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 § 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 39-40, 57, 59-60 and 65-66 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.
Claim 39 recites an outer catheter and an inner catheter. It is unclear whether Applicant is attempting to claim an outer catheter in addition to the “elongate body” of claim 38, or whether the outer catheter should refer back to the “elongate body” in claim 38. Claim 40 depends from claim 39 and is indefinite for the same reason.
Claim 57 appears to have typographical errors which render the scope of this claim language indefinite. The claim is interpreted similar to claim 62 for the purpose of expediting prosecution.
Claim 59 recites an outer catheter and an inner catheter. It is unclear whether Applicant is attempting to claim an outer catheter in addition to the “elongate body” of claim 38, or whether the outer catheter should refer back to the “elongate body” in claim 58. Claim 60 depends from claim 59 and is indefinite for the same reason.
Claim 65 recites an outer catheter and an inner catheter. It is unclear whether Applicant is attempting to claim an outer catheter in addition to the “elongate body” of claim 64, or whether the outer catheter should refer back to the “elongate body” in claim 64. Claim 66 depends from claim 65 and is indefinite for the same reason.
Claim Rejections - 35 USC § 102
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.
Claim(s) 38, 43, 46, 57, 58, 61, 62, 64, 67 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2018/0092661 (Prabhu).
In regards to claim 38: Prabhu discloses an assembly in Fig. 9 comprising an elongated body (802) with an engagement assembly carried at the distal end, the engagement assembly having first and second engagement members (824) capable of moving from a collapsed shape to an expanded engagement configuration to couple to a valve (Fig. 10A; see description of control of prongs 824 at [0058] and in regards to actuatable elements 315 in Fig. 3A-F at [0040]), and 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]).
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 regards to claim 57, the cutting element (812) is moveable while the engagement assembly (824) is coupled to the heart valve when the assembly is positioned at or near the heart valve.
In regards to claim 58: Prabhu discloses an assembly in Fig. 9 comprising an elongated body (802) with an engagement assembly carried at the distal end, the engagement assembly having first and second engagement members (824) capable of moving from a collapsed shape to an expanded engagement configuration to couple to a valve (Fig. 10A; see description of control of prongs 824 at [0058] and in regards to actuatable elements 315 in Fig. 3A-F at [0040]), and 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 curved portion (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]).
Regarding claim 61, Prabhu discloses the cutting element can be electrified (either by power source Fig. 4 [0046]; RF energy [0049] or thermal energy [0051]).
In regards to claim 62, the cutting element (812) is moveable while the engagement assembly (824) is coupled to the heart valve when the assembly is positioned at or near the heart valve.
In regards to claim 64: Prabhu discloses an assembly in Fig. 9 comprising an elongated body (802) with an engagement assembly carried at the distal end, the engagement assembly having first and second engagement members (824) capable of moving from a collapsed shape to an expanded engagement configuration to couple to a valve (Fig. 10A; see description of control of prongs 824 at [0058] and in regards to actuatable elements 315 in Fig. 3A-F at [0040]), and 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 curved portion (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]).
Regarding claim 67, Prabhu discloses the cutting element can be electrified (either by power source Fig. 4 [0046]; RF energy [0049] or thermal energy [0051]).
In regards to claim 68, the cutting element (812) is moveable while the engagement assembly (824) is coupled to the heart valve when the assembly is positioned at or near the heart valve.
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) 39-40, 56, 59-60, 63, 65-66 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu in view of US 4,222,380 (Terayama).
Regarding claims 39, 59 and 65, Prabhu fails to disclose an outer catheter defining a first channel and an inner catheter moveable within the first channel. 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 include both inner and outer catheters, 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 regards to claims 56, 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
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774