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 .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 1 should be renumbered to claim 21.
Claim Rejections - 35 USC § 112
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.
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.
Claims 24-25, 30-35 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 24, line 6, “an initial porosity” is vague as this term is also used in line 3 and it is unclear if this is the same element from line 3 or a different element. As the porosity has been adjusted by being increased, it is suggested to use “the increased porosity” in line 6.
Claim 39 uses the same language and is therefore vague.
In claim 30, the active agent delivery system and the rest of the device are not connected together and the device is vague, incomplete, and just a listing of parts. It is suggested to have the control unit also control the delivery system.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 23-24, 26-34, 36, and 38-40 are rejected under 35 U.S.C. 102a2 as being anticipated by Smyth (12070596).
Smyth discloses the claimed limitations as follows:
--at least one implantable electrode to deliver electrical stimulation to the neurological site (e.g. figures 1b, 3b, element 148, etc., where the neurological site is the nerve/hair cells of the cochlea and auditory nerve, col. 1, lines 15-30, etc.)
--a control unit including a processor and memory with instructions (e.g. cochlear implant 100, figure 1; figure 6, element 620; figure 3A/B, element 350; having a programmed processor with algorithm,, and therefore necessarily a memory with instructions since the processor is programmed and performs the functional/method steps of the algorithm, col. 9, lines 58 to col. 10, line 13;col. 4, lines 47-65, col. 24, lines 12-38, etc.).
--to generate a first electrical stimulation to increase permeability and porosity from an initial porosity/permeability (e.g. claims 1 and 10 of the patent; col. 23, line 44 to col. 24, line 11; col. 11, lines 22-38; col. 15, line 55 to col. 16, line 27; col. 11, lines 42-61; etc.)
-- to then generate a second electrical stimulation to decrease permeability and porosity from the increased porosity/permeability (e.g. col. 23, line 44 to col. 24, line 11, stating that the system goes from opening to closing; claims 1 and 10 of the patent; col. 11, lines 22-38; col. 15, line 55 to col. 16, line 27; col. 11, lines 42-61; etc.). The system and method of Smyth also operates on a closed loop feedback, therefore operating to increase and then decrease permeability/porosity based on the particular situation of the patient.
For claims 26-28 and 32-34, Smyth discloses that an agent concentration is monitored with a sensor to operate in a closed loop manner to adjust the permeability/porosity and determine if the permeability has increased or decreased due to the monitored concentration so that the system can operate in a closed loop feedback (e.g. col. 23, line 44 to col. 24, line 11; col. 15, lines 10-35, col. 24, lines 12-37, claims 1-3 and 10 of the patent, etc.).
For claims 30 and 40, Smyth discloses the additional element of an active agent delivery catheter system to deliver the agent to the biological barrier before the initial stimulation (note also that the claim is an open-ended “comprising” claim and does not preclude previous stimulation) to pass the drug through the barrier during increase permeability (e.g. col. 24, lines 12-37; figures 8-9; col. 12, lines 35-67, etc.).
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Smyth.
Smyth discloses the claimed invention for delivering electrical pulses and using wireless communication with the sensor, except for the electrical pulses being bi-phasic waveforms and using wireless communication between the control unit and the electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Smyth, with electrical pulses being bi-phasic waveforms and using wireless communication between the control unit and the electrode, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of providing a charge balanced pulse that does not degrade the electrode or leave charge, or cause tissue damage, at the electrode tissue interface, and allowing the system to operate without wires so that the control unit can be placed in an unobtrusive remote location and/or so that the wires do not need to be snaked through the body to control the electrodes.
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 and 22-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and claims 1-20 of U.S. Patent Nos. 12383735 and 12544569. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are narrower and meet the limitations of this application’s broader claims. In addition for the ‘735 patent, it would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have included the structure to perform the method, such as the structure having the electrode, catheter, sensor, control unit, processor and memory, since it would provide the predictable results of providing the physical elements to perform the method steps and allowing the device to be automated so that human interaction is not necessary.
Allowable Subject Matter
Claims 22 and 37 would be allowable upon overcoming the double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 3/2/26