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
The present Office Action is in response to the Request for Continued Examination dated 04/15/2026.
In the amendment dated 04/15/2026, the following occurred: Claims 1, 10, 11, 15 and 17 have been amended, claims 4, 8, 9, 16, 18 and 19 have been canceled. Claims 20-26 are new.
Claims 1-3, 5-7, 10-15, 17 and 20-26 are currently pending.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/15/2026 has been entered.
Claim Rejections
Claims 1, 15 and 17 are objected to for the following informality: “…a diagnostic device or a treatment device, connected to the computer system, wherein the generated digital workflow items comprise device instructions, which are used by the respective devices for performing the patient specific diagnostic procedural step…” should read “…a diagnostic device or a treatment device, connected to the computer system, wherein the generated digital workflow items comprise device instructions, which are used by the diagnostic device or the treatment device for performing the patient specific diagnostic procedural step…”
Claims 3, 21 and 25 are objected to for the following informality: “…device specific data of required ophthalmic diagnostic devices for diagnostic measurement of the at least on eye of the patient, device specific data of required ophthalmic treatment devices for ophthalmic treatment…” should read “…device specific data of the ophthalmic diagnostic device for diagnostic measurement of the at least on eye of the patient, device specific data of the ophthalmic treatment device for ophthalmic treatment…”
Claim 13 is objected to for the following informality: “…displaying the generated patient specific digital workflow via the human machine interface device…” should read “…displaying the generated patient specific digital workflow via the human machine interface …”
Claim 14 is objected to for the following informality: “…receiving instructions, in the processor of the computer system, from the human machine interface device…” should read “…receiving instructions, in the processor of the computer system, from the human machine interface …”
Appropriate action is required. The Applicant is encouraged to use consistent terminology.
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 1-3, 5-7, 10-15, 17 and 20-26 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, 15 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method, a computer program product and an ophthalmic workflow generator for generating a patient specific digital workflow of a physical ophthalmic treatment procedure of at least one eye of a patient, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
Regarding claims 1, 15 and 17, the limitation of (claim 1 being representative) receiving selection data selecting the physical ophthalmic treatment procedure to be performed on the at least one eye of the patient; determining resource data of required resources for performing at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure; receiving patient specific ophthalmic data of the at least one eye to be treated, wherein the received patient specific ophthalmic data comprises measured data of the at least one eye of the patient; generating the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the determined resource data and the received patient specific ophthalmic data, wherein each of the interrelating digital workflow items represents and determines at least one of the ophthalmic procedural steps of the physical ophthalmic treatment procedure of the at least one eye to be treated and transmitting at least one of the generated digital workflow items, wherein the generated digital workflow items comprise device instructions, which are used for performing the patient specific diagnostic procedural step or the patient specific treatment procedural step of the patient specific ophthalmic treatment procedure as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, for receiving selection data, determining resource data, receiving patient specific ophthalmic data of the at least one eye to be treated, generating the patient specific digital workflow and transmitting at least one of the generated digital workflow items, in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receiving…determining…receiving…generating… and transmitting the generated digital workflow items” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a processor and a computer system (in claim 1), a computer program product, a processor and a computer system (in claim 15) and an ophthalmic workflow generator, a computer system and a processor (in claim 17), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). 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.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a processor and a computer system. Claim 15 recites the additional elements of a computer program product, a processor and a computer system. Claim 17 recites the additional elements of an ophthalmic workflow generator, a computer system and a processor. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions) 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 they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 15 and 17 further recite the additional elements of an ophthalmic diagnostic device, a diagnostic device and a treatment device. These additional elements merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
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 element of the processor, computer system, computer program product and the ophthalmic workflow generator 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.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional elements of an ophthalmic diagnostic device, a diagnostic device and a treatment device were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
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)).
Claims 2-3, 5-7, 10-14 and 20-26 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, 20 and 24 further merely describe(s) the resource data is determined using received availability data. Claim(s) 3, 21 and 25 further merely describe(s) the resource data. Claim(s) 3, 21 and 25 includes the additional element of “ophthalmic treatment device” which is interpreted the same as the ophthalmic diagnostic device and does not provide practical application or significantly more for the same reasons. Claim(s) 5, 22 and 26 further merely describe(s) the received patient specific ophthalmic data. Claim(s) 5, 11, 22 and 26 include the additional element of “human machine interface” which merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application and MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Claim(s) 6 and 23 further merely describe(s) generating diagnostic digital workflow item. Claim(s) 7 further merely describe(s) the diagnostic digital workflow item, the treatment digital workflow item, or any other generated digital workflow item. Claim(s) 10 further merely describe(s) updating the interrelating digital workflow items using newly received patient specific ophthalmic data. Claim(s) 11 further merely describe(s) the at least one of the plurality of the interrelating digital workflow items. Claim(s) 12 further merely describe(s) the patient individual verification data. Claim(s) 13 further merely describe(s) displaying the generated patient specific digital workflow. Claim(s) 14 further merely describe(s) receiving instructions which update at least one of the plurality of interrelating digital workflow items. Claim(s) 13 and 14 include the additional element of “human machine interface device” which merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application and MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Claims 2-3, 5-7, 10-14 and 20-26 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 15 and 17.
Claims 15, 20-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 15 is recited to comprise a system having various features that, under the broadest reasonable interpretation, may be entirely embodied in software. According to MPEP 2106 (I), there are four categories of invention: process, machine, article of manufacture, and composition of matter. Therefore, as "software" is neither a category of invention nor a subset of one of the categories it does not represent patent eligible subject matter. See In re Nuijten, Docket No. 2006-1371 (Fed. Cir. Sept. 20, 2007). As such, the system is directed to software per se and is not directed to a statutory category of invention as described below.
The system of Claim 15 consist(s) of the following features that are not described to contain any structure: a computer program product.
The Specification at [0038] describes the computer program product to comprise computer program code configured to direct a processor of a computer system such that the processor performs the steps of claim 15, and thus it is interpreted as software. The specification does not describe the computer program product as containing any structure.
By virtue of their dependence from the independent claim, this basis of rejection also applies to dependent Claims 20-23.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-7, 10-15, 17 and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Petro (US 2006/0173713) and in further view of Taleb (US 2019/0000671).
REGARDING CLAIM 1
Petro discloses a computer implemented method of generating a patient specific digital workflow of a physical treatment procedure of a patient to be treated, the method comprising: receiving, in a processor of a computer system, selection data selecting the physical treatment procedure to be performed of the patient ([0004] teaches a medical device management system includes a repository of patient medical records and a scheduling system for use in scheduling of a medical procedure (interpreted by examiner as the physical treatment procedure) for a particular patient. [0009] teaches Hospital Information System (HIS) [0026] and Fig. 4 teach workflow management system and a treatment processor in HIS 12 that recommends multiple candidate treatment procedures in response to user entered diagnosis criteria. A scheduling system in HIS 12 schedules performance of a medical procedure by a healthcare worker for a particular patient. The medical procedure comprises a candidate treatment procedure selected by a user from the multiple candidate treatment procedures (interpreted by examiner as receiving, in a processor of a computer system, selection data selecting the physical treatment procedure to be performed of the patient)); determining, by the processor of the computer system, resource data of required resources for performing procedural step of the selected physical treatment procedure ([0009] teaches assessment of clinical resources to best perform recommended treatment protocols and parallel operations. Clinical resource availability information is used to plan patient workflow in a clinical setting and to preconfigure diagnostic, therapeutic, monitoring and other devices to accelerate and improve patient care. [0016] teaches a resource scheduling system and communicating resource availability, utilization, and location data to the workflow management system. [0022] teaches examining availability of resources for performing the ultrasound examination and [0028] teaches scheduling of resources supporting performance of the medical procedure or ordering of resources supporting performance of the medical procedure (interpreted by examiner as determining resource data of required resources for performing procedural step of the selected physical treatment procedure)); receiving, in the processor of the computer system, patient specific data to be treated ([0027] teaches automatically initiates pre-configuration of the medical device in step 911 for use in the medical procedure using medical record information of the particular patient (interpreted by examiner as receiving the patient specific data to be treated) derived from a repository in HIS 12); and generating, by the processor of the computer system, the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the determined resource data and the received patient specific data, wherein each of the interrelating digital workflow items represents and determines at least one of the procedural steps of the physical treatment procedure to be treated ([0009] teaches a workflow management system that utilizes standardized treatment protocols and assessment of clinical resources to best perform recommended treatment protocols and parallel operations (such as pre-configuration of diagnostic, therapeutic, and monitoring equipment). Workflow as used herein comprises a sequence of tasks, at least partially in a particular order, employed by either, or both, personnel and devices in providing healthcare to a patient and [0018] teaches initiates a workflow task sequence implementing the diagnosis and treatment plan (interpreted by examiner as wherein each of the interrelating digital workflow items represents and determines at least one of the procedural steps of the physical treatment procedure to be treated). Clinical resource availability information is used to plan patient workflow in a clinical setting (interpreted by examiner as generating the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the determined resource data) [0018] teaches a diagnosis and treatment plan is developed and system initiates a workflow task sequence implementing the diagnosis and treatment plan and [0026] teaches the workflow management system and treatment processor in HIS 12 recommend multiple candidate treatment procedures in response to user entered diagnosis criteria (interpreted by examiner as generating the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the received patient specific data)); and transmitting, by the processor of the computer system, at least one of the generated digital workflow items to at least one of: a diagnostic device or a treatment device, connected to the computer system, wherein the generated digital workflow items comprise device instructions, which are used by the respective devices for performing the patient specific diagnostic procedural step or the patient specific treatment procedural step of the patient specific ophthalmic treatment procedure (Petro at [0014] teaches the patient workflow management system operating within a hospital information system (HIS), allows diagnostic and treatment protocols to be selected. These in turn are used by the system to advantageously automatically pre-configure diagnostic, therapeutic, and monitoring equipment. [0020] teaches device configuration. [0027] teaches a configuration manager in system in bidirectional communication with a medical device (interpreted by examiner as the at least one of a diagnostic device or a treatment device) via interface system automatically initiates pre-configuration of the medical device for use in the medical procedure (interpreted by examiner as means for performing the patient specific diagnostic procedural step) and [0029] teaches initiating pre-configuration of medical device for use in a medical procedure and automatically initiating communication of device settings, clinical data and task representative data to one or more destinations. It also teaches acquiring medical device availability information, medical device utilization information and medical device location information from multiple medical devices via interface system (interpreted by examiner transmitting, by the processor of the computer system, at least one of the generated digital workflow items to at least one of: a diagnostic device or a treatment device, connected to the computer system, wherein the generated digital workflow items comprise device instructions, which are used by the respective devices for performing the patient specific diagnostic procedural step or the patient specific treatment procedural step of the patient specific ophthalmic treatment procedure)).
Petro does not explicitly disclose the treatment procedure to be performed is a physical ophthalmic treatment procedure of at least one eye of a patient and the patient specific data is patient specific ophthalmic data wherein the received patient specific ophthalmic data comprises measured data of the at least one eye of the patient, which is measured by an ophthalmic diagnostic device, however Taleb discloses:
the treatment procedure to be performed is a physical ophthalmic treatment procedure of at least one eye of a patient and the patient specific data is patient specific ophthalmic data (Taleb at [0007] teaches an ophthalmic surgical system. [0015] teaches the ophthalmic surgical device receives data from RFID chip that includes a first image of an eye of the patient and [0036] teaches the RFID chip includes information on plurality of parameters about the patient eye (interpreted by examiner as patient specific ophthalmic data). [0031] teaches the ophthalmic surgical system includes a user interface and a surgical microscope for observing an eye during surgery and [0039] teaches execution of an ophthalmic surgery procedure (interpreted by examiner as physical ophthalmic treatment procedure of at least one eye of a patient)) wherein the received patient specific ophthalmic data comprises measured data of the at least one eye of the patient, which is measured by an ophthalmic diagnostic device (Taleb at [0041] and [0047] teach taking a number of measurements of the patients pre-operative eye measured by the ophthalmic surgical system (interpreted by examiner as the measured data of the at least one eye of the patient, which is measured by an ophthalmic diagnostic device)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the workflow of treatment procedure of Petro to incorporate the treatment procedure to be performed is a physical ophthalmic treatment procedure of at least one eye of a patient and the patient specific data is patient specific ophthalmic data wherein the received patient specific ophthalmic data comprises measured data of the at least one eye of the patient, which is measured by an ophthalmic diagnostic device as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 2
Petro and Taleb disclose the limitation of claim 1.
Taleb does not explicitly disclose, however Petro further discloses:
The method according to claim 1, wherein the resource data is determined, by the processor, using received availability data determining the availability of the required resources for performing at least one procedural step of the selected physical treatment procedure (Petro at [0009] teaches clinical resource availability information is used to plan patient workflow in a clinical setting and to preconfigure diagnostic, therapeutic, monitoring and other devices to accelerate and improve patient care (interpreted by examiner as received availability data determining the availability of the required resources for performing at least one procedural step of the selected physical treatment procedure)).
Petro does not explicitly disclose at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure, however Taleb discloses:
at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure (Taleb at [0028] teaches execution of an ophthalmic surgery procedure and [0040]-[055] teaches different steps of the ophthalmic treatment procedure)
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the procedural step of Petro to incorporate at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 3
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose wherein the resource data comprises at least one of: device specific data of required ophthalmic diagnostic devices for diagnostic measurement of the at least on eye of the patient, device specific data of required ophthalmic treatment devices for ophthalmic treatment of the at least one eye of the patient, or further required resource data required for performing at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure, however Taleb further discloses:
The method according to claim 1, wherein the resource data comprises at least one of: device specific data of required ophthalmic diagnostic devices for diagnostic measurement of the at least on eye of the patient, device specific data of required ophthalmic treatment devices for ophthalmic treatment of the at least one eye of the patient, or further required resource data required for performing at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure (Taleb at [0006] teaches an ophthalmic surgical device, [0009] teaches the ophthalmic surgical device further includes a control device associated with the ophthalmic surgical system, wherein the RFID chip is connected to the ophthalmic surgical device, the RFID chip operable to transmit data to the processor and [0015] teaches the ophthalmic surgical device receives data from the RFID chip, wherein the data from the RFID chip includes a first image of an eye of the patient. [0041] teaches the ophthalmic surgical system commences by taking a number of measurements of the patients pre-operative eye. The ophthalmic surgical system may also take images of the pre-operative patient eye. This data is used to make a diagnosis. In one example, the data indicates that the patient requires cataract surgery. The patient data, including measurements and images, is written to the RFID chip using RFID read-write module 140 (interpreted by examiner as device specific data of required ophthalmic diagnostic devices for diagnostic measurement of the at least on eye of the patient)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the resource data of Petro to incorporate wherein the resource data comprises at least one of: device specific data of required ophthalmic diagnostic devices for diagnostic measurement of the at least on eye of the patient, device specific data of required ophthalmic treatment devices for ophthalmic treatment of the at least one eye of the patient, or further required resource data required for performing at least one ophthalmic procedural step of the selected physical ophthalmic treatment procedure as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 5
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose wherein the received patient specific ophthalmic data comprises non-measured patient data received via a human machine interface, which is configured to provide a non-measured patient data input possibility, however Taleb further discloses:
The method according to claim 1, wherein the received patient specific ophthalmic data comprises non-measured patient data received via a human machine interface, which is configured to provide a non-measured patient data input possibility (Taleb at [0026] teaches images of the eye (interpreted by examiner as non-measured patient data). [0032] teaches a user interface that includes an image display (interpreted by examiner the human machine interface). [0037] teaches the ophthalmic surgical system includes surgical instrumentation such as imaging instruments and [0041] teaches the patient data includes measurements and images).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the received patient data of Petro to incorporate wherein the received patient specific ophthalmic data comprises non-measured patient data received via a human machine interface, which is configured to provide a non-measured patient data input possibility as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 6
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose wherein generating of the plurality of interrelating digital workflow items comprises to generate at least one of: a diagnostic digital workflow item determining a patient specific diagnostic procedural step of the physical ophthalmic treatment procedure for measuring ophthalmic data of the at least one eye of the patient to be treated; or a treatment digital workflow item defining a patient specific treatment procedural step of the physical ophthalmic treatment procedure for treating the at least one eye of the patient, however Taleb further discloses:
The method according to claim 1, wherein generating of the plurality of interrelating digital workflow items comprises to generate at least one of: a diagnostic digital workflow item determining a patient specific diagnostic procedural step of the physical ophthalmic treatment procedure for measuring ophthalmic data of the at least one eye of the patient to be treated; or a treatment digital workflow item defining a patient specific treatment procedural step of the physical ophthalmic treatment procedure for treating the at least one eye of the patient (Taleb at [0007] teaches an ophthalmic surgical system. [0031] teaches the ophthalmic surgical system includes a user interface 130 and a surgical microscope 120 for observing an eye during surgery and [0043] teaches execution of an ophthalmic surgery procedure. [0046] teaches developing a surgical plan. [0053] teaches performing operation step and what occurs during a procedure (interpreted by examiner as a diagnostic digital workflow item determining a patient specific diagnostic procedural step of the physical ophthalmic treatment procedure for measuring ophthalmic data of the at least one eye of the patient to be treated))
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the diagnostic digital workflow item of Petro to incorporate wherein generating of the plurality of interrelating digital workflow items comprises to generate at least one of: a diagnostic digital workflow item determining a patient specific diagnostic procedural step of the physical ophthalmic treatment procedure for measuring ophthalmic data of the at least one eye of the patient to be treated; or a treatment digital workflow item defining a patient specific treatment procedural step of the physical ophthalmic treatment procedure for treating the at least one eye of the patient as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 7
Petro and Taleb disclose the limitation of claim 1.
Taleb does not explicitly disclose, however Petro further discloses:
The method according to claim 6, wherein the diagnostic digital workflow item, the treatment digital workflow item, or any other generated digital workflow item comprises at least one of: action type data, patient parameter data, diagnostic or treatment device specific data, personnel specific data, or time specific data (Petro at (0020] teaches device configuration and [0023] teaches pre-configuring an ultrasound imaging device with settings for the particular type of examination required (interpreted by examiner as diagnostic or treatment device specific data)).
REGARDING CLAIM 10
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose wherein at least one of the interrelating digital workflow items is updated, by the processor of the computer system, using newly received patient specific ophthalmic data, which is captured during the implementation of a temporarily previously arranged ophthalmic treatment procedural step associated with a temporarily previously assigned digital workflow items, or wherein at least one of the plurality of the digital workflow items is updated, by the processor, using newly determined resource data or newly received availability data, however Taleb further discloses:
The method according to claim 9, wherein at least one of the interrelating digital workflow items is updated, by the processor of the computer system, using newly received patient specific ophthalmic data, which is captured during the implementation of a temporarily previously arranged ophthalmic treatment procedural step associated with a temporarily previously assigned digital workflow items, or wherein at least one of the plurality of the digital workflow items is updated, by the processor, using newly determined resource data or newly received availability data (Taleb at [0047] teaches comparing the image of the patient eye 200 stored to the RFID chip 150 and an image of the patient eye received by the surgical microscope 120. In another embodiment, the surgical system 100 compares at least one parameter stored to the RFID chip 150 to at least one parameter measured by the ophthalmic surgical system. [0048] teaches altering surgical plan in the case that a patient's eye has changed so drastically in the time period since the last scan (interpreted by examiner as at least one of the interrelating digital workflow items is updated, by the processor of the computer system, using newly received patient specific ophthalmic data, which is captured during the implementation of a temporarily previously arranged ophthalmic treatment procedural step associated with a temporarily previously assigned digital workflow items)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the interrelating digital workflow items of Petro to incorporate updating wherein at least one of the interrelating digital workflow items is updated, by the processor of the computer system, using newly received patient specific ophthalmic data, which is captured during the implementation of a temporarily previously arranged ophthalmic treatment procedural step associated with a temporarily previously assigned digital workflow items, or wherein at least one of the plurality of the digital workflow items is updated, by the processor, using newly determined resource data or newly received availability data as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 11
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose wherein at least one of the plurality of the interrelating digital workflow items comprises patient individual verification data, uniquely identifying the patient, and wherein the patient individual verification data is configured to be compared with respective data for enabling the execution of the associated ophthalmic treatment procedural step at the respective at least one devices, however Taleb further discloses:
The method according to claim 9, wherein at least one of the plurality of the interrelating digital workflow items comprises patient individual verification data, uniquely identifying the patient, and wherein the patient individual verification data is configured to be compared with respective data for enabling the execution of the associated ophthalmic treatment procedural step at the respective at least one devices (Taleb [0047] teaches comparing the image of the patient eye 200 stored to the RFID chip 150 and an image of the patient eye received by the surgical microscope 120. In another embodiment, the surgical system 100 compares at least one parameter (interpreted by examiner as patient individual verification data, uniquely identifying the patient) stored to the RFID chip 150 to at least one parameter measured by the ophthalmic surgical system (interpreted by examiner as compared with respective data for enabling the execution of the associated ophthalmic treatment procedural step at the respective at least one devices)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the interrelating digital workflow items of Petro to incorporate wherein at least one of the plurality of the interrelating digital workflow items comprises patient individual verification data, uniquely identifying the patient, and wherein the patient individual verification data is configured to be compared with respective data for enabling the execution of the associated ophthalmic treatment procedural step at the respective at least one devices as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIM 12
Claim 12 is analogous to Claims 10 and 11 thus Claim 12 is similarly analyzed and rejected in a manner consistent with the rejection of Claims 10 and 11.
REGARDING CLAIM 13
Petro and Taleb disclose the limitation of claim 1.
Taleb does not explicitly disclose, however Petro further discloses:
The method according to claim 1, wherein the method further comprises the step of displaying the generated patient specific digital workflow via a human machine interface device forming part of the computer system or being connected to the computer system to a user (Petro at [0010] teaches a user interface comprises one or more display images enabling user interaction with a processor or other device. [0022] teaches recommending via a display image multiple candidate treatment procedures based on a weighted measure of clinical efficacy and cost in response to physician entered patient diagnosis and assessment data. A physician is also able to select another treatment procedure other than one of the multiple displayed candidate treatment procedures and a scheduled appointment (interpreted by examiner as displaying the generated patient specific digital workflow via a human machine interface device forming part of the computer system or being connected to the computer system to a user)).
REGARDING CLAIM 14
Petro and Taleb disclose the limitation of claim 1.
Petro and Taleb does not explicitly disclose wherein the method further comprises receiving instructions, in the processor of the computer system, from the human machine interface device, which update at least one of the plurality of interrelating digital workflow items of the patient specific digital workflow, however Taleb further discloses:
The method according to claim 13, wherein the method further comprises receiving instructions, in the processor of the computer system, from the human machine interface device, which update at least one of the plurality of interrelating digital workflow items of the patient specific digital workflow (Taleb at [0010] teaches modifying and transmitting information for use by an executable procedure. [0014] teaches making alternative clinical decisions. Clinicians use this data to make fully informed alternative treatment plans in the event of resource unavailability and [0017] teaches configuring adjustable settings of diagnostic devices 33, therapeutic devices 37, monitoring devices 39 and other devices 43 (interpreted by examiner as receiving instructions, in the processor of the computer system, from the human machine interface device, which update at least one of the plurality of interrelating digital workflow items of the patient specific digital workflow)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the interrelating digital workflow items of Petro to incorporate wherein the method further comprises receiving instructions, in the processor of the computer system, from the human machine interface device, which update at least one of the plurality of interrelating digital workflow items of the patient specific digital workflow as taught by Taleb, with the motivation of providing improved methods of storing and retrieving measurements that increase precision in cataract surgery, and therefore improving the accuracy and safety of ophthalmic procedures. (Taleb at [0005]).
REGARDING CLAIMS 15 and 17
Claims 15 and 17 are analogous to Claim 1 thus Claims 15 and 17 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
REGARDING CLAIMS 20-26
Claims 20-26 are analogous to Claims 2, 3, 5 and 6 thus Claims 20-16 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 2, 3, 5 and 6.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-3, 5-7, 10-15, 17 and 20-26, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
While the Examiner characterizes the claim as "organizing human activity," the amended claims demonstrate they are directed to a technological ophthalmological medical system. Applicant's claim 1 does not merely recite rules or instructions for humans to follow; it rather relates to the generation of a patient specific digital twin (workflow) (see e.g. para. [0011] of the original application as filed). This is different from organizing human activity. The digital twin is a functional technological model of a physical surgical procedure that interrelates dynamic clinical resources with measured data.
Regarding 1, The Examiner respectfully disagrees. Claim 1 is directed to an abstract idea. Stripped of all generic computer components, claim 1 recites receiving selection data, determining resource data, receiving patient specific ophthalmic data, generating the patient specific digital workflow and transmitting the generated digital workflow items, which is a series of rules or instructions for a person or persons to follow, with or without the aid of a computer and is a processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity. Moreover, using measured data and clinical resource data to generate workflows does not provide relevance. Regardless of the type of data, this is still an abstract idea.
The process of translating a physical measurement (the patient's eye data) into a machine-executable instruction (the device instruction) via a digital workflow is a technical conversion of data for hardware control. This represents a technical solution to a challenge in ophthalmic surgery - bridging the gap between diagnosis and execution - which is not a routine human organizational activity. Further, claim 1 requires providing the technical diagnostic/treatment devices with instructions. In particular, these instructions are used for performing the procedural step of the patient specific ophthalmic treatment procedure. Already the mere influence of these instructions on the physical world renders the claim more than just an abstract idea. Therefore, the claimed subject-matter cannot be categorized simply as an abstract idea in the sense of "organizing human activity". Even assuming, without admitting, that an abstract idea was present, Applicant's claim 1 still is eligible because it integrates the idea into a practical application that improves a technical field. According to the MPEP, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. Applicant's amended claim 1 requires the computer system to be connected to and transmit instructions to specific medical hardware. This presents a meaningful limitation because it restricts the application of the data processing to a particular clinical environment involving the physical manipulation of medical instruments, thereby integrating the logic into a practical application that improves the operation of those instruments. The claim is narrowly tailored to the specific environment of ophthalmic surgery and require the interaction of multiple physical devices. These limitations ensure the claim does not preempt the general concept of "organizing activity" but applies it to a specific, practical medical application… Claim 1 not only requires the transmission of the workflow items to the device, but further requires the device to use these instructions, which are patient-specific, to treat the patient. This cannot be anything but a practical application with a technical effect.
Regarding 2, the Examiner respectfully disagrees. Providing a device with instructions is an abstract idea as this is mere transmission of data. This cannot provide a practical application nor does it provide technical improvements. The technical environment in which the claim is confined to is a generic processor of a computer system. The claims do not require an active step of controlling the treatment/diagnostic device to perform treatment step. It just sends an instruction.
Automating this process by using the (measured) data provided to the digital twin makes the treatment faster, safer and more personalized to the individual patient, which increases the success rate of the ophthalmological treatment. Using the claimed solution therefore provides a practical application (requirements of the treatment procedure) which improves a technical field (the ophthalmological treatment)… This practical application has a technical effect: it reduces setup time and mistakes made during manual treatment and further increases the precision of the treatment. It ensures that the resulting device instructions and treatment execution are uniquely tailored to the actual patient's condition, leading to enhanced patient safety and increased precision. This instructions via the digital twin are a significant technical improvement of the treatment, as device preparation and operation are optimized for time, cost, and potential for human error associated with manual device instructions are reduced. Further, the digital twin is a digitalized representation of the physical treatment that can be made accessible and adaptable from anywhere. This allows for a centrally managed and synchronized workflow across different devices and clinical locations.
Regarding 3, the Examiner respectfully notes that the improvements the Applicant addresses are not technical improvement nor an improvement to the functioning of a computer. Such improvement are improvements to healthcare provided to a patient. The claim does not improve the functioning of a computer nor improve upon technology.
Lastly, the claimed elements provide an inventive concept that is significantly more than the alleged judicial exception. While processors and medical devices exist, the specific logic of reconciling dynamic resource availability with measured ophthalmological data to drive automated device instructions is not conventional in the field. In particular, the concept of having a digital twin instructing the treatment devices for the treatment procedure is not well-under- stood, routine, or conventional in the field. Furthermore, amended claim 1 moves the invention beyond mere "organizing activity" into the realm of machine-to-machine control. The combination of the digital workflow items being generated using the measured patient-specific data and then being used as device instructions creates a functional loop where the system doesn't just "organize" a schedule but automatically configures medical hardware. Therefore, it is significantly more. The Office previously dismissed the measurement by the ophthalmic diagnostic device as mere "data gathering." However, within the context of amended claim 1, this step is an integrated prerequisite for the closed-loop technological system. The specific measurements from this device are the essential inputs used to generate the device instructions that drive the treatment device. The automation of device setup based on a patient-specific digital model is an inventive concept that replaces the time-consuming and costly manual configuration used in the prior art. Therefore, it is by no means well-understood, routine, or conventional.
Regarding 4, the Examiner respectfully disagrees. The claims do not control a machine but rather receiving selection data, determining resource data, receiving patient specific ophthalmic data, generating the patient specific digital workflow and transmitting the generated digital workflow items, which is an abstract idea. Regardless of the type of data used to generate the workflow items, the claim sends an instruction to a device and that is not the same as controlling a device. As stated above, providing a device with instructions is an abstract idea as this is mere transmission of data. Moreover, 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)). Furthermore, gathering measurement is mere data gathering. The claim is ineligible.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-3, 5-7, 10-15, 17 and 20-26, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Additionally, amended claim 1 requires the workflow to be generated by using determined resource data and measured patient data to determine the procedural steps. As outlined in para. [0074] of the application as filed, this makes the digital workflow in particular accurate and useful for planning and performing the physical ophthalmic treatment procedure. Petro however utilizes resource data solely for the purpose of scheduling and initiating basic device pre-configuration. It does not use this data to determine the content or sequence of procedural steps as part of a patient-specific digital workflow. Neither does Petro use measured patient data to schedule the treatments.
Regarding 1, The Examiner respectfully disagrees. Petro teaches the limitation of “generating, by the processor of the computer system, the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the determined resource data and the received patient specific data, wherein each of the interrelating digital workflow items represents and determines at least one of the procedural steps of the physical treatment procedure to be treated.” Paragraph [0009] of Petro teaches a workflow management system that utilizes standardized treatment protocols and assessment of clinical resources to best perform recommended treatment protocols and parallel operations and that clinical resource availability information is used to plan patient workflow in a clinical setting, which is interpreted by examiner as generating the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the determined resource data. Paragraph [0018] teaches upon patient arrival and admission at a healthcare institution, a diagnosis and treatment plan is developed and system initiates a workflow task sequence implementing the diagnosis and treatment plan, which is interpreted by examiner as generating the patient specific digital workflow comprising a plurality of interrelating digital workflow items using the received patient specific data. Moreover, paragraph [0026] teaches the workflow management system and the treatment processor in HIS 12 recommend multiple candidate treatment procedures in response to user entered diagnosis criteria, interpreted by the examiner as the patient specific information. Moreover, Taleb is relied upon to teach that the patient specific information of Petro is patient specific ophthalmic data that is measured by an ophthalmic diagnostic device. Given the broadest reasonable interpretation, the cited references in combination teach the claimed feature.
Further, amended claim 1 requires that each of the transmitted digital workflow items "represents and determines at least one of the ophthalmic procedural steps" and comprise device instructions for performing those steps. Petro is directed to scheduling and pre- configuring devices based on medical record information. It does not disclose workflow items that are digital representations of the actual procedural steps themselves. Therefore, Petro focuses on the administrative task of making a device available and "ready." It lacks the disclosure of a digital item that determines the actual content of a treatment step by providing instructions for the performance of that step based on the interrelation of resources and measured data.
Regarding 2, the Examiner respectfully disagree. Petro at paragraph [0018] teaches initiating a workflow task sequence implementing the diagnosis and treatment plan, which is interpreted by examiner as the workflow items that are digital representations of the actual procedural steps. Given the broadest reasonable interpretation, the cited references in combination teach the claimed feature.
Further, Applicant does not agree to the Office's interpretation on Petro's "pre- configuration" as a proxy for the claimed "device instructions" comprised by the digital workflow items. Petro discloses that devices are configured in a preliminary stage so they are "advantageously configured ready" for treatment or diagnosis (see para. [0020] of Petro). There is a fundamental technical distinction between configuring a device to be ready for a patient and providing specific instructions for performing a treatment step. Petro's disclosure is limited to setting up the hardware environment based on general medical records. It provides no hint or teaching as to how patient-specific measured data are used to pre-configure the device, let alone to drive the actual execution of a medical step. Consequently, Petro fails to teach not only the presence of workflow items representing a treatment step, but further even if there were said items, they would be merely intended for pre-configuring, and not for enabling the devices to carry out the treatment step, as required in amended claim 1.
Regarding 3, the Examiner respectfully disagrees. Petro at paragraph [0014] teaches the patient workflow management system operating within a hospital information system (HIS) allows diagnostic and treatment protocols to be selected. These in turn are used by the system to advantageously automatically pre-configure diagnostic, therapeutic, and monitoring equipment and at paragraph [0020] teaches device configuration. The examiner interprets that reconfiguration requires the transmission of instructions to the device. Moreover, paragraph [0027] teaches a configuration manager in system in bidirectional communication with a medical device (interpreted by examiner as the at least one of a diagnostic device or a treatment device) via interface system automatically initiates pre-configuration of the medical device for use in the medical procedure (interpreted by examiner as means for providing specific instructions for performing a treatment step) and paragraph [0029] teaches initiating pre-configuration of medical device for use in a medical procedure and automatically initiating communication of device settings, clinical data and task representative data to one or more destinations, which is interpreted by examiner transmitting, by the processor of the computer system, at least one of the generated digital workflow items to at least one of: a diagnostic device or a treatment device, connected to the computer system, wherein the generated digital workflow items comprise device instructions, which are used by the respective devices for performing the patient specific diagnostic procedural step or the patient specific treatment procedural step of the patient specific ophthalmic treatment procedure. The examiner notes that the claim only requires device instruction to be sent, which Petro teaches. Given the broadest reasonable interpretation, the cited references in combination teach the claimed feature.
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:
Walsh (US 2017/0311796) discloses medical devices, systems, and methods for performing eye exams using displays comprising mems scanning mirrors. Kashani (US 2023/0031527) discloses systems and methods for generating accurate ophthalmic measurements.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
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