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 09/18/2025 have been fully considered. Claims 1-4, 7-11, 14-19, 22-26, 29-30, 32-34, 38-39, 41, and 43 are pending in this application. Claims 5-6, 12-13, 20-21, 27-28, 31, 35-37, 40, and 42 are cancelled. Claims 1, 3-4, 9, 18-19, 25-26, 32, and 43 are amended.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 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. The applicant’s amended independent claims 1 and 32 changed the scope of the invention and required a change in the grounds of the rejection as detailed below in the prior art rejection. The amendments to the claim limitations of independent claims 1 and 32 will be addressed in the rejection below.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, line 2: “the second region of the fluid impermeable barrier the fluid collection device” should read “the second region of the fluid impermeable barrier of the fluid collection device”. Appropriate correction is required.
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, 8-11, 15, 32, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1) in view of Nussbaumer et al. (Patent No. US 4,692,160 A1).
Regarding claim 1, Davis teaches a fluid collection system (Figure 1), comprising: a fluid collection device (device 10; Paragraph 0052; Figure 1) including:
a fluid impermeable barrier at least partially defining a chamber (external covering 20 that defines a chamber within it; Paragraph 0052; Figure 1), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a urethra of a user (fenestration 30 extends longitudinally across covering 20 and positioned at urethra of patient; Paragraph 0052; Figure 1), and an aperture configured to receive a conduit therethrough (top end of covering 20 has an aperture 33 where tube is received; Figure 4 and 20; Paragraph 0060 and 0079), wherein the fluid impermeable barrier is substantially cylindrical and includes a first region defining the opening (covering 20 is substantially cylindrical and has a first region/top region that has the fenestration 30; Figure 1), a second region generally opposite to the first region (bottom region, opposing the top region; Figure 1), a proximal end region defining the aperture and extending proximally from the opening (proximal end region is region where first end of tubing 32 is located and above fenestration 30; Figure 4), and a distal end region extending distally from the opening (distal end region is region opposing the proximal end and is below fenestration 30; Figure 4); 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 (outer collection layer 40 is made of fluid permeable material and is located in the chamber of the covering 20 to extend across the fenestration 30 and wick fluid away from fenestration 30; Paragraph 0056-0057; Figure 7). Davis further teaches that the device can have a strap to wrap around the waist or leg of the user (Paragraph 0093).
Davis does not teach wherein at least one strap of the one or more straps are fixedly or releasably secured or securable to the fluid impermeable barrier at one or more of the proximal end region of the fluid impermeable barrier between the opening and the aperture, the distal end region of the fluid impermeable barrier distal to the opening, the second region of the fluid impermeable barrier generally opposite to the opening, or the second region of the fluid impermeable barrier at the distal end region of the fluid impermeable barrier.
However, Nussbaumer teaches wherein at least one strap of the one or more straps are fixedly or releasably secured or securable to the fluid impermeable barrier (belts 3, 4a, and 4b are attached to part 2 with different types of connections; Figure 1, 15, and 18; Column 2, lines 29-44 and Column 6, lines 27-28).
Nussbaumer 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 Nussbaumer to incorporate the teachings of Davis to have the waist strap of Nussbaumer be attached to the proximal end region between the opening and aperture of Davis and the buttock straps of Nussbaumer be attached to the distal end region of the fluid impermeable barrier of Davis. This would allow for the device to fit onto the user similar to a brief by securing the device around the waist of the user (Nussbaumer; Column 2, lines 23-44). Davis further teaches the anchor 50, or replacement strap, is located between the fenestration and the aperture 33 of the device (Figure 4), thus the strap of Nussbaumer is placed at the proximal end region between the opening and aperture of Davis.
Furthermore, 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 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 Davis in view of Nussbaumer further teaches wherein at least one strap of the one or more straps are fixedly or releasably secured or securable to the fluid impermeable battier at one or more of the proximal end region of the fluid impermeable barrier between the opening and the aperture, the distal end region of the fluid impermeable barrier distal to the opening, the second region of the fluid impermeable barrier generally opposite to the opening, or the second region of the fluid impermeable barrier at the distal end region of the fluid impermeable barrier (straps of Nussbaumer are secured to the distal end and proximal end region at the second end of the fluid impermeable barrier of Davis; see combination above).
Regarding claim 2, Davis in view of Nussbaumer teaches the system of claim 1. The combination of Davis in view of Nussbaumer 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 (Nussbaumer; waist belt 3, Figure 1; Column 2, lines 29-44).
Regarding claim 3, Davis in view of Nussbaumer teaches the system of claim 2. The combination of Davis in view of Nussbaumer 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 (strap of Nussbaumer on the proximal end region of the fluid impermeable barrier between the aperture and the opening of the device of Davis; see rejection of claim 1 above).
Regarding claim 4, Davis in view of Nussbaumer teaches the system of claim 2. The combination of Davis in view of Nussbaumer further teaches wherein the waist strap is secured or securable to the second region of the fluid impermeable barrier the fluid collection device opposite to a portion of the opening (Nussbaumer; belt 3 are securable to rings 28a and 28b on front ends 2a and 2b which are on the opposite side from opening 11; Column 4, lines 62-65; Figure 15 and 18; see rejection of claim 1 above).
Regarding claim 8, Davis in view of Nussbaumer teaches the system of claim 2. The combination of Davis in view of Nussbaumer further teaches wherein the waist strap is fixedly secured to the fluid collection device (Nussbaumer; end of belt 3 is enclosed around the rings; Figure 1 and 5).
Regarding claim 9, Davis in view of Nussbaumer teaches the system of claim 2. The combination of Davis in view of Nussbaumer further teaches wherein the fluid collection device includes one or more buttocks straps secured or securable to the second end region of the fluid impermeable barrier and the waist strap (Nussbaumer; belts 4a and 4b is attached to second end region/below aperture 7 of part 2 and attached to waist strap; Figure 1; see rejection of claim 1 above).
Regarding claim 10, Davis in view of Nussbaumer teaches the system of claim 9. The combination of Davis in view of Nussbaumer further teaches wherein the one or more buttocks straps includes a strap configured to position between buttocks of the user when secured to the second end region and the waist strap (Nussbaumer; belts 4a and 4b are positioned between or on buttocks and attached to waist strap; Figure 1).
Regarding claim 11, Davis in view of Nussbaumer teaches the system of claim 9. The combination of Davis in view of Nussbaumer 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 (Nussbaumer; belts 4a and 4b are positioned around two different buttocks; Figure 1).
Regarding claim 15, Davis in view of Nussbaumer teaches the system of claim 9. The combination of Davis in view of Nussbaumer further teaches wherein each of the one or more buttocks straps is fixedly secured to the fluid collection device (Nussbaumer; end of belts 4a and 4b is enclosed around the rings; Figure 1 and 5).
Regarding claim 32, Davis teaches a method of collecting fluid (Abstract), the method comprising:
providing fluid collection device (device 10; Paragraph 0052; Figure 1) comprising
a fluid impermeable barrier at least partially defining a chamber (external covering 20 that defines a chamber within it; Paragraph 0052; Figure 1), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a urethra of a user fenestration 30 extends longitudinally across covering 20 and positioned at urethra of patient; Paragraph 0052; Figure 1), and an aperture configured to receive a conduit therethrough (top end of covering 20 has an aperture 33 where tube is received; Figure 4 and 20; Paragraph 0060 and 0079), wherein the fluid impermeable barrier is substantially cylindrical and includes a first region defining the opening (covering 20 is substantially cylindrical and has a first region/top region that has the fenestration 30; Figure 1), a second region generally opposite to the first region (bottom region, opposing the top region; Figure 1), a proximal end region defining the aperture and extending proximally from the opening (proximal end region is region where first end of tubing 32 is located and above fenestration 30; Figure 4), and a distal end region extending distally from the opening (distal end region is region opposing the proximal end and is below fenestration 30; Figure 4); 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 (outer collection layer 40 is made of fluid permeable material and is located in the chamber of the covering 20 to extend across the fenestration 30 and wick fluid away from fenestration 30; Paragraph 0056-0057; Figure 7);
positioning the fluid permeable body of the fluid collection device to cover the urethra of the user (Paragraph 0052), and receiving fluids discharged from the urethra into a chamber of the fluid collection device (Paragraph 0052). Davis further teaches that the device can have a strap to wrap around the waist or leg of the user (Paragraph 0093).
Davis does not teach positioning one or more straps around a user, wherein the one or more straps are fixedly or releasably secured or securable 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, Nussbaumer further teaches positioning one or more straps around a user, wherein the one or more straps are fixedly or releasably secured or securable to the fluid impermeable barrier (belts 3, 4a, and 4b are attached to part 2 with different types of connections; Figure 1, 15, and 18; Column 2, lines 29-44 and Column 6, lines 27-28); the one or more straps hold the fluid collection device in place with the fluid permeable body covering the urethra of the user (waist belt 3 and auxiliary belts 4a, 4b are attached to part 2 and holds the device in place to cover the urethra of the user; Figure 1 and 3; Column 2, lines 29-44 and 50-62).
Nussbaumer 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 Nussbaumer to incorporate the teachings of Davis to have the waist strap of Nussbaumer be attached to the proximal end region between the opening and aperture of Davis and the buttock straps of Nussbaumer be attached to the distal end region of the fluid impermeable barrier of Davis. This would allow for the device to fit onto the user similar to a brief by securing the device around the waist of the user (Nussbaumer; Column 2, lines 23-44). Davis further teaches the anchor 50, or replacement strap, is located between the fenestration and the aperture 33 of the device (Figure 4), thus the strap of Nussbaumer is placed at the proximal end region between the opening and aperture of Davis.
Furthermore, 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 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 Davis in view of Nussbaumer teaches at one or more of the proximal end region of the fluid impermeable barrier between the opening and the aperture, the distal end region of the fluid impermeable barrier distal to the opening, the second region of the fluid impermeable barrier generally opposite to the opening, or the second region of the fluid impermeable barrier at the distal end region of the fluid impermeable barrier (straps of Nussbaumer are secured to the distal end and proximal end region at the second end of the fluid impermeable barrier of Davis; see combination above).
Regarding claim 43, Davis in view of Nussbaumer teaches the system of claim 1. The combination of Davis in view of Nussbaumer further teaches one or more straps are fixedly or releasably secured or securable to the fluid impermeable barrier with one or more of an adhesive, a molding, a strip on the fluid impermeable barrier, or an eyelet on the fluid impermeable barrier (Nussbaumer; belts 3 and 4a/4b are secured onto part 2 of device 1 by the eyelets/rings 28a/28b that are on the part 2; Figure 1, 15, and 18; Column 4, lines 62-65).
Claim(s) 7, 14, 16-19, 22-26, 29-30, 33, 38, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1) in view of Nussbaumer et al. (Patent No. US 4,692,160 A1), in view of claim 1, and further in view of Walters (Publication No. US 2008/0183157 A1).
Regarding claim 7, Davis in view of Nussbaumer teaches the system of claim 2. The combination of Davis in view of Nussbaumer does not teach wherein the waist strap is 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 the waist 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 14, Davis in view of Nussbaumer teaches the system of claim 9. The combination of Davis in view of Nussbaumer does not teach 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.
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 buttocks 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 16, Davis in view of Nussbaumer teaches the system of claim 1. The combination of Davis in view of Nussbaumer 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).
Davis in view of Nussbaumer 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 Davis in view of Nussbaumer to incorporate the teachings of Walters to have the thigh straps of Walters connected to the rings of the device of Nussbaumer. 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 Davis in view of Nussbaumer and Walters teaches where the first strap 551 of Walters would be attached to rings 28a and 28b on the left side of the device of Nussbaumer and the second strap 553 of Walters would be attached to rings 28a and 28b on the right side of the device of Nussbaumer.
Regarding claim 17, Davis in view of Nussbaumer and Walters teaches the system of claim 16. The combination of Davis in view of Nussbaumer 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, Davis in view of Nussbaumer and Walters teaches the system of claim 17. The combination of Davis in view of Nussbaumer 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 ring 28b on the proximal end region of Davis in view of Nussbaumer; Figure 18; see rejection of claim 16 above).
Regarding claim 19, Davis in view of Nussbaumer and Walters teaches the system of claim 18. The combination of Davis in view of Nussbaumer 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 rings 28b which are on the opposite side from opening 11 of Nussbaumer and is located on the second region of the fluid impermeable barrier of Davis; Column 4, lines 62-65; Figure 18; see rejection of claim 16 above).
Regarding claim 22, Davis in view of Nussbaumer and Walters teaches the system of claim 17. The combination of Davis in view of Nussbaumer 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, Davis in view of Nussbaumer and Walters teaches the system of claim 17. The combination of Davis in view of Nussbaumer 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 rings 28a and 28b of Nussbaumer attached to the fluid impermeable barrier of Davis; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 24, Davis in view of Nussbaumer and Walters teaches the system of claim 23. The combination of Davis in view of Nussbaumer 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 rings 28a and 28b; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 25, Davis in view of Nussbaumer and Walters teaches the system of claim 24. The combination of Davis in view of Nussbaumer 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 rings 28a and 28b on the left side of the device of Davis in view of Nussbaumer and the second strap of Walters would be attached to rings 28a and 28b on the right side of the device of Davis in view of Nussbaumer – 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, Davis in view of Nussbaumer and Walters teaches the system of claim 24. The combination of Davis in view of Nussbaumer 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 Davis in view of Nussbaumer and the second strap of Walters would be attached to rings 28a and 28b on the right side of the device of Davis in view of Nussbaumer – 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 rings 28a and 28b on front ends 2a and 2b which are on the opposite side from opening 11 – see Nussbaumer; Column 4, lines 62-65; Figure 15 and 18; see rejection of claim 16 above; Davis; straps are attached to second end region; see rejection of claim 1 above).
Regarding claim 29, Davis in view of Nussbaumer and Walters teaches the system of claim 24. The combination of Davis in view of Nussbaumer 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, Davis in view of Nussbaumer and Walters teaches the system of claim 24. The combination of Davis in view of Nussbaumer 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 rings 28a and 28b on both sides of the device of Davis in view of Nussbaumer; Figure 15 and 18; see rejection of claim 16 above).
Regarding claim 33, Davis in view of Nussbaumer teaches the method of claim 32. The combination of Davis in view of Nussbaumer does not teach further comprising securing the one or more straps to the fluid impermeable barrier of 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 the belt and 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.). The combination of Davis in view of Nussbaumer and Walters further teaches further comprising securing the one or more straps to the fluid impermeable barrier of the fluid collection device (Walters; Paragraph 0030, 0037, and 0042).
Regarding claim 38, the combination of Davis in view of Nussbaumer teaches the method of claim 32. The combination of Davis in view of Nussbaumer 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).
Davis in view of Nussbaumer 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 Davis in view of Nussbaumer to incorporate the teachings of Walters to have the thigh straps of Walters connected to the rings of the device of Davis in view of Nussbaumer. 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 Davis in view of Nussbaumer and Walters teaches the method of claim 38. The combination of Davis in view of Nussbaumer 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 Davis in view of Nussbaumer and Walters teaches the method of claim 38. The combination of Davis in view of Nussbaumer 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).
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1) in view of Nussbaumer et al. (Patent No. US 4,692,160 A1), as applied to claim 32 above, and further in view of Graetz (Patent No. US 4,031,897 A).
Regarding claim 34, the combination of Davis in view of Nussbaumer teaches the method of claim 32. The combination of Davis in view of Nussbaumer does not teach wherein positioning one or more straps around the user includes positioning fastening two ends of at least a waist strap together such that the waist strap is positioned around a waist of the user.
However, Graetz teaches wherein positioning one or more straps around the user includes positioning fastening two ends of at least a waist strap together such that the waist strap is positioned around a waist of the user (two ends of belt 10 is fastened together at the ends with hook and loop sections 11 to be fitted around the waist of the user; Figure 1; Column 2, lines 25-35).
Davis in view of Nussbaumer and Graetz are considered to be analogous to the claimed invention because they are in the same field of external fluid 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 Nussbaumer to incorporate the teachings of Graetz to have the waist strap of Nussbaumer be the belt with the hook and loop ends as taught by Graetz. This would allow for the adjustment of the fit of the belt to accommodate the waist of a pregnant mother (Graetz; Column 2, lines 25-35).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781