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 the Claims
The office action is in response to the claim amendments and remarks filed on October 7, 2025 for the application filed October 16, 2023 which claims priority to a foreign application filed on April 30, 2018. Claim 1 has been amended. Claims 1-9 are currently pending and have been examined.
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 1-9 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 1 recites “share via the network the identification of the at least one item of equipment appearing in the captured image based on the data points formulated within the at least one validation system for retrieval by a second user utilizing a second mobile computing device” which does not appear to have written description support in the specification. While paragraph [0067] describes the identification of equipment from captured images, it does not described sharing this identification with a second user device. Furthermore this identification appears to be used when a user does not know what a the equipment is or how is works. Paragraph [0066], discusses sharing relevant equipment information with users such as store managers or ordering systems, it is unclear why the identification of equipment from the captured image would be shared with other users as it is only used to inform a user as to what the equipment is and how it works.
Claims 2-9 are rejected at least based on their dependency on claim 1.
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 1-9 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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-9 are directed towards a perioperative system (i.e. a machine), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the claim 1 is identified as:
a perioperative system for assisting a plurality of users to prepare for surgery on a patient in an operating room of a medical facility, the perioperative system including:
a server in communication with a medical facility computing system over a network;
at least one validation system in communication with an inventory system, the at least one validation system configured to query the inventory system to obtain data representing a real-time availability of at least one item of equipment;
a sensor system in communication with the at least one validation system, the sensor system configured to obtain an identifier and a location of at least one item of equipment and to transmit, to the at least one validation system, data representing a real-time location of the at least one sensed item of equipment; and
a first mobile computing device having a network interface for communicating over the network, a memory, and a user interface, the memory having stored thereon processor-executable instructions that, when executed by the first mobile computing device, cause the first mobile computing device to run an application adapted to:
allow a first user to log in and select a role of the first user via the user interface, the role being stored on the server;
display a list of surgical procedures on the user interface for selection by the first user, the list of surgical procedures being stored on the server or the medical facility computing system;
filter the list of surgical procedures displayed on the user interface based on the role selected by the first user, wherein procedure parameters are filtered according to the role in order to provide a functional configuration which outlines a perioperative preparation required for each role;
retrieve, from the at least one validation system, at least one of: data representing real-time availability of at least one item of equipment, data representing real-time location of at least one item of equipment;
receive a captured image of at least one item of equipment and determine, using the at least one validation system, an identification of the at least one item of equipment appearing in the captured image based on data points formulated within the at least one validation system;
display a plurality of checklists including a patient preparation checklist, an operating room checklist, a patient positioning checklist, and an equipment checklist on the user interface, each checklist including one or more tasks for the first user to perform in order to prepare for the surgery based on a surgical procedure selected by the first user, each checklist being operable by the first user via the user interface to generate an indication of a completion of the checklist, each checklist being stored on the server or the memory of the first mobile computing device;
share via the network an indication of the completion of each of the checklists with the server or the medical facility computing system;
share via the network the identification of the at least one item of equipment appearing in the captured image based on the data points formulated within the at least one validation system for retrieval by a second user utilizing a second mobile computing device; and
display an indication on the user interface that all tasks have been completed to prepare for the surgery in response to the indications that the plurality of checklists of the first user have been completed and in response to an indication received via the network that a second user has completed a plurality of checklists on a second mobile computing device;
wherein the equipment checklist includes:
one or more items of equipment for the first user to prepare for the surgical procedure selected by the first user to be performed, and
at least one of: the data representing real-time availability of the at least one item of equipment, or data representing real-time location of the at least one item of equipment.
The identified limitations of the in claim 1 recite the abstract idea of preparing for surgery on a patient in an operating room of a medical facility, which falls within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions). The claims recite a series of steps to perform in order to prepare for surgery. These steps include obtaining and querying equipment identifiers and locations; providing, completing and sharing role based checklists for selected from a list of surgical procedures filtered based on a user role; and determining and sharing identification of equipment in captured images based on data points, which may all be performed by humans. The mere recitation of the generic server, validation system, sensor system, mobile computing devices, computing system, network and user interfaces does not take the claim out of the certain methods of organizing human activity grouping.
Accordingly, claim 1 recites an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in claim 1 are identified in italics as:
a perioperative system for assisting a plurality of users to prepare for surgery on a patient in an operating room of a medical facility, the perioperative system including:
a server in communication with a medical facility computing system over a network;
at least one validation system in communication with an inventory system, the at least one validation system configured to query the inventory system to obtain data representing a real-time availability of at least one item of equipment;
a sensor system in communication with the at least one validation system, the sensor system configured to obtain an identifier and a location of at least one item of equipment and to transmit, to the at least one validation system, data representing a real-time location of the at least one sensed item of equipment; and
a first mobile computing device having a network interface for communicating over the network, a memory, and a user interface, the memory having stored thereon processor-executable instructions that, when executed by the first mobile computing device, cause the first mobile computing device to run an application adapted to:
allow a first user to log in and select a role of the first user via the user interface, the role being stored on the server;
display a list of surgical procedures on the user interface for selection by the first user, the list of surgical procedures being stored on the server or the medical facility computing system;
filter the list of surgical procedures displayed on the user interface based on the role selected by the first user, wherein procedure parameters are filtered according to the role in order to provide a functional configuration which outlines a perioperative preparation required for each role;
retrieve, from the at least one validation system, at least one of: data representing real-time availability of at least one item of equipment, data representing real-time location of at least one item of equipment;
receive a captured image of at least one item of equipment and determine, using the at least one validation system, an identification of the at least one item of equipment appearing in the captured image based on data points formulated within the at least one validation system;
display a plurality of checklists including a patient preparation checklist, an operating room checklist, a patient positioning checklist, and an equipment checklist on the user interface, each checklist including one or more tasks for the first user to perform in order to prepare for the surgery based on a surgical procedure selected by the first user, each checklist being operable by the first user via the user interface to generate an indication of a completion of the checklist, each checklist being stored on the server or the memory of the first mobile computing device;
share via the network an indication of the completion of each of the checklists with the server or the medical facility computing system;
share via the network the identification of the at least one item of equipment appearing in the captured image based on the data points formulated within the at least one validation system for retrieval by a second user utilizing a second mobile computing device; and
display an indication on the user interface that all tasks have been completed to prepare for the surgery in response to the indications that the plurality of checklists of the first user have been completed and in response to an indication received via the network that a second user has completed a plurality of checklists on a second mobile computing device;
wherein the equipment checklist includes:
one or more items of equipment for the first user to prepare for the surgical procedure selected by the first user to be performed, and
at least one of: the data representing real-time availability of the at least one item of equipment, or data representing real-time location of the at least one item of equipment.
The additional limitations pertaining to the server, validation system, sensor system, computing system, and mobile devices having a network interface for communicating over the network, a memory, and a user interface, the memory having stored thereon processor-executable instructions that, when executed by the first mobile computing device, cause the first mobile computing device to run an application adapted to in communication over the network merely describes how to generally apply the abstract in a generic networked computer environment and are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The computer components are recited at a high level of generality and used in their ordinary capacity to input, output, store, receive, transmit and display data. There are no details as to how the systems function or details as to how they are configured to achieve the desired result. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
The additional limitations pertaining to the mobile computing device running an application which allows a user to login is determined to be no more than generally linking the use of the abstract idea to the particular technological environment of mobile device applications under MPEP §2106.05(h), which does not meaningfully limit the claim. Similarly, the mobile computing device adapted to receive a captured image of the equipment and determine an identification of the equipment in the captured image based on data points is determined to be no more than generally linking the use of the abstract idea of determining an identification of an item of equipment in a captured image based on datapoints to the particular technological environment of computer image recognition under MPEP §2106.05(h), which does not meaningfully limit the claim.
The limitations reciting transmitting identifiers and locations between systems, sharing via a network, receiving data via a network and receiving captures images is determined to be no more than insignificant extra-solution activity of mere necessary data gathering and data outputting in conjunction with the abstract idea under MPEP §2106.05(g).
Accordingly, claim 1 does not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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 limitations amount to mere instructions to apply an abstract idea under MPEP §2106.05(f), generally linking the use of the abstract idea to the particular technological environment of mobile device application under MPEP §2106.05(h) and no more than insignificant extra-solution activity of mere necessary data gathering and data outputting in conjunction with the abstract idea under MPEP §2106.05(g). Evidence that transmitting identifiers and locations between systems, sharing via a network, receiving data via a network and receiving captures images is well-understood, routine and conventional is provided by MPEP §2106.05(d), subsection II.
Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. Claims 2-3 and 5-9 are determined to be encompassed by the identified abstract idea as they merely recite additional details regarding the lists, checklists and displaying thereof. Claim 4 recites providing at least one parameter for displaying the equipment checklist, which is determined to be encompassed by the identified abstract idea, as it merely recites additional details regarding the data used for the checklists. The additional element of the sensor input is recited at a high level of generality and used in its ordinary capacity to provide parameter data, and therefore is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Therefore, whether taken individually or as an ordered combination, claims 1-9 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed October 7, 2025 regarding claims 1-9 being rejected under 35 U.S.C. §101 have been fully considered but they are not persuasive.
Applicant argues that the mobile device adapted to receive a captured image of an item of equipment, and automatically determine an identification of the item of equipment is a particular special purpose machine that represents a technical improvement that has the potential to reduce operating room delays and therefore improve surgery outcome.
In response, the mobile devices receiving captured images is determined to be the no more than insignificant extra-solution activity of mere necessary data gathering in conjunction with the abstract idea under MPEP §2106.05(g), which is well-understood, routine and conventional as evidenced by MPEP §2106.05(d), subsection II. Using the validation system to automatically determine an identification of the item of equipment in the captured image using data points is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), such as mere instructions to implement the abstract idea of determining an identification of the item of equipment in the captured image using data points on a computer/validation system. This is also determined to be no more than generally linking the use of the abstract idea of determining an identification of an item of equipment in a captured image based on datapoints to the particular technological environment of computer image recognition under MPEP §2106.05(h), which does not meaningfully limit the claim. The claims do not recite any details as how the identification is determined based on the data points which could be considered an improvement to computer image recognition, but merely the use thereof. Furthermore, MPEP §2106.05(b) makes clear that a generic computer or generic computer components that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Here, the claimed mobile device and validation system used to perform the determination is considered to be generic computers/components that applies the abstract idea, which does not qualify as a particular machine.
Applicant argues that the provisioning of real-time availability and real-time location of equipment have the effect of integrating an allegedly abstract idea of organizing human activity into a practical application through the use of the validation system and sensory system which the application argues are particular machines or manufactures integral to the claim.
In response, the provisioning of real-time availability and real-time location of equipment is determined to be encompassed by the abstract idea and the additional elements of a validation system and sensor system are recited at a high level of generality without any details as to how the systems are configured so as to achieve the desired results of provisioning of real-time availability and real-time location of equipment and are therefore considered mere instructions to apply an abstract idea under MPEP §2106.05(f) which does not qualify as a particular machine as detailed in MPEP §2106.05(b).
Applicant argues that claim 1 included even more technological details than Example 42 of the Subject Matter Eligibility Examples and recites a specific practical application of the technology to resolve a technical issues and should therefore be patent eligible.
However, the Applicant fails to provide a detailed rationale as to what the technical issues are and how the claims solve the technical issues. Furthermore, Example 42 was found to be eligible because it recited a specific improvement over prior art systems as supported by the specification. Here, the Applicant has not detailed how claim 1 recites a specific improvement over prior art systems and the specification to not appear to recite how the invention provides a specific improvement over prior art systems.
The remainder to the remarks appear to be explanations of the claim amendments and what the claim limitations enable, without any specific arguments as to subject matter eligibility.
Applicant's arguments filed October 7, 2025 regarding claims 1-9 being rejected under 35 U.S.C. §103 have been fully considered are persuasive. The rejection under 35 U.S.C. §103 has been withdrawn.
While Shetty discloses filtering patient care applications, which include surgery applications, based on a user role and completing and sharing checklists for auditing compliance; DeVries and Vazquez teach the details perioperative surgical checklists and completion and sharing thereof; and Lee teaches the inventory system and sensor system to obtain equipment locations and identifiers and the identification of equipment based on captured images and data points, which may be shared with other users (i.e. other users can identify the equipment using the system), upon further consideration, it is determined that it would not have been obvious to one of ordinary skill in the art to combine these references in such as way so as to render the claims obvious without relying on hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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/DEVIN C HEIN/Examiner, Art Unit 3686