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
Acknowledgment is made of applicant’s claim for priority to foreign document AU2020902667 filed on the July 30, 2020.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “third tube portion comprises a connecting position configured to fit into a second aperture in the first tube portion” in claim 13; the “wherein the nasal portion comprises a lip superior portion which contacts the lip superior of the patient in use.” in claim 62; “wherein the nasal portion comprises a superior-facing medial portion which contacts the inferior and partially anterior surfaces of the patient's pronasale in use” in claim 63; “wherein the oral portion comprises a lip inferior portion which contacts the chin region of the patient in use.” in claim 64; and “wherein the oral portion comprises an oral hole peripheral portion which contacts the cheeks of the patient in use.” in claim 65 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“This application is the U.S. national phase of International Application No. PCT/AU2021/050825 filed July 29, 2021 which designated the U.S. and claims priority to AU Provisional Patent Application No. 2020902667 filed July 30, 2020, the entire contents of each of which are hereby incorporated by reference.”
Examiner suggest replacing this paragraph with “This application is the U.S. national phase of International Application No. PCT/AU2021/050825 filed July 29, 2021 which designated the U.S. and claims priority to AU Provisional Patent Application No. 2020902667 filed July 30, 2020.”
Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot be added after an application’s filing date. Since a 371 application’s filing date is the date the PCT was filed, an amendment in the 371 application to add an incorporation by reference is not effective and improper as new matter.
Appropriate correction is required.
Claim Objections
Claims 2-10, 12-14, 17-23, 25-26, and 28 and 57-65 objected to because of the following informalities:
Regarding Claims 2-10, 12-14, 17-23, 25-26, and 28, a comma should come after “The connection member of claim _” .
Regarding Claims 57-65, a comma should come after “The patient interface assembly of claim _”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13 and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 13 recites the limitation "a connecting portion" in line 2. There is insufficient antecedent basis for this limitation in the claim
Regarding Claim 13 recites the limitation "a second aperture" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "when dependent on claim 6" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of this Office Action, Examiner is interpreting that Claim 27 is dependent off of Claim 26. It is indefinite which claim 27 is supposed to be depended on. The claim limitation stated the “connection member of claim 26, when dependent off of 6”; however, claim 26 is only dependent off of claim 1. They is also an insufficient antecedent basis for the limitation of “the hingedly mounted flap”. Same issues for claim 28, there is also insufficient antecedent basis for the limitation of “the hingedly mounted flap”. For the purpose of the Office Action, the Examiner is examining Claim 27 as it depending on Claim 6 instead of 26.
Claim Interpretation
Regarding the limitation in claim 13, "wherein the third tube portion comprises a connecting portion configured to fit into a second aperture in the first tube portion", the examiner is interpretating that the connection portion is on the third tube portion and the aperture is on the first tube portion opposite of claim 12. For the purpose of this Office Action, Claim 13 is read on as it is depended off of Claim 11.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 56, and 62-65 and its dependencies rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 positively recites “a vent for venting gas exhaled by the patient to the ambient air,” in line 18. It is suggested that the language be amended to read --…a vent adapted to vent gas exhaled by the patient to the ambient air,..—to overcome the rejection.
Claim 56 positively recites “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,” in lines 10-11. It is suggested that the language be amended to read --… said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is configured to be delivered to at least an entrance to the patient's nares..—to overcome the rejection.
Claim 62 positively recites “wherein the nasal portion comprises a lip superior portion which contacts the lip superior of the patient in use.,” in line 2. It is suggested that the language be amended to read --… wherein the nasal portion comprises a lip superior portion which is configured to contact the lip superior of the patient in use...—to overcome the rejection.
Claim 63 positively recites “wherein the nasal portion comprises a superior-facing medial portion which contacts the inferior and partially anterior surfaces of the patient's pronasale in use,” in lines 2-3. It is suggested that the language be amended to read --… wherein the nasal portion comprises a superior-facing medial portion which is configured to contact the inferior and partially anterior surfaces of the patient's pronasale in use...—to overcome the rejection.
Claim 64 positively recites “wherein the oral portion comprises a lip inferior portion which contacts the chin region of the patient in use,” in lines 2-3. It is suggested that the language be amended to read --… wherein the oral portion comprises a lip inferior portion which is configured to contact the chin region of the patient in use..—to overcome the rejection.
Claim 65 positively recites “wherein the oral portion comprises an oral hole peripheral portion which contacts the cheeks of the patient in use,” in lines 2-3. It is suggested that the language be amended to read --… wherein the oral portion comprises an oral hole peripheral portion which is configured to contact the cheeks of the patient in use....—to overcome the rejection.
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) 1-6, 10-11, and 26-28 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 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) for venting gas exhaled by the patient to the ambient air, the vent formed between the first tube portion and the second 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).
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Zhou is silent on at least a portion of the patient-proximal end of the second tube portion positioned inside at least a portion of the patient-distal end of the first 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 tube portion positioned inside at least a portion of the patient-distal end of the first 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, Meffred teaches at least a portion of the patient-proximal end of the second tube portion (Fig. 2; 12, 20) positioned inside at least a portion of the patient-distal end of the first 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 tube portion positioned inside at least a portion of the patient-distal end of the first 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 tube portion (32, 36) 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 tube portion (32, 36).
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 tube portion (32).
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 6, Modified Zhou discloses the connection member of claim 5, wherein the flap (361) is mounted to the first tube portion (32, 36).
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 tube portion to an outer surface of the first tube portion.
However, Mefferd teaches a tube connector (Fig. 2; 16) configured to connect the second tube portion (Fig. 2; 12, 30) to an outer surface of the first 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 tube portion to an outer surface of the first 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 tube portion (16) mounted (examiner notes: when connected) to an outer surface of the second tube portion (Fig. 2; 12, 30; Mefferd/Fig. 28-29; 31; Zhou), wherein the third tube portion surrounds the patient-distal end of the first 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 tube portion (Annotated Fig. A above; C) thereby preventing flow of gas between the first tube portion(Fig. 2; 14, 32; Mefferd/Fig. 28-29; 32, 36; Zhou) and the second 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 27, Modified Zhou discloses the connection member of claim 6 (see objection above), wherein in the second position the hingedly mounted flap (361) contacts the patient-proximal end of the second tube portion (Fig. 2; 12, 30; Mefferd/Fig. 28-29; 31; Zhou Examiner notes: flap contacts it indirectly).
Regarding Claim 28, Modified Zhou discloses the connection member of claim 27, wherein the patient-proximal end of the second 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 hingedly mounted flap (361; Zhou) contacts the patient-proximal end of the second tube portion(Annotated Fig. A above; C), the hingedly mounted flap is oriented at substantially the second tube angle to the second longitudinal central axis, the second tube angle being substantially non- perpendicular (Fig. 28-29; Zhou).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view Mefferd, as applied to claim 6, in further view of Lubke et al. (US 20120145158 A1), hereafter as Lubke.
Regarding Claim 7, Modified Zhou discloses the connection member of claim 6, wherein the flap (361) comprises a base portion (at the end of 361), configured to fit into a first aperture in the first tube portion (32; Examiner notes: the limitation is functional, the flap fits into the hole of the tube; Fig. 29).
Modified Zhou does not specifically teach the flap comprises a base portion to fit into a first aperture in the first tube portion.
However, Lubke teaches teach the flap (Fig. 131-134; 1063) comprises a base portion (Fig. 131-134; 1095) to fit into a first aperture (Fig. 131-134; 1097) in the tube portion (Fig. 131-134; 1033) via snap-fit connection (para. 0305-0306).
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 flap connection to the first tube portion of Modified Zhou to include the flap comprises a base portion to fit into a first aperture in the first tube portion as taught by Lubke for the purpose of preventing incorrect assembly of the AAV (para. 0307).
Regarding Claim 8, Modified Zhou discloses the connection member of claim 7, wherein the base portion (Fig. 131-134; 1095; Lubke) is configured to fit into the first aperture (Fig. 131-134; 1097; Lubke) via a snap-fit connection (Examiner notes: this limitation is functional; para. 0305-0307; Lubke).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view Mefferd, as applied to claim 11, in further view of Maurer et al. (WO 2020065581 A1), hereafter as Maurer.
Regarding Claim 12, Modified Zhou discloses the connection member of claim 11, wherein the first tube portion (Fig. 2; 14, 32; Mefferd/Fig. 28-29; 32, 36; Zhou) and the third tube portion (Fig. 2; 16; Mefferd).
Modified Zhou does not disclose specifically that the first tube portion comprises a connecting portion configured to fit into a second aperture of third tube portion.
However, Maurer teaches that the portion (Fig. 64; 5140) comprises a connecting portion (Fig. 64; 5142) configured to fit into a aperture (Fig. 64; 5144) of portion (Fig. 64; 5130; para. 0389, 0391; this limitation is functional).
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 first and third tube portion connection pieces of Modified Zhou to include a connecting portion configured to fit into a aperture as taught by Maurer for the purpose of to effectively locking in the operative position (para. 0391).
Regarding Claim 13, Modified Zhou discloses the connection member of claim 11 (see rejection above),
Modified Zhou does not specifically disclose wherein the third tube portion comprises a connecting portion configured to fit into a second aperture in the first tube portion.
However, Maurer teaches that the portion (Fig. 64; 5140) comprises a connecting portion (Fig. 64; 5142) configured to fit into a aperture (Fig. 64; 5144) of portion (Fig. 64; 5130; para. 0389, 0391; this limitation is functional).
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 first and third tube portion connection pieces of Modified to include a connecting portion configured to fit into a aperture as taught by Maurer for the purpose of to effectively locking in the operative position (para. 0391).
Regarding Claim 14, Modified Zhou discloses the connection member of claim 12, wherein the connecting portion (Fig. 64; 5142; Maurer) fits into the second aperture (Fig. 64; 5144; Maurer) via a snap-fit connection (para. 0391; Maurer).
Claim(s) 1, 9-10, 15-16, 18-25, 55—56, and 59-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana et al. (WO 2017049358 A1), hereafter as Dantanarayana in view of Lubke.
Regarding Claim 1, Dantanarayana discloses a connection member (Figs. 15A-15F) configured to connect an air circuit to a patient interface 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; para. 0412-0419), the connection member comprising a housing comprising:
a first tube portion (Fig. 15D; 9200 to 9120) having a patient-proximal end (closer to 9210) configured to connect to the patient interface (para. 0412-0419) and having a patient-distal end (9120), the first tube portion having a first longitudinal central axis that is substantially straight between the patient-proximal end and the patient-distal end (Figs. 15A-15F);
a second tube portion (Fig. 15D; 9110) having a patient-proximal end (closest to 9120) and a patient-distal end (end of 9110; 9115) configured to connect to the air circuit (para. 0419; not shown), the second tube portion having a second longitudinal central axis that is substantially straight between the patient-proximal end and the patient-distal end (Figs. 15A-15F),
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 (Figs. 15A-15F) and at least a portion of the patient-proximal end of the second tube portion positioned inside at least a portion of the patient-distal end of the first tube portion (shown best in Fig. 15A, C, or D; 9110 is within 9130),
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 (para. 0413);a vent (9130)and vents (9130) for venting gas exhaled by the patient to the ambient air, the vent formed between the first tube portion and the second tube portion (Fig. 15A); and an anti-asphyxia valve (AAV) (Fig. 15c; 9135) comprising an opening to the ambient air.
Dantanarayana does not specifically disclose a closure configured to move between a first position in which the closure covers the opening and a second position in which the opening is uncovered.
However, Lubke specifically teaches a closure (Fig. 131-134; 1063) configured to move between a first position (1063; para. 0305) in which the closure covers the opening (1093; para. 0305) and a second position in which the opening is uncovered (para. 0303-0307).
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 AAV flap of Dantanarayana to include the closure configured to move between a first position in which the closure covers the opening and a second position in which the opening is uncovered as taught by Lubke for the purpose of easier assembly of AAV and it can be removably attached to the tube portion (para. 0306).
Regarding Claim 9, Modified Dantanarayana discloses the connection member of claim 1, wherein the opening is positioned to face an anterior direction when in use (para. 0416; Fig. 15A; Dantanarayana).
Regarding Claim 10, Modified Dantanarayana discloses the connection member of claim 1, further comprising a tube connector (Fig. 15A; 9123) configured to connect the second tube portion (Fig. 15D; 9110) to an outer surface of the first tube portion (Fig. 15D; 9200 to 9120; Examiner notes: this limitation is functional).
Regarding Claim 15, Modified Dantanarayana discloses the connection member of claim 1, wherein the vent (15A; 9130; Dantanarayana) comprises a plurality of vent slots (Examiner notes: the plurality of holes) arranged in a region between the first tube portion (Fig. 15D; 9200 to 9120; Dantanarayana) and the second tube portion (Fig. 15D; 9110; Dantanarayana).
Regarding Claim 16, Modified Dantanarayana discloses the connection member of claim 15, wherein the plurality of vent slots (9130; 15A) are arranged around the second tube portion (Fig. 15D; 9110; Dantanarayana).
Regarding Claim 18, Modified Dantanarayana discloses the connection member of claim 15, wherein the vent comprises four vent slots (9130; 15A; Dantanarayana).
Regarding Claim 19, Modified Dantanarayana discloses the connection member of claim 15, wherein the plurality of vent slots are equally spaced apart (9130; 15A; Dantanarayana).
Regarding Claim 20, Modified Dantanarayana discloses the connection member of claim 1, wherein a plane of the patient-proximal end of the first tube portion (closer to 9210; Dantanarayana) is arranged at a substantially non-perpendicular angle to the first longitudinal central axis (Figs. 15A-15F; Dantanarayana).
Regarding Claim 21, Modified Dantanarayana discloses the connection member of claim 20, wherein the plane of the patient-proximal end of the first tube portion (closer to 9210; Dantanarayana) is angled with respect to the first longitudinal central axis so that, in use, the connection member is directed in an anterior-inferior direction (Figs. 15A-15F; Dantanarayana).
Regarding Claim 22, Modified Dantanarayana discloses the connection member of claim 1, wherein the first tube portion (Fig. 15D; 9200 to 9120; Dantanarayana) is cylindrical in shape (Figs. 15A-15F).
The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 23, Modified Dantanarayana discloses the connection member of claim 1, wherein the second tube portion (Fig. 15D; 9110; Dantanarayana) is cylindrical in shape (Figs. 15A-15F; Dantanarayana).
The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 24, Modified Dantanarayana discloses the connection member of claim 23, wherein the vent slots (9130; Dantanarayana) are arranged around an annular region (Fig. 15C; Dantanarayana) between the first(Fig. 15D; 9200 to 9120; Dantanarayana) and second tube portions (Fig. 15D; 9110; Dantanarayana).
Regarding Claim 25, Modified Dantanarayana discloses the connection member of claim 1, wherein the first longitudinal central axis and the second longitudinal central axis are axially aligned (Figs. 15A-15F; Dantanarayana).
Regarding Claim 55, Modified Dantanarayana discloses an air circuit assembly configured to fluidly connect a respiratory therapy device (Fig. 4A; 4000; para. 0048-0056; Dantanarayana) to a patient interface (Fig. 3A; 3000; para. 0020-0029), the air circuit assembly comprising an air circuit (para. 0018; 0472; 4170); and a connection member (Fig. 15A-15G; Dantanarayana) of claim 1.
Regarding Claim 56, Modified Dantanarayana discloses a patient interface assembly comprising: a connection member (Fig. 15A-15G; Dantanarayana) of claim 1; and a patient interface (Fig. 3A; 3000; para. 0020-0029), comprising:
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).
Regarding Claim 59, Modified Dantanarayana discloses the patient interface of claim 56, wherein the seal-forming structure (3100) 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 Dantanarayana discloses the patient interface of claim 59, wherein the seal-forming structure (3100) 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).
Regarding Claim 61, Modified Dantanarayana discloses the patient interface of claim 59, wherein the seal-forming structure (3100) comprises an oral portion and a nasal portion airways (para. 0030-0037, 0093-0095, 0097; Dantanarayana).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana and Lubke, as applied to claim 15, in further view of Goldspink et al. (US 20180236200 A1), hereafter as Goldspink.
Regarding Claim 17, Modified Dantanarayana discloses the connection member of claim 15, wherein the vent slots (9130; 15A) are formed between a plurality of ribs (Fig. 15 D; Examiner note; the ribs are shown in 9130)
Modified Dantanarayana does not specifically discloses 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 Dantanarayana 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) 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana and Lubke, as applied to claim 56, in further view of Henry et al. (US 20160296720 A1) , hereafter as Henry.
Regarding Claim 57, Modified Dantanarayana discloses the patient interface assembly of claim 56, plenum chamber (3200).
Modified Dantanarayana 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 Dantanarayana 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).
Regarding Claim 58, Modified Dantanarayana discloses the patient interface of claim 57 wherein the plenum chamber (3200) is formed from silicone (para. 0521; Henry).
Claim(s) 62-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana and Lubke, as applied to claim 61, in further view of Kooij et al. (US 20190022343 A1), hereafter as Kooij.
Regarding Claim 62, Modified Dantanarayana discloses the patient interface of claim 61,
Modified Dantanarayana does not specifically disclose wherein the nasal portion comprises a lip superior portion which contacts the lip superior of the patient in use.
However, Kooji wherein the nasal portion (Fig. 4D; 3170) comprises a lip superior portion which contacts 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 Dantanarayana to include wherein the nasal portion comprises a lip superior portion which contacts 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 Dantanarayana discloses the patient interface of claim 62, wherein the nasal portion (Fig. 4D; 3170; Kooji) comprises a superior-facing medial portion (Fig. 4D) which contacts the inferior and partially anterior surfaces of the patient's pronasale in use (Fig. 4; para. 0143; Kooji).
Regarding Claim 64, Modified Dantanarayana discloses the patient interface of claim 61,
Modified Dantanarayana does not specifically disclose wherein the oral portion comprises a lip inferior portion which contacts the chin region of the patient in use.
However, Kooji teaches wherein the oral portion (Fig. 4D; 3180) comprises a lip inferior portion which contacts the chin region 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 Dantanarayana to include wherein the oral portion comprises a lip inferior portion which contacts the chin region 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 65, Modified Dantanarayana discloses the patient interface of claim 62, wherein the oral portion (Fig. 4D; 3180; Kooji) comprises an oral hole peripheral portion which contacts the cheeks of the patient in use (para. 0143; Fig. 4D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include: Starr et al. (US 5438981 A; Figs. 1-4; AAV), Walker et al. (US 20060076017 A1; Fig. 8), and Mashal et al. (WO 2015193821 A1; Fig. 8).
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/MAAP ELLABIB/Examiner, Art Unit 3785 /KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785