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 .
Claims Pending
Applicant's arguments, filed 10/17/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/17/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant's cancellation of claim 2 in the response filed 10/17/2025 and previous addition of claims 15-17 is acknowledged.
Claims 1 and 3-17 are the current claims hereby under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards an inflation cuff with an inlet connected to a non-invasive blood pressure measurement device, an inflatable bladder, and a valve that allows the cuff to inflate at a desired flow rate.
Claim(s) 1, 3-4, 6-12, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganske (US Pub. No. 20120265240) hereinafter Ganske, and further in view of Sano (US Pub. No. 20150182133) hereinafter Sano, Lamego (US Pub. No. 20140163402) hereinafter Lamego, and Hanna (US Pat. No. 6450966) hereinafter Hanna.
Regarding claim 1, Ganske discloses a cuff (Par. 48, cuff – 4) for use with an inflation-based non-invasive blood pressure (NIBP) measurement apparatus (Par. 43, controller – 8) (Par. 48, (“A user may then press start button 74 to initiate the treatment…” “with a desired pressure such as a pressure greater than the measured systolic blood pressure”)), the cuff (cuff – 4) comprising:
an inlet (Fig. 4, valve – 30 (inlet is at the valve)) configured to be coupled to an outlet (Fig. 9A, outlet – 48)(Par. 36 (in fluid communication)) of the inflationbased NIBP measurement apparatus to receive a flow of fluid (Par. 36, (“Valve 30 may be placed in sealed fluid communication with a corresponding structure 33 on controller attachment section 6 which may also be in sealed fluid communication with an outlet 48 of controller 8”));
a bladder (Par. 36, bladder -20) coupled to the inlet (Par. 36, (“Bladder 20 may have a valve 30 arranged and adapted to provide a fluid inlet to the interior of bladder 20”)) and inflatable to pressurize a measurement site of a subject (Par. 48, (“The treatment includes placing…” “…circuitry of PCB 66 monitors the pressure sensor and turns pump 62 on to inflate the cuff 4.”))(Par. 36).
Ganske highly suggests but fails to explicitly disclose a bladder inflatable by receiving the flow of fluid.
However, Ganske does teach providing gas to a bladder (Par. 36, “valve 30 may provide pressurized gas such as air to bladder 20”).
Sano teaches a bladder inflatable by receiving the flow of fluid (Par. 30).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske with that of Sano to include a bladder inflatable by receiving the flow of fluid through the substitution of the air bladder for the fluid bladder (Sano (Par. 190)) and it would have yielded the same or similar results.
Modified Ganske fails to explicitly disclose an operational valve disposed along a flow path between the inlet and the bladder or disposed on the bladder.
However, Lamego teaches an operational valve (Par. 56, Regulator – 103) (Par. 56, “regulator 103 and/or valve can be implemented using any number of different valves, such as a globe valve, butterfly valve, poppet valve, needle valve, etc., or any other type of valve capable of operating as a variable restriction to the gas flow.”) disposed along a flow path between the inlet (Par. 53, (output from reservoir – 102)) and the bladder (Par. 53, (bladder of inflatable cuff 104)) (Par. 53, “Thus, gas flows from the gas reservoir 102, through the regulator 103 to the bladder of the inflatable cuff 104.”) (Par. 76, “FIG. 1B illustrates a block diagram of gas pathways between different components of the patient monitoring system 100”) or disposed on the bladder.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske and Sano with that of Lamego to include an operational valve disposed along a flow path between the inlet and the bladder or disposed on the bladder through the combination of references as it would have yielded the predictable result of controlling the flow rate of the gas (Lamego (Par. 57)).
Modified Ganske fails to explicitly disclose wherein the operational valve has a fixed, predetermined flow resistance corresponding to a physical property of the cuff such that the operational valve passes part of the flow of fluid received in the bladder to an atmosphere to inflate the bladder at a required flow rate for inflating the cuff.
Sano further teaches wherein the operational valve has a fixed, predetermined flow resistance corresponding to the cuff such that the operational valve passes part of the flow of fluid received in the bladder to an atmosphere to inflate the bladder at a required flow rate for inflating the cuff (Par. 30-31 (“by controlling the driving of the flow control valve serving as the exhaust valve so that the internal pressure of the pressurizing fluid bladder increases slowly;”)(the flow rate is controlled by utilizing the exhaust valve)) (Fig. 2,16 (Cuff - 40, bladder - 42)) (Examiner's Note: fluid passes through the valve, which is connected to the fluid bladder in the cuff, and as such the valve has a fixed, predetermined flow resistance that corresponds to the cuff).
However, Hanna teaches wherein the valve has a fixed, predetermined flow resistance corresponding to a physical property of the cuff (Col. 6, lines 47-57, cuff plug – 30, gas-flow restrictor – 42, cuff – 20).
Ganske, Sano, Lamego, and Hanna are considered to be analogous art to the claimed invention as they are involved with inflatable bladders and blood pressure measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, and Lamego with that of Sano and Hanna to include wherein the operational valve has a fixed, predetermined flow resistance corresponding to a physical property of the cuff such that the operational valve passes part of the flow of fluid received in the bladder to an atmosphere to inflate the bladder at a required flow rate for inflating the cuff through the combination of references as differing valves are known in the art (Lamego (Par. 56)) and it would have yielded the predictable result of providing precise flow rate control of the fluid entering the bladder (Sano (Par. 31)) and sizing the valve to the cuff as it would have yielded the predictable result of customizing the size of the device based on different limb sizes of the user (Hanna (Col. 6, lines 47-57)).
Regarding claim 15, Ganske discloses A system for performing an inflation-based non-invasive blood pressure (NIBP) measurement of a subject (Par. 43, controller – 8 (determination of blood pressure)) (Par. 48, (“A user may then press start button 74 to initiate the treatment…” “with a desired pressure such as a pressure greater than the measured systolic blood pressure”)), the system comprising:
an inflation-based NIBP measurement apparatus (Par. 43, controller – 8 (determination of blood pressure)) (Par. 48, (“A user may then press start button 74 to initiate the treatment…” “with a desired pressure such as a pressure greater than the measured systolic blood pressure”)); and
an inflatable cuff (Par. 48, cuff – 4) configured to be placed around a limb of the subject (Par. 48 (cuff around the limb of the user)), the inflatable cuff comprising:
an inlet (Fig. 4, valve – 30 (inlet is at the valve)) configured to be coupled to an outlet (Fig. 9A, outlet – 48)(Par. 36 (in fluid communication)) of the inflationbased NIBP measurement apparatus to receive a flow of fluid (Par. 36, (“Valve 30 may be placed in sealed fluid communication with a corresponding structure 33 on controller attachment section 6 which may also be in sealed fluid communication with an outlet 48 of controller 8”));
a bladder (Par. 36, bladder -20) coupled to the inlet (Par. 36, (“Bladder 20 may have a valve 30 arranged and adapted to provide a fluid inlet to the interior of bladder 20”)) and inflatable to pressurize a measurement site of a subject (Par. 48, (“The treatment includes placing…” “…circuitry of PCB 66 monitors the pressure sensor and turns pump 62 on to inflate the cuff 4.”))(Par. 36).
Ganske highly suggests but fails to explicitly disclose a bladder inflatable by receiving the flow of fluid.
However, Ganske does teach providing gas to a bladder (Par. 36, “valve 30 may provide pressurized gas such as air to bladder 20”).
Sano teaches a bladder inflatable by receiving the flow of fluid (Par. 30).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ganske with that of Sano to include a bladder inflatable by receiving the flow of fluid through the substitution of the air bladder for the fluid bladder (Sano (Par. 190)) and it would have yielded the same or similar results.
Modified Ganske fails to explicitly disclose an operational valve disposed along a flow path between the inlet and the bladder or disposed on the bladder.
However, Lamego teaches an operational valve (Par. 56, Regulator – 103) (Par. 56, “regulator 103 and/or valve can be implemented using any number of different valves, such as a globe valve, butterfly valve, poppet valve, needle valve, etc., or any other type of valve capable of operating as a variable restriction to the gas flow.”) disposed along a flow path between the inlet (Par. 53, (output from reservoir – 102)) and the bladder (Par. 53, (bladder of inflatable cuff 104)) (Par. 53, “Thus, gas flows from the gas reservoir 102, through the regulator 103 to the bladder of the inflatable cuff 104.”) (Par. 76, “FIG. 1B illustrates a block diagram of gas pathways between different components of the patient monitoring system 100”) or disposed on the bladder.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ganske and Sano with that of Lamego to include an operational valve disposed along a flow path between the inlet and the bladder or disposed on the bladder through the combination of references as it would have yielded the predictable result of controlling the flow rate of the gas (Lamego (Par. 57)).
Modified Ganske fails to explicitly disclose wherein the operational valve has a fixed, predetermined flow resistance corresponding to a physical property of the inflatable cuff such that the operational valve passes part of the flow of fluid received in the bladder to the atmosphere to inflate the bladder at a required flow rate for inflating the inflatable cuff.
Sano further teaches wherein the operational valve has a fixed, predetermined flow resistance corresponding to the inflatable cuff such that the operational valve passes part of the flow of fluid received in the bladder to the atmosphere to inflate the bladder at a required flow rate for inflating the inflatable cuff (Par. 30-31 (“by controlling the driving of the flow control valve serving as the exhaust valve so that the internal pressure of the pressurizing fluid bladder increases slowly;”)(the flow rate is controlled by utilizing the exhaust valve))(Fig. 2,16 (Cuff - 40, bladder - 42)) (Examiner's Note: fluid passes through the valve, which is connected to the fluid bladder in the cuff, and as such the valve has a fixed, predetermined flow resistance that corresponds to the cuff).
However, Hanna teaches wherein the valve has a fixed, predetermined flow resistance corresponding to a physical property of the cuff (Col. 6, lines 47-57, cuff plug – 30, gas-flow restrictor – 42, cuff – 20).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Ganske, Sano, and Lamego with that of Sano and Hanna to include wherein the operational valve has a fixed, predetermined flow resistance corresponding to a physical property of the inflatable cuff such that the operational valve passes part of the flow of fluid received in the bladder to the atmosphere to inflate the bladder at a required flow rate for inflating the inflatable cuff through the combination of references as differing valves are known in the art (Lamego (Par. 56)) and it would have yielded the predictable result of providing precise flow rate control of the fluid entering the bladder (Sano (Par. 31)) and sizing the valve to the cuff as it would have yielded the predictable result of customizing the size of the device based on different limb sizes of the user (Hanna (Col. 6, lines 47-57)).
Regarding claim 3, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Hanna further teaches further discloses wherein the physical property of the cuff comprises any one or more of: a size of the cuff (as indicated in claim 1 above); an elasticity of the cuff; and a compliance of the cuff.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Hanna to include wherein the physical property of the cuff comprises any one or more of: a size of the cuff for the reasoning as indicated in claim 1 above.
Regarding claim 4, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Lamego further teaches wherein the predetermined flow resistance of the operational valve is defined based on a flow range of a pump configured to output the flow of fluid (Lamego (Par. 56 (flow based on the regulator))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Lamego to include wherein the predetermined flow resistance of the operational valve is defined based on a flow range of a pump configured to output the flow of fluid through the combination of references as it would have yielded the predictable result of identifying pressure levels leaving the reservoir to control the rate of flow (Lamego (Par. 56)).
Regarding claim 6, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Hanna further teaches wherein the operational valve has a diameter that defines the predetermined flow resistance of the operational valve (Hanna (Col. 6, lines 47-57, cuff plug – 30, gas-flow restrictor)).
Therefore, it would have been further obvious to modify the device of Ganske, Sano, Lamego, and Hanna with that of Hanna to include wherein the operational valve has a diameter that defines the predetermined flow resistance of the operational valve through the combination of references as it would have yielded the predictable result of customizing the size of the device based on different limb sizes based on the user (Hanna (Col. 6, lines 47-57)).
Regarding claim 7, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Lamego further teaches wherein the operational valve is a needle valve, a globe valve, a butterfly valve, or a poppet valve (Lamego (Par. 56, “the regulator 103 and/or valve can be implemented using any number of different valves, such as a globe valve, butterfly valve, poppet valve, needle valve, etc., or any other type of valve capable of operating as a variable restriction to the gas flow.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Lamego to include wherein the operational valve is a needle valve, a globe valve, a butterfly valve, or a poppet valve through the substitution of valve types as different valve types are known in the art (Lamego (Par. 56)) and would have yielded predictable results of controlling the flow rate (Lamego (Par. 56)).
Regarding claim 8, modified Ganske further discloses wherein the cuff comprises:
a deflation valve controllable to deflate the bladder (Ganske (Par. 48, (“the controller may activate valve 68 to deflate cuff 4 and initiate the reperfusion duration”))).
Regarding claim 9, modified Ganske further discloses A system (Ganske (abstract)) comprising:
at least one cuff (Ganske (abstract) (cuff - 4)) as claimed in claim 1 (as indicated in claim 1 above).
Regarding claim 10, modified Ganske further discloses wherein the system comprises:
the inflation-based NIBP measurement apparatus (Ganske (Par. 43, controller – 8) (Par. 48, (“A user may then press start button 74 to initiate the treatment…” “with a desired pressure such as a pressure greater than the measured systolic blood pressure”))).
Regarding claim 11, modified Ganske further discloses wherein the inflation-based NIBP measurement apparatus (Ganske (Par. 43, controller – 8)) comprises:
a deflation valve controllable to deflate the bladder (Ganske (Par. 48, (“the controller may activate valve 68 to deflate cuff 4 and initiate the reperfusion duration”))).
Regarding claim 16, modified Ganske teaches the device of claim 11 above, which comprises the system of claim 16. As the claims are similar, claim 16 is rejected in the same manner as claim 11.
Regarding claim 12, modified Ganske further discloses wherein the inflation-based NIBP measurement apparatus (Ganske (controller – 8)) comprises:
a pump configured to output the flow (Ganske (Par. 48)).
Modified Ganske fails to explicitly teach a pump configured to output the flow of fluid.
However, Sano further teaches a pump configured to output the flow of fluid (Sano (Par. 5)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Sano to include a pump configured to output the flow of fluid through the substitution of the air for the fluid (Sano (Par. 190)) and would have the yielded predictable result of providing precise control of the flow rate (Sano (Par. 31)).
Regarding claim 17, modified Ganske teaches the device of claim 12 above, which comprises the system of claim 17. As the claims are similar, claim 17 is rejected in the same manner as claim 12.
Regarding claim 14, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Hanna teaches a plurality of cuffs (Hanna (Col. 5, lines 9-10)), wherein at least two cuffs of the plurality of cuffs are of different sizes and the predetermined flow resistance of the operational valve of each of the at least two cuffs is different (Hanna (Col. 6, lines 47-57)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Hanna to include a plurality of cuffs, wherein at least two cuffs of the plurality of cuffs are of different sizes and the predetermined flow resistance of the operational valve of each of the at least two cuffs is different as varying cuff locations (Hanna (Col. 6, lines 11-15)) and the use of more than one cuff (Col. 1-2, lines 64-3) are known variations and would have yielded the predictable result of providing more than one location from which the blood pressure can be measured, ensuring optimal measurements and overall accuracy.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganske in view of Sano, Lamego, and Hanna as applied to claim 1 above, and further in view of Sato (US Pub. No. 20170156603) hereinafter Sato.
Ganske, Sano, Lamego, and Hanna teach the device of claim 1 above.
Regarding claim 5, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Sato teaches wherein the predetermined flow resistance of the operational valve is defined based on a target inflation rate for the cuff to reach for determining a blood pressure measurement for the subject (Par. 76).
Ganske, Sano, Lamego, Hanna, and Sato are considered to be analogous art to the claimed invention as they are involved with inflatable bladders and blood pressure measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Sato to include wherein the predetermined flow resistance of the operational valve is defined based on a target inflation rate for the cuff to reach for determining a blood pressure measurement for the subject through the combination of references as it would have yielded the predictable result of ensuring the optimal flow rate is achieved.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganske in view of Sano, Lamego, and Hanna as applied to claim 9 above, and further in view of Baron (US Pub. No. 20130060152) hereinafter Baron.
Ganske, Sano, Lamego, and Hanna teach the device of claim 9 above.
Regarding claim 13, modified Ganske fails to explicitly disclose the limitations of the claim.
However, Baron teaches wherein the system comprises a processor (Par. 184) configured to:
acquire a signal indicative of pressure oscillations detected in the cuff during inflation of the cuff(Par. 184); and
determine a blood pressure measurement for the subject based on the acquired signal(Par. 184).
Ganske, Sano, Lamego, Hanna, and Baron are considered to be analogous art to the claimed invention as they are involved with inflatable bladders and blood pressure measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ganske, Sano, Lamego, and Hanna with that of Baron to include wherein the system comprises a processor configured to: acquire a signal indicative of pressure oscillations detected in the cuff during inflation of the cuff; and determine a blood pressure measurement for the subject based on the acquired signal through the combination of references as it would have yielded the predictable result of providing a continuous measurement of BP values of a user (Baron (Par. 154)) and inform the user on the status of their vitals.
Response to Arguments
Applicant's arguments filed 10/17/2025, regarding the 103 rejection have been fully considered, but are moot in view of the newly applied rejection as a result of the applicant’s amendments to the claims.
Applicant's arguments filed 10/17/2025, regarding the previous 103 rejection, have been fully considered but they are not persuasive.
The applicant's argument, that the prior art does not teach the added limitations to claim, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation been addressed in the 103 rejection as indicated above.
The applicant’s argument, that the prior art does not teach that the operational valve is selected based on physical properties of the cuff has been fully considered and deemed as not persuasive. As indicated in the 103 rejection above, Hanna teaches wherein the valve has a fixed, predetermined flow resistance corresponding to a physical property of the cuff (Col. 6, lines 47-57, cuff plug – 30, gas-flow restrictor – 42, cuff – 20). As such, the rejection is maintained.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant's arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
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 ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571) 272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARI S PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791