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 .
Information Disclosure Statement
The information disclosure statements filed on 02/14/2024, 09/11/2024, 12/02/2024, 04/29/2025, and 08/13/2025 have been received and considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 18, and 20-21 of U.S. Patent No. 11,786,683B2 (hereinafter ‘683).
Regarding claim 1, ‘683 discloses an irrigating cannula system for use with a tracheostomy, comprising: an outer cannula comprising a suction fitting for connecting to a source of suction; and an inner cannula sized to be inserted in the outer cannula, the inner cannula comprising: an outer surface; a plurality of longitudinal ridges on the outer surface that abut a lumen of the outer cannula and divide an annular space between the inner cannula and the outer cannula into at least a first chamber and a second chamber; a ledge formed at a proximal end of the at least first and second chambers, the ledge abutting the lumen of the outer cannula; and a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula; wherein the second chamber is coupled to the suction fitting to draw secretions from the first chamber, through a lumen of inner cannula into the second chamber and out of the suction fitting (Claim 5).
Regarding claim 2, ‘683 discloses the limitations (Claim 5).
Regarding claim 3, ‘683 discloses an irrigating cannula system comprising: an outer cannula comprising a suction fitting for connecting to a source of suction and an irrigation fitting for connecting to a source of irrigant; an inner cannula sized to be inserted in the outer cannula, the inner cannula comprising: an outer surface; a plurality of longitudinal ridges on the outer surface that abut a lumen of the outer cannula and divide an annular space between the inner cannula and the outer cannula into at least a first chamber and a second chamber; a ledge at a proximal end of each chamber of the plurality of chambers, the ledge abutting the lumen of the outer cannula; and a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula; wherein a first chamber of the plurality of chambers is coupled to the irrigation fitting to receive irrigant from the source of irrigant and a second chamber is coupled to the suction fitting to draw secretions and irrigant from the first chamber, through a lumen of inner cannula into the second chamber and out of the suction fitting; an irrigant line attached to the irrigation fitting; a suction line attached to the suction fitting; and an actuating device coupled between the irrigant line and a source of irrigant and coupled between the suction line and a vacuum source, said actuating device controllably connecting the irrigant line to the source of irrigant and the suction line to the vacuum source (Claim 5).
Regarding claim 4-11, ‘683 discloses these limitations (Claims 6-13)
Regarding claim 14, ‘683 discloses a method of cleaning a tracheostomy tube comprising an outer cannula and an inner cannula comprising a plurality of holes and one or more ridges dividing an airspace between the outer tracheostomy tube and the inner cannula into a plurality of regions when the inner cannula is inserted in the outer tracheostomy tube, the method comprising: attaching a suction line to the inner cannula so that it is in communication with a first region of the plurality of regions; attaching an actuating device between the suction line and a vacuum source, said actuating device controllably connecting the suction line to the vacuum source; and controlling the actuating device to suction from a lumen of the inner cannula through a first portion of the plurality of holes, the first region and the suction line (1 and 20).
Regarding claim 15, ‘683 discloses the limitations (Claims 1, 20, and 21).
Claims 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of ‘683 in view of WO2018178098A1 to Schnell et al. (hereinafter “Schnell”).
Regarding claims 12 and 13, ‘683 in view of Schnell discloses the limitations of claims 12 and 13 (Paragraph 0001 discloses the present invention is a tracheostomy tube; Fig. 4 shows cuff 6; Paragraph 0018 discloses the cuff 6 may be present in the system; Figs. 1 & 4 show the cannula system may be fenestrated or non-fenestrated; Paragraph 0001 discloses the present invention is a tracheostomy tube).
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 are rejected under 35 U.S.C. 103 as being unpatentable over Schnell in view of US20120247473A1 to Fendler (hereinafter “Fendler”).
Regarding claim 1, Schnell discloses an irrigating cannula system for use with a tracheostomy (See Figs. 1 and 2 generally; Paragraph 0005 discloses a flushing fluid can be supplied and sucked off), comprising:
an outer cannula (Figs. 2 & 4 profile 3 and connector 3d; Paragraph 0018 discloses connector 3d is manufactured together with profile elements 3 as a single piece) comprising a suction fitting for connecting to a source of suction (Paragraph 0006 discloses any one of the separate lines 4 may be used to accommodate a suction hose); and an inner cannula sized to be inserted in the outer cannula (Fig. 1 cannula tube 2; Fig. 3a shows cannula tube 2 slides into tracheal cannula 1), the inner cannula comprising:
an outer surface (Fig. 1 shows cannula 2 has an outer surface);
a plurality of longitudinal ridges on the outer surface that abut a lumen of the outer cannula (Figs. 1 & 3a latching noses 5b abuts profile elements 3) and divide an annular space between the inner cannula and the outer cannula into at least a first chamber and a second chamber (Fig. 3b separate lines 4; Paragraph 0015 discloses the grooves 2a and their respectively facing surfaces of the cannula tube 2 define the inner cross section of the separate lines 4, which are consequently formed between mutually facing surfaces of the profile element 3 and recess 2e; Examiner notes there are chambers formed by each of the separate lines; Examiner further notes the first chamber would be associated with an irrigation line and the second chamber would be associated with a suction line);
a ledge formed at a proximal end of the at least first and second chambers, the ledge abutting the lumen of the outer cannula (Examiner notes there are ledges formed at the proximal end of each of the ends of separate lines 4, and the top of the line 4 abuts the outer cannula 3; Examiner further notes broadest reasonable interpretation of a ledge would be a where a surface comes to an end).
Schnell does not disclose a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula. However, Fendler teaches an inner cannula with holes and ridges that has an aspiration line connected to an outer tube surface through a passage (Fig. 3 suction openings 22 on inner cannula 16; Webs 28 on inner cannula 16’s outer surface).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Schnell to use an inner cannula with a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula, as taught by Fendler, in order to aspirate the sputum as efficiently as possible (Paragraph 0034).
Modified Schnell discloses wherein the second chamber is coupled to the suction fitting to draw secretions from the first chamber, through a lumen of inner cannula into the second chamber and out of the suction fitting (Examiner notes that Schnell’s cannula 2 would have holes on the bottoms of lines 4 which would connect the suction and irrigation chambers (lines 4) in a circuit; Thus when suction is activated, any irrigation fluid present would be sucked out through the fenestrations and other chambers used for fluid).
Regarding claim 2, Schnell in view of Fendler discloses the irrigating cannula system of claim 1, and Schnell further discloses wherein the outer cannula further comprises an irrigation fitting for connection to a source of irrigant (Schnell Paragraph 0005 discloses one of the conduits may supply a flushing (irrigation) fluid to the system; Examiner notes there inherently must be a source of irrigant to supply the flushing fluid).
Claims 3-7 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schnell in view of Fendler and WO202026997A1 to Bagwell et al. (hereinafter “Bagwell”).
Regarding claim 3, Schnell discloses an irrigating cannula system (See Figs. 1 and 2 generally; Paragraph 0005 discloses a flushing fluid can be supplied and sucked off) comprising:
an outer cannula (Figs. 2 & 4 profile 3 and connector 3d; Paragraph 0018 discloses connector 3d is manufactured together with profile elements 3 as a single piece) comprising a suction fitting for connecting to a source of suction (Paragraph 0006 discloses any one of the separate lines 4 may be used to accommodate a suction hose) and an irrigation fitting for connecting to a source of irrigant ( Paragraph 0005 discloses one of the conduits may supply a flushing (irrigation) fluid to the system; Examiner notes there inherently must be a source of irrigant to supply the flushing fluid);
an inner cannula sized to be inserted in the outer cannula (Figs. 1 & 2 show cannula 2 slides into profile elements 3; Examiner notes the outer cannula is the profile 3 and connector 3d manufactured as one piece), the inner cannula comprising:
an outer surface (Fig. 1 shows cannula 2 has an outer surface);
a plurality of longitudinal ridges on the outer surface that abut a lumen of the outer cannula (Figs. 1 & 3a latching noses 5b abuts profile elements 3) and divide an annular space between the inner cannula and the outer cannula into at least a first chamber and a second chamber (Fig. 3b separate lines 4; Paragraph 0015 discloses the grooves 2a and their respectively facing surfaces of the cannula tube 2 define the inner cross section of the separate lines 4, which are consequently formed between mutually facing surfaces of the profile element 3 and recess 2e; Examiner notes there are chambers formed by each of the separate lines; Examiner further notes the first chamber would be associated with an irrigation line and the second chamber would be associated with a suction line);
a ledge at a proximal end of each chamber of the plurality of chambers, the ledge abutting the lumen of the outer cannula (Examiner notes there are ledges formed at the proximal end of each of the ends of separate lines 4, and the top of the line 4 abuts the outer cannula 3; Examiner further notes broadest reasonable interpretation of a ledge would be a where a surface comes to an end); and
wherein a first chamber of the plurality of chambers is coupled to the irrigation fitting to receive irrigant from the source of irrigant (Schnell Paragraph 0005 discloses one of the conduits may supply a flushing (irrigation) fluid to the system; Examiner notes there inherently must be a source of irrigant to supply the flushing fluid); and
an irrigant line attached to the irrigation fitting (Schnell Paragraph 0005 discloses one of the conduits may supply a flushing (irrigation) fluid to the system; Examiner notes there inherently must be a source of irrigant and irrigant line to supply the flushing fluid);
a suction line attached to the suction fitting (Paragraph 0006 discloses any one of the separate lines 4 may be used to accommodate a suction hose; Examiner notes that there are 4 conduits and thus one could be used for suction, and another used for irrigation).
Schnell does not disclose a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula. However, Fendler teaches an inner cannula with holes and ridges that has an aspiration line connected to an outer tube surface through a passage (Fig. 3 suction openings 22 on inner cannula 16; Webs 28 on inner cannula 16’s outer surface).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Schnell to use an inner cannula with a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula, as taught by Fendler, in order to aspirate the sputum as efficiently as possible (Paragraph 0034).
Schnell does not disclose an actuating device coupled between the irrigant line and a source of irrigant and coupled between the suction line and a vacuum source, said actuating device controllably connecting the irrigant line to the source of irrigant and the suction line to the vacuum source. However, Bagwell teaches a handset for an occlusion clearing device that has an actuating device coupled between the irrigant line and a source of irrigant and coupled between the suction line and a vacuum source (Fig. 1 handset 150, aspiration port 154, irrigation port 157; Fig. 9 aspiration lumen 122, irrigation lumen 126; Page 22 lines 17-18 disclose the aspiration port is connected to an aspiration source such as a vacuum pump; Page 23 lines 4-5 disclose the irrigation port is connected to an irrigation source), said actuating device controllably connecting the irrigant line to the source of irrigant and the suction line to the vacuum source (Page 11 lines 19-22 discloses the handset controls valves for controlling the flow of aspiration and irrigation through their tubings).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suction and irrigation lines of Schnell to have an actuating device coupled between the irrigant line and a source of irrigant and coupled between the suction line and a vacuum source, said actuating device controllably connecting the irrigant line to the source of irrigant and the suction line to the vacuum source, as taught by Bagwell, in order to provide user control over aspiration of irrigation of occlusive material in the tubes (Page 11 line 22-Page 12 lines 1-2; Page 22 lines 5-11). Examiner notes that providing an actuator to control irrigant supply and suction supply allows easy clearance of the inner cannula and chambers associated therewith. Examiner further notes Bagwell is being introduced to allow a means for controlling irrigant and suction.
Modified Schnell discloses a second chamber is coupled to the suction fitting to draw secretions and irrigant from the first chamber, through a lumen of inner cannula into the second chamber and out of the suction fitting (Examiner notes that Schnell’s cannula 2 would have holes on the bottoms of lines 4 which would connect the suction and irrigation chambers (lines 4) in a circuit; Thus when suction is activated, any irrigation fluid present would be sucked out through the fenestrations and other chambers used for fluid).
Regarding claim 4, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell further discloses, wherein the outer cannula further comprises indentations on an inner surface corresponding to the plurality of longitudinal ridges such that the plurality of longitudinal ridges engages with the indentations when the inner cannula is inserted into the outer cannula (Fig. 1 & 2 latching noses 5b of cannula 2 interlock with grooves in outer cannula 3).
Regarding claim 5, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell as modified by Bagwell further discloses wherein the actuating device may be coupled between only the suction line and the inner cannula (Bagwell Fig. 1 handset 150, aspiration port 154, irrigation port 157; Fig. 9 aspiration lumen 122, irrigation lumen 126; Page 22 lines 17-18 disclose the aspiration port is connected to an aspiration source such as a vacuum pump; Page 23 lines 4-5 disclose the irrigation port is connected to an irrigation source; Examiner notes the handset is coupled between the aspiration port and Schnell’s conduit 4 of the inner cannula 2).
Regarding claim 6, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell as modified by Bagwell further discloses wherein the actuating device may be incorporated within a ventilator (Bagwell Fig. 1 coupler 190; ventilator port 196; Page 20 lines 21-23 disclose the ventilator port may attach to a ventilator system on which a patient may be established; Examiner notes the connector 3d of Schnell would facilitate the ventilator port in order to provide the patient machine ventilation).
Regarding claim 7, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell as modified by Bagwell further discloses wherein the source of irrigant is positioned at a distance below a vertical height of the inner cannula to prevent spontaneous flow (Examiner notes that the irrigant port 157 is connected to flexible tubing 125a; Thus the irrigant port is capable of connecting to a source of irrigant below a vertical height of the inner cannula 2 of Schnell).
Regarding claim 12, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell further discloses wherein the cannula system is a cuffed or uncuffed tracheostomy tube (Paragraph 0001 discloses the present invention is a tracheostomy tube; Fig. 4 shows cuff 6; Paragraph 0018 discloses the cuff 6 may be present in the system).
Regarding claim 13, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 3, and Schnell further discloses wherein the cannula system is a fenestrated or non- fenestrated tracheostomy tube (Figs. 1 & 4 show the cannula system may be fenestrated or non-fenestrated; Paragraph 0001 discloses the present invention is a tracheostomy tube).
Regarding claim 14, Schnell discloses a method of cleaning a tracheostomy tube comprising an outer cannula (Figs. 2 & 4 profile 3 and connector 3d; Paragraph 0018 discloses connector 3d is manufactured together with profile elements 3 as a single piece; Paragraph 0005 discloses cleaning the system with fluid) and an inner cannula (Figs. 1 & 2 show cannula 2) and one or more ridges dividing an airspace between the outer tracheostomy tube and the inner cannula into a plurality of regions when the inner cannula is inserted in the outer tracheostomy tube (Figs. 1 & 3a latching noses 5b abuts profile elements 3; Fig. 3b separate lines 4; Paragraph 0015 discloses the grooves 2a and their respectively facing surfaces of the cannula tube 2 define the inner cross section of the separate lines 4, which are consequently formed between mutually facing surfaces of the profile element 3 and recess 2e; Examiner notes there are chambers formed by each of the separate lines; Examiner further notes the first chamber would be associated with an irrigation line and the second chamber would be associated with a suction line), the method comprising:
attaching a suction line to the inner cannula so that it is in communication with a first region of the plurality of regions (Paragraph 0006 discloses any one of the separate lines 4 may be used to accommodate a suction hose).
Schnell does not disclose a plurality of holes in the inner cannula. However, Fendler teaches an inner cannula with holes and ridges that has an aspiration line connected to an outer tube surface through a passage (Fig. 3 suction openings 22 on inner cannula 16; Webs 28 on inner cannula 16’s outer surface).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Schnell to use an inner cannula with a plurality of holes in the outer surface between the annular space and the lumen of the inner cannula, as taught by Fendler, in order to aspirate the sputum as efficiently as possible (Paragraph 0034).
Schnell does not disclose attaching an actuating device coupled between the coupled between the suction line and a vacuum source, said actuating device controllably connecting the suction line to the vacuum source. However, Bagwell teaches a handset for an occlusion clearing device that has an actuating device coupled between the suction line and a vacuum source (Fig. 1 handset 150, aspiration port 154; Fig. 9 aspiration lumen 122; Page 22 lines 17-18 disclose the aspiration port is connected to an aspiration source such as a vacuum pump), said actuating device controllably connecting the suction line to the vacuum source (Page 11 lines 19-22 discloses the handset controls valves for controlling the flow of aspiration and irrigation through their tubings).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suction and irrigation lines of Schnell to have an actuating device coupled between the suction line and a vacuum source, said actuating device controllably connecting the suction line to the vacuum source, as taught by Bagwell, in order to provide user control over aspiration of irrigation of occlusive material in the tubes (Page 11 line 22-Page 12 lines 1-2; Page 22 lines 5-11). Examiner notes that providing an actuator to control suction supply allows easy clearance of the inner cannula and chambers associated therewith. Examiner further notes Bagwell is being introduced to allow a means for controlling suction.
Schnell as modified by Fendler and Bagwell discloses controlling the actuating device to suction from a lumen of the inner cannula through a first portion of the plurality of holes, the first region and the suction line (Examiner notes that Schnell’s cannula 2 would have holes on the bottoms of lines 4 (from Fendler) which would connect the suction and irrigation chambers (lines 4) in a circuit; Thus when suction is activated via Bagwell’s handset, suction would occur through the fenestrations and other chambers used for suction).
Regarding claim 15, Schnell in view of Fendler and Bagwell discloses the method of claim 14, and Schnell further discloses attaching an irrigant line to the inner cannula so that it is in communication with a second region of the plurality of regions (Schnell Paragraph 0005 discloses one of the conduits may supply a flushing (irrigation) fluid to the system; Examiner notes the irrigant line would be attached to another conduit 4 than the suction conduit).
Schnell does not disclose attaching the actuating device between the irrigant line and a source of irrigant, said actuating device controllably connecting the irrigant line to the source of irrigant. However, Bagwell teaches a handset for an occlusion clearing device that has an actuating device coupled between the irrigant line and a source of irrigant (Fig. 1 handset 150, aspiration port 154, irrigation port 157; Fig. 9 aspiration lumen 122, irrigation lumen 126; Page 23 lines 4-5 disclose the irrigation port is connected to an irrigation source), said actuating device controllably connecting the irrigant line to the source of irrigant (Page 11 lines 19-22 discloses the handset controls valves for controlling the flow of aspiration and irrigation through their tubings).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suction and irrigation lines of Schnell to have an actuating device coupled between the irrigant line and a source of irrigant said actuating device controllably connecting the irrigant line to the source of irrigant, as taught by Bagwell, in order to provide user control over aspiration of irrigation of occlusive material in the tubes (Page 11 line 22-Page 12 lines 1-2; Page 22 lines 5-11). Examiner notes that providing an actuator to control irrigant supply and suction supply allows easy clearance of the inner cannula and chambers associated therewith. Examiner further notes Bagwell is being introduced to allow a means for controlling irrigant and suction.
Schnell as modified by Fendler and Bagwell discloses controlling the actuating device to provide irrigant to the lumen of the inner cannula through a second portion of the plurality of holes, the second region and the irrigant line (Examiner notes that Schnell’s cannula 2 would have holes on the bottoms of lines 4 (from Fendler) which would connect the suction and irrigation chambers (lines 4) in a circuit; Thus when suction is activated via Bagwell’s handset, irrigation would occur through the fenestrations and conduit(s) used for fluid).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schnell in view of Fendler and Bagwell as applied to claim 7 above, and further in view of US20220062574A1 to Tassitano et al. (hereinafter “Tassitano”).
Regarding claim 8, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 7, but Schnell does not disclose comprising a flow sensor for monitoring a flow of irrigant or suction. However, Tassitano discloses a catheter system which uses a flow sensor to monitor negative pressure (suction) application (Fig. 5C aspiration device 52, negative pressure unit 320, flow sensor 326; Paragraph 0062-0063 discloses the flow sensor monitors function of the aspiration device).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suction line of Schnell to further include a flow sensor, as taught by Tassitano, in order to provide information about the suction function of the aspiration device (Paragraphs 0062-0063).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schnell in view of Fendler, Bagwell, and Tassitano as applied to claim 8 above, and further in view of US20230087973A1 to Wu et al. (hereinafter “Wu”).
Regarding claim 9, Schnell in view of Fendler, Bagwell, and Tassitano discloses the cannula system of claim 8, and Schnell as modified by Bagwell further discloses further comprising further comprising valves (Bagwell Figs. 8 and 10A-10B valves 170, 172), flow-limiters, mechanical flow and pressure sensors, or electrical flow and pressure sensors. Modified Schnell does not disclose pressure sensors. However, Wu teaches a ventilation system which has pressure sensors connected to valves (Figs. 1 & 2 first pressure sensor 214, first check valve 211; Paragraph 0092 discloses an alarm goes off when pressure exceeds a maximum threshold or is lower than a minimum threshold value).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schnell as modified by Bagwell to further include pressure sensors, as taught by Wu, in order to provide monitoring of pressure within the system (Paragraph 0092).
Regarding claim 10, Schnell in view of Fendler, Bagwell, Tassitano, and Wu discloses the cannula system of claim 9, and Schnell as modified by Bagwell and Wu further discloses further comprising an alarm or notification when excessive or unexpected flow of irrigant or suction is detected (Paragraph 0092 discloses an alarm goes off when pressure exceeds a maximum threshold or is lower than a minimum threshold value).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schnell in view of Fendler and Bagwell as applied to claim 6 above, and further in view of US20150258297A1 to Blom et al. (hereinafter “Blom”).
Regarding claim 11, Schnell in view of Fendler and Bagwell discloses the cannula system of claim 6, but Schnell does not disclose wherein the inner cannula further comprises tabs for retaining the inner cannula inside the outer cannula. However, Blom teaches an endotracheal tube having outer and inner cannulae wherein the inner cannula further comprises tabs for retaining the inner cannula inside the outer cannula (Fig. 1 locking tabs 100 on outer cannula 12 attaches outer cannula 12 to couple of inner cannula; Examiner notes the coupler and inner coupler are attached and thus the outer cannula and inner cannula are attached).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner cannula of Schnell to further include tabs for retaining the inner cannula inside the outer cannula, as taught by Blom, in order to provide an additional means of securing the inner cannula to the outer cannula (Paragraph 0041).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20210093814-A1 Nolan; US-20210015509-A1 to Wan; US-20200405989-A1 to Farris; US-20200107957-A1 Zhang; US-20200061321-A1 to White; US-20200009340-A1 Elia; US-20190321575-A1 White; US-20190117860-A1 to Zachar; and US-20190060594-A1 to Qiu.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799