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 .
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.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method (process), which falls into a statutory category. This method includes the steps of (1) selecting a plurality of patients, (2) generating first and second patient categories, (3) identifying patients in the first and second categories, (4) obtaining demographic and physical data, (5) obtaining electrical signal data, (6) generating TM-EMG data, (7) associating TM-EMG data with demographic and physical data, and (8) generating ODS diagnostic information. These limitations, as drafted, are processes that, under their broadest reasonable interpretation, covers performance of the limitation in the mind. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “selecting,” “generating,” “obtaining,” “processing,” and “associating” in the context of this claim encompasses the user manually performing these steps. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the abstract steps of steps of (1) selecting a plurality of patients, (2) generating first and second patient categories, (3) identifying patients in the first and second categories, (4) obtaining demographic and physical data, (5) obtaining electrical signal data, (6) generating TM-EMG data, (7) associating TM-EMG data with demographic and physical data, and (8) generating ODS diagnostic information. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Merely performing instructions in the mind cannot provide an inventive concept. Therefore, claim 1 is not patent eligible.
Claims 2-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception explained above. Merely reciting steps which may be performed in the mind cannot provide an inventive concept. Therefore, claims 2-20 are not patent eligible.
Relevant Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Powell et al., (US 20160150993; hereinafter Powell).
Similar to the claimed invention, Powell discloses a method for the diagnosis of Obstruction Sleep Apnea (OSA), ([0043], [0047]). Generally, Powell discloses obtaining electrical signal data from target tissue in the upper airway cavities of non-apnea patients, processing the electrical signal data to generate TM-EMG data for the non-apnea patients, associating the TM-EMG data characteristics generated for each of the non-apnea patients, and generating OSA diagnostic information for use in the evaluation of a new patient for a presence or absence of OSA in an OSA evaluation event by comparing the data of the new patient to that of a non-apnea patient ([0062]-[0075]). Therefore, Powell is only concerned with the collection of data related to non-apnea patients to compare to the data of a new patient for OSA diagnosis. In contrast, the claimed invention is concerned with the collection of data related to both apnea and non-apnea patients to compare to the data of a new patient for OSA diagnosis, specifically:
“a. selecting a plurality of patients for detection of electrical signal data differences generated from their respective oral cavities by:
i. generating a first patient category associated with a presence of a previous diagnosis of obstructive sleep apnea (“OSA”) and a second patient category associated with an absence of a previous diagnosis of OSA;
ii. identifying a first plurality of patients for incorporation in the first patient category and a second plurality of patients for incorporation in the second patient category; and
iii. obtaining a collection of demographic and physical data from each of the plurality of patients in the first and second patient categories;
b. obtaining electrical signal data from target tissue in the upper airway cavities of each of the plurality of patients in each of the first and second patient categories in an electrical signal data collection operation conducted on each of the plurality of patients;
c. processing the electrical signal data to generate TM-EMG data for each of the plurality of patients;
d. associating the TM-EMG data characteristics generated for each of the plurality of patients in the first and second patient categories demographic and physical examination data associated with each of the plurality of patients; and
e. generating OSA diagnostic information for use in the evaluation of a new patient for a presence or absence of OSA in an OSA evaluation event.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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