DETAILED ACTION
Claims 1-21 are pending in this application.
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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-16) in the reply filed on 11/03/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/25.
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.
Claim 16 is 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 16, line 2 recites the limitation "the central lumen". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be read as --the at least one lumen--.
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 1-2, 7, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cribier et al., hereinafter “Cribier” (U.S. Patent No. 4,777,951).
Regarding claim 1, Cribier discloses a multifunction catheter adapted for valvuloplasty (aortic valvuloplasty dilatation catheter instrument 10; see Figure 1, col. 10, lines 55-56 and abstract), the multifunction catheter comprising:
a shaft (catheter shaft of 10) defining at least one lumen (Figure 2; multiple lumens 12, 14, 16), the shaft comprising a distal end (tip distal to side holes 21), a proximal end (opposite end near ports in Figure 1), and a bend (see annotated Figure 1 below):
a valvuloplasty expansion device comprising a balloon 22 or expandable braid valvuloplasty device, the valvuloplasty expansion device disposed along the shaft between the proximal end and the bend of the shaft (Id.); and
an opening (one of side holes 21; Id.) through the shaft or a pressure sensor, the opening or pressure sensor adapted to facilitate a hemodynamic pressure measurement within a left ventricle of a heart (col. 12, lines 55-60: side holes 21 can be placed inside the left ventricle and measure a pressure gradient across the aortic valve) and the opening or pressure sensor is disposed along the shaft between the bend and the distal end of the shaft (see annotated Figure 1 below).
FIGURE 1 OF CRIBIER
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Regarding claim 2, Cribier discloses the bend of the shaft comprises at least one of the group comprising: a single bend (see annotated Figure 1 above), a double bend, and a pigtail bend.
Regarding claim 7, Cribier discloses the opening comprises a plurality of openings (side holes 21).
Regarding claim 10, Cribier discloses at least one port (see proximal end containing ports for lumens 12, 14, 16 in Figure 1) is disposed in fluid communication with the at least one lumen (Figure 2).
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.
Claims 3-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cribier (U.S. Patent No. 4,777,951) in view of Ramanathan (U.S. Pub. No. 2018/0256848).
Regarding claim 3, Cribier discloses the claimed invention, as discussed above, except for the single bend comprises a bend of approximately 75 degrees.
Ramanathan teaches a valvuloplasty catheter including a shaft 103 defining a bend (see different curled distal tips in Figures 1-3), wherein the bend may be different shapes/angles as best suited for a particular application or depending on which shape/angle an operator prefers to gain access to a particular area of the anatomy ([0050], [0054]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the bend in Cribier such that it is approximately 75 degrees since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. Ramanathan teaches that the bend shape/angle is result effective variable known to affect results, namely facilitating access and placement of the catheter through anatomical regions in the heart for treatment.
Regarding claim 4, Cribier discloses the claimed invention, as discussed above, except for the bend of the shaft comprises a double bend that comprises a primary curvature of approximately 180 degrees with a distal secondary to the opposite direction of approximately 90 degrees.
Ramanathan teaches a valvuloplasty catheter including a shaft 103 with a double bend (at distal end 107; Figure 1) that comprises a primary curvature of approximately 180 degrees with a distal secondary to the opposite direction of approximately 90 degrees (Id.). Ramanathan further teaches the bend may be different shapes/angles as best suited for a particular application or depending on which shape/angle an operator prefers to gain access to a particular area of the anatomy ([0050], [0054]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the bend in Cribier such that it is a double bend that comprises a primary curvature of approximately 180 degrees with a distal secondary to the opposite direction of approximately 90 degrees since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. Ramanathan teaches that the bend shape/angle is result effective variable known to affect results, namely facilitating access and placement of the catheter through anatomical regions in the heart for treatment.
Regarding claim 5, Cribier discloses the claimed invention, as discussed above, except for the bend of the shaft comprises a pigtail bend that comprises a bend of approximately 450 degrees.
Ramanathan teaches a valvuloplasty catheter including a shaft 103 with a pigtail bend (at distal end 205; Figure 2). Although Ramanathan does not expressly teach a bend of approximately 450 degrees, Ramanathan further teaches the bend may be different shapes/angles as best suited for a particular application or depending on which shape/angle an operator prefers to gain access to a particular area of the anatomy ([0050], [0054]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the bend in Cribier such that it is a pigtail bend that comprises a bend of approximately 450 degrees since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. Ramanathan teaches that the bend shape/angle is result effective variable known to affect results, namely facilitating access and placement of the catheter through anatomical regions in the heart for treatment.
Regarding claim 8, Cribier discloses the claimed invention, as discussed above, except for an atraumatic tip is disposed at the distal end of the shaft.
Ramanathan teaches a valvuloplasty catheter including a shaft 103 with an atraumatic tip (pigtail shape at distal end 205; Figure 2) disposed at the distal end of the shaft.
It would have been obvious to one of ordinary skill before the effective filing date to modify the tip of Cribier such that it is atraumatic, as taught by Ramanthan, in order to prevent injury or trauma to the anatomical regions of the heart as the catheter is being delivered.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cribier (U.S. Patent No. 4,777,951) in view of Lampropoulos et al., hereinafter “Lampropoulos” (U.S. Pub. No. 2016/0250444).
Regarding claim 6, Cribier discloses the claimed invention, as discussed above, including a pressure sensor (col. 12, lines 55-60: side holes 21 can be placed inside the left ventricle and measure a pressure gradient across the aortic valve) adapted to facilitate a hemodynamic measurement within a left ventricle of a heart (Id.), except Cribier does not expressly teach the pressure sensor comprises at least one of an electrical and mechanical pressure sensor.
Lampropoulos teaches a valvuloplasty catheter including a pressure sensor ([0038]), wherein the pressure sensor is electrical/mechanical (a pressure transducer contains both mechanical and electrical components), wherein one of ordinary skill in the art will recognize that a variety of pressure transducers in different configurations as well as other types of pressure sensors could be used in a valvuloplasty catheter (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the pressure sensor side holes in Cribier such that they are an electrical/mechanical pressure sensor, as taught by Lampropoulos, since doing so would be substitution of one known pressure transducer for another, which would yield predictable results, namely measuring a degree of pressure and obtaining a hemodynamic within a patient’s heart. See MPEP 2143.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cribier (U.S. Patent No. 4,777,951) in view of Abele et al., hereinafter “Abele” (U.S. Patent No. 5,693,014).
Regarding claim 9, Cribier discloses the claimed invention, as discussed above, except for the balloon comprises a wrapped and pleated material disposed along a length of the shaft.
Abele teaches a balloon catheter including a balloon 51 comprising a wrapped and pleated material (Figure 10, col. 5, lines 33-47; see pleats 60-67 in wrapped/compact state) disposed along a length of a shaft 53 (Figure 11).
It would have been obvious to one of ordinary skill before the effective filing date to modify the balloon of Cribier such that it comprises a wrapped and pleated material disposed along a length of the shaft, as taught by Abele, since the pleating facilitates maintaining the balloon in a compact, low profile form for introduction into the body.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cribier (U.S. Patent No. 4,777,951) in view of Valley et al., hereinafter “Valley” (U.S. Patent No. 5,766,151).
Regarding claims 11-12, Cribier discloses the claimed invention, as discussed above, including ports (Figure 1; see ports at proximalmost end of lumens 12, 14) disposed on the shaft being in fluid communication with each of a pair of the lumens 12, 14 (Figure 2), except for the ports being luer ports disposed between the proximal end of the shaft and the balloon.
Valley teaches a balloon catheter including a pair of luer ports 122, 124 (Figure 5A; col. 21, lines 25-28) disposed between the proximal end of a shaft 104 and a balloon 110.
It would have been obvious to one of ordinary skill before the effective filing date to modify the ports in Cribier such that they are luer ports disposed between the proximal end of the shaft and the balloon, as taught by Valley, since luer ports are known medical standard fluid ports and would substituting one known port for another for yielding predictable results, namely maintaining leak-free connections with fluid sources. See MPEP 2143. Furthermore, moving the ports from a proximalmost end of the shaft to a location between the proximal end of the shaft and the balloon would be obvious to a skilled artisan since it has been held that rearranging parts of an invention involves only routine skill in the art, wherein the device would perform equally well with the rearrangement. In re Japikse, 86 USPQ 70.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cribier (U.S. Patent No. 4,777,951) in view of Mas (U.S. Pub. No. 2009/0264859).
Regarding claims 13-16, Cribier discloses the claimed invention, as discussed above, except for the valvuloplasty expansion device comprises an expandable braid valvuloplasty device, the expandable braid valvuloplasty device comprising a plurality of interwoven wires surrounding the at least one lumen defined by the shaft, the plurality of interwoven wires are fixed to the shaft distal to an expansion location of the valvuloplasty expansion device, wherein the plurality of interwoven wires comprises nitinol wires, or wherein the plurality of interwoven wires comprises metallic or plastic wires, and wherein a proximal portion of the plurality of interwoven wires are attached to an outer shaft surrounding the central lumen, the plurality of interwoven wires are adapted to expand in width and compress in length as the outer shaft is advanced toward the distal end of the shaft.
Mas teaches an expandable tip catheter including an expansion device comprising an expandable braid device 310 (Figures 3A-3B), comprising a plurality of interwoven wires ([0033]; expandable tip 315 can include braided wires; [0033]) surrounding at least one lumen defined by a shaft 320, the plurality of interwoven wires are fixed to the shaft distal to an expansion location of the expansion device (at 317; [0035]), wherein the plurality of interwoven wires comprises nitinol wires ([0033]), or wherein the plurality of interwoven wires comprises metallic or plastic wires (Id.), and wherein a proximal portion of the plurality of interwoven wires are attached to an outer shaft surrounding the central lumen (at 319; [0035]), the plurality of interwoven wires are adapted to expand in width and compress in length as the outer shaft is advanced toward the distal end of the shaft (as in Figure 3B).
It would have been obvious to one of ordinary skill before the effective filing date to modify the valvuloplasty expansion device to comprise an expandable braid device as claimed, as taught by Mas, since doing so would be substitution of one known expansion device for another, which would yield predictable results, namely to expand a narrowed valve during valvuloplasty. See MPEP 2143.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771