CTNF 18/544,607 CTNF 91146 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/434,496 filed December 22, 2022. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-15, filed December 19, 2023, are presently pending in this application. Claim Objections 07-29-01 AIA Claim s 3 and 14 are objected to because of the following informalities: Claim 3 recites “integrally as a portion of the portion of the patient circuit”, ln 3-4 should read --integrally as the portion of the portion of the patient circuit--. Claim 14 recites “integrally as a portion of the portion of one of the delivery conduit or the patient circuit”, ln 3-4 should read --integrally as the portion of the portion of one of the delivery conduit or the patient circuit --. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim (s) 1, 3, and 8 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Fong et al. (U.S. Pub. No. 2014/0150798; hereinafter: “Fong”) . Regarding Claim 1, Fong discloses an exhaust arrangement for exhausting gases from a passage defined within a portion (200; Fig. 38-48) of a patient circuit (Fig. 38-48) used in providing a flow of a breathing gas to an airway of a patient (¶¶ 0098, 0124), the exhaust arrangement comprising: a body (300; Fig. 38-47) defining a number of exhaust ports (A, Fig. A annotated below) passing therethrough (¶¶ 0131, 0137, 0138), each exhaust port having an inlet (B, Fig. A annotated below) and an outlet (C, Fig. A annotated below) and sized and configured to provide for the passage of gasses therethrough (¶¶ 0131, 0137, 0138); and a raised portion (310; Fig. 46 and D, Fig. A annotated below) positioned about the number of exhaust ports and extending from the body (¶¶ 0135, 0138, 0139), wherein the raised portion is sized and configured to extend into the passage of the portion of the patient circuit from an inner surface (E, Fig. A annotated below) of the portion of the patient circuit immediately adjacent the exhaust arrangement (Fig. 46, ¶¶ 0126-0139). PNG media_image1.png 505 629 media_image1.png Greyscale Figure A, Adapted from Figure 46 of Fong. Regarding Claim 3, Fong discloses the exhaust arrangement wherein: the portion of the patient circuit comprises a supply conduit (200, 250, 260, 290; Fig. 38-48); and the passage of the portion comprises a supply passage (passage formed by 200, 250, 260, 290; Fig. 38-48) of the supply conduit (¶¶ 0098, 0124; Examiner notes: Fong discloses the portion of the patient circuit as the elbow connected to a flow generator or blower.). Regarding Claim 8, Fong discloses the exhaust arrangement wherein: the body of the exhaust arrangement is formed integrally as the portion of the portion of the patient circuit (¶ 0127; Examiner notes: Fong discloses the body of the exhaust arrangement the portion of the portion of the patient circuit may be molded in one piece.) . 07-15-03-aia AIA Claim(s) 1-2, 4-7, 9-11, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Klinkenberg et al. (WO 2022/204761 A1; hereinafter: “Klinkenberg”) . Regarding Claim 1, Klinkenberg discloses an exhaust arrangement for exhausting gases from a passage defined within a portion of a patient circuit (3100, 4170; Fig. 11A-11C, 12A-12E) used in providing a flow of a breathing gas to an airway of a patient (Fig. 6A-24), the exhaust arrangement comprising: a body (3400, 3420; Fig. 9B, 11C, 12A-12E) defining a number of exhaust ports passing therethrough (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401), each exhaust port having an inlet (3410; Fig. 11C) and an outlet (3520; Fig. 11C) and sized and configured to provide for the passage of gasses therethrough (¶¶ 0366, 0367, 0374, 0393-0401); and a raised portion (A, Fig. B annotated below) positioned about the number of exhaust ports and extending from the body (Fig. 11A-12E), wherein the raised portion is sized and configured to extend into the passage of the portion of the patient circuit from an inner surface (B, Fig. B annotated below) of the portion of the patient circuit immediately adjacent the exhaust arrangement (Fig. 11A-12E). PNG media_image2.png 536 801 media_image2.png Greyscale Figure B, Adapted from Figure 11C of Klinkenberg. Regarding Claim 2, Klinkenberg discloses the exhaust arrangement wherein: the portion of the patient circuit comprises a patient interface (3100; Fig. 10A-12D); and the passage of the portion comprises a main cavity (C, Fig. B annotated above) of the patient interface. Regarding Claim 4, Klinkenberg discloses the exhaust arrangement wherein: the raised portion completely encircles the exhaust port (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401). Regarding Claim 5, Klinkenberg discloses the exhaust arrangement wherein: wherein the number of exhaust ports comprises only a single exhaust port (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401) Regarding Claim 6, Klinkenberg discloses the exhaust arrangement wherein: wherein the number of exhaust ports comprises a plurality of exhaust ports (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401). Regarding Claim 7, Klinkenberg discloses the exhaust arrangement wherein: wherein the body of the exhaust arrangement is structured to be positioned in an aperture (D, Fig. B annotated above) defined in the portion of the patient circuit and coupled to the portion of the patient circuit. Regarding Claim 9, Klinkenberg discloses the exhaust arrangement wherein: wherein the raised portion comprises a flange (A, Fig. C annotated below) portion extending radially outward from the number of exhaust ports, wherein the flange portion is sized and configured to overhang a region (B, Fig. C annotated below) of, and be spaced a predetermined distance (C, Fig. C annotated below) from, the inner surface of the portion of the patient circuit immediately adjacent the exhaust arrangement. PNG media_image3.png 870 816 media_image3.png Greyscale Figure C, Adapted from Figure 6D of Klinkenberg Regarding Claim 10, Klinkenberg discloses a patient circuit for use in providing a flow of breathing gas to an airway of a patient from a pressure generating device (3000, 4000, 4170, 5000; Fig. 1A-1C; ¶¶ 0116-0118), the patient circuit comprising: a delivery conduit (4170, 4172; Fig. 6A) having a first end (at 4000/5000; Fig. 1A-1C) structured to be coupled to the pressure generating device and a second end (at 3210Fig. 6A) opposite the first end, the delivery conduit structured to convey the flow of breathing gas from the first end to the second end (¶¶ 0217-0219, 0288-0291, 0325, 0369, 0391); a patient interface device (3000; Fig. 1A-1C; 6A-24) coupled to the second end of the delivery conduit (Fig. 1A-1C, 6C) and structured to engage about the airway of the patient and convey the flow of breathing gas from the second end of the delivery conduit to the airway of the patient (¶¶ 0116-0118, 0212-0224); and an exhaust arrangement for exhausting gases from a passage (Fig. 11A-11C, 12A-12E) defined within the patient interface device (Fig. 11A-11C, 12A-12E), the exhaust arrangement comprising: a body (3400, 3420; Fig. 9B, 11C, 12A-12E) defining a number of exhaust ports passing therethrough (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401), each exhaust port having an inlet (3410; Fig. 11C) and an outlet (3520; Fig. 11C) and sized and configured to provide for the passage of gasses therethrough (¶¶ 0366, 0367, 0374, 0393-0401); and a raised portion (A, Fig. B annotated above) positioned about the number of exhaust ports and extending from the body (Fig. 11A-12E), wherein the raised portion is sized and configured to extend into the passage of the portion of the patient circuit from an inner surface (B, Fig. B annotated above) of the portion of the patient circuit immediately adjacent the exhaust arrangement (Fig. 11A-12E). Regarding Claim 11, Klinkenberg discloses the patient circuit wherein: the portion of the patient circuit comprises a patient interface (3100; Fig. 10A-12D); and the passage of the portion comprises a main cavity (C, Fig. B annotated above) of the patient interface. Regarding Claim 13, Klinkenberg discloses the patient circuit wherein: the raised portion completely encircles the exhaust port (Fig. 11A-12E; ¶¶ 0214, 0366, 0367, 0374, 0393-0401). Regarding Claim 15, Klinkenberg discloses the patient circuit wherein: the raised portion comprises a flange (A, Fig. C annotated above) portion extending radially outward from the number of exhaust ports, wherein the flange portion is sized and configured to overhang a region (B, Fig. C annotated above) of, and be spaced a predetermined distance (C, Fig. C annotated above) from, the inner surface of the portion of the patient circuit immediately adjacent the exhaust arrangement . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fing in view of Klinkenberg . Regarding Claim 10, Fong discloses a patient circuit for use in providing a flow of breathing gas to an airway of a patient from a pressure generating device (Abstract; ¶¶ 0098, 0124) the patient circuit comprising: a delivery conduit (“air delivery tube or conduit”; ¶¶ 0098, 00124); a patient interface device (130; Fig. 32-34) coupled to the delivery conduit and structured to engage about the airway of the patient and convey the flow of breathing gas to the airway of the patient (¶¶ 0098, 0124); and an exhaust arrangement (300, 310; Fig. 38-47) for exhausting gases from a passage defined within the delivery conduit, the exhaust arrangement comprising: a body (300; Fig. 38-47) defining a number of exhaust ports (A, Fig. A annotated above) passing therethrough (¶¶ 0131, 0137, 0138), each exhaust port having an inlet (B, Fig. A annotated above) and an outlet (C, Fig. A annotated above) and sized and configured to provide for the passage of gasses therethrough (¶¶ 0131, 0137, 0138); and a raised portion (310; Fig. 46 and D, Fig. A annotated above) positioned about the number of exhaust ports and extending from the body (¶¶ 0135, 0138, 0139), wherein the raised portion is sized and configured to extend into the passage of the portion of the patient circuit from an inner surface (E, Fig. A annotated above) of the portion of the patient circuit immediately adjacent the exhaust arrangement (Fig. 46, ¶¶ 0126-0139). Fong does not specifically discloses the patient circuit for use in providing a flow of breathing gas to an airway of a patient from a pressure generating device, the patient circuit comprising: a delivery conduit having a first end structured to be coupled to the pressure generating device and a second end opposite the first end, the delivery conduit structured to convey the flow of breathing gas from the first end to the second end; a patient interface device coupled to the second end of the delivery conduit and structured to engage about the airway of the patient and convey the flow of breathing gas from the second end of the delivery conduit to the airway of the patient. Klinkenberg teaches a patient circuit for use in providing a flow of breathing gas to an airway of a patient from a pressure generating device (3000, 4000, 4170, 5000; Fig. 1A-1C; ¶¶ 0116-0118), the patient circuit comprising: a delivery conduit (4170, 4172; Fig. 6A) having a first end (at 4000/5000; Fig. 1A-1C) structured to be coupled to the pressure generating device and a second end (at 3210Fig. 6A) opposite the first end, the delivery conduit structured to convey the flow of breathing gas from the first end to the second end (¶¶ 0217-0219, 0288-0291, 0325, 0369, 0391); a patient interface device (3000; Fig. 1A-1C; 6A-24) coupled to the second end of the delivery conduit (Fig. 1A-1C, 6C) and structured to engage about the airway of the patient and convey the flow of breathing gas from the second end of the delivery conduit to the airway of the patient (¶¶ 0116-0118, 0212-0224) for the purpose of providing a connection that can swivel between a pressure generating device and the patient interface device (¶¶ 0217-0219, 0288-0291, 0325, 0337, 0369, 0391). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patient circuit of Fong to include the delivery conduit having the first end structured to be coupled to the pressure generating device and the second end opposite the first end, the delivery conduit structured to convey the flow of breathing gas from the first end to the second end; the patient interface device coupled to the second end of the delivery conduit and structured to engage about the airway of the patient and convey the flow of breathing gas from the second end of the delivery conduit to the airway of the patient as taught by Klinkenberg for the purpose of providing a connection that can swivel between a pressure generating device and the patient interface device (See Klinkenberg: ¶¶ 0217-0219, 0288-0291, 0325, 0337, 0369, 0391). Regarding Claim 12, the modified device of Fong discloses the patient circuit wherein: the portion of the patient circuit comprises a supply conduit (200, 250, 260, 290; Fig. 38-48); and the passage of the portion comprises a supply passage (passage formed by 200, 250, 260, 290; Fig. 38-48) of the supply conduit (¶¶ 0098, 0124; Examiner notes: Fong discloses the portion of the patient circuit as the elbow connected to a flow generator or blower.). Regarding Claim 14, the modified device of Fong discloses the patient circuit wherein: the body of the exhaust arrangement is formed integrally as the portion of the portion of the patient circuit (¶ 0127; Examiner notes: Fong discloses the body of the exhaust arrangement the portion of the portion of the patient circuit may be molded in one piece.). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST. 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. 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. /ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785 Application/Control Number: 18/544,607 Page 2 Art Unit: 3785 Application/Control Number: 18/544,607 Page 3 Art Unit: 3785 Application/Control Number: 18/544,607 Page 5 Art Unit: 3785 Application/Control Number: 18/544,607 Page 6 Art Unit: 3785 Application/Control Number: 18/544,607 Page 7 Art Unit: 3785 Application/Control Number: 18/544,607 Page 8 Art Unit: 3785 Application/Control Number: 18/544,607 Page 9 Art Unit: 3785 Application/Control Number: 18/544,607 Page 10 Art Unit: 3785
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