DETAILED ACTION
Applicant’s arguments, filed on 06/10/2026, 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 on 06/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
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 .
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.
The factual inquiries 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.
Claims 1-2, 5-8, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20190082982) in view of Shimuta (US 20190209030).
Regarding independent claim 1, Li teaches a finger cuff connectable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method (Abstract: “Disclosed is a finger cuff that is attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method”), the finger cuff comprising:
a finger cavity to receive the patient's finger (Fig. 3B shows the finger inside the finger cuff, which forms the finger cavity);
a light emitter (LEDs 450).
However, Li does not teach the light emitter being a micro-laser.
Shimuta discloses a blood pressure measuring apparatus. Specifically, Shimuta teaches the light emitter being a micro-laser ([0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”. A VSCEL is a type of micro-laser.). Li and Shimuta are analogous art as they are both related to the same field of endeavor of blood pressure measurement devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the micro-laser from Shimuta into the device from Li as Shimuta discloses a known type of light emitter, therefore it would be a simple substitution to use the micro-laser from Shimuta instead of the LEDs from Li so as to obtain predictable results.
The Li/Shimuta combination teaches a detector to measure a plethysmogram (pleth) signal (Li, PDs 455; [0020]: “The LED-PD pair 335a-b may be used to perform measurements of a pleth signal to aid in measuring the patient's blood pressure”), the micro- laser configured to direct light into the patient's finger at an acute angle relative to a surface of the patient's finger and to pass through an opposite surface of the patient's finger in order to increase path length of the light between the micro-laser and the detector (Li, Fig. 4C shows the LEDs directing light towards the PDs at different angles including acute angles to pass the light through an opposite surface of the patient’s finger; the micro-lasers of Shimuta being used in place of the LEDs of Li);
a bladder mountable within the finger cavity, wherein the patient's finger received in the finger cavity abuts against the bladder (Li, Fig. 5 show the inflatable bladder inside the finger cuff, which indicates it is mounted in the finger cavity and in contact with the finger); and
a processor (Li, [0035]: “It should be appreciated that aspects of the invention previously described may be implemented in conjunction with the execution of instructions by processors, circuitry, controllers, control circuitry, etc.”) configured to control pressure applied by the bladder to the patient's finger based upon measuring the pleth signal received from the detector and the micro- laser to keep the pleth signal constant to replicate the patient's blood pressure to implement the volume clamp method and to measure the patient's blood pressure (Li, [0022]: “As an example, as part of the volume clamp method, the pneumatic pressure is applied to the bladder 340 of the finger cuff based upon measuring the pleth signal received from the LED-PD pair 335a and 335b of the finger cuff (e.g., to keep the pleth signal constant) so that the pressure applied to the bladder 340 and measured by a pressure sensor should be correlated to the patient's blood pressure.”; [0003]: “Volume clamping is a technique for non-invasively measuring blood pressure in which pressure is applied to a patient's finger in such a manner that arterial pressure may be balanced by a time varying pressure to maintain a constant arterial volume. In a properly fitted and calibrated system, the applied time varying pressure is equal to the arterial blood pressure in the finger. The applied time varying pressure may be measured to provide a reading of the patient's arterial blood pressure.”).
Regarding claim 2, the Li/Shimuta combination teaches the finger cuff of claim 1, wherein, the micro-laser and the detector are embedded on the interior of the finger cavity of the finger cuff to be adjacent to the patient's finger (Li, [0026]: “an LED-PD pair 435a-b, mounted on the interior of the finger cuff 400”; the micro-lasers of Shimuta being used in place of the LEDs of Li).
Regarding claim 5, the Li/Shimuta combination teaches the finger cuff of claim 1, further comprising a plurality of pairs of micro-lasers and detectors comprising the micro-laser and the detector to generate and receive a plurality of signals comprising the pleth signal through the patient's finger (Li, Fig. 4C shows multiple LEDs (450) and multiple PDs (455); the micro-lasers of Shimuta being used in place of the LEDs of Li).
Regarding claim 6, the Li/Shimuta combination teaches the finger cuff of claim 1, wherein the micro-laser is a vertical cavity surface emitting laser (VCSEL) (Shimuta, [0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”).
Regarding independent claim 7, Li teaches a system to measure a patient's blood pressure (Abstract: “Disclosed is a finger cuff that is attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method”), the system comprising:
a finger cuff connectable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method (Abstract: “Disclosed is a finger cuff that is attachable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing a volume clamp method”), the finger cuff comprising:
a finger cavity to receive the patient's finger (Fig. 3B shows the finger inside the finger cuff, which forms the finger cavity);
a light emitter (LEDs 450).
However, Li does not teach the light emitter being a micro-laser.
Shimuta discloses a blood pressure measuring apparatus. Specifically, Shimuta teaches the light emitter being a micro-laser ([0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”. A VSCEL is a type of micro-laser.). Li and Shimuta are analogous art as they are both related to the same field of endeavor of blood pressure measurement devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the micro-laser from Shimuta into the system from Li as Shimuta discloses a known type of light emitter, therefore it would be a simple substitution to use the micro-laser from Shimuta instead of the LEDs from Li so as to obtain predictable results.
The Li/Shimuta combination teaches a detector to measure a plethysmogram (pleth) signal (Li, PDs 455; [0020]: “The LED-PD pair 335a-b may be used to perform measurements of a pleth signal to aid in measuring the patient's blood pressure”), the micro-laser configured to direct light into the patient's finger at an acute angle relative to a surface of the patient's finger and to pass through an opposite surface of the patient's finger in order to increase path length of the light between the micro- laser and the detector (Li, Fig. 4C shows the LEDs directing light towards the PDs at different angles including acute angles to pass the light through an opposite surface of the patient’s finger; the micro-lasers of Shimuta being used in place of the LEDs of Li); and
a bladder mountable within the finger cavity, wherein the patient's finger received in the finger cavity abuts against the bladder (Li, Fig. 5 show the inflatable bladder inside the finger cuff, which indicates it is mounted in the finger cavity and in contact with the finger); and
a processor (Li, [0035]: “It should be appreciated that aspects of the invention previously described may be implemented in conjunction with the execution of instructions by processors, circuitry, controllers, control circuitry, etc.”) configured to control pressure applied by the bladder to the patient's finger based upon measuring the pleth signal received from the detector and the micro- laser to keep the pleth signal constant to replicate the patient's blood pressure to implement the volume clamp method and to measure the patient's blood pressure (Li, [0022]: “As an example, as part of the volume clamp method, the pneumatic pressure is applied to the bladder 340 of the finger cuff based upon measuring the pleth signal received from the LED-PD pair 335a and 335b of the finger cuff (e.g., to keep the pleth signal constant) so that the pressure applied to the bladder 340 and measured by a pressure sensor should be correlated to the patient's blood pressure.”; [0003]: “Volume clamping is a technique for non-invasively measuring blood pressure in which pressure is applied to a patient's finger in such a manner that arterial pressure may be balanced by a time varying pressure to maintain a constant arterial volume. In a properly fitted and calibrated system, the applied time varying pressure is equal to the arterial blood pressure in the finger. The applied time varying pressure may be measured to provide a reading of the patient's arterial blood pressure.”).
Regarding claim 8, the Li/Shimuta combination teaches the system of claim 7, wherein, the micro-laser and the detector are embedded on the interior of the finger cavity of the finger cuff to be adjacent to the patient's finger (Li, [0026]: “an LED-PD pair 435a-b, mounted on the interior of the finger cuff 400”; the micro-lasers of Shimuta being used in place of the LEDs of Li).
Regarding independent claim 13, Li teaches a method to measure a patient's blood pressure by a finger cuff connectable to a patient's finger with a blood pressure measurement system utilizing a volume clamp method (Claim 7: “A method to measure a patient's blood pressure by a blood pressure measurement system utilizing a finger cuff and a volume clamp method”), the method comprising:
attaching the finger cuff to the patient's finger (Fig. 3B shows the finger inside the finger cuff), wherein the patient's finger received in a finger cavity of the finger cuff abuts against a bladder mounted within the finger cavity (Fig. 5 show the inflatable bladder inside the finger cuff, which indicates it is mounted in a finger cavity and in contact with the finger);
a light emitter (LEDs 450).
However, Li does not teach the light emitter being a micro-laser.
Shimuta discloses a blood pressure measuring apparatus. Specifically, Shimuta teaches the light emitter being a micro-laser ([0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”. A VSCEL is a type of micro-laser.). Li and Shimuta are analogous art as they are both related to the same field of endeavor of blood pressure measurement devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the micro-laser from Shimuta into the method from Li as Shimuta discloses a known type of light emitter, therefore it would be a simple substitution to use the micro-laser from Shimuta instead of the LEDs from Li so as to obtain predictable results.
The Li/Shimuta combination teaches directing light into the patient's finger at an acute angle relative to a surface of the patient's finger and to pass through an opposite surface of the patient's finger in order to increase path length of the light between the micro-laser and the detector (Li, Fig. 4C shows the LEDs directing light towards the PDs at different angles including acute angles to pass the light through an opposite surface of the patient’s finger; the micro-lasers of Shimuta being used in place of the LEDs of Li); and
controlling pressure applied by the bladder to the patient's finger based upon measuring a plethysmogram (pleth) signal received from the micro-laser and a detector of the finger cuff to keep the pleth signal constant to replicate the patient's blood pressure to implement the volume clamp method and to measure the patient's blood pressure (Li, [0022]: “As an example, as part of the volume clamp method, the pneumatic pressure is applied to the bladder 340 of the finger cuff based upon measuring the pleth signal received from the LED-PD pair 335a and 335b of the finger cuff (e.g., to keep the pleth signal constant) so that the pressure applied to the bladder 340 and measured by a pressure sensor should be correlated to the patient's blood pressure.”; [0003]: “Volume clamping is a technique for non-invasively measuring blood pressure in which pressure is applied to a patient's finger in such a manner that arterial pressure may be balanced by a time varying pressure to maintain a constant arterial volume. In a properly fitted and calibrated system, the applied time varying pressure is equal to the arterial blood pressure in the finger. The applied time varying pressure may be measured to provide a reading of the patient's arterial blood pressure.”).
Regarding claim 14, the Li/Shimuta combination teaches the method of claim 13, wherein, the micro-laser and the detector are embedded on the interior of the finger cavity of the finger cuff to be adjacent to the patient's finger (Li, [0026]: “an LED-PD pair 435a-b, mounted on the interior of the finger cuff 400”; the micro-lasers of Shimuta being used in place of the LEDs of Li).
Claims 3, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the Li/Shimuta combination as applied to claims 1, 7, and 13 above, and further in view of Fine (US 20180310891).
Regarding claim 3, the Li/Shimuta combination teaches the finger cuff of claim 1.
However, the Li/Shimuta combination does not teach wherein the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff.
Fine discloses a method and apparatus for optically measuring blood pressure. Specifically, Fine teaches wherein, the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff ([0114]: “both laser 160 and light detector 170 are facing inwards (i.e. towards the finger in this case) and are mounted to an outward-facing surface of the ring assembly”). Li, Shimuta, and Fine are analogous art as they are all related to the same field of endeavor of measuring blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the position of the laser and detector from Fine into the Li/Shimuta combination as Fine discloses another suitable location for the sensors and therefore would be a simple substitution for one known location for another to obtain predictable results.
Regarding claim 9, the Li/Shimuta combination teaches the system of claim 7.
However, the Li/Shimuta combination does not teach wherein the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff.
Fine discloses a method and apparatus for optically measuring blood pressure. Specifically, Fine teaches wherein, the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff ([0114]: “both laser 160 and light detector 170 are facing inwards (i.e. towards the finger in this case) and are mounted to an outward-facing surface of the ring assembly”). Li, Shimuta, and Fine are analogous art as they are all related to the same field of endeavor of measuring blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the position of the laser and detector from Fine into the Li/Shimuta combination as Fine discloses another suitable location for the sensors and therefore would be a simple substitution for one known location for another to obtain predictable results.
Regarding claim 15, the Li/Shimuta combination teaches the method of claim 13.
However, the Li/Shimuta combination does not teach wherein the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff.
Fine discloses a method and apparatus for optically measuring blood pressure. Specifically, Fine teaches wherein, the micro-laser and the detector are positioned on the exterior of the finger cavity of the finger cuff ([0114]: “both laser 160 and light detector 170 are facing inwards (i.e. towards the finger in this case) and are mounted to an outward-facing surface of the ring assembly”). Li, Shimuta, and Fine are analogous art as they are all related to the same field of endeavor of measuring blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the position of the laser and detector from Fine into the Li/Shimuta combination as Fine discloses another suitable location for the sensors and therefore would be a simple substitution for one known location for another to obtain predictable results.
Claims 4 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over the Li/Shimuta combination as applied to claim 1 above, and further in view of Islam (US 12268475).
Regarding claim 4, the Li/Shimuta combination teaches the finger cuff of claim 1.
However, the Li/Shimuta combination does not teach further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector.
Islam discloses a wearable device for emitting light through a tissue and measuring the reflected light. Specifically, Islam teaches further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector (Column 29, lines 33-35: “Different kinds of LDs may be used, including Fabry-Perot LDs, distributed feedback (DFB) LDs, distributed Bragg reflector (DBR) LDs”. The light emitters can include a Bragg reflector, which includes reflectors in the device that reflects the light towards the detector.). Li, Shimuta, and Islam are analogous art as they are all related to devices using light to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the type of sensor including a reflector from Islam into the Li/Shimuta combination as Islam discloses different suitable light emitters for measuring physiological parameters, therefore it would be a simple substitution to include the sensor with the reflector so as to obtain predictable results.
Regarding claim 19, the Li/Shimuta/Islam combination teaches the finger cuff of claim 4, wherein the reflector is disposed opposite the detector (Islam, Column 29, lines 33-35: “Different kinds of LDs may be used, including Fabry-Perot LDs, distributed feedback (DFB) LDs, distributed Bragg reflector (DBR) LDs”. Since the reflectors are in the light emitters, and the light emitters are disposed opposite the detector, then the reflectors are also opposite the detector.).
Regarding claim 20, the Li/Shimuta/Islam combination teaches the finger cuff of claim 4, wherein the reflector is configured to reflect the signal back through the patient's finger at an acute angle to the detector (Li, Fig. 4C shows the light entering the detector at acute angles, and since the reflectors are in the light emitters, they reflect the signal at an acute angle; Islam, Column 29, lines 33-35: “Different kinds of LDs may be used, including Fabry-Perot LDs, distributed feedback (DFB) LDs, distributed Bragg reflector (DBR) LDs”.).
Claims 10-12 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over the Li/Shimuta/Fine combination as applied to claims 9 and 15 above, and further in view of Islam.
Regarding claim 10, the Li/Shimuta/Fine combination teaches the system of claim 9.
However, the Li/Shimuta combination does not teach further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector.
Islam discloses a wearable device for emitting light through a tissue and measuring the reflected light. Specifically, Islam teaches further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector (Column 29, lines 33-35: “Different kinds of LDs may be used, including Fabry-Perot LDs, distributed feedback (DFB) LDs, distributed Bragg reflector (DBR) LDs”. The light emitters can include a Bragg reflector, which includes reflectors in the device that reflects the light towards the detector.). Li, Shimuta, and Islam are analogous art as they are all related to devices using light to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the type of sensor including a reflector from Islam into the Li/Shimuta combination as Islam discloses different suitable light emitters for measuring physiological parameters, therefore it would be a simple substitution to include the sensor with the reflector so as to obtain predictable results.
Regarding claim 11, the Li/Shimuta/Fine/Islam combination teaches the system of claim 10, further comprising a plurality of pairs of micro-lasers and detectors comprising the micro-laser and the detector to generate and receive a plurality of signals through the patient's finger (Li, Fig. 4C shows multiple LEDs (450) and multiple PDs (455)).
Regarding claim 12, the Li/Shimuta/Fine/Islam combination teaches the system of claim 11, wherein the micro-laser is a vertical cavity surface emitting laser (VCSEL) (Shimuta, [0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”).
Regarding claim 16, the Li/Shimuta/Fine combination teaches the method if claim 15.
However, the Li/Shimuta combination does not teach further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector.
Islam discloses a wearable device for emitting light through a tissue and measuring the reflected light. Specifically, Islam teaches further comprising a reflector, wherein, the micro-laser emits a signal through the patient's finger, the signal is reflected by the reflector back through the patient's finger to the detector (Column 29, lines 33-35: “Different kinds of LDs may be used, including Fabry-Perot LDs, distributed feedback (DFB) LDs, distributed Bragg reflector (DBR) LDs”. The light emitters can include a Bragg reflector, which includes reflectors in the device that reflects the light towards the detector.). Li, Shimuta, and Islam are analogous art as they are all related to devices using light to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the type of sensor including a reflector from Islam into the Li/Shimuta combination as Islam discloses different suitable light emitters for measuring physiological parameters, therefore it would be a simple substitution to include the sensor with the reflector so as to obtain predictable results.
Regarding claim 17, the Li/Shimuta/Fine/Islam combination teaches the method of claim 16, further comprising a plurality of pairs of micro-lasers and detectors comprising the micro-laser and the detector to generate and receive a plurality of signals through the patient's finger, the plurality of signals comprising the pleth signal (Li. Fig. 4C shows multiple LEDs (450) and multiple PDs (455)).
Regarding claim 18, the Li/Shimuta/Fine/Islam combination teaches the method of claim 17, wherein the micro-laser is a vertical cavity surface emitting laser (VCSEL) (Shimuta, [0059]: “The first light emitting element 101 preferably emits light in accordance with a pulse-shape driving signal output from a driving unit 351 of the signal processor 31. As the first light emitting element 101, for example, an LED, a VCSEL (Vertical Cavity Surface Emitting LASER), a resonator-type LED, or the like may be used”).
Response to Arguments
Applicant’s arguments with respect to claims 1-18 have been considered but are moot because the new ground 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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