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 amended claims 1, 3, 6, and 11. Claims 1-16 are currently pending.
Response to Arguments
Applicant’s arguments, see page 5 of Applicant’s Remarks, filed 12/22/25, with respect to the rejections of claims 1 and 6 under 35 U.S.C. 112(b) as being indefinite have been fully considered and are persuasive in light of the amendments to claims 1 and 6. Accordingly, the rejections have been withdrawn.
Applicant’s arguments, see pages 5-8 of Applicant’s Remarks, with respect to the rejections of claims 1-2, 6-7, 11, 14-15 under 35 U.S.C. 102(a)(1) as anticipated by Michaels, of claims 3-4 under 35 U.S.C. 103 as being unpatentable over Michaels in view of Wright, of claim 5 as unpatentable over Michaels in view of Superfos, of claims 8-9 as unpatentable over Michaels in view of Pavlik, of claim 12 as unpatentable over Michaels in view of Asher, of claim 13 as unpatentable over Michaels in view of Fomby, and of claim 16 as unpatentable over Michaels in view of Puderbaugh have been fully considered and are persuasive in light of the amendment to claim 1. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 6-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels et al. (US 2005/0183780 A1) in view of Pavlik (US 2015/0290448 A1).
Regarding claim 1, Michaels discloses a fluid collection device (Figs. 1 and 2A-5, feat. 12; ¶0034-0035: container 12 is a fluid waste collection receptacle, and is therefore a fluid collection device), comprising: a fluid collection container (Figs. 2A-5, feat. 12; ¶0035) comprising a vent (230; ¶0035: port 230 is open to the environment when uncapped, and would therefore vent pressure from inside the container); and an adapter (Figs. 1 and 2D-5, feats. 40 and 60; ¶0039-0040) including a connecting portion configured to removably couple with the fluid collection container over the vent (Figs. 3-5 and 11-12, feat. 40; ¶0042-0044) and a port attachable to the connecting portion (Figs. 3-5, feat. 60; ¶0045-0046), wherein the connecting portion (40) includes a top surface (Annotated Fig. 11, feat. A) defining an aperture (Annotated Fig. 11, feat. B) and one or more side panels coupled to the top surface (Annotated Fig. 11, feat. C), the top surface and the one or more side panels defining an interior portion (Annotated Fig. 11, feat. D), the port having a non-sealed position (Figs. 1 and 4, feat. 60) and a sealed position (Fig. 5, feat. 60) with respect to the vent when the connecting portion is coupled to the fluid collection container and positioned over the vent (Figs. 3-5, feats. 40 and 230), wherein in the non-sealed position, the vent is in fluid communication with a surrounding environment (Fig. 3, feats. 40 and 230; ¶0042-0044: vent 230 is open to the environment through inner wall 106 of the connecting portion 40 of the adapter).
Michaels does not disclose that the port is attached to the top surface of the connecting portion.
Pavlik teaches an aseptic connector (Figs. 1-3, feat. 100; ¶0023-0033) comprising a connecting portion (Figs. 1-3, feat. 210; ¶0027) which connects to a container (Fig. 3, feat. 301) and a conduit or port portion (105; ¶0023). The port portion (Figs. 1-3, feat. 105; ¶0023) is slidably held within a channel (107) formed in pivoting or hinging portion (Fig. 2, feat. 103) held in a body portion (Fig. 2, feat. 101) attached to the connecting portion (Fig. 2, feat. 210). Such a configuration allows the port portion (105) to be rotated from a disconnected configuration in which the port is not in fluid communication with the container (Fig. 2), which corresponds to the non-sealed position of Michaels, to a connected configuration in which the port is in fluid communication with the container (Fig. 3), which corresponds to the sealed position of Michaels (¶0028-0029). Pavlik teaches that this advantageously maintains the sterility of the connection system and container (¶0007-0015). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Michaels so that the port is attached to the top surface of the connecting portion by a hinge like the one taught by Pavlik in order to maintain
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[AltContent: textbox (Annotated Fig. 11: Adapted from figures 11 and 12 of Michaels to show
A: an annular top surface
B: the aperture defined by the top surface
C: an annular side panel
D: the annular interior portion defined by the top surface and side panel)]the sterility of the connection system and container as taught by Pavlik.
Regarding claim 2, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses that the vent of the fluid collection container is an outlet vent configured to passively expel displaced gas (Figs. 2A-3, feat. 230; ¶0035 and 0042-0044: vent 230 is open to the environment when uncapped and the adapter port is not attached, and therefore allows pressure equalization through it).
Regarding claim 6, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses that the port (Figs. 3-5, feat. 60) in the sealed position (Fig. 5, feat. 60) is positioned perpendicular to an upper surface of the fluid collection device (Fig. 5, feat. 16; ¶0034).
Regarding claim 7, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses that the port is shaped as a hollow cylinder (Figs. 4-5, feat. 60).
Regarding claim 8, Michaels in view of Pavlik suggests the device of claim 1. As discussed above, Pavlik teaches an aseptic connector (Figs. 1-3, feat. 100; ¶0023-0033) comprising a connecting portion (Figs. 1-3, feat. 210; ¶0027) which connects to a container (Fig. 3, feat. 301) and a conduit or port portion (105; ¶0023). The port portion (Figs. 1-3, feat. 105; ¶0023) is slidably held within a channel (107) formed in pivoting or hinging portion (Fig. 2, feat. 103) held in a body portion (Fig. 2, feat. 101) attached to the connecting portion (Fig. 2, feat. 210). Such a configuration allows the port portion (105) to be rotated from a disconnected configuration in which the port is not in fluid communication with the container (Fig. 2), which corresponds to the non-sealed position of Michaels, to a connected configuration in which the port is in fluid communication with the container (Fig. 3), which corresponds to the sealed position of Michaels (¶0028-0029). Pavlik teaches that this advantageously maintains the sterility of the connection system and container (¶0007-0015). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik so that the port is attached to the connecting portion via a hinge, and wherein transitioning from the non-sealed position to the sealed position includes rotating the port from a horizontal position to a vertical position in order to maintain the sterility of the connection system and container as taught by Pavlik.
Regarding claim 9, Michaels in view of Pavlik suggests the device of claim 8. As discussed above, Pavlik teaches that the port portion (Fig. 2, feat. 105) is slidably held within a channel (107) formed in pivoting or hinging portion (Fig. 2, feat. 103) held in a body portion (Fig. 2, feat. 101) attached to the connecting portion (Fig. 2, feat. 210). Therefore, Michaels in view of Pavlik further suggests that the connecting portion includes a cavity configured to accommodate the port in the non-sealed position.
Regarding claim 10, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses that the port (Figs. 4-5, feat. 60) includes a protrusion (176) configured for receipt into a recess (Figs. 3 and 5: the space between inner wall 106 and outer wall 104) in the connecting portion (Figs. 3 and 5, feat. 40) to lock the port in the sealed position (Fig. 5; ¶0045-0046).
Regarding claim 11, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses that the port (Figs. 1 and 4, feat. 60) is initially unattached to the connecting portion (Figs. 1 and 3, feat. 40), wherein the aperture (Annotated Fig. 11, feat. B) is configured to receive a bottom section of the port (Figs. 3 and 5, feat. 176), and wherein the connecting portion is configured to couple to the fluid collection container prior to attaching the port to the connecting portion (Figs. 1 and 2D-3, feat. 40).
Regarding claim 14, Michaels in view of Pavlik suggests the device of claim 1. Michaels further discloses that the fluid collection container is a medical receptacle for liquid waste (Figs. 1 and 2A-5, feat. 12; ¶0034). Therefore, the container is configured to collect urine, which is a medical liquid waste. Therefore, Michaels in view of Pavlik further suggests that the fluid collection container is configured to collect urine.
Regarding claim 15, Michaels in view of Pavlik suggests the device of claim 1, and Michaels further discloses a gas suction line configured for connection to the adapter to remove gas from the fluid collection container when the port is in the sealed position (Figs. 1, 4, and 5, feat. 30; ¶0045-0048).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of Pavlik and in further view of Wright et al. (US 2005/0245898 A1).
Regarding claim 3, Michaels in view of Pavlik suggests the device of claim 1, but does not disclose that the connecting portion includes opposing longitudinal ridges in an interior portion, wherein the fluid collection container includes a rim around an upper surface, and wherein the opposing longitudinal ridges are configured to removably couple the adapter to the fluid collection container.
Wright teaches a quick connection system (Figs. 1-3, feats. 12 and 18; ¶0019; Fig. 8, feats. 60 and 62; ¶0032; Fig. 9, feats. 80 and 90; ¶0033-0034) for sealingly connecting irrigation (14, 64, 86) and aspiration (16, 66, 88) lines to a surgical handpiece (10, 58, 90). The quick connection system may comprise a keyed body comprising a rim or flange (Fig. 8, feat. 62; ¶0032; Fig. 9, feat. 94; ¶0034) which mates with a slot defined by opposing longitudinal ridges extending inwards (Fig. 8, feat. 70; ¶0032; Fig. 9, feat. 98; ¶0034). Wright teaches that such a quick connect system advantageously prevents improper connections associated with manual press-fitting, such as press-fitting the connecting portion (Michaels: Figs. 2D-5, feat. 40) and the vent (Michaels: Figs. 2A-5, feat. 230) of Michaels, by ensuring that the lines are properly connected (¶0006-0007). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik so that the connecting portion includes opposing longitudinal ridges in an interior portion, wherein the fluid collection container includes a rim around an upper surface, and wherein the opposing longitudinal ridges are configured to removably couple the adapter to the fluid collection container in order to ensure that there is a proper connection between the connecting portion of the adapter and the vent as taught by Wright.
Regarding claim 4, Michaels in view of Pavlik and in further view of Wright suggests the device of claim 3. As discussed above, Wright teaches a quick connection system comprising a keyed body comprising a rim or flange (Fig. 8, feat. 62; ¶0032; Fig. 9, feat. 94; ¶0034) which mates with a slot defined by opposing longitudinal ridges extending inwards (Fig. 8, feat. 70; ¶0032; Fig. 9, feat. 98; ¶0034). Wright further teaches that the keyed body may mated with the slot by sliding (Fig. 8, feat. 68; ¶0032; Fig. 9, feat. 92; ¶0034). Therefore, Michaels in view of Pavlik and in further view of Wright further suggests that the adapter is configured to couple to the fluid container by sliding the longitudinal ridges under the rim. Wright teaches that the slots are defined by flat longitudinal ridges (Fig. 8, feat. 70; Fig. 9, feat. 98), instead of the claimed rounded ridges. However, changing the flat longitudinal ridges of Wright so that they are rounded is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the claimed rounded ridges are significant. Please see MPEP §2144.04(IV)(B). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik and in further view of Wright so that the opposing longitudinal ridges are rounded.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of Pavlik, in further view of Wright, and in further view of Superfos (GB 1408821 A).
Regarding claim 5, Michaels in view of Pavlik and in further view of Wright suggests the device of claim 3, but does not disclose that the opposing longitudinal ridges include a flat top side and a tapered edge extending under the flat top side, and wherein the adapter is configured to couple to the fluid container by pressing the connecting portion onto the fluid container until the flat top side is under the rim.
Superfos teaches a container (Fig. 1, feat. 1; Page 2, lines 20-28) comprising a flange or rim (4) with a downwardly directed face (5) and an upper rim portion (6). Superfos further teaches a cover (Figs. 1-2, feat. 7; Page 2, lines 28-60) comprising an outer flange portion (Fig. 2, feat. 11) with a shoulder or ridge with a flat top side and tapered edge (13) which allows the cover to slide under the downwardly directed face (5) of the rim (4) of the container by applying a downward pressure (Page 2, lines 50-60). Superfos teaches that this advantageously provides a seal between the cover (7) and the upper rim portion (6) of the container (Page 2, lines 50-60). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik and in further view of Wright so that the opposing longitudinal ridges include a flat top side and a tapered edge extending under the flat top side, and wherein the adapter is configured to couple to the fluid container by pressing the connecting portion onto the fluid container until the flat top side is under the rim in order to provide a seal between the connecting portion of the adapter and the container as taught by Superfos.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of Pavlik and in further view of Asher (US 4,266,689 A).
Regarding claim 12, Michaels in view of Pavlik suggests the device of claim 11, but does not disclose that the aperture of the connecting portion includes a ringed lip, wherein the port includes an exterior ridge, and wherein the port is configured to attach to the connecting portion by pressing the exterior ridge into the ringed lip.
Asher teaches a closure (Figs. 1-2, feat. 12; Col. 2, lines 4-33) for a container (11). The container comprises a ringed lip (Fig. 2, feat. 24) and the closure comprises an exterior ridge (Fig. 2, feat. 27) such that the closure is inserted into the container opening by pushing the ridge past the ringed lip (Col. 2, lines 34-49). Asher teaches that such a connection is easily removable and resealable (Col. 1, lines 31-41). Modifying the device of Michaels so that the outer wall (Michaels: Figs. 3 and 5, feat. 104) of the connecting portion (Michaels: Figs. 3 and 5, feat. 40) includes the ringed lip of Asher and the inlet (Michaels: Figs. 4-5, feat. 176) of the port (Michaels: Figs. 4-5, feat. 60) includes the external ridge of Asher would provide an easily removable and resealable connection as taught by Asher. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik so that the aperture of the connecting portion includes a ringed lip, wherein the port includes an exterior ridge, and wherein the port is configured to attach to the connecting portion by pressing the exterior ridge into the ringed lip in order to provide an easily removable and resealable connection as taught by Asher.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of Pavlik and in further view of Fomby (US 4,711,365 A).
Regarding claim 13, Michaels in view of Pavlik suggests the device of claim 11, but does not disclose that the aperture of the connecting portion includes a threaded interior, wherein the port includes exterior threads, and wherein the port is configured to attach to the connecting portion by rotating the port exterior threads into the threaded interior.
Fomby teaches a container (Figs. 1-2, feat. 12; Col. 3, line 35 – Col. 4, line 37) and a corresponding closure (14) in which the container comprises interior threads (24; Col. 3, line 43 – Col. 4, line 9) on the inner surface of the sidewalls (18) and the closure includes exterior threads (26; Col. 4, lines 10-37). Fomby teaches that such a connection system is inexpensive to manufacture (Col. 2, line 62 – Col. 3, line 12). Modifying the device of Michaels so that the outer wall (Michaels: Figs. 3 and 5, feat. 104) of the connecting portion (Michaels: Figs. 3 and 5, feat. 40) includes the interior threads of Fomby and the inlet (Michaels: Figs. 4-5, feat. 176) of the port (Michaels: Figs. 4-5, feat. 60) includes the external threads of Fomby would help make the device inexpensive to manufacture as taught by Fomby. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik so that the aperture of the connecting portion includes a threaded interior, wherein the port includes exterior threads, and wherein the port is configured to attach to the connecting portion by rotating the port exterior threads into the threaded interior to help make the device inexpensive to manufacture as taught by Fomby.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Michaels in view of Pavlik and in further view of Puderbaugh et al. (US 4,013,076 A).
Regarding claim 16, Michaels in view of Pavlik suggests the device of claim 15, but does not disclose a collection bag coupled to the vent of the fluid collection container, wherein the gas suction line is configured to remove gas from the collection bag.
Puderbaugh teaches a fluid collection device (Figs. 1-5, feat. 10; Col. 3, lines 14-25) comprising an inlet port (26) and a vent (28) which may be connected to a suction source via an adapter (30; Col. 5, line 13 – Col. 6, line 2). Puderbaugh further teaches that the device may include a collection bag (Fig. 5, feat. 50; Col. 3, line 67 – Col. 4, line 50) in fluid communication with both the inlet port (26) and the vent (28; Col. 1, line 62 – Col. 2, line 24). Puderbaugh teaches that such a collection bag advantageously acts as a liner for the container (Col. 1, line 62 – Col. 2, line 24). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Michaels in view of Pavlik so that it includes a collection bag coupled to the vent of the fluid collection container, wherein the gas suction line is configured to remove gas from the collection bag in order to provide a liner to the container as taught by Puderbaugh.
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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781