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
Acknowledgement is made to Applicant’s claim to priority to Provisional App. No. 63/359,923 filed July 11, 2022 and to Provisional App. No. 63/255,496 filed October 14, 2021.
Status of Claims
Claims 1-21, filed August 18, 2022, are presently pending in this application.
Information Disclosure Statement
Acknowledgement is made to Applicant's lack of an Information Disclosure Statement submission.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “from the outlet of the air switch” , ln 2-3 should read --from the outlet port of the air switch --. Appropriate correction is required.
Claim Interpretation
The term “generally” in the limitation “a switch body having a cavity with a generally semicircular portion” in claim 20 is interpreted to not meaningfully alter the plain meaning of “a switch body having a cavity with a semicircular portion” and allows for minor variance in manufacturing and minimal variations under conditions of use. 2173.05 (b) is fine instead of trying for the 2173.05(b)(III)(D).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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, 17, and 21, and claims 2-16, 18-20, and 22-23 by dependency, are 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).
Claims 1, 17, and 21 recite the limitation “the nasal interface coupling a user's nose to the outlet of the mask body”, ln 4 which requires the user's nose (i.e. a human organism) to define the device. The limitation should read, "the nasal interface configured to couple to a user's nose to the outlet of the mask body".
Claims 2 and 18, recite the limitation "that outputs air received from a user's nostrils" which requires the user's nostrils (i.e. a human organism) to define the device. The limitation should read, "that is configured to output air received from the user's nostrils".
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, 2, 11, 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Marsh (U.S. Pub. No. 2019/0209797) in view of Brydon et al. (U.S. Pat. No. 6,526,974; hereinafter: “Brydon”).
Regarding Claim 1, Marsh discloses a positive air way pressure mask comprises a mask body (41; Fig. 3A-3I; ¶¶ 0021-0029) having an inlet (43; Fig. 3A, 3F, 3G) and an outlet (47a, 47b; Fig. 3A, 3D, 3E, 3F-3I); a nasal interface (45a, 45b; Fig. 3A, 3B, 3D-3H) supported on the mask body (Fig. 3A, 3B, 3D-3H; ¶¶ 0021-0029), the nasal interface having air passages (41a, 41b; Fig. 3B), with the nasal interface coupling a user's nose to the outlet of the mask body (¶¶ 0021-0029).
Marsh does not specifically disclose the mask comprising an air switch having an input port and an output port, with the input port configured to receive air from a continuous positive airway pressure machine and deliver the received air to the output port during a user inhalation, and further configured to at least partially block the air from the continuous positive airway pressure machine from passing from the input port to the output port during a user exhalation.
Brydon teaches: an air switch (122’; Fig. 19a, 19b) having an input port (159’; Fig. 19a, 19b) and an output port (162’; Fig. 19a, 19b), with the input port configured to receive air from a continuous positive airway pressure machine (12, 18; Fig. 17-18b; col 9, ln 26 to col 10, ln 46) and deliver the received air to the output port during a user inhalation (col 9, ln 26 to col 10, ln 46), and further configured to at least partially block the air from the continuous positive airway pressure machine from passing from the input port to the output port during a user exhalation (col 10, ln 11-53) for the purpose of providing low impedance path for patient expiration (col 10, ln 11-26).
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 mask of Marsh to include the air switch having the input port and the output port, with the input port configured to receive air from the continuous positive airway pressure machine and deliver the received air to the output port during the user inhalation, and further configured to at least partially block the air from the continuous positive airway pressure machine from passing from the input port to the output port during the user exhalation as taught by Brydon for the purpose of low impedance path for patient expiration (See Brydon: col 10, ln 11-26).
Regarding Claim 2, the modified device of Marsh discloses the positive air way pressure mask further comprising: an exhalation valve (See Marsh: 46a, 46b, 47a, 47b, 49a, 49b, 63a, 63b; Fig. 3A-3I) having an inlet port (See Marsh: 3a, 63b; Fig. 3E) that receives air from the outlet of the air switch (See Marsh: ¶¶ 0025, 0026, 0028, 0029), the exhalation valve having an outlet port (See Marsh: 46a, 46b; Fig. 3B) that outputs air received from a user's nostrils (See Marsh: ¶¶ 0022, 0026), and further having at least one bi-directional port (A, Fig. A annotated below) disposed in an airway that couples to the air passages in the nasal interface (See Marsh: Fig. 3F-3I), with an exhalation opening the outlet ports when the user exhales to minimize air resistance during the user exhaling (See Marsh: ¶¶ 0022-0029, See Brydon: col 9, ln 26 to col 10, ln 46; See Examiner notes: For the purpose of this Office action “the outlet ports” have been interpreted as the outlet port of the exhalation valve and the outlet port of the air switch).
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Figure A, Adapted from Figures 3F and 3H of Marsh.
Regarding Claim 11, the modified device of Marsh discloses the positive air way pressure mask comprises wherein the mask body houses the nasal interface, the air switch, and the exhalation valve (See Marsh: Fig. 3A-3I; ¶¶ 0022, 0025, 0026, 0028, 0029, See Brydon: 17-19b; col 9, ln 26 to col 10, ln 46).
Regarding Claim 17, Marsh discloses a continuous positive air way pressure mask arrangement comprises: a mask body (41; Fig. 3A-3I; ¶¶ 0021-0029) having an inlet (43; Fig. 3A, 3F, 3G) and an outlet (47a, 47b; Fig. 3A, 3D, 3E, 3F-3I); a nasal interface (45a, 45b; Fig. 3A, 3B, 3D-3H) supported on the mask body (Fig. 3A, 3B, 3D-3H; ¶¶ 0021-0029), the nasal interface having air passages (41a, 41b; Fig. 3B), with the nasal interface coupling a user's nose to the outlet of the mask body (¶¶ 0021-0029);
Marsh does not specifically disclose the mask comprising an air switch having an input port, an output port, and a diversion port, with the input port configurable to receive air from a continuous positive airway pressure machine and deliver the received air to the inlet of the mask body during an inhalation, and which switches the air from the positive airway pressure machine from entering the inlet port of the mask body to the diversion port diverting the received air to ambient during an exhalation.
Brydon teaches: an air switch (122’; Fig. 19a, 19b) having an input port (159’; Fig. 19a, 19b), an output port (162’; Fig. 19a, 19b), and a diversion port (164’; Fig. 19a, 19b), with the input port configured to receive air from a continuous positive airway pressure machine (12, 18; Fig. 17-18b; col 9, ln 26 to col 10, ln 46) and deliver the received air to the output port during an inhalation (col 9, ln 26 to col 10, ln 46), and which switches the air from the positive airway pressure machine from entering the inlet port of the mask body to the diversion port diverting the received air to ambient during an exhalation (col 9, ln 63 to col 10, ln 53) for the purpose of providing low impedance path for patient expiration (col 10, ln 11-26).
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 continuous positive air way pressure mask of Marsh to include the air switch having the input port, the output port, and the diversion port, with the input port configurable to receive air from the continuous positive airway pressure machine and deliver the received air to the inlet of the mask body during the inhalation, and which switches the air from the positive airway pressure machine from entering the inlet port of the mask body to the diversion port diverting the received air to ambient during the exhalation as taught by Brydon for the purpose of providing low impedance path for patient expiration (col 10, ln 11-26).
Regarding Claim 18, the modified device of Marsh discloses the continuous positive air way pressure mask further comprising: an exhalation valve (See Marsh: 46a, 46b, 47a, 47b, 49a, 49b, 63a, 63b; Fig. 3A-3I) having an inlet port (See Marsh: 3a, 63b; Fig. 3E) that receives air from the air switch output port (See Marsh: ¶¶ 0025, 0026, 0028, 0029), the exhalation valve having an outlet port (See Marsh: 46a, 46b; Fig. 3B) that outputs air received from a user's nostrils (See Marsh: ¶¶ 0022, 0026), and further having at least one bi-directional port (A, Fig. A annotated above) disposed in an airway that couples to the air passages in the nasal interface (See Marsh: Fig. 3F-3I), with exhaling opening the outlet ports when the user exhales to minimize air resistance during the user exhaling (See Marsh: ¶¶ 0022-0029, See Brydon: col 9, ln 26 to col 10, ln 46; See Examiner notes: For the purpose of this Office action “the outlet ports” have been interpreted as the outlet port of the exhalation valve and the outlet port of the air switch).
Regarding Claim 20, the modified device of Marsh discloses the continuous positive air way pressure mask wherein the air switch comprises: a switch body (A, Fig. B annotated below) having a cavity (B, Fig. B annotated below); a rotatable diversion element (See Brydon: 170; Fig. 19a, 19b) that forms part of a first passage (C, Fig. B annotated below) through the air switch and that is disposed in the semicircular portion and that has a channel (along C, Fig. B annotated below) that forms an air flow path with the first passage (col 9, ln 26 to col 10, ln 53);.
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Figure B, Adapted from Figure 19a of Brydon.
The modified device of Marsh does not specifically disclose the continuous positive air way pressure mask comprising a solenoid that is disposed to control rotation of the rotatable diversion element to complete or partially complete the first passage or the second passage, according to a mode of operation of the air switch and wherein the switch body having the cavity with a generally semicircular portion.
Brydon teaches a solenoid (94; Fig. 15; col 8, ln 47 to col 9, ln 26) that is disposed to control rotation of the rotatable diversion element to complete or partially complete the first passage or the second passage, according to a mode of operation of the air switch (col 9, ln 26 to col 10, ln 53) for the purpose providing fine control over the desired treatment pressure (col 9, ln 3-6).
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 Marsh to include the solenoid that is disposed to control rotation of the rotatable diversion element to complete or partially complete the first passage or the second passage, according to the mode of operation of the air switch as taught by Brydon for the purpose of providing fine control over the desired treatment pressure (See Brydon: col 9, ln 3-6).
Finally, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the cavity of the switch body as having a semicircular portion in the modified device of Marsh because Applicant has not disclosed that the switch body having the cavity with a semicircular portion provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Specification: Pg. 5, ln 27 to Pg. 6 ln 2; Pg. 14, ln 10-25). One of ordinary skill in the art, furthermore, would have expected the cavity of the switch body of the modified device of Marsh, and Applicant’s switch body having the cavity with a generally semicircular portion, to perform equally well because both mechanisms perform the same function of housing the rotatable diversion element.
Therefore, it would have been prima facie obvious to modify the modified device of Marsh to obtain the invention as specified in claim 20 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired housing of the rotatable diversion element and thus fails to patentably distinguish over the modified device of Marsh.
Allowable Subject Matter
Claims 3, 4, and 19, and claims 5-10 and 12-16 by dependency, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21-23 are allowed.
Prior art Wickham et al. (U.S. Pat. No. 6,269,839) discloses a pressure sensor (col 6, ln 1-13) but fails to disclose a further bi-directional port of a exhalation valve that the pressure sensor is in fluid communication with; and electronic control circuit to control operation of the air switch in response to the pressure signal received from the pressure sensor, as recited in dependent claims 3 and 19.
Prior art of Marsh, Brydon, and Wickham et al. alone or in combination fail to disclose or render obvious wherein the air switch is a voice coil actuated air switch that comprises: a switch body having a cavity; a first gasket; a second gasket; a plunger having a bulb portion and a shaft portion attached to the bulb portion; a soft magnetic, iron pull piece attached to an end of the shaft portion; and a coil that causes the bulb portion to move into a passage in the first gasket to block air through the voice coil actuated air switch in a first mode and that causes the bulb portion to move away from the passage in the first gasket and into the second gasket to allow air to enter the voice coil actuated air switch and exit through output port of the air switch, as recited in dependent claim 4 and independent claim 21.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785