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 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 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.
In claims 1 and 12, it is unclear it intended to be limiting to the claimed logic as a whole or whether it is intended to only limit the logic of (iv).
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al (US Pub 2015/0297140 -cited by applicant) in view of Schmidt et al (US Pub 2021/0038148 -cited by applicant).
Re claims 1, 12: Hernandez discloses a system comprising:
a machine including a control unit storing a treatment prescription that provides at least one parameter for performing a treatment using the machine [0008, 0011, figure 1; see the computing device 102 that stores instructions and output parameters to perform treatment];
a first and second sensor having a first and second output indicative of a patient stress level [0012; see the one or more image sensors, cameras, microphones]; and
logic configured to determine the patient stress level based on the outputs, the patient stress level used for at least one of (i) comparing against a non-stressed patient baseline, (ii) developing a patient stress level trend, (iii) updating the non-stressed patient baseline, or (iv) determining if the treatment prescription needs updating, wherein the logic is further configured to send a notification to a smart device prompting modification by a doctor/clinician [0014-0016, 0018; see the assessment whether the patient is stressed and comparison baselines; also see 0018, 0028, 0031, 0040; wherein a plurality of smart devices can be used which implies that a notification is sent to a different/separate smart device and wherein information/notifications are communicated to social networks, Internet devices, and through the cloud indicating that it is sent to a smart device].
Hernandez discloses all features except that the monitor is implemented in a PD system with a PD machine. However, Schmidt teaches of a PD machine with sensors [0007, figures 1, 3]. It would have been obvious to the skilled artisan to modify the system to be used for a PD machine as taught by Schmidt, in order to improve patient treatment for a dialysis patient which has well known stessors.
Re claims 2, 14: Hernandez discloses a cloud/mobile network in operable communication with the control unit, and wherein the logic is implemented at the cloud/mobile network [0031; see the logic machine and cloud computing].
Re claim 3: Hernandez discloses logic is implemented at the control unit of the machine [0008, 0028; see the smartphone as the computing control unit].
Re claims 4, 5, 16, 17: Hernandez discloses the sensor includes a camera provided by the machine, and wherein the logic analyzes the output from the camera for at least one of facial expression, eye movement, head motion, or mouth movement for at least one of (i) to (iv) [0012; see the camera to analyze facial features].
Re claims 6, 7, 18: Hernandez discloses the sensor includes a microphone provided by the machine, and wherein the logic analyzes the output from the microphone for at least one of patient voice pitch or patient voice loudness for at least one of (i) to (iv) [0012; see the microphone to analyze voice input].
Re claims 8, 9, 19: Hernandez discloses the sensor includes at least one of a blood pressure monitor or a heart rate monitor that is wireless and worn by the patient, and wherein the logic analyzes the output level from the at least one blood pressure monitor or heart rate monitor for at least one of (i) to (iv) [0008, 0012, 0040; see the blood flow or heart rate captured by a thermal camera, wherein the monitor is provided by a machine with wireless capability].
Re claims 10, 13, 15, 20: Hernandez discloses the patient stress level includes a patient stress index relative to the non-stressed patient baseline, the logic forming the patient stress index based on outputs from at least two sensors selected from the group including: a camera, a microphone, a blood pressure monitor and a heart rate monitor [0012, 0014-0016; see the camera or microphone and the stress level is relative to a baseline].
Re claim 11: Hernandez discloses all features except that the logic is further configured to analyze at least one of a fluid/caloric intake of the PD patient or a sleep pattern of the PD patient. However, Schmidt teaches at least one of a fluid/caloric intake of the PD patient or a sleep pattern of the PD patient is analyzed [0006; see the sleep state readings].
Response to Arguments
Applicant's arguments filed 4/21/26 have been fully considered but they are not persuasive. Applicant argues that Hernandez/Schmidt do not teach determining if a prescription needs updating, then a notification is sent to a smart device. Respectfully, Examiner disagrees. First, the amendment results in a 112 rejection because it is unclear if the wherein clause is intended to limit any of (i) – (iv), or if it only limits (iv). It appears Applicant intends that it only limit (iv) because Applicant Remarks recite that the references do not teach the patient stress level is used to determine if the prescription needs updating and sending a notification to a smart device.
If the wherein clause only limits (iv), the claimed limitations are met because Hernandez discloses (i), (ii), and (iii) as the claim only require one of (i) – (iv) be met. For example, Hernandez discloses comparing the measured data to an average which is a comparison to a non-stressed baseline. Furthermore, Hernandez is found to disclose (iv) because a determination that the measured level is high is a determination that the prescription needs updating. The logic configured to send the notification to a smart device, whether this limitation is limiting to the logic as a whole or only to (iv), is additionally met by Hernandez as cited in the action above. Furthermore, the secondary reference Schmidt teaches communication with a smart device [0017] which meets the limitation.
The prior 112 rejections are withdrawn due to amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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