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 § 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10, 12-14, 16-17, 19, 28, 31, and 41-42 are rejected under 35 U.S.C. 101 due to the claims being directed to a mental process without significantly more.
Claims 1-10, 12-14, 16-17, 19, 28, and 31 are directed to a system for assessing ADHD status of a subject, which comprises receiving a measurement signal including measurements of a plurality of nasal respirations for sensing the nasal respirations of a subject, determining values of one or more nasal respiration parameters from the measurement signal, and evaluating the subject based on the values of the one or more respiration parameter to provide an indication of ADHD status of the subject. Claims 41-42 are directed to a method of determining whether a therapy or therapeutic agent is effective in managing ADHD in a subject, which comprises applying therapy to the subject or a therapeutic agent to a subject, and determining the status of ADHD of the subject in a time window shorter than 15 minutes, which could be performed by the human mind and/or by a human with a physical aid as with pen and paper. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1:
Claims 1-10, 12-14, 16-17, 19, 28, and 31, and 41-42 recite a system and method for assessing an ADHD status of a patient and determining the effectiveness of a therapy or therapeutic agent in managing ADHD in a subject, comprising:
receiving a measurement signal including measurements of a plurality of nasal respirations for sensing the nasal respirations of a subject, determining values of one or more nasal respiration parameters from the measurement signal, and evaluating the subject based on the values of the one or more respiration parameter to provide an indication of ADHD status of the subject. Claims 41-42 recite applying therapy to the subject or a therapeutic agent to a subject, and determining the status of ADHD of the subject in a time window shorter than 15 minutes, and thus meet the requirements for step 1.
Step 2A (Prong 1):
Claims 1-10, 12-14, 16-17, 19, 28, and 31, and 41-42 recite the steps of:
Receiving a measurement signal including a plurality of nasal respirations from a sensor configured to sense a nasal respirations of a subject.
Determining values of the one or more nasal respiration parameter from the measurement signal.
Evaluating the subject based on said values of the one or more respiration parameters to provide an indication of ADHD status of the subject.
Applying the therapy or administering a therapeutic agent to a subject.
Determining a status of ADHD in a time window shorter than 15 minutes.
The steps above, under broadest reasonable interpretation, can be performed by mental process steps because they can be practically performed in the human mind. For instance, a status of ADHD of a subject can be determined using values of one or more nasal respiration parameters from a measurement signal, and an evaluation can be provided based of the respiration parameter values. Furthermore, the effectiveness of therapy can be determined by applying the therapeutic agent/therapy to the subject, and then evaluating the subject within the time window shorter than 15 minutes.
Step 2A, Prong 2:
Claims 1-10, 12-14, 16-17, 19, 28, and 31, and 41-42 include the additional elements of:
Receiving circuitry to receive a measurement signal including measurements of a plurality of nasal respirations. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Determining circuitry configured to determine values of one or more nasal respiration parameters. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
Evaluation circuitry configured to evaluate the subject based on said one or more respiration parameter values. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
Administering a therapy or therapeutic agent to subject. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Linking the use of a judicial exception to another technological environment or field of use; generic computer implementation; and insignificant extra-solution activity do not provide integration into a practical application.
Step 2B:
Claims 1-10, 12-14, 16-17, 19, 28, and 31, and 41-42 include the additional elements of:
Receiving circuitry to receive a measurement signal including measurements of a plurality of nasal respirations. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Determining circuitry configured to determine values of one or more nasal respiration parameters. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
Evaluation circuitry configured to evaluate the subject based on said one or more respiration parameter values. This is merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.04 (d).
Administering a therapy or therapeutic agent to subject. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
These additional elements in claims 1-10, 12-14, 16-17, 19, 28, and 31, and 41-42 by the courts, either alone or in combination, have found not to be enough to qualify as “significantly more” than the abstract idea itself when recited in a claim with a judicial exception.
Dependent claims:
Claims 1-10, 12-14, 16-17, 19, 28, 31, and 41 - 42 further define the mental process and abstract idea, therefore failing to amount to “significantly more” than the abstract ideas either alone or in combination as previously stated for the independent claims.
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 1, 3, 5-9, 13, 16-17, and claim 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0367651 A1 to Tzvieli et al (hereinafter “Tzvieli”).
Regarding claim 1 Tzvieli teaches:
A system for assessing an ADHD status of a subject (see abstract and para [0205]) and method for determining Attention Deficit Hyperactivity Disorder (ADHD) (see abstract, para [0021], para [0205], and para [0243]-[0244]) comprising:
receiving circuitry/sensors configured to receive a measurement signal including measurements of a plurality of nasal respirations from a sensor (the microbolometer or thermopile sensor) configured to sense a nasal respiration of a subject (see abstract, para [0011], para [0229], para [0236], para [0260]);
determining circuitry (made up of the computer/analog circuit) configured to determine values of one or more nasal respiration parameter from said measurement signal (see abstract, figs. 9 and 11, para [0011], para [0097] – “In some embodiments, the HMS described above (e.g., illustrated in FIG. 1a or FIG. 3), is further configured to forward TH.sub.ROI1 and TH.sub.ROI2 to a computer that is configured to detect a physiological response based on TH.sub.ROI1 and TH.sub.ROI2. One example of such a computer is the computer 16 in FIG. 1a…….Optionally, the computer may be at least one of the following: a computer belonging to a device carried by the user, a computer of a smartphone, a personal computer, a remote server (e.g., a cloud-based server), and an analog circuit.”, para [0242]-[0243], para [0245], para [0260, and para [0297]-[0298]);
evaluation circuitry/model configured to evaluate said subject, based on said values of one or more respiration parameter to provide an indication of ADHD status of said subject (see fig. 11 – 392, para [0161], para [0268], and para [0297]-[0298]).
Regarding claim 3, Tzvieli teaches:
The system of claim 1, comprising collecting a plurality nasal or mouth breathing parameters, wherein said plurality of nasal respirations comprises at least two consecutive nasal respirations of the subject (see para [0260], para [1248]-[1249], and para [0817] - [0818]). The plurality of nasal respirations taken together equates to at least two consecutive nasal respirations of the subject.
Regarding claim 5, Tzvieli teaches:
The system of claim 1, wherein said at least one respiration parameter comprises a volume-associated parameter or a timing-associated parameter (see para [1248]- [1249]).
Regarding claim 6, Tzvieli teaches:
The system of claim 1, wherein said at least one respiration parameter comprises a timing-associated parameter (see para [1248]).
Regarding claim 7, Tzvieli teaches:
The system of claim 6, wherein said timing-associated parameter comprises at least one of a duration of a nasal inhalation, a duration of a nasal exhalation, a time between two nasal inhalations, a duty cycle and a time between two nasal exhalations (see para [1248]).
Regarding claim 8, Tzvieli teaches:
The system of claim l, wherein said at least one respiration parameter comprises at least one of a breathing rate, an inter-breath interval, an inhale volume, an exhale volume, a tidal volume, a minute ventilation and a duty cycle (see para [1248]).
Regarding claim 9, Tzvieli teaches:
The system of claim 8, wherein said at least one parameter comprises inhalation and/or exhalation velocity and/or duration (see abstract - last sentence, para [0260], and para [0593]).
Regarding claim 13, Tzvieli teaches:
The system of claim 1, wherein said evaluation circuitry/model includes a classifier trained to classify nasal breathing data into ADHD status (see fig. 21, para [0161], para [1218], para [0297], para [0344], and para [0397]).
Regarding claim 16, Tzvieli teaches:
The system of claim 1, wherein said evaluation circuitry is configured to compare said value of said at least one respiration parameter with a reference value/threshold, wherein a difference between said value of at least one respiration parameter of said subject and said reference value is indicative of a status of ADHD (para [0268], para [0885], and para [0297]-[0298]).
Regarding claim 17, Tzvieli teaches:
The system of claim 1, comprising memory storing therein at least one reference value personalized for the subject (see para [0163]).
Regarding claim 19, Tzvieli teaches:
The system of claim l, wherein said indication comprises a
diagnosis of ADHD (see para[0268] and para [0297]-[0299]);
(ii) a change in status of ADHD;
(iii) recommendation to take medication or apply a therapy;
and/or (iv) an indication regarding an effectiveness therapy.
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.
Claims 4, 2-10 and 12-13, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli in view of WO 2021/209999 A2 to Sobel et al. (hereinafter “Sobel”).
Regarding claim 2, Tzvieli teaches:
A system according to claim 1, but does not explicitly disclose wherein the system comprises at least one nasal flow sensor which provides said measurement signal.
However, Sobel teaches wherein the system comprises at least one nasal flow sensor which provides said measurement signal (See abstract and page 26, lines 23-24 - “In some embodiments, respiration is measured e.g. by one or more sensor (e.g. sensor/s 104 FIG. 1D sensor/s 204 FIG. 2, sensor/s 304 FIG. 3)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tzvieli with the teachings of Sobel to arrive at the claimed invention, since such modification would improve the system by directly collecting and evaluating the nasal respirations of the subject efficiently in order to make an accurate diagnosis of ADHD.
Regarding claim 4, Tzvieli teaches:
The system of claim 1, wherein a certain percentage of breaths are collected over a period of time (see para [1021] and para [1249] - [1250]), and wherein said measurement signals (which are used to calculate respiration parameters/respiratory parameters), but does not explicitly disclose wherein the measurement signal includes at least 10 % of all breaths over a time period of at least five minutes.
However, Sobel teaches a method for assessing a subject by measuring a plurality of nasal respirations of a subject to determine one or more respiration parameters in order to identify a state of consciousness of a subject and/or a prognosis of a subject (see abstract and fig. 2). The system (fig. 2) teaches wherein the measurement signal (such as the variability of respiration/ “trace”) includes at least 10 % of all breaths over a time period of at least five minutes (see page 15-16, lines 30-32 and lines 1-5). Since the measurement signal collects 100% of respirations over a time period of 5 minutes in order to derive the variability of respiration parameter, the measurement signal includes at least 10 % of all breaths over a time period of at least five minutes.
Therefore, it would have been obvious to combine the teachings of Tzvieli with the teachings of Sobel to arrive at the claimed invention. Doing so would improve the system by directly collecting and evaluating the nasal respirations of the subject efficiently in order to make an accurate diagnosis of ADHD. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of Applicant' s invention to engage in routine experimentation to discover the optimal percentage of at least 10% of all breaths over a period of at least 5 minutes in order to derive an accurate respiration parameter of the subject from the measurement signal for effectively diagnosing a patient with ADHD. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 10, Tzvieli teaches:
The system of claim 1, but does not explicitly disclose wherein said evaluating comprises evaluating one or both of a coefficient of variation of said parameter over a predetermined time period and a peak value of said parameter over a predetermined time period.
However, Sobel teaches wherein said evaluating comprises evaluating one or both of a coefficient of variation of said parameter over a predetermined time period and a peak value/peak airflow speed of said parameter over a predetermined time period (see page 15, lines 14 - 30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tzvieli with the teachings of Sobel to arrive at the claimed invention, since such modification would improve the system by providing an accurate determination of the respiration parameters in order to properly make an accurate diagnosis of ADHD in the patient.
Regarding claim 12, Tzvieli teaches:
The system of claim 1, but does not explicitly disclose wherein said evaluation circuitry is configured to monitor at least one parameter of a nasal respiratory waveform of the subject.
However Sobel teaches wherein said evaluation circuitry is configured to monitor at least one parameter of a nasal respiratory waveform of the subject (see page 33 – “In some embodiments, respiration measurement/s other than respiration airflow
20 measurements have a waveform similar to that of airflow measurements e.g. as illustrated in
FIG. 25. Where, in some embodiments, respiration feature/s for non-airflow measurements are
extracted as described regarding and/or illustrated in FIG. 25.” And claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tzvieli with the teachings of Sobel to arrive at the claimed invention, since such modification would improve the system by providing an accurate determination of the respiration parameters in order to properly make an accurate diagnosis of ADHD in the patient.
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli in view of US 2020/0054618 A1 to Avital et al. (hereinafter “Avital”).
Regarding claim 14, Tzvieli teaches:
The system of claim l, but does not disclose wherein said ADHD status comprises an ADHD sub-classification or an ADHD severity score.
However, Avital teaches methods for diagnosing and determining a need of a stimulant ADHD drug (see abstract). The method (fig. 1) teaches wherein ADHD status comprises an ADHD sub-classification or an ADHD severity score (see para [0025] and para [0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tzvieli with the teachings of Avital to arrive at the claimed invention. Such modification would improve the system by properly identifying the specific sub-group of ADHD the patient has, ultimately allowing for more precise and accurate treatment for the patient, and ultimately providing more effective therapy for the patient.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli in view of Sobel, and further in view of US 2003/0100844 A1 to Miller et al. (hereinafter “Miller”).
Regarding claim 31, Tzvieli teaches:
A method according to claim 28, but does not explicitly disclose wherein said measuring comprises measuring in a timed relationship to taking of ADHD-related medication by the subject.
However, Miller teaches a method for determining an appropriate dosage of medication for treating an individual with Attention Deficit Hyperactivity Disorder (see abstract). The method (figs. 1 and 3b) teaches wherein said measuring comprises measuring in a timed relationship (by waiting a certain period of time) to taking of ADHD-related medication by the subject (see fig. 3b and para [0059] – [0060] and para [0068]). The timed relationship is one in which the subject will wait a certain amount of time following the administering of the drug in order to test the effectiveness of the prescribed drug.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Tzvieli with the teachings of Miller to arrive at the claimed invention. Such modification would improve the system by promptly identifying the proper dosage for the ADHD patient, ultimately improving treatment efficiency.
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of US 2020/0174557 A1 to Alailima et al. (hereinafter “Alailima”).
Regarding claim 41, Miller teaches:
A method of determining whether a therapy or therapeutic agent is effective in managing ADHD (see abstract, lines 1-3) in a subject comprising:
applying the therapy to the subject or administering the therapeutic agent to the subject (See fig. 3b – 70 and para [0068]);
and determining a status of ADHD in a time window/time period (see abstract, fig. 4, fig. 3b, and para [0068]),
wherein the indication of ADHD is a responsiveness to the therapy or therapeutic agent (see para [0068]), wherein said applying or administering is affected prior to or during the measuring (see para [0068]). However, Miller does not explicitly teach determining a status of ADHD in a time window shorter than 15 minutes.
However, Alailima teaches methods, systems, and apparatuses for improving cognitive skills in an individual (see abstract). The system (fig. 1) teaches determining a status of ADHD and/or cognitive impact in a time window of 30 minutes (see para [0159]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal evaluating time window of 15 minutes or less in order to effectively evaluate the status of ADHD in a patient. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Doing so would improve the system providing a more efficient way of diagnosing and treating a patient with ADHD, ultimately providing more effective treatment/therapy for the patient.
Regarding claim 42, Miller teaches:
A method according to claim 41, wherein said applying comprises indicating such applying or administering to a system used to measure the ADHD status (see fig. 3b and para [0068]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Westbrook (US 2010/0240982 A1) teaches system and methods for assessing sleep quality in both children and adults in order to provide an accurate differential diagnosis in a patient (see abstract, para [0092], and para [0099]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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