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.
(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, 3, 4, 8, 10-13, 15-17, 22 and 23 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Fleischman et al. (US 5,836,947, hereinafter “Fleischman”).
In regards to claim 1, Fleischman discloses a temporary intra-cardiac pacing device (col. 10, lines 6-10) comprising:
a device body (Fig. 15), wherein the device body comprises a first body and a second body at a distal region (two elements 22), wherein the distal region comprises an electrode (elements 28) coupled to an electrode conduction wire extended through a proximal end of the device body (col. 9, lines 49-59), wherein the electrode is configured to contact a wall tissue and electrically connect the wall tissue to a pulse generator (Fig. 16);
a coupling system comprising a loop control member and extending longitudinally within the device body, and disposed between the first body and the second body (Fig. 15, element 80); and
a loop actuator disposed at the proximal end of the device body and coupled to the loop control member (Fig. 15, element 82), wherein:
when the loop control member is activated by tension applied from the loop actuator, the coupling system operate the first body and the second body to separate to form a loop in the distal region and to bring the electrode into contact with the wall tissue (Figs. 15 and 16).
In regards to claim 3, the device further comprises a plurality of electrodes (Fig. 15, elements 28).
In regards to claim 4, the electrode comprises at least one ring electrode (Fig. 11A, element 34; col. 9, lines 29-37).
In regards to claim 8, the coupling system further comprises a hinge disposed near the distal region of the device body and coupled to the loop control member, wherein activation of the loop control member causes the hinge to be pulled and causes a bended expansion of the first body and the second body (Figs. 4 and 15, element 24).
In regards to claim 10, the coupling system further comprises a pivot adjoining a proximal end of the first body and the second body, such that activation of the loop control member causes the first body and the second body to separate at the pivot (Figs. 15 and 16; proximal bend of elements 22 in the area where 22 meets 26).
In regards to claim 11, the distal region comprises a beveled portion, such that the loop is configured to form a curved shape via the loop control member (Figs. 4 and 15, element 24 is beveled).
In regards to claim 12, Fleischman discloses an in vivo deployment platform (Figs. 15 and 16) comprising:
a device body (Fig. 15), wherein the device body comprises a first body and a second body at a distal region (two elements 22), wherein the distal region comprises an end node (elements 28) coupled to an electrode conduction wire extended through a proximal end of the device body (col. 9, lines 49-59), wherein the end node is configured to contact a wall tissue and electrically connect the wall tissue to a pulse generator (Fig. 16);
a coupling system comprising a loop control member and extending longitudinally within the device body, and disposed between the first body and the second body (Fig. 15, element 80); and
a loop actuator disposed at the proximal end of the device body and coupled to the loop control member (Fig. 15, element 82), wherein:
when the loop control member is activated by tension applied from the loop actuator, the coupling system operate the first body and the second body to separate to form a loop in the distal region, wherein the loop is held by the applied tension, such that, when the distal region is inserted into the body cavity and the loop control member is activated, the loop at the distal region of the device body travels within the body cavity without damaging wall tissues of the body cavity (Figs. 15 and 16).
In regards to claim 13, the end node comprises a sensor (col. 9, lines 1-7).
In regards to claim 15, the end node comprises an actuator (col. 10, lines 6-10; the electrode actuates the heart tissue via pacing).
In regards to claim 16, the actuator comprises a thermal application device (col. 11, lines 3-9; ablation is the application of thermal energy).
In regards to claim 17, the end node comprises a conducting ring (Fig. 11A, element 34; col. 9, lines 29-37).
In regards to claim 22, the distal region comprises a beveled portion, such that the loop is configured to form a curved shape via the loop control member (Figs. 4 and 15, element 24 is beveled).
In regards to claim 23, the coupling system further comprises a hinge disposed near the distal region of the device body and coupled to the loop control member, wherein activation of the loop control member causes the hinge to be pulled and causes a bended expansion of the first body and the second body (Figs. 4 and 15, element 24).
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.
Claim 2, 6, 14, 18, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman in view of Edwards et al. (US 6,258,087, hereinafter “Edwards”).
In regards to claims 2, 6, 18, 19, and 21, Fleischman discloses the essential features of the claimed invention, but does not expressly disclose wherein the electrode comprises a retractable fixation electrode and the electrode conduction wire connected to two retractable fixation electrodes, wherein each of the two retractable fixation electrodes extends out of a separate lead distal openings at the distal region, and comprises a fixation electrode conduction wire coupled to a slide member at the proximal end of the device body, wherein the retractable fixation electrode is disposed at a lead distal opening at the distal region, such that activation of the slide member causes the retractable fixation electrode to extend in a predetermined angle from the loop away from a distal end at the lead distal opening, such that the retractable fixation electrode is releasably coupled to the wall tissue.
However, Edwards in the same field of endeavor of intravascular electrical therapy devices teaches providing a device wherein the electrode comprises a retractable fixation electrode (Fig. 7, element 66) and the electrode conduction wire comprises a fixation electrode conduction wire connected to two retractable fixation electrodes, wherein each of the two retractable fixation electrodes extends out of a separate lead distal openings at the distal region, and coupled to a slide member at the proximal end of the device body (Fig. 5, elements 68, col. 11, lines 52-56), wherein the retractable fixation electrode is disposed at a lead distal opening at the distal region (Fig. 7), such that activation of the slide member causes the retractable fixation electrode to extend in a predetermined angle from the loop away from a distal end at the lead distal opening, such that the retractable fixation electrode is releasably coupled to the wall tissue (Fig. 7; col. 11, lines 52-56) to provide the predictable results of more effectively anchoring the device and targeting tissue below the tissue surface (col. 11, line 57 to col. 12, line 31).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fleischman by providing the device wherein the electrode comprises a retractable fixation electrode and the electrode conduction wire comprises a fixation electrode conduction wire connected to two retractable fixation electrodes, wherein each of the two retractable fixation electrodes extends out of a separate lead distal openings at the distal region, and coupled to a slide member at the proximal end of the device body, wherein the retractable fixation electrode is disposed at a lead distal opening at the distal region, such that activation of the slide member causes the retractable fixation electrode to extend in a predetermined angle from the loop away from a distal end at the lead distal opening, such that the retractable fixation electrode is releasably coupled to the wall tissue to provide the predictable results of more effectively anchoring the device and targeting tissue below the tissue surface.
In regards to claim 14, Fleischman discloses the essential features of the claimed invention except for wherein the sensor comprises a camera. However, Edwards teaches providing a sensor including a camera (Fig. 50, element 86) to provide the predictable results of allowing the clinician to observe the procedure (col. 14, lines 10-24). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fleischman by providing a sensor including a camera to provide the predictable results of allowing the clinician to observe the procedure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman. Fleischman discloses the essential features of the claimed invention, but does not expressly disclose wherein the loop comprises a planar gap, wherein the planar gap comprises an end-to-end separation distance between 2-2.5 ±1 cm. However, Fleischman’s system includes a continuous slider control (Figs. 15 and 16) that would allow a user to set a planar gap including a value within the range claimed, as this is a distance of typical human anatomy within the vasculature. Further, it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fleischman by providing a separation within the claimed range to yield no more than predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman in view of Whayne et al. (US 6,071,279, hereinafter “Whayne”). Fleischman discloses the essential features of the claimed invention, including a hinge bonded at the distal region of the device body (Figs. 3, 4, 15 and 16), but does not expressly disclose that the hinge is thermally bonded. However, Whayne in the same field of endeavor of intravascular electrical therapy devices teaches that it is known to thermally bond a wire element (such as Fleischman’s) to a polymer element using thermal bonding (col. 13, lines 26-39) to provide the predictable results of a rigid attachment between wire and polymer elements that avoids a complex additional hub element (col. 13, lines 26-39). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fleischman by thermally bonding the wire element to the polymer hinge element using thermal bonding to provide the predictable results of a rigid attachment between wire and polymer elements that avoids a complex additional hub element.
Allowable Subject Matter
Claims 5 and 20 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. The prior art lacks disclosure or a suggestion, alone or in combination, of providing a retractable fixation element comprising a coiled end, with the slide member configured to transmit a rotational torque to cause the coil end to screw into wall tissue, in combination with the remaining requirements of claims 2 and 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bly et al. (US 7,949,409) is another example of an intravascular device the is actuated via applying tension to an actuator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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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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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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