DETAILED ACTION
Primary Examiner acknowledges Claims 2-19 are pending in this application, with Claims 2-19 having been newly added, and Claim 1 having been cancelled by preliminary amendment on March 9, 2023.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference characters “1070, 1072” has been used to designate “elongate extensions” and “corresponding nozzles” (Para 0043). Appropriate correction is required.
Reference character “323” has been used to designate “recesses” and “groove” (Para 0055). Appropriate correction is required.
Reference character “423” has been used to designate “recesses” and “groove” (Para 0055). Appropriate correction is required.
Reference characters “525, 530” have been used to designate “nasal inserts” (Para 0057 – 2 instances) and “nozzles”. Appropriate correction is required.
Reference character “555” has been used to designate “inlet” (Para 0057 – 2 instances) and “nozzle body portion”. Appropriate correction is required.
Reference characters “560, 561” have been used to designate “flange portions” (Para 0057) and “flanges”. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
Specification
The disclosure is objected to because of the following informalities:
Reference characters “1070, 1072” has been used to designate “elongate extensions” and “corresponding nozzles” (Para 0043). Appropriate correction is required.
Reference character “323” has been used to designate “recesses” and “groove” (Para 0055). Appropriate correction is required.
Reference character “423” has been used to designate “recesses” and “groove” (Para 0055). Appropriate correction is required.
Reference characters “525, 530” have been used to designate “nasal inserts” (Para 0057 – 2 instances) and “nozzles”. Appropriate correction is required.
Reference character “555” has been used to designate “inlet” (Para 0057 – 2 instances) and “nozzle body portion”. Appropriate correction is required.
Reference characters “560, 561” have been used to designate “flange portions” (Para 0057) and “flanges”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-11 and 14-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport et al. (6,165,133) in view of Sato et al. (4,681,099) and Tiep et al. (4,535,767).
As to Claims 2 and 14, Rapoport discloses a nasal interface (Figures 1, 2, and 4-6) configured to engage with the nares of a user (via 12, “The nasal prongs 12 extend into the patient's nostrils and are in fluid communication 18 with a sensitive pressure sensor.” Column 3, Lines 20-30), comprising: a tubular base (defined by the lateral extensions at the base of 12 extending to the left and right of the patient’s nose) configured to reside external to the nares of the user (via 12) and defining a hollow central portion (defined by the lumen of 18) toward the nares of the user; first and second nasal nozzles (12/12, “The nasal prongs 12 extend into the patient's nostrils and are in fluid communication 18 with a sensitive pressure sensor.” Column 3, Lines 20-30) that extend substantially perpendicular to the central axis of the hollow central portion (defined by the lumen of 18) of the tubular base (defined by the lateral extensions at the base of 12 extending to the left and right of the patient’s nose) for insertion into the nares of the user (via 12), each of the first and second nasal nozzles (12/12) includes an exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor - 14 of Figure 1, 22 of Figure 2, 26 of Figure 4, 30 of Figure 5, 32 of Figure 6) that surrounds a nozzle passageway (lumen of 12/12) extending from the tubular base (defined by the lateral extensions at the base of 12 extending to the left and right of the patient’s nose) toward a nozzle outlet port (defined by the lumen at the apex of 12/12); and a first gas property sensor (“thermistor”, one of 14/22/26/30/32: 14 of Figure 1, 22 of Figure 2, 26 of Figure 4, 30 of Figure 5, 32 of Figure 6, wherein 14 – “A thermistor is coated 14 about each nasal prong and extends downwardly 16 to cover the patient's mouth.” Column 3, Lines 20-30, wherein 22 – “FIG. 2 illustrates an alternative embodiment wherein the thermistor 22 is wound or coiled about the nasal prongs.” Column 3, Lines 25-35, wherein 26 – “FIG. 4 illustrates a configuration wherein the thermistor element 26 is detachable and held in place by a clip 28.” Column 3, Lines 35-45, wherein 30 – “FIG. 5 shows a detachable configuration wherein the thermistor comprises bands 30 that slip over the nasal prong …” Column 3, Lines 35-45; and wherein 32 – “ … while FIG. 6 illustrates an embodiment wherein the thermistors comprise coils 32 that similarly fit over the nasal prongs.” Column 3, Lines 35-45) integrated (“coated”, “wound or coiled”, “detachable”, “slip over”, “fit over”) into the an exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the first nasal nozzle (one of 12/12) such that the first gas property sensor (“thermistor”, one of 14/22/26/30/32) is fixedly mounted to the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) for exposure to gaseous flow along an exterior lateral side of the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) to measure a gas property (“temperature”) external to the first nasal nozzle (one of 12/12), wherein a sensor wire (20, “The thermistor is electrically linked 20 with electronic sensing equipment to provide a signal that is roughly proportional to the temperature.” Column 3, Lines 20-30) extending from the first gas property sensor (“thermistor”, one of 14/22/26/30/32) passes through at least a portion of both the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the first nasal nozzle (one of 12/12) and the tubular base portion (defined by the lateral extensions at the base of 12 extending to the left and right of the patient’s nose) to connect with a control system (“electronic sensing equipment” Column 3, Lines 20-30) which receives sensor information (“temperature”) detected by the first gas property sensor (“thermistor”, one of 14/22/26/30/32) integrated into the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the first nasal nozzle (one of 12/12).
Yet, Rapoport does not expressly disclose the construction of the nasal interface being “non-sealing” with “non-sealing nasal nozzles … that are shaped to prevent sealing with the nares of the user” nor the configuration of the nasal interface for “high-flow respiratory therapy” in which “an air mixture for delivery of the high-flow respiratory therapy toward the nares of the user”, “outputting the air mixture from the tubular base into the nares for the delivery of the high- flow respiratory therapy”, and further having “a control system configured to modify a flow of the air mixture in response to sensor information detected by the first gas property sensor integrated into the exterior nozzle wall of the first non-sealing nasal nozzle.”
Regarding the “high-flow respiratory therapy” configuration, Sato teaches an alternative nasal interface (Figure 1) having a tubular base and first and second nasal nozzles in the form of a conventional nasal cannula (26, “26 is a nasal cannula” Column 6, Lines 15-40; also see: “As a sensor to detect the exhalation phase of the respiration of the patient 22, this embodment uses a thermocouple 28 mounted on the nasal cannula 26 in such a manner that the thermocouple 28 is exposed to the respiratory air flow through the patient's nostril.” Column 7, Lines 40-50) and including a first gas property sensor (28, “28 is a thermocouple” Column 6, Lines 15-40; also see: “As a sensor to detect the exhalation phase of the respiration of the patient 22, this embodment uses a thermocouple 28 mounted on the nasal cannula 26 in such a manner that the thermocouple 28 is exposed to the respiratory air flow through the patient's nostril.” Column 7, Lines 40-50) integrated (“mounted”) into the conventional nasal cannula (26), wherein the first gas property sensor (28) includes a sensor wire (defined by the line extending from 28 to 29 in Figure 1) which directs sensory data from the first gas property sensor (28) to a control system (29, “29 is a gas-supply regulator” Column 6, Lines 15-40; also see: “The output from the thermocouple 28 is applied to a gas-supply regulator 29 which controls the operation of the breath-synchronizing solenoid valve 24 based on the information from the thermocouple 28.” Column 7, Lines 40-50) to modify the flow of the air mixture in response to the sensor information detected by the first gas property sensor (28) of the conventional nasal cannula (26) during high-flow respiratory therapy (“The oxygen concentrator in the illustrated embodiment of the invention uses two adsorption cylinders which are operated alternately in such a manner that a part of the oxygen-enriched gas produced by one adsorption cylinder and saved by closing the breath-synchronizing valve is delivered to the other adsorption cylinder as purge gas, so that the oxygen concentrator can operate at a fairly high flow rate of the oxygen-enriched gas without reducing the oxygen concentration therein. Accordingly, the performance of such oxygen concentrator can be considerably improved as compared with conventional oxygen concentrators. The improved performance facilitates further miniaturation, weight reduction and energy saving in the oxygen concentrator.” Column 16, Lines 35-55) to provide the air mixture to the patient in a synchronized manner consistent with the inhalation of the patient (Title and Abstract).
In light of the teachings of Sato, it would have been obvious to modify the patient interface of Rapoport to operate at a high flow therapy pressure as claimed in order to provide a synchronized delivery of gas to the patient during the inhalation period to optimized oxygen usage as provided to the patient.
Regarding the construction of the nasal interface being “non-sealing”, Tiep teaches an alternative construction of a nasal interface (Figure 1) having a tubular base (16, “an elongated, necked down section 16. This section 16 preferably is slightly longer than the distance across the base of the nostrils of an individual (not shown).” Column 3, Lines 15-35; also see: “These cannula 32 are located so as to extend off of the section 16 generally midway between the two nipples 18. These cannula 32 must be sufficiently small in diameter so that they will not effectively close off or block the nostrils of a patient.” Column 3, Lines 45-60; “In order to avoid any possibility of the cannula 32 fitting inside the nostrils so as to block air flow around them it is possible to form them so that they include small radially projecting fins 34 which will serve to space them more or less in the center areas of nostrils. When such fins 34 are used it is also considered preferable to extend them to a limited extent along the section 16 as shown in FIGS. 1 and 4 so as to avoid any possibility of the section 16 fitting against the face of the user in such a manner as to effectively block or impede air flow generally around or passed it as the apparatus 10 is used in the intended manner.” Column 3, Line 60 thru Column 4, Line 10) defining a hollow central portion (best seen Figure 4) and including first and second nasal nozzles (32/32, “These cannula 32 are located so as to extend off of the section 16 generally midway between the two nipples 18. These cannula 32 must be sufficiently small in diameter so that they will not effectively close off or block the nostrils of a patient.” Column 3, Lines 45-60; “In order to avoid any possibility of the cannula 32 fitting inside the nostrils so as to block air flow around them it is possible to form them so that they include small radially projecting fins 34 which will serve to space them more or less in the center areas of nostrils. When such fins 34 are used it is also considered preferable to extend them to a limited extent along the section 16 as shown in FIGS. 1 and 4 so as to avoid any possibility of the section 16 fitting against the face of the user in such a manner as to effectively block or impede air flow generally around or passed it as the apparatus 10 is used in the intended manner.” Column 3, Line 60 thru Column 4, Line 10) that are non-sealing (“These cannula 32 must be sufficiently small in diameter so that they will not effectively close off or block the nostrils of a patient.” Column 3, Lines 45-60) in order to permit the conveyance of oxygen to the patient and to permit the patient to exhaust gas around the first and second nasal nozzles (32) as desired.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the nasal interface of Rapoport in a conventional nasal cannula formation to include the ability to deliver high flow respiratory therapy, as taught by Sato to ensure the synchronized delivery of oxygen to the patient during the patient’s inhalation cycle, and to include a non-sealing formation, as taught by Tiep to permit the patient to readily receive and exhaust gases about the first and second nasal nozzles as desired.
As to Claims 3 and 15, the modified Rapoport, specifically Rapoport discloses a second gas property sensor (“thermistor”, other of 14/22/26/30/32: 14 of Figure 1, 22 of Figure 2, 26 of Figure 4, 30 of Figure 5, 32 of Figure 6, wherein 14 – “A thermistor is coated 14 about each nasal prong and extends downwardly 16 to cover the patient's mouth.” Column 3, Lines 20-30, wherein 22 – “FIG. 2 illustrates an alternative embodiment wherein the thermistor 22 is wound or coiled about the nasal prongs.” Column 3, Lines 25-35, wherein 26 – “FIG. 4 illustrates a configuration wherein the thermistor element 26 is detachable and held in place by a clip 28.” Column 3, Lines 35-45, wherein 30 – “FIG. 5 shows a detachable configuration wherein the thermistor comprises bands 30 that slip over the nasal prong …” Column 3, Lines 35-45; and wherein 32 – “ … while FIG. 6 illustrates an embodiment wherein the thermistors comprise coils 32 that similarly fit over the nasal prongs.” Column 3, Lines 35-45) integrated (“coated”, “wound or coiled”, “detachable”, “slip over”, “fit over”) into the an exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the second non-sealing nasal nozzle (other of 12/12) such that the second gas property sensor (“thermistor”, other of 14/22/26/30/32) is fixedly mounted to the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the second non-sealing nasal nozzle (other of 12/12) for exposure to gaseous flow along an exterior lateral side of the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) to measure a gas property (“temperature”) external to the second non-sealing nasal nozzle (other of 12/12).
As to Claims 4 and 16, the modified Rapoport, specifically Rapoport discloses a second sensor wire (20, best seen as duplicate 20s of Figures 1 and 2, “The thermistor is electrically linked 20 with electronic sensing equipment to provide a signal that is roughly proportional to the temperature.” Column 3, Lines 20-30) extending from the second gas property sensor (“thermistor”, other of 14/22/26/30/32) passes through at least a portion of both the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the second non-sealing nasal nozzle (other of 12/12) and the tubular base portion (defined by the lateral extensions at the base of 12 extending to the left and right of the patient’s nose) to connect with the control system (“electronic sensing equipment” Column 3, Lines 20-30).
As to Claims 5, 7, and 17, the modified Rapoport, specifically Tiep teaches first and second non-sealing nasal nozzles (32/32) having an additional extensions (34, “In order to avoid any possibility of the cannula 32 fitting inside the nostrils so as to block air flow around them it is possible to form them so that they include small radially projecting fins 34 which will serve to space them more or less in the center areas of nostrils. When such fins 34 are used it is also considered preferable to extend them to a limited extent along the section 16 as shown in FIGS. 1 and 4 so as to avoid any possibility of the section 16 fitting against the face of the user in such a manner as to effectively block or impede air flow generally around or passed it as the apparatus 10 is used in the intended manner.” Column 3, Line 60 thru Column 4, Line 10) located along the perimeter of the non-sealing nasal nozzles (32/32) effectively providing between each extension (34) at least one claimed exterior recesses – which are located on an exterior lateral side of the exterior nozzle wall so that the first non-sealing nasal nozzle (32) is shaped to prevent sealing with the nares of the user.
As to Claims 6, 8, and 18, the modified Rapoport, specifically Tiep teaches first and second non-sealing nasal nozzles (32/32) with at least one claimed recesses (located between each extension -34).
In light of the modification of the modified Rapoport, the orientation of the first or second gas property sensor (“thermistor”, 14/22/26/30/32) would include at least a portion retained within the claimed recesses, as the first or second gas property sensor (“thermistor”, 14/22/26/30/32) is (“coated”, “wound or coiled”, “detachable”, “slip over”, “fit over”) into the an exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor).
Primary Examiner notes the claimed invention does not require the entirety of the gas property sensor to be located within the recess as shown in the instantly disclosed invention of Figure 2. In the absence of this explicit structural orientation being positively recited, the configuration of the modified Rapoport meets the limitations of the claims.
Still further, Applicant is cautioned even with the explicit recitation of the entirety of the gas property sensor being located within the recess, Applicant may be subject to an obviousness rationale – e.g. obvious to try – and wish to particularly point out any criticality as to why the specific orientation is necessary to expedite compact prosecution.
As to Claims 9 and 19, the modified Rapoport, specifically Rapoport discloses the first or second gas property sensor (“thermistor”, 14/22/26/30/32) is configured to transmit a signal via the sensor wire (20, “The thermistor is electrically linked 20 with electronic sensing equipment to provide a signal that is roughly proportional to the temperature.” Column 3, Lines 20-30) that indicates a measured gas property (“temperature”) along the exterior lateral side wall of the exterior nozzle wall (defined by the external perimeter of 12/12, which receives a sensor) of the first or second nasal nozzle (12/12).
As to Claim 10, the modified Rapoport, specifically Tiep teaches first and second non-sealing nasal nozzles (32/32) having an additional extensions (34, “In order to avoid any possibility of the cannula 32 fitting inside the nostrils so as to block air flow around them it is possible to form them so that they include small radially projecting fins 34 which will serve to space them more or less in the center areas of nostrils. When such fins 34 are used it is also considered preferable to extend them to a limited extent along the section 16 as shown in FIGS. 1 and 4 so as to avoid any possibility of the section 16 fitting against the face of the user in such a manner as to effectively block or impede air flow generally around or passed it as the apparatus 10 is used in the intended manner.” Column 3, Line 60 thru Column 4, Line 10) located along the perimeter of the non-sealing nasal nozzles (32/32) effectively providing the claimed one or more projections (34) extending outwardly from the exterior nozzle wall (defined by the external perimeter of 32/32) so that the first and second non-sealing nasal nozzles (32/32) is shaped to prevent sealing with the nares of the user.
As to Claim 11, the modified Rapoport, specifically Tiep teaches the claimed one or more projections (34) extending outwardly from the exterior nozzle wall (defined by the external perimeter of 32/32) so that the first and second non-sealing nasal nozzles (32/32) in the form of one or more flanges (34). As best shown in Figures 1-4 of Tiep, there are four (4) projections (34), where by each projection (34) is a flange (34) oriented circumferentially about the exterior nozzle wall (defined by the external perimeter of 32/32).
Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport et al. (6,165,133) in view of Sato et al. (4,681,099) and Tiep et al. (4,535,767), as applied to Claim 11, and further in view of Bertram (5,355,874).
As to Claim 12, the modified Rapoport, specifically Tiep teaches the claimed flanges (34) in the form of pairs – wherein two flanges on the same nasal nozzle (32) forms a pair, whether adjacent or oppositely located about the exterior nozzle wall (defined by the external perimeter of 32/32).
Yet, the modified Rapoport does not expressly disclose the shape of the pairs to include a “co-facing” configuration (Claim 12) and further including a “C-shaped cross section” (Claim 13).
Bertram teaches an additional device suitable for insertion within the body of the user having a pair of co-facing flanges (6 at one end of 12 and 6 at the other end of 12, best seen Figures 2 and 5) resulting in a C-shape Cross section (7, best seen Figures 2 and 5) to produce a device that can be introduced into the body of the user with “little risk of injury to the patient” (Column 5, Lines 55-65).
Although Bertram describes the shape of 7 as “U-shaped” (Column 4, Lines 40-55; also see: Column 3, Lines 45-60 and Column 5, Lines 1-10), Primary Examiner contents the shape configuration of a “U” as compared to a “C” is substantially coextensive.
Nevertheless, in light of the teaching of Bertram as modifying the modified Rapoport, it would have been obvious to one having ordinary skill in the art to select the specific shape of the of the flanges to be in a co-facing C shape as claimed, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art.
Hence, the decision to explicitly conform the “U” shape to a “C” shape would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to permit the introduction/insertion of the device into the body of the patient with limited harm to the patient.
Moreover, Primary Examiner notes Applicant has not asserted the specific shape of a C-shaped cross section resulting from the co-facing flanges, provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of providing a shape suitable for insertion within the patient; thus, the use of the specific C-shape formed by the co-facing flanges appears to lack criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Rapoport, as the specific shape of the C-shaped cross section formed from the co-facing flanges would yield the predictable result of providing insertion of the device with minimal harm to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the pair of flanges of the modified Rapoport, to include the co-facing configuration resulting in a C-shaped cross section as taught by Bertram to provide a device suitable for insertion within the body of the patient with limited harm to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sato et al. (4,648,395) discloses a nasal interface in the form of a conventional nasal cannula (25) having a temperature sensor (27) located at the nozzle and a sensor wire (via 110) to direct a signal from the temperature sensor (27) to the control device (28) to modulate the flow of gases provided to the patient.
Sato et al. (4,868,974) discloses a nasal interface in the form of a conventional nasal cannula (14) having a temperature sensor (15) located at the nozzle and a sensor wire (via 17) to direct a signal from the temperature sensor (15) to the control device (19) to modulate the flow of gases provided to the patient.
LEGER, PATRICK et al. (FR 2594034 A1) discloses a nasal interface in the form of a nasal probe sensor (Translation, Page 5) having “a thermistor or a pressure sensor integrated into a nasal scope” (Translation, Page 5).
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785