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 9, 14, 19, and 33 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 9 depends from cancelled claim 7. For the purpose of advancing prosecution, claim 9 is interpreted to depend from claim 1.
Claim 9 recites the limitation "the threshold level.” There is insufficient antecedent basis for this limitation in the claim.
Claims 14 & 33 recite the limitation "the personal care action.” There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “computed patient status.” It is unclear if this is the same as “computed post-treatment or post-consultation status” as recited in claim 1. For the purpose of continued examination, “computed patient status” is interpreted as being equivalent to “computed post-treatment or post-consultation status.”
Claim 19 recites the limitation "the computed patient status.” There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5-6, 9-10, 14, 16, 19, 22, 28, 31-38 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step 1:
Independent claims 1 and 19 are directed to a method and a system; thus, the claims all fall under one of the four patent eligible categories.
Under Step 2A, Prong 1:
Claims 1 & 19 recite steps comprising obtaining data; determining a metric; computing a status; and generating a data report. Under broadest reasonable interpretation, these limitations appear to be directed to mental processes because they can be performed in the mind or with pen and paper. A trained clinician can obtain user data indicative of pain through observations; analyze data to calculate a pain metric; determine patient status by evaluating pain metric trends; and generate a data report with pen and paper. Accordingly, claims 1 & 19 are directed to a judicial exception including one or more abstract ideas under mental processes and mathematical concepts.
Claim 10 recites an additional limitation of comparing a rate of change but appears to be directed to mental processes because comparing concerns evaluation which can be performed in the mind or with pen and paper.
Claim 28 recites an additional limitation of performing a response but appears to be directed to mental processes because performing concerns selecting a response through observations and judgements which can be performed in the mind or with pen and paper.
Under Step 2A, Prong 2:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claim 19 includes an input/output, processor(s), and sensor(s) and steps of obtain information; determine a metric; compute a status; and generate a data report; wherein the input/output and sensor(s) only generally link the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology; wherein the input/output and processor(s) are generic computer components; generate is post-solution activity (data outputting).
Claims 2 & 32 includes a sensor with an additional limitation of at least one sensor is integrated in a personal care device wherein the sensor only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology.
Claim 3 includes a biological sensor with an additional limitation of sensor data includes data from biological sensor wherein the biological sensor only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology.
Claims 5 & 22 include force sensors, motion sensors, and operational sensors with additional limitations of sensor data includes data from force sensor(s), motion sensor(s), or operational sensor(s) integrated into the personal care device wherein the force sensors only generally link the use of the judicial exception to a particular technological environment or field of use, does not improve upon technology, and further limits an abstract idea; output an operational signal is post-solution activity (data outputting).
Claim 6 includes a reference sensor with an additional limitation of personal care sessions determined based on pattern analysis wherein the reference sensor only generally links the use of the judicial exception to a particular technological environment or field of use, does not improve upon technology, and further limits an abstract idea.
Claim 9 includes a sensor with additional limitations of a threshold level determined based on a pre-treatment or pre-consultation metric level using sensor data acquired in advance of treatment or consultation wherein the sensor only generally links the use of the judicial exception to a particular technological environment or field of use, does not improve upon technology, and further limits an abstract idea.
Claims 14 & 33 include an oral care device with additional limitations of an oral cleaning session and cleaning action wherein the oral care device only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology.
Claim 36 includes an oral care device, a skin care device, a grooming device, and muscle/joint care device but only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology.
Claim 37 includes force sensors, motion sensors, operational sensors, and biological sensors with additional limitations of generate sensor data; and operational sensor(s) integrated in the personal care device; wherein force, motion, operational, and biological sensors only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology; generate is pre-solution activity (data gathering).
Claim 38 includes an external computing device and a cloud-based device but only generally links the use of the judicial exception to a particular technological environment or field of use and does not improve upon technology; external computing and cloud-based devices are generic computers.
Claims 16, 28, 31, 34, 35 do not include any additional elements.
Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for “anonymous loan shopping” was an abstract idea because it could be “performed by humans without a computer”). See MPEP 2106.04(a)(2)(III).
Furthermore, generic computers and/or components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “processor(s)”, “input/ouput”, “external computing device” and “cloud-based device” appear to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Under Step 2B:
Claims 1-3, 5-6, 9-10, 14, 16, 19, 22, 28, 31-38 fail to include any additional elements that, alone or in combination, amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “sensors”, “biological sensor”, “force sensor”, “operational sensor”, “motion sensor”, “reference sensor”, “oral care device”, “skin care device”, “grooming device”, “muscle/joint care device” are well-understood, routine, and conventional activities previously known in the field of electrostimulation as indicated in the following references:
*Examiner notes that reference sensor can be any sensor that provides reference data; grooming device comprises oral care and skin care devices;
WO 2023/006558 A1
See ([pg. 10:25-27], Fig. 1 & 2) for processor, force sensor, biological sensor
See [pg. 5:24-35] for oral care device
See [pg. 6:1-5] actuation drive signal for operational sensor
WO 2023/088697 A1
See [pg. 3:6-7] for processor
See [pg. 3:9] for oral care device
See [pg. 11:36-37] for force sensor, motion sensor
WO 2018/089450 A1
See [0003] for skin care device
See [0087] optical strain sensor for biological sensor
US 2023/0270352 A1
See Abstract for muscle/joint care device
See [0031] for motion sensor
US 2023/0104675 A1
See Abstract for muscle/joint care device
See [0007] RFID position sensors for operational sensors
US 2017/0056685 A1
See Abstract for skin care device
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) 1-3, 6, 9-10, 14, 16, 19, 28, 31-36 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spelt et al (International Publication WO 2023/006558 A1).
Regarding claims 1 & 19, Spelt teaches a method and a processing device, comprising:
an input/output ([pg. 10:22], Fig. 1); and
one or more processors (12, Fig. 1), configured to:
obtain information indicative of user pain as a function of time over the course of each of a series of personal care sessions by a user using a personal care device ([pg. 10:25-27], Fig. 1 & 2; processor 12 receives contact signal 22 and biological signal 24, [pg. 17:28-32]; information transmitted based on pain trends necessitates a plurality of personal care sessions), the personal care sessions following a treatment or consultation ([pg. 17:26-32]; remote pain monitoring necessitates consultation before monitoring; information used to determine next appointment and subsequent care session implements consultation parameters), and wherein the data indicative of user pain is determined based on sensor data from at least one sensor ([pg. 10:30-37], Fig. 1 & 2; processor 12 receives biological signal 24 from sensing apparatus; adapted to classify pain and non-pain states);
determine a metric for each session based on the data indicative of user pain ([pg. 13:22-33; processor computes pain level and/or sum of a total pain amount over the course of the measurement session);
compute a post-treatment or post-consultation status based on trending of said metric over the series of personal care sessions following the treatment or consultation ([pg. 17:24-32]; quantification of total pain and/or non-pain over a measurement session; pain trends determine status e.g. pain getting worse or not improving), and
generate a data report for export indicative of the computed patient status ([pg. 18:1-2]; report generated based on collated data).
Regarding claims 2 & 32, Spelt teaches the method of claim 1 and the system of claim 31, and further teaches wherein the personal care device comprises the at least one sensor ([pg. 5:24-35]; oral care device includes pressure sensor).
Regarding claim 3, Spelt teaches the method of claim 1, and further teaches wherein the sensor data includes data from a biological sensor ([pg. 13:1-2]; galvanic skin response electrode).
Regarding claim 6, Spelt teaches the method of claim 5, and further teaches wherein the information indicative of user pain during each of the one or more personal care sessions is determined based on analysis of patterns in the sensor data ([pg. 11:16-18]; detected responses and biological signals analyzed for correlation and synchronicity), and/or based on reference sensor pattern information associated with user pain or user comfort.
Regarding claim 9, Spelt teaches the method of claim 1, and further teaches wherein the threshold level is determined based on a pre-treatment or pre-consultation metric level measured using sensor data from the at least one sensor acquired in advance of the treatment or consultation ([pg. 16:28-32]; processor 12 acquires a baseline biological signal before examination or procedure; threshold determined by event detection criteria).
Regarding claim 10, Spelt teaches the method of claim 1, and further teaches wherein the determining the post-treatment or post-consultation status comprises comparing a rate of change of said metric over the series of sessions following treatment or consultation against a threshold rate of change ([pg. 4:15-21]; signal spikes compared against threshold upward gradient of rising edge of peak).
Regarding claims 14 & 33, Spelt teaches the method of claim 1 and the system of claim 31, and further teaches wherein the personal care device is an oral care device ([pg. 5:24]; oral care device), the personal care session is an oral cleaning session and the personal care action is cleaning action ([pg. 5:24-28]; oral cleaning device performs oral cleaning during an oral cleaning session).
Regarding claims 16 & 35, Spelt teaches the method of claim 1 and the system of claim 31, and further teaches wherein the personal care device is a device for application to an area of the body of the user for a care function ([pg. 5:24-26]; oral care device applied to oral region for cleaning), whereby physical stimulation of one or more areas of the body is caused by such application during the personal care session ([pg. 5:24-28]; brushing action).
Regarding claim 28, Spelt teaches the device of claim 19, and further teaches wherein the one or more processors are further configured to perform a response action based on the patient status ([pg. 3:17-22; scheduling an appointment with a dental practitioner based on pain level).
Regarding claim 31, Spelt teaches the system comprising:
the processing device according to claim 19, and further teaches;
a personal care device ([pg. 5:24-35]; oral care device); and
at least one sensor ([pg. 5:24-35]; oral care device includes pressure sensor);
wherein the processing device is arranged to receive sensor data generated by the at least one sensor as an input at the input/output ([pg. 10:25-36], Fig. 1 & 2; processor 12 receives contact signal 22).
Regarding claim 34, Spelt teaches the system of claim 31, and further teaches wherein the personal care session comprises performance of a personal care function by the personal care device involving interaction with the user ([pg. 5:24-28]; oral cleaning device performs oral cleaning on a user during an oral cleaning session).
Regarding claim 36, Spelt teaches the system of claim 31, and further teaches wherein the personal care device is one of: an oral care device ([pg. 5:24-28]; oral cleaning device), a skin care device, a grooming device, and a muscle/joint care device.
Regarding claim 38, Spelt teaches the system of claim 31, and further teaches wherein:
the processing device is integrated in the personal care device; or
the processing device comprises a computing device external to the personal care device, the computing device communicatively coupled with the personal care device or with a datastore with which the personal care device is communicatively coupled; or
the processing device is a cloud-based processing device ([pg. 11:6-8]; distributed processing system).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 22, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spelt et al (International Publication WO 2023/006558 A1).
Regarding claims 5 & 22, Spelt teaches the method of claim 1 and the device of claim 19, but does not disclose wherein the sensor data includes data from one or more force and/or motion sensors integrated in the personal care device indicative of personal care action by the user using the device over the course of one or more personal care sessions, or from one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces,
as claimed.
However, Spelt teaches an embodiment with a contact sensor and further teaches, wherein the sensor data includes data from one or more force (92, Fig. 8) and/or motion sensors integrated in the personal care device indicative of personal care action by the user using the device over the course of one or more personal care sessions ([pg. 15:15-19]; contact sensor 92 detects force when tip of dental probe applied against a surface), or from one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Spelt, with sensor data includes data from one or more force and/or motion sensors integrated in the personal care device indicative of personal care action by the user using the device over the course of one or more personal care sessions, or from one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces. One of ordinary skill in the art would have been motivated to make these modifications to improve patient monitoring data by detecting device contact with oral tissue (Spelt, [pg. 15:20-26]).
Regarding claim 37, Spelt teaches the system of claim 31, but does not disclose,
wherein the at least one sensor comprises:
one or more force and/or motion sensors configured to generate sensor data indicative of personal care action by the user using the device over the course of one or more personal care sessions, or one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces;
a biological sensor configured to generate sensor data indicative of a biological parameter of the user over the course of one or more personal care sessions,
as claimed.
However, Spelt teaches an embodiment with a contact sensor and further teaches,
wherein the at least one sensor comprises:
one or more force (92, Fig. 8) and/or motion sensors configured to generate sensor data indicative of personal care action by the user using the device over the course of one or more personal care sessions ([pg. 15:15-19]; contact sensor 92 detects force when tip of dental probe applied against a surface), or one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces;
a biological sensor (78, Fig. 8) configured to generate sensor data indicative of a biological parameter of the user over the course of one or more personal care sessions ([pg. 15:27-29]; galvanic skin response measurement).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Spelt, with at least one sensor comprises, one or more force and/or motion sensors configured to generate sensor data indicative of personal care action by the user using the device over the course of one or more personal care sessions, or one or more operational signal sensors integrated in the personal care device adapted to output an operational signal indicative of an operational parameter of the device which correlates with physical interaction of the device with bodily surfaces, and a biological sensor configured to generate sensor data indicative of a biological parameter of the user over the course of one or more personal care sessions. One of ordinary skill in the art would have been motivated to make these modifications to improve patient monitoring data by detecting device contact with oral tissue (Spelt, [pg. 15:20-26]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sarvazyan et al (US Pre Grant Publication 2011/0066078 A1) discloses a system and a method for monitoring pain during a surgical procedure; force sensor measures squeezing force [0016]; data processor converts signals into a pain metric [0016].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792 /William J Levicky/ Primary Examiner, Art Unit 3796
