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 .
Claims 1-3, 5, 7-10 and 14-16 have been amended. Claims 17-20 have been cancelled. Claims 21-24 are new. Claims 1-16 and 21-24 are pending.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “determining that the treatment repository is temporarily inaccessible, wherein determining temporary inaccessibility of the treatment repository comprises detecting that the treatment repository is unavailable to respond to a communication directed to the treatment repository.” While the specification [0055] discusses that an external database may be “temporarily inaccessible” and [0041] discusses situations in which the data source can be inaccessible, it does not provide for a way of determining that it is inaccessible.
Claims 2-7 and 21-24 are rejected as they depend from claim 1.
Claim 8 and its dependents, claims 9-14, are rejected for similar reasons.
Claim 9 and its dependents, claims 15-16, are rejected for similar reasons.
Claim 22 recites “wherein the determining that the treatment repository is temporarily inaccessible is based on the communicating with the treatment repository at the plurality of predetermined differing time intervals.” Similar to claim 1, there is no support for this determination provided in the instant disclosure.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 and 21-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein, based at least partially on the second subset of potential treatments, an intervening action comprising a particular treatment procedure is administered to the individual in connection with treating a particular condition associated with the one or more conditions” in the last limitation. It is unclear what is meant by “an intervening action comprising a particular treatment procedure is administered to the individual in connection…” as the claim is being implemented by a computer per the instant disclosure. As such, it appears “an intervening action comprising a particular treatment procedure is administered to the individual in connection…” is missing a word and should read and will be interpreted as “an intervening action comprising a particular treatment procedure that is administered to the individual in connection…” for purposes of examination.
Claims 2-7 and 21-24 are rejected as they depend from claim 1.
Claim 8 and its dependents, claims 9-14, are rejected for similar reasons.
Claim 9 and its dependents, claims 15-16, are rejected for similar reasons.
Appropriate correction is required.
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 1-16and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-7 and 21-24 are drawn to a system for the dynamic management of treatments for one or more conditions which is within the four statutory categories (i.e. machine). Claims 8-14 are drawn to a non-transitory medium for the dynamic management of treatments for one or more conditions which is within the four statutory categories (i.e. manufacture). Claims 15-16 are drawn to a method for the dynamic management of treatments for one or more conditions which is within the four statutory categories (i.e. process).
Step 2A | Prong One
Claim 1 of Claims 1-7 and 21-24 (Group I) recites a system having one or more hardware processors configured to facilitate a plurality of operations (MPEP § 2106.05 (f), apply it), the operations comprising:
generating treatment information for a plurality of treatments, wherein generating the treatment information comprises, for each treatment of the plurality of treatments: (i) identifying a plurality of different treatment names utilized for the treatment by disparate healthcare computer systems; and (ii) assigning, to the treatment, a standardized-concept unique identifier code that normalizes the plurality of different treatment names to a common concept, such that the treatment is identifiable across the disparate healthcare computer systems by the standardized-concept unique identifier code;
storing the treatment information in a treatment repository, wherein storing the treatment information (MPEP § 2106.05 (g), insignificant extra-solution activity) comprises associating, in the treatment repository (MPEP § 2106.05 (f), apply it), each treatment of the plurality of treatments having a common active ingredient with a single standardized- concept unique identifier code corresponding to the common active ingredient, such that treatments of the plurality of treatments having the common active ingredient are retrievable from the treatment repository via a computerized search of the single standardized-concept unique identifier code;
retrieving one or more active treatments, from among the plurality of treatments, that have been utilized by an individual to treat one or more conditions associated with the individual, each of the one or more active treatments having a corresponding standardized-concept unique identifier code;
communicating a computerized (MPEP § 2106.05 (f), apply it) search query, that includes the standardized-concept unique identifier code of at least one of the one or more active treatments, to search the treatment repository (MPEP § 2106.05 (f), apply it);
responsive to the communicating, identifying, from the treatment information stored in the treatment repository (MPEP § 2106.05 (f), apply it, MPEP § 2106.05 (g), insignificant extra-solution activity), one or more characteristics of the at least one of the one or more active treatments;
using the one or more characteristics to generate a first criteria for filtering one or more potential treatments associated with the one or more conditions;
applying the first criteria to the one or more potential treatments, for the filtering, to identify a first subset of potential treatments that satisfy the first criteria from within the one or more potential treatments;
identifying a second criteria associated with the one or more conditions;
applying the second criteria to the first subset of potential treatments;
in response to applying the second criteria, identifying a second subset of potential treatments that satisfy the second criteria, providing content of the second subset of potential treatments corresponding to the applying of the first criteria and the second criteria to the one or more potential treatments based on the computerized search query at the treatment repository (MPEP § 2106.05 (f), apply it), and storing the second subset of potential treatments at a data store separate from the treatment repository (MPEP § 2106.05 (g), insignificant extra-solution activity); and
determining that the treatment repository is temporarily inaccessible, wherein determining temporary inaccessibility of the treatment repository comprises detecting that the treatment repository is unavailable to respond to a communication directed to the treatment repository;
in response to determining that the treatment repository is temporarily inaccessible, retrieving the second subset of potential treatments from the data store and providing the second subset of potential treatments from the data store instead of from the treatment repository, such that the providing of the second subset of potential treatments continues regardless of whether the treatment repository is accessible,
wherein, based at least partially on the second subset of potential treatments, an intervening action comprising a particular treatment procedure that is administered to the individual in connection with treating a particular condition associated with the one or more conditions.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 8-14 and 15-16 is identical as the abstract idea for Claims 1-7 and 21-24 (Group I), because the only difference between them is they are directed towards different statutory categories. Claim 8 further recites one or more non-transitory media having computer-readable instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations (MPEP § 2106.05 (f), apply it).
Dependent Claims 2-7, 9-14, 16 and 21-24 include other limitations, for example Claims 2 and 9 recite wherein the first criteria comprises a medication relating to diabetes/asthma condition of the individual, Claims 3 and 10 recite wherein the first criteria comprises an active ingredient for the diabetes/asthma condition (Claim 10 further recites wherein each active treatment is assigned a corresponding standardized-concept unique identifier code), Claims 4 and 11 recite wherein the second criteria comprises a delivery mechanism for delivering the one or more potential treatments to the individual, Claim 5 recites wherein the delivery mechanism comprises intravenous delivery, Claims 6 and 13 recite wherein the operations further comprise identifying a third criteria comprising a dosage of the one or more potential treatments, Claims 7 and 14 recite wherein the operations further comprise storing the first subset of potential treatments with the second subset of potential treatments at the data store for future use (MPEP § 2106.05 (g), insignificant extra-solution activity), Claim 12 recites wherein the delivery mechanism comprises at least one of oral delivery or intravenous delivery, Claim 16 recites wherein: the first criteria comprises a medication relating to a heart disease condition of the individual, each active treatment is assigned a corresponding standardized- concept unique identifier code, the first criteria comprises an active ingredient, the second criteria comprises a delivery mechanism for delivering the one or more potential treatments to the individual, and the delivery mechanism comprises at least one of oral delivery or intravenous delivery, Claim 21 recites wherein, for each treatment of the plurality of treatments, assigning the standardized-concept unique identifier code comprises (i) generating the standardized-concept unique identifier code and (ii) mapping the standardized-concept unique identifier code to a standardized concept to which one or more treatments of the plurality of treatments correspond, Claim 22 recites wherein the operations further comprise (i) communicating with the treatment repository at a plurality of predetermined differing time intervals and (ii) based on the communicating with the treatment repository at the plurality of predetermined differing time intervals, dynamically updating the one or more potential treatments that satisfy the first criteria and the second criteria, wherein the determining that the treatment repository is temporarily inaccessible is based on the communicating with the treatment repository at the plurality of predetermined differing time intervals, Claim 23 recites wherein the operations further comprise, for a second individual having a condition in common with the one or more conditions, retrieving the second subset of potential treatments from the data store and providing the second subset of potential treatments for the second individual without communicating an additional computerized search query to the treatment repository, and Claim 24 recites wherein the temporary inaccessibility of the treatment repository results from the treatment repository being at least one of turned off, undergoing an update, or experiencing a power outage, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1, 8 and 15.
Step 2A | Prong Two
Furthermore, Claims 1-16 and 21-24 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a hardware processor, computerized, repository, data store, non-transitory computer-readable medium, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0016] and [0019] of the present Specification, see MPEP 2106.05(f); and
add insignificant extra-solution activity to the abstract idea – for example, the recitation of storing data, which amounts to an insignificant application, see MPEP 2106.05(g).
Step 2B
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0016] and [0019] of the Specification discloses that the additional elements (i.e. a hardware processor, computerized, repository, non-transitory computer-readable medium) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of one or both of the first subset of potential treatments and the second subset of potential treatments (treatment data) at a data store.
Dependent Claims 2-7, 9-14, 16 and 21-24 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than electronic recordkeeping (e.g. the storing of data feature of dependent Claims 7 and 14) or repeat the additional elements found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-16 and 21-24 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Double Patenting
The nonstatutory double patenting rejection is withdrawn in view of the Terminal Disclaimer filed 06/29/2026.
Subject Matter Free from Prior Art
The closest prior art of record does not teach or render obvious the entirety of claim 1. The closest prior art of record includes, Luce (U.S. Pub. No. 2003/0163353 A1), which discloses filtering out treatment options based on user preferences, including administration routes, however it is for an initial treatment, not an active treatment as currently required by the claims.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
Examiner notes that the claims were not indicated as “allowable” over all prior art as stated by Applicant. The claims are not subject to an art rejection but are not allowable as there are other rejections present.
Regarding the § 101 rejection, Applicant asserts that the claims are “technical computing operations” and therefore are not abstract (Remarks, page 12). Examiner disagrees as the claims are following rules and instructions for determining a treatment for a patient using various filtering criteria. While the claims are performed on a computer, the computer components themselves are not improved as result of the claimed invention.
Applicant asserts that the “operations transform and normalize data and reconfigure the system's own provisioning behavior in response to a detected fault (Remarks, page 12).” Examiner maintains that this is part of the abstract idea because it is applying different rules based on the input received.
Applicant further asserts that “the additional elements integrate it into a practical application, and the claim is eligible at Step 2A, Prong Two, without reaching Step 2B. MPEP 2106.04(d)” specifically because 1) “the claim improves the interoperability of computer systems,” 2) “provides a computer-rooted solution to a technical problem arising from its distributed architecture (Remarks, page 13)” and 3)“the claim applies the result of the process to effect treatment (Remarks, page 14).”
Regarding 1), the claims do not result in improved interoperability between devices. The claims do not even require more than one device. Claim 1 recites “one or more hardware processors” which could read just one processor, meaning there is just one computer required to implement the abstract idea. The claims simply require storing data in a second data store/repository, which is not an improvement to any device.
Regarding 2), saving data in a different data store/repository does not improve the computer itself. While the data can be accessed while a data source is offline or there is an update or otherwise unavailable, the computer itself is not improved as a result of the claimed invention.
Regarding 3), there is no treatment, particular or otherwise, actually administered to the patient. The claim describes that an intervening action includes administering a treatment, but does not positively recite treating a patient or effecting a treatment as alleged by Applicant. The disclosure provides for the various treatments being filtered out based on criteria. Even if the treatment was administered, it is not particular as required by MPEP § 2106. The claims require filtering out treatments on a computer and do not provide for actually administering a treatment. In the light of the disclosure, the claimed system is a hardware processor and a computer-implemented method, which according to the disclosure (Paragraph [0019] discusses a processing unit, internal system memory, and a suitable system bus for coupling various system components, including data store, with the control server.), would not be capable of such administration.
Regarding Step 2B, Applicant asserts that the “limitations form a specific, non-conventional ordered combination (Remarks, page 14).” Applicant points to multiple limitations that are considered are part of the abstract idea, so they are not considered in the non-conventional analysis under Step 2B. In other words, the abstract idea itself cannot be used to be considered “significantly more” than itself. Furthermore, the “Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions.” See MPEP § 2106.04. In other words, even if the claims recite a new abstract idea, the claims can still be considered abstract.
The claims remain rejected as being directed towards ineligible subject matter.
Regarding the § 112(b) rejections, claims 1-16 remain rejected as the issue was not addressed with the current amendment. Newly added Claims 21-24 are also rejected as they depend from rejected claim 1. Examiner notes that the current amendments have raised new issues which necessitated additional § 112 rejections.
Regarding the double patenting rejection, it has been withdrawn in view of the Terminal Disclaimer filed 06/29/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686