DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “bell crank assembly” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: Lines 16-17 reading “the movement” should read --movement--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 3 reading “a volume sensor assembly” should read --the volume sensor assembly--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 3 reading “a portion” should read --the portion--. Appropriate correction is required.
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 1-9, 11-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 7-9, 11-15 and 17 of USPN 11,964,126, hereinafter Patent ‘126. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present case lacks limitations directed to the disposable housing assembly and reusable housing assembly.
Re Claim 1, Patent ‘126 discloses in its Claim 1 a wearable infusion pump assembly comprising: a reservoir; a controller; and a fluid delivery system having a fluid path to deliver an infusible fluid from the reservoir to a fluid delivery system outlet, the fluid delivery system comprising: a pump assembly for extracting a quantity of the infusible fluid from the reservoir and providing the quantity of the infusible fluid to the fluid delivery system outlet, the pump assembly having a displaceable member which is displaced as the infusible fluid is transferred with actuations of the pump assembly; a first sensor assembly including a light emitter and a sensor, to optically sense movement of the displaceable member which is displaced as the infusible fluid is transferred with actuations of the pump assembly; a first valve assembly selectively isolating the pump assembly from the reservoir; a second valve assembly selectively isolating the pump assembly from the fluid delivery system outlet; and a second sensor assembly, including a light emitter and a sensor, to optically sense the movement of the second valve assembly.
Re Claims 2-4, Patent ‘126 discloses in its Claims 7-9 respectively a volume sensor assembly, wherein the quantity of the infusible fluid is provided to the volume sensor assembly, and wherein the volume sensor assembly is configured to determine a volume of at least a portion of the quantity of the infusible fluid; wherein the volume sensor assembly is in the fluid path between the second valve assembly and the fluid delivery system outlet; and wherein the controller is configured to determine when the reservoir is empty based at least in part upon an output of the first sensor assembly.
Re Claim 5, Patent ‘126 discloses in its Claim 9 wherein the controller is configured to determine when the reservoir is empty based at least in part upon an output of the first sensor assembly.
Re Claim 6, Patent ‘126 discloses in its Claim 11 the wearable infusion pump assembly further comprising a computer readable medium coupled to the controller, the computer readable medium including a plurality of instructions stored thereon which, when executed by the controller, cause the controller to perform operations comprising: activating the first valve assembly to isolate the pump assembly from the reservoir; and activating the pump assembly to provide the quantity of the infusible fluid to the volume sensor assembly.
Re Claim 7, Patent ‘126 discloses in its Claim 13 wherein the fluid delivery system includes an actuator associated with the first valve assembly and activating the first valve assembly includes energizing the actuator.
Re Claim 8, Patent ‘126 discloses in its Claim 14 wherein the actuator includes a shape memory actuator.
Re Claim 9, Patent ‘126 discloses in its Claim 15 wherein the fluid delivery system includes an actuator associated with the pump assembly and activating the pump assembly includes energizing the actuator.
Re Claim 11, Patent ‘126 discloses in its Claim 14 wherein the actuator includes a shape memory actuator.
Re Claim 12, Patent ‘126 discloses in its Claim 12 wherein the computer readable medium further includes instructions for: activating the volume sensor assembly to determine the volume of at least the portion of the quantity of the infusible fluid provided to the volume sensor assembly from the pump assembly; and activating the second valve assembly to fluidly couple the volume sensor assembly to the fluid delivery system outlet.
Re Claim 13, Patent ‘126 discloses in its Claim 17 wherein the fluid delivery system includes an actuator associated with the second valve assembly and activating the second valve assembly includes energizing the actuator.
Re Claim 15, Patent ‘126 discloses in its Claim 14 wherein the fluid delivery system includes a bell crank assembly for mechanically coupling the second valve assembly to the actuator.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 9 of USPN 11,964,126 in view of Crankshaw et al. (USPN 4,741,732).
Re Claim 10, the claims of Patent ‘126 disclose all of the limitations of Claim 9. The claims of Patent ‘126 fail to disclose wherein the fluid delivery system includes a bell crank assembly for mechanically coupling the pump assembly to the actuator. Crankshaw teaches an infusion pump assembly (Crankshaw Fig. 11) comprising a fluid delivery system (101) wherein the fluid delivery system (101) includes a bell crank assembly (Crankshaw Figs. 15 and 17) for mechanically coupling a pump assembly (306, 307, 308) to an actuator (105) for creating a permanent driving connection between the actuator and the pump assembly (Crankshaw Col. 14 Line 28 to Col. 15 Line 35). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the fluid delivery system of Patent ‘126 a bell crank assembly mechanically coupling the pump to the actuator as disclosed by Crankshaw for creating a permanent driving connection between the actuator and the pump assembly (Crankshaw Col. 14 Line 28 to Col. 15 Line 35).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 13 of USPN 11,964,126 in view of Crankshaw et al. (USPN 4,741,732).
Re Claim 14, the claims of Patent ‘126 disclose all of the limitations of Claim 13. The claims of Patent ‘126 fail to disclose wherein the fluid delivery system includes a bell crank assembly for mechanically coupling the pump assembly to the actuator. Crankshaw teaches an infusion pump assembly (Crankshaw Fig. 11) comprising a fluid delivery system (101) wherein the fluid delivery system (101) includes a bell crank assembly (Crankshaw Figs. 15 and 17) for mechanically coupling a pump assembly (306, 307, 308) to an actuator (105) for creating a permanent driving connection between the actuator and the pump assembly (Crankshaw Col. 14 Line 28 to Col. 15 Line 35). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the fluid delivery system of Patent ‘126 a bell crank assembly mechanically coupling the pump to the actuator as disclosed by Crankshaw for creating a permanent driving connection between the actuator and the pump assembly (Crankshaw Col. 14 Line 28 to Col. 15 Line 35).
Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 13 of USPN 11,964,126 in view of Flaherty et al. (USPGPub 2002/0040208).
Re Claims 16-17, the claims of Patent ‘126 disclose all of the limitations of Claim 12. The claims of Patent ‘126 fail to disclose wherein the fluid delivery system further includes: a bracket assembly configured to maintain the second valve assembly in an activated state; and wherein the computer readable medium further includes instructions for: activating the bracket assembly to release the second valve assembly from the activated state; and wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly. Flaherty teaches an infusion pump assembly (Flaherty Figs. 1a-2) comprising a bracket assembly (47) configured to maintain a second valve assembly (42) in an activated state (Flaherty ¶ 0117), a computer readable memory (52) wherein the computer readable medium (52) further includes instructions for: activating the bracket assembly (47) to release the second valve assembly (42) from the activated state (Flaherty ¶ 0117) for the purpose of allowing the use of multiple accumulators in the infusion pump assembly (Flaherty ¶ 0117).
Furthermore, with regard to the limitation wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly, in order for the actuator of Patent ‘126 in view of Flaherty to change the state of the first valve, some form of energy must be imparted upon the actuator, thus energizing the actuator. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the fluid delivery system a bracket assembly configured to maintain the second valve assembly in an activated state; and wherein the computer readable medium further includes instructions for: activating the bracket assembly to release the second valve assembly from the activated state; and wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly as disclosed by Flaherty for the purpose of allowing the use of multiple accumulators in the infusion pump assembly (Flaherty ¶ 0117).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 13 of USPN 11,964,126 in view of Flaherty et al. (USPGPub 2002/0040208) as applied to Claim 17 above, and further in view of Krumme et al. (USPN 4,645,489).
Re Claim 18, Patent ‘126 in view of Flaherty teach all of the limitations of Claim 17. Patent ‘126 in view of Flaherty fail to teach wherein the bracket actuator includes a shape memory actuator. Krumme teaches an infusion pump assembly using shape memory actuator elements (71) (Krumme Fig. 3a) for controlling valves (Krumme Col. 6 Lines 39-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the bracket assembly of Patent ‘126 in view of Flaherty a shape memory actuator as disclosed by Krumme for controlling valves (Krumme Col. 6 Lines 39-46).
Claims 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 4 of USPN 11,964,126 in view of Flaherty et al. (USPGPub 2002/0040208).
Re Claims 19-20, the claims of Patent ‘126 disclose all of the limitations of Claim 4. The claims of Patent ‘126 fail to disclose wherein the fluid delivery system further includes: a bracket assembly configured to maintain the second valve assembly in an activated state; and wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly. Flaherty teaches an infusion pump assembly (Flaherty Figs. 1a-2) comprising a bracket assembly (47) configured to maintain a second valve assembly (42) in an activated state (Flaherty ¶ 0117) for the purpose of allowing the use of multiple accumulators in the infusion pump assembly (Flaherty ¶ 0117).
Furthermore, with regard to the limitation wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly, in order for the actuator of Patent ‘126 in view of Flaherty to change the state of the first valve, some form of energy must be imparted upon the actuator, thus energizing the actuator. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the fluid delivery system a bracket assembly configured to maintain the second valve assembly in an activated state; and wherein activating the bracket assembly includes energizing a bracket actuator associated with the bracket assembly as disclosed by Flaherty for the purpose of allowing the use of multiple accumulators in the infusion pump assembly (Flaherty ¶ 0117).
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). 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. 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/PatentForms. The filing date of the application will determine what form 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/TerminalDisclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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