DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the preliminary amendment filed 2/22/2024. As directed by the amendment, claim 1 has been amended, and claims 2-37 have been added. As such, claims 2-37 are pending in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed provisional applications, Application Nos. 61/230,128 and 61/334,761, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional applications do not disclose a transfer wire as claimed (in as far as one is supported by instant Fig. 27 and the discussion thereof in light of the 112 issues below), i.e. one configured for transfer of power to, and transfer of data to/from, the patient interface. Therefore, the priority date of instant claims is the filing date of the earliest parent application (12/847,201) containing Fig. 27 and relevant discussion thereof, that is, 7/30/2010.
Drawings
The drawings are objected to because the claimed “transfer wire” is not labeled in the Figures (see the 112 discussion below regarding the wire in Fig. 27 that is understood to correspond to the claimed transfer wire). 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Applicant should make it clear which disclosed wire is intended to correspond to/support the claimed “transfer wire,” preferably by using the same naming conventions in the claims as the specification (or vice versa).
The disclosure is objected to because of the following informalities: para [00152] refers to “signal wire 404 of the patient interface” (and para [00153] also references “signal wire 404”), but Fig. 27, to which para [00152] is referring, depicts wire 404 as the same wire as discussed in paras [0086-88], where it described as “a heater/sensing/ sense wire” and is part of the heated conduit. Applicant should provide the data/power wire for the patient interface with its own label [not 404], see the 112 discussion below regarding the wire in Fig. 27 that is understood to correspond to the signal wire of paras [00152-153]/the claimed data/power “transfer” wire.
Appropriate correction is required.
Claim Objections
Claims 19, 25 and 37 are objected to because of the following informalities:
Claim 19, line 2 should read “the flow generator” because it is understood to be referring to that of claim 2
Claim 19, line 3 should read “the humidifier” because it is understood to be referring to that of claim 2
Claim 19, line 4 should read “the controller” because it is understood to be referring to that of claim 18
Claim 25, line 4 should read “the flow generator, and the humidifier” because it is understood to be referring to those of claim 22
Claim 37, line 2 should read “the flow generator” because it is understood to be referring to that of claim 22
Claim 37, line 4 should read “the humidifier” because it is understood to be referring to that of claim 22
Claim 37, line 6 should read “the controller” because it is understood to be referring to that of claim 25
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,201,768 in view of Bedford et al. (WO 2009/022004 A2; hereinafter “Bedford”; wherein the PGPub of the WIPO document, US 2012/0125333 A1, will be referenced in the rejection below for the ease of citing to paragraphs). The patented claims recite and thus anticipate all of the limitations of the instant claims (where patented claim 1 maps to instant claims 2, 4 and 5, patented claims 2-18 map to instant claims 6-21 and 3, respectively, patented claim 19 maps to instant claims 22, 24 and 25, and patented claims 20-32 map to instant claims 26-37 and 23, respectively), except that the patent claims do not recite that the grouping of wires includes the transfer wire. However, Bedford teaches that it was known in the art at the time of invention for a power-and-data-transmitting respiratory conduit to include a grouping of wires (grouped within element 37) (Fig. 2) including a pair of heating wires (two heating wires 21) and a transfer wire (signal wire 20) (wire…for carrying signals for communication and power for the patient mask, para [0060]) extending along the length of the heatable conduit between the first end and the second end of the heatable conduit (Figs. 2 and 5; paras [0052], [0059-60] and [0165]). Therefore, it would have been obvious to an artisan at the time of invention to include the absent limitations in the patented claims, in order to provide a known, compact arrangement for the patented wires.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 2 and 22 (and thus their dependent claims), the specification as originally filed does not disclose a transfer wire configured as claimed, that is, one a) included in a grouping of wires along with a pair of heating wires that extends along a heatable conduit while also b) connecting to a sensing circuit that is also connected to a sensing device and c) configured to transfer power and/or data to (/receive data from, in the case of claim 2) the patient interface. The specification as originally filed depicts a heater/signal/sense wire 504 that is included in a grouping of wires along with a pair of heating wires 506/508 (Figs. 15, 18 and 27), which in turn connects to heater/sensing/sense wire 404 that is connected to a sensing circuit (428)/connects sensing device 410 to the sensing circuit, and a separate wire (unlabeled, see Fig. 27 modified below) for transferring power to and data to/from the patient interface. As currently written, the claims appear to improperly conflate wire 504 and the unlabeled wire, but wire 504 is not described as transferring power to and/or data to/from the patient interface, such that the newly added claims contain new matter.
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Regarding claim 3 and 23, the specification at para [0079] as originally filed indicates that the pair of heating wires (506,508) are part of the heating circuit, whereas claims 3 and 23 recite the system further comprising a heating circuit. There is not support for a heating circuit in addition to the pair of heating wires recited in claims 2 and 22, such that claims 3 and 23 contain new matter. Applicant could address this rejection by amending claims 3 and 23 to read “ comprising the pair of heating wires,”.
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 5-21 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.
Regarding claims 5, 18, 19, 25 and 37 (and their dependents), it is unclear whether “data” and/or “power” in the dependent claims is intended to refer to the data and/or power of the independent claims, or different data and/or power, or could broadly include but is not limited to that of the independent claims. For purposes of examination, any data and/or power will be considered to meet the claim limitations.
Claim 37 recites the limitation "the flexible tube" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 2, 3, 5-7, 15, 18, 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton (US 2004/0163648 A1; hereinafter “Burton”) in view of Bedford.
Regarding claim 2, Burton discloses/teaches a respiratory system configured to deliver a supply of breathable gas to a patient (paras [0003], [0013] and [0068]) through a patient interface (mask 10) (e.g. Figs. 1-7) sealingly mounted on the patient’s face (para [0010]), the respiratory system comprising:
a conduit (hose 32) configured to convey the breathable gas and comprising a first end (not shown) configured to be fluidly coupled to a flow generator or a humidifier and a second end (to the left in Figs. 4/7) configured to be fluidly coupled to the patient interface (para [0013]; wherein the outside sources of gases are fully capable of being a flow generator or humidifier, as nothing would preclude this intended use);
a transfer wire (within cable 30) (connect the sensors to the mask interface connector 16 and to the cable 30 for transmitting data, para [0035]; data collected can be converted to a serial data stream to allow a single wire to interface all the sensors, para [0063]) extending near the conduit (hose 32);
wherein the transfer wire is configured to be electrically connected (via mask interface connector 16) to the patient interface (mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; where “plugging in” would have reasonably suggested to an artisan at the time of invention that an electrical connection is made between the connector 16 and wire(s) within cable 30 as a standard means for connecting electrical components, in order to reliably/directly connect the mask sensors to power and for data transmission), and
wherein the transfer wire is further configured to receive data from the patient interface (sensors 25 connected to the leads 27, which connect the sensors to the mask interface connector 16 and to cable 30 for transmitting data, para [0035]).
Burton is silent regarding the conduit being heatable and electrically connected to the patient interface, and Burton is silent regarding
a grouping of wires including a pair of heating wires and the transfer wire extending along the length of the heatable conduit between the first end and the second end of the heatable conduit;
a sensing device extending from an interior surface of the heatable conduit; and
a sensing circuit electrically connected to the sensing device and the transfer wire,
and wherein the transfer wire configured for transferring data is also configured to transfer power to the patient interface.
However, Bedford teaches that it was known in the respiratory therapy art at the time of invention for a respiratory conduit (hose 54) (e.g. Fig. 6) to be heatable (Bedford claim 1) and electrically connected to the patient interface (patient interface 43) (e.g. via cuff 9 of Bedford Figs. 8-9, as would have been obvious to an artisan at the time of invention as a standard means connecting the heatable tube 54 to an associated component, see e.g. Bedford Fig. 14 and paras [0087-89], [0255] and [0259]), and to include
a grouping of wires (grouped within element 37) (Fig. 2) including a pair of heating wires (two heating wires 21) and a transfer wire (signal wire 20) (wire…for carrying signals for communication and power for the patient mask, para [0060]) extending along the length of the heatable conduit between the first end and the second end of the heatable conduit (Figs. 2 and 5; paras [0052], [0059-60] and [0165]);
a sensing device (sensor 4/thermistor) extending from an interior surface of the heatable conduit (Fig. 9/17; paras [0088] and [0232-234], in view of the obvious connection of cuff 9 to the hose 54 discussed above); and
a sensing circuit (e.g. Fig. 17; para [0267]) electrically connected to the sensing device and a transfer wire (com wire 1 or 2),
and wherein the transfer wire (signal wire 20) is also configured to transfer power to the patient interface (wire…for carrying signals for communication and power for the patient mask, para [0060]).
Therefore, it would have been obvious to an artisan at the time of invention to modify Burton to include the conduit being heatable and electrically connected to the patient interface by virtue of including a grouping of wires including a pair of heating wires and the transfer wire extending along the length of the heatable conduit between the first end and the second end of the heatable conduit; a sensing device extending from an interior surface of the heatable conduit; and a sensing circuit electrically connected to the sensing device and the transfer wire, and wherein the transfer wire is also configured to transfer power to the patient interface, as taught and obvious in view of Bedford, in order to provide the predictable results of using a known heatable conduit configuration to provide heated (and/or humidified) and monitored air to the patient interface of Burton for patient comfort, as well as to avoid the expense and/or bulk of multiple and/or exposed wires by transmitting the power and data on the same internal conduit wire (Bedford Figs, 2, 5 and 6, paras [0058-60] and [0147]), and to electrically connect the transfer/signal wires of all of the sensors within the system (i.e. those in the mask of Burton as well as in the conduit taught by Bedford), and thus their associated sensing circuits, to the same combined sensing system/overall circuit to predictably provide an integrated sensing/monitoring/control system for comprehensive monitoring and control of the entire system.
Regarding claim 3, Burton in view of Bedford teaches the respiratory system of claim 2, wherein, as best understood, Bedford educates modified Burton to further include a heating circuit comprising the pair of heating wires, wherein the heating circuit is configured to provide heat to the heatable conduit (Bedford e.g. Fig. 17; para [0267]), in order to provide the heating functionality taught by Bedford.
Regarding claim 5, Burton in view of Bedford teaches the respiratory system of claim 2, wherein Burton further discloses/suggests the system further comprising the patient interface (mask 10) (e.g. Figs. 1-7), the patient interface comprising:
at least one circuit (comprising leads 27 and sensors 25, 26, 85, etc.) configured to receive a supply of power from, send data to, and receive data from, a power supply and a controller (mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; [i]n some embodiments…sensors 25 do not require an outside source of power, para [0031], which infers, in contrast, that the power of para [0030] is intended to be supplied to the sensors; sensors 25 connected to the leads 27, which connect the sensors to the mask interface connector 16 and to cable 30 for transmitting data, para [0035]; transmission of the data to a microprocessor or computer, para [0013]; monitoring data may be used to…increase or decrease air supplies to a patient, para [0066]; and, in the event that it is deemed not inherent, it would have been obviousness to an artisan at the time of invention to ensure that the mask circuit of Burton is configured to receive data (conveyed by the transfer wire), e.g. to instruct operation of the sensors) of at least one of: the flow generator, and the humidifier (para [0013]; wherein there is nothing that would preclude the power source and microprocessor/computer/air supply controller of Burton from belonging to a flow generator or humidifier, for the obvious purpose of providing the air supply disclosed by Burton (humified if desired), as was well known in the respiratory therapy art at the time of invention, see e.g. Bedford Fig. 6; therefore, Burton meets or renders obvious this intended use limitation).
Regarding claim 6, Burton in view of Bedford teaches the respiratory system of claim 5, wherein Burton further discloses wherein the at least one circuit of the patient interface (Fig. 4; e.g. para [0029]) comprises at least one sensor (e.g. sensors 25, 26, etc.).
Regarding claim 7, Burton in view of Bedford teaches the respiratory system of claim 6, wherein Burton further discloses wherein the at least one sensor comprises at least one of: a temperature sensor (sensors 26 measure…ambient temperature, para [0029]), a humidity sensor, a flow and pressure sensor (gas flow sensors…mask pressure, para [0008]; paras [0029], [0045] and [0050]), a microphone (microphone 80, para [0046]), a noise cancellation sensor, a G force sensor, a motion sensor (position sensors 87 indicate potion or activity, para [0059]), a gagging detection sensor, a pulse oximeter (oximetry sensor 85) (para [0051]), and a particulates detector sensor.
Regarding claim 15, Burton in view of Bedford teaches the respiratory system of claim 5, wherein Burton further teaches wherein the patient interface comprises a microprocessor in communication with the at least one circuit of the patient interface (transmission of the data to a microprocessor…[f]or portability the microprocessor can be attached to the mask, para [0013]), which is fully capable of being used to pre-condition signals, because it is a microprocessor connected to sensors, and it would have been obvious to artisan at the time of invention to include such a microprocessor in modified Burton, in order to provide the expected result of requiring less processing power at the flow generator/humidifier/power/gas source.
Regarding claim 18, Burton in view of Bedford teaches the respiratory system
of claim 5, wherein modified Burton teaches wherein a first end of the transfer wire is configured to be electrically coupled to the at least one circuit of the patient interface, wherein a second end of the transfer wire is configured to be electrically connected to a controller, and wherein the transfer wire is configured to convey data to the patient interface (see claims 2 and 5 discussions above in view of Burton Fig. 4 and Bedford Figs. 2, 5 and 6).
Regarding claim 22, Burton discloses/teaches a respiratory system configured to deliver a supply of breathable gas to a patient (paras [0003], [0013] and [0068]) through a patient interface (mask 10) (e.g. Figs. 1-7) sealingly mounted on the patient’s face (para [0010]), the respiratory system comprising:
a tube (hose 32) configured to convey the breathable gas and comprising a first end (not shown) configured to be fluidly coupled to a flow generator or a humidifier and a second end (to the left in Figs. 4/7) configured to be fluidly coupled to the patient interface (para [0013]; wherein the outside sources of gases are fully capable of being a flow generator or humidifier, as nothing would preclude this intended use);
at least one transfer wire (within cable 30) (connect the sensors to the mask interface connector 16 and to the cable 30 for transmitting data, para [0035]; data collected can be converted to a serial data stream to allow a single wire to interface all the sensors, para [0063]) extending near the tube (hose 32);
wherein the at least one transfer wire is configured to be electrically connected (via mask interface connector 16) to the patient interface (mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; where “plugging in” would have reasonably suggested to an artisan at the time of invention that an electrical connection is made as a standard means for connecting electrical components, in order to reliably/directly connect the mask sensors to power and for data transmission) and to transfer at least one of power and data to the patient interface (mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; connect the sensors to the mask interface connector 16 and to cable 30 for transmitting data, para [0035]).
Burton is silent regarding the tube being heatable and electrically connected to the patient interface, and Burton is silent regarding
a grouping of wires including a pair of heating wires and the at least one transfer wire extending along the length of the heatable conduit between the first end and the second end of the heatable conduit;
a sensing device extending from an interior surface of the heatable conduit; and
a sensing circuit electrically connected to the sensing device and the transfer wire.
However, Bedford teaches that it was known in the respiratory therapy art at the time of invention for a respiratory conduit/tube (hose 54) (e.g. Fig. 6) to be heatable (Bedford claim 1) and electrically connected to the patient interface (patient interface 43) (e.g. via cuff 9 of Bedford Figs. 8-9, as would have been obvious to an artisan at the time of invention as a standard means connecting the heatable tube 54 to an associated component, see e.g. Bedford Fig. 14 and paras [0087-89], [0255] and [0259]), and to include
a grouping of wires (grouped within element 37) (Fig. 2) including a pair of heating wires (two heating wires 21) and a transfer wire (signal wire 20) (wire…for carrying signals for communication and power for the patient mask, para [0060]) extending along the length of the heatable conduit between the first end and the second end of the heatable tube (Figs. 2 and 5; paras [0052], [0059-60] and [0165]);
a sensing device (sensor 4/thermistor) extending from an interior surface of the heatable conduit (Fig. 9/17; paras [0088] and [0232-234], in view of the obvious connection of cuff 9 to the hose 54 discussed above); and
a sensing circuit (e.g. Fig. 17; para [0267]) electrically connected to the sensing device and at least one transfer wire (com wire 1 or 2).
Therefore, it would have been obvious to an artisan at the time of invention to modify Burton to include the tube being heatable and electrically connected to the patient interface by virtue of including a grouping of wires including a pair of heating wires and at least one transfer wire extending along the length of the heatable tube between the first end and the second end of the heatable tube; a sensing device extending from an interior surface of the heatable conduit; and a sensing circuit electrically connected to the sensing device and the at least one transfer wire as taught and obvious in view of Bedford, in order to provide the predictable results of using a known heatable tube configuration to provide heated (and/or humidified) and monitored air to the patient interface of Burton for patient comfort, as well as to avoid the expense and/or bulk of multiple and/or exposed wires by transmitting the power and data on internal and/or the same conduit wire(s) (Bedford Figs, 2, 5 and 6, paras [0058-60] and [0147]), and to electrically connect the transfer/signal wires of all of the sensors within the system (i.e. those in the mask of Burton as well as in the conduit taught by Bedford), and thus their associated sensing circuits, to the same combined sensing system/overall circuit to predictably provide an integrated sensing/monitoring/control system for comprehensive monitoring and control of the entire system.
Regarding claim 23, Burton in view of Bedford teaches the respiratory system of claim 22, wherein, as best understood, Bedford educates modified Burton to further include a heating circuit comprising the pair of heating wires, wherein the heating circuit is configured to provide heat to the heatable conduit (Bedford e.g. Fig. 17; para [0267]), in order to provide the heating functionality taught by Bedford.
Claims 8-11 and 28-31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton in view of Bedford as applied to claim 5 above OR Burton in view of Bedford and Daniell as applied to claim 25 below, and further in view of Kwok et al. (US 2007/0023044 A1; hereinafter “Kwok”).
Regarding claims 8-11 and 28-31, Burton in view of Bedford teaches the respiratory system of claim 5 OR Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, wherein Burton further teaches wherein the at least one circuit of the patient interface comprises at least one patient interface processor (transmission of the data to a microprocessor…[f]or portability the microprocessor can be attached to the mask, para [0013]), but Burton silent regarding the microprocessor being a controller, wherein the at least one patient interface controller of the patient interface is at least one of: an actuator configured to directly humidify the patient interface, an active vent, a speaker, an alarm, a noise cancellation control, a vibration control, a lamp, a heater, a controlled expansion foam seal, and a controllable membrane seal, and modified Burton is silent regarding wherein the patient interface comprises at least one alert device in communication with the at least one circuit of the patient interface, wherein the at least one alert device comprises at least one of: a light, and a speaker. However, Kwok demonstrates that it was known in the respiratory therapy art at the time of invention to provide sensor data to a controller (inferred in order to provide the audio/visual alarm incorporated into the patient interface of para [0061]), wherein the at least one patient interface controller of the patient interface is at least one of: an actuator configured to directly humidify the patient interface, an active vent, a speaker (in view of para [0061], as an obvious/well known means for generating an audible alarm, see also paras [0036-37]), an alarm (basic alarm clock, para [0061]), a noise cancellation control (noise cancelling, paras [0036-37]), a vibration control, a lamp (a light, para [0061]), a heater, a controlled expansion foam seal, and a controllable membrane seal/to include at least one alert device (basic alarm clock, para [0061]) in communication with the at least one circuit of the patient interface (paras [0057-58]), wherein the at least one alert device comprises at least one of: a light, and a speaker (para [0061]; see also paras [0036-37]). Therefore, it would have been obvious to an artisan at the time of invention for modified Burton to include wherein the at least one circuit of the patient interface comprises at least one patient interface controller, wherein the at least one patient interface controller of the patient interface is at least one of: an actuator configured to directly humidify the patient interface, an active vent, a speaker, an alarm, a noise cancellation control, a vibration control, a lamp, a heater, a controlled expansion foam seal, and a controllable membrane seal/at least one alert device in communication with the at least one circuit of the patient interface, wherein the at least one alert device comprises at least one of: a light, and a speaker as taught by Burton and Kwok, in order to provide the expected result of a patient-mounted (and thus immediately noticed/heard) sleep-stage-controlled alarm, alarm clock, light and/or noise cancelling means.
Claims 12 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton in view of Bedford applied to claim 5 above OR Burton in view of Bedford and Daniell as applied to claim 25 below, and further in view of Mumford et al. (US 20050268916 A1; hereinafter “Mumford”).
Regarding claims 12 and 32, Burton in view of Bedford teaches the respiratory system of claim 5 OR Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, but modified Burton is silent regarding the at least one circuit of the patient interface comprises a modem. However, Mumford demonstrates that it was known in the respiratory therapy interface art at the time of invention to include at least one modem (wireless modem, para [0082]) in communication with at least one circuit of a patient interface (Figs. 5a-6), such that it would have been obvious to an artisan at the time of invention to include such a modem in the patient interface of modified Burton, in order to provide the expected result of allowing the patient interface to transmit data (e.g. directly from the sensors thereof for reduced lag time) wirelessly to a remote location for e.g. review.
Claims 13, 14, 21 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton in view of Bedford as applied to claim 5 above or Burton in view of Bedford and Alami as applied to claim 20 below or Burton in view of Bedford and Daniell as applied to claim 25 below, and further in view of Delache et al. (US 2005/0188989 A1; hereinafter “Delache”) and McCoy (US 2009/0315749 A1; hereinafter “McCoy”).
Regarding claim 13, Burton in view of Bedford teaches the respiratory system of claim 5, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein the patient interface comprises at least one multiplexor in communication with the at least one circuit of the patient interface. However, Delache teaches that it was known in the respiratory therapy art at the time of invention for data to be modulated/demodulated onto a power source wire using a FSK modulator/demodulator (Delache para [0078]), and McCoy demonstrates that it was well known in the sensor signal conversion art at the time of invention to utilize a multiplexor for FSK modulation (Fig. 6) (FSK modulator 612 uses a simple multiplexer design, para [0046]). Therefore, it would have been obvious to an artisan at the time of invention for the patient interface of modified Burton to include at least one multiplexor in communication with the at least one circuit of the patient interface as taught by Burton, Delache and McCoy, in order to provide the expected result of performing the data consolidation taught by Burton and transmission along the power line using a known component as taught by Bedford and Delache and/or to allow the interface to receive multiple data streams from the transfer wire and then expand them out to the appropriate recipient/sensor locations and/or to make sense of the data/power transmission.
Regarding claim 14, Burton in view of Bedford teaches the respiratory system of claim 5, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein the patient interface comprises at least one encoder in communication with the at least one circuit of the patient interface. However, Delache teaches that it was known in the respiratory therapy art at the time of invention for data to be modulated/demodulated onto a power source wire using a FSK modulator/demodulator (Delache para [0078]), and McCoy demonstrates that it was well known in the sensor signal conversion art at the time of invention to utilize an encoder (encoder 610) in conjunction with FSK modulation (Fig. 6; para [0039]). Therefore, it would have been obvious to an artisan at the time of invention for the patient interface of modified Burton to include at least one encoder in communication with the at least one circuit of the patient interface as taught by Burton, Delache and McCoy, in order to provide the expected result of performing the data consolidation taught by Burton and transmission along the power line taught by Delache while allowing for error detection (McCoy para [0039]).
Regarding claim 21, Burton in view of Bedford and Alami teaches the respiratory system of claim 20, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein at least one of the flow generator and the humidifier comprises at least one apparatus multiplexor in communication with the patient interface. However, Delache teaches that it was known in the respiratory therapy art at the time of invention for data to be modulated/demodulated onto a power source wire using a FSK modulator/demodulator (Delache para [0078]), and McCoy demonstrates that it was well known in the sensor signal conversion art at the time of invention to utilize a multiplexor for FSK modulation (Fig. 6) (FSK modulator 612 uses a simple multiplexer design, para [0046]). Therefore, it would have been obvious to an artisan at the time of invention for at least one of the flow generator and the humidifier of modified Burton to include at least one apparatus multiplexor in communication with the patient interface as taught by Burton, Delache and McCoy, in order to provide the predictable result of using a known component to allow the flow generator and/or humidifier to receive the multiple sensor data streams from the transfer wire and then expand them out to the appropriate recipient locations for analysis and/or control adjustment and/or to perform data consolidation as taught by Burton and transmission along the power line towards the mask in order to send e.g. operating instructions to the various mask sensors of Burton.
Regarding claim 33, Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein the patient interface comprises at least one encoder in communication with the at least one circuit of the patient interface. However, Delache teaches that it was known in the respiratory therapy art at the time of invention for data to be modulated/demodulated onto a power source wire using a FSK modulator/demodulator (Delache para [0078]), and McCoy demonstrates that it was well known in the sensor signal conversion art at the time of invention to utilize an encoder (encoder 610) in conjunction with FSK modulation (Fig. 6; para [0039]). Therefore, it would have been obvious to an artisan at the time of invention for the patient interface of modified Burton to include at least one encoder in communication with the at least one circuit of the patient interface as taught by Burton, Delache and McCoy, in order to provide the expected result of performing the data consolidation taught by Burton and transmission along the power line taught by Delache while allowing for error detection (McCoy para [0039]).
Claims 13, 21, 25-27, 34 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton in view of Bedford as applied to claims 5 and 22 above and Burton in view of Bedford and Alami as applied to claim 20 above, and in further view of Daniell et al. (US 5,558,084; hereinafter “Daniell”).
Regarding claim 13, Burton in view of Bedford teaches the respiratory system of claim 5, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein the patient interface comprises at least one multiplexor in communication with the at least one circuit of the patient interface. However, Daniell demonstrates that it was well known in the respiratory therapy art at the time of invention to utilize at least one multiplexor (input multiplexer 64) (Fig. 5; col. 4, lines 61-65) in communication with at least one circuit (comprising inputs 63/transducer 9/sensors 71-73). Therefore, it would have been obvious to an artisan at the time of invention for the patient interface of modified Burton to comprise at least one multiplexor in communication with the at least one circuit of the patient interface as taught by Daniell, in order to provide the expected result of utilizing a standard component to perform the data consolidation taught by Burton and/or to allow the interface to receive multiple data streams from the transfer wire and then expand them out to the appropriate recipient/sensor locations.
Regarding claim 21, Burton in view of Bedford and Alami teaches the respiratory system of claim 20, wherein Burton further discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), but modified Burton is silent regarding wherein at least one of the flow generator and the humidifier comprises at least one apparatus multiplexor in communication with the patient interface. However, Daniell demonstrates that it was well known in the respiratory therapy art at the time of invention to utilize at least one multiplexor (input multiplexer 64) (Fig. 5; col. 4, lines 61-65) in communication with at least one circuit (comprising inputs 63/transducer 9/sensors 71-73). Therefore, it would have been obvious to an artisan at the time of invention for at least one of the flow generator and the humidifier of modified Burton to include at least one apparatus multiplexor in communication with the patient interface as taught by Burton and Daniell, in order to provide the predictable result of using a known component to allow the flow generator and/or humidifier to receive the multiple sensor data streams from the transfer wire and then expand them out to the appropriate recipient locations for analysis and/or control adjustment and/or to perform data consolidation as taught by Burton and transmission along the power line towards the mask in order to send e.g. operating instructions to the various mask sensors of Burton.
Regarding claim 25, Burton in view Bedford teaches the respiratory system of claim 22, wherein Burton further discloses/suggests the system further comprising the patient interface (mask 10) (e.g. Figs. 1-7), the patient interface comprising:
at least one circuit (comprising leads 27 and sensors 25, 26, 85, etc.) configured to receive a supply of power from, send data to, and receive data from, a power supply and a controller (mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; [i]n some embodiments…sensors 25 do not require an outside source of power, para [0031], which infers, in contrast, that the power of para [0030] is intended to be supplied to the sensors; sensors 25 connected to the leads 27, which connect the sensors to the mask interface connector 16 and to cable 30 for transmitting data, para [0035]; transmission of the data to a microprocessor or computer, para [0013]; monitoring data may be used to…increase or decrease air supplies to a patient, para [0066]; and, in the event that it is deemed not inherent, it would have been obviousness to an artisan at the time of invention to ensure that the mask circuit of Burton is configured to receive data (conveyed by the transfer wire), e.g. to instruct operation of the sensors) of at least one of: [the] flow generator, and [the] humidifier (para [0013]; wherein there is nothing that would preclude the power source and microprocessor/computer/air supply controller of Burton from belonging to a flow generator or humidifier, for the obvious purpose of providing the air supply disclosed by Burton (humified if desired), as was well known in the respiratory therapy art at the time of invention, see e.g. Bedford Fig. 6; therefore, Burton meets or renders obvious this intended use limitation).
While Burton discloses consolidating the data from the multiple sensors onto a single transfer wire (para [0063]), Burton does not explicitly state how this is done, such that Burton is silent regarding at least one multiplexor in communication with the at least one circuit of the patient interface; wherein the at least one multiplexor is configured to perform at least one of: multiplexing multiple signals onto the transfer wire, and de-multiplexing of an incoming signal received from the transfer wire into original respective signals. However, Daniell demonstrates that it was well known in the respiratory therapy art at the time of invention to utilize at least one multiplexor (input multiplexer 64) (Fig. 5; col. 4, lines 61-65) in communication with at least one circuit (comprising inputs 63/transducer 9/sensors 71-73); wherein the at least one multiplexor is configured to perform at least one of: multiplexing multiple signals onto a transfer wire (inferred between multiplexer 64 and microprocessor 61) (Fig. 5; col. 5, lines 1-4), and de-multiplexing of an incoming signal received from the transfer wire into original respective signals. Therefore, it would have been obvious to an artisan at the time of invention to utilize in the system of modified Burton at least one multiplexor in communication with the at least one circuit of the patient interface; wherein the at least one multiplexor is configured to perform at least one of: multiplexing multiple signals onto the transfer wire, and de-multiplexing of an incoming signal received from the transfer wire into original respective signals as taught by Daniell, in order to provide the expected result of performing the data consolidation taught by Burton and/or to allow the interface to receive multiple data streams from the transfer wire and then expand them out to the appropriate recipient locations.
Regarding claim 26, Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, wherein Burton further discloses wherein the at least one circuit of the patient interface (Fig. 4; e.g. para [0029]) comprises at least one sensor (e.g. sensors 25, 26, etc.).
Regarding claim 27, Burton in view of Bedford and Daniell teaches the respiratory system of claim 26, wherein Burton further discloses wherein the at least one sensor comprises at least one of: a temperature sensor (sensors 26 measure…ambient temperature, para [0029]), a humidity sensor, a flow and pressure sensor (gas flow sensors…mask pressure, para [0008]; paras [0029], [0045] and [0050]), a microphone (microphone 80, para [0046]), a noise cancellation sensor, a G force sensor, a motion sensor (position sensors 87 indicate potion or activity, para [0059]), a gagging detection sensor, a pulse oximeter (oximetry sensor 85) (para [0051]), and a particulates detector sensor.
Regarding claim 34, Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, wherein Burton further teaches wherein the patient interface comprises a microprocessor in communication with the at least one circuit of the patient interface (transmission of the data to a microprocessor…[f]or portability the microprocessor can be attached to the mask, para [0013]), which is fully capable of being used to pre-condition signals, because it is a microprocessor connected to sensors, and it would have been obvious to artisan at the time of invention to include such a microprocessor in modified Burton, in order to provide the expected result of requiring less processing power at the flow generator/humidifier/power/gas source.
Regarding claim 37, Burton in view of Bedford and Daniell teaches the respiratory apparatus of claim 25, wherein Bedford further educates the system of modified Burton to further comprise:
a flow generator (flow generator 12) to generate a supply of pressurized breathable gas to be delivered to the patient (Bedford Fig. 6; para [0173]);
a humidifier (humidifier system 41) to humidify the supply of pressurized breathable gas (Bedford Fig. 6; para [0173]);
a first gas flow path (through inlet hose 52) leading from the flow generator to the humidifier (Bedford Fig. 6; para [0173]); to provide the heated and/or humidified gas discussed above, wherein Burton further discloses/teaches
a controller configured to supply power and send and receive data (Burton: mask interface connector 16 for plugging in a cable 30 for a power supply and for data transmission, para [0030]; [i]n some embodiments…sensors 25 do not require an outside source of power, para [0031], which infers, in contrast, that the power of para [0030] is intended to be supplied to the sensors; sensors 25 connected to the leads 27, which connect the sensors to the mask interface connector 16 and to cable 30 for transmitting data, para [0035]; transmission of the data to a microprocessor or computer, para [0013]; monitoring data may be used to…increase or decrease air supplies to a patient, para [0066]; and, in the event that it is deemed not inherent, it would have been obviousness to an artisan at the time of invention to ensure that the mask circuit of Burton is configured to receive data, e.g. to instruct operation of the sensors); Bedford further teaches/suggests
at least one electrical contact in communication with the controller, wherein the at least one electrical contact is configured to be electrically coupled to at least one transfer wire along the tube and is configured to transfer data to the transfer wire, because Bedford’s teachings of electrical interfaces on both ends of a respiratory tube (see Bedford Fig. 14) would have rendered it obvious to an artisan at the time of invention to include an electrical contact in electrical communication with the controller for electrical communication with the second end of the transfer wire of modified Burton, in order to provide the expected result of a well-known/standard means for connecting two electrical components for the transmission of data therebetween and allowing the tube to be detachable from both the mask and the humidifier for convenience and/or cleaning,
and Daniell further teaches at least one apparatus multiplexor in communication with the patient interface (it would have been obvious to an artisan at the time of invention in view of the patient interface multiplexer taught by Daniell as discussed above regarding claims 13/25 to also include an apparatus multiplexor as discussed above regarding claim 21, in order to allow the flow generator and/or humidifier to send and/or receive (the) combined data streams to/from the patient interface); and
wherein the at least one apparatus multiplexor is configured to perform at least one of: multiplexing multiple signals onto the at least one transfer wire, and de-multiplexing of an incoming signal received from the transfer wire into original respective signals (per the standard function of a multiplexer, as discussed above and see also the discussion of claims 13/21/25 above).
Claims 16, 17, 19, 20, 35 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton in view of Bedford as applied to claims 5 and 18 above OR Burton in view of Bedford and Daniell as applied to 25 above, and further in view of Alami et al. (WO 2010/027282 A2; hereinafter “Alami”).
Regarding claims 16, 17, 35 and 36, Burton in view of Bedford teaches the respiratory system of claim 5 OR Burton in view of Bedford and Daniell teaches the respiratory system of claim 25, but modified Burton is silent regarding an isolation circuit in communication with the at least one circuit of the patient interface, wherein the isolation circuit comprises at least one of: a transformer, a capacitor, and optical coupling. However, Alami demonstrates that it was known in the respiratory therapy art at the time of invention for a powered patient interface (patient interface 12) (Figs. 1-2) to include an isolation circuit (regulator circuit) in communication with the at least one circuit (secondary circuit 31) of the patient interface (patient interface 12), wherein the isolation circuit comprises at least one of: a transformer, a capacitor (secondary circuit 31 may also include an energy buffer, such as a capacitor), and optical coupling. Therefore, it would have been obvious to an artisan at the time of invention for modified Burton to include an isolation circuit in communication with the at least one circuit of the patient interface, wherein the isolation circuit comprises a capacitor as taught by Alami, in order to provide the expected result of allowing the patient interface circuit to compensate for any inconsistencies in the power being supplied thereto (Alami, page 8, lines 25-31).
Regarding claim 19, Burton in view of Bedford teaches the respiratory system of claim 18, wherein Bedford further educates the system of modified Burton to further comprise:
[the] flow generator (flow generator 12) configured to pressurize the breathable gas (Bedford Fig. 6; para [0173]);
[the] humidifier (humidifier system 41) configured to humidify the pressurized breathable gas (Bedford Fig. 6; para [0173]), in order to utilize standard components to predictably supply pressurized, humidified gas for efficacious, comfortable respiratory therapy; but Bedford does not explicitly disclose
[the] controller configured to regulate power to the flow generator and the humidifier and send and receive data.
However, Alami demonstrates that it was well known in the respiratory therapy art at the time of invention for a powered patient interface (patient interface 12) (Figs. 1-2) to be used in conjunction with a flow generator (blower unit 15) configured to pressurize the breathable gas (page 4, lines 5-10) and a humidifier (comprising humidifier chamber 5) configured to humidify the pressurized breathable gas (page 4, lines 11-31), to include a controller (controller 9) configured to regulate power to the flow generator and the humidifier and send and receive data (page 5, lines 11-30). Therefore, it would have been obvious to utilize the system comprising a powered patient interface connected to a flow generator and humidifier of modified Burton to comprise a controller configured to regulate power to the flow generator and the humidifier and send and receive data as taught by Alami, in order to provide the expected result of a system capable of controlling delivery of both pressurized gases and humidity to a patient for maximum comfort and/or enhanced therapy.
Regarding claim 20, Burton in view of Bedford and Alami teaches the respiratory system of claim 19, wherein modified Burton further teaches/suggests an electrical contact in electrical communication with the controller and configured to be coupled to the transfer wire, because Bedford’s and Alami’s teachings of electrical interfaces on both ends of a respiratory tube (see Bedford Fig. 14 and Alami Fig. 4) would have rendered it obvious to an artisan at the time of invention to include an electrical contact in electrical communication with the controller for electrical communication at the second end of the transfer wire/tube of modified Burton, in order to provide the expected result of a well-known/standard means for connecting two electrical components and allowing the tube to be detachable from both the mask and the humidifier for convenience and/or cleaning.
Allowable Subject Matter
Claims 4 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching a (heated) respiratory conduit with power to and/or data transmission to/from the patient interface: Jumpertz (US 2005/0016540 A1); Sofranko (US 2012/0204874 A1); Carlson (US 6,367,510 B1); Vandine (US 2008/0078388 A1); Darling (US 2,745,074); Elsworth et al. (US 4,708,831).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785