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 .
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-10 are directed to a system, claims 11-20 are directed to a method; 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:
change a patient profile for a user patient, which comprises a medication routine for the user patient;
identify an instance where the user patient changes the patient profile;
generate a first alert according to the identification of the instance where the user patient changes the patient profile; and
upon generation of the first alert, communicate, via the alerting GUI, the first alert to additional users that are identified as other stakeholders of the patient profile, and
wherein an input GUI is configured to receive an input that the user patient is experiencing certain side effects from the medication routine,
wherein the computing system is further configured to activate a second alert based on the receiving of the input that the user patient is experiencing certain side effects from the medication routine, and
wherein the input GUI displays a chat feature configured to facilitate the user patient reaching out to the additional users regarding concerns of the user patient related to the second alert.
The underlined 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., tracking medication changes and generating alerts (result of an analysis)). This is similar to a concept held by the courts as abstract, and more particularly, a mental process.
Per MPEP 2106.04(a)(2)(III)(A), examples of claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)
Per MPEP 2106.04(a)(2)(II)(C), examples of managing personal behavior recited in a claim include:
iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)
Apart from the use of generic technology (discussed further below), each of the limitations recited above describes activities that would encompass actions performed in tracking changes the patient profile; and generating alerts based on the identification of the instance where the user patient changes the patient profile; and communicate, the first alert.
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 collecting and performing analysis of patient data and communicating the result of analysis (alert). 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, claims 1, 11, and 20 recites a computer system and an alerting graphical user interface. The computing system ais 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 provider computing system or circuits to perform the various steps of “change”, “identify”, “generate”, and “communicate” amount 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.
Similarly, the recited computing systems and circuits are used as a tool to perform the abstract idea. See MPEP 2106.05(f): “[u]se of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.” An example where the courts have found the additional elements to be mere instruction to apply an exception, because they do no more than merely invoke computers or machinery as a tool to perform an existing process includes a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223 (MPEP 2106.05(f)(2)). The use of computing systems and circuits emulates what an individual would do in evaluating the candidacy of a case dataset for a clinical study. 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, 11, and 20 are not similar to any of these limitations. The additional elements (the provider computing system and circuits) do not improve the functioning of a computer, improve any technology or technical field, use a particular machine, transform subject matter to a different state or thing, integrate the abstract idea into a practical application or significantly more.
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, 11, and 20 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 case dataset for matching clinical studies predate the use of computers.
Looking at the limitations of claims 1, 11, and 20 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, 11, and 20 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 2-10 or 12-19 recite any further additional elements.
Dependent claim 2-4, 6, 12-14, and 16 are directed to routine computer functions of storing, accessing, and displaying data that amount to no more than instructions to perform the abstract idea using routine computing components
Dependent claims 5, 7-10, 15, and 17-19 further narrow the scope of the abstract idea in claims 1 and 11 by providing additional information or considerations used in the analysis.
However, none of these additional 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.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,347,539 and claims 1-16 of patent 11,869,645. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a broader embodiment of the patent and contain all of the features of the patents.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2004/0243445 to Keene in view of U.S. Patent Application 2011/0225004 to Loncar in further view of U.S. Patent 7,944,342 Sekura.
As to claims 1 and 11, Keene discloses a system comprising:
an alerting graphical user interface (GUI) (Keene [0016] and [0095]); and
a computing system, configured to:
change a patient profile for a user patient, which comprises a medication routine for the user patient (Keene [0061]);
identify an instance where the user patient changes the patient profile (Keene [0063]).
However, Keene does not explicitly teach:
generate a first alert according to the identification of the instance where the user patient changes the patient profile; and
upon generation of the first alert, communicate, via the alerting GUI, the first alert to additional users that are identified as other stakeholders of the patient profile, and
wherein the input GUI displays a chat feature configured to facilitate the user patient reaching out to the additional users regarding concerns of the user patient related to the second alert.
Loncar discloses:
generate a first alert according to the identification of the instance where the user patient changes the patient profile (Loncar [0063]); and
upon generation of the first alert, communicate, via the alerting GUI, the first alert to additional users that are identified as other stakeholders of the patient profile (Loncar [0063]).
wherein the input GUI displays a chat feature (Loncar [0087] Examiner notes that the intended use of the chat feature does not patentably distinguish the claim from the chat feature of the reference).
It would have been obvious to one of ordinary skill in the art before the effective filing date to generate an alert to a stakeholder as in Loncar in the system of Keene to improve treatment management.
However, Keene and Loncar do not explicitly teach:
wherein an input GUI is configured to receive an input that the user patient is experiencing certain side effects from the medication routine, wherein the computing system is further configured to activate a second alert based on the receiving of the input that the user patient is experiencing certain side effects from the medication routine.
Sekura discloses:
wherein an input GUI is configured to receive an input that the user patient is experiencing certain side effects from the medication routine, wherein the computing system is further configured to activate a second alert based on the receiving of the input that the user patient is experiencing certain side effects from the medication routine (Sekura column 29 lines 5-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date to identify and monitor side effects as in Sekura in the system of Keene and Loncar to reduce adverse effects.
As to claims 2 and 12, see the discussion of claim 1, additionally, Loncar discloses the system wherein the computing system is further configured to store a chat session provided by the chat feature (Loncar [0107]-[0109]).
As to claims 3 and 13, see the discussion of claim 2, additionally, Loncar discloses the system wherein the input GUI is further configured to provide access to the stored chat session (Loncar [0107]-[0109]).
As to claims 4 and 14, see the discussion of claim 1, however, Keene, Loncar, and Sekura do not explicitly teach the system wherein the chat feature is displayed at a lower portion of the medication input UI when the medication input UI is displayed on an end-user device. The layout of the UI is not functionally related to the computer system. It is therefore non-functional descriptive material. It would have been an obvious matter of design choice in light of the UI as taught by Keene, Loncar, and Sekura with the results being predictable.
As to claims 5 and 15, see the discussion of claim 1, additionally, Loncar discloses the system wherein the input GUI is a first input GUI, and wherein the upon generation of the second alert, the computing system is further configured to communicate, via a second input GUI, the second alert to the additional users that are identified as the other stakeholders of the patient profile (Loncar [0087]).
As to claims 6 and 16, see the discussion of claim 5, additionally, Loncar discloses the system wherein the communication of the second alert via the second input GUI occurs through the chat feature (Loncar [0087]).
As to claims 7 and 17, see the discussion of claim 1, additionally, Loncar discloses the system wherein the computing system is further configured to identify an occurrence of the user patient not interacting with the patient profile for a preselected duration of time (Loncar [0087]).
As to claims 8 and 18, see the discussion of claim 7, additionally, Loncar discloses the system wherein the computing system is further configured to generate a third alert according to the identification of the occurrence of the user patient not interacting with the patient profile for the preselected duration of time (Loncar [0087]).
As to claim 9, see the discussion of claim 8, additionally, Loncar discloses the system wherein the input GUI is a first input GUI, and wherein the computing system is further configured to, upon generation of the third alert, communicate, via the alerting GUI or a second input GUI, the third alert to the additional users that are identified as the other stakeholders of the patient profile (Loncar [0087]).
As to claim 10, see the discussion of claim 1, additionally, Keene discloses the system wherein the patient profile includes medications and the medications are mapped to a pre-stored set of instructions and information for the medications (Keene [0061]).
As to claim 20, Keene discloses a method, comprising:
changing, by a computing system, a patient profile for a user patient, which comprises a medication routine for the user patient, wherein the patient profile includes medications and the medications are mapped to a pre-stored set of instructions and information for the medications (Keene [0061]);
identifying, by the computing system, an instance where the user patient changes the patient profile (Keene [0061]-[0063]);
However, Keene does not explicitly teach:
generating, by the computing system, a first alert according to the identification of the instance where the user patient changes the patient profile;
upon generation of the first alert, communicating, via an alerting graphical user interface (GUI), the first alert to additional users that are identified as other stakeholders of the patient profile;
displaying, by the input GUI, a chat feature configured to facilitate the user patient reaching out to the additional users regarding concerns of the user patient related to the second alert.
Loncar discloses:
generating, by the computing system, a first alert according to the identification of the instance where the user patient changes the patient profile (Loncar [0063]);
upon generation of the first alert, communicating, via an alerting graphical user interface (GUI), the first alert to additional users that are identified as other stakeholders of the patient profile (Loncar [0063]);
displaying, by the input GUI, a chat feature (Loncar [0087] Examiner notes that the intended use of the chat feature does not patentably distinguish the claim from the chat feature of the reference).
It would have been obvious to one of ordinary skill in the art before the effective filing date to generate an alert to a stakeholder as in Loncar in the system of Keene to improve treatment management.
However, Keene and Loncar do not explicitly teach:
receiving, by an input GUI, an input that the user patient is experiencing certain side effects from the medication routine;
activating, by the computing system, a second alert based on the receiving of the input that the user patient is experiencing certain side effects from the medication routine.
Sekura discloses:
receiving, by an input GUI, an input that the user patient is experiencing certain side effects from the medication routine (Sekura column 29 lines 5-31);
activating, by the computing system, a second alert based on the receiving of the input that the user patient is experiencing certain side effects from the medication routine (Sekura column 29 lines 5-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date to identify and monitor side effects as in Sekura in the system of Keene and Loncar to reduce adverse effects.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication 2007/0016443 to Wachman
U.S. Patent Application Publication 2007/0186923 to Poutiatine et al.
U.S. Patent Application Publication 2014/0058560 to Kanagala
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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/ELIZA A LAM/Primary Examiner, Art Unit 3681
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