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 Non-Provisional App. No. 16/646,283 filed March 11, 2020 now Pat. No. 11,878,12; to PCT No. US2018/054096 filed October 3, 2018; and to U.S. Provisional App. No. 62/567,554 filed October 3, 2017
Status of Claims
This Office Action is responsive to the amendment filed on November 3, 2025. As directed by the amendment: claims 1-4, 6-10, 12-20 have been amended; claims 5 and 11 have been cancelled; and claims 21-43 have been added. Thus, claims 1-4, 6-10, and 12-43 are presently pending in this application.
Applicant’s cancelling of claim 11 obviates the previous Drawing objection. Applicant’s amendments to claim 18 obviates the previous objection made thereto. 6. Claims 1, 7-9, and 12-14 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,878,125 in view of Labaere (U.S. Pat. No. 5,193,529). Applicant’s amendments to independent claim 1 obviate the previous rejection on the ground of nonstatutory double patenting.
Claims 1-9, 11-13, and 16-20 were previously rejected under 35 U.S.C. 103 as being unpatentable over Liardet (U.S. Patent No. 5,451,190) in view of Guo et al . (U. S. Pub. No. 2013/0228174) in view of Labaere (U.S. Pat. No. 5,193,529). Claim(s) 10 was previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Labaere in view of Gao (U.S. Pat. No. 10,004,872).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Claim Objections
Claim 16, 17, and 19 are objected to because of the following informalities:
Claim 16 recites “wherein the inhalation oscillatory valve interchangeable”, ln 1-3 should read --wherein the inhalation oscillatory valve is interchangeable--;
Claim 17 recites “wherein inhalation oscillatory valve”, ln 1-2 should read --wherein the inhalation oscillatory valve--;
Claim 19 recites “that is different that the inhalation oscillatory valve”, ln 4 should read --that is different than the inhalation oscillatory valve--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26, and claims 27-31 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites “The respiratory therapy kit of claim 1,”, ln 1, however independent claim 1 is directed to a respiratory therapy device. It is unclear whether there is a typographical error or Applicant is introducing a new apparatus. Based on Applicant’s statement that new claims 22-29 depend from new independent claim 21, Pg. 14, Examiner believes there is a typographical error. Therefore, for the purpose of this Office Action claim 26 has been interpreted as --The respiratory therapy kit of claim 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.
Claim(s) 1, 2, 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Liardet (U.S. Patent No. 5,451,190).
Regarding Claim 1, Liardet discloses a respiratory therapy device, comprising an airflow mixing channel (70, 71, 74; Fig. 8-9; col 5, ln 53-68) including a first inflow opening (72; Fig. 8), a second inflow opening (holes in cover 7’; Fig. 1, 8-9; col. 3, ln 63-68; Examiner notes: Liardet discloses holes in cover 7' enabling inhaled air to be admitted.), and an outflow opening (A, Fig. A annotated below), wherein the first inflow opening is fluidly connectable to a nebulizer (73; Fig. 8; col 5, ln 53-59); a one-way air intake valve (3, 5’, 6’; Fig. 1-2, 8-9; col 3, ln 63 to col 4, ln 14; col 6, ln 1-3) fluidly coupled to the second inflow opening (Fig. 1-2, 8-9; col 3, ln 63 to col 4, ln 14); wherein the one-way air intake valve is an inhalation oscillatory valve (6’; Fig. 8, 9; col 6, ln 1-3; Claim 3); outflow opening, wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (C, Fig. A annotated below) and an exhalation oscillatory valve (5, 6; Fig. 1, 2, 4, 7)
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Figure A, Adapted from Figure 8 of Liardet.
Liardet does not explicitly disclose the respiratory therapy device wherein the one-way air intake valve is positioned below the outflow opening.
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). Liardet clearly depicts the one-way air intake valve positioned downstream the outflow opening and depicts a portion (D, Fig. A annotated above) of the air intake valve is positioned below the outflow opening. (Examiner notes: The term “below” is a relative term and the Instant Specifically fails to provide guidance.) Furthermore, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to locate the one-way air intake valve to be positioned below the outflow opening in the Liardet device because Applicant has not disclosed that the one-way air intake valve positioned below the outflow opening provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s specification is silent regarding the one-way air intake valve being positioned below the outflow opening. One of ordinary skill in the art, furthermore, would have expected the one-way air intake valve positioned in relationship to the outflow opening of Liardet, and Applicant’s one-way air intake valve positioned downstream the outflow opening, to perform equally well because both mechanisms perform the same function of allow for mixing and the oscillation of intake air.
Therefore, it would have been prima facie obvious to modify Liardet to obtain the invention as specified in claim 1 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired mixing and oscillation of intake air and thus fails to patentably distinguish over the prior art of Liardet.
Regarding Claim 2, the modified device of Liardet discloses the respiratory therapy device wherein the respiratory therapy kit device includes a second one-way air intake valve (See Liardet: 6’; Fig. 8), that is interchangeable with the one-way air intake valve (See Liardet: col 6, ln 1-3).
Regarding Claim 8, the modified device of Liardet discloses the respiratory therapy device wherein the exhalation oscillatory valve of the oscillating positive expiratory pressure assembly includes a valve seat (See Liardet: 5; Fig. 1, 4, 7; col 3, ln 63 to col 4, ln 14) and a weighted ball (See Liardet: 6; Fig. 1, 2, 4, 7) that provides airflow vibration as the weighted ball oscillates over the valve seat when actuated by the exhalation [See Liardet: col 1, ln 29-57; col 3, ln 63 to col 4, ln 14; Examiner notes: Liardet disclose the ball (6; Fig. 1, 2, 4, 7) as being weighted such that the gravitational force acting of the weight of the ball must be overcome to produce percussive ventilation (i.e. oscillating positive expiratory pressure).].
Regarding Claim 17, the modified device of Liardet discloses the respiratory therapy device wherein the inhalation oscillatory valve includes a valve seat (See Liardet: 5’; Fig. 7, 8) and a weighted ball (See Liardet: 6’; Fig. 7, 8) that provides airflow vibration as the weighted ball oscillates over or adjacent to the valve seat when actuated by the inhalation (See Liardet: col 3, ln 63 to col 4, ln 14; col 6, ln 1-3; Claim 3).
Regarding Claim 18, the modified respiratory therapy device of Liardet discloses a method of using the respiratory therapy device of claim 1, see above, comprising: providing the respiratory therapy device
i) deliver an aerosolized liquid medicament from the first inflow opening to a user interface opening upon inhalation by a user (See Liardet: col 5 ln 11 to col 6, ln 3, See Guo: Fig. 1, 3, 6; ¶¶ 0040, 0054-0061),
ii) provide oscillatory inhalation therapy to the user via inhalation through the inhalation oscillatory valve (See Liardet: col 3, ln 63 to col 4, ln 14; col 6, ln 1-3; Claim 3), and
iii) provide oscillatory exhalation therapy to the user via the exhalation oscillatory valve (See Liardet: col 3, ln 63 to col 4, ln 14; col 5, ln 53-68);
fluidly coupling to the first inflow opening to generate the aerosolized liquid medicament delivered to the airflow mixing chamber (See Liardet: Fig. 8; col 5, ln 53-59);flowing air through the one-way air intake valve (See Liardet: 3, 5’, 6’; Fig. 1-2, 8-9; col 3, ln 63 to col 4, ln 14; col 6, ln 1-3; Claim 3) into the airflow mixing channel upon inhalation by the user to mix with the aerosolized liquid medicament and form a diluted aerosolized liquid medicament (See Liardet: col 5 ln 11 to col 6, ln 3); flowing the diluted aerosolized liquid medicament from the airflow mixing channel
upon inhalation by the user at the user interface opening (See Liardet: col 5 ln 11 to col 6, ln 3); and exhaling through the user interface opening to cause the exhalation oscillatory valve to provide oscillatory exhalation therapy (See Liardet: col 3, ln 63 to col 4, ln 14; col 5, ln 53-68).
Claim(s) 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Liardet as applied to claim 1 above, and further in view of Guo et al . (U. S. Pub. No. 2013/0228174; hereinafter: “Guo”).
Regarding Claim 4, the modified device of Liardet discloses the respiratory therapy device, shown above.
The modified device of Liardet discloses the respiratory therapy device wherein the respiratory therapy device includes a one-way medicament valve fluidly coupled to or couplable with the outflow opening
Guo teaches an oscillatory pep with nebulizer device comprising an airflow mixing channel (tubular portion 302, Fig. 1, 3, 6; ¶¶ 0054, 0056-0057) having an outflow opening (opening of proximal end of connector 300 at port 40; Fig. 1, ¶¶ 0040, 0056), and a one-way medicament valve fluidly coupled to the outflow opening (one-way valve 310; Fig. 1; ¶¶ 0056-0061); wherein the one -way medicament valve is closed during exhalation (¶¶ 0056-0058; Examiner notes: Guo discloses the one-way medicament valve as being normally closed and specifically closed during exhalation.) for the purpose of providing a substantially airtight seal from the airflow mixing channel which opens in response to a user inhaling and minimizing the waste of the medicament during exhalation (¶¶ 0056, 0058).
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 Liardet to include the one-way medicament valve fluidly coupled to or couplable with the outflow opening as taught by Guo for the purpose of providing a substantially airtight seal from the airflow mixing channel which opens in response to a user inhaling and minimizing the waste of the medicament during exhalation (See Guo: ¶¶ 0056, 0058).
Regarding Claim 6, the modified device of Liardet discloses the respiratory therapy device of claim 4 wherein the respiratory therapy device wherein is in the form of a one-way rubber stopper valve (See Liardet: col 5, ln 11-33).
Claim(s) 7, 9, 12-13, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liardet as applied to claims 1 and 18, respectively above, and further in view of Labaere (U.S. Pat. No. 5,193,529).
Regarding Claim 7, the modified device of Liardet discloses the respiratory therapy device of claim 1, shown above.
The modified device of Liardet does not specifically disclose wherein the respiratory therapy device wherein the respiratory therapy kit device includes positive expiratory pressure assemblythat is interchangeable with
Labaere teaches a respiratory therapy device comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
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 Liardet to include the a second oscillating positive expiratory pressure assembly that is interchangeable with the oscillating positive expiratory pressure assembly as taught by Labaere for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54).
Regarding Claim 9, the modified device of Liardet discloses the respiratory therapy device of claim 1, shown above.
The modified device of Liardet does not specifically disclose wherein the respiratory therapy device wherein includes a second oscillating positive expiratory pressure assembly that is interchangeable with the oscillating positive expiratory pressure assembly, and wherein the includes a second valve seat and a second weighted ball that provides airflow vibration as the second weighted ball oscillates over or adjacent to the second valve seat when actuated by the exhalation.
Labaere teaches a respiratory therapy kit comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11; col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) wherein the second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11) includes a second valve seat (7’; Fig. 11, 11) and a second weighted ball (26; Fig. 10, 11) that provides airflow vibration as the second weighted ball oscillates over or adjacent to the second valve seat when actuated by the exhalation (col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
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 Liardet to include the includes the second oscillating positive expiratory pressure assembly that is interchangeable with the oscillating positive expiratory pressure assembly, and wherein the second exhalation oscillatory valve includes a second valve seat and a second weighted ball that provides airflow vibration as the second weighted ball oscillates over or adjacent to the second valve seat when actuated by the exhalation as taught by Labaere for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54).
Regarding Claim 12, the modified device of Liardet discloses the respiratory therapy device of claim 1, shown above.
The modified device of Liardet does not specifically disclose the respiratory therapy device wherein the exhalation oscillatory valve is configured for interchanging the weighted ball for a second weighted ball, wherein the second weighted ball has a different size, density, weight, or a combination thereof compared to the weighted ball to provide a different level of oscillatory resistance, frequency response, amplitude, mean airflow pressure, or a combination thereof when actuated by exhalation.
Labaere teaches a respiratory therapy kit comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11; col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) wherein the exhalation oscillatory valve is configured for interchanging the weighted ball for a second weighted ball, wherein the second weighted ball has a different size, density, weight, or a combination thereof compared to the weighted ball to provide a different level of oscillatory resistance, frequency response, amplitude, mean airflow pressure, or a combination thereof when actuated by exhalation (col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
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 Liardet to include the exhalation oscillatory valve is configured for interchanging the weighted ball for a second weighted ball, wherein the second weighted ball has a different size, density, weight, or a combination thereof compared to the weighted ball to provide a different level of oscillatory resistance, frequency response, amplitude, mean airflow pressure, or a combination thereof when actuated by exhalation.as taught by Labaere for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54).
Regarding Claim 13, the modified device of Liardet discloses the respiratory therapy kit device wherein the exhalation oscillatory valve includes a removable cage or perforated cap (See Labaere: 23, 23’, 25; Fig. 6c, 6e, 8, 10, 11; col 5, ln 13-31; col 5, ln 43-67; col 6, ln 65 to col 7, ln 17) providing access to the weighted ball for interchanging with the second weighted ball (See Labaere: col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54).
Regarding Claim 19, the modified device of Liardet discloses the method of claim 18, shown above.
The modified device of Liardet does not specifically discloses the method respiratory therapy device further comprising at least partially disassembling the respiratory therapy device, and
replacing the inhalation oscillatory valve with a second one-way air intake valve that is different that the inhalation oscillatory valve;
inserting a between the airflow mixing chamber and the oscillating positive expiratory pressure assembly;
replacing the oscillating positive expiratory pressure assembly with a second oscillating positive expiratory pressure assembly;
replacing the oscillating positive expiratory pressure assembly with an airflow mouthpiece that does not include an exhalation oscillatory valve,
replacing a component of the exhalation oscillatory valve with a second component of the exhalation oscillatory valve; or a combination thereof.
Labaere teaches a method comprising a respiratory therapy device comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) and replacing: a component of the exhalation oscillatory valve with a second component of the exhalation oscillatory valve (col 5, ln 55-67; col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
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 method of the modified device of Liardet to include replacing the component of the exhalation oscillatory valve with a second component of the exhalation oscillatory valve as taught by Labaere for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54).
Regarding Claim 20, the modified device of Liardet discloses the method of claim 18 wherein the oscillating positive expiratory pressure assembly includes a valve seat (See Liardet: 5; Fig. 1, 4, 7; col 3, ln 63 to col 4, ln 14) for receiving the weighted ball and to allow expiratory air to oscillate the weighted ball over or adjacent to the valve seat when actuated by exhalation [See Liardet: col 1, ln 29-57; col 3, ln 63 to col 4, ln 14; Examiner notes: Liardet disclose the ball (6; Fig. 1, 2, 4, 7) as being weighted such that the gravitational force acting of the weight of the ball must be overcome to produce percussive ventilation (i.e. oscillating positive expiratory pressure).].
The modified device of Liardet does not specifically discloses the method respiratory therapy device wherein the method includes replacing the oscillating positive expiratory pressure assembly with a second oscillating positive expiratory pressure assembly or a component thereof to provide a second weighted ball having a different size, density, weight, or a combination thereof.
Labaere teaches a method comprising a respiratory therapy device comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) and wherein the method includes replacing the oscillating positive expiratory pressure assembly with a second oscillating positive expiratory pressure assembly or a component thereof (col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) to provide a second weighted ball (26; Fig. 10, 11) having a different size, density, weight, or a combination thereof (col 5, ln 55-67, col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
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 method of the modified device of Liardet to include replacing the oscillating positive expiratory pressure assembly with a second oscillating positive expiratory pressure assembly or a component thereof to provide a second weighted ball having a different size, density, weight, or a combination thereof as taught by Labaere for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liardet as applied to claim 8 above, and further in view of Labaere in view of Gao (U.S. Pat. No. 10,004,872).
Regarding Claim 10, the modified device of Liardet discloses the respiratory therapy device of claim 8, shown above.
The modified device of Liardet does not specifically disclose the respiratory therapy device wherein the respiratory therapy kit includes a second oscillating positive expiratory pressure assembly that is interchangeable with the oscillating positive expiratory pressure assembly, and wherein the
Labaere teaches a respiratory therapy device comprising an oscillating positive expiratory pressure assembly (5, 8, 7, 26; Fig. 1a-3a, 8, 10, 11); wherein the oscillating positive expiratory pressure assembly includes a user-interface opening (through 8; Fig. 1a, 2a, 3a, 8) and an exhalation oscillatory valve (5, 7, 26; Fig. 1a-3a, 8, 10, 11; col 5, ln 55-67) and a second exhalation oscillatory valve (5’, 7’, 26; Fig. 10, 11) interchangeable with the exhalation oscillatory valve or component thereof (col 6, ln 65 to col 7, ln 17; col 9, ln 14-54) for the purpose of providing varying resistance and alternating pattern in which the patient has to exhale against (col 9, ln 45-54).
Gao teaches an oscillating positive expiratory pressure assembly (30; Fig. 1-7) which comprises a exhalation oscillatory valve (40, 44; Fig. 1-7) having a stopper (44; Fig. 2, 4, 7) associated with an oscillating lever (40; Fig. 1-7) that opens and closes an airflow opening of a valve seat when actuated by exhalation (col 5, ln 18 to col 7, ln 31) for the purpose of providing an improved PEP module for respiratory therapy or to perform exercises to prevent pneumonia (col 2, ln 26-30).
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 Liardet to include the second oscillating positive expiratory pressure assembly that is interchangeable with the oscillating positive expiratory pressure assembly as taught by Labaere and include
the second oscillating positive expiratory pressure assembly which comprises the second exhalation oscillatory valve having the stopper associated with the oscillating lever that opens and closes the airflow opening of a second valve seat when actuated by exhalation as taught by Gao for the purpose of providing an improved PEP module for respiratory therapy or to perform exercises to prevent pneumonia (See Gao: col 2, ln 26-30) and providing varying resistance and alternating pattern in which the patient has to exhale against (See Labaere: col 9, ln 45-54)
Claim(s) 41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Liardet as applied to claim 1 above, and further in view of Adam et al. (U.S. Pub. No. 2013/0284171; hereinafter: “Adam”).
Regarding Claim 41, the modified device of Liardet discloses the respiratory therapy device of claim 1, shown above.
The modified device of Liardet does not specifically disclose the respiratory therapy device wherein adjusting an angle relationship between the exhalation oscillatory valve and to the airflow mixing channel modifies an oscillation frequency of the exhalation oscillatory valve.
Adam teaches an oscillating positive expiratory pressure system (Fig. 6-7) comprising an oscillating positive expiratory pressure assembly (300; Fig. 10-21; ¶¶ 0083-0090; Examiner notes Adam discloses the usability of the oscillating positive expiratory pressure assembly in the oscillating positive expiratory pressure system (Fig. 6-7; ¶ 0083).] having an exhalation oscillatory valve (320; Fig. 10-21) comprising a valve seat (318; Fig. 12-15), wherein at least the valve seat of the exhalation oscillatory valve is pivotable with respect to an airflow mixing channel (A, Fig. B annotated below) wherein adjusting an angle relationship between the exhalation oscillatory valve and to the airflow mixing channel modifies an oscillation frequency of the exhalation oscillatory valve (See Adam: Fig. 3-5, 11, 13-15, 29-33; ¶¶ 0077, 0104; Examiner notes: Adam discloses the when at angle of least the valve seat of the exhalation oscillatory valve is adjusted the oscillation frequency of the exhalation oscillatory valve will change and can be set according to the prescribed therapy.) for the purpose of maintaining alignment of at least the valve seat with the direction of gravity and thereby permitting the administration of therapy (¶¶ 0084, 0085).
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Figure B, Adapted from Figure 7 of Adam.
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 Liardet to include the adjusting an angle relationship between the exhalation oscillatory valve and to the airflow mixing channel modifies an oscillation frequency of the exhalation oscillatory valve as taught by Adam for the purpose of maintaining alignment of at least the valve seat with the direction of gravity and thereby permitting the administration of therapy (See Adam: ¶¶ 0084, 0085).
Regarding Claim 43, the modified device of Liardet discloses the respiratory therapy device of claim 1, shown above.
The modified device of Liardet does not specifically disclose the respiratory therapy device wherein the exhalation oscillatory valve and the inhalation oscillatory valve independently generate an oscillation frequency from 6 Hz to 20 Hz.
Adam teaches the oscillatory valve (320; Fig. 10-21) comprising a valve seat (318; Fig. 12-15), wherein the oscillatory valve generates an oscillation frequency from 10 Hz to 40 Hz (¶ 0065) for the purpose of adjusting the oscillation frequency of the oscillatory valve will change to be set according to the prescribed therapy (¶¶ 0077, 0104).
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 Liardet to include the inhalation oscillatory valve that generates the oscillation frequency from 10 Hz to 40 Hz as taught by Adam for the purpose of adjusting the oscillation frequency of the oscillatory valve will change to be set according to the prescribed therapy (See Adam: ¶¶ 0077, 0104).
The modified device of Liardet still does not explicitly disclose the respiratory therapy apparatus wherein the exhalation oscillatory valve and the inhalation oscillatory valve independently generate an oscillation frequency from 6 Hz to 20 Hz.
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 oscillation frequency of the modified device of Liardet from between 10 Hz and 40 Hz to between 6 Hz and 20 Hz as Applicant appears to have placed no criticality on the claimed range (Instant Spec.: Pg. 22, ln 8-31; Pg. 41, 29 to Pg. 42, ln 1; indicating the claimed range as merely exemplary with the recitation of “for example” and not indicating any unexpected results as a result of the claimed range.) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See MPEP: 2144.05(II)).
Allowable Subject Matter
Claims 21-39 are allowed.
Claims 3, 14-16, 40, and 42 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.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of Liardet, Guo, Labaere, and Gao alone or in combination fail to disclose or render obvious the respiratory therapy device:
“wherein the second one-way air intake valve is not an inhalation oscillatory valve.”, as recited in dependent claim 3.
“wherein at least the valve seat of the exhalation oscillatory valve is configured to be modified with respect to the airflow mixing channel by exterior manipulation to provide a modifiable angle relationship that remains stable regardless of orientation until acted upon by a user to adjust the modifiable angle relationship by said exterior manipulation.” , as recited in dependent claims 14 and 42.
“including the airflow mouthpiece for interchanging with the oscillating positive expiratory pressure assembly, wherein the airflow mouthpiece does not include an exhalation oscillatory valve.”, as recited in dependent claim 15 and independent claim 21.
“wherein the inhalation oscillatory valve is interchangeable with a one-way valve that is not an inhalation oscillatory valve.”, as recited in dependent claim 16.
“wherein the nebulizer includes a nebulizer chamber having a nebulizing volume where aerosolized liquid medicament is generated which is not part of an airflow mixing channel volume, and wherein the nebulizing volume to airflow mixing channel volume is from about 1:1 to about 1:10, and wherein at least 60 vol % of the aerosolized liquid medicament is inhaled by the user.”, , as recited in dependent claim 40.
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “the one-way air intake valve is positioned below the outflow opening” as recited in independent claim 1 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 Liardet, shown above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785