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 § 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.
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.
Claim(s) 1, 4, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Kaib (US 2011/0288605 A1).
Regarding claims 1 and 21, Kaib discloses An electrocardio monitoring system (eg. Abstract, Fig. 1A-G), comprising: at least two sets of electrocardio channels (eg. Para. 6-8, 90-99, 111), each of the at least two sets of electrocardio channels including at least two electrodes (Eg. Para. 6- 8, 90-99, 111, channels corresponding to pairs of electrodes), wherein each of the at least two sets of electrocardio channels is configured to collect signals from a human body through the at least two electrodes (Eg. Para. 6- 8, 90-99, 111), the signals including an electrocardio signal and a noise signal (eg. Para. 6- 8, 90-99, 111); and a processing circuit (eg. Para. 24 Fig. 4, processor 410), configured to extract the electrocardio signal from the signals collected by the at least two sets of electrocardio channels (eg. multiple embodiments Para. 78, 81-82, 93, 96, 115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of Kaib to have both channel selection and filtering to provide the predictable result of providing a cleaner EG signal for more accurate analysis and diagnosis.
Regarding claim 4, Kaib discloses the at least two sets of electrocardio channels include a first electrocardio channel and a second electrocardio channel, the first electrocardio channel includes a first electrode and a second electrode, and the second electrocardio channel including the first electrode and a third electrode (eg. Para. 9-15, 20, 74, 76, 111).
Claim(s) 2, 5-8, 10-11, 14-15. And 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib (US 2011/0288605 A1) in view of Farringdon (US 8369936 B2).
Regarding claims 2 and 23, Kaib discloses the invention of claim 1 and multiple electrode configurations across the torso (Para. 6- 8, 90-99, 111, Fig. 1A-G) at least two sets of electrocardio channels include a first electrocardio channel and a second electrocardio channel, the first electrocardio channel includes a first electrode and a second electrode, and the second electrocardio channel includes a third electrode and a fourth electrode, the first electrode and the second electrode are located on two sides of a median sagittal plane of the human body, respectively, and the third electrode and the fourth electrode are located on the two sides of the median sagittal plane of the human body, respectively..
Farringdon teaches an ECG electrode configuration that uses electrodes on 4 separate quadrants (Eg. Col. 2, Ln. 32 – Col. 3, Ln. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kaib to adjust the leads to have electrodes in each quadrant as claimed since bilateral placement of electrodes are commonly known in the art for detecting ECG signals.
Regarding claim 5, the combined invention of Kaib and Farringdon discloses each set of the at least two sets of electrocardio channels includes two electrodes and a reference electrode, the reference electrode being located between the two electrodes (eg. Farringdon, Col. 3, Ln. 30 – Col. 4, Ln. 10, Col. 25, Ln. 12-30 ground electrodes are common in the art for use as reference points in electrical circuits).
Regarding claim 6, the combined invention of Kaib and Farringdon discloses a central distance between two electrodes corresponding to different electrocardio channels is not less than 5 mm (eg. Farringdon, Col. 12, Ln. 4-34, spacing around 70-80 mm or 130 mm, one of ordinary skill would have used spacings above 5 mm in the art given the normal size of a torso and the spacing needed to detect different parts of the ECG signal from each electrode).
Regarding claim 7, the combined invention of Kaib and Farringdon discloses the at least two electrodes corresponding to the at least two sets of electrocardio channels are made of metal fabric, and a thickness of the metal fabric is in a range of 10 pm to 5 mm (eg. Kaib, Para. 10, 66-69, use of germents such as shirts which are commonly known to have a thickness in 10 pm to 5 mm, Farringdon, Col. 53, Ln. 10-40).
Regarding claim 8, the combined invention of Kaib and Farringdon discloses wherein the at least two sets of electrocardio channels are arranged on a same wearable body, the wearable body includes a belt structure, the belt structure is configured to surround a waist region of the human body, and a size of the electrodes corresponding to the electrocardio channels along a first extending direction of the belt structure is greater than a size of the electrodes corresponding to the electrocardio channels along a second extending direction of the belt structure (eg. Kaib, Para. 66-73, ECG sensing electrodes integrated into garment 20b, Farringdon, Col. 2, Ln. 32 – Col. 3, Ln. 6).
Regarding claim 10, the combined invention of Kaib and Farringdon discloses the at least two electrodes corresponding to one set of the at least two sets of electrocardio channels are respectively located at iliac bones on two sides of a median sagittal plane of the human body, and the at least two electrodes corresponding to another set of the at least two sets of electrocardio channels are respectively located at the lower back and on the two sides of the median sagittal plane of the human body (eg. Kaib, Para. 66-73, ECG sensing electrodes integrated into garment 20b, Farringdon, Col. 2, Ln. 32 – Col. 3, Ln. 6, electrodes on a waist belt are inherently located at the iliac bones).
Regarding claim 11, the combined invention of Kaib and Farringdon discloses the at least two sets of electrocardio channels are arranged on different wearable bodies (eg. Kaib, Fig. 1A-G, belt and vest).
Regarding claim 14, the combined invention of Kaib and Farringdon discloses a weight element is provided on the electrodes corresponding to one set of the at least two sets of electrocardio channels (eg. Kaib, Para.71, adjustable belt and straps can create a weighted pressure to ensure proper contact of the electrodes).
Regarding claim 15, the combined invention of Kaib and Farringdon discloses the weight element includes at least a portion of a circuit structure of the processing circuit. (eg. Kaib, Para.71, adjustable belt and straps can create a weighted pressure to ensure proper contact of the electrodes, the weight and electrodes are integrated in the belt).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib (US 2011/0288605 A1) in view of Lange (US 2016/036986 A1), further in view of Kothe (US 2016/0113587 A1).
Regarding claim 16, Kaib discloses the invention of claim 1, but does not disclose the processing circuit is configured to extract the electrocardio signal from the signals collected by the at least two sets of electrocardio channels by: extracting characteristic points of the signals collected by each set of the at least two sets of electrocardio channels, respectively; matching the characteristic points of the signals collected by the at least two sets of electrocardio channels; and determining a signal corresponding to matched characteristic points of the at least two sets of electrocardio channels as the electrocardio signal.
Lange discloses an ECG detecting device that extracts characteristic points such as R peaks and other fiduciary points of ECG waveforms, matching the characteristics across the channels, and determining the ECG signal from matched segments (eg. Para. 45-50, using clean signal as a reference to extract a signal and determine trends).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Kaib with the signal referencing and extracting as taught by Lange to improve signal extraction in the presence of noise as both references of Kaib and Lange address the same problem of ECG extraction from noisy wearable device signals.
Kothe teaches ECG signal reconstruction from multi-channel signals while removing artifact components using transformation matrices from baselines and performing comparing components via energy thresholds (eg. Para. 4, 28, 41, 60, 73-77, 89-99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Kaib and Lange with the reconstruction technique as taught by Kothe since all inventions are in the same field of endeavor of removing artifacts from ECG signals and providing a way to adequately mark components for removal while selectively preserving the portion of activity in the removed component that is not contaminated (eg. Kothe, Para. 5).
Regarding claim 17, the combined invention of Kaib, Lange, and Kothe discloses the matching the characteristic points of the signals collected by the at least two sets of electrocardio channels includes: determining that the characteristic points of the signals collected by the at least two sets of electrocardio channels are successfully matched in response to that the characteristic points are within a deviation threshold range, wherein the deviation threshold includes a time threshold and/or an intensity threshold (eg. Lange, Para. 45-50 and Kothe, Para. 26, 29, 33, 44-46).
Regarding claim 18, the combined invention of Kaib, Lange, and Kothe discloses before extracting the characteristic points of the signals collected by each set of the at least two sets of electrocardio channels, the signals collected by different electrocardio channels are converted based on a transformation matrix between the different electrocardio channels (eg. Kothe, Para. 4, 28, 41, 60, 73-77, 89-99).
Regarding claim 19, the combined invention of Kaib, Lange, and Kothe discloses after extracting the characteristic points of the signals collected by each set of the at least two sets of electrocardio channels, characteristic points corresponding to different electrocardio channels are converted based on a transformation matrix between the different electrocardio channels (eg. Kothe, Para. 4, 28, 41, 60, 73-77, 89-99).
Regarding claim 20, the combined invention of Kaib, Lange, and Kothe discloses the transformation matrix is obtained based on historical electrocardio signals or electrocardio signals measured in real-time when the human body is in a stationary state(eg. Kothe, Para. 4, 28, 41, 60, 73-77, 89-99, baseline signals).
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib (US 2011/0288605 A1) in view of Jumbe (US 2021/03459339 A1).
Regarding claims 30-31, Kaib discloses the invention of claim 1, but does not disclose extracting the electrocardio signal from the signals collected by the at least two sets of electrocardio channels is performed by a processing circuit, the processing circuit includes a low-pass filter circuit, and a cutoff frequency of the low-pass filter circuit is not lower than 400 (or 100) Hz.
Jumbe teaches extracting raw signals from ECG sensors with low pass filters with a cutoff at about 0.01 Hz to 120 KHz (Eg. Para. 298-300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Kaib with a low pass filter as taught by Jumbe to provide the predictable result of amplifying or filtering the signal as desired. It would be obvious to one of ordinary skill in the art to try different cutoff frequency values to filter a heart rate signal since a normal heart rate signal is typically within a known specific range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LAU/Examiner, Art Unit 3796
Prosecution Insights