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
This office action is responsive to the amendment filed as May 26, 2026. As directed by the amendment: claims 1-5, 10-11, 15-17 24, 26, 28, 56-57, 59-60, and 62-63 have been amended, claims 6-9, 12-14, 18-23, 25, 27, 29-54, 58, 61, 64-65 have been canceled, and no claims have been added. Thus, claims 1-5, 10-11, 15-17, 24, 26, 28, 55-57, 59-60, and 62-are presently pending in the application.
. Response to Arguments
Applicant argues on page 9-10 of the remarks that the objection made on drawings should be withdrawn. Applicant response is persuasive as claims 13, 64-65 are canceled and the previous drawing objections has been hereby withdrawn.
Applicant argues on page 10 of the remarks that the objection made on specification should be withdrawn. Applicant’s response is persuasive, previous specification objections are hereby withdrawn
Applicant argues on page 11 of the remarks that the objection made on claims should be withdrawn. Applicant’s response is persuasive, previous claim objections are hereby withdrawn
Applicant argues on page 11 of the of the remarks that the 112(b)-rejection made on Claims shown be withdrawn. Applicant’s response is persuasive, previous 112(b)-rejections have been withdrawn.
Applicant argues on page 11 of the of the remarks that the 101-rejection made on Claims shown be withdrawn. Applicant’s response is persuasive, previous 101-rejections have been withdrawn.
Applicant argues on page 11-12 of the remarks that the 103 rejections should be withdrawn. However, Applicant amended the claim to add new limitation from claim 1, “having a patient-proximal end configured to directly connect to the patient interface and having a patient-distal end” and “ the first rigid tube portion and the second rigid tube portion” and “ first tube is arranged at a substantially non-perpendicular angle to the first longitudinal central axis so that, in use, the connection member is directed in an anterior-inferior direction,” that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitation of the claim.
Applicant’s arguments with respect to claim(s) dependent from the independent claim have been considered but are not persuasive.
Claim Objections
Claim 1 objected to because of the following informalities:
Regarding Claim 1, line 7-8, "the patient-proximal end and the patient distal end" should read as "the patient-proximal end of the first rigid tube portion and the patient distal end of the first rigid tube portion" for consistency.
Regarding Claim 1, line 11-12, "the patient-proximal end and the patient distal end" should read as "the patient-proximal end of the second rigid tube portion and the patient distal end of the second rigid tube portion" for consistency.
Appropriate correction is required.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1-5, 10-11, and 26, 28, 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (CN211611179U) in view of Mefferd (US 5269572 A).
Regarding Claim 1, Zhou discloses a connection member (Fig. 28, 29) configured to connect an air circuit (Fig. 28; 50) to a patient interface (Fig. 28; 211, 212) to convey a flow of pressurised breathable gas from the air circuit to the patient interface for breathing by a patient (Examiner notes: this limitation is functional), the connection member comprising a housing comprising:
a first tube portion (32, 36) having a patient-proximal end (Annotated Fig. A below; A) configured to directly connect to the patient interface (212) and having a patient-distal end (Annotated Fig. A below; B), the first tube portion having a first longitudinal central axis that is substantially straight between the patient-proximal end and the patient-distal end (Examiner notes: the axis is “substantially straight”);
a second tube (Fig. 28; 31connected to 50) portion having a patient-proximal end (Annotated Fig. A below; C) and a patient-distal end (Annotated Fig. A below; D) configured to connect to the air circuit (50), the second tube portion having a second longitudinal central axis that is substantially straight between the patient-proximal end and the patient-distal end (Fig. 29; Examiner notes: the axis is “substantially straight”),
wherein the first tube portion and the second tube portion are arranged with the first longitudinal central axis of the first tube portion substantially parallel to the second longitudinal central axis of the second tube portion (Fig. 29; The tubes connected togethers shows ‘substantially’ parallel), the flow of breathable gas being conveyed from the air circuit to the patient interface through the first tube portion and the second tube portion (pg. 6; para. 5; pg. 9; para. 2-5);
a vent (311) configured to vent gas exhaled by the patient to the ambient air, the vent formed between the first tube portion and the second rigid tube portion (Fig. 29; pg. 8 para. 5-7; Examiner notes: The vent holes 311 are in between the first tube and the second tube); and
an anti-asphyxia valve (AAV) (36; 361) comprising an opening to the ambient air (Fig. 28: pg. 8 para. 5) and a closure (361) configured to move between a first position in which the closure covers the opening (Examiner notes: when 361 closes AAV) and a second position in which the opening is uncovered (pg. 8 para. 5; all of pg. ; Examiner notes: when 361 closes the pathway so exhale air goes though the AAV), wherein a plane of the patient-proximal end (dotted line in Fig A below) of the first tube (32, 36) is arranged at a substantially non-perpendicular angle to the first longitudinal central axis (dashed line in Figure A below; Examiner notes) so that, in use, the connection member is directed in an anterior-inferior direction (Fig. 29).
.
PNG
media_image1.png
459
880
media_image1.png
Greyscale
Figure A
Zhou is silent on first and second tubes are rigid and at least a portion of the patient-proximal end of the second rigid tube portion positioned inside at least a portion of the patient-distal end of the first rigid tube portion, but Zhou et al. discloses, possible to prevent the first pipe 31 and the second pipe 32 from being separated unexpectedly and affecting the flow of the medium. (abstract, page 6, para. 5) Examiner note that the connection using method of insertion requires one element to be male type and other element to be female type (Fig. 28, 29, Examiner interprets that in order to properly connect the two pieces of the tube need to be insert into the other) which appears that one of the ordinary skills in the art would have reasonable expectation when performing insertion method for connection between two parts.
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 connection part of Zhou to include the at least a portion of the patient-proximal end of the second rigid tube portion positioned inside at least a portion of the patient-distal end of the first rigid tube portion as taught by the parts can be interchangeable to make the properly connection needed. Modifying Zhou to have the claimed connection parts would not have adverse effects on the performance of the device and thus the changing female and male parts would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
However, Mefferd teaches first and second tubes are rigid (Col. 4 lines 16-21) least a portion of the patient-proximal end of the second rigid tube portion (Fig. 2; 12, 20) positioned inside at least a portion of the patient-distal end of the first rigid tube portion (Fig. 2; 14, 32).
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 how the connection of Zhou to include the at least a portion of the patient-proximal end of the second rigid tube portion positioned inside at least a portion of the patient-distal end of the first rigid tube portion as taught by Mefferd for the purpose of providing a tight secure mating fit (Col. 4 lines 41-44).
Regarding Claim 2, Modified Zhou discloses the connection member (Figs. 28-29) of claim 1, wherein the AAV (36, 361) is located in a position on the connection member closer to the patient-proximal end (Annotated Fig. A above; A) of the first rigid tube portion (32, 36; Zhou and Mefferd) than the vent (311).
Regarding Claim 3, Modified Zhou discloses the connection member (Figs. 28-29) of claim 2, wherein the AAV (36, 361) is located proximate the patient-proximal end (Annotated Fig. A above; A) of the first rigid tube portion (32, 36; Zhou and Mefferd).
Regarding Claim 4, Modified Zhou discloses the connection member (Figs. 28-29) of claim 2, wherein the vent (311) is located proximate the patient-distal end of the first rigid tube portion (32; Zhou and Mefferd).
Regarding Claim 5, Modified Zhou discloses the connection member of claim 1, wherein the closure (361) comprises a hingedly mounted flap (Figs. 29).
Regarding Claim 10, Modified Zhou discloses the connection member of claim 1,
Modified Zhou does not specifically disclose further comprising a tube connector configured to connect the second rigid tube portion to an outer surface of the first rigid tube portion.
However, Mefferd teaches a tube connector (Fig. 2; 16) configured to connect the second rigid tube portion (Fig. 2; 12, 30) to an outer surface of the first rigid tube portion (Fig. 2; 14, 32).
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 connection member of Zhou to include the tube connector configured to connect the second rigid tube portion to an outer surface of the first rigid tube portion as taught by Mefferd to surround the two tubes and hold them together and against axial movement away from one another (Col. 4 lines 5-15).
Regarding Claim 11, Modified Zhou discloses the connection member of claim 10, wherein the tube connector (Fig. 2; 16; Mefferd) comprises a third rigid tube portion (16; Zhou and Mefferd) mounted (examiner notes: when connected) to an outer surface of the second rigid tube portion (Fig. 2; 12, 30; Mefferd/Fig. 28-29; 31; Zhou), wherein the third rigid tube portion surrounds the patient-distal end of the first rigid tube portion (Fig. 2; 14, 32; Mefferd/Fig. 28-29; 32, 36; Zhou).
Regarding Claim 26, Modified Zhou discloses the connection member of claim 1, wherein, when the closure (Fig. 29; 361; Zhou) is in the second position (shown in Fig. 29; Zhou), the closure substantially covers the patient-proximal end of the second rigid tube portion (Annotated Fig. A above; C) thereby preventing flow of gas between the first rigid tube portion(Fig. 2; 14, 32; Mefferd/Fig. 28-29; 32, 36; Zhou) and the second rigid tube portion (Fig. 2; 12, 30; Mefferd/Fig. 28-29; 31; Zhou) during use (pg. 8; para. 4; examiner notes: when the flap is blocking the tube opening; there no meets and bounds for “substantially”).
Regarding Claim 28, Modified Zhou discloses the connection member of claim 26, wherein the patient-proximal end of the second rigid tube portion (Annotated Fig. A above; C) is at a second tube angle to the second longitudinal central axis (Fig. 28-29; Zhou) and, when the closure covers (361; Zhou) the patient-proximal end of the second rigid tube portion(Annotated Fig. A above; C), the closure is oriented at substantially the second rigid tube angle to the second longitudinal central axis, the second rigid tube angle being substantially non- perpendicular (Fig. 28-29; Zhou).
Regarding Claim 55, Modified Zhou discloses an air circuit assembly (Fig. 28; 50; Zhou) configured to fluidly connect a respiratory therapy device (Pg. 9; para. 5; Zhou) to a patient interface (Fig. 29; 211, 212; Pg. 9; para. 5; Zhou), the air circuit assembly comprising an air circuit (Fig. 29; 50); and a connection member (Fig. 28-29; 36, 33, 31) of claim 1.
Claim(s) 15-16, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou and Mefferd, as applied to claim 1, in view of Dantanarayana et al. (WO 2017049358 A1), hereafter as Dantanarayana.
Regarding Claim 15, Modified Zhou discloses the connection member of claim 1,
vents (311).
Modified Zhou does not disclose wherein the vent comprises a plurality of vent slots arranged in a region between the first rigid tube portion and the second rigid tube portion.
However, Dantanarayana teaches wherein the vent (42A-43G; 13404) comprises a plurality of vent slots (Examiner notes: the plurality of holes) arranged in a region between the first rigid tube portion (Fig. 42F; 13402) and the second rigid tube portion (Fig. 42F; 13410).
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 vents of Modified Zhou to include the vent comprises a plurality of vent slots arranged in a region between the first rigid tube portion and the second rigid tube portion as taught by Dantanarayana for the purpose of provide a path from the interior of the vent system to the atmosphere (para. 0316).
Regarding Claim 16, Modified Zhou discloses the connection member of claim 15, wherein the plurality of vent slots (13404; 42A-43G) are arranged around the second tube portion (Fig. 42F; 13410; Dantanarayana).
Regarding Claim 24, Modified Zhou discloses the connection member of claim 16, wherein the vent slots (13404; 42A-43G) are arranged around an annular region (42A) between the first(Fig. 42F; 13402; Dantanarayana) and second rigid tube portions (Fig. 42F; 13410; Dantanarayana).
Regarding Claim 56, Modified Zhou discloses a patient interface assembly comprising: a connection member (Fig. 28-29; Zhou) of claim 1; and a patient interface (Fig. 29; 211, 212), comprising:
Modified Zhou does not disclose specifically a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having a hole therein configured to deliver the flow of air at said therapeutic pressure to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
However, Dantanarayana teaches a plenum chamber (3200) pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (para. 0093-0095, 0097, 0432); and a seal-forming structure (3100) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways (para. 0030-0037, 0093-0095, 0097), said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares (para. 0093), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (para. 0269-0274; Dantanarayana).
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 pad and sealing-forming structure of Modified Zhou to include specifically a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having a hole therein configured to deliver the flow of air at said therapeutic pressure to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use as taught by Dantanarayana for the purpose of adding a cushioning function and shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use and sealing engagement may be sufficient to allow a pressurised flow of air to travel therethrough (para. 0269, 0384)
Regarding Claim 59, Modified Zhou discloses the patient interface of claim 56, wherein the seal-forming structure (3100; Dantanarayana ) is configured to form a seal around both the patient's nose and mouth in use (para. 0020, 0031; Examiner notes: this limitation is functional; Dantanarayana).
Regarding Claim 60, Modified Zhou discloses the patient interface of claim 59, wherein the seal-forming structure (3100; Dantanarayana) is configured to form a seal over the bridge of the patient's nose in use (para. 0020, 0031; Examiner notes: this limitation is functional; Dantanarayana).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou, Mefferd and Dantanarayana, as applied to claim 15, in further view of Goldspink et al. (US 20180236200 A1), hereafter as Goldspink.
Regarding Claim 17, Modified Zhou discloses the connection member of claim 15, wherein the vent slots (13404; Fig. 42A-43G) are formed between a plurality of ribs (shown best in 42A)
Modified Zhou does not specifically disclose vents slots are formed between a plurality of ribs extending between an outer surface of the second tube portion and an inner surface of the first tube portion.
Goldspink teaches vents slots (Fig. 30; 7639) are formed between a plurality of ribs (Fig. 30; 7637) extending between an outer surface (Fig. 30; 7632) of the tube portion and an inner surface of the tube portion (Fig. 30; 7630).
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 vent slots of Modified Zhou to include the formed between a plurality of ribs extending between an outer surface of the second tube portion and an inner surface of the first tube portion as taught by Goldspink for the purpose of permitting the exit of exhausted gases from the patient interface to atmosphere and direct the gases radially outwardly (para. 0181).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou, Mefferd, and Dantanarayana, as applied to claim 56, in further view of Henry et al. (US 20160296720 A1) , hereafter as Henry.
Regarding Claim 57, Modified Zhou discloses the patient interface assembly of claim 56, plenum chamber (3200).
Modified Zhou does not specifically disclose wherein the plenum chamber is formed from a flexible material.
However, Henry teaches wherein the plenum chamber is formed from a flexible material (para. 0521; Examiner notes: the plenum chamber is made from flexible material like silicone).
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 plenum chamber of Modified Zhou to be formed from a flexible material as taught by Henry for the purpose of increased flexibility of the plenum chamber may allow for greater dimensional stability during shipping and transportation because the more flexible plenum chamber is better able to absorb vibration and impact (para. 0566).
Claim(s) 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou, Mefferd, and Dantanarayana, as applied to claim 59, in further view of Kooij et al. (US 20190022343 A1), hereafter as Kooij.
Regarding Claim 62, Modified Zhou discloses the patient interface of claim 61,
Modified Zhou does not specifically disclose wherein the seal-forming structure comprises a lip superior portion which is configured to contact the lip superior of the patient in use.
However, Kooij wherein the seal-forming structure (Fig. 4D; 3170) comprises a lip superior portion which is configured to contact the lip superior of the patient in use (para. 0143).
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 of Modified Zhou to include the seal-forming structure comprises a lip superior portion which is configured to contact the lip superior of the patient in use as taught by Kooji for the purpose of the air or breathable is supplied in use through separate orifices to the patient's nares and the patient's mouth (para. 0143).
Regarding Claim 63, Modified Zhou discloses the patient interface of claim 62, wherein seal-forming structure (Fig. 4D; 3170; Kooji) comprises a superior-facing medial portion (Fig. 4D) which is configured to contact the inferior and partially anterior surfaces of the patient's pronasale in use (Fig. 4; para. 0143; Kooji).
Conclusion
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 MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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.
/MAAP ELLABIB/Examiner, Art Unit 3785 /KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights