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 .
Response to Amendment
2. This action is responsive to the amendments filed 3/3/2026. Claims 1-6 have been amended. Claim 9 was newly added. No claims have been canceled.
Response to Arguments
3. Applicant’s arguments filed on 3/3/2026 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) The combination of the prior art does not teach the amended limitations of claim 1.
4. In response to A), the examiner respectfully disagrees.At the onset, it is important to note the scope of the claims. The claims are directed to a device. Device claims cover what a device is, not what the device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). So long as the device is capable of performing a function, the metes and bounds of the claims have been met. With regards to the newly added limitations of
“in a case where it is determined that the electrocardiographic waveform has the quality of being able to extract the feature of the electrocardiographic waveform, the electrocardiographic feature extraction unit searches the electrocardiographic waveform on a basis of the first reference point and extracts for each beat the feature of the electrocardiographic waveform, and in a case where it is determined that the electrocardiographic waveform does not have the quality of being able to extract the feature of the electrocardiographic waveform, the electrocardiographic feature extraction unit searches the electrocardiographic waveform on a basis of the second reference point and extracts for each beat the feature of the electrocardiographic waveform”, the Examiner notes that these are contingent limitations and the claim does not require that these criteria be met. The combination of Baxi, Lange, and Mitsumoto teaches the required structure (see rejection of claim 1 below) and thus teaches scope of the required limitations as currently claimed.
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 limitations are:
“electrocardiographic waveform acquisition unit”, “electrocardiographic feature extraction unit”, “pulse wave feature extraction unit”, “electrocardiographic waveform quality determination unit”, and a “first/second search reference point setting unit” in claim 1.
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The examiner notes that Applicant’s specification in paragraphs [0033-0034] refer to an electrocardiographic sensor and pulse wave sensor for “electrocardiographic waveform acquisition unit”, “electrocardiographic feature extraction unit”, “pulse wave feature extraction unit”. Additionally, paragraphs [0040] and [0071] refer to a generic control unit (comprising generic CPU, RAM, memory) for “electrocardiographic waveform quality determination unit”, and “first/second search reference point setting unit”.
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 § 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 1-9 are rejected under 35 U.S.C 103 as being unpatentable over Baxi et al. (US Pub.: 2018/0184921 A1, – Previously Cited) and further in view of Lange et al. (US 2016/0360986 A1 – Previously Cited) and Mitsumoto et al. (Japanese Publication: JP 2012/045304 A – Previously Cited).
Regarding claim 1, Baxi teaches a biological state estimation device which comprises:
an electrocardiographic waveform acquisition unit which acquires an electrocardiographic waveform ([0023] ECG sensor 106);
an electrocardiographic feature extraction unit which searches the electrocardiographic waveform and extracts a feature of the electrocardiographic waveform ([0029] detecting R wave peaks in the ECG signal);
a pulse waveform acquisition unit which acquires a pulse waveform ([0023] PPG sensor 104); and
a pulse wave feature extraction unit which searches the pulse waveform and extracts a feature of the pulse waveform ([0028] the PPG peaks are easily identifiable), wherein
the biological state estimation device estimates a biological state on a basis of at least the feature of the electrocardiographic waveform among the feature of the electrocardiographic waveform and the feature of the pulse waveform ([0024] Based on the PPG and ECG signals, circuitry on the wearable blood pressure patch can determine a pulse transit time. PTT is a measurement of the time it takes for a pulse of blood to travel from the heart to a peripheral location on the body. PTT is inversely correlated to BP (and blood pressure is a biological state according to the disclosure of the present invention), [0029] identifying segments based on R-wave peaks). Baxi fails to teach a quality determination unit. Mitsumoto teaches the biological state estimation device further comprising:
an electrocardiographic waveform quality determination unit which determines whether or not the electrocardiographic waveform has a quality of being able to extract the feature of the electrocardiographic waveform from only the electrocardiographic waveform;
a first search reference point setting unit which sets a first reference point for searching the electrocardiographic waveform in a case where it is determined that the electrocardiographic waveform has the quality of being able to extract the feature of the electrocardiographic waveform ([0035] the signal quality calculation logic 26 splits the pulse signal acquired by the pulse sensor 12 and the electrocardiographic signal acquired by the heart rate sensor 14 at a fixed period and calculates the quality q1 of the pulse signal and the quality q2 of the electrocardiographic signal in the period).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Baxi with Mitsumoto because constitutes applying a known technique to a known device. Analyzing the quality of a signal is well-known in the art of analyzing ECGs so it would be obvious to use that concept as part of the ECG waveform analysis in Baxi.
Lange teaches a second search reference point setting unit which sets a second reference point for searching the electrocardiographic waveform on a basis of the feature of the pulse waveform ([0047] the first derivative of PPG 430 can be used as a reference signal. The first derivative PPG 430 can include sharp peaks R corresponding to the times of sharp peaks R in the pulse waveform, the points in time in the ECG corresponding to the times of the sharp peaks R in the pulse waveform) in a case where it is determined that the electrocardiographic waveform does not have the quality of being able to extract the feature of the electrocardiographic waveform, ([0047] since it takes a time for blood to flow from the heart to the wrists, the peaks R are shifted by a time period A relative to the heart beats R in clean ECG signal 420).
It would have been obvious to modify the combination of Baxi and Mitsumoto with Lange because there is some teaching, suggestion, or motivation to do so. Lange teaches “the average data can be analyzed to detect and track changes and trends in average ECG data over an extended period of time” ([0049]).
With regards to the limitations of “in a case where it is determined that the electrocardiographic waveform has the quality of being able to extract the feature of the electrocardiographic waveform, the electrocardiographic feature extraction unit searches the electrocardiographic waveform on a basis of the first reference point and extracts for each beat the feature of the electrocardiographic waveform, and in a case where it is determined that the electrocardiographic waveform does not have the quality of being able to extract the feature of the electrocardiographic waveform, the electrocardiographic feature extraction unit searches the electrocardiographic waveform on a basis of the second reference point and extracts for each beat the feature of the electrocardiographic waveform”, the Examiner notes that these are contingent limitations and thus the apparatus claim does not require that these criteria be met. The combination of Baxi, Lange, and Mitsumoto teaches the required structure as recited in claim 1 and thus teaches scope of the required limitations as currently claimed.
Regarding claim 2, the combination of Baxi, Lange, and Mitsumoto teaches the device of claim 1. The combination further teaches a pulse waveform quality determination unit which determines whether or not the pulse waveform has a quality of being able to extract the feature of the pulse waveform, wherein in a case where it is determined that the pulse waveform has the quality of being able to extract the feature of the pulse waveform, the pulse wave feature extraction unit extracts the feature of the pulse waveform. This would be obvious from the above combination because feature extraction requires a minimum level of quality in the signal.
Regarding claim 3, the combination of Baxi, Lange, and Mitsumoto teaches the device of claim 1. The combination further teaches the pulse wave feature extraction unit extracts a rise of the pulse waveform, and the second search reference point setting unit sets a rising time of the pulse waveform as the second reference point. Baxi teaches extracting PPG peaks ([0028]). Lange also teaches that the first derivative PPG 430 can include sharp peaks R ([0047]). The derivative of Lange reads on the rise of the waveform in the current application.
Regarding claim 4, the combination of Baxi, Lange, and Mitsumoto teaches the device of claim 1. The combination further teaches the pulse wave feature extraction unit extracts a peak of the pulse waveform, and the second search reference point setting unit sets a time of the peak of the pulse waveform as the second reference point. Baxi teaches extracting PPG peaks ([0028]).
Regarding claim 5, the combination of Baxi, Lange, and Mitsumoto teaches the device of claim 1. The combination further teaches the pulse wave feature extraction unit extracts a peak in a first differential waveform calculated from the pulse waveform, and the second search reference point setting unit sets, as the second reference point, a time of the peak in the first differential waveform calculated from the pulse waveform. Baxi teaches extracting PPG peaks ([0028]). Lange also teaches that the first derivative PPG 430 can include sharp peaks R ([0047]).
Regarding claim 6, the combination of Baxi, Lange, and Mitsumoto teaches the device of claim 1. The combination further teaches the pulse wave feature extraction unit extracts a peak in a second differential waveform calculated from the pulse waveform, and the second search reference point setting unit sets, as the second reference point, a time of the peak in the second differential waveform calculated from the pulse waveform. Lange teaches that the first derivative PPG 430 can include sharp peaks R ([0047]). This would make it obvious to calculate a second derivative waveform.
Regarding claim 7, the combination of Baxi, Lange, and Mitsumoto teaches the device according to claim 1. Baxi further teaches a blood pressure value is estimated as the biological state (abstract - blood pressure estimation).
Regarding claim 8, the combination of Baxi, Lange, and Mitsumoto teaches the device according to claim 1. Baxi further teaches a heart rate is estimated as the biological state ([0041] heart rate).
Regarding claim 9, the combination of Baxi, Lange, and Mitsumoto teaches the device according to claim 1. Mitsumoto further teaches wherein the first reference point is a point in time identified from the electrocardiographic waveform ([0031-0035]). Additionally, Lange further teaches wherein the second reference point is a point in time identified from the pulse waveform ([0030] and ([0047]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
Prosecution Insights