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 .
Election/Restrictions
Applicant’s election without traverse of group II, claims 55-64 in the reply filed on 04/24/2026 is acknowledged.
Claims 45-54 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/2026.
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 55-64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than
an abstract idea. A streamlined analysis of claim 55 follows.
Regarding claim 55, the claim recites A mouth guard for detecting impacts experienced by a user during an activity. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention. The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
"determine, based at least on the linear impact data and the rotational impact data, a concussion probability that the at least one impact caused the user to suffer a concussion; and in response to the concussion probability exceeding a predetermined threshold, provide an indication using the mouth guard."
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered:
"A mouth guard for detecting impacts experienced by a user during an activity, the mouth guard comprising: a main body comprising a soft plastic material, the main body being configured to fit into an oral cavity of the user; at least one linear force detector disposed within or coupled to the main body, the at least one linear force detector configured to generate linear impact data associated with linear force imparted to the user by at least one impact experienced by the user during the activity; at least one rotational force detector disposed within or coupled to the main body, the at least one rotational force detector configured to generate rotational impact data associated with rotational force imparted to the user by the at least one impact experienced by the user during the activity; and a microcontroller disposed within or coupled to the main body…”.
These additional limitations do not integrate the judicial exception into a practical
application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they are recited at a high level of generality. Moreover, Examiner takes official notice that “mouthguard, linear force detector, rotational force detector, and, microcontroller" are widely- understood, routine, and conventional as shown in Rush (US 6941952) (col. 4-6).
Dependent claims 56-64 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 55-64 are not patent eligible under 35 USC 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.
Claim(s) 55, 61-62 is/are rejected under 35 U.S.C. 102(a(1)) as being anticipated by Mack (WO 2011091347A2)
Regarding claim 55, Mack discloses A mouth guard for detecting impacts experienced by a user during an activity (abstract, paragraph 0028) (Fig 3-4, 8-13), the mouth guard comprising: a main body comprising a soft plastic material, the main body being configured to fit into an oral cavity of the user (paragraph 0030-0031, 0042, fig 3-4, 9); at least one linear force detector (412) disposed within or coupled to the main body (paragraph 0043) the at least one linear force detector configured to generate linear impact data associated with linear force imparted to the user by at least one impact experienced by the user during the activity (paragraph 0043-0044); at least one rotational force detector (414) disposed within or coupled to the main body, the at least one rotational force detector configured to generate rotational impact data associated with rotational force imparted to the user by the at least one impact experienced by the user during the activity (paragraph 0043-0045); and a microcontroller (440) disposed within or coupled to the main body, the microcontroller being configured to: determine, based at least on the linear impact data and the rotational impact data, a concussion probability that the at least one impact caused the user to suffer a concussion (paragraph 0054-0059); and in response to the concussion probability exceeding a predetermined threshold, provide an indication using the mouth guard (paragraph 0032, 0035-0036, 0054-0059).
Regarding claim 61, Mack discloses The mouth guard of claim 55, wherein the microcontroller is further configured to determine, based at least on the linear impact data and the rotational impact data, a direction of the at least one impact relative to the user (paragraph 0044, 0058).
Regarding claim 62, Mack discloses The mouth guard of claim 61, wherein the direction of the at least one impact being to a front of the user or a back of the user increases the determined concussion probability compared to the direction of the at least one impact being to a side of the user (paragraph 0044, 0058).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 56-58, 60, 63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mack in view of Miele (WO 2012112936)
Regarding claim 56, Mack discloses all of the claimed limitations except The mouth guard of claim 55, wherein the microcontroller is further configured to receive biometric data associated with the user, the determination of the concussion probability being further based on the biometric data. Miele teaches wherein the microcontroller is further configured to receive biometric data associated with the user, the determination of the concussion probability being further based on the biometric data (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Regarding claim 57, Mack discloses all of the claim limitations except The mouth guard of claim 56, wherein the biometric data includes an age of the user, and wherein the microcontroller is further configured to determine if the age of the user is below a lower age threshold or above an upper age threshold. Miele teaches wherein the biometric data includes an age of the user, and wherein the microcontroller is further configured to determine if the age of the user is below a lower age threshold or above an upper age threshold (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Regarding claim 58, Mack discloses all of the claimed limitations except The mouth guard of claim 57, wherein the determined concussion probability for the at least one impact is higher in response to the age of the user being below the lower age threshold or above the upper age threshold as compared to the age of the user being above the lower age threshold and below the upper age threshold. Miele wherein the determined concussion probability for the at least one impact is higher in response to the age of the user being below the lower age threshold or above the upper age threshold as compared to the age of the user being above the lower age threshold and below the upper age threshold (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Regarding claim 60, Mack discloses all of the claimed limitations except The mouth guard of claim 56, wherein the biometric data includes a weight of the user, the user being in a high weight category decreasing the determined concussion probability for the at least one impact compared to the user being in an average weight category, the user being in the average weight category decreasing the determined concussion probability for the at least one impact compared to the user being in a low weight category. Miele teaches wherein the biometric data includes a weight of the user, the user being in a high weight category decreasing the determined concussion probability for the at least one impact compared to the user being in an average weight category, the user being in the average weight category decreasing the determined concussion probability for the at least one impact compared to the user being in a low weight category (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26, pages 20-27 generally). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Regarding claim 63, Mack discloses all of the claimed limitations except The mouth guard of claim 55, wherein the microcontroller is further configured to: determine the concussion probability of a first impact of the at least one impact to the user that imparts (i) a first amount of rotational force and (ii) an amount of total force; and determine the concussion probability of a second impact of the at least one impact to the user that imparts (i) a second amount of rotational force that is greater than the first amount of rotational force and (ii) an equal amount of total force, wherein the concussion probability of the second impact is greater than the concussion probability of the first impact if biometric data associated with the user indicates that an age of the user is less than a threshold age. Miele teaches The mouth guard of claim 55, wherein the microcontroller is further configured to: determine the concussion probability of a first impact of the at least one impact to the user that imparts (i) a first amount of rotational force and (ii) an amount of total force; and determine the concussion probability of a second impact of the at least one impact to the user that imparts (i) a second amount of rotational force that is greater than the first amount of rotational force and (ii) an equal amount of total force, wherein the concussion probability of the second impact is greater than the concussion probability of the first impact if biometric data associated with the user indicates that an age of the user is less than a threshold age (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26, pages 20-27 generally). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Regarding claim 64, Mack discloses all of the claimed limitations except The mouth guard of claim 55, wherein the microcontroller is further configured to: determine the concussion probability of a first impact of the at least one impact to the user that imparts (i) a first amount of rotational force and (ii) an amount of t0, 63-064otal force; and determine the concussion probability of a second impact of the at least one impact to the user that imparts (i) a second amount of rotational force that is greater than the first amount of rotational force and (ii) an equal amount of total force, wherein the concussion probability of the second impact is greater than the concussion probability of the first impact if historical impact data indicates that the user has experienced at least one prior impact. Therefore, Miele teaches wherein the microcontroller is further configured to: determine the concussion probability of a first impact of the at least one impact to the user that imparts (i) a first amount of rotational force and (ii) an amount of total force; and determine the concussion probability of a second impact of the at least one impact to the user that imparts (i) a second amount of rotational force that is greater than the first amount of rotational force and (ii) an equal amount of total force, wherein the concussion probability of the second impact is greater than the concussion probability of the first impact if historical impact data indicates that the user has experienced at least one prior impact (page 19, lines 10-14, page 23, lines 5-25, page 24, lines 1-26, pages 20-27 generally). Therefore, it would have obvious at the effective filing date of the invention to modify Mack’s mouthguard which detects impacts by Miele’s mouthguard which detects impacts based on biometrics and therefore, allow for a more objective and effective interpretation of the data gathered to reduce injury (page 26-27 of Miele disclose various details of why biometrics would be useful).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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