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 .
Response to Arguments
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. The Examiner’s position regarding obviousness is considered to be clearly stated in the rejections below.
Claim Objections
Claim 68 is objected to because of the following informalities: the term “engagement assembly” should be amended to correspond with amended claim 64. Appropriate correction is required.
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) 38, 40, 43, 46, 47, 56-58, 60-64, and 66-69 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2018/0092661 (Prabhu) in view of US 4,222,380 (Terayama).
In regard to claim 38: Prabhu discloses an assembly in Fig. 9 comprising an outer shaft (802) with a plurality of engagement members (824) positionable relative to the distal end of the outer shaft, wherein the engagement members move from a collapsed insertion configuration to an expanded shape (Fig. 10A; see description of control of prongs 824 at [0058] and in regard to actuatable elements 315 in Fig. 3A-F at [0040]).
Prabhu includes a cutting element (812) carried by and being moveable relative to the elongate body (802) (See description of cutting element moveable relative to catheter at [0036]), which has a shaft and a sharp tip configured to pierce a leaflet of the valve (Fig. 9; [0057-0059]; see description of needle at [0048]). Prabhu discloses the outer shaft defines a first channel having a port defined by its open terminal end (see description of catheter shaft 102 at [0036]), and a cutting mechanism routed through the catheter and out of the port (distal end 106; see Figure 1; [0036]).
Prabhu teaches that forming the cutting element to be moveable within the outer shaft is an obvious alternative to form the cutting mechanism to be coupled to the distal end of the catheter [0036][, but fails to explicitly disclose or teach an inner catheter moveable within the first channel that carries the cutting element.
Terayama discloses another surgical device having both an engagement assembly with first and second engagement members (41) in combination with a cutting element (needle 42). Terayama includes an outer catheter (16) defining a first channel in which an inner catheter (19) is disposed, wherein the needle (42) is moveable within the second channel defined by the inner catheter from a retracted position of Figure 3 to an extended position of Figure 4. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to construct the Prabhu device to so that the cutting element is carried on an inner shaft moveable within the outer shaft, as taught by Terayama, as the modification merely involves a combination of known catheters according to known methods that obtains a predictable result of a surgical instrument having relatively moveable tissue engagement and cutting elements.
In regard to claim 40, modified Prabhu has a cutting element capable of being moveable from a retracted configuration within the outer shaft (see Fig. 3 of Terayama) to an extended configuration out of the port (see Fig. 4 of Terayama).
Regarding claim 43, Prabhu discloses the cutting element can be electrified (either by power source Fig. 4 [0046]; RF energy [0049] or thermal energy [0051]).
Regarding claim 46, the cutting element has a first sharpened region defined by the sharp tip (see description of needle structure of cutting element at [0048]).
In regard to claim 56, Terayama further teaches that the handle includes a locking element (ball and detent) enabling the cutting element (needle 42) to be locked relative to the elongate body (16) (Fig. 1-3; see description of driving member 32 fixed to proximal end of needle 42; col 4, lines 1-10). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a locking mechanism on the modified Prabhu device, as taught by Terayama, as the modification merely involves a combination of known catheters according to known methods that obtains a predictable result of a selectively locking moveable components of a catheter system.
In regard to claim 57, the cutting element (812) is capable of being moved when the engagement members (824) are coupled to the heart valve (see engagement members 41 of Terayama coupled to tissue and needle being moved Fig. 3-4).
In regard to claim 58 and 64: Prabhu discloses an assembly in Fig. 9 comprising an outer shaft (802) with a plurality of engagement members (824) positionable relative to the distal end of the outer shaft, wherein the engagement members move from a collapsed insertion configuration to an expanded shape (Fig. 10A; see description of control of prongs 824 at [0058] and in regard to actuatable elements 315 in Fig. 3A-F at [0040]).
Prabhu includes a cutting element (812) carried by and being moveable relative to the elongate body (802) (See description of cutting element moveable relative to catheter at [0036]), which has a shaft and a sharp tip configured to pierce a leaflet of the valve (Fig. 9; [0057-0059]; see description of needle at [0048]). The curved needle (812) is considered to be capable of lacerating a valve, as the term “lacerating” is given its broadest reasonable interpretation to encompass the cutting function disclosed by Prabhu (Fig. 5a-b; abstract; [0048]). Prabhu discloses the outer shaft defines a first channel having a port defined by its open terminal end (see description of catheter shaft 102 at [0036]), and a cutting mechanism routed through the catheter and out of the port (distal end 106; see Figure 1; [0036]).
Prabhu teaches that forming the cutting element to be moveable within the outer shaft is an obvious alternative to form the cutting mechanism to be coupled to the distal end of the catheter [0036][, but fails to explicitly disclose or teach an inner catheter moveable within the first channel that carries the cutting element.
Terayama discloses another surgical device having both an engagement assembly with first and second engagement members (41) in combination with a cutting element (needle 42). Terayama includes an outer catheter (16) defining a first channel in which an inner catheter (19) is disposed, wherein the needle (42) is moveable within the second channel defined by the inner catheter from a retracted position of Figure 3 to an extended position of Figure 4. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to construct the Prabhu device to so that the cutting element is carried on an inner shaft moveable within the outer shaft, as taught by Terayama, as the modification merely involves a combination of known catheters according to known methods that obtains a predictable result of a surgical instrument having relatively moveable tissue engagement and cutting elements.
In regard to claims 60 and 66, modified Prabhu has a cutting element capable of being moveable from a retracted configuration within the outer shaft (see Fig. 3 of Terayama) to an extended configuration out of the port (see Fig. 4 of Terayama).
Regarding claims 61 and 67, Prabhu discloses the cutting element can be electrified (either by power source Fig. 4 [0046]; RF energy [0049] or thermal energy [0051]).
In regard to claims 62 and 68, the cutting element (812) is capable of being moved when the engagement members (824) are coupled to the heart valve (see engagement members 41 of Terayama coupled to tissue and needle being moved Fig. 3-4).
In regard to claims 63 and 69, Terayama further teaches that the handle includes a locking element (ball and detent) enabling the cutting element (needle 42) to be locked relative to the elongate body (16) (Fig. 1-3; see description of driving member 32 fixed to proximal end of needle 42; col 4, lines 1-10). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a locking mechanism on the modified Prabhu device, as taught by Terayama, as the modification merely involves a combination of known catheters according to known methods that obtains a predictable result of a selectively locking moveable components of a catheter system.
Claim(s) 47 is rejected under 35 U.S.C. 103 as being unpatentable over Prabhu in view of USPAP 2006/0095055 (Douglas et al.).
Prabhu discloses the cutting element (812) has a generally curved shape, but fails the cutting element has a sharpened region at the intersection of a shaft and an angled leg. Douglas discloses another cutting device with a blade configured for cutting blood vessels. As shown in Figure 5a-c, the blade comprises a piercing tip (148d/248d/348d), an angled leg (148b,248b,348b), a shaft (147, 247 and 347, and a sharpened region (148a, 248a, and 348a) at the intersection of the shaft and the angled leg. Since the Douglas device is in the same field of endeavor of cutting vasculature (abstract), one of ordinary skill in the art would have found it obvious to modify the cutting element of Prabhu to include a sharpened region at the intersection of a shaft and an angled leg, as taught by Douglas, as the modification merely involves a combination of known surgical cutting blades according to known methods that obtains a predictable result.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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