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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 APRIL 2026 has been entered.
Drawings
The drawings were received on 16 April 2026. These drawings are accepted.
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 -20 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.
The terms "just prior to the impact" (line 13, Claim 1; line 8, Claim 9) and “just after the impact” (line 15,Claim 1; line 9, Claim 9) in claims 1 and 9 are relative terms which render the claim indefinite. The terms “just prior” and “just after” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what window of time is encompassed by “just”, whether a number of milliseconds, seconds, etc., and what is outside of the metes and bounds of that window. The term “just before” is not a particular term in the art, and there is no explanation in the specification to designate what “just” is intended to mean. For the purposes of examination, the terms "just prior to the impact" and "just after the impact" are deemed to claim "prior to the impact" and "after the impact". Claims 2 – 8 and Claims 10 – 20 are similarly rejected due to their dependence on Claims 1 and 9, respectively.
Claim 7 (line 2) and Claim 8 (line 2) each recite the term “teeth of a user” in line 2. It is unclear if this is intended to be the same or different than the previously-recited user in Claim 1, from which each of these claims depends. For the purposes of examination, the term “teeth of a user” is deemed to claim “teeth of the user”.
Claim 19 recites the term “the workload to the user”. There is insufficient antecedent basis for this term in the claim. There is no previously-recited “workload”, and it is unclear if this is intended to be the same or different than the previously recited “historical workload average” or “weekly workload average” recited in Claims 17 and 18, from which this claim depends. For the purposes of examination, the term “the workload to the user” is deemed to claim “a workload to the user.”
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 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 9, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of claims 1 – 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 20 recites an abstract idea.
Specifically, Claims 1 – 20 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1:
A system for sensing an impact and identifying whether the impact is true positive, the system comprising:
a sensing device configured to be securely coupled to a user and comprising:
a motion sensor configured for sensing accelerations associated with the impact and for generating an impact signal based on the impact;
a control sensor for sensing when the sensing device is in position for sensing;
a computer-readable storage medium having instructions stored thereon for:
receiving and capturing the impact signal from the motion sensor; and
comparing first and second control signals from the control sensor to determine if the impact signal reflects that the impact is true positive, the first control signal from the control sensor being captured at a time just prior to the impact or during an early portion of the impact and the second control signal from the control sensor being captured at a late portion of the impact or just after the impact; and
a processor for processing the instructions to capture the impact signal, capture the first and the second control signals, perform the comparing, identify the impact as true positive depending on a result of the comparing, and discard the impact signal if the impact is not identified as true positive.
Claim 9
A method of identifying an impact as true positive, the method comprising:
using a motion sensor arranged on a sensing device that is configured to be securely coupled to a user and is also configured for sensing accelerations associated with the impact to generate an impact signal;
using a control sensor arranged on the sensing device:
sensing a first control signal just prior to the impact; and
sensing a second control signal just after the impact; using a computer processor:
receiving the impact signal from the motion sensor;
receiving the first control signal from the control sensor;
receiving the second control signal from the control sensor;
comparing the first control signal to the second control signal; and
identifying the impact as true positive based on the comparing; and
discarding the impact signal if the impact is not identified as a true positive.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 9, these limitations include:
observation and judgment to compare first and second control signals from the control sensor to determine if the impact signal reflects that the impact is true positive
observation and judgment to perform the comparing
observation and judgment to identify the impact as true positive depending on a result of the comparing
observation and judgment to discard the impact signal if the impact is not observed and judged as true positive.
observation and judgment to use a control sensor arranged on the sensing device that is configured to be securely coupled to a user and is also configured for sensing accelerations associated with the impact to generate an impact signal;
observation and judgment to use a control sensor arranged on the sensing device
observation and judgment to identify an impact as true positive
observation and judgment to compare first and second control signals from the control sensor
observation and judgment to identify the impact as true positive based on the comparing
all of which are grouped as mental processes or mathematical calculations under the 2019 PEG.
Similarly, Dependent Claims 2 – 8, and 10 - 20 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 9 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
identify the impact as true positive when the second signal differs from the first signal by no more than 15% or no more than 5%.
Observation and judgment to identify the impact as true positive when the second signal differs from the first signal by no more than 15% or not more than 5%.
comparing the first control signal from the control sensor to a threshold value indicating that the sensing device is in position for sensing.
Observation and judgment to compare the first control signal from the control sensor to a threshold value indicating that the sensing device is in position for sensing.
comparing a proximity level of the first control signal to a proximity level of the second control signal to identify a difference in proximity level.
Observation and judgment to compare a proximity level of the first control signal to a proximity level of the second control signal to identify a difference in proximity level.
the difference in proximity level is further compared to a threshold.
the difference in proximity level is further observed and judged to compare to a threshold.
the threshold is met when the second control signal differs from the first control signal by less than 15%.
the threshold is observed and judged to be met when the second control signal differs from the first control signal by less than 15%.
discarding the signal when the threshold is not met.
Observation and judgment to discard the signal when the threshold is not met.
accumulating a series of impacts, that have each been identified as true positive, over time to establish a workload for the user;
Observation and judgment to accumulate a series of impacts, that have each been identified as true positive, over time to establish a workload for the user;
reporting the workload to the user
Observation and judgment to communicate the workload to the user.
parsing the true positive signals into head impacts where the g-force exceeds 15 and collisions where the g-force is less than 15.
Observation and judgment to evaluate the true positive signals into head impacts where the g-force exceeds 15 and collisions where the g-force is less than 15.
calculating a historical or weekly workload average.
evaluating a historical or weekly workload average.
populating a workload interface
Observation and judgment to fill out a workload interface with information
displaying the workload interface
Observation and judgment to communicate a workload interface
repeating the method for a series of users
observation and judgment to repeat the method for a series of users.
tabulating results for several users.
observation and judgment to communicate results for several users
all of which are grouped as mental processes or mathematical calculations under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1 and 9 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 9), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“sensing device”
“motion sensor“
“control sensor”
“computer-readable storage medium”
“processor”
“proximity sensor”
“mouthguard”
Additional elements recited include a “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” in the Independent Claims 1 and 9, their dependent claims. These component are recited at a high level of generality, , i.e., as a generic ECG sensing device performing a generic function of sensing ECG data. These generic hardware component limitations for “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1 and 9 include pre-solution activity limitations, such as:
a sensing device configured for secured coupling to a user
a motion sensor configured for sensing accelerations associated with the impact and for generating an impact signal based on the impact;
a control sensor for sensing when the sensing device is in position for sensing;
a computer-readable storage medium having instructions stored thereon for receiving and capturing the impact signal from the motion sensor;
the first control signal from the control sensor being captured at a time just prior to the impact or during an early portion of the impact and the second control signal from the control sensor being captured at a late portion of the impact or just after the impact;
a processor for processing the instructions to capture the impact signal, capture the first and the second control signals,
sensing a first control signal prior to the impact event; and
sensing a second control signal after the impact event; using a computer processor:
receiving the impact signal from the motion sensor;
receiving the first control signal from the control sensor;
receiving the second control signal from the control sensor;
and from the dependent claims:
wherein the control sensor is a proximity sensor.
wherein the sensing device is a mouthguard configured for secured coupling to teeth of a user.
wherein the control sensor is arranged on the mouthguard facing the teeth of a user.
wherein the first and second control signals are proximity sensor signals.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” as recited in Independent Claims 1 and 9 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1 and 9 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1 and 9 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 9 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” as recited in Independent Claims 1 and 9 and their dependent claims.
The additional elements of the “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” Claims 1 - 20, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, the “sensing device” is described generically in [032] that it “may be the same or similar to those that are shown and described in” four patent numbers, further stating, “Still other sensing devices and process may be used.” There is a lack of specificity of the particular requirements for the “sensing device”, as it can be any of sensing devices or mouthguard appliances given in 12 different patent documents. Further, the “sensing device” 108 is presented in Figure 2 as a generic semicircular mouthguard shape with rectangles on its surface. It is further described in [022] that the alternative wearable devices may be used, “for example, a body or skin patch, a clothing patch, a head band, mouthpiece, earpiece, or other wearable device”. There is nothing particular to the structure of the “sensing device” that deems it more than well-understood, routine, or conventional.
Per applicant’s specification, the “motion sensor” is described generically in [025] as “The sensors may include accelerometers including linear accelerometers, angular accelerometers, gyroscopes, or other motion sensing micro electro-mechanical devices.” And in [026] “the sensor 112 may be kinematic sensors”. The “motion sensor” is shown as a “kinematic sensor” 112 black-box generic rectangle in Figure 2.
Per applicant’s specification, the “control sensor” is described generically as optionally [026] “the control sensors may be proximity sensors, capacitive sensors, or other sensors…” The “control sensors” are shown as a “control sensors” 128 black-box generic rectangles in Figure 2.
Per applicant’s specification, the “computer-readable storage medium” is described generically in [083] as “…computer-readable storage medium, which is intended to cover all physical, non-transitory, or similar embodiments of computer-readable media.” The “computer-readable storage medium” is shown as “data storage medium” 114 generic rectangle in Figure 2.
Per Applicant’s specification, the “processor” is described generically as optionally a [030] “high performance unit such as a 32-bit microcontroller from ST Microelectronics”, or [084] “These computer-executable program portions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus…” and that code portions “execute via the processor of the computer or other programmable data processing apparatus”. The “processor” is shown as “processor” 116 generic rectangle in Figure 2.
Per Applicant’s specification, the ”proximity sensor” is described generically in [026] “the control sensors may be proximity sensors, capacitive sensors, or other sensors…” and readings from the proximity sensors are described as [043] “the proximity or other control sensor readings”. The “proximity sensors” are shown as a “control sensors” 128 black-box generic rectangles in Figure 2. There is nothing particular to the structure or specification of the “proximity sensor” that deems it more than well-understood, routine, or conventional.
Per Applicant’s specification, the “mouthguard” is described generically in [021] as “a mouthguard worn by athletes during athletic events” and in [022] is described as a “In the case of a mouthguard, the mouthguard my include a dentition portion” that is “generally flat and u-shaped”, and is “adapted for molding to the teeth using a heating and biting process or the dentition may be custom-fitted and molded”. The physical characteristics of the described mouthguard are well-understood, routine, and conventional characteristics of all-purpose mouthguards formed for athletic mouthguards, anti-bruxism mouthguards, orthodontic mold mouthguards, and the like. The mouthguard is shown in Fig 2. as “sensing device” 108 with a generic semicircular mouthguard shape with rectangles on its surface. As claimed, a specialized mouthguard is not necessary. As such, this additional element does not impose any meaningful limits on practicing the claimed abstract idea.
Accordingly, in light of Applicant’s specification, the claimed terms “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “sensing device”, “motion sensor”, “control sensor”, “computer-readable storage medium”, “processor”, ”proximity sensor”, and “mouthguard” This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and method of Claims 1 - 20 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 - 20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1 and 9 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 - 20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 - 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 - 20 are not patent eligible and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cam, et. al., (US 2014/0257051 A1), hereinafter Cam.
Regarding Claim 1, Cam discloses A system for sensing an impact and identifying whether the impact is true positive (Fig 1A, device; [Abstract] “The device also includes a processing unit that includes methodology to detect false positives such as chewing, dropping, and throwing. [0090] “Data from motion sensors can be classified as true or false on-body impacts using various signal processing techniques.”; [0121] “…numbers of true positives (TP)…are calculated”), the system comprising:
a sensing device (Fig 1A, “a device is an oral appliance”; Fig 1, “base member” 1) configured to be securely coupled to a user ([0059] “(a) a base member 1 having a generally U-shaped form defining a channel to receive a row of teeth.”) and comprising:
a motion sensor (Fig 1A, “motion sensor” 5) configured for sensing accelerations associated with the impact ([0082] “Single-axial and multi-axial accelerometers can be used to detect the magnitude and direction of the proper acceleration (or g-force), as a vector quantity, and can be used to sense orientation, coordinate acceleration, shock, and falling in a resistive medium”; [0104] “…mouthguard records all events with linear acceleration exceeding 7 g.”) and for generating an impact signal based on the impact ([0091] “…motion signals associated with an event”);
a control sensor ([0107] “an engagement sensor”) for sensing when the sensing device is in position for sensing ([Abstract] “…one or more engagement sensors to detect whether the device is properly placed on the human subject”; Fig 11, Block 119, “Device is on-teeth, record impacts”);
a computer-readable storage medium ([0085] “…the memory can be any non-transitory computer-readable storage medium storing program code…”) having instructions stored thereon ([0085] “…for implementing software methodologies described in the present disclosure. One such data processing methodology for the impact detection is illustrated in Fig 11.”) for:
receiving and capturing the impact signal from the motion sensor ([0085]”…a memory and a processor for receiving and processing data collected from sensors to detect on-body impacts”); and
comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold…”; Fig 11, Blocks 116 -119, which are “Infrared Reflection NOT Detected”, “Device is NOT on-teeth, data not recorded”, “Infrared Detection”, and “Device is on-teeth, record impacts”) first (Fig 16A, “Off-teeth Distribution” µ = 0.17) and second control signals ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”) from the control sensor ([0107] “an engagement sensor”) to determine if the impact signal ([0091] “…motion signals associated with an event”) reflects that the impact is true positive ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”, “After the classification, numbers of true positives (TP)…are calculated”) the first control signal from the control sensor ([0121] “…proximity sensor readings below the on-teeth and off-teeth threshold…”; Fig 11, Blocks 116-119, Fig 16A, “Off-teeth Distribution” µ = 0.17; Fig 13A; Fig 13B) being captured at a time just prior to the impact ([0088] “engagement sensor…When the device is fully engaged on the teeth, the signal transmitted from the emitter…events during which the device is not fully engaged on teeth can be reflected as non-impact events based on the strength of the received signal at the receiver”; Fig 11, Fig 16A, Fig 13A; Fig 13B) (Examiner notes that the first control signal occurs before the second control signal. Cam’s disclosure performs calibration data for the proximity sensor before acquiring further impact measurements, described in [0107], “In vitro sensing behavior of an infrared proximity sensor is characterized by unit-testing sensor components”. Based on the sensor itself, its calibration baseline average “off-teeth” signal is µ = 0.17 in Figure 16A. Further, the engagement sensor data is generally measured simultaneously with the motion signals so that it can used with the motion signals to correlate if the mouthguard is on the teeth during the impact measurement from the motion signals. Note the 112b interpretation for “just prior to”.) or during an early portion of the impact
and the second control signal from the control sensor being captured at a late portion of the impact event or just after the impact ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”; Fig 13A; Fig 13B)(Examiner notes for subsequent measurements on the user, the second signal (as above, proximity sensor readings that occur at the end of each 100 ms kinematic reading from the motion sensor) is compared against the reference sensor calibration baseline average signal (or first control signal) µ = 0.17. This comparison occurs against the threshold value that is based on the calibration “off-teeth” baseline average signal µ = 0.17, as µ = 0.17 + 29σ, or 0.81 on Figure 16A. ([0111] “A threshold at 5 standard deviations below the on-teeth mean (a normalized proximity value of 0.81) is chosen. This threshold is also 29 standard deviations above the off-teeth mean…”); and
a processor for processing the instructions to capture the impact signal ([0085] “a processor…for implementing software methodologies…impact detection is illustrated in Fig 11.”) [0091] “…motion signals associated with an event”; [0082] “…accelerometers…shock; [0104] “…mouthguard records all events…linear acceleration exceeding 7 g.”), capture the first and the second control signals (Fig 16A, “Off-teeth Distribution” µ = 0.17; [0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”; [0088] “engagement sensor…When the device is fully engaged on the teeth, the signal transmitted from the emitter…events during which the device is not fully engaged on teeth can be reflected as non-impact events based on the strength of the received signal at the receiver”; Fig 11, Fig 13A; Fig 13B), perform the comparing, ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold…”; Fig 11, Blocks 116 -119, which are “Infrared Reflection NOT Detected”, “Device is NOT on-teeth, data not recorded”, “Infrared Detection”, and “Device is on-teeth, record impacts”) identify the impact as true positive depending on a result of the comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”, “After the classification, numbers of true positives (TP)…are calculated”; Fig 13A; Fig 13B) (See examiner notes above regarding the first and second control signal comparison.) and discard the impact signal if the impact is not identified as true positive ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events…”)
Regarding Claim 2, Cam discloses The system of claim 1, wherein the control sensor ([0107] “an engagement sensor”) is a proximity sensor ([0087]“…an engagement sensor, such as an infrared proximity sensor”).
Regarding Claim 3, Cam discloses The system of claim 2, wherein comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”) comprises comparing a proximity level of the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17; [0112] “On-teeth and off-teeth proximity sensor output distributions are shown in Fig 16A”) to a proximity level of the second control signal ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”; [0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”)
Regarding Claim 4, Cam discloses The system of claim 3, wherein the processor ([0085] “…a processor for receiving and processing data collected from sensors to detect on-body impacts”) is configured to identify the impact ([0091] “…motion signals associated with an event”) as true positive ([0121] “After the classification, numbers of true positives (TP)…are calculated”) when the second control signal ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”) differs from the control first signal (Fig 16A, “Off-teeth Distribution” µ = 0.17) by no more than 15% (Fig 16A, “Off-teeth distribution”, “µ = 0.17”, “σ = 0.026”, “On-Teeth/Off-Teeth Threshold = 0.81”) (Examiner notes that a second signal measurement signal that differs by 15%, or “µ = 0.17” +/- 15% would be a range of 0.1615 - 0.1785, which is entirely below than the “On-Teeth/Off-Teeth Threshold = 0.81”)
Regarding Claim 5, Cam discloses The system of claim 4, wherein the processor is configured to identify the impact as true positive when the second control signal differs from the first control signal as described above in Claim 4. Cam further discloses by no more than 5% (Fig 16A, “Off-teeth distribution”, “µ = 0.17”, “σ = 0.026”, “On-Teeth/Off-Teeth Threshold = 0.81”) (Examiner notes that a second signal measurement signal that differs by 5%, or “µ = 0.17” +/- 5% would be a range of 0.1675 - 0.1725, which is entirely below than the “On-Teeth/Off-Teeth Threshold = 0.81”)
Regarding Claim 6, Cam discloses The system of claim 4, further comprising wherein the processor ([0085]) is further configured for comparing the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17) from the control sensor ([0107] “an engagement sensor”) to a threshold value (Fig 16A, “On-Teeth and Off-Teeth Proximity Sensor Distribution output distributions”; “on-teeth/off-teeth threshold = 0.81) indicating that the sensing device is in position for sensing ([Abstract] “…one or more engagement sensors to detect whether the device is properly placed on the human subject”; Fig 11, Block 119, “Device is on-teeth, record impacts”).
Regarding Claim 7, Cam discloses The system of claim 1, wherein the sensing device (Fig 1A, “a device is an oral appliance”; Fig 1, “base member” 1) is a mouthguard (Fig 1A, “base member” 1; [0012] “In some embodiments, the base member of the device includes one of a mouthguard”) configured for secured coupling to teeth of a user ([0059] (a) a base member 1 having a generally U-shaped form defining a channel to receive a row of teeth.”).
Regarding Claim 8, Cam discloses The system of claim 7, wherein the control sensor ([0107] “an engagement sensor”) is arranged on the mouthguard (Fig 1A, “base member” 1; [0012] “In some embodiments, the base member of the device includes one of a mouthguard”) facing the teeth of a user (Fig 5A, “emitter and receiver pairs” 52; [0108] “…by embedding a sensor in the mouthguard to face the tooth, a device can use the infrared signal drop to detect mouthguard dislocation.”).
Regarding Claim 9, Cam discloses A method of identifying an impact as true positive, (Fig 13A; Fig 13B; Fig 1A; [Abstract]; [0090]), the method comprising:
using a motion sensor (Fig 1A, “motion sensor” 5) arranged on a sensing device (Fig 1A, “a device is an oral appliance”; Fig 1, “base member” 1) that is configured to be securely coupled to a user ([0059] “(a) a base member 1 having a generally U-shaped form defining a channel to receive a row of teeth.”) and is also configured for sensing accelerations ([0082] “Single-axial and multi-axial accelerometers can be used to detect the magnitude and direction of the proper acceleration (or g-force), as a vector quantity, and can be used to sense orientation, coordinate acceleration, shock, and falling in a resistive medium”; [0104] “…mouthguard records all events with linear acceleration exceeding 7 g.”) generating a signal of the accelerations associated with the impact to generate an impact signal ([0091] “…motion signals associated with an event”; [0082] “…the magnitude and direction of the proper acceleration (or g-force), as a vector quantity…”)
Using a control sensor ([0107] “an engagement sensor”) arranged on the sensing device ([0011] “…engagement sensor affixed to the base member”):
Sensing a first control signal just prior to the impact ([0107], “In vitro sensing behavior of an infrared proximity sensor is characterized by unit-testing sensor components”; [0088] “engagement sensor…When the device is fully engaged on the teeth, the signal transmitted from the emitter…events during which the device is not fully engaged on teeth can be reflected as non-impact events based on the strength of the received signal at the receiver”; Fig 11, Fig 16A, Fig 13A, Fig 13B)(Examiner notes that Cam’s disclosure performs calibration data for the proximity sensor before acquiring further impact measurements, described in [0107]. Based on this earlier calibration from measurements from the sensor itself, its calibration baseline average signal is µ = 0.17 in Figure 16A. Further, the engagement sensor data is generally measured simultaneously with the motion signals so that it can used with the motion signals to correlate if the mouthguard is on the teeth during the impact measurement from the motion signals. Note the 112b interpretation for “just prior to”.) and
Sensing a second control signal just after the impact ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”; [0088] “engagement sensor…When the device is fully engaged on the teeth, the signal transmitted from the emitter…events during which the device is not fully engaged on teeth can be reflected as non-impact events based on the strength of the received signal at the receiver”; Fig 11, Fig 16A, Fig 13A; Fig 13B) (Examiner notes that the engagement sensor data is generally measured simultaneously with the motion signals so that it can used with the motion signals to correlate if the mouthguard is actively one the teeth during the impact measurement from the motion signals. Note the 112b interpretation for “just after the”.)
Using a computer processor ([0085] “…a processor for receiving and processing data collected from sensors to detect on-body impacts”):
Receiving the impact signal from the motion sensor ([0085] “processor…receiving and processing data collected from sensors to detect on-body impacts”; [0104]; [0091]);
receiving the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17) from the control sensor ([0107] “an engagement sensor”; [0107], “In vitro sensing behavior of an infrared proximity sensor is characterized by unit-testing sensor components”)(Examiner notes that Cam’s disclosure performs calibration data for the proximity sensor before acquiring further impact measurements, described in [0107]. Based on this earlier calibration from measurements from the sensor itself, its calibration baseline average signal is µ = 0.17 in Figure 16A);
receiving the second control signal from the control sensor ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”)
comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold…”; Fig 11, Blocks 116 -119, which are “Infrared Reflection NOT Detected”, “Device is NOT on-teeth, data not recorded”, “Infrared Detection”, and “Device is on-teeth, record impacts”) the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17) to the second control signal ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”)(See Examiner note in Claim 1 for comparing the first and second control signals); and
identifying the impact ([0091] “…motion signals associated with an event”) as true positive based on the comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”, “After the classification, numbers of true positives (TP)…are calculated”; Fig 13A; Fig 13B)(Examiner notes that Cam’s disclosure performs calibration data for the proximity sensor before acquiring further impact measurements, described in [0107], “In vitro sensing behavior of an infrared proximity sensor is characterized by unit-testing sensor components”. Based on the sensor itself, its calibration baseline average signal is µ = 0.17 in Figure 16A. For subsequent measurements on the user, the second signal (as above, proximity sensor readings that occur at the end of each 100 ms kinematic reading from the motion sensor) is compared against the reference sensor calibration baseline average signal (or first signal) µ = 0.17. This comparison occurs against the threshold value that is based on the calibration baseline average signal µ = 0.17, as µ = 0.17 + 9σ, or 0.81 on Figure 16A.) and
discarding the impact signal if the impact is not identified as true positive ([0121] “events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events”).
Regarding Claim 10, Cam discloses The method of claim 9, wherein the first (Fig 16A, “Off-teeth Distribution” µ = 0.17; [0112] “On-teeth and off-teeth proximity sensor output distributions are shown in Fig 16A”) and second control signals ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”) are proximity sensor [0087]“…an engagement sensor, such as an infrared proximity sensor”) signals.
Regarding Claim 11, Cam discloses The method of claim 10, wherein comparing ([0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”) comprises comparing a proximity level of the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17; [0112] “On-teeth and off-teeth proximity sensor output distributions are shown in Fig 16A”; [0121] “proximity sensor readings…”) to a proximity level of the second control signal ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”; [0121] “First, events in the testing data with proximity sensor readings below the on-teeth and off-teeth threshold are rejected as off-teeth, non-impact events, while events with proximity sensor readings above the threshold remain unclassified as potential impacts.”) to identify a difference in proximity level (Examiner notes, The second signal proximity measurement lands on a location on Fig 16A. By comparing the second signal proximity reading to the threshold value on 16A, a difference can be seen between the measured second signal value of interest and the first signal µ = 0.17.)
Regarding Claim 12, Cam discloses The method of claim 11, wherein the difference in proximity level, as described above. For the remainder of Claim 12, Cam discloses is further compared to a threshold (Fig 16A, “On-Teeth and Off-Teeth Proximity Sensor Distribution output distributions”; “on-teeth/off-teeth threshold = 0.81).
Regarding Claim 13, Cam discloses The method of claim 12, wherein the threshold (Fig 16A, “On-Teeth and Off-Teeth Proximity Sensor Distribution output distributions”; “on-teeth/off-teeth threshold = 0.81) is met when the second control signal ([0104] “A proximity sensor reading in 10-bit resolution is obtained at the end of the 100 ms kinematic recording period for each triggered event.”) differs from the first control signal (Fig 16A, “Off-teeth Distribution” µ = 0.17) by less than 15% (Fig 16A, “Off-teeth distribution”, “µ = 0.17”, “σ = 0.026”, “On-Teeth/Off-Teeth Threshold = 0.81”) (Examiner notes that a second signal measurement signal that differs by 15%, or “µ = 0.17” +/- 15% would be a range of 0.1615 - 0.1785, which is entirely below than the “On-Teeth/Off-Teeth Threshold = 0.81”).
Regarding Claim 14, Cam discloses The method of claim 13, wherein discarding the impact signal ([0091] “…motion signals associated with an event”) is performed when the threshold is not met (Fig 11, Block 117 “Device is NOT on-teeth, data not recorded”; [0088] “…events during which the device is not fully engaged on teeth can be rejected as non-impact events based on the strength of the received signal at the receiver (blocks 115-117);
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.
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 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cam in view of Mack, (US 2012/0210498 A1), hereinafter Mack.
Regarding Claim 15, Cam discloses as described above, The method of claim 9. For the remainder of Claim 15, Cam discloses further comprising: accumulating a series of impacts, that have each been identified as true positive over time (Table 2, “Head Impact: Front, Number Simulated 16”; [0115] “A labeled data set including both head impacts and non-impact events…Head impacts are reconstructed…Impacts at 5 different orientations and 8 velocities…are listed in Table 2…An instrumented mouthguard…on the upper jaw…records the reconstructed head impacts…”)(Examiner notes that the impacts have been identified as true positive over the time of the testing with the headform user by the researchers with the intent to train a model.)
Cam does not specifically disclose to establish a workload for the user; and reporting the workload to the user.
Mack teaches an impact system that uses an impact sensor in headgear to build a reporting interface that categorizes head impact magnitudes and presents them over time for multiple players. Specifically for Claim 15, Mack teaches accumulating a series of impacts over time ([0042] “…the system thereafter will continue to monitor the impact sensors for impact events, and likewise will continually monitor the proximity sensors to determine whether the headgear is in place”) to establish a workload for the user ([0012] severity of impact, frequency of impact…)(Examiner notes that one way that applicant describes “workload” is [047] “Another proxy for workload may, more simply, be the number of impacts experienced by a user where the number of impacts is stored, counted, or otherwise analyzed, for example”. Recording a “frequency of impact” would constitute a number of impacts, or a workload)
and reporting the workload to the user ([0012] “the database module includes a database of players and associated impact data arrangeable by name, team, date, severity of impact, frequency of impact…”; [0055] “Such a database provides players, parents, coaches, trainers, administrators, and other stakeholders access to a record of what impact event information was conveyed, when, to whom, and about which player”.)
Mack provides a workload calculation and report based on input from a head impact sensor system worn by a player during sports activity. Cam discloses a head impact sensor worn by a user in their mouth during sports activity. Mack provides a motivation to combine at [0055] with “[0055] “Such a database provides players, parents, coaches, trainers, administrators, and other stakeholders access to a record of what impact event information was conveyed, when, to whom, and about which player” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that it would be helpful for personnel associated with players to have accessible workload data that can be reviewed regarding impact event information in order to increase safety and long-term health accommodations for players over time.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the mouthguard system for detecting actual head impact events disclosed by Cam with the workload calculation and reporting from head impact event data taught by Mack, creating a single head impact mouthguard device that can convey head impact information over time to users in the form of a workload metric.
Regarding Claim 20, Cam in view of Mack discloses The method of claim 15. For the remainder of Claim 20, Cam does not specifically disclose further comprising repeating the method for a series of users and tabulating results for several users.
Mack teaches further comprising repeating the method ([0009] “…a wirelessly linked impact sensing and reporting system”) for a series of users ([0011] “Receiving signals from any of the play modules participating on the wireless mesh network in real-time”) and tabulating results for several users ([0011] “…a display capable of indicating impact information per player on the wireless mesh network”, [Abstract] “…in real-time for dozens of players at a time on one or more adjacent fields”) (Examiner notes that there is a plurality of players connected to the wireless mesh network, with the intent being for a coach to monitor a team of players for head impacts.)
The motivation for Claim 20 to combine Cam with Mack is the similar to that described in more detail in Claim 15. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the mouthguard system for detecting actual head impact events disclosed by Cam with the workload calculation and reporting from head impact event data taught by Mack, creating a single head impact mouthguard device that can convey head impact information over time for multiple users in the form of a workload metric on an interface.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cam in view of Mack, further in view of Broglio et. al., “The Biomechanical Properties of Concussions in High School Football”, hereinafter Broglio.
Regarding Claim 16, Cam discloses as described above, The method of claim 9. For the remainder of Claim 16, Cam discloses the series of impacts (Table 2, “Head Impact: Front, Number Simulated 16”; [0115] “A labeled data set including both head impacts and non-impact events…Head impacts are reconstructed…)
Cam does not specifically disclose further comprising parsing the series of impacts into head impacts where the g-force exceeds 15 and collisions where the g-force is less than 15. Cam does broadly disclose a threshold at which acceleration magnitudes are classified as impacts at [0125] “all events with peak linear acceleration magnitude greater than a predetermined threshold (e.g., 10 g) are classified as impacts.”
Mack teaches further comprising parsing the series of impacts ([0013] “…impact data is from an event when the helmet is in place on the head of the player”; [0069] “number of total impacts…”) into head impacts ( [0068] “…receive processed sensor information on a human form. For example, the event modeling engine 208 creates a vector of impact and a rotational arc on a model skull to display the effect of an event on a player’s head”) and collisions ([0075] ”A magnitude of the most recent sensor information is shown in the screen area 306…the presentation is in the form of a partial dial, using color such as red/yellow/green to indicate when experienced acceleration (or other impact parameter) is within an acceptable range or has heightened to a level indicative of risk of injury.”) (Examiner that the dial-based threshold accelerations are presented such that multiple magnitudes of contact can be parsed, as with discerning higher magnitude impacts in the red from lower magnitude collision measurements in other colors.)
Mack provides a motivation to combine at [0054] with “…classification of incoming impact data into categories, indicating differing levels of concern and differing levels of urgency of response….color-coded system…red indicates a severe enough impact that the player be removed from play and referred to a physician immediately.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that categorizing levels of impact with color coding would be useful for determining if, when, and for how long a player should be removed from play for medical attention and recovery.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the mouthguard system for detecting actual head impact events with thresholds disclosed by Cam disclosed in Cam with the categorization of impacts and collisions based on threshold for the magnitude of the impact data taught by Mack, creating a single head impact measurement device with categorization of impacts and collisions into lower and higher magnitude levels to promote appropriate medical attention and recovery protocols for players who experience the head impacts.
Mack does not specifically teach head impacts where the g-force exceeds 15, and collisions where the g-force is less than 15.
Broglio teaches concussion research for high school football athletes using an instrumented helmet in which accelerometer data has a threshold of 15 g-forces for recording an impact. Specifically for Claim 16, Broglio teaches head impacts where the g-force exceeds 15 [Page 4, Top] “In order for an impact to be recorded, a minimum threshold of 15g must be exceeded on at least one accelerometer”, and collisions where the g-force is less than 15 [Page 4, Top] “In order for an impact to be recorded, a minimum threshold of 15g must be exceeded on at least one accelerometer.”)(Examiner notes that when the g-force is less than 15 g, then the impact is below the “threshold” where injurious impulse is suspected, putting it in lower category of impact (one which is chosen to not be recorded, in this study.))
Broglio provides a motivation to combine at [Page 3, 1st full paragraph] “…the purpose of this investigation is to elucidate the biomechanical threshold for concussive injuries sustained during high school football,” and [Page 4, Top] “In order for an impact to be recorded, a minimum threshold of 15g must be exceeded on at least one accelerometer.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that an impact of 15 g-forces in one or more axes would be an appropriate level to begin investigating for potentially injurious impact to a person’s head.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the head impact measurement device with categorization of impacts and collisions into lower and higher magnitude levels disclosed in Cam in view of Mack with the particular impact threshold of 15 g-forces for higher impacts taught by Broglio, creating a single head impact measurement device with categorization of impacts and collisions into lower and higher magnitude levels, using a particular threshold of 15 g-forces, to investigate concussion injury to promote appropriate medical attention and recovery protocols for players who experience the head impacts.
Claims 17 - 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cam in view of Mack, further in view of Stemper, et.al, “Repetitive Head Impact Exposure in College Football Following an NCAA Rule Change to Eliminate Two-A-Day Preseason Practices: A Study from the NCAA-DoD CARE Consortium”, hereinafter Stemper.
Regarding Claims 17 and 18, Cam discloses as described above The method of claim 9, and Cam in view of Mack discloses The method of claim 17.
For the remainder of Claims 17 and 18, Cam does not specifically disclose calculating a historical workload average or calculating a weekly workload average.
Mack teaches calculating a workload ([0012] severity of impact, frequency of impact…)
The motivation for Claims 17 and 18 to combine Cam with Mack is the same as that described in more detail in Claim 15. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the mouthguard system for detecting actual head impact events disclosed by Cam with the workload calculation and reporting from head impact event data taught by Mack, creating a single head impact mouthguard device that can convey head impact information over time to users in the form of a workload metric.
Mack does not specifically teach calculating a historical workload average or calculating a weekly workload average. However, Mack is open to reporting a historical workload average weekly because the database of players includes sorting capabilities for data over time at [012] "...the database module includes a database of players and associated impact data arrangeable by name, team, date, severity of impact, frequency of impact, and many other parameters." Additionally, Mack teaches at [0059] “aggregation of sensor information such as head acceleration information or head-rotational information received from a plurality of sensors and makes the information available to relevant parties”. Therefore, the sensor information is available and ready to combine with a method step that specifically averages the head acceleration information, or impacts, on a weekly basis.
Stemper teaches a study method performed using an instrumented device (Head Impact Telemetry, or HIT) for measuring football players’ head impacts and calculating the average number of impacts for each athlete over the course of preseason and regular season play. Stemper teaches calculating a historical workload average, and where that workload average is weekly (Page 2076, Left Column, Analysis of Athlete Exposure heading, Paragraph 1, “The number of recorded head impacts per week was calculated for each athlete over the course of the entire preseason and regular season”, ”The number of impacts per week were averaged and compared across seasons and playing positions”; Page 2076, Right Column, Line, 17 - 18: “…quantifying head impact burden on a daily, weekly, and seasonal basis”)(Examiner again notes that applicant describes workload as i[047] “..the number of impacts experienced by a user where the number of impacts is stored, counted, or otherwise analyzed”).
The “Analysis of Athlete Exposure” method of Stemper would perform the same function of calculating weekly historical head impacts for players from headgear sensor data if combined with Cam in view of Mack’s method of gathering, storing, and reporting head impact data using a headgear impact sensor and database. Therefore, it would have been predictable to use the “analysis of Athlete Exposure” method step of Stemper in any similar method of gathering, storing, and reporting head impact data with associated sensors to measure head impact, as it would continue to operate with the function of calculating historical average head impacts for football players from supplied sensor data. Further, Cam in view of Mack discloses that the requisite head impact information required for Stemper’s “Analysis of Athlete Exposure” method are available from the sensors and data storage, so Cam in view of Mack is open to additional head impact analysis calculations, which could include the “Analysis of Athlete Exposure” method to determine average weekly historical workload, as taught by Stemper.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of gathering, storing, and reporting head impact data using a mouthguard impact sensor and database disclosed by Cam in view of Mack with Stemper’s “Analysis of Athlete Exposure” method to calculate weekly historical head impacts for players using supplied sensor data, creating a single method to collect head workload data for users and calculate weekly historical workload averages. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 19, Cam in view of Mack, further in view of Stemper discloses The method of claim 18 as described above. For the remainder of Claim 19, Cam does not disclose wherein reporting the workload to the user comprises populating a workload interface and displaying the workload interface.
Mack teaches wherein reporting the workload to the user comprises populating a workload interface ([0012] “the database module includes a database of players and associated impact data arrangeable by name, team, date, severity of impact, frequency of impact…”; [0056] “Such a database provides players, parents, coaches, trainers, administrators, and other stakeholders access to a record of what impact event information was conveyed, when, to whom, and about which player”, [0057] “The database is populated by an automatic interface to the wide area radio network accessed by the sideline network”) and displaying the workload interface (Fig 8, “user interface” 300; [0052] “ An example sideline module is an electronic data gathering and display device incorporated into a portable enclosure that is easy for a coach, trainer, or other such game official to carry, consults, and interact with during the activities of the practice or game.”)
The motivation for Claim 19 to combine Cam with Mack is the same as that described in more detail in Claim 15. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the mouthguard system for detecting actual head impact events disclosed by Cam with the workload calculation and reporting from head impact event data taught by Mack, creating a single head impact mouthguard device that can convey head impact information over time to users in the form of a workload metric on an interface.
Response to Arguments
Applicant's arguments filed 16 April 2026 have been fully considered but they are not persuasive to overcome the 35 U.S.C. 101, 35 U.S.C. 102, or 35 U.S.C. 103 rejections for Claims 1 – 20.
In regard to 35 U.S.C. 101 analysis:
Applicant argues at [Page 9, “Rejection of Claims under 101” Section] - [Page 10, 2nd Full Paragraph] and [Page 13, 2nd Full Paragraph] that the abstract ideas were not identified in the claims, nor were the abstract ideas effectively explained to Applicant during the interview on 24 March 2026, and that “the Office is required to determine if the claim recites a judicial exception, not merely whether it involves one”. Applicant argues that underlining aspects of claim 1 and 9 does not indicate recitation of the elements in the claim, but rather that they “involve” these ideas. Applicant further argues that claims do no recite a judicial exception because claims that recite an exception require further eligibility analysis and claims that involve an exception do not.
Looking to MPEP 2106.04(II)(A)(1) for an example of a claim that merely involves, but does not recite an exception:
“An example of a claim that merely involves, or is based on, an exception is a claim to "A teeter-totter comprising an elongated member pivotably attached to a base member, having seats and handles attached at opposing sides of the elongated member." This claim is based on the concept of a lever pivoting on a fulcrum, which involves the natural principles of mechanical advantage and the law of the lever. However, this claim does not recite these natural principles and therefore is not directed to a judicial exception.”
Evaluating the instant claims as per the Step 2A – Prong 1 analysis above, they do not merely involve an exception, such as the law of nature idea that impacts to a football player abide by the laws of momentum and energy conservation, or the mechanical advantage natural principle that governs the teeter-totter lever example above. Rather, the instant claims explicitly recite a judicial exception, Abstract Idea, which can be found in more detail in the 35 U.S.C. 101 analysis above. For Claim 1, as an example, this includes the elements of
comparing first and second control signals from the control sensor to determine if the impact signal reflects that the impact is true positive,
perform the comparing,
identify the impact as true positive depending on a result of the comparing, and
discard the impact signal if the impact is not identified as true positive.
(See 35 U.S.C. 101 analysis above for remaining claims). These limitations fall into at least one of the groupings of abstract ideas, mental processes, since these are concepts that can be performed in the human mind (MPEP 2106.04(a)) These elements are identified as falling under the abstract idea exception because they encompass abstract ideas that encompass broadly comparing provided data sets, making an observation or judgment based on a conclusion drawn from the comparison (from either applying mathematical calculation or making a qualitative observation that data is present), and making a judgment to discard non-useful data. As recited, these are mental concepts that are routinely performed by persons of ordinary skill in the art, making observations and judgments of provided data. Looking to MPEP 2106.04(II)(A)(1) immediately following the teeter-totter example,
“If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two.”
After the presence of judicial exceptions is identified, then the analysis under Prong two commences (to determine if the ideas are integrated into a practical application), which is delineated in the 35 U.S.C. 101 analysis above. The argument is not persuasive.
Applicant argues at [Page 10, 3rd Full Paragraph] – [Page 11, Top] that claim 1 recites “generating an impact signal”, which cannot be performed in the human mind. The concept of “generating an impact signal” in line 6 of the claim is identified in the 35 U.S.C. 101 analysis above as pre-solution data gathering step in the interpretation that it refers to the motion sensor making a measurement that is designated as the impact signal. Extra-solution activity is performed by the motion sensor as a tool to gather data in the well-understood, routine, and conventional way that this type of sensor is normally used (measuring acceleration data during an impact, corresponding to the “impact signal”, of which an impact would appear as a “peak” in the data). This pre-solution data-gathering is then used for the subsequently-recited abstract ideas in the claim, those abstract ideas being the aspects that can be performed in the human mind. The argument is not persuasive.
Applicant argues at [Page 11, 1st Full Paragraph] that the bolded language of “the first control signal from the control sensor being captured at a time just prior to the impact or during an early portion of the impact and the second control signal from the control sensor being captured at a late portion of the impact or just after the impact” indicates that this aspect is not performable by a human because they are not underlined. Applicant further argues that a human mind is not capable of capturing control signals as claimed, since the claim “does not merely call for “receiving a value, but, instead, requires that a “signal” be “captured”’. On the interpretation that “receiving and capturing” the signal signifies performing a measurement with a sensor, as opposed to observing a file from the sensor and saving it, then performing the measurement with a sensor to “receive and capture the impact signal” is extra-solution activity serving as data-gathering for subsequent steps. Extra-solution activity is performed by the motion sensor as a tool to gather data in the well-understood, routine, and conventional way that this type of sensor is normally used (measuring acceleration data during an impact, corresponding to the “impact signal”, of which an impact would appear as a “peak” in the data). This pre-solution data-gathering is then used for the subsequently-recited abstract ideas in the claim, those abstract ideas being the aspects that can be performed in the human mind. The argument is not persuasive.
Applicant argues at [Page 11, 3rd Full Paragraph] – [Page 12, 1st Full Paragraph] that the claims are integrated into a practical application by being directed to an improvement to another technology or technical field, solving the problem of adoption of impact sensors in sporting events because play gets unnecessarily interrupted due to false positive readings “(readings that suggest a serious impact has occurred when it actually has not)”. There is nothing particular in the claims recited that indicates that the determination of false positives is made while the sensing device is still being worn. As recited, the data gathering step by the motion sensor and control sensor could occur while it is worn, and then the data processing to compare the control signals can occur at a later date, looking at the previously-obtained data to determine if it measured true positives or not. This is a routine application of data analysis. From MPEP 2106.05(a): It is important to note, 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)). The argument is not persuasive.
Applicant argues that the prior art obtains a mouthguard sensor reading at or around the time of impact, unlike the claimed invention of claims 1 and 9, which compares two temporally-related control signals “just before” and “just after” impact. Looking to the 35 US.C. 112(b) rejection above, “just” is a relative term, and it is unclear what window of time is encompassed by “just”, whether a number of milliseconds, seconds, etc., and what is outside of the metes and bounds of that window. The term “just before” is not a particular term in the art, and there is no explanation in the specification to designate what “just” is intended to mean. Generally, Cam discloses obtaining calibration data prior to the impact testing to determine thresholds for on-teeth and off-teeth (Fig 16A and Fig 16B), and it records simultaneous proximity data and linear acceleration/rotation velocity data of impacts (Figure 13A, top box), then rejects off-teeth events measured by the linear acceleration/rotational velocity data based on the proximity measurements (Figure 13A, 2nd box). There is proximity data disclosed that is captured before and after an impact while the accelerometer is measuring.
Furthermore, from MPEP § 2106.05 I: Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (“The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”). The argument is not persuasive.
Applicant argues at [Page 12, 2nd Full Paragraph] – [Page 13, 1st Full Paragraph] that the language of the claim has not been considered as a whole, such that an inventive arrangement and interaction of the computer components are not considered. Applicant argues that the presence of a motion sensor and a control sensor on the device allows for the control sensor to capture control signals that are temporally related to the impact signal. There is nothing particularly claimed regarding the “inventive arrangement” of the computer components on the structure. In Claim 1, there is a “sensing device” that is generally configured to be “coupled to a user”, including a “control sensor” (identified in the specification at [027] as “proximity sensors, capacitive sensors, or other sensors allowing for assessment to be made…” that senses position and a “motion sensor” that collects a signal before and after an impact. There is nothing particularly unique about using a position sensor, such as a proximity sensor, together with a motion sensor, such as an accelerometer, attached to a body (“user”) during an impact. Looking to Applicant’s specification at [021] – [022] with the “sensing device” “may be in the form of a mouthguard”, and “the sensing device 108 may include a body portion” and “The body portion may be in the form of a mouthguard or an alternative wearable device may be used. The alternative wearable device may be, for example, a body or skin patch, a clothing patch, a head band, mouthpiece, earpiece, or other wearable device.” There appears to be nothing particular to the structure of the “sensing device” or how the sensors are arranged or physically “interacting” thereon. Regarding abstract idea data manipulation recited in the claim, from MPEP 2106.05(a): It is important to note, 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)). There is nothing particularly recited that indicates that the computer components are interacting in an inventive way that improves the measurement function of the sensors themselves, as their measurements are well-understood, routine, and conventional pre-solution data gathering steps. The argument is not persuasive.
Applicant argues at [Page 13, 2nd Full Paragraph] – [Page 13, 3rd Full Paragraph] that claims 1 and 9 leverage technology in a particular way to generate impact and control measurement signals to assess their relevance. As recited, the claims appear to couple a motion sensor and a control sensor (proximity sensor) to a person and collect data as the person moves or is impacted. This is a well-understood, routine, and conventional use of these types of sensors. These types of sensors can be used to obtain a continuous signal over an extended period of time, which would include time before and after an impact that occurs while they are attached to the measurement object of interest. There is not a particular unique use or arrangement of these sensors recited in the claims. The generation of the signals themselves is extra-solution data gathering step that obtains data for the recited subsequent abstract idea data observation and judgment steps. The argument is not persuasive.
Applicant argues at [Page 13, Bottom] – [Page 14, 1st Full Paragraph] that similar to BASCOM, Applicants claims provide non-conventional and non-generic arrangement of motion sensors and control sensors combined with particular processing techniques that provide a technical improvement in the art.
Looking to BASCOM, the claims therein recite a particular filter implementation for network technology by associating individual accounts with their own filtering scheme and elements while locating the filtering system on an ISP server, improving the known technical concept of “filtering content on the Internet” with a flexible, individualized filter implementation that can be installed remotely in a single location (Pages 16 and 17 of BASCOM decision). This provided a meaningful improvement. This is a level of detail and device improvement that is not reflected in the instant, broadly-recited claims. In the instant claims, merely including the abstract ideas of comparing signals, identifying something in a signal to make a judgment, and discarding data judged to be false positive does not improve the performance of the motion sensor, control sensor, processor, or computer-readable storage medium. There is nothing particular claimed about the arrangement of the motion and control sensors in claim 1 that is non-conventional and non-generic. They are part of an entity (“sensing device”) which is recited to be “configured to be coupled to a user”. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation as claimed can be routinely accomplished with the aid of education, background, experience, time, equations, and paper. The argument is not persuasive.
Regarding the 35 U.S.C. 102 Rejections:
Applicant argues at [Page 14, “The Rejection of Claims Under 102” Section] that Cam does not disclose a control signal captured at a time just prior to the impact or during an early portion of the impact, but rather potentially a calibration proximity sensor reading. Looking to the 35 US.C. 112(b) rejection above, “just” is a relative term, and it is unclear what window of time is encompassed by “just”, whether a number of milliseconds, seconds, etc., and what is outside of the metes and bounds of that window. The term “just before” is not a particular term in the art, and there is no explanation in the specification to designate what “just” is intended to mean. Generally, Cam discloses obtaining calibration data prior to the impact testing to determine thresholds for on-teeth and off-teeth (Fig 16A and Fig 16B), and it records simultaneous proximity data and linear acceleration/rotation velocity data of impacts (Figure 13A, top box), then rejects off-teeth events measured by the linear acceleration/rotational velocity data based on the proximity measurements (Figure 13A, 2nd box). There is proximity data disclosed that is captured before and after an impact while the accelerometer is measuring. The argument is not persuasive.
Applicant summarily argues at [Page 15, Top] that claims 2 – 8 are not anticipated for the same reasons as Claims 1 and 9 and are thereby patent-eligible. Based on the 35 U.S.C 102 analysis herein and the discussion of arguments above, Claims 2 – 8 do not qualify as eligible subject matter under 35 U.S.C. 102. The argument is not persuasive.
Regarding the 35 U.S.C. 103 Rejections:
Applicant argues at [Page 15, “The Rejection of Claims Under 103” Section] that Claim 14 (and its dependent claims 15 – 20) are not anticipated by Cam for the reasons outlined above, and Mack, Broglio, and Stemper do not teach or suggest the claimed first control signal that is captured at a time just prior to the impact. Looking to the 35 U.S.C. 102 analysis, the 35 U.S.C. 112(b) rejection and interpretation, and the discussion of arguments above, the contents of Claim 1 and 9 regarding the control signal are anticipated by Cam. The argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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