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
Claim 1 is objected to because of the following informalities: it is clear that applicant intended to introduce opposite ends of the driveshaft when applicant recited a distal end and proximate end. Indeed, applicant recited a driveshaft having a proximal end and distal end at p. 5, 4th ¶ of applicant’s Specification. As such, “a rotatable driveshaft having a distal end and proximate end; a cutting bit non-rotatably coupled to the distal end of the driveshaft; a rotational actuator coupled to the proximate end of the driveshaft; at least one circular stabilizer rotatably coupled to the driveshaft proximate to the cutting bit and distal to the rotational actuator” should be amended to - - a rotatable driveshaft having a distal end and proximal end; a cutting bit non-rotatably coupled to the distal end of the driveshaft; a rotational actuator coupled to the proximal end of the driveshaft; at least one circular stabilizer rotatably coupled to the driveshaft proximal to the cutting bit and distal to the rotational actuator - - to follow the convention in the art. Appropriate correction is required.
Claims 2- 18 and 22- 23 are objected to because they depend off claim 1.
Claim 2 is objected to because of the following informalities: line 2- ‘the stabilizer’ should be amended to - - the at least one circular stabilizer - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: line 4- “a great circumference than the circumference of the central shaft” should be amended to - - a [[great]] greater circumference than the circumference of the central shaft - - to correct an apparent typographical error. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: line 10 – ‘adjacent to the channel’ should be amended to - - adjacent to the one or more channels . Appropriate correction is required.
Claim 6 is objected to because of the following informalities: line 2- ‘the stabilizer’ should be amended to - - the at least one circular stabilizer - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: line 3- ‘the stabilizer’ should be amended to - - the at least one circular stabilizer - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: it is clear that applicant intended to recite the longitudinal axis of the driveshaft. Indeed, applicant recites, “The actuator provides rotary motion of the driveshaft along the longitudinal axis” at p. 10, 2nd ¶ of applicant’s Specification. As such, line 3- ‘the horizontal axis of the driveshaft’ – should be amended to - - the longitudinal axis of the driveshaft- - to follow the convention in the art. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: line 2- ‘the rotatable bit’ should be amended to - - the cutting bit - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: line 2- ‘the stabilizing element’ should be amended to - - the at least one circular stabilizer - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: lines 2- 3- ‘the rotatable bit’ should be amended to - - the cutting bit - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: lines 2- 3- ‘the rotatable bit’ should be amended to - - the cutting bit - - to be consistent with previous claim terminology. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: it is clear that applicant intended to introduce opposite ends of the first cannula when applicant recited a distal end and proximate end. As such, line 4- ‘a proximate end’ should be amended to - - a proximal end - - to follow the convention in the art. Appropriate correction is required.
Claims 18 and 22- 23 are objected to because they depend off claim 17.
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.
Application claims 1- 7, 9- 11,13- 18 and 22- 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 15 and 17- 18 of U.S. Patent No. 11,771,458. U.S. Patent No. 11,771,458 is cited in the IDS filed 12/19/24. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of U.S. Patent No. 11,771,458 anticipate the following application claims:
Application claim
Claim of U.S. Patent 11,771,458
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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 12, 17- 18 and 22- 23 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 12 recites the limitation "the collecting basket" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether applicant intended to introduce “a collecting basket” or whether applicant intended to depend claim 12 off of claim 8 which introduces a collecting basket. For the purposes of examination, claim 12 is interpreted as reciting - - [[the]] a collecting basket - -.
Claim 17 recites the limitation "the clot" in line 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether applicant intended to introduce “a clot” or whether applicant intended to refer to “the blockage.” For the purposes of examination, claim 17 is interpreted as reciting - - the blockage [[clot]] - -.
Claims 18 and 22- 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off of claim 17.
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) 1- 3, 6- 7 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanson (US Pat. No. 5,267,955). Hanson is cited in the IDS filed 12/19/24.
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Regarding claim 1, Hanson discloses a rotary embolectomy device, comprising:
a rotatable driveshaft (38) (Fig. 2) having a distal end and proximate end;
a cutting bit (62) (Figs. 2, 4) non-rotatably coupled to the distal end of the driveshaft;
a rotational actuator (20) (Figs. 1- 2, 4- 5) coupled to the proximate end of the driveshaft (38);
at least one circular stabilizer (52) (Fig. 2) rotatably coupled to the driveshaft (38) proximate to the cutting bit (62) and rotational actuator (20).
Regarding claim 2, Hanson further discloses wherein an outer circumference of the stabilizer (52) is greater than or equal to an outer circumference of the cutting bit (62) (See Figs. 2, 4 - - approximately equal outer circumferences).
Regarding claim 3, Hanson further discloses wherein the cutting bit (62) comprises one or more sharp edges (64a- 64n) (Col. 3, l. 33- 46 - - The cutting operation is performed by inwardly beveled cutting edges 64a-64n).
Regarding claim 6, Hanson further discloses wherein the stabilizer comprises a circular element comprising:
an annular outer portion (OP) (See Annotated Fig. 2) comprising an outer surface and an inner surface;
an annular inner portion (IP) (See Annotated Fig. 2) comprising an outer surface and an inner surface defining a loop (L) (See Annotated Fig. 2), wherein the driveshaft (38) is disposed through the loop (L); and
at least one spoke (marked as 72, 74, 76, 78 on Fig. 2 but not described in document) extending radially between the inner surface of the outer portion (OP) and the outer surface of the inner portion (IP) (See Annotated Fig. 2).
Regarding claim 7, Hanson further discloses wherein the driveshaft (38) comprises at least one fixation element (46) restricting the movement of the stabilizer (52) along the horizontal axis of the driveshaft (38) (Col. 3, l. 30- 32 - - since bushing 46 serves as the bearing surface between coil spring 38, when rotated, and stationary portion 52, bushing 46, which is in direct contact with driveshaft (38), is interpreted as an axial stop portion of the driveshaft (38)). It is noted that horizontal axis of the driveshaft and longitudinal axis of the driveshaft are used interchangeably in applicant’s Specification.
Regarding claim 15, Hanson further discloses wherein the rotatable actuator (20) is an electric motor (Col. 2, l. 46- 50).
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 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Patterson et al. (CA 2 309 428 A1). Patterson is cited in the IDS filed 12/19/24.
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Regarding claims 4 and 5, Hanson discloses the apparatus of claim 1, Hanson further disclosing a rotational atherectomy cutting bit (cutter head 62 inwardly beveled cutting edges 64a-64n), but Hanson does not specifically disclose
(claim 4) a cutting bit with a boring head as claimed;
(claim 5) a spade bit, a twist bit, a step bit, or a center bit as claimed.
However, Patterson discloses a rotational atherectomy device in the same field of endeavor having a cutting bit (230) used to separate and remove occluding material from the wall of a body lumen (p. 29, l. 7- 15)
(claim 4) wherein the cutting bit (230) (Fig. 9B) comprises:
a central shaft (232) (Fig. 9B) non-rotatably coupled to the driveshaft (56) (Fig. 9B),
a boring head (BH) (See Annotated Fig. 9B) centered on the central shaft (232), said boring head (BH) having a greater circumference than a circumference of the central shaft (232);
an outer wall (OW) (See Annotated Fig. 9B) along the circumference of the boring head (BH), said outer wall (OW) having one or more channels (C) (See Annotated Fig. 9B); and
a cutting edge (234, 236) (Fig. 9B) extending diametrically across the entire circular cross-section of the boring head (BH), said cutting edge (234, 236) contacting the outer wall (OW) at a location immediately adjacent to the channel (C) (p. 29, l. 7- 15 - - Forstner cutter 230 defined by cylindrical shaft 232 having a widened annular coring blade or cutting edge 234; since scraping surfaces 236 are 180 degrees apart to break apart the occluding material that has been cored by the coring blade 234, at least the scraping surface 236 are interpreted as being adjacent a channel (C), indicated in Annotated Fig. 9B as the space between the sloping line and straight line; it is noted that Patterson’s Forstner bit is similar to applicant’s Forstner bit shown in applicant’s Figure 2 and described at p. 7, 1st ¶ of applicant’s Specification).
Patterson further disclosing that any rotational atherectomy removal mechanism including a rotatable helical cutter, a rotatable modified Forstner cutter, a rotary cutting burr, a side cutter, or any other similar device would perform the same function of separating and removing occluding material from the wall of the body lumen (Patterson - - p. 4, l. 20- 29). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of applicant’s claimed invention to substitute one known element (claim 4- modified Forstner bit having a boring head (230) taught by Patterson; claim 5- a spade bit, a twist bit, a step bit, or a center bit) for another (rotational atherectomy cutting bit having a cutter head 62 inwardly beveled cutting edges 64a-64n associated with Hanson) since the substitution would have yielded predictable results, namely, separating and removing occluding material from the wall of the body lumen. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Additionally, Hanson discloses the claimed invention except for (claim 4) a cutting bit with a boring head and (claim 5) a spade bit, a twist bit, a step bit, or a center bit. Given that it is known in the atherectomy art that any rotational atherectomy removal mechanism including a rotatable helical cutter, a rotatable modified Forstner cutter, a rotary cutting burr, a side cutter, or any other similar device would perform the same function of separating and removing occluding material from the wall of the body lumen (Patterson - - p. 4, l. 20- 29), it would have been an obvious matter of design choice to substitute a cutting bit with a boring head, a spade bit, twist bit, step bit or a center bit for the cutting bit associated with Hanson since applicant has not disclosed that any of the claimed bits solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with cutting bit associated with Hanson.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Kobayashi et al. (US Pub. No. 2017/0224463 A1). Kobayashi is cited in the IDS filed 12/19/24.
Regarding claim 8, Hanson discloses the apparatus of claim 1, Hanson further disclosing that the cutting bit (62) has an aperture 59 that corresponds with the lumen 39 of the rotatable drive shaft (38) for passage of a guidewire (Col. 3, l. 45- 47), but Hanson does not disclose
(claim 8) further comprising a retractable collecting basket proximate to the cutting bit.
However, Kobayashi teaches an atherectomy device (100) in the same field of endeavor including a collecting basket (50) that collects debris (D) so as to be filtered by the collecting basket (50) to prevent debris (D) from flowing into a peripheral portion of the blood vessel and prevent a new stenosed site from occurring in the peripheral blood vessel.
(claim 8) further comprising a retractable collecting basket (50) (Figs. 11A- 12B) proximate to the cutting bit (101) (Figs. 11B- 12A) (Ps. [0066]- [0068] - - The stenosis substances are scraped off by the rotary member 101 and flow to the distal side (downstream side) after becoming debris D, the debris D flowing to the distal side enters the inside of the concave portion 53 of the basket shaped filter portion 50 extending through distal end opening 104 of the rotary member 101, and is collected so as to be filtered by the filter portion 50, which can help prevent the debris D from flowing to a peripheral portion, and can help prevent a new stenosed site from occurring in the peripheral blood vessel).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus associated with Hanson to include a retractable collecting basket extending through a distal opening of a rotary cutting bit as taught by Kobayashi because it would allow the debris from the stenosed material cut by the cutting bit associated with Hanson to be collected in the basket and then filtered by the basket (Kobayashi - - P. [0068]). The motivation for the modification would have been to prevent debris from flowing into a peripheral portion of the blood vessel and prevent a new stenosed site from occurring in the peripheral blood vessel (Kobayashi - - P. [0068]).
Claims 9- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Kensey (US Pat. No. 4,589,412). Kensey is cited in the IDS filed 12/19/24.
Regarding claims 9- 11, Hanson discloses the apparatus of claim 1, but Hanson does not disclose
(claims 9- 11) a dispensing element as claimed.
However, Kensey teaches an apparatus for surgically removing remote deposits in the same field of endeavor including a dispensing element integrated into a cutting bit and a stabilizing element so as to provide oxygenated fluid during the procedure to eliminate distal ischemia
(claim 9) further comprising a dispensing element (30, 52, 74) (Figs. 2- 5) (Col. 3, l. 56- 63; Col. 4, l. 11- 14; Col. 4, l. 25- 29 - - fluid passing through passageways 74 on cutting bit (58) and openings 52 on stabilizing element (36); During the cutting procedure, positive pressure introduced through the annular passageway 30 will not only serve to drive the rotating cutting head 58, but the fluid infused through this passageway can be oxygenated to eliminate distal ischemia during the procedure);
(claim 10) further comprising a dispensing element (30, 52, 74) integrated with the rotatable bit (58) (Col. 3, l. 40- 41; Col. 3, l. 56- 63- - rotating cutting head 58 mounted on driveshaft 44; fluid passing through passageways 74 on cutting bit (58) and openings 52 on stabilizing element (36));
(claim 11) further comprising a dispensing element (30, 52, 74) integrated with the stabilizing element (36) (Col. 3, l. 11- 13; Col. 3, l. 56- 63 - - affixed rigid head 36 is interpreted as the stabilizing element because it does not rotate and is coupled to the drive shaft 44 as shown in Fig. 5; fluid passing through passageways 74 on cutting bit (58) and openings 52 on stabilizing element (36)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus associated with Hanson to include a dispensing element integrated with the cutting bit and the at least one circular stabilizer as taught by Kensey because it would allow fluid to be infused into the blood vessel (Kensey - - Col. 4, l. 25- 29). The motivation for the modification would have been to provide oxygenated blood to eliminate distal ischemia during the procedure as well as to provide nitrates, contrast media or any other drugs can be added to the fluid as needed during the procedure to decrease time and/or effort on the part of the surgeon (Kensey - - Col. 4, l. 25- 29).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Kobayashi et al. (US Pub. No. 2017/0224463 A1) and Guo et al. (US Pub. No. 2002/0099367 A1). Guo is cited in the IDS filed 12/19/24.
Regarding claim 12 in view of the rejection under 35 USC § 112(b) above, Hanson discloses the apparatus of claim 1, Hanson further disclosing that the cutting bit (62) has an aperture 59 that corresponds with the lumen 39 of the rotatable drive shaft (38) for passage of a guidewire (Col. 3, l. 45- 47), but Hanson does not disclose
(claim 12) a collecting basket as claimed;
(claim 12) a dispensing element as claimed.
However, Kobayashi teaches an atherectomy device (100) in the same field of endeavor including a collecting basket (50) that collects debris (D) so as to be filtered by the collecting basket (50) to prevent debris (D) from flowing into a peripheral portion of the blood vessel and prevent a new stenosed site from occurring in the peripheral blood vessel.
(claim 12) further comprising a retractable collecting basket (50) (Figs. 11A- 12B) proximate to the cutting bit (101) (Figs. 11B- 12A) (Ps. [0066]- [0068] - - The stenosis substances are scraped off by the rotary member 101 and flow to the distal side (downstream side) after becoming debris D, the debris D flowing to the distal side enters the inside of the concave portion 53 of the basket shaped filter portion 50 extending through distal end opening 104 of the rotary member 101, and is collected so as to be filtered by the filter portion 50, which can help prevent the debris D from flowing to a peripheral portion, and can help prevent a new stenosed site from occurring in the peripheral blood vessel).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus associated with Hanson to include a retractable collecting basket extending through a distal opening of a rotary cutting bit as taught by Kobayashi because it would allow the debris from the stenosed material cut by the cutting bit associated with Hanson to be collected in the basket and then filtered by the basket (Kobayashi - - P. [0068]). The motivation for the modification would have been to prevent debris from flowing into a peripheral portion of the blood vessel and prevent a new stenosed site from occurring in the peripheral blood vessel (Kobayashi - - P. [0068]).
Hanson in view of Kobayashi does not disclose
(claim 12) a dispensing element integrated with the collecting basket.
However, Guo teaches a rotating burr (12) for ablating a blood vessel lesion in the same field of endeavor, the burr (12) including a shaft (16) extending distal of the rotating burr (12) for distal infusion for washing a treatment area
(claim 12) further comprising a dispensing element (16) (Fig. 6) integrated with the collecting basket (See Fig. 6 to Guo and Fig. 11B to Kobayashi) (Guo - - Ps. [0029] – [0030]- - a shaft 16 surrounding the guidewire 14 at a location distally of the burr 12 such that distally expelled infusion liquid can wash the treating area. Regardless of whether or not distal infusion is occurring, infusion liquid exits through the transverse passages 36, both for washing the vessel wall W and for maintaining sufficient liquid in the treatment area to prevent collapse of the vessel while aspiration is occurring through the sheath 19; when Guo is combined with Hanson in view of Kobayashi, the guidewire over which the filter basket 50 is disposed would also include a shaft over which to provide distal infusion into the debris caught by concave filter basket 50; it is noted that the teaching of Guo is not wholly incorporated and that the shaft applied to Hanson in view of Kobayashi could be a tube or shaft and not a driveshaft).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus of Hanson in view of Kobayashi to include a distally extending tube or shaft located on a guidewire such that when Guo is combined with Hanson in view of Kobayashi, the guidewire over which the filter basket 50 is disposed would also include a shaft over which to provide distal infusion into the debris caught by concave filter basket 50, thereby combining or integrating the dispensing element taught by Guo with the filter basket taught by Kobayashi because it would selectively distribute fluid beyond a distal end of the rotary embolectomy device to an occlusion, including occlusion or debris located in the concave filter basket (Guo - - P. [0029]). The motivation for the modification would have been to provide for distal infusion of the treatment area, both for washing the vessel and for maintaining sufficient liquid in the treatment area to prevent collapse of the vessel while aspiration is occurring through the sheath (Guo - - P. [0029]).
Claims 13- 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Guo et al. (US Pub. No. 2002/0099367 A1).
Regarding claims 13- 14, Hanson discloses the apparatus of claim 1, but Hanson does not disclose
(claims 13- 14) a dispensing element as claimed.
However, Guo teaches a rotating burr (12) for ablating a blood vessel lesion in the same field of endeavor, the burr (12) including a shaft (16) extending distal of the rotating burr (12) for distal infusion for washing a treatment area
(claim 13) further comprising a dispensing element (16) (Fig. 6) (Fig. 6) comprising a tube disposed adjacent to the rotatable bit (12) (Fig. 5) (Guo - - Ps. [0029]- [0030]- - a shaft 16 surrounding the guidewire 14 at a location adjacent of the burr 12 such that distally expelled infusion liquid can wash the treating area. Regardless of whether or not distal infusion is occurring, infusion liquid exits through the transverse passages 36, both for washing the vessel wall W and for maintaining sufficient liquid in the treatment area to prevent collapse of the vessel while aspiration is occurring through the sheath 19; when Guo is combined with Hanson, the guidewire extending through aperture 59 would also include a shaft over which to provide distal infusion to wash the treating area; it is noted that the teaching of Guo is not wholly incorporated and that the shaft applied to Hanson could be a tube or shaft and not a driveshaft).
(claim 14) further comprising a dispensing element (16) (Fig. 6) (Fig. 6) comprising a tube disposed distal to the rotatable bit (12) (Fig. 5) (Guo - - Ps. [0029]- [0030]- - a shaft 16 surrounding the guidewire 14 at a location distally of the burr 12 such that distally expelled infusion liquid can wash the treating area. Regardless of whether or not distal infusion is occurring, infusion liquid exits through the transverse passages 36, both for washing the vessel wall W and for maintaining sufficient liquid in the treatment area to prevent collapse of the vessel while aspiration is occurring through the sheath 19; when Guo is combined with Hanson, the guidewire extending through aperture 59 would also include a shaft over which to provide distal infusion to wash the treating area; it is noted that the teaching of Guo is not wholly incorporated and that the shaft applied to Hanson could be a tube or shaft and not a driveshaft).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus of Hanson to include a distally adjacent extending tube or shaft on a guidewire such that when Guo is combined with Hanson, when Guo is combined with Hanson, the guidewire extending through the aperture of the cutting bit associated with Hanson would also include a shaft over which to provide distal infusion to wash the treating area because it would selectively distribute fluid beyond a distal end of the rotary embolectomy device to an occlusion (Guo - - P. [0029]). The motivation for the modification would have been to provide for distal infusion of the treatment area, both for washing the vessel wall and for maintaining sufficient liquid in the treatment area to prevent collapse of the vessel while aspiration is occurring through the sheath (Guo - - P. [0029]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US Pat. No. 5,267,955) in view of Siegel (US Pub. No. 2014/0257112 A1). Siegel is cited in the IDS filed 12/19/24.
Regarding claim 16, Hanson discloses the apparatus of claim 1, Hanson further disclosing wherein the rotatable actuator (20) is an electric motor (Col. 2, l. 46- 50 - - While holding the distal tip of the catheter in contact with the occlusion, electric motor 20 is energized, thereby causing the cutter head of catheter 18 to rotate), but Hanson does not disclose
(claim 16) wherein the rotatable actuator is a hand crank.
However, Siegel a rotatable actuator (114) (Figs. 1, 6C) for rotating a cutting edge (208) (Fig. 2) of a morcellator (110) (Figs. 1- 2) in the same field of endeavor (Ps. [0007], [0020], [0023])
(claim 16) wherein the rotatable actuator (114) is a hand crank (P. [0020] - - The elongate element 112 can be connected to an actuator 114 which is used to rotate the elongate element 112 (and therefore, the morcellator 110). The actuator 114 may be a powered device, such as an electric motor, or a manually-operated device, such as a foot pedal or hand-crank).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute the hand crank actuator taught by Siegel for the electric motor actuator disclosed by Hanson because, as disclosed by Siegel, a hand crank actuator and an electric motor actuator are structural equivalents, and as such, the substitution would have yielded predictable results, namely, performing the same function of rotating a cutter (Hanson - - Col. 2, l. 46- 50; Siegel - - P. [0020]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim 17- 18 and 22- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Pat. No. 6,719,717 B1) in view of Hanson (US Pat. No. 5,267,955). Johnson is cited in the IDS filed 12/19/24.
Regarding claim 17 in view of the rejection under 35 USC § 112(b) above, Johnson discloses a method of removing a blockage in the cerebrovascular system in a patient (Col. 1, l. 15- 30; Col. 1, l. 57- 67 - - Johnson discloses removing blockages or clots from the vessel system, including vessels that supply blood to the brain), comprising:
providing a first cannula (20) (Figs. 1- 2) disposed within a patient, said cannula (20) having a distal end adjacent to the blockage (120) (Fig. 1), and a proximate end comprising an access port (45) (Fig. 1);
(claim 17) advancing the distal end of the treatment device (160) (Fig. 1) towards the blockage (120) (Step 230 – clot breakage step) (Fig. 3) (Col. 6, l. 18- 33 - - treatment device 160 may be a suitable device useful to break up blood clots 120).
Johnson further disclosing a clot breakage step (230) and anticipating that a treatment device (160) that is suitable for breaking up clots is used for this step, but Johnson does not specifically disclose
(claim 17) the device according to claim 1.
However, Hanson teaches an atherectomy device for breaking up clots in the same field of endeavor including the device according to claim 1 (see the rejection of claim 1 above)
Hanson further discloses the method step of
(claim 17) rotating the cutting bit (62) to break apart the clot (Col. 3, l. 33- 46 - - When cutter head 62 is rotated in the direction of arrow 70 and in contact with occluding material, the material is milled away with the free particles being forced in a proximal direction by cutting edges 64a-64n).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to include the atherectomy device according to claim 1 taught by Hanson to perform the method step of rotating the cutting bit to break apart the clot because the method step of rotating a cutting bit of an atherectomy device to break apart clot is well-known in the art of atherectomy and would have yielded predictable results, namely breaking up clots in to remove a blockage or occlusion to a vessel, thereby reducing the risk of stroke (Hanson - - Col. 1, l. 49- 51).
Regarding claim 18, Johnson in view of Hanson discloses the method of claim 17, Johnson further disclosing further comprising administering at least one chemical reagent to the blockage (120) (Step 225- apply dissolution agent) (Fig. 3) (Col. 4, l. 8- 15 - - A thrombolytic agent, such as a tissue plasminogen activator, may be delivered to the blood clot 120 through the secondary catheter 65 or systemically to promote dissolution of the clot 120 as an aid to withdrawal of the clot 120 through the catheter 20).
Regarding claim 22, Johnson in view of Hanson disclose the method of claim 17, Johnson further disclosing wherein the first cannula (20) is in fluid communication with a pump (110) (Fig. 1) and a filter (90) (Fig. 1), and applying suction through the first cannula (20) to withdraw the blockage (120) through the cannula (20) into the filter (90) (Step 215- application of suction) (Fig. 3) (Col. 5, l. 62- Col. 6, l. 5 - - suction is applied, at step 215, to the proximal end of catheter 20 by the suction source 110 via the blood filtration device 90 which is in fluid communication with the catheter 20).
Regarding claim 23, Johnson in view of Hanson disclose the method of claim 22, Johnson further disclosing wherein the filter (90) is in fluid communication with a reservoir (95) (Fig. 1), said reservoir (95) in fluid communication with a second cannula (140) (Fig. 1) disposed within the patient, comprising the step of reinfusing filtered fluid from the reservoir (95) back into the patient (Step 270- reinfuse filtered blood into patient) (Fig. 3) (Col. 6, l. 59- Col. 7, l. 6 - - reinfuser 140 draws the filtered blood from the blood collection device 95 and delivers it into the vascular system of the patient through the delivery device comprising an IV needle and IV tubing; the IV tubing is interpreted as a second cannula).
Conclusion
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771