rings, hook and loops, snap devices, and buttons (Paragraph 0037 and 0042).
Since the prior art of Walters recognizes the equivalency of rings, hook and loops, snap devices, and buttons as fastening devices in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute ring connection of the thigh strap with releasable hook and loops 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 23, Sanchez in view of SanAntonio and Walters teaches the system of claim 17. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the single thigh strap is fixedly secured to the fluid impermeable barrier (thigh strap 551 of Walters is attached onto the loops of SanAntonio attached to the fluid impermeable barrier of Sanchez; Walters; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 24, Sanchez in view of SanAntonio and Walters teaches the system of claim 16. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the one or more thigh straps include two thigh straps each configured to wrap a different thigh of the user (thigh straps 551 and 553 of Walters are attached to loops 118 of SanAntonio; Walters; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 25, Sanchez in view of SanAntonio and Walters teaches the system of claim 24. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the two thigh straps are each secured or securable to the fluid impermeable barrier at the proximal end region of the fluid collection device proximate to the aperture and also secured or securable to the fluid impermeable barrier at the distal end region of the fluid collection device distal to the proximal end region (the first strap of Walters would be attached to loops 118 of SanAntonio on the left side of the device of Sanchez in view of SanAntonio and the second strap of Walters would be attached to loops 118 of SanAntonio on the right side of the device of Sanchez in view of SanAntonio – each strap is secured on the proximal end and distal end region of each side of the device; see rejection of claim 16 above).
Regarding claim 26, Sanchez in view of SanAntonio and Walters teaches the system of claim 24. The combination of Sanchez in view of SanAntonio and Walters does not teach wherein the two thigh straps are each secured or securable to the second region of the fluid impermeable barrier opposite to a portion of the opening and also secured or securable to the fluid impermeable barrier at the distal end region of the fluid collection device distal to the proximal end region.
However, it would have been obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the location of the connection of the thigh straps to the fluid impermeable barrier to be coupled to the second region of the fluid impermeable barrier. The strap will perform the same function of fixing the device around the waist of the user, whether on the first region or the second region. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the two thigh straps are each secured or securable to the second region of the fluid impermeable barrier opposite to a portion of the opening and also secured or securable to the fluid impermeable barrier at the distal end region of the fluid collection device distal to the proximal end region (the first strap of Walters would be attached to rings 28a and 28b on the left side of the device of Sanchez in view of SanAntonio and the second strap of Walters would be attached to loops 118 of SanAntonio on the right side of the device of Sanchez in view of SanAntonio – each strap is secured on the proximal and distal end region of each side of the device and the attachment of the belts to the loops 118 of SanAntonio; Walters; Figure 15 and 18; see rejection of claim 16 above; Sanchez; straps are attached to second end region; see combination above).
Regarding claim 29, Sanchez in view of SanAntonio and Walters teaches the system of claim 24. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the two thigh straps are each releasably secured or securable to the fluid collection device.
However, Walters teaches wherein the strap is securable to the fluid collection device by fastening devices such as rings, hook and loops, snap devices, and buttons (Paragraph 0037 and 0042).
Since the prior art of Walters recognizes the equivalency of rings, hook and loops, snap devices, and buttons as fastening devices in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute ring connection of both thigh straps with releasable hook and loops 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 30, Sanchez in view of SanAntonio and Walters teaches the system of claim 24. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein the two thigh straps are each fixedly secured to the fluid collection device (thigh straps 551 and 553 of Walters is attached onto the loops 118 on both sides of the device of Sanchez in view of SanAntonio; Walters; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 38, the combination of Sanchez in view of SanAntonio teaches the method of claim 32. The combination of Sanchez in view of SanAntonio does not teach wherein positioning one or more straps around the user includes positioning at least one or more thigh straps around thighs of the user.
However, Walters teaches wherein positioning one or more straps around the user includes positioning at least one or more thigh straps around thighs of the user (straps 551 and 553 are straps to go around the thighs; Paragraph 0042; Figure 5).
Sanchez in view of SanAntonio and Walters 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 Sanchez in view of SanAntonio to incorporate the teachings of Walters to have the thigh straps of Walters connected to the loops of the device of Sanchez in view of SanAntonio. This would allow for the additional security of the device onto the thighs of the user and reduce potential movement of the device from the body (Walters; Paragraph 0030 and 0042).
Regarding claim 39, the combination of Sanchez in view of SanAntonio and Walters teaches the method of claim 38. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein positioning at least one or more thigh straps around thighs of the user includes positioning a single thigh strap around the thighs of the user (Walters; Figure 5; Paragraph 0042; see rejection of claim 38 above).
Regarding claim 41, the combination of Sanchez in view of SanAntonio and Walters teaches the method of claim 38. The combination of Sanchez in view of SanAntonio and Walters further teaches wherein positioning at least one or more thigh straps around thighs of the user includes positioning two thigh straps around the thighs of the user (Walters; Figure 5; Paragraph 0042; see rejection of claim 38 above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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