DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the amendment filed on 02/27/2026.
Claims 4-9, 11, 17-20 have been amended and are hereby entered.
Claims 1-20 are currently pending and have been examined.
This action is made final.
Priority
Applicant’s claim to the benefit of and priority to US Provisional Application 63/359,130 is acknowledged. Accordingly, a priority date of 07/07/22 has been given to this application.
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 1-20 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-11 and 16-20 are drawn to a system, and Claims 12-15 are drawn to a method, both of which are within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
managing transfer of patient data for a first medical device between first and second regional entities based on patient data privacy (PDP) requirements for the corresponding first and second regional entities; (Examiner prospectively notes that “first medical device” is included in the scope of the abstract idea as it only describes the type of patient data for which transfer is being managed)
when the first and second regional entities maintain corresponding status indicators associated with a common medical device, communicate with the first and second regional entities to manage the status indicators, maintained by the first and second regional entities, associated with the common medical device;
responsive to a registration request, for a candidate device, from the first regional entity, return a registration response indicating either: i) the candidate device is registered in another regional entity or ii) the candidate device is available for registration; or
responsive to an un-registration request, for a registered device, from the first regional entity, update the status indicator in the global device index for the registered device in connection with the first regional entity.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Managing patient data transfer between different regional entities based on PDP requirements, communicating with the regional entities to manage a status indicator associated with a common medical device, providing a response to a registration request to indicate the device is registered in another entity or is available for registration, and updating a status indicator in an index for a registered device in response to an un-registration request are all personal behaviors that may be performed by personnel working in healthcare fields.
Independent claim 12 recites similar limitations and also recites an abstract idea under the same analysis.
Claim 16 recites implementing the steps of:
sending or receiving patient data, for a first medical device, to or from a second region, the patient data based on patient data privacy (PDP) requirements for at least one of the first and second regions;
responsive to an update request, for a registered device, update the status indicator for the registered device;
responsive to a registration request, for a candidate device, fail the registration of the candidate device if the candidate device is registered in the regional patient device list; or
responsive to an un-registration request, for a registered device, un-register the registered device in the regional patient device list.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Transferring patient data for a medical device between regions, receiving an update request and updating a status indicator, receiving a registration request and either failing the request or un-registering the device are personal behaviors that may be performed by personnel working in healthcare fields.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
a central service center comprising one or more processors that, when executing the program instructions, as implementing the steps of the abstract idea (Claim 1)
first/second regional “systems” as a means of implementing regional entities electronically (Claims 1, 12, 16)
one or more processors executing specific program instructions as implementing the steps of the abstract idea (Claim 12)
a first regional system, comprising: one or more processors executing the program instructions as implementing the steps of the abstract idea (Claim 16)
a second regional system associated with a second region (Claim 16)
regional patient device database as a means of storing information about patients and device registration electronically (Claim 16)
The broad recitation of the above-mentioned general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools. Regarding the one or more processors executing program instructions, this is understood to be a general purpose processor functioning in its ordinary capacity per [0212]. Regarding the central service center comprising one or more processors, this is understood to be a general purpose computer server with a processor functioning in its ordinary capacity per [0185] and [0210]. Regarding “regional systems” this is understood to amount to using computing systems at each region, e.g., paras. [0073], [0187]-[0190]. Regarding the patient database, this is understood to be a general purpose database functioning in its ordinary capacity to maintain/store data electronically, per [0049], [0067], [0073]).
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
B. Insignificant Extra Solution Activity
Claim 1 recites
memory configured to store program instructions and a global device index including database records associated with medical devices, each record including a corresponding unique device identifier (ID), region code and status indicator, the region code associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region
Claim 10 recites:
storing, in memory, a global device index that comprises database records associated with medical devices, each record including a corresponding unique device identifier (ID), region code and status indicator, the region code associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region;
Claim 16 recites:
memory configured to store program instructions and a regional patient device database including database records associated with medical devices, each record including a corresponding unique device identifier (ID) and status indicator, the regional patient device database associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region
As explained above, Claims 1, 12, and 16 are directed to an abstract idea in the forms of managing patient data transfer between different regional entities based on PDP requirements, communicating with the regional entities to manage a status indicator associated with a common medical device, providing a response to a registration request to indicate the device is registered in another entity or is available for registration, or updating a status indicator in an index for a registered device in response to an un-registration request. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the function of storing the first recommendation in memory of the client device is only nominally or tangentially related to the processes described above (e.g., managing data transfer between regional entities or updating a device registration status indicator), and accordingly constitutes insignificant extra-solution activity.
These elements in sections A and B above are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Claims 1, 12, 16 as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1, 12, 16 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the limitations of (Claim 1) memory configured to store program instructions and a global device index including database records associated with medical devices, each record including a corresponding unique device identifier (ID), region code and status indicator, the region code associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region; (Claim 10) storing, in memory, a global device index that comprises database records associated with medical devices, each record including a corresponding unique device identifier (ID), region code and status indicator, the region code associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region; (Claim 16) memory configured to store program instructions and a regional patient device database including database records associated with medical devices, each record including a corresponding unique device identifier (ID) and status indicator, the regional patient device database associated with a region having corresponding patient data privacy (PDP) requirements, the status indicator indicative of whether the corresponding medical device is active in the corresponding region, only amount to insignificant extra-solution activity of the abstract idea.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B above constitute well-understood, routine and conventional activity. The steps listed in Section B above only amounts to storing/retrieving data in memory, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims 2-11, 13-15, 17-20 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 an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claims 2, 10, 13 recite limitations which further narrow the scope of the independent claims. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 3 recites wherein the global device index is further configured to store, associated with the unique IDs, data that does not include patient information identified by the PDP requirements of the first and second regional systems, which amounts to insignificant extra-solution activity, as storing data associated with the unique IDs that does not include patient information is only nominally or tangentially related to the abstract ideas set out above. In addition to amounting to insignificant extra-solution activity, this limitation also constitutes well-understood, routine and conventional activity in the form of storing/retrieving information in memory. These types of activities have been recognized by the courts as well-understood, routine and conventional activity when claimed as insignificant extra-solution activity. See MPEP 2106.05(d).
Claims 4-9, 11, 14-15, 18-20 merely describe performing additional data collection, processing, analysis and/or output functions, which amount to certain methods of organizing human activity including managing personal behavior or interactions between people. The claims recite additional elements consistent with the additional elements identified above with respect to the independent claims (e.g., processors, regional “systems”) and only amount to mere instructions to apply the abstract idea. MPEP 2106.05(f). Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claims 4-9, 11, 14, 15, 17-20 also include recitations of transmitting or receiving data (e.g., Claim 4 recites limitations pertaining to “receiving the registration request” and “transmitting a communication to the first regional system”) which only amounts to insignificant extra-solution activity in the form in the form of transmitting/receiving data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Claim 11, 17 also recite receiving an “input token value” which amounts to mere instructions to apply the abstract idea using a general purpose computer (MPEP 2106.05(f)); see at least paras. [0140]-[0150]). These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1, 12 or 16 respectively. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 2-11, 13-15, 17-20, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-20 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
Claim Objections
The objections to Claims 4-9, 11, 17-20 for minor informalities are withdrawn in view of Applicant’s amendments to these claims.
35 USC 101 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks at pages 13-14 pertaining to Step 2A Prong 1, Applicant states “The claims do not concern a mental process to be followed by a physician or other person”. Examiner respectfully submits that the claims have been identified as being directed to certain methods of organizing human activity, and not mental processes; nor was it stated that the claims “concern a mental process to be followed by physician or other person”. Regarding the footnote to the example in MPEP pertaining to “mental process that a neurologist should follow when testing a patient for nervous system malfunctions”, Examiner submits that this is a non-limiting example. This argument is not persuasive.
Applicant asserts (page 13), “The claims require the manage, communicate, return, and update operations to be performed by or under control of a processor. Also, the present specification is clear and consistent throughout that the manage, communicate, return, and update operations are performed by the processor. For example, Applicant's application supports the use of the processor(s) as shown in FIGS. 3-7 and 9-11 and at least at the following (citations to paras. [0068], [0069], [0072]). Examiner respectfully submits that performing the steps with a processor only amounts to applying the abstract idea using general purpose computing elements, e.g., mere instructions to apply the abstract idea. Applicant has not provided, nor can Examiner find evidence that the processor is anything other than a general purpose processor functioning in its ordinary capacity to implement the steps of the abstract idea. See MPEP 2106.05(f):
As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding remarks pertaining to certain methods of organizing human activity (page 14), Examiner respectfully disagrees with Applicant’s position. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent personal behaviors that a person working in the healthcare space would perform, with or without the aid of a computer, for managing patient data transfer between different regional entities based on PDP requirements, communicating with the regional entities to manage a status indicator associated with a common medical device, providing a response to a registration request to indicate the device is registered in another entity or is available for registration, and updating a status indicator in an index for a registered device in response to an un-registration request. Examiner submits that the independent claims have been parsed to identify additional elements and the limitations falling within the scope of the abstract idea, e.g., personal behaviors that may be performed by personnel working in the healthcare space. Recitation of “processor” only amounts to mere instructions to apply the abstract idea (MPEP 2106.05(f) as discussed above). This argument is not persuasive.
Regarding remarks directed to Step 2A Prong 2 and integration into a practical application, Applicant remarks at page 15 “The claims recite additional elements demonstrating that the claims as a whole are integrated into a practical application”. Examiner respectfully disagrees. The Examiner respectfully disagrees. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer. Applicant has not identified, nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to run faster, more efficiently, or utilize less power. Because there is no improvement to the function of the computer, a practical application is not present.
MPEP 2106.04(d)(1) also states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer (see Spec. Para. [0185] and [0210]-[0211]) and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine). Applicant’s claimed invention recites the additional element(s) of a central service center comprising one or more processors, one or more processors executing specific program instructions, a first regional system, comprising: one or more processors executing the program instructions, a second regional system, a regional patient device database. While these additional elements implement the steps of the abstract idea, there is no indication that these additional elements operate in a manner different than they normally operate. Operating another device in the manner it normally operates is insufficient to improve that other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Regarding remarks beginning at bottom of page 15 (“Applicant is solving problems associated with the location of medical devices and associated patient data in healthcare systems that include multiple regions with different PDP requirements…”), Examiner respectfully submits that any purported improvements may be improvements to the abstract idea, but are not technological improvements. For example, Applicant states at page 16, “Applicant's systems and methods identify the location of a medical device and request patient data from and/or push patient data to another region without exposing protected patient data to any personnel, and locate the medical device based on data that is de-identified of patient information”. Examiner submits that any purported improvements come from the abstract idea itself – e.g., identifying the location of a medical device, requesting patient data and/or providing patient data to another region without exposing protected patient data, are within the scope of the abstract idea as they are personal behaviors that may be performed by personnel working in the healthcare space. Please see 2106.04(d)(II) which states “The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h)”, and see also, MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements” (Emphasis Examiner). Applicant has not provided, nor can Examiner find evidence of, how any of the additional elements identified above in main 101 analysis section are providing an improvement over prior art systems. The additional elements identified above are understood to be computing components functioning in their normal operating capacity, which is not sufficient to integrate the judicial exception into a practical application. Therefore, this argument is not persuasive.
Regarding remarks at page 16 in which Applicant asserts “the claims apply the alleged judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment”, Examiner respectfully disagrees. Specifically, with respect to remark pertaining to “practical result these additional elements achieve together”, Examiner notes that Applicant has not cited to, nor can Examiner find, evidence in the specification regarding how the additional elements amount to anything more than general purpose computing components functioning in their ordinary capacities. Applicant has not cited to, nor can Examiner find, evidence in specification regarding how the combination of additional elements provides an improvement over prior art systems or amounts to significantly more. This argument is not persuasive.
Regarding remarks at bottom of page 16, Examiner respectfully disagrees with Applicant’s position; see above remarks pertaining to MPEP 2106.05(a). Any purported improvements appear to come from the abstract idea itself, which is not sufficient to integrate the judicial exception into a practical application. Examiner prospectively notes that Applicant appears to be arguing a particular interpretation of the claims. For example, representative Claim 1 uses “at least one of” claim construction for the limitations (“manage transfer…”, “communicate…”, “return a registration response…”, “update the status indicator…”). If only one of these is required per claim construction, e.g., the last limitation pertaining to updating a status indicator in response to an un-registration request, Examiner submits that no secure transfer of PDP is required. This is not persuasive.
Regarding remarks directed to the dependent Claims, Examiner submits that the dependent claims only amount to limitations which further narrow the scope of the abstract idea, amount to mere instructions to apply the abstract idea (MPEP 2106.05(f)) or amount to insignificant extra-solution activity that amounts to well-understood, routine and conventional activity, as delineated in Non-Final Action and above in 101 section. This is not persuasive.
Regarding remarks at page 19 pertaining to Step 2B, Examiner respectfully disagrees that the claims as a whole amount to significantly more than the abstract idea. Applicant remarks, “Patients move and/or travel between regions with different PDP requirements, and patients' personal data must be protected and not exposed as they receive healthcare”. Examiner submits that the problem of patients moving/traveling between regions with different PDP requirements is not a problem caused by the technological environment of the claim, e.g., this problem is not caused by the computer systems. Any purported improvements may be, at best, improvements to the abstract idea, which is not sufficient to amount to significantly more than the judicial exception.
For the above reasons, the rejections of Claims 1-20 under 35 USC 101 are maintained.
35 USC 103 Rejections
Applicant’s remarks have been fully considered and are persuasive. A search of publicly available prior art fails to yield a reference or combination of references that would make the claimed combination obvious when considered as a whole. The rejections of Claims 1-20 are withdrawn.
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20190125486 A1, teaching on methods and systems for tracking an asset in a medical environment and determining its status
US Publication 20220359064A1, teaching on management of medical equipment and responders
US Publication 20160055740 A1, teaching on systems and methods for medical device location discovery
US Publication 20210021423 A1, teaching on a procedure for unified global registration and universal identification of spatially locatable objects
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST, and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long, can be reached on 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
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