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 .
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 5, 10, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 line 3 recites the term “optionally”, which renders the claim indefinite as the element that follows the term “optionally” creates ambiguity as to whether the element is necessary in defining the scope of the invention, thus rendering the claim indefinite.
Claim 10 line 7 recites the term “optionally”, which renders the claim indefinite as the element that follows the term “optionally” creates ambiguity as to whether the element is necessary in defining the scope of the invention, thus rendering the claim indefinite. Claim 14 is rejected due to its dependence upon claim 10.
Claim 14 line 1 recites “The method of claim 10…”, which renders the claim indefinite as claim 10 is drawn to a system and not a method. If claim 14 properly depends from claim 10, the examiner recommends changing the claim language to “The system of claim 10…”. If claim 14 is intended to depend from a different claim, appropriate correction is required.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
A system for assessing ear pathologies in a subject, the system comprising:
an earplug configured to be at least partially inserted in the ear canal of an ear of a subject,
wherein the earplug comprises a pressure sensor adapted to generate passive pressure signals representative of passive pressure changes within the ear canal induced by maneuvers performed by the subject,
wherein characteristics of the passive pressure signals are representative of one or more ear pathologies; and
a processor configured to:
receive the passive pressure signals from the pressure sensor of the earplug; and
determine an indication of one or more ear pathologies in the ear of the subject based on the passive pressure signal.
Independent Claim 11 recites:
A method for assessing ear pathologies in a subject, the method comprising:
receiving passive pressure signals representative of passive pressure changes induced by maneuvers performed by the subject from a pressure sensor inserted in the ear canal of the subject; and
determining an indication of ear pathologies in the ear of the subject based on the passive pressure signal,
wherein characteristics of the passive pressure signals are representative of one or more ear pathologies.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of generating, receiving, and determining recite mental processes and mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “generating” passive pressure signals in claim 1 and “receiving” the passive pressure signals in independent Claims 1 and 11 is an insignificant extra-solution activity that amounts to mere data gathering steps that utilizes a computational device. The step of “determining” an indication of one or more ear pathologies can be interpreted as either a mental process or a mathematical concept. For example, as a mental process, the human mind is capable of performing a “determination” on whether one species of animal is larger than another. In another interpretation, the use of algorithms/machine learning models (such as those disclosed in applicant’s specification on page 6 lines 24-26) to aid in “determining” data features is an example of a mathematical concept.
The claimed steps of generating, receiving, and determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 2-10 and 12-15, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in Claims 1-15 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for generating, receiving, and determining merely invoke a computer as a tool.
• The data-gathering step (generating and receiving) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for generating, receiving, and determining.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for generating, receiving, and determining. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: ear plug, processor, pressure sensor, and accelerometer.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. page 11 lines 16-17]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. generating, receiving, and determining) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
• Kimmig (US 20210100507 A1) which discloses in para. 0044 that “an ear plug” with sensors is known in the art;
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Goldstein (US 20160166203 A1) in view of Keefe (US 8241224 B2).
Regarding claim 1, Goldstein teaches a system for assessing ear pathologies in a subject, the system comprising:
an earplug configured to be at least partially inserted in the ear canal of an ear of a subject [0072 “…ear plugs comprising a fluid-containing balloon or solid filled balloon for fully or partially occluding the ear canal…”],
wherein the earplug comprises a pressure sensor adapted to generate passive pressure signals representative of passive pressure changes within the ear canal induced by maneuvers performed by the subject [0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure. The pressure of the fluid in the balloon can be determined using a pressure sensor on the balloon surface…”], and
a processor [0193 “…device 850 comprises (…) a processor 860 for managing operations thereof”] configured to:
receive the passive pressure signals from the pressure sensor of the earplug [0134 “….the earpiece 120 can also transmit the at least one parameter of the biometric signal to a connected device…”, see also 0193 “…a multimedia device 850 suitable for use for use with, and/or practicing the aspects of the inventive elements disclosed herein…”].
Goldstein teaches measuring passive pressure within the ear canal [0105] and the output of an indicator based on passive pressure signals [0134 “…a voice message warning the user of a rate change or increase of a biometric parameter above or below a predetermined threshold, and also providing indication of the biometric parameter”], but fails to teach characteristics of the passive pressure signals are representative of one or more ear pathologies; and indication of one or more ear pathologies.
Keefe teaches characteristics of the passive pressure signals are representative of one or more ear pathologies [col. 49 lns. 4-10]; and
determining an indication of one or more ear pathologies [col. 48 lns. 19-22].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Goldstein and incorporate the teachings of Keefe to include characteristics of the passive pressure signals are representative of one or more ear pathologies; and indication of one or more ear pathologies. Doing so configures the system to analyze pressure acquired pressure change data and draw inferences to the patient’s ear health/condition.
Regarding claim 2, Goldstein and Keefe teach the system of claim 1, wherein characteristics of the passive pressure signals are further representative of the type of ear pathologies [Keefe col. 49 lns. 4-10] and the type of maneuver performed by the subject [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”].
Regarding claim 3, Goldstein and Keefe teach the system of claim 1, wherein the processor is further configured to receive an indication of the type of maneuver performed by the subject subject [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”], and wherein determining an indication of ear pathologies is further based on the type of maneuver performed by the subject [taught by the combination of Goldstein 0105 and Keefe col. 49 lns. 4-10].
Regarding claim 4, Goldstein and Keefe teach the system of claim 3, wherein the system further comprises one or more of:
a camera located within the earplug configured to image the ear canal;
an external camera configured to monitor the maneuver performed by the subject;
an accelerometer located within the earplug for determining the type of maneuver [Goldstein 0179 “…the earpiece can include a separate accelerometer…”]; and
a gyroscope located within the earplug for determining the type of maneuver, or a combination thereof.
Regarding claim 5, Goldstein and Keefe teach the system of any one of claim 1, wherein the maneuver comprises actions performed by the subject resulting in passive pressure changes within the ear [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”], optionally wherein the maneuver is one or more of:
moving jaw up and/or down [Goldstein 0105];
moving jaw sideways [Goldstein 0105];
swallowing;
yawning; and
tilting head, or combination thereof.
Regarding claim 6, Goldstein and Keefe teach the system of any one of claim 1, wherein determining an indication of an ear pathology further comprises:
determining the characteristics of the passive pressure signals [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”], wherein the characteristics comprise one or more of:
amplitude values of the passive pressure signal;
peaks and/or valleys of the passive pressure signals [Keefe col. 39 lns. 12-13];
temporal relationships of the peaks and/or valleys of the passive pressure signals;
a duration of the maneuver;
ratios of a subset of the passive pressure signals;
differences between peaks and valleys; and
frequency domain analysis [Keefe col. 7 lns. 57-62], or a combination thereof, and
comparing the characteristics of the passive pressure signals to baseline signals [Goldstein 0134 “…a biometric parameter above or below a predetermined threshold”], wherein the baseline signals are representative of the type of maneuver performed by the subject [Goldstein 0105].
Regarding claim 10, Goldstein and Keefe teach the system of any one of claim 1, wherein the processor is further configured to:
receive a second passive pressure signal from the pressure sensor of the earplug [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure. The pressure of the fluid in the balloon can be determined using a pressure sensor on the balloon surface…”], wherein the second passive pressure signal is induced by a second maneuver performed by the subject [Goldstein 0105 “jaw movement”], and wherein the processor is configured to determine an indication of one or more ear pathologies in the ear of the subject further based on characteristics of the second passive pressure signal [taught by the combination of Goldstein 0134 and Keefe col. 48 lns. 19-22], and optionally wherein the processor is adapted, when determining an indication of one or more ear pathologies in the ear of the subject further based on characteristics of the second passive pressure signal, to compare the characteristics of the passive pressure signal to the characteristics of the second passive pressure signal. [The examiner notes that when receiving/detecting “changes”, it is obvious that more than one measurement, or signal, must be acquired and compared to one another.]
Regarding claim 11, Goldstein teaches a method for assessing ear pathologies in a subject, the method comprising:
receiving passive pressure signals representative of passive pressure changes induced by maneuvers performed by the subject from a pressure sensor inserted in the ear canal of the subject [0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure. The pressure of the fluid in the balloon can be determined using a pressure sensor on the balloon surface…”].
Goldstein teaches determining an indication based on the passive pressure signal [0134 “…a voice message warning the user of a rate change or increase of a biometric parameter above or below a predetermined threshold, and also providing indication of the biometric parameter”], but fails to teach an indication of ear pathologies in the ear of the subject and wherein characteristics of the passive pressure signals are representative of one or more ear pathologies.
Keefe teaches an indication of ear pathologies in the ear of the subject [col. 48 lns. 19-22] and wherein characteristics of the passive pressure signals are representative of one or more ear pathologies [col. 49 lns. 4-10].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Goldstein and incorporate the teachings of Keefe to include an indication of ear pathologies in the ear of the subject and wherein characteristics of the passive pressure signals are representative of one or more ear pathologies. Doing so configures the system to analyze pressure acquired pressure change data and draw inferences to the patient’s ear health/condition.
Regarding claim 12, Goldstein and Keefe teach the method of claim 11, further comprising receiving an indication of the type of maneuver performed by the subject [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”], wherein determining an indication of ear pathologies is further based on the type of maneuver performed by the subject [taught by the combination of Goldstein 0105 and Keefe col. 49 lns. 4-10].
Regarding claim 13, Goldstein and Keefe teach the method of claim 11, wherein determining an indication of ear pathologies comprises:
determining the characteristics of the passive pressure signals [Goldstein 0105 “…we can determine that jaw movement has occurred if the pressure of a fluid in the balloon changes from the at rest pressure to a different pressure”], wherein the characteristics comprise one or more of:
amplitude values of the passive pressure signals;
peaks and/or valleys of the passive pressure signals [Keefe col. 39 lns. 12-13];
temporal relationships of the peaks and/or valleys of the passive pressure signals;
a duration of the maneuver;
ratios of a subset of the passive pressure signals;
differences between peaks and valleys of the passive pressure signals; and
frequency domain analysis [Keefe col. 7 lns. 57-62], or combination thereof, and
comparing the characteristics of the passive pressure signals to baseline signals [Goldstein 0134 “…a biometric parameter above or below a predetermined threshold”], wherein the baseline signals are representative of the type of maneuver performed by the subject [Goldstein 0105].
Regarding claim 15, Goldstein and Keefe teach a computer program product comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method [Goldstein claim 10, see also Keefe col. 31 lns. 28-30] according to claim 11 [see claim 11 rejection above].
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Goldstein and Keefe as applied to claim 1 above, and further in view of Senaras (US 10932662 B2).
Regarding claim 7, Goldstein and Keefe teach the system of any one of claim 1, wherein the combination of Goldstein and Keefe further teaches determining an indication of ear pathologies based on analyzing the passive pressure signals [Keefe col. 48 lns. 19-22], but fail to teach determining using a machine learning algorithm, wherein the machine learning algorithm has been trained to output an indication of ear pathologies.
Senaras teaches determining using a machine learning algorithm, wherein the machine learning algorithm has been trained to output an indication of ear pathologies [col. 10 lns. 39-41].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Goldstein and Keefe and incorporate the teachings of Senaras to include determining using a machine learning algorithm, wherein the machine learning algorithm has been trained to output an indication of ear pathologies. Doing so configures the system to utilize algorithms to improve accuracy through pattern recognition, enhance efficiency via task automation, and increase competitiveness by enabling data-driven insights and predictions.
Regarding claim 8, Goldstein, Keefe, and Senaras teach the system of claim 7, wherein the inputs of the machine learning algorithm are the characteristics of the passive pressure signals [taught by the combination of Senaras col. 10 lns. 39-41 and Keefe col. 49 lns. 4-10] and one or more of:
maneuver type [Goldstein 0105 “jaw movement”];
subject data, which comprises one or more of:
physical dimensions of the ear;
subject age [Senaras col. 10 lns. 16-19];
subject gender [Senaras col. 10 lns. 16-19];
a known subject condition subject demographic data; and
a diagnosis of the subject.
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Goldstein and Keefe as applied to claims 1 and 10 above, and further in view of Cao (US 20170202444 A1).
Regarding claim 9, Goldstein and Keefe teach the system of claim 1, wherein the earplug further comprises a humidity sensor for measuring the humidity inside the ear canal of the ear [Goldstein 0098 “The biometric sensor can detect one or more biometric signals, alone or in combination with other sensors, for example, sensors measuring (…), humidity…”], wherein the humidity sensor is adapted to generate a humidity signal [this is an inherent function of a “humidity” sensor], but fails to explicitly teach wherein determining an indication of an ear pathology is further based on analyzing the humidity signal.
Cao teaches wherein determining an indication of an ear pathology is further based on analyzing the humidity signal [0030 “…the display device 9 may display messages such as (…) “higher humidity in the ear canal” or the like, so that the user may be prompted that the ear canal has probably had a pathological change”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Goldstein and Keefe and incorporate the teachings of Cao to include determining an indication of an ear pathology is further based on analyzing the humidity signal. Doing so configures the system to incorporate additional data into analysis so that a more robust diagnosis of the patient’s condition by acquiring and analyzing additional data points that correspond to ear health.
Regarding claim 14, Goldstein and Keefe teach the method of claim 10, further comprising receiving a humidity signal corresponding to the humidity of the ear canal of the subject [Goldstein 0098 “The biometric sensor can detect one or more biometric signals, alone or in combination with other sensors, for example, sensors measuring (…), humidity…”], but fail to teach wherein determining an indication of ear pathologies is further based on the humidity signal.
Cao teaches wherein determining an indication of an ear pathology is further based on analyzing the humidity signal [0030 “…the display device 9 may display messages such as (…) “higher humidity in the ear canal” or the like, so that the user may be prompted that the ear canal has probably had a pathological change”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Goldstein and Keefe and incorporate the teachings of Cao to include determining an indication of an ear pathology is further based on analyzing the humidity signal. Doing so configures the system to incorporate additional data into analysis so that a more robust diagnosis of the patient’s condition by acquiring and analyzing additional data points that correspond to ear health.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791