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 .
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 application 17/677,319, now US Patent No. 12,243,630.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,243,630 in view of Vishnubhatla, US Patent Application Publication No. 2010/0324936.
Claims 1-18 of the ‘630 include all of the limitations recited in claims 1-19 of the instant application, with the exception of executing a machine learning model (claims 1-20) and an artificial intelligence engine (claim 8). Vishnubhatla teaches applying machine learning (see paragraph 0054) and artificial intelligence (see paragraph 0392) for processing prescription data, including identifying therapeutic equivalents (see paragraph 0105). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to implement machine learning and artificial intelligence in claims 1-18 of the ‘630 patent with the motivation of assisting in the automating of medical documentation (see paragraph 0392 of Vishnubhatla).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,243,630 in view of Vishnubhatla, US Patent Application Publication No. 2010/0324936 and further in view of Hoffman, US Patent Application Publication No. 2019/0367196.
Claim 15 of the ‘630 include all of the limitations recited in claim 20 (dependent on claim 10) of the instant application, with the exception of transporting the prescription container beneath an automated dispensing device. Hoffman teaches transporting a prescription container beneath an automated dispensing device (see paragraph 0096). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the container transporting of Hoffman to claim 15 of the ‘630 patent with the motivation of improving the pharmacy container management and sorting (see paragraphs 0003 and 0029 of Hoffman).
Claim Rejections - 35 USC § 112
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.
Claim 10-20 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 10 recites “controlling, a transport system, a location of the prescription container.” As recited, the step appears to require “controlling” both “a transport system” and “a location” of a container. Based on the specification, and system claim 1, it appears that this step is related to controlling the transport system to move the container to a location. However, as recited, is unclear how “a location” can be controlled.
Claims 11-20 are rejected based on their dependencies on claim 10.
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 1-18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claim 1 recites identifies, in a first database, one or more covered alternative drugs based on a requested drug and a drug coverage plan associated with a patient identifier; identifies, in a second database, one or more additional alternative drugs based on at least one of the requested drug and at least one covered alternative drug of the one or more covered alternative drugs; determines, based on the covered drug plan associated with the patient identifier, whether the one or more additional alternative drugs includes at least one covered additional alternative drug; in response to a determination that the one or more additional alternative drugs includes at least one covered additional alternative drug, determines, for the at least one covered additional alternative drug and the one or more covered alternative drugs, an alternative drug value; identifies the at least one covered additional alternative drug and the one or more covered alternative drugs having a desired alternative drug value; rank the at least one covered additional alternative drug and the one or more covered alternative drugs having the desired alternative drug value based on number of times the at least one covered additional alternative drug and the one or more covered alternative drugs having the desired alternative drug value has been filled for an associated prescription; and generate a request response indicating at least the desired alternative drug of the at least one covered additional alternative drug and the one or more covered alternative drugs having the desired alternative drug value ordered according to the rank; communicate an order associated with a prescription request to fill the alternative drug to an automated pharmacy; fulfill the order; identifies a prescription container of the order.
Claim 10 recites identifying, in a first database, one or more covered alternative drugs based on a requested drug and a drug coverage plan associated with a patient identifier; identifying, in a second database, one or more additional alternative drugs based on at least one of the requested drug and at least one covered alternative drug of the one or more covered alternative drugs; determining, based on the covered drug plan associated with the patient identifier, whether the one or more additional alternative drugs includes at least one covered additional alternative drug; in response to a determination that the one or more additional alternative drugs includes at least one covered additional alternative drug, determining, for each of the at least one covered additional alternative drug and the one or more covered alternative drugs, an alternative drug value; identifying the at least one covered additional alternative drug and the one or more covered alternative drugs having a lowest alternative drug value; and rank the at least one covered additional alternative drug and the one or more covered alternative drugs having the lowest alternative drug value based on number of times each of the at least one covered additional alternative drug and the one or more covered alternative drugs having a desired alternative drug value has been filled for an associated prescription; and generating a request response indicating at least the alternative drug of the at least one covered additional alternative drug and the one or more covered alternative drugs having the lowest alternative drug value ordered according to the rank; communicating an order associated with a prescription request to fill the alternative drug to a high-volume pharmacy; receiving instructions to fulfill the order; identifying a prescription container for the order; controlling a location of the prescription container.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people and fundamental economic practices, which are subgroupings of Certain Methods of Organizing Human Activity. For example, the claims encompass identifying covered and additional alternative drugs based on a requested drug associated with a patient, determining whether a drug plan associated with the patient covers an additional alternative drug, determining a drug value and identifying additional and covered alternative drugs having a lowest value, and generating a request response for alternative drugs having the lowest alternative value, ordering a prescription to fill the drug at a pharmacy and identifying a prescription container for the order. These manual steps could be carried out by individuals in the healthcare and pharmaceutical industry and represent fundamental economic practices in these industries.
Claims 2-9, 11-18, and 20 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claims 2-4, 8, 10-12, and 16 include limitations already addressed above. Claims 5-7, 13-15, 18, and 20 further expand on processing prescription benefit requests and alternative drugs. For similar reasons as given above, these limitations also encompass managing interactions between people and fundamental economic practices, which are subgroupings of Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with adding elements similar to adding the words “apply it” to the abstract idea, and generally linking the abstract idea to a particular technological environment, along with insignificant, extra-solution data gathering activity.
Claims 1-9, directly or indirectly, recite the following generic computer components: “a processor in communication with a memory including instructions that, when executed by the processor, cause the processor to execute a machine learning model.” Claims 10-18 and 20, , directly or indirectly, recite the following generic computer components: “running a machine learning model,” “controlling, a transport system, a location of the prescription container.”
The written description discloses that the recited computer components encompass generic components including “a general purpose computer to execute one or more particular functions embodied in computer programs” (see paragraph 0152). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Additionally, claims 9-16 do not recite any additional elements and, therefore, do not integrate the abstract idea into a practical application.
Claims 1-18 and 20, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data gathering and transmitting activity: “transmits a control signal to a transport system,” “transmits a dispensing control signal to the automated dispensing device,” communicating an order “to an order processing device,” “receiving instructions “at a pharmacy fulfillment device from the order processing device.” These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data gathering and transmitting of data over a generic computer network. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Claims 8, 10, and 20, recite the following additional elements at a high level of generality, generally linking the abstract idea to a particular technological environment: “the processor is part of an artificial intelligence engine,” “controlling a drug dispenser to insert the alternative drug into the prescription container,” “activating the automated dispensing device with the prescription container beneath the automated dispensing device.” The “artificial intelligence engine,” does not include any specific features or operations. Additionally, the controlling and activating are recited at a broad level that encompasses simply pressing a button by a user to begin an activation process. Such broad recitations merely linking the abstract idea to a particular technological environment.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data gathering activity (e.g. transmitting and receiving data) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Generally linking the abstract idea to a particular technological environment (e.g. generic artificial intelligence and activating a control) does not amount to significantly more than the abstract idea (see MPEP 2016.05(h) and Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim 19
Claim 19 further requires the controlling the prescription container to include identifying a puck having dimensions corresponding to the prescription container of the order, controlling a robotic arm to position the puck on a pallet, and controlling a loading device to load the prescription container into the puck. These additional steps require the operation of a particular machine, integrating the abstract idea into a practical application.
Distinguishing Subject Matter
The following is a statement of reasons for the indication of distinguishing subject matter: The primary reason that claims 1-20 distinguish over the prior art is the inclusion of the combination of limitations of the series of steps for identifying covered alternative drugs and additional alternative drugs, based on a drug coverage plan, ranking covered additional alternative drugs and covered alternative drugs based on desired drug value and number of times being filled for an associated prescription, and using the results to fill a drug order using the series of controlled functions. The closest prior art (Kaye and Joplin) describes processing a prescription benefit request to identify covered alternative drugs and alternative drugs for a covered drug plan and fulfilling a drug resulting drug order using a robotically controlled puck and pallet system. Additionally, Greenblatt describes ranking generic equivalent and alternative drugs to select a highest ranked generic or alternative. Szela describes ranking brand drugs according to the number of times previously prescribed. However, there is no description of combining these rankings to achieve the recited ranking and there is no suggestion to combine the disparate rankings with the drug order and filling process of Kaye and Joplin. Therefore, the claim limitations, considered in combination, distinguish over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cannata, US Patent Application Publication No. 2012/0136809, discloses ranking drugs based on generic and brand name values.
Stevenson, International Publication No. WO 2016/115615 A1, discloses assigning drugs to ranked tiers and adding preferred alternative drugs to the tiers.
Zhang et al., A Framework of Hybrid Recommender System for Personalized Clinical Prescription, discloses a ranking system for recommending drugs to prescribe.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683