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 .
Response to Amendment
In response to the amendment filed 7/22/2026; claims 1-22 are pending.
Claim Objections
Claims 1 – 22are 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 - 22 recites "System of claim" believed to be "The system of claim".
2173.05(e) Lack of Antecedent Basis [R-01.2024]
A claim is indefinite when it contains words or phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise where a claim refers to “said lever” or “the lever,” where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference. Similarly, if two different levers are recited earlier in the claim, the recitation of “said lever” in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. A claim which refers to “said aluminum lever,” but recites only “a lever” earlier in the claim, is indefinite because it is uncertain as to the lever to which reference is made. Obviously, however, the failure to provide explicit antecedent basis for terms does not always render a claim indefinite. If the scope of a claim would be reasonably ascertainable by those skilled in the art, then the claim is not indefinite. Ex parte Porter, 25 USPQ2d 1144, 1145 (Bd. Pat. App. & Inter. 1992) (“controlled stream of fluid” provided reasonable antecedent basis for “the controlled fluid”).
It's unclear the “system” in claims 1 – 6 and 8 - 22 are referring “the” system in claim 7, or they are separate systems independent from claim 7. The antecedent basis for each of these claims is unclear.
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 - 22 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 based on a drug library, defining a simulated medical device graphical user interface: and creating and/or revising the 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 2 – 6 and 8 – 22 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 – 22 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) based on a drug library (Martucci, [0109], “comparing prescription parameters as received from server 108a to the applicable programmed pump settings received from the hub 107 system”; [0124]; [0341], “infusion pumps 120 can include a database having a table of medications having associated flow rate tolerances”; [0462]); and creating and/or revising the 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).
Re claim 22:
22. System of claim 7 wherein said simulating comprises context sensitivity (Martucci, [0012]; [0109], “applicable programmed pump settings”; Butler, [0024], “The configuration library database can include drug dosing limits and infuser master settings”; [0149], “FIG. 14 can also be configured to provide a master medical device settings, for example a master infuser settings, selection box, button, or link”; ).
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 – 22 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 – 22 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 – 22 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.
Applicant argues: … Notably, the rules governing claim structure fail to require inclusion of an article, such as "a" or "the." U.S. patent application examination guidelines recognize that "there is no set statutory form for claims ... Each claim begins with a capital letter and ends with a period."3 Notably, the MPEP section governing claim structure fails to require inclusion of an article, such as "a" or "the."
The examiner submits that according to 2173.05(e) Lack of Antecedent Basis [R-01.2024] A claim is indefinite when it contains words or phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise where a claim refers to “said lever” or “the lever,” where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference. Similarly, if two different levers are recited earlier in the claim, the recitation of “said lever” in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. A claim which refers to “said aluminum lever,” but recites only “a lever” earlier in the claim, is indefinite because it is uncertain as to the lever to which reference is made. Obviously, however, the failure to provide explicit antecedent basis for terms does not always render a claim indefinite. If the scope of a claim would be reasonably ascertainable by those skilled in the art, then the claim is not indefinite. Ex parte Porter, 25 USPQ2d 1144, 1145 (Bd. Pat. App. & Inter. 1992) (“controlled stream of fluid” provided reasonable antecedent basis for “the controlled fluid”). The “system” in claims 1 – 6 and 8 - 22 are referring “the” system in claim 7, or they are separate systems independent from claim 7. The preamble it contains words (“system”) or phrases whose meaning is unclear.
Applicant argues: … The invention of claim 7 as amended is, in pertinent part: simulating a graphical user interface of a medical device based on a drug library. The invention enables caregivers to ensure that a medical device, such as an infusion pump, behaves as intended when executing a treatment. If not, then a caregiver may make changes and/or provide feedback for making adjustments for obtaining a desired result. This protects potential patients from harm that otherwise could occur without the simulating. The advancement pertains to ensuring safe operations of medical equipment according to a treatment order through simulating how it would perform prior to subjecting a patient to the treatment.
The claimed “simulating a graphic user interface” is a mere recitation of basic computer display to perform basic input / output. Claim 7 only recites a simulating a graphical user interface of a medical device; however, Claim 7 does not explicitly recites any medical equipment, let alone improvement to a medical equipement. In other word, Claim 7 only recites a GUI for creating and/or revising a drug library. A human has been known to manually perform the functions such as creating and/or revising the drug library using pen and paper (medical prescription). The GUI merely claimed to add insignificant extra-solution activity to the judicial exception (e.g., data gathering) and/or do no more than generally link the use of a judicial exception to a particular technological environment or field of use. The claimed GUI is directed to collecting and displaying information (id.), which has been characterized as insignificant extra-solution activity that does not integrate a judicial exception into a practical application. Elec. Power Grp., LLC v. Alstom SA., 830 F.3d 1350, 1354 (Fed. Cir. 2016) (finding abstract steps for "gathering and analyzing information of a specified content, then displaying the results").
Applicant argues: … Neither the '983 pub. nor '466 pub., individually or in combination, teach or suggest accessing medical error reduction software configured for simulating a graphical user interface of a medical device based on a drug library, hence not all the claim limitations of claim 7. Accordingly, claim 7 and claims 1-6 and 8-21 depending therefrom are allowable over the '983 pub. and '466 pub.
The examiner submits that the cited reference Martucci teaches 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) based on a drug library (Martucci, [0109], “comparing prescription parameters as received from server 108a to the applicable programmed pump settings received from the hub 107 system”; [0124]; [0341], “infusion pumps 120 can include a database having a table of medications having associated flow rate tolerances”; [0462]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACK YIP whose telephone number is (571)270-5048. The examiner can normally be reached Monday thru Friday; 9:00 AM - 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, XUAN THAI can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JACK YIP/Primary Examiner, Art Unit 3715
Prosecution Insights