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 Objections
Claims 1 and 8 objected to because of the following informalities:
“Pre-Plus Inhibition” should read “Prepulse Inhibition”. 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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 8 recites (additional limitations crossed out):
A system for determining Auditory Sustained Attention (ASAT) performance of a subject comprising:
a
an acoustic background noise;
a first acoustic startle stimulus at an intensity higher than the background noise;
a second acoustic startle stimuli comprising a pre-plus acoustic stimulus and an acoustic startle stimulus;
receive responses, of the subject, to the acoustic background noise, the first acoustic startle stimulus, and the second acoustic startle stimulus;
calculate a Pre-Plus Inhibition (PPI) as a percentage of response inhibition between the first acoustic startle stimulus and the second acoustic startle stimuli;
determine ASAT performance of the subject based on the calculated PPI; and
present the ASAT performance on a screen.
The above limitations, as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior, and mental processes. That is, other than reciting the steps as being performed by a “computerized human startle response monitoring system”, “headphones”, and a “computer”, nothing in the claim precludes the steps as being described as managing personal behavior, or mental processes. For example, but for the “computerized human startle response monitoring system”, “headphones”, and “computer” language, the limitations describe the receiving of responses to provided stimuli, calculating a PPI, determining ASAT performance based on the calculated PPI, and presenting the ASAT performance, which describes both managing personal behavior, and actions that may be performed mentally and/or with pen and paper. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a “computerized human startle response monitoring system”, “headphones”, and a “computer” to perform the steps. The “headphones” and “computer” are recited at a high level of generality such that they amount to no more than mere instructions to apply the exception using generic computing components. Moreover, the integration of the “computerized human startle response monitoring system” merely links the judicial exception to a particular technological environment or field of use.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a “computerized human startle response monitoring system”, “headphones”, and a “computer” to perform the steps amounts to no more than mere instructions to apply an exception using a generic computer component, or generally linking the judicial exception to a particular environment, which cannot provide an inventive concept. Therefore, the claim is not found to be patent eligible.
Claims 2-7 are dependent on claim 1, and include all the limitations of claim 1. Claim 9-14 are dependent on claim 8, and includes all the limitations of claim 8. Therefore, they are also directed to the same abstract idea. The remaining dependent claims do not feature any additional elements, and have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 4 and 11, the limitation “…wherein said method confirms or predicts responsiveness of the subject to an administration of a stimulant ADHD drug”. The specification does not appear to disclose any particular algorithms/methodologies detailing how the method confirms or predicts responsiveness of the subject to an administration of a stimulant ADHD drug.
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 4, 5, 11, and 12 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.
The term “responsiveness” in claims 4 and 11 is a relative term which renders the claim indefinite. The term “responsiveness” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The terms “short-acting”, “long-acting” and “intermediate-acting” in claims 5 and 12 are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention
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.
Claim(s) 1, 2, 7, 8, 9, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Selective and nonselective attention effects on prepulse inhibition of startle: a comparison of task and no-task protocols” by Diane Filion, available April 1, 2003, hereinafter referred to as Filion1 in view of TOVA Clinical Manual by Lawrence Greenberg, available February 20, 2008, hereinafter referred to as TOVA2
Regarding claim 1, Filion discloses A method of determining Auditory Sustained Attention (ASAT) performance of a subject comprising the steps of:
providing, via headphones, an acoustic background noise; providing, via the headphones, a first acoustic startle stimulus at an intensity higher than the background noise;
providing, via the headphones, a second acoustic startle stimuli comprising a pre- plus acoustic stimulus and an acoustic startle stimulus;
(See at least page 287 (5 of 14) – “The startle-eliciting stimulus was a 105 dB(A) burst of broad-band white noise, 50 ms in duration with a rise time of 5 ms. The prepulse stimuli consisted of 75 dB(A) tones, 800 or 1200 Hz, with a rise time of 25 ms and a duration of either 5000 or 7000 ms. Acoustic stimuli were presented binaurally through Sony P45 headphones.”
Filion also discloses receiving responses, of the subject, to the acoustic background noise, the first acoustic startle stimulus, and the second acoustic startle stimulus; (See at least page 287 (5 of 14) – “Startle eyeblink responses were recorded as EMG activity from 3-mm Ag–AgCl electrodes placed over the orbicularis oculi muscle of the lower left eyelid. One electrode was centered below the pupil and the other was positioned approximately 10-mm lateral to the first. The EMG signal was amplified and filtered (8–250 Hz), rectified, integrated at a time constant of 10 ms, then digitized at a rate of 1000 Hz for a period of 300 ms following startle stimulus onset.”)
Filion also discloses calculating a Pre-Plus Inhibition (PPI) as a percentage of response inhibition between the first acoustic startle stimulus and the second acoustic startle stimuli; (See at least page 290 (8 of 14) – “Next, a PPI score was calculated for each prepulse type as a percent-change score using the startle-alone presentations as the baseline (baseline minus prepulse-trial, divided by baseline, multiplied by 100).)
Filion also discloses:
determining ASAT performance of the subject based on the calculated PPI; and
presenting the ASAT performance
(See at least Fig. 2)
Filion does not explicitly disclose presenting the ASAT performance on a computer screen (See TOVA, at least page 23 (28 of 94) – “The Graph presents T.O.V.A. results using standard scores and %iles for Variability, Response Time, Commissions, and Omissions. If the standard score is below the horizontal axis, it would be noted as ! ! and not be displayed in the graph.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion to display results as taught by TOVA since it demonstrates standard computer implementation.
Regarding claim 2, Filion discloses The method of claim 1, wherein receiving the responses comprises recording an electromyographic activity of the subject, from the orbicularis oculi muscle. (See at least page 287 (5 of 14) – “Startle eyeblink responses were recorded as EMG activity from 3-mm Ag–AgCl electrodes placed over the orbicularis oculi muscle of the lower left eyelid. One electrode was centered below the pupil and the other was positioned approximately 10-mm lateral to the first. The EMG signal was amplified and filtered (8–250 Hz), rectified, integrated at a time constant of 10 ms, then digitized at a rate of 1000 Hz for a period of 300 ms following startle stimulus onset.”)
Regarding claim 7, Filion discloses The method of claim 1, wherein providing the second acoustic startle stimuli comprises providing a predetermined inter-stimulus-interval between the pre-plus acoustic stimulus and the acoustic startle stimulus. (See at least page 283 (1 of 14) – “Prepulse inhibition of startle (PPI) refers to the reduction in startle reflex amplitude that occurs when a startle-eliciting stimulus is preceded by a non-startling stimulus (prepulse) at a lead interval of approximately 50–500 ms (see review by Blumenthal, 1999).”)
Claim 8 features limitations similar to those of claim 1, and is therefore rejected using the same rationale.
Claim 9 features limitations similar to those of claim 2, and is therefore rejected using the same rationale.
Claim 14 features limitations similar to those of claim 7, and is therefore rejected using the same rationale.
Claim(s) 3-6, 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Selective and nonselective attention effects on prepulse inhibition of startle: a comparison of task and no-task protocols” by Diane Filion, available April 1, 2003, hereinafter referred to as Filion and TOVA Clinical Manual by Lawrence Greenberg, available February 20, 2008, hereinafter referred to as TOVA, and in further view of Silva (WO 2005/120496)
Regarding claim 3, Filion and TOVA do not explicitly disclose The method of claim 1, further comprising:
diagnosing Attention Deficit Hyperactivity Disorder (ADHD) based on the ASAT performance; (TOVA teaches interpreting test results to suggest that a patient may have ADHD (See page 22 (27 of 94)), however, said interpretation is not based on ASAT performance which in turn is based on a calculated PPI. See Silva, Para. [0140] – “Children with attention-deficit hyperactivity disorder (ADHD) are reported to have significantly reduced pre-pulse inhibition (PPI). This task assays sensory "gating" of environmental stimuli. A powerful and sudden acoustic stimulus will elicit a whole body startle response. When the startle producing stimulus is preceded by a weak pre-stimulus (by approximately 100 milliseconds) the startle response is inhibited in normal persons and animals. Previous studies show a high incidence of ADHD in NF1 and support an association between ADHD and learning problems in these children.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion and TOVA to utilize the teachings of Silva since they are within the same field of endeavor (i.e. study of ADHD symptoms), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Filion does not presenting the diagnosis. (See TOVA, page 22 (27 of 94) It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion to utilize present results as taught by TOVA since it demonstrates standard computer implementation.
Regarding claim 4, Filion and TOVA do not explicitly disclose The method of claim 3, wherein said method confirms or predicts responsiveness of the subject to an administration of a stimulant ADHD drug. (In light of the 112 rejection above, Silva teaches this. See Silva, Para. [0140] – “Children with attention-deficit hyperactivity disorder (ADHD) are reported to have significantly reduced pre-pulse inhibition (PPI). This task assays sensory "gating" of environmental stimuli. A powerful and sudden acoustic stimulus will elicit a whole body startle response. When the startle producing stimulus is preceded by a weak pre-stimulus (by approximately 100 milliseconds) the startle response is inhibited in normal persons and animals. Previous studies show a high incidence of ADHD in NF1 and support an association between ADHD and learning problems in these children.” The Examiner asserts that a person having ordinary skill in the art would understand that a person being administered a stimulant would be responsive. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion and TOVA to utilize the teachings of Silva since they are within the same field of endeavor (i.e. study of ADHD symptoms), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 5, Filion and TOVA do not explicitly disclose The method of claim 4, wherein said stimulant ADHD drug is selected from: a short- acting stimulant drug, a long-acting stimulant drug, an intermediate-acting stimulant drug, or any combination thereof. (In light of the 112 rejection above, Silva teaches this. See Silva – Para. [0040] – “The most common pharmacologic therapy for ADHD is stimulants or stimulant mixtures, such as Ritaline® (methyphenidate), Adderall®, pemoline, or dextroamphetamine. It is believed that stimulants affect nonepinephrine and dopamine pathways, thereby providing impulse control and working memory.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion and TOVA to utilize the teachings of Silva since they are within the same field of endeavor (i.e. study of ADHD symptoms), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention
Regarding claim 6, Filion and TOVA do not explicitly disclose The method of claim 5, wherein said stimulant ADHD drug comprises methylphenidate or any derivative thereof. (See Silva – Para. [0040] – “The most common pharmacologic therapy for ADHD is stimulants or stimulant mixtures, such as Ritaline® (methyphenidate), Adderall®, pemoline, or dextroamphetamine. It is believed that stimulants affect nonepinephrine and dopamine pathways, thereby providing impulse control and working memory.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Filion and TOVA to utilize the teachings of Silva since they are within the same field of endeavor (i.e. study of ADHD symptoms), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention
Claim 10 features limitations similar to those of claim 3, and is therefore rejected using the same rationale.
Claim 11 features limitations similar to those of claim 4, and is therefore rejected using the same rationale.
Claim 12 features limitations similar to those of claim 5, and is therefore rejected using the same rationale.
Claim 13 features limitations similar to those of claim 6, and is therefore rejected using the same rationale.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
“Prepulse inhibition of startle in adults with ADHD” by David Feifel
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://www.sciencedirect.com/science/article/pii/S0301051103000772?via%3Dihub
2 Available at https://files.tovatest.com/documentation/7.3/clinical_manual_844.pdf
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