DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 5/22/23 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because document D4 is not in English and does not include an English translation. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections – 35 USC 102 (AIA )
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 15, 19-24, and 38-40 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2005/0131307 A1 to RUITER.
Regarding claim 1, RUITER teaches a system, comprising:
a patient simulator having a simulated body portion (simulator with body portion 100, Fig 1, taught simulating the blood pressure of a patient, Para [0016]: 'The preferred embodiment presented herein is an oscillometric blood pressure simulator 100');
an air pressure sensor positioned within the simulated body portion (136, Fig 1, Para [0020]: 'The pressure induced in the cuff 152 is concurrently measured by the pressure feedback mechanism, i.e., the pressure sensor 136');
a first air chamber positioned within the patient simulator, the first air chamber in communication with the air pressure sensor (air chamber 104, Fig 1, shown connected to sensor 136 via tubing 126, Para [0019]: 'In the preferred embodiment, the displacement of the follower 112 drives the slider 118 up and down within the housing 102, thereby adapting the slider to serve as a piston 120 for exerting a force against the pneumatic chamber 104.');
a mechanism for selectively contacting the first air chamber (118, 106, Fig 1, Para [0019]: 'In the preferred embodiment, the displacement of the follower 112 drives the slider 118 up and down within the housing 102, thereby adapting the slider to serve as a piston 120 for exerting a force against the pneumatic chamber 104.'); and
an adapter positioned outside the patient simulator, the adapter in communication with the air pressure sensor and configured to be in communication with an air line of an automated pressure monitoring apparatus (adapter 142. Fig 1, shown outside 100 connecting air line 140 in communication with air pressure sensor with air lines connected to 152 and 153).
Regarding claim 2, RUITER further teaches wherein the mechanism for selectively contacting the first air chamber is configured to contact the first air chamber to provide a simulated pulse (the actuator are taught simulating a pulse, Para [0023]: ‘the microprocessor 132 causes the drive circuit 134 to turn the cam 106 in a CCW direction wherein the piston 120 deforms the pneumatic chamber 104, thus introducing the first pressure pulse 206. The direction of the cam 106 is reversed after the cuff pressure 302 has been increased by the magnitude of the first pressure pulse 206 given in FIG. 2. As the cuff pressure continues to decrease under the control of the pressure regulator 154, the magnitude of the pressure pulses injected by the actuator control mechanism increases in accordance with the oscillometric envelope 204 until the ambient cuff pressure equals the simulated mean pressure 310 which coincides with the mean pressure point 210’).
Regarding claim 15, RUITER further teaches wherein the mechanism for selectively contacting the first air chamber is configured to contact the first air chamber with varying amounts of force to provide the simulated pulse (the magnitude of force provided by the actuator is taught being varied, Para [0023]: 'As the cuff pressure further decreases, the actuator control mechanism further reduces the magnitude of the pressure pulses until the last pulse 208 is injected and the ambient cuff pressure falls below the simulated diastolic pressure 314.').
Regarding claim 19, RUITER further teaches wherein the adapter is configured to connect the air pressure sensor to the air line of the automated pressure monitoring apparatus such that the air pressure sensor can monitor an air pressure generated by the automated pressure monitoring apparatus (Fig 1, adapter 142 is shown connecting air line in communication with air pressure sensor 136 to pressure regulator 154, Para [0018]: 'The collective pressure induced by the pressure regulator 154 and the pressure pulses induced by the bi-directional actuator are therefore sensed by the BP monitor 153 as well as the pressure feedback mechanism.').
Regarding claim 20, RUITER further teaches wherein the adapter is in communication with the air pressure sensor via tubing (Para [0018]: 'Both the actuator housing 102 and control housing 130 are pneumatically coupled to the cuff 152 and BP monitor 153 by means of a pneumatic conduit 126 and extension hose 140').
Regarding claim 21, RUITER further teaches the automated pressure monitoring apparatus, wherein: the automated pressure monitoring system comprises a cuff, a monitor, and the air line (cuff 152, air lines 140, 156, line between 154, 142, and monitor 153, Para [0017]: 'a blood pressure (BP) monitor 153 including a pressure regulator 154 and a pressure display unit 155. The cuff 152 and BP monitor 153 are pneumatically coupled via an elastic hose 156 and T-connector 142. The pressure regulator 154 is adapted to pressurize the cuff 152 above a patient's systolic pressure'); and
the adapter is coupled with the air line such that the cuff and the monitor are in fluid communication through the air line and the adapter (adapter 142, shown connecting air line 140, cuff 152, or monitor 153).
Regarding claim 22, RUITER further teaches wherein the adapter is coupled to a first portion of the air line extending between the adapter and the monitor and coupled to a second portion of the air line extending between the adapter and the cuff (adapter 142 coupled to portion of air line connecting 142, 153, Fig 1) and coupled to a second portion of the air line extending between the adapter and the cuff (adapter 142 coupled to air line between 142, 154, Fig 1).
Regarding claim 23, RUITER teaches a method, comprising:
providing a patient simulator having a simulated body portion (simulator with body portion 100, Fig 1, taught simulating the blood pressure of a patient, Para [0016]: 'The preferred embodiment presented herein is an oscillometric blood pressure simulator 100'), an air pressure sensor (136, Fig 1, Para [0020]: 'The pressure induced in the cuff 152 is concurrently measured by the pressure feedback mechanism, i.e., the pressure sensor 136'), a first air chamber (air chamber 104, Fig 1, Para [0019]: 'In the preferred embodiment, the displacement of the follower 112 drives the slider 118 up and down within the housing 102, thereby adapting the slider to serve as a piston 120 for exerting a force against the pneumatic chamber 104.'), and a mechanism for selectively contacting the first air chamber (118, 106, Fig 1, Para [0019]: 'In the preferred embodiment, the displacement of the follower 112 drives the slider 118 up and down within the housing 102, thereby adapting the slider to serve as a piston 120 for exerting a force against the pneumatic chamber 104.');
connecting an air line of an automated pressure monitoring apparatus to the air pressure sensor of the patient simulator (air line shown connecting 153 to 136 using adapter 142, Para [0018]: 'Both the actuator housing 102 and control housing 130 are pneumatically coupled to the cuff 152 and BP monitor 153 by means of a pneumatic conduit 126 and extension hose 140'); and
simulating a blood pressure of the patient simulator (simulating a blood pressure is taught, Para [0004]: 'The invention in the preferred embodiment features a system for generating pulses having a user-defined waveform to simulate the pressure waves acquired by a blood pressure cuff and transmitted to a blood pressure (BP) monitor') using at least the air pressure sensor (Para [0020]: 'The pressure induced in the cuff 152 is concurrently measured by the pressure feedback mechanism, i.e., the pressure sensor 136, and the sensed pressure signal 160 transmitted to the actuator control mechanism in real-time via the amplifier 138', the sensor is used in simulating the pulse), the first air chamber, and the mechanism for selectively contacting the first air chamber (the air chamber and mechanism are taught being used in the simulation, Para [0023]: 'the microprocessor 132 causes the drive circuit 134 to turn the cam 106 in a CCW direction wherein the piston 120 deforms the pneumatic chamber 104, thus introducing the first pressure pulse 206. The direction of the cam 106 is reversed after the cuff pressure 302 has been increased by the magnitude of the first pressure pulse 206 given in FIG. 2. As the cuff pressure continues to decrease under the control of the pressure regulator 154, the magnitude of the pressure pulses injected by the actuator control mechanism increases in accordance with the oscillometric envelope 204 until the ambient cuff pressure equals the simulated mean pressure 310 which coincides with the mean pressure point 210').
Regarding claim 24, RUITER further teaches wherein the simulating the blood pressure of the patient simulator comprises: simulating a pulse of the patient simulator by selectively contacting the first air chamber with the mechanism for selectively contacting the first air chamber (actuator contacts the air chamber with the mechanism with selective magnitudes, Para [0023]: 'As the cuff pressure further decreases, the actuator control mechanism further reduces the magnitude of the pressure pulses until the last pulse 208 is injected and the ambient cuff pressure falls below the simulated diastolic pressure 314.').
Regarding claim 38, RUITER further teaches wherein the connecting the air line of the automated pressure monitoring apparatus to the air pressure sensor of the patient simulator comprises connecting an adapter to the air line of the automated pressure monitoring apparatus such that the air pressure sensor can monitor an air pressure generated by the automated pressure monitoring apparatus (Fig 1, adapter 142 is shown connecting air line in communication with air pressure sensor 136 to pressure regulator 154, allowing the sensor lo measure the air pressure in the tubing connected to the automated pressure monitoring apparatus, Para [0018]: 'The collective pressure induced by the pressure regulator 154 and the pressure pulses induced by the bi-directional actuator are therefore sensed by the BP monitor 153 as well as the pressure feedback mechanism.').
Regarding claim 39, RUITER further teaches wherein the connecting the air line of the automated pressure monitoring apparatus to the air pressure sensor of the patient simulator further comprises having tubing extend between the adapter and the air pressure sensor (Para [0018]: 'Both the actuator housing 102 and control housing 130 are pneumatically coupled to the cuff 152 and BP monitor 153 by means of a pneumatic conduit 126 and extension hose 140').
Regarding claim 40, RUITER further teaches wherein the connecting the adapter to the air line of the automated pressure monitoring apparatus comprises: coupling a first portion of the air line extending from a monitor of the automated pressure monitoring apparatus to the adapter (adapter 142 coupled to first portion of air line connecting 142, 153, Fig 1); and coupling a second portion of the air line extending from a cuff of the automated pressure monitoring apparatus to the adapter (adapter 142 coupled to second air line portion between 142, 154, Fig 1).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-18 and 37 are rejected under 35 U.S.C. 103 as being obvious over RUITER in view of US 5,027,641 A to COSTELLO.
Regarding claim 16, RUITER teaches the elements above and additionally the apparatus simulating pressure that is measured by a cuff meant to be worn on an arm (Para [0017]: 'An exemplary device under test is represented by the pressure sensing system 150 which includes an inflatable cuff 152 adapted to engage the patient's arm or wrist'), but does not expressly disclose wherein the simulated body portion includes a simulated arm. However, COSTELLO teaches wherein a part of a simulated blood pressure apparatus can be shaped in the general shape of an arm to support a cuff (12, Fig 4, Col 4, lines 2-7: 'The simulator 10 is housed in a cylindrical enclosure 12 with a control console 14 (containing switches and an alphanumeric readout) on the top face 16 of enclosure 12. The cylindrical shape of closure 12 provides a convenient post for wrapping an arm cuff 18 from an oscillometer 20 to be tested'). Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the simulated body of RUITER in the cylindrical shape as taught by COSTELLO in order to provide a means to support a cuff during testing.
Regarding claim 17, RUITER teaches the elements above, and additionally the sensor connected via lubing (sensor 136, tubing 126, Fig 1), but does not expressly disclose wherein the air pressure sensor is positioned within an upper portion of the simulated arm. While RUITER in view of COSTELLO do not specify the position of the air pressure sensor within the arm, it is known that it would have been obvious to try, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, to have arrived at wherein the sensor is placed in an upper portion of the arm. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed the sensor in an upper portion of the simulated arm in the modified device of RUITER in order to provide an efficient arrangement of components within the simulated arm.
Regarding claim 18, RUITER teaches the elements above, but does not expressly disclose wherein the first air chamber is positioned within the simulated arm. However, COSTELLO further teaches the simulated body 100 (Fig 1) as shown containing chamber 104, is taught being provided in the shape of simulated arm, as seen at 12, Fig 4. Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the arm-shaped simulated body containing a chamber as taught by COSTELLO into the simulated body of RUITER in order to provide an efficient arrangement of components within the simulated arm.
Regarding claim 37, RUITER teaches the elements above and additionally the apparatus simulating pressure that is measured by a cuff meant to be worn on an arm (Para [0017]: 'An exemplary device under test is represented by the pressure sensing system 150 which Includes an inflatable cuff 152 adapted to engage the patient's arm or wrist'), but does not expressly disclose wherein the simulated body portion includes a simulated arm and the air pressure sensor is positioned within an upper portion of the simulated arm; and further comprising: positioning a cuff of the automated pressure monitoring apparatus around the simulated arm, wherein the cuff is in communication with the air line of the automated pressure monitoring apparatus. COSTELLO teaches wherein a part of a simulated blood pressure apparatus can be shaped in the general shape of an arm to support a cuff (12, Fig 4, Col 4, lines 2-7: 'The simulator 10 is housed in a cylindrical enclosure 12 with a control console 14 (containing switches and an alphanumeric readout) on the top face 16 of enclosure 12. The cylindrical shape of closure 12 provides a convenient post for wrapping an arm cuff 18 from an oscillometer 20 to be tested'). Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the simulated body of RUITER in the cylindrical shape and to have positioned the cuff around the simulated arm as taught by COSTELLO in order to provide a means to support a cuff during testing. Further, while RUITER in view of COSTELLO do not specify the air pressure sensor positioned within the upper portion of the simulated arm, RUITER does teaches the sensor connected via tubing (sensor 136, tubing 126, Fig 1 ). It is known that it would have been obvious to try, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, to have arrived at wherein the sensor is placed in an upper portion of the arm. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed the sensor in an upper portion of the simulated arm in the modified device of RUITER in order to provide an efficient arrangement of components within the simulated arm.
Allowable Subject Matter
Claims 3-14 and 25-36 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 closest prior art includes RUITER, US 2019/0275223 A1 to STEINGRABER, and EP 0300412 A1 to ARTHUR.
Regarding claim 3, RUITER teaches the system of claim 2, but does not teach wherein the mechanism for selectively contacting the first air chamber comprises a second air chamber.
RUITER does teach other types of actuators can be used (Para [0021]: 'In the preferred embodiment, the cam 106 is a linear cam adapted to displace the follower 112 linearly in proportion to the angular displacement of the cam 106. One skilled in the art will appreciate that a nonlinear cam 106 may also be employed in alternative embodiments provided a bi-directional actuator is adapted to rotate the cam CW and CCW. In addition to the bi-direction rotary actuator of the preferred embodiment, various other actuators may be employed including linear actuators, solenoids, and piezoelectric devices, for example'). STEINGRABER teaches a pump for providing pressure to a heart comprising a second chamber that contacts and actuates a first chamber (second chamber 23, first chamber 2d, Fig 1, Para [0068]: 'The cardiac support system according to the invention has an extracorporeal membrane blood pump 2 and an drive device 1. The drive device 1 and the membrane blood pump 2 are connected to one another via a pressure line 4. The membrane blood pump 2 has an inlet 2a and an outlet 2b. At the inlet 2a the membrane blood pump 2 is connected via an inlet cannula 21 to a left ventricle 31 of the heart 30. At the outlet 2b the membrane blood pump 2 is connected via an outlet cannula to a blood vessel (aorta) 32. In addition, the membrane blood pump 2 comprises a blood chamber 2d and an air chamber 2e that are separated from one another by a membrane 2 c.'). However, STEINGRABER teaches the pump being used to pumping blood to support a heart and not for simulating a blood pressure to test medical equipment. ARTHUR teaches providing a respiration simulator (Para [0001]: 'The invention relates to a device for practicing cardiopulmonary resuscitation.') comprising a chamber actuated by a second chamber (chamber 12 actuated by movement of chamber 11, Para [0028]: 'The learner or trainee now presses-the surface of the plate 9, which is arranged on the cushion 1, with the palm of his hand. Due to the pressure, the gas In the bag 1 Is transmitted through the duct 5 to the chamber 11 and to the partition 13, the indicator of which moves in opposite directions more or less depending on the pressure applied.'). However, ARTHUR does not teach the second chamber being used to provide a simulated pressure in the first chamber. Therefore, the prior art does not teach or suggest fairly in combination the system comprising a second air chamber as claimed. Regarding claims 4-14, the prior art does not teach or fairly suggest the system as claimed since they are dependent upon claim 3.
Regarding claim 25, RUITER teaches the method of claim 24, but does not teach wherein the mechanism for selectively contacting the first air chamber comprises a second air chamber. RUITER does teach other types of actuators can be used (Para [0021]: 'In the preferred embodiment, the cam 106 is a linear cam adapted to displace the follower 112 linearly in proportion to the angular displacement of the cam 106. One skilled in the art will appreciate that a nonlinear cam 106 may also be employed in alternative embodiments provided a bi-directional actuator is adapted to rotate the cam CW and CCW. In addition to the bi-direction rotary actuator of the preferred embodiment, various other actuators may be employed including linear actuators, solenoids, and piezoelectric devices, for example'). STEINGRABER teaches a pump for providing pressure to a heart comprising a second chamber that contacts and actuates a first chamber (second chamber 23, first chamber 2d, Fig 1, Para [0068]: 'The cardiac support system according to the invention has an extracorporeal membrane blood pump 2 and an drive device 1. The drive device 1 and the membrane blood pump 2 are connected to one another via a pressure line 4. The membrane blood pump 2 has an inlet 2a and an outlet 2b. At the inlet 2a the membrane blood pump 2 is connected via an inlet cannula 21 to a left ventricle 31 of the heart 30. At the outlet 2b the membrane blood pump 2 is connected via an outlet cannula to a blood vessel (aorta) 32. In addition, the membrane blood pump 2 comprises a blood chamber 2d and an air chamber 2e that are separated from one another by a membrane 2c.'). However, STEINGRABER teaches the pump being used to pumping blood to support a heart and not for simulating a blood pressure to test medical equipment. ARTHUR teaches providing a respiration simulator (Para [0001]: ' The invention relates to a device for practicing cardiopulmonary resuscitation.') comprising a chamber actuated by a second chamber (chamber 12 actuated by movement of chamber 11, Para [0028]: 'The learner or trainee now presses the surface of the plate 9, which is arranged on the cushion 1, with the palm of his hand. Due to the pressure, the gas in the bag 1 is transmitted through the duct 5 to the chamber 11 and to the partition 13, the indicator of which moves in opposite directions more or less depending on the pressure applied.'). However, ARTHUR does not teach the second chamber being used to provide a simulated pressure in the first chamber. Therefore, the prior art does not teach or suggest fairly in combination the system comprising a second air chamber as claimed. Regarding claims 26-36, the prior art does not teach or fairly suggest the method as claimed since they are dependent upon claim 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715