DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment on filed 1/20/26. Claims 21-40 are pending.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12,115,339 in view of Mullan et al (US 20050055244 A1). Claims 1-20 of US 12,115,339 substantially teach the limitations recited in claim 21-40, but do not expressly disclose “displaying at least a portion of the generated list of actions” and “obtaining an indication of one or more actuations of user input elements of the medical device, as recited in claims 21, 29, and 37 of the instant application. Mullan discloses displaying at least a portion of the generated list of actions. (Fig. 25; par. 454; 486; 517; 533) Mullan further discloses: obtaining an indication of one or more actuations of user input elements of the medical device (par. 454-455) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system, method and product of claims 21-40 with the teaching of Mullan to include a display step with the motivation notifying the user of the steps to be performed.
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 21-40 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 21-28 are drawn to a method; and claims 29-36 are drawn to a system. As drafted, claims 37-40 are drawn to non-statutory subject matter under Step 1. However, in the interest of compact prosecution, further analysis under Step 2 will also be provided.
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 21-40 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method, system, and product are drawn to generating instructions and tracking the completion of tasks instructions. (i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) )
In particular, the claims recite a method and system for:
generating based on the indication from or of the current display of the graphical user interface and the user objective with respect to the medical device, a list of actions to take with respect to the medical device to achieve the user objective;
obtaining an indication of one or more actuations of user input elements of the medical device, and
dynamically updating the list of actions in response to one or more actuations of user input elements of the medical device.
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. Claims 21, 29, and 37 additionally recite:
receiving an indication of a user objective with respect to a medical device having a graphical user interface; obtaining an indication from or of a current display of the graphical user interface; and displaying at least a portion of the generated list of actions. These additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 21, 29, and 37 recite additional limitation(s), including: a processor/ one or more processors; medical device; display of a graphical user interface; user input elements. Claims 29 and 37 also recite “one or more computer-readable media storing instructions.” However, the additional components is/are generic components performing well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “the control module 1502 may be implemented or realized with a general purpose processor, a microprocessor, a controller, a microcontroller, a state machine, a content addressable memory, an application specific integrated circuit, a field programmable gate array, any suitable programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. In this regard, the steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in firmware, in a software module executed by the control module 1502, or in any practical combination thereof. " (par. 72)
The disclosure also states: “The infusion system 1100 includes, without limitation, a fluid infusion device (or infusion pump) 1102 (e.g., infusion device 102, 302), a sensing arrangement 1104 (e.g., sensing arrangement 104), a command control device (CCD) 1106, and a computer 1108, which could be realized as any one of the computing devices 106, 114, 306 described above. For example, in one embodiment, the CCD 1106 is realized as a client device 106, 306 and the computer 1108 is realized as remote device 114. The components of an infusion system 1100 may be realized using different platforms, designs, and configurations, and the embodiment shown in FIG. 11 is not exhaustive or limiting..” (par. 52)
The application explains: “In various embodiments, the HMI elements 1232, 1234 may be realized as physical objects (e.g., buttons, knobs, joysticks, and the like) or virtual objects (e.g., using touch-sensing and/or proximity-sensing technologies). For example, in some embodiments, the display 1226 may be realized as a touch screen or touch-sensitive display, and in such embodiments, the features and/or functionality of the HMI elements 1232, 1234 may be integrated into the display 1226 and the HMI 1230 may not be present..” (see par. 67) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 21, 29, and claim 37:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
Claims 22-28 are dependent from Claim 21 and include(s) all the limitations of claim(s) 21. However, the additional limitations of the claims 22-28 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 22-28 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 30-36 are dependent from Claim 29 and include(s) all the limitations of claim(s) 29. However, the additional limitations of the claims 30-36 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 30-36 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 38-40 are dependent from Claim 37 and include(s) all the limitations of claim(s) 37. However, the additional limitations of the claims 38-40 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 38-40 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes (US 20150151050 A1) in view of Rosinko (US 20210146041 A1), in further view of Campbell et al (US 20050022274 A1)
Claims 21, 29, 37 Estes discloses a system comprising:
one or more processors (par. 50-51 par. 54; par. 66-68 device and controller); and
one or more processor-readable media storing instructions which, when executed by the one or more processors (par. 54-The remote server 310 can include one or more processors 312 that can execute instructions embodied in a computer program. The processors 312 can include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer), cause performance of a method comprising:
receiving an indication of a user objective with respect to a medical device having a graphical user interface (par. 27-29: par. 27-the user may press one or more of the buttons 63a, 63b, 64a, 64b, and 64c to change the dispensation rate of insulin or to request that a bolus of insulin be dispensed immediately, at a scheduled later time, over a period of time, or following a particular time-based profile; par. 28 In response to receiving the voice input, the infusion pump system 10 can interpret the statement 16, determine a recommended bolus dispensation, and present the recommendation to the user 15 for confirmation; par. 29-the user 15 speaks the statement 16 that reflects a task or set of tasks that the user 15 wants the infusion pump system 10 to perform. )
obtaining an indication from or of a current display of the graphical user interface, (par. 26-the portable pump 60 includes the user interface 62 that permits a user to monitor and control the operation of the infusion pump system 1; the user may press one or more of the buttons 63a, 63b, 64a, 64b, and 64c to shuffle through a number of menus or program screens that show particular status indicators, settings, and/or data; )
Estes does not disclose, but Rosinko teaches:
generating based on the indication from or of the current display of the graphical user interface and the user objective with respect to the medical device, a list of actions to take with respect to the medical device to achieve the user objective, (par. 54- any information that can be displayed on the pump 12 may be displayed on the phone 102 in any desired format or quantity. For instance, the phone 402 display can simply “mirror” that information displayed or capable of being displayed on the pump 12 in exactly or substantially the same manner. Alternatively, any subset of data that is otherwise displayed or capable of being displayed on pump 12 may be displayed on the phone 402 as desired; Fig. 4A-B: “press and hold the quick bolus button to deliver”)
displaying via the guidance interface at least a portion of the generated list of actions; (Fig. 4A-B” press and hold the quick bolus button”) and
At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the method/system of Estes with the teaching of Rosinko to generate updated displays with assistive guidance with the motivation of providing the help information that is synchronized with the current status of the application program, and without interrupting the user's operation of the application program.
Claims 1, 27, and 39 have been amended to further recite:
obtaining an indication of one or more actuations of user input elements of the medical device, and
dynamically updating the list of actions displayed by the guidance interface in response to one or more actuations of user input elements of the medical device. (par. 98
Estes and Rosinko do not expressly disclose, but Campbell teaches obtaining an indication of one or more actuations of user input elements of the medical device, and dynamically updating the list of actions displayed by the guidance interface in response to one or more actuations of user input elements of the medical device. (par. 98-99; par. 105-107) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system, method and product with the teaching of Mullan to include a display update step with the motivation notifying the user of the steps to be performed.
Claims 22,30, 38 Estes teaches a system/method further comprising obtaining, by the processor, settings information corresponding to a current configuration of the medical device. (par. 26- the display 65 may be used to communicate a number of status indicators, alarms, settings, and/or menu options for the infusion pump system; par. 50)
Claims 23, 31 Estes does not disclose, but Rosinko teaches the system/method wherein displaying is based on the settings information. (par. 37-38: Depictions of various quick bolus delivery configuration pages 62 that can be displayed on the graphical user interface 60 of a pump 12 are depicted in FIGS. 4A-4D;
par. 54- any information that can be displayed on the pump 12 may be displayed on the phone 102 in any desired format or quantity. For instance, the phone 402 display can simply “mirror” that information displayed or capable of being displayed on the pump 12 in exactly or substantially the same manner. Alternatively, any subset of data that is otherwise displayed or capable of being displayed on pump 12 may be displayed on the phone 402 as desired; Fig. 4A-B)
At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the method/system of Estes with the teaching of Rosinko to generate updated displays with assistive guidance with consideration for device configurations. One would have been motivated to include this feature to provide the help information that is synchronized with the current status of the application program, and without interrupting the user's operation of the application program.
Claims 24, 32 Estes teaches the system/method, wherein the settings information corresponds to a feature of the medical device, and wherein the user objective is to enable the feature of the medical device. (par. 26-29 such, speaks a statement to use a feature of the device)
Claims 25, 33 Estes teaches a system/method, wherein the feature corresponds to a fluid delivery feature of the medical device. (par. 26-28-infusion pump)
Claims 26, 34, 39 Estes teaches a system/ method including a generated list of actions (par. 26-the user may press one or more of the buttons 63a, 63b, 64a, 64b, and 64c to shuffle through a number of menus or program screens that show particular status indicators, settings, and/or data; par. 77- referring to FIG. 4, in this example at step D', the task is presented to the user for confirmation that the task is what the user 15 desires. The task may be presented to the user audibly using voice synthesis at the remote control device 450, or visually by presenting an indication on the display of the remote control device 450, or by a combination of audible and visual indicators… To confirm that task, the user can select "YES" 452 on the remote control device 450. In response to a selection of the "YES" button 452, the control device 450 can communicate with the pump device 60 so as to initiate the dispensation of the bolus dosage (e.g., 4.9 Units in this example), as described below. Or to deny that task, the user can select "NO" 454 on the remote control device 450.)
Estes does not disclose, but Rosinko discloses wherein the generated list of actions identifies a first user input element on the medical device and a number of times that the first user input element should be actuated before moving on to another user input element (fig. 4A-B “press and hold quick bolus button;” par. 38- The quick bolus delivery configuration page 64 asks the user to press a quick bolus button (which can be, for example, a physical button or switch on pump 12 or a touch-selectable portion of the user interface 60) one or more times to increase the size of a desired bolus.)
At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the method/system of Estes with the teaching of Rosinko to generate updated displays with assistive guidance with consideration for device configurations. One would have been motivated to include this feature to provide the help information that is synchronized with the current status of the application program, and to ensure that proper therapy/treatment is provided.
Claims 27, 35 Estes does not expressly disclose, but Rosinko teaches a system/method wherein the generated list of actions identifies a second user input element on the medical device and a number of times that the second user input element should be actuated, wherein the second user input element is different from the first user input element. (Fig. 9-10; par. 38: The bolus size can be increased, for example, based on a fixed number of carbohydrates associated with each button press and/or by a fixed number of units of insulin corresponding to each button press. Each time the user presses the bolus button, for example, the grams of carbohydrates and units of insulin displayed on the quick bolus delivery configuration page increases. For example, as shown in FIG. 4B, if the pump has stored a predefined value of five grams of carbohydrates for each button press, after the user has pressed the button three times the configuration page 64 can indicate that a bolus of 1.5 units of insulin corresponding to, in this example, 15 grams of carbohydrates will be delivered. The conversion between carbohydrates and units of insulin can be based on known and/or stored carbohydrate ratios for the user. The user can cancel the quick bolus delivery at any time by selecting a cancel button 66; par. 51-53-correction of bolus amount/ cancelation of input data; par. 54-remote device control)
At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the method/system of Estes with the teaching of Rosinko to generate updated displays with assistive guidance with consideration for device configurations. One would have been motivated to include this feature to provide the help information that is synchronized with the current status of the application program, and to ensure that proper therapy/treatment is provided.
Claims 28, 36, and 40 Estes does not teach, but Rosinko discloses a system/method, wherein dynamically updating the list of actions includes graphically deemphasizing at least one of the displayed actions to reflect performance and indicate to a user where the user resides within the list of actions. (Fig. 4C-D-countdown to delivery beginning and notification of bolus starting when the appropriate input elements are selected; par. 39) At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the method/system of Estes with the teaching of Rosinko to generate updated displays with assistive guidance. One would have been motivated to include this feature to provide the help information that is synchronized with the current status of the application program, and to ensure that proper therapy/treatment is provided.
Response to Arguments
Applicant's arguments filed 1/20/26 have been fully considered but they are not persuasive.
(A) Applicant argues that the proposed amendments address the rejections under 35 USC 101.
In response the examiner disagrees. The claims remain drawn to an abstract idea as explained in the updated 101 rejection. The amended claim language has been noted.
(B) Applicant argues that the prior art does not disclose the language of the claims as amended.
In response, new grounds of rejection has been provided to address the newly added claim limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cork et al (US 20130138452 A1) teaches a system including a troubleshooter guide for drug delivery medical devices. (Fig. 4; Par. 61; par. 85)
THIS ACTION IS MADE FINAL. 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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached on M-F, 10-6:30.
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/Rachel L. Porter/Primary Examiner, Art Unit 3626