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 Nonfinal Office Action is in response to the Application filed 10/25/2024. Claims 1-26 are pending and considered herein.
Claim Objections
Claim 22 is objected to because of the following informalities: “a respective surgical parameter other air exchange” should read “other than air exchange,” and “said second data” should read “said fifth data.” Appropriate correction is required.
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 1-26 are rejected under 35 U.S.C. §101 because they recite an abstract idea without significantly more.
Claim 1 recites, wherein the abstract idea is not emboldened:
A device comprising: a processor configured to: receive, during a surgery, first data, said first data being representative of a patient's intraoperative air exchange for a breath cycle, receive, during the surgery, second data, said second data being representative of a surgical parameter other than one related air exchange, and output, during the surgery, information indicative of prolonged- air-leak-likelihood based on the first and second data.
Independent claim 9 recites substantially similar limitations.
Independent claim 22, recites, wherein the abstract idea is not emboldened:
A device comprising: a computer configured to: receive first data being representative of a plurality of intraoperative air exchanges respective to individual patients in a population, receive second data being representative of respective patient outcomes corresponding to the individual patients in the population, receive third data being representative of a respective surgical parameter other air exchange and outcome corresponding individual patients in a population, to update a model of prolonged-air-leak-likelihood based on the first, second, and third data, and send the model to a surgical hub, wherein the surgical hub is configured to: receive, during a surgery, fourth data, said fourth data being representative of a patient's intraoperative air exchange for a breath cycle, receive, during the surgery, fifth data, said second data being representative of a surgical parameter other than one related air exchange, output, during the surgery, information indicative of prolonged-air-leak-likelihood based on the fourth data, the fifth data, and the model.
The claimed invention is broadly directed to the abstract idea of collecting patient information, analyzing the information, and determining feedback related to the patient including a health state based on the analyses.
The limitations to “receive, during a surgery, first data, said first data being representative of a patient's intraoperative air exchange for a breath cycle, receive, during the surgery, second data, said second data being representative of a surgical parameter other than one related air exchange, and output, during the surgery, information indicative of prolonged- air-leak-likelihood based on the first and second data,” as drafted in claim 1 and to “receive first data being representative of a plurality of intraoperative air exchanges respective to individual patients in a population, receive second data being representative of respective patient outcomes corresponding to the individual patients in the population, receive third data being representative of a respective surgical parameter other air exchange and outcome corresponding individual patients in a population, a prolonged-air-leak-likelihood based on the first, second, and third data, and receive, during a surgery, fourth data, said fourth data being representative of a patient's intraoperative air exchange for a breath cycle, receive, during the surgery, fifth data, said second data being representative of a surgical parameter other than one related air exchange, output, during the surgery, information indicative of prolonged-air-leak-likelihood based on the fourth data, the fifth data,” as drafted in claim 22, describe a process that, under its broadest reasonable interpretation, is an abstract idea that covers performance of the limitation as certain methods of organizing human activity. For example, but for the generic device, processor, computer, model and surgical hub, in the context of this claim, the recitations are an abstract idea that covers performance of the limitation as organizing human activity including following rules or instructions. These recited limitations fall within certain methods of organizing human activity grouping of abstract ideas because the limitations to access patient data, analyze the data, and generate risk likelihoods and other parameters based on the analyses. This is a method of managing interactions between people. Under its broadest reasonable interpretation, the limitations are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people including a patient and surgeon. Therefore, the limitation falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). The mere nominal recitation of a generic computer system, processors, memory, IoT devices and computer devices does not remove the claims from the method of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The claims also recited an abstract idea including mental processes. But for the generic reciting of a device, processor, computer, model and surgical hub, nothing in the claims is precluded from being performed in the mind. For example, a physician can collect the patient data and analyze the parameters events and determine/predict if there is some risk for the patient based on the analyses. Thus, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of being implemented by a generic device, processor, computer, model and surgical hub. The devices in these steps are recited at a high-level of generality (i.e., as a generic processor/server/storage/display performing a generic computer function of receiving inputs, analyzing the inputs, and displaying or sending selected information) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The limitations appear to monopolize the abstract idea of patient analysis and general diagnostic techniques between a physician and his patient. Furthermore, there is no clear improvement to the underlying computer technology in the claim. The claim is thus directed to an abstract idea.
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 integration of the abstract idea into a practical application, the additional elements of being implemented by a generic device, processor, computer, model and surgical hub amounts to no more than mere instructions to apply the exception using a computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
The dependent claims do not remedy the deficiencies of the independent claims with respect to patent eligible subject matter. The dependent claims further limit the abstract idea and do not overcome the rejection under 35 U.S.C. §101. Claims 2 and 10 recite a ventilator device and parameters, which are recited at a high level of generality such that it amounts to no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the ventilator does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself. Claims 3-5, 11-13 and 23-25 detail patient medical, operational and respiration information and further limit the abstract idea. Claim 6 describes a type of lung surgery and limits the abstract idea. Claims 7-8 and 15-16 describe a machine learning model, which is recited at a high level of generality such that it amounts to no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the machine learning model does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself. Claim 17 describes a display, which is recited at a high level of generality such that it amounts to no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the display does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself. Claims 18-21 describe an adjustment to care and a risk assessment and further limits the abstract idea. Claim 26 describes a treatment recommendation based on collected information and limits the abstract idea.
Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 102
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 1-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2026/0047789 A1 to Shelton et al., hereinafter “Shelton.”
Regarding claim 1, Shelton discloses A device comprising: a processor configured to: receive, during a surgery, first data, said first data being representative of a patient's intraoperative air exchange for a breath cycle (See Shelton at least at Abstract; Paras. [0030]-[0034] (processor and phase of respiration, prolonged air leak probability of occurrence), [0200]-[0202] (ventilator and respiration rate, breath frequency and pattern), [0772], [0845] (breathing data during surgery), [1573], [1825], [1962]; Figs. 54-61, 86), receive, during the surgery, second data, said second data being representative of a surgical parameter other than one related air exchange (See id. at least at Title; Abstract; Paras. [0026]-[0032], [0221]-[0222], [0389], [0398], [0408] (operating theater devices and parameters), [0887], [1043]; Claim 2; Figs. 1-3, 8, 54-61, 122), and output, during the surgery, information indicative of prolonged- air-leak-likelihood based on the first and second data (See id. at least at Abstract; Paras. [0026]-[0034] (prolonged air leak probability of occurrence), [0200]-[0202], [0221]-[0222], [0772], [1573], [1825], [1962]; Claim 4; Figs. 38-40, 54-60, 86).
Regarding claim 2, Shelton discloses the limitations of claim 1 and further discloses wherein the first data comprises any of ventilator inlet flow rate, ventilator inlet pressure, ventilator output pressure, chest tube flow rate, or chest tube pressure (See id. at least at Paras. [0200]-[0202], [0322], [0885], [1198], [1206]-[1207]; Claim 19; Figs. 54, 58-63).
Regarding claim 3, Shelton discloses the limitations of claim 1 and further discloses wherein the second data comprises patient medical record data (See id. at least at Paras. [0466], [0499]-[0502]; Claims 18-20).
Regarding claim 4, Shelton discloses the limitations of claim 1 and further discloses wherein the second data comprises intraoperative reporting data (See id. at least at Paras. [0772], [1193]-[1194], [1231], [1573], [1825], [1962]; Claims 15-20).
Regarding claim 5, Shelton discloses the limitations of claim 1 and further discloses wherein the second data comprises procedure data associated with the surgery (See id. at least at Paras. [0026]-[0032], [0221]-[0222], [0389], [0398], [0408], [0887], [1043]).
Regarding claim 6, Shelton discloses the limitations of claim 5 and further discloses wherein the procedure data comprises information characterizing a type of lung resection being performed during the surgery (See id. at least at Paras. [0084]-[0087], [0325], [0843]; Figs. 40-43).
Regarding claim 7, Shelton discloses the limitations of claim 1 and further discloses wherein the information indicative of prolonged- air-leak-likelihood is based on a machine learning model to which the first data and second data are input (See id. at least at Abstract; Paras. [0030]-[0034], [0786], [0856], [1233], [1253], [1272]-[1275], [1287]-[1289], [1832]-[1839], [2136], [2145]-[2146]; Claims 1-2, 8-10; Figs. 11, 54-61, 102-110).
Regarding claim 8, Shelton discloses the limitations of claim 1 and further discloses wherein the processor is configured to receive an updated machine learning model from a cloud resource and wherein the information indicative of prolonged-air-leak-likelihood is based on the updated machine learning model to which the first data and second data are input (See id.).
Regarding claim 9, claim 9 recites substantially the same limitations as recited in independent claim 1. Therefore, claim 9 is rejected under the same grounds of rejection and for the same reasoning as applied to claim 1, above.
Regarding claims 10-16, claims 10-16 recite substantially the same limitations as recited in claims 2-8, respectively. Therefore, the claims are rejected under the same grounds of rejection and for the same reasoning as applied to claims 2-8, above.
Regarding claim 17, Shelton discloses the limitations of claim 1 and further discloses displaying the information indicative of prolonged-air-leak-likelihood (See id. at least at Paras. [0030]-[0034], [1206]-[1207], [1229]-[1230], [1300]-[1302]; Figs. 1-3, 54-61).
Regarding claim 18, Shelton discloses the limitations of claim 1 and further discloses determining an adjustment to post-operative care based on the information indicative of prolonged- air-leak-likelihood (See id. at least at Paras. [0030]-[0034], [0389], [0398], [0853]-[0854], [1002]-[1003], [1229]-[1230]; Figs. 1-3, 54-61, 102-110).
Regarding claim 19, Shelton discloses the limitations of claim 1 and further discloses determining an adjustment to intra-operative care based on the information indicative of prolonged- air-leak-likelihood (See id.).
Regarding claim 20, Shelton discloses the limitations of claim 1 and further discloses determining a risk level for at least one surgical outcome based, at least in part, on the information indicative of prolonged-air-leak-likelihood (See id.).
Regarding claim 21, Shelton discloses the limitations of claim 20 and further discloses comparing the risk level to a predetermined threshold (See id. at least at Paras. [0030]-[0034], [0502]).
Regarding claim 22, Shelton discloses A device comprising: a computer configured to: receive first data being representative of a plurality of intraoperative air exchanges respective to individual patients in a population (See Shelton at least at Abstract; Paras. [0030]-[0034] (processor and phase of respiration, prolonged air leak probability of occurrence), [0200]-[0202] (ventilator and respiration rate, breath frequency and pattern), [0772], [0845] (breathing data during surgery), [1573], [1825], [1962]; Fig. 54-60, 86), receive second data being representative of respective patient outcomes corresponding to the individual patients in the population (See id. at least at Paras. [0027]-[0034], [0398], [0777], [0783], [1244]-[1254]; Figs. 106-110), receive third data being representative of a respective surgical parameter other air exchange and outcome corresponding individual patients in a population (See id. at least at Title; Abstract; Paras. [0026]-[0032], [0221]-[0222], [0389], [0398], [0408] (operating theater devices and parameters), [0887], [1043]; Claim 2; Figs. 1-3, 54-61, 122), to update a model of prolonged-air-leak-likelihood based on the first, second, and third data (See id. at least at Abstract; Paras. [0030]-[0034], [0786], [0856], [1233], [1253], [1272]-[1275], [1287]-[1289], [1832]-[1839], [2136], [2145]-[2146]; Claims 1-2, 8-10; Figs. 11, 54-61, 102-110), and send the model to a surgical hub (See id. at least at Paras. [0367]-[0369], [0383]-[0388], [1192]-[1193], [1272]-[1282], [1300]-[1302]; Figs. 1-3, 11, 54-61), wherein the surgical hub is configured to: receive, during a surgery, fourth data, said fourth data being representative of a patient's intraoperative air exchange for a breath cycle (See Shelton at least at Abstract; Paras. [0030]-[0034] (processor and phase of respiration, prolonged air leak probability of occurrence), [0200]-[0202] (ventilator and respiration rate, breath frequency and pattern), [0772], [0845] (breathing data during surgery), [1573], [1825], [1962]; Figs. 54-61, 86), receive, during the surgery, fifth data, said second data being representative of a surgical parameter other than one related air exchange (See id. at least at Paras. [0221]-[0222], [0389], [0398], [0408], [0772], [1193]-[1194], [1231], [1573], [1825], [1962]; Claims 2, 15-20), and output, during the surgery, information indicative of prolonged-air-leak-likelihood based on the fourth data, the fifth data, and the model (See id. at least at Abstract; Paras. [0026]-[0034] (prolonged air leak probability of occurrence), [0200]-[0202], [0221]-[0222], [0772], [1573], [1825], [1962]; Claim 4; Figs. 38-40, 54-60, 86).
Regarding claim 23, Shelton discloses the limitations of claim 22 and further discloses wherein the third data comprises patient medical record data (See id. at least at Paras. [0466], [0499]-[0502]; Claims 18-20).
Regarding claim 24, Shelton discloses the limitations of claim 22 and further discloses wherein the third data comprises intraoperative reporting data (See id. at least at Paras. [0772], [1193]-[1194], [1231], [1573], [1825], [1962]; Claims 15-20).
Regarding claim 25, Shelton discloses the limitations of claim 1 and further discloses wherein the third data comprises procedure data corresponding to respective surgical procedures of the respective intraoperative air exchanges (See id. at least at Paras. [0026]-[0032], [0221]-[0222], [0389], [0398], [0408], [0887], [1043]).
Regarding claim 26, Shelton discloses the limitations of claim 22 and further discloses wherein the surgical hub is further configured to generate a treatment recommendation based, at least in part, on the information indicative of prolonged-air-leak-likelihood, wherein the treatment recommendation is intended to improve a surgical outcome (See id. at least at Paras. [0027]-[0034], [0398], [0777], [0783], [1244]-[1254]; Figs. 106-110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. 2023/0057961 A1 to Roh et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 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, FONYA LONG can be reached at (571) 270-5096. 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.
/WILLIAM T. MONTICELLO/Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682