DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 17th, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I and Species B, which corresponds to claims 86-90, 92 and 94-103 in the reply filed on October 20th, 2023 is acknowledged. Claims 91, 93, 104 and 105 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed January 19th, 2026 have been fully considered but they are not persuasive.
Applicant argues that:
The Office Action cites O'Donnell as teaching "the controller is configured to control the heater to heat a liquid in the chamber to produce vapor at or above a target dewpoint temperature." (Office Action, at 5-6). Applicant respectfully disagrees as the Office Action mischaracterizes what O'Donnell teaches.
The Office Action relies on paragraphs [0027] and [0046]-[0052] to teach the aforementioned limitation. However, the cited language of O'Donnell is directed to disinfection methods that rely on dry heat for disinfection. For example, paragraph [0047] notes that the first step of the method comprises "removing said water from said chamber and replacing said chamber on said apparatus." (O'Donnell, at [0047]). The heater and the heating element then "heat said gases supplied to said at least one of said breathing conduit and patient interface to a predetermined temperature to dry and disinfect said at least one of said breathing conduit and patient interface so as to prevent accumulation of bacteria in said at least one of said breathing conduit and patient interface." (Id., at [0049]). O'Donnell goes on to say that "[t]he first, second and third disinfection methods outlined above use hea[]ted dry air to disinfect, or at least reduce the incidence of microbial build-up in elements of the breathing circuit 100." (Id., at [0110]).
While O'Donnell discloses using vapor from a disinfection agent added to the chamber (see e.g. O'Donnell, at [0110]-[0112]), the Office Action has failed to cite any language in O'Donnell that teaches a disinfection mode that heats the same liquid used in the respiratory mode to form vapor or steam to disinfect the system. The Office Action has therefore failed to identify where O'Donnell discloses, teaches, or suggests a controller that operates according to a respiratory mode wherein "a humidifier of the apparatus humidifies the gases flow by heating a liquid in the chamber prior to delivery of the gases flow to the user or patient during the respiratory mode" and then subsequently operates according to a disinfection mode wherein "the controller is configured to control the heater to heat the liquid in the chamber to produce vapor or steam at or above a target dewpoint temperature."
For at least the reason stated above, Applicant respectfully submits that the Office Action fails to establish that O'Donnell and Ishizuka, alone or in combination, would have rendered obvious independent Claim 86, to one of ordinary skill in the art. Applicant therefore submits that independent Claim 86 is patentable over the asserted references.
The Examiner would respectfully respond that:
Such are intended use recitations. Claim 86 is an apparatus claim. The Applicant is reminded that The Manual of Patent Examining Procedures (MPEP) specifically discloses, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Further the MPEP states “while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function” as well as, “a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.” (MPEP 2114 II).
As disclosed in paragraphs 69-74 the apparatus of O’Donnell operates in a respiratory mode that delivers humidified gases to a patient by heating a liquid with a humidifier comprising a chamber (5) in which the liquid is located therein. The liquid in the chamber (5) is heated by the heater (25) and sent to a patient via conduit (3) as shown in Figure 3. The apparatus of O’Donnell also operates in a disinfection mode in which a disinfecting liquid is added to the same chamber (5) as before, wherein said disinfecting liquid is heated by the heater (25) and transferred to the conduit (3) in order to disinfect said conduit (paragraphs 110-112). As such, it is the exact same process in the respiratory and disinfection mode, wherein the only difference between said process is that a respiratory liquid (i.e., water) is utilized instead of a disinfecting liquid. However, in an apparatus claim, the liquid being heated in one process versus another is immaterial. Because the respiratory assistance apparatus of O’Donnell is capable of heating the same liquid in a disinfection mode as the liquid that is utilized in a respiratory mode, then said reference of O’Donnell meets the limitations of the claim.
Therefore, this response is not persuasive.
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 86-90, 92 and 94-103 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over O’Donnell et al. (U.S. Publication No. 2008/0310994) in view of Ishizuka (Document Identification No. JP 2001321443 A).
Concerning claim 86, O’Donnell discloses a respiratory assistance apparatus adapted to deliver a gases flow to a user or patient, the respiratory assistance apparatus comprising:
A housing (4) provided with a heater (25);
A chamber (5) comprising at least one chamber port (15) configured to be connected to at least one intermediate passageway (12), the housing (4) being configured to receive the chamber (5) as shown in Figure 2; and
A controller that controls the respiratory assistance apparatus to operate according to a respiratory mode (paragraphs 69-74) and a disinfection mode (paragraphs 27 and 46-52), wherein the respiratory assistance apparatus is arranged such that in the respiratory mode, a humidifier of the respiratory assistance apparatus humidifies the gases flow by heating a liquid in the chamber (5) prior to delivery of the gases flow to the user or patient during the respiratory mode (paragraphs 69-74);
Wherein, during the disinfection mode, the controller is configured to control the heater to heat the liquid in the chamber to produce vapor or steam at or above a target dewpoint temperature, the respiratory assistance apparatus is configured such that, in use during the disinfection mode, the vapor or steam produced by heating the liquid in the chamber (5) is delivered to the at least one intermediate passageway (12) connected to the chamber (5) through the at least one chamber port (15) to disinfect the at least one intermediate passageway with hot vapor or steam, the vapor or steam being at a temperature above the target dewpoint temperature (paragraphs 95-99 and 111).
O’Donnell does not appear to disclose that the controller controls the respiratory assistance apparatus to operate in a drying mode subsequent to the disinfection mode to dry the at least one intermediate passageway. Ishizuka discloses a respiratory assistance apparatus adapted to deliver a gases flow to a user, wherein the apparatus is provided with a housing having a heater, a chamber, and a controller that controls the apparatus to operate according to a disinfection mode (Abstract; page 2, first two paragraphs of summary; page 3, third paragraph). The reference continues to disclose that the controller controls the respiratory assistance apparatus to operate in a drying mode subsequent to the disinfection mode to dry the at least one intermediate passageway (7/32) in order to remove residual condensation from the disinfection process (page 4, paragraph 11). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the controller of O’Donnell to control the respiratory assistance apparatus to operate in a drying mode subsequent to the disinfection mode to dry the at least one intermediate passageway in order to remove residual condensation from the disinfection process as exemplified by Ishizuka.
Therefore, claim 86 is not patentable over O’Donnell in view of Ishizuka.
Concerning claim 87, O’Donnell continues to disclose that the chamber (5) is removably mountable on the respiratory assistance apparatus, the at least one chamber port (15)t comprises a chamber outlet port, and the chamber further comprises a chamber inlet port (26) arranged to be in fluid communication with a gases source in the housing (paragraph 111).
Regarding claims 88 & 89, O’Donnell further discloses a removable disinfection tube (14) comprising a separate heater element (19) to deliver vapor or steam to the at least one intermediate passageway (12), the respiratory assistance apparatus being configured to be controlled according to the disinfection mode when:
A first end of the at least one intermediate passageway (12) is connected to a chamber outlet port (15); and
The first end of the at least one intermediate passageway (12) is connected to the chamber outlet port (15) with the removable disinfection tube (14) as set forth in paragraphs 80-100.
With respect to claim 90, O’Donnell also discloses a sensor that measures a parameter of gases flowing in or proximate to the intermediate passageway (paragraph 88).
Regarding claim 92, the apparatus of O’Donnell is fully capable of operating such that the controller controls the respiratory assistance apparatus to operate in the drying mode by using heat generated by a separate heater element (19) as set forth in paragraphs 27-52.
Concerning claim 94, O’Donnell continues to disclose that the controller is capable of controlling the apparatus to operate in the drying mode with a predetermined duration (paragraphs 35-50).
With respect to claim 95, O’Donnell further discloses a safety cap provided with a connector that fluidly couples the safety cap to a downstream end of the at least one intermediate passageway (12), a duct (3) forming a vapor flow path into the safety cap, and the safety cap configured to condense vapor received from the duct (3), and the safety cap intrinsically comprising a condensing surface onto which vapor from the duct (3) condenses (paragraph 100).
Regarding claim 96, O’Donnell also discloses a compressor (paragraph 69) in fluid communication with the chamber (5), the compressor configured to urge gases through the chamber (5) to the at least one intermediate passageway (12), and prior to termination of the disinfection mode, the controller is capable of controlling the compressor to provide a ramped increase in flow to dry and/or cool the at least one intermediate passageway (paragraphs 27-31, 45, 75 and 84).
Concerning claim 97, O’Donnell further discloses that the controller is capable of controlling the compressor (paragraph 69) to slowly discharge any remaining vapor or steam from the chamber near an end of the disinfection mode (paragraph 111) and then subsequently provides a higher flow rate to cause accelerated drying and/or cooling (paragraphs 27-31, 45, 75 and 84).
With respect to claim 98, O’Donnell also discloses that the controller is capable of determining completion of the disinfection mode based on stored cycle times for a given respiratory assistance apparatus configuration and a predetermined or detected level of liquid present in the chamber at a start of the disinfection mode (paragraphs 94, 107 and 111).
Regarding claim 99, O’Donnell continues to disclose that the target dewpoint temperature is greater than 70°C (paragraphs 40, 73 and 81).
Concerning claim 100, O’Donnell also discloses that the disinfection mode has a predetermined profile that includes a duration of the disinfection mode, the target dewpoint temperature being set sufficiently high that the vapor provides sufficient moist heat to disinfect the at least one intermediate passageway at least over the duration of the disinfection mode (paragraphs 46-54 and 73).
With respect to claims 101 & 102, O’Donnell further discloses that the target dewpoint temperature is inversely proportional to the duration of the disinfection mode, and that said target dewpoint temperature and said duration of the disinfection mode are predetermined (paragraphs 46-54 and 73).
Regarding claim 103, O’Donnell discloses that the target dewpoint temperature and the duration of the disinfection mode are variable according to a user selection of one of the target dewpoint temperature or the duration of the disinfection mode (paragraphs 73-75).
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 86-90, 92 and 94-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,285,290 (herein referred to as ‘290).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the instant application are met by claims 1-20 of ‘290. More specifically, each claim a respiratory assistance apparatus adapted to deliver a gases flow to a user or patient, wherein the apparatus includes a housing provided with a heater, and a chamber comprising at least one chamber port configured to be connected to at least one intermediate passageway in which the housing is configured to receive the chamber. Each claim a controller that controls the respiratory assistance apparatus to operate according to a disinfection mode, and during the disinfection mode, the controller is configured to control the heater to heat a liquid in the chamber to produce vapor at or above a target dewpoint temperature. Furthermore, each claim that the apparatus is configured such that, in use during the disinfection mode, the vapor produced by heating the liquid in the chamber is delivered to the at least one intermediate passageway connected to the chamber through the at least one chamber port to disinfect the at least one intermediate passageway with hot vapor at a temperature above the target dewpoint temperature. Still further, each claim that the controller controls the respiratory assistance apparatus to operate in a drying mode subsequent to the disinfection mode to dry the at least one intermediate passageway.
As such, the obviousness type double patenting rejection exists.
Claims 86-90, 92 and 94-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,653,855 (herein referred to as ‘855).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the instant application are met by claims 1-26 of ‘855. More specifically, each claim a respiratory assistance apparatus adapted to deliver a gases flow to a user or patient, wherein the apparatus includes a housing provided with a heater, and a chamber comprising at least one chamber port configured to be connected to at least one intermediate passageway in which the housing is configured to receive the chamber. Each claim a controller that controls the respiratory assistance apparatus to operate according to a disinfection mode, and during the disinfection mode, the controller is configured to control the heater to heat a liquid in the chamber to produce vapor at or above a target dewpoint temperature. Furthermore, each claim that the apparatus is configured such that, in use during the disinfection mode, the vapor produced by heating the liquid in the chamber is delivered to the at least one intermediate passageway connected to the chamber through the at least one chamber port to disinfect the at least one intermediate passageway with hot vapor at a temperature above the target dewpoint temperature. Still further, each claim that the controller controls the respiratory assistance apparatus to operate in a drying mode subsequent to the disinfection mode to dry the at least one intermediate passageway.
As such, the obviousness type double patenting rejection exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799