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 .
Applicant’s arguments have been considered but are moot in view of the new grounds of rejected necessitated by the claim amendments.
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over D11 and further in view of D22 or D33.
With regard to claim 1, D1 teach obtaining, using a set of one or more processors, a patient state indicating that a patient is associated with one or more of a spontaneous awakening trial (SAT) and a spontaneous breathing trial (SBT) , each of the SAT and SBT being associated with both objective observation items and subjective observation items (see ¶¶ 5, 33, 41, 48, 53, 55: objective measurements such as blood pressure, heart rate, respiratory rate etc. and associated subjective items such as patient comfort/discomfort); obtaining, using a set of one or more sensors, imagery of the patient associated with one or more of the SAT and the SBT (see ¶¶ 5, 41, 48: images of the patient to analyze patient movement, breath rate, analyze ventilation parameters etc.); evaluating, using the set of one or more processors, the imagery of the patient to classify the imagery using an objective model of a computer vision process as indicative of one of the subjective observation items associated with one or more of the SAT and SBT (see ¶¶ 41, 48, 53, 55: imagery data analyzed using AI/ML to track patient movement, analyze signs of comfort or discomfort, signs of spontaneous breathing, measurement of breathing rates etc); and providing, using the set of one or more processors, an objective indication of the one of the subjective observation items based on the evaluating the imagery using the objective model (see ¶¶ 48-49, fig. 3c).
D1 fails to explicitly teach wherein the evaluating comprises using the objective model to evaluate selected facial action coding system (FACS) features, however D2 teach the missing features (see p. 288 col 2 ¶ 1: FACS based pain expression score). See also D3 p. 645 col 2 ¶ 2, p. 646 ¶ 2, col 2 ¶ 1.
Based on the combined teachings, one skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, D1 relates to determining features such as comfort/discomfort which can be used to assess SAT and SBT trails. Separately, D2 and D3 teach image features based on FACS coding system that can measure pain in a patient. It would have been obvious to incorporate known FACS coding system into the configuration of D1 yielding predictable and enhanced results.
With regard to claim 2, D1 teach wherein the imagery comprises facial imagery (see fig. 3c).
With regard to claim 3, D1 teach wherein the evaluating comprises classifying the facial imagery as indicative of the one or of the subjective observation item including one or more of pain, agitation, and anxiety (see ¶ 48: discomfort).
With regard to claim 4, D1 teach wherein the imagery is obtained in a continuous manner during a protocol time window (see ¶¶ 41, 48, fig. 3c).
With regard to claim 5, D1 teach the obtaining, using the set of one or more sensors, comprises obtaining sensor data indicative of one or more of patient movement and body posture (see fig. 3: plurality of sensors; ¶48: patient movement); and the evaluating further comprises using the sensor data and the imagery to classify the patient for readiness for one or more of the SAT and the SBT (see ¶ 102: patient's readiness to be weaned from mechanical ventilatory support).
With regard to claim 6, D1 teach the obtaining, using the set of one or more sensors, comprises obtaining sensor data indicative of one or more of patient movement and body posture (see fig. 3: plurality of sensors; ¶48: patient movement); and the evaluating further comprises using the sensor data and the imagery to classify the patient as failing one or more of the SAT and the SBT (see ¶ 102: patient's readiness to be weaned from mechanical ventilatory support).
With regard to claim 7, D1 teach further comprising displaying the indication or data derived therefrom in an interactive display, wherein the interactive display comprises a display component having one or more interactive elements associated with one or more of the SAT and the SBT (see figs. 3c, 5: display).
With regard to claim 8, D1 teach wherein the one or more interactive elements comprise a link to the imagery or data derived therefrom (see figs. 3c. 5).
With regard to claim 9, D1 teach wherein the displaying the objective indication comprises incorporating the indication into an electronic health record (EHR) (see ¶ 53: patient records).
With regard to claim 10, D1 teach wherein the providing the indication comprises providing an objective indication to an end point including one or more of an in-room patient display, a clinician mobile device, a centralized monitoring station for an ICU, a remotely located telemedicine facility, and a scheduling system (see ¶ 49).
With regard to claims 11-13, see discussion of claims 1-3, respectively. See fig. 5 for memory and processor.
With regard to claims 14-15, see discussion of claims 1 and 3, respectively. See fig. 5 for computer readable medium or memory.
With regard to claim 16, D1 teach wherein the evaluating comprises using the objective model to produce a score (¶ 67: positive determination score). See also D2 p. 288 col 2 ¶ 1: FACS based pain expression score. See also D3 abstract, p. 645 last ¶: score.
With regard to claim 17, D2 teach wherein the selected FACS features do not include FACS features related to a patient mouth (see D2 p. 294 ¶ 2: features related to brows and raising of the cheeks, see figs. 1-2: eye and brow features). See also D3 p. 647 col 2 ¶ 2: feature extracted from eye regions. The motivation for combining the teachings is the same as stated above.
With regard to claim 18, D1 teach initiating one or more of the SAT and SBT based on the objective indication (see ¶ 103: SBT trails).
With regard to claim 19, D1 teach concluding one or more of the SAT and SBT have failed based on the objective indication (see ¶ 103: SBT determined to be successful or not).
With regard to claim 20, D1 wherein the protocol time window lasts at least several hours (see ¶ 107: evaluation for few hours).
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 AVINASH YENTRAPATI whose telephone number is (571)270-7982. The examiner can normally be reached on 8AM-5PM.
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, Sumati Lefkowitz can be reached on (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVINASH YENTRAPATI/Primary Examiner, Art Unit 2672
1 US Publication No. 2024/0207555.
2 Littlewort, Gwen C., Marian Stewart Bartlett, and Kang Lee. "Automatic coding of facial expressions displayed during posed and genuine pain." Image and Vision Computing 27.12 (2009): 1797-1803.
3 Nerella, Subhash, et al. "Pain action unit detection in critically ill patients." 2021 IEEE 45th Annual Computers, Software, and Applications Conference (COMPSAC). IEEE, 2021.
Prosecution Insights