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
Applicant filed a preliminary amendment on April 11, 2025. Claims 1-13 have been canceled. Claims 14-31 are new and examined hereinbelow.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a continuation of U.S. Application No. 18/477,397, filed September 28, 2023, which is a continuation of U.S. Application No. 17/182,835, filed February 23, 2021, which claims the benefit of U.S. Provisional Application No. 62/981,439, filed February 25, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 21, 2025 and August 26, 2025 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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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;
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 an 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; and
transmit the alert;
in response to receiving the alert to display 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;
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”, “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 are 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.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art:
The limitations in claims 14 and 23 stating:.
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:
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; and
transmit the alert to the computing device via the network;
wherein the computing device is further configured to activate an application on the computing device, in response to receiving the alert from the remote computing system, to display the first alert to the user.
The most remarkable prior arts of record are as follows: Sobol (US 2010/0274495 A1) and Holmes (US 2011/0093249 A1).
Sobol discloses a method for a multiplexed continuous biomarker clinical trial is disclosed that evaluates multiple drugs concurrently or subsequently against a continuously collected and enlarging control group with increasing statistical power.
Holmes discloses an integrated health care surveillance and monitoring system that provides real-time sampling, modeling, analysis, and recommended interventions.
Neither Sobol nor Holmes teach on the specific claim language which includes, 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; and transmit the alert to the computing device via the network; wherein the computing device is further configured to activate an application on the computing device, in response to receiving the alert from the remote computing system, to display the first alert to the user.
Therefore, claims 14-31 are free of the prior art.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682