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 .
Status of Claims
This communication is in response to the application filed 07/30/2024.
Claims 1-20 are currently pending and have been examined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 11 and 20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1, 11 and 20 of U.S. Patent No. 12,051,500 B2 to Grantcharov et al (“Patent Document”).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claim 1 of the Patent Document recites all the limitations of claim 1 of the instant application; however, claim 1 of the Patent Document differs since it further recites additional claim limitations including: 1) predictions generated by an artificial neural network, 2) generate a session container data structure, 3) identify, one or more potential time-stamped clinical error events within the session container data structure, 4) corresponding to the at least of video or audio data streams of the session container data structure, and 5) labels corresponding to at least one of the time-stamped potential clinical error events.
However, it would have been obvious to a person of ordinary skill in the art to modify claim 1 of the Patent Document by removing the additional limitations (1-5), resulting generally in the claims of the present application, since the claims of the present application and the claim recited in the Patent Document actually perform a similar function. It is well settled that the omission of an element and its function is an obvious expedient if the remaining elements perform the same function as before. In re Karison, 136 USPQ 184 (CCPA 1963). Also, note Ex parte Rainu, 168 USPQ 375 (Bd. App. 1969). Thus, omission of a reference element whose function is not needed would be obvious to one of ordinary skill in the art.
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-10 are directed to a system (i.e., a machine), 11-19 are directed to a method (i.e., a process), and claim 20 is directed to non-transitory computer readable medium (i.e., a manufacture). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 1 includes limitations that recite an abstract idea. Note that independent claim 1 is the system claim, while claim 11 covers a method claim and claim 20 covers the matching computer readable medium.
Specifically, independent claim 1 recites:
An electronic recording apparatus configured for automatically processing audio-visual recordings of one or more medical procedures to automatically generate data structures representing durations of time where predicted events are estimated by associating digital recordings of one or more medical procedures with the predicted events based on predictions generated by a machine learning data model architecture, the apparatus comprising:
at least one recording device including at least one of cameras, sensors, audio devices, and patient monitoring hardware recording time synchronized real-time medical or surgical data streams relating to a real-time medical procedure within an operating or clinical site;
a processor adapted for machine learning, coupled with a non-transitory computer- readable memory maintaining a trained machine learning data model architecture, the processor configured to:
identify, using the trained machine learning data model architecture, one or more potential time-stamped clinical events within the real-time medical or surgical data streams;
generate a time-synchronized metadata track representing timestamp markers corresponding to specific timestamps or timestamp ranges of the durations of time, each timestamp marker of the timestamp markers corresponding to a specific time-stamped potential clinical event;
train the machine learning data model architecture using reviewer validation inputs representing one or more labels corresponding to at least one of the time-stamped potential clinical events, the one or more labels each indicating whether the corresponding time-stamped potential clinical event was correct or false; and
control generation of machine learning outputs correlating one or more key events or case variables associated with each specific time-stamped potential clinical event.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because processing audio-visual recordings of medical procedures to automatically generate data structures representing durations of time, recording time synchronized real-time medical or surgical data streams relating to a real-time medical procedure within an operating or clinical site and correlating key events or case variables associated with each specific time-stamped potential clinical event are a part of a medical workflow and investigates when surgical events occurred, which are managing human behavior/interactions between people. Furthermore, these limitations constitute (b) “a mental process” because processing audio-visual recordings of medical procedures to automatically generate data structures representing durations of time and identifying a specific timestamped marker and potential clinical events are investigative by nature and overall and corresponding time-stamped potential clinical event was correct or false observations/evaluations/analysis that can be performed in the human mind or with a pen and paper. The foregoing underlined limitations also relate to claim 1 (similarly to claims 11 and 20).
Accordingly, the claim describes at least one abstract idea.
In relation to dependent claims 2-10 and 12-19, these claims merely recite determining steps such as: claims 2 & 12 - for exploratory analysis of the machine learning outputs, claims 3 & 13 - prior time synchronizing real-time medical or surgical data streams are re-processed using a current version of the trained machine learning data model architecture to generate additional predictions linked to the prior time synchronized real-time medical or surgical data streams, claims 4 & 14 - rendering the timestamp markers corresponding to a specific time- stamped potential clinical event with different colors based on threshold ranges indicative of a range of an associated confidence level, claims 5 & 15 – maintaining within one or more attribute-relation file format files, claim 6 & 16 - the one or more attribute-relation file format files are utilized to instantiate the trained machine learning data model architecture, which is then used to process a recording to generate the time-synchronized metadata track and to identify the specific time-stamped potential clinical event, claims 7 & 17 - upon identifying the specific time- stamped potential clinical event using the trained machine learning data model architecture, a random time point in a media clip not proximate to any specific time-stamped potential clinical event is selected and the trained machine learning data model architecture is run again on the random time point to identify an example time point with no medical event, claims 8 & 18 - generating from the real-time medical or surgical data streams, storing the one or more attribute-relation file format files alongside one or more media clips both associated with and not associated with a medical event and claims 9 & 19 - maintaining each associated with one or more features of the one or more media clips and claim 10 - tolerating an increased number of false positive predictions.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 8 and 12, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the human mind but for the recitation of generic computer components. That is, other than reciting an electronic recording apparatus, at least one recording device including at least one of cameras, sensors, audio devices, a patient monitoring hardware, a processor, and a non-transitory computer- readable memory to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment in the human mind but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the electronic recording apparatus, at least one recording device including at least one of cameras, sensors, audio devices, patient monitoring hardware, a processor, and non-transitory computer- readable memory are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding the additional limitations “a machine learning data model architecture”, “trained to support iterative machine learning”, and “a trained machine learning data model architecture” the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Regarding dependent claims 2-10 and 12-19, the additional limitation “the machine learning outputs”, “exploratory analysis”, “the decision support graphical user interface” and “a session container data structure”, the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see 2019 PEG and MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 1, regarding the additional limitations of the electronic recording apparatus, at least one recording device including at least one of cameras, sensors, audio devices, patient monitoring hardware, a processor, and non-transitory computer- readable memory, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 8 and analogous independent claims 11 and 20 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA S WILLIAMS whose telephone number is (571)270-5509. The examiner can normally be reached Mon-Fri, 8:30 am -6:30 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, MAMON OBEID can be reached on (571) 270-1813. 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.
/T.S.W./Examiner, Art Unit 3686 02/17/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687