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 .
Amendment Entered
In response to the amendment filed on November 28th, 2025, claims 1-12 are cancelled, and new claims 17-24 are entered. Claims 13-16 remain withdrawn from consideration.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(a) have been fully considered. Although the rejections are withdrawn in view of the cancellation of claims 1-12, Examiner notes that the new claims still fail to comply with the written description requirement for similar reasons to the previous rejection. Therefore, the 112(a) rejections have been reproduced and further clarified for the new claims below.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the cancellation of claims 1-12.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 103 have been fully considered but are not persuasive. Although the rejections are withdrawn in view of the cancellation of claims 1-12, Examiner respectfully disagrees that “none of the cited references disclose nor taught generating a blood pressure data from a pulse wave velocity data through a gradient boosting data model” (cited from Page 3 of the Reply). The previously cited references have been used in the new rejections below.
Applicant's remarks and amendments with respect to the request for rejoinder have been fully considered but are not persuasive. At Pg. 3 of the Reply, Applicant argues that “claim 13 includes the limitation…that corresponds to the abovesaid inventive concept of new claim 17” and therefore requests a rejoinder of claims 13-16. Examiner respectfully disagrees. This is not found persuasive because the two sets of claims are still related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. See MPEP § 806.05(e). In this case, the apparatus as claimed can be used to practice another materially different process such as a method for measuring pulse rate. Therefore, Claims 13-16 remain withdrawn from further consideration.
Claim Objections
Claim 17 is objected to because of the following informality:
Claim 17 recites “data and” in lines 22-23, but should read “data; and”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “force generation device” in Claim 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 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 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 17-24 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 17-24 fail to satisfy the written description requirement because “the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function.” MPEP 2161.01 I.
“When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.” Id.
“[F]or computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into both the sufficiency of the disclosed hardware as well as the disclosed software due to the interrelationship and interdependence of computer hardware and software.” Id.
“If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made." Id.
An algorithm (e.g. necessary steps and/or flowcharts) that performs the claimed functions in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter is not present in the instant application. Although [0054] of the Applicant’s Specification recites an “XGBoost algorithm” and its effectiveness, the Applicant’s Specification fails to provide support for the claimed “gradient boosting data model” nor state its relationship to the “XGBoost algorithm”. Furthermore, programming for the claimed functions is absent from the disclosure.
The necessary steps to perform the function are not disclosed. Mere reference to necessary steps without providing detail about the necessary steps is not an adequate disclosure to satisfy the written description requirement. The specification does not sufficiently identify how the invention achieves the claimed function and therefore fails to satisfy the written description requirement.
Claims 17-24 encompass 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, at the time the application was filed, had possession of the claimed invention. By not limiting the claimed functions to any particular means for performing the function, the claims are broadened beyond the scope.
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 17-19, 21-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al (U.S. Publication No. 2020/0054221; previously cited) in view of Omron Healthcare Co Ltd (WO 2023276623A1; the machine translation, provided herewith, is referred to below; previously cited) and Im (U.S. Publication No. 2010/0210956; previously cited).
Regarding Claim 17, Ward discloses a blood pressure measuring system (wearable assembly; Abstract), comprising:
a portable blood pressure sensor (As illustrated in FIGS. 2A and 2B, wearable sensor 102 includes a thin piezoelectric sensor (or sensor assembly) 200 that is capable of measuring raw signal data that alters in response to blood pressure changes in a subject. The wearable sensor 102 is an example implementation of the wearable sensor 816; [0067]) comprising:
a sensing device (electrode layer 206; [0069-0070]) comprising:
a first piezoelectric layer (piezoelectric electrode 212; [0069-0070]); and
a second piezoelectric layer (piezoelectric electrode 214; [0069-0070]);
a force generation device (The hard backing substrate 208 may be held in place by a strap 210 (such as Velcro, constant tension spring, small inflatable cuff, glove, or other adjustable band); [0068]);
a first processor (controller 804) electrically connected to the sensing device and the force generation device (A signal-processing device 802 (or “signal processor”) may be coupled to a patient 820 via one or more wearable sensors 816 (or a “wearable sensor assembly”)…the signal-processing device 802 may have a controller 804…it is understood that any or the entire signal processing functionality and/or components of the signal-processing device 802 may be combined with a wearable sensor assembly, such as the wearable sensor 816; [0061-0063]; Figure 1);
a first flexible layer (second compliant polymer layer 204; [0068]); and
a second flexible layer (strap 210; [0068]);
a second processor wirelessly (A link 824, which may include one or more wired and/or wireless (Bluetooth, WLAN, etc.) connections, may operatively connect the controller 804 to a wearable sensor 816 through the I/O circuit 812; [0061]; the signal processing functionality of the signal processing computer 802 may be integrated into the wearable computing or communication device or may be divided between the wearable computing or communication device and another wirelessly connected computing device; [0077]; In reference to FIG. 5, at blocks 402 and 404 raw signal data from piezoelectric sensor 200 and a raw signal data from secondary sensor are provided to the signal processor system 300, for example through a wireless or wired interface…wireless interfaces may include one or more wireless routers, modems, antennas, transceivers, etc., facilitating communications via any suitable wireless networking protocol, such as Bluetooth or a protocol standardized under IEEE 802.11; [0085]) connected to the first processor (one or more processors 808 (may be called microcontrollers or a microprocessors)…it should be appreciated that although only one processor 808 is shown, the controller 804 may include multiple microprocessors 808; [0061]; one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein; [0161]; Similarly, the methods or routines described herein may be at least partially processor-implemented. For example, at least some of the operations of a method may be performed by one or more processors or processor-implemented hardware modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but also deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of locations; [0166-0167]);
a display (display 826) electrically connected to the second processor (The signal-processing device 802 may also include various types of input/output hardware such as a visual display 826 and input device(s) 828 (e.g., keypad, keyboard, etc.). In an embodiment, the display 826 is touch-sensitive, and may cooperate with a software keyboard routine as one of the software routines 832 to accept user input; [0062]; The output data from the stage 312 may be displayed as a health report and/or alarm condition, for example, using the display 826 of signal-processing device 802, a health report and/or alarm condition may be displayed as a web page, mobile alert, tactile alert or alarm (e.g., via a vibrating function of a smartwatch or smartphone), or any other suitable visual and/or tactile display; [0094]); and
a third processor wirelessly (A link 824, which may include one or more wired and/or wireless (Bluetooth, WLAN, etc.) connections, may operatively connect the controller 804 to a wearable sensor 816 through the I/O circuit 812; [0061]; the signal processing functionality of the signal processing computer 802 may be integrated into the wearable computing or communication device or may be divided between the wearable computing or communication device and another wirelessly connected computing device; [0077]; In reference to FIG. 5, at blocks 402 and 404 raw signal data from piezoelectric sensor 200 and a raw signal data from secondary sensor are provided to the signal processor system 300, for example through a wireless or wired interface…wireless interfaces may include one or more wireless routers, modems, antennas, transceivers, etc., facilitating communications via any suitable wireless networking protocol, such as Bluetooth or a protocol standardized under IEEE 802.11; [0085]) connected to the second processor (one or more processors 808 (may be called microcontrollers or a microprocessors)…it should be appreciated that although only one processor 808 is shown, the controller 804 may include multiple microprocessors 808; [0061]; one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein; [0161]; Similarly, the methods or routines described herein may be at least partially processor-implemented. For example, at least some of the operations of a method may be performed by one or more processors or processor-implemented hardware modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but also deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of locations; [0166-0167]);
wherein the second flexible layer encapsulates the sensing device, the force generation device, and the first processor on the first flexible layer (the layer 202 is proximal to a subject's finger and provides a sensing surface, while the layer 204 is disposed distally and adjacent a reference substrate 208, in the form hard backing curved substrate designed to extend at least partial around the subject's finger. The hard backing substrate 208 may be held in place by a strap 210 (such as Velcro, constant tension spring, small inflatable cuff, glove, or other adjustable band); [0069-0070]; the sensor 200 may be entirely secured within an adjustable band, that extends around the entire wrist; [0077]; Figure 2A);
wherein the first processor generates a first data, and the second processor receives the first data; wherein the second processor generates a second data according to the first data, and the third processor receives the second data (one or more processors 808 (may be called microcontrollers or a microprocessors)…it should be appreciated that although only one processor 808 is shown, the controller 804 may include multiple microprocessors 808; [0061]; one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein; [0161]; Similarly, the methods or routines described herein may be at least partially processor-implemented. For example, at least some of the operations of a method may be performed by one or more processors or processor-implemented hardware modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but also deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of locations; [0166-0167]);
wherein the third processor generates a blood pressure data from the second data through a gradient boosting data model (The raw signal data is collected at a raw mechanical pressure converter 302, which provides the raw signal to a filtering stage 304 that applies signal filtering algorithms 406 of FIG. 5; [0085]; The stage 308 contains algorithms for extracting any of a plurality of different waveform features from the received raw signal data. For example, the stage 308 may be designed to analyze raw signal data and extract any number of features from the waveform and thereby identify any number of physiological conditions expressive by one or more of the waveform features, including, but not limited to blood pressure (BP); [0086]; machine learning may be performed to optimize feature extraction and data analysis. Example machine learning implementations include decision tree learning algorithms, clustering algorithms, support vector machine algorithms, pattern recognition algorithms, feature selection algorithms, and others known to those skilled in the art; [0090]; Signal processors may also utilize machine learning, based on extracted features, to predict physiological events/complications. Feature, such as those discussed above, or subset of features may be input to a machine learning algorithm, which is trained to predict one or more targeted physiologic events, such as hemorrhagic shock. By example and without limitation, such a machine learning algorithm may utilize SVM, Random Forest, Neural Networks, ECOC combined with SVM, and ensemble classifiers to predict the one or more targeted physiologic events; [0093]; Examiner’s Note: As best understood, “gradient boosting data model” is equivalent to a machine learning algorithm that may utilize decision trees), and the second processor receives the blood pressure data, and the display shows a blood pressure information according to the blood pressure data (The signal-processing device 802 may have a controller 804 operatively connected to the database 814 via a link 822 connected to an input/output (I/O) circuit 812. It should be noted that, while not shown, additional databases may be linked to the controller 804 in a known manner…it should be appreciated that although only one processor 808 is shown, the controller 804 may include multiple microprocessors 808…a link 824, which may include one or more wired and/or wireless (Bluetooth, WLAN, etc.) connections, may operatively connect the controller 804 to a wearable sensor 816 through the I/O circuit 812…the signal-processing device 802 may also include various types of input/output hardware such as a visual display 826 and input device(s) 828 (e.g., keypad, keyboard, etc.). In an embodiment, the display 826 is touch-sensitive, and may cooperate with a software keyboard routine as one of the software routines 832 to accept user input. It may be advantageous for the signal-processing device 802 to communicate with a broader medical treatment network (not shown) through any of a number of known networking devices and techniques (e.g., through a commuter network such as a hospital or clinic intranet, the Internet, etc.); [0061-0062]) and
wherein the first data includes a continuous waveform data (the sensor 200 may be a continuous sensor that collects raw signal data continually and accurately, irrespective of changes in the subject's physiological state, position, etc.; [0067]; the sensor 200 (as well as other example sensors herein) is capable of continuous blood pressure waveform or vascular tone measurement, due to the implementation of piezoelectric electrodes 212 and 214, to produce a time history of blood pressure of a subject; [0077]; the stage 308 may be designed to analyze raw signal data and extract any number of features from the waveform and thereby identify any number of physiological conditions expressive by one or more of the waveform features, including, but not limited to blood pressure (BP), pulse pressure (PP), pulse pressure variability (PPV), heart rate (HR), heart rate variability (HRV), arterial wall stiffness (AWS) or other vascular wall motion related features, blood flow (BF), and respiratory rate (RR). In various examples discussed below, feature extraction from pressure sensor and pulse-oximetry sensor data may include applied power from a peripheral member such as from a subject's finger, vascular radius, and vascular resistance/vascular stiffness; [0086-0087]).
Although Ward discloses a small inflatable cuff ([0068]), Ward fails to specifically disclose a force generation device providing back pressure to the first and second piezoelectric layers.
In a similar technical field, Omron Healthcare Co Ltd teaches a blood pressure measurement device (Abstract), comprising a force generation device (pump 14) providing back pressure to the first and second piezoelectric layers (The pump 14 is, for example, a piezoelectric pump. The pump 14 compresses the fluid and supplies the compressed fluid to the cuff 70 via the channel portion 15…the pump 14 includes a piezoelectric element and a diaphragm connected to the piezoelectric element. When an AC voltage, which is a drive signal, is applied to the piezoelectric element, the diaphragm vibrates together with the piezoelectric element, and the diaphragm vibrates; Page 4 Paragraphs 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pump teachings of Omron Healthcare Co Ltd into the invention of Ward in order to controllably provide force while reducing the size of the blood pressure measurement device (Omron Healthcare Co Ltd Page 4 Paragraph 5).
Although Ward discloses wherein the first data includes a continuous waveform data (the sensor 200 may be a continuous sensor that collects raw signal data continually and accurately, irrespective of changes in the subject's physiological state, position, etc.; [0067]; the sensor 200 (as well as other example sensors herein) is capable of continuous blood pressure waveform or vascular tone measurement, due to the implementation of piezoelectric electrodes 212 and 214, to produce a time history of blood pressure of a subject; [0077]; the stage 308 may be designed to analyze raw signal data and extract any number of features from the waveform and thereby identify any number of physiological conditions expressive by one or more of the waveform features, including, but not limited to blood pressure (BP), pulse pressure (PP), pulse pressure variability (PPV), heart rate (HR), heart rate variability (HRV), arterial wall stiffness (AWS) or other vascular wall motion related features, blood flow (BF), and respiratory rate (RR). In various examples discussed below, feature extraction from pressure sensor and pulse-oximetry sensor data may include applied power from a peripheral member such as from a subject's finger, vascular radius, and vascular resistance/vascular stiffness; [0086-0087]), Ward and Omron Healthcare Co Ltd fail to disclose wherein the first data includes a pulse wave velocity data.
In a similar technical field, Im teaches a radial arterial pulse sensing apparatus for noninvasive and continuous measurement of blood pressure and arterial elasticity (Abstract), wherein pulse wave velocity data is generated from sensor data (the pulse wave velocity calculating unit may detect a starting point of the pulses at two portions under the optical pressure condition and calculates the pulse wave velocity using a distance between the sensors, thereby assuming an absolute value of a brachial blood pressure; [0019]; FIG. 8 is views illustrating calculation of pulse wave velocity using pulses detected by the radial arterial pulse sensing apparatus of FIGS. 1A to 1C; [0065-0067]; Figure 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pulse wave velocity teachings of Im into those of Ward and Omron Healthcare Co Ltd because pulse wave velocity may be an indicator reflecting the variation of the blood pressure and the blood vessel elasticity; therefore, the correlation with the blood pressure value can be found using the pulse wave velocity (Im [0067]).
Regarding Claim 18, Ward discloses wherein the first piezoelectric layer maintains a fixed distance from the second piezoelectric layer (The electrodes 212 and 214 are spaced apart by sufficiently small distance 213 to facilitate highly sensitive raw data measurements under a force applied to the sensing layer 202, and resulting in a measurable change in a sensed voltage as shown in the circuit level depiction of FIG. 2C; [0069]).
Regarding Claim 19, although Ward discloses a sufficiently small distance between the first and second piezoelectric layers to facilitate highly sensitive raw data measurements under a force applied to the sensing layer, and resulting in a measurable change in a sensed voltage ([0069]), Ward does not expressly disclose wherein the fixed distance between the first and second piezoelectric layers ranges from 14.5 mm to 15.5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ward to have a fixed distance between the piezoelectric layers between 14.5 mm to 15.5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ward would not operate differently with the claimed distance and since the distance between the piezoelectric layers is intended to reside within the wearable sensor, which is intended to be applied to a subject’s finger or wrist, the device would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “may” range from 14.5 mm to 15.5 mm (Applicant’s Specification [0006] and [0038]).
Regarding Claim 21, although Ward discloses a small inflatable cuff ([0068]), Ward fails to specifically disclose wherein the force generation device comprises: a micro pump; a first micro airbag disposed above the first piezoelectric layer; and a second micro airbag disposed above the second piezoelectric layer; wherein the first micro airbag is connected to the micro pump, and the second micro airbag is connected to the micro pump, wherein the micro pump is configured to pump up the first micro airbag and the second micro airbag.
Omron Healthcare Co Ltd teaches wherein the force generation device comprises: a micro pump (pump 14); a first micro airbag (A cuff includes a bag-like structure that is wrapped around the upper arm, wrist, or the like of a living body when blood pressure is measured, and expands when fluid is supplied. When the fluid is air, the bag-like structure For example, it is an air bag that is inflated with air; Page 2 Paragraph 11) disposed above the first piezoelectric layer (the pump 14 includes a piezoelectric element and a diaphragm connected to the piezoelectric element. When an AC voltage, which is a drive signal, is applied to the piezoelectric element, the diaphragm vibrates together with the piezoelectric element, and the diaphragm vibrates; Page 4 Paragraph 5); and a second micro airbag disposed above the second piezoelectric layer (a plurality of fluidly connected air bags in the pressing direction of the sensing cuff 73; Page 6 Paragraph 3); wherein the first micro airbag is connected to the micro pump (The flow path section 15 connects the pump 14, the valve 16 and the pressure sensor 17 to the cuff 70. The flow path part 15 is any one of a tube, a pipe, a tank, a hollow part and a groove formed in the case 11, or a combination thereof. In addition, the fluid circuit configuration of the flow path portion 15 and the cuffs 70 can be varied in various ways, such as how to flow the fluid, the number and configuration of the cuffs 70, the supply order of the plurality of cuffs 70, the method of exhausting the plurality of cuffs 70, and the method of measuring blood pressure; Page 4 Paragraph 6), and the second micro airbag is connected to the micro pump (a plurality of fluidly connected air bags in the pressing direction of the sensing cuff 73; Page 6 Paragraph 3), wherein the micro pump is configured to pump up the first micro airbag and the second micro airbag (The pump 14 is, for example, a piezoelectric pump. The pump 14 compresses the fluid and supplies the compressed fluid to the cuff 70 via the channel portion 15; Page 4 Paragraph 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pump teachings of Omron Healthcare Co Ltd into the invention of Ward in order to controllably provide force while reducing the size of the blood pressure measurement device (Omron Healthcare Co Ltd Page 4 Paragraph 5).
Regarding Claim 22, Ward and Omron Healthcare Co Ltd fail to disclose wherein pressure in the first and second micro airbags ranges from 0 to 12 kPa.
In a similar technical field, Im teaches a radial arterial pulse sensing apparatus for noninvasive and continuous measurement of blood pressure and arterial elasticity (Abstract), wherein pressure in the first and second micro airbags ranges from 0 to 6.66 kPa (the cuff may be pressurized step by step by 3-5 mmHg up to 30-50 mmHg to determine an optimal pressure and the pulses are detected while maintaining the determined optimal pressure; [0017]; When the apparatus 500 starts operating, as shown in FIG. 4B, only the cuff 401 of the sensor 410 located on a forearm operates to apply pressure of 5-10 mmHg to the sensor 410. After this, the pressure is increased step by step by 3-5 mmHg up to 30-50 mmHg; [0051]; The initial pressure is 3-5 mmHg and the pressure increases by 3-5 mmHg at each step (F12) up to 30-50 mmHg (F13). That is, the pressure starts from 5 mmHg and increases by 5 mmHg at each step up to 50 mmHg through 10 steps; [0057]; Examiner’s Note: 0 mmHg is equivalent to 0 kPa, and 50 mmHg is equivalent to 6.66 kPa).
Although Im fails to explicitly disclose the range being from 0 to 12 kPa, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of Im from between 0 to 6.66 kPa to between 0 to 12 kPa since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range (see [0044] of the Applicant’s Specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressurization teachings of Im into those of Ward and Omron Healthcare Co Ltd in order to determine an optimal pressure and detect pulses while maintaining the determined optimal pressure (Im [0017]).
Regarding Claim 24, although Ward discloses wherein the first piezoelectric layer generates a first piezo response data to the first processor (The sensor 200 is able to measure a force from a subject's finger, e.g., in the form of a pressure. The applied force, which is isolatable from other potential forces affecting the subject's finger, is due to blood pressure and/or blood flow changes in the subject, which are measured as the highly accurate raw signal data. Each piezoelectric electrode 212 and 214 may function as a separate sensor, while the combination of the two (or more) can provide more accurate results as output values are combined and signal processed; [0070]), and the second piezoelectric layer generates a second piezo response data to the first processor (The sensor 200 is able to measure a force from a subject's finger, e.g., in the form of a pressure. The applied force, which is isolatable from other potential forces affecting the subject's finger, is due to blood pressure and/or blood flow changes in the subject, which are measured as the highly accurate raw signal data. Each piezoelectric electrode 212 and 214 may function as a separate sensor, while the combination of the two (or more) can provide more accurate results as output values are combined and signal processed; [0070]), and the first processor generates the first data according to the first and second piezo response data (Each piezoelectric electrode 212 and 214 may function as a separate sensor, while the combination of the two (or more) can provide more accurate results as output values are combined and signal processed. Additional numbers of sensors may be used, for example, formed of parallel and co-extensive strips of piezoelectric electrodes sandwiched between the layers 202 and 204. In other examples, the piezoelectric sensors may be of different lengths to one another, or at least not all the same length. Moreover, in some examples, the electrodes are not parallel. For example, the electrodes herein may form a crossing pattern or a mesh pattern. The electrodes, for example, may be in crossing array configuration, which would have the benefit of offering mapping of the resulting blood pressure data from the sensor; [0070]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ward, Omron Healthcare Co Ltd, and Im, as applied to claim 17 above, and further in view of Wang et al (U.S. Publication No. 2019/0223736; previously cited).
Regarding Claim 20, Ward, Omron Healthcare Co Ltd, and Im fail to disclose wherein the sensing device comprises: a first bottom electrode; a second bottom electrode; a first top electrode; and a second top electrode; wherein the first piezoelectric layer is located between the first bottom electrode and the first top electrode, and the second piezoelectric layer is located between the second bottom electrode and the second top electrode.
In a similar technical field, Wang teaches a blood pressure measuring device (Abstract), wherein the sensing device comprises:
a first bottom electrode (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…a second lower electrode layer 2045; [0069]);
a second bottom electrode (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…a second lower electrode layer 2045; [0069]);
a first top electrode (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…a second upper electrode layer 2047; [0069]); and
a second top electrode (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…a second upper electrode layer 2047; [0069]);
wherein the first piezoelectric layer (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…piezoelectric material layer 2046) is located between the first bottom electrode and the first top electrode ([0069]; Examiner’s Note: Figure 2B shows a plurality of pressure sensors, wherein in each one, the piezoelectric material layer 2046 is located between the lower electrode layer 2045 and the upper electrode layer 2047), and the second piezoelectric layer (the plurality of pressure sub-sensors can be a plurality of first pressure sub-sensors which have a shape of strip and are arranged in parallel on the second pressure sensor substrate 2043, each of the plurality of pressure sub-sensors comprises…piezoelectric material layer 2046) is located between the second bottom electrode and the second top electrode ([0069]; Examiner’s Note: Figure 2B shows a plurality of pressure sensors, wherein in each one, the piezoelectric material layer 2046 is located between the lower electrode layer 2045 and the upper electrode layer 2047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the piezoelectric, upper electrode, and lower electrode layer teachings of Wang into those of Ward, Omron Healthcare Co Ltd, and Im as the piezoelectric material layer can convert a pressure signal into an electrical signal, the upper electrode layer can be configured as a signal transmission layer, and the lower electrode layer can be configured as a common electrode layer (Wang [0052]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ward, Omron Healthcare Co Ltd, and Im, as applied to claim 21 above, and further in view of Kondo et al (U.S. Patent No. 8,147,418; previously cited).
Regarding Claim 23, Ward, Omron Healthcare Co Ltd, and Im fail to disclose wherein diameters of the first and second micro airbags range from 5.5 to 6.5 mm, and thicknesses of the first and second micro airbags range from 0.5 to 1.5 mm.
In a similar technical field, Kondo teaches blood pressure measuring cuffs and a blood pressure measuring device (Abstract), wherein diameters of the first and second micro airbags range from 5 to 10 mm (the diameter of said cuff bladder is within a 5 to 10 mm range; Column 2 Lines 47-48), and thicknesses of the first and second micro airbags range from 0.1 to 0.8 mm (the thickness of said body is within a 0.1 to 0.8 mm; Column 2 Lines 51-52).
Although Kondo fails to explicitly disclose wherein diameters of the first and second micro airbags range from 5.5 to 6.5 mm, and thicknesses of the first and second micro airbags range from 0.5 to 1.5 mm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Kondo since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range (see [0045] of the Applicant’s Specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the airbag sizing teachings of Kondo into those of Ward, Omron Healthcare Co Ltd, and Im as in order to obtain accurate blood pressure measurements through solid contact at a small measurement site (Kondo Column 2 Lines 10-12).
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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/CHANEL J JHIN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791