DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges the reply filed on 06/25/2026 in which claims 34, 36, and 42 have been amended, claim 38 has been canceled, and claim 35 has been added. Currently, claims 34-37 and 39-55 are pending for examination in this application, of which 42-54 are withdrawn from consideration.
Response to Arguments
Applicant has resolved the objections to the claims.
Applicant’s arguments, see Remarks pg. 2, filed 06/25/2026, with respect to the rejection(s) of amended claim(s) 34 under 35 35 U.S.C. § 103in view of the spacer 157 and seal 153 of Holyoake have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of a different embodiment of Holyoake.
Applicant's arguments, see Remarks pg. 3-4, filed 06/25/2026 have been fully considered but they are not persuasive.
Election/Restrictions
Claims 42-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/02/2026.
Applicant's election with traverse of claims 34-41 in the reply filed on 03/02/2026 is acknowledged. The traversal is on the ground(s) that claim 34 and claim 42 are similarly amended to recite “a support extending across the base for supporting an aerosol or gas delivery head” and Varga does not disclose the amended limitation. This is not found persuasive because while Varga does not teach the amended limitation, the Varga reference was used to teach technical feature at the time the restriction requirement as made. As seen by the rejection below, the technical feature of a patient interface comprising a base, a shell, and a support extending across the base for supporting an aerosol or gas delivery head cited in amended claims 34 and 42 is not a special technical feature in view of Holyoake et al. (US 20180085544 A1).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 34-36, 39, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holyoake et al. (US 20180085544 A1) and Moenning, JR. (US 20100122705 A1).
Regarding claim 34, Holyoake discloses a patient interface for aerosol treatment ([1085] user interface 151; figure 62A-64), the interface comprising:
a base configured to surround at least part of a patient’s mouth and nose and engage a patient’s skin with a resilient seal ([1087] seal 153; figure 62A-64),
a support extending across the base for supporting an aerosol or gas delivery head ([1097] In some configurations, a separate spacer component is provided which rests on the user's face and which assists in locating the conduit 154 on the user's face. FIGS. 63A-63C each shows a different configuration of such spacer component 157. The spacer component 157 surrounds at least a portion of the conduit 154 and preferably, the spacer component 157 is provided to the portion of the conduit 154 which engages the accommodation site or portion 156 when the interface 151 is worn by the user; figure 63A-64) configured to be attached to an aerosol generator ([1086] the gases supply system which is in gases communication with the gas conduit 154 is a high flow humidified oxygen delivery system. A nasal interface such as a nasal cannula (not shown) may be provided at an end of the gas conduit 154 and within the interior volume of interface 151 for providing for example a high flow of oxygen or blended gases directly into the nares of the user),
a shell configured to form an enclosure together with the base ([1087] The mask comprises a body 155, such as a shell. The shell may be made of any suitable materials such as polycarbonate, plastic and similar thereof. At or adjacent the rim of the body 155, there is provided a seal 153 which accommodates the creating or forming of the seal between the interface 151 and the user's face and/or a component so provided on said face; figure 62A-64), and
an extraction port ([1085] In-use, the interface 151 is to be placed over the nasal and/or oral area, preferably both the mouth and the nose, of a user for conveying gases to and/or from the user from a gases supply system (not shown) via an aperture or a port 152 provided on the interface 151; figure 62A-64) but is silent as to for attachment of an extraction system to extract gas from within the enclosure.
However, Moenning, JR. teaches a patient interface (Combination Anesthesia and Scavenger Surgical Mask; title; figure 1-3) comprising an extraction port for attachment of an extraction system to extract gas from within the enclosure ([0035] A gas port 22 is defined in the shell 16 of the oral mask 12. The gas port 22 includes a hollow tube 24 that extends outwardly from the oral chamber 36. The hollow tube 24 has a proximal end that opens into the oral chamber 36. A threaded distal end 28 of the hollow tube 24 may be coupled (e.g., screwed) to a hose or other type of fluid line of a scavenger circuit 72 (see FIG. 3). As such, the chamber 36 of the oral mask 12 may be exposed to the negative fluid pressure generated by the scavenger circuit 72. In other words, when the threaded distal end 28 of the hollow tube 24 is coupled to the scavenger circuit 72, a vacuum pump (not shown) associated with the scavenger circuit 72 may be used to evacuate the gases exhaled by the patient into the oral mask 12; figure 1 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Holyoake to implement a scavenger circuit and a vacuum pump to optionally connect to the gas port in order to evacuate the gases exhaled by the patient, as taught by Moenning, JR. [0035].
Holyoake is silent as to the support extending laterally and entirely across the base for supporting the aerosol or gas delivery head.
However, a different embodiment of the device of Holyoake (figure 2-3 and 35) comprising a support extending laterally and entirely across the base (seal region 304; figure 3. also see figure 35) for supporting the gas delivery head ([0668] The patient interface may further comprise mounts and/or supports, e.g., cheek supports 210, for attaching and/or supporting the gas lumen 202 on the patient's face; figure 2-3 and 35. also see figure 6-7, cheek supports 210 extend across to both sides of the user’s face).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the spacer component of Holyoake to include the cheek supports extending laterally and entirely across the seal of the face mask in order to further assist in attaching and supporting the gas conduit on the patient’s face, as taught by Holyoake [0668].
Regarding claim 35, modified Holyoake teaches the patient interface as claimed in claim 34, wherein the base is annular (seal 153; see figure 62A-63A and 64), configured to fully surround the patient’s mouth and nose ([1087] At or adjacent the rim of the body 155, there is provided a seal 153 which accommodates the creating or forming of the seal between the interface 151 and the user's face and/or a component so provided on said face; figure 62A-64), and wherein the base comprises a spine ([1101] protrusion 156a extending from an underside of the seal 153; figure 64) on which there is an inner soft layer for engaging a face of the patient ([1087] The seal 153 is preferably made of a soft, flexible material to readily conform to the facial profile of a user when the interface is worn by the user to create a seal between the user's face and the interface 151; figure 64), and wherein the support is mounted to the spine ([1101] A complimentary groove 1512 is formed in the exterior of the upper surface of the spacer component 157. The groove 1512 receives the protrusion 156a to form the coupling arrangement and to secure the spacer component 157 in place relative to the interface 151.; figure 64).
Regarding claim 36, modified Holyoake teaches the patient interface as claimed in claims 34, wherein the support comprises openings ([1098] In the embodiment shown in FIG. 63A, the spacer component 157 is in the form of a padded sleeve which surrounds a length of the conduit 154; figure 63B. Examiner notes channel 159 on top sleeve of spacer component 157 comprises one opening and channel 159 on bottom sleeve of spacer component 157 comprises another opening. also see figure 6-7, opening at 210) to receive nasal prongs of the aerosol delivery head ([1086] A nasal interface such as a nasal cannula (not shown) may be provided at an end of the gas conduit 154 and within the interior volume of interface 151 for providing for example a high flow of oxygen or blended gases directly into the nares of the user), and wherein the shell has at least one opening for passage of an aerosol delivery tube ([1085] the interface 151 is to be placed over the nasal and/or oral area, preferably both the mouth and the nose, of a user for conveying gases to and/or from the user from a gases supply system (not shown) via an aperture or a port 152 provided on the interface 151; figure 62A-64. [1086] In some configurations, the gases supply systems which are in gases communication with the gas conduit 154 and the interface 151 via the aperture or the port 152 respectively, are separate and independent of each other. In one configuration, the gases supply system which is in gases communication with the aperture or the port 152 is a part of an anaesthesia system comprising an anaesthesia machine for delivering gas to the user, whereas the gases supply system which is in gases communication with the gas conduit 154 is a high flow humidified oxygen delivery system).
Regarding claim 39, modified Holyoake teaches the patient interface as claimed in claim 34, wherein the extraction port is located at a location approximately central to the base for alignment in use with a patient’s mouth (port 152; figure 62A-64).
Regarding claim 41, modified Holyoake teaches the patient interface as claimed in claim 34, but is silent as to wherein the shell includes at least one vent.
However, Moenning, JR. teaches the shell includes at least one vent ([0036] The oral mask 12 also includes a number of holes 30 extending through the shell 16. The holes 30 allow for minor venting of the chamber 36 of the oral mask 12 when it is subjected to negative fluid pressure from the scavenger circuit 72. This prevents the oral mask 12 from uncomfortably locking onto the patient's face due to the suction generated by the scavenger circuit 72).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shell of Holyoke to implement at least one hole for minor venting of the mask to prevent the mask from uncomfortably locking onto the patient's face due to the suction during an extraction process, as taught by Moenning, JR. [0036].
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holyoake et al. (US 20180085544 A1) and Moenning, JR. (US 20100122705 A1) as applied to claim 34 above, and further in view of Rollins, III (US 9186474 B1).
Regarding claim 37, modified Holyoake teaches the patient interface as claimed in claim 34, wherein the shell has at least one opening for passage of an aerosol delivery tube ([1085] the interface 151 is to be placed over the nasal and/or oral area, preferably both the mouth and the nose, of a user for conveying gases to and/or from the user from a gases supply system (not shown) via an aperture or a port 152 provided on the interface 151; figure 62A-64. [1086] In some configurations, the gases supply systems which are in gases communication with the gas conduit 154 and the interface 151 via the aperture or the port 152 respectively, are separate and independent of each other. In one configuration, the gases supply system which is in gases communication with the aperture or the port 152 is a part of an anaesthesia system comprising an anaesthesia machine for delivering gas to the user, whereas the gases supply system which is in gases communication with the gas conduit 154 is a high flow humidified oxygen delivery system), but is silent as to wherein the shell comprises a pair of openings to allow connection of an aerosol head at either side, and wherein the shell comprises blanks to seal off an un-used opening.
However, Rollins, III teaches an oxygen mask (figure 1-3) wherein the shell comprises a pair of openings to allow connection of a tube at either side (one or more naso-gastric tube apertures 126 may be formed through the mask body 120 and adjacent to sealing surface 124 such that a naso-gastric tube may pass there through. Although naso-gastric tube apertures 126 are illustrated in a generally circular shape other geometric profiles may be employed and will be readily understood by those of ordinary skill in the art. Further, a relief cut 300 may be provided through sealing surface 124 and into an adjacent naso-gastric aperture 126 wherein a naso-gastric tube can be routed into and out of the mask body 120 without having to remove the naso-gastric tube from the patient; figure 1-3; col. 5 line 51-61), wherein the shell comprises blanks to seal off an un-used opening (To enhance the sealing capability of sealing surface 124, relief cut 300 may be a semi-perforated seam that can be opened when required for use; figure 2; col. 5 line 61-64. Examiner notes the relief cut 300 extends into the mask body portion 120, as seen in figure 2, and seals off the apertures 126 from the sealing surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask of Holyoake to implement a pair of relief cuts provided through the sealing surface and leading to a pair of apertures formed on the mask body, the relief cuts being semi-perforated to open and close the pair of apertures while being used or un-used, in order to allow for the passage of a tube from the sealing surface to the mask body without having to remove the mask from the patient as taught by Rollins, III col. 5 line 51-64.
As modified, the openings of modified Holyoake may allow for connection of an aerosol head at either side (Holyoake: [1086] A nasal interface such as a nasal cannula (not shown) may be provided at an end of the gas conduit 154 and within the interior volume of interface 151 for providing for example a high flow of oxygen or blended gases directly into the nares of the user).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holyoake et al. (US 20180085544 A1) and Moenning, JR. (US 20100122705 A1) as applied to claim 34 above, and further in view of Muellinger et al. (US 20060191537 A1).
Regarding claim 40, modified Holyoake teaches the patient interface as claimed in claim 34, but is silent as to further comprising a pressure sensor mounted to the shell.
However, Muellinger teaches an inhalation device (title) comprising a mask (56; figure 14) including a pressure sensor mounted to the shell ([0068] In the embodiment of FIG. 14 a pressure sensor 62 is further provided. This pressure sensor measures the pressure in the interior 56 of the mask and supplies the suction device 54 with the result. The suction device 54 may then set a suction rate depending on or controlled according to the pressure; figure 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask of Holyoake to implement a pressure sensor mounted on the shell as seen in Muellinger in order to measure the pressure inside the mask and control the extraction device or inhalation device accordingly, as taught by Muellinger claim 24 and [0068].
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duquette et al. (US 20090165799 A1) and Moenning, JR. (US 20100122705 A1).
Regarding claim 55, Duquette discloses a patient interface for aerosol treatment (Continuous Positive Airway Pressure Device; title; figure 1-4), the interface comprising:
a base (“base”; see Examiner Annotations 1 below);
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Examiner Annotations 1
a support, included in the base ([0022] receiver; figure 2 and Examiner Annotations 1), for supporting an aerosol or gas delivery head ([0027]receiver cap 24; figure 2 and Examiner Annotations 1) configured to be attached to an aerosol generator ([0025] the air flow within the CPAP device is illustrated. Supply air enters the housing 16 via a fitting 22 from a pressurized source through the tubing 14. The supply air enters a supply air channel 30 which feeds two supply air nozzle jets 32. [0027] The jets 32 direct air towards the receiver cap assembly 24, and more particularly to two funnel shaped receivers 38. The nasal prongs 26 then receive air directly from the receivers 38; figure 4);
a shell fitted to the base ([0022] One side of the rectangular box shape of the housing 16 is open, and is adapted to receive a receiver assembly 20 which will be described in more detail below; figure 2-4 and Examiner Annotations 1) to form a volume enclosed by the patient interface (see figure 4), such that the aerosol or gas delivery head is supported within the volume enclosed by the patient interface and between the base and the shell (see figure 4, receiver cap assembly 24, and more particularly to two funnel shaped receivers 38); and
an extraction port ([0020] an exhalation port 18 which permits outlet of the exhalation air; figure 2-3) but is silent as to for attachment of an extraction system to extract gas from the volume enclosed by the patient interface.
However, Moenning, JR. teaches a patient interface (Combination Anesthesia and Scavenger Surgical Mask; title; figure 1-3) comprising an extraction port for attachment of an extraction system to extract gas from the volume enclosed by the patient interface ([0035] A gas port 22 is defined in the shell 16 of the oral mask 12. The gas port 22 includes a hollow tube 24 that extends outwardly from the oral chamber 36. The hollow tube 24 has a proximal end that opens into the oral chamber 36. A threaded distal end 28 of the hollow tube 24 may be coupled (e.g., screwed) to a hose or other type of fluid line of a scavenger circuit 72 (see FIG. 3). As such, the chamber 36 of the oral mask 12 may be exposed to the negative fluid pressure generated by the scavenger circuit 72. In other words, when the threaded distal end 28 of the hollow tube 24 is coupled to the scavenger circuit 72, a vacuum pump (not shown) associated with the scavenger circuit 72 may be used to evacuate the gases exhaled by the patient into the oral mask 12; figure 1 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Holyoake to implement a scavenger circuit and a vacuum pump to optionally connect to the gas port in order to evacuate the gases exhaled by the patient, as taught by Moenning, JR. [0035].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mao et al. (US 20110000487 A1) teaches a patient interface for a CPAP.
Ng et al. (US 20090126739 A1) teaches an interchangeable mask assembly.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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