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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application aftter final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/13/2026 has been entered. Claims 1 – 21 are pending.
Claim Objections
Claims 1 – 21 are objected to because of the following informalities:
Claim 7 recites "System for reducing medical errors" believed to be "A System for reducing medical errors".
Claims 1 – 6 and 8 - 20 recites "System of claim" believed to be "The system of claim".
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 - 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1: Is the claimed invention a statutory category of invention?
Claim 1 is directed to a system for reducing medical errors (Step 1, Yes).
Step 2A, Prong 1: Does the claim recite an abstract idea?
The limitation of steps: … System for reducing medical errors comprising an editor computer configured for accessing medical error reduction software configured for simulating a graphical user interface of a medical device, defining a simulated medical device graphical user interface: and creating and/or revising a drug library in accordance with the simulated medical device graphical user interface as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The claimed method akin to mental process of observations, evaluations, and judgements for providing prescription. The mere nominal recitation of a biomed personal computer (“PC”) tool performing these steps does not take the claim limitation outside of the mental processes grouping. Thus, the claim recites a mental process (Step 2A, Prong 1: yes).
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Per the 2019 Revised Patent Subject Matter Eligibility Guidance, if a claim as a whole integrates the recited judicial exception into a practical application of that exception, a claim is not "directed to" a judicial exception. Alternatively, a claim that does not integrate a recited judicial exception into a practical application is directed to the exception. Evaluating whether a claim integrates an abstract idea into a practical application is performed by a) identifying whether there are any additional elements recited in the claim beyond the abstract idea, and b) evaluating those additional elements individual and in combination to determine whether they integrate the abstract idea into a practical application, using one or more of the considerations laid out by the Supreme Court and the Federal Circuit. Exemplary considerations indicative that an additional element (or combination of elements) may have or has not been integrated into a practical application are set forth in the 2019 PEG.
With respect to the instant claims, claim 1 recites the additional elements of: “a biomed personal computer (“PC”) tool. It is particularly noted that the use of processor "as a tool" to perform an abstract method and steps for responding to an indication that only amount to extra solution activity (basic output) are indicated in the 2019 PEG as examples that an additional element has not been integrated into a practical application. Even in combination, the recited additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits, such as an improvement to a computing system, on practicing the abstract idea (STEP 2A, Prong 2: NO).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 recites the additional elements of: “a biomed personal computer (“PC”) tool” set forth above for Step 2A, Prong 2. Regarding these limitations: Applicant's specification describes these features in generic manner "… disclosure, a device of the devices 26 is a monitoring client, such as a tablet computer, a tablet device, a PDA, a smart phone, a laptop computer, or a touchscreen-based computer.” in the Applicant’s published application, para. [0379]). There is no indication in the Specification that Applicants have achieved an advancement or improvement in computer for display and editing drug prescription. Dependent claims 1 – 6 and 8 – 21 inherit the deficiencies of their respective parent claims through their dependencies and do not recite additional limitations sufficient to direct the claims to more than the claimed abstract idea, and are thus rejected for the same reasons.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Martucci et al. (US 2004/0172302 A1) in view of Butler et al. (US 2008/0091466 A1).
Re claim 7:
Martucci teaches 7. System for reducing medical errors comprising an editor computer configured for accessing medical error reduction software (Martucci, [0261], “minimizing the possibility of errors in
medication preparation”) configured for simulating a graphical user interface of a medical device (Martucci, figs. 38 – 44 shows a GUI for a medical device (pump) and defining medical device); and creating and/or revising a drug library in accordance with the simulated medical device
graphical user interface (Martucci, [0021], “include, inter alia, blocks for setting infusion system parameters, infusion order creation, infusion order preparation, medication administration, infusion order modifications, and messaging”; [0199], “new infusion orders can be configured to provide messages alerting the clinician of a new order”; [0244], “Clinician 116 accesses the prescription modification module 336 in order to make adjustments to an order”).
Martucci does not teaches defining a simulated medical device. Butler teaches a method of aggregating and using medical device data from a plurality of remote institutions (Butler, Abstract). Butler teaches defining a simulated medical device graphical user interface (Butler, figs. 8 – 13 show simulated medical GUI, i.e., fig. 8, “Infuser Type Plum A+ … ”) and creating and/or revising a drug library in accordance with the simulated medical device graphical user interface (Butler, fig. 17, “Edit”; fig. 21, “Edit”; [0139], “listing of directly related drug library entries for use in development of new drug libraries and/or editing existing drug libraries”). Therefore, in view of Butler, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Martucci, by providing simulated medical device as taught by Butler, in order to provide an interface screen display of selection functions for facility viewing of critical care area configuration
information preferences (Butler, [0043]; [0143]) and provide interface for development of new drug
libraries and/or editing existing drug libraries (Butler, [0139]).
Re claims 1 - 2:
1. System of claim 7, wherein said editor computer is configured for indicating that a drug library was simulated, further comprising a biomed personal computer ("PC") tool configured for responding to said indicating (Martucci, [0109]; [0112]). 2. System of claim 1 wherein said biomed PC tool is configured for communicating the drug library to the medical device (Martucci, [0109]; [0112]).
Re claim 3:
3. System of claim 2 wherein the medical device is configured for validating the drug library (Martucci, [0308]; [0179]).
Re claim 4:
4. System of claim 2 wherein the medical device is configured for installing the drug library (Martucci, [0272]). 5. System of claim 4 wherein the medical device is configured for communicating a confirmation that the drug library was installed (Martucci, fig. 4).
Re claim 6:
6. System of claim 5 wherein said biomed PC tool is configured for communicating the confirmation to a server (Martucci, [0105]).
Re claim 8:
8. System of claim 21 wherein said editor computer is configured to for notifying a user of an existence of the edited drug library (Martucci, [0107]; [0172]).
Re claim 9:
9. System of claim 7 further comprising the medical error reduction software configured for: creating and revising the drug library; being executed by a server; and being accessible via said editor computer (Martucci, fig. 56; fig. 4).
Re claim 10:
10. System of claim 9 wherein the drug library is configured for guiding user programming of the medical device (Martucci, [0305).
Re claim 11:
11. System of claim 10, wherein the drug library is organized in a hierarchy that comprises a plurality of care areas that are subordinate to a care group (Martucci, fig. 5; [0345]).
Re claim 12:
12. System of claim 10, wherein the drug library is organized in a hierarchy wherein each level of the hierarchy includes a number of delivery parameters for the medical device (Martucci, [0007]).
Re claim 13:
13. System of claim 7 wherein the simulating is for a plurality of medical device types (Martucci, [0093]; [0247]; [0342]).
Re claim 14:
14. System of claim 7 further comprising the medical error reduction software configured for: creating and revising the drug library; and providing a privilege that defines an ability of a user to revise the drug library (Martucci, [0257]; [0260]).
Re claim 15:
15. System of claim 14 wherein said medical error reduction software is configured for providing quality improvement information (Martucci, figs. 55A – 55C).
Re claim 16:
16. System of claim 14 wherein the simulated medical device graphical user interface is a software functionality configured to be toggled on and off based on the privilege (Martucci, fig. 5; fig. 6, “pharmacy authorization”; [0228]; [0260]).
Re claim 17:
17. System of claim 7 wherein the drug library includes an entry corresponding to a medicament (Martucci, figs. 55A – 55C).
Re claim 18:
18. System of claim 7 wherein the drug library comprises a parameter for informing operation of the medical device (Martucci, figs. 55A – 55C).
Re claim 19:
19. System of claim 7 wherein the drug library includes a programming limit configured for programming the medical device (Martucci, [0230]).
Re claim 20:
20. System of claim 7 further comprising a monitoring client configured to for communicating with the medical device (Martucci, [0350]; [0408]).
Re claim 21:
21. System of claim 7 wherein said editor computer is configured for editing the drug library and defining an edited drug library (Martucci, fig. 56; fig. 4).
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 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 36 of U.S. Patent No. 11244745 (‘745). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the more specific claims of ‘745.
Claims 1 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 36 of U.S. Patent No. 11810653 (‘653). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the more specific claims of ‘653.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/JACK YIP/Primary Examiner, Art Unit 3715
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