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 statement (IDS) submitted 07/31/2023 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 is rendered indefinite as the snap-on mechanism is referred to as a “second snap-on mechanism”, however there is no first snap-on mechanism mentioned. This is interpreted as being a snap on mechanism that connects both the first and second duct portions.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 40 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasinski et al. 2020/0282173
Regarding claim 40, Yasinski teaches a method of manufacturing a connection piece (Figure 9), comprising the steps of - providing a main body (airflow mixing channel 30) having a first inflow end (leading into inflow channel 30) and an outflow end defining a channel (Outflow leading to valve 50), and a second inflow end portion (inflow to air intake valve 40) arranged at an angle of less than 90 degrees in a direction of the channel (angled arm 43 is less than 90 degrees),- attaching, by means of a snap-on mechanism (Figure 15), a duct portion to the second inflow end portion (Parts vii and vi), wherein at least one of a valve flapper (intake valve 40 can be a flapper as stated in 0057) and a ring (Figures 1 and 2 depict intake valve 40 containing a ring surround the valve) is arranged between the duct portion and the second inflow end portion (Depicted in figure 15 with the connection between parts viii and vi).
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 25-26, 29-33, 35, 37-38, 41, 44, 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Yasinski et al. 2020/0282173 in view of Kemps et al. 2015/0151075
Regarding claim 25, Yasinski teaches a connection piece for a medical ventilator assembly (Figure 9, Connector in between 20 and 50), comprising a main body (airflow mixing channel 30) with a first inflow end (leading into inflow channel 30) and a second inflow end (inflow to air intake valve 40), and an outflow end (Outflow leading to valve 50), the first inflow end and the outflow end defining a channel with a longitudinal axis (mixing channel 30), wherein the second inflow end comprises a one-way valve adapted to allow gas flow toward the channel (one-way air intake valve 40), wherein the second inflow end is shaped and/or oriented with respect to the channel such that a gas flow from the second inflow end enters the channel, at an entry point (Connection point between 30 and 43 depicted by airflow 36), at an angle of less than 90° with respect to a direction of the longitudinal axis at said entry point from the first inflow end to the outflow end (angled arm 43 is less than 90 degrees).
Yasinski fails to teach wherein the connection piece further comprising a leak valve arranged downstream of the one-way valve. Kemps teaches an analogous connector that does teach wherein the connection piece (figure 6) further comprising a leak valve (pressure regulator 601) arranged downstream of the one-way valve (Figure 7 depicts 601 located downstream from the one-way valve 605). 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 Yasinski with the teachings of Kemps and include wherein the connection piece further comprising a leak valve arranged downstream of the one-way valve as this would allow for the varying of pressure by way of the exhaust of excess gasses (0065 and 0093). Modified Yasinksi would now have the leak valve located downstream from the one-way valve which located within the second inflow end.
Regarding claim 26, Yasinski teaches the connection piece according to claim 25, wherein the second inflow end is arranged at an angle of less than 90* with respect to the direction of the longitudinal axis at said entry point from the first inflow end to the outflow end (angled arm 43 of Yasinski is less than 90 degrees).
Regarding claim 29, modified Yasinski teaches the connection piece according to claim 25, wherein the leak valve comprises a mechanism for adjusting a leak flow (orifice 634 of Kemps).
Regarding claim 30, Yasinski teaches the connection piece according to claim 29, wherein the leak valve comprises a leak valve cap (cap 622) which is screwed or screwable to the main body (depicted in figure 6 of Yasinski), the leak valve cap comprising a plug adapted for closing a leak opening in the main body when the leak valve cap is screwed onto the main body (Seat member 611, figure 9 of Yasinski), and wherein the mechanism for adjusting the leak flow is a screwing mechanism for adjusting a distance between the plug and the leak opening (0114 of Yasinski states “The top or end of cap 622 terminates in orifice 634 and as shown in the markings thereon in FIG. 6, is rotatable to adjust the PEEP. More particularly, when a user rotates the cap 622, the seat member 611 also rotates since the projections 654 mate with the teeth 652 locking the cap 622 in position rotationally relative to the seat member 611. The rotation of the cap 622 generates movement in the direction A of the seat member 611 through action of the thread 642 against the thread 644. The movement of the seat member 611 is accommodated in the portion of the cap 622 that engages the mount 613”).
Regarding claim 31, modified Yasinski teaches the connection piece according to claim 30, wherein the leak valve cap is adapted to allow the leak flow through the leak opening which correlates with a rotational position of the leak valve cap (0073 of Kemps states “a pressure regulator which is arranged to regulate pressurised gases supplied to a patient by releasing or exhausting some gases when the pressure exceeds a threshold. This threshold is preferably easily manipulated by manual adjustment of the regulator by a user's digits including fingers and/or thumbs. In an embodiment this is achieved by adjusting the position of a valve seal against which a valve member is biased”).
Regarding claim 32, Yasinski teaches the connection piece according to claim 25, wherein the one-way valve comprises a valve flapper (0057 states “the one-way valve used operates to some extent based on gravity, e.g., a flapper valve that closes using gravity after user inhalation”).
Regarding claim 33, Yasinski teaches the connection piece according to claim 25, wherein an opening of the one-way valve, when opened for gas flow, has a size corresponding to at least half a size of a cross sectional area of the second inflow end (Figures 1 and 2 of Yasinski depict the opening of the one-way valve 40 as being about half the size of the overall inflow end.).
Regarding claim 35, Yasinski teaches the connection piece according to claim 25, wherein the second inflow end is formed by a first duct portion integrally formed with at least one of the first inflow end and the outflow end (Figure 15, part viii), and a second duct portion attached or attachable to the first duct portion (part vi).
Regarding claim 37, Yasinski teaches the connection piece according to claim 25, wherein the one-way valve is arranged substantially between the first and the second duct portions (Figure 15 and the connection between parts viii and vi depict the one-way valve being located between the first and second duct portion).
Regarding claim 38, Yasinski teaches the connection piece according to claim 25, wherein the one-way valve comprises an opening which is offset with respect to duct axis of the second inflow end (Figure 2 depicts the opening of the valve, being located in line with the second duct axis as shown in figure 1.).
Regarding claim 41, Yasinski teaches the method according to claim 40, but fails to teach wherein the main body further comprises a leak valve opening with a thread, further comprising the step of screwing on a leak valve cap onto the thread. Kemps does teach wherein the main body (Figure 6, apparatus 600) further comprises a leak valve opening (pressure regulator 601) with a thread (thread 644 and lip 648), further comprising the step of screwing on a leak valve cap onto the thread (0113 states “a lip 646 of the cap 622 engages a lip 648 of the mount 613”). 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 Yasinski with the teachings of Kemps and include a leak valve as this would allow for the varying of pressure by way of the exhaust of excess gasses (0065 and 0093).
Regarding claim 44, modified Yasinski teaches a method of ventilating a patient (abstract of Yasinski, respiratory therapy), using at least a first ventilating device which is not an airway clearance therapy device (Compressor 70), and the first ventilation device delivers breathing cycles to the first inflow end of a connecting piece according to claim 25 (Delivery of pressurized gas 12).
Regarding claim 46 modified Yasinski teaches the connection piece according to claim 32, wherein the second inflow end is formed by a first duct portion integrally formed with at least one of the first inflow end and the outflow end (Figure 15 of Yasinski, part viii), and a second duct portion attached or attachable to the first duct portion (part vi).
Regarding claim 47, modified Yasinski teaches the connection piece according to claim 46, wherein the valve flapper is held against the first duct portion by the second duct portion (0057 states “This configuration, e.g., angled at from 30° to 90° from perpendicular (perpendicular shown in FIG. 1), can be useful when the one-way valve used operates to some extent based on gravity, e.g., a flapper valve that closes using gravity after user inhalation. Thus, the one-way air intake valve and the one-way medicament 50 valve in this example can be positioned generally in a downward position to allow gravity to close the valves more efficiently when a user is not inhaling.” In this position, the valve flapper would be held against the first duct portion when opened.).
Regarding claim 48, modified Yasinski in view of Tatarek teaches the connection piece according to claim 28, wherein the leak valve comprises a leak valve cap (cap 622 of Yasinski) which is screwed or screwable to the main body (depicted in figure 6 of Yasinski), the leak valve cap comprising a plug adapted for closing a leak opening in the main body when the leak valve cap is screwed onto the main body (Seat member 611, figure 9 of Yasinski), and wherein the mechanism for adjusting the leak flow is a screwing mechanism for adjusting a distance between the plug and the leak opening (0114 of Yasinski states “The top or end of cap 622 terminates in orifice 634 and as shown in the markings thereon in FIG. 6, is rotatable to adjust the PEEP. More particularly, when a user rotates the cap 622, the seat member 611 also rotates since the projections 654 mate with the teeth 652 locking the cap 622 in position rotationally relative to the seat member 611. The rotation of the cap 622 generates movement in the direction A of the seat member 611 through action of the thread 642 against the thread 644. The movement of the seat member 611 is accommodated in the portion of the cap 622 that engages the mount 613”).
Claims 27, 28, 42, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over modified Yasinski in view of Tatarek et al. 2009/0293878
Regarding claim 27, modified Yasinski teaches the connection piece according to claim 25, but fails to teach wherein the leak valve comprises a filter for filtering gas flowing from the channel to ambient through the leak valve. Tatarek teaches an analogous connector (figure 1) that does teach wherein the leak valve (Figure 8, exhale valve 57) comprises a filter for filtering gas flowing from the channel to ambient through the leak valve (Filter 53). 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 Yasinski with the teachings of Tatarek and include wherein the leak valve comprises a filter for filtering gas flowing from the channel to ambient through the leak valve as the use of a filter allows for the filtering out of contaminated gas (0030).
Regarding claim 28, modified Yasinski teaches the connection piece according to claim 26, but fails to teach wherein the filter is held onto the leak valve by means of a filter cap. Tatarek does teach wherein the filter is held onto the leak valve by means of a filter cap (Figure 8, Frame 61). 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 Yasinski with the teachings of Tatrek and include wherein the filter is held onto the leak valve by means of a filter cap, as this allows for structure that holds the pieces of the valve together (0046).
Regarding claim 42, Yasinski in view of Kemps teaches the method according to claim 41, but fails to teach further comprising a step of arranging a filter on the leak valve cap. Tatarek does teach a step of arranging a filter (figure 8, filter 53) on the leak valve cap (Cover 52). 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 Yasinski in view of Kemps with the teachings of Tatarek and include a step of arranging a filter on the leak valve cap as this would allow for the use of a filter for filtering out contaminated gases (0030).
Regarding claim 49, modified Yasinski in view of Tatarek teaches the connection piece according to claim 48, wherein a filter cap is attached to the leak valve cap (Figure 8 of Yasinski, Frame 61), and the filter is arranged between the leak valve cap and the filter cap (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 further modify modified Yasinski to include a filter cap as this would further help to hold the filter in place (0046).
Claims 34 and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over modified Yasinski in view of Reiner et al. 2018/0272084
Regarding claim 34, modified Yasinski teaches the connection piece according to claim 25, but fails to teach further comprising a cap attached to the main body, by a tether and adapted for closing the second inflow end. Reiner teaches an analogous adaptor that does teach a cap (Figure 2A, cap 150) attached to the main body (attached to adaptor body 112), by a tether (156) and adapted for closing an inflow end (Closes end 116). 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 second end of Yasinski with the cap and tether as taught by Reiner as this cap can cover the end to prevent the leakage of air (0073).
Regarding claim 50, modified Yasinski in view of Reiner teaches the connection piece according to claim 34, wherein the second inflow end is formed by a first duct portion integrally formed with at least one of the first inflow end and the outflow end (Figure 15 of Yasinski, part viii), and a second duct portion attached or attachable to the first duct portion (part vi).
Regarding claim 51, modified Yasinski in view of Reiner teaches the connection piece according to claim 50, wherein the tether (tether 156 of Reiner) is attached to the second inflow end (Figure 2b) by means of a ring (loop 162) arranged between the first duct portion and the second duct portion (Figure 2b depicts the ring overlapping a section containing a first duct portion of body 112 and a second duct portion of sidewall 152.). 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 further modify modified Yasinski to include a ring as a means of holding the inflow cover in place.
Claims 36 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over modified Yasinski in view of Geraci et al. 2020/0164171
Regarding claim 36, modified Yasinski teaches the connection piece according to claim 35, but fails to teach wherein the second snap- on mechanism comprises a protrusion which prevents a torsion about a duct axis and/or decoupling of the first and second duct portion. Geraci teaches an analogous ventilation connector (Figure 5) that does teach wherein the second snap-on mechanism (Exhalation port 440, figure 5) comprises a protrusion which prevents a torsion about a duct axis and/or decoupling of the first and second duct portion (0048 states “the exhalation device 400 using any method or mechanism of attachment suitable to prevent significant leak. For example, the adapter and/or exhalation port may be sized or otherwise configured such that the adapter is positioned within the exhalation port using a tapered locking fit, via screwing or a twist lock with or without threads (in which case the adapter 600 and exhalation port 440 may comprise complementary threads), a snap fit, or any other method or mechanism.” Figure 7 depicts a connection of the two ducts with adaptor 600.). 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 Yasinski with the teachings of Geraci and include wherein the second snap- on mechanism comprises a protrusion which prevents a torsion about a duct axis and/or decoupling of the first and second duct portion as this prevents significant leaks from occurring between the two pieces (0048).
Regarding claim 43, Yasinski in view of Kemps teaches the method according to claim 41, but fails to teach further comprising arranging a protrusion between the duct portion and the second inflow end portion, said protrusion being adapted to prevent a rotation about a duct axis and/or decoupling of duct portion and the second inflow end portion. Geraci does teach a protrusion between the duct portion and the second inflow end portion, said protrusion being adapted to prevent a rotation about a duct axis and/or decoupling of duct portion and the second inflow end portion (0048 states “the exhalation device 400 using any method or mechanism of attachment suitable to prevent significant leak. For example, the adapter and/or exhalation port may be sized or otherwise configured such that the adapter is positioned within the exhalation port using a tapered locking fit, via screwing or a twist lock with or without threads (in which case the adapter 600 and exhalation port 440 may comprise complementary threads), a snap fit, or any other method or mechanism.” Figure 7 depicts a connection of the two ducts with adaptor 600.). 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 Yasinski and Kemps with the teachings of Geraci and include wherein the second snap- on mechanism comprises a protrusion which prevents a torsion about a duct axis and/or decoupling of the first and second duct portion as this prevents significant leaks from occurring between the two pieces (0048).
Claims 39 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over modified Yasinski in view of Roehl et al. 2007/0034208
Regarding claim 39, modified Yasinski teaches the connection piece according to claim 25, but fails to teach a ventilator system for airway clearance therapy and/or ventilation of a patient, comprising a source of pulsatile gas, wherein the source of pulsatile gas is attached to the second inflow end. Roehl teaches an analogous connector (injection module 75, figure 2A) that does teach a ventilator system for airway clearance therapy and/or ventilation of a patient (gas delivery system 10), comprising a source of pulsatile gas (NO delivery module 50, figure 2), wherein the source of pulsatile gas is attached to the second inflow end (supply line 64 is connected to injection point 62.). 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 Yasinski with the teachings of Roehl and include a ventilator system for airway clearance therapy and/or ventilation of a patient, comprising a source of pulsatile gas, wherein the source of pulsatile gas is attached to the second inflow end as this allows for a synchronized supply of nitric oxide to be inserted into the breathing gasses being delivered to the patient (0001).
Regarding claim 45, modified Yasinski teaches the method according to claim 44, but fails to teach wherein the second inflow end is connected to a second ventilating device, which is an airway clearance therapy device, and receives percussive pulses. Roehl does teach wherein the second inflow end (injection point 62) is connected to a second ventilating device (Delivery device 50), which is an airway clearance therapy device (0002 states “Nitric oxide (NO) is a gas that, when inhaled, acts to dilate blood vessels in the lungs, improving oxygenation of the blood and reducing pulmonary hypertension.”), and receives percussive pulses (0062 states “central processing unit 114 operates valve 112 to provide continuous or pulsatile doses of NO to injector element 62”). 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 Yasinski with the teachings of Roehl and include percussive pulses to the second inflow end in order to provide the delivery of gas that improves the outcomes of the patient (0002).
Conclusion
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785