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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 27, 2026 has been entered.
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage App. PCT/IB2021/051708 filed March 2, 2021; to Provisional App. No. 63/117,044 filed November 23, 2020; and to Provisional App. No. 62/984,718 filed March 3, 2020.
Status of Claims
This Office Action is responsive to the amendment filed on February 27, 2026. As directed by the amendment: claims 161 and 162 have been amended and claims 171 has been cancelled. Thus, claims 161-166, 169-170, and 172-180 are presently pending in this application.
Claim(s) 161, 162, 164-166, 169-172 and 177-180 are rejected under 35 U.S.C. 103 as being unpatentable over Fai et al. (U.S. Pub. No. 2016/0121068) in view of Guney et al. (U.S. Pub. No. 2009/0044808). Claim(s) 173-176 are rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Guney as applied to claim 161 above, and further in view of Gunaratnam et al. (U.S. Pub. No. 2004/0226566).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Claim Rejections - 35 USC § 103
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 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) 161, 162, 164-166, 169-170, 172 and 177-180 are rejected under 35 U.S.C. 103 as being unpatentable over Fai et al. (U.S. Pub. No. 2016/0121068; hereinafter: “Fai”) in view of Guney et al. (U.S. Pub. No. 2009/0044808; hereinafter: “Guney”)
Regarding Claim 161, Fai discloses a patient interface assembly (Fig. 11-16; ¶¶ 0064-0070) comprising: a first interface body (204; Fig. 11-16); a housing (232; Fig. 13-16) configured to detachably couple with the first interface body or a second interface body (¶¶ 0066, 0067; Fig. 13), the housing having a first housing opening (A, Fig. A annotated below) and a second housing opening (B, Fig. A annotated below) at opposing sides thereof (Fig. 13, 15, 16); and a first interface tube (12; Fig. 26) connected to the first housing opening and a second interface tube (12; Fig. 26) connected to the second housing opening (¶¶ 0050, 0064; Examiner notes: Fai discloses that one or both of the first housing openings and the second housing openings can be coupled to a pressure support system.), wherein the first interface body is coupled to the housing in a first configuration (Fig. 11-16), wherein each of the first interface body comprise a manifold (C, Fig. A annotated below) configured to be at least partially received by the housing when the first interface body is detachably coupled to the housing (Fig. 13-16; ¶¶ 066, 0067, 0070), the manifold comprising a first manifold opening (D, Fig. A annotated below) on a first lateral side (E, Fig. A annotated below) of the manifold, and a second manifold opening (F, Fig. A annotated below) on an opposing second lateral side (G, Fig. A annotated below) of the manifold and wherein the positioning of the first and second manifold openings define lateral entry points openings for lateral gas flow into and out of from each of the first interface body and the second interface body (Fig. 15, 16; ¶¶ 0050, 0064, 0066; Examiner notes: Fai discloses that one or both of the first housing openings and the second housing openings can be coupled to a pressure support system.); and wherein the first interface body is configured to form a seal with a user’s face (¶¶ 0064, 0065; Examiner notes: Fai discloses the first interface body sealing to the nasal openings of a user’s face, thus the first interface body seals to the user’s face).
PNG
media_image1.png
539
520
media_image1.png
Greyscale
Figure A, Adapted from Figure 13 of Fai.
Fai does not specifically disclose the patient interface comprising a second interface body; wherein the first interface body and the second interface body are interchangeable, such that the first interface body is coupled to the housing in a first configuration, and the second interface body is coupled to the housing in a second configuration, wherein each of the first interface body and the second interface body comprise a manifold configured to be at least partially received by the housing when the first interface body or the second interface body is detachably coupled to the housing; and wherein each of the first interface body and the second interface body are configured to form a seal with a user's face.
It is noted that the court has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to duplicate the essential working part of the first interface body to achieve the recited second interface body. As evidenced by Guney which discloses a first interface body (2520; Fig. 5-23-1) and a duplicate second interface body (2520; Fig. 5-23-2) wherein the first interface body and the second interface body are interchangeable (¶¶ 0301-0303), such that the first interface body is coupled to the housing in a first configuration, and the second interface body is coupled to the housing in a second configuration (¶¶ 0301-0303; Fig. 5-23-1 and 5-23-2), wherein each of the first interface body and the second interface body comprise a manifold (2522; Fig. 5-23-1, 5-23-1) configured to be at least partially received by the housing when the first interface body or the second interface body is detachably coupled to a housing (23; Fig. 2-1, 2-2; ¶ 0222) and wherein each of the first interface body and the second interface body are configured to form a seal with a user's face (¶¶ 0221-0222, 0064-0065; Examiner notes: Guney discloses the first interface body and the second interface body sealing to the nasal openings of a user’s face, thus the first interface body and the second interface body seals to the user’s face) for the purpose provide a trampoline or bounce effect that can differ between the first and second interface body (¶¶ 0301, 0302).
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 interface assembly of Fai to duplicate the essential working part of the first interface body to achieve the recited second interface body because mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success (See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8), such that the first interface body and the second interface body are interchangeable, and the first interface body is coupled to the housing in a first configuration, and the second interface body is coupled to the housing in a second configuration, wherein each of the first interface body and the second interface body comprise a manifold configured to be at least partially received by the housing when the first interface body or the second interface body is detachably coupled to the housing and wherein each of the first interface body and the second interface body are configured to form a seal with a user's face, as taught by Guney for the purpose provide a trampoline or bounce effect that can differ between the first and second interface body (See Guney: ¶¶ 0301, 0302).
Regarding Claim 162, the modified device of Fai discloses the patient interface assembly wherein the
Regarding Claim 164, the modified device of Fai discloses the patient interface assembly wherein the first and second manifold openings are configured to couple to the first and second openings, when the first interface body or the second interface body is detachably coupled to the housing (See Fai: Fig. 15, 16; ¶¶ 0050, 0064, 0066, See Guney: 0222, 0301-0303).
Regarding Claim 165, the modified device of Fai discloses the patient interface assembly wherein the first and second housing openings are at lateral entry points on opposite ends of the housing (See Fai: Fig. 11-16; ¶¶ 0064-0067).
Regarding Claim 166, the modified device of Fai discloses the patient interface assembly wherein one interface tube comprises an inspiratory conduit (See Fai: 12; Fig. 26; ¶¶ 0050, 0064).
Regarding Claim 169, the modified device of Fai discloses the patient interface assembly wherein the first interface body is a cannula body (See Fai: 204; Fig. 11-15, See Guney: 2524; Fig. 5-23-1, 5-23-2).
Regarding Claim 172, the modified device of Fai discloses the patient interface assembly wherein an upper edge (A, Fig. B annotated below) of the housing is symmetrical with respect to a lower edge (B, Fig. B annotated below) of the housing (symmetrical about C, Fig. B annotated below).
PNG
media_image2.png
489
429
media_image2.png
Greyscale
Figure B, Adapted from Figure 14 of Fai.
Regarding Claim 177, the modified device of Fai discloses the patient interface assembly further comprising a securement member (See Fai: 240; Fig. 11-16; ¶¶ 0068-0070) configured to be attached to the housing (See Fai: Fig. 11-16; ¶¶ 0068-0070).
Regarding Claim 178, the modified device of Fai discloses the patient interface assembly wherein the manifold comprises a ridge (A and B, Fig. C annotated below) at each of the first and second manifold
PNG
media_image3.png
528
776
media_image3.png
Greyscale
Figure C, Adapted from Figure 15 of Fai.
Regarding Claim 179, the modified device of Fai discloses the patient interface assembly wherein the ridge is an annular ridge (at A and B, Fig. C annotated above).
Regarding Claim 180, the modified device of Fai discloses the patient interface assembly wherein the manifold comprises a visual indicator (See Fai: 247; Fig. 13) for indicating correct positioning and proper alignment with the housing when the first interface body or second interface body is detachably coupled to the housing (See Chou: Fig. 13, 14; ¶ 0070; Examiner notes: Fai discloses the housing visible when correctly positioned and proper aligned with the housing when protrusion 246 is seated in element 247.).
Claim(s) 173-176 are rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Guney as applied to claim 161 above, and further in view of Gunaratnam et al. (U.S. Pub. No. 2004/0226566; herein after: “Gunaratnam”).
Regarding Claim 173, the modified device of Fai discloses the patient interface assembly, shown above.
The modified device of Fai does not specifically disclose the patient interface assembly wherein the manifold comprises a housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing.
Gunaratnam teaches a patient interface assembly (Fig. 59-85) comprising a first interface (518; Fig. 59-62) having a manifold (536, 548; Fig. 61); wherein the manifold comprises a housing coupling portion (536; Fig. 61) configured to be received within a housing (516; Fig. 59-65) when the first interface body is detachably coupled to the housing [¶¶ 0288-0302; Examiner notes: Gunaratnam discloses the housing coupling portion received within channels (565, 567; Fig. 61).] for the purpose of ensuring proper alignment and flush assembly (Fig. 62-63; ¶¶ 0290, 0297).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify patient interface assembly of the modified device of Fai to include the manifold comprising the housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing as taught by Gunaratnam for the purpose of ensuring proper alignment and flush assembly (See Gunaratnam: Fig. 62-63; ¶¶ 0290, 0297).
Regarding Claim 174, the modified device of Fai discloses the patient interface assembly wherein the manifold further comprises a raised portion (See Gunaratnam: 534; Fig. 0297) adjacent the housing coupling portion, wherein the raised portion is configured to inhibit rotation of the manifold about the housing when the first interface body or the second interface body is detachably coupled to the housing (See Gunaratnam: ¶¶0297, 0298).
Regarding Claim 175, the modified device of Fai discloses the patient interface assembly wherein the housing coupling portion and the manifold are shaped and/or sized to be inserted in and received by the housing and form a gas tight seal with the housing (See Gunaratnam: ¶¶ 0288-0302).
Regarding Claim 176, the modified device of Fai discloses the patient interface assembly, shown above.
The modified device of Fai does not specifically disclose the patient interface assembly wherein the housing coupling portion comprises a trapezoidal shape.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the housing coupling portion to have a trapezoidal shape in the modified device of Fai because Applicant has not disclosed that forming the housing coupling portion to have a trapezoidal shape provides an advantage, is used for a particular purpose, or solves a stated problem. (See instant Specification: ¶¶ 0434, 0435). One of ordinary skill in the art, furthermore, would have expected the shape of the housing coupling portion of the modified device of Fai, and Applicant’s trapezoidal shaped housing coupling portion, to perform equally well because both mechanisms perform the same function of coupling the manifold to the housing.
Therefore, it would have been prima facie obvious to modify the modified device of Fai to obtain the invention as specified in claim 176 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired coupling of the manifold to the housing and thus fails to patentably distinguish over the prior art of the modified device of Fai.
Response to Arguments
Applicant's arguments filed February 27, 2026 have been fully considered but they are not persuasive. Applicant asserts the inclusion of previously indicated allowable limitations in to independent claim 161 places the application in condition for allowance, Pg. 5.
Examiner respectfully disagrees. In Examiner-Initiated Interview Summary of December 2, 2025 the Examiner indicated that amending the claims to include “the first interface body comprises a nasal cannula and wherein the second interface body comprises a nasal mask” would put the application in condition for allowance. However, Applicant’s representative did not agree to the amendments and the Final Office Action was sent.
Further, in the Final Office Action filed December 2, 2025 the Examiner indicated that the limitations “wherein the second interface body is a nasal mask body comprising a manifold configured to be at least partially received by the housing when the second interface body is detachably coupled to the housing and the manifold comprising a first manifold opening on a first lateral side of the manifold, and a second manifold opening on an opposing second lateral side of the manifold and wherein the positioning of the first and second manifold openings define lateral entry points openings for lateral gas flow into and out of from the second interface body” would put the application in condition for allowance.
Neither of these limitations were included in the submitted claims. Therefore, the application is not in condition for allowance. Examiner suggest including the previously indicated limitations, above, to place the application in condition for allowance.
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