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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
Response to Amendment
This Office Action is in response to the request for continued examination filed on 02/02/2026 and the amendment filed on 02/02/2026. As per the amendment, claims 29, 48, and 51-52 are as currently amended; claims 1-28, 33-35, 37, 39, 45, and 47 are cancelled; claims 30-32, 36, 38, 40-44, 46, 49-50, and 53-54 are as previously presented; and claim 55 is new. As such, claims 29-32, 36, 38, 40-44, 46, and 48-55 are pending in the instant application.
Specification
The disclosure is objected to because of the following informalities:
In [0141] of the specification, the nasal cannula portion is reference by both “320” and “360”.
Appropriate correction is required.
Claim Objections
Claims 29 and 44 are objected to because of the following informalities:
Claim 29, line 17: “a body” should read “a securement portion body” for clarity.
Claim 44 (line 2), claim 51 (line 3), and claim 53 (line 2): “the body” should read “the securement portion body” for clarity and to avoid potential confusion with the manifold body.
Appropriate correction is required.
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.
Claims 29-32, 36, 38, 40, 43-44, 48-49, 51, 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Harwood et al. (US 20150209541 A1), hereinafter Harwood, in view of Curti et al. (US 20100113956 A1), hereinafter Curti.
Regarding claim 29, Harwood discloses a patient interface (nasal interface 50; Fig. 8), comprising:
a user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) comprising:
a manifold (104 and 108; Fig. 9), the manifold comprising:
a manifold body (body of 104, where an opening in the body of 104 is enclosed by 108, see Fig. 13; [0093]);
a first open end (open end of manifold 104; Fig. 15) configured to be in fluid communication with a first tube (90; Fig. 9), wherein the first tube is a gas delivery tube ([0087]);
wherein the manifold is a gas chamber (Figs. 12 and 15; [0093], lines 17-19); and
at least one nasal prong (82; Fig. 9) for providing a flow of gas to a patient ([0087], lines 1-3), the at least one nasal prong (82) extending from the manifold (Fig. 14, where the nasal prong 82 extends from insert 108 that is received by manifold 104), wherein the at least one nasal prong (82) is unitary with the manifold ([0093], lines 13-14); and
a securement portion comprising (frame 62; Fig. 9):
a body (central portion 100, pair of lateral side portions 102; Fig. 9);
a pair of facial pads (114; Fig. 9), each facial pad of the pair of facial pads on opposing sides of the body (each of 114 on opposite sides of 100, see Fig. 8; [0095], lines 7-9); and
a pair of bridging portions (arms 60; Fig. 8), each bridging portion of the pair of bridging portions connecting the body (central portion 100, pair of lateral side portions 102; Fig. 9) and a respective facial pad of the pair of facial pads (114; Fig. 9; [0095], lines 4-8, where the frame 62 comprises the central portion 100 and pair of lateral side portions 102; Fig. 9);
wherein the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) and the securement portion (frame 62; Fig. 9) are detachable from each other ([0091], lines 6-8, where the central portion 100 is a portion of frame 62).
Harwood fails to disclose a second open end configured to be in fluid communication with a second tube, wherein the manifold body extends laterally between the first open end and the second open end, and wherein the first open end is in fluid communication with the second open end and the at least one nasal prong.
However, Curti teaches an analogous patient interface (60; Fig. 19B) with a first open end (75; Fig. 19B) that connects with a tube (76; Fig. 19B) to deliver gas flow to a patient (flow of gas from 86G, see Fig. 19B; [0082]), a second open end (73; Fig. 19B) connected to a second tube (74; Fig. 19B) to exhaust exhaled air from the patient (86MA includes a vacuum pump or other configurations to draw exhaled breath from the patient, see [0048]; Fig. 19B), where a main body of the patient interface (main body 71; Fig. 19B) extends laterally between the first open end (75) and the second open end (73, see Fig. 19B), and where the first open end (75) is in fluid connection with the second open end (75 in fluid connection with 73 via 71’ and 71”, see Fig. 19B) and two nares (75 in fluid connection with nares 65 and 67 via 71”, 95, 71’, and 91, see Fig. 19B).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the manifold taught by Harwood to have two open ends that respectively connect with two tubes as taught by Curti, such that the manifold has a first open end (Curti 75; Curti Fig. 19B) that connects with a first tube (Curti 76; Curti Fig. 19B) to deliver gas flow to a patient (flow of gas from Curti 86G, see Curti Fig. 19B; Curti [0082]), a second open end (Curti 73; Curti Fig. 19B) configured to be in fluid communication with a second tube (Curti 74; Curti Fig. 19B) to exhaust exhaled air from the patient (Curti 86MA includes a vacuum pump or other configurations to draw exhaled breath from the patient, see Curti [0048]; Curti Fig. 19B), wherein the manifold body extends laterally between the first open end and the second open end (manifold body extends laterally between Curti 75 and Curti 73, see Curti Fig. 19B), and wherein the first open end is in fluid communication with the second open end (Curti 75 in fluid connection with Curti 73 via Curti 71’ and Curti 71”, see Curti Fig. 19B) and the at least one nasal prong (Curti 75 in fluid with Harwood 82 via Curti 71’ and Curti 71”, see Curti Fig. 19B) to improve patient treatment and comfort by monitoring the breathing of the patient and sampling the end tidal CO2 content in the exhaled breath of the patient due to the lateral arrangement of the open ends of the manifold (last two sentences of Curti [0063]).
Regarding claim 30, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) is a sealing cannula, a non-sealing cannula, a nasal mask, or an oronasal mask (user interface is a nasal mask, see Abstract).
Regarding claim 31, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) is detachably attached ([0091], lines 6-8, where the central portion 100 is a portion of frame 62) to the body (central portion 100, pair of lateral side portions 102; Fig. 9) of the securement portion (frame 62; Fig. 9; manifold 104 is removably secure to the central portion 100; [0091], lines 6-8).
Regarding claim 32, Harwood as modified teaches the claimed invention as set forth in claim 29, further comprising a connection mechanism (snap-fit, see [0091], lines 9-12) which detachably attaches ([0091], lines 6-13) the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) with the securement portion (frame 62; Fig. 9).
Regarding claim 36, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the first tube (Curti 76; Curti Fig. 19B) and the second tube (Curti 74; Curti Fig. 19B) are configured to be connected to the manifold (see Curti Fig. 19B).
Regarding claim 38, Harwood as modified teaches the claimed invention as set forth in claim 36, wherein the first tube (Curti 76; Curti Fig. 19B) is an inspiratory tube (flow of gas from Curti 86G, see Curti Fig. 19B, hence Curti 76 is an inspiratory tube; Curti [0082]) and the second tube (Curti 74; Curti Fig. 19B) is an expiratory tube (Curti 86MA includes a vacuum pump or other configurations to draw exhaled breath from the patient, see Curti [0048], hence Curti 74 is an expiratory tube; Curti Fig. 19B).
Regarding claim 40, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the manifold (104 and 108; Fig. 9) further comprises a thinned region at a patient facing side (frame 62, where portion of frame 62 that is in contact with pad 64 is at a patient facing side; [0116], lines 3-10, where the thinner material of frame 62 allows for flexibility of the structure; Fig. 12) below the at least one nasal prong (Fig. 12), the thinned region being an area of reduced thickness relative to portions of the manifold around the thinned region (frame 62, where portion of frame 62 that is in contact with pad 64 is at a patient facing side; [0116], lines 3-10, where the thinner material of frame 62 allows for flexibility of the structure; Fig. 12).
Regarding claim 43, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the pair of bridging portions (arms 60; Fig. 8) have a curved shape (Fig. 11) configured in use to urge the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) toward nares of the patient ([0078], lines 2-6, where a nasal delivery element 82 is provided for each nare of the user, [0078], lines 7-8) to create or maintain sealing engagement between the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) and the nares of the patient (nasal delivery element 82 provided in nare of user, [0078], lines 2-6; seal element 86 of nasal delivery element 82 maintains seal between the interface and the user's nares, [0079], lines 7-11).
Regarding claim 44, Harwood as modified teaches the claimed invention as set forth in claim 43, wherein the pair of bridging portions (arms 60; Fig. 8) are configured to roll ([0095], lines 10-12, where the supports are arms 60) in response to movement between the pair of facial pads (114; Fig. 8) and the body (central portion 100, pair of lateral side portions 102; Fig. 9; formable or bendable arms 60 permit adjustable positioning of the pads 114, [0095], lines 10-16, where the supports are arms 60 and if the position of pads 114 is adjustable, the pads 114 have the ability to adjust due to movement between the pads 114 and structures the pads 114 are in direct contact with).
Regarding claim 48, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the first open end (Curti 75; Curti Fig. 19B) and the second open end (Curti 73; Curti Fig. 19B) allow gas flow to and from the patient via the manifold (Curti 73 and Curti 75 are fluidly connected and allow gas flow to and from the patient via Curti 71’ and Curti 71”, where Curti 71’ and Curti 71” is the internal hollow volume of the manifold, see Curti Fig. 19B; Curti [0082] and Curti [0048]), wherein the first open end is a gas inlet (Curti 75 is a gas inlet as it connects with the gas supply line 76 and insufflating gas source 86G, see Curti Fig. 19B; Curti [0082]) and the second open end is a gas outlet (Curti 73 is a gas outlet as it connects with Curti 74 and Curti 86MA to draw exhaled breath from the patient, see Curti Fig. 19B; Curti [0048]), and wherein the first open end and the second open end are in fluid communication with each other via the manifold (see claim 29 above).
Regarding claim 49, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) is a nasal cannula ([0072], lines 3-5), but fails to disclose wherein an inner, patient facing side of the manifold (104 and 108; Fig. 14) is thinner to conform over a philtrum of the patient.
However, an alternate embodiment of Harwood teaches a thinner side (thin-walled portion 198; Figs. 39 and 40) of the manifold (104 and 108; Fig. 14) that faces the user (Figs. 39 and 40, where seal element 86 is in direct contact with user's nare, [0079], lines 16-17, where the seal element 86 must be located on a patient facing side to be in direct contact with the patient), wherein the thinner side (thin-walled portion 198; Figs. 39 and 40) allows for adjustability of position and location of the manifold (104 and 108; Fig. 14) between the upper lip and nose of the user ([0130], lines 7-15, where thin-walled portion 198 defines the roll point 200 and adjustable positioning of nasal pillows 86 can adjust the position and location of the manifold 104 to conform to the philtrum of a user, [0119], lines 8-15).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the primary embodiment of Harwood taught in claim 29 above with this secondary embodiment of Harwood, such that an inner, patient facing side (Figs. 39 and 40, where seal element 86 is in direct contact with user's nare, [0079], lines 16-17, where the seal element 86 must be located on a patient facing side to be in direct contact with the patient) of the manifold (104 and 108; Fig. 14) is thinner (thin-walled portion 198; Figs. 39 and 40) to conform over a philtrum of the patient ([0130], lines 7-15, where thin-walled portion 198 defines the roll point 200 and adjustable positioning of nasal pillows 86 can adjust the position and location of the manifold 104 to conform to the philtrum of a user, [0119], lines 8-15) to maintain a good seal with the user's nares, even if the interface moves slightly on the user's face ([0079], lines 9-11).
Regarding claim 51, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein each bridging portion of the pair of bridging portions (arms 60; Fig.8) is an arm (arms 60; Fig. 8; [0074], lines 8-9) shaped to have a non-linear or curved path (Fig. 11) between a first end at a junction between the body (See annotated Fig. 13) and the bridging portion and a second end at a junction (See annotated Fig. 13) between the bridging portion and a base of the associated facial pad (See annotated Fig. 13).
PNG
media_image1.png
286
473
media_image1.png
Greyscale
Annotated Fig. 13
Regarding claim 53, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein each bridging portion of the pair of bridging portions (arms 60; Fig. 8) is attached to the body (central portion 100, pair of lateral side portions 102; Fig. 9) separately (Fig. 8).
Regarding claim 54, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein each bridging portion of the pair of bridging portions (arms 60; Fig. 8) is attached to a front of the securement portion (frame 62; Fig. 9, where arms 60 are attached to a surface, or front, of the frame 62).
Claims 41-42, 50, 52, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Curti as applied to claim 29 above, and further in view of Johnson et al. (US 20170348500 A1), hereinafter Johnson.
Regarding claim 41, Harwood as modified teaches the claimed invention as set forth in claim 29, but fails to teach further comprising a first patch assembly coupled to a first facial pad of the pair of facial pads (114; Fig. 8) and a second patch assembly coupled to a second facial pad of the pair of facial pads, the first patch assembly and the second patch assembly for securing the pair of facial pads (114; Fig. 8) to the patient.
However, Johnson teaches a two-part connection system ([0698]) comprising patches that attach to a recessed area (4760) of each arm of a body of an interface (see [0698], Fig. 38B) to connect the patch located on the recessed area (4760) to the opposite patch on the face of the user ([0698]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Harwood with Johnson such that Harwood as modified further comprises a first patch assembly (Johnson: first part of two-part connection system; [0698]) coupled to a first facial pad (a first 114; Johnson: a first patch attached to a first patch recessed area 4760 in one of the arms of the body of the interface, see [0698], see Fig. 38B) and a second patch assembly (Johnson: second part of two-part connection system; [0698]) coupled to a second facial pad of the pair of facial pads (a second 114; Johnson: a second patch attached to a first patch recessed area 4760 in one of the arms of the body of the interface, see [0698], see Fig. 38B), the first patch assembly (Johnson: first part of two-part connection system; [0698]) and the second patch assembly (Johnson: second part of two-part connection system; [0698]) for securing the pair of facial pads (114; Fig. 8) to the patient (Johnson: [0698], where pad positioned in recessed section 4760 is a loop pad section that connects to the hook pad section on the user's face) to maintain the interface's position when being worn by a user (Johnson: [0044], lines 2-3).
Regarding claim 42, Harwood as modified teaches the claimed invention as set forth in claim 41, wherein at least one of the first patch assembly (Johnson: first part of two-part connection system; [0698]) or the second patch (Johnson: second part of two-part connection system; [0698]) comprises a hook or loop material (Johnson: [0698], lines 1-3).
Regarding claim 50, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the user interface portion (nasal delivery elements 82, manifold 104 and 108; Fig. 14) is a nasal cannula ([0072], lines 3-5), but does not disclose the manifold (104 and 108; Fig. 14) comprises thinned regions adjacent to the pair of prongs (nasal delivery elements 82; Fig. 9).
However, Johnson teaches a thinned region (205) adjacent to a pair of prongs (see Fig. 7B; [0609], line 3-6).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Harwood with Johnson such that the manifold (104 and 108; Fig. 14) of Harwood comprises thinned regions (Johnson: 205; Fig. 7B) adjacent to the pair of prongs (nasal delivery elements 82; Johnson: Fig. 7B; [0609], line 3-6) to enable bending or flexure to absorb or dampen force experienced by the interface from being transferred to increase user comfort (Johnson: [0609], lines 5-6; [0552], lines 1-7).
Regarding claim 52, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein the pair of facial pads (114; Fig. 8) are configured to secure to the face of the patient directly or indirectly by an external force (Johnson: two-part connection system, [0045]-[0052]; [0698], where pad positioned in recessed section 4760 is a loop pad section that connects to the hook pad section on the user's face), using one or more of an adhesive connection, a headgear arrangement, or a hook or loop connection (Johnson: [0698], lines 1-3).
Regarding claim 55, Harwood as modified teaches the claimed invention as set forth in claim 29, wherein each facial pad of the pair of facial pads (each of 114; Fig. 8) comprises a fastener (Johnson two-part connection system; Johnson [0045]-[0052] and Johnson [0698]) configure to secure the securement portion to opposing sides of a patient’s face (Johnson [0698], where pad positioned in recessed section 4760 is a loop pad section that connects to the hook pad section on the user's face; Harwood [0095], where 114 is connected to 62 via 60, see Harwood Fig. 11; hence, Johnson two-part connection system on Harwood 114 secures Harwood 62 to opposing sides of a patient’s face).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view Curti as applied to claim 29 above, and further in view of Klenner et al. (US 20160030696 A1), hereinafter Klenner.
Regarding claim 46, Harwood as modified teaches the claimed invention as set forth in claim 29, but fails to explicitly teach wherein the securement portion comprises a component which can be detachably attached to at least one of the first tube or the second tube.
However, Klenner teaches analogous patient interface (10800; Fig. 57A) with a cannula part (10801; Fig. 57A) having side arms (10804; Fig. 57A), where said side arms are provided with a clip (10806; Fig. 57A) having at least one receptacle (10807; Fig. 57A) to detachably receive conduits (10806 with conduits 100003a and 100003b, see Fig. 57A).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the securement portion taught by Harwood to include the clips taught by Klenner, such that the securement portion (62; Fig. 9) comprises a component (Klenner 10806; Klenner Fig. 57A) which can be detachably attached to at least one of the first tube or the second tube (at least one of Curti 76 or Curti 74 detachably received in Klenner 10807 of Klenner 10806; Curti Fig. 19B; Klenner Fig. 57A) to retain at least one of the first tube or the second tube in place (Klenner [0715], line 25).
Response to Arguments
Applicant’s arguments with respect to claim 29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On pages 5-6 of the Remarks (filed on 02/02/2026), Applicant argues Harwood fails to disclose “wherein the manifold body extends laterally between the first open end and the second open end,” as recited in claim 29. While Harwood does not disclose this limitation of claim 29, Harwood in view of Curti does teach a manifold body extending laterally between a first open end and a second open end (see 35 U.S.C. 103 rejection of claim 29 above).
On pages 6-7 of the Remarks, Applicant argues Harwood fails to disclose “a second open end configured to be in fluid communication with a second tube,” as recited in claim 29. While Harwood does not disclose this limitation of claim 29, Harwood in view of Curti does teach a second open end configured to be in fluid communication with a second tube (see 35 U.S.C. 103 rejection of claim 29 above).
On page 7 of the Remarks, Applicant argues Harwood fails to disclose “wherein the first open end is in fluid communication with the second open end and the at least one nasal prong,” as recited in claim 29. While Harwood does not disclose this limitation of claim 29, Harwood in view of Curti does teach a first open end in fluid communication with a second open end and at least one nasal prong (see 35 U.S.C. 103 rejection of claim 29 above).
For at least the reasons stated above claim 29, and its dependents therein, are not patentable over the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ho et al. (US 8701667 B1): Regarding a patient interface device with pads to rest on the face, and a cannula portion that is removeable from a support frame.
Ronayne (WO 2018042355 A1): Regarding a patient interface system with facial pads to rest on a patient’s face, a tube for inspiratory flow, and a tube for expiratory flow.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm 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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785