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 Arguments
Applicant’s amendments merit new grounds for rejection to claim 7 under 35 U.S.C. § 103(a) and claim 10 under 35 U.S.C. §112(d).
Applicant’s certified copy of a FP document was received on 11/13/2025. However, Applicant’s certified copies are lacking a certified English translation and therefore, Applicant may not overcome pending rejections by translation.
Applicant's arguments filed 2/4/2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 101 on pp. 9-14, Applicant first argues that the claimed “photoplethysmographic sensor that includes a light emitting element and a light receiving element disposed on the main body and configured to detect biodata including a blood pressure” specifies a particular sensor technology and therefore is not considered a generic sensor invoked for data gathering.
This is not found persuasive because the PPG sensor as claimed only serves to nominally tie the abstract idea to a field of use or device. In this instance, the claims recite limitations considered to positively claim a mental process, these are identified in the rejection below. The claims do comprise additional elements that are not considered abstract, such as the PPG and acceleration sensors, but these additional elements do not integrate the abstract idea into a practical application and therefore do not transform the claims into patent eligible subject matter.
Applicant goes on to allege that the instant claims are similar to cases such as Research Corp. Techs. v. Microsoft Corp., and SiRF Technology, Inc. v. International Trade Commission. Contrary to Applicant’s assertion, the instant claims do not appear to comprise any subject matter that “could not, as a practical matter, be performed entirely in a human’s mind.” As MPEP § 2106 further guides, or with the aid of a pen and paper. There is no evidence of record that a human being, with or without the aid of pen and paper, is not capable of performing coordinate transforms or calculating an angle of an axis relative to another axis. These are tasks commonly performed in Geometry and Linear Algebra, and not outside the capacity of human mental processes.
On pp. 12-14, Applicant goes on to state that the claimed abstract idea reflects an improvement to the functioning of a computer, or the improvement of another technology or technical field. This is not found persuasive because the functioning of a computer itself is not improved by the claimed invention directed to blood pressure calculations, and because in order to integrate the abstract idea into a practical application, the improvement must be reflected in more than just the abstract idea. It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.
With respect to the rejections under 35 U.S.C. § 103, on pp. 15-18 of the Remarks filed 2/4/2026, Applicant generally alleges that Sato does not teach an inclination of a center axis of an annular device. As noted in the rejection below, Sato does teach determining this inclination, as even if the claims specifically defined the center axis of the device as an orthogonal axis intersecting the center of a circle formed by the circumference of the device, Sato teaches determining the inclination of this axis, labeled as ɵ2 in Fig. 3. Applicant’s remaining arguments with respect to these rejections amount to general allegations that the claims are not taught by the cited combination of references and are therefore not found persuasive.
Priority
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 appears to lack further limitations aside from what is claimed in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, and 7-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1 and 16-17 claim a biosensor with a main body, sensor detecting blood pressure, accelerometer, and control unit which determines whether a user is sleeping and estimates the user’s posture, then determines a difference between the height of the main body and heart of the user and whether the difference is within a threshold amount, finally determining a blood pressure based on the sleeping and posture determinations.
Claims 2-7, 10-15, and 18-20 include additional algorithmic or calculation parameters, with steps for managing data and sensing.
Claims 8-9 include the shape of the main body is asymmetric in a plurality of axes.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 recites the following limitations:
determine…whether the user is sleeping
estimate a posture of the user during a measurement based on the inclination of the main body relative to the vertical direction
determine whether a difference in height between the main body and a heart of the user is within a predetermined range
estimate the height of the heart of the user based on the obtained physical information
based on a result of determining whether the user is sleeping and a result of determining the posture of the user during the measurement, detect the biodata including the blood pressure
estimate the difference in height between the biosensor and the heart of the user based on an inclination of a center axis of the biosensor, being a z-axis, relative to only the vertical direction, being an x-axis.
The above identified claim limitations comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the claimed evaluation of a user’s posture and sleeping state mentally or with the aid of a pencil and paper. They do not require any computer implementation and therefore are directed to a mental process of determining whether a subject is likely to be experiencing a condition state, and the mathematical relationship between hydrostatic pressure due to body posture and blood pressure
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1, 17: main body having an annular shape, PPG sensor, accelerometer, control unit
In claim 2: control unit, processor (implicitly)
In claims 8-9, asymmetrical shape
In claim 16: microprocessor, memory
The claims do not require active PPG or acceleration sensor sampling of the subject. Even in considering the main body configured to be coupled to the finger or wrist of a user, the sensors as claimed are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processor, control unit, microprocessor, and memory appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the analysis under Step 2A Prong Two, above.
The claims do not require active PPG or acceleration sensor sampling of the subject. Even in considering the main body configured to be coupled to the finger or wrist of a user, the sensors as claimed are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processor, control unit, microprocessor, and memory appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
Claim(s) 1-2, 10-11, 13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (U.S. Patent Application Publication No. 2017/0172431) hereinafter referred to as Kim; in view of Sato et al. (U.S. Patent Application Publication No. 2013/0237865) hereinafter referred to as Sato.
Regarding claim 1, Kim teaches a biosensor (Abstract) comprising:
a main body having an annular shape that is configured to be worn on a finger of a hand or a wrist of a user (Fig. 1B, element 110 wearable device worn on wrist of element 120 user);
a photoplethysmographic sensor that includes a light emitting element and a light receiving element disposed in the main body and configured to detect biodata including a blood pressure (¶¶[0056-0057]);
an acceleration sensor disposed in the main body and configured to detect an acceleration of the main body and an inclination of the main body relative to a vertical direction (¶[0056] inertial sensor, accelerometer, gyroscope or tilt sensor); and
a control unit (¶[0055], Fig. 1A) configured to:
determine, from the acceleration of the main body, when the user is sleeping (Fig. 7, ¶[0101]),
estimate a posture of the user during a measurement based on the inclination of the main body relative to the vertical direction (Fig. 5, ¶[0091],
determine whether a difference in height between the main body and a heart of the user is within a predetermined range (Fig. 7, height difference ¶¶[0101-0102]),
obtain previously stored physical information of the user (¶[0060]), and estimate the height of the heart of the user based on the obtained physical information (¶[0085] training position with hand at height of the heart, collected in advance);
based on a result of determining whether the user is sleeping and a result of determining the posture of the user during the measurement, detect the biodata including the blood pressure with the plethysmographic sensor (Fig. 5, Fig. 7, ¶[0070] based on body information and sleep, ¶¶[0101-0102]) and
Kim does not explicitly teach wherein the control unit is configured to estimate the difference in height between the biosensor and the heart of the user based on an inclination of a center axis of the biosensor, being a z-axis, relative to the vertical direction, being an x-axis.
Attention is brought to the Sato reference, which teaches a control unit configured to estimate the difference in height between a biosensor and the heart of a user based on an inclination of a center axis of the biosensor, being a z-axis (¶[0033] inclination of the blood pressure measurement device itself, therefore a center axis of the device, although unclaimed, even if Applicant requires that this axis is orthogonal to the center of the circle formed by the device, the inclination angle relative to the axis of the drawing, labeled an X axis, is indicated in Fig. 3 as ɵ2 and this inclination angle is calculated in the invention of Sato through a geometric relationship), relative to the vertical direction, being an x-axis (Fig. 3, X axis ¶¶[0033-0034]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the biosensor blood pressure calculation of Kim to include inclination height estimation, as taught by Sato, because accurate calculation of patient’s wrist location I improves blood pressure measurement accuracy (Sato ¶[0007]).
Regarding claim 2, Kim as modified teaches the biosensor according to Claim 1.
Kim further teaches wherein the control unit (Fig. 1A) is further configured to execute a processing of the biodata including the detected blood pressure (¶[0057].
Regarding claim 10, Kim as modified teaches the biosensor according to Claim 1.
Kim further teaches wherein the control unit is configured to obtain physical information of the user that is stored in advance (¶[0060]), and configured to estimate the height of the heart of the user based on the physical information (¶[0085] training position with hand at height of the heart, collected in advance).
Regarding claim 11, Kim as modified teaches the biosensor according to Claim 1.
Kim further teaches wherein the biodata includes at least one of a blood sugar level, a pulse, breathing data, a plethysmographic wave, an oxygen saturation level, a body surface temperature, an activity level, and a sleeping condition (¶[0056], ¶[0070], ¶[0091]).
Regarding claim 13, Kim as modified teaches the biosensor according to Claim 1.
Kim further teaches wherein the control unit is configured to correct the biodata including the obtained blood pressure based on a result of determining the posture of the user during the measurement (Fig. 2, final blood pressure is corrected blood pressure, and calibration value is based on posture).
Regarding claim 15, Kim as modified teaches the biosensor according to Claim 1.
Kim does not teach wherein the control unit is configured to obtain information specifying a location where the biosensor is worn and to determine the difference in height between the biosensor and the heart of the user based at least partly on the location where the biosensor is worn.
Attention is brought to the Sato reference, which teaches a control unit configured to obtain information specifying a location where a biosensor is worn and to determine the difference in height between the biosensor and the heart of the user based at least partly on the location where the biosensor is worn (¶¶[0033-0034], Fig. 3, ¶[0039]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the biosensor blood pressure calculation of Kim to include inclination height estimation, as taught by Sato, because accurate calculation of patient’s wrist location I improves blood pressure measurement accuracy (Sato ¶[0007]).
Regarding claims 16-20, the claims are directed to a biosensor comprising substantially the same subject matter as claims 1-2 and 10, and are rejected under substantially the same sections of Kim and Sato.
Claim(s) 3-5, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Sato as applied to claim 1 above, and further in view of Pantelopoulos et al. (U.S. Patent Application Publication No. 2017/0209053) hereinafter referred to as Pantelopoulos.
Regarding claim 3, Kim teaches the biosensor according to Claim 1.
Kim does not explicitly teach when the detected acceleration being greater than or equal to a predetermined value is not detected for at least a predetermined time, the control unit is further configured to determine that the user is in a resting state
Attention is brought to the Pantelopoulos reference, which teaches wherein, when detected acceleration greater than or equal to a predetermined value is not detected for at least a predetermined time, a control unit is configured to determine that a user is in a resting state (¶[0189]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the blood pressure detection system of Kim to include thresholds for motion detection of sedentary or sleeping states of the user, as taught by Pantelopoulos, because Pantelopoulos teaches that blood pressure patterns while a user is sleeping are specifically of medical import (Pantelopoulos ¶[0003]).
Regarding claim 4, Kim as modified teaches the biosensor according to Claim 3.
Kim further teaches wherein, when the user is determined to be in the resting state, the control unit is further configured to estimate the posture of the user during the measurement and determine whether the difference in height between the main body and the heart of the user is within the predetermined range (Fig. 7, ¶¶[0101-0102] height difference).
Regarding claim 5, Kim as modified teaches the biosensor according to Claim 4.
Kim does not teach wherein, when the control unit determines that the biosensor is not worn on the finger of the hand or the wrist, the control unit does not determine (i) whether the user is sleeping, (ii) whether the user is in the resting state, and (iii) the posture of the user during the measurement.
Pantelopoulos teaches wherein, when the control unit determines that the biosensor is not worn on the finger of the hand or the wrist (¶[0427]), the control unit does not determine (i) whether the user is sleeping, (ii) whether the user is in the resting state, and (iii) the posture of the user during the measurement (¶[0194] sensors and device are off or on standby, so none of these are performed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device of Kim as modified to include a standby power saving mode, as taught by Pantelopoulos, because the device is then able to reduce it power consumption (Pantelopoulos ¶[0194]).
Regarding claim 12, Kim teaches the biosensor according to Claim 1.
Kim does not teach wherein the control unit is further configured to calculate reliability of the biodata including the obtained blood pressure based on a result of determining the posture of the user during the measurement.
Attention is brought to the Pantelopoulos reference, which teaches wherein a control unit is further configured to calculate reliability of biodata including obtained blood pressure based on a result of determining the posture of a user during measurement (¶[0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the blood pressure measurement of Kim to include calculating a reliability of data based on posture of the user, as taught by Pantelopoulos, because reliable data used for calibration of blood pressure measurement improves the accuracy of blood pressure measuring devices (Pantelopoulos, ¶[0007]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Sato as applied to claim 1 above, and further in view of Mahajan et al. (U.S. Patent Application Publication No. 2024/0000326) hereinafter referred to as Mahajan.
Sato further teaches wherein the control unit is further configured to estimate the difference in height between the biosensor and the heart of the user based on an inclination of an axis, being a y-axis, to the center axis of the biosensor relative to the vertical direction (Fig. 3, Y axis, ¶¶[0033-0034], ¶[0037], gravitational direction).
Sato does not teach that the XY-plane and the center axis of the device are orthogonal.
Attention is drawn to the Mahajan reference, which teaches determining a difference in height between a biosensor and the heart of the user based on inclination angles in an XYZ coordinate system, that the XY-plane and the center axis of the device are orthogonal (¶[0043] the center/Z axis of the device is considered the top-to-bottom direction of the phone, Fig. 6 step 3 using the XYZ local coordinate system of the phone).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the orientation determination of Kim as modified to use a local coordinate system of the device, as taught by Mahajan, enabling calculation of height difference based on only one-axis of accelerometer data (Mahajan ¶[0043]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Sato as applied to claim 1 above, and further in view of Nuovo et al. (U.S. Patent Application Publication No. 2015/0335284) hereinafter referred to as Nuovo.
Regarding claim 8, Kim teaches the biosensor according to Claim 1.
Kim does not teach wherein the main body comprises a shape that is asymmetrical with respect to a plane including a center axis of the main body or wherein the main body comprises a shape that is asymmetrical with respect to a plane orthogonal to the center axis.
Attention is drawn to the Nuovo reference, which teaches wherein a main body comprises a shape that is asymmetrical with respect to a plane including a center axis of the main body and wherein the main body comprises a shape that is asymmetrical with respect to a plane orthogonal to the center axis (¶¶[0047-0048]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the biosensor of Kim to use alternative shapes, as taught by Nuovo, because Nuovo teaches that the shape and orientation of a wearable sensor system maintains user comfort and improves reliability of measurements (Nuovo ¶[0093]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Sato as applied to claim 1 above, and further in view of Raymann et al. (U.S. Patent Application Publication No. 2020/0345298) hereinafter referred to as Raymann.
Regarding claim 14, Kim teaches the biosensor according to Claim 1.
Kim does not teach wherein the control unit is configured to determine that the user is not sleeping when a portable controller unit configured to communicate with the biosensor is being operated.
Attention is drawn to the Raymann reference, which teaches a control unit configured to determine that a user is not sleeping when a portable controller unit configured to communicate with the biosensor is being operated (¶[0029]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the biosensor of Kim to include additional logic for determining sleep or wake states of the user, as taught by Raymann, because Raymann teaches that multiple signals improve the determination of sleep state (Raymann ¶[0022]).
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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