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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/22/2026 has been entered.
Response to Arguments
There are new claim objections in view of the amendment.
There are new 35 USC 112 rejections in view of the amendment.
Applicant's arguments, see Remarks pages 7-10, filed 05/22/2026, with respect to the 35 USC 101 rejection of claims 1, 4-5, 8-11, and 14-18 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the claims recite significantly more than the judicial exception, the examiner respectfully disagrees. The applicant contends that the features of “identifying the vital sign determined through a first signal obtained through the biometric sensor, and normalizing the trend pattern of the first vital sign data based on the first vital sign data and the activity level of the user obtained through the activity sensor” is unconventional. The examiner disagrees and looks to MPEP 2106.05(a)II for support, wherein the examiner asserts that the claimed invention of the present application is akin to the example of “(g)athering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48”. The examiner provided examples in the previous office action of using biometric and activity sensors to acquire vital signs and activity level information. Even, in arguendo, if one were to ignore the data acquisition steps using sensors are insignificant extra-solution activity that amounts to necessary data gathering, the examiner contends that different types of sensors are designed acquire corresponding types of signals that would most certainly be recognized by one of ordinary skill in the art. The “analyzing” steps (i.e., detecting, identifying, normalizing, determining, and modifying) appear to be performed by a generic processor (see claim 1 lines 10-30) using the words "apply it" (or an equivalent) with the judicial exception (see MPEP § 2106.05(f). Thus, the examiner does not find the claim drawn to significantly more.
In response to the applicant’s argument that the claims provide an improvement to a technical field, the examiner respectfully disagrees. The examiner notes the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field. As mentioned above, the examiner disagrees applying the judicial exception on a general computing component (i.e., processor) provides an improvement to a technical field.
In response to the argument that the human mind does not have a biometric sensor, located in a wearable electronic device, for detecting a vital sign of a user and an activity sensor, located in the wearable electronic device, for detecting an activity signal of the user, the examiner agrees. However, the examiner also notes that the data acquisition steps with their corresponding additional elements are being interpreted as insignificant extra-solution activity that amounts to necessary data gathering. The examiner must consider whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B. See also MPEP 2106.05(g).
Thus, for the reasons provided above, the examiner maintains the 35 USC 101 rejection of claims 1, 4-5, 8-11, and 14-18.
Claim Objections
Claims 1, 11, and 17 are objected to because of the following informalities:
Claim 1 line 5 should recite “an activity sensor”;
Claim 11 line 13 should recite “an activity sensor”;
Claim 17 line 16 should recite “an activity sensor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-5, 8-11, and 14-18 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.
Claim 1 recites the limitation “…determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user…”. It is unclear from the claim language whether ALL of the elements of the clause are required for the determination of an activity level, one element is required, or a combination, thus rendering the scope of the claim unable to be determined. The examiner recommends including “and” or “or” before the last element (“activity duration of the user”) to convey the intended scope of the limitation. For purposes of compact prosecution, the examiner is interpreting the limitation with an “or”, thus requiring the determination to only require one of the three factors. Claims 4-5 and 8-10 are rejected due to their dependence upon rejected claim 1.
Claim 11 recites the limitation “…determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user…”. It is unclear from the claim language whether ALL of the elements of the clause are required for the determination of an activity level, one element is required, or a combination, thus rendering the scope of the claim unable to be determined. The examiner recommends including “and” or “or” before the last element (“activity duration of the user”) to convey the intended scope of the limitation. For purposes of compact prosecution, the examiner is interpreting the limitation with an “or”, thus requiring the determination to only require one of the three factors. Claims 14-16 are rejected due to their dependence upon rejected claim 11.
Claim 17 recites the limitation “…determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user…”. It is unclear from the claim language whether ALL of the elements of the clause are required for the determination of an activity level, one element is required, or a combination, thus rendering the scope of the claim unable to be determined. The examiner recommends including “and” or “or” before the last element (“activity duration of the user”) to convey the intended scope of the limitation. For purposes of compact prosecution, the examiner is interpreting the limitation with an “or”, thus requiring the determination to only require one of the three factors. Claim 18 is rejected due to its dependence upon rejected claim 17.
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, 4-5, 8-11, and 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
A wearable electronic device determining a vital sign while a user is active, the wearable electronic device comprising:
a biometric sensor, located in the wearable electronic device, for detecting a vital sign of a user;
a activity sensor, located in the wearable electronic device, for detecting an activity signal of the user;
memory, comprising one or more storage media and storing instructions; and
at least one processor connected to the biometric sensor, the activity sensor, and the memory,
wherein the instructions, when executed by the at least one processor individually or collectively, cause the wearable electronic device to:
identify the vital sign determined through a first signal obtained through the biometric sensor,
identify whether a quality value of the vital sign is greater than or equal to a threshold,
identify a first vital sign data, of which the quality value is greater than or equal to a threshold, among the vital sign determined through the first signal,
identify a trend pattern of the first vital sign data,
determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user,
normalize the trend pattern of the first vital sign data based on the first vital sign data and the activity level of the user obtained through the activity sensor,
identify a second vital sign data, of which the quality value is less than the threshold, among the vital sign determined through the first signal,
calculate the second vital sign data based on the normalized trend pattern of the first vital sign data, and
modify the vital sign by merging the first vital sign data and the calculated second vital sign data.
Independent Claim 11 recites:
A method for operating a wearable electronic device determining a vital sign while a user is active, the method comprising:
identifying a vital sign of the user determined through a first signal obtained through a biometric sensor located in the wearable electronic device;
identifying whether a quality value of the vital sign is greater than or equal to a threshold;
determining a first vital sign data, of which the quality value is greater than or equal to the threshold, among the vital sign determined through the first signal;
determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user,
normalizing a trend pattern of the first vital sign data based on the first vital sign data and the activity level of the user obtained through a activity sensor located in the wearable electronic device;
identifying a second vital sign data, of which the quality value is less than the threshold, among the vital sign determined through the first signal;
calculating the second vital sign data based on the normalized trend pattern of the first vital sign data; and
modifying the vital sign by merging the first vital sign data and the calculated second vital sign data.
Independent Claim 17 recites:
One or more non-transitory computer-readable storage media storing one or more computer programs including computer-executable instructions that, when executed by one or more processors of a wearable electronic device individually or collectively, cause the wearable electronic device to perform operations, the operations comprising:
identifying a vital sign of a user determined through a first signal obtained through a biometric sensor located in the wearable electronic device;
identifying whether a quality value of the vital sign is greater than or equal to a threshold;
determining a first vital sign data, of which the quality value is greater than or equal to the threshold, among the vital sign determined through the first signal;
determine an activity level of the user while wearing the wearable electronic device based on activity type of the user, activity intensity of the user, activity duration of the user,
normalizing a trend pattern of the first vital sign data based on the first vital sign data and the activity level of the user obtained through a activity sensor located in the wearable electronic device;
identifying a second vital sign data, of which the quality value is less than the threshold, among the vital sign determined through the first signal;
calculating the second vital sign data based on the normalized trend pattern of the first vital sign data; and
modifying the vital sign by merging the first vital sign data and the calculated second vital sign data.
Step 1:
The examiner determines that claim 1 and 17 are drawn to machines and claim 11 is drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of detecting, identifying, normalizing, determining, and modifying recite mental processes capable of being performed by the human mind.
The steps of “detecting”, “identifying”, and “determining” a vital sign or an activity of a user in independent Claims 1, 11, and 17 are mental processes capable of being performed in the human mind. For example, the human mind is capable of “detecting”, “identifying”, and/or “determining” respiration rate by counting a patient’s breaths while simultaneously observing a clock to account for time. The step of “identifying” a quality value of the vital sign is greater than or equal to a threshold is a mental process capable of being performed in the human mind. For example, the human mind can decide whether a cup of coffee is hot enough to drink by mentally comparing its perceived temperature to a minimum/maximum comfortable threshold. The step of “normalizing” the vital sign in independent Claims 1, 11, and 17 is a mental process capable of being performed by the human mind. For example, the human mind is capable of considering a patient’s current vital sign in comparison to a patient’s usual or previous measurements, as well as factors such as the normal ranges for age, medical history, fitness level, etc. The step of “modifying” a vital sign signal in independent claims 1, 11, and 17 is an example of a mental process capable of being performed by the human mind. For example, the human mind is capable modifying a hypothesis or idea with new information.
The claimed steps of detecting, identifying, normalizing, determining, and modifying can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 4-5, 8-10, 12-16, and 18, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 1, 4-5, 8-11, and 14-18 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for detecting, identifying, normalizing, determining, and modifying merely invoke a computer as a tool.
• The data-gathering step (detecting) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for detecting, identifying, normalizing, determining, and modifying.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for detecting, identifying, normalizing, determining, and modifying. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: sensor, processor, and memory.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. paragraph [0033]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. detecting, identifying, normalizing, determining, and modifying) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
• Applicant’s specification (e.g. paragraph [0035]) which discloses that the memory comprises generic memory components that are configured to perform the generic memory functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
• Bang (US 20220192600 A1) para. 0052 which discloses conventional methods of sensing using ECG and accelerometers;
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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