DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a response filed 15 December 2025, on an application filed 3 July 2024, which claims domestic priority to multiple applications with dates as distant as 22 January 2010.
Claims 1, 3, 7, 8, 10, 11, 13-21, 23 and 24 have been amended.
Claims 33-35 have been added by amendment.
Claims 1-35 are currently pending and have been examined.
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 1-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,244,745 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are contained within the patented claims.
Claim Rejections - 35 USC § 112
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.
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.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 35 contains the undefined acronym biomed PC tool. As the acronym PC is not defined, it is unclear how to interpret the 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 1-35 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
Claims 1-35 are within the four statutory categories. Claims 24-32 are drawn to a method of producing a drug library comprising configuring a privilege, which is within the four statutory categories (i.e. process). Claims 1-23 and 33-35 are drawn to a system for reducing medical error comprising a medical error reduction software, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1 recites: System for reducing medical error comprising a medical error reduction software configured for:
creating, reviewing and/or editing a drug library; and
configuring a privilege configured for allocating a degree of software functionality respecting the drug library.
assigning the privilege to a care group; and
transmitting a notification respecting the drug library;
wherein the notification comprises one or more of: a device type, a location of the drug library, documentation respecting the drug library, a release notes URL, an installer URL, a checksum, and an installation dependency.
Claim 24 recites: Method of producing a drug library comprising configuring a privilege for enabling:
Creating, reviewing and/or editing a drug library;
specifying a master medication list;
defining a medication record;
verifying the medication record;
approving the drug library for release to a medical device; and
transmitting a notification respecting the drug library;
wherein the notification comprises one or more of: a device type, a location of the drug library, documentation respecting the drug library, a release notes URL, an installer URL, a checksum, and an installation dependency; and
assigning the privilege to a care group.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, a person creates a drug library and determines corresponding privileges, then verifies and approves information and assigns the privilege to a care group) or using a pen and paper, but for the recitation of generic computer components (i.e. the medical device), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2-23 and 25-35 include other limitations, for example claims
5-16, 18-21, 31 and 32 recites details on the drug library and/or the corresponding privileges,
claims 25-29 recites details on the medications or medication record, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2-23 and 25-32 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-23 and 25-35 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 24.
Prong 2 of Step 2A
Claims 1 and 24 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the medical device, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph 69 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language reciting the use of software, which amounts to limiting the abstract idea to the field of healthcare programs, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-23 and 25-35 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g. the medical device disclosed in dependent claims 4, 8, 10, 11, 22 and 31 and 19-20), generally linking the abstract idea to a particular technological environment or field of use (e.g. the software recited in claims 1, 5, 12, 23, 30 and 32-35), and/or do not include any additional elements beyond those already recited in independent claims 1 and 24, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1 and 24 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the medical device and the software), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraph 69 of the Specification discloses that the additional elements (i.e. the medical device) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
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;
Dependent claims 2-23 and 25-35 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1 and 24, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the medical device disclosed in dependent claims 4, 8, 10, 11, 22 and 31 and 19-20), and/or generally link the abstract idea to a particular technological environment or field of use (e.g. the software recited in claims 1, 5, 12, 23, 30 and 32-35), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-35 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 2, 4-11, 13-16, 18-24, 26-29, 34 and 35 are rejected under 35 U.S.C. 103(a) as being obvious over Ford et al. (U.S. Patent 5,681,285 A), hereinafter Ford, further in view of Cook (U.S. PG-Pub 2005/0027560 A1), hereinafter Cook.
As per claims 1 and 24, Ford discloses a System for reducing medical error comprising a medical error reduction software and a Method of producing a drug library comprising configuring a privilege (Ford, Figs. 5 and 6.) for enabling:
creating, reviewing and/or editing a drug library (Ford, Col. 11, lines 16-38 discloses a system to create, review and edit a drug library.);
specifying a master medication list (Institution/software provides a standard drug library 90, see C11L16-38.);
defining a medication record (Ford, Fig. 10.);
verifying the medication record (Ford, Col. 18, line 55 to Col. 19, line 43. Supervisory level access is required to deliver the drug library to the medical device);
approving the drug library for release to a medical device (Ford, Col. 18, line 55 to Col. 19, line 43. Supervisory level access is required to deliver the drug library to the medical device); and
transmitting a notification respecting the drug library; wherein the notification comprises one or more of: a device type, a location of the drug library, documentation respecting the drug library, a release notes URL, an installer URL, a checksum, and an installation dependency (Ford discloses transmitting documentation respecting the drug library, such as sending the full customized drug library to a printer or displaying it on a PC screen, see Ford C16L41-44. Device also transmits a checksum to be displayed on the device screen, see C21L63-C22L2.); and
assigning the privilege to a care group (Users with supervisory access have the ability to assign various access levels of privileges to a username and password, see Ford C19L1-43. Any user with that username and password will be able to utilize the privileges; effectively a care group with access to the username and password would all be assigned the privilege simultaneously.); and
1. configuring a privilege configured for allocating a degree of software functionality respecting the drug library (Ford, Col. 18, line 55 to Col. 19, line 43 discloses setting privileges for different users for access levels to the drug library.);
Although it is the Office’s position that Ford discloses providing privileges to a care group, as shown above, in the interest of expediting prosecution, the Office will provide a secondary reference disclosing this limitation.
Cook teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide assigning privileges to a care group (See Cook Fig. 12 and corresponding text.) in order to provide permissions simultaneously to a larger set of users.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford to include assigning privileges to a care group, as taught by Cook, in order to arrive at a method of programming an infusion pump that can provide permissions simultaneously to a larger set of users.
Both Ford and Cook are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 2, 4-11, 13-16, 18-23, 26-29, 34 and 35, Ford/Cook discloses claim 1, discussed above. Ford also discloses:
2. a server configured for executing the software (Ford, C4L50-61.);
4. wherein the drug library is configured for use in a medical device (Ford, C4L50-61.);
5. wherein the degree of software functionality is configured for defining an ability to alter the drug library (Ford, Col. 18, line 55 to Col. 19, line 43.);
6. wherein the drug library is configured for a hierarchy (Ford, Col. 18, line 55 to Col. 19, line 43 discloses a hierarchy of access levels for the drug library.);
7. wherein the hierarchy comprises a care area that is subordinate to the care group (Ford, Col. 18, line 55 to Col. 19, line 43. Care area access level 4 is subordinate to care groups Supervisory, 1, 2 and 3.);
8. wherein a level of the hierarchy comprises a delivery parameter for the medical device (Ford, Col. 18, line 55 to Col. 19, line 43. Supervisory level access is required to deliver the drug library to the medical device);
9. wherein the drug library comprises an entry corresponding to a medicament (Ford, Fig. 10.);
10. wherein the drug library comprises a parameter configured for informing operating a medical device (Ford, Fig. 10.);
11. wherein the drug library comprises a programming limit for a medical device (Ford, Fig. 10.);
13. wherein the privilege is configured for enabling creating, editing and/or reviewing a drug library (Ford, Col. 18, line 55 to Col. 19, line 43.);
14. wherein the privilege is configured for enabling creating, editing and/or reviewing a privilege set (Ford, Col. 18, line 55 to Col. 19, line 43.);
15. wherein the privilege is configured for enabling adding and/or subtracting a user (Ford, Col. 18, line 55 to Col. 19, line 43.);
16. wherein the privilege is configured for enabling compels collaborating respecting creating and/or editing the drug library (Ford, Col. 18, line 55 to Col. 19, line 43.);
18. wherein the privilege is configured for enabling requesting a change to the drug library (Access levels 1-4 have the ability to write requested drug changes to the proposed library. Only the supervisory level has the ability to accept a change by approving it/signing off on it to be loaded into the medical device using the “write to file with approval” option, see Ford, Figs. 7, 22 and 23, Col. 18, line 55 to Col. 20, line 46.);
19. wherein the privilege is configured for enabling accepting and/or declining implementing a request for a change to the drug library (Access levels 1-4 have the ability to write requested drug changes to the proposed library. Only the supervisory level has the ability to accept a change by approving it/signing off on it to be loaded into the medical device using the “write to file with approval” option, see Ford, Figs. 7, 22 and 23, Col. 18, line 55 to Col. 20, line 46.);
20. wherein the privilege is configured for enabling submitting a question respecting the change (System enabled to confirm choices, see C22L56-C23L8.);
21. wherein the privilege is configured for enabling proposing a revision respecting the change (Supervisory access levels can approve all changes or implement any changes, see Ford, Col. 18, line 55 to Col. 19, line 43.);
22. wherein the medical device comprises an infusion pump (Ford, C4L50-61.);
23. wherein said editor computer is configured for providing access to the medical error reduction software (Ford, C4L50-61.);
26. wherein said defining comprises selecting a medication from the master medication list (Ford, Fig. 8 discloses a screen for a selecting a medication from the standard drug library aka master medication list.);
27. wherein said defining comprises defining a parameter for the medication (Ford, Fig. 10.);
28. wherein said verifying comprises reviewing the medication record (Ford, Col. 18, line 55 to Col. 19, line 43. Supervisory level access is required to deliver the drug library to the medical device.);
29. wherein said verifying comprises editing and/or revising the medication record (Ford, Col. 18, line 55 to Col. 19, line 43. Supervisory level access is required to deliver the drug library to the medical device.); and
34. wherein said software is configured for recording the accessing the drug library and/or installing the drug library on a medical device (Ford discloses the use of a PC to install a drug library on a medical device and for creating an event log, see Figs. 5 and 7 and corresponding text, and C28L9-29.); and
35. wherein the accessing is by a biomed PC tool (Ford, Figs. 6-16. The software utilized in Ford is the functional equivalent of the listed biomed PC tool. The name of the software utilized amounts to a nonfunctional design choice.)
Claims 3, 12 and 17 are rejected under 35 U.S.C. 103(a) as being obvious over Ford/Cook further in view of Perkins et al. (U.S. PG-Pub 2005/0288571 A1), hereinafter Perkins.
As per claims 3, 12 and 17, Ford/Cook discloses claims 1, 2 and 24, discussed above. Ford also discloses:
3. an editor computer configured for communicating with a display and/or user interface … (Ford, Fig. 5 and C4L50-61.).
Ford fails to explicitly disclose:
3. a network in a client-server based model;
12. wherein the software is configured for providing quality improvement information; and
17. wherein said editor computer and said server are configured for communicating via a network in a client-server based model.
Perkins teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
3. a network in a client-server based model (Perkins, Fig. 8.);
12. wherein the software is configured for providing quality improvement information (Perkins, paragraph 161.); and
17. wherein said editor computer and said server are configured for communicating via a network in a client-server based model (Perkins, Fig. 8.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook to include a client-server based model that provides feedback, as taught by Perkins, in order to arrive at a method of programming an infusion pump that can provide a medical device programming system that is configured to operate within a network environment from a remote location.
Both Ford and Perkins are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 30 is rejected under 35 U.S.C. 103(a) as being obvious over Ford/Cook further in view of Blomquist et al. (U.S. Patent 5,338,157), hereinafter Blomquist.
As per claim 30, Ford discloses claim 24, discussed above. Ford also discloses:
30. wherein said verifying comprises reviewing the medication record (Ford, Col. 18, line 55 to Col. 19, line 43.).
Ford fails to explicitly disclose:
30. … a simulated medical device user interface.
Blomquist teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
30. … a simulated medical device user interface,
in order to provide a training aid of the simulated device (Blomquist, Abstract.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook to include a simulated medical device user interface, as taught by Blomquist, in order to arrive at a method of programming an infusion pump that can provide a training aid of the simulated device.
Both Ford and Blomquist are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 25 and 31 are rejected under 35 U.S.C. 103(a) as being obvious over Ford/Cook further in view of Howard et al. (U.S. PG-Pub 2007/0213598 A1), hereinafter Howard.
As per claims 25 and 31, Ford/Cook discloses claim 24, discussed above. Ford also discloses:
31. producing a drug library file … (Ford, Figs. 8-10.).
Ford fails to explicitly disclose:
25. wherein said specifying comprises selecting a medication from a formulary database; and
31. … conducting a pilot phase for the drug library file comprising testing the drug library file on a test medical device.
Howard teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
25. wherein said specifying comprises selecting a medication from a formulary database (Howard, paragraphs 5, 41, 43, 46 and 68.);
31. … conducting a pilot phase for the drug library file comprising testing the drug library file on a test medical device (Howard, paragraphs 50, 53, 68 and 82.);
in order to provide a medical device programming system that enables system review checking.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook to include selecting a medication from a formulary and conducting a pilot phase for the drug library file comprising testing the drug library file on a test medical device, as taught by Howard, in order to arrive at a method of programming an infusion pump that can provide a medical device programming system that enables system review checking.
Both Ford and Howard are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 32 is rejected under 35 U.S.C. 103(a) as being obvious over Ford/Cook further in view of Howard and Blomquist.
As per claim 32, Ford/Cook discloses claim 24, discussed above. Ford also discloses:
32. producing a drug library file … (Ford, Figs. 8-10.).
Ford fails to explicitly disclose:
32. … conducting a pilot phase for the drug library file comprising testing the drug library file on a simulated medical device user interface.
Howard teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
32. … conducting a pilot phase for the drug library file comprising testing the drug library file on a … medical device;
in order to provide a medical device programming system that enables system review checking.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook to include conducting a pilot phase for the drug library file comprising testing the drug library file on a test medical device, as taught by Howard, in order to arrive at a method of programming an infusion pump that can provide a medical device programming system that enables system review checking.
Neither Ford, nor Cook, nor Howard disclose a simulated medical device interface.
Blomquist teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
32. … a simulated medical device user interface,
in order to provide a training aid of the simulated device (Blomquist, Abstract.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook/Howard to include a simulated medical device user interface, as taught by Blomquist, in order to arrive at a method of programming an infusion pump that can provide a training aid of the simulated device.
Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 33 is rejected under 35 U.S.C. 103(a) as being obvious over Ford/Cook further in view of Golden (U.S. PG-Pub 2010/0292556 A1), hereinafter Golden.
As per claim 33, Ford/Cook discloses claim 1, discussed above. Ford also discloses wherein said software is configured for downloading the drug library (Ford, Fig. 7 and corresponding text.).
Ford fails to explicitly disclose sending data to a gateway.
Golden teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide sending data to a gateway.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of programming an infusion pump of Ford/Cook to include sending data to a gateway, as taught by Golden, in order to provide additional technology for safer communications.
Both Ford and Golden are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Response to Arguments
Applicant’s arguments filed 15 December 2025 concerning the rejection of all claims under 35 U.S.C. 112 have been fully considered and are persuasive. Accordingly, the previous rejection was withdrawn, but a new rejection has been implemented in view of the claims added by amendment.
Applicant’s arguments filed 15 December 2025 concerning the rejection of all claims under 35 U.S.C. 101 and 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on page 7 that the amendments to the claims overcome the statutory rejection.
The Office respectfully disagrees. Please see the statutory rejection, above, wherein the claims are shown to be directed to an abstract idea without significantly more.
With regard to the prior art rejection of the claims, Applicant argues on pages 7-9 that the amendments to the claims indicating that the privileges are set for a care group overcome the citation of Ford.
The Office respectfully disagrees. As shown above, Users with supervisory access have the ability to assign various access levels of privileges to a username and password, see Ford C19L1-43. Any user with that username and password will be able to utilize the privileges; effectively a care group with access to the username and password would all be assigned the privilege simultaneously.
Although it is the Office’s position that Ford discloses providing privileges to a care group, as shown above, in the interest of expediting prosecution, the Office provided a secondary reference disclosing this limitation, Cook, as shown above.
The remainder of Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new references necessitated by amendment, Cook and Golden, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Ford, Cook, Perkins, Blomquist, Howard, Nishikawa and Golden, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Action (18 June 2025), and incorporated herein.
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 extension fee 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 date of this final action.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
6 February 2025