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 .
Claim Objections
Claims 32 and 35 are objected to because of the following informalities:
Claim 32 line 2: “medical tube” should read “the second medical tube”
Claim 35 line 2: “medical tube” should read “the second medical tube”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 23-26, 28, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Bafile et al. 2015/0320962, in view of Gansel et al. 5,794,986
Regarding claim 23, Bafile teaches a respiratory assistance system (Figure 1, pressure support system) comprising: a patient interface (Figure 9, 40) comprising an interface tube (Figure 11, 182); a connector (rotary coupling device 60-1, figure 2) comprising: an internal component (middle cylindrical wall 76, figure 3) attached to a medical tube (0036 states “In addition, the outer surface of middle cylindrical wall 76 provides a surface to which delivery conduit 22 may be sealingly attached”), and wherein the internal component is configured to provide fluid flow through a length of the connector (Through second passage 82); and an external component comprising an outer wall and an inner wall (First cylindrical portion 70), wherein the inner wall is spaced a distance from the internal component and forms a cavity between the external component and the internal component (depicted in figure 3 as wall 74 is spaced apart from 76); and wherein the cavity is configured to receive a portion of the medical tube (Since the medical tube is connected to 76, the cavity would receive a portion of this tubing).
Bafile fails to teach the internal component comprising a plurality of fingers extending from the internal component, wherein the plurality of fingers are configured to attach to a medical tube. Gansel teaches an analogous ventilator circuit tubing that does teach wherein the internal component (inner coupling member 16, figure 1) comprises a plurality of fingers extending from the internal component (male circumferential barbs 28), wherein the plurality of fingers are configured to attach to a medical tube (Column 5 line 17 states “In addition, male circumferential barbs 28 are aligned with female circumferential barbs 40 when threaded portions 24 and 32 are fully engaged). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner component of Bafile with the barbs of Gansel as they would allow for a strong connection of the tubing at the point of engagement (column 5 line 21).
Regarding claim 24, Bafile teaches the respiratory assistance system of claim 23, wherein the outer wall and the inner wall are concentric (The outer and inner walls of 74 are concentric as depicted in figure 2).
Regarding claim 25, Bafile teaches the respiratory assistance system of claim 23, wherein the external component is configured to interact with different sized medical tubes (70 of Bafile can interact with different sized tubes either though an outer or inner wall of 74, or behind at the second narrower cylinder as depicted in figure 4).
Regarding claim 26, Bafile teaches the respiratory assistance system of claim 23, wherein the external component further comprises an internal coupling face (Second narrow cylinder 72) configured to couple with a second medical tube (Second coupling member 64).
Regarding claim 28, Bafile teaches the respiratory assistance system of claim 26, wherein the internal coupling face is an outer surface of the inner wall of the external component (Figure 3 of Bafile depicts the internal coupling face within the wall 74 (modified by Matlock above) as being an outer surface of 76.).
Regarding claim 35, Bafile teaches the respiratory assistance system of claim 23, wherein an external coupling face is configured to form a seal with the medical tube (Based on figure 4, the internal coupling face if cylinder 72 would form a seal with second coupling member 64).
Regarding claim 36, Bafile teaches the respiratory assistance system of claim 23, wherein an external coupling face is configured to form a press-fit with the medical tube (Figure 4 depicts second coupling 64 with a press-fit with cylinder 72).
Regarding claim 37, Bafile teaches the respiratory assistance system of claim 23, wherein the external component is a single-piece construction (Cylinder 72 and 70 are a one-ice construction as depicted in figure 4).
Claims 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over modified Bafile, in view of Matlock et al. 2007/0255258
Regarding claim 27, modified Bafile teaches the respiratory assistance system of claim 26, but fails to teach wherein the internal coupling face is an inner surface of the outer wall of the external component. Matlock teaches an analogous tube connector that does teach wherein the internal coupling face is an inner surface of the outer wall of the external component (Figure 4, inside face tube 310). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer connector to Bafile with the teachings of Matlock and include wherein the internal coupling face is an inner surface of the outer wall of the external component, as this allows for a secure connection of the tubing (0047).
Regarding claim 29, Bafile teaches the respiratory assistance system of claim 26, but fails to teach wherein the internal coupling face is configured to couple with the second medical tube via a snap-fit. Matlock does teach wherein the internal coupling face is configured to couple with the second medical tube via a snap-fit (connection of inner cannula to 310 is by way of a snap-fit through ribs 315.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bafile with the teachings of Matlock and include wherein the internal coupling face is configured to couple with the second medical tube via a snap-fit as this allows for a secure connection of the tubing (0047).
Claims 30-31 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over modified Bafile, in view of Matlock et al. 2007/0255258
Regarding claim 30, modified Bafile teaches the respiratory assistance system of claim 26, but fails to teach wherein the internal coupling face is configured to couple with a male connector on the second medical tube. White teaches an analogous connector that does teach wherein the internal coupling face (Internal surface of connector piece 36) is configured to couple with a male connector on the second medical tube (The internal coupling face does have the ability to couple to a male connector by way ridges 50 and 51 and the ribs 38 located on a second medical tube in the left hand part of end part 34 as depicted in figure 7). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of White and include wherein the internal coupling face is configured to couple with a male connector on the second medical tube, as this allows for a secure method of attachment of the second medical tube.
Regarding claim 31, modified Bafile teaches the respiratory assistance system of claim 26, but fails to teach wherein the internal coupling face comprises at least one rib configured to interact with a corresponding groove on the second medical tube. White does teach, wherein the internal coupling face comprises at least one rib (Ridges 50 and 51 of 36, figure 11) configured to interact with a corresponding groove on the second medical tube (interacts with rib 41). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of White and include wherein the internal coupling face comprises at least one rib configured to interact with a corresponding groove on the second medical tube, as this allows for a secure method of attachment of the second medical tube.
Regarding claim 39, modified Bafile teaches the respiratory assistance system of claim 23, but fails to teach wherein the external component comprises a gripping region. White does teach wherein the external component comprises a gripping region (a gripping portion is located on end part 36 as depicted in figure 8). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of White and include wherein the external component comprises a gripping region, as it provides a surface that gives the user a way to disconnect and connect both components.
Regarding claim 40, modified Bafile teaches the respiratory assistance system of claim 23, but fails to teach wherein the internal component comprises a thread to attach to the interface tube. White does teach wherein the internal component comprises a thread to attach to the interface tube (Depicted on the end of male portion 37 as depicted in figure 8). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of White and include wherein the internal component comprises a thread to attach to the interface tube, as this connects the connector to the user interface, providing the needed treatment to the user.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over modified Bafile, in view of Guala et al. 2013/0187361
Regarding claim 32, modified Bafile teaches the respiratory assistance system of claim 23, wherein an external coupling face comprises an external taper (Figure 4, external coupling face of cylinder 72) but fails to teach this face being configured to couple with a tapered female connector on the medical tube. Guala teaches an analogous medical line connector that does teach an external face (Figure 5, hollow lock element 10) configured to couple with a tapered female connector on the medical tube (Hollow end 10 has a ring of teeth 19, which provides the ability for a connection to an outside female connector). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of Guala and include the external face being configured to couple with a tapered female connector on the first medical tube, as this structural design choice allows for a connection with an outside female connector.
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Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over modified Bafile, in view of Takeuchi et al. Wo 2016133139
Regarding claim 33, modified Bafile teaches the respiratory assistance system of claim 23, but fails to teach wherein the external component comprises a first internal coupling face and a second internal coupling face one or both of the first internal coupling face and the second internal coupling face configured to form a seal with a second medical tube. Takeuchi does teach wherein the external component (Figure 11, female connector 200) comprises a first internal coupling face (Face of luer 227) and a second internal coupling face (The face on the inside of the connector, surrounding luer 227, this outer surrounding space has the ability to couple with a larger connector) one or both of the first internal coupling face and the second internal coupling face configured to form a seal with a second medical tube (both faces have the ability to couple to an additional tube). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Bafile with the teachings of Takeuchi by providing space between the inner wall and external wall of the connector and include wherein the external component comprises a first internal coupling face and a second internal coupling face one or both of the first internal coupling face and the second internal coupling face configured to form a seal with a second medical tube, as this configuration provides multiple faces within the external component that allows for connection to be made.
Regarding claim 34, modified Bafile in view of Takeuchi teaches the respiratory assistance system of claim 33, wherein one or both of the first internal coupling face and the second internal coupling face is tapered (Page 12 of the attached translated reference states that “The outer peripheral surface of the male luer 227 is a male tapered surface”).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over modified Bafile
Regarding claim 38, modified Bafile teaches the respiratory assistance system of claim 23, but fails to teach wherein the external component is a two-piece construction, the two-piece construction comprising a first piece and a second piece provided in a permanent attachment arrangement with each other once attached to each other. However, regarding the use of a two-piece construction of the external component, the court has held that making components separable may be considered obvious to a person of ordinary skill in the art. MPEP § 2144.04-V-C. Once made separable, the two components would have the ability to be attached to each other.
Response to Arguments
Applicant’s arguments with respect to claim 23 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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