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 .
Status of the Claims
This office action is responsive to the amendment filed on 03/31/2026. As directed by the amendment: claims 1, 3-5, and 7-8 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The term “continuous leak” from line 18 of claim 1 must be set forth and defined by the specification without the addition of new matter not supported by the original disclosure.
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.
Claims 1-9, 12, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tarler (US 10226591 B1) in view of Ahmad (US 20140326242 A1).
Regarding claim 1, Tarler discloses a respiratory support apparatus (The rebreathing circuit set forth in the Abstract and column 16 lines 21-24 as shown in FIG. 2) configured to provide a gases flow to a patient (FIG. 2 Gas is delivered by the delivery air hose 166 of the delivery device as set forth in column 16 lines 34-35), the respiratory support apparatus comprising: a flow generator (FIG. 2 pressurized air generator 162 as set forth in column 17 lines 5-7) configured to generate the gases flow and comprising a flow generator inlet (FIG. 2 Regulatory valve 178 from second input port 172 as set forth in column 17 lines 5-7) and a flow generator outlet (FIG. 2 output port 180 as set forth in column 17 line 16), the flow generator being configured to draw inspiratory gases in through the flow generator inlet (FIG. 2 Pressurized air generator 162 pressurizes air leaving the mixing chamber 158 to a pressure greater than atmospheric pressure as well as helps pull air into and through the mixing chamber 158 as set forth in column 17 lines 7-12) , and to deliver the gases flow through the flow generator outlet (FIG. 2 The output port 180 of the PAP device 156 is connected to the delivery device at the distal end of the air delivery hose 166 such that pressurized air is preferably forced into and through the air delivery hose 166 and eventually into the oronasal mask 152 as set forth in column 17 lines 16-22);
a patient interface (FIG. 2 Oronasal mask 152 as set forth in column 16 line 39) configured to be mounted on the patient and to receive the gases flow from the flow generator outlet to deliver the gases flow to the patient (FIG. 2 The output port 180 of the PAP device 156 is connected to the delivery device at the distal end of the air delivery hose 166 such that pressurized air is preferably forced into and through the air delivery hose 166 and eventually into the oronasal mask 152 connected at the proximal end of the air delivery hose where it can then be inhaled by the subject 150 as set forth in column 17 lines 16-22);
an expiratory conduit (FIG. 2 Air capture hose 154 as set forth in column 16 line 33) configured to extend between, and be in fluid communication with, a region at or adjacent the patient interface (As shown in FIG. 2) and the flow generator inlet (FIG. 2 Air capture hose 154 leads to input port 170, which is connected to mixing chamber 158, which connects to regulatory valve 178 as set forth in column 16 line 58 – column 17 line 7 and shown in the figure), to provide a flow path for expiratory gases between the region at or adjacent the patient interface and the flow generator inlet (As set forth in as set forth in column 16 line 66 – column 17 line 7);
wherein the generation by the flow generator of the gases flow also generates forces in the expiratory conduit, such that the flow generator forces expiratory gases along the expiratory conduit from the region at or adjacent the patient interface (FIG. 2 Air generator 162 helps pull air into and through the mixing chamber 158 as set forth in column 17 lines 7-11; the mixing chamber being connected to the air capture hose 154 through input port 170);
Tarler fails to explicitly disclose, wherein the respiratory support apparatus comprises a leak port or a valve configured to provide a controlled continuous leak of the gases flow between the flow generator outlet and the patient interface.
However, Ahmad teaches wherein the respiratory support apparatus (Ahmad: FIG. 1 System 100 as set forth in [0017]) comprises a leak port or a valve (Ahmad: FIG.1 First exhaust valve 181 as set forth in [0017]) configured to provide a controlled continuous leak of the gases flow (Ahmad: FIG. 1 First exhaust valve 181 may be configured to exhaust gas selectively from delivery circuit 180 as set forth in [0017]; controlled by valve control module 112 as set forth in [0033]; Examiner’s Note: A "continuous leak" is being interpreted to mean an uninterrupted leak occurring during a predetermined time frame or at a predetermined threshold. In the case of Tarler as modified by Ahmad, wherein the pressure rises above a threshold level as set forth in [0017] or when in the rebreathing therapy mode, during the exhalation phase as set forth in [0020]) between the flow generator outlet (Ahmad: FIG. 1 Inhalation valve 141 set forth in [0015]) and the patient interface (Ahmad: FIG.1 Interface appliance 184 set forth in [0015]).
Tarler and Ahmad are both considered to be analogous to the claimed invention because they are in the same field of systems for providing a ventilator for partial CO2 rebreathing. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the air delivery hose at the flow generator outlet and the control system of Tarler to incorporate the teaching of Ahmad and include wherein the respiratory support apparatus (Ahmad: FIG. 1 System 100 as set forth in [0017]) comprises a leak port or a valve (Ahmad: FIG.1 First exhaust valve 181 as set forth in [0017]) configured to provide a controlled leak of the gases flow (Ahmad: FIG. 1 First exhaust valve 181 may be configured to exhaust gas selectively from delivery circuit 180 as set forth in [0017]; controlled by valve control module 112 as set forth in [0033]) between the flow generator outlet (Ahmad: FIG. 1 Inhalation valve 141 set forth in [0015]) and the patient interface (Ahmad: FIG.1 Interface appliance 184 set forth in [0015]). Doing so would allow for gas to be exhausted from the breathing circuit responsive to pressure rising unexpectedly to provide relief for the subject 106 and to protect the flow generator from excess pressure (Ahmad: As set forth in [0017])
Regarding claim 2, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further teaches, wherein the leak port or the valve is provided at the flow generator outlet at a location that is upstream of the patient interface (Ahmad: FIG. 1 First exhaust valve 181 may be configured to exhaust gas selectively from delivery circuit 180 as set forth in [0017], at the flow generator outlet as set forth in the rejection above for claim 1).
Regarding claim 3, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified further disclose, wherein the patient interface comprises a mask (FIG. 1 Oronasal mask 152).
Tarler as modified fails to explicitly disclose, wherein the leak port or the valve is provided at the nasal cannula or the sealed mask.
However, Ahmad teaches wherein a leak port or valve is provided at the sealed mask (Ahmad: FIG. 1 Second exhaust valve 188 may be located along delivery circuit 180 between the airway of subject 106 and first exhaust point 181a, which would include a position at the sealed mask, where the second exhaust valve 188 may fluidly couple delivery circuit 180 to ambient air, or to an inlet of pressure generator 140 via conduit 182, or to subject interface appliance 184, and/or to another component of system 100 as set forth in [0018]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve location of Tarler as modified to incorporate the teaching of Ahmad and include wherein the leak port or the valve is provided at the sealed mask (Ahmad: FIG. 1 Second exhaust valve 188 may be located along delivery circuit 180 between the airway of subject 106 and first exhaust point 181a, which would include a position at the sealed mask, where the second exhaust valve 188 may fluidly couple delivery circuit 180 to ambient air, or to an inlet of pressure generator 140 via conduit 182, or to subject interface appliance 184, and/or to another component of system 100 as set forth in [0018]). Doing so provides an alternative leak port location closer to the patient’s airway (Ahmad: As set forth in [0018]).
Regarding claim 4, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further discloses wherein the leak port or the valve is configured to be controlled (Ahmad: As set forth in [0033]; where the valve can be closed, opened, or in reference to the second exhaust valve, partially closed, all which would result in a different amount of gas leaking from the gases flow).
Tarler as modified fails to explicitly disclose, wherein the leak port or the valve is configured to leak specifically, between 5 and 50% of the gases flow.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the valve control means of the device of Tarler as modified by Ahmad to leak specifically, between 5 and 50% of the gases flow, for the purpose of providing the desired amount of gas leak from the inspiratory path that could account for excess exhalation, and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that between 5 and 50% provides an advantage, is used for a particular purpose, or solves a stated problem, and simply states that the leak port or valve may be configured to leak between 5 and 50% of the high flow of gases, in some examples between 15 and 40%, and in other examples around 30%, see [0018] in the specification, and that the leak port can be configured to allows for additional leak to be allowed for a patient who frequently sneezes, or who otherwise has periods of excess exhalation as stated in [0289]). Further it appears Tarler as modified by Ahmad would perform equally well with the recited valve control abilities. MPEP 2144.05(II).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A) as to the specific percentage of leakage from the gases flow when provided a need to ensure a desired leak rate is achieved that accounts for excess exhalation.
Regarding claim 5, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further discloses wherein the leak port or the valve is configured to leak a predetermined flow rate of the gases flow (Ahmad: The predetermined flow rate would be the rate of flow that occurs when the exhaust valve is completely open or fully/partially closed as a result of the control parameters set by the valve control module to exhaust exhaled gas from the delivery circuit as set forth in [0003]).
Regarding claim 6, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Tarler as modified fails to explicitly disclose, wherein the predetermined flow rate of the gases flow is between 15 L/min and 25 L/min.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the valve control means of the device of Tarler as modified by Ahmad to leak specifically, at predetermined flow rate between 15 L/min and 25 L/min, for the purpose of providing the desired amount of gas leak from the inspiratory path that could account for excess exhalation, and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that between 15 L/min and 25 L/min provides an advantage, is used for a particular purpose, or solves a stated problem, and simply states that the leak port can be configured to allow for additional leak to be allowed for a patient who frequently sneezes, or who otherwise has periods of excess exhalation as stated in [0289]). Further it appears Tarler as modified by Ahmad would perform equally well with the recited valve control abilities. MPEP 2144.05(II).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A) as to the specific flow rate of leakage from the gases flow when provided a need to ensure a desired leak rate is achieved that accounts for excess exhalation.
Regarding claim 7, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further discloses wherein the leak port or the valve is configured to leak a predetermined proportion of the gases flow (Ahmad: The predetermined proportion would be the proportion of the gas flow that leaks when the exhaust valve is completely open or fully/partially closed as a result of the control parameters set by the valve control module to exhaust exhaled gas from the delivery circuit as set forth in [0003]).
Regarding claim 8, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further discloses wherein the leak port or the valve is configured to vary an amount of the gases flow that leaks through the leak port or the valve (Ahmad: The exhaust valve in a completely open or fully/partially closed state as a result of the control parameters set by the valve control module to exhaust exhaled gas from the delivery circuit as set forth in [0003]; would indicate a variance in the amount of gas leaking through the port).
Regarding claim 9, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified further discloses, wherein the flow generator inlet (FIG. 2 Regulatory valve 178 from second input port 172) comprises an ambient inlet configured to receive ambient air (FIG. 2 Input ports 172 for dilutive gas 108, which may include fresh air, as set forth in column 16 lines 5-6).
Regarding claim 12, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified further discloses, wherein the flow generator is configured to recirculate expiratory gases received from the expiratory conduit into the gases flow (FIG. 2 Air generator 162 helps pull air into and through the mixing chamber 158 as set forth in column 17 lines 7-11; the mixing chamber being connected to the air capture hose 154 through input port 170, expiratory gases being in the air capture hose).
Regarding claim 16, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified further discloses, further comprising an inspiratory conduit configured to provide an inspiratory gases flow path for the gases flow between the flow generator outlet and the patient interface (FIG. 2 Air delivery hose 166).
Regarding claim 20, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified by Ahmad further teaches, further comprising a plurality of valves (FIG. 2 Regulatory valves 174, 176, 178 as set forth in column 17 line 12, as well as the exhaust valve of Ahmad as shown in the rejection for claim 1 above).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tarler (US 10226591 B1) in view of Ahmad (US 20140326242 A1) as applied to claim 9, in view of Briend (US 5651358 A).
Regarding claim 10, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Tarler as modified fails to explicitly disclose that in addition to the ambient air inlet, the flow generator inlet comprises a supplemental gases inlet configured to receive supplemental gases.
However, Briend teaches the flow generator inlet (Briend: FIG. 1 Respirator 1 supplies the flow of respiratory gas as set forth in column 2 lines 41-42) comprises a supplemental gases inlet configured to receive supplemental gases as well as an air inlet (Briend: FIG. 1 Oxygen inlet 5 and an air inlet 6 as set forth in column 2 lines 18-22).
Tarler and Briend are both considered to be analogous to the claimed invention because they are in the same field of respiratory apparatuses. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inlet of Tarler to incorporate the teaching of Briend and include wherein the flow generator inlet (Briend: FIG. 1 Respirator 1 supplies the flow of respiratory gas as set forth in column 2 lines 41-42) comprises a supplemental gases inlet configured to receive supplemental gases as well as an air inlet (Briend: FIG. 1 Oxygen inlet 5 and an air inlet 6 as set forth in column 2 lines 18-22). Doing so means that the respiratory mixture will be enriched with oxygen (Briend: As set forthin column 2 lines 35-39); in which the therapeutic benefits are well known in the art of the claimed invention.
Regarding claim 11, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tarler as modified by Briend further teaches, wherein the supplemental gases comprise concentrated oxygen (Briend: FIG. 1 Oxygen inlet 5 as set forth in column 2 lines 18-22).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tarler (US 10226591 B1) in view of Ahmad (US 20140326242 A1) as applied to claim 1, in view of Cewers (US 5694924 A).
Regarding claim 13, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified fails to explicitly disclose a filter located between the patient interface and the flow generator and that is configured to filter the expiratory gases.
However, Cewers teaches a filter (Cewers: FIG. 1 Carbon dioxide absorber as set forth in column 5 lines 51-55) located between the patient interface (Cewers: FIG. 1 Where the anesthetic system 2 is connected to a patient 4) and the flow generator (Cewers: FIG. 1 The bellows 18 mechanically connected to a control rod 20 operated by a servo-motor 22 as set forth in column 4 lines 39-40) and that is configured to filter the expiratory gases (Cewers: FIG. 1 Carbon dioxide absorber 12 that filters out carbon dioxide from the exhaled gas as set forth in column 5 lines 51-55).
Tarler and Cewers are both considered to be analogous to the claimed invention because they are in the same field of closed breathing circuits providing ventilation to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expiratory pathway of Tarler to incorporate the teaching of Cewers and include wherein a filter (Cewers: FIG. 1 Carbon dioxide absorber as set forth in column 5 lines 51-55) located between the patient interface (Cewers: FIG. 1 Where the anesthetic system 2 is connected to a patient 4) and the flow generator (Cewers: FIG. 1 The bellows 18 mechanically connected to a control rod 20 operated by a servo-motor 22 as set forth in column 4 lines 39-40) and that is configured to filter the expiratory gases (Cewers: FIG. 1 Carbon dioxide absorber 12 that filters out carbon dioxide from the exhaled gas as set forth in column 5 lines 51-55). Doing so allows for excess carbon dioxide to be absorbed from the expiratory gas (Cewers: As set forth in column 5 lines 51-55); which would be utilized in provided a desired gas mixture to the patient.
Regarding claim 14, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tarler as modified fails to explicitly disclose a gases scrubber that is located between the patient interface and the flow generator and that is configured to scrub the expiratory gases.
However, Cewers teaches a gases scrubber (Cewers: FIG. 1 Carbon dioxide absorber as set forth in column 5 lines 51-55) that is located between the patient interface (Cewers: FIG. 1 Where the anesthetic system 2 is connected to a patient 4) and the flow generator (Cewers: FIG. 1 The bellows 18 mechanically connected to a control rod 20 operated by a servo-motor 22 as set forth in column 4 lines 39-40) and that is configured to scrub the expiratory gases (Cewers: FIG. 1 Carbon dioxide absorber 12 that filters out carbon dioxide from the exhaled gas as set forth in column 5 lines 51-55).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expiratory pathway of Tarler to incorporate the teaching of Cewers and include wherein a filter (Cewers: FIG. 1 Carbon dioxide absorber as set forth in column 5 lines 51-55) located between the patient interface (Cewers: FIG. 1 Where the anesthetic system 2 is connected to a patient 4) and the flow generator (Cewers: FIG. 1 The bellows 18 mechanically connected to a control rod 20 operated by a servo-motor 22 as set forth in column 4 lines 39-40) and that is configured to filter the expiratory gases (Cewers: FIG. 1 Carbon dioxide absorber 12 that filters out carbon dioxide from the exhaled gas as set forth in column 5 lines 51-55). Doing so allows for excess carbon dioxide to be absorbed from the expiratory gas (Cewers: As set forth in column 5 lines 51-55); which would be utilized in provided a desired gas mixture to the patient.
Regarding claim 15, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 14 above.
Tarler as modified by Cewers further teaches, wherein the gases scrubber is a C02 scrubber (Cewers: FIG. 1 Carbon dioxide absorber 12 that filters out carbon dioxide from the exhaled gas as set forth in column 5 lines 51-55).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tarler (US 10226591 B1) in view of Ahmad (US 20140326242 A1) as applied to claim 16, in view of Kolkowski (US 8720439 B1).
Regarding claim 17, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Tarler as modified fails to explicitly disclose a humidifier that is configured to humidify the gases flow of gases.
However, Kolkowski teaches a humidifier that is configured to humidify the gases flow of gases (Kolkowski: FIG. 1 a humidifier 10 is included in the CPAP system as set forth in column 5 lines 58-61).
Tarler and Kolkowski are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits providing ventilation to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inspiratory pathway of Tarler to incorporate the teaching of Kolkowski and include a humidifier that is configured to humidify the gases flow of gases (Kolkowski: FIG. 1 a humidifier 10 is included in the CPAP system as set forth in column 5 lines 58-61). Doing so would prevent the effects of dryness like bleeding, swelling, excess mucous, congestion, or sneezing (Kolkowski: As set forth in column 1 lines 40-50).
Regarding claim 18, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Tarler as modified is silent as to the configuration of the humidifier in relation to the leak port and fails to explicitly disclose, wherein the leak port or the valve is located upstream of the humidifier.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to configure the device to wherein the leak port or the valve is located upstream of the humidifier in the device of Tarler as modified because Applicant has not disclosed that the specific configuration 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 configuration of modified Tarler, and Applicant' s configurations, to perform equally well because both mechanisms perform the same function of humidifying the gas delivered to the patient’s airway.
Therefore, it would have been prima facie obvious to further modify Tarler as modified to obtain the invention as specified in claim 18, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired humidification of gas and thus fails to patentably distinguish over the prior art of Tarler as modified.
Regarding claim 19, Tarler as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Tarler as modified is silent as to the configuration of the humidifier in relation to the leak port and fails to explicitly disclose, wherein the leak port or the valve is located downstream of the humidifier.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to configure the device to wherein the leak port or the valve is located downstream of the humidifier in the device of Tarler as modified because Applicant has not disclosed that the specific configuration 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 configuration of modified Tarler, and Applicant' s configurations, to perform equally well because both mechanisms perform the same function of humidifying the gas delivered to the patient’s airway.
Therefore, it would have been prima facie obvious to further modify Tarler as modified to obtain the invention as specified in claim 19, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired humidification of gas and thus fails to patentably distinguish over the prior art of Tarler as modified.
Response to Arguments
The rejections under 35 U.S.C. 112(b) have been withdrawn.
Applicant's arguments are drawn to amended claim 1, further defining the leak as continuous.
However, the term "continuous leak" is not defined by the specification and therefore the BRI will be taken. The scope of claims in patent applications not solely determined on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). The claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." Hence, a "continuous leak" is being interpreted to mean an uninterrupted leak occurring during a predetermined time frame or at a predetermined threshold. In the case of Tarler as modified by Ahmad, wherein the pressure rises above a threshold level as set forth in [0017] or when in the rebreathing therapy mode, during the exhalation phase as set forth in [0020].
Applicant argues that Ahmad does not tech or suggest a continuous leak throughout all phases of breathing.
However, it is noted that the features upon which applicant relies (i.e., a continuous leak throughout all phases of breathing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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