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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference character 122. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities:
Claim 2, line 1, “the lumen second end” should read “the second end of the lumen”
Claim 3, line 2, “the lumen second end” should read “the second end of the lumen”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
Regarding “wherein the connector body comprises a guide portion for positioning the elongate tube relative to the connector body” in claim 10.
Uses the term “portion” which is a generic placeholder for means
The functional language that modified the “guide portion” is that it positions the elongate tube relative to the connector body
“guide portion” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, the guide portion is being interpreted as a channel, an eyelet, a groove, slot [0013] or other suitable alternative for positioning the elongate tube as described in the specification and drawings.
Regarding “a locating feature for preventing the lumen from protruding out of the invasive patient interface when in use” in claim 16.
Uses the term “feature” which is a generic placeholder for means
The functional language that modified the “locating feature” is that it prevents the lumen from protruding out of the invasive patient interface
“locating feature” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, the guide portion is being interpreted as an engagement structure such as one or more of a protrusion, a rib, a groove and a flange on an internal or external surface or wall [0156]-[0158] or other suitable alternative for engagement/coupling as described in the specification and drawings.
Because these claim limitation are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 25, 32, 33, and 35 are 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 25 recites the phrase "preferably" in lines “and preferably in a range of about 2 cmH2O to about 20 cmH2O, preferably about 2 cmH2O to about 10 cmH2O, and more preferably about 2 cmH2O to about 5 cmH2O”. This language creates confusion as to whether the “preferably” components are required by the claimed invention or are optional/preferred components. It is unclear what structure/limitation is required due to the use of “preferably” in the claim, therefore the claim is indefinite under 35 U.S.C. 112(b).
Further, Claim 25 recites “at least about 2 cmH2O”. This limitation is unclear as “at least about” can be interpreted multiple different ways. For example, it can be interpreted as the pressure is at least around 2 cmH2O (i.e. 2 cmH2O +/- 1 cmH2O) or it can be interpreted that it is at least 2 cmH2O (i.e. ~2 cmH2O or more). Therefore, because there is uncertainty on how the claim may be interpreted, the claim is indefinite under 35 U.S.C. 112(b). For purposes of examination, “at least about 2 cmH2O” is being interpreted as “at least 2 cmH2O”.
Claim 32 recites the limitation "one or both of the first and predetermined velocity" and “one or both of the first and second predetermined velocity” in lines 4-5 and 7-8. There is insufficient antecedent basis for this limitation in the claim. Therefore, it is unclear what a predetermined velocity and second predetermined velocity are referring to. Claim 29 recites a first predetermined velocity. For purposes of examination, “one or both of the first and predetermined velocity” and “one or both of the first and second predetermined velocity” are being interpreted as “the first predetermined velocity”.
Claim 33 is also rejected due to being dependent on claim 32.
Claim 35 recites the phrase "preferably" in lines “wherein the predetermined velocity is in a range of about 5 m/s to about 25 m/s, preferably about 5 m/s to about 15 m/s m/s”. This language creates confusion as to whether the “preferably” components are required by the claimed invention or are optional/preferred components. It is unclear what structure/limitation is required due to the use of “preferably” in the claim, therefore the claim is indefinite under 35 U.S.C. 112(b).
Claim 36 recites the phrase "preferably" in lines “wherein the inlet port receives a flow of respiratory gas having a flow rate in a range of about 10 LPM to about 150 LPM, preferably about 20 LPM to about 70 LPM”. This language creates confusion as to whether the “preferably” components are required by the claimed invention or are optional/preferred components. It is unclear what structure/limitation is required due to the use of “preferably” in the claim, therefore the claim is indefinite under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christopher (US 20140238398).
Regarding claim 1, Christopher discloses
a connector for coupling with an invasive patient interface providing respiratory support to a patient (figs. 3-19; adapter 70 for use with a patient airway interface 60 (which may include any variety of tracheal tubes, such as a tracheostomy tube 80 or endotracheal tube 90) to supply gas to the patient; [0082] and [0096]), the connector comprising:
(a) a connector body (see fig. 10; body of adapter 70) having:
(i) an inlet port couplable with a flow source providing a flow of respiratory gas (fig. 10; adapter 70 has first cylindrical connector 71 that removably fits into and engages the standard connector on a ventilator hose; [0096]; proximal end 74 of cannula 73 also allows for atmosphere gas for inhalation; [0097]);
(ii) a gases exit port (fig. 10; opening in cap of adapter 70 which provides an open proximal end 74 of the inner cannula 73 to extend through; therefore, the cap and open proximal end 74 provide a port to the atmosphere for patient inhalation and exhalation; [0097]); and
(iii) a device port couplable with the invasive patient interface (fig. 10; adapter 70 has a second cylindrical connector 72 that removably fits over and engages the standard proximal connector on a tracheal tube 80, 90 (patient airway interface 60); [0096]); and
(b) a lumen having a first end and a second end (fig. 10; proximal end 74 of cannula 73 and distal end of cannula 73 which is near the distal opening of the tracheostomy tube 80 (see fig. 10; bottom opening of tube near user’s airways); [0097]);
wherein the connector body defines a gas flow path between the inlet port and both the device port and the lumen first end (see fig. 10; flow path arrows between cylindrical connector 71 and cylindrical connector 72 and flow path arrows inside cannula 73); and
wherein the lumen second end is disposed outside the device port (see fig. 10; distal end of cannula 73 which is near the distal opening of the tracheostomy tube 80 (see fig. 10; bottom opening of tube near user’s airways) is positioned outside of second cylindrical connector 72; [0097]).
Regarding claim 2, Christopher further discloses
the connector (adapter 70) of claim 1,
wherein the lumen second end is disposed outside the device port (see fig. 10; distal end of cannula 73 which is near the distal opening of the tracheostomy tube 80 (see fig. 10; bottom opening of tube near user’s airways) is positioned outside of second cylindrical connector 72; [0097]) for delivery of gas at a target location deeper in the patient's airway than the device port (see fig. 10; distal end of cannula 73 delivers atmosphere air deeper into the patient’s airway compared to second cylindrical connector 72 which is positioned outside the user’s mouth).
Regarding claim 3, Christopher further discloses
the connector (adapter 70) of claim 1,
wherein the lumen provides an outflow path for gases (see fig. 10; flow path arrows inside cannula 73) entering the lumen second end at a target location deeper in the patient's airway than the device port (see fig. 10; flow arrows show air from patient’s airways entering the distal end of cannula 73 moving upwards towards the proximal end 74 of cannula 73 for patient exhalation; [0097]).
Regarding claim 4, Christopher further discloses
the connector (adapter 70) of claim 3,
wherein the lumen first end provides for gases in the outflow path to flow to surrounding atmosphere (see fig. 10; open proximal end 74 of the inner cannula 73 to extend through opening of cap of adapter; providing a port to the atmosphere for patient inhalation and exhalation; [0097], see arrows inside cannula 73 showing gas/air path going from distal end of cannula 73 to proximal end 74 of cannula 73 which exits to atmosphere).
Regarding claim 6, Christopher further discloses
the connector (adapter 70) of claim 2,
wherein the target location is within the invasive patient interface, at a proximal end of the invasive patient interface (see fig. 10, inner cannula 73 is removable inserted into endotracheal tube 80, 90; [0097]-[0099]; fig. 10 shows distal end of cannula 73 (target location) where gas/air is delivered/exits from is within the endotracheal tube 80, 90; additionally, as the cannula is removably inserted, it is capable of being inserted at different locations inside the endotracheal/tracheostomy tube 80, 90, such as closer/further towards the proximal end).
Regarding claim 9, Christopher further discloses
the connector (adapter 70) of claim 1,
wherein the lumen comprises an elongate tube (see figs. 8 and 10; inner cannula 73 is an elongated tube that is inserted into the adapter 70 and tracheostomy/endotracheal tube 80, 90; [0082], [0097], and [0100]) which, when in use, extends through at least part of the connector body (see fig. 10; cannula 73 extends through adapter 73; [0096]-[0097]).
Regarding claim 10, Christopher further discloses
the connector (adapter 70) of claim 9,
wherein the connector body comprises a guide portion for positioning the elongate tube relative to the connector body (see fig. 10; cap of the adaptor 70 has a flexible air-tight seal that maintains the position of the inner cannula 73, but allows rotation of the adaptor 70 around the tracheostomy tube connector 86 for orientation; [0098]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US 20140238398).
Regarding claim 7, Christopher discloses
the connector (adapter 70) of claim 1,
wherein at least part of the lumen is integral with the connector body.
With respect to claim 7, as instant specification is silent to unexpected results (see applicant’s specification: [0012], [0027], [0037]-[0038], [0047], [0133], [0148], and [0153]; where it merely states that the lumen may at least partly be integral, integral, or separate components with no further reasoning), it would have been obvious to one of ordinary skill in the art at the time the invention was made to connect the adapter 70 with the proximal end 74 of the cannula 73, since such modification would have involved making elements integral. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US 20140238398) in view of Wondka (US 10058668).
Regarding claim 16, Christopher discloses
the connector (adapter 70) of claim 1, comprising
Christopher does not explicitly disclose a locating feature for preventing the lumen from protruding out of the invasive patient interface when in use.
However, Wondka discloses a connector with a catheter and outer tube with
a locating feature (see figs. 5, 12C, and 15; ventilation catheter seal and connector 116 and flange 115; col. 14, lines 51-67 and col. 15, lines 1-4; seal and connector may be “a friction fit seal/connector, a twist and lock seal/connector, or a snap-fit seal/connector, a compressible gasket such as silicone, a line-to-line fit between the mating parts, a mating tapered interface, and/or a slight interference fit with one soft material and an opposing hard material”) for preventing the lumen from protruding out of the invasive patient interface when in use (see figs. 5, 12C, and 15, seal and connector 116 is used for sealing, securing, and positioning the catheter 26 to the outer tube/cannula 28, col. 14, lines 51-67 and col. 15, lines 1-4; therefore, it is capable of positioning the catheter 26 from protruding out of the outer tube/cannula 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter, cannula, and tracheostomy/endotracheal tube of Christopher with the seal, connector, and flange of Wondka to help connect the inner cannula to the outer cannula/tube by sealing, securing and positioning them as well as facilitating insertion and removal of the catheter from the outer cannula (Wondka: col. 14, lines 51-67 and col. 15, lines 1-4).
Claims 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US 20140238398) in view of Landis (US 20120272954).
Regarding claim 21, Christopher discloses
the connector (adapter 70) of claim 1,
Christopher does not explicitly disclose wherein the connector is configured to generate a predetermined airway pressure when coupled with the invasive patient interface in use, and wherein the connector includes one or more constrictions configured to generate the predetermined airway pressure.
Landis discloses an artificial airway interface (tee connector, [0028]-[0029]) for an artificial airway (endotracheal tubes (ET), nasotracheal tubes and tracheotomy tubes, [0005])
wherein the connector is configured to generate a predetermined airway pressure (fig. 3; connector 200 has high flow orifice 214 which generates an increase in airway pressure (determined by the diameter of the orifice); [0029]) when coupled with the invasive patient interface in use (see fig. 3; tee connector 200 is connected/coupled to artificial airway 210 through connection 208 and conduit 206; [0028]-[0029]), and
wherein the connector includes one or more constrictions configured to generate the predetermined airway pressure (fig. 3; orifice 214 (of connector 200) can be smaller than the diameter of the artificial airway 210 that can assist with the formation of a gas jet or turbulence. The formation of a gas jet or turbulence in the breathable gas can have the advantage of generating an increase in airway pressure; [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first cylindrical connector of the adapter of Christopher with the orifice and wall diverter of Landis such that a gas jet or turbulence is formed in the breathable gas to have the advantage of generating an increase in airway pressure directed towards the artificial airway, which can act to reduce the work of breathing (Landis: [0028]-[0029]).
Regarding claim 23, the modified device of Christopher further discloses
the connector (Christopher: adapter 70; Landis: high flow orifice and wall diverter 214) of claim 21,
wherein the one or more constrictions are disposed between the inlet port and the device port (Christopher: first cylindrical connector 71 with high flow orifice and wall diverter of Landis as modified above; Landis: see fig. 3; the high flow orifice 214 and wall diverter 214 is positioned between the inlet 202 and conduit 206 (device port for connection to the artificial airway/endotracheal/tracheostomy tube 210); [0028]-[0029]).
Regarding claim 24, the modified device of Christopher further discloses
the connector (Christopher: adapter 70; Landis: high flow orifice and wall diverter 214) of claim 23,
wherein the one or more constrictions (Christopher: first cylindrical connector 71 with high flow orifice and wall diverter of Landis as modified above; Landis: see fig. 3; high flow orifice 214; [0028]-[0029]) are disposed upstream of where a gas flow path connecting the inlet port and the device port meets a gas outflow flow path connecting the device port and the gases exit port (Christopher modified with Landis: high flow orifice 214 is positioned with the first cylindrical connector 71 which provides air/gas (see arrows) to the end of the endotracheal/tracheostomy tube 80, 90; this gas flow path meets the gas outflow path (arrows in cannula 73) which provides exhaled air/gas from the distal end of the cannula 73 towards the proximal end 74 of the cannula 73 and cap of the adapter 70 (gas exit port)).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US 20140238398) in view of Landis (US 20120272954) and further in view of Ratner (US 20140053841).
Regarding claim 25, the modified device of Christopher discloses
the connector (Christopher: adapter 70; Landis: high flow orifice and wall diverter 214) of claim 21,
The modified device of Christopher does not explicitly disclose wherein the predetermined pressure is at least about 2 cmH2O and preferably in a range of about 2 cmH2O to about 20 cmH2O, preferably about 2 cmH2O to about 10 cmH2O, and more preferably about 2 cmH2O to about 5 cmH2O.
Ratner discloses an analogous breathing device which may be engaged with an endotracheal tube [0164] and contains a jet orifice [0185]-[0186]
wherein the predetermined pressure is at least about 2 cmH2O (see figs. 1 (device) and 13-21 (tables 1-9); jet orifice 110 was experimented having different diameters with different wall shapes and distances (to a patient end opening) to yield static pressures ranging from 4.3 cmH2O to 14 cmH2O (which is at least 2 cmH2O), [0186]-[0187], see fig. 17-19 which three different experiments done with orifices with a diameter of 0.58 mm, 0.65 mm, and 0.79mm) and preferably in a range of about 2 cmH2O to about 20 cmH2O, preferably about 2 cmH2O to about 10 cmH2O, and more preferably about 2 cmH2O to about 5 cmH2O.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the high flow orifice of the modified device of Christopher with the different types of orifices of Ratner to design an optimized device that reduces the amplitude of large fluctuations of internal pressure making breathing more difficult for the patient whose breathing is already distressed (Ratner: [0011], [0166], and [0169]).
Claims 29, 32, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US 20140238398) in view of Leonard (US 20200405991).
Regarding claim 29, Christopher discloses
the connector (adapter 70) of claim 1,
wherein the flow of respiratory gas into the inlet port is divided between at least the device port and the lumen (see fig. 10; air flow is divided between the adapter 70 with the cylindrical connector end 72 and the cannula 73; [0096] and [0097]),
Christopher does not explicitly disclose achieving a flow state in which respiratory gas is delivered to the target location at a first predetermined velocity sufficient to achieve enhanced CO2 clearance.
Leonard discloses a cannula for providing respiratory therapy with multiple geometries for
achieving a flow state in which respiratory gas is delivered to the target location at a first predetermined velocity sufficient to achieve enhanced CO2 clearance (fig. 5; nasal cannula may have a diameter 530 of 3 mm and has a circular lumen 528 with a cross-sectional area of about 7 mm.sup.2 with a breathing gas provided at a medium flow rate of 10 L/min, and a velocity of the flow provided at 24 m/s; [0060] and [0061]; geometry of lumen may be changed to provide and maintain a velocity for flushing CO2 [0002] and [0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula and/or tracheostomy tube of Christopher with the variable geometries of cannulas as disclosed in Leonard to provide sufficient velocity to flush the patient’s airways at lower flow rates of gas (Leonard: [0002], [0057], [0060]-[0062], and [0070]-[0071]). Additionally, Leonard discusses that such implementations and features may be adapted in any other suitable manner applied to respiratory systems such as for tracheostomy ([0019] and [0042]).
Regarding claim 32, the modified device of Christopher further discloses
the connector (Christopher: adapter 70; Leonard: variable geometry) of claim 29, wherein:
the lumen has an internal diameter (Christopher: see fig. 10; internal diameter of cannula 73; [0096] and [0097]; Leonard: fig. 5, diameter 530 of 3 mm; [0060]-[0061]) which, relative to the internal diameter of the invasive patient interface (Christopher: see fig. 10; internal diameter of the tracheostomy tube 80, 90 is larger relative to the internal diameter of the cannula 73), achieves one or both of the first and predetermined velocity during use (Leonard: fig. 5; geometry of lumen may be changed to provide and maintain a velocity for flushing CO2 [0002] and [0005]); and
the lumen has an internal cross-sectional area (Christopher: see fig. 10; internal cross-sectional area of cannula 73; [0096] and [0097]; Leonard: fig. 5, cross-sectional area of about 7 mm.sup.2; [0060]-[0061]) which, relative to the internal cross- sectional area of the invasive patient interface (Christopher: see fig. 10; internal cross-sectional area of the tracheostomy tube 80, 90 is larger relative to the internal cross-sectional area of the cannula 73), achieves one or both of the first and second predetermined velocity during use (Leonard: fig. 5; geometry of lumen may be changed to provide and maintain a velocity for flushing CO2 [0002] and [0005]).
Regarding claim 33, the modified device of Christopher further discloses
the connector (Christopher: adapter 70; Leonard: variable geometry) according to claim 32,
wherein the lumen has an internal diameter of about 2 mm to about 5 mm (Christopher: see fig. 10; internal diameter of cannula 73; [0096] and [0097]; Leonard: fig. 5, diameter 530 of 3 mm; [0060]-[0061]).
Regarding claim 35, the modified device of Christopher further discloses
the connector (Christopher: adapter 70; Leonard: variable geometry) of claim 32,
wherein the predetermined velocity is in a range of about 5 m/s to about 25 m/s (Leonard: fig. 5; geometry can provide a breathing gas provided at a medium flow rate of 10 L/min and a velocity of the flow provided at 24 m/s, alternatively flow may be provided at 5 L/min and a velocity of 12 m/s; [0060]-[0061]), preferably about 5 m/s to about 15 m/s m/s.
Claims 1, 21, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Klaus (US 10478577) in view of Wondka (US 10058668).
Regarding claim 1, Klaus discloses
a connector for coupling with an invasive patient interface providing respiratory support to a patient (figs. 2-7b; tracheal applicator 6 that is connected to a high flow ventilatory support system to invasively supply high flow respiration; col. 4, lines 48-53), the connector comprising:
(a) a connector body (figs. 3a-7b; tracheal applicator 6 comprises adapter 8 and connecting piece 9; col. 5, lines 1-3) having:
(i) an inlet port couplable with a flow source providing a flow of respiratory gas (see figs. 3a-7b; end of applicator 6/connecting piece 9 has an opening connecting to the transnasal insufflation device (TNI device) to provide high flow therapy; col. 5, lines 1-26);
(ii) a gases exit port (figs. 3a-7b; connecting piece 9 has ventilation openings 25; col. 5, lines 58-63); and
(iii) a device port couplable (figs. 3a-7b; adapter 8 has an end 10 facing towards the tracheostoma to plug in connect; col. 5, lines 1-9) with the invasive patient interface; and
(b) a lumen having a first end and a second end (see figs. 3a and 3b; tracheal cannula 7 inherently has two ends (first end at proximal end of cannula and second end at distal end of the cannula); col. 5, lines 1-9);
wherein the connector body defines a gas flow path between the inlet port and both the device port and the lumen first end (see figs. 6a-6b; shows sketched flow arrows 27; col. 7, lines 3-6 and 27-29) and wherein the lumen second end is disposed outside the device port (see figs. 3a-3b; distal end of tracheal cannula 7 is disposed outside of end 10 of the adapter 8; col. 5, lines 1-9).
While Klaus does disclose having an applicator (connector) that is connected to a tracheal cannula for invasive respiratory therapy, Klaus does not explicitly disclose the connector having an invasive patient interface and the connector having a lumen (in other words having two separate lumens/interfaces).
However, Wondka discloses ventilation gas delivery circuit with an inner catheter/cannula 27 and an outer tracheostomy tube 28 (figs. 4-15; col. 11, lines 61-67 and col. 12, lines 1-7; col. 14, lines 63-67 and col. 15, lines 1-17)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the tracheal cannula of Klaus with dual tracheostomy configuration of an tracheostomy/outer tube and an inner cannula/catheter as disclosed in Wondka to facilitate spontaneous respiration and protect the inner cannula and sensors against the accumulation of debris and tracheal wall contact (Wondka: col. 11, lines 61-67 and col. 12, lines 1-7; col. 14, lines 63-67 and col. 15, lines 1-17).
It directly follows that the resultant the modified applicator of Klaus combined with the dual tracheostomy configuration of Wondka would meet the claimed structural limitations since:
(iii) a device port couplable (Klaus: figs. 3a-7b; adapter 8 has an end 10 facing towards the tracheostoma to plug in connect; col. 5, lines 1-9) with the invasive patient interface (Wondka: figs. 4-15; outer tube 28; col. 11, lines 61-67 and col. 12, lines 1-7; col. 14, lines 63-67 and col. 15, lines 1-17); and a lumen (Wondka: figs. 4-15; inner catheter/cannula; col. 11, lines 61-67 and col. 12, lines 1-7; col. 14, lines 63-67 and col. 15, lines 1-17).
Regarding claim 21, the modified device of Klaus further discloses
the connector (Klaus: applicator 6; Wondka: dual tracheostomy configuration) of claim 1,
wherein the connector is configured to generate a predetermined airway pressure (Klaus: fig. 4b; applicator supply air at a pressure around 2-3 mbar above atmospheric pressure in order to supply the lungs with enough breathing air; col. 7, lines 6-26) when coupled with the invasive patient interface in use (Wondka: figs. 4-15; outer tracheostomy tube 28; col. 11, lines 61-67 and col. 12, lines 1-7; col. 14, lines 63-67 and col. 15, lines 1-17), and
wherein the connector includes one or more constrictions configured to generate the predetermined airway pressure (Klaus: fig. 4b; bottleneck tapering 23 and contours 21 of connecting piece 9 help maintain the 2-3 mbar positive pressure; col. 7, lines 6-26).
Regarding claim 28, the modified device of Klaus further discloses
the connector (Klaus: applicator 6; Wondka: dual tracheostomy configuration) of claim 21,
wherein the flow of respiratory gas into the inlet port is divided only between the device port and the gases exit port (see figs. 3a-3b, 6b, and 7b; flow (see sketch arrows 27) from connecting piece 9 goes through the end 10 of adapter 8 and through ventilation openings 25; col. 7, lines 3-43) achieving a flow state in which airway pressure is maintained at the predetermined pressure (figs. figs. 3a-3b, 6b, and 7b; bottleneck tapering 23 and contours 21 of connecting piece 9 allows for pressures (2-3 mbar pressure during inspiration and 4-6 mbar higher during expiration) to be maintained during inhalation and exhalation; col. 7, lines 6-26).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Allum (US 8677999) – an apparatus for providing mechanical ventilation with a connector and an open airway interface
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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