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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “303” has been used to designate both the “slidable ring” (see Fig. 1C,2B,3B) and the “distal tip” (see Figs. 4A/B,5A/B/C). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Reference number 339 shown in Fig. 4B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1410" and "1422" have both been used to designate the “molded distal portion” (see Spec. paragraph [0054]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1422” has been used to designate both the “molded distal portion” and the “transparent section” (see Spec. paragraph [0054]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claims 1 and 9 recite one of “such that drive shaft” and “wherein drive shaft” in lines 6 and 1, respectively, however these lines are not grammatically correct as there are no articles (a/an/the) before the noun, therefore the Examiner suggests the lines be amended to read “such that the drive shaft” and “wherein the drive shaft”, respectively;
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, 11, 14, 22, 23, and 25 of U.S. Patent No. 10,357,277.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 10,357,277.
Regarding claim 1 of the Instant Application, claim 1 of U.S. Patent No. 10,357,277 also claims an occlusion crossing device comprising:
a rotatable drive shaft having a distal end with a drill tip, wherein the drill tip includes a pointed distal end that allows forward drilling through an occlusion within a blood vessel (claim 1); and
an outer shaft having a lumen that accommodates the drive shaft, the outer shaft removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (claim 1).
Regarding claim 2 of the Instant Application, claim 14 of U.S. Patent No. 10,357,277 also claims wherein the drill tip includes a plurality of flutes that come together at the pointed distal end of the drill tip (claim 14).
Regarding claims 3 – 5 of the Instant Application, claim 1 of U.S. Patent No. 10,357,277 also claims wherein the drive shaft further includes an optical fiber configured to generate images, wherein the optical fiber extends within the drive shaft substantially along a central axis of the drive shaft, and wherein a distal tip of the optical fiber is attached to the drill tip (claim 1).
Regarding claim 6 of the Instant Application, claim 1 of U.S. Patent No. 10,357,277 also claims wherein the outer shaft is configured to engage with the drive shaft when a force is applied to the drive shaft in a longitudinal direction to bend the outer shaft (claim 1).
Regarding claims 7 and 8 of the Instant Application, claim 3 of U.S. Patent No. 10,357,277 also claims wherein the drive shaft is removably coupled with the outer shaft with a lock that is configured to lock and unlock the drive shaft relative to the outer shaft (claim 3) and makes obvious wherein the lock is controllable by a proximal handle of the occlusion crossing device (Examiner’s note: it would be obvious for the lock to be controllable via a handle at the proximal end of the drive shaft for the purpose of the user being able to control said lock).
Regarding claim 9 of the Instant Application, claim 6 of U.S. Patent No. 10,357,277 also claims wherein drive shaft includes an annular member that is configured to engage with an inner lip of the outer shaft to bend the outer shaft when the drive shaft is pushed distally (claim 6).
Regarding claim 10 of the Instant Application, claim 7 of U.S. Patent No. 10,357,277 also claims wherein the drive shaft includes an annular member that is configured to engage with an inner lip of the outer shaft to bend the outer shaft when the drive shaft is pulled proximally (claim 7).
Regarding claim 11 of the Instant Application, claim 1 of U.S. Patent No. 10,357,277 also claims wherein the draft shaft is configured to displace longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: because the drive shaft of claim 1 of U.S. Patent No. 10,357,277 is removable, the drive shaft is configured to displace relative to the outer shaft at least within the claimed range).
Regarding claim 12 of the Instant Application, claim 22 of U.S. Patent No. 10,357,277 also claims a method of crossing an occlusion, the method comprising:
inserting a device into a blood vessel having the occlusion therein, the device having a drive shaft within a lumen of an outer shaft, wherein the drive shaft includes a drill tip with a pointed distal end (claim 22);
rotating the drive shaft and advancing the device forward such that the pointed distal end of the drill tip drills through the occlusion (claim 22); and
removing the drive shaft from the outer shaft while the outer shaft is in the blood vessel (claim 22).
Regarding claim 13 of the Instant Application, claim 23 of U.S. Patent No. 10,357,277 also claims further comprising inserting a guidewire through the outer shaft after the drive shaft is removed from the outer shaft (claim 23).
Regarding claims 14 – 15 of the Instant Application, claim 22 of U.S. Patent No. 10,357,277 also claims further comprising collecting images of the blood vessel using an optical fiber attached to the drill tip and wherein the images are collected as the optical fiber rotates with the drill tip (claim 22).
Regarding claim 16 of the Instant Application, claim 22 of U.S. Patent No. 10,357,277 also claims further comprising bending the outer shaft by applying a force to the drive shaft in a longitudinal direction while the drive shaft is coupled with the outer shaft (claim 22).
Regarding claim 17 of the Instant Application, claim 22 of U.S. Patent No. 10,357,277 also claims wherein an inner portion of the outer shaft engages with the drive shaft when the drive shaft is pushed distally (claims 22 and 26).
Regarding claim 18 of the Instant Application, claim 26 of U.S. Patent No. 10,357,277 also claims wherein an inner portion of the outer shaft engages with the drive shaft when the drive shaft is pulled proximally (claims 22 and 26).
Regarding claim 19 of the Instant Application, claim 25 of U.S. Patent No. 10,357,277 also claims wherein the draft shaft is displaced longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (claim 25).
Claims 1, 3 – 6, and 9 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, 10, 13, and 15 – 18 of U.S. Patent No. 11,147,583.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,147,583.
Regarding claim 1 of the Instant Application, claim 1 of U.S. Patent No. 11,147,583 also claims an occlusion crossing device comprising:
a rotatable drive shaft having a distal end with a drill tip, wherein the drill tip includes a pointed distal end that allows forward drilling through an occlusion within a blood vessel (claim 1); and
an outer shaft having a lumen that accommodates the drive shaft, the outer shaft removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (claim 1).
Regarding claims 3 – 5 of the Instant Application, claim 10 of U.S. Patent No. 11,147,583 also claims wherein the drive shaft further includes an optical fiber configured to generate images, wherein the optical fiber extends within the drive shaft substantially along a central axis of the drive shaft, and wherein a distal tip of the optical fiber is attached to the drill tip (claim 10).
Regarding claim 6 of the Instant Application, claim 1 of U.S. Patent No. 11,147,583 also claims wherein the outer shaft is configured to engage with the drive shaft when a force is applied to the drive shaft in a longitudinal direction to bend the outer shaft (claim 1).
Regarding claim 9 of the Instant Application, claim 8 of U.S. Patent No. 11,147,583 also claims wherein drive shaft includes an annular member that is configured to engage with an inner lip of the outer shaft to bend the outer shaft when the drive shaft is pushed distally (claim 8).
Regarding claim 10 of the Instant Application, claim 9 of U.S. Patent No. 11,147,583 also claims wherein the drive shaft includes an annular member that is configured to engage with an inner lip of the outer shaft to bend the outer shaft when the drive shaft is pulled proximally (claim 9).
Regarding claim 11 of the Instant Application, claim 1 of U.S. Patent No. 11,147,583 also claims wherein the draft shaft is configured to displace longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: because the drive shaft of claim 1 of U.S. Patent No. 11,147,583 is removable, the drive shaft is configured to displace relative to the outer shaft at least within the claimed range).
Regarding claim 12 of the Instant Application, claim 13 of U.S. Patent No. 11,147,583 also claims a method of crossing an occlusion, the method comprising:
inserting a device into a blood vessel having the occlusion therein, the device having a drive shaft within a lumen of an outer shaft, wherein the drive shaft includes a drill tip with a pointed distal end (claim 13);
rotating the drive shaft and advancing the device forward such that the pointed distal end of the drill tip drills through the occlusion (claim 13); and
removing the drive shaft from the outer shaft while the outer shaft is in the blood vessel (claim 13).
Regarding claim 13 of the Instant Application, claim 15 of U.S. Patent No. 11,147,583 also claims further comprising inserting a guidewire through the outer shaft after the drive shaft is removed from the outer shaft (claim 15).
Regarding claims 14 – 15 of the Instant Application, claim 16 of U.S. Patent No. 11,147,583 also claims further comprising collecting images of the blood vessel using an optical fiber attached to the drill tip and wherein the images are collected as the optical fiber rotates with the drill tip (claim 16).
Regarding claim 16 of the Instant Application, claim 13 of U.S. Patent No. 11,147,583 also claims further comprising bending the outer shaft by applying a force to the drive shaft in a longitudinal direction while the drive shaft is coupled with the outer shaft (claim 13).
Regarding claims 17 and 18 of the Instant Application, claim 18 of U.S. Patent No. 11,147,583 also claims wherein an inner portion of the outer shaft engages with the drive shaft when the drive shaft is pushed distally and/or when the drive shaft is pulled proximally (claims 13 and 18).
Regarding claim 19 of the Instant Application, claim 17 of U.S. Patent No. 11,147,583 also claims wherein the draft shaft is displaced longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (claim 17).
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, 10, 13, and 15 – 18 of U.S. Patent No. 11,147,583 in view of Simpson et al (US 2012/02531286 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,147,583 and Simpson et al (US 2012/02531286 A1).
Regarding claim 2 of the Instant Application, as discussed above claim 1 of U.S. Patent No. 11,147,583 claims the device of claim 1 of the Instant Application.
However, claim 1 of U.S. Patent No. 11,147,583 is silent regarding (i) wherein the drill tip includes a plurality of flutes that come together at the pointed distal end of the drill tip.
As to the above, Simpson teaches, in the same field of endeavor, Simpson teaches, in the same field of endeavor, an occlusion crossing device (shaft 301) comprising a rotatable drive shaft (drive shaft 421) with a drill tip with a pointed end and flutes that come together at the pointed end (rotating drill tip 305 / cutting edge 403) and an outer shaft (outer sheath 284) (paragraphs [0087 – 0091] and Figs. 3A – 3D).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the driveshaft of claim 14 of U.S. Patent No. 11,147,583 to have a pointed drill tip, as taught by Simpson, for the purpose of being able to move the debris out of the way of the drill tip as the drill tip is advanced through the occlusion.
Claims 7, 8, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, 10, 13, and 15 – 18 of U.S. Patent No. 11,147,583 in view of Mustapha et al (US 2011/0034937 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,147,583 and Mustapha et al (US 2011/0034937 A1).
Regarding claims 7, 8, and 20 of the Instant Application, as discussed above claims 1 and 13 of U.S. Patent No. 11,147,583 claims the device of claims 1 and 12 of the Instant Application, respectively.
However, claims 1 and 12 of U.S. Patent No. 11,147,583 is silent regarding (i) wherein the drive shaft is removably coupled with the outer shaft with a lock that is configured to lock and unlock the drive shaft relative to the outer shaft / unlocking a lock of the device prior to removing the drive shaft from the outer shaft and wherein the lock is controllable by a proximal handle of the occlusion crossing device.
As to the above, Mustapha teaches an occlusion crossing device (revascularization device 10) (abstract, paragraphs [0009], [0019 – 0021], and Figs. 2A – 3D) comprising a rotatable drive shaft (inner tubular body 14) having a distal end with a drill tip (distal end 14b) (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 is attached via a screw like rotational movement to the actuator assembly; therefore the inner tubular body 14 is rotatable), wherein the drill tip (distal end 14b) includes a pointed distal end (piercing portion 68) that allows forward drilling through an occlusion within a blood vessel (Examiner’s note: as shown in Fig. 2A the piercing portion 68 is a pointed end, and allows for forward drilling through an occlusion) and an outer shaft (outer tubular body 12) having a lumen that accommodates the drive shaft (paragraph [0034] and Fig. 2A), the outer shaft (outer tubular body 12) removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (paragraph [0019]), wherein the drive shaft (inner tubular body 14) is removably coupled with the outer shaft with a lock (latch) that is configured to lock and unlock the drive shaft relative to the outer shaft, wherein the lock is controlled by a proximal handle (deployment actuator) (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 (i.e., the drive shaft) is connected to the actuation assembly via a latch and the rotational threads. Moreover, stated in paragraph [0019], the inner tubular assembly 14 is removed from the system, and in order to remove the inner tubular assembly 14 from the system the latch (i.e., the lock) must be un-latched (i.e., unlocked). Therefore, Mustapha discloses the limitations above under BRI).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device and method of claims 1 and 12 of U.S. Patent No. 11,147,583, respectively, to incorporate the lock and the step of unlocking the lock via a proximal handle on the drive shaft, for the purpose of securing drive shaft to the outer shaft in order to prevent any unwanted relative movement between the two shafts.
Claims 1, 3 – 6, 9, 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, and 10 of U.S. Patent No. 11,931,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,931,061.
Regarding claim 1 of the Instant Application, claim 1 of U.S. Patent No. 11,931,061 also claims an occlusion crossing device comprising:
a rotatable drive shaft having a distal end with a drill tip, wherein the drill tip includes a pointed distal end that allows forward drilling through an occlusion within a blood vessel (claim 1); and
an outer shaft having a lumen that accommodates the drive shaft, the outer shaft removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (claim 1).
Regarding claims 3 – 5 of the Instant Application, claim 13 of U.S. Patent No. 11,931,061 also claims wherein the drive shaft further includes an optical fiber configured to generate images, wherein the optical fiber extends within the drive shaft substantially along a central axis of the drive shaft, and wherein a distal tip of the optical fiber is attached to the drill tip (claim 13).
Regarding claim 6 of the Instant Application, claim 4 of U.S. Patent No. 11,931,061 also claims wherein the outer shaft is configured to engage with the drive shaft when a force is applied to the drive shaft in a longitudinal direction to bend the outer shaft (claim 4).
Regarding claims 7 and 8 of the Instant Application, claim 1 of U.S. Patent No. 11,931,061 also claims wherein the drive shaft is removably coupled with the outer shaft with a lock that is configured to lock and unlock the drive shaft relative to the outer shaft and wherein the lock is controllable by a proximal handle of the occlusion crossing device (claim 1).
Regarding claim 11 of the Instant Application, claim 1 of U.S. Patent No. 11,931,061 also claims wherein the draft shaft is configured to displace longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: because the drive shaft of claim 1 of U.S. Patent No. 11,931,061 is removable, the drive shaft is configured to displace relative to the outer shaft at least within the claimed range).
Claims 2, 12 – 17, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 16 – 18 of U.S. Patent No. 11,931,061 in view of Simpson et al (US 2012/02531286 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,931,061 and Simpson et al (US 2012/02531286 A1).
Regarding claim 2 of the Instant Application, as discussed above claim 1 of U.S. Patent No. 11,931,061 claims the device of claim 1 of the Instant Application.
However, claim 1 of U.S. Patent No. 11,931,061 is silent regarding (i) wherein the drill tip includes a plurality of flutes that come together at the pointed distal end of the drill tip.
As to the above, Simpson teaches, in the same field of endeavor, Simpson teaches, in the same field of endeavor, an occlusion crossing device (shaft 301) comprising a rotatable drive shaft (drive shaft 421) with a drill tip with a pointed end and flutes that come together at the pointed end (rotating drill tip 305 / cutting edge 403) and an outer shaft (outer sheath 284) (paragraphs [0087 – 0091] and Figs. 3A – 3D).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the driveshaft of claim 14 of U.S. Patent No. 11,931,061 to have a pointed drill tip, as taught by Simpson, for the purpose of being able to move the debris out of the way of the drill tip as the drill tip is advanced through the occlusion.
Regarding claim 12 of the Instant Application, A method of crossing an occlusion, the method comprising:
inserting a device into a blood vessel having the occlusion therein, the device having a drive shaft within a lumen of an outer shaft, wherein the drive shaft includes a drill tip with a pointed distal end (claim 14);
rotating the drive shaft and advancing the device forward such that the pointed distal end of the drill tip drills through the occlusion (claim 13); and
removing the drive shaft from the outer shaft while the outer shaft is in the blood vessel (claim 14).
However, claim 14 of U.S. Patent No. 11,931,061 is silent regarding (i) the drive shaft having a drill tip with a pointed end.
As to the above, Simpson teaches, in the same field of endeavor, Simpson teaches, in the same field of endeavor, an occlusion crossing device (shaft 301) comprising a rotatable drive shaft (drive shaft 421) with a drill tip with a pointed end (rotating drill tip 305 / cutting edge 403) and an outer shaft (outer sheath 284) (paragraphs [0087 – 0091] and Figs. 3A – 3D).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the driveshaft of claim 14 of U.S. Patent No. 11,931,061 to have a pointed drill tip, as taught by Simpson, for the purpose of being able to puncture and breakup the occlusion.
Regarding claim 13 of the Instant Application, claim 18 of U.S. Patent No. 11,931,061 also claims further comprising inserting a guidewire through the outer shaft after the drive shaft is removed from the outer shaft (claim 18).
Regarding claims 14 and 15 of the Instant Application, claim 17 of U.S. Patent No. 11,931,061 also claims further comprising collecting images of the blood vessel using an optical fiber attached to the drill tip and wherein the images are collected as the optical fiber rotates with the drill tip (claim 17).
Regarding claim 16 of the Instant Application, claim 14 of U.S. Patent No. 11,931,061 also claims further comprising bending the outer shaft by applying a force to the drive shaft in a longitudinal direction while the drive shaft is coupled with the outer shaft (claim 14).
Regarding claim 19 of the Instant Application, claim 14 of U.S. Patent No. 11,931,061 also claims wherein the draft shaft is displaced longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: because the drive shaft of claim 14 of U.S. Patent No. 11,931,061 is removable, the drive shaft is will displace relative to the outer shaft at least within the claimed range).
Regarding claim 20 of the Instant Application, claim 14 of U.S. Patent No. 11,931,061 also claims further comprising unlocking a lock of the device prior to removing the drive shaft from the outer shaft (claim 14).
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, 8, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams (US 2012/0203230 A1).
Regarding claim 1, Adams discloses a device (rotary abrader 100) capable of crossing an occlusion (abstract, paragraphs [0004], [0025], and Figs. 1 – 9) (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 ) comprising:
a rotatable drive shaft (inner tube assembly 80) having a distal end with a drill tip (burr 116) (paragraphs [0026 – 0029] and Fig. 2C), wherein the drill tip includes a pointed distal end (Examiner’s note: the burr tip 116 has a plurality of sharp helical cutting flutes that converge at the distal most tip which makes the distal tip relatively pointed) that allows forward drilling through an occlusion within a blood vessel (Examiner’s note: the burr tip 116 allows for the drilling through an occlusion); and
an outer shaft (outer assembly 50) having a lumen that accommodates the drive shaft (paragraph [0026] and Figs. 2A/B), the outer shaft removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, because the inner tube assembly 80 (i.e., the drive shaft) is removably coupled to the outer shaft assembly 50 (i.e., the outer shaft) then the system is capable of functioning as claimed).
Regarding claim 2, Adams discloses wherein the drill tip (burr tip 116) includes a plurality of flutes that come together at the pointed distal end of the drill tip (paragraph [0029]).
Regarding claim 7, Adams discloses wherein the drive shaft (inner tube assembly 80) is removably coupled with the outer shaft (outer shaft assembly 50) with a lock (retaining ring) that is configured to lock and unlock the drive shaft relative to the outer shaft (Examiner’s note: as discussed in paragraph [0026] the two assemblies are secured by the retaining ring, therefore, the retaining ring is a lock as it secures the two assemblies together. Additionally, the outer shaft is removably coupled to the drive shaft via the hubs).
Regarding claim 8, Adams discloses wherein the lock (retaining ring) is controllable by a proximal handle (hub 122) of the occlusion crossing device (rotary abrader 100) (Examiner’s note: the hub 122 pushes the two hubs together to lock the assemblies together; therefore the locking is controlled by a proximal handle (i.e., the hub)).
Regarding claim 11, Adams discloses wherein the draft shaft (inner tube assembly 80) is configured to displace longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed. With that said, because the inner tube assembly (i.e., the drive shaft) is removably coupled to the outer tube assembly (i.e., the outer shaft) the inner tube assembly (i.e., the drive shaft) is capable of functioning as claimed).
Claims 1, 7, 8, 11 – 13, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mustapha et al (US 2011/0034937 A1).
Regarding claim 1, Mustapha discloses an occlusion crossing device (revascularization device 10) (abstract, paragraphs [0009], [0019 – 0021], and Figs. 2A – 3D) comprising:
a rotatable drive shaft (inner tubular body 14) having a distal end with a drill tip (distal end 14b) (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 is attached via a screw like rotational movement to the actuator assembly; therefore the inner tubular body 14 is rotatable), wherein the drill tip (distal end 14b) includes a pointed distal end (piercing portion 68) that allows forward drilling through an occlusion within a blood vessel (Examiner’s note: as shown in Fig. 2A the piercing portion 68 is a pointed end, and allows for forward drilling through an occlusion); and
an outer shaft (outer tubular body 12) having a lumen that accommodates the drive shaft (paragraph [0034] and Fig. 2A), the outer shaft (outer tubular body 12) removably coupled to the drive shaft such that drive shaft can be removed from the lumen of the outer shaft when the outer shaft is within the blood vessel (paragraph [0019]).
Regarding claims 7 and 8, Mustapha discloses wherein the drive shaft (inner tubular body 14) is removably coupled with the outer shaft with a lock (latch) that is configured to lock and unlock the drive shaft relative to the outer shaft, wherein the lock is controlled by a proximal handle (deployment actuator) (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 (i.e., the drive shaft) is connected to the actuation assembly via a latch and the rotational threads. Moreover, stated in paragraph [0019], the inner tubular assembly 14 is removed from the system, and in order to remove the inner tubular assembly 14 from the system the latch (i.e., the lock) must be un-latched (i.e., unlocked). Therefore, Mustapha discloses the limitations above under BRI).
Regarding claim 11, Mustapha discloses wherein the draft shaft (inner tubular body 14) is configured to displace longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed. With that said, because the inner tubular 14 (i.e., the drive shaft) is removably coupled to the outer tubular body 12 (i.e., the outer shaft) the inner tube assembly (i.e., the drive shaft) is capable of functioning as claimed).
Regarding claim 12, Mustapha discloses a method of crossing an occlusion (abstract, paragraphs [0009], [0019 – 0021], and Figs. 2A – 3D), the method comprising:
inserting a device (revascularization device 10) into a blood vessel having the occlusion therein (paragraph [0040]),
the device having a drive shaft (inner tubular member 14) within a lumen of an outer shaft (outer tubular member 12) (paragraph [0034] and Fig. 2A),
wherein the drive shaft (inner tubular member 14) includes a drill tip (distal end 14b) with a pointed distal end (piercing portion 68) (Examiner’s note: as shown in Fig. 2A the piercing portion 68 is a pointed end);
rotating the drive shaft (inner tubular member 14) (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 is attached via a screw like rotational movement to the actuator assembly; therefore, the drive shaft is rotated at some point along the process) and advancing the device forward such that the pointed distal end of the drill tip drills through the occlusion (Examiner’s note: the definition of “to drill” is to make a hole in a substance with a pointed end; and as discussed in paragraph [0042] the pierced portion creates a bore through the occlusion); and
removing the drive shaft (inner tubular member 14) from the outer shaft (outer tubular member 12) while the outer shaft is in the blood vessel (paragraph [0019] and Figs. 3A-D).
Regarding claim 13, Mustapha discloses further comprising inserting a guidewire (guidewire 18) through the outer shaft after the drive shaft is removed from the outer shaft (Fig. 3A).
Regarding claim 19, Mustapha discloses wherein the draft shaft (inner tubular member 14) is displaced longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft when a longitudinal force is applied to the drive shaft (Examiner’s note: when the inner tubular member is pushed (or pulled) through the outer tubular member, the inner tubular member will be displaced a distance within that range since the outer tubular member is longer that the max value of that range and the inner tubular member is fully removed from the outer tubular member).
Regarding claim 20, Mustapha discloses further comprising unlocking a lock (latch) of the device prior to removing the drive shaft from the outer shaft (Examiner’s note: as stated in paragraph [0050] the inner tubular assembly 14 (i.e., the drive shaft) is connected to the actuation assembly via a latch and the rotational threads. Moreover, stated in paragraph [0019], the inner tubular assembly 14 is removed from the system, and in order to remove the inner tubular assembly 14 from the system the latch (i.e., the lock) must be un-latched (i.e., unlocked). Therefore, Mustapha discloses the limitations above under BRI).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US 2012/0203230 A1) as applied to claim 1 above, and further in view of Simpson et al (US 2012/0253186 A1).
Regarding claims 3 – 5, as discussed above, Adams discloses the occlusion crossing device of claim 1.
However, Adams is silent regarding [claims 3 – 5] (i) wherein the drive shaft further includes an optical fiber configured to generate images extending within the drive shaft substantially along a central axis of the drive shaft and with a distal tip attached to the drill tip.
As to the above, Simpson teaches, in the same field of endeavor, an occlusion crossing device (shaft 301) comprising a rotatable drive shaft (drive shaft 421) with a drill tip with a pointed end (rotating drill tip 305 / cutting edge 403) and an outer shaft (outer sheath 284) (paragraphs [0087 – 0091] and Figs. 3A – 3D); the device further comprising wherein the drive shaft (drive shaft 421) further includes an optical fiber (he optical fiber 411) configured to generate images extending within the drive shaft substantially along a central axis of the drive shaft and with a distal tip attached to the drill tip (paragraph [0089]) for the purpose of generating information that may be used to guide the catheter, and/or to confirm when an occlusion has been reached or crossed (paragraph [0033]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Adams to incorporate the optical fiber at the distal end of the bore, based on the teachings of Simpson, for the purpose of generating information that may be used to guide the catheter, and/or to confirm when an occlusion has been reached or crossed (paragraph [0033] – Simpson).
Claims 3 – 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mustapha et al (US 2011/0034937 A1) as applied to claim 1 above, and further in view of Simpson et al (US 2012/0253186 A1).
Regarding claims 3 – 5, as discussed above, Mustapha discloses the occlusion crossing device of claim 1.
However, Mustapha is silent regarding [claims 3 – 5] (i) wherein the drive shaft further includes an optical fiber configured to generate images extending within the drive shaft substantially along a central axis of the drive shaft and with a distal tip attached to the drill tip, and [claim 14] further comprising collecting images of the blood vessel using an optical fiber attached to the drill tip.
As to the above, Simpson teaches, in the same field of endeavor, an occlusion crossing device (shaft 301) comprising a rotatable drive shaft (drive shaft 421) with a drill tip with a pointed end (rotating drill tip 305 / cutting edge 403) and an outer shaft (outer sheath 284) (paragraphs [0087 – 0091] and Figs. 3A – 3D); the device further comprising wherein the drive shaft (drive shaft 421) further includes an optical fiber (he optical fiber 411) configured to generate images extending within the drive shaft substantially along a central axis of the drive shaft and with a distal tip attached to the drill tip (paragraph [0089]) for the purpose of generating information that may be used to guide the catheter, and/or to confirm when an occlusion has been reached or crossed (paragraph [0033]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Mustapha to incorporate the optical fiber at the distal end of the bore, based on the teachings of Simpson, for the purpose of generating information that may be used to guide the catheter, and/or to confirm when an occlusion has been reached or crossed (paragraph [0033] – Simpson).
Allowable Subject Matter (over the prior art)
Claims 6, 9, 10, and 15 – 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Furthermore, the above claims are rejected under Non-Statutory Double Patenting, which must be overcome in order for the claims to be allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
Pflueger (US 2002/0138091 A1), Noriega et al (US 2005/0119615 A1), Jenson (US 2005/0288695 A1), and Stevens (US 4,923,462) teach a rotatable occlusion crossing device.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771