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 .
Status of Claims
Claims 21-36 are pending in the present application with claims 21 and 30 being independent, as set forth in the Preliminary Amendment dated January 27, 2025.
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 21-36 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 21-29 are directed to a device (i.e., a machine) and claims 30-36 are directed to a method (i.e., a process). Accordingly, claims 21-36 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 21 includes limitations that recite at least one abstract idea. Specifically, independent claim 21 recites:
A device worn in an ear of a user for health monitoring, comprising:
at least one first sensor to collect physiological information from an ear of a user;
at least one second sensor to collect environmental information; and
a processor configured to:
detect a level of an event causing damage or potential damage to a portion of a body of the user via at least one of the first sensor or the second sensor, wherein the level is detected when outside of an expected reading for the portion of the body; and
generate an alert to the user when the level is detected, wherein the alert includes notifying the user based on the event.
The Examiner submits that the foregoing underlined limitations recite “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance a person could practically in their mind with pen and paper detect (e.g., via listening) a level outside of an expected reading for a portion of a body (e.g., ear) of the user regarding an event causing damage to the body portion and then generate an alert to the user (e.g., via writing it down) when the level is detected to notify the user based on the event. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
The foregoing underlined limitations also recite “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). These recitations, under their broadest reasonable interpretation, are similar to the concept of a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 22-28 and 31-36 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 22 and 31 recite how the level is detected based on exposure to a sound causing potential damage to the ear which just further defines the above noted abstract idea(s).
-Claims 23 and 32 recite how the level is detected based on exposure to a loud external noise causing potential damage to a tympanic membrane of the user which just further defines the above noted abstract idea(s).
-Claims 24 and 33 recite how the level is detected based on exposure to noise-induced hearing loss (NIHL) toxins causing potential damage to a tympanic membrane of the user which just further defines the above noted abstract idea(s).
-Claims 25 and 34 recite how the level is detected based on an erratic heart rate, cardiac signature, or heart murmur of the user which just further defines the above noted abstract idea(s).
-Claims 26 and 35 recite how the expected reading is adjusted based on exercise of the user which just further defines the above noted abstract idea(s).
-Claim 27 recites how the alert includes notifying the user to move away from a noise source or seek medical treatment which just further defines the above noted abstract idea(s).
-Claim 28 recites how the alert includes the physiological and/or environmental information which just further defines the abstract idea(s).
-Claim 36 recites how the alert includes at least one of the physiological information or the environmental information which just further defines the above noted abstract idea(s).
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A device worn in an ear of a user for health monitoring, comprising:
at least one first sensor to collect physiological information from an ear of a user;
at least one second sensor to collect environmental information; and
a processor configured to:
detect a level of an event causing damage or potential damage to a portion of a body of the user via at least one of the first sensor or the second sensor, wherein the level is detected when outside of an expected reading for the portion of the body; and
generate an alert to the user when the level is detected, wherein the alert includes notifying the user based on the event.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the ear worn device including sensors for collecting physiological/environmental information and processor, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 21 and analogous independent claim 30 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 21 and analogous independent claim 30 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 29 recites how the at least one first sensor includes an ear canal microphone and the at least one second sensor includes an ambient microphone which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 21 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the ear worn device including sensors for collecting physiological/environmental information and processor, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 29 recites how the at least one first sensor includes an ear canal microphone and the at least one second sensor includes an ambient microphone which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
Therefore, claims 21-36 are ineligible 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-23 and 29-32 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2012/0321094 to Schiller et al. ("Schiller"):
Regarding claim 21, Schiller discloses a device worn in an ear of a user for health monitoring (personal monitoring subsystem 150 in Figure 1 worn by user per [0014] where left/right microphone 104/106 of subsystem 150 are worn in the ear of the user), comprising:
at least one first sensor to collect physiological information from an ear of a user (left/right microphone 104/106 measure sound pressure (physiological information) in left/right ear canals per [0013]);
at least one second sensor to collect environmental information (microphone 122 measures sound pressure of ambient environment (environmental information) per [0021]); and
a processor (processor 204 of master control unit 120 of personal monitoring subsystem 150) configured to:
detect a level of an event causing damage or potential damage to a portion of a body of the user via at least one of the first sensor or the second sensor, wherein the level is detected when outside of an expected reading for the portion of the body ([0014], [0021] disclose how the data from the microphones 104/106/122 (the first and second sensors) can be used to determine that the sound levels are high and/or the user has exceeded an exposure limit (sound level outside of an expected reading for the ear) and hearing protection is warranted); and
generate an alert to the user when the level is detected, wherein the alert includes notifying the user based on the event ([0014], [0021] disclose alerting/warning the user based on the above-noted determination of the high sound levels and/or exposure limit being exceeded).
Regarding claim 22, Schiller discloses the device of claim 21, further including wherein the level is detected based on exposure to a sound causing potential damage to the ear ([0014], [0021] disclose how the data from the microphones 104/106/122 (the first and second sensors) can be used to determine that the user has exceeded an exposure limit (sound level outside of an expected reading for the ear) and hearing protection is warranted).
Regarding claim 23, Schiller discloses the device of claim 21, further including wherein the level is detected based on exposure to a loud external noise causing potential damage to a tympanic membrane of the user ([0014], [0021] disclose how the data from the microphones 104/106/122 (the first and second sensors) can be used to determine that the environmental sound levels are high (loud external noise) and hearing protection is warranted which would necessarily be in relation to causing potential damage to left/right TM 116/118).
Regarding claim 29, Schiller discloses the device of claim 21, further including wherein the at least one first sensor comprises an ear canal microphone (left/right microphone 104/106 in Figure 1), and wherein the at least one second sensor comprises an ambient microphone (ambient microphone 122 in Figure 1 and [0021]).
Claims 30-32 are rejected in view of Schiller as respectively discussed above in relation to claims 21-23.
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.
Claims 24, 25, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2012/0321094 to Schiller et al. ("Schiller") in view of U.S. Patent App. Pub. No. 2018/0089976 to Yariagadda et al. ("Yariagadda"):
Regarding claim 24, Schiller discloses the device of claim 21, further including wherein the level is detected based on exposure to noise-induced hearing loss (NIHL) … causing potential damage to a tympanic membrane of the user ([0014], [0021] disclose how the data from the microphones 104/106/122 (the first and second sensors) can be used to determine that the sound levels are high and/or the user has exceeded an exposure limit (sound level outside of an expected reading for the ear) in relation to exposure to excess sound levels (Abstract) leading to potential noise induced hearing loss ([0002]) which necessarily causes potential damage to the left/right TM 116/118).
However, Schiller might be silent regarding NIHL toxins cause the potential damage to the tympanic membrane of the user.
Nevertheless, Yariagadda teaches ([0012], [0030]) that it was known in the healthcare informatics art to detect potential hearing damage due to loud noise and/or exposure to workplace chemicals (ototoxicity) as sensed by sensors which can cause potential damage to a tympanic membrane/eardrum of the user (as evidenced by U.S. Patent App. Pub. No. 2015/0044271 to Slattery et al. ("Slattery") at [0029]) to advantageously allow proactive measures to be taken to avoid/treat such hearing damage/loss.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the level to be detected based on exposure to NIHL toxins causing potential damage to a tympanic membrane of the user in the system of Schiller as taught by Yariagadda to advantageously allow proactive measures to be taken to avoid/treat such hearing damage/loss. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 25, Schiller discloses the device of claim 21, but appears to be silent regarding wherein the level is detected based on an erratic heart rate, cardiac signature, or heart murmur of the user.
Nevertheless, Yariagadda teaches ([0018], [0021]-[0022]) that it was known in the healthcare informatics art to utilize sensors to measure a user's biometric information (heart rate per [0028] which is at least a "cardiac signature") and use the sensed data to determine exposure values that may presents risks to a user (events that may cause damage/potential damage to a portion of the body of the user) to advantageously more effectively detect dangerous conditions that can present hazards to user to allow for alerts and other preventative measures to be taken.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the level of Schiller to be detected based on a cardiac signature of the user as taught by Yariagadda to advantageously more effectively detect dangerous conditions that can present hazards to user to allow for alerts and other preventative measures to be taken. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 33 and 34 are rejected in view of the Schiller/Yariagadda combination as respectively discussed above in relation to claims 24 and 25.
Claims 26 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2012/0321094 to Schiller et al. ("Schiller") in view of U.S. Patent App. Pub. No. 2008/0266118 to Pierson et al. ("Pierson"):
Regarding claim 26, Schiller discloses the device of claim 21, but appears to be silent regarding wherein the expected reading is adjusted based on exercise of the user.
Nevertheless, Pierson teaches ([0020], [0039]) that it was known in the healthcare informatics art for a normal (expected) heart rate of a user to be increased (adjusted) due to exercise of the user and to utilize an ear worn device to monitor the user's heart rate to identify changes that can be indicative of more serious conditions to allow for corrective actions to be taken.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the expected reading of Schiller to be adjusted based on exercise of the user as taught by Pierson to advantageously identify changes that can be indicative of more serious conditions to allow for corrective actions to be taken. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 35 is rejected in view of the Schiller/Pierson combination as discussed above in relation to claim 26.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2012/0321094 to Schiller et al. ("Schiller") in view of U.S. Patent App. Pub. No. 2008/0146890 to LeBoeuf et al. ("LeBoeuf"):
Regarding claim 27, Schiller discloses the device of claim 21, further including wherein the alert includes notifying the user to utilize hearing protection ([0014], [0021]) and also that individuals could move to quieter environments ([0003]).
However, Schiller might be silent regarding the alert specifically notifying the user to move away from a noise source or seek medical treatment.
Nevertheless, LeBoeuf teaches ([0026]) that it was known in the healthcare informatics for a monitoring apparatus to notify a user to move away from a noise source that exposes the user to a potentially damaging sound level which advantageously avoids damage or further damage to the user's ears from the potentially damaging sound.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the alert of Schiller to specifically notify the user to move away from a noise source as taught by LeBoeuf to advantageously avoid damage or further damage to the user's ears from the potentially damaging sound. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 28 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2012/0321094 to Schiller et al. ("Schiller") in view of U.S. Patent App. Pub. No. 2016/0034042 to Joo ("Joo"):
Regarding claim 28, Schiller discloses the device of claim 21, but appears to be silent regarding wherein the alert includes at least one of the physiological information or the environmental information.
Nevertheless, Joo teaches ([0497]) that it was known in the healthcare informatics art to measure and send biometric (physiological) information to a user regarding an emergency to advantageously allow the user to more accurately assess such emergency situation and take appropriate remedial actions.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the alert of Schiller to include the physiological information as taught by Joo to advantageously allow the user to more accurately assess emergency/dangerous situations and take appropriate remedial actions. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 36 is rejected in view of the Schiller/Joo combination as discussed above in relation to claim 28.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham, can be reached at 571-272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
Prosecution Insights