Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15 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 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.
Step 1
Claims 1-15 are within the four statutory categories. Claims 1-13 are drawn to a system for processing medical information, which is within the four statutory categories (i.e. machine). Claim 14 is drawn to a method for processing medical information, which is within the four statutory categories (i.e. process). Claims 15 is drawn to a “program” for processing medical information, which does not distinguish Claim 15 from a transitory medium or article of manufacture and/or software per se, and hence Claim 15 does not fall within the four statutory categories. However, as will be shown below, even assuming, arguendo, that Claim 15 were directed towards a non-transitory medium or article of manufacture, Claim 15 is nonetheless unpatentable under 35 U.S.C. 101.
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: A medical information processing system comprising:
a central processing unit (CPU) configured to:
manage a software list of a plurality of registered softwares, wherein:
the software list includes contraindication information associated with each registered software of the plurality of registered softwares, and
the contraindication information includes a medical practice that is not adapted to a particular disease and is prohibited due to an adverse effect;
acquire patient information and device information, wherein
the patient information is regarding a patient to whom a software to be activated, of the plurality of registered softwares, is used, and
the device information is regarding an electronic device used for the patient;
determine whether activation of the software to be activated is to be contraindicated, based on whether at least one of the acquired patient information or the acquired device information corresponds to the contraindication information associated with the software to be activated; and
control the activation of the software to be activated, based on whether the activation of the software to be activated is contraindicated.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of managing softwares including contraindication information, acquiring patient and device information, and determining whether software activation is to be contraindicated based on the patient or device information include following rules or instructions to provide access to healthcare software functions to certain users and/or devices), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract ideas are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 14-15 is identical as the abstract idea for Claim 1, because the only difference between Claims 1, 14, and 15 is that Claim 1 recites a system, whereas Claim 14 recites a method, and Claim 15 recites a program.
Dependent Claims 2-13 include other limitations, for example Claims 2-4 recite receiving updated contraindication information that may be updated patient or device information, Claims 5-7 recite particular types of patient information, Claims 8-9 recite particular types of contraindication and device information, Claims 10-11 recite first and second contraindication information, and Claims 12-13 recite stopping the activation of the software based on the contraindication information, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-13 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Hence Claims 1-15 are directed towards the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1 and 14-15 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the list management unit, the information acquisition unit, the contraindication determination unit, and the step of managing the software list) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the CPU, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0169]-[0176] of the as-filed Specification, and see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language reciting the receiving of patient and contraindication information including disease data, which amounts to limiting the abstract idea to the field of healthcare, e.g. see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of managing the software list, which amounts to selecting a particular data source or type of data to be manipulated, and the recitation of activating the software, which amounts to an insignificant application, e.g. see MPEP 2106.05(g).
Additionally, dependent Claims 2-13 include other limitations, but these limitations also amount to no more than generally linking the abstract idea to a particular technological environment or field of use (e.g. the patient state information recited in dependent Claim 6, the state information comprising a state of an endoscope recited in dependent Claim 9), insignificant extra-solution activity (e.g. the stopping of the activating step recited in dependent Claim 12, and the activating based on the selection recited in dependent Claim 13), and/or do not include any additional elements beyond those already recited in independent Claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-15 do not include additional elements that integrate the judicial exceptions into a practical application.
Step 2B
Claims 1 and 14-15 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the list management unit, the information acquisition unit, the contraindication determination unit, and the step of managing the software list), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0169]-[0176] of the as-filed Specification discloses that the additional elements (i.e. the list management unit, the information acquisition unit, and the contraindication determination unit) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives patient and device data over a network, e.g. see [0022] and [0040] of the as-filed Specification;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the creating and maintaining of a software list with corresponding contraindication data;
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing software contraindication data, and retrieving the contraindication data in order to evaluate it against the patient and device data to determine whether the software should be activated;
Cutting hair after first determining the hair style, e.g. see In re Brown – similarly, the additional elements merely recite, at a high level of generality, activating the software based on the determination of whether or not the software is contraindicated;
Dependent Claims 2-13 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the patient state information recited in dependent Claim 6, the state information comprising a state of an endoscope recited in dependent Claim 9), insignificant extra-solution activity (e.g. the preventing of the activating step recited in dependent Claim 12, and the activating recited in dependent Claim 13), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claim 1, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-15 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-4, 10-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2019/0206542) in view of Jain (US 2020/0119986).
Regarding Claim 1, Shelton teaches the following: A medical information processing system comprising:
a central processing unit (CPU) (The system includes a processor, e.g. see Shelton [0255]-[0256].) configured to:
manage a software list of a plurality of registered softwares (The system includes a surgical hub that determines whether to activate various modes (i.e. registered softwares) based on various information including patient data and modular device data, e.g. see Shelton [0325]-[0326] and [0329]-[0335], a normal sequence of procedures, a distance from a surgical site, and/or contact with tissue, e.g. see Shelton [0347], and/or a predetermined threshold that determines the progress of a procedure, e.g. see Shelton [0330].), wherein:
the software list includes contraindication information associated with each registered software of the plurality of registered softwares (The aforementioned various information is used as a basis for determining whether or not modes (i.e. registered software) should be activated, e.g. see Shelton [0325]-[0326], [0329]-[0335], [0347] – that is, the various information used to make the determination of whether or not to activate the mode is interpreted as contraindication information.), and
acquire patient information and device information (The system obtains patient and device data, e.g. see Shelton [0325].), wherein
the patient information is regarding a patient to whom a software to be activated, of the plurality of registered softwares, is used (The system acquires patient data including patient location data and various physiological parameters for the patient in order to determine whether to activate the various modes, e.g. see Shelton [0329]-[0335], Fig. 19.), and
the device information is regarding an electronic device used for the patient (The device data comprises modular devices used in the surgery room, e.g. see Shelton [0241]-[0242], [0322], and [0327].);
determine whether activation of the software to be activated is to be contraindicated, based on whether at least one of the acquired patient information or the acquired device information corresponds to the contraindication information associated with the software to be activated (The system utilizes the obtained data to determined which modules should be activated, e.g. see Shelton [0326]-[0327].); and
control the activation of the software to be activated, based on whether the activation of the software to be activated is contraindicated (The system activates the appropriate modules based on the determination, e.g. see Shelton [0326]-[0327].).
But Shelton does not teach and Jain teaches the following:
wherein the contraindication information includes a medical practice that is not adapted to a particular disease and is prohibited due to an adverse effect (The system includes different programs that may monitor and provide interventions to improve different aspects of the user’s health, wherein the programs may be specialized for treatment or management of specific health conditions including various diseases such as heart disease, e.g. see Jain [0172]. Furthermore, the system utilizes user data in order to determine which programs should be activated and/or deactivated/disabled, e.g. see Jain [0171], [0192], [0203], [0205], and [0212].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Shelton to incorporate activating or deactivating programs based on contraindication information comprising user disease information as taught by Jain in order to improve the user’s behavior or health, e.g. see Jain [0172].
Regarding Claim 2, the combination of Shelton and Jain teaches the limitations of Claim 1, and Shelton further teaches the following: The medical information processing system according to claim 1, wherein the CPU is further configured to:
detect update of at least one of the contraindication information of the software to be activated or the patient information (The system collects data from devices in real time (i.e. the latest data is interpreted as “updated” data), wherein the collected data may include patient data such as patient images, e.g. see Shelton [0242]-[0243] and [0329]-[0335].); and
determine whether the activation of the software to be activated is to be contraindicated based on the detected update of at least one of the contraindication information of the software to be activated or the patient information (The system determines whether to activate a program mode based on the patient information, e.g. see Shelton [0326]-[0327] and [0334].).
Regarding Claim 3, the combination of Shelton and Jain teaches the limitations of Claim 2, and Shelton further teaches the following: The medical information processing system according to claim 2, wherein the CPU is further configured to
determine, based on the detected update of the contraindication information of the software to be activated, whether the acquired patient information or the acquired device information corresponds to the updated contraindication information of the software to be activated (The system includes situational awareness functionality that continuously derives inferences regarding a procedure as data is received, wherein the system may perform actions based on the inferences, for example activating monitors, e.g. see Shelton [0301]. Furthermore, the responses of the system may be altered based on a user’s preferences, e.g. see Shelton [0353] – that is, the system may use a different set of preferences for a user to determine whether or not the system should respond by activating a mode.).
Regarding Claim 4, the combination of Shelton and Jain teaches the limitations of Claim 2, and Shelton further teaches the following: The medical information processing system according to claim 2, wherein the CPU is further configured to
determine, based on the detected update of the patient information, whether the updated patient information corresponds to the contraindication information of the software to be activated (The system collects data from devices in real time (i.e. data for a later time period is interpreted as “updated” data relative to data for an earlier time period), wherein the collected data may include patient data such as patient images, e.g. see Shelton [0242]-[0243] and [0329]-[0335], and wherein the patient data is used as a basis for (i.e. corresponding to) determining whether to activate a mode, e.g. see Shelton [0325]-[0327].).
Regarding Claim 10, the combination of Shelton and Jain teaches the limitations of Claim 1, and Shelton further teaches the following: The medical information processing system according to claim 1, wherein
the contraindication information includes first contraindication information indicating that the software to be activated is prohibited and second contraindication information indicating that the software to be activated is used based on a condition (The system determines when the software should be activated based on various information including patient data and modular device data, e.g. see Shelton [0325]-[0326], a normal sequence of procedures, a distance from a surgical site, and/or contact with tissue, e.g. see Shelton [0347], and/or a predetermined threshold that determines the progress of a procedure, e.g. see Shelton [0330] – that is, the information indicating the software should not be activated is interpreted as “first contraindication information,” and the requirement for the data that indicate that the software should be activated is interpreted as “second contraindication information.”), and
the CPU is further configured to determine whether the acquired patient information or the acquired device information corresponds to the second contraindication information (The system determines whether to activate a previous procedure/network interaction mode and an interactive configurable control mode (i.e. software) based on the received patient and device data, e.g. see Shelton [0326] and [0334].).
Regarding Claim 11, the combination of Shelton and Jain teaches the limitations of Claim 10, and Shelton further teaches the following: The medical information processing system according to claim 10, wherein the CPU is further configured to
determine a change by a certain level or more associated with at least one of the acquired patient information or the acquired device information (The system continually collects data from devices in real time, wherein the collected data may include patient data such as patient images, e.g. see Shelton [0242]-[0243], wherein the system continually derives inferences as new (i.e. changed) data is received, e.g. see Shelton [0301].); and
determine, based on the determined change in at least one of the acquired patient information or the acquired device information, whether the acquired patient information or the acquired device information corresponds to the second contraindication information (The system collects data from devices in real time, wherein the collected data may include patient data such as patient images, e.g. see Shelton [0242]-[0243], wherein the system continually derives inferences as new (i.e. changed) data is received, e.g. see Shelton [0301], and wherein the patient data may dictate that the system activate a program mode, e.g. see Shelton [0326] and [0334] – that is, the patient data collected over time may change from a state dictating that the program mode not be activated (i.e. first contraindication information) to a state dictating that the program mode be activated (i.e. second contraindication information).).
Regarding Claims 14-15, the limitations of Claims 14-15 are substantially similar to those claimed in Claim 1, with the sole difference being that Claim 1 recites a system, whereas Claim 14 recites a method and Claim 15 recites a program. Specifically pertaining to Claims 14-15, Examiner notes that Shelton teaches that the invention may be embodied as machine executable instructions (i.e. a process) and program modules, e.g. see Shelton [0260], [0271], and [0391]-[0393], and hence the grounds of rejection provided above for Claim 1 are similarly applied to Claims 14-15.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shelton and Jain in view of Greenwald (US 2002/0198624).
Regarding Claim 5, the combination of Shelton and Jain teaches the limitations of Claim 2, but does not teach and Greenwald teaches the following: The medical information processing system according to claim 2, wherein
the contraindication information includes a state of the patient to whom the software to be activated is prohibited (The system tracks patient allergy information, wherein the patient allergy information may prevent the distribution of medication, e.g. see Greenwald [0045], and wherein the distribution of the medication may be controlled by a software program, e.g. see Greenwald [0039] and [0045].), and
the CPU is further configured to acquire patient state information regarding the state of the patient as the patient information (The system collects patient records in a database, e.g. see Greenwald [0045].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton and Jain to incorporate the patient allergy state information as taught by Greenwald in order to prevent the execution of conflicting operations, e.g. see Greenwald [0045].
Regarding Claim 6, the combination of Shelton, Jain, and Greenwald teaches the limitations of Claim 5, and Greenwald further teaches the following: The medical information processing system according to claim 5, wherein
the state of the patient includes an allergy or a surgical situation (The system tracks patient allergy information, wherein the patient allergy information may prevent the distribution of medication, e.g. see Greenwald [0045], and wherein the distribution of the medication may be controlled by a software program, e.g. see Greenwald [0039] and [0045].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton and Jain to incorporate the patient allergy state information as taught by Greenwald in order to prevent the execution of conflicting operations, e.g. see Greenwald [0045].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shelton, Jain, and Greenwald in view of Smith (US 2017/0177802).
Regarding Claim 7, the combination of Shelton, Jain, and Greenwald teaches the limitations of Claim 6, but does not teach and Smith teaches the following: The medical information processing system according to claim 6, wherein the CPU is further configured to:
output the state of the patient as analysis information obtained by analysis of a patient image (The system obtains a patient image, for example a skin wheal image captured by an imaging device, wherein the patient image is analyzed to identify an antigen, e.g. see Smith [0006]-[0007] and [0045].), and
detect the update of the patient information based on the obtained analysis information (The system analyzes the patient data over specified time periods (i.e. a later time period is interpreted as an “update”), e.g. see Smith [0027].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton, Jain, and Greenwald to incorporate the patient imaging analysis as taught by Greenwald in order to provide improved recommendations for the patient, e.g. see Smith [0018] and [0020].
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination Shelton and Jain in view of Kimura (US 2020/0265142).
Regarding Claim 8, the combination of Shelton and Jain teaches the limitations of Claim 2, but does not teach and Kimura teaches the following: The medical information processing system according to claim 2, wherein
the contraindication information includes a state of the electronic device to which the software to be activated is prohibited (The system includes a boot processing process that verifies the validity of firmware in order to determine whether or not to prevent the use of a device, e.g. see Kimura [0008]-[0012].), and
the CPU is further configured to acquire the state of the electronic device as the device information (The system obtains an encrypted file that is used to determine the validity of the firmware of the device, e.g. see Kimura [0008]-[0012] and [0055]-[0059].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton and Jain to incorporate the device state information as taught by Kimura in order to prevent the falsification of the device and preventing activation of software whose validity is not ensured, e.g. see Kimura [0012].
Regarding Claim 9, the combination of Shelton, Jain, and Kimura teaches the limitations of Claim 8, and Kimura further teaches the following: The medical information processing system according to claim 8, wherein
the state of the electronic device includes an observation mode of an endoscope (The system prevents the operation of an endoscope if it is determined that the software is not valid, e.g. see Kimura [0008]-[0012] and [0055]-[0059].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton and Jain to incorporate the device state information as taught by Kimura in order to prevent the falsification of the device and preventing activation of software whose validity is not ensured, e.g. see Kimura [0012].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shelton and Jain in view of Harris (US 2017/0296180).
Regarding Claim 12, the combination of Shelton and Jain teaches the limitations of Claim 1, and Shelton further teaches the following: The medical information processing system according to claim 1, wherein the CPU is further configured to:
execute a process associated with the activation of the software to be activated (The system performs a determination (i.e. a process associated with the activation) as to whether a mode (i.e. software to be activated) should be activated based on various received information, e.g. see Shelton [0325]-[0326], [0329]-[0335], [0347].).
But the combination of Shelton and Jain does not teach and Harris teaches the following:
stop the activation of the software to be activated, based on the determination that the activation of the software to be activated is to be contraindicated (The system includes the ability to initiate a program pause (i.e. stopping of activation) based on various conditions, for example a magnitude of forces on a surgical instrument, e.g. see Harris [0140] and [0485]-[0486].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton and Jain to incorporate the pausing of the activation of the program as taught by Harris in order to prevent the surgical equipment from experiencing excessive forces, e.g. see Harris [0485].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shelton, Jain, and Harris in view of Eckert (US 2018/0049792).
Regarding Claim 13, the combination of Shelton, Jain, and Harris teaches the limitations of Claim 12, but does not teach and Eckert teaches the following: The medical information processing system according to claim 12, wherein the CPU is further configured to:
present selection information to select the activation of the software to be activated, based on the determination that the activation of the software to be activated is to be contraindicated (The system is embodied as computer systems executing software program instructions, e.g. see Eckert [0058]-[0059], wherein the system may display to a user an indication that the movement of a blade has stopped (i.e. activation of the software function is contraindicated), wherein a user may provide input to override the stoppage (i.e. selection of necessity of the activation), e.g. see Eckert [0042].), wherein
activate the software to be activated based on the selection of the activation of the software to be activated (The system enables the user to provide input (i.e. a selection) that overrides the stoppage (i.e. activates the software), e.g. see Eckert [0042].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Shelton, Jain, and Harris to incorporate the device stoppage indication as well as the option of manual override as taught by Eckert in order to enable a user to perform actions in an emergency surgical situation, e.g. see Eckert [0042].
Response to Arguments
Applicant’s arguments, see Remarks, filed October 22, 2025, with respect to the interpretation of Claims 1-13 under 35 U.S.C. 112(f) have been fully considered and, in combination with the claim amendments, are persuasive, as the Claims now recite sufficient structure (i.e. the CPU) to perform the claimed functions and hence no longer necessitate interpretation under 35 U.S.C. 112(f). Hence Claims 1-13 are no longer interpreted under 35 U.S.C. 112(f).
Applicant’s arguments, see Remarks, filed October 22, 2025, with respect to the rejections of Claims 1-15 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicants first allege that the claimed invention is patent eligible because it does not recite a mental process and/or a certain method of organizing human activities, specifically because it recites the determination of whether software should be activated, e.g. see pgs. 13-14 of Remarks – Examiner disagrees.
As an initial matter, Examiner notes that, as shown above, the present Claims are no longer interpreted as reciting a mental process, so any arguments pertaining to mental processes is moot.
However, the limitations of managing softwares including contraindication information, acquiring patient and device information, and determining whether software activation is to be contraindicated based on the patient or device information include following rules or instructions to provide access to healthcare software functions to certain users and/or devices. Hence, the claimed limitations cover the abstract idea of a certain method of organizing human activities.
Applicants further allege that the claimed invention is patent eligible because it integrates any abstract idea into a practical application, specifically because the determination of the activation of the software achieves an improvement in the technology by enhancing patient safety, e.g. see pgs. 14-15 of Remarks – Examiner disagrees.
Even assuming, arguendo, that the present invention achieves the improvement of, for example, preventing an inappropriate use of medical device software, this represents an improvement to the abstract idea of a certain method of organizing human activities rather than a technological improvement and/or an improvement to the functioning of the computer itself. This is because the problem of enabling certain functions and/or operations based on various data such as patient and device data has existed since long before the advent of any type of computer technology. That is, the claimed invention may improve the workflow of a patient procedure and/or more efficiently track patient data by virtue of automating these operations on computer hardware, but the problem of “efficiently and safely carrying out a patient procedure” has existed since before computers, and in the present application is only improved by virtue of utilizing a computer as a tool to perform the process.
Applicants also allege that the claimed invention is patent eligible because it recites significantly more than the abstract idea, specifically because the determination of the activation of the software is unconventional, e.g. see pgs. 15-16 of Remarks – Examiner disagrees.
The claim language recites determining whether software is contraindicated based on at least one of the patient and device information corresponding to contraindication information. That is, the claimed invention performs a check prior to activations, wherein the check comprises a check of patient and device data for contraindication data. The operation of performing a safety check prior to activating a software function is a well-understood, routine, and conventional limitation because it is reasonably analogized to storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc., e.g. see MPEP 2106.05(d)(II).
For the aforementioned reasons, Claims 1-15 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed October 22, 2025, regarding the rejections of Claims 1-4, 10-11, and 14-15 under 35 U.S.C. 102(a)(1) have been considered and, in combination with the amendments, are persuasive. The rejections of Claims 1-4, 10-11, and 14-15 under 35 U.S.C. 102(a)(1) have been withdrawn. However, as shown above, due to the newly amended subject matter, Claims 1-15 are nonetheless rejected under 35 U.S.C. 103.
Applicant’s arguments, see Remarks, filed October 22, 2025, regarding the rejections of Claims 5-9 and 12-13 under 35 U.S.C. 103 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection. As stated above, the newly amended claim limitations of Claims 1 and 14-15 has necessitated the new grounds of rejection, and Jain is now cited to address the newly amended claim limitations regarding the contraindication information. Hence Claims 1-13 are rejected under 35 U.S.C. 103 for the reasons disclosed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm PST.
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/JOHN P GO/Examiner, Art Unit 3681