DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 21-50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21 and 39 recite “deformation signal capturing spatio-temporal contact conditions of the superficial artery.” It is not clear what contact conditions of the superficial artery refers to. The “contact” condition, by definition, requires contact between two parts/elements, but the claim does not specify the contact condition of which elements are referred. Thus, it is not clear whether contact conditions are recited for contact between the artery and the skin, or between the artery and the sensor or between the sensor and the skin.
The examiner has searched specification to find a support for the claimed limitations, and found that “contact conditions” are defined as geometrical and force changes ([0010]) and does not provide enough details on contact condition of the superficial artery, rather contact condition is caused by variation of blood pressure at sensor region ([0040]).
Thus, for a purpose of examination, the examiner will interpret contact conditions as any changes in its geometrical or pressure/forces.
Claims 22-38 and 40-50 are rejected as they inherit the rejection of independent claims 21 and 39 set forth above.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 21-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 and 39 recite “deformation signal capturing spatio-temporal contact conditions of the superficial artery.” The specification does not provide support and/or details on what defines and qualifies for contact conditions of the superficial artery as claimed. The examiner has searched specification to find a support for the claimed limitations, and found that “contact conditions” are defined as geometrical and force changes ([0010]) but “contact conditions of the superficial artery” is not supported for one of ordinary skill in the art would understand what contact conditions of the superficial artery with respect to part/element. The specification seems to provide that contact condition is caused by variation of blood pressure at sensor region, thus defines that the contact conditions of the sensor to skin surface are result of variation of blood pressure and are measured as deformation signal ([0040]). The specification does not demonstrate that applicant has made an invention that achieves the claimed limitation because the invention is not described with sufficient details that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed limitation.
Claims 22-38 and 40-50 are rejected as they inherit the rejection of independent claims 21 and 39 set forth above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over “Gorenberg et al.,” US 2005/0171443 (hereinafter Gorenberg) and “Nakamura et al.,” US 2018/0184909 (hereinafter Nakamura).
Regarding to claim 21, Gorenberg teaches a method for measuring blood pressure based on skin displacement, the method comprising:
providing a calibrated measurement device having a sensor array with a sensor surface (a pressure sensor [0145]-[0146], sensor in Figures 13 and 15 has surface );
placing the sensor surface in contact with a skin surface (Figure 13 shows sensor in contact with a skin) near a superficial artery (artery is located close to the surface of the limb [0126]); s
applying a controlled amount of pressure to press the sensor surface against the skin surface with a respective force (applying pressure enough to make a longitudinal segment of an artery within the limb achieves a collapsed state [0066]);
in response to the skin deformation of the skin surface, causing a sensor deformation to the sensor surface (deformation sensor sensing deformation changes of at least one of the plurality of cushions [0046]; pressure applied to a portion of the limb [0072]);
in response to the sensor deformation, detecting a deformation signal of the sensor surface, via the sensor array, during a heartbeat cycle, the deformation signal capturing spatio-temporal contact conditions of the superficial artery (sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state [0067]; Figures 7a-d shows time and spatial changes, Figures 8-10 shows time and spatial positions); and measuring and processing, via a controller, the deformation signal to determine a blood- pressure parameter (calculating parameters indicating heart performance [0070]-[0071], [0151]).
Gorenberg does not explicitly disclose sensor surface is in direct contact with a skin surface and in response to the respective force, causing a skin deformation in the skin surface based on size and shape changes of the superficial artery.
The examiner notes that deformation in the skin is a natural consequence of applying a pressure/force on a limb (skin) and submits that Nakamura for disclosing the limitation.
In the analogous field of endeavor in blood pressure monitoring method, Nakamura teaches that sensor array in direct contact with the skin surface ([0037] and [0064] Figure 13) and pressing force against the skin, the pressure in the blood vessel and the force caused by a deformation of the blood vessel is positioned and figures A-C show skin deformation as claimed ([0059] Figures 10A-C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify deformation sensor as taught by Gorenberg to incorporate teaching of Nakamura, since sensor in direct contact with skin for deformation measurement and skin deformation is a natural consequence of pressing the skin with sensor array, and was well known in the art as taught by Nakamura. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, configuring sensor surface to be in direct contact with skin and the skin deformation was caused by pressing the sensor to the skin (limb), and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate measure of blood pressure ([0059] and [0072]), and there was reasonable expectation of success.
Regarding to claims 22-25 and 27-32, Gorenberg and Nakamura together teach all limitations of claim 21 as discussed above.
Gorenberg further teaches following limitations:
Of claim 22, wherein the superficial artery is a radial artery (radial artery [0126]).
Of claim 23, wherein the sensor array includes one or more of a tactile sensor, an ultrasound imaging sensor, a resistive sensor, a piezoelectric sensor, and a capacitive sensor (capacitive sensor [0049]).
Of claim 24, wherein the controlled amount of pressure is applied with a blood-flow control balloon (inflatable mechanism by applying external pressure [0161]; collapse of artery to stop the blood flow and blood flow increases [0162]), the blood-flow control balloon being mechanically coupled with the sensor array (mechanical changes due to opening of the artery sensed by applying pressure using cushions [0165]).
Of claim 25, wherein the controlled amount of pressure is achieved by inflating or deflating the blood-flow control balloon (cushion inflating [0163]; deflation [0130])
Of claim 27, wherein the controller is configured to estimate blood pressure from a pressure sweep that includes a gradual increase and decrease of the controlled amount of pressure (gradual decrease [0126]; gradual increase [0170])
Of claim 28, wherein the pressure sweep includes a rising sweep in which an air pressure is increased from a low value at a rate standard for blood pressure measurement (external pressure applied to a level above the systolic blood pressure and decrease at a rate of 2-3 mmHg per second while pressure and piezoelectric transducers are measured [0126]-[0127]), the rising sweep continuing until (a) a saturation pressure is reached, or (b) a pulsation amplitude of the deformation signal is attenuated below a predetermined threshold if the air pressure reaches a nominal value (external pressure is decreased from above systolic to below diastolic blood pressure, modulations are observed, external pressure decreases, the modulations increase until the external pressure is approximately at the mean artery pressure and then it decreases [0128])
Of claim 29, wherein the pressure sweep includes a falling sweep in which the air pressure is decreased back to the low value (external pressure decreased to below diastolic blood pressure [0128])
Of claim 30, wherein the pressure sweep includes a mean pressure averaged over a cardiac cycle, the mean pressure being a primary measurement for estimating the blood pressure ( means pressure [0060], [0135], [0153])
Of claim 31, further comprising displaying at least one of the one or more blood-pressure parameters on a display, the display being communicatively coupled with the controller (calculations of pressure measurement displayed on a display [0149])
Of claim 32, further comprising controlling the amount of pressure via an external device, the external device being communicatively coupled with the calibrated measurement device (external pressure control device is connected with the inflatable cushion with the sensors [0121]; Figure 13 )
Regarding to claim 26, Gorenberg and Nakamura together teach all limitations of claim 21 as discussed above.
Nakamura further teaches following limitations:
Of claim 26, wherein the blood-pressure parameter is an oscillometric blood-pressure parameter (oscillometric method [0004])
Claim(s) 33-34 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gorenberg and Nakamura as applied to claim 21 above, and further in view of “Bakar et al.,” US 2013/0339043 (hereinafter Bakar).
Regarding to claims 33-34 and 36-38, Gorenberg and Nakamura teach all limitations of claim 21 as discussed above.
Gorenberg does disclose deformation sensor being optical sensors ([0115]), but does not further disclose details of structured light projection and optical markers.
However, in the analogous field of endeavor in method of measuring biological parameters, Bakar teaches using structured light illuminated on the surface of the body, and includes light patterns (dot patterns [0049]), such as array of small, closely spaced circular dots or other structural elements impinging on the surface of interest and camera capturing the image on the dots on the surface, thus, used as optical markers as claimed ([0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify optical sensor as taught by Gorenberg to incorporate teaching of Bakar, since structure light including optical marker of array of dots was well known in the art as taught by Bakar. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, adding a camera to capture structured light pattern on the skin for measuring deformation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide measurement of the surface deviation accurately ([0049]), and there was reasonable expectation of success.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Gorenberg, Nakamura and Bakar as applied to claim 34 above, and further in view of “Yoon et al.,” US 2017/0055855 (hereinafter Yoon).
Regarding to claim 35, Gorenberg, Nakamura and Bakar together teach all limitations of claim 34 as discussed above.
Bakar does not further teach that the projected light patterns are stripes.
However, in the analogous field of endeavor in method of acquiring blood pressure, Toon discloses using structure light projection wherein the optical markers are arranged in stripes (Figures 8A and 8B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify array of dots as taught by Nakamura to substitute with stripes, since stripe pattern was well known in the art as taught by Yoon. One of ordinary skill in the art could have combined the elements as claimed by Bakar with no change in their respective functions, replacing its array of dots with stripe patterns, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide measurement of the surface change from changes in patterns ([0059]), and there was reasonable expectation of success.
Claims 39-45 are rejected under 35 U.S.C. 103 as being unpatentable over “Gorenberg et al., US 2005/0171443 (hereinafter Gorenberg), “Nakamura et al.,” US 2018/0184909 (hereinafter Nakamura) and “Maltz,” US 2014/0128747 (hereinafter Maltz).
Regarding to claim 39, Gorenberg teaches a system for measuring blood pressure based on skin displacement, the system comprising:
a balloon having an inflated state in which a controlled amount of pressure isolates a spatio- temporal signal from a superficial artery (inflatable cushions [0043]-[0044], applying pressure enough to make a longitudinal segment of an artery within the limb achieves a collapsed state [0066]; Figures 7a-d shows time and spatial changes, Figures 8-10 shows time and spatial positions);
a sensor array positioned between the balloon and a skin surface to non-invasively monitor blood pressure (Figure 13 shows sensors positioned between balloon and the skin [0121]), the sensor array having a sensor surface that is in contact with the skin surface near the superficial artery (artery is located close to the surface of the limb [0126]),
a controller having a processor and a memory device (processor and memory [0124]), the controller being configured to receive a deformation signal from the sensor array (deformation sensor sensing deformation changes of at least one of the plurality of cushions [0046]; pressure applied to a portion of the limb [0072]), the deformation signal being caused by detecting a sensor deformation of the sensor surface in response to the skin deformation, the deformation signal being detected during at least one heartbeat cycle, the deformation signal capturing spatio-temporal contact conditions of the superficial artery sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state [0067]; Figures 7a-d shows time and spatial changes, Figures 8-10 shows time and spatial positions ), and measuring and processing the deformation signal to determine a blood-pressure parameter (calculating parameters indicating heart performance [0070]-[0071], [0151])..
Gorenberg does not explicitly disclose sensor surface is in direct contact with a skin surface and cause a skin deformation in the skin surface based on size and shape changes of the superficial artery.
The examiner notes that deformation in the skin is a natural consequence of applying a pressure/force on a limb (skin) and submits that Nakamura for disclosing the limitation.
However, in the analogous field of endeavor in blood pressure monitoring system, Nakamura teaches that sensor array in direct contact with the skin surface (Figure 13 [0037] and [0064]) and pressing force against the skin, the pressure in the blood vessel and the force caused by a deformation of the blood vessel is positioned and figures A-C show skin deformation as claimed ([0059] Figures 10A-C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify deformation sensor as taught by Gorenberg to incorporate teaching of Nakamura, since sensor in direct contact with skin for deformation measurement and skin deformation is a natural consequence of pressing the skin with sensor array, and was well known in the art as taught by Nakamura. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, configuring sensor surface to be in direct contact with skin and the skin deformation was caused by pressing the sensor to the skin (limb), and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate measure of blood pressure ([0059] and [0072]), and there was reasonable expectation of success.
Gorenberg does not further teach the balloon inflated with a controlled amount of pressure to isolate without compromising venous and lymphatic circulation or flow in other arteries of a limb containing the superficial artery.
However, in the analogous field of endeavor in blood pressure measurement device, Maltz teaches that applying a local pressure that does not substantially affect other blood vessel in a same limb as artery ([0021]), and cuff being inflated to a pressure below diastolic pressure, distorting the shape of the artery causing the artery to partially collapse ([0042]-[0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify deformation sensor as taught by Gorenberg to incorporate teaching of Maltz, since regulating pressure of inflatable cuff to not to affect other arteries in a limb was well known in the art as taught by Maltz. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, regulating its pressure to ne just under diastolic pressure, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate measurement of arterial caliber ([0042]), and there was reasonable expectation of success.
Regarding to claims 40 and 42-44, Gorenberg, Nakamura and Maltz together teach all limitations of claim 39 as discussed above.
Gorenberg further teaches following limitations:
Of claim 40, wherein the sensor array includes one or more of a tactile sensor, an ultrasound imaging sensor, a resistive sensor, a piezoelectric sensor, and a capacitive sensor (capacitive sensor [0049]).
Of claim 42, wherein the controller is configured to estimate blood pressure from a pressure sweep that includes a gradual increase and decrease of the controlled amount of pressure (gradual decrease [0126]; gradual increase [0170])
Of claim 43, wherein the pressure sweep includes a rising sweep in which an air pressure is increased from a low value at a rate standard for blood pressure measurement (external pressure applied to a level above the systolic blood pressure and decrease at a rate of 2-3 mmHg per second while pressure and piezoelectric transducers are measured [0126]-[0127]), the rising sweep continuing until (a) a saturation pressure is reached, or (b) a pulsation amplitude of the deformation signal is attenuated below a predetermined threshold if the air pressure reaches a nominal value (external pressure is decreased from above systolic to below diastolic blood pressure, modulations are observed, external pressure decreases, the modulations increase until the external pressure is approximately at the mean artery pressure and then it decreases [0128])
Of claim 44, further comprising a display communicatively coupled with the controller, the display displaying the blood-pressure parameter (calculations of pressure measurement displayed on a display [0149])
Of claim 45, further comprising an external device communicatively coupled with the balloon, the external device controlling the amount in inflating or deflating the balloon (external pressure control device is connected with the inflatable cushion with the sensors [0121]; Figure 13 )
Regarding to claim 41, Gorenberg, Nakamura and Maltz together teach all limitations of claim 39 as discussed above.
Nakamura further teaches wherein the blood-pressure parameter is an oscillometric blood-pressure parameter (oscillometric method [0004]).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Gorenberg, Nakamura, and Maltz as applied to claim 45 above, and further in view of “Klaassen et al.,” US 2017/0340209 (hereinafter Klaassen).
Regarding to claim 46, Gorenberg, Nakamura and Maltz together teach all limitations of claim 45 as discussed above.
Gorenberg teaches external pressure device but does not further teach the external device is a mobile phone of a user.
However, in the analogous field of endeavor in measuring blood pressure, Klaassen teaches a controller is an external device such as mobile device ([0017]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify external device as taught by Gorenberg to incorporate teaching of Klaassen, since mobile device controller was well known in the art as taught by Klaassen. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, configuring its external device to be mobile device, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide convenience of controlling the calibration using a mobile device ([0017]) and there was reasonable expectation of success.
Claims 47-48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Gorenberg, Nakamura, and Maltz as applied to claim 39 above, and further in view of “Bakar et al.,” US 2013/0339043 (hereinafter Bakar).
Regarding to claims 47-48 and 50, Gorenberg, Nakamura, and Maltz teach all limitations of claim 39 as discussed above.
Gorenberg does disclose deformation sensor being optical sensors ([0115]), but does not further disclose details of structured light projection and optical markers.
However, in the analogous field of endeavor in method and system of measuring biological parameters, Bakar teaches using structured light illuminated on the surface of the body, and includes light patterns (dot patterns [0049]), such as array of small, closely spaced circular dots or other structural elements impinging on the surface of interest and camera capturing the image on the dots on the surface, thus, used as optical markers as claimed ([0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify optical sensor as taught by Gorenberg to incorporate teaching of Bakar, since structure light including optical marker of array of dots was well known in the art as taught by Bakar. One of ordinary skill in the art could have combined the elements as claimed by Gorenberg with no change in their respective functions, adding a camera to capture structured light pattern on the skin for measuring deformation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide measurement of the surface deviation accurately ([0049]), and there was reasonable expectation of success.
Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Gorenberg, Nakamura, Maltz, and Bakar as applied to claim 34 above, and further in view of “Yoon et al.,” US 2017/0055855 (hereinafter Yoon).
Regarding to claim 49, Gorenberg, Nakamura, Maltz, and Bakar together teach all limitations of claim 48 as discussed above.
Bakar does not further teach that the projected light patterns are stripes.
However, in the analogous field of endeavor in system of acquiring blood pressure, Toon discloses using structure light projection wherein the optical markers are arranged in stripes (Figures 8A and 8B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify array of dots as taught by Nakamura to substitute with stripes, since stripe pattern was well known in the art as taught by Yoon. One of ordinary skill in the art could have combined the elements as claimed by Bakar with no change in their respective functions, replacing its array of dots with stripe patterns, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide measurement of the surface change from changes in patterns ([0059]), and there was reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PATRICIA J PARK/Primary Examiner, Art Unit 3798