DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Step 1
Claims 1-5, 7-12, 14-28, 31-34, 42-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-5 and 7-28 are directed to a method, claims 31-34 and 42-51 are directed towards an apparatus; thus, each of the pending claims are directed to a statutory category of invention.
Step 2A Prong One
Claim 1, representative of the claimed invention, recites the steps of receiving, at an order entry system, an order that includes at least a portion of a therapy description corresponding to a therapy to be administered to a patient, the order including at least an order number, a patient identifier, a drug name, and a dose amount for a first time duration; identifying, by a configuration output generator, a type of patient care device to be used to administer the therapy to the patient, wherein the patient care device has a predetermined configuration protocol for therapy administration, wherein the predetermined configuration specifies a predetermined data input sequence in which parameters for configuring the patient care device are requested for input from a user and entered into a user interface of the patient care device; generating, by the configuration output generator, a configuration output for the order comprising patient care device configuration data for use in manually configuring the patient care device for administration of the therapy, the configuration output being based at least in part on at least a portion of each of the corresponding therapy description and the predetermined configuration protocol specifying the predetermined data input sequence in which the parameters for configuring the patient care device are requested for input; determining, via the configuration output generator, (i) a dose concentration, (ii) an administration rate, (iii) a volume to be infused, and (iv) a patient weight of the configuration output are not specified by the order; after determining the dose concentration is not specified by the order, retrieving, in the configuration output generator from a pharmacy work flow management system over a network, (i) the dose concentration corresponding the drug name specified by the order; after the dose concentration is retrieved, determining, via the configuration output generator, the administration rate and the volume to be infused based on the dose concentration and the dose amount; accessing, via the configuration output generator over a network, an electronic medical record associated with the patient to determine the patient weight; writing, via the configuration output generator, (i) the dose concentration, (ii) the administration rate, (iii) the volume to be infused, and (iv) the patient weight to corresponding fields of the configuration output as at least some of the patient care device configuration data; determining, via the configuration output generator, a sequential order for the fields of the configuration output among a plurality of different possible sequential orders that corresponds to different types of patient care devices based on the type of the identified patient care device and the predetermined sequence in which the patient care device configuration data from the order is to be entered into the user interface of the patient care device; generating a label comprising the configuration output arranged according to the predetermined sequence in which the patient care device configuration data is to be entered into the user interface of the patient care device for transcribing the patient care device configuration data for manual entry of the patient care device configuration data at the patient care device for administration of the therapy to the patient; and causing the label to be affixed to a receptacle associated with the therapy to be administered to the patient using the patient care device, wherein the user interface of the patient care device enables a user to program the patient care device without having to access the network by manually entering the patient care device configuration data as arranged on the label accessing, via the configuration output generator over a network, an electronic medical record associated with the patient to determine the patient weight and the location; writing, via the configuration output generator, (i) the dose concentration, (ii) the administration rate, (iii) the volume to be infused, and(iv) the patient weight, and (v) the location within a patient care facility to corresponding fields of the configuration output as at least some of the patient care device configuration data; determining, via the configuration output generator, a sequential order for the fields of the configuration output among a plurality of different possible sequential orders that corresponds to different types of patient care devices based on the type of the identified patient care device and the predetermined sequence in which the patient care device configuration data from the order is to be entered into the user interface of the patient care device; generating a label comprising the configuration output arranged according to the predetermined sequence in which the patient care device configuration data is to be entered into the user interface of the patient care device for transcribing the patient care device configuration data for manual entry of the patient care device configuration data at the patient care device for administration of the therapy to the patient, a specific one of the type of the identified patient care device assigned based upon the location within a patient care facility; and causing the label to be affixed to a receptacle associated with the therapy to be administered to the patient using the patient care device, wherein the user interface of the patient care device enables a user to program the patient care device without having to access the network by manually entering the patient care device configuration data as arranged on the label.
The limitations above, as drafted, recite a process that, under its broadest reasonable interpretation, encompass mental processes and also certain methods of organizing human activity. The claimed steps recite several steps that include observations, evaluations, judgments and opinions, and “can be performed in the human mind, or by a human using a pen and paper” which have been considered by the courts to be a mental process. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). The claimed steps also are directed towards managing personal behavior (e.g., instructing a user in programming a device).
Apart from the use of generic technology (discussed further below), each of the limitations recited above describes activities that would encompass actions performed in determining an appropriate programming sequence based on a device and patient data.
Based on the broadest reasonable interpretation in light of the specification, these activities describe concepts relating to managing personal behavior and mental processes in that the activities relate to determining an appropriate programming sequence based on a device and patient data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, commercial interactions, or fundamental economic practices, then it falls within the “Method of Organizing Human Activity” grouping of abstract ideas. The recited steps also are considered to be a mental process as methods that can be performed mentally, or which are the equivalent of human mental work. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of an order entry system and a configuration output generator. Claim 31 recites the additional elements of a machine accessible device and machine. The system, generator, and machine are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving information, performing calculations, and providing/transmitting information) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
This judicial exception is not integrated into a practical application because the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a processor to perform the steps of the steps of “receiving, at an order entry system, an order that includes at least a portion of a therapy description corresponding to a therapy to be administered to a patient, the order including at least an order number, a patient identifier, a drug name, and a dose amount for a first time duration; identifying, by a configuration output generator, a type of patient care device to be used to administer the therapy to the patient, wherein the patient care device has a predetermined configuration protocol for therapy administration, wherein the predetermined configuration specifies a predetermined data input sequence in which parameters for configuring the patient care device are requested for input from a user and entered into a user interface of the patient care device; generating, by the configuration output generator, a configuration output for the order comprising patient care device configuration data for use in manually configuring the patient care device for administration of the therapy, the configuration output being based at least in part on at least a portion of each of the corresponding therapy description and the predetermined configuration protocol specifying the predetermined data input sequence in which the parameters for configuring the patient care device are requested for input; determining, via the configuration output generator, (i) a dose concentration, (ii) an administration rate, (iii) a volume to be infused, and (iv) a patient weight of the configuration output are not specified by the order; after determining the dose concentration is not specified by the order, retrieving, in the configuration output generator from a pharmacy work flow management system over a network, (i) the dose concentration corresponding the drug name specified by the order; after the dose concentration is retrieved, determining, via the configuration output generator, the administration rate and the volume to be infused based on the dose concentration and the dose amount; accessing, via the configuration output generator over a network, an electronic medical record associated with the patient to determine the patient weight; writing, via the configuration output generator, (i) the dose concentration, (ii) the administration rate, (iii) the volume to be infused, and (iv) the patient weight to corresponding fields of the configuration output as at least some of the patient care device configuration data; determining, via the configuration output generator, a sequential order for the fields of the configuration output among a plurality of different possible sequential orders that corresponds to different types of patient care devices based on the type of the identified patient care device and the predetermined sequence in which the patient care device configuration data from the order is to be entered into the user interface of the patient care device; generating a label comprising the configuration output arranged according to the predetermined sequence in which the patient care device configuration data is to be entered into the user interface of the patient care device for transcribing the patient care device configuration data for manual entry of the patient care device configuration data at the patient care device for administration of the therapy to the patient; and causing the label to be affixed to a receptacle associated with the therapy to be administered to the patient using the patient care device, wherein the user interface of the patient care device enables a user to program the patient care device without having to access the network by manually entering the patient care device configuration data as arranged on the label accessing, via the configuration output generator over a network, an electronic medical record associated with the patient to determine the patient weight and the location; writing, via the configuration output generator, (i) the dose concentration, (ii) the administration rate, (iii) the volume to be infused, and(iv) the patient weight, and (v) the location within a patient care facility to corresponding fields of the configuration output as at least some of the patient care device configuration data; determining, via the configuration output generator, a sequential order for the fields of the configuration output among a plurality of different possible sequential orders that corresponds to different types of patient care devices based on the type of the identified patient care device and the predetermined sequence in which the patient care device configuration data from the order is to be entered into the user interface of the patient care device; generating a label comprising the configuration output arranged according to the predetermined sequence in which the patient care device configuration data is to be entered into the user interface of the patient care device for transcribing the patient care device configuration data for manual entry of the patient care device configuration data at the patient care device for administration of the therapy to the patient, a specific one of the type of the identified patient care device assigned based upon the location within a patient care facility; and causing the label to be affixed to a receptacle associated with the therapy to be administered to the patient using the patient care device, wherein the user interface of the patient care device enables a user to program the patient care device without having to access the network by manually entering the patient care device configuration data as arranged on the label.” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Thus, even considering the additional elements in combination, the claims do not include elements that are significantly more than the judicial exception.
Step 2B
Limitations that the courts have found to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Claims 1 and 31 are not similar to any of these limitations.
Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Claims 1 and 31 recite additional elements that are regarded as “apply it” as seen in the Step 2A Prong 2 discussion above. The claims do not set forth a solution to a problem rooted in technology (e.g., technical solution), as collecting and analyzing user behavior to identify deficiencies and recommendations to correct or remedy said deficiencies predate the use of computers or machine learning models.
Looking at the limitations of claims 1 and 31 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, effects a transformation of subject matter to a different state or thing, applies the use of a particular machine, integrate the abstract idea into a practical application or provide any meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, claims 1 and 31 are not patent eligible.
The dependent claims further describe the abstract idea and do not recite a practical application or significantly more than the judicial exception. None of dependent claims 2-5,7-28 or 32-51 recite any further additional elements.
Dependent claims 2-5, 7-28, and 32-51 further narrow the scope of the abstract idea in claims 1 and 31 by providing additional information or considerations used in the analysis.
Thus, claims 1-5, 7-12, 14-28, and 31-34, 42-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Allowable Subject Matter
Claims 1-5, 7-28, 31-34, and 42-51 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Response to Arguments
Applicant’s arguments filed 3/2/26 have been fully considered.
Applicant argues with respect to the 101 rejection that the claims solves known problems: reducing errors associated with the configuration of patient care devices, especially configurable infusion devices. There are no claimed features that change the operation of the patient care device, it is therefore, not improved by the claimed invention. The operations of the configuration output generator is the identified abstract idea. The comparing data to rules and outputting a result are routine computer functions, there is no improvement to a technology.
The rejection is therefore maintained.
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.
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/ELIZA A LAM/Primary Examiner, Art Unit 3686
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