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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 02/19/2024 and 06/24/2025 have been received and fully considered.
Claim Objections
Claims 13 and 22 are objected to because of the following informalities:
Claim 13 lines 3-4 “20 Umin to about 90 Umin” should be corrected to “20 [[U]]L/min to about 90 [[U]]L/min” for the sake of appropriate units.
Claim 22 line 2 discloses “copmrises” should be corrected to “comp[[m]]rises” for the sake of proper spelling.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-8, 13, 16-17, 22-23, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20180085544A1 to Holyoake et al. (hereinafter “Holyoake”).
Regarding claim 1, Holyoake discloses a patient interface (See Fig. 3 generally) comprising:
a gases delivery interface (Fig. 3 flow manifold 206) configured to deliver an apparatus gas flow to a patient (Paragraph 0665 discloses the flow manifold receives gases from the first gas lumen 202 and passes them to one or more nasal delivery elements), the gases delivery interface comprising:
a delivery outlet to deliver the apparatus gas flow to the patient (Fig. 3 nasal delivery elements 208); and
a gases delivery side member extending from a first side of the delivery outlet and comprising an apparatus gases flow path in fluid communication with the delivery outlet (Fig. 3 first portion 204, cheek supports 210; Paragraph 0669 discloses the first gas lumen 202 may have a first portion 204), the gases delivery side member comprising a collapsible portion movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed in order to reduce or stop the apparatus gas flow through the apparatus gases flow path (Paragraphs 0680-0681 discloses the first portion 204 is configured to be collapsible and in the first configuration is substantially open and the second condition is substantially closed; The lumen 202 is configured to be collapsible to fully close off flow at the fist portion 204); and
a gas sampling interface (Figs. 32-33 show pressure sampling line 829, inlet 87, pressure inlet 831) comprising:
a sampling inlet configured to receive a patient gas flow at the patient (Fig. 32 inlet 87; Examiner notes the arrows show the inlet receives air from the patient);
a sampling outlet configured for delivery of the patient gas flow away from the patient (Fig. 33 pressure inlet 831; Examiner notes the arrows show the outlet delivers gas away from the patient); and a sampling conduit in fluid communication with the sampling inlet and the sampling outlet (Figs. 32-34 pressure sampling line 829 is the sampling conduit which is in communication with inlet 87 and pressure inlet 831), the sampling conduit configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is moved to the collapsed configuration (Paragraph 0798 discloses a face mask may be applied to the patient which will occlude [collapse] a portion of the conduit 831; Paragraph 0798 also discloses the pressure sensing line senses pressure at the inlet during occlusion via a pressure sensor; Thus the sensing line must remain open even during a collapse of the conduit to relay pressure information; Examiner further notes the sample line is capable of remaining open in the event of collapsing the collapsible portion by an external force (i.e. a patient pinching the line, or clamps per paragraph 0683) without necessarily also clamping/pinching closed the supply line).
Regarding claim 5, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the gas sampling interface provided is to the gases delivery side member (Fig. 32 & 35 show the line 829 is on the same side as the conduit 831), the gases delivery side member comprises a delivery inlet at one end to receive the apparatus gas flow (Fig. 33 flow source conduit 827; Paragraph 0807 discloses the flow source conduit provides air to the conduit 831), and the gases delivery side member comprises a patient-facing wall and a non-patient- facing wall (See Annotated Fig. 32).
PNG
media_image1.png
310
692
media_image1.png
Greyscale
Regarding claim 6, Holyoake discloses the patient interface according to claim 5, and Holyoake further discloses wherein the sampling inlet is located proximate to the delivery outlet and the sampling outlet is located proximate to the delivery inlet (Fig. 32 shows nasal prongs 85 are proximate to inlet 87 of pressure line 829; Fig. 34 shows outlet 821 is proximate to fluid source conduit 827).
Regarding claim 7, Holyoake discloses the patient interface according to claim 5, and Holyoake further discloses wherein the sampling conduit comprises a sampling lumen for the patient gas flow (Fig. 32 shows the interior of pressure sensing line 829 defines a lumen) and the gases delivery side member comprises a gases delivery lumen for the apparatus gas flow (Fig. 32 shows the interior of conduit 831 defines a lumen for the gas flow).
Regarding claim 8, Holyoake discloses the patient interface according to claim 5, and Holyoake further discloses wherein the sampling conduit extends alongside an external surface of the gases delivery side member (Fig. 32 & 35 shows pressuring sensing line 829 extends along an external surface of conduit 831).
Regarding claim 13, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein in the normally open configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of about 20 Umin to about 90 Umin through the apparatus gases flow path (Paragraph 0653 discloses acceptable flow rates of the gases supplied to the interface or via the system may be 15L/min – 95L/min).
Regarding claim 16, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the patient interface comprises a single sampling conduit (Fig. 32 shows there is a singular sample line 829).
Regarding claim 17, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the sampling conduit comprises a single lumen and the single lumen being a sampling lumen for the patient gas flow (Fig. 32 singular sample line 829 interior defines a lumen and measures pressure (flow); Paragraph 0798).
Regarding claim 22, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the sampling conduit copmrises a wall of uniform thickness (Figs. 32-35 show pressure line 829 has a uniform wall thickness along its length) and the collapsible portion comprising a wall of non-uniform thickness (See Fig. 8 where the collapsible portion has a thinner wall than the rest of the pathway).
Regarding claim 23, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the collapsible portion comprises one or more thin-walled portions configured to facilitate bending or folding and thereby facilitate movement of the collapsible portion to the collapsed configuration (See Fig. 8 where the collapsible portion has a thinner wall than the rest of the pathway).
Regarding claim 26, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the sampling conduit has a width that is less than a width of the collapsible portion (Fig. 35 shows the width of the sample line 829 is less than the collapsible portion of conduit 831).
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holyoake in view of WO20190159063A1 to Evans et al. (hereinafter “Evans”).
Regarding claim 4, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the gases delivery interface further comprises a non-delivery side member extending from a second side of the delivery outlet that is opposite to the first side (Right side of Fig. 2 shows the non-delivery side member (See also Figs. 6-7)). Holyoake does not disclose the non-delivery side member comprising a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and a non-patient-facing wall. However, Evans teaches a collapsible conduit patient interface and headgear connector which has a non-delivery side member having a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and non-patient facing wall (Fig. 10A left side of figure; headstrap connector 810, plug 808; Examiner notes there is an internal wall of the plug and connector facing the patient, and an external wall which does faces outward away from the patient).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to modify the system of Holyoake to further include the non-delivery side member comprising a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and a non-patient-facing wall, as taught by Evans, in order to provide a stable connection where the headgear connector and conduit connector meet (Paragraph 0503).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO2018070885A1 to Chilcott et al. (hereinafter “Chilcott”) and US20170281888A1 to McMurray (hereinafter “McMurray”).
Regarding claim 9, Holyoake discloses the patient interface according to claim 7, but does not explicitly disclose wherein the sampling conduit is configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force, and the sampling conduit is one of: formed of a material having sufficient material stiffness to retain the shape of the sampling lumen, formed of a material that has greater material stiffness than a material of the collapsible portion, or configured via geometric features to be stiffer than the collapsible portion. Chilcott teaches a breath sampling interface which has a gas sampling conduit made of stiff silicone (Paragraph 0166 discloses the gas sampling conduit 101 may be made of silicone up to a hardness shore A reading of 90).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas sampling line of Holyoake to be made of stiff silicone, as taught by Chilcott, in order to reduce torque of the conduit line on the patient (Paragraph 0166).
McMurray teaches a medical apparatus which has an air supply tube made of soft thermoplastic elastomer (Figs. 2-5 tube 105; Paragraph 0035 discloses the tube may be made of thermoplastic elastomer with a hardness shore A reading of 50).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the air supply tube of Holyoake to be made of soft material, as taught by McMurray, in order to allow the tube to be easily flexible and compressible (Paragraph 0035).
Holyoake as modified by Chilcott and McMurray discloses wherein the sampling conduit is configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force (Holyoake as modified by McMurray has a supply tube with the collapsible portion having a hardness of 50 while the sampling line has a hardness of 90; Examiner notes that the gas supply line thus would collapse before the sampling line would collapse), and the sampling conduit is one of: formed of a material having sufficient material stiffness to retain the shape of the sampling lumen, formed of a material that has greater material stiffness than a material of the collapsible portion (Holyoake as modified by McMurray has the supply tube with a hardness of 50 and sampling line with a hardness of 90), or configured via geometric features to be stiffer than the collapsible portion. Examiner further notes it would be desirable to make these modifications in order to keep reading the system’s pressure of Holyoake in the event of the conduit collapsing due to external force (as per Paragraph 0798).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Holyoake in view of US20130303929A1 to Martino et al. (hereinafter “Martino”).
Regarding claim 14, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein in the collapsed configuration, the patient interface is configured to allow an apparatus gas flow rate through the apparatus gases flow path (Paragraph 0653 discloses the flowrate provided to an interface may be between about 5 or 10L/min to 100L/min; Examiner notes the mask introduction to the system puts the system in the collapsed configuration). Holyoake does not disclose the flow rate through the apparatus path is at least 20 times greater than a patient gas flow rate through the sampling interface. However, Martino discloses an exhalation sampling tube which is configured to receive an exhalation flow rate of 100mL/min – 1L/min (Paragraph 0027 discloses a tube receives the breath of the users and the channels a formed to receive predetermined flow rates through the channels from about 100mL/min – 1L/min, especially about 250mL/min).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify sampling line of Holyoake to receive exhalation pressure at 250mL/min – 1L/min, as taught by Martino, in order to provide controlled flow rate and flow volume over a predetermined measuring time period (Paragraph 0027). Holyoake as modified by Martino discloses the flow rate through the apparatus path is at least 20 times greater than a patient gas flow rate through the sampling interface (Holyoake’s provided flow rate from the apparatus may be 5-100L/min which is at least 20 times greater than 100mL/min – 1L/min).
Regarding claim 15, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein in the collapsed configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of less than about 10L/min through the apparatus gases flow path (Paragraph 0653 discloses the flowrate provided to an interface may be between about 5 or 10L/min; Examiner notes the mask introduction to the system puts the system in the collapsed configuration). Holyoake does not disclose the gas sampling interface is configured to allow a patient gas flow rate of less than about 500mL/min, optionally about 40mL/min to about 500mL/min through the gas sampling interface. However, Martino discloses an exhalation sampling tube which is configured to receive an exhalation flow rate of 100mL/min – 1L/min (Paragraph 0027 discloses a tube receives the breath of the users and the channels a formed to receive predetermined flow rates through the channels from about 100mL/min – 1L/min, especially about 250mL/min).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify sampling line of Holyoake to receive exhalation pressure at 250mL/min – 1L/min, as taught by Martino, in order to provide controlled flow rate and flow volume over a predetermined measuring time period (Paragraph 0027).
Claims 18, 21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Holyoake in view of Chilcott.
Regarding claim 18, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the sampling inlet comprises a nasal inlet (Fig. 32 inlet 87). Holyoake does not disclose wherein the sampling inlet further comprises a mouth inlet. However, Chilcott teaches a gas sampling unit which has a mouth inlet (Fig. 70 gas sampling unit 100 has an inlet 7050 at the patient’s mouth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sampling inlet of Holyoake to also have a mouth inlet, as taught by Chilcott, in order to read pressure being exhaled from the patient’s mouth (Paragraph 0152).
Regarding claim 21, Holyoake discloses the patient interface according to claim 1, but does not disclose wherein the sampling conduit comprises a thicker wall than a wall of the collapsible portion. However Chilcott teaches a gas sampling system where the sampling conduit has a thicker wall (Paragraph 0235 discloses the conduit side has a thicker wall (1.5mm-2mm) compared to the cannula side wall (0.5mm-1mm)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Holyoake’s sampling line wall to be thicker than the cannula line wall, as taught by Chilcott, in order to ensure the cannula wall has sufficient stretch (Paragraph 0235). Examiner notes the compressible portions in Holyoake also already are thin to allow for better compressibility (Figs. 8 & 42B).
Regarding claim 24, Holyoake discloses the patient interface according to claim 1, and Holyoake further discloses wherein the collapsible portion is made of a polymer (Paragraph 0421 discloses the compressible portion made be made of a polymer). Chilcott teaches a breath sampling interface which has a gas sampling conduit made of stiff silicone (Paragraph 0166 discloses the gas sampling conduit 101 may be made of silicone up to a hardness shore A reading of 90).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas sampling line of Holyoake to be made of stiff silicone, as taught by Chilcott, in order to reduce torque of the conduit line on the patient (Paragraph 0166).
Holyoake as modified by Chilcott discloses wherein the gas sampling interface is formed of a different material than the collapsible portion (Holyoake would have a gas sampling line of silicone and the collapsible portion made of a polymer).
Regarding claim 25, Holyoake in view of Chilcott discloses the patient interface according to claim 24, and Holyoake as modified by Chilcott further discloses wherein the gas sampling interface comprises at least one of silicone or a thermoplastic elastomer (Holyoake as modified by Chilcott has a gas sampling line made of silicone).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20140311492-A1 to Stuebiger; US-20140358019-A1 to Johnson; US-20150025407-A1 to Eichler; US-20150032019-A1 to Acker; US-20150099993-A1 to Weaver; US-20150119744-A1 to Lawson; US-20160030696-A1 to Klenner; US-20160193438-A1 to White; US-20160220777-A1 to Weaver; US-20160345863-A1 to Johnson; US-20160346495-A1 to Payton; US-20170209022-A1 to Molnar; US-20170281051-A1 to Molnar; US-20190209803-A1 to Hermez; US-20190232003-A1 to Chaudhry; US-20190298960-A1 to Kabumoto; US-20190307978-A1 to Liu; US-20190209801-A1 to Kimble; US-20190175861-A1 Holyoake; US-5005571-A to Dietz; US-9199053-B1 to Allum; and US-9931054-B2 to Fudge.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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 571-270-3525. 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.
/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
Prosecution Insights