DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 31 July 2024 has been entered. Claim(s) 1-61 has/have been canceled. New claim(s) 62-78 has/have been added, and is/are pending.
Claim Objections
Claim(s) 74 is/are objected to because of the following informalities: "mouth leak even" should be amended/corrected to "mouth leak event."
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 70 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 70 and claims dependent thereon, the limitation "wherein the controller is configured to cause an alert to be outputted by the nasal interface upon determination of the mouth leak event" is indefinite. It is unclear in what manner "the nasal interface" outputs an alert, such as a tone, a series of tones, speech, written text, or flashing lights, as Applicant does not disclose the nasal interface comprises any type of "input/output module" (e.g., ¶ [0114]). For the purpose of this Office action, claim 70 will be further discussed with the understanding that the alert is output by the system generally, rather than the nasal interface of said system specifically, e.g., within the scope of, "wherein the controller is configured to cause an alert to be outputted by the respiratory therapy system upon determination of the mouth leak event."
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 70 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 70 and claims dependent thereon, the disclosure of a continuation or divisional application cannot include anything which would constitute new matter if inserted in the prior-filed application. As discussed above with respect to rejections under 35 U.S.C. 112(b), Applicant does not disclose a nasal interface comprising an input/output module by which an alert may be output, such that the limitation "wherein the controller is configured to cause an alert to be outputted by the nasal interface upon determination of the mouth leak event" is directed to new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 62-63, 67-69, 74 and 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0186741 A1 ("Aylsworth") in view of WO 2015/135040 A1 ("Harrington").
Regarding claims 62 and 68-69, Aylsworth discloses and/or suggests a respiratory therapy system (e.g., Fig. 3) comprising:
a nasal interface configured to form a seal (mask 10 comprising nose portion 12 that covers the nose, and seal 14 that seals against the patient's face);
a flow generator configured to provide a flow of pressurized gases to the user via the nasal interface (fan or blower 30; ¶ [0010]);
a humidifier configured to humidify the flow of pressurized gases (means for adjusting humidity of the provided air, as described in, e.g., ¶ [0006], ¶ [0017], ¶ [0047], etc.); and
a controller (processor 29; ¶¶ [0010]-[0011]) configured to determine the presence of a mouth leak event (e.g., Fig. 10, block 113 and/or 117), adjust an output humidity of the humidifier upon determination of the mouth leak event (e.g., Fig. 10, block 120 and/or 121), and decrease a pressure and/or flow rate of the flow of pressurized gases provided by the flow generator upon determination of the mouth leak event (e.g., Fig. 10, block 115).
Aylsworth does not expressly disclose the nasal interface is configured to form a seal with a user's nares.
Harrington discloses a comparable system (e.g., Figs. 1A, 4, etc.) comprising:
a nasal interface configured to form a seal with a user's nares (patient interface 3000, which may be in the form of a nasal pillows; ¶ [0193]),
a flow generator configured to provide a flow of pressurized gases to the user via the nasal interface (RPT device 4000, or pressure device 4140 thereof; ¶ [0024]),
a humidifier configured to humidify the flow of pressurized gases (humidifier 5000), and
a controller (central controller 4230) configured to at least adjust an output humidity of the humidifier upon determination of a mouth leak event (¶¶ [0394]-[0395] humidification algorithm 5650 may be configured to provide a period of higher humidity than the humidity provided during the rest of the therapy session, wherein the period of higher of humidity may be triggered based on one or more factors, including mouth leak).
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 system of Aylsworth with a nasal interface configured to form a seal with a user's nares as taught/suggested by Harrington as a simple substitution of one suitable nasal interface (i.e., means for providing a supply of air at positive pressure to the nasal passages) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 63, Aylsworth as modified discloses/suggests the limitations of claim 62 as discussed above, and further discloses and/or suggests the output humidity of the humidifier is increased upon determination of the mouth leak event (e.g., ¶ [0047] humidity levels are adjusted at block 120 (i.e., upon determination of a mouth leak event) to aid in the prevention of patient airway drying, which one of ordinary skill in the art would at once envisage comprises increasing, rather than decreasing, the humidity level of the supplied gases). Alternatively/Additionally, Harrington more expressly discloses the controller increases the output humidity of the humidifier in response to a determined leak and/or an increase in humidity level may counteract any decreases in patient comfort due to increased leak and dryness (e.g., ¶ [0384]), such that 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 system of Aylsworth with the output humidity of the humidifier being increased upon determination of the mouth leak event in order to prevent dryness of the airway of the patient (Aylsworth, ¶ [0047]; Harrington, ¶ [0384]).
Regarding claim 67, Aylsworth as modified discloses/suggests the limitations of claim 62 as discussed above, but does not disclose the humidifier is a passover humidifier. Harrington discloses a passover humidifier as one exemplary form of humidification used with an RPT device (e.g., ¶ [0030]). 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 system of Aylsworth with the humidifier being a passover humidifier as taught/suggested by Harrington as a simple substitution of one suitable type of humidifier for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 74, Aylsworth as modified discloses/suggests the respiratory therapy system further comprises a sensor (e.g., sensor 36), wherein the controller is configured to receive sensor data from the sensor and determine the presence of a mouth leak even from the sensor data (e.g., ¶ [0038], ¶ [0041], etc.).
Regarding claim 78, Aylsworth as modified discloses/suggests the flow generator is a positive airway pressure (PAP) apparatus (e.g., ¶ [0010]; ¶ [0032]; etc.).
Claim(s) 64-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth in view of Harrington as applied to claim(s) 62 above, and further in view of US 2013/0317765 A1 ("Rao").
Regarding claim 64, Aylsworth as modified discloses/suggests the limitations of claim 62, as discussed above, but does not expressly disclose the mouth leak event is a mouth leak breath.
Rao discloses/suggests a respiratory therapy system comprising a controller (e.g., Fig. 1, leak detection controller 104) configured to determine the presence of a mouth leak event, wherein the mouth leak event is a mouth leak breath (¶¶ [0144]-[0147]). Rao, similar to Aylsworth, further discloses adjusting applied therapy upon determination of the mouth leak event (e.g., ¶ [0236]), and presence of mouth leak may lead to increased nasal airway resistance, dehydration of the upper airway, etc. (e.g., ¶ [0013]).
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 system of Aylsworth the mouth leak event being a mouth leak breath as taught/suggested by Rao in order to facilitate identifying and/or classifying from a plurality of types of mouth leak, such as a valve-like mouth leak, by which therapy may be adjusted (Rao, ¶ [0021]; etc.).
Regarding claims 65-66, Aylsworth as modified discloses/suggests the limitations of claim 62, as discussed above, but does not expressly disclose the mouth leak event is a mouth leak epoch, wherein the controller is configured to determine the presence of a mouth leak epoch based on a threshold number of mouth puff breaths in a predetermined time.
Rao discloses/suggests a respiratory therapy system comprising a controller (e.g., Fig. 1, leak detection controller 104) configured to determine the presence of a mouth leak event, wherein the mouth leak event is a mouth leak epoch by based on a threshold number of mouth puff breaths in a predetermined time (e.g., ¶ [0030] a leak event may be determined to be a mouth leak event, such as a continuous mouth leak event, based on comparing the plurality of features with time and magnitude thresholds). Rao, similar to Aylsworth, further discloses adjusting applied therapy upon determination of the mouth leak event (e.g., ¶ [0236]), and presence of mouth leak may lead to increased nasal airway resistance, dehydration of the upper airway, etc. (e.g., ¶ [0013]).
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 system of Aylsworth the mouth leak event being a mouth leak breath as taught/suggested by Rao in order to facilitate identifying and/or classifying from a plurality of types of mouth leak, such as continuous mouth leak, by which therapy may be adjusted (Rao, ¶ [0021]; etc.).
Claim(s) 65-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth in view of Harrington as applied to claim(s) 62 above, and further in view of Rao and US 2009/0223514 A1 ("Smith").
Regarding claims 65-66, Aylsworth as modified discloses/suggests the limitations of claim 62, as discussed above, but does not expressly disclose the mouth leak event is a mouth leak epoch, wherein the controller is configured to determine the presence of a mouth leak epoch based on a threshold number of mouth puff breaths in a predetermined time.
Rao discloses/suggests a respiratory therapy system comprising a controller (e.g., Fig. 1, leak detection controller 104) configured to determine the presence of a mouth leak event, wherein the mouth leak event is a mouth leak/puff breath (¶¶ [0144]-[0147]). Rao further discloses the controller may determine a mouth leak epoch (e.g., prolonged VML event) based on a threshold number of mouth puff breaths occurring in a predetermined time (¶ [0121], ¶ [0140], etc.). Smith disclose and/or suggests a system configured respond to detection of sustained mouth leak (e.g., ¶ [0206]).
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 system of Aylsworth the mouth leak event being a mouth leak epoch, wherein the controller is configured to determine the presence of a mouth leak epoch based on a threshold number of mouth puff breaths in a predetermined time, as taught/suggested by Rao and Smith in order to facilitate identifying prolonged/sustained mouth leak events and subsequently responding thereto (Rao, ¶ [0121]; Smith, ¶ [0206]; etc.).
Claim(s) 70-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth in view of Harrington as applied to claim(s) 62 above, and further in view of US 2009/0107498 A1 ("Plattner").
Regarding claims 70-73, Aylsworth as modified discloses/suggests the limitations of claim 62, as discussed above, but does not expressly disclose the controller is configured to cause an alert to be outputted by the respiratory therapy system upon determination of the mouth leak event.
However, Aylsworth does disclose existing respiratory therapy systems (e.g., CPAP machines) determine the presence of a mask leak, and inform the user so that the leak can be addressed (¶ [0012]). Similarly, Plattner discloses and/or suggests a respiratory therapy system comprising a controller (e.g., Fig. 4) configured to determine the presence of a mouth leak event (e.g., ¶ [0104]; ¶ [0306]; etc.); and cause an alert, such as written text, to be output by the therapy system upon determination of the mouth leak event to provide a patient interface recommendation to the user, the patient interface recommendation comprises a recommendation to use a full-face mask (e.g., ¶ [0306] if high mouth leakages occur, a recommendation to apply a full-face mask is displayed).
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 system of Aylsworth the controller being further configured to cause an alert, such as written text, to be outputted by the respiratory therapy system upon determination of the mouth leak event, wherein the alert provides a recommendation to use a full-face mask to the user as taught/suggested by Plattner in order to guide a user to a more appropriate interface that will provide the therapeutic benefits of positive airway therapy (Aylsworth ¶ [0012]; Plattner ¶ [0043]; etc.).
Claim(s) 75-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth in view of Harrington as applied to claim(s) 62 above, and further in view of US 2014/0276168 A1 ("Vissapragada").
Regarding claim 75-76, Aylsworth as modified discloses/suggests the limitations of claim 62, as discussed above, and further discloses the respiratory therapy system may comprise a flow sensor configured to generate a flow signal based at least in part on gas flow within the respiratory therapy system (flow sensor 32). Aylsworth does not expressly disclose the controller is configured to receive data from the flow sensor and determine the presence of a mouth leak event from the flow sensor data.
Vissapragada discloses/suggests a respiratory therapy system (e.g., Fig. 1) comprising a flow sensor (¶ [0026] sensor 20 comprising a flow sensor) configured to generate a flow signal based at least in part on gas flow within the respiratory therapy system (flow signal 40 and/or 42 representing flow of breathable gas passing through interface 30); and a controller (processor 24) configured to determine the presence of a mouth leak event (mouth-breathing detection module 38 configured to determine whether the subject is breathing by mouth during a given expiratory phase), wherein the controller is configured to determine the presence of a mouth leak event as a function of the flow signal within a sub-window of an expiratory window of a breath (¶¶ [0040]-[0050] detecting mouth-breathing in early phase expiration during respiratory treatments involving a pressure support device, e.g., Fig. 4, steps 74-76), wherein the controller is configured to determine the presence of a mouth leak event if a slope of the flow signal within the expiratory window is less than a mouth leak event slope threshold (¶ [0041] where a mouth-breathing breath can be identified where the flow gradient in the sampling window is less than or equal to zero).
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 system of Aylsworth with the controller being configured to determine the presence of a mouth leak event as a function of the flow signal within a sub-window of an expiratory window of a breath if a slope of the flow signal within the expiratory window is less than a mouth leak event slope threshold as taught/suggested by Vissapragada in order to provide a more accurate determination of a mouth leak event by additionally utilizing signals from the existing sensors of the respiratory therapy system and/or as a simple substitution of one suitable mouth leak event detection method for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth in view of Harrington and Vissapragada as applied to claim(s) 62 above, and further in view of US 2007/0068528 A1 ("Bohm").
Regarding claim 77, Aylsworth as modified discloses/suggests the limitations of claim 62, and further discloses/suggests the controller is configured to determine the presence of a mouth leak event if a slope of the flow signal within the expiratory window is less than a mouth leak event slope threshold, as discussed above. Aylsworth as modified does not expressly disclose the slope is a linear regression slope.
Bohm discloses/suggests a system comprising a controller configured to calculate a slope of measured values during a sub-window of breathing phase using linear regression (e.g., I [0067] where Phase II slope is derived from least squares linear regression).
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 system of Aylsworth with the slope being determined by linear regression as taught/suggested Bohm as a simple substitution of one known method for deriving slope/gradient over the sampling window for another to yield no more than predictable results. See MPEP 2143(1)(B).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim(s) 62, 64 and 74-77 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 17 of USPN 10,912,489 in view of Aylsworth and Harrington.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 17 of USPN 10,912,489 anticipates each limitation of claims 62, 64 and 74-77 of the present application with the exception of a nasal interface configured to form a seal with a user's nares, a flow generator configured to provide a flow of pressurized gases to the user via the nasal interface, a humidifier configured to humidify the flow of pressurized gases, and the controller being configured to: adjust an output humidity of the humidifier upon determination of the mouth leak (puff) event. As discussed with respect to the prior art rejections above, Aylsworth and (or in view of) Harrington disclose/suggest said features. It would have been obvious to modify the system of claim 17 of USPN 10,912,489 with the above-noted features in order to prevent drying of the patient airway as a result of the mouth leak(s) (Aylsworth, ¶ [0005], ¶ [0047]).
Claim(s) 62, 64 and 74-76 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 8 and/or 16 of USPN 12,076,132 in view of Aylsworth and Harrington.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 8 and/or 16 of USPN 12,076,132 anticipates each limitation of claims 62, 64 and 74-76 of the present application with the exception of a nasal interface configured to form a seal with a user's nares, a flow generator configured to provide a flow of pressurized gases to the user via the nasal interface, a humidifier configured to humidify the flow of pressurized gases, and the controller being configured to: adjust an output humidity of the humidifier upon determination of the mouth leak (puff) event. As discussed with respect to the prior art rejections above, Aylsworth and (or in view of) Harrington disclose/suggest said features. It would have been obvious to modify the system of claims 8 and/or 16 of USPN 12,076,132 with the above-noted features in order to prevent drying of the patient airway as a result of the mouth leak(s) (Aylsworth, ¶ [0005], ¶ [0047]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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