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 amendment dated 11/12/2025, the following occurred: Claims 1, 9, 11, 13, 15 and 17 have been amended, claims 4, 16 and 18 have been canceled without prejudice or disclaimer, and claim 19 has been added.
Claims 1-3, 5-15, 17 and 19 are currently pending.
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 1-15, 17 and 19 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. The claim recites a method and a system for generating a patient specific digital workflow of a physical ophthalmic treatment procedure of at least one eye of a patient to be treated.
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; and 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 as crafted, 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 (in claim 1) a processor and a computer system, (in claim 15) a computer program product, a processor and a computer system and (in claim 17) an ophthalmic workflow generator, a computer system and a processor, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the processor, computer system, computer program product and the ophthalmic workflow generator, the claims encompass generating a patient specific digital workflow of a physical ophthalmic treatment procedure of at least one eye of a patient to be treated 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 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 server or generic computer component 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 and 5 further recite the additional element of an ophthalmic diagnostic device. This additional element is recited at a high level of generality (i.e. general means to measure data) and amounts to extra solution data gathering activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
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 element an ophthalmic diagnostic device was considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare. Well-understood, routine and conventional activity cannot provide an inventive concept (“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)); 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 2-3, 5-14 and 19 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 3 further merely describe(s) the resource data. Claim(s) 3 includes the additional element of “ophthalmic treatment device” which is interpreted as additional element and does not provide practical application or significantly more. Claim(s) 5 further merely describe(s) the received patient specific ophthalmic data. Claim(s) 3 include the additional element of “ophthalmic diagnostic device” which is interpreted as additional elements and does not provide practical application or significantly more. Claim(s) 6 further merely describe(s) generating diagnostic digital workflow item. Claim(s) 7 further merely describe(s) the diagnostic digital workflow item. Claim(s) 8 further merely describe(s) transmitting the generated digital workflow items. Claim(s) 9 further merely describe(s) the generated digital workflow items. Claim(s) 10 further merely describe(s) updating the interrelating digital workflow items. Claim(s) 11 further merely describe(s) at least one of the plurality of the interrelating digital workflow items. Claim(s) 9 and 11 include the additional element of “at least one devices” which is interpreted as additional elements and does not provide practical application or significantly more. Claim(s) 12 further merely describe(s) the patient individual verification data. Claim(s) 12 includes the additional element of “a treatment device” which is interpreted as additional element and does not provide practical application or significantly more. Claim(s) 13 further merely describe(s) displaying generated patient specific digital workflow. Claim(s) 14 further merely describe(s) receiving instructions. Claim(s) 13 and 14 include the additional element of “a human machine interface” which is interpreted as additional element and does not provide practical application or significantly more. Claim(s) 8 and 19 include the additional element of “a diagnostic device”, “a treatment device” and “a human machine interface” which are interpreted as additional elements and do not provide practical application or significantly more. Claim(s) 19 further merely describe(s) the computer program code.
Claims 15 and 19 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 Claim 19.
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, 5-15, 17 and 19 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 ([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 20 (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. [0018] teaches a diagnosis and treatment plan is developed and system 15 initiates a workflow task sequence implementing the diagnosis and treatment plan and [0029] teaches configuration manager initiates communication of device settings, clinical data and task representative data to one or more destinations, in response to a determination of unavailability of the first medical device for the scheduling of the particular patient to receive the medical procedure. The configuration manager in step 914 acquires medical device availability information, medical device utilization information and medical device location information from multiple medical devices via interface system 20. (interpreted by examiner generating 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)).
Petro does not explicitly disclose, 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 130 and a surgical microscope 120 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 ophthalmic surgery and ophthalmic patient 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 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 the system uses intelligent, networked diagnostic, therapeutic, monitoring and other devices to provide device performance and availability information. 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, 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 the ophthalmic procedural step 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, 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 210. 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 150 using RFID read-write module 140).
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 data of Petro to incorporate the device specific 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 5
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose, 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 data of Petro to incorporate the non-measured patient data received via a human machine interface 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 6
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose, 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 the diagnostic digital workflow item determining a patient specific diagnostic procedural step of the 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 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 8
Petro and Taleb disclose the limitation of claim 1.
Taleb does not explicitly disclose, however Petro further discloses:
The method according to claim 1, the method further comprising transmitting at least one of the generated digital workflow items to at least one of: a diagnostic device, a treatment device, or a human machine interface, connected to the computer system (Petro at [0027] teaches a configuration manager in system 15 in bidirectional communication with a medical device via interface system 20 automatically initiates pre-configuration of the medical device for use in the medical procedure (interpreted by examiner as transmitting at least one of the generated digital workflow items to at least a diagnostic device)).
REGARDING CLAIM 9
Petro and Taleb disclose the limitation of claim 1.
Taleb does not explicitly disclose, however Petro further discloses:
The method according to claim 8, wherein the generated digital workflow items comprise device instructions, which are used by the respective at least one of 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 (0020] teaches device configuration (interpreted by examiner as the device instructions, which are used by the respective at least one of devices for performing the patient specific diagnostic procedural step)).
REGARDING CLAIM 10
Petro and Taleb disclose the limitation of claim 1.
Petro does not explicitly disclose, 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 the interrelating digital workflow items using newly received patient specific ophthalmic 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, 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 patient individual verification data, uniquely identifying the patient and comparing with respective data for enabling the execution of the associated ophthalmic treatment procedural step 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 and 19 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, however Petro and 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 the updates 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 19
Claim 19 is analogous to Claim 8 thus Claim 19 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 8.
REGARDING CLAIMS 15 and 17
Claims 15 and 17 are analogous to Claims 1-14 thus Claims 15 and 17 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-14.
Response to Arguments
Drawing Objections
Regarding the drawing objection(s), the Applicant has amended the fig. 8 and 9 to overcome the basis/bases of objection.
Claim Objections
Regarding the drawing objection(s), the Applicant has amended claims 4, 9, 11 and 13 to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-3, 5-15, 17 and 19, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Amended claim 1 is directed to a specific technological solution: generating patient specific ophthalmic workflow items based on measured patient-specific ophthalmic data and resource data. This is an implementation improving medical device coordination and patient care, in particular using real world measured data (measured data of the at least one eye of the patient). Accordingly, claim 1 is not directed to an abstract idea. Even assuming arguendo that the claim involves an abstract concept, it is at least integrated into a practical application. In particular, the claimed subject matter uses measured patient- specific ophthalmic data, not generic data, and previously determined resource data to generate workflows. These workflow items enable accurate and efficient planning (see Applicants' original disclosure) and therefore demonstrate a technological improvement in ophthalmic treatment delivery, a practical application. Amended claim 1 recites significantly more than generic computing: The integration of measured ophthalmic data ensures that the workflows are tailored to actual patient conditions. The generation of interrelated workflow items based on both resource data and measured patient- specific data is not routine or conventional in the field. The combination of these elements produces a specific technical effect: improved accuracy and consistency in ophthalmic treatment planning, reduced clinician burden, and enhanced patient safety. Therefore, it overcomes disadvantages of the prior art (see, e.g., paragraph [0004] of Applicants' description as originally filed). This inventive concept transforms the amended new claim 1 into patent-eligible subject matter.
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 and generating the patient specific digital workflow, represents and determines at least one of the ophthalmic procedural steps of the physical ophthalmic treatment procedure, which is a processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including a person following a set of rules or instructions to receiving selection data, determining resource data, receiving patient specific ophthalmic data and generating the patient specific digital workflow, represents and determines at least one of the ophthalmic procedural steps of the physical ophthalmic treatment procedure). Moreover, using measured patient- specific ophthalmic data, not generic data, and previously determined resource data to generate workflows does not provide a practical application. Regardless of the type of data, this is still an abstract idea.
Furthermore, improving medical device coordination and patient care, in particular using real world measured data (measured data of the at least one eye of the patient), improving accuracy and consistency in ophthalmic treatment planning, reducing clinician burden, and enhancing patient safety are not a 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.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-3, 5-15, 17 and 19, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Furthermore, it would not have been obvious for a person skilled in the art to combine Petro with Taleb. As the Office states, Taleb teaches the surgical device receives data from an RFID chip (paragraph [0015]). Office, p. 12. Applicants contend that cited paragraph [0015] in fact teaches away from the system approach essential in Petro (see, e.g., paragraphs [0012]-[0013]), which details the drawbacks of such an approach as degraded patient care, undetected theft, hampered performance management and no system wide clinical utility. Paragraph [0036] of Taleb further suggests encrypting the data stored on the RFID chip to prevent unauthorized access. In a clinic wide network as used in Petro, data security cannot be ensured with the same level of control as with data stored on a local device. Taleb teaches in paragraph [0005] that improved methods of storing and retrieving these data are desirable. Therefore, a person skilled in the art would have refrained from inserting measured patient specific ophthalmic data into the workflow management system used in Petro. Instead, a person skilled in the art would have kept the data on an RFID chip as suggested by Taleb and would have read out these data only when the patient arrived for treatment at the specific device with his RFID chip. Therefore, the workflow management system of Petro cannot be obviously adapted to use patient specific ophthalmic data to generate the digital workflow items, because the system would never have access to such data. Accordingly, as the combination of Petro and Taleb fail to teach and suggest each and every features of Applicants' claim 1, withdrawal of the rejection is respectfully requested. Claim 15 has been amended to recite similar features as in claim 1. Thus for at least similar reasons, claim 15 is allowable over the art of record. Claims 2-3, 5-14, 17, and 19, which depend from one of claims 1 or 15, are allowable over the art of record for their dependency and further in view of the novel features recited therein..
Regarding 1, The Examiner respectfully disagrees. Taleb is relied upon to teach that 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 130 and a surgical microscope 120 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)).
Given the broadest reasonable interpretation, the cited references in combination teach the claimed feature.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
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:
DelMonego (US 7562026 B2) healthcare procedure and resource scheduling system.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683