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 .
Election/Restrictions
Applicant’s election without traverse of Group I which encompass claims 1 - 5 in the reply filed on 01/26/2026 is acknowledged. Claims 6 - 15 have been cancelled. Claims 16 - 20, which are drawn to the subject matter of Group I have been entered.
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 2, 3, 5, and 20 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 regard to claim 2, line 2 recites “detecting movement of the patient by a change in a light intensity signal over time.” However, it is unclear if the detected movement is different than the detected pattern of movement of the patient disclosed in claim 1 from which claim 2 depends. Claim 3 is rejected by virtue of dependence on claim 2.
In regard to claim 3, lines 3 - 4 recite, “detecting movement of the patient from a light intensity reflection signal of a feature projected onto the patient in the ROI,” but it is unclear how the feature is projected onto the patient and if the processor is in communication with the projector.
In regard to claim 5, lines 1 - 4 recite, “the steps further comprise: correlating the detected pattern of movement to one or more of Essential tremor… or a diabetic episode”. However, as written, it is unclear if the claim requires a correlating step in addition to the step of “correlating the detected pattern of movement to a disease or condition” as introduced in claim 1 from which claim 5 depends, or if claim 5 is attempting to place further limitations on the “disease or condition” introduced in claim 1. Further clarification is required to define the metes and bounds of claim 5.
In regard to claim 20, lines 1 - 3 recite, “the steps further comprise: correlating the detected pattern of movement to one or more of Essential tremor… or a diabetic episode”. However, as written, it is unclear if the claim requires a correlating step in addition to the step of “correlating the detected pattern of movement to a disease or condition” as introduced in claim 16 from which claim 20 depends, or if claim 20 is attempting to place further limitations on the “disease or condition” introduced in claim 16. Further clarification is required to define the metes and bounds of claim.
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, 4, 5, 16, 17, 19, & 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite executable instructions as part of a system, which is within a statutory category of invention, for “detecting a pattern of movement” from collected data and “correlating the detected pattern of movement to a disease or condition”, which falls into the category of a mental process. This judicial exception is not integrated into a practical application because with regard to Revised step 2A, prong 1, an exception is present as noted above, and with regard to Revised step 2A, prong 2, the claim does not recite additional elements that integrate the judicial exception into a practical application. Further, with regard to step 2B, the claim does not recite additional elements that integrate the judicial exception into practical application. In particular, the executable instructions that include “determining a treatment” as disclosed in claim 1 are directed towards generalized post-processing of previously obtained data. The other details including the “depth-sensing camera”, “display,” “processor,” and “memory” as disclosed in independent claims 1 and 16 are all general structures that do not impose a meaningful limitation onto the claim scope, as the limitations do not constitute use of the exception in the context of “a particular machine”. Dependent claims 2, 4, 5, 17, 19, & 20 do not include additional steps or elements that are sufficient to amount to significantly more than the judicial exception because they are also directed towards generalized data collection and processing and thus fail to provide details to integrate the judicial exception into practice.
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 16 & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kayser (EP 3245943 A1).
In regard to claim 16, Kayser discloses a non-contact monitoring system comprising:
a depth-sensing camera; Kayser discloses that their system includes a depth sensor such as an active infrared time of flight camera, active structured infrared camera, or infrared stereo camera with infrared lamp (page 3, paragraph 2).
a processor; Although Kayser does not explicitly disclose a processor or memory, one of ordinary skill in the art would recognize that a processor and associated memory or storage device for storing executable instructions would be inherent to the system as the method specifically requires the preprocessing and processing of data collected from the depth camera (page 3, paragraph 7).
and a memory storing instructions that when executed by the processor cause the system to implement steps, comprising:
receiving, from the depth-sensing camera, a depth signal corresponding to a region of interest (ROI) of the patient; Kayser discloses that depth sensors such as active infrared time of flight cameras, active structured infrared cameras, or infrared stereo cameras with infrared lamps (page 3, paragraph 2) are used to capture a depth signal of at least one body area or ROI such as the torso or the legs (page 2, paragraphs 7 - 8).
based on one or more changes in the depth signal over time, detecting a pattern of movement of the patient in the region of interest (ROI); Kayser discloses that their invention includes the steps of detecting a ROI, which includes generating masks of the chest area and the leg area (FIG. 4, see “Maske”; page 5, paragraphs 3 - 8). The ROIs are imaged using a depth camera (page 3, paragraph 2) and the images are processed to determine at least one motion characteristic for each depth image of the at least one ROI within the generated mask (page 7, paragraph 1). The processing includes detecting the average depth data corresponding to the torso region of each respective depth image wherein respiratory movement is associated with at least one motion signal that comprises a temporal sequence where all measurements are taken together to reflect the entire respiratory movement over the measurement period (page 7, paragraphs 3 - 6). Kayser additionally discloses that the lateral displacement of the ROI masks corresponding to the leg region to determine a pattern of leg movement (page 8, paragraph 4 - page 9, paragraph 3; page 9, paragraph 7).
correlating the detected pattern of movement to a disease or condition. Kayser further discloses that their invention includes the steps of identifying pathological movement patterns which correspond to individual movements (page 7, paragraphs 6 - 7; page 9, paragraph 7) and using the data to determine if a person suffers from a sleep disorder, including sleep apnea based on a comparison of the measured respiratory movements patterns with pathological respiratory movement patterns using a pattern matching algorithm (page 7, paragraph 6 - 7) or restless leg movement syndrome based on the frequency of detected pathological movement signals of the legs (page 8, paragraph 5; page 15, paragraph 4).
In regard to claim 20, Kayser discloses the invention of claim 16, wherein the steps further comprise: correlating the detected pattern of movement to restless leg syndrome (page 8, paragraph 5; page 15, paragraph 4).
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 1, 4, & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kayser (EP 3245943 A1) in view of Addison (US 20190209046 A1 - Cited by Applicant) and further in view of Lim (US 20250134452 A1)
Kayser discloses a non-contact monitoring system for monitoring a patient (FIG. 1), the system comprising:
a depth-sensing camera; Kayser discloses that their system includes a depth sensor such as an active infrared time of flight camera, active structured infrared camera, or infrared stereo camera with infrared lamp (page 3, paragraph 2).
a processor; Although Kayser does not explicitly disclose a processor or memory storing instructions, one of ordinary skill in the art would recognize that a processor and associated memory or storage device for storing executable instructions would be inherent to the system as the method specifically requires the preprocessing and processing of data collected from the depth camera (page 3, paragraph 7).
a memory storing instructions that when executed by the processor cause the system to implement steps, comprising:
detecting a pattern of movement of the patient in a region of interest (ROI) with the non-contact monitoring system based on a change in a depth signal over time; Kayser discloses that their invention includes the steps of detecting a ROI, which includes generating masks of the chest area and the leg area (FIG. 4, see “Maske”; page 5, paragraphs 3 - 8). The ROIs are imaged using a depth camera (page 3, paragraph 2) and the images are processed to determine at least one motion characteristic for each depth image of the at least one ROI within the generated mask (page 7, paragraph 1). The processing includes detecting the average depth data corresponding to the torso region of each respective depth image wherein respiratory movement is associated with at least one motion signal that comprises a temporal sequence where all measurements are taken together to reflect the entire respiratory movement over the measurement period (page 7, paragraphs 3 - 6). Kayser additionally discloses that the lateral displacement of the ROI masks corresponding to the leg region to determine a pattern of leg movement (page 8, paragraph 4 - page 9, paragraph 3; page 9, paragraph 7).
correlating the detected pattern of movement to a disease or condition; Kayser further discloses that their invention includes the steps of identifying pathological movement patterns which correspond to individual movements (page 7, paragraphs 6 - 7; page 9, paragraph 7) and using the data to determine if a person suffers from a sleep disorder, including sleep apnea based on a comparison of the measured respiratory movements patterns with pathological respiratory movement patterns using a pattern matching algorithm (page 7, paragraph 6 - 7) or restless leg movement syndrome based on the frequency of detected pathological movement signals of the legs (page 8, paragraph 5; page 15, paragraph 4).
While Kayser discloses a non-contact monitoring system, they do not disclose that the system includes a display.
However, Addison teaches a non-contact monitoring system that includes an image capture device (FIG. 2, component 385) and a computing device (FIG. 2, component 300) with a user interface or display (FIG. 2, component 310) in communication with a processor (FIG. 2, component 315; paragraph [0089]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Kayser with the teaching of Addison that a non-contact monitoring system can include a display because it would be considered combining prior art elements, in this case the non-contact monitoring system that collects data and detects the presence of a sleep disorder such as restless leg syndrome and the display for showing objects, applications, and data (Addison, paragraph [0089]), to yield the predictable result of monitoring a sleep disorder. Additionally, examiner notes that the ability to display collected data from a sensor assembly is well known in the medical diagnostics field.
While Kayser discloses a non-contact monitoring system that diagnoses a sleep condition based on motion data collected from a depth imaging sensor, they do not disclose that the system determines a treatment for the patient based on the correlated disease or condition.
However, Lim teaches a method and system for monitoring sleep activity that includes a treatment algorithm (paragraphs [0040] - [0041]) that takes collected sensor data, including from image sensors (paragraph [0030]), and a diagnosis associated with the user as an input (paragraph [0041]) and outputs treatment options including medication, examination, consultation, nurse care, or further analysis on vital signs and sleep activity measurements (paragraph [0044]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Kayser that includes a depth sensing imaging sensor and algorithm for processing the depth data and diagnosing a sleep condition, such as apnea or restless leg movement syndrome, with the teaching of Lim that a sleep monitoring method and device can include a treatment algorithm that determines a suggested treatment based on imaging sensor data and a user’s diagnosis because it would be considered combining prior art elements, in this case the system for collecting data and diagnosing a sleep disorder and the system for outputting a treatment option based on the collected data and diagnosis, to yield the predictable result of monitoring a sleep disorder.
In regard to claim 4, Kayser as modified discloses the invention of claim 1, wherein the steps further comprise: notifying a user via the display of the determined treatment for the patient for the detected disease or condition. Lim teaches that a treatment algorithm outputs a recommendation for treatment such as medication, examination, consultation, nurse care, or further analysis on vital signs and sleep activity measurements (paragraph [0044]) and can provide an automatic notification to a health care provider or patient (Lim, paragraph [0044]). Addison further teaches a display that is a part of a non-contact monitoring system that can be used to display objects, applications, data, etc. generated or sent by the processor (Addison, paragraph [0089]; FIG. 2, component 310). One of ordinary skill in the art would recognize that the monitor would reasonably be able to display the output of the treatment algorithm taught by Lim.
In regard to claim 5, Kayser as modified discloses the invention of claim 1, wherein the steps further comprise: correlating the detected pattern of movement to restless leg syndrome (page 8, paragraph 5; page 15, paragraph 4).
Claims 2 - 3 are rejected under 35 U.S.C. 103 as being unpatentable over Kayser (EP 3245943 A1) in view of Addison (US 20190209046 A1 - Cited by Applicant) and further in view of Lim (US 20250134452 A1) as applied to claim 1 above, and further in view of Yu (WO 2019173237 A1).
In regard to claim 2, Kayser as modified discloses the invention of claim 1. While Kayser discloses a non-contact imaging system for monitoring respiratory and leg movements using an imaging sensor (FIG. 1, see “Sensor”), they do not disclose that the steps further comprise: detecting movement of the patient by a change in the light intensity over time.
However, Yu teaches a non-contact monitoring system for tracking and analyzing the motion of a patient (FIG. 1B, component 102) that can be used in a variety of applications including in homes, hospitals, and sleep labs (paragraph [0192]) that includes collecting motion data and/or patient images and further analyzed to determine movement or a position of the patient or a portion of the patient as a function of time using the intensity variation due to motion or light absorption that is observed in the image (paragraphs [0085] - [0086]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system for determining the presence of respiratory and leg movements disclosed by Kayser as modified with the teaching that movement of a region or portion of a patient can be monitored over time as a function of light intensity from Yu because it would be considered combining prior art elements, in this case the steps of analyzing imaging data to detect movement of a patient, according to known methods to yield the predictable result of monitoring a region of interest of a patient over time.
In regard to claim 3, Kayser as modified discloses the invention of claim 2, wherein the system further comprises a projector, and wherein the steps further comprise: detecting movement of the patient from a light intensity reflection signal of a feature projected on the patient in the ROI. Yu further teaches that the non-contact monitoring system can track positioning information or movement of the chest by placing one or more markers on the chest of the patient and processing the imaging data. The dot markers can be projected onto the chest using a dot projector (paragraph [0148]).
Claims 17 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kayser (EP 3245943 A1) as applied to claim 16 above, and further in view of Yu (WO 2019173237 A1).
In regard to claim 17, Kayser discloses the invention of claim 16. While Kaiser discloses a non-contact imaging system for monitoring respiratory and leg movements using imaging sensors (FIG. 1, see “Sensor”), they do not disclose that the pattern of movement of the patient is detected based on a change in a light intensity signal over time.
However, Yu teaches a non-contact monitoring system for tracking and analyzing the motion of a patient (FIG. 1B, component 102) that can be used in a variety of applications including in homes, hospitals, and sleep labs (paragraph [0192]) that includes collecting motion data and/or patient images and further analyzed to determine movement or a position of the patient or a portion of the patient as a function of time using the intensity variation due to motion or light absorption that is observed in the image (paragraphs [0085] - [0086]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system for determining the presence of respiratory and leg movements disclosed by Kayser as modified with the teaching that movement of a region or portion of a patient can be monitored over time as a function of light intensity from Yu because it would be considered combining prior art elements, in this case the steps of analyzing imaging data to detect movement of a patient, according to known methods to yield the predictable result of monitoring a region of interest of a patient over time.
In regard to claim 18, Kayser as modified discloses the invention of claim 17, further comprising: a projector configured to project a feature onto the patient in the ROI, wherein the pattern of movement of the patient is detected based on a light intensity reflection signal of the feature. Yu further teaches that the non-contact monitoring system can track positioning information or movement of the chest by placing one or more markers on the chest of the patient and processing the imaging data. The dot markers can be projected onto the chest using a dot projector (paragraph [0148]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kayser (EP 3245943 A1) as applied to claim 16 above, and further in view of Addison (US 20190209046 A1 - Cited by Applicant).
In regard to claim 19, Kayser discloses the invention of claim 16. While Kaiser discloses that their system correlates measured movement patterns to pathological movement patterns using a pattern matching algorithm (page 7, paragraph 7; page 15, paragraphs 3 - 4), they do not specify that the system further comprises a display configured to provide a notification to a user regarding the correlated disease or condition.
However, Addison teaches a system and method for video-based non-contact monitoring that includes a computing device (FIG. 2, component 300) that comprises a display (FIG. 2, component 310) that can be used to display objects, applications, data, etc. (paragraph [0089]). One of ordinary skill in the art would recognize that the display taught by Addison could be used to display information regarding the correlated disease or condition determined by the system disclosed by Kayser.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Kayser with the teaching of Addison that a non-contact monitoring system can include a display because it would be considered combining prior art elements, in this case the non-contact monitoring system that collects data and detects the presence of a sleep disorder such as restless leg syndrome and the display for showing objects, applications, and data (Addison, paragraph [0089]), to yield the predictable result of monitoring a sleep disorder. Additionally, examiner notes that the ability to display collected data from a sensor assembly is well known in the medical diagnostics field.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Garn (WO 2021007605 A1) discloses a non-contact monitoring system for detecting body movement of an ROI of a patient using a depth sensor (FIG. 1, component 2; page 9, paragraphs 1 & 2) to determine if the user is suffering from a condition such as REM sleep behavior disorder (page 16, paragraphs 6 - 7).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791