DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 December 2025 has been entered.
Status of Claims
Claim(s) 1, 12 and 18 is/are currently amended. Claim(s) 1-20 is/are pending.
Claim Interpretation
As noted in the prior Office action(s), each of the pending claims contain at least one limitation that has been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph).
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 pre-AIA 35 U.S.C. 112, 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(s) 1, 18 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 1 and claims dependent thereon, the limitation(s) "a transmission system disposed within the housing, the transmission system being…configured to…pair with a plurality of display devices" is indefinite. It is unclear if the limitation(s) is/are intended to indicate the transmission system is configured to simultaneously pair with multiple display devices, or to indicate the transmission system is configured to pair with any one of a plurality of display devices at a given time. For the purpose of this Office action, the above-noted limitation will be further discussed with the understanding the transmission system is configured to pair with any one of a plurality of display devices, as is apparently consistent with the specification as filed (see rejection under 35 U.S.C. 112(a) below).
Regarding claim 18 and claims dependent thereon, the limitation "wherein the indicator provides a visual indication that the transmission system is paired with the display device" is indefinite, as it is unclear to which of the previously-recited transmission systems the limitation refers, the transmission system of the measuring device or the transmission system of the display device. For the purpose of this Office action claim 18 will be discussed with the understanding the above-noted limitation refers to the transmission system of the measuring device.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and claims dependent thereon, as discussed above, the limitation(s) "a transmission system disposed within the housing, the transmission system being…configured to…pair with a plurality of display devices" is indefinite. If it is Applicant's intention that the limitation is intended to indicate that the transmission system is configured to be paired with a plurality of/multiple display devices simultaneously, said limitation(s) lacks sufficient support in the application as filed. Rather, Applicant discloses, "In some implementations, the sensor 401A includes an indicator 419A. The indicator 419A is configured to provide a visual indication as to which display system the sensor 401A is paired with. For example, the indicator 419A may include a light emitting diode or a series of light emitting diodes that provide a visual indication as to which display system the sensor 401A is paired with" (¶ [0050]). The above-noted paragraph the sensor indicator indicates a single "display system" to which a sensor is paired, rather than a plurality of/multiple "display systems." Accordingly, at least one reasonable interpretation of the above-noted limitation lacks sufficient support in the application as filed, and therefore is directed to and/or encompasses new matter.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1-8 and 10-11 is/are rejected under 35 U.S.C. 103 as obvious over US 2016/0113576 A1 (previously cited, Hulvershorn) in view of US 2005/0197585 A1 (previously cited, Brockway) and US 2014/0275876 A1 (Hansen).
Regarding claim 1, Hulvershorn teaches/suggests an invasive blood pressure measuring apparatus (anatomical environment characterization device, AECD), comprising:
a housing (Abstract, housing, e.g., Fig. 1A, housing 110):
a detection system disposed within the housing (Abstract, sensing unit carried by the housing, e.g., Fig. 1C, sensing unit 140), the detection system being configured to be operatively coupled to a patient and to measure a blood pressure of the patient (¶ [0069] sensing unit 140 includes a piezoelectric pressure transducer 144 coupled to a diaphragm 146 that is exposed to an opening in the chamber 130, such that when the chamber 130 is in fluid communication with blood sourced from a vessel, vascular pressure exerts a displacement force upon the diaphragm 146, which in turn exerts a force upon the piezoelectric pressure transducer 144 to generate an electrical signal corresponding to vessel pressure reading at a distal probe segment or the probe tip 24);
a transmission system disposed within the housing (Abstract, output unit carried by the housing, e.g., Fig. 1C, communication unit 185), the transmission system being operatively coupled to the detection system and configured to pair with one or more display devices (one or more remote systems or devices 90 or 92, such as a computer system or a given piece of medical equipment 92; ¶ [0084]) and to transmit a wireless signal indicative of a blood pressure of the patient (¶ [0087] communication unit 185 can transfer stored pressure values to a remote device 92 that is configured to receive the individual pressure values, display and/or analyze a corresponding pressure waveform (e.g., a vascular pressure waveform)); and
an indicator coupled to the housing and configured to provide a visual indication (output unit 180 that may include one or more types of output devices, e.g., LCD 182, LEDs 184, etc.).
Hulvershorn does not teach the apparatus comprises a motion detector system disposed within the housing, the motion detection system being configured to detect motion of the housing.
Brockway teaches/suggests an invasive blood pressure measuring apparatus (e.g., Fig. 6) comprising a housing (housing 202); a detection system configured to be operatively coupled to a patient and to measure a blood pressure of the patient (sensor and catheter assembly 100; ¶ [0025]); a transmission system disposed within the housing, the transmission system being operatively coupled to the detection system and configured to transmit a wireless signal indicative of a blood pressure of the patient (transmitter/transceiver 250 with associated antenna 260; ¶ [0036]); and a motion detection system disposed within the housing, the motion detection system configured to detect motion of the housing (motion detector 280; ¶ [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn to comprise a motion detector system disposed within the housing, the motion detection system being configured to detect motion of the housing as taught/suggested by Brockway in order to facilitate flagging pressure data upon an indication of movement, thus enabling an attending nurse or physician to determine if pressure changes are due to an clinical change in blood pressure or are due to patient movement (Brockway, ¶ [0045]).
While Hulvershorn as modified disclose the transmission system is configured to pair with a plurality of display device (i.e., "one or more" remote devices), Hulvershorn does not disclose the indicator is configured to provide a visual indication as to which of the plurality of display devices the transmission system is paired.
Hansen discloses a measuring apparatus (wireless sensor 14) including a housing (body 28); a detection system disposed configured to be operatively coupled to a patient and to measure a blood pressure of the patient (detector 26; ¶ [0025]; etc.); a transmission system disposed within the housing (wireless module 22) configured to pair with a plurality of display devices (patient monitors 12; ¶ [0054]) and to transmit a wireless signal indicative of a blood pressure of the patient (¶ [0083] communication channel 92 may be used to exchange patient-specific data, such as physiological parameter trend data acquired over time; ¶ [0026]; etc.); and an indicator coupled to the housing (audio/visual feature 80; display 190; etc.) and configured to provide a visual indication as to which of the plurality of display devices the transmission system is paired (e.g., ¶ [0038] an operator may engage activation feature 83 on patient monitor 12 to trigger the audio/visual feature 80 on the wireless sensor 14 in order to locate and/or identify the patient sensor 14 wirelessly communicating with the patient monitor 12; ¶ [0022] a display feature on wireless sensor 14 may display identification information, e.g., of a patient monitor; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn with the transmission system being configured to pair with a plurality of display devices, and to comprise an indicator coupled to the housing and configured to provide a visual indication as to which of the plurality of display devices the transmission system is paired as taught/suggested by Hansen in order to provide coupling flexibility to the measuring apparatus as it moves about a facility (Hansen, ¶ [0022]; ¶ [0054]; etc.) and to ensure that a given display device is displaying information from the intended source or patient (Hansen, ¶ [0022]; ¶ [0038]; etc.).
Regarding claims 2-3, Hulvershorn as modified teaches/suggests a power system disposed within the housing and being operatively coupled to the detection system and the transmission system (Fig. 1C, power source 190), the power system including a battery (¶ [0063] power source 190 includes a battery).
Regarding claims 4-5, Hulvershorn as modified teaches/suggests the detection system includes a pressure transducer (¶ [0069] piezoelectric pressure transducer 144), wherein the pressure transducer is disposed adjacent a line that is configured to be fluidically coupled to an artery or a vein of the patient (e.g., Fig. 1C, transducer 144 is disposed adjacent chamber 130, which is in fluid communication with blood sourced from a vessel, ¶ [0069]).
Regarding claim 6, Hulvershorn as modified teaches/suggests the transmission system includes a radiofrequency transmitter (Hulvershorn, ¶ [0084] communication unit 185 includes a RF communication circuit; Hansen, ¶¶ [0049]-[0050]; etc.).
Regarding claim 7, Hulvershorn as modified teaches/suggests the housing includes a port (Fig. 1A, first opening or port 114), the port being configured to be coupled to a tubular member (Fig. 1A, needle 20; e.g., ¶ [0065] chamber 130 and passage 132 are fluid communicable/in fluid communication with the bore of the needle 20 by way of the first port 114).
Regarding claim 8, Hulvershorn as modified teaches/suggests the housing includes a port, the port being configured to be operatively coupled to an artery or vein of the patient (¶ [0065] chamber 130 and passage 132 are fluid communicable/in fluid communication with the bore of the needle 20 by way of the first port 114, wherein needle 20 is inserted into an individual's body, such that a bodily fluid such as blood can flow or be drawn from the tip 24 of the needle into the chamber 130 and the passage 132).
Regarding claim 10, Hulvershorn as modified teaches/suggests the apparatus comprises an activation switch, the activation switch extending from the housing and being operatively coupled to the detection system and the transmission system (Figs. 1A, 1C, activation switch 192 that can be repositioned/toggled by a user; ¶ [0084] switch 192 selectively couples AECD 102 to power source 190).
Regarding claim 11, Hulvershorn as modified teaches/suggests the apparatus comprises a power source disposed within the housing (Fig. 1C, power source 190); and an activation switch extending from the housing and being configured to activate the power source (Figs. 1A, 1C, activation switch 192 that can be repositioned/toggled by a user; ¶ [0084] switch 192 selectively couples AECD 102 to power source 190).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as obvious over Hulvershorn in view of Brockway and Hansen as applied to claim(s) 1 above, and further in view of WO 2023/099246 A2 (previously cited, Zong).
Regarding claim 9, Hulvershorn as modified teaches/suggests the limitations of claim 1, as discussed above, and further teaches/suggests the housing includes a first port (Fig. 1A, first port 114) and a second port (Fig. 1A, second port 116), the first port being configured to receive blood from an artery or a vein of the patient (¶ [0065] chamber 130 and passage 132 are in fluid communication with the bore of needle 20 by way of first port 114, wherein needle 20 is inserted into an individual's body, such that a bodily fluid such as blood can flow or be drawn from tip 24 of the needle into chamber 130 and passage 132), the second port being configured to receive fluid from a fluid reservoir (¶ [0064] second coupling structure 118 includes one or more coupling, fitting, securing, retaining, or connecting elements configured to mate with another medical implement, such as syringe 50).
As noted above, Hulvershorn discloses a second connector carrying the second port is configured to connect to a medical device, which may comprise a fluid reservoir (e.g., syringe), thereby enabling/configuring the second port to receive fluid from a fluid reservoir. Accordingly, the prior art structure is capable of performing the recited function, and therefore meets the claim.
Alternatively/Additionally, Zong teaches a similar apparatus (pressure sensor or transducer 112), wherein the apparatus, or housing thereof, includes a first port configured to receive blood from an artery or a vein (Fig. 1, 3, etc.; ¶ [0031] port by which sensor 112 is in fluid communication with the blood vessel, e.g., artery, via catheter tubing 108) and a second port configured to receive fluid from a fluid reservoir (Fig. 1, 3, etc.; ¶ [0031] port by which sensor 112 is in fluid communication with pressure bag 102 via flush tubing 104). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn with the housing including a first port and a second port, the first port being configured to receive blood from an artery or a vein of the patient, and the second port being configured to receive fluid from a fluid reservoir as taught/suggested by Zong in order to enable providing fluids to the patient (Hulvershorn, ¶ [0003]; Zong, ¶ 0031]); providing a high-pressure flushing of fluid in order to keep the tubular member (e.g., catheter) clear and to check the dynamic characteristics of the system (Zong, ¶ [0031]); etc.
Claim(s) 12-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of US 2015/0173681 A1 (previously cited, Hammerling), Brockway and Hansen.
Regarding claim 12, Hulvershorn teaches/suggests an invasive blood pressure measuring apparatus (anatomical environment characterization device, AECD), comprising:
a housing defining a cavity (Abstract, housing, e.g., Fig. 1A, housing 110 defining an internal space, e.g., ¶ [0114]):
a detection system disposed within the cavity of the housing (Abstract, sensing unit carried by the housing, e.g., Fig. 1C, sensing unit 140), the detection system including a pressure transducer and being configured to measure a blood pressure of a patient (¶ [0069] sensing unit 140 includes a piezoelectric pressure transducer 144 coupled to a diaphragm 146 that is exposed to an opening in the chamber 130, such that when the chamber 130 is in fluid communication with blood sourced from a vessel, vascular pressure exerts a displacement force upon the diaphragm 146, which in turn exerts a force upon the piezoelectric pressure transducer 144 to generate an electrical signal corresponding to vessel pressure reading at a distal probe segment or the probe tip 24);
a transmission system disposed within the cavity of the housing (Abstract, output unit carried by the housing, e.g., Fig. 1C, communication unit 185), the transmission system being operatively coupled to the detection system and configured to pair with a display device (one or more remote systems or devices 90 or 92, such as a computer system or a given piece of medical equipment 92; ¶ [0084]) and transmit a wireless signal indicative of a blood pressure of the patient (¶ [0087] communication unit 185 can transfer stored pressure values to remote device 92 that is configured to receive the individual pressure values, display and/or analyze a corresponding pressure waveform (e.g., a vascular pressure waveform));
a battery disposed within the cavity of the housing and operatively coupled to the detection system and to the transmission system (Fig. 1C, power source 190; ¶ [0063] power source 190 includes a battery);
an activation switch operatively coupled to the battery, at least a portion of the activation switch being disposed outside of the cavity of the housing (Figs. 1A, 1C, activation switch 192 that can be repositioned/toggled by a user; ¶ [0084] switch 192 selectively couples AECD 102 to power source 190); and
an indicator coupled to the housing and configured to provide a visual indication (output unit 180 that may include one or more types of output devices, e.g., LCD 182, LEDs 184, etc.)
Hulvershorn does not disclose the apparatus comprises a coupling member configured to couple the housing to a portion of a body of the patient.
Hammerling teaches and/or suggests an apparatus comprising, inter alia, a detection system including a pressure transducer that is configured to measure a blood pressure of a patient (Fig. 1, transducer 22; e.g., ¶¶ [0003]-[0004]); and a coupling member configured to couple the detection system, or a housing thereof, to a portion of a body of the patient (e.g., Figs. 1-5, transducer holder assembly 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn to comprise a coupling member configured to couple the housing to a portion of a body of the patient as taught/suggested by Hammerling in order to ensure, or increase the likelihood, that the transducer remains in-line with a target organ (e.g., heart) of the patient (Hammerling, ¶ [0047]), thereby enabling more accurate and/or reliable blood pressure measurements (Hammerling, ¶ [0003]).
Hulvershorn as modified does not teach the apparatus further comprises a motion detector system disposed within the housing, the motion detection system being configured to detect motion of the housing.
Brockway teaches/suggests an invasive blood pressure measuring apparatus (e.g., Fig. 6) comprising a housing (housing 202); a detection system configured to be operatively coupled to a patient and to measure a blood pressure of the patient (sensor and catheter assembly 100; ¶ [0025]); a transmission system disposed within the housing, the transmission system being operatively coupled to the detection system and configured to transmit a wireless signal indicative of a blood pressure of the patient (transmitter/transceiver 250 with associated antenna 260; ¶ [0036]); and a motion detection system disposed within the housing, the motion detection system configured to detect motion of the housing (motion detector 280; ¶ [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn to comprise a motion detector system disposed within the housing, the motion detection system being configured to detect motion of the housing as taught/suggested by Brockway in order to facilitate flagging pressure data upon an indication of movement, thus enabling an attending nurse or physician to determine if pressure changes are due to an clinical change in blood pressure or are due to patient movement (Brockway, ¶ [0045]).
Hulvershorn as modified does not disclose the indicator is configured to provide a visual indication as to which of the plurality of display devices the transmission system is paired.
Hansen discloses a measuring apparatus (wireless sensor 14) including a housing (body 28); a detection system disposed configured to be operatively coupled to a patient and to measure a blood pressure of the patient (detector 26; ¶ [0025]; etc.); a transmission system disposed within the housing (wireless module 22) configured to pair with a plurality of display devices (patient monitors 12; ¶ [0054]) and to transmit a wireless signal indicative of a blood pressure of the patient (¶ [0083] communication channel 92 may be used to exchange patient-specific data, such as physiological parameter trend data acquired over time; ¶ [0026]; etc.); and an indicator coupled to the housing (audio/visual feature 80; display 190; etc.) and configured to provide a visual indication indicating that the transmission system is paired with the display device (e.g., ¶ [0038] audio/visual feature 80 on the wireless sensor 14 may indicate the status of connectivity (e.g., wireless communication established) and/or an operator may engage activation feature 83 on patient monitor 12 to trigger the audio/visual feature 80 on the wireless sensor 14 to locate or identify the patient sensor 14 wirelessly communicating with the patient monitor 12; ¶ [0022] a display feature on wireless sensor 14 may display identification information, e.g., of a patient monitor; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn to comprise an indicator coupled to the housing and configured to provide a visual indication indicating that the transmission system is paired with the display device as taught/suggested by Hansen in order to provide coupling flexibility to the measuring apparatus as it moves about a facility (Hansen, ¶ [0022]; ¶ [0054]; etc.) and to ensure that a given display device is displaying information from the intended source or patient (Hansen, ¶ [0022]; ¶ [0038]; etc.).
Regarding claim 13, Hulvershorn as modified teaches/suggests the pressure transducer is operatively coupled to an artery or vein of the patient (e.g., Fig. 1C, transducer 144 is disposed adjacent chamber 130, which is in fluid communication with blood sourced from a vessel, ¶ [0069]).
Regarding claim 14, Hulvershorn as modified teaches/suggests the transmission system includes a RF transmitter (Hulvershorn, ¶ [0084] communication unit 185 includes an RF communication circuit; Hansen, ¶¶ [0049]-[0050]; etc.).
Regarding claim 15, Hulvershorn as modified teaches/suggests the housing includes a port (Fig. 1A, first opening or port 114), the port being configured to be coupled to a tubular member (Fig. 1A, needle 20; e.g., ¶ [0065] chamber 130 and passage 132 are fluid communicable/in fluid communication with the bore of the needle 20 by way of the first port 114).
Regarding claim 16, Hulvershorn as modified teaches/suggests the housing includes a port, the port being configured to be operatively coupled to an artery or vein of the patient (¶ [0065] chamber 130 and passage 132 are fluid communicable/in fluid communication with the bore of the needle 20 by way of the first port 114, wherein needle 20 is inserted into an individual's body, such that a bodily fluid such as blood can flow or be drawn from the tip 24 of the needle into the chamber 130 and the passage 132).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of Hammerling, Brockway and Hansen as applied to claim(s) 12 above; or alternatively, over Hulvershorn in view of Hammerling, Brockway and Hansen as applied to claim(s) 12 above, and further in view of Zong.
Regarding claim 17, Hulvershorn as modified teaches/suggests the limitations of claim 12, as discussed above, and further teaches/suggests the housing includes a first port (Fig. 1A, first port 114) and a second port (Fig. 1A, second port 116), the first port being configured to receive blood from an artery or a vein of the patient (¶ [0065] chamber 130 and passage 132 are in fluid communication with the bore of needle 20 by way of first port 114, wherein needle 20 is inserted into an individual's body, such that a bodily fluid such as blood can flow or be drawn from tip 24 of the needle into chamber 130 and passage 132), the second port being configured to be operatively coupled to a fluid reservoir (¶ [0064] second coupling structure 118 includes one or more coupling, fitting, securing, retaining, or connecting elements configured to mate with another medical implement, such as syringe 50).
As noted above, Hulvershorn discloses a second connector carrying the second port is configured to connect to a medical device, which may comprise a fluid reservoir (e.g., syringe), thereby enabling and/or configuring the second port to be operatively coupled to a fluid reservoir. Accordingly, the prior art structure is capable of performing the recited intended use, and therefore meets the claim.
Alternatively/Additionally, Zong teaches a similar apparatus (pressure sensor or transducer 112), wherein the apparatus, or housing thereof, includes a first port configured to receive blood from an artery or a vein (Fig. 1, 3, etc.; ¶ [0031] port by which sensor 112 is in fluid communication with the blood vessel, e.g., artery, via catheter tubing 108) and a second port configured to receive fluid from a fluid reservoir (Fig. 1, 3, etc.; ¶ [0031] port by which sensor 112 is in fluid communication with pressure bag 102 via flush tubing 104). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn with the housing including a first port and a second port, the first port being configured to receive blood from an artery or a vein of the patient, and the second port being configured to be operatively coupled to a fluid reservoir as taught and/or suggested by Zong in order to enable providing fluids to the patient (Hulvershorn, ¶ [0003]; Zong, ¶ 0031]); providing a high-pressure flushing of fluid in order to keep the tubular member (e.g., catheter) clear and to check the dynamic characteristics of the system (Zong, ¶ [0031]); etc.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of Hammerling and Hansen.
Regarding claim 18, Hulvershorn teaches/suggests a system comprising:
an invasive blood pressure measuring device (anatomical environment characterization device, AECD) having:
a housing (Abstract, housing, e.g., Fig. 1A, housing 110):
a detection system disposed within the housing (Abstract, sensing unit carried by the housing, e.g., Fig. 1C, sensing unit 140), the detection system configured to be operatively coupled to an artery or vein of a patient and to measure a blood pressure of a patient (¶ [0069] sensing unit 140 includes a piezoelectric pressure transducer 144 coupled to a diaphragm 146 that is exposed to an opening in the chamber 130, such that when the chamber 130 is in fluid communication with blood sourced from a vessel, vascular pressure exerts a displacement force upon the diaphragm 146, which in turn exerts a force upon the piezoelectric pressure transducer 144 to generate an electrical signal corresponding to vessel pressure reading at a distal probe segment or the probe tip 24);
a transmission system disposed within the cavity of the housing (Abstract, output unit carried by the housing, e.g., Fig. 1C, communication unit 185), the transmission system being operatively coupled to the detection system and configured to transmit a wireless signal indicative of a blood pressure of the patient (¶ [0087] communication unit 185 can transfer stored pressure values to remote device 92); and
an indicator coupled to the housing (output unit 180 that may include one or more types of output devices, e.g., LCD 182, LEDs 184, etc.); and
a display device having a transmission system and a display (one or more remote systems or devices 90 or 92, e.g., Fig. 1C, remote device 92), the transmission system of the display device being configured to pair with and receive the wireless signal indicative of a blood pressure of the patient from the transmission system of the measuring device, the display being configured to display a blood pressure of the patient (¶ [0087] remote device 92 is configured to receive the individual pressure values, display and/or analyze a corresponding pressure waveform (e.g., a vascular pressure waveform)).
Hulvershorn does not disclose the apparatus comprises a coupling member configured to couple the housing to a portion of a body of the patient.
Hammerling teaches and/or suggests an apparatus comprising, inter alia, a detection system including a pressure transducer that is configured to measure a blood pressure of a patient (Fig. 1, transducer 22; e.g., ¶¶ [0003]-[0004]); and a coupling member configured to couple the detection system, or a housing thereof, to a portion of a body of the patient (e.g., Figs. 1-5, transducer holder assembly 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hulvershorn with the invasive blood pressure measuring device comprising a coupling member configured to couple the housing to a portion of a body of the patient as taught and/or suggested by Hammerling in order to ensure, or increase the likelihood, that the transducer remains in-line with a target organ of the patient (Hammerling, ¶ [0047]), thereby enabling more accurate/reliable blood pressure measurements (Hammerling, ¶ [0003]).
Hulvershorn as modified does not teach the transmission system of the measuring device is paired with the display device based on proximity between the transmission system of the measuring device and the display device.
Hansen discloses a system comprising a blood pressure measuring device (wireless sensor 14; ¶¶ [0025]-[0026]) including a transmission system configured to transmit a wireless signal indicative of a blood pressure of the patient (wireless module 22; ¶¶ [0025]-[0026]); and a display device (patient monitor 14) having a transmission system (wireless module 18) and a display (display 16), wherein the transmission system of the measuring device is paired with the display device based on proximity between the transmission system of the measuring device and the display device (e.g., ¶¶ [0049]-[0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn the transmission system of the measuring device being paired with the display device based on proximity between the transmission system of the measuring device and the display device as taught/suggested by Hansen in order to enable establishing communication between the measuring and display devices using a standard (e.g., NFC) technique (Hansen, ¶¶ [0049]-[0051]).
Hulvershorn as modified does not teach the indicator provides a visual indication that the transmission system of the measuring device is paired with the display device.
Hansen discloses a measuring apparatus (wireless sensor 14) including a housing (body 28); a detection system disposed configured to be operatively coupled to a patient and to measure a blood pressure of the patient (detector 26; ¶ [0025]; etc.); a transmission system disposed within the housing (wireless module 22) configured to pair with a plurality of display devices (patient monitors 12; ¶ [0054]) and to transmit a wireless signal indicative of a blood pressure of the patient (¶ [0083] communication channel 92 may be used to exchange patient-specific data, such as physiological parameter trend data acquired over time; ¶ [0026]; etc.); and an indicator coupled to the housing (audio/visual feature 80; display 190; etc.) and configured to provide a visual indication indicating that the transmission system is paired with the display device (e.g., ¶ [0038] audio/visual feature 80 on the wireless sensor 14 may indicate the status of connectivity (e.g., wireless communication established) and/or an operator may engage activation feature 83 on patient monitor 12 to trigger the audio/visual feature 80 on the wireless sensor 14 to locate or identify the patient sensor 14 wirelessly communicating with the patient monitor 12; ¶ [0022] a display feature on wireless sensor 14 may display identification information, e.g., of a patient monitor; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Hulvershorn to comprise an indicator coupled to the housing and configured to provide a visual indication indicating that the transmission system of the measuring device is paired with the display device as taught/suggested by Hansen in order to provide coupling flexibility to the measuring device as it moves about a facility (Hansen, ¶ [0022]; ¶ [0054]; etc.) and to ensure that a given display device is displaying information from the intended source or patient (Hansen, ¶ [0022]; ¶ [0038]; etc.).
Regarding claim 19, Hulvershorn as modified teaches/suggests the measuring device further comprises a power source disposed within the housing (Fig. 1C, power source 190).
Regarding claim 20, Hulvershorn as modified teaches/suggests the measuring device further comprises a power source disposed within the housing (Fig. 1C, power source 190); and an activation switch, wherein at least a portion of the activation switch is disposed outside of the housing (Figs. 1A, 1C, activation switch 192 that can be repositioned/toggled by a user).
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground(s) of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791