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 .
Detailed Action
This is in response to the amendment filed 12/18/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 repeats a first radiopaque marker under the advance segment and a second radiopaque marker under the trailing segment which is already recited in claim 36 (claim 5 depends on claim 4 which depends on claim 3 which depends on claim 2 which depends on claim 36). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 8, 10, 12, 13, 34, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 4,030,503 (Clark, III)
Regarding claims 1, 8, 12, 13, 35 Clark, III discloses as shown in Figure 5, a thrombus engagement tool configured to be advanced through a catheter and to engage thrombus, the thrombus engagement tool comprising: a rotatable core (flexible spring wire 8, see col. 1, lines 38-46) having a proximal end and a distal end; a thrombus engagement tip on the distal end of the rotatable core, the thrombus engagement tip comprising: a helical thread (helix 12, see col. 1, lines 47-56); an advance segment distal (rounded knob 10, see col. 1, lines 38-45) to the helical thread; and a trailing segment proximal (flexible shaft 4, see col. 1 lines 38-46) to the helical thread; and wherein the helical thread, the advance segment, and the trailing segment each extend radially outward from the rotatable core, a handle (handle 6, see col. 1, lines 47-56) on the proximal end of the rotatable core capable of hand turning the rotatable core, the rotatable core is a solid wire, where the advanced segment comprises an atraumatic tip (rounded knob 10), where the helical thread does not extend over the advanced segment or the trailing segment.
Regarding claim 10, the limitations of claim 10 are directed towards a product by process (“wherein the advance segment, the helical thread, and the trailing segment are all molded onto the rotatable core.”). ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
In this there is no significant structure implied by the molding on process as described by the applicant. Accordingly, the Office interprets Clark, III as disclosing the same.
Regarding claim 34, the advance segment comprises a cylindrical portion (generally indicated as A) and a tip portion (generally indicated as B) extending from the cylindrical portion, wherein the tip portion tapers in a distal direction, wherein the advance segment is shaped to be capable of moving past the thrombus without pushing the thrombus in a distal direction as the thrombus engagement tip is advanced.
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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.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Number 6,697,677 (Dahl et al.)
Regarding claim 9, Clark et al. III fails to disclose a limit bearing surface on the handle, the limit bearing surface being configured to limit projection of the thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter.
Dahl, from the same field of endeavor teaches a similar tool as shown in Figure 8 a limit bearing surface (travel limiter 102, see col. 9, lines 14-27) on the handle, the limit bearing surface being configured to limit projection of a thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter. See col. 9, lines 14-27.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark et al. III such that a limit bearing surface was on the handle, the limit bearing surface being configured to limit projection of the thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2021/0137584 (Urbanski et al.)
Regarding claim 11, Clark et al. III fails to disclose the rotatable core is cannulated.
Urbanski et al., from a related field of endeavor taches a similar rotatable core as shown in Figure 1 where the rotatable core is cannulated for the purpose of accommodating contrast media. See paragraph [0019].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark, III by cannulating the rotatable core as taught by Urbanski et al. in order to configure it to accommodate contrast media, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III)
Regarding claim 16, Clark, III fails to disclose the thrombus engagement tip has an axial length within a range of from about 15 mm to about 30 mm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the thrombus engagement tool disclosed by Clark, III such that the thrombus engagement tip has an axial length within a range of from about 15 mm to about 30 mm as matter of engineering design choice.
Applicant has not disclosed that spacing the length of the tip provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0073] of the specification. One of ordinary skill in the art, furthermore, would have expected Clark, III’s tip, and applicant’s invention, to perform equally well with either the spacing taught by Clark, III or the claimed 15 mm to about 30 mm length because both spacing dimensions would perform the same function of providing a tip length from falling-out equally well considering relative dimensions disclosed.
Claim(s) 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2008/0312672 (Bonnette et al.)
Regarding claims 17, 18 Clark, III et al. fails to disclose in combination with a catheter having an inside diameter, wherein an outside diameter of the helical thread is no more than about 60% of the inside diameter of the catheter, wherein the outside diameter of the helical thread is no more than about 40% of the inside diameter of the catheter.
Bonnette et al. from the same field of endeavor teaches a similar tool as shown in Figure 10, where in combination with a catheter (catheter 32 with tapered tip 36, see paragraph [0042]) having an inside diameter, wherein an outside diameter of a tool (guidewire 120, see paragraph [0044]) used for the same purpose of clearing an obstruction in the body as disclosed by the helical thread in Clark, III is no more than about a percentage of the inside diameter of the catheter, is recognized as a result effective variable for purpose of ensuring fluid flow past the tool to facilitate providing a path through the chronic total occlusion. See paragraphs [0009], [0057].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed Clark, III et al. to include the catheter 32 with tapered tip 36 and size it such that it had an inside diameter, wherein an outside diameter of the helical thread is no more than about 60% of the inside diameter of the catheter, wherein the outside diameter of the helical thread is no more than about 40% of the inside diameter of the catheter because it would only require discovering an optimum value of a result effective variable involves only routine skill in the art in order to provide a path for fluid to flow past the helical thread to facilitate providing a path through the chronic total occlusion. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2006/0135962 (Kick et al.)
Regarding claims 19, 20 Clark et al. III fails to disclose a position indicator carried by the rotatable core, the position indicator comprises a distal end of a tube surrounding the rotatable core.
Kick et al., from a related field of endeavor teaches a similar tool as shown in figure 16, which includes a position indicator (one of radiopaque markers 1620, 1622, 1624, and 1626, see paragraph [0083]) carried by the rotatable core, wherein the position indicator comprises a distal end of a tube surrounding the rotatable core, for the purpose of tracking the rotatable core. See paragraph [0083].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark to include one of radiopaque markers 1620, 1622, 1624, and 1626 such that it was carried by the rotatable core, where the position indicator comprises a distal end of a tube surrounding the rotatable core in order to track the rotatable core, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 21, 23, 25, 27-29, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.)
Regarding claims 21, 23, 27, 28 Clark, III discloses as shown in Figure 5A, a thrombus engagement tool configured to be advanced through a catheter and to engage thrombus, the thrombus engagement tool comprising: a rotatable core (flexible spring wire 8, see col. 1, lines 38-46) having a proximal end and a distal end; and a thrombus engagement tip on the distal end of the rotatable core, the thrombus engagement tip comprising: a helical thread (helix 12, see col. 1, lines 47-56) comprising an outer periphery and a proximal surface, the outer periphery substantially conforming to a surface of a cylinder, the helical thread being fixed, an advance segment (rounded knob 10, see col. 1, lines 38-45) distal to the helical thread; and a trailing segment (flexible shaft 4, see col. 1 lines 38-46) proximal to the helical thread, a handle (handle 6, see col. 1, lines 47-56) on the proximal end of the rotatable core capable of hand turning the rotatable core, the rotatable core is a solid wire, where the advanced segment comprises an atraumatic tip (rounded knob 10), the rotatable core is a solid wire, where the advanced segment comprises an atraumatic tip (rounded knob 10).
Clark, III fails to disclose the proximal surface inclines radially outwardly in a proximal direction to define a proximally opening undercut.
Zhang et al., from the same field of endeavor teaches a similar tool as shown in Figures 11, 11a where a proximal surface similar to the helical thread disclosed by Clark, III (used to clear obstructions in vasculature) with a proximal surface that inclines radially outwardly in a proximal direction to define a proximally opening undercut (undercut 41C, see paragraph [0059]) for the purpose of directing particles of material in the proximal direction. See paragraph [0059].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Clark, III such that the proximal surface inclines radially outwardly in a proximal direction to define a proximally opening undercut taught by Zhang et al. such that the proximal surface defines a proximally opening undercut in order to direct particles removed by the helical thread in a proximal direction, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 25, the limitations of claim 10 are directed towards a product by process (“wherein the advance segment, the helical thread, and the trailing segment are all molded onto the rotatable core.”). ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
In this there is no significant structure implied by the molding on process as described by the applicant. Accordingly, the Office interprets Clark, III as disclosing the same.
Regarding claim 29, Clark, III fails to disclose the thrombus engagement tip has an axial length within a range of from about 15 mm to about 30 mm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the thrombus engagement tool disclosed by Clark, III such that the thrombus engagement tip has an axial length within a range of from about 15 mm to about 30 mm as matter of engineering design choice.
Applicant has not disclosed that spacing the length of the tip provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0073] of the specification. One of ordinary skill in the art, furthermore, would have expected Clark, III’s tip, and applicant’s invention, to perform equally well with either the spacing taught by Clark, III or the claimed 15 mm to about 30 mm length because both spacing dimensions would perform the same function of providing a tip length from falling-out equally well considering relative dimensions disclosed.
Regarding claim 38, Clark, III discloses as shown in Figure 5, a thrombus engagement tool configured to be advanced through a catheter and to engage thrombus, the thrombus engagement tool comprising: a rotatable core (flexible spring wire 8, see col. 1, lines 38-46) having a proximal end and a distal end; and a thrombus engagement tip on the distal end of the rotatable core, the thrombus engagement tip comprising: a helical thread (helix 12, see col. 1, lines 47-56) comprising an outer periphery and a proximal surface, the outer periphery substantially conforming to a surface of a cylinder; an advance segment (rounded knob 10, see col. 1, lines 38-45) distal to the helical thread, wherein the advance segment has a larger outside diameter than the rotatable core; wherein the advance segment has a maximum outside diameter that is smaller than a maximum outside diameter of the helical thread to facilitate crossing of the thrombus with the advance segment and engagement of the thrombus with the helical thread and a trailing segment proximal (flexible shaft 4, see col. 1 lines 38-46) to the helical thread.
Clark, III fails to disclose the proximal surface inclining radially outwardly in a proximal direction defining a proximally opening undercut.
Zhang et al., from the same field of endeavor teaches a similar tool as shown in Figures 11, 11a where a proximal surface similar to the helical thread disclosed by Clark, III (used to clear obstructions in vasculature) with a proximal surface that inclines radially outwardly in a proximal direction to define a proximally opening undercut (undercut 41C, see paragraph [0059]) for the purpose of directing particles of material in the proximal direction. See paragraph [0059].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Clark, III to incline the proximal surface such that it defines an undercut as taught by Zhang et al. such that the proximal surface defines a proximally opening undercut in order to direct particles removed by the helical thread in a proximal direction, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 22, 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.) as applied to claim 21 above, and further in view of U.S. Patent Publication Number 2006/0135962 (Kick et al.)
Regarding claim 22, Clark et al. III fails to disclose a first radiopaque marker under the advance segment a second radiopaque maker under the trailing segment.
Kick et al., from a related field of endeavor teaches a similar tool as shown in figure 16, which includes a first and second radiopaque maker (two radiopaque markers 1620, 1622, 1624, and 1626, see paragraph [0083]) for the purpose of tracking an advance segment and trailing segment. See paragraph [0083].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark et al. III to include one of radiopaque markers 1620, 1622, 1624, and 1626 and one of the other of the other radiopaque markers 1620, 1622, 1624, and 1626 such carried by the advanced segment and trailing segment respectively in order to track those areas of the tip, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
It would have been further obvious to one of ordinary skill in the art to modify the tool disclosed by Clark, III in view of Kick such that the at least the first radiopaque marker was underneath the advance segment and second radiopaque marker was underneath the trailing segment because it would only require the rearrangement of parts without changing how the device operates (it would still provide a marker) or because it is obvious to try. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) or see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Attaching the marker to the catheter shaft (which is what the art discloses) can only be done in a certain number of ways (within the inner lumen, embedded so they are beneath the other surface, on top of the exterior surface) and it is the position of the Office that embedding the markers such they were underneath at least one of the advance segment and the trailing segment represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claims 32, 33 Clark et al. III fails to disclose a position indicator carried by the rotatable core, the position indicator comprises a distal end of a tube surrounding the rotatable core.
Kick et al., from a related field of endeavor teaches a similar tool as shown in figure 16, which includes a position indicator (one of radiopaque markers 1620, 1622, 1624, and 1626, see paragraph [0083]) carried by the rotatable core, wherein the position indicator comprises a distal end of a tube surrounding the rotatable core, for the purpose of tracking the rotatable core. See paragraph [0083].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark to include one of radiopaque markers 1620, 1622, 1624, and 1626 such that it was carried by the rotatable core, where the position indicator comprises a distal end of a tube surrounding the rotatable core in order to track the rotatable core, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.) as applied to claim 21 above, and further in view of U.S. Patent Number 6,697,677 (Dahl et al.)
Regarding claim 24, Clark et al. III fails to disclose a limit bearing surface on the handle, the limit bearing surface being configured to limit projection of the thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter.
Dahl, from the same field of endeavor teaches a similar tool as shown in Figure 8 a limit bearing surface (travel limiter 102, see col. 9, lines 14-27) on the handle, the limit bearing surface being configured to limit projection of a thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter. See col. 9, lines 14-27.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark et al. III such that a limit bearing surface was on the handle, the limit bearing surface being configured to limit projection of the thrombus engagement tip in a distal direction relative to a distal end of an aspiration catheter, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.) as applied to claim 21 above, and further in view of U.S. Patent Publication Number 2021/0137584 (Urbanski et al.)
Regarding claim 26, Clark et al. III fails to disclose the rotatable core is cannulated.
Urbanski et al., from a related field of endeavor taches a similar rotatable core as shown in Figure 1 where the rotatable core is cannulated for the purpose of accommodating contrast media. See paragraph [0019].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Clark, III by cannulating the rotatable core as taught by Urbanski et al. in order to configure it to accommodate contrast media, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 30, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.) as applied to claim 21 above, and further in view of U.S. Patent Publication Number 2008/0312672 (Bonnette et al.)
Regarding claims 30, 31 Clark, III et al. fails to disclose in combination with a catheter having an inside diameter, wherein an outside diameter of the helical thread is no more than about 60% of the inside diameter of the catheter, wherein the outside diameter of the helical thread is no more than about 40% of the inside diameter of the catheter.
Bonnette et al. from the same field of endeavor teaches a similar tool as shown in Figure 10, where in combination with a catheter (catheter 32 with tapered tip 36, see paragraph [0042]) having an inside diameter, wherein an outside diameter of a tool (guidewire 120, see paragraph [0044]) used for the same purpose of clearing an obstruction in the body as disclosed by the helical thread in Clark, III is no more than about a percentage of the inside diameter of the catheter, is recognized as a result effective variable for purpose of ensuring fluid flow past the tool to facilitate providing a path through the chronic total occlusion. See paragraphs [0009], [0057].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed Clark, III et al. to include the catheter 32 with tapered tip 36 and size it such that it had an inside diameter, wherein an outside diameter of the helical thread is no more than about 60% of the inside diameter of the catheter, wherein the outside diameter of the helical thread is no more than about 40% of the inside diameter of the catheter because it would only require discovering an optimum value of a result effective variable involves only routine skill in the art in order to provide a path for fluid to flow past the helical thread to facilitate providing a path through the chronic total occlusion. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 36, 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2006/0135962 (Kick et al.)
Regarding claim 36, 3-5 Clark, III fails to disclose a projection carried by the rotatable core, the projection being underneath at least one of the advance segment and the trailing segment to form an interference fit with the thrombus engagement tip.
Kick et al., from a related field of endeavor teaches a similar tool as shown in figure 16, which includes a projection (one of radiopaque markers 1620, 1622, 1624, and 1626, see paragraph [0083]) coupled to at least one of the advance segment and the trailing segment to form an interference fit with a thrombus engagement tip, the projection comprising an annular ring, the projection comprising a radiopaque marker, a first radiopaque maker and a second radiopaque maker (two others of radiopaque markers 1620, 1622, 1624, and 1626, see paragraph [0083]), for the purpose of tracking one of those segments. See paragraph [0083].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tool disclosed by Root to include one of radiopaque markers 1620, 1622, 1624, and 1626 such that it was coupled to at least one of the advance segment and the trailing segment to form an interference fit with the thrombus engagement tip in order to track one of those segments.
It would have been further obvious to one of ordinary skill in the art to modify the tool disclosed by Clark, III in view of Kick such that the at least one projection was underneath at least one of the advance segment and the trailing segment because it would only require the rearrangement of parts without changing how the device operates (it would still provide a marker) or because it is obvious to try. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) or see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Attaching the marker to the catheter shaft (which is what the art discloses) can only be done in a certain number of ways (within the inner lumen, embedded so they are beneath the other surface, on top of the exterior surface) and it is the position of the Office that embedding the markers such they were underneath at least one of the advance segment and the trailing segment represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 6, Clark, III discloses as shown in Figure 5a an outer periphery and a proximal surface, the outer periphery substantially conforming to a surface of a cylinder.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2011/0130777 (Zhang et al.) as applied to claim 21 above, and further in view of U.S. Patent Publication Number 2008/0021408 (Jacobsen et al.)
Regarding claim 37, Clark, III fails to disclose wherein the trailing segment tapers in a proximal direction.
Jacobsen et al., from a related field of endeavor teaches a similar tool as shown in Figure 24, wherein the trailing segment tapers in a proximal direction for the purpose of minimize or avoid a substantial change in stiffness. See paragraph [0123].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the trailing segment to taper in a proximal direction in order to minimize or avoid a substantial change in stiffness, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,030,503 (Clark, III) in view of U.S. Patent Publication Number 2006/0135962 (Kick et al.) as applied to claim 6 above, and further in view of U.S. Patent Publication Number 2006/0135962 (Kick et al.)
Regarding claim 7, Clark, III fails to disclose the proximal surface inclines radially outwardly in a proximal direction to define a proximally opening undercut.
Zhang et al., from the same field of endeavor teaches a similar tool as shown in Figures 11, 11a where a proximal surface similar to the helical thread disclosed by Clark, III (used to clear obstructions in vasculature) with a proximal surface that inclines radially outwardly in a proximal direction to define a proximally opening undercut (undercut 41C, see paragraph [0059]) for the purpose of directing particles of material in the proximal direction. See paragraph [0059].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Clark, III such that the proximal surface inclines radially outwardly in a proximal direction to define a proximally opening undercut taught by Zhang et al. such that the proximal surface defines a proximally opening undercut in order to direct particles removed by the helical thread in a proximal direction, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1, 3-13, 16-38 have been considered but are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771