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 Application No. (CN202111165590.X) filed on the September 30, 2021.
Claim Objections
Claims 23 and 31 are objected to because of the following informalities:
Regarding Claim 31, line 2 “wherein the frame is provided with a connector, the connector is rotatably connected to the flexible hose.” should read as – wherein the frame is provided with a connector, wherein the connector is rotatably connected to the flexible hose. —
Regarding Claim 23 “face of a user” in line 5-6. It is suggested that the language be amended to read --… the upper part comprises a face contact part configured to be in contact with a face of a user.
Appropriate correction is required.
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.
Claim 35 is 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 35 positively recites in lines 3-5. “wherein the first skeleton arm and the second skeleton arm extend to upsides of ears along cheeks of a.
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.
Claim 3 and 5 is 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.
Claims 3 and 5 recites the limitation "the first exhaust hole" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner is unsure if the Applicant is referring to “the first exhaust holes” in claim 1, or a new second exhaust hole. For the purpose of this Office Action, Examiner is interpreting that it is the same first exhaust holes from claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheiner et al. (US 20150352306 A1), hereafter as Scheiner first embodiment (Fig. 34).
Regarding Claim 12, Scheiner discloses a frame assembly configured for a patient interface device (Fig. 34), comprising:
a frame main body (Fig. 34; 3310) with a first side being connected to an intake tube (Fig. 34; 4180), and a second side being connected to a cushion assembly (Fig. 34; 3100);
a pair of skeleton arms (Fig. 34; 3300, 3305, 3301, 3307) comprising a first skeleton arm (one of 3305) and a second skeleton arm (the other of 3305) disposed oppositely on the frame main body (Best shown in Fig. 39); and
a connecting body (Fig. 34; 3313) configured to connect the cushion assembly to the frame main body (para. 0389), wherein the connecting body and the cushion assembly are sealed to form a closed connection (para. 0444), the connecting body is provided with a boss (examiner notes: part of 3313 along 3211.1) raised from an inner side of the frame main body (Fig. 34), a recess (Fig. 34; 3211.1) for accommodating the cushion assembly is formed between the boss and an inner wall of the frame main body (Fig. 34), and the boss extends into a bottom of the cushion assembly (Fig. 34; .para. 0444-0445).
Regarding Claim 15, Scheiner discloses the frame assembly according to claim 12, wherein the first and second skeleton arms (Fig. 34; 3300, 3305, 3301, 3307) are made of Polypropylene (PP) (para. 0589).
Claim(s) 22-23, and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheiner et al. (US 20150352306 A1), hereafter as Scheiner second embodiment (Fig. 233a-h).
Regarding Claim 22, Scheiner discloses a patient interface device, comprising:
a cushion assembly (Fig. 233a-h; 3100) comprising a nasal cushion (Fig. 233a-h; 3112) configured to be in contact with a face of a patient (Fig. 233a-233h; 1000; para. 390; Examiner notes: this limitation is functional), wherein the nasal cushion is configured to be adaptively fitted around nostrils of the patient in response to the patient interface device being worn by the patient (Fig. 233a-233h; para. 0395), and the nasal cushion is configured to, when being pressed against a basis nasi of the patient due to a pressurized gas to seal (para. 0395), apply no clamping effect on an ala nasi of the patient (para. 0391; there is a gap in between the protruding end 3114); a frame assembly (Fig. 233a-233h; 3310, 3360, 3400) with two sides being connected to the nasal cushion (3310 is connected to 3100 on one side) and a vent tube (3310 is connected to 4180 on the another side), respectively; and a head strap (Fig. 233a-233h; 3315; 3316; 3370) connected to frame (Fig. 233a-233h; 3310), wherein the head strap is configured to be fixed around a head of the patient in response to the patient interface device being worn by the patient (this limitation is functional; best shown in 233g).
Regarding Claim 23, Scheiner discloses the patient interface device according to claim 22, wherein the nasal cushion (Fig. 233a-h; 3112;) comprises an upper part (Fig. 234a; 3116; See “A” in Annotated Figure A below) , a lower part (Fig. 234a; See “B” in Annotated Figure A below) opposite to the upper part, and a circumferential side part (See “C” in Annotated Figure A below0 disposed between the upper part and the lower part (Fig. 234a; Fig A below), and the upper part and the lower part are surrounded by the circumferential side part to form a cavity (Fig. 233a-233h; 3200; plenum chamber is the cavity), the cavity is communicated with the vent tube(Fig. 233a-233h; 4180); the upper part comprises a face contact part (the nasal cushion has face the contacts the users face; best shown in Fig. 233a-233h) to be in contact with a face of a user; wherein the face contact part comprises a middle part (See “D” in Annotated Figure A below) as well as a first side part (See “E” in Annotated Figure A below) and a second side part (See “E” the second E in Annotated Figure A below) located on two sides of the middle part (Fig. 234a; Fig. A below), and the first side part and the second side part are both connected to the circumferential side part (Fig. 234a); and the middle part comprises a nose opening communicated (Fig. 234a; 3104) with the cavity and a periphery sealing part surrounding the nose opening (3104.1-3104.3), and the nose opening is configured to surround lower sides of nostrils of the user in response to the nasal cushion being worn by the user (Fig. 233a-233h), and is adaptively fitted around the nostrils of the user through the periphery sealing part to seal (Fig. 233a-233h).
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Figure A: Adapted Figure. 234a from Scheiner
Regarding Claim 35, Scheiner discloses the patient interface device according to claim 22, further comprising a first skeleton arm (Fig. 233a-233h; 3370) and a second skeleton arm (Fig. 233a-233h; 3371) respectively disposed on two ends of the frame (Fig. 233a-233h), wherein the first skeleton arm and the second skeleton arm extend to upsides of ears along cheeks of a
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
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 and 6 -7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Graham et al. (US 20190030272 A1), hereafter as Graham.
Regarding Claim 1, Graham discloses an exhaust assembly (Fig. 2; 100 or Fig. 21-29C; 410) disposed on a patient interface device (Fig. 1; para. 0146; or Fig. 20; para. 0233-0235), comprising a main body (Fig. 2; 102, 103 or Fig. 21; 410), wherein the main body comprises:
a tapered boss (Fig. 2; 114; or Fig. 21; 430 ), wherein the tapered boss is provided with first exhaust holes (Fig. 2; 127 or Fig. 21; 438) arranged in an array in a circumferential direction of the tapered boss (Fig. 2; or Fig. 21; para. 0173),
wherein the tapered boss comprises an inner wall (Fig. 2; 116 or Fig. 21; 432), an outer wall (Fig. 2; 118 or Fig. 21; 434), and an inclined wall (Examiner notes: the collar is inclined; para.0027; Fig. 2; 135 or Fig. 28-29; para. 0245 ) disposed between the inner wall and the outer wall (Fig. 2 or Fig. 28-29), and the first exhaust holes are disposed on the inclined wall (Fig. 2; 127 are on the collar 114; para. 0137-0153; or Figs. 21-29C para. 0233-0259).
So, with regard to limitations, the first exhaust holes are formed through kiss off of an upper mold and a lower mold, The Examiner considers this as a product by process limitation. The product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. Therefore, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I. Therefore, the Examiner reads that the limitations have been met.
In alternative, to the limitations not seen as product by process, Graham teaches there are exhaust holes that form in tapered inclined boss (Fig. 2). 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 Graham to include the exhaust holes as shown by Graham for purpose of holes of the frame, when located on the angled surface are therefore angled away from the user. As a result, when the frame is in use, the flow of gas through the flow holes is directed away from the user (para. 0172). Therefore, regardless of the process one will come to the same product, the process provides a different product one could chose a process that will be able to produce the same product.
Regarding Claim 6, Modified Graham discloses the exhaust assembly according to claim 1, wherein the first exhaust holes (Fig. 2; 127 or Fig. 21; 438) are in a divergent arrangement (Fig. 2; best shown in Fig. 26D; The holes are facing in different directions making it a divergent arrangement), and each of the first exhaust holes has at most two neighboring first exhaust holes (Fig. 2 or Fig. 28-29C).
Regarding Claim 7, Modified Graham discloses the exhaust assembly according to claim 1, wherein the first exhaust holes (Fig. 2; 127 or Fig. 21; 438) are round holes (Fig. 2 or Fig. 21).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graham, as applied to claim 1, in view of Ng et al. (US 20090050156 A1), hereafter as Ng.
Regarding Claim 3, Graham discloses the exhaust assembly according to claim 1, a thickness of the inclined wall is 0.7mm to 2.0mm (para. 0253; Examiner notes: the inlet collar 430 has a thickness t.sub.ic of 1.46 mm or approximately 1.46 mm).
Graham does not disclose specifically wherein an inner aperture of the first exhaust hole is greater than an outer aperture of the first exhaust hole,
Ng teaches wherein an inner aperture (Fig. 2-21-3; para. 206-0210) of the first exhaust hole (1856) is greater than an outer aperture of the first exhaust hole (Fig. 2-21-3; para. 206-0210).
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 exhaust holes of Graham to include wherein an inner aperture of the first exhaust hole is greater than an outer aperture of the first exhaust hole as taught by Ng for the purpose of a reduce vent noise in use (para. 0208).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graham, as applied to claim 1, in view of Guney et al. (US 20090044808 A1), hereafter as Guney.
Regarding Claim 5, Modified Graham discloses the exhaust assembly according to claim 1,
Modified Graham does not specifically teach wherein the first exhaust hole is in a shape of a long ellipse.
However, Guney teaches wherein the first exhaust hole (7928) is in a shape of a long ellipse (Fig. 18-15-1, 18-15-2).
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 shape of the vent holes of Graham to be a shape of a long ellipse as taught by Guney as it known that these vents can be any suitable hole arrangements, hole numbers, and/or hole shapes (para. 7060).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner first embodiment, as applied to claim 12, in view of Graham.
Regarding Claim 13, Scheiner discloses the frame assembly according to claim 12, wherein the frame main body (Fig. 34; 3310) is provided withtapered boss comprises an inner wall, an outer wall, and an inclined wall disposed between the inner wall and the outer wall (Fig. 36;),
Scheiner does not specifically disclose wherein the tapered boss is provided with first exhaust holes arranged in an array in a circumferential direction of the tapered boss, and the first exhaust holes are formed through kiss off of an upper mold and a lower mold; and the first exhaust holes are disposed on the inclined wall.
However, Graham wherein the tapered boss is provided with first exhaust holes (Fig. 2; 127 or Fig. 21; 438) arranged in an array in a circumferential direction of the tapered boss (Fig. 2; or Fig. 21; para. 0172-0173), and the first exhaust holes are disposed on the inclined wall (Fig. 2; 127 are on the collar 114; para. 0137-0153; or Figs. 21-29C para. 0233-0259).
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 assembly of Scheiner to include the tapered boss is provided with first exhaust holes arranged in an array in a circumferential direction of the tapered boss and the first exhaust holes are disposed on the inclined wall. as taught by Graham for the purpose of the holes being located on the angled surface are therefore angled away from the user. As a result, when the frame is in use, the flow of gas through the bias flow holes is directed away from the user (para. 0172).
Modified Scheiner does not disclose the first exhaust holes are formed through kiss off of an upper mold and a lower mold.
However, Graham further teaches there are exhaust holes that form in an upper and lower mold (Fig. 2). So, with regard to Claim 1 which is a product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. Therefore, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I.
Regarding Claim 14, Modified Scheiner discloses the frame assembly according to claim 13, wherein the exhaust assembly (Fig. 2; 127 or Fig. 21; 438; Graham) and the frame main body (Fig. 34; 3310; Scheiner) are integrally molded (para. 0717; Scheiner).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner second embodiment, as applied to claim 22, in view of Graham.
Regarding Claim 24, Scheiner discloses the patient interface device according to claim 22, further comprising an exhaust assembly (Fig. 233a-233h; 3400) comprising a main body, wherein the main body comprises: a tapered boss (Fig. 233a-233h; 3600), wherein the tapered boss comprises an inner wall, an outer wall, and an inclined wall disposed between the inner wall and the outer wall (Fig. 233a-233h)
Scheiner does not specifically disclose wherein the tapered boss is provided with first exhaust holes arranged in an array in a circumferential direction of the tapered boss, and the first exhaust holes are formed through kiss off of an upper mold and a lower mold; and the first exhaust holes are disposed on the inclined wall.
However, Graham wherein the tapered boss is provided with first exhaust holes (Fig. 2; 127 or Fig. 21; 438) arranged in an array in a circumferential direction of the tapered boss (Fig. 2; or Fig. 21; para. 0172-0173), and the first exhaust holes are disposed on the inclined wall (Fig. 2; 127 are on the collar 114; para. 0137-0153; or Figs. 21-29C para. 0233-0259).
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 assembly of Scheiner to include the wherein the tapered boss is provided with first exhaust holes arranged in an array in a circumferential direction of the tapered boss and the first exhaust holes are disposed on the inclined wall. as taught by Graham for the purpose of the holes being located on the angled surface are therefore angled away from the user. As a result, when the frame is in use, the flow of gas through the bias flow holes is directed away from the user (para. 0172).
Modified Scheiner does not disclose the first exhaust holes are formed through kiss off of an upper mold and a lower mold.
However, Graham further teaches there are exhaust holes that form in an upper and lower mold (Fig. 2). So, with regard to Claim 1 which is a product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. Therefore, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I.
Claim(s) 25-26, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner second embodiment, as applied to claim 22 and 23, in view of Scheiner first embodiment.
Regarding Claim 25, Scheiner discloses the patient interface device according to claim 22, wherein the frame assembly (Fig. 233a-233h; 3310, 3360, 3400) comprises: a frame main body (Fig. 233a-233h; 3310) with a first side being connected to an intake tube (Fig. 233a-233h;4810), and a second side being connected to the cushion assembly (Fig. 233a-233h; 3122); a pair of skeleton arms (Fig. 233a-233h; 3370, 3371) comprising a first skeleton arm (3370) and a second skeleton arm (3371) disposed oppositely on the frame main body (Fig. 233b);
Scheiner this embodiment does not specifically teach a connecting body configured to connect the cushion assembly to the frame main body, wherein the connecting body and the cushion assembly are sealed to form a closed connection, the connecting body is provided with a boss raised from an inner side of the frame main body, a recess for accommodating the cushion assembly is formed between the boss and an inner wall of the frame main body, and the boss extends into a bottom of the cushion assembly.
However, Scheiner (Fig. 34) teaches a connecting body (Fig. 34; 3313) configured to connect the cushion assembly to the frame main body (para. 0389), wherein the connecting body and the cushion assembly are sealed to form a closed connection (para. 0444), the connecting body is provided with a boss (examiner notes: part of 3313 along 3211.1) raised from an inner side of the frame main body (Fig. 34), a recess (Fig. 34; 3211.1) for accommodating the cushion assembly is formed between the boss and an inner wall of the frame main body (Fig. 34), and the boss extends into a bottom of the cushion assembly (Fig. 34; para. 0444-0445).
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 frame and cushion assembly of Scheiner first embodiment to include the a connecting body configured to connect the cushion assembly to the frame main body, wherein the connecting body and the cushion assembly are sealed to form a closed connection, the connecting body is provided with a boss raised from an inner side of the frame main body, a recess for accommodating the cushion assembly is formed between the boss and an inner wall of the frame main body, and the boss extends into a bottom of the cushion assembly as taught by Scheiner first embodiment for the purpose of snap-in compression-fit member to provide a high retention force (to prevent accidental disengagement) and also enable relatively easy intentional removal (para. 0445).
Regarding Claim 26, Modified Scheiner discloses the patient interface device according to claim 25, wherein the frame assembly (Fig. 233a-233h; 3310, 3360, 3400, 3600) comprises the frame main body (Fig. 233a-233h; 3310) and a tapered boss (Fig. 233a-233h; 3600) disposed on an outer side of the frame main body (Fig. 233a-233h), the tapered boss is provided with a connecting aperture (Fig. 233a-233h; 3600; para. 0422) passing through the tapered boss and the frame main body (the connecting aperture goes into the opening of the nasal cushion), and two ends of the connecting aperture are connected to the nasal cushion (Fig. 233a-233h; 3122) and the vent tube (Fig. 233a-233h; 4180) in a sealing way, respectively (para. 0390—0392).
Regarding Claim 33, Scheiner discloses the patient interface device according to claim 23,
Scheiner does not disclose specifically wherein a connecting body is provided on an inner side of the frame, and the nasal cushion is connected to the frame in a sealing way through the connecting body; a base is provided on a lower side of the nasal cushion, and a bottom opening is provided on the base; and the connecting body is configured as a boss raised from the inner side of the frame, a recess is formed between the boss and an inner wall of the frame, the base of the nasal cushion is disposed in the recess, and the boss extends into the bottom opening.
However, Scheiner (Fig. 30; 34) teaches a connecting body (Fig. 34; 3313) is provided on an inner side of the frame (Fig. 34; 3211.1; para. 0389), and the nasal cushion (Fig. 34; 3100) is connected to the frame in a sealing way through the connecting body (para. 0444), a base is provided on a lower side of the nasal cushion (Fig. 30; 3101, 3310), and a bottom opening is provided on the base (there is bottom opening of 3313, 3310); and the connecting body is configured as a boss (examiner notes: part of 3313 along 3211.1) raised from the inner side of the frame(Fig. 34), a recess (Fig. 34; 3211.1) is formed between the boss and an inner wall of the frame, the base of the nasal cushion is disposed in the recess, and the boss extends into the bottom opening Fig. 34; para. 0444-0445).
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 frame and cushion assembly of Scheiner first embodiment to include wherein a connecting body is provided on an inner side of the frame, and the nasal cushion is connected to the frame in a sealing way through the connecting body; a base is provided on a lower side of the nasal cushion, and a bottom opening is provided on the base; and the connecting body is configured as a boss raised from the inner side of the frame, a recess is formed between the boss and an inner wall of the frame, the base of the nasal cushion is disposed in the recess, and the boss extends into the bottom opening as taught by Scheiner first embodiment for the purpose of snap-in compression-fit member to provide a high retention force (to prevent accidental disengagement) and also enable relatively easy intentional removal (para. 0445).
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner second and first embodiments, as applied to claim 26, in view of Galgali et al. (US 20180256844 A1), hereafter as Galgali.
Regarding Claim 27, Modified Scheiner discloses the patient interface device according to claim 26, wherein the frame assembly (Fig. 233a-233h; 3310, 3360, 3400, 3600) comprises the frame main body (Fig. 233a-233h; 3310).
Modified Scheiner does not specifically disclose an elbow rotatably connected to the frame main body, and the elbow is connected to the vent tube in a sealing way.
However, Galgali teaches an elbow (Fig. 2; 122) rotatably connected to the frame main body (Fig. 2; 144), and the elbow is connected to the vent tube (Fig. 2; 120) in a sealing way (para. 0311-0313).
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 tube and the frame is connected in Modified Scheiner to include the an elbow rotatably connected to the frame main body, and the elbow is connected to the vent tube in a sealing way as taught by Galgali for the purpose of elbow can swivel about one or more swivel axes relative to the mask so that the path of the conduit relative to the positioning of the mask on the face of the user can adapt to the sleeping position of the user (para. 0311).
Regarding Claim 28, Modified Scheiner discloses the patient interface device according to claim 26,
Modified Scheiner does not specifically disclose wherein the frame assembly is directly connected to an elbow, the elbow is connected to an air delivery tube configured to be connected to a pressure device; and an inner diameter of the air delivery tube is 15 mm to 22 mm.
However, Galgali teaches wherein the frame assembly (Fig. 2; 144) is directly connected to an elbow (Fig. 2; 122), the elbow is connected to an air delivery tube (Fig. 2; 124) configured to be connected to a pressure device (Fig. 1; 27; para. 0311-0313); and an inner diameter of the air delivery tube is 15 mm to 22 mm (Fig. 25; para. 0277).
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 tube and the frame is connected in Modified Scheiner to include the frame assembly is directly connected to an elbow, the elbow is connected to an air delivery tube configured to be connected to a pressure device; and an inner diameter of the air delivery tube is 15 mm to 22 mm as taught by Galgali for the purpose of elbow can swivel about one or more swivel axes relative to the mask so that the path of the conduit relative to the positioning of the mask on the face of the user can adapt to the sleeping position of the user (para. 0311); also, that internal diameters (or cross-sectional areas) of swivels, elbows and/or other parts of the flow path can be increased or maximized, or made as close to the internal diameter (or cross sectional area) of the air supply (CPAP) hose as possible or practical. Such an arrangement will keep the flow velocity and, hence, turbulence to a minimum resulting in the creation of less noise (para. 0390).
Claim(s) 29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner second and first embodiments, as applied to claim 26, in view of Galgali and Kooij et al. (US 20190022343 A1), hereafter as Kooij.
Regarding Claim 29, Modified Scheiner discloses the patient interface device according to claim 26, wherein the frame assembly (Fig. 233a-233h; 3310, 3360, 3400, 3600) is directly connected to a flexible hose (Fig. 233a-233h; 4180),
Modified Scheiner does not specifically disclose the flexible hose is connected to an air delivery tube configured to be connected to a pressure device; and an inner diameter of the flexible hose is 12 mm to 15 mm, and the inner diameter of the air delivery tube is 15 mm to 22 mm wherein the flexible hose is an elastic tube.
However, Galgali teaches the flexible hose is connected to an air delivery tube(Fig. 2; 124) configured to be connected to a pressure device(Fig. 1; 27; para. 0311-0313); and an inner diameter of the flexible hose is 12 mm to 15 mm (Fig. 25), and the inner diameter of the air delivery tube is 15 mm to 22 mm (Fig. 25).
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 tube and delivery device is connected in Modified Scheiner to include the flexible hose is connected to an air delivery tube configured to be connected to a pressure device; and an inner diameter of the flexible hose is 12 mm to 15 mm, and the inner diameter of the air delivery tube is 15 mm to 22 mm as taught by Galgali for the purpose of the tube being flexible and the user can adapt to the sleeping position of the user (para. 0311); also, that internal diameters (or cross-sectional areas) of swivels, elbows and/or other parts of the flow path can be increased or maximized, or made as close to the internal diameter (or cross sectional area) of the air supply (CPAP) hose as possible or practical. Such an arrangement will keep the flow velocity and, hence, turbulence to a minimum resulting in the creation of less noise (para. 0390).
Modified Scheiner does not specifically disclose wherein the flexible hose is an elastic tube.
However, Kooij teaches flexible hose is an elastic tube (claim 101; para. 0333).
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 tube of Modified Scheiner to be an elastic tube as taught by Kooij for the purpose of the tube can have the tendency to return to its non-stretched state (para. 0333).
Regarding Claim 31, Modified Scheiner discloses the patient interface device according to claim 29, wherein the frame (Fig. 233a-233h; 3310) is provided with a connector (3600),.
Modified Scheiner does not disclose the connector is rotatably connected to the flexible hose.
However, Galgali teaches a connector (Fig. 2; 122) rotatably connected to the frame main body (Fig. 2; 144), and the connector is connected to the flexible tube (Fig. 2; 120)(para. 0311-0313).
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 frame of Modified Scheiner to include have a connector that is connected to the flexible hose as taught by Galgali for the purpose of the purpose of the tube being flexible and the user can adapt to the sleeping position of the user (para. 0311).
Conclusion
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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