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
In response to preliminary amendment filed December 11, 2023, no claims are amended and no claims are added. Claims 2-4, 6-7, 13-15, 22, 25-28, and 34-80 are cancelled. Claims 1, 5, 8-12, 16-21, 23-24, and 29-33 are pending.
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, 5, 8-12, 16-21, 23-24 and 29-33 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 “wherein the ear-wearable device is configured to” in line 7. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the functions of receiving, evaluating, and determining in lines 8-11. That is, the functions in lines 8-11 are not recited as being performed by any of the claimed structures of the device such that the relationship between these functions and the claimed structures of the device is not clear, thus rendering claim 1 indefinite.
Claims 5, 8-12, 16-21, 23-24 and 29-33 are rejected by virtue of their dependence from claim 1 and because they inherit and do not remedy the deficiencies of claim 1.
Claim 5 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of evaluation in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 5 indefinite.
Claim 8 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of determination in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 8 indefinite.
Claim 9 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear whether which recited component, if any, performs the function of evaluation in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 9 indefinite.
Claim 10 is rejected by virtue of its dependence on claim 9 and because it inherits and does not remedy the deficiencies of claim 9.
Claim 11 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of detection in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 11 indefinite.
Claim 12 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of evaluation in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 125 indefinite.
Claim 16 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of detection in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 16indefinite.
Claim 17 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of evaluation in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 17 indefinite.
Claims 18-19 are rejected by virtue of their dependence on claim 17 and because they inherit and do not remedy the deficiencies of claim 17.
Claim 18 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of detection in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 18 indefinite.
Claim 19 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of change in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 19 indefinite.
Claim 20 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of detection in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 20 indefinite.
Claim 21 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of query in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 21 indefinite.
Claim 23 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of evaluation in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 23 indefinite.
Claim 24 is rejected by virtue of its dependence on claim 23 and because it inherits and does not remedy the deficiencies of claim 23.
Claim 24 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of sending in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 24 indefinite.
Claim 29 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is which recited component, if any, performs the function of providing in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 29 indefinite.
Claim 30 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of providing in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 30 indefinite.
Claim 31 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of providing in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 5 indefinite.
Claim 32 is rejected by virtue of its dependency on claim 31 and because it inherits and does not remedy the deficiencies of claim 31.
Claim 33 recites “wherein the ear-wearable device is configured to”. A lack of clarity arises as “the ear-wearable device” refers to the preamble of the claim and it is unclear which recited component, if any, performs the function of providing in line 2. That is, the function in line 2 is not recited as being performed by any of the claimed structures of the device such that the relationship between this function and the claimed structures of the device is not clear, thus rendering claim 33 indefinite.
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, 8-12, 16-21, 23-24 and 29-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 5, 8-12, 16-21, 23-24 and 29-33 are all within at least one of the four categories.
The independent claim 1 recites:
evaluating signals from the sensor package and/or the microphone; and
determine a rehabilitative status of a device wearer with respect to the orthopedic procedure.
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. See footnotes 14 and 15.
“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) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of evaluating and determining 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.
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 (claim 1), 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.
With respect to the pending claims, for example, a physician can perform the claimed step of evaluating by mentally looking at collected signals. The physician can then further determine a rehabilitative status mentally. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
Regarding the dependent claims 5, 8-12, 16-21, 23-24 and 29-33, 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. For example, dependent claims recite steps (e.g. evaluating, determining, detecting, changing, querying, sending and providing) that can be performed in the mind. 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.
This judicial exception (abstract idea) in claims 1, 5, 8-12, 16-21, 23-24 and 29-33is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for evaluating, determining, detecting, changing, querying, sending and providing merely invoke a computer as a tool.
The data-gathering step (receiving an input) does 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 computer that is used as a tool for evaluating, determining, detecting, changing, querying, sending and providing.
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 provide information about a rehabilitative status of a user.
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 computer for evaluating, determining, detecting, changing, querying, sending and providing. The claims do not apply the obtained data to a particular machine. Rather, the data is merely output in an post-solution step.
The additional elements are identified as follows: a control circuit; a microphone; and a sensor package.
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 (p. 22, 30) which discloses that the control circuit, the microphone, and sensor package comprise generic computer components that are configured to perform the generic computer functions (e.g. evaluating, determining, detecting, changing, querying, sending and providing) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
the non-patent literature cited herewith:
Ko, Wen H., et al. "Studies of MEMS acoustic sensors as implantable microphones for totally implantable hearing-aid systems." IEEE Transactions on Biomedical Circuits and Systems 3.5 (2009): 277-285.
See Fig 1. and Section A: Requirements of Implantable Acoustic Sensor
Seong, Ki Woong, et al. "A vibro-acoustic hybrid implantable microphone for middle ear hearing aids and cochlear implants." Sensors 19.5 (2019): 1117.
See Fig. 1 and Section 2: Middle Ear Cavity Implantable Sensors
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 elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 8-9, 17-21, 23-24 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel (US 20180317837 A1; cited by applicant) in view of Georgiou (US 20220386959 A1).
With respect to claim 1, Burwinkel teaches
An ear-wearable device (see paragraph 0034, hearing assistance device #302) comprising:
a control circuit (see paragraph 0034 and see Fig. 3, mother flexible circuit #303);
a microphone (see paragraph 0034 and see Fig. 3, microphone #306), wherein the microphone is in electrical communication with the control circuit (see paragraph 0034 and see Fig. 3, microphone #306 is electrically connected to mother flexible circuit #303); and
a sensor package (see paragraph 0034 and see Fig. 3, sensor arrangement #320), wherein the sensor package is in electrical communication with the control circuit (see paragraph 0034 and see Fig. 3, sensor arrangement #320 is electrically connected to mother flexible circuit #303);
wherein the ear-wearable device is configured to
receive an input (see paragraph 0036, hearing assistance device can include a physical therapy engine #402 that implements multiplicity of different therapies and receives an input from selection engine #404 that allows selection of several different therapies; and see paragraph 0040, therapy can be any therapy that involves vestibular rehabilitation therapy to strength after surgery) […];
evaluate signals from the sensor package and/or the microphone (see paragraph 0027, an output of an electrical signal indicating successes or lack of successes of each or a series of specified bodily actions is transmitted; and see paragraph 0018, hearing assistance device typically include microphones; and see paragraph 0026, sensor arrangement senses movement of user and data produced by sensor arrangement is operated on by a processor) ; and
determine a rehabilitative status of a device wearer (see paragraph 0027, an output of an electrical signal indicating successes or lack of successes of each or a series of specified bodily actions is transmitted where the successes of lack of success is the rehabilitative status; and see paragraph 0026, sensor arrangement senses movement of user and data produced by sensor arrangement is operated on by a processor to determine if a specified action was successfully or unsuccessfully executed by user) with respect to the orthopedic procedure.
Burwinkel does not specifically disclose receiving an input regarding an occurrence of an orthopedic procedure.
Georgiou teaches receiving an input regarding an occurrence of an orthopedic procedure (see paragraph 0151 and 0191, input from clinician on a threshold for detecting risk of presence of infection after medical procedure such as a surgical implementation in form of joint replacement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to receive an input on the occurrence of an orthopedic procedure because it would have resulted in the predictable result of monitoring signals from sensors to identify the risk of onset and/or presence of an infection (Georgiou: see [0149]) by generating a health status of a user (Georgiou: see [0151]).
With respect to claim 5, all limitations of claim 1 apply in which Burwinkel does not disclose wherein the ear-wearable device is configured to evaluate signals from the sensor package and/or the microphone for indicia of pain.
Georgiou teaches wherein an ear-wearable device is configured to evaluate signals from the sensor package and/or the microphone for indicia of pain (see paragraph 0095, ear wearable infection sensor device is configured to estimate at least one of pain and discomfort experienced by user based on data from sensor package and microphone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have evaluated pain because it would have resulted in the predictable result of estimating pain to normalize real time data (Georgiou: see [0182]).
With respect to claim 8, all limitations of claim 1 apply in which Burwinkel does not disclose wherein the ear-wearable device is configured to determine a post-procedural mobility value and compare the same with a pre- procedure mobility value.
Georgiou teaches wherein the ear-wearable device is configured to determine a post-procedural mobility value and compare the same with a pre- procedure mobility value (see paragraph 0151, compare set of data received as signals from one or more sensors against stored data; and see paragraph 0154, movement data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have mobility values because it would have resulted in the predictable result of comparing and reflecting on a health status of a user and characterizing an infection status based on a change in the movement (Georgiou: see [0151]).
With respect to claim 9, all limitations of claim 1 apply in which Burwinkel does not disclose wherein the ear-wearable device is configured to evaluate a post-procedural gait parameter of the device wearer.
Georgiou teaches wherein the ear-wearable device is configured to evaluate a post-procedural gait parameter of the device wearer (see paragraph 0247, walking protocol).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have mobility values because it would have resulted in the predictable result comparing and reflecting on a health status of a user and characterizing an infection status based on a change in the movement (Georgiou: see [0151]).
With respect to claim 17, all limitations of claim 1 apply in which Burwinkel does not disclose wherein the ear-wearable device is configured to evaluate signals from the microphone to detect one or more phrases or utterances indicative of pain, stiffness, or other discomfort associated with the orthopedic procedure.
Georgiou teaches wherein the ear-wearable device is configured to evaluate signals from the microphone to detect one or more phrases or utterances indicative of pain, stiffness, or other discomfort associated with the orthopedic procedure (see paragraph 0095, ear wearable infection sensor device is configured to estimate at least one of pain and discomfort experienced by user based on data from sensor package and microphone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have evaluated pain because it would have resulted in the predictable result of estimating pain to normalize real time data (Georgiou: see [0182]).
With respect to claim 18, all limitations of claim 17 apply in which Georgiou further teaches wherein the ear-wearable device is configured to detect a posture change or activity of the device wearer (see paragraph 0048, posture of user is determined based on sensor package data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have detected posture because it would have resulted in the predictable result of providing insight into optical times to evaluate for the risk of the presence of infection as it can be advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171]).
With respect to claim 19, all limitations of claim 17 apply in which Georgiou further teaches wherein the ear-wearable device is configured to change a pain, stiffness, or other discomfort detection threshold value when the device wearer is detected to be sitting down, standing up, using stairs, or exercising (see paragraph 0095, ear wearable infection sensor device is configured to estimate at least one of pain and discomfort experienced by user based on data from sensor package and microphone; and see paragraph 0188, sitting or lying down).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have evaluated pain because it would have resulted in the predictable result of estimating pain to normalize real time data (Georgiou: see [0182]).
With respect to claim 20, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to detect a posture change or activity of the device wearer and detect a left-right weight distribution during the posture change or activity (see paragraph 0048, posture of user is determined based on sensor package data; and see paragraph 0171, posture change during movement such as lying down and detecting the direction of gravity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have detected posture because it would have resulted in the predictable result of providing insight into optical times to evaluate for the risk of the presence of infection as it can be advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171]).
With respect to claim 21, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to query the device wearer regarding pain, stiffness, or other discomfort (see paragraph 0055, 0182 and 0200, ear wearable sensor device is configured to query user on how they feel and record response with respect to pain or discomfort).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to query a user as it can be used at part of the data set for determining whether an infection is present as added information (Georgiou: see [200]).
With respect to claim 23, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to evaluate signals from the sensor package to detect possible post-procedural infection (see paragraph 0053, determine infection status after medical procedure using data collected from sensor package).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to evaluate signals to detect infection because it would have resulted in the predictable result of being able to detect infection rapidly as typically ear wearable devices are worn all the time (Georgiou: see [0148]).
With respect to claim 24, all limitations of claim 23 apply in which Georgiou further teaches wherein the ear-wearable device is configured to send an alert to a care provider if a possible post-procedural infection is detected (see paragraph 0056 and 0153, ear wearable device is configured to issue an alert to clinician if risk of infection is detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to send an alert to a clinician because it would have resulted in the predictable result of warning a medical care provider that an infection has been detected (Georgiou: see [0153]-[0154]) for early treatment.
With respect to claim 29, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to provide a reminder to the device wearer if a duration of a detected post-procedural activity crosses a threshold value (see paragraph 0090, detecting physical activity and gathering data on if activity falls below a threshold value; and see paragraph 0167, alert issued if physical activity is above a threshold value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to send a reminder if activity crosses a threshold because it would have resulted in the predictable result of suspending operations related to detection infection if activity is above a threshold (Georgiou: see [0167]) as it is advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171]).
With respect to claim 30, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to provide a reminder to the device wearer if a post-procedural activity that is not recommended is detected (see paragraph 0090, detecting physical activity and gathering data on if activity falls below a threshold value; and see paragraph 0167-0170, alert issued if physical activity is above or below a threshold value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to provide a reminder if activity that is not recommended is detected because it would have resulted in the predictable result of suspending operations related to detection infection if activity is above a threshold (Georgiou: see [0167]) as it is advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171])
With respect to claim 31, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to provide reminders to the device wearer regarding recommended post-procedural activities (see paragraph 0090, detecting physical activity and gathering data on if activity falls below a threshold value; and see paragraph 0167-0170, alert issued if physical activity is above or below a threshold value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to provide a reminder on recommended activities because it would have resulted in the predictable result of suspending operations related to detection infection if activity is above a threshold (Georgiou: see [0167]) as it is advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171])
With respect to claim 32, all limitations of claim 31 apply in which the combination of Burwinkel and Georgiou further teaches the recommended post-procedural activities comprising stretching and/or exercises (Burwinkel: see paragraph 0027, an output of an electrical signal indicating successes or lack of successes of each or a series of specified bodily actions is transmitted; and see paragraph 0021, exercise routine or physical therapy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to have an exercise be an activity because it would have resulted in the predictable result of measuring activity as it is advantageous to evaluate risk of infection when user is laying down or seated with limited physical activity (Georgiou: see [0171]).
With respect to claim 33, all limitations of claim 1 apply in which Georgiou further teaches wherein the ear-wearable device is configured to provide instructions to the device wearer regarding recommended post-procedural activities (see paragraph 0194, ear wearable sensor device can instruct user to move if an infection is detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel with the teachings of Georgiou to provide instructions because it would have resulted in the predictable result of using sound to determine whether or not an infection is present (Georgiou: see [0194]) and tell a user what to do if an infection is detected.
Claims 10-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel in view of Georgiou as applied to claim 1 above, and further in view of Burwinkel-2 (US 20180233018 A1).
With respect to claim 10, all limitations of claim 9 apply in which Burwinkel and Georgiou do not specifically teach wherein the gait parameter comprising at least one selected from the group consisting of gait velocity, step length, swing and stance phase, double support time, ground reaction forces, impulse, and propulsion during habitual walking.
Burwinkel-2 teaches gait parameters (see paragraph 0082, parameters including gait of user) that comprise at least one selected from the group consisting of gait velocity, step length, swing and stance phase, double support time, ground reaction forces, impulse, and propulsion during habitual walking (see paragraph 0082: walking speed, cadence, gait symmetry and variance, step clearance, sway, speed of postural transitioning (how long it takes to stand up or sit down), total number of steps per day, number of transitions each day, number of walks per day, distance or duration of each walk on average, total walking distance per day, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel and Georgiou with the teachings of Burwinkel-2 to have utilized gait parameters because it would have resulted in the predictable result of monitoring intrinsic factors of a user that contributes to their risk of falling (Burwinkel-2: see [0003]) to monitor post procedurally.
With respect to claim 11, all limitations of claim 1 apply in which Burwinkel and Georgiou do not specifically teach wherein the ear-wearable device is configured to detect leg swinging associated with leg stiffness.
Burwinkel-2 teaches detecting leg swinging associated with leg stiffness (see paragraph 0082, parameters including gait of user that include cadence which is leg swinging and the inverse of cadence gives leg stiffness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel and Georgiou with the teachings of Burwinkel-2 to have utilized gait parameters because it would have resulted in the predictable result of monitoring intrinsic factors of a user that contributes to their risk of falling (Burwinkel-2: see [0003]) to monitor post procedurally.
With respect to claim 12, all limitations of claim 1 apply in which Burwinkel and Georgiou do not specifically teach wherein the ear-wearable device is configured to evaluate a gait parameter symmetry of the device wearer.
Burwinkel-2 teaches evaluating a gait parameter symmetry of the device wearer(see paragraph 0082, parameters including gait of user including gait symmetry and variance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel and Georgiou with the teachings of Burwinkel-2 to have utilized gait parameters because it would have resulted in the predictable result of monitoring intrinsic factors of a user that contributes to their risk of falling (Burwinkel-2: see [0003]) to monitor post procedurally.
With respect to claim 16, all limitations of claim 1 apply in which Burwinkel and Georgiou do not specifically teach wherein the ear-wearable device is configured to detect an asymmetrical leaning pattern of the device wearer during ambulation.
Burwinkel-2 teaches detecting an asymmetrical leaning pattern of the device wearer during ambulation (see paragraph 0082, parameters including gait of user including gait symmetry and variance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burwinkel and Georgiou with the teachings of Burwinkel-2 to have utilized gait parameters because it would have resulted in the predictable result of monitoring intrinsic factors of a user that contributes to their risk of falling (Burwinkel-2: see [0003]) to monitor post procedurally.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
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.
/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791