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 .
Notice to Applicant
In the amendments filed on June 15, 2026. Claims 1-13 were previously canceled. Claims 14 and 23 have been amended. Claims 14-31 are pending and examined hereinbelow.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 7, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
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Claims 14, 16-23, and 25-31 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 14, 16-23, and 25-31 of US Patent No. 12,205,727 (hereafter, ‘727 Patent). Although the conflicting claims are not identical, they are not patentably distinct from each other. Claim 14 of the instant application and Claim 14 of the ‘727 Patent are drawn to a system for selecting a treatment regimen for a particular patient, respectively. Claim 23 of the instant application and Claim 23 of the ‘727 Patent are drawn to a computer-implemented method for selecting a treatment regimen for a particular patient. The claim limitations of these two inventions are substantially identical with the exception of specifically, determine a likelihood estimation that the first treatment regimen is an appropriate treatment regimen to treat the first microbial infection.
Claim 1 of instant application
Claim 1 of US Patent 12,205,727
A system for selecting a treatment regimen for a particular patient, the system comprising: a computing device in communication via a network with a remote computing system, the remote computing system in communication with a periodically updated first data store comprising a plurality of patient records for a plurality of patients and a periodically updated second data store comprising efficacy rates of a plurality of treatment regimens against a plurality of microbial infections, the efficacy rates indicating resistance rates of the plurality of microbial infections to the plurality of treatment regimens, the remote computing system configured to generate a database comprising a subset of the plurality of patient records from the first data store appended with efficacy rates for the first microbial infection from the second data store, each patient record of the subset associated with diagnosis or treatment of the first microbial infection, the computing device comprising one or more processors and a non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to:
A system for selecting a treatment regimen for a particular patient, the system comprising: a dynamically updated first data store comprising a plurality of patient records for a plurality of patients; a dynamically updated second data store comprising efficacy rates of a plurality of treatment regimens against a plurality of microbial infections, the efficacy rates indicating resistance rates of the plurality of microbial infections to the plurality of treatment regimens; and a hardware processor configured to execute computer-executable instructions to:
generate a database comprising a subset of the plurality of patient records from the first data store appended with efficacy rates for the first microbial infection from the second data store, each patient record of the subset associated with diagnosis or treatment of the first microbial infection;
receive, from a user of the computing device, an indication of a first microbial infection of the particular patient and a first treatment regimen to be prescribed to treat the first microbial infection;
receive an indication of a first microbial infection of the particular patient and a first treatment regimen to be prescribed to treat the first microbial infection;
and transmit the indication to the remote computing system via the network, wherein the transmitted indication causes the remote computing system to:
generate a model configured to identify, based on the database, a first efficacy rate of the first treatment regimen to treat the first microbial infection and a second efficacy rate of a second treatment regimen to treat the first microbial infection;
generate a dynamic model configured to: determine a likelihood estimation that the first treatment regimen is an appropriate treatment regimen to treat the first microbial infection; and identify, based on the database, a first efficacy rate of the first treatment regimen to treat the first microbial infection and a second efficacy rate of a second treatment regimen to treat the first microbial infection;
generate an alert when the identified first efficacy rate is less than a first threshold level or the identified second efficacy rate is greater than a second threshold level, the alert configured to cause the computing device to activate an application on the computing device to display the alert to the user;
generate a first alert when the identified first efficacy rate is less than a first threshold level or the identified second efficacy rate is greater than a second threshold level;
transmit the alert to the computing device via the network; wherein the computing device is further configured to activate the application on the computing device, in response to receiving the alert from the remote computing system, to display the first alert to the user.
transmit the first alert to a computing device associated with the user via a wireless communication network, wherein the first alert causes the computing device to activate an application on the computing device to display the first alert to the user.
Claim 14 of the ’727 patent embodies all of the limitations of Claim 1 of the instant application with the exception of: determine a likelihood estimation that the first treatment regimen is an appropriate treatment regimen to treat the first microbial infection.
At the time the application was filed the limitation of “determine a likelihood estimation that the first treatment regimen is an appropriate treatment regimen to treat the first microbial infection” were old and well-known to persons having ordinary skill in the art. For example, U.S. Patent Application Publication No. 2002/0107641 by inventor Schaeffer teaches knowledge discovery techniques may further operate on the database to provide suggested courses of treatment for a virtual class of patients, epidemic threat awareness, and knowledge of drug resistance mutations by a pathogen without direct query of the database, (Abstract), The present invention thus allows prediction, or diagnosis, for the particular patient, of the most likely pathogen to the causative agent of the infection and prediction, or prescribing, of an effective treatment for the infection, (para. 44), predicting an effective course of treatment for the bacterial infection prior to performing a diagnostic test on a sample from the human patient, (para. 47). The Schaeffer reference in combination with the ‘727 Patent renders the claims of the instant application not patentably distinct.
Claim 23 of the instant application and Claim 23 of the ‘727 patent contain the same limitations as Claim 14 of the instant application and Claim 14 of the ‘727 patent. Therefore, Claim 23 is not patentably distinct from Claim 23 of the ‘727 patent in view of Schaeffer for the same reasons as Claim 14 of the instant application.
Claim 16 of the instant application disclose substantially the same subject matter as Claim 16 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 17 of the instant application disclose substantially the same subject matter as Claim 17 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 18 of the instant application disclose substantially the same subject matter as Claim 18 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 19 of the instant application disclose substantially the same subject matter as Claim 19 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 20 of the instant application disclose substantially the same subject matter as Claim 20 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 21 of the instant application disclose substantially the same subject matter as Claim 21 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 22 of the instant application disclose substantially the same subject matter as Claim 22 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 24 of the instant application disclose substantially the same subject matter as Claim 24 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 25 of the instant application disclose substantially the same subject matter as Claim 25 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 26 of the instant application disclose substantially the same subject matter as Claim 25 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 27 of the instant application disclose substantially the same subject matter as Claim 27 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 28 of the instant application disclose substantially the same subject matter as Claim 28 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 29 of the instant application disclose substantially the same subject matter as Claim 29 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 30 of the instant application disclose substantially the same subject matter as Claim 30 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
Claim 31 of the instant application disclose substantially the same subject matter as Claim 31 of the ‘727 patent and are thus not patentably distinct in view of Schaeffer.
For these reasons, the claims of the instant application are not identical to claims 14 and 16-31 of US Patent No. 12,205,727 but they are not patentably distinct.
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 14-31 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 14-31 are directed to selecting a treatment regimen for a particular patient, which is considered managing personal behavior. Managing personal behaviors fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea).
Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claim 14-22 recite a system comprising a computing device in communication via a network. Claims 23-31 recite a method and at least one step. Therefore, the claims are each directed to one of the four statutory categories of invention (process and manufacture).
Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claim 14, the claim sets forth a system for selecting a treatment regimen for a particular patient, in the following limitations:
comprising a plurality of patient records for a plurality of patients and comprising efficacy rates of a plurality of treatment regimens against a plurality of microbial infections, the efficacy rates indicating resistance rates of the plurality of microbial infections to the plurality of treatment regimens, comprising a subset of the plurality of patient records appended with efficacy rates for the first microbial infection, each patient record of the subset associated with diagnosis or treatment of the first microbial infection,
receive an indication of a first microbial infection of the particular patient and a first treatment regimen to be prescribed to treat the first microbial infection; and
transmit the indication to:
configured to identify a first efficacy rate of the first treatment regimen to treat the first microbial infection and a second efficacy rate of a second treatment regimen to treat the first microbial infection;
generate an alert when the identified first efficacy rate is less than a first threshold level or the identified second efficacy rate is greater than a second threshold level, the alert configured to alert to the user; and
transmit the alert;
in response to receiving the alert, the first alert to the user.
The above-recited limitations manage personal behavior of a patient to select a treatment regimen for a particular patient. This arrangement amounts to managing personal behavior. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 14 does recite additional elements:
a computing device in communication via a network with a remote computing system, the remote computing system in communication with a periodically updated first data store;
a periodically updated second data store;
the remote computing system configured to generate a database;
from the first data store;
from the second data store;
the computing device comprising one or more processors and a non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to;
from a user of the computing device;
to the remote computing system via the network, wherein the transmitted indication causes the remote computing system;
generate a model;
based on the database;
cause the computing device to activate an application on the computing device to display;
to the computing device via the network;
wherein the computing device is further configured to activate an application on the computing device;
from the remote computing system.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“a computing device in communication via a network with a remote computing system, the remote computing system in communication with a periodically updated first data store”, “a periodically updated second data store”, “the remote computing system configured to generate a database”, “from the first data store”, “from the second data store”, “the computing device comprising one or more processors and a non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to”, “from a user of the computing device”, “to the remote computing system via the network, wherein the transmitted indication causes the remote computing system”, “generate a model”, “based on the database”, “cause the computing device to activate an application on the computing device to display“, “to the computing device via the network”, “wherein the computing device is further configured to activate an application on the computing device”, “from the remote computing system”) and insignificant pre-and-post solution activity (periodically updating, receiving, transmitting, generating, and activating). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 97-99 and 126-130 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable, i.e. the dynamic system 103 may include, for example, hardware, firmware, and software, or any combination therein, (para. 130). That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claim 23 is parallel in scope to claim 14 and ineligible for similar reasons.
Dependent Claims:
Dependent Claims 15-22 and 24-31 add further limitations which are also directed to an abstract idea.
For example, Claims 16 and 25 sets forth:
update based on patient records of the additional patient records that are associated with the first microbial infection and the efficacy rates for the first microbial infection.
Such a recitation merely embellishes the abstract idea of selecting a treatment regimen for a particular patient. These limitations amount to managing personal behavior. Managing personal behaviors fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain Method of Organizing Human Activity). While the claim does set forth the additional limitation of “the remote computing system”, “the database”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Response to Arguments
Applicant's arguments filed June 15, 2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are not directed to an abstract idea and that the claims amount to significantly more than the identified judicial exception.
In response, Examiner respectfully disagrees. The steps of the claim limitations outlined above in the 35 U.S.C. 101 rejection are comprised of generic computer elements to perform an existing business process. Examiner finds the claims recite mere instructions to implement the abstract idea on a computer and uses the computer as a tool to perform the abstract idea without reciting any improvements to a technology, technological process or computer- related technology. The activation of an application is not a technological improvement and is just extra solution activity. It does not improve the function of the computer. Further, the improvement is not to a computing device, the computing device is recited at a high level of generality that it merely adds the words apply it with the judicial exception (See MPEP 2106), where nothing specific with regard to the computing device are claimed at all. Regarding, the steps that Applicant points to (receive, from a user of the computing device, an indication of a first microbial infection of the particular patient and a first treatment regimen to be prescribed to treat the first microbial infection; and transmit the indication to the remote computing system via the network, wherein the transmitted indication causes the remote computing system to: generate a model configured to identify, based on the database, a first efficacy rate of the first treatment regimen to treat the first microbial infection and a second efficacy rate of a second treatment regimen to treat the first microbial infection; generate an alert when the identified first efficacy rate is less than a first threshold level or the identified second efficacy rate is greater than a second threshold level, the alert configured to cause the computing device to activate an application on the computing device to display the alert to the user; and transmit the alert to the computing device via the network; wherein the computing device is further configured to activate the application on the computing device, in response to receiving the alert from the remote computing system, to display the alert to the user) are merely narrowing the abstract idea to a particular technological environment, which has been found to be ineffective to render an abstract idea eligible. The structural elements of the present application (i.e. “a computing device in communication via a network with a remote computing system, the remote computing system in communication with a periodically updated first data store”, “a periodically updated second data store”, “the remote computing system configured to generate a database”, “from the first data store”, “from the second data store”, “the computing device comprising one or more processors and a non-transitory memory storing instructions that, when executed by the one or more processors, cause the one or more processors to”, “from a user of the computing device”, “to the remote computing system via the network, wherein the transmitted indication causes the remote computing system”, “generate a model”, “based on the database”, “cause the computing device to activate an application on the computing device to display“, “to the computing device via the network”, “wherein the computing device is further configured to activate an application on the computing device”, “from the remote computing system”, etc.) are used as tools to perform an existing business process and does not improve upon a technology, technological field or computer-related technology.
Questions of preemption are inherent in the two-part framework from Alice Corp. and Mayo (incorporated in the 2014 IEG as Steps 2A and 2B), and are resolved by using this framework to distinguish between preemptive claims, and "those that integrate the building blocks into something more...the latter pose no comparable risk of pre-emption, and therefore remain eligible". This framework found that the claims do tie up the exception. (See the 35 U.S.C. 101 rejection above).
Further, the claims do not integrate the abstract idea into a practical application, and does not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). (Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (Fed. Cir. 2014)). The claims do not recite any unconventional computer functions. The claims are directed to selecting a treatment regimen for a particular patient, which is considered managing personal behavior. Managing personal behaviors fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity - MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). As a result, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, and the claims are properly rejected under 35 U.S.C. 101 as being directed to non- statutory subject matter. The claim is silent on any computer operation and specific technological implementation that would move the claim beyond a general link to a technological environment. Accordingly, it does not amount to significantly more, and the application of the abstract idea is therefore not eligible.
B. Applicant further argues that amended claim 14 is analogous to claim 2 of Example 21 of the July 2015 Update on Subject Matter Eligibility.
In response, Examiner respectfully disagrees. With regard to claim 2 of Example 21 of the July 2015 Update on Subject Matter Eligibility, this example is not analogous to the claims in the present application. The present claims do not follow the same fact pattern as Example 21. In claim 2 of Example 21, “the claimed invention addresses the Internet‐centric challenge of alerting a subscriber with time sensitive information when the subscriber’s computer is offline. This is addressed by transmitting the alert over a wireless communication channel to activate the stock viewer application, which causes the alert to display and enables the connection of the remote subscriber computer to the data source over the Internet when the remote subscriber computer comes online. These are meaningful limitations that add more than generally linking the use of the abstract idea (the general concept of organizing and comparing data) to the Internet, because they solve an Internet‐centric problem with a claimed solution that is necessarily rooted in computer technology, similar to the additional elements in DDR Holdings. These limitations, when taken as an ordered combination, provide unconventional steps that confine the abstract idea to a particular useful application”. The claim, in Example 21, as a whole integrates the mental process into a practical application. Specifically, the additional elements recite “the additional limitations of using a transmission server with a microprocessor and a memory to store subscriber preferences, transmitting a stock quote alert from the transmission server over a data channel to a wireless device, and providing a stock viewer application that causes the stock quote alert to display on the subscriber computer and enables a connection from the subscriber computer to the data source over the Internet when the subscriber computer comes online”. The present application does not solve an Internet-centric problem with a claimed solution that is necessarily rooted in computer technology. The present application generates an alert when an efficacy rate is less than a first threshold or greater than a second threshold level,the alert causes the computing device to activate an application on the computing device to display the alert to the user, it does not enhance solve an Internet-centric problem with a claimed solution that is necessarily rooted in computer technology. Therefore, the present claims are not analogous to the limitations in claim 2 of example 21.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Methods and kits for managing diagnosis and therapeutics of bacterial infections (US 20020107641 A1) teaches construction and utilization of a medical records system capable of providing a continuous data stream of epidemiological data to the records system via kits provided to the symptomatic population to obtain and record an epidemiological profile in a searchable database by applying data mining or automated intelligence techniques whereby, when a valid epidemiological profile is established in the database, automated diagnosis and prescription of treatment may be had for patients presenting similar symptoms
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER ALTSCHUL MISIASZEK whose telephone number is (571)270-1362. The examiner can normally be reached M-TH 8AM-6PM.
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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682
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