DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 24, 2026 has been entered.
Status of Claims
This Office Action is responsive to the amendment filed on June 24, 2026. As directed by the amendment: claims 1, 11, 21, and 31 have been amended. Thus, claims 1, 3-11, 13-16, 18, 20-21, 23-27, 29, 31-32, and 34 are presently pending in this application, claims 11, 13-16, 18, 20-21, 23-27, 29, and 34 being withdrawn from consideration.
Applicant’s amendments to claim 31 obviate the previous objection made thereto. Claim(s) 1, 3-9, and 31-32 were previously rejected under 35 U.S.C. 103 as being unpatentable over Mah et al. (U.S. Pub. No. 2016/0256655) in view of Hartono et al. (U.S. Pub. No. 2022/0134039) in view of Forrester (U.S. Pub. No. 2014/0130931) in view of Cullen et al (U.S. Pub. No. 2015/0352308). Claim 10 was previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Farrow et al. (U.S. Pub. No. 2021/0228830).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Election/Restrictions
This application was previously subject to a restriction in the Requirement for Restriction filed February 1, 2024 because this application contains claims directed to the following patentably distinct species
Species A – Fig. 1 and 3-6 (claims 1-10) wherein the frame assembly further includes an exhaust channel located on the frame classified in A61M16/06.
Species B – Fig. 6-8 (claims 11-20) wherein the frame assembly further including: an exhaust channel located on the first end of the gas delivery hose classified in A61M16/0816.
Species C – Fig. 9A-10 (claims 21-30, 34) wherein the exhaust channel and exhaust connector are a separate element that is connected between the frame assembly and the hose A61M16/208.
Applicant's election with traverse of Species A Fig. 1 and 3-6 (claims 1-10) in the reply filed on March 26, 2024 was acknowledged and responded to in the Non-Final Office action filed April 11, 2024 and made FINAL.
Information Disclosure Statement
Acknowledgement is made to Applicant's lack of an Information Disclosure Statement submission.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-9, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Mah et al. (U.S. Pub. No. 2016/0256655; hereinafter: “Mah”) in view of Hartono et al. (U.S. Pub. No. 2022/0134039; hereinafter: “Hartono”) in view of Forrester (U.S. Pub. No. 2014/0130931) in view of Cullen et al (U.S. Pub. No. 2015/0352308; hereinafter: “Cullen”).
Regarding Claim 1, Mah discloses a frame assembly comprising: a frame (3310; Fig. 10, 11, 16, 18, 19, 30-37, 39, 40, 42-44, 47-56, 71-77, 84-107) for securing a nasal pillow (3100, 3200; Fig. 4, 5, 7-16, 18, 19, 34, 35, 71-77, 84-107; ¶¶ 0229-0233, 0239, 0240, 0250-0272), a gas delivery hose (4170, 4178, 4180; Fig. 1a-1c, 18, 71-77, 84-100) directly connected to the frame for delivering breathable gas to the nasal pillow (Fig. 1a-1c, 71-77, 84-100; ¶¶ 0229, 0240, 0327, 0476, 0487-0490, 0494), and side connectors (3300; Fig. 30-34, 65-73) for securing the frame to a user's face (¶¶ 0229, 0236, 0242, 0252, 0253, 0287-0290, 0293); wherein the frame is configured to accommodate the nasal pillow and position the nasal pillow at a user's nostrils with at least a part of the frame being rigid (Fig. 4, 5, 7-16, 18, 19, 34, 35, 71-77, 84-107; ¶¶ 0229-0233, 0239, 0240, 0250-0272, 0283), and the frame is configured to bend towards the user's face such that the frame fits to the user's face and ensures a secure attachment of the nasal pillow to the user's face (¶¶ 0229-0233, 0239, 0240, 0250-0272, 0283, 0320, 0340); the frame including: a fixed opening (3600; Fig. 10, 15, 16, 18, 31, 33, 35-37, 39, 40, 42-44, 47, 49, 50, 52, 54-58, 71-77, 84-107) located in a middle of the frame (A, Fig. A annotated below), wherein the frame connects to the gas delivery hose through the fixed opening (Fig. 18, 31, 33, 34, 71-77, 84-107), and the fixed opening is a tubular body (B, Fig. A annotated below) of a certain length (C, Fig. A annotated below), providing a contact surface (D, Fig. A annotated below) for connection of the gas delivery hose to the fixed opening (Fig. 18, 31, 33, 34, 71-77, 84-107; ¶¶ 0229, 0240, 0253, 0480); the gas delivery hose including: a first end (where 4180 meets 3600; Fig. 18) located at an upper part (4180; Fig. 1b, 1c, 18) of the gas delivery hose for detachable connection to the frame (¶¶ 0252, 0257 wherein the gas delivery hose is configured to rotate relative to the frame once the gas delivery hose is connected to the frame (4190; Fig. 1b, 1c; ¶¶ 0476, 0487, 0488); a middle hose (portion of 4180 between the first and second ends; Fig. 1a-1c, 18, 71-77, 84-100) positioned between the first end and a second end (4190 where 4180 meets 4170; Fig. 1a-1c), and connected to both the first end and the second end (Fig. 1a-1c; ¶¶ 077, 0229, 0240, 0456, 0480, 0487, 0488), the middle hose is enabled to bend and stretch (Fig. 1a-1c, 18, 30, 74, 77, 105-107, ¶¶ 0489, 0490); the second end located at a lower part (4190; Fig. 1b, 1c) of the gas delivery hose and configured to connect with an other tubular connector (4170; Fig. 1a-1c, 18, 71-77, 84-100); wherein the side connectors consists of a front end (3305; Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294) and a rear end (3301; Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294), the front end configured to connect with the frame (Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294), while the rear end is configured to make contact with the user's face (Fig. 1a-1c, 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294); the frame further including an exhaust channel (3400; Fig. 18; ¶¶ 0253, 0479-0482), wherein the exhaust channel is located on the frame (Fig. 18, 19, 30-34; ¶¶ 0481, 0494) and configured to allow for expulsion of exhaled gas from the user's nostrils through the nasal pillow (¶¶ 0253, 0479-0482), the exhaled gas then flows into the frame and exits via the exhaust channel on the frame (Fig. 18, 19, 30-34; ¶¶ 0253, 0479-0482, 0494), wherein, during use, the frame assembly is configured to allow airflow to flow from the second end of the gas delivery hose to the first end of the gas delivery hose (Fig. 18, 31; ¶¶ 0229, 0240, 0456, 0480, 0487, 0488), and then directly flows into the frame assembly through the fixed opening (Fig. 1b, 1c, 18, 31; ¶ 0229, 0456, 0480, 0487, 0488).
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Figure A, Adapted from Figure 39 of Mah.
Mah does not specifically disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams; wherein the middle hose has multiple continuous evenly folded walls, enabling the middle hose to bend and stretch; and the second end consisting of a first part and a second part, wherein the first part is fixedly connected to a lower end of the middle hose, with an other end of the first part away from the middle hose connected to the second part, an other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils, and wherein a continuous inner wall of the first end includes a protrusion and an outer wall of the fixed opening includes a corresponding recess for receiving the protrusion; wherein, during use, the continuous inner wall of the first end and the outer wall of the fixed opening form a detachable airtight connection.
Hartono teaches a respiratory apparatus (Fig. 1-18) comprising a frame (3500; Fig. 1, 2, 3b, 5a-5d), a gas delivery hose (4180; Fig. 4-7, 9-10, 12, 15; ¶¶ 0234, 0235, 0294, 0295) a first end (3600; Fig. 4-18) for detachable connection to the frame (¶¶ 0292-0298), wherein the frame includes a fixed opening (opening through 3540; Fig. 15, 16, 18, 19) located in a middle of the frame (Fig. 15, 16, 18, 19; ¶¶ 0292-0298, 0377, 0378), wherein the frame connects to the gas delivery hose through the fixed opening (Fig. 9, 10, 12, ¶¶ 0292-0298, 0377, 0378), and the fixed opening is a tubular body (Fig. 15, 16, 18, 19; ¶¶ 0292-0298) of a certain length (Fig. 15, 16, 18, 19), wherein an inner wall (A, Fig. B annotated below) of the fixed opening includes a protrusion (3545; Fig. 13) and a continuous outer wall (B, Fig. B annotated below) of the first end includes a corresponding recess (3595; Fig. 13) for receiving the protrusion (¶ 0297); wherein, during use, the continuous inner wall of the first end and the outer wall of the fixed opening form a detachable airtight connection (¶¶ 0295-0299), and the frame assembly is configured to allow airflow to flow from a second end (other end of 4180; Fig. 4-7; ¶¶ 0234, 0235, 0294, 0295) of the gas delivery hose to the first end of the gas delivery hose (¶¶ 0234, 0235, 0294, 0295), and then directly flows into the frame assembly through the fixed opening (Fig. 9, 10, 12, 15; ¶¶ 0234, 0235, 0292-0299) for the purpose of allowing for a snap fir connection of the frame directly to the gas deliver hose without the need for an elbow (¶¶ 0295, 0297).
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Figure B, Adapted from Figure 13 of Hartono.
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 assembly of Mah to include the wherein a continuous outer wall of the first end includes the protrusion and an inner wall of the fixed opening includes the corresponding recess for receiving the protrusion; wherein, during use, the continuous outer wall of the first end and the inner wall of the fixed opening form the detachable airtight connection as taught by Hartono for the purpose of allowing for a snap fir connection of the frame directly to the gas deliver hose without the need for an elbow (See Hartono: ¶¶ 0295, 0297).
Further, it has been held by the court that rearranging parts of a prior art structure involves only routing skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) See MPEP 2144.04 VI. In this case, one of ordinary skill in the art would with reasonable expectation of success rearrange the parts of the modified device of Mah such that a continuous inner wall of the first end includes the protrusion and an outer wall of the fixed opening includes the corresponding recess for receiving the protrusion; wherein, during use, the continuous inner wall of the first end and the outer wall of the fixed opening form the detachable airtight connection. This is further understood by Applicant’s statements regarding the rearrangement of parts (Pg. 19, ln 21-24).
The modified device of Mah does not specifically disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams; wherein the middle hose has multiple continuous evenly folded walls, enabling the middle hose to bend and stretch; and the second end consisting of a first part and a second part, wherein the first part is fixedly connected to a lower end of the middle hose, with an other end of the first part away from the middle hose connected to the second part, an other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils.
Forrester teaches a hose (100; Fig. 1-5) has multiple continuous evenly folded walls (130, 150; Fig. 2-5), enabling the hose to bend and stretch (¶¶ 0023, 0037, 0038) for the purpose of providing a gentle spring effect that tends to return the hose to its normal fully contracted condition (¶ 0037).
Cullen teaches a hose (4180; Fig. 120) comprising a second end (4190; Fig. 120) consisting of a first part (A, Fig. C annotated below) and a second part (B, Fig. C annotated below; ¶¶ 0267, 0268; Examiner notes: Cullen discloses the second end as a swivel assembly consisting of two parts that are configured to connect the tube to an other tube), wherein the first part is fixedly connected to a lower end (at 4190; Fig. 120) of the hose, with an other end (C, Fig. C annotated below) of the first part away from the hose connected to the second part, and an other end (D, Fig. C annotated below) of the second part connects with an other tubular connector (E, Fig. C annotated below), thereby being configured to deliver breathable gas to the gas delivery hose (¶ 0166, 0167, 0173, 0215, 0229), which is then channeled through a frame (3310; Fig. 36) and a cushion (3100; Fog. 36) to a user's nostril (¶¶ 0166, 0172-0177) for the purpose of allowing cleaning and disinfection without the need for disassembly (¶ 0267) and allowing swiveling a full 360° (¶ 0268).
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Figure C, Adapted from Figure 120 of Cullen.
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 assembly of Mah to include the middle hose to have multiple continuous evenly folded walls, enabling the middle hose to bend and stretch as taught by Forrester; and to include the second end consisting of the first part and the second part, wherein the first part is fixedly connected to the lower end of the middle hose, with the other end of the first part away from the middle hose connected to the second part, and the other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils, as taught by Cullen for the purpose of providing a gentle spring effect that tends to return the hose to its normal fully contracted condition (See Forrester: ¶ 0037); and allowing cleaning and disinfection without the need for disassembly (See Cullen: ¶ 0267); allowing swiveling a full 360° (See Cullen: ¶ 0268), respectively.
Finally, the modified device of Mah does not expressly disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams.
Mah discloses the weight of the first end needs to be optimized to reduce the overall weight of the frame assembly (¶ 0258), while Hartono further discloses “another advantage for the curvature is that less material may be required, which leads to an overall weight reduction of the patient interface 3000” (¶ 0300), and Cullen still further discloses the need to reduce the weight of the first end to reduce drag forces (¶ 0382). Thus, the weight of the first end of the gas delivery hose is disclosed to be a result effective variable in that changing the weight of the first end reduces drag forces. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Mah to have a weight within the claimed range, as it involves only adjusting the dimensions/material of a component disclosed to require adjustment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Mah by making the weight of the first end is between 1 and 10 grams as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 3, the modified device of Mah disclose the frame assembly wherein with an expandability of the gas delivery hose being a ratio of the length to which the hose can be stretched in comparison to the length of the hose in the normal condition that is at least 1.5:1 (See Forrester: Claim 21, 30).
The modified device of Mah does not specifically disclose the frame assembly wherein a length of the gas delivery hose is at or between 200 to 600 mm, an external diameter of the gas delivery hose is between 25 to 45 mm, and a wall thickness of the gas delivery hoses is at or between 1 to 5 mm, with an expandability of the gas delivery hose being at or between 80% to 120%.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set a length of the gas delivery hose to be at or between 200 to 600 mm, an external diameter of the gas delivery hose to be between 25 to 45 mm, and a wall thickness of the gas delivery hoses to be at or between 1 to 5 mm, with an expandability of the gas delivery hose to be at or between 80% to 120% in the modified device of Mah because Applicant has not disclosed that setting the length of the gas delivery hose to be at or between 200 to 600 mm, the external diameter of the gas delivery hose to be between 25 to 45 mm, and the wall thickness of the gas delivery hoses to be at or between 1 to 5 mm, with the expandability of the gas delivery hose being at or between 80% to 120% provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the modified device of Mah, and Applicant’s gas delivery hose to perform equally well because both mechanisms perform the same function of expanding and delivering air flow to the frame.
Therefore, it would have been prima facie obvious to modify the modified device of Mah to obtain the invention as specified in claim 3 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired length, external diameter, wall thickness, and expandability of the gas delivery hose and thus fails to patentably distinguish over the modified device of Mah.
Regarding Claim 4, the modified device of Mah disclose the frame assembly wherein at least one of the connections between the gas delivery hose and the frame, the front end of the side connectors and the frame, and the nasal pillow and the frame are connected by at least one connector that includes one or more of buckles, snap fasteners, hook and loop fasteners, rotary knobs, or magnetic attraction fasteners (See Mah: ¶¶ 0040, 0263, 0283, 0329, 0346, 0466).
Regarding Claim 5, the modified device of Mah disclose the frame assembly wherein there are multiple exhaust channels (See Mah: ¶ 0480) on the frame.
The modified device of Mah does not specifically disclose the frame assembly comprising a combined area of the exhaust channels constitutes 20%-50% of an outer surface area of the frame.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to include a combined area of the exhaust channels constitutes 20%-50% of an outer surface area of the frame in the modified device of Mah because Applicant has not disclosed that the combined area of the exhaust channels constitutes 20%-50% of an outer surface area of the frame provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the of modified inject device of Mah, and Applicant’s multiple exhaust channels, to perform equally well because both mechanisms perform the same function of allow for the washout of exhaled air.
Therefore, it would have been prima facie obvious to modify the modified device of Mah to obtain the invention as specified in claim 5 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired exhaled air washout and thus fails to patentably distinguish over the modified device of Mah.
Regarding Claim 6, the modified device of Mah disclose the frame assembly of claim 1, shown above.
The modified device of Mah does not specifically disclose the frame assembly wherein the exhaust channel is positioned towards a side of the gas delivery hose, includes a noise reduction piece that covers the exhaust channel and is configured to reduce noise when the frame vents to an external environment through the exhaust channel.
Hartono teaches the respiratory apparatus comprising an exhaust channel (3400, 6400; Fig. 4-24, 76-82C) is located on the frame and configured to allow for expulsion of exhaled gas from the user's nostrils through the nasal pillow (¶¶ 0234, 0264, 0292, 0298, 0372-0376, 0382, 0385, 0389-0394, 0403-0407, 0409) wherein the exhaust channel is positioned towards a side of the gas delivery hose (Fig. 4-24, 76-82C), includes a noise reduction piece (3450; Fig. 9-11, 15-18) that covers the exhaust channel and is configured to reduce noise when the frame vents to an external environment through the exhaust channel (¶¶ 0066, 0376, 0378, 0380, 0382-0386) for the purpose of diffusing the exhaust vent flow to produce less noise and the diffused vent flow also reduces or eliminates jetting to that vent flow will not jet onto the bed and/or a partner adjacent the patient interface (¶ 0376).
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 modified device of Mah to include the exhaust channel is positioned towards the side of the gas delivery hose, includes the noise reduction piece that covers the exhaust channel and is configured to reduce noise when the frame vents to the external environment through the exhaust channel as taught by Hartono for the purpose of diffusing the exhaust vent flow to produce less noise and the diffused vent flow also reduces or eliminates jetting to that vent flow will not jet onto the bed and/or a partner adjacent the patient interface (See Hartono: ¶ 0376).
Regarding Claim 7, the modified device of Mah disclose the frame assembly of claim 1, shown above.
The modified device of Mah does not specifically disclose the frame assembly wherein the exhaust channel includes exhaust grids or exhaust holes, and the exhaust grids have through holes opened on a surface of the frame and are attached to the frame to cover the through holes by adhesive, buttons, ultrasonic bonding, or heat pressing; and the exhaust holes are formed by multiple small circular holes on the surface of the frame.
Hartono teaches the respiratory apparatus comprising an exhaust channel (3400, 6400; Fig. 4-24, 76-82C) is located on the frame and configured to allow for expulsion of exhaled gas from the user's nostrils through the nasal pillow (¶¶ 0234, 0264, 0292, 0298, 0372-0376, 0382, 0385, 0389-0394, 0399, 0403-0407, 0409) wherein the exhaust channel includes exhaust holes (3515, 3516; Fig. 11, 16-19, 21, 22), and the exhaust holes are formed by multiple small circular holes (3516; Fig. 11, 16-19, 21, 22) on the surface of the frame (¶¶ 0377-0379, 0383) for the purpose of preventing cross flow and allow substantially even distribution of air flow volume (¶ 0393).
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 modified device of Mah to include the exhaust channel includes exhaust holes, and the exhaust holes are formed by multiple small circular holes on the surface of the frame as taught by Hartono for the purpose of preventing cross flow and allow substantially even distribution of air flow volume (See Hartono: ¶ 0393).
Regarding Claim 8, the modified device of Mah disclose the frame assembly wherein the second part of the second end of the gas delivery hose is a cylinder (See B, Fig. C annotated above) that is configured to rotate coaxially relative to the first part, allowing the second part to achieve coaxial rotation relative to the gas delivery hose (See Cullen: ¶¶ 0267, 0268; Examiner notes: Cullen discloses the second end as a swivel assembly consisting of two parts that are configured to connect the tube to an other tube and rotate a full 360°).
Regarding Claim 9, the modified device of Mah disclose the frame assembly wherein the front end and rear end of the side connectors are integrally formed through injection molding (See Mah: ¶¶ 0290-0294, 0298-0305, 0309-0311, 0313-0317; Examiner notes: The claimed phrase “the front end and rear end of the side connectors are integrally formed through injection molding”, ln 1-3 is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Mah is silent as to the process used to form the front end and rear end of the side connectors they are or could be integrally formed, it appears that the modified device of Mah’s product would be the same or similar as that claimed, especially since both applicant’s product and the prior art product is made to be integrally. See MPEP 2113.).
The modified device of Mah does not specifically disclose the frame assembly wherein a linear distance between a center point of the front end and a center point of the rear end is at or between 20 to 200 mm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form a linear distance between a center point of the front end and a center point of the rear end is at or between 20 to 200 mm in the modified device of Mah because Applicant has not disclosed that forming the linear distance between the center point of the front end and the center point of the rear end is at or between 20 to 200 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the modified device of Mah’s and Applicant’s frame assembly, to perform equally well because both mechanisms perform the same function of providing sealing nasal device that provides a flow of air to the nars.
Therefore, it would have been prima facie obvious to modify the modified device of Mah to obtain the invention as specified in claim 9 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and delivered flow to the nars and thus fails to patentably distinguish over the modified device of Mah.
Regarding Claim 31, Mah discloses a frame assembly comprising: a frame (3310; Fig. 10, 11, 16, 18, 19, 30-37, 39, 40, 42-44, 47-56, 71-77, 84-107) for securing a nasal pillow (3100, 3200; Fig. 4, 5, 7-16, 18, 19, 34, 35, 71-77, 84-107; ¶¶ 0229-0233, 0239, 0240, 0250-0272), a gas delivery hose (4170, 4178, 4180; Fig. 1a-1c, 18, 71-77, 84-100) directly connected to the frame for delivering breathable gas to the nasal pillow (Fig. 1a-1c, 71-77, 84-100; ¶¶ 0229, 0240, 0327, 0476, 0487-0490, 0494), and side connectors (3300; Fig. 30-34, 65-73) for securing the frame to a user's face (¶¶ 0229, 0236, 0242, 0252, 0253, 0287-0290, 0293); wherein the frame is configured to accommodate the nasal pillow and position the nasal pillow at a user's nostrils with at least a part of the frame being rigid (Fig. 4, 5, 7-16, 18, 19, 34, 35, 71-77, 84-107; ¶¶ 0229-0233, 0239, 0240, 0250-0272, 0283), and the frame is configured to bend towards the user's face such that the frame fits to the user's face and ensures a secure attachment of the nasal pillow to the user's face (¶¶ 0229-0233, 0239, 0240, 0250-0272, 0283, 0320, 0340); the frame including: a fixed opening (3600; Fig. 10, 15, 16, 18, 31, 33, 35-37, 39, 40, 42-44, 47, 49, 50, 52, 54-58, 71-77, 84-107) located in a middle of the frame (A, Fig. A annotated above), wherein the frame connects to the gas delivery hose through the fixed opening (Fig. 18, 31, 33, 34, 71-77, 84-107), and the fixed opening is a tubular body (B, Fig. A annotated above) of a certain length (C, Fig. A annotated above), providing a contact surface (D, Fig. A annotated above) for connection of the gas delivery hose to the fixed opening (Fig. 18, 31, 33, 34, 71-77, 84-107; ¶¶ 0229, 0240, 0253, 0480); the gas delivery hose including: a first end (where 4180 meets 3600; Fig. 18) located at an upper part (4180; Fig. 1b, 1c, 18) of the gas delivery hose for detachable connection to the frame (¶¶ 0252, 0257 wherein the gas delivery hose is configured to rotate relative to the frame once the gas delivery hose is connected to the frame (4190; Fig. 1b, 1c; ¶¶ 0476, 0487, 0488); a middle hose (portion of 4180 between the first and second ends; Fig. 1a-1c, 18, 71-77, 84-100) positioned between the first end and a second end (4190 where 4180 meets 4170; Fig. 1a-1c), and connected to both the first end and the second end (Fig. 1a-1c; ¶¶ 077, 0229, 0240, 0456, 0480, 0487, 0488), the middle hose is enabled to bend and stretch (Fig. 1a-1c, 18, 30, 74, 77, 105-107, ¶¶ 0489, 0490); the second end located at a lower part (4190; Fig. 1b, 1c) of the gas delivery hose and configured to connect with an other tubular connector (4170; Fig. 1a-1c, 18, 71-77, 84-100); wherein the side connectors connect to the first connection parts on both sides of the frame (Fig. 31-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0293, 0299, 0304, 0305, 0320-0325, 0337-0342); and the side connectors consists of a front end (3305; Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294) and a rear end (3301; Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294), the front end configured to connect with the frame (Fig. 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294), while the rear end is configured to make contact with the user's face (Fig. 1a-1c, 19, 30-37, 39-60, 71-77, 84-100; ¶¶ 0253, 0287, 0290-0294); the frame further including an exhaust channel (3400; Fig. 18; ¶¶ 0253, 0479-0482), wherein the exhaust channel is located on the frame (Fig. 18, 19, 30-34; ¶¶ 0481, 0494) and configured to allow for expulsion of exhaled gas from the user's nostrils through the nasal pillow (¶¶ 0253, 0479-0482); the exhaled gas then flows into the frame and exits via the exhaust channel on the frame (Fig. 18, 19, 30-34; ¶¶ 0253, 0479-0482, 0494); and wherein an angle (A, Fig. D annotated below) is formed between an axis of symmetry (B, Fig. D annotated below) of the frame and a central axis of the fixed opening (C, Fig. D annotated above), and wherein, during use, the frame assembly is configured to allow airflow to flow from the second end of the gas delivery hose to the first end of the gas delivery hose (Fig. 18, 31; ¶¶ 0229, 0240, 0456, 0480, 0487, 0488), and then directly flows into the frame assembly through the fixed opening (Fig. 1b, 1c, 18, 31; ¶ 0229, 0456, 0480, 0487, 0488).
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Figure D, Adapted from Figure 55 of Mah.
Mah does not specifically disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams; wherein the middle hose has multiple continuous evenly folded walls, enabling the middle hose to bend and stretch; and the second end consisting of a first part and a second part, wherein the first part is fixedly connected to a lower end of the middle hose, with an other end of the first part away from the middle hose connected to the second part, and an other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils, and wherein a continuous inner wall of the first end includes a protrusion and an outer wall of the fixed opening includes a corresponding recess for receiving the protrusion; and wherein a central axis of the fixed opening and an axis of symmetry of the frame form an angle there between, wherein the angle being in a range of 30° to 150°.
Hartono teaches a respiratory apparatus (Fig. 1-18) comprising a frame (3500; Fig. 1, 2, 3b, 5a-5d), a gas delivery hose (4180; Fig. 4-7, 9-10, 12, 15; ¶¶ 0234, 0235, 0294, 0295) a first end (3600; Fig. 4-18) for detachable connection to the frame (¶¶ 0292-0298), wherein the frame includes a fixed opening (opening through 3540; Fig. 15, 16, 18, 19) located in a middle of the frame (Fig. 15, 16, 18, 19; ¶¶ 0292-0298, 0377, 0378), wherein the frame connects to the gas delivery hose through the fixed opening (Fig. 9, 10, 12, ¶¶ 0292-0298, 0377, 0378), and the fixed opening is a tubular body (Fig. 15, 16, 18, 19; ¶¶ 0292-0298) of a certain length (Fig. 15, 16, 18, 19), wherein an inner wall (A, Fig. B annotated above) of the fixed opening includes a protrusion (3545; Fig. 13) and a continuous outer wall (B, Fig. B annotated above) of the first end includes a corresponding recess (3595; Fig. 13) for receiving the protrusion (¶ 0297); wherein, during use, the continuous inner wall of the first end and the outer wall of the fixed opening form a detachable airtight connection (¶¶ 0295-0299), and the frame assembly is configured to allow airflow to flow from a second end (other end of 4180; Fig. 4-7; ¶¶ 0234, 0235, 0294, 0295) of the gas delivery hose to the first end of the gas delivery hose (¶¶ 0234, 0235, 0294, 0295), and then directly flows into the frame assembly through the fixed opening (Fig. 9, 10, 12, 15; ¶¶ 0234, 0235, 0292-0299) for the purpose of allowing for a snap fir connection of the frame directly to the gas deliver hose without the need for an elbow (¶¶ 0295, 0297).
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 assembly of Mah to include the wherein a continuous outer wall of the first end includes the protrusion and an inner wall of the fixed opening includes the corresponding recess for receiving the protrusion; wherein, during use, the continuous outer wall of the first end and the inner wall of the fixed opening form the detachable airtight connection as taught by Hartono for the purpose of allowing for a snap fir connection of the frame directly to the gas deliver hose without the need for an elbow (See Hartono: ¶¶ 0295, 0297).
It has been held by the court that rearranging parts of a prior art structure involves only routing skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) See MPEP 2144.04 VI. In this case, one of ordinary skill in the art would with reasonable expectation of success rearrange the parts of the modified device of Mah such that a continuous inner wall of the first end includes the protrusion and an outer wall of the fixed opening includes the corresponding recess for receiving the protrusion; wherein, during use, the continuous inner wall of the first end and the outer wall of the fixed opening form the detachable airtight connection. This is further understood by Applicant’s statements regarding the rearrangement of parts (Pg. 19, ln 21-24).
The modified device of Mah does not specifically disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams; wherein the middle hose has multiple continuous evenly folded walls, enabling the middle hose to bend and stretch; and the second end consisting of a first part and a second part, wherein the first part is fixedly connected to a lower end of the middle hose, with an other end of the first part away from the middle hose connected to the second part, an other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils.
Forrester teaches a hose (100; Fig. 1-5) has multiple continuous evenly folded walls (130, 150; Fig. 2-5), enabling the hose to bend and stretch (¶¶ 0023, 0037, 0038) for the purpose of providing a gentle spring effect that tends to return the hose to its normal fully contracted condition (¶ 0037).
Cullen teaches a hose (4180; Fig. 120) comprising a second end (4190; Fig. 120) consisting of a first part (A, Fig. C annotated above) and a second part (B, Fig. C annotated above; ¶¶ 0267, 0268; Examiner notes: Cullen discloses the second end as a swivel assembly consisting of two parts that are configured to connect the tube to an other tube), wherein the first part is fixedly connected to a lower end (at 4190; Fig. 120) of the hose, with an other end (C, Fig. C annotated above) of the first part away from the hose connected to the second part, and an other end (D, Fig. C annotated above) of the second part connects with an other tubular connector (E, Fig. B annotated below), thereby being configured to deliver breathable gas to the gas delivery hose (¶ 0166, 0167, 0173, 0215, 0229), which is then channeled through a frame (3310; Fig. 36) and a cushion (3100; Fog. 36) to a user's nostril (¶¶ 0166, 0172-0177) for the purpose of allowing cleaning and disinfection without the need for disassembly (¶ 0267) and allowing swiveling a full 360° (¶ 0268).
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 assembly of Mah to include the middle hose to have multiple continuous evenly folded walls, enabling the middle hose to bend and stretch as taught by Forrester; and to include the second end consisting of the first part and the second part, wherein the first part is fixedly connected to the lower end of the middle hose, with the other end of the first part away from the middle hose connected to the second part, and the other end of the second part connects with the other tubular connector, thereby being configured to deliver breathable gas to the gas delivery hose, which is then channeled through the frame and the nasal pillow to the user's nostrils, as taught by Cullen for the purpose of providing a gentle spring effect that tends to return the hose to its normal fully contracted condition (See Forrester: ¶ 0037) and allowing cleaning and disinfection without the need for disassembly (See Cullen: ¶ 0267) and allowing swiveling a full 360° (See Cullen: ¶ 0268), respectively.
Further, though prior art drawings are not interpreted as depicting scale, unless specified, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Mah clearly depicts the central axis of the fixed opening and the axis of symmetry of the frame form the angle there between, wherein the angle being in a range of 30° to 150°.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the angle to be in a range of 30° to 150°.for the benefit of improved user comfort.
Finally, the modified device of Mah does not expressly disclose the frame assembly wherein a weight of the first end is between 1 and 10 grams.
Mah discloses the weight of the first end needs to be optimized to reduce the overall weight of the frame assembly (¶ 0258), while Hartono further discloses “another advantage for the curvature is that less material may be required, which leads to an overall weight reduction of the patient interface 3000” (¶ 0300), and Cullen still further discloses the need to reduce the weight of the first end to reduce drag forces (¶ 0382). Thus, the weight of the first end of the gas delivery hose is disclosed to be a result effective variable in that changing the weight of the first end reduces drag forces. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Mah to have a weight within the claimed range, as it involves only adjusting the dimensions/material of a component disclosed to require adjustment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Mah by making the weight of the first end is between 1 and 10 grams as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 32, the modified device of Mah disclose the frame assembly, shown above.
The modified device of Mah does not explicitly disclose the frame assembly wherein the certain length of the fixed opening is between 0.3 mm to 30 mm.
There is no evidence of record that establishes that changing the certain length of the fixed opening would result in a difference in function of the modified device of Mah. Further, a person having ordinary skill in the art, being faced with modifying the fixed opening of the modified device of Mah, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the fixed opening “can” be within any range, (Pg. 18, ln 9-16) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the certain length of the fixed opening of the modified device of Mah to be between 0.3 mm to 30 mm as an obvious matter of design choice within the skill of the art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mah in view of Hartono in view of Forrester in view of Cullen as applied to claim 6 above, and further in view of Farrow et al. (U.S. Pub. No. 2021/0228830; hereinafter: “Farrow”).
Regarding Claim 10, the modified device of Mah disclose the frame assembly of claim 6 wherein the noise reduction piece includes one or more of non-woven fibrous material or woven fibrous material noise-reducing material.
The modified device of Mah does not specifically disclose the frame assembly wherein the noise reduction piece includes one or more of noise-reducing cotton or noise-reducing mesh, wherein the noise-reducing cotton is made from at least one material selected from polyester, polypropylene, polyethylene, nylon, vinylon, and natural fabric; and wherein the noise-reducing mesh is made from at least one material selected from polyvinyl chloride, polypropylene, polytetrafluoroethylene, or nylon.
Farrow teaches a noise reduction piece (3000, 3004; Fig. 42, 44-49; ¶¶ 0351, 0357, 0360, 0361, 0379, 0381, 0391-0393) includes a noise-reducing cotton made from at least one material selected from polyester, polypropylene, polyethylene, nylon, vinylon, and natural fabric [¶ 0357; Examiner notes: Farrow discloses the noise reduction piece as non-woven fabrics (e.g. felt) ] for the purpose of forming a tortuous path for the air passing through thereby dispersing the air flow, reducing its velocity and therefore noise (¶ 357).
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 modified device of Mah to include the noise reduction piece being the noise-reducing cotton made from at least one material selected from polyester, polypropylene, polyethylene, nylon, vinylon, and natural fabric as taught by Farrow for the purpose of forming a tortuous path for the air passing through thereby dispersing the air flow, reducing its velocity and therefore noise (See Farrow: ¶ 357).
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “wherein a weight of the first end is between 1 and 10 grams;” as recited in independent claims 1 and 31 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection over Mah in view of Hartono in view of Forrester in view of Cullen, shown above.
Conclusion
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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