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 Amendment
This Office action is responsive to the amendment filed 05/06/2026. As directed by the amendment, claims 1-2, 6, 14 and 17 have been amended, claims 3, 8, and 16 have been cancelled and claims 21-25 have been added, thus, claims 1-2, 4-7, 9-10, 12, 14-15 and 17-25 are presently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No.15/885,904, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to provide written description in regards to physiological parameter in relation to constituent in blood in claim 2 , onset of hypoglycemia or an episode thereof in claims 9 and 15,. If examiner is mistaken, Applicant is respectfully requested to cite specific sections of the prior filed application that provides written description of the subject matter in question. In view of these, claims 2, 9 and 15 are not afforded the effective filing date of the prior filed application.
Claim Objections
Claim 2 is objected to because of the following informalities: the word “wherein” should be deleted. Appropriate correction is required.
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.
Claims 1, 4, 6-7, 10, 17-18, 22, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20050061315 A1 to Lee et al.(“Lee”).
Regarding claims 1 and 17, Lee discloses a method ([abstract])comprising: sensing from at least one sensor, a physiological parameter of a subject ([0061] patient internal sensors 241 and/or patient-external sensors 242) ; wirelessly communicating the physiological parameter to a control unit ([0066] monitoring device 210 reads on a control unit and is in wireless communication with sensors 241 and/or 242 ), monitoring a condition of the subject at the control unit by analyzing the physiological parameter to predict an onset of an episode of a physiological event/ sleep apnea ([0183] detection of sleep apnea); and causing an appropriate treatment to mitigate the physiological event/sleep apnea ([0043]), wherein causing an appropriate treatment to mitigate the physiological event includes adjusting a threshold for activation of the appropriate treatment ([0044] and [0059] “… feedback information may be transmitted to the therapy device and used to automatically adjust the therapy delivered to the patient. For example, if the AHI is high, the breathing therapy pressure may be adjusted upward to provide a more effective therapy. If the patient experiences an arousal rate greater than a threshold without experiencing sleep disordered breathing episodes, the therapy may be determined to be too aggressive. The breathing therapy pressure may be adjusted downward to provide a disordered breathing therapy that is more comfortable to the patient and allows the patient to sleep better”).
Regarding claims 4 and 22, see Figs. 10A-15B, 17-18 and 21, the physiological parameter is a time series of a biological response.
Regarding claims 6 and 24, see [0043] operation of a device to mitigate the physiological response/sleep apnea.
Regarding claims 7 and 25, analyzing include pattern analysis, see table 2 in page 15 regarding use of respiration pattern to detect disorderly breathing.
Regarding claims 10 and 18, see e.g., [0062] regarding temperature sensors.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claim 1 or 17 above, and further in view of previously cited Lange et al. US 20050192508 A1 (“Lange”).
Regarding claims 2, 9 and 21, Lee does not explicitly disclose the method further comprising determining a level of a particular constituent in the blood of the subject, or wherein the physiological parameter is indicative of hypoglycemia.
Lange in [0027] discloses hypoglycemia can be deduced from breathing patterns. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Lee to include deducing hypoglycemia from the monitored breathing patterns, to increase versatility of the method of Lee to include monitoring of hypoglycemia. In modified Lee, the physiological parameter can be described as being indicative of an onset of hypoglycemia, and hypoglycemia is related to a level of particular constituent (glucose) in blood of the subject.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Laitinen as applied to claim 12 above, and further in view of Lange.
Regarding claim 21, Lee in view of Laitinen does not explicitly disclose the method further comprising determining a level of a particular constituent in the blood of the subject.
Lange in [0027] discloses hypoglycemia can be deduced from breathing patterns. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Lee to include deducing hypoglycemia from the monitored breathing patterns, to increase versatility of the method of Lee to include monitoring of hypoglycemia. Examiner note: hypoglycemia is related to a level of particular constituent (glucose) in blood of the subject.
Claims 5 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claim 1 or 17 above and further in view of previously cited Lamelson US 5738102 A.
Regarding claims 5 and 23, Lee does not explicitly disclose causing appropriate treatment involves driving an alert when the physiological parameter is outside an acceptable level.
Lamelson discloses a patient monitoring system ([abstract]) and teaches in [ Col. 4: 31-59] wherein treatment involves driving an alert when a physiological condition is outside an acceptable level, to warn of a serious condition. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified the method of Lee to include generating an alert when the physiological condition is outside an acceptable level, to warn and/or inform an attendant or user of a detected serious condition and/or start of treatment of the serious condition detected.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claim 1 and further in view of previously cited Naruse et al. US 20030214399 A1 (“Naruse”).
Regarding claim 19, Lee does not explicitly disclose that the at least one sensor is battery powered. However, Naruse discloses analogous wireless sensors ([abstract]) that can be arranged on a bed ([0122]) and further teaches in [0183] that the wireless sensor comprises a coaxial condenser that stores electric charge and works as an equivalent battery. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the wireless sensors of Lee to include a battery, so as to provide power the sensors as a battery was a well-known component for providing power to wireless sensor as exemplified by Naruse.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claim 1 or 19 above, and further in view of previously cited Laitinen et al. US 20040101146 A1 (“Laitinen”).
Regarding claims 12 and 20, Lee as discussed above discloses that the control unit is wireless communicated with the at least one sensors, however, Lee does not explicitly disclose that the at least one sensor is selectively paired with the control unit.
Laitinen discloses that it was known in the prior art, to connect a processor unit or CPU (control unit) to sensors for monitoring a patient via a sensor interface, either via wired connection or wirelessly ([0046], [0077-0079] and illustration Fig. 6), where the wireless sensors utilize short-range RF technique or a Bluetooth technique([0039]). Examiner notes that Bluetooth works by pairing devices and hopping frequencies for stable, secure communication i.e., the sensor is selectively paired to the control unit. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the at least one sensor of Lee to be wirelessly connected to the control unit via Bluetooth technology, for a stable and more secure communication between the control unit and the at least one sensor. Examiner notes that in modified Lee, the use of Bluetooth technology would enable selective pairing between the control unit and the at least one sensor.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Laitinen as applied to claim 12 above, and further in view of Naruse.
Regarding claim 14, Lee in view of Laitinen does not explicitly disclose that the at least one sensor is battery powered. However, Naruse discloses analogous wireless sensors ([abstract]) that can be arranged on a bed ([0122]) and further teaches in [0183] that the wireless sensor comprises a coaxial condenser that stores electric charge and works as an equivalent battery. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the wireless sensors of Lee in view of Laitinen to include a battery, so as to provide power the sensors as a battery was a well-known component for providing power to wireless sensor as exemplified by Naruse.
Response to Argument
Any objection(s) and/or rejection(s) from the previous Office action of 01/06/2026 not reiterated above is considered withdrawn.
Applicant' s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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