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 Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 20-22, 24-26, 29-34, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Byron et al. (5,746,199).
Regarding claim 20, Byron discloses a breathing assistance connector valve (respiratory valve apparatus, Figures 1-14, Abstract) comprising: a valve body (valve body 12, Figure 1) defining first (port 18, Figure 2), second (port 28, Figure 2) and third ports (port 32, Figure 2); a valve core (valve core disk 14, Figure 2) defining a ported chamber (see valve core disk 14 comprising a ported chamber with ports 36, 34, Figure 2) rotatable about a valve axis between (valve disk 14 can be rotated via the handle 50 to one of the two switching positions which align the ports and disk channels as needed, Col. 6 lines 10-15): a first stable configuration in which the ported chamber provides fluid communication between the first port and the second port and isolates the third port from the first and second ports (see dashed lines shown in Figure 3 showing a first valve configuration wherein the first port 18 and second port 28 are in fluid communication, while the third port 32 is blocked; see also Abstract describing the first and second switching positions); and a second stable configuration in which the ported chamber provides fluid communication between the first port and the third port and isolates the second port from the first and third ports (when the handle 50 is rotated to third port 32 and sits in the indexing slot 48, the first port 18 is in fluid communication with the third port 32 and held in this second valve configuration, Figure 3; see also Abstract), wherein an outer surface of the valve core is configured to engage with an inner surface of the valve body to define a detent for resisting rotation of the valve core between the first stable configuration and the second stable configuration (the outer surface of valve core disk 14 is configured to engage with an inner surface 44 of valve body 12 via a first indexing slot 46, second indexing slot 48, and ramping down to the face of the housing via ramps 467 and 49, therefore defining a detent to snap configuration in place, therefore resisting rotation between the first and second switching positions, Figure 2 and Col. 6 lines 4-16; the Examiner notes Applicant describes the “detent” as an undulated surface, therefore the Examiner notes Bryon’s valve surface comprising slots and ramps constitutes an undulated surface); and an actuator configured to overcome the detent to rotate the valve core between the first and second stable configurations (the handle 50 may be rotated and therefore cause the valve core disk 14 to rotate to one of the two switching positions, Col. 6 lines 10-16).
Regarding claim 21, Byron further discloses comprising a biasing element configured to exert a biasing force along the valve axis to urge together the outer surface of the valve core and the inner surface of the valve body (to facilitate secure insertion of the valve core 14 within the valve body 12, a circumferential groove 40 is formed around the surface of chamber 38, with a corresponding circumferential ridge 42 formed around valve core 14, such that when valve core 14 is inserted into chamber 38, the grooves mate with the ridge 42 so that the valve core 14 securely snaps into place and seals, Figure 2 and Col. 5 lines 55-67).
Regarding claim 22, Byron further discloses wherein the actuator is configured to overcome the detent and the biasing force such that the valve core: rotates about the valve axis between the first stable configuration and the second stable configuration; and is displaced along the valve axis away from the inner surface of the valve body (the handle 50 may be rotated and therefore cause the valve core disk 14 to rotate to one of the two switching positions, therefore overcoming both the detent and biasing forces, Col. 6 lines 10-16).
Regarding claim 24, Byron further discloses wherein the valve core comprises one or more sealing portions on an outer surface of the valve core configured to provide a seal between the valve core and the first, second and third ports (the outer surface of valve core 14 comprises channels to provide a seal between the core 14 and the corresponding ports of the valve body, Figures 2-3).
Regarding claim 25, Byron further discloses wherein the outer surface of the valve core and the inner surface of the valve body each comprise one or more corresponding detent features configured to engage with one another to define the detent (outer surface of valve core 14 comprise the handle 50 flexible enough to bend up and over the ramps 47 and 49 to fall into the indexing slots 46, 48 of the inner surface of the valve body 12, Figure 2 and Col. 6 lines 5-11).
Regarding claim 26, Byron further discloses wherein the outer surface of the valve core and the inner surface of the valve body each comprise an undulating surface (outer surface of valve core 14 comprises a circumferential ridge 43, and the inner surface of the valve body 12 comprises both slots and ramps, therefore both surfaces comprise an undulating surface, Figure 2).
Regarding claim 29, Byron further discloses wherein the outer surface of the valve core and the inner surface of the valve body each have 90-degree rotational symmetry about the valve axis (the handle 50 may be rotated and therefore cause the valve core disk 14 to rotate to one of the two switching positions, therefore overcoming both the detent and biasing forces, therefore fully capable of 90-degree rotation, Figure 3 and Col. 6 lines 10-16).
Regarding claim 30, Byron further discloses wherein the detent comprises a first rotational range and a second rotational range between the first stable configuration and the second stable configuration and wherein (the handle 50 comprises first and second rotational ranges corresponding to the switching between the first and second switching positions; outer surface of valve core 14 comprise the handle 50 flexible enough to bend up and over the ramps 47 and 49 to fall into the indexing slots 46, 48 of the inner surface of the valve body 12, Figure 2 and Col. 6 lines 5-11): the detent biases the valve core towards the first stable configuration when the valve core is within the first rotational range (when handle is moved to the first port 18, therefore within the first rotational range, the slots/ramps are biased to keep valve core 14 within the first position, Figures 2-3); and the detent biases the valve core towards the second stable configuration when the valve core is within the second rotational range (when handle is moved to the second port 28, therefore within the second rotational range, the slots/ramps are biased to keep valve core 14 within the second position, Figures 2-3).
Regarding claim 31, Byron further discloses wherein the actuator comprises a lever rotatable about the valve axis and coupled to the valve core (the handle 50 comprises a lever capable of being rotatable about the axis of the valve and drives the rotation of the valve core 14, Figure 3 and Col. 6 lines 10-16).
Regarding claim 32, Byron further discloses wherein the valve body further comprises a cap enclosing a first end of the valve body (see valve body comprising a cap enclosing valve assembly Figure 1), wherein the cap comprises first and second stops to block rotation of the lever and valve core beyond the respective first and second stable configurations (the handle 50 rests is either slot 46 or 48 to therefore block further rotation of the handle, Figures 1-2).
Regarding claim 33, Byron further discloses wherein the valve core is displaceable along the valve axis relative to the valve body and the lever (the handle 50 may be rotated and therefore cause the valve core disk 14 to rotate to one of the two switching positions, Col. 6 lines 10-16).
Regarding claim 34, Byron further discloses wherein the first port is configured for connection to a patient airway maintaining device (first port 18 is an endotracheal tube connection port, therefore connecting to a patient airway maintaining device, Col. 5 lines 42-49), and the second and third ports are each configured for connection to a ventilator breathing circuit or breathing assistance device (second port 28 configured to connect to a resuscitation bag attachment and third port 32 is a respirator attachment port, Col. 5 lines 42-49 and Figure 2).
Regarding claim 36, Byron further discloses further including a ventilation apparatus couplable to at least one of the second and third ports (second port 28 configured to connect to a resuscitation bag attachment and third port 32 is a respirator attachment port, Col. 5 lines 42-49 and Figure 2).
Regarding claim 37, Byron further discloses further including an endotracheal tube couplable to the first port (first port 18 is an endotracheal tube connection port, Col. 5 lines 42-49).
Regarding claim 38, Byron discloses a method of configuring breathing assistance apparatus for a patient (respiratory valve apparatus comprising a rotational valve assembly configured to switch between a first and second position, Abstract and Figure 1) comprising: providing a valve comprising: a valve body (valve body 12, Figure 1) defining first (port 18, Figure 2), second (port 28, Figure 2) and third ports (port 32, Figure 2) a valve core (valve core disk 14, Figure 2) defining a ported chamber (see valve core disk 14 comprising a ported chamber with ports 36, 34, Figure 2) rotatable about a valve axis between (valve disk 14 can be rotated via the handle 50 to one of the two switching positions which align the ports and disk channels as needed, Col. 6 lines 10-15): a first stable configuration in which the ported chamber provides fluid communication between the first port and the second port and isolates the third port (see dashed lines shown in Figure 3 showing a first valve configuration wherein the first port 18 and second port 28 are in fluid communication, while the third port 32 is blocked; see also Abstract describing the first and second switching positions); and a second stable configuration in which the ported chamber provides fluid communication between the first port and the third port and isolates the second port (when the handle 50 is rotated to third port 32 and sits in the indexing slot 48, the first port 18 is in fluid communication with the third port 32 and held in this second valve configuration, Figure 3; see also Abstract), wherein an outer surface of the valve core is configured to engage with an inner surface of the valve body to define a detent for resisting rotation of the valve core between the first stable configuration and the second stable configuration (the outer surface of valve core disk 14 is configured to engage with an inner surface 44 of valve body 12 via a first indexing slot 46, second indexing slot 48, and ramping down to the face of the housing via ramps 467 and 49, therefore defining a detent to snap configuration in place, therefore resisting rotation between the first and second switching positions, Figure 2 and Col. 6 lines 4-16; the Examiner notes Applicant describes the “detent” as an undulated surface, therefore the Examiner notes Bryon’s valve surface comprising slots and ramps constitutes an undulated surface); and an actuator overcome the detent to rotate the valve core between the first and second stable configurations (the handle 50 may be rotated and therefore cause the valve core disk 14 to rotate to one of the two switching positions, Col. 6 lines 10-16).; coupling a patient breathing tube to the first port (first port 18 is an endotracheal tube connection port, Col. 5 lines 42-49); coupling a first ventilation device to the second port (second port 28 configured to connect to a resuscitation bag attachment, Col. 5 lines 42-49 and Figure 2); while the valve is in the first stable configuration (see Figure 3 showing first valve configuration) coupling a second ventilation device to the third port (third port 32 is a respirator attachment port, Col. 5 lines 42-49 and Figure 2); switching the valve to the second stable configuration (movement of the handle 50 causes valve core 14 to rotate, to therefore provide fluid communication between first port 18 and third port 32, Figure 3); and disconnecting the first ventilation device from the second port (in second configuration, second port 28 is not fluidly connected to valve body, Figure 3 and Abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Byron et al. (5,746,199). in view of Fink (4,219,021).
Regarding claim 23, Byron teaches the valve of claim 22, and although Byron teaches a valve body configured to receive a valve core (Figure 2), Byron is silent wherein: the valve core comprises a tapered portion defining the ported chamber, wherein a second end of the tapered portion is narrower than a first end of the tapered portion; and the valve body comprises a tapered portion for receiving the tapered portion of the valve core.
However, Fink teaches a multi-ported and variable-position valve assembly (Abstract and Figure 1) comprising a valve body (valve body 12, Figure 6) configured to receive a valve core (valve core 14, Figure 7), wherein the valve core has a tapered portion with a narrower first end (valve core 14 is generally cylindrical and slightly tapered to rest snugly within the corresponding tapered valve body, Col. 3 lines 60-65 and Figure 6).
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 Byron’s valve assembly such that the valve core comprises a tapered portion, as taught by Fink, as providing a tapered portion on the valve core may assist in a snug fit between the valve core and the valve body, providing overall structural integrity to the valve assembly.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Byron et al. (5,746,199) in view of Thomas (2,702,050).
Regarding claim 27, Byron teaches the valve of claim 26, however is silent wherein each undulating surface comprises a repeating substantially sinusoidal or triangular profile extending around the valve axis.
However, Thomas teaches a multi-ported valve assembly (Abstract and Figure 1) comprising undulated surfaces on both the valve core and valve body surfaces (see undulated cam surface 45 on valve core 11 configured to co-act with cam surface 46 on valve body 15, Figures 4-5), wherein the undulated surfaces comprise a repeating sinusoidal profile extending around the valve axis (see cam surfaces 45, 46 having a repeating sinusoidal profile extending around valve axis 12, Figure 4).
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 Byron’s valve assembly by having the undulated surfaces of the valve core and body comprising repeating sinusoidal profiles, as taught by Thomas, as providing repeating sinusoidal profiles may provide a finer and smoother control of the rotation of the valve assembly.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Byron et al. (5,746,199) in view of Thomas (2,702,050) and in further view of DeVries et al. (US 2016/0279375 A1).
Regarding claim 28, Bryon in view of Thomas teach the valve of claim 27, wherein at least one of the undulating surfaces is formed as a plurality of concentric rings around the valve axis.
However, DeVires teaches a respiratory valve assembly (Abstract and Figure 1) comprising a valve core comprising an undulated surface, such that the undulated surface is formed as a plurality of concentric rings around the valve axis (see plurality of concentric rings 476 formed around valve axis, Figure 2E).
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 Byron’s valve assembly by having the undulated surfaces comprise a plurality of concentric rings, as taught by DeVires, as using concentric rings in a rotational valve assembly is well-known within the art, and may provide benefits to the overall valve structure such as evenly-distributed pressures between the valve components.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Byron et al. (5,746,199) in view of Morejon (US 10,279,137 B1).
Regarding claim 35, Byron teaches the valve of claim 34, however is silent in which the first port has a 22 mm tapered outer diameter connector surface and the second and third ports each have a 22 mm tapered internal diameter connector surface.
However, Morejon teaches a respiratory valve assembly (Abstract and Figure 1) comprising first, second and third ports (Figure 1) having tapered outer and internal diameters of 22 mm (the ports may be configured with a standard 2mm outside diameter to accept respiratory circuit tubing of 22 mm inside diameter, Col.3 lines 40-46).
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 Byron’s valve assembly by having the ports comprise 22 mm diameters, as taught by Morejon, as 22 mm is an art-recognized dimension commonly used in respiratory devices and is the dimension of standard respiratory circuitry components (Col. 3 lines 40-46 of Morejon).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bayron et al. (US 8,656,915 B2), Evans (US 5,466,228), and Brody (5,288,290).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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