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 Objections
Claims 7-10, 12-13, and 20 are objected to because of the following informalities:
-Claim 7, line 1: please correct “the eyelets” to “the plurality of eyelets”
-Claim 8, line 1: please correct “each eyelet” to “each of the plurality of eyelets”
-Claim 9, line 1: please correct “each eyelet” to “each of the plurality of eyelets”
-Claim 10, line 1: please correct “the at least one eyelet” to “the plurality of eyelets”
-Claim 12, lines 1-2: please correct “the at least one eyelet” to “the plurality of eyelets”
-Claim 13, line 2: please correct “the occlusion” to “an occlusion”
-Clam 20, line 4: please correct “the inserted guide sheath” to “the guide sheath”
-Claim 20, line 6: please correct “the guide wire” to “the guidewire”
Appropriate correction is required.
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 1-3, 5, 7, 11, 14-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayaraman (US 2003/0233068 A1).
Regarding claim 1, Jayaraman discloses an intravascular therapy device (see Fig. 3A, par. [0002]), comprising:
a treatment catheter (balloon catheter 100) having a guidewire lumen (sleeve member 106) extending between a guidewire port (exit port 112 of sleeve member 106) of the treatment catheter (balloon catheter 100) and a distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]), a length of the guidewire lumen (sleeve member 106) being less than a length of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]-[0094], [0101]); and
a plurality of eyelets (sleeve members 108) disposed on an exterior of the treatment catheter (balloon catheter 100) and configured to secure an associated guidewire (not shown, see par. [0090]) to the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]-[0094], [0101]).
Regarding claim 2, Jayaraman discloses the intravascular therapy device of claim 1, wherein no eyelet of the plurality of eyelets (sleeve members 108) is disposed between the guidewire port (exit port 112 of sleeve member 106) and the distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090], sleeve members 108 are proximal to sleeve member 106).
Regarding claim 3, Jayaraman discloses the intravascular therapy device of claim 1, wherein a ratio of the length of the guidewire lumen (sleeve member 106) to the length of the treatment catheter (balloon catheter 100) is 0.5 or less (see Fig. 3A, par. [0090] and [0093]-[0094], sleeve members 106 and 108 can be located on only the distal 1/3 of the catheter such that the length of sleeve member 106 would be considered less than half of the length of the catheter).
Regarding claim 5, Jayaraman discloses the intravascular therapy device of claim 2, wherein the plurality of eyelets (sleeve members 108) are equally spaced along the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090], [0096], [0111]).
Regarding claim 7, Jayaraman discloses the intravascular therapy device of claim 1, wherein the plurality of eyelets (sleeve members 108) comprises a plastic (see par. [0102]).
Regarding claim 11, Jayaraman discloses the intravascular therapy device of claim 1, wherein the treatment catheter (balloon catheter 100) comprises a plastic (see par. [0102]).
Regarding claim 14, Jayaraman discloses an intravascular therapy device (see Fig. 3A, par. [0002]), comprising:
a treatment catheter (balloon catheter 100) having a guidewire lumen (sleeve member 106) extending between a guidewire port (exit port 112 of sleeve member 106) of the treatment catheter (balloon catheter 100) and a distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]), the guidewire lumen (sleeve member 106) providing a path between the guidewire port (exit port 112 of sleeve member 106) and the distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]-[0094], [0101]), a length of the guidewire lumen (sleeve member 106) being less than one-half of a length of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090]-[0094], [0101], sleeve members 106 and 108 can be located on only the distal 1/3 of the catheter such that the length of sleeve member 106 would be considered less than half of the length of the catheter); and
a plurality of eyelets (sleeve members 108) disposed on an exterior of the treatment catheter (balloon catheter 100) along a portion of the length of the treatment catheter (balloon catheter 100) located between a proximal end (proximal end of balloon catheter 100 (right end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) and the guidewire port (exit port 112 of sleeve member 106) (see Fig. 3A, par. [0090]-[0094], [0101]).
Regarding claim 15, Jayaraman discloses the intravascular therapy device of claim 14, wherein no eyelet of the plurality of eyelets (sleeve members 108) is disposed between the guidewire port (exit port 112 of sleeve member 106) and the distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090], sleeve members 108 are proximal to sleeve member 106).
Regarding claim 16, Jayaraman discloses the intravascular therapy device of claim 14, wherein a ratio of the length of the guidewire lumen (sleeve member 106) to the length of the treatment catheter (balloon catheter 100) is 0.5 or less (see Fig. 3A, par. [0090] and [0093]-[0094], sleeve members 106 and 108 can be located on only the distal 1/3 of the catheter such that the length of sleeve member 106 would be considered less than half of the length of the catheter).
Regarding claim 18, Jayaraman discloses the intravascular therapy device of claim 15, wherein the plurality of eyelets (sleeve members 108) are equally spaced along the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0090], [0096], [0111]).
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 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1), as applied to claims 1 and 14 above, in view of Bagaoisan et al. (US 2002/0177800 A1).
Regarding claims 4 and 17, Jayaraman discloses the intravascular therapy devices of claims 1 and 14. However, Jayaraman fails to expressly state wherein the length of the treatment catheter is at least 30 cm, and the length of the guidewire lumen is 15 cm or less.
Bagaoisan teaches an intravascular therapy device (see Fig. 9, par. [0082] and [0084]-[0085]) wherein the length of the treatment catheter (catheter 420) is at least 30 cm (see par. [0082], the aspiration catheter 420 can be about 145 cm in length), and the length of the guidewire lumen (guidewire lumen 432) is 15 cm or less (see par. [0085], the guidewire lumen 432 can be less than 10 cm in length).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy devices of Jayaraman to include wherein the length of the treatment catheter is at least 30 cm, and the length of the guidewire lumen is 15 cm or less, as taught by Bagaoisan, because these lengths are suitable for a single operator to use the device to remove occlusions in blood vessels (see Bagaoisan par. [0082] and [0084]-[0085]).
Claims 6, 10, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1), as applied to claims 1, 5, and 18 above.
Regarding claims 6 and 19, Jayaraman discloses the intravascular therapy devices of claims 5 and 18. However, Jayaraman fails to expressly state wherein the plurality of eyelets are spaced from each other along the length of the treatment catheter at an interval of 5-10 cm.
Jayaraman teaches that the plurality of eyelets (sleeve members 108) can be spaced from each other along the length of the treatment catheter (balloon catheter 100) at equal intervals (see par. [0111]). The plurality of eyelets (sleeve members 108) and the intervals between them serve the purpose of enabling the combination of the catheter and the guidewire to have improved friction characteristics, trackability, and pushability (see par. [0111] and [0114]). The length of the intervals between the plurality of eyelets is disclosed to be a result effective variable in that changing the length of the intervals changes the friction characteristics, trackability, and pushability of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Jayaraman to include intervals within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment (see Jayaraman par. [0101], [0106], [0111]). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy devices of Jayaraman to include wherein the plurality of eyelets are spaced from each other along the length of the treatment catheter at an interval of 5-10 cm as a matter of routine optimization since 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). Further, Applicant appears to place no criticality on the claimed range, stating merely that “in some examples” the claimed range “would be suitable” and that the claimed ranges are “merely illustrative examples, and should not be construed as limiting” (see Specification par. [0021] and [0026]).
Regarding claim 10, Jayaraman, in the embodiment of Fig. 3A, discloses the intravascular therapy device of claim 1. However, Jayaraman, in the embodiment of Fig. 3A, fails to state wherein the at least one eyelet comprises a partial cutout of a portion of the exterior of the treatment catheter.
Jayaraman teaches an alternative embodiment of an intravascular therapy device (see Fig. 3B, par. [0002]) wherein the at least one eyelet (sleeve members 120) comprises a partial cutout of a portion of the exterior of the treatment catheter (catheter 114) (see Fig. 3B, par. [0096], sleeve members 120 are integral parts of the catheter body 122).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of the embodiment of Fig. 3A of Jayaraman to include wherein the at least one eyelet comprises a partial cutout of a portion of the exterior of the treatment catheter, as taught by the embodiment of Fig. 3B of Jayaraman, as an alternative mechanism to secure the eyelets to the treatment catheter (see Jayaraman par. [0096] and [0101]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1), as applied to claim 1 above, in view of Nash et al. (US 2008/0051720 A1).
Regarding claim 8, Jayaraman discloses the intravascular therapy device of claim 1. However, Jayaraman fails to state wherein each eyelet comprises a loop surrounding the exterior of the treatment catheter.
Nash teaches an intravascular therapy device (see Figs. 5-6, par. [0053]) wherein each eyelet (channel 120) comprises a loop surrounding the exterior of the treatment catheter (catheter 100) (see Figs. 5-6, par. [0053]-[0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of Jayaraman to include wherein each eyelet comprises a loop surrounding the exterior of the treatment catheter, as taught by Nash, as an alternative mechanism to secure the eyelets to the treatment catheter and thus secure the guidewire along the exterior of the treatment catheter (see Nash par. [0053]-[0056]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1) in view of Nash et al. (US 2008/0051720 A1), as applied to claim 8 above, further in view of Tarunaga et al. (US 2018/0214677 A1).
Regarding claim 9, modified Jayaraman teaches the intravascular therapy device of claim 8 substantially as claimed. While Jayaraman teaches wherein a portion of each eyelet is coupled to the exterior of the treatment catheter by various known methods of attachment (see par. [0101]), Jayaraman fails to expressly state wherein a portion of each eyelet is thermally fused to the exterior of the treatment catheter.
Tarunaga teaches an intravascular therapy device (see Figs. 1 and 2B, par. [0043]) wherein tubular lumens of the treatment catheter (balloon catheter 1) are thermally fused to the exterior of the treatment catheter (balloon catheter 1) (see Figs. 1 and 2B, par. [0067]-[0068]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of Jayaraman to include wherein a portion of each eyelet is thermally fused to the exterior of the treatment catheter, as suggested by Tarunaga, as a method of securely coupling and integrating the eyelets and the treatment catheter together (see Jayaraman par. [0101] and Tarunaga par. [0008] and [0067]-[0068]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1), as applied to claim 1 above, in view of Ascher et al. (US 2020/0316348 A1).
Regarding claim 12, Jayaraman, in the embodiment of Fig. 3A, discloses the intravascular therapy device of claim 1. However, Jayaraman, in the embodiment of Fig. 3A, fails to expressly state wherein the treatment catheter and the at least one eyelet comprise PEBAX.
Jayaraman teaches an alternative embodiment of an intravascular therapy device (see Fig. 3B, par. [0002]) wherein the treatment catheter (catheter 114) and the at least one eyelet (sleeve members 120) are a single, integral piece of material (see Fig. 3B, par. [0096], sleeve members 120 are integral parts of the catheter body 122).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of the embodiment of Fig. 3A of Jayaraman to include wherein the treatment catheter and the at least one eyelet comprise a single, integral piece of material, as taught by the embodiment of Fig. 3B of Jayaraman, as an alternative mechanism to secure the eyelets to the treatment catheter (see Jayaraman par. [0096] and [0101]).
However, modified Jayaraman still fails to expressly state wherein the treatment catheter and the at least one eyelet comprise PEBAX.
Ascher teaches an intravascular therapy device (see Fig. 1, par. [0077]) wherein the treatment catheter (infusion catheter 10) comprises PEBAX (see par. [0077] and [0214]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of modified Jayaraman to include wherein the treatment catheter and the at least one eyelet (which have previously been modified to be a single, integral piece of material) comprise PEBAX, as suggested by Ascher, in order to be flexible and compatible with blood vessels (see Ascher par. [0214]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1), as applied to claim 1 above, in view of Margolis (US 2015/0112307 A1).
Regarding claim 13, Jayaraman discloses the intravascular therapy device of claim 1. However, Jayaraman fails to expressly state a guide sheath configured to deliver the treatment catheter and the associated guidewire to the occlusion.
Margolis teaches an intravascular therapy device (see par. [0004]) comprising a guide sheath configured to deliver the treatment catheter and the associated guidewire to the occlusion (see par. [0004]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy device of Jayaraman to include a guide sheath configured to deliver the treatment catheter and the associated guidewire to the occlusion, as taught by Margolis, because Margolis teaches that it is typical for an intravascular therapy device to include a guide sheath to allow access to the target lesion (see Margolis par. [0004]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Jayaraman (US 2003/0233068 A1) in view of Margolis (US 2015/0112307 A1).
Regarding claim 20, Jayaraman discloses an intravascular therapy method (see Fig. 3A, par. [0002]), comprising:
inserting a proximal end of a guidewire (not shown, see par. [0090]) into a distal end (distal end of balloon catheter 100 (left end of balloon catheter 100 in Fig. 3)) of a treatment catheter (balloon catheter 100), through a guidewire lumen (sleeve member 106) of the treatment catheter (balloon catheter 100), and out a guidewire port (exit port 112 of sleeve member 106) of the treatment catheter (balloon catheter 100), wherein a length of the guidewire lumen (sleeve member 106) is less than a length of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0027], [0090]-[0094], [0101]);
after exiting the guidewire port (exit port 112 of sleeve member 106), threading the proximal end of the guidewire (not shown, see par. [0090]) through a plurality of eyelets (sleeve members 108) disposed on an exterior of the treatment catheter (balloon catheter 100) (see Fig. 3A, par. [0027], [0090]-[0094], [0101]); and
performing a therapy on the occlusion using the treatment catheter (balloon catheter 100) (see par. [0027]-[0028] and [0101]-[0102]).
However, Jayaraman fails to expressly state inserting a guide sheath in a blood vessel of a patient and to an occlusion in the blood vessel; inserting a guidewire through the inserted guide sheath at least up to the occlusion in the blood vessel; after the threading, sliding the treatment catheter through the guide sheath along the guidewire toward the occlusion in the blood vessel; and after the sliding, performing a therapy on the occlusion using the treatment catheter.
Margolis teaches an intravascular therapy method (see par. [0004]) comprising inserting a guide sheath in a blood vessel of a patient and to an occlusion in the blood vessel (see par. [0004]); inserting a guidewire through the inserted guide sheath at least up to the occlusion in the blood vessel (see par. [0004]); after the inserting, sliding the treatment catheter through the guide sheath along the guidewire toward the occlusion in the blood vessel (see par. [0004]); and after the sliding, performing a therapy on the occlusion using the treatment catheter (see par. [0004]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular therapy method of Jayaraman to include inserting a guide sheath in a blood vessel of a patient and to an occlusion in the blood vessel; inserting a guidewire through the inserted guide sheath at least up to the occlusion in the blood vessel; after the threading, sliding the treatment catheter through the guide sheath along the guidewire toward the occlusion in the blood vessel; and after the sliding, performing a therapy on the occlusion using the treatment catheter, as suggested by Margolis, because Margolis teaches that it is typical for an intravascular therapy method to include steps utilizing a guide sheath to allow access to the target lesion (see Margolis par. [0004]).
Conclusion
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783