DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claims 1-5, 9, 13, 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vreeman (US 2012/0078175).
Regarding claim 1, an invention relating to catheters, Vreeman discloses (Figs. 1 & 3B) a catheter (10) for treating a blood vessel (Par. 0039-0040), the catheter comprising: an elongated shaft (14) having a proximal region, a distal region (see annotated figure below), and a lumen (16) extending therebetween (Par. 0032); wherein a distal tip (18b) is disposed at the distal region (Figs. 1 & 3B; Par. 0036); wherein the distal tip includes an angled opening [i.e. distal opening exposing lumen 16 that is defined at ends 34a-b, and that the guidewire GW goes through (Fig. 3B)] in fluid communication with the lumen (Par. 0034 & 0036-0037); and wherein the angled opening is arranged at an angle that varies along a length thereof [i.e. primary and secondary angles of ends 34a-b which define a length of exposed lumen] (Par. 0036-0037).
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Regarding claim 2, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein the elongated shaft has a length such that the distal region can be positioned in an artery adjacent to a brain and the proximal region can be positioned in a common carotid artery during use [i.e. the shaft can have a length of 10-300 cm and more specifically the shaft can have a length of 60 cm, hence the shaft can be positioned as claimed] (Par. 0032). Note, in view of paragraph 0021 of instant application, a length of 40-70 cm is sufficient to extend from the carotid artery to the cerebral artery.
Regarding claim 3, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein a radiopaque marker is disposed along the distal region [i.e. longitudinal stripes of radiopaque filler or materials may be incorporated into tip sidewall] (Par. 0036).
Regarding claim 4, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein the elongated shaft includes a coil [i.e. reinforced with coil] (Par. 0032).
Regarding claim 5, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein the elongated shaft includes a braid [i.e. reinforced with braid] (Par. 0032).
Regarding claim 9, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein the elongated shaft has a working length of 40-70 centimeters [i.e. shaft length of 60 cm] (Par. 0032).
Regarding claim 13, Vreeman discloses the catheter of claim 1. Vreeman discloses (Fig. 3B) further comprising an inner member [i.e. guidewire (GW)] disposed along the lumen (Par. 0034 & 0037).
Regarding claim 15, Vreeman discloses the catheter of claim 1. Vreeman further discloses wherein the angled opening opens to a side of the elongated shaft [i.e. the side defined by ends 34a-b] (Par. 0036-0037).
Regarding claim 16, an invention relating to catheters, Vreeman discloses (Figs. 1 & 3B) an aspiration catheter (10) for aspiration thrombotic material from a blood vessel (Par. 0032 & 0039-0040), the aspiration catheter comprising: an aspiration shaft (14) having a proximal region, a distal region (see annotated figure below), and an aspiration lumen (16) extending therebetween (Par. 0032); wherein a distal tip (18b) is disposed at the distal region (Figs. 1 & 3B; Par. 0036); wherein the distal tip includes an angled opening [i.e. distal opening exposing lumen 16 that is defined at ends 34a-b, and that the guidewire GW goes through (Fig. 3B)] in fluid communication with the aspiration lumen (Par. 0034 & 0036-0037); and wherein the angled opening opens to a side of the aspiration shaft [i.e. the side defined by ends 34a-b] (Par. 0036-0037).
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Regarding claim 17, Vreeman discloses the aspiration catheter of claim 16. Vreeman further discloses wherein the aspiration shaft includes a coil [i.e. reinforced with coil] (Par. 0032).
Regarding claim 18, Vreeman discloses the aspiration catheter of claim 16. Vreeman further discloses wherein the aspiration shaft includes a braid [i.e. reinforced with braid] (Par. 0032).
Regarding claim 20, an invention relating to catheters, Vreeman discloses (Figs. 1 & 3B) an aspiration catheter (10) for aspiration thrombotic material from a blood vessel (Par. 0032 & 0039-0040), the aspiration catheter comprising: an aspiration shaft (14) having a proximal region, a distal region (see annotated figure below), and an aspiration lumen (16) extending therebetween (Par. 0032); wherein the distal region is configured to be positioned in an artery adjacent to a brain during use of the aspiration catheter; wherein the proximal region is configured be positioned in a common carotid artery during use of the aspiration catheter [i.e. the shaft can have a length of 10-300 cm and more specifically the shaft can have a length of 60 cm, hence the shaft can be positioned as claimed] (Par. 0032) [Note, in view of paragraph 0021 of instant application, a length of 40-70 cm is sufficient to extend from the carotid artery to the cerebral artery]; wherein a distal tip (18b) is disposed at the distal region (Fig. 1); wherein the distal tip includes a variable angle angled opening [i.e. primary and secondary angles of ends 34a-b which define a length of exposed lumen] in fluid communication with the aspiration lumen (Par. 0034 & 0036-0037); and wherein the variable angle angled opening opens to a side of the aspiration shaft [i.e. the side defined by ends 34a-b] (Par. 0036-0037).
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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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 1 above, and further in view of Griffin et al. (US 2003/0093059).
Regarding claim 6, Vreeman discloses the catheter of claim 1. Vreeman further discloses the shaft may comprise a distal region more flexible than a proximal region (Par. 0033). Vreeman fails to further disclose wherein the elongated shaft includes a cut hypotube.
In the same field of endeavor, which is catheters, Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a cut hypotube (Par. 0013 & 0019-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vreeman to have wherein the elongated shaft includes a cut hypotube, as taught by Griffin. Since, Vreeman discloses it’s shaft comprising a distal region more flexible than a proximal region (Par. 0033), adding Griffin’s cut hypotube structure that provides proximal stiffness that gradually reduces with the changing pitch of the distal portion of the cut hypotube will lead to Vreeman’s shaft comprising a distal region more flexible than a proximal region. Doing so would provide the catheter with pushability and torqueability (Par. 0020), as taught by Griffin.
Regarding claim 7, Vreeman discloses the catheter of claim 1. Vreeman further discloses the shaft may comprise a distal region more flexible than a proximal region (Par. 0033). Vreeman fails to further disclose wherein the elongated shaft includes a transition section between the proximal region and the distal region, and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region.
Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a transition section (16) between a proximal region (12) and a distal region (14), and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region [i.e. a smooth mid-shaft transition portion comprising voids/cut hypotube (22) and portions of the flexible distal composite shaft section] (Par. 0011, 0013, 0015, 0018-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vreeman to have wherein the elongated shaft includes a transition section between the proximal region and the distal region, and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region. Doing so would provide the catheter with pushability and torqueability, trackability, and smooth transition that provides a secure connection and that minimizes profile increase (Par. 0020), as taught by Griffin.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 1 above, and further in view of Bourang et al. (US 2008/0255447).
Regarding claim 8, Vreeman discloses the catheter of claim 1. Vreeman further discloses the lumen accommodates a guidewire having a diameter 0.035” (Par. 0032). However, Vreeman fails to explicitly disclose wherein the elongated shaft has an inner diameter of 0.035 to .095 inches.
In the same field of endeavor, which is catheters, Bourang teaches a catheter having an inner diameter of 0.039” to fit over a 0.035 inch diameter guidewire (Par. 0033).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vreeman to have wherein the elongated shaft has an inner diameter of 0.035 to .095 inches, as taught by Bourang. Since, Vreeman discloses a catheter lumen that can accommodate a guidewire that is 0.035” in diameter is desired (Par. 0110), Bourang’s 0.039” inner diameter for a catheter would lead to Vreeman’s catheter having an inner diameter of 0.035 to .095 inches which can accommodate/ fit a guidewire that is 0.035”.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 1 above, and further in view of Chiang et al. (US 5,899,890).
Regarding claim 10, Vreeman discloses the catheter of claim 1. Vreeman fails to explicitly disclose wherein the proximal region has a stiffness of 100 to 500 N-mm2.
In the same field of endeavor, which is catheters, Chiang teaches the proximal shaft will have a flexural modulus from 20,000 psi to 1,000,000 psi [i.e. 137.89 to 6894.75 N-mm2] (Col. 6, lines 18-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify stiffness of the proximal region of Vreeman, in view of Chiang, from 20,000 psi to 1,000,000 psi [i.e. 137.89 to 6894.75 N-mm2] to 100 to 500 N-mm2 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0024] of applicant’s specification). Also, modifying Vreeman’s device to have the claimed proximal region stiffness range, which is within the stiffness range taught by Chiang, would provide a sufficiently rigid proximal region to permit axial positioning of the catheter (Col. 6, lines 13-16), as taught by Chiang.
Regarding claim 11, Vreeman discloses the catheter of claim 1. Vreeman fails to explicitly disclose wherein the distal region has a stiffness of 3 to 10 N- mm2.
In the same field of endeavor, which is catheters, Chiang teaches the flexural modulus for the distal segment will be from 100 psi to 2000 psi [i.e. 0.689 to 13.78N-mm2] (Col. 6, lines 24-28).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify stiffness of the distal region of Vreeman, in view of Chiang, from 100 psi to 2000 psi [i.e. 0.689 to 13.78N-mm2] to 3 to 10 N- mm2 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0024] of applicant’s specification). Also, modifying Vreeman’s device to have the claimed distal region stiffness range, which is within the stiffness range taught by Chiang, would provide a sufficiently flexible and supple distal region that may be carried by blood flow through the patient’s vasculature (Col. 6, lines 20-23), as taught by Chiang.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 1 above, and further in view of Chou et al. (US 2011/0034986).
Regarding claim 12, Vreeman discloses the catheter of claim 1. Vreeman fails to further disclose wherein the distal region has a length of 3 to 15 centimeters.
In the same field of endeavor, which is catheters, Chou teaches wherein a distal region has a length of approximately 2 to 4 centimeters (Par. 0152).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the distal region of Vreeman, in view of Chou, from 2 to 4 centimeters to 3 to 15 centimeters since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0022] of applicant’s specification). Also, modifying Vreeman’s device to have the claimed distal region length range, which is within the length range taught by Chou, would permit this section to be positioned in the common carotid artery CCA via the transcervical approach with reduced risk that the distal end will contact the bifurcation, and permit a reduction in size of the arteriotomy for introducing the catheter into the artery while having a minimal impact in the level of flow resistance (Par. 0152), as taught by Chou.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 13 above, and further in view of Grandfield (US 2006/0047224).
Regarding claim 14, Vreeman discloses the catheter of claim 13. However, Vreeman fails to disclose wherein the inner member has a tapered leading edge.
In the analogous art of guidewires, Grandfield teaches wherein the inner member has a tapered leading edge [i.e. a guide wire having a tapered distal coil coated with a highly conforming polymer while sections proximal thereto are coated with a substantially less conforming polymer will yield a guide wire that is more easily advanced through vasculature while nonetheless providing tactile feedback] (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vreeman to have wherein the inner member has a tapered leading edge. Doing so would yield a guide wire that is more easily advanced through vasculature while nonetheless providing tactile feedback (Abstract), as taught by Grandfield.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vreeman (US 2012/0078175) as applied to claim 16 above, and further in view of Griffin et al. (US 2003/0093059).
Regarding claim 19, Vreeman discloses the aspiration catheter of claim 16. Vreeman discloses the shaft may comprise a distal region more flexible than a proximal region (Par. 0033). However, Vreeman fails to further disclose wherein the aspiration shaft includes a cut hypotube.
In the same field of endeavor, which is catheters, Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a cut hypotube (Par. 0013 & 0019-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vreeman to have wherein the aspiration shaft includes a cut hypotube, as taught by Griffin. Since, Vreeman discloses it’s shaft comprising a distal region more flexible than a proximal region (Par. 0033), adding Griffin’s cut hypotube structure that provides proximal stiffness that gradually reduces with the changing pitch of the distal portion of the cut hypotube will lead to Vreeman’s shaft comprising a distal region more flexible than a proximal region. Doing so would provide the catheter with pushability and torqueability (Par. 0020), as taught by Griffin.
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, 13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than the listed claims of Patent Publication No. 2025/0375209 and therefore are “anticipated” by the listed claims in Patent Publication No. 2025/0375209.
Claims
19/238,932
1
13
15
16
Claims
US Patent Publication No
2025/0375209
1
1
1
1
Claims 2-5, 9, 17-18, and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209 in view of Vreeman (US 2012/0078175).
Claims
19/238,932
2
3
4
5
9
17
18
20
Claims
US Patent Publication No
2025/0375209
1
1
1
1
1
1
1
1
Regarding instant claim 2, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft has a length such that the distal region can be positioned in an artery adjacent to a brain and the proximal region can be positioned in a common carotid artery during use [in Claim 2 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the elongated shaft has a length such that the distal region can be positioned in an artery adjacent to a brain and the proximal region can be positioned in a common carotid artery during use [i.e. the shaft can have a length of 10-300 cm and more specifically the shaft can have a length of 60 cm, hence the shaft can be positioned as claimed] (Par. 0032). Note, in view of paragraph 0021 of instant application, a length of 40-70 cm is sufficient to extend from the carotid artery to the cerebral artery.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the elongated shaft has a length such that the distal region can be positioned in an artery adjacent to a brain and the proximal region can be positioned in a common carotid artery during use. Doing so would provide a catheter with a length that can reach a treatment area within the cerebral artery that needs aspiration of substances (Par. 0032), as taught by Vreeman.
Regarding instant claim 3, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein a radiopaque marker is disposed along the distal region [in Claim 3 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein a radiopaque marker is disposed along the distal region [i.e. longitudinal stripes of radiopaque filler or materials may be incorporated into tip sidewall] (Par. 0036).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein a radiopaque marker is disposed along the distal region. Doing so would show the orientation of the distal most tip under fluoroscopy (Par. 0036), as taught by Vreeman.
Regarding instant claim 4, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft includes a coil [in Claim 4 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the elongated shaft includes a coil [i.e. reinforced with coil] (Par. 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the elongated shaft includes a coil. Doing so would provide a reinforced catheter (Par. 0032), as taught by Vreeman.
Regarding instant claim 5, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft includes a braid [in Claim 5 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the elongated shaft includes a braid [i.e. reinforced with braid] (Par. 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the elongated shaft includes a braid. Doing so would provide a reinforced catheter (Par. 0032), as taught by Vreeman.
Regarding instant claim 9, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft has a working length of 40-70 centimeters [in Claim 9 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the elongated shaft has a working length of 40-70 centimeters [i.e. shaft length of 60 cm] (Par. 0032).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Patent Publication No. 2025/0375209 to have wherein the elongated shaft has a working length of 40-70 centimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Patent Publication No. 2025/0375209 would not operate differently with the claimed working length. Further, it appears that applicant places no criticality on the range claimed, indicating that the catheter has a working length ranging from 40 to 70 cm; in an embodiment, the catheter has a working length of less than 70 cm, less than 60 cm, or less than 50 cm; a similar catheter designed for a transfemoral access site may have a working length of between 100 and 130 cm; alternately, the length of catheter can be defined relative to the location of the access site and the target cerebral artery site; in an embodiment, the catheter is configured to be introduced into the artery at a location in the artery that is less than 40 cm, less than 30 cm, or less than 20 cm from the location of the target site as measured through the arterial pathway, see paragraph 0021 of applicant’s original specification.
Regarding instant claim 17, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the aspiration shaft includes a coil [in Claim 17 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the aspiration shaft includes a coil [i.e. reinforced with coil] (Par. 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the aspiration shaft includes a coil. Doing so would provide a reinforced catheter (Par. 0032), as taught by Vreeman.
Regarding instant claim 18, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the aspiration shaft includes a braid [in Claim 18 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the aspiration shaft includes a braid [i.e. reinforced with braid] (Par. 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the aspiration shaft includes a braid. Doing so would provide a reinforced catheter (Par. 0032), as taught by Vreeman.
Regarding instant claim 20, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the distal region is configured to be positioned in an artery adjacent to a brain during use of the aspiration catheter; wherein the proximal region is configured be positioned in a common carotid artery during use of the aspiration catheter [in Claim 20 of application 19/238,932].
In the same field of endeavor, which is catheters, Vreeman teaches wherein the distal region is configured to be positioned in an artery adjacent to a brain during use of the aspiration catheter; wherein the proximal region is configured be positioned in a common carotid artery during use of the aspiration catheter [i.e. the shaft can have a length of 10-300 cm and more specifically the shaft can have a length of 60 cm, hence the shaft can be positioned as claimed] (Par. 0032) [Note, in view of paragraph 0021 of instant application, a length of 40-70 cm is sufficient to extend from the carotid artery to the cerebral artery]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the distal region is configured to be positioned in an artery adjacent to a brain during use of the aspiration catheter; wherein the proximal region is configured be positioned in a common carotid artery during use of the aspiration catheter. Doing so would provide a catheter with a length that can reach a treatment area within the cerebral artery that needs aspiration of substances (Par. 0032), as taught by Vreeman.
Claims 6-7 and 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209 in view of Griffin et al. (US 2003/0093059).
Claims
19/238,932
6
7
19
Claims
US Patent Publication No
2025/0375209
1
1
1
Regarding instant claim 6, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft includes a cut hypotube [in Claim 6 of application 19/238,932].
In the same field of endeavor, which is catheters, Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a cut hypotube (Par. 0013 & 0019-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the elongated shaft includes a cut hypotube. Doing so would provide the catheter with pushability and torqueability (Par. 0020), as taught by Griffin.
Regarding instant claim 7, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft includes a transition section between the proximal region and the distal region, and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region [in Claim 7 of application 19/238,932].
In the same field of endeavor, which is catheters, Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a transition section (16) between a proximal region (12) and a distal region (14), and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region [i.e. a smooth mid-shaft transition portion comprising voids/cut hypotube (22) and portions of the flexible distal composite shaft section] (Par. 0011, 0013, 0015, 0018-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the elongated shaft includes a transition section between the proximal region and the distal region, and wherein the transition section has a stiffness between a proximal stiffness of the proximal region and a distal stiffness of the distal region. Doing so would provide the catheter with pushability and torqueability, trackability, and smooth transition that provides a secure connection and that minimizes profile increase (Par. 0020), as taught by Griffin.
Regarding instant claim 19, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the aspiration shaft includes a cut hypotube [in Claim 19 of application 19/238,932].
In the same field of endeavor, which is catheters, Griffin teaches (Fig. 1) wherein an elongated shaft (10; Par. 0010) includes a cut hypotube (Par. 0013 & 0019-0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the aspiration shaft includes a cut hypotube. Doing so would provide the catheter with pushability and torqueability (Par. 0020), as taught by Griffin.
Claim 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209 in view of Bourang et al. (US 2008/0255447).
Claims
19/238,932
8
Claims
US Patent Publication No
2025/0375209
1
Regarding instant claim 8, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the elongated shaft has an inner diameter of 0.035 to .095 inches [in Claim 8 of application 19/238,932].
In the same field of endeavor, which is catheters, Bourang teaches a catheter having an inner diameter of 0.039” to fit over a 0.035 inch diameter guidewire (Par. 0033).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Patent Publication No. 2025/0375209 to have wherein the elongated shaft has an inner diameter of 0.035 to .095 inches since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Patent Publication No. 2025/0375209 would not operate differently with the claimed inner diameter and since the lumen is intended to house a guidewire the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating that the central lumen of the tubular body “may” have an inner diameter of .068” to .095” or .035” to .062”, see paragraph 0030 of applicant’s original specification.
Claims 10-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209 in view of Chiang et al. (US 5,899,890).
Claims
19/238,932
10
11
Claims
US Patent Publication No
2025/0375209
1
1
Regarding instant claim 10, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the proximal region has a stiffness of 100 to 500 N-mm2 [in Claim 10 of application 19/238,932].
In the same field of endeavor, which is catheters, Chiang teaches the proximal shaft will have a flexural modulus from 20,000 psi to 1,000,000 psi [i.e. 137.89 to 6894.75 N-mm2] (Col. 6, lines 18-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify stiffness of the proximal region of Patent Publication No. 2025/0375209, in view of Chiang, from 20,000 psi to 1,000,000 psi [i.e. 137.89 to 6894.75 N-mm2] to 100 to 500 N-mm2 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0024] of applicant’s specification). Also, modifying Patent Publication No. 2025/0375209 device to have the claimed proximal region stiffness range, which is within the stiffness range taught by Chiang, would provide a sufficiently rigid proximal region to permit axial positioning of the catheter (Col. 6, lines 13-16), as taught by Chiang.
Regarding instant claim 11, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the distal region has a stiffness of 3 to 10 N- mm2 [in Claim 11 of application 19/238,932].
In the same field of endeavor, which is catheters, Chiang teaches the flexural modulus for the distal segment will be from 100 psi to 2000 psi [i.e. 0.689 to 13.78N-mm2] (Col. 6, lines 24-28).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify stiffness of the distal region of Patent Publication No. 2025/0375209, in view of Chiang, from 100 psi to 2000 psi [i.e. 0.689 to 13.78N-mm2] to 3 to 10 N- mm2 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0024] of applicant’s specification). Also, modifying Patent Publication No. 2025/0375209 device to have the claimed distal region stiffness range, which is within the stiffness range taught by Chiang, would provide a sufficiently flexible and supple distal region that may be carried by blood flow through the patient’s vasculature (Col. 6, lines 20-23), as taught by Chiang.
Claim 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent Publication No. 2025/0375209 in view of Chou et al. (US 2011/0034986).
Claims
19/238,932
12
Claims
US Patent Publication No
2025/0375209
1
Regarding instant claim 12, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the distal region has a length of 3 to 15 centimeters [in Claim 12 of application 19/238,932].
In the same field of endeavor, which is catheters, Chou teaches wherein a distal region has a length of approximately 2 to 4 centimeters (Par. 0152).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the distal region of Patent Publication No. 2025/0375209, in view of Chou, from 2 to 4 centimeters to 3 to 15 centimeters since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0022] of applicant’s specification). Also, modifying Patent Publication No. 2025/0375209 device to have the claimed distal region length range, which is within the length range taught by Chou, would permit this section to be positioned in the common carotid artery CCA via the transcervical approach with reduced risk that the distal end will contact the bifurcation, and permit a reduction in size of the arteriotomy for introducing the catheter into the artery while having a minimal impact in the level of flow resistance (Par. 0152), as taught by Chou.
Claim 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent Publication No. 2025/0375209 in view of Grandfield (US 2006/0047224).
Claims
19/238,932
14
Claims
US Patent Publication No
2025/0375209
1
Regarding instant claim 14, Claim 1 of Patent Publication No. 2025/0375209 fails to claim wherein the inner member has a tapered leading edge [in Claim 14 of application 19/238,932].
In the analogous art of guidewires, Grandfield teaches wherein the inner member has a tapered leading edge [i.e. a guide wire having a tapered distal coil coated with a highly conforming polymer while sections proximal thereto are coated with a substantially less conforming polymer will yield a guide wire that is more easily advanced through vasculature while nonetheless providing tactile feedback] (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent Publication No. 2025/0375209 to have wherein the inner member has a tapered leading edge. Doing so would yield a guide wire that is more easily advanced through vasculature while nonetheless providing tactile feedback (Abstract), as taught by Grandfield.
Conclusion
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/CHIMA U IGBOKO/ Examiner, Art Unit 3771
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