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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/26/2026 has been entered.
Response to Amendment
The amendments filed 1/26/2026 have been entered. Accordingly, claims 6-8, 11, 19-21, 24, 26-27, 30, 33, 39, 41, 43-47 remain pending in the currently application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 6-8, 11, 19-21, 24, 26-27, 30, 33, 39, 41, 43-47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner notes that while the secondary reference of Dryden is still being relied upon, a different embodiment is now being cited to, to better reflect the newly added limitations. Furthermore, a different tertiary reference is now being introduced to better reflect the newly added limitations.
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.
Claim(s) 6-8, 11, 19-20, 24, 26, 30, 33 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1) and in further view of Kaczorowski (US 2017/0120034 A1).
Regarding claim 19, Baczkowski discloses a capnography fitting (bridge member 57, Figure 2; exhaled gas travels through bridge member 57 to a conventional gas scavenging device, therefore fully capable of being used with a capnography system to measure exhaled CO2, Col. 4 lines 63-65; the Examiner notes the term “capnography fitting” is an intended use of a system without positively reciting CO2 as being a component of the system and being delivered to a conduit) comprising a first tube having a proximal end inlet configured to receive an inhalation gas (bridge member 57 is a double barreled hollow cylindrical member connected in parallel by transverse band 58, first tube/barrel being element 60 having a proximal and distal end, Figure 2 and Col. 4 lines 43-50; the proximal end of barrel 60 connects with gas delivery passage 49 of delivery conduit, Figure 2 and Col. 4 lines 34-36), and a distal end outlet configured to couple with an inlet of an inhalation mask (opposing or distal end of barrel 60 coupled with inhalation port 51 of a mask 45, Figure 2 and Col. 4 lines 59-60), a second tube having a proximal end outlet and a distal end inlet configured to receive an exhalation gas (bridge member 57 also comprises a second barrel 59 having a proximal and distal end, Figure 2; distal end of barrel 59 configured to receive an exhalation gas from the mask 45 through the exhalation port 53, Figure 2 and Col. 4 lines 37-38), the second tube adjacent to and extending substantially parallel to the first tube (barrels 59 and 60 of bridge member 57 are connected in parallel by transverse band 58 and adjacent to one another, Figure 2 and Col. 4 lines 42-43), and having a diameter smaller than a diameter of the first tube (the outer circumference of the two barrels are not the same, with barrel 59 having a smaller outside diameter than barrel 60, Col. 4 lines 44-46) the distal end inlet configured to engage an outlet of a nasal mask (the distal end of barrel 59 fits inside exhalation port 53 of nasal mask 45, Figure 2 and Col. 4 lines 43-50); and a support attached to the first tube and the second tube (barrels 59 and 60 of bridge member 58 are connected in parallel by transverse band 58, Figure 2 and Col. 4 lines 42-43); and wherein the proximal end inlet of the first tube is configured to engage an upper section of a sleeve (proximal end inlet of barrel 60 engages with an upper port passageway 49 of delivery conduit 20, conduit 20 acting as a sleeve, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 60 fitting inside port 49) and wherein the proximal end outlet of the second tube is configured to engage a lower section of the sleeve (proximal end outlet of second barrel 59 engages with a lower connect port 46 of the conduit sleeve 20, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 59 fitting inside port 46).
Baczkowski is silent on the first tube having an angled port in fluid communication with and disposed adjacent to the distal end outlet, wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, which is configured to extend from the distal end out of the first tube into the inlet of the inhalation mask, wherein the first tube and the angled port are monolithic, and wherein an inner surface of the angled port has threading disposed thereon and is configured to removably secure at least the portion of the sampling tube within the angled port, the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube, and wherein the angled port is configured to couple with a threaded luer fitting, so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port, and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting.
However, in regards to an angled port in fluid communication and disposed adjacent with a distal end outlet, the distal end outlet configured to engage an inlet of a nasal mask, wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, and is configured to removably secure at portion of the sampling tube within the angled port, the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube into the inlet of the inhalation mask, and wherein the first tube and the angled port are monolithic, Dryden teaches a gas sampling lumen for a breathing system (Abstract and Figure 1) comprising both a first and second tube (see first tube 17 comprising an adaptor 23 and second tube 16 disposed adjacent to first tube 17, Figure 1) wherein the distal end of the first tube is engaged with an inlet of a nasal mask (via a gas machine 18, gas is delivered through tube 17 to the inlet 12 of the inhalation mask 11, Col. 2 lines 20-25 and Figure 1), therefore functioning as the inspiratory conduit similarly to the first tube barrel 60 of Baczkowski’s device as noted above, wherein the first tube (tube 17, Figure 1) has an angled port in fluid communication and disposed adjacent with a distal end outlet, the distal end outlet configured to engage an inlet of a nasal mask (see angled port 32A in fluid communication with and disposed adjacent the distal end outlet of the first tube 17, the distal end outlet of tube 17 configured to engage with an inlet of nasal mask 11, Figures 3-4), wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, and is configured to removably secure at portion of the sampling tube within the angled port (see Figures 3-4 showing the inner surface of angled port 32A configured to slidably receive a sampling tube 31, the Examiner notes Col. 3 lines 38-42 describes the tube 31 being inserted through port 32A and held in place via a clip 36, however the tube 31 would otherwise be free to longitudinally move, therefore fully capable of being slidably received and/or removably secured within the angled port 32A), the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube into the inlet of the inhalation mask (see sampling tube 31 configured to extend from the angled port 32A and bend at an angle to thereby extend through the distal end outlet of the first tube 17 into the inlet of the mask 11, Figures 3-4; the Examiner also notes Col. 3 line 28 noting the sampling tube 31 being made of polyvinylchloride, a flexible plastic material, therefore fully able of bending); wherein the first tube and the angled port are monolithic (see cross-section of angled port 32A and the first tube 17 being made from a single piece of material / monolithic as shown in Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Baczkowski’s fitting to include an angled port in fluid communication with the distal end outlet of the first tube, such that the angled port slidably receives a sampling tube, as taught by Dryden, as providing such a port would allow for the insertion of a gas sampling line without the need to disconnect/reconnect the fitting from the nasal mask. Once modified, the resultant angled port would therefore be disposed adjacent to the distal end outlet of Baczkowski’s tube 60, as the angled port would be placed substantially in the center of tube 60.
Regarding the port having an inner surface with threading disposed thereon, Koch teaches a respiratory device (Abstract and Figure 1) comprising a port having a threaded inner surface (see connecting port having internal threads 61, Paragraph 0023 and Figure 2) configured to receive a sampling tube (see connecting port having internal threads 61 receiving sampling tube 24, Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting by including a port having an inner threaded surface, to therefore receive a gas sampling tube, as taught by Koch, as providing an internally threaded surface to a port to therefore correspond to a mating component, such as a sampling tube, is an art-recognized means of joining two components together, and may further aide in securing the tube to the connector.
Regarding the angled port being configured to couple with a threaded luer fitting, so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port, and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting, Kaczorowski teaches a cannula adapter (Abstract) comprising a tube coupler comprising an angled side port (tube coupler 50’ includes an angled access port 55’, Figure 16 and Paragraph 0087) wherein the inner surface of the angled port is threaded (angled side port may have a thread to allow interaction with Luer connections, Paragraph 0066; see Figure 16 showing inner threading of angled port 55’), wherein the angled port is configured to couple with a threaded luer fitting so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port (the threads of the angled port interacts with counter threads of a Luer connection on the connector 35, Paragraph 0066), and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting (a cap connector 43 may be shaped as a Luer connected and may include threads disposed along an inner surface for receiving the lip the angled side port, Paragraph 0076).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting such that it includes an angled port configured for engagement with a threaded Luer fitting, as taught by Kaczorowski, as providing an angled port with internal threading and configured to mate with threading on a corresponding Luer fitting is an art-recognized means of joining two components together, and providing a Luer connection between the port and the adapter provides a secure and leak-proof connection between two components.
Regarding claim 6, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Dryden further teaching wherein the angled port is spaced a greater distance from the proximal end inlet than a distance from the distal end outlet (once modified, the resultant angled port would be spaced a greater distance from the proximal end inlet of the first tube from the distal end outlet of the first tube, due to the angled port being disposed on the first tube 60 and the length of the inhalation tube 51 as shown in Figure 2 of Baczkowski).
Regarding claim 7, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Dryden further teaching wherein the capnography fitting comprises a plastic material (the adapter 23 comprising the angled port 32A is made of polyvinylchloride, a high-strength thermoplastic material, Col. 4 lines 26-27).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Baczkowski’s fitting by having it be made from a plastic material, as taught by Dryden, as providing such a high-strength plastic material may assist with the overall stability of the fitting within the assembly.
Regarding claim 8, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Dryden further teaching wherein the sampling tube (sample tube 31, Figures 3-4) is flexible (Col. 3 line 28 noting the sampling tube 31 being made of polyvinylchloride, a flexible plastic material).
Regarding claim 11, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Baczkowski further teaching wherein the support (traverse band 58, Figure 2) comprises a first channel configured to receive at least a portion of the first tube and a second channel configured to receive at least a portion of the second tube and hold the first tube and the second tube in a stacked configuration (traverse band 58 is used to connect and hold the two cylindrical barrels 59 and 60 of the bridge member 57, therefore comprises a first and second channel to receive at least a portion of the first barrel 60 and second barrel 59, Figure 2 and Col. 4 lines 43-44).
Regarding claim 20, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Dryden further teaching wherein the angled port is disposed at an acute angle relative to a surface of the proximal end inlet of the first tube (see angled port 32A disposed at an acute angle relative to the top surface of the first tube 17, Figure 1).
Regarding claim 24, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, with Dryden further teaching wherein at least a portion of the sampling tube extends into a nasal chamber of the nasal mask (see a portion of the sample tube 31 extending into the chamber of the nasal mask 11, Figures 3-4).
Regarding claim 26, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting according to claim 19, with Baczkowski further teaching wherein the inhalation gas is anesthetic gas (first barrel 60 configured to receive inhalation gas via an anesthesia gas supply, Col. 4 lines 13-15).
Regarding claim 30, Baczkowski discloses a method of assembling a capnography system (see Figure 2 showing the exploded view of the various components including a bridge member 57 used to connect to a conventional gas scavenging device, Col. 4 lines 63-65), the method comprising: providing a capnography fitting (bridge member 57, Figure 2), the capnography fitting comprising a first tube having a proximal end inlet and a distal end outlet (bridge member 57 is a double barreled hollow cylindrical member connected in parallel by transverse band 58, first tube/barrel being element 60 having a proximal and distal end, Figure 2 and Col. 4 lines 43-50), a second tube having a proximal end outlet and a distal end inlet (bridge member 57 also comprises a second barrel 59 having a proximal and distal end, Figure 2), the second tube adjacent to and extending substantially parallel to the first tube (barrels 59 and 60 of bridge member 58 are connected in parallel by transverse band 58 and adjacent to one another, Figure 2 and Col. 4 lines 42-43), and having a diameter smaller than a diameter of the first tube (the outer circumference of the two barrels are not the same, with barrel 59 having a smaller outside diameter than barrel 60, Col. 4 lines 44-46), and a support attached to the first tube and the second tube (barrels 59 and 60 of bridge member 58 are connected in parallel by transverse band 58, Figure 2 and Col. 4 lines 42-43); inserting the proximal end inlet of the first tube and the proximal end outlet of the second tube into a flexible sleeve (proximal ends of barrels 60 and 59 are inserted into a flexible conduit 20, Figure 2) and coupling the distal end outlet of the first tube to an inlet of a nasal mask (the distal end of barrel 60 fits inside a first inhalation port 51 of nasal mask 45, Figure 2 and Col. 4 lines 43-50); and coupling the distal end inlet of the second tube to an outlet of the nasal mask to assemble the capnography system (the distal end of barrel 59 fits inside exhalation port 53 of nasal mask 45, Figure 2 and Col. 4 lines 43-50), wherein the inlet of the nasal mask is separate from and adjacent to the outlet of the nasal mask (inlet port 51 and exhalation port 53 of mask 45 are separate and adjacent one another, Figure 2).
Baczkowski is silent on the first tube having an angled port in fluid communication with and disposed adjacent to the distal end outlet; and removably securing at least a portion of a sampling tube in the angled port with the sampling tube extending at an angle from the angled portion into the first tube and through the distal end outlet of the first tube, the angled port being monolithic with the first tube and comprising an inner surface that is threaded or is at least partially threaded, coupling a threaded luer fitting to the angled port so that a threaded section of the luer fitting engages threading on the inner surface of the angled port, coupling an internally threaded cap to the angled port through the threaded section of the threaded luer fitting.
However, Dryden teaches a gas sampling lumen for a breathing system (Abstract and Figure 1) comprising both a first and second tube (see first tube 17 comprising an adaptor 23 and second tube 16 disposed adjacent to first tube, Figure 1) wherein the distal end of the first tube is engaged with an inlet of a nasal mask (via a gas machine 18, gas is delivered through tube 17 to the inlet 12 of the inhalation mask 11, Col. 2 lines 20-25 and Figure 1), therefore functioning as the inspiratory conduit similarly to the first tube barrel 60 of Baczkowski’s device as noted above, wherein the first tube (tube 17, Figure 1) has an angled port in fluid communication with the distal end outlet (see angled port 32A in fluid communication with the proximal end inlet and the distal end inlet, Figures 3-4) and removably securing at least a portion of a sampling tube in the angled port with the sampling tube extending at an angle from the angled portion into the first tube and through the distal end outlet of the first tube (see Figures 3-4 showing the inner surface of angled port 32A configured to slidably receive a sampling tube 31, the Examiner notes Col. 3 lines 38-42 describes the tube 31 being inserted through port 32A and held in place via a clip 36, however the tube 31 would otherwise be free to longitudinally move, see tube 31 extending at an angle from the angled portion 32A into the first tube 17 and through the distal end outlet. Figures 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Baczkowski’s fitting to include an angled port in fluid communication with the proximal end inlet and the distal end outlet of the first tube, as taught by Dryden, as providing such a port would allow for the insertion of a gas sampling line without the need to disconnect/reconnect the fitting from the nasal mask. Once modified, the resultant angled port would therefore be disposed adjacent the distal end outlet of Baczkowski’s tube 60, as the angled port would be placed substantially in the center of tube 60.
Regarding the port having an inner surface with threading disposed thereon, Koch teaches a respiratory device (Abstract and Figure 1) comprising a port having a threaded inner surface (see connecting port having internal threads 61, Paragraph 0023 and Figure 2) configured to receive a sampling tube (see connecting port having internal threads 61 receiving sampling tube 24, Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting by including a port having an inner threaded surface, to therefore receive a gas sampling tube, as taught by Koch, as providing an internally threaded surface to a port to therefore correspond to a mating component, such as a sampling tube, is an art-recognized means of joining two components together, and may further aide in securing the tube to the connector.
Regarding the angled port being configured to couple with a threaded luer fitting, so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port, and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting, Kaczorowski teaches a cannula adapter (Abstract) comprising a tube coupler comprising an angled side port (tube coupler 50’ includes an angled access port 55’, Figure 16 and Paragraph 0087) wherein the surface of the angled port is threaded (angled side port may have a thread to allow interaction with Luer connections, Paragraph 0066; see Figure 16 showing inner threading of angled port 55’), wherein the angled port is configured to couple with a threaded luer fitting so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port (the threads of the angled port interacts with counter threads of a Luer connection on the connector 35, Paragraph 0066), and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting (a cap connector 43 may be shaped as a Luer connected and may include threads disposed along an inner surface for receiving the lip the angled side port, Paragraph 0076).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting such that it includes an angled port with internal threading, configured for engagement with an internally threaded Luer fitting, as taught by Kaczorowski, as providing an angled port with internal threading and configured to mate with threading on a corresponding Luer fitting is an art-recognized means of joining two components together, and providing a Luer connection between the port and the adapter provides a secure and leak-proof connection between two components.
Regarding claim 33, Baczkowski in view of Dryden, Koch and Kaczorowski teach the method of claim 30, with Dryden further teaching wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube (angled port 32A comprises an interior surface configured to slidably receive the sampling tube 31, Figures 3-4), the sampling tube configured to extend out from the distal end outlet of the first tube into the inlet and a nasal chamber of the nasal mask (see sample tube 31 extending from the distal end of the first tube 17 into the inlet of the inhalation mask 11, Figure 1 and Col. 2 lines 40-44).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify the device of Baczkowski in view of Dryden to include the angled port being configured to slidably receive at least a portion of a sample tube, as further taught by Dryden, as providing a port configured to slidably receive a sampling tube that extends from the distal end of the first tube to the inlet of the inhalation mask allows for access to a gas sample area precisely where it is desired (Col. 2 lines 40-44 of Dryden).
Regarding claim 39, Baczkowski further discloses wherein the proximal end inlet of the first tube is configured to slidably engage the upper section (proximal end inlet of barrel 60 slidably engages with an upper port passageway 49 of delivery conduit 20, conduit 20 acting as a sleeve, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 60 fitting inside port 49) of the sleeve and the proximal end outlet of the second tube is configured to slidably engage the lower section of the sleeve (proximal end outlet of second barrel 59 slidably engages with a lower connect port 46 of the conduit sleeve 20, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 59 fitting inside port 46).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1), Kaczorowski (US 2017/0120034 A1) and in further view of Dwyer (US 2010/0071688 A1).
Regarding claim 21, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 20, and although Dryden teaches the angled port being disposed at an acute angle, Dryden does not explicitly state wherein the angled port has an angle of about 10 to about 60 degrees relative to the surface of the proximal end inlet of the first tube.
However, Dwyer teaches an adapter used in a respiratory system (adapter 10, Figure 1 and Abstract) comprising a first and second tube (see first tube 29 and second tube 12, Figure 1) wherein the first tube comprises an angled port (see angled port opening 20, Figure 1) disposed at an angle of about 10 to about 60 degrees relative to the surface of the proximal end of the first tube (see angle alpha formed between angled opening 20 and first tube 29, Figure 1; angle alpha can be anywhere between 0 degrees to 45 degrees, therefore having an angle of about 10 degrees to about 60 degrees, Paragraph 0032; the Examiner notes the Applicant appears to place no criticality on the angle, merely stating that angle is “about” 10 degrees to “about” 60 degrees, as noted in Paragraph 0062 of the specification).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify the device of Baczkowski in view of Dryden to have the resulting angled port be disposed at an angle of between 10 and 60 degrees, as taught by Dwyer, as providing such an acute angle between the angled port and the first inhalation tube may aid in the insertion of the sampling line tube through the angled port and thus through the first tube.
Claim 27 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1), Kaczorowski (US 2017/0120034 A1) and in further view of Wondka (2005/0005936).
Regarding claim 27, Baczkowski discloses a capnography fitting (bridge member 57, Figure 2; exhaled gas travels through bridge member 57 to a conventional gas scavenging device, therefore fully capable of being used with a capnography system to measure exhaled CO2, Col. 4 lines 63-65; the Examiner notes the term “capnography fitting” is an intended use of a system without positively reciting CO2 as being a component of the system and being delivered to a conduit) comprising a first tube having a proximal end inlet configured to receive an inhalation gas (bridge member 57 is a double barreled hollow cylindrical member connected in parallel by transverse band 58, first tube/barrel being element 60 having a proximal and distal end, Figure 2 and Col. 4 lines 43-50; the proximal end of barrel 60 connects with gas delivery passage 49 of delivery conduit, Figure 2 and Col. 4 lines 34-36), and a distal end outlet configured to couple with an inlet of an inhalation mask (opposing or distal end of barrel 60 coupled with inhalation port 51 of a mask 45, Figure 2 and Col. 4 lines 59-60), a second tube having a proximal end outlet and a distal end inlet configured to receive an exhalation gas (bridge member 57 also comprises a second barrel 59 having a proximal and distal end, Figure 2; distal end of barrel 59 configured to receive an exhalation gas from the mask 45 through the exhalation port 53, Figure 2 and Col. 4 lines 37-38), the second tube adjacent to and extending substantially parallel to the first tube (barrels 59 and 60 of bridge member 57 are connected in parallel by transverse band 58 and adjacent to one another, Figure 2 and Col. 4 lines 42-43), and having a diameter smaller than a diameter of the first tube (the outer circumference of the two barrels are not the same, with barrel 59 having a smaller outside diameter than barrel 60, Col. 4 lines 44-46) the distal end inlet configured to engage an outlet of a nasal mask (the distal end of barrel 59 fits inside exhalation port 53 of nasal mask 45, Figure 2 and Col. 4 lines 43-50); and a support attached to the first tube and the second tube (barrels 59 and 60 of bridge member 58 are connected in parallel by transverse band 58, Figure 2 and Col. 4 lines 42-43); and wherein the proximal end inlet of the first tube is configured to engage an upper section of a sleeve (proximal end inlet of barrel 60 engages with an upper port passageway 49 of delivery conduit 20, conduit 20 acting as a sleeve, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 60 fitting inside port 49) and wherein the proximal end outlet of the second tube is configured to engage a lower section of the sleeve (proximal end outlet of second barrel 59 engages with a lower connect port 46 of the conduit sleeve 20, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrel 59 fitting inside port 46).
Baczkowski is silent on the first tube having an angled port in fluid communication with and disposed adjacent to the distal end outlet, wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, which is configured to extend from the distal end out of the first tube into the inlet of the inhalation mask, wherein the first tube and the angled port are monolithic, and wherein an inner surface of the angled port has threading disposed thereon and is configured to removably secure at least the portion of the sampling tube within the angled port, the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube, and wherein the angled port is configured to couple with a threaded luer fitting, so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port, and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting; and a kit comprising instructions for assembling the kit for capnography monitoring. The Examiner notes that the limitation of “a kit comprising instructions” constitutes non-functional descriptive material, and therefore carries no patentable weight.
However, in regards to an angled port in fluid communication and disposed adjacent with a distal end outlet, the distal end outlet configured to engage an inlet of a nasal mask, wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, and is configured to removably secure at portion of the sampling tube within the angled port, the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube into the inlet of the inhalation mask, and wherein the first tube and the angled port are monolithic, Dryden teaches a gas sampling lumen for a breathing system (Abstract and Figure 1) comprising both a first and second tube (see first tube 17 comprising an adaptor 23 and second tube 16 disposed adjacent to first tube 17, Figure 1) wherein the distal end of the first tube is engaged with an inlet of a nasal mask (via a gas machine 18, gas is delivered through tube 17 to the inlet 12 of the inhalation mask 11, Col. 2 lines 20-25 and Figure 1), therefore functioning as the inspiratory conduit similarly to the first tube barrel 60 of Baczkowski’s device as noted above, wherein the first tube (tube 17, Figure 1) has an angled port in fluid communication and disposed adjacent with a distal end outlet, the distal end outlet configured to engage an inlet of a nasal mask (see angled port 32A in fluid communication with and disposed adjacent the distal end outlet of the first tube 17, the distal end outlet of tube 17 configured to engage with an inlet of nasal mask 11, Figures 3-4), wherein an inner surface of the angled port is configured to slidably receive at least a portion of a sampling tube within the angled port, and is configured to removably secure at portion of the sampling tube within the angled port (see Figures 3-4 showing the inner surface of angled port 32A configured to slidably receive a sampling tube 31, the Examiner notes Col. 3 lines 38-42 describes the tube 31 being inserted through port 32A and held in place via a clip 36, however the tube 31 would otherwise be free to longitudinally move, therefore fully capable of being slidably received and/or removably secured within the angled port 32A), the sampling tube configured to extend from the angled port and bend at an angle to extend through the distal end outlet of the first tube into the inlet of the inhalation mask (see sampling tube 31 configured to extend from the angled port 32A and bend at an angle to thereby extend through the distal end outlet of the first tube 17 into the inlet of the mask 11, Figures 3-4; the Examiner also notes Col. 3 line 28 noting the sampling tube 31 being made of polyvinylchloride, a flexible plastic material, therefore fully able of bending); wherein the first tube and the angled port are monolithic (see cross-section of angled port 32A and the first tube 17 being made from a single piece of material / monolithic as shown in Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Baczkowski’s fitting to include an angled port in fluid communication with the distal end outlet of the first tube, such that the angled port slidably receives a sampling tube, as taught by Dryden, as providing such a port would allow for the insertion of a gas sampling line without the need to disconnect/reconnect the fitting from the nasal mask. Once modified, the resultant angled port would therefore be disposed adjacent to the distal end outlet of Baczkowski’s tube 60, as the angled port would be placed substantially in the center of tube 60.
Regarding the port having an inner surface with threading disposed thereon, Koch teaches a respiratory device (Abstract and Figure 1) comprising a port having a threaded inner surface (see connecting port having internal threads 61, Paragraph 0023 and Figure 2) configured to receive a sampling tube (see connecting port having internal threads 61 receiving sampling tube 24, Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting by including a port having an inner threaded surface, to therefore receive a gas sampling tube, as taught by Koch, as providing an internally threaded surface to a port to therefore correspond to a mating component, such as a sampling tube, is an art-recognized means of joining two components together, and may further aide in securing the tube to the connector.
Regarding the angled port being configured to couple with a threaded luer fitting, so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port, and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting, Kaczorowski teaches a cannula adapter (Abstract) comprising a tube coupler comprising an angled side port (tube coupler 50’ includes an angled access port 55’, Figure 16 and Paragraph 0087) wherein the inner surface of the angled port is threaded (angled side port may have a thread to allow interaction with Luer connections, Paragraph 0066; see Figure 16 showing inner threading of angled port 55’), wherein the angled port is configured to couple with a threaded luer fitting so that a threaded section of the threaded luer fitting can be configured for engagement with the threading on the inner surface of the angled port (the threads of the angled port interacts with counter threads of a Luer connection on the connector 35, Paragraph 0066), and wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting (a cap connector 43 may be shaped as a Luer connected and may include threads disposed along an inner surface for receiving the lip the angled side port, Paragraph 0076).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify Baczkowski’s fitting such that it includes an angled port configured for engagement with a threaded Luer fitting, as taught by Kaczorowski, as providing an angled port with internal threading and configured to mate with threading on a corresponding Luer fitting is an art-recognized means of joining two components together, and providing a Luer connection between the port and the adapter provides a secure and leak-proof connection between two components.
Regarding a kit comprising instructions for assembly, the Examiner notes again the term “a kit comprising instructions” is non-functional descriptive material. However, even if this limitation is narrowly construed, Wondka teaches a medical device having a kit including instructions for the medical device (Paragraph 0074) as well as the components and accessories to retain operation of the device (spare battery 602, wall charger 640, cleaning supplies 645, Paragraph 0074). Additionally, it should be noted that Wondka’s medical device (as best shown in Figure 13) includes a CO2 sensor 619 (Paragraph 0073) for the purpose of gas removal through the device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the device of Baczkowski in view of Dryden to include a kit containing instructions for assembly, as taught by Wondka, in order to ensure proper assembly of the system’s components.
Regarding claim 43, Baczkowski in view of Dryden, Koch, Kaczorowski and Wondka teach the kit of claim 27, with Baczkowski further disclosing a sleeve configured to slidably engage the proximal end inlet of the first tube and the proximal end outlet of the second tube (proximal ends of barrels 60 and 59 are inserted into a flexible conduit 20, Figure 2; see also Col. 4 lines 46-53 describing the respective ends of barrels 59 and 60 fitting inside ports 49 and 46).
Claim 41 are rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1) and in further view of Kaczorowski (US 2017/0120034 A1) and Colman (2013/0345587 A1).
Regarding claim 41, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 40, and although Dryden teaches a sampling tube engaged with a threaded luer fitting, Dryden doesn’t explicitly state wherein a first end of the sampling tube engages with a tapered section of the threaded luer fitting.
However Colman teaches a threaded luer fitting (luer male connector 302 includes threads 320, Paragraph 0104 and Figure 3A) configured to engage with a first end of a sampling tube (primary luer male connector of a patient sampling tube, Paragraph 0050), wherein the first end of the sampling tube engages with a tapered section of the threaded luer fitting (luer male connector comprises a tapered cone, Paragraph 0019 and Figure 3A).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify the device of Baczkowski in view of Dryden and Kaczorowski by having the first end of the sampling tube engage with a tapered section of a threaded luer fitting, as taught by Colman, as providing a tapered section of a threaded luer fitting is an art-recognized standard of luer fittings, and having a tapered section may further assist in the secure attachment between the sampling tube and the threaded luer fitting.
Regarding claim 42, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 41, with Kaczorowski further teaching wherein the angled port is further configured to couple with an internally threaded cap through the threaded section of the threaded luer fitting (a cap connector 43 may be shaped as a Luer connecter and may include threads disposed along an inner surface for receiving the lip the angled side port, Paragraph 0076).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1), Kaczorowski (US 2017/0120034 A1) and in further view of Knipple et al. (US 2008/0191466 A1).
Regarding claim 44, Baczkowski in view of Dryden, Koch and Kaczorowski teach the fitting of claim 19, and although Kaczorowski teaches a Luer fitting comprising threads that interact with both a cap (Paragraph 0076) and the angled side port (Paragraph 0054), Kaczorowski doesn’t explicitly state the threaded luer fitting including an exterior surface having a proximal end with a threaded portion configured to engage the internally threaded cap the exterior surface also having a distal end with a threaded section configured to engage the angled port, a flange defined by the exterior surface between the proximal end and the distal end.
However, Knipple teaches a fluid connector fitting configured to be used in a medical setting (fluid connector 50, Figure 2, Abstract) wherein the fitting includes an exterior surface having as proximal end with a threaded portion (see exterior threads 134 disposed on a proximal end of connector 50, Figure 2 and Paragraph 0103) and a distal end having a threaded section (see exterior threads 143 disposed on a distal end connector, Figure 2), and a flange defined by the exterior surface between the proximal and distal ends (see housing portions 74 and 58 defined by the exterior surface between the proximal and distal ends, Paragraph 0103 and Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify the device of Baczkowski in view of Dryden and Kaczorowski by having the Luer fitting comprise exterior threaded sections on both the proximal and distal ends, to thereby interact with the internal threaded cap and the angled port, as taught by Knipple, as providing a fitting with exterior threads provides an alternative means of joining the components together in an effective and secure manner, and providing exterior threads on either end of a Luer fitting is well-known in the art.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1), Kaczorowski (US 2017/0120034 A1), Wondka (2005/0005936), and in further view of Knipple et al. (US 2008/0191466 A1).
Regarding claim 45, Baczkowski in view of Dryden, Koch, Kaczorowski and Wondka teach the kit of claim 27, and although Kaczorowski teaches a Luer fitting comprising threads that interact with both a cap (Paragraph 0076) and the angled side port (Paragraph 0054), Kaczorowski doesn’t explicitly state the threaded luer fitting including an exterior surface having a proximal end with a threaded portion configured to engage the internally threaded cap the exterior surface also having a distal end with a threaded section configured to engage the angled port, a flange defined by the exterior surface between the proximal end and the distal end.
However, Knipple teaches a fluid connector fitting configured to be used in a medical setting (fluid connector 50, Figure 2, Abstract) wherein the fitting includes an exterior surface having as proximal end with a threaded portion (see exterior threads 134 disposed on a proximal end of connector 50, Figure 2 and Paragraph 0103) and a distal end having a threaded section (see exterior threads 143 disposed on a distal end connector, Figure 2), and a flange defined by the exterior surface between the proximal and distal ends (see housing portions 74 and 58 defined by the exterior surface between the proximal and distal ends, Paragraph 0103 and Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify the device of Baczkowski in view of Dryden and Kaczorowski by having the Luer fitting comprise exterior threaded sections on both the proximal and distal ends, to thereby interact with the internal threaded cap and the angled port, as taught by Knipple, as providing a fitting with exterior threads provides an alternative means of joining the components together in an effective and secure manner, and providing exterior threads on either end of a Luer fitting is well-known in the art.
Claim 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Baczkowski (US 6,736,140 B1) in view of Dryden et al. (4,838,258), Koch (US 2014/0243698 A1), Kaczorowski (US 2017/0120034 A1) and in further view of Knipple et al. (US 2008/0191466 A1) and Colman (2013/0345587 A1).
Regarding claim 46, Backowski in view of Dryden, Koch, Kaczorowski, and Knipple teach the fitting of claim 44, however are silent wherein the distal end of the exterior surface further including a tapered section distal to the threaded section configured to engage the angled port, the tapered section engaging the sampling tube.
However Colman teaches a threaded luer fitting (luer male connector 302 includes threads 320, Paragraph 0104 and Figure 3A) configured to engage with a first end of a sampling tube (primary luer male connector of a patient sampling tube, Paragraph 0050), wherein the first end of the sampling tube engages with a tapered section of the threaded luer fitting (luer male connector comprises a tapered cone, Paragraph 0019 and Figure 3A).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify the device of Baczkowski in view of Dryden and Kaczorowski and Knipple by having the first end of the sampling tube engage with a tapered section of a threaded luer fitting, as taught by Colman, as providing a tapered section of a threaded luer fitting is an art-recognized standard of luer fittings, and having a tapered section may further assist in the secure attachment between the sampling tube and the threaded luer fitting.
Regarding claim 47, Backowski in view of Dryden, Koch, Kaczorowski, and Knipple teach the fitting of claim 44, however are silent wherein the distal end of the exterior surface further including a tapered section distal to the threaded section configured to engage the angled port, the tapered section engaging the sampling tube.
However Colman teaches a threaded luer fitting (luer male connector 302 includes threads 320, Paragraph 0104 and Figure 3A) configured to engage with a first end of a sampling tube (primary luer male connector of a patient sampling tube, Paragraph 0050), wherein the first end of the sampling tube engages with a tapered section of the threaded luer fitting (luer male connector comprises a tapered cone, Paragraph 0019 and Figure 3A).
Therefore, it would have been obvious to one of ordinary skill in the art to further modify the device of Baczkowski in view of Dryden and Kaczorowski and Knipple by having the first end of the sampling tube engage with a tapered section of a threaded luer fitting, as taught by Colman, as providing a tapered section of a threaded luer fitting is an art-recognized standard of luer fittings, and having a tapered section may further assist in the secure attachment between the sampling tube and the threaded luer fitting.
Conclusion
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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