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 .
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.
Election/Restrictions
Applicant's election with traverse of Group I comprising claims 1-2 and 4 in the reply filed on 22 April 2026 is acknowledged. The traversal is on the ground(s) that the other groups “could be made without serious search burden”. This is not found persuasive because no evidence was provided for how these groups would not provide a serious search burden or how a thorough search of the claims within Group I would encompass material covered in the remaining groups that were not elected. That statement alone is not enough to overcome the examiner’s previous reasons for restriction. The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “used by being worn on a wrist of a human body” recited in the preamble is not the proper recitation of this type of element. It is advised that this limitation be recited “configured to be worn on a wrist of a human body” in order to better represent how this device is able to or intended to be used. Additionally, it is best practice to separate elements within a written claim with a semicolon “;”, therefore the examiner advises the applicant separate lines 22 and 23 with a semicolon, lines 27 and 28 with a semicolon, and lines 32 and 33 with a semicolon instead of the currently recited comma “,” at each of these locations.
Claim 2 is objected to because of the following informalities: the limitation “substantially same as a height” contains a minor grammatical error. This limitation would be better suited to recite “substantially the same as a height”.
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.
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 (unit) 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: “blood pressure measurement unit”, "input unit”, “electrocardiographic waveform measurement unit”, “electrode contact state detection unit”, "position detection unit", “first correctness determination unit”, “second correctness determination unit”, "third correctness determination unit", and “collective measurement control unit” in Claim 1.
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. The following elements and their structures are interpreted as such:
“blood pressure measurement unit” is recited with the structure “blood pressure measurement unit include a cuff, a pressure sensor, a pump, and the like for measuring blood pressure by an oscillometric method” in paragraph [0020] of the instant application’s specification.
"input unit" is recited with the structure "operation button" in paragraph [0021] of the instant application’s specification.
“electrocardiographic waveform measurement unit” does not contain a positively recited structure within the instant application’s specification beyond including “a plurality of electrodes” in paragraph [0009] of the instant application’s specification.
“electrode contact state detection unit” is recited with the structure “electrocardiographic signal measuring circuit” as recited in paragraph [0069] of the instant application’s specification.
"position detection unit" is recited with the structure "triaxial acceleration sensor" or "other unit…position of the device vertical axis" in paragraph [0010] of the instant application’s specification.
“first/second/third correctness determination unit" do not contain positively recited structures within the instant application’s specification beyond being part of the controller.
“collective measurement control unit” does not contain a positively recited structure within the instant application’s specification beyond being part of the controller.
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
Claims 1-2 and 4 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The elements “first correctness determination unit”, “second correctness determination unit”, “third correctness determination unit" and “collective measurement control unit” have not been provided with any structure within the instant application’s specification that make it understood what comprises each of the “correction detection units” or the “collective measurement control unit”. Are these each a different algorithm within the controller? Are they each a separate sub-system within the controller? Without proper clarification, it is unclear what entails a “first correctness determination unit”, “second correctness determination unit”, “third correctness determination unit", and “collective measurement control unit” that would enable one of ordinary skill in the art to recreate these elements.
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 1-2 and 4 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.
Regarding Claim 1, the limitations containing the phrase “correctness” are indefinite. More specifically, the limitations “determines…correctness as to whether or not a wrist of the human body…” recited in line 19, “ determines…correctness as to whether or not the human body is stably in contact…” recited in line 24, “determination unit indicates correctness” recited in line 26, “determines…correctness as to whether or not the wrist of the human body on which the device is positioned…” recited in line 28, “unit indicates correctness” recited in line 31, and “on condition that…indicates correctness” recited in line 35 (emphasis added). How are each of these units “determining correctness” or “indicating correctness”? What does the level or content of “correctness” entail? It is unclear what the term “correctness” is representing or what kind of metric is in place to ensure this determination is upheld. For this examination, the phrase “correctness” is being interpreted as “verification” or “proof”.
The term “stably” in Claim 1 is a relative term which renders the claim indefinite. The term “stably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In fact, the instant application’s specification describes the process of determining if the electrodes are “stable” as “arbitrary” (Paragraph [0076] - whether or not the contact is stable can be distinguished by an arbitrary index).
Claim limitations “first correctness determination unit”, “second correctness determination unit”, “third correctness determination unit", and “collective measurement control unit” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure beyond being part of a “controller” that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not explicitly rejected above are rejected due to their dependence on the above claims
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Deno et. al.'274 (U.S. Patent Publication 20210177274) in view of Chou'937 (U.S. Patent Publication 20180020937) and further in view of Nishioka et. al.’963 (U.S. Patent Publication 20110237963).
Regarding Claim 1, Deno et. al.'274 discloses a biological information measurement device used by being worn on a wrist of a human body (Paragraph [0045] - As illustrated in FIG. 2, the measurement device 100 is a wristwatch device), the biological information measurement device comprising:
a blood pressure measurement unit configured to measure a blood pressure of the human body (Paragraph [0038] - The blood pressure measurement unit 40 is provided in the belt portion 20 and measures blood pressure of the user);
an input unit configured to receive an instruction to start blood pressure measurement of the human body (Paragraph [0058] - The input device 107 enables the user to input an instruction to the measurement device 100. The input device 107 receives an operation by the user, for example, an operation corresponding to an instruction to start measurement);
an electrocardiographic waveform measurement unit which includes a plurality of electrodes and is configured to measure an electrocardiographic waveform of the human body (Paragraph [0037] - The electrocardiogram generation unit 33 generates an electrocardiogram based on a potential difference between the electrode 31 and the electrode 32);
an electrode contact state detection unit configured to detect a contact state of the human body with the plurality of electrodes (Paragraph [0104] - The contact detection unit 261 detects contact of the user);
a position detection unit configured to detect a position of the device (Paragraph [0059] - The acceleration sensor 108 is, for example, a triaxial acceleration sensor and outputs an acceleration signal representing acceleration in three directions orthogonal to one another; Paragraph [0074] - The posture detection unit 158 detects, based on the acceleration signal output from the acceleration sensor 108, that the user is in posture appropriate for blood pressure measurement. The posture appropriate for blood pressure measurement is, for example, posture as illustrated in FIG. 6 in which the left wrist that is a target measurement site; Paragraph [0100] - [0100] As with the posture detection unit 158 (FIG. 5) of the first embodiment, the posture detection unit 258 detects that the user is in posture appropriate for blood pressure measurement.; Paragraph [0119] - The measurement device 100 may further include a height detection unit that detects the height of a target measurement site relative to a heart as a reference, and a blood pressure measurement value may be corrected based on the height detected by the height detection unit);
a controller configured to control the electrocardiographic waveform measurement unit and the blood pressure measurement unit (Paragraph [0096] - The control unit 101 of the measurement device 200 executes a program stored in the storage unit 105 to cause the input unit 251, the display control unit 252, the electrocardiogram measurement control unit 253, the electrocardiogram acquisition unit 254, the blood pressure measurement control unit 255, the blood pressure value calculation unit 256, the measurement end detection unit 257, the posture detection unit 258, the notification unit 259, the instruction unit 260, and the contact detection unit 261 to execute processing described below);
a first correctness determination unit which determines, on a basis of an output of the position detection unit, correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a first predetermined range after receiving an instruction to start blood pressure measurement of the human body via the input unit (Paragraph [0014] - the measurement device may further include an instruction unit configured to instruct the user to assume posture appropriate for the blood pressure measurement, when the posture detection unit does not detect that the user is in posture appropriate for the blood pressure measurement; Paragraph [0077] - When the posture detection unit 158 does not detect that the user is in posture appropriate for blood pressure measurement, before a predetermined period of time (for example, 15 seconds) has elapsed since the end of electrocardiogram measurement, the instruction unit 160 instructs the user to assume posture appropriate for blood pressure measurement; Paragraph [0096] - the measurement device 200 includes…an instruction unit 260; Paragraph [0100] – entire paragraph - As with the posture detection unit 158 (FIG. 5) of the first embodiment, the posture detection unit 258 detects that the user is in posture appropriate for blood pressure measurement);
a second correctness determination unit which determines, on a basis of an output of the electrode contact state detection unit, correctness as to whether or not the human body is in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness (Paragraph [0111] - At step S35, the control unit 101 operates as the contact detection unit 261 to determine whether the right hand of the user has come into contact with the electrode 132. In a case where the right hand of the user does not come into contact with the electrode 132 before a predetermined period of time (for example, 15 seconds) has elapsed since the end of blood pressure measurement); and
a collective measurement control unit which performs control to collectively execute blood pressure measurement of the human body by the blood pressure measurement unit (Paragraph [0101] - The blood pressure measurement control unit 255 controls an operation associated with blood pressure measurement. The blood pressure measurement control unit 255 controls the pump drive circuit 146 and the valve drive circuit 147 to perform blood pressure measurement by the oscillometric method) and measurement of an electrocardiographic waveform of the human body by the electrocardiographic waveform measurement unit (Paragraph [0112] - At step S37, the control unit 101 operates as the contact detection unit 261 to determine whether the right hand of the user has come into contact with the electrode 132. In a case where the right hand of the user does not come into contact with the electrode 132 before a predetermined period of time (for example, 10 seconds) has elapsed since the notification, the processing proceeds to step S39. At step S39, the control unit 101 operates as the electrocardiogram measurement control unit 253 to stop the signal processing circuit 133. In this case, the processing ends without performing electrocardiogram measurement), on condition that determination result of the second correctness determination unit and the third correctness determination unit indicates correctness (Paragraphs [0074] and [0112]).
Deno et. al.'274 fails to disclose determining a correctness as to whether or not the human body is stably in contact with the plurality of electrodes (emphasis added). Chou'937 teaches ensuring that contact electrodes are stably in contact with a surface of the skin of the user (Paragraph [0053] - the contact stability between the electrode and the skin can be determined, so as to decide if the ECG measurement can be started; Paragraph [0055] - When making the decision, if the switch is not switched, and/or the physical state change is not conformed to a preset criteria, e.g., not higher than a threshold, which means the contact between the second electrode and the skin is not enough to perform the ECG measurement, so that the device will remain in an OFF state. On the other hand, if the switch has switched and/or the physical state change has reached the threshold, which means the contact is sufficient to perform the ECG measurement, and thus, the device will be converted into an ON state). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Deno et. al.'274 to include ensuring the contact between the user and the electrodes is stable in order to ensure that an accurate and sufficient reading is able to be obtained when performing the proper measurements as seen in Chou’937.
Deno et. al.'274 further fails to disclose a third correctness determination unit, on a basis of an output of the position detection unit, correctness as to whether or not the wrist of the human body on which the device is worn is positioned at a height within a second predetermined range when a determination result of the second correctness determination unit indicates correctness. Nishioka et. al.’963 teaches determining a wrist of a human is positioned at an appropriate height for a second measurement following confirmation that the height of the wrist of the human during the first measurement was appropriate (Figure 6; Paragraphs [0080-0087] and [0090]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Deno et. al.’274 in view of Chou’937 to include repeating a step of measuring a posture/height of a wrist of a user after receiving a first confirmation that the height/posture of the wrist of the user was appropriate but before taking a blood pressure measurement in order to ensure that the wrist of the user stays at an appropriate posture/height for a given amount of time that makes it more likely for an accurate measurement reading to take place as seen in Nishioka et. al.’963.
It is noted by the examiner that although the recited prior art of record Deno et. al.’274 has involved two different embodiments within their description, the elements within each embodiment are not limited to such and can be combined (Paragraph [0121] - In short, the present invention is not limited to the embodiments described above as they are, and the component can be modified and embodied without departing from the gist of the present invention in a practical phase. Additionally, various inventions can be formed by appropriately combining a plurality of components disclosed in the embodiments described above. Further, the components of the different embodiments may be combined appropriately). Therefore, the examiner would like to note that it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the second embodiment of Deno et. al.’274 (as relied on the above recitations from Figure 10) to include steps S14 to S17 from the first embodiment (as seen in Figure 7) into the second embodiment such as before step S31 (as seen in Figure 11) in order to provide instructions to a user that would assist a user in creating an appropriate posture during a second posture measurement reading if a first reading indicated that the initial posture was not correct.
Regarding Claim 2, Deno et. al.'274 in view of Chou'937 and further in view of Nishioka et. al.’963 discloses the system outlined in Claim 1 above. Deno et. al.’274 further discloses wherein a height within the second predetermined range is set to be substantially same as a height of a heart of the human body (Paragraph [0074] – entire paragraph - The posture detection unit 158 detects, based on the acceleration signal output from the acceleration sensor 108, that the user is in posture appropriate for blood pressure measurement. The posture appropriate for blood pressure measurement is, for example, posture as illustrated in FIG. 6 in which the left wrist that is a target measurement site is at the same height as the height of a heart; Paragraph [0075] - No blood pressure difference occurs in the measurement performed in posture in which the left wrist is at the same height as the height of the heart, and thus a highly reliable measurement value can be obtained; Paragraph [0119] - The measurement device 100 may further include a height detection unit that detects the height of a target measurement site relative to a heart as a reference, and a blood pressure measurement value may be corrected based on the height detected by the height detection unit).
Regarding Claim 4, Deno et. al.'274 in view of Chou'937 and further in view of Nishioka et. al.’963 discloses the system outlined in Claim 1 above. Deno et. al.’274 further discloses wherein the biological information measurement device is a wristwatch-type wearable device (Paragraph [0035] - The measurement device 10 is a wearable device and is attached to the left wrist of a user in the example of FIG. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Klaassen et. al.’209 (U.S. Patent Publication 20170340209) discloses a wearable wristwatch-type device configured to measure blood pressure at variable heights of the wrist in relation to the heart. Pantelopoulos et. al.’758 (U.S. Patent 11589758) discloses a wearable wristwatch-type device configured to measure blood pressure and comprising an altimeter. Brumback et. al.’631 (U.S. Patent Publication 20140135631) discloses a wearable wristwatch-type device configured to measure blood pressure and comprising an altimeter and tri-axial accelerometers. Colburn et. al.’529 (U.S. Patent Publication 20210378529) discloses a wearable wristwatch-type device configured to measure blood pressure and comprising an altimeter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791
Prosecution Insights