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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 7 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 7, line 3: “the third blood oxygen threshold” lacks proper antecedent.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou (US 2022/0218293) in view of Hood (US 2015/0136146).
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Regarding claim 1, Chou discloses substantially the same invention as claimed (Figure 9A shown above for example), including a sleep state monitoring earplug wearable in an ear canal of a user (abstract; Figure 9A), the sleep state monitoring earplug comprising: a main body (Figure 9A); and a detection module inside the main body (abstract), the detection module comprising: a processing unit (Figure 1); a respiratory detection unit connected to the processing unit and configured to generate respiratory rate information to the processing unit (Paragraphs 91-92); and an alert unit connected to the processing unit and configured to generate a warning signal if the respiratory rate information meets a respiratory threshold, and the alert unit to issue a warning according to the warning signal (Paragraph 95).
Further regarding claim 1, Chou discloses alerting to stop a sleep apnea event (Paragraph 95), but does not specifically disclose the respiratory rate lower than a threshold. However, Hood teaches determining if a respiratory rate is lower than a threshold (Paragraph 74), in order to identify a sleep apnea event. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Chou as taught by Hood to include determining if a respiratory rate is lower than a threshold, in order to identify a sleep apnea event.
Regarding claim 2, Chou discloses blood oxygen and pulse rate information (Paragraphs 91, 92) and a communication unit as recited (Paragraphs 63, 175).
Regarding claim 3, Chou discloses transmitting a notification to an external device as recited (Paragraph 115).
Regarding claims 4-5, Chou discloses an orientation detection unit (Paragraph 46), determining sensed information is outside a second range based on the angle information (Paragraph 20), and communicating a second notification as recited (Paragraph 115).
Regarding claim 6, Chou discloses different thresholds for different positions (Paragraph 20), but does not specifically disclose certain thresholds being higher/lower or wider/narrower. However, Hood teaches a patient may be at higher risk (e.g. narrower threshold) in certain positions, including when respiratory rate is evaluated (Paragraph 84). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Chou as taught by Hood to include at least a narrower threshold for respiratory rate, in order to adapt different thresholds for high risk positions.
Regarding claim 7, the sleep apnea detection of Hood can further include blood oxygen lower than a threshold as recited (Paragraph 74).
Regarding claim 8, Chou teaches a sound unit as recited (Paragraph 60).
Regarding claim 9, Chou teaches a microphone for respiratory detection (Paragraph 234).
Regarding claim 10, Chou discloses a battery (Paragraph 64).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ayers (US 2022/0096002) shows an earpiece for monitoring sleep apnea.
Dugan (US 2021/0077010) shows different positions may be associated with higher/lower blood oxygen levels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796
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