DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites adding the two-days-ago difference data to “the cumulative value of the two-days-ago difference data”. The specification discloses no such limitation. [0105] of the printed publication notes that S148 compares difference between current day data and two-days-ago data against “a cumulative value of the previous day difference data calculated two days ago”. The example provided appears to confirm this – [0113-122] shows that on 4/5, the two-days-ago difference data of “0.1” is added to the cumulative value of the previous day difference data on 4/3, not to any accumulation of two-days-ago differences. Accordingly, the original disclosure fails to provide support for the claim language as recited.
Claim 13 has the same issue.
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 4 and 13 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.
Claim 4 recites “if a sign of the two-days-ago difference data and a sign of a cumulative value of the two-days-ago difference data are the same” and further recites “adding the two-days-ago difference data to the cumulative value of the two-days-ago difference data”. It is unclear what the bolded phrase means. In particular, the specification discloses accumulation of the previous day difference data; the cumulative value of two-days-ago difference data is not defined nor calculated anywhere within the specifications. Accordingly, it’s not clear whether the term refers to the cumulative value of the previous day difference data that was calculated for the day two days prior to the current day, or some other defined running sum of successive two-days-ago differences.
Claim 4 further recites updating a “cumulative value for the current day”. It is unclear whether this quantity is the same as “a cumulative value of the previous day difference data” that is recited in claim 1, or a distinct quantity. If the same, it should be recited as “the cumulative value of the previous data difference data for the current day.”
Claim 13 has similar issues to claim 4 above.
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.
Claim(s) 1-3, 5-8, 10-12, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. (US 2008/0269625) in view of Stadler et al. (US 2004/0172080).
As to claim 1, Halperin teaches a detection apparatus comprising: a biosignal acquisition unit configured to acquire a biosignal of a user ([0180]); and a controller ([0221]), wherein the controller is configured to; calculate at least one parameter value related to breathing of the user based on the biosignal acquired by the biosignal acquisition unit ([0110]), detect a presence of a symptom of aggravation of cardiac failure in the user ([0114] – generating an early warning of an impending clinical worsening of the heart condition; [0122] – predicting an onset), and output an alert notification to a notification unit or a terminal device when the presence of the symptom is detected ([0222]). Halperin fails to expressly teach calculating previous day difference data for the at least one parameter value; calculate a cumulative value of the previous day difference data by adding the previous day difference data for a current day to a cumulative value of the previous day difference data for one day ago, only when a sign of the previous day difference data for the current day and a sign of the cumulative value of the previous day difference data for one day ago are the same; when the at least one parameter value includes a calculated parameter value in which the cumulative value of the previous day difference data has exceeded a predetermined threshold.
Stadler teaches a device for outputting a patient indicator ([0094]) by calculating previous data difference data for the at least one parameter value ([0072] – average of all impedance measurements is calculated; [0075] – Fig. 8A reflects a graphical representation of impedance data by calculating an average of all values collected once per day, thus representing a single value; [0085] – the short term average is updated by taking a weighted sum of the short term average for the two previous days; and [0090] – the current difference between the current calculated period average and the baseline impedance is made”), calculate a cumulative value of the previous day difference data by adding the previous day difference data for a current day to a cumulative value of the previous day difference data for one day ago, only when a sign of the previous day difference data for the current day and a sign of the cumulative value of the previous day difference data for one day ago are the same ([0074] – the integral of the difference (IntDiff) accumulates the difference between baseline impedance and the calculated period average impedances; [0090] – the microprocessor updates the integral of the difference between the period average impedance and the baseline impedance; [0089] – determining whether the relative position of the short term average impedance and the baseline impedance has changed, such as would occur if either the short term average impedance was greater than the baseline impedance but is now less than or equal to the baseline impedance (i.e. – whether the sign of the accumulating difference has reversed); and [0090] - upon such a reversal, sets the integral of the difference between the period average impedance and the baseline impedance equal to zero, [0089] – as crossing of the baseline impedance by the short term average impedance is an indication that there is no longer any evidence to suspect abnormal impedance; thus accumulation of the daily difference occurs only while the sign of the daily difference agrees with the sign of the existing accumulation), and to detect a presence of a symptom of aggravation of cardiac failure in the user when the at least one parameter value includes a calculated parameter value in which the cumulative value of the previous day difference data has exceeded a predetermined threshold ([0090] – determination is then made as to whether significant changes in impedance has occurred, [0033] – the determination being an indication of fluid accumulation or dehydration in the thorax as a result of cardiac decompensation and provide guidance to caretakers). In addition, Stadler teaches the alert output of the final limitation of an alarm or patient indicator when a significant change in impedance has occurred ([0093]). It would have been obvious to modify Halperin with Stadler to modify the cardiac-failure monitoring device of Halperin such that the controller calculates previous data difference data for the daily breathing parameter, accumulates that difference data into a running cumulative only when the sign of the current day’s difference agrees with the sign of the cumulative value for one day ago, and detect a symptom of early cardiac failure when that cumulative value exceeds a predetermined threshold in order to obtain earlier detection of heart condition deterioration using a longer trend rather than a comparison of a single day’s value against a baseline for increased accuracy.
As to claim 2, Stadler teaches wherein the controller is further configured to calculate: (i) a single representative value for the at least one parameter value per day ([0072] – the average is calculated to obtain a period average impedance, [0075] – average impedance was determined from measurements that were collected once a day); and (ii) the previous day difference data by subtracting the single representative value of a previous day from the single representative value of the current day ([0090] – determines the current difference between the current calculated period average impedance and the baseline impedance).
As to claim 3, Stadler teaches resetting the cumulative value of the previous day difference data to the previous day difference data for the current day when the sign of the previous day difference data for the current day and the sign of the cumulative value of the previous day difference data for one day ago are different ([0089] – determining that the relative position of the short term average impedance and the baseline impedance has changed, an indication that the sign of the accumulating difference has reversed; [0090] – set the integral of the difference between the period average impedance and the baseline impedance equal to zero). It would have been obvious to one of ordinary skill in the art to reset the cumulative value upon sign disagreement as taught by Stadler, in order to ensure that the accumulated quantity reflects only the current trend and prevent alarms based on stale evidence.
As to claim 5, Halperin teaches the at least one parameter value related to breathing of the user includes an average value of a respiratory rate and/or a variation of the respiratory rate ([0131] – breathing rate pattern), which becomes an average with the combination of Stadler.
As to claim 6, Halperin teaches the controller is further configured to calculate at least one parameter value related to a heartbeat of the user ([0110] – data is processed to yield at least one periodic heartbeat-related movement pattern, from which the heartbeat pattern is extracted)
As to cl aim 7, Halperin teaches at least any one of at least one parameter value related to the heartbeat of the user includes an average value of a heartbeat rate, a variation of the heartbeat rate, or a heartbeat rate non-calculation rate ([0138]).
As to claim 8, Halperin teaches at least one parameter value related to breathing of the user includes an average value of a respiratory rate and a variation of the respiratory rate ([0138])..
As to claims 10-12 and 14-17, the claims recite the method counterpart to the apparatus claims of 1-3 and 5-8, respectively, and are rejected in the same fashion.
Response to Arguments
Applicant’s arguments 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.
Allowable Subject Matter
Claims 4 and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art of record fails to teach and/or fairly suggest, in combination with all other recited limitations, calculating two-days-ago difference data by subtracting a parameter value of two days ago from a parameter value of the current day, and, upon sign agreement, updating the cumulative value for the current day by adding the two-days-ago difference data to the cumulative value recorded for two days ago.
Claims 9 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to teach or fairly suggest, in combination with all other recited limitations, a parameter value related to a heartbeat rate non-calculation rate.
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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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, Robert Chen can be reached at 571-272-3672. 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.
CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/11/26
Prosecution Insights