DETAILED ACTION
A complete action on the merits of pending claims 1-13 and 15-21 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1-6, 11-13, 15-17 and 20 rejected under 35 U.S.C. 103 as being unpatentable over Tegg US 20100168647 in view of Malecki US 20060241583 and LePivert US 20080300571.
Regarding claims 1, 2, 11, and 20, Tegg teaches an electrical energy source; an electrocautery probe electrically coupled to the electrical energy source (par. [0028] where the ablation energy comes from), the electrocautery probe having a cannula shaft portion (Fig. 2b 30), a distal penetrating tip (Fig. 2b 42), and an intermediate portion interposed between the cannula shaft portion and distal penetrating tip (Fig. 2b where the splines 36 are at), wherein the electrocautery probe is configured to generate heat (par. [0048] ablation through electrodes on basket); a fluid source (Fig. 1 and par. [0027] fluid delivery valves) wherein: the cannula shaft portion has a cannula lumen coupled in fluid communication with the fluid source (Fig. 2b where ports 34 are coming out of); and the intermediate portion is an expandable portion that is coupled in fluid communication with the fluid source via the cannula lumen (Fig. 3a), wherein the expandable portion is configured to define a plurality of openings, and the sealing fluid that is supplied by the fluid source exits the expandable portion through the plurality of openings to a location external to the electrocautery probe (Fig. 3a ports 34 of the area between the splines).
Tegg does not explicitly teach the tip having a pointed end and a monopolar electrocautery probe and grounding pad cooperate to generate heat and a protein source being a fluid source coupled to the intermediate portion of the electrocautery probe, the protein source having a protein that is denatured by heat.
Malecki, in an analogous device, teaches that the basket catheter can be operated in a bipolar or monopolar mode using a ground pad attached to the patient (par. [0061]). The device can incorporate liquid albumin (par. [0077]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Tegg to have the fluid contain albumin, as in Malecki. The albumin acts as a tissue soldering agent (pars. [0016] and [0016]).
Maleck does not explicitly teach the tip having a pointed end.
LePivert, in an analogous device, teaches the tip of the expandable device can have a blunted or pointed tip (par. [0075]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Tegg and Malecki to have a pointed tip. The pointed tip can be used instead of the blunt tip to create different characteristics for the device favorable for different procedures (LePivert par. [0075])
Regarding claims 3 and 12, Tegg teaches wherein the expandable portion has an extended position that defines a collapsed state (Fig. 2a) and a retracted position that defines an expanded state (Fig. 2b and par. [0033]), the expandable portion including a plurality of expansion members (Fig. 2b splines 36), wherein a respective opening of the plurality of openings is located between each pair of adjacent expansion members of the plurality of expansion members (Fig. 3a).
Regarding claims 4 and 13, Tegg teaches wherein: each expansion member of the plurality of expansion members has a proximal end connected to the cannula shaft portion and a distal end connected to the distal penetrating tip; and each expansion member of the plurality of expansion members further comprises an articulation joint located between the proximal end and the distal end (Annotated Fig. 2b), wherein the expanded state facilitates a flow of the sealing fluid between the plurality of fluid expansion members to a location external to the expandable portion (Fig. 3a).
Regarding claims 5 and 15, Tegg teaches wherein the cannula shaft portion has a first diameter and the expandable portion has a second diameter, wherein in the collapsed state the first diameter and the second diameter are substantially equal (Fig. 2a).
Regarding claims 6 and 16, Tegg teaches wherein in the expanded state, the cannula shaft portion has a first diameter and the expandable portion has a largest circumference having a second diameter, wherein the second diameter is greater than the first diameter (Fig. 2b).
Regarding claim 17, Tegg teaches wherein the expandable portion is made from a biocompatible metal (par. [0044] nitinol deployment member par. [0046] stainless steel splines).
Claims 8-10 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tegg, Malecki, and LePivert as applied to claims 1 and 11 above, and further in view of Anderson US 20090093809.
Regarding claims 8-10 and 21, Tegg, Malecki, and LePivert do not explicitly teach wherein the intermediate portion is an expandable portion that includes a plurality of expansion members, the plurality of expansion members having a coating as the protein source, the coating being a heat-activated material that includes the protein, the plurality of expansion members having a collapsed state and an expanded state and wherein the coating includes a collagen.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Tegg, Malecki, and LePivert to have a collagen coated ablation area, as in Anderson. The collagen allows for fusion (par. [0124] and absorbing over time par. [0149]).
Claims 7, 18, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tegg, Malecki, and LePivert as applied to claims 1 and 11 above, and further in view of Edwards US 62545598.
Regarding claims 7, 18, and 19, Malecki teaches wherein the sealing fluid includes albumin (par. [0077]).
Tegg, Malecki, and LePivert do not explicitly teach wherein the fluid source is a syringe and further comprising a Luer fitting connected to a proximal end of the cannula shaft portion, the Luer fitting being in fluid communication with the cannula lumen, and wherein the syringe is connected to the Luer fitting.
Edwards, in an analogous device, teaches the fluid ports can be a Luer fitting (col 5 lines 42-44) and the fluid delivery source can be a syringe (col 8 lines 29-34).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Tegg, Malecki, and LePivert to us a syringe and Luer fitting, as in Edwards. These are known elements in the art that are used for fluid delivery (col 5 lines 42-44 and col 8 lines 29-34).
Response to Arguments
Applicant’s arguments with respect to the independent claims have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The applicant states that the addition of a pointed tip would make Tegg unsatisfactory for its intended purpose but did not present any evidence. Tegg does not teach away using a pointed tip. The applicant argues that Tegg cannot be used to read on the joint since there are no fold lines in the splines. There are no limitations regarding joints being fold lines in the claims. As stated in the interview there is an inflection point that the splines bend at and that is what is interpreted as the joint. Therefore, the arguments presented by the applicant are not persuasive.
Annotated Figures
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Conclusion
THIS ACTION IS MADE FINAL. 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.
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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