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 .
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, 3-13, 16-25, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-11, 13, 14, 17, 29 of U.S. Patent No.10,709,879 to Iskandar et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to instant claims 1, 16, 18, 22, Iskandar ’879 claim 1 sets forth a shunt with a valve, a proximal catheter, a distal catheter, and a pressure sensor that produces a signal representing an intracranial pressure, a valve diver control circuit communicating with the pressure sensor and the valve, wherein the driver is configured to receive signal representing the intracranial pressure and to control the valve to close when the intracranial pressure is below a predetermined value, and cycle between open and closed when the intracranial pressure is above a predetermined value, wherein the pressure sensor is a piezo bender actuator that receives electrical signals to open or close the valve.
With regard to claims 3, 20, see patented claim 17.
With regard to instant claims 4-12 see patented claims 2-10, respectively.
With regard to claim 13, patented claim 11 recites the time period of 5-10 minutes, anticipating instantly claimed 2-10 minutes.
With regard to claim 15, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114. In the instant case, interpretation of a signal does not create a structural limitation that distinguishes over the claims of the prior art.
With regard to instant claims 17, 19, see patented claims 13, 14.
With regard to instant claims 21, 23, see patented claim 29.
With regard to claim 24, Iskandar ’879 claim 6 sets forth a shunt with a valve, a proximal catheter, a distal catheter, and a pressure sensor that produces a signal representing an intracranial pressure, a valve diver control circuit communicating with the pressure sensor and the valve, wherein the driver is configured to receive signal representing the intracranial pressure and to control the valve to close when the intracranial pressure is below a predetermined value, and cycle between open and closed when the intracranial pressure is above a predetermined value, wherein the driver opens the valve for a period of time to limit irreversible shape change.
With regard to claim 25, Iskandar ’879 claims 9-10 set forth a shunt with a valve, a proximal catheter, a distal catheter, and a pressure sensor that produces a signal representing an intracranial pressure, a valve diver control circuit communicating with the pressure sensor and the valve, wherein the driver is configured to receive signal representing the intracranial pressure and to control the valve to close when the intracranial pressure is below a predetermined value, and cycle between open and closed when the intracranial pressure is above a predetermined value, wherein the driver is configured to receive a signal from an ambient pressure sensor in an external device and the external device receives user defined valve parameters, sending those parameters wirelessly to the driver.
Claims 1-14, 16-23, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 20 of U.S. Patent No.11,806,490 to Iskandar et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to instant claims 1-3, 14, 20, Iskandar ’490 claim 1 sets forth a shunt with a valve, a proximal catheter, a distal catheter, and a pressure sensor that produces a signal representing an intracranial pressure, a valve diver control circuit communicating with the pressure sensor and the valve, wherein the driver is configured to receive signal representing the intracranial pressure and to control the valve to close when the intracranial pressure is below a predetermined value, and cycle between open and closed when the intracranial pressure is above a predetermined value, in order to provide a period of tissue relaxation between periods of drainage, wherein a relative time that the valve is in the open position is a function of the intracranial pressure.
With regard to instant claims 4-12, see patented claims 2-10, respectively.
With regard to claim 13, patented claim 11 recites the time period of 5-10 minutes, anticipating instantly claimed 2-10 minutes.
With regard to claim 15, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114. In the instant case, interpretation of a signal does not create a structural limitation that distinguishes over the claims of the prior art.
With regard to claims 16-19, see patented claims 12-15, respectively.
With regard to claims 21-23, see patented claim 20.
With regard to claim 24, Iskandar ’490 claim 6 sets forth a shunt with a valve, a proximal catheter, a distal catheter, and a pressure sensor that produces a signal representing an intracranial pressure, a valve diver control circuit communicating with the pressure sensor and the valve, wherein the driver is configured to receive signal representing the intracranial pressure and to control the valve to close when the intracranial pressure is below a predetermined value, and cycle between open and closed when the intracranial pressure is above a predetermined value, wherein the driver opens the valve for a period of time to limit irreversible shape change.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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, Sarah Al-Hashimi can be reached at 571-272-7159. 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.
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 12 January 2026