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 on 10/24/2025 has been fully considered. Claims 1-28 are pending in this application. Claims 1, 16, and 19 are amended. Claims 25-28 are newly added. Claims 6-12 and 22 are withdrawn.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive. Regarding the argument of claim 1, 16, and 19, wherein the teaching of Glickman is contrary to the device of Sanchez, the argument is unpersuasive. Sanchez does not teach a multiport valve assembly, however, Glickman teaches the multiport valve assembly (drainage tube 2 and secondary tube 7; Figure 1-2; Paragraph 0021-0023). In the embodiment of Figure 1-2 of Glickman, the drainage opening 3 and aperture 8 are in an open (Figure 1) and closed (Figure 2) position to allow for the user to control the flow of fluid into the conduit and through/into the device. The application of the conduit of Glickman with the drainage hole located in the interior chamber of Sanchez would allow for the user to control the flow of fluid from the chamber and into the conduit and the rest of the device of Sanchez for the removal of urine from the user. The prior art of Sanchez and Glickman teaches the same function of the removal of fluid away from the user and through the catheter by having the urine travel into and through the device’s conduit (see Abstract of Sanchez and Glickman).
Regarding the amended claim limitation of claim 1 and the argument regarding claim 2, the applicant’s arguments 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.
Regarding the newly added claims 25-28, the claims will be addressed in the rejection below.
Though overall the same prior art references are used herein, at least applicant’s amended independent claims 1, 16, and 19 and newly added independent claim 26-28 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) 1-3, 13-21, 23-24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Publication No. US 2019/0142624 A1) in view of Glickman et al. (Publication No. US 2015/0290421 A1).
Regarding claim 1, Sanchez teaches a fluid collection device (assembly 1602; Figure 32; Paragraph 0132), comprising:
a fluid impermeable barrier (impermeable casing 1604; Paragraph 0132; Figure 32) at least partially defining an interior chamber and an opening through which the interior chamber is exposed to an external environment (casing 1604 forms a volume/interior chamber and an opening 1604A to expose interior chamber to environment; Figure 32; Paragraph 0132-0133);
a fluid permeable body positioned at least partially within the interior chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening (permeable membrane 1630 and permeable support 1640 is within interior chamber and extends across opening 1604A to wick fluid away from opening; Figure 32; Paragraph 0132-0133);
a conduit extending into the interior chamber (conduit 1621 extends into chamber; Figure 32; Paragraph 0132-0133). Sanchez does not teach a multiport valve assembly disposed within the interior chamber.
However, Glickman teaches a multiport valve assembly (drainage tube 2 and secondary tube 7 is multiple valve assembly; Figure 4-5; Paragraph 0021-0023 and 0027).
Sanchez and Glickman are considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez to incorporate the teachings of Glickman and have the multiport valve assembly with the first and second holes of Glickman to be the conduit/sheath of the device of Sanchez. This allows for the user to actuate the flow of urine into the device and through the conduit for the drainage of urine from the user (Glickman; Paragraph 0004-0005).
The combination of Sanchez in view of Glickman further teaches the multiport valve assembly disposed within the interior chamber (multiport valve assembly of Glickman is located in the interior chamber of Sanchez, see combination above).
The combination of Sanchez in view of Glickman does not teach wherein the multiport valve assembly is configured to selectively remove at least one of air or bodily fluids from different regions of the chamber via the conduit.
However, Glickman further teaches that multiple drainage openings 3 may be provided around the periphery and corresponding multiple apertures 8 can be provided (Paragraph 0026).
Since the applicant has not disclosed that placing additional first and second holes in the multiport valve assembly does anything more than produce predictable results (i.e. provide additional drainage at different locations on the conduit), the mere duplication of the drainage hole and aperture is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the effective filing date, to modify Sanchez in view of Glickman to include an additional first hole and second hole proximally adjacent on the conduit and sheath of the multiport valve of Sanchez in view of Glickman, in order to predictably have additional drainage locations on the conduit of Sanchez in view of Glickman. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The combination of Sanchez in view of Glickman further teaches wherein the multiport valve assembly is configured to selectively remove at least one of air or bodily fluids from different regions of the chamber via the conduit (two first holes and second holes of the multiport valve assembly of Sanchez in view of Glickman allows for the removal of air/fluid at the different locations of the first holes on the conduit, located in the chamber; see combination above).
Regarding claim 2, Sanchez in view of Glickman teaches the device of claim 1. The combination of Sanchez in view of Glickman further teaches wherein: the multiport valve assembly includes, a terminal end of the conduit (Glickman; end of secondary tube 7; Figure 4 and 5; Paragraph 0022-0023 and 0027), the terminal end of the conduit defining a first plurality of holes thereon (Glickman; duplication of apertures 8; Figure 4 and 5; Paragraph 0022-0023 and 0027; see rejection of claim 1 above), and a sheath concentrically disposed over the terminal end of the conduit within the interior chamber (Glickman; drainage tube 2 that is concentrically covers the secondary tube 7; Figure 4 and 5; Paragraph 0022-0023 and 0027), the sheath defining a second plurality of holes therein (Glickman; tube 2 with duplication of openings 3; Figure 4 and 5; Paragraph 0022-0023 and 0027; see rejection of claim 1 above).
The combination of Sanchez in view of Glickman does not teach the first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end with respect to the sheath.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first plurality of holes to be longitudinally adjacent and opposing to each other at a first and second side of the conduit and the second plurality of holes to be longitudinally adjacent and both at a first side of the sheath, aligned at the second end region with the first plurality of holes, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located at the second end region of the device or located elsewhere on the conduit/sheath, with the common function at either locations of intaking fluid from the user and through the conduit/sheath, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The modified Sanchez in view of Glickman further teaches the first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end with respect to the sheath (first plurality of holes are laterally opposing each other, thus, only one first plurality of hole and align to one second plurality of hole at a given orientation when the sheath and conduit are rotated; see combination above).
Regarding claim 3, Sanchez in view of Glickman teaches the device of claim 2. The combination of Sanchez in view of Glickman further teaches wherein:
the first plurality of holes include,
a conduit distal hole on a first side of the conduit at a second end region of the fluid collection device (Glickman; aperture 8 is on the first side of the tube 7 at the distal end 4 of device; Paragraph 0027; Figure 4-5; see rejection of claim 2 above), and
a conduit medial hole on a second side of the conduit and longitudinally spaced from the conduit distal hole by a first distance (Glickman; duplicate aperture is proximally adjacent and longitudinally spaced from aperture 8 at a first distance and on the second side of the tube 7; see rejection of claim 2 above),
the second plurality of holes includes,
a sheath distal hole on a first side of the sheath at a second end region of the fluid collection device (Glickman; tube 2 has an opening 3 at the first side of the sheath and at a distal end 4 of device Paragraph 0027; Figure 4-5; see rejection of claim 2 above), and a sheath medial hole on the first side of sheath and longitudinally spaced from the sheath distal hole by the first distance (Glickman; duplicate opening is proximally adjacent and longitudinally spaced from opening 3 at a first distance and on the first side of tube 2; see rejection of claim 2 above). The embodiment of Figure 4-5 of Glickman does not teach the conduit is rotatable with respect to the sheath.
However, an alternative embodiment, Figure 8 of Glickman, teaches the conduit is rotatable with respect to the sheath (rotational and axial movement between the tube 2 and 7 through indent 15 and detent 16; Paragraph 0030-0031; Figure 8).
Glickman is considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez in view of Glickman to incorporate the teachings of the Figure 8 of Glickman and have the conduit and sheath of Sanchez in view of Glickman be shaped with the indent and detent, as taught by the embodiment of Figure 8 of Glickman. This allows for the user to align and de-align the drainage outlet and aperture when drainage of urine into the conduit is desired (Glickman; Paragraph 0030-0031).
Regarding claim 13, Sanchez in view of Glickman teaches the device of claim 1. Sanchez further teaches wherein the fluid permeable body includes a fluid permeable support and a fluid permeable membrane disposed over at least a portion of the fluid permeable support (permeable body is permeable membrane 1630 disposed over permeable support 1640; Figure 32; Paragraph 0132).
Regarding claim 14, Sanchez in view of Glickman teaches the device of claim 1. Sanchez further teaches further comprising at least one reservoir within the interior chamber (reservoir 1610 at end of assembly 1602 and another reservoir where the permeable membrane 1630 and support 1640 are located; Paragraph 0132; Figure 32).
Regarding claim 15, Sanchez in view of Glickman teaches the device of claim 14. Sanchez further teaches wherein the at least one reservoir includes one or more of a first reservoir located at a second end region of the fluid collection device (reservoir 1610 is at end of assembly 1602; Figure 32; Paragraph 0132) or a second reservoir located in a medial portion of the fluid collection device (another reservoir is the space between permeable membrane 1630/support 1640 and impermeable backing 1650 is located; Paragraph 0132; Figure 32).
Regarding claim 16, Sanchez teaches a fluid collection system (Abstract), the system comprising: a fluid collection device (assembly 1602; Figure 32; Paragraph 0132) including, a fluid impermeable barrier (impermeable casing 1604; Paragraph 0132; Figure 32) at least partially defining an interior chamber and an opening through which the interior chamber is exposed to an external environment (casing 1604 forms a volume/interior chamber and an opening 1604A to expose interior chamber to environment; Figure 32; Paragraph 0132-0133), a fluid permeable body positioned at least partially within the interior chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening (permeable membrane 1630 is within interior chamber and extends across opening 1604A to wick fluid away from opening; Figure 32; Paragraph 0132-0133), a conduit extending into the interior chamber (conduit 1621 extends into chamber; Figure 32; Paragraph 0132-0133); a fluid storage container fluidly connected to the fluid collection device via the conduit (external receptacle 160 is connected to discharge line 122/conduit which is connected to device; Paragraph 0067; Figure 1 and 32), the fluid storage container being configured to store fluids therein (Paragraph 0067); and a vacuum source fluidly connected to the fluid storage container (vacuum source 170 fluidly connected to external receptacle 160 through line 124; Paragraph 0067; Figure 1), the vacuum source being configured to provide vacuum force into the interior chamber via the fluid storage container and the conduit (Paragraph 0067). Sanchez does not teach a multiport valve assembly disposed within the interior chamber; wherein the multiport valve assembly is configured to selectively remove at least one of air or bodily fluids from different regions of the chamber via the conduit and into the fluid storage container.
However, Glickman teaches a multiport valve assembly (drainage tube 2 and secondary tube 7 is multiple valve assembly; Figure 4-5; Paragraph 0021-0023 and 0027).
Sanchez and Glickman are considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez to incorporate the teachings of Glickman and have the multiport valve assembly with the first and second holes of Glickman to be the conduit/sheath of the device of Sanchez. This allows for the user to actuate the flow of urine into the device and through the conduit for the drainage of urine from the user (Glickman; Paragraph 0004-0005).
The combination of Sanchez in view of Glickman further teaches the multiport valve assembly disposed within the interior chamber (multiport valve assembly of Glickman is located in the interior chamber of Sanchez, see combination above).
The combination of Sanchez in view of Glickman does not teach wherein the multiport valve assembly is configured to selectively remove at least one of air or bodily fluids from different regions of the chamber via the conduit and into the fluid storage container.
However, Glickman further teaches that multiple drainage openings 3 may be provided around the periphery and corresponding multiple apertures 8 can be provided (Paragraph 0026).
Since the applicant has not disclosed that placing additional first and second holes in the multiport valve assembly does anything more than produce predictable results (i.e. provide additional drainage at different locations on the conduit), the mere duplication of the drainage hole and aperture is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the effective filing date, to modify Sanchez in view of Glickman to include an additional first hole and second hole proximally adjacent on the conduit and sheath of the multiport valve of Sanchez in view of Glickman, in order to predictably have additional drainage locations on the conduit of Sanchez in view of Glickman. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The combination of Sanchez in view of Glickman further teaches wherein the multiport valve assembly is configured to selectively remove at least one of air or bodily fluids from different regions of the chamber via the conduit (two first holes and second holes of the multiport valve assembly of Sanchez in view of Glickman allows for the removal of air/fluid at the different locations of the first holes on the conduit of Glickman, located in the chamber; see combination above) and into the fluid storage container (Sanchez; external receptacle 160 is connected to conduit of Glickman for urine collection; Figure 1 and 32; Paragraph 0067).
Regarding claim 17, Sanchez in view of Glickman teaches the system of claim 16. Sanchez further teaches wherein the fluid storage container includes a canister (Paragraph 0067 and 0074).
Regarding claim 18, Sanchez in view of Glickman teaches the system of claim 17. Sanchez further teaches wherein the vacuum source includes one or more of a vacuum pump, a wall-mounted vacuum line, or a hand pump (vacuum source can be vacuum pump; Paragraph 0071 and 0077).
Regarding claim 19, Sanchez teaches a method to collect bodily fluid (Abstract), the method comprising:
positioning a fluid collection device adjacent to a urethra of a wearer (assembly 1602 is positioned to urethra of user; Figure 32; Paragraph 0132; Paragraph 0063 and 0068), the fluid collection device including:
a fluid impermeable barrier (impermeable casing 1604; Paragraph 0132; Figure 32) at least partially defining an interior chamber and an opening through which the interior chamber is exposed to an external environment (casing 1604 forms a volume/interior chamber and an opening 1604A to expose interior chamber to environment; Figure 32; Paragraph 0132-0133),
a fluid permeable body positioned at least partially within the interior chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening (permeable membrane 1630 is within interior chamber and extends across opening 1604A to wick fluid away from opening; Figure 32; Paragraph 0132-0133),
a conduit extending into the interior chamber (conduit 1621 extends into chamber; Figure 32; Paragraph 0132-0133), and
receiving fluid from the urethra into the fluid collection device (Paragraph 0068).
Sanchez does not teach a multiport valve assembly disposed within the interior chamber.
However, Glickman teaches a multiport valve assembly (drainage tube 2 and secondary tube 7 is multiple valve assembly; Figure 4-5; Paragraph 0021-0023 and 0027).
Sanchez and Glickman are considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez to incorporate the teachings of Glickman and have the multiport valve assembly with the first and second holes of Glickman to be the conduit/sheath of the device of Sanchez. This allows for the user to actuate the flow of urine into the device and through the conduit for the drainage of urine from the user (Glickman; Paragraph 0004-0005).
The combination of Sanchez in view of Glickman further teaches the multiport valve assembly disposed within the interior chamber (multiport valve assembly of Glickman is located in the interior chamber of Sanchez, see combination above), the multiport valve assembly including a terminal end of the conduit and a sheath concentrically disposed over the terminal end of the conduit (Glickman; end of secondary tube 7; Figure 4 and 5; Paragraph 0022-0023 and 0027).
The combination of Sanchez in view of Glickman does not teach a first plurality of holes and a second plurality of holes.
However, Glickman further teaches that multiple drainage openings 3 may be provided around the periphery and corresponding multiple apertures 8 can be provided (Paragraph 0026).
Since the applicant has not disclosed that placing additional first and second holes in the multiport valve assembly does anything more than produce predictable results (i.e. provide additional drainage at different locations on the conduit), the mere duplication of the drainage hole and aperture is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the effective filing date, to modify Sanchez in view of Glickman to include an additional first hole and second hole proximally adjacent on the conduit and sheath of the multiport valve of Sanchez in view of Glickman, in order to predictably have additional drainage locations on the conduit of Sanchez in view of Glickman. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The modified combination of Sanchez in view of Glickman further teaches wherein the terminal end of the conduit defines a first plurality of holes thereon (Glickman; duplication of apertures 8; Figure 4 and 5; Paragraph 0022-0023 and 0027; see combination above), the sheath defines a second plurality of holes therein (Glickman; tube 2 with duplication of openings 3; Figure 4 and 5; Paragraph 0022-0023 and 0027; see combination above).
The modified combination of Sanchez in view of Glickman does not teach the first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end with respect to the sheath.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first plurality of holes to be longitudinally adjacent and opposing to each other at a first and second side of the conduit and the second plurality of holes to be longitudinally adjacent and both at a first side of the sheath, aligned at the second end region with the first plurality of holes, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located at the second end region of the device or located elsewhere on the conduit/sheath, with the common function at either locations of intaking fluid from the user and through the conduit/sheath, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The modified Sanchez in view of Glickman further teaches the first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end with respect to the sheath (first plurality of holes are laterally opposing each other, thus, only one first plurality of hole and align to one second plurality of hole at a given orientation when the sheath and conduit are rotated; see combination above), removing the fluid from the fluid collection device via the multiport valve assembly and the conduit (Sanchez; Paragraph 0132; Glickman; Abstract; see combination above – device of Sanchez with conduit and sheath/multivalve assembly of Glickman to collect urine from user and remove urine from user).
Regarding claim 20, Sanchez in view of Glickman teaches the method of claim 19. The combination of Sanchez in view of Glickman further teaches further comprising selecting a port of the multiport valve assembly (Glickman; alignment of holes 3 and 8; Figure 4 and 5; Paragraph 0027).
Regarding claim 21, Sanchez in view of Glickman teaches the method of claim 20. The combination of Sanchez in view of Glickman does not teach wherein selecting a port includes rotating the conduit with respect to the sheath.
However, an alternative embodiment, Figure 8 of Glickman, teaches the conduit is rotatable with respect to the sheath (rotational and axial movement between the tube 2 and 7 through indent 15 and detent 16; Paragraph 0030-0031; Figure 8).
Glickman is considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez in view of Glickman to incorporate the teachings of the Figure 8 of Glickman and have the conduit and sheath of Sanchez in view of Glickman be shaped with the indent and detent, as taught by the embodiment of Figure 8 of Glickman, with the method of rotating the conduit/sheath for port selection, as taught by the embodiment of Figure 8 of Glickman. This allows for the user to align and de-align the drainage outlet and aperture when drainage of urine into the conduit is desired (Glickman; Paragraph 0030-0031).
Regarding claim 23, Sanchez in view of Glickman teaches the method of claim 19. Sanchez further teaches wherein receiving fluid from the urethra into the fluid collection device includes wicking the fluid into the fluid permeable body (permeable membrane has wicking properties to wick urine away from the user and into the device; Paragraph 0068).
Regarding claim 24, Sanchez in view of Glickman teaches the method of claim 19. Sanchez further teaches wherein removing the fluid from the fluid collection device via the conduit includes applying a vacuum in the interior chamber via a port of the multiport valve assembly (vacuum source 170 applied vacuum to the device through the attachment of the vacuum to the conduit of the device; Paragraph 0067 and 0132; Figure 1).
Regarding claim 26, Sanchez in view of Glickman teaches the device of claim 2. The combination of Sanchez in view of Glickman does not teach wherein the sheath is only disposed in the chamber.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the sheath only disposed in the chamber, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located partially in the reservoir or only in the chamber, with the common function at either locations of intaking fluid from the user and through the conduit/sheath, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Regarding claim 27, Sanchez in view of Glickman teaches the device of claim 2. The combination of Sanchez in view of Glickman further teaches wherein: the first plurality of holes only include, a conduit distal hole on a first side of the conduit at a second end region of the fluid collection device (Glickman; aperture 8 is on the first side of the tube 7 at the distal end 4 of device; Paragraph 0027; Figure 4-5; see rejection of claim 2 above), and a conduit medial hole on a second side of the conduit and longitudinally spaced from the conduit distal hole by a first distance (Glickman; duplicate aperture is proximally adjacent and longitudinally spaced from aperture 8 at a first distance and on the second side of the tube 7; see rejection of claim 2 above); the second plurality of holes only includes, a sheath distal hole on a first side of the sheath at a second end region of the fluid collection device (Glickman; tube 2 has an opening 3 at the first side of the sheath and at a distal end 4 of device Paragraph 0027; Figure 4-5; see rejection of claim 2 above), and a sheath medial hole on the first side of sheath and longitudinally spaced from the sheath distal hole by the first distance (Glickman; duplicate opening is proximally adjacent and longitudinally spaced from opening 3 at a first distance and on the first side of tube 2; see rejection of claim 2 above).
Regarding claim 28, Sanchez in view of Glickman teaches the device of claim 15. Sanchez further teaches wherein the first reservoir and the second reservoir are substantially unoccupied (reservoir 1610, first reservoir, and space between permeable membrane 1630/support 1640 and impermeable backing 1650 is located, second reservoir, both have empty spaces that are not occupied; Figure 32; Paragraph 0132).
Claim(s) 4-5 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Publication No. US 2019/0142624 A1) in view of Glickman et al. (Publication No. US 2015/0290421 A1) and O’Day (Publication No. US 2013/0274711 A1).
Regarding claim 4, Sanchez in view of Glickman teaches the device of claim 3. The combination of Sanchez in view of Glickman does not teach further comprising an alignment assembly disposed around the conduit on a first end of the fluid impermeable barrier, the alignment assembly including: a fixed collar operably coupled to the fluid impermeable barrier; and an inner collar operably coupled to the terminal end of the conduit, the inner collar being disposed within the fixed collar; wherein the fixed collar and the inner collar have markings to align the conduit distal hole with the sheath distal hole and the conduit medial hole with the sheath medial hole.
However, Glickman further teaches further comprising an alignment assembly disposed around the conduit on a first end of the fluid impermeable barrier (ratchet mechanism 18; Figure 10; Paragraph 0035), the alignment assembly including: a fixed collar operably coupled to the fluid impermeable barrier (elongate members 20 with barbs 19; Figure 10; Paragraph 0035); and an inner collar operably coupled to the terminal end of the conduit (receiving portion 22 with teeth is coupled to end of secondary tube 7; Figure 10; Paragraph 0035), the inner collar being disposed within the fixed collar (receiving portion 22 with the teeth is within the elongate members 20 with barbs 19; Paragraph 0035).
Sanchez in view of Glickman and Glickman are both considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez in view of Glickman to incorporate the teachings of Glickman and have the alignment assembly of Glickman on the device of Sanchez. This allows for the user to lock the flow configuration of the device to prevent re-use of the device (Glickman; Paragraph 0035).
The combination of Sanchez in view of Glickman does not teach wherein the fixed collar and the inner collar have markings to align the conduit distal hole with the sheath distal hole and the conduit medial hole with the sheath medial hole.
However, O’Day further teaches wherein the fixed collar and the inner collar have markings to align the conduit distal hole with the sheath distal hole and the conduit medial hole with the sheath medial hole (markings can be placed on handles 34 and 32 which control the alignment of tubes 20, 24, and 26 and the ports; Paragraph 0023).
Sanchez in view of Glickman and O’Day are both considered to be analogous to the claimed invention because they are in the same field of medical fluid 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 Glickman to incorporate the teachings of O’Day and have the inner and fixed collar of Sanchez in view of Glickman to have the alignment markings, as taught by O’Day. This allows for the user to visually determine the rotational configuration of the device for adjustment (O’Day; Paragraph 0023).
Regarding claim 5, Sanchez in view of Glickman and O’Day teaches the device of claim 4. The combination of Sanchez in view of Glickman and O’Day further teaches wherein: the markings on the fixed collar correspond to a position of the sheath distal hole and the sheath medial hole on the sheath; and the markings on the inner collar correspond to a position of the conduit distal hole and the conduit medial hole on the conduit (O’Day; markings can be placed on handles 34 and 32 which control the alignment of tubes 20, 24, and 26 and the ports, including the distal and medial holes of the conduit and the sheath; Paragraph 0023).
Regarding claim 25, Sanchez in view of Glickman teaches the device of claim 2. The combination of Sanchez in view of Glickman does not teach further comprising an alignment assembly disposed on a first end of the fluid impermeable barrier, the alignment assembly including: a fixed collar operably coupled to the fluid impermeable barrier; and an inner collar disposed within the fixed collar, the inner collar at least one of: coupled to and positioned between a first portion of the conduit at least partially disposed in the chamber and a second portion of the conduit at least partially disposed outside of the chamber; or integrally formed with and positioned between the first portion of the conduit at least partially disposed in the chamber and the second portion of the conduit at least partially disposed outside of the chamber.
However, Glickman further teaches further comprising an alignment assembly disposed on a first end of the fluid impermeable barrier (ratchet mechanism 18 at the first end of device; Figure 10; Paragraph 0035), the alignment assembly including: a fixed collar operably coupled to the fluid impermeable barrier (elongate members 20 with barbs 19; Figure 10; Paragraph 0035); and an inner collar disposed within the fixed collar (receiving portion 22 with the teeth is within the elongate members 20 with barbs 19; Paragraph 0035).
Sanchez in view of Glickman and Glickman are both considered to be analogous to the claimed invention because they are in the same field of urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez in view of Glickman to incorporate the teachings of Glickman and have the alignment assembly of Glickman on the device of Sanchez at the first end of the fluid impermeable barrier of Sanchez. This allows for the user to lock the flow configuration of the device to prevent re-use of the device (Glickman; Paragraph 0035).
The combination of Sanchez in view of Glickman does not teach the inner collar at least one of: coupled to and positioned between a first portion of the conduit at least partially disposed in the chamber and a second portion of the conduit at least partially disposed outside of the chamber; or integrally formed with and positioned between the first portion of the conduit at least partially disposed in the chamber and the second portion of the conduit at least partially disposed outside of the chamber.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the inner collar located between a first portion and a second portion of the conduit, since it has been held that rearranging parts of an invention involves only routine skill in the art since the device would not perform differently than the prior art device, whether located between the first and second portion of the conduit or outside of the first and second portion, with the common function at either locations of allowing the user to manipulate the alignment of the first and second holes of the device, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
The modified combination of Sanchez in view of Glickman further teaches the inner collar at least one of: coupled to and positioned between a first portion of the conduit at least partially disposed in the chamber and a second portion of the conduit at least partially disposed outside of the chamber (see combination 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.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781