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 .
DETAILED ACTION
In the preliminary amendment dated 09/02/2024, the following occurred: The Specification was amended at para. [001] and [002].
This is the first action on the merits. Claims 1-16 are currently pending.
Priority
This application claims priority from Provisional Application Nos. 63602040, 63602028, 63601998, 63602003, 63602006, 63602011, 636022013, 63602037 and 63602007 dated 11/22/2023.
Drawings
The drawings are further objected to as failing to comply with 37 CFR 1.84(g) because following figure(s) do not conform to the margin requirements (note that the margin requirement includes text):
One inch (1”) left margin - Fig. 1, 5, 8, 14A;
One inch (1”) top margin – Fig. 1, 3, 5, 6, 7, 8, 9, 10, 12, 14A;
Five eighths inch (5/8”) right margin – Fig. 1, 5, 4, 8, 9, 10, 14A;
three eighths inch (3/8”) bottom margin – Fig. 5, 6.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method and a system for inter-connectivity of data flows between independent smart systems, which are within a statutory category.
Regarding claims 1 and 9, the limitation of (claim 1 being representative) determining capability information associated with a surgical environment, wherein the capability information indicates information, wherein the information comprises at least a list associated with the surgical environment; receiving first data indicated in the information, wherein the first data comprises first metadata that indicates the first data is control data or response data; selecting an operation configuration based on the first metadata, wherein the operation configuration is the first operation configuration or a second operation configuration; generating second data based on the selected operation configuration; determining in the list associated with the surgical environment to send at least a portion of the second data; and sending, via a data stream, the at least a portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data as drafted, is a process that, under the broadest reasonable interpretation, covers a method organizing human activity but for the recitation of generic computer components. That is other than reciting a surgical system, a first surgical system, a second surgical system and a third surgical system (in claim 1) and a processor, a surgical system, a first surgical system, a second surgical system and a third surgical system (in claim 9), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the processor and the surgical systems, the claims encompass determining capability information, receiving first data comprising first metadata that indicates the first data is control data or response data, selecting an operation configuration based on the first metadata, generating second data, send at least a portion of the second data comprising second metadata that indicates that the at least a portion of the second data is control data or response data in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a surgical system, a first surgical system, a second surgical system and a third surgical system. Claim 9 recites the additional elements of a processor, a surgical system, a first surgical system, a second surgical system and a third surgical system. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server for enabling access to medical information or generic computer components for performing generic computer functions. See specification at para. [0029], [0030], [0045], [0055] that describe generic surgical systems) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is 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 the processor, surgical system, first surgical system, second surgical system and the third surgical system to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-8 and 10-16 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 and 10 further merely describe(s)… Claim(s) 3 and 11 further merely describe(s)… Claim(s) 4 and 12 further merely describe(s)… Claim(s) 5 and 13 further merely describe(s)… Claim(s) 6 and 14 further merely describe(s)… Claim(s) 7 and 15 further merely describe(s)… Claim(s) 8 and 16 further merely describe(s)… As can be seen, claims 2-8 and 10-16 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1 and 9.
Claim Rejections - 35 USC § 112
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 1-16 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.
Claims 1 and 9 recite “… select an operation configuration based on the first metadata, wherein the operation configuration is the first operation configuration or a second operation configuration; …” There is insufficient antecedent basis for this limitation in the claim. A first operation configuration was never previously recited. The Examiner suggests amending limitation to say “… select an operation configuration based on the first metadata, wherein the operation configuration is a first operation configuration or a second operation configuration; …”
Dependent claims are rejected by virtue of dependency.
Claim Rejections - 35 USC § 102
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 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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (US 2021/0315580).
REGARDING CLAIM 1
Shelton discloses a method for operating a first surgical system using a first operation configuration comprising: determining capability information associated with a surgical environment, wherein the capability information indicates surgical system information, wherein the surgical system information comprises at least a list of surgical systems associated with the surgical environment (Shelton at [0116] teaches a list of surgical items and [0991] teaches a list of medical supplies to be used in the procedure (interpreted by examiner as the list of surgical systems associated with the surgical environment). [0957] teaches the surgical hub can be configured to compare the list of items for the procedure and/or a list of devices paired with the surgical hub to a recommended or anticipated manifest of items and/or devices for the given surgical procedure (interpreted by examiner as determining capability information that indicates surgical system information that comprises at least a list of surgical systems)); receiving first data from a second surgical system indicated in the surgical system information, wherein the first data comprises first metadata that indicates the first data is control data or response data ([0014] teaches receiving first usage data (interpreted by examiner as the first data), from a first subset of surgical hubs of the surgical system (interpreted by examiner as the second surgical system indicated in the surgical system information) [0476] teaches a cloud service provider that coordinates the usage and control of the devices 1a-1n/2a-2m located in one or more operating theaters and [1393] teaches generating self-describing data (e.g., metadata) including identification of notable features or configuration and that the data collection and aggregation module can generate aggregated metadata or other organized data based on raw data received from the surgical hubs (interpreted by examiner as wherein the first data comprises first metadata that indicates the first data is control data or response data)); selecting an operation configuration based on the first metadata, wherein the operation configuration is the first operation configuration or a second operation configuration ([0542] teaches the control circuit may be programmed to select a firing control program or closure control program based on tissue conditions (interpreted by examiner as selecting an operation configuration)); generating second data based on the selected operation configuration ([0014] teaches receiving second usage data (interpreted by examiner as generating second data based on the selected operation configuration)); determining a third surgical system in the list of surgical systems associated with the surgical environment to send at least a portion of the second data ([0524] teaches a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions. In certain instances, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain instances, the plurality of motors of robotic surgical instrument can be individually activated to cause firing, closure, and/or articulation motions in the end effector (interpreted by examiner as determining a third surgical system in the list of surgical systems associated with the surgical environment)); and sending, via a data stream, the at least a portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data ([0015] teaches transmitting first and second usage data, [0613] teaches using data streams, [1393] teaches generating self-describing data (e.g., metadata) including identification of notable features or configuration and that the data collection and aggregation module can generate aggregated metadata or other organized data based on raw data received from the surgical hubs, and [1887] teaches transmit a control signal to the detected surgical device to transmit to the surgical hub surgical parameter data associated with the detected surgical device (interpreted by examiner as sending, via a data stream, the at least a portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data)).
REGARDING CLAIM 2
Shelton further discloses:
The method of claim 1, wherein based on a determination that the first metadata indicates the first data is control data, the second operation configuration is selected as the operation configuration, and wherein based on a determination that the first metadata indicates the first data is response data, the first operation configuration is selected as the operation configuration ([0818] teaches the control circuit is configured to select one of a master mode of operation or a slave mode of operation in the master-slave arrangement. [1163] teaches a surgeon to select, operate and control a plurality of different surgical devices through a common input device. [1204] teaches changing configurations and [1331] teaches adjust one or more of their operating parameters thereby allowing them to optimize their manipulation of the tissue (interpreted by examiner as wherein based on a determination that the first metadata indicates the first data is control data, the second operation configuration is selected as the operation configuration, and wherein based on a determination that the first metadata indicates the first data is response data, the first operation configuration is selected as the operation configuration)).
REGARDING CLAIM 3
Shelton further discloses:
The method of claim 1, wherein the method further comprises: determining the second operation configuration based on the first data, wherein the first operation configuration is associated with performing an action based on a first parameter, wherein the second operation configuration is associated with performing an action based on a second parameter, and wherein the second parameter is determined based on the first data ([0014] teaches operational parameter of a surgical system and [1330] teaches determine parameters associated with the function of the instruments (interpreted by examiner as the first/second operation configuration is associated with performing an action based on a first/second parameter)).
REGARDING CLAIM 4
Shelton further discloses:
The method of claim 1, wherein the third surgical system is the first surgical system, wherein based on a determination that the first metadata indicates the first data is control data, and wherein the method further comprises: determining that the at least a portion of the second data is response data based on the determination that the first metadata indicates that the first data is control data, wherein the second metadata indicates that the at least a portion of the second data is response data ([0544] teaches response of an instrument and based on the response of the robotic surgical instrument during the open-loop portion of the stroke, the control circuit may select a firing control program in a closed-loop configuration. [0557] teaches the control circuit can be configured to simulate the response of the actual system of the instrument in the software of the controller (interpreted by examiner as determining that the at least a portion of the second data is response data based on the determination that the first metadata indicates that the first data is control data, wherein the second metadata indicates that the at least a portion of the second data is response data)).
REGARDING CLAIM 5
Shelton further discloses:
The method of claim 1, wherein the method further comprises: receiving surgical environment information, wherein the surgical environment information indicates surgical system information associated with a default surgical system environment; and performing discovery associated with the surgical environment to determine discovered surgical environment information, wherein the capability information comprises the default surgical system environment and the discovered surgical environment information ([0890] teaches interaction with an interactive surgical system environment including a surgical hub, in one aspect, self-describing data packets as shown in FIG. 69 are generated at an issuing instrument, or device or module located in or in communication with the operating theater, and include identifiers for all devices that handle the packet along a communication path (interpreted by examiner as wherein the surgical environment information indicates surgical system information associated with a default surgical system environment) [1415] teaches based on all of the data, trends may be determined, and here, it may be discovered that there is a small window of the number of firings that results in the best performance outcomes, at interval “a” as shown. The magnitude of this performance compared to the most common number of firings is shown as interval “b.” Because the number of firings that results in the best outcomes may not be what is commonly practiced, it may not be readily easily to have discovered these outcomes without the aggregation and analytical abilities of the cloud system and [1459] teaches the cloud-based system may first provide a baseline recommendation for how a smart instrument should be used, based on best practices discovered in the aggregate data (interpreted by examiner as performing discovery associated with the surgical environment to determine discovered surgical environment information)).
REGARDING CLAIM 6
Shelton further discloses:
The method of claim 1, wherein the capability information further indicates for each surgical system in the list of surgical systems associated with the surgical environment respective surgical system capability information, wherein the respective surgical system capability information indicates at least one type of data that the associated surgical system is capable of generating ([0097] teaches determining type of data and [0105] teaches determining procedure type (interpreted by examiner as wherein the respective surgical system capability information indicates at least one type of data that the associated surgical system is capable of generating)).
REGARDING CLAIM 7
Shelton further discloses:
The method of claim 1, wherein the list of surgical systems indicates the second surgical system and indicates that the second surgical system is capable of generating a first type of data and a second type of data, and wherein the method further comprises: determining that the first data comprises at least a first portion of data associated with the first type of data; determining that the first data is missing data associated with the second type of data; and sending an indication to the second surgical system indicating that the second type of data is missing ([0957] teaches the surgical hub can be configured to determine the relative distance or position of the modular devices and patient monitoring devices via proximity sensors, for example. The surgical hub can compare the relative positions of the devices to a recommended or anticipated layout for the particular surgical procedure. If there are any discontinuities between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout for the surgical procedure deviates from the recommended layout and [0958] teaches a situationally aware surgical hub could determine whether the surgeon (or other medical personnel) was making an error or otherwise deviating from the expected course of action during the course of a surgical procedure and provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at the particular step in the surgical procedure (interpreted by examiner as means to determine that the first data comprises at least a first portion of data associated with the first type of data and to determine that the first data is missing data associated with the second type of data and sending an indication to the second surgical system indicating that the second type of data is missing)).
REGARDING CLAIM 8
Shelton further discloses:
The method of claim 7, wherein the first type of data is processed data, wherein the second type of data is unprocessed data, and wherein the indication indicating that the second type of data is missing further indicates to send data associated with the second type of data ([1527] teaches the cloud system may review the information supplied by the medical device that triggered the suspicious activity, and if the information is unequivocally fraudulent or faulty, an alert and a rejection of the device can occur, such that the medical device will be prevented from operating with the medical hub and/or other medical hubs in the same facility (interpreted by examiner as wherein the first type of data is processed data, wherein the second type of data is unprocessed data, and wherein the indication indicating that the second type of data is missing further indicates to send data associated with the second type of data)).
REGARDING CLAIMS 9-16
Claims 9-16 are analogous to Claims 1-8 thus Claims 9-16 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-8.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Juergens (US 2019/0343588) discloses operating method for a medical system, and medical system for performing a surgical procedure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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 Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683