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 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.
Claims 1-5, 7-10, 13, and 15 are rejected under 35 U.S.C. 102a1 as being anticipated by Fey et al (2003/0078618). Fey discloses the claimed elements as follows:
--implantable electrostimulation device (e.g. figure 17, element 222; figure 20, element 322, etc.) that is capable of being inserted into the migration mitigation component after implantation of the component since the electrostimulation device can be placed after implantation
--an introducer sheath (e.g. figure 17, element 216; figure 20 element 316, etc.) with integrally formed migration mitigation component (e.g. figure 17, from distal hole 217 to tapered distal end near element 230, paras. 84-85; figure 20, area around 2nd or 3rd distal hole to rounded distal end near element 330, para. 92; both having same outer diameter where the sheath meets the mitigation component such as at holes 217 or 317; etc.) where the mitigation component will directly mechanically connect with an outer surface of the electrostimulation device (e.g. figure 18, figure 21, as the device is pushed out of the component, etc.).
For claims 4 and 5, Fey discloses several holes/perforations in the sidewall (e.g. holes 217 or 317, figures 18 and 21, etc.) that will allow for the separation of the mitigation component from the sheath at the holes/breakaway junction, such as by cutting the introducer at the holes (in the alternative, see the 103 rejection below).
For claims 7-10, Fey has multiple electrodes (e.g. element 223/323, etc.) and circuitry housing (e.g. 222, 322, etc.) and incorporates different microstimulators/electrical stimulation devices for implantation (e.g. paras. 3, 59, etc.) that describe the location of the electrodes, circuitry, and antenna, such as patent 5193539, in which figure 12 shows the multiple electrodes and other elements of the claims. For claims 8 and 9, the claims do not state the mitigation component is “directly” coupled or attached to the housing or antenna, and therefore Fey meets the limitations of the claims as the component is attached to the housing/antenna as the component is: near the housing/antenna and coupled through other elements; and/or coupled through the other elements of the introducer system to the housing/antenna. In addition, as the microstimulator slides through the mitigation component, it will couple with each region of the microstimulator, such as at the housing/antenna. For claim 10, as the microstimulator is circular as is the introducer/mitigation component, and the component will be coupled circumferentially around the circuitry housing (in the alternative, see the 103 rejection below).
For claim 13, the mitigation component does include indents or through holes as holes 217/317, or distal end through hole.
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.
In the alternative, claims 4, 5, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fey et al. Fey discloses the claimed invention with mitigation component circumferentially coupled to the electrostimulation device and with perforations/holes in a sidewall of the introducer and/or between the component and introducer sheath to form a breakaway region. If it is argued that Fey does not have perforation in the sidewall as a breakaway region between the component and sheath, and the component being coupled circumferentially about the circuitry housing, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system and method as taught by Fey, with the use of a perforation in the sidewall as a breakaway region between the component and sheath and the mitigation component being coupled circumferentially about the circuitry housing, as is well known and common knowledge in the art (mpep 2144I, 2144.03), as it would provide the predictable results of: providing regions between the component and sheath that still have the two elements coupled, but that can easily allow for separation of the two elements when needed; and providing a greater extent of coupling between the two components to provide more resistance to movement to prevent the stimulator from being accidently implanted before it is at the proper location.
Allowable Subject Matter
Claims 12 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 1/28/26