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 95 – 109 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of U.S. Patent No. 12,233,260. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the ‘260 patent claim a first electrode at a nucleus pulposus and a second electrode outside the nucleus pulposus, and a control unit configured to detect a pressure difference in order to drive fluid between the nucleus pulposus and outside the nucleus pulposus by applying a treatment voltage between the first and the second electrodes. The claims differ in that the ‘260 patent contains an extra limitation “by detecting a streaming voltage between the first and the second electrode.” This is further limiting for the ‘260 patent and therefore anticipates the claims of the present application.
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Claim 95 (present application)
Claims 1 and 2 (‘260 Patent)
Apparatus comprising:
a first electrode, configured to be implanted at a first anatomical site in a nucleus pulposus of an intervertebral disc of a subject;
a second electrode, configured to be implanted at a second anatomical site outside the nucleus pulposus of the disc;
and a control unit, configured to: detect a pressure difference between the first and the second anatomical sites,
and in response to the detected pressure difference, drive fluid between the nucleus pulposus and outside the nucleus pulposus by applying a treatment voltage between the first and the second electrodes,
wherein the apparatus is configured not to apply the treatment voltage while detecting the pressure difference.
Apparatus comprising:
a first electrode, configured to be implanted at a first anatomical site in a nucleus pulposus of an intervertebral disc of a subject;
a second electrode, configured to be implanted at a second anatomical site outside the nucleus pulposus of the disc;
and a control unit, configured to: detect a pressure difference between the first and the second anatomical sites by detecting a streaming voltage between the first and the second electrodes,
and in response to the detected pressure difference, drive fluid between the nucleus pulposus and outside the nucleus pulposus by applying a treatment voltage between the first and the second electrodes,
wherein the apparatus is configured not to apply the treatment voltage while detecting the pressure difference (claim 2).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 95 – 109 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gross (US PGPUB 2009/0312816 – in IDS).
Regarding claims 95, 102 and 105, Gross discloses an apparatus and method comprising: a first electrode (e.g. 30), configured to be inserted into a nucleus pulposus (e.g. 40) of the disc (e.g. 20), and a second electrode (e.g. 32), configured to be placed outside of the nucleus pulposus (e.g. 40), in a vicinity of the nucleus pulposus (e.g. 40); and a control unit (e.g. 34), configured to: detect a pressure difference and in response to the detected pressure difference, drive fluid between the nucleus pulposus and outside the nucleus by applying a treatment voltage between he electrodes (e.g. ¶ 81). Gross fails to specifically recite that the apparatus is configured not to apply the treatment voltage while detecting the pressure difference.
However, ¶ 81 of Gross teaches that the pressure sensor 50 is coupled to or integrated with first electrode 30 and that the sensor measures the intradisc pressure, and control unit 34 regulates application of the current responsively to the measured pressure. Because the same electrode 30 is used to both sense and deliver the current, and because the delivery is dependent upon the sensing, it is understood that the treatment voltage is not applied while detecting the pressure difference.
In the alternative, It would have been obvious to one having ordinary skill in the art to modify the device and method as taught by Gross with the sensing and treatment timing as claimed, since all patients respond to therapy differently, and finding the optimum ranges and parameters requires only routine skill in the art.
Regarding claims 96, 97, 103, and 104, Gross discloses that the control unit may only drive treatment at certain times of day, or only at times of certain activity or patient orientation (e.g. ¶ 82). Therefore, the control unit would be configured to periodically stop applying the treatment voltage (i.e. claims 97, and 104) since it is not necessarily delivered continuously. As discussed above, because the same electrode 30 is used to both sense and deliver the current, and because the delivery is dependent upon the sensing, it is understood that the treatment voltage is not applied while detecting the pressure difference, and it would operate sequentially (i.e. claims 96 and 103).
In the alternative, It would have been obvious to one having ordinary skill in the art to modify the device and method as taught by Gross with the sensing and treatment timing as claimed, since all patients respond to therapy differently, and finding the optimum ranges and parameters requires only routine skill in the art.
Regarding claims 98, 99, 107, and 108, Gross discloses driving fluid both to and from the nucleus pulposus (e.g. ¶ 37 and 38).
Regarding claims 100 and 109, Gross discloses providing a rest period from treatment as described above, and applying an opposite voltage (e.g. ¶ 88).
Regarding claims 101 and 106, Gross discloses the claimed invention but does not specifically recite the capacitive current. Using capacitive currents to apply treatment to tissue is well known in the art. It would have been obvious to one having ordinary skill in the art to modify the treatment as taught by Gross with the capacitive current, since such a modification would provide the predictable results of a using a non-invasive treatment that has uniform effects in hydrated tissue
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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