DETAILED ACTION
This office action is in response to the preliminary amendment filed 11/4/2022. As directed by the amendment, claims 26, 42, 44, and 46 have been amended, claims 5, 7, 9, 11, 13, 15, 17-19, 21-25, 27, 29, 31, 33, 36-41, 43, 45, and 47-63 have been cancelled, and no claims have been newly added. Thus, claims 1-4, 6, 8, 10, 12, 14, 16, 20, 26, 28, 30, 32, 34-35, 42, 44 and 46 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8, line 5 recites “a waste collection contained receiving waste from a subject”; it is suggested to amend the claim to recite --configured to receive waste from a subject-- so that it is clear that the human body is not being claimed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 32 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 32 recites the limitation "the controller" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 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.
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, 6, 8, 10, 14, 28, 32, 34-35, 42, 44 and 46 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al (2014/0366874) in view of Plahey et al (2007/0112297).
Regarding claim 1, Deutsch discloses a fluid distribution device for mechanical ventilation, comprising: a disposable pneumatic module (132) which includes a disposable enclosure (as it can be detached from housing (132)) (para [0110]), wherein the disposable pneumatic module (132) is connected to modules including a rinsing module (152) for executing the rinsing operation, a suctioning module (154) for executing the suctioning operation, a cuff inflation module (156) for executing the cuff inflation operation, a leak detection module (158) for executing the leak detection operation and a venting module (160) for executing the venting operation or controlling flow in a tracheal tube device (102) (para [0122]), wherein the pneumatic module (132) includes outlets to connect to lines (106a, 106b) to connect the modules to fluid lines of said tracheal tube device and controlled using valves (para [0126]).
Deutsch does not disclose the device includes a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by a valve system; wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device.
However, Plahey teaches a cassette fluid distribution system for a medical device, including a housing (20) (housing of cassette) (para [0036]), as shown in the annotated fig 11 above, discloses a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by a valve system (as shown in the annotated fig 11, left side of the device includes a first manifold for receiving inputs, and right side of device includes a second manifold for receiving outputs, with the first manifold and second manifold connected to one another and controlling using valve system including valves (1-16)), wherein said first manifold comprises a fluid inlet for receiving fluid (first manifold includes fluid inlets (11-15) and drain (10) to waste bag) (para [0060]), and wherein said second manifold comprises a plurality of fluid distribution ports (second manifold includes fluid outlets (6-7)) (para [0060]) adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device (as shown in figs 13A-C, valves (1-16) can be selectively opened and closed to provide different paths to different inputs and outputs) (para [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Deutsch by configuring the pneumatic module to includes a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by a valve system; wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device as taught by Plahey in order to provide maximum flexibility in functionality for the pneumatic module to provide different flow paths (Plahey, para [0013], [0071]).
Regarding claim 2 the modified Deutsch’s references discloses the second manifold (fig 11 of Plahey) is structured to established separate flow paths to at least two different distribution ports (as shown in fig 11 of Plahey, second manifold has includes multiple distributions ports (6-7 of Plahey), and Deutsch discloses that outlet includes at least three fluid distribution ports comprising fluid lines (106a, b) and cuff inflation lumen (106c) (para [0093]), and can provide a first fluid flow path between rinsing module (152) and either fluid line (102a, b) (para [0126]) and a second fluid flow path between cuff inflation module (156) and cuff inflation line (106c) (para [0144]).
Regarding claim 3, the modified Deutsch’s references discloses said separate flow paths comprise a first fluid path between a first pair of fluid interconnectors and a first distribution port (first fluid path between rinsing module (152 of Deutsch) and either fluid line (102a, b of Deutsch) (Deutsch, para [0126]) can include an interconnector controlling input of fluid in first manifold (11 of Plahey) and interconnector controlling input of fluid in second manifold (6 of Plahey)), and a second fluid path between a second pair of fluid interconnectors and a second distribution port (a second fluid flow path between cuff inflation module (156 of Deutsch) and cuff inflation line (106c of Deutsch) (Deutsch, para [0144]) can include an interconnector controlling input of fluid in first manifold (11 of Plahey) and interconnector controlling input of fluid in second manifold (6 of Plahey)).
Regarding claim 4, the modified Deutsch’s references discloses the second manifold (fig 11 of Plahey) is structured to established separate flow paths a plurality of fluid distribution ports (as shown in fig 11 of Plahey, second manifold includes multiple distributions ports (6-7 of Plahey), and Deutsch discloses that outlet includes at least three fluid distribution ports comprising fluid lines (106a, b) and cuff inflation lumen (106c) (para [0093])
Regarding claim 6, Deutsch discloses said disposable fluid connectors comprise a disposable cuff inflation connector connectable to a compatible control panel cuff inflation connector (pneumatic module (132) connects to a cuff inflation module (156) (para [0144]), and an outlet comprising a cuff inflation port (106c) for establishing a fluid communication between said disposable cuff inflation connector and a cuff inflation line of said tracheal tube device (para [0144]), and the modified Deutsch’s reference discloses that the second manifold connects to outlets of distributions ports (6-7 of Plahey), and therefore the cuff inflation port comprising an outlet would be disposed on the second manifold.
Regarding claim 8, Deutsch discloses disposable fluid connectors comprise a disposable vacuum connector connectable to a compatible control panel vacuum connector (pneumatic module (132) connects to a suctioning module (154) (para [0134]), and a vacuum port (134) for establishing a fluid communication between said disposable vacuum connector (154) and a vacuum line (line connecting vacuum port (134) and drain collection container (138)) () generating under pressure in a waste collection container (138) receiving waste fluid from a subject (para [0100]), and the modified Deutsch’s reference discloses that the second manifold connects to outlets of distributions ports (6-7 of Plahey), and therefore the vacuum port comprising an outlet would be disposed on the second manifold.
Regarding claim 10, Deutsch discloses a waste port (136) (drain vacuum connector) connectable to a waste line (137) (trap line) (para [0137]) delivering said waste fluid to said waste collection container (para [0100]); and the modified Deutsch’s references disclose that the waste port (10 of Plahey) (drain line) is disposed on the first manifold (see fig 11 of Plahey) (Plahey, para [0060]).
Regarding claim 14, the modified Deutsch’s reference in fig 11 of Plahey discloses the first manifold comprises at least two separate channels therein (as shown in fig 11 of Plahey, first manifold includes a channel for a drain (10) and channels for inputs (11-14)) (Plahey, para [0060]).
Regarding claim 28, the modified Deutsch’s reference discloses said valve system comprises a plurality of movable pressing members (1-15 of Plahey) (small dome shaped flexible pod like diaphragms forming occludable valves) each aligned to engage a wall of one of said fluid interconnectors (para [0059]), such that a motion of a pressing member toward a respective wall generates a compressive force on said respective wall and restricts or ceases flow through a respective fluid interconnector (para [0062]).
Regarding claim 32, Deutsch discloses a device whose ordinary use discloses a method of distributing fluid within a tracheal tube device, the method comprising the steps of: connecting the device according to claim 1 to a control system; and operating said controller of said control system (120) to transmit control signals to said valve system (pneumatic module (132) includes valves which is controlled by controller (120)) (para [0109]).
Regarding claim 34, Deutsch discloses a system for controlling and monitoring flow in a cuffed tracheal tube device, comprising: a connector panel adapted for connecting to a disposable enclosure of a fluid distribution device, and adapted for connecting to disposable fluid connectors of said fluid distribution device (as shown in fig 1B), fluid distribution device (132) is configured to be detached by device (100), and therefore would include connectors to connect to between the input modules shown in fig 1A and the connector panel with the outputs shown in fig 1A) (para [0110]); a valve system, configured for selectively controlling flow within said fluid distribution device (132) (pneumatic module) (pneumatic module (132) includes an arrangement of valves); and a controller (120) configured to transmit control signals to said valve system (arrangement of valves is controlled by the controller (120)) (para [0109]);
Deutsch does not disclose said fluid distribution device comprises a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each controllable by said valve system, wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between fluid interconnectors and fluid lines of said tracheal tube device.
However, Plahey teaches a cassette fluid distribution system for a medical device, including a housing (20) (housing of cassette) (para [0036]), as shown in the annotated fig 11 above, discloses a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by a valve system (as shown in the annotated fig 11, left side of the device includes a first manifold for receiving inputs, and right side of device includes a second manifold for receiving outputs, with the first manifold and second manifold connected to one another and controlling using valve system including valves (1-16)), wherein said first manifold comprises a fluid inlet for receiving fluid (first manifold includes fluid inlets (11-15) and drain (10) to waste bag) (para [0060]), and wherein said second manifold comprises a plurality of fluid distribution ports (second manifold includes fluid outlets (6-7)) (para [0060]) adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device (as shown in figs 13A-C, valves (1-16) can be selectively opened and closed to provide different paths to different inputs and outputs) (para [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Deutsch by configuring the pneumatic module to includes a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by a valve system; wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device as taught by Plahey in order to provide maximum flexibility in functionality for the pneumatic module to provide different flow paths (Plahey, para [0013], [0071]).
Regarding claim 35, Deutsch discloses a device whose ordinary use discloses method of distributing fluid within a tracheal tube device, the method comprising: connecting a fluid distribution device (132) (pneumatic module) to a control system (120) (controller) controlling flow in a tracheal tube device (pneumatic module (132) includes an arrangement of valves controlled by the controller (120)) (para [0109]); and operating a controller (120) of said control system to transmit control signals to a valve system controlling flow within said fluid distribution device (132) (arrangement of valves is controlled by controller (120)) (para [0109]); wherein said fluid distribution device comprises: a disposable enclosure (pneumatic module (132) is disposable, and as it can be detached from housing (132), is considered to include a housing) (para [0110]).
Deutsch does not disclose the fluid distribution device includes disposable fluid connectors connectable to compatible panel connectors of said control system; and a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by said valve system, wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between fluid interconnectors and fluid lines of said tracheal tube device.
However, Plahey teaches a cassette fluid distribution system for a medical device, including a housing (20) (housing of cassette) (para [0036]), and as shown in the annotated fig 11 above, discloses disposable fluid connectors (10-15) (fluid inlets (10-15) are connectable to fluid inlets and outlets) (para [0060]) and as shown in the annotated fig 11 discloses a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by said valve system (as shown in the annotated fig 11, left side of the device includes a first manifold for receiving inputs, and right side of device includes a second manifold for receiving outputs, with the first manifold and second manifold connected to one another and controlling using valve system including valves (1-16)), wherein said first manifold comprises a fluid inlet for receiving fluid (first manifold includes fluid inlets (11-15) and drain (10) to waste bag) (para [0060]), and wherein said second manifold comprises a plurality of fluid distribution ports (second manifold includes fluid outlets (6-7)) (para [0060]) adapted for establishing fluid communications between said fluid interconnectors and fluid lines of said tracheal tube device (as shown in figs 13A-C, valves (1-16) can be selectively opened and closed to provide different paths to different inputs and outputs) (para [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to method the device of Deutsch by configuring the fluid distribution device to include disposable fluid connectors connectable to compatible panel connectors of said control system; and a first manifold and a second manifold, both mounted within said disposable enclosure and being connected to each other via a plurality of fluid interconnectors each being controllable by said valve system, wherein said first manifold comprises a fluid inlet for receiving fluid from one of said panel connectors, and wherein said second manifold comprises a plurality of fluid distribution ports adapted for establishing fluid communications between fluid interconnectors and fluid lines of said tracheal tube device as taught by Plahey in order to provide maximum flexibility in functionality for the pneumatic module to provide different flow paths (Plahey, para [0013], [0071]).
Regarding claim 42, Deutsch discloses said control signals comprise a signal causing said valve system to open a fluid path from a fluid distribution port (106a) to a waste port (136) (device can perform a suctioning operation from line (106a) to trap line (137) and into trap bottle (138) (para [307]).
Regarding claim 44, Deutsch discloses said signal also causes said valve system to simultaneously open another fluid path from a panel connector of said control system to another fluid distribution port (106b) (venting operation is performed through line (106b)) (para [0307]).
Regarding claim 46, Deutsch discloses said control signals comprise a signal causing said valve system to open a fluid path from a panel connector of said control system to a vacuum source (134) (outlet of container (139) can be connected to a vacuum source (134), and from the vacuum source (134) to a waste port (136) (drain vacuum connector) (para [0100]), and the modified Deutsch’s reference discloses that each port includes an interconnector (1-15 of Plahey) (Plahey, fig 11), and therefore, the vacuum source and waste port each include an interconnector).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al and Plahey et al as applied to claim 1 above, and further in view of Suzuki et al (2004/0031756).
Regarding claim 26, modified Deutsch discloses a disposable enclosure.
Modified Deutsch does not disclose said disposable enclosure comprises a window exposing said fluid interconnectors to allow said valve system to engage said fluid interconnectors.
However, Suzuki teaches a fluid distribution device including a disposable enclosure (81) (cassette body), wherein the enclosure (81) includes a window (8b) (openings) (para [0083]) exposing fluid interconnectors (flow passage switching portion includes clamps (111-118) (para [0088]) to allow a valve system comprising dampers (240) (para [0083]) to engage said fluid interconnectors (111-118) (para [0088]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to substitute the flexible dome valve system of modified Deutsch with a valve system including dampers, wherein the fluid distribution device includes an enclosure with a window exposing said fluid interconnectors to allow the dampers to engage said fluid interconnectors, as it would be a simple substitution of one known means of opening and closing fluid interconnectors in a disposable fluid distribution device for another, and it appears that the device of modified Deutsch would perform equally well to control the opening and closing of the interconnectors of the valve system includes dampers to engage the fluid interconnectors via a window exposing said fluid interconnectors to allow said valve system to engage said fluid interconnectors. See MPEP 2143(I)(B).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al and Plahey et al as applied to claim 28 above, and further in view of Nichols et al (2003/0230303).
Regarding claim 30, modified Deutsch discloses said valve system comprises dome shaped diaphragms which is opened and closed by pressing members comprising piston heads (Plahey, para [0059]).
Modified Deutsch does not disclose said valve system comprises a cam shaft having a plurality of cams each aligned with one of said pressing members in a manner that rotation of a cam establishes a linear motion of a respective pressing member.
However, Nichols teaches a respiratory device including a valve system including a plurality of pressing members (120a, 124a, 130a) (valve plungers) and a cam shaft (132) having a plurality of cams (132b-e) (camshaft lobes) each aligned with one of said pressing members (120a, 124, 130) in a manner that rotation of a cam (132b-e) establishes a linear motion of a respective pressing member (120a, 124a, 130a) (para [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Deutsch so that the valve system comprises a cam shaft having a plurality of cams each aligned with one of said pressing members in a manner that rotation of a cam establishes a linear motion of a respective pressing member as taught by Nichols, as the use of a camshaft having a plurality of cams configured so that rotation of a cam establishes a linear motion of a respective pressing member is known in the art, and it appears that the device of modified Deutsch would perform equally well to provide a linear motion to a respective pressing member if the valve system comprises a cam shaft having a plurality of cams.
Allowable Subject Matter
Claims 12, 16, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Deutsch et al (2014/0366874) and Plahey et al (2007/0112297) disclose the limitations of claims 1 and 10. However, neither Deutsch et al, Plahey et al, or the other prior art of record, disclose said first manifold comprises therein a first fluid channel and a second fluid channel separated from each other, and wherein said waste port of said first manifold is constituted to be fed by fluid from said second fluid channel, and is fluidly separated within said first manifold from said first fluid channel as recited in claim 12, said disposable fluid connectors comprise a disposable fluid inlet connector connectable to a compatible gas supply panel connector of said control system, wherein a first fluid channel is in fluid communication with said disposable fluid inlet connector, and wherein a second fluid channel is fluidly separated within said first manifold from said disposable fluid inlet connector as recited in claim 16, and a saline inlet port connectable to saline supply line, wherein a first fluid channel is constituted to be fed by saline from said saline inlet port, and wherein a second fluid channel is fluidly separated within said first manifold from said saline inlet port as recited in claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Madsen et al (2004/0221842) discloses an endotracheal tube that provides irrigation and suction, and Shah et al (7,790,103), Childers (2004/0019313), and Demers et al (11,975,128) disclose disposable fluid distribution devices for a medical device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-48354835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785