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 .
Response to Arguments
I. Claim Rejections under 35 U.S.C. § 101
Concerning Step 2A, Prong One, Applicant argues that “the human mind is not equipped to simultaneously process multi-channel EEG waveform data, PPG waveform data, and patient-reported side-effect data, extract computational feature values from each, and use those combined feature values to detect and classify events associated with the physiological condition, including side-effect events.” The Examiner respectfully disagrees. The human mind, especially with physical aids such as pen and paper, can review multiple types of diagnostic data and make various determinations therefrom, such as diagnosing physiological conditions, detect side effects, etc. This is a type of analysis in which doctors are routinely engaged; the claims here merely automate various diagnostic analysis steps (which could be carried out mentally) to be carried out by a processor.
Concerning Step 2A, Prong Two, Applicant argues that the claims here recite a particular treatment or prophylaxis. The Examiner respectfully disagrees. The independent claims do not recite any treatment step. As noted in MPEP § 2106.04(d)(2):
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
As such, simply determining or recommending a treatment (e.g. determining a dose) or giving advice on how to get treatment etc. does not qualify as a “particular treatment or prophylaxis” because it does not require that the treatment actually happen.
Concerning claim 13, as noted in the rejection, Applicant argues that the claimed treatment step is particular because “claim 13 recites administering, via a treatment device coupled to the microprocessor, a change in a dose, concentration, timing, or frequency of a pharmacological agent to treat the physiological condition according to the detected and classified events. This specifies the type of change (dose, concentration, timing, or frequency), the class of treatment (a pharmacological agent that the patient is already being given), the mechanism (via a treatment device coupled to the microprocessor), and the basis for the change (according to the detected and classified events).” The Examiner respectfully disagrees. First, claim 13 requires this only as a possible alternative to a “recommend …” step, which is clearly not a treatment as discussed above. As such, claim 13 does not require the “administer …” step at all, making the arguments ultimately moot. But even if it was required, Applicant has only identified several non-particular parameters and argues that collectively they amount to a particular treatment. The Examiner respectfully disagrees. The claim encompasses a non-specified pharmacological agent, administered by a non-specified treatment device, and the change in that agent can be virtually anything (“dose, concentration, timing, or frequency” encompasses just about any possible change in the administration of the agent). Collectively this encompasses virtually any possible pharmacological regimen. This cannot be considered particular.
Concerning Step 2B, Applicant argues that the specific combination of elements, “including an EEG electrode array, a PPG sensor, a user interface receiving side-effect data, an analysis routine that determines feature values from all three data types and classifies events including side- effect events, and a routine that monitors efficacy along two axes and determines a therapeutic dose within a side-effect free therapeutic window” recited in amended claim 1 is not well-understood, routine and conventional. The Examiner respectfully disagrees. Applicant’s argument looks at the entirety of limitations in the claim including those limitations considered part of the mental process such as the “analysis routine” and “routine that monitors …” These limitations are not considered in Step 2B for the “well-understood, routine and conventional” consideration. Rather, this consideration looks only to the “additional elements” in the claims other than the mental step(s). So, for example, it is not relevant in this step whether or not the “analysis routine” or other mental steps, alone or taken in combination, are well-understood, routine and conventional.
Here, the additional elements in claim 1 are the data collection elements (EEG, PPG and user interface) and the processor for carrying out the mental steps. Applicant does not dispute that such elements are well-known, routine and conventional individually. Combining multiple types of data for diagnostic analysis is extremely commonplace, and can be seen in e.g. the Loddenkemper reference cited in the prior art rejections. The Examiner respectfully submits that merely combining multiple well-known diagnostic sensors/data gathering elements to perform medical diagnostic analysis on a process is nothing more than well-understood, routine and conventional activity. Applicant’s arguments rely on the consideration of the mental steps in combination with the additional elements, which as noted above is not the correct analysis for Step 2B; as such, Applicant’s arguments and traverse of the official notice is not persuasive.
II. Claim Rejections under 35 U.S.C. §§ 102 and 103
Applicant’s remarks concerning the previous prior art rejections have been fully considered. Although the Examiner does not agree with all of the individual arguments made, after further consideration, the Examiner agrees that the cited art fails to anticipate or render obvious the total combination of limitations now recited in each of claims 1 and 19. As such, the previous rejections under 35 U.S.C. §§ 102 and 103 are withdrawn.
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 1-2, 6-7, 11, 13, 16-19 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-2, 6-7, 11, 13, 16-19 and 37 are directed either to a method/process or to a system/machine.
Step 2A, Prong One: The claims recite a mental process, e.g. in claim 1 all the steps carried out under both the “analysis routine” and the “routine that monitors …” are steps which could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of sensing (“gathering”) data, such as EEG and PPG data, and receiving side-effect data is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; the step of “recommending” a change in pharmacological agent administration in claim 13 is considered insignificant post-solution activity since it merely outputs the result of the mental process and does not actually require the treatment to be performed; similarly, also in claim 13, the limitation of “administer, via a treatment device coupled to the microprocessor, a change in a dose, concentration, timing, or frequency of a pharmacological agent” is considered insignificant post-solution activity since, at a minimum, it is not specific/particular and thus does not qualify as a particular treatment or prophylaxis. Furthermore, merely carrying out mental steps using generic computing technology such as a processor device, microprocessor, static model, etc. is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection and output components. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Dependent claim 2 merely adds further generic computing technology, and thus follows the same analysis above.
Dependent claims 6-7, 11 and 16 merely add further mental steps and thus follow the same analysis above.
Dependent claim 13 was already discussed above; this claim merely adds further insignificant post-solution activity.
Dependent claims 17-18 merely add further insignificant pre-solution activity (additional data gathering) and further mental steps, and thus follow the same analysis above.
Independent claims 19 and 37 follow the same analysis as claim 1 above as they are substantially identical in scope for the purposes of § 101 evaluation.
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 1-2, 6-7, 11, 13, 16-19 and 37 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 1 recites “a user-interface, stored in the memory and configured to be executed by the microprocessor to cause a display of the processor device to display a user interface …” A user-interface isn’t “executed” by a processor, and it is unclear how it can be used to generate itself. It appears there may have been a typographical error here.
Claims 1 and 19 recite receiving “side-effect data indicating side effects perceived by the patient.” It is unclear whether this necessarily refers to side effects of some treatment, or could encompass any possible side effects of any cause. Although breadth is not indefiniteness, the wording here is unclear as to what would and would not constitute “side effects.”
The remaining claims are rejected by virtue of depending on a rejected claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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