DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. This action is made non-final.
Claims 1-17 are pending in the case. Claims 1 and 9 are independent claims.
Priority
The instant application is a continuation of 15/149,559 filed 05/09/2016, which is a continuation of 13/801,274 filed 03/13/2013, which claims domestic benefit of provisional application 61/637,210 filed 04/23/2012.
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 1-17 are rejected on the ground of nonstatutory anticipatory-type double patenting as being unpatentable over claims 1-4, 4, 4, 4, 5, 6-8, 7, 7, 7, 9, 1, and 6, respectively, of U.S. Patent No. 9335910 B2.
Claims 1-17 are anticipated by US 9335910 B2. For clarity, the claims are rejected as follow:
18/202,172
US 9335910 B2
(n/m denotes n is dependent of m)
1
1
2
2/1
3
3/2/1
4
4/1
5
4/1
6
4/1
7
4/1
8
5/2/1
9
6
10
7/6
11
8/7/6
12
7/6
13
7/6
14
7/6
15
9/8/7/6
16
1
17
1
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are directed toward an ambulatory infusion pump having a user interface comprising a touchscreen that is automatically locked during an operation and is unlocked following completion of the operation. For example, independent claims 1 and 9 of the instant application are made obvious by independent claims 1 and 6, respectively, of U.S. patent no. 9335910 B2 as illustrated in the following table (with differences between the claims underlined):
18/202,172
US 9335910 B2
1. An ambulatory infusion pump system, comprising:
a housing;
a delivery mechanism at least partially contained within the housing and adapted to facilitate delivery of fluid to a user;
a user interface comprising a touchscreen; and
a processor configured to generate menu screens for display on the touchscreen and to receive and process touch input from the touchscreen for navigation between or among the menu screens and for setting pump parameters, the processor further configured to:
receive touch input through the user interface indicating that an uninterrupted operation involving physical manipulation of the pump is to be performed on the pump;
automatically lock the touchscreen during the uninterrupted operation in response to the touch input such that touch input received at the touchscreen is not processed by the processor to navigate between or among menu screens or set pump parameters; and
unlock the touchscreen following completion of the uninterrupted operation.
9. An ambulatory infusion system, comprising:
a reservoir for containing a fluid;
a pump device configured to selectively receive the reservoir to deliver fluid from the reservoir through infusion tubing to a user;
a user interface comprising a touchscreen; and
a processor configured to generate menu screens for display on the touchscreen and to receive and process touch input from the touchscreen for navigation between or among the menu screens and for setting pump parameters, the processor further configured to:
receive touch input through the user interface indicating that an uninterrupted operation involving physical manipulation of the pump is to be performed on the pump;
automatically lock the touchscreen during the uninterrupted operation in response to the touch input such that touch input received at the touchscreen is not processed by the processor to navigate between or among menu screens or set pump parameters; and
unlock the touchscreen following completion of the uninterrupted operation.
1. An ambulatory infusion pump, comprising:
a housing;
a delivery mechanism at least partially contained within the housing and adapted to facilitate delivery of fluid to a user;
a user interface comprising a touchscreen disposed on a surface of the housing; and
a processor disposed in the housing and configured to generate menu screens for display on the touchscreen and to receive and process touch input from the touchscreen for navigation between or among the menu screens and for setting pump parameters, the processor further configured to:
receive touch input through the touchscreen indicating that a specific task is to be performed on the pump, the specific task being an operation in which the user directly modifies a physical state of the pump and being selected from the group consisting of replacement of an infusion cartridge, filling the infusion cartridge with fluid and filling infusion tubing with fluid;
automatically lock the touchscreen during the operation in response to the indication of the specific task to be performed such that touch input received at the touchscreen is not processed by the processor to navigate between or among menu screens or set pump parameters; and
unlock the touchscreen following completion of the operation.
6. An ambulatory infusion system, comprising:
an infusion cartridge, the infusion cartridge including a reservoir for containing a fluid and an outlet adapted to be coupled to infusion tubing;
a pump device configured to selectively receive the infusion cartridge and cooperate with the infusion cartridge to deliver fluid from the reservoir, out the outlet and through infusion tubing to a user;
a user interface comprising a touchscreen disposed on a surface of the pump device; and
a processor located in one of the infusion cartridge and the pump and configured to generate menu screens for display on the touchscreen and to receive and process touch input from the touchscreen for navigation between or among the menu screens and for setting pump parameters, the processor further configured to:
receive touch input through the touchscreen indicating that a specific task is to be performed on the pump, the specific task selected from the group consisting of replacement of an infusion cartridge, filling the infusion cartridge with fluid and filling infusion tubing with fluid;
determine that the specific task is an uninterrupted operation during which the user directly modifies a physical state of the pump such that a failsafe mechanism should be employed;
automatically lock the touchscreen as the failsafe mechanism during the uninterrupted operation in response to the touch input indicating that the specific task is to be performed such that touch input received at the touchscreen is not processed by the processor to navigate between or among menu screens or set pump parameters; and
unlock the touchscreen following completion of the uninterrupted operation.
Besides minor syntactical differences, the distinction between the claimed subject matter is that independent claim 1 of the instant application recites “an uninterrupted operation involving physical manipulation of the pump” while independent claim 1 of the patent recites “a specific task is to be performed on the pump, the specific task being an operation in which the user directly modifies a physical state of the pump and being selected from the group consisting of replacement of an infusion cartridge, filling the infusion cartridge with fluid and filling infusion tubing with fluid.” Any one of the operations, corresponding to the specific task, “selected from the group consisting of replacement of an infusion cartridge, filling the infusion cartridge with fluid and filling infusion tubing with fluid”, as recited in the patent, reads on “an uninterrupted operation involving physical manipulation of the pump”. An “uninterrupted operation involving physical manipulation of the pump”, as recited in the instant application, may occur for any duration and the specific task, as recited in the patent, occurs at least for some duration uninterrupted for at least one instance of the specific task. Thus, “uninterrupted operation” in claim 1 of the instant application is anticipated by “a specific task is to be performed on the pump, the specific task being an operation in which the user directly modifies a physical state of the pump and being selected from the group consisting of replacement of an infusion cartridge, filling the infusion cartridge with fluid and filling infusion tubing with fluid” in claim 1 of the patent.
Besides minor syntactical differences, independent claim 9 of the instant application recites “an uninterrupted operation involving physical manipulation of the pump” while independent claim 6 of the patent recites “a specific task”. However, claim 6 of the patent further limits “the specific task is an uninterrupted operation”. Thus, claim 9 of the instant application is anticipated by claim 6 of the patent.
The dependent claims of the instant application are also anticipated by the claims of US 9335910 B2 as set forth above and are also rejected for double patenting accordingly.
Note that this is a nonprovisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered and they are found persuasive with respect to the amended claims. As for double patenting, Applicant states in Remarks, “submitted herewith is a Terminal Disclaimer that disclaims the terminal portion of any patent issuing from the present application that would extend beyond the expiration of the related patent” (p. 6). However, no terminal disclaimer was submitted by Applicant. Without an appropriately filed terminal disclaimer, the claims remain rejected under nonstatutory double patenting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including:
US 2008/0312584 A1: locked user interface to prevent inadvertent activation of infusion pump functions
US 8932250 B2: keys locked icon for infusion pump
US 2012/0277668 A1: disable specific pump settings to prevent accidental modification of delivery therapy
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNY NGUYEN whose telephone number is (571)272-4980. The examiner can normally be reached M-Th 7AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KIEU D VU can be reached on (571)272-4057. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNY NGUYEN/Primary Examiner, Art Unit 2171
Prosecution Insights