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 .
Response to Amendment
The Amendment filed 10/29/25 has been entered. Claims 1, 10, 15 and 20 are amended. Claims 9 and 18 are canceled. Claims 1- 8, 10- 17 and 19- 20 are being addressed by this Office Action.
Response to Arguments
Applicant’s Amendment has obviated the objection to claims 17 and 20 made in the Non-Final Office Action, mailed 7/30/25, and as such, the objection to claims 17 and 20 made in the Non-Final Office Action, mailed 7/30/25 are withdrawn.
Applicant's arguments filed 10/29/25 regarding the rejection of claims 1- 3, 5- 8 and 10- 14 under 35 U.S.C. 103 as being unpatentable over Vale in view of Behl have been fully considered but they are not persuasive. The Office acknowledges that applicant amended claim 1 to include, verbatim, the substance of canceled claim 9. Claim 9 had previously been rejected under 35 U.S.C. 103 as being unpatentable over Vale in view of Behl and Macoviak. It is noted that the amendment to claim 1, changed the scope of the claim for claims 2- 8, which previously did not require the substance of claim 9.
Further, it is noted that “wherein the distal portion of the catheter comprises a coiled core and a proximal portion of the catheter comprises a braided core” is entirely new to independent claim 10, requiring a new rejection for claims 10- 14.
Regarding to the amendment to independent claim 15, “wherein the distal region comprises a coiled core and the proximal region comprises a braided core” does not incorporate, verbatim, the substance of canceled claim 18, and as such, has changed the scope of claims 15- 17 and 19- 20, requiring a new rejection.
Applicant’s argument that Vale in view of Behl and Macoviak does not teach or suggest canceled claim 9, “wherein the distal portion of the delivery microcatheter comprises a coiled core and the proximal portion of the delivery microcatheter comprises a braided core” such that the rejection of amended claim 1 should be withdrawn is not persuasive. Since the Macoviak reference speaks for itself, the rejection of claim 1 is maintained.
Macoviak teaches “Suitable materials for the tubular body 104 include, but are not limited to, polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides (nylons), and alloys or copolymers thereof, as well as braided, coiled or counterwound wire or filament reinforced composites.” The Office respectfully submits that this sentence teaches that suitable materials include a) several types of polymers and/or a combination of the polymers AND b) three types of wire or filament reinforcement. That is to say, the second clause of this sentence teaches:
1) braided wire or filament reinforcement,
2) coiled wire or filament reinforcement, or
3) counterwound wire or filament reinforcement.
Applicant’s argument that Macoviak teaches that braided and coiled are taught in the alternative only is inapposite because the broadest reasonable interpretation of the third option of “counterwound wire or filament” is in fact a combination of being braided and coiled such that the requirements of the claim have been met. In order to form a cylindrical tube of counterwoven wire or filament, a helical coil wire or filament must be wound in one direction and then wound in the opposite direction such that the overlapping helical coil wire or filament forms a non-woven braid.
Support for the broadest reasonable interpretation can be found in Ju et al. (US Pat. No. 6,217,566), which teaches a catheter reinforced with counterwoven wire: “ It is within the scope of this invention that braid (140) (in FIG. 4A) may be simply a pair of counter-woven helically wound coils such as described as a non-woven braid.” (See Fig. 4A below) (Col. 10, l. 5- 8):
PNG
media_image1.png
472
436
media_image1.png
Greyscale
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.
Claim(s) 1- 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al. (US Pub. No. 2017/0071614 A1) in view of Behl et al. (US Pub. No. 2011/0172678 A1) and Macoviak et al. (US Pub. No. 2002/0143362 A1). Vale and Behl are cited in the Non-Final Office Action, mailed 7/30/25. Macoviak is cited in the IDS filed 12/01/22.
Regarding claim 1, claim 2, claim 3 and claim 5, Vale discloses a clot removal assembly, comprising:
a delivery microcatheter (1053, 1103) (Figs. 30, 33) (Ps. [0175], [0177], [0178] - - microcatheter 1053 can be forwarded again to partially resheath the device 1051 and generate a pinch on the clot between the distal tip of the microcatheter and the struts; microcatheter 1103 can be forwarded to resheath the device 1102 until the physician feels a resistance to movement indicating that the clot has been pinched in the device; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200, which is being used for this rejection) comprising:
a distal portion (See Figs. 30, 33) and
a proximal portion;
a cage structure (1200) (Fig. 34) configured to transform between a delivery configuration and an expanded pinching configuration (Fig. 34) (Ps. [0002], [0003], [0178] - - the expandable structure having a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration; the expandable structure comprises a clot pinching structure which is configured to pinch clot on movement from the deployed configuration to the clot pinching configuration; device 1200 incorporates a helical tubular component 1205 which can be used to generate a pinch on the clot by partial resheathing with the microcatheter as described previously; it is noted that Vale refers to the helical tubular component shown in FIGS. 29 to 33 and Ps. [0174]- [0177]) to describe generating a pinch on the clot by partial resheathing with the microcatheter); and
a shaft (1210) (Fig. 34) in communication with the cage structure (1200) and substantially disposed within the delivery microcatheter (1053, 1103) (Ps. [0002], [0003]- - the expandable structure having a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration; the expandable structure comprises a clot pinching structure which is configured to pinch clot on movement from the deployed configuration to the clot pinching configuration),
wherein there is an impingement of the cage structure (1200) on the delivery microcatheter (1053, 1103) (Ps. [0002], [0003], [0178] - - the expandable structure having a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration; the expandable structure comprises a clot pinching structure which is configured to pinch clot on movement from the deployed configuration to the clot pinching configuration;
device 1200 incorporates a helical tubular component 1205 which can be used to generate a pinch on the clot by partial resheathing with the microcatheter as described previously; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200, which is being used for this rejection).
Vale further disclosing that the clot retrieval device is configured to provide a flow path for oxygenated, nutrient carrying blood to reach the ischaemic area distal of the clot (P. [0135]), but Vale does not explicitly disclose
(claim 1, claim 2 and claim 3) wherein the microcatheter has substantially straight state and a substantially wavy state as claimed;
(claim 1, claim 2, claim 3 and 5) wherein the microcatheter has an elongate radiopaque indicator as claimed.
(claim 1) wherein the distal portion of the delivery microcatheter comprises a coiled core and the proximal portion of the delivery microcatheter comprises a braided core as claimed.
However, Behl teaches a catheter (182, 190) (Figs. 12C, 12D) for “decompressing” or creating a flow path through a blockage in a lumen (P. [0010])
(claim 1) the catheter (182, 190) and tension member (184, 186) configured to transform between a substantially straight non-indicating state (Fig. 12C) and a substantially wavy indicating state (12D) responsive to an impingement on the catheter (182, 190) (P. [0059] - - Apparatus 180 is a guidewire structure having an outer coil 182 and an inner core wire 184. The inner core wire 184 has an actuator grip 186 at its proximal end and is attached to a flexible tip 188, …A generally tubular film structure 190 is attached at its proximal end 192 to the shaft 182 and at its distal end 194 to the flexible tip 188. Thus, by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D);
(claim 2) the catheter (182, 190) and tension member (184, 186) configured to transform between the substantially straight non-indicating state (12C) and the substantially wavy indicating state (12D) responsive to a proximally directed pulling force by the tension member (184, 186) (P. [0059] - - by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D);
(claim 3) the catheter (182, 190) and tension member (184, 186) configured to transform between the substantially straight non-indicating state (12C) and the substantially wavy (12D) indicating state responsive to a distally directed pushing force applied to the catheter (182, 190) (P. [0059] - - by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D; it is noted that since catheter (182, 190) and tension member (184, 186) are adapted to slide relative to each other, flexible tip 188 is capable of being held steady while the grip 186 is pushed distally in order transform into the substantially wavy indicating state).
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 modify the microcatheter and shaft associated with the cage structure of the clot removal assembly disclosed by Vale such that the microcatheter is configured to transform between a substantially straight non-indicating state and a substantially wavy indicating state responsive to an impingement of the cage structure (via the shaft being pulled proximally or pushed distally) according to the teachings of Behl because it would decompress a blockage in the body lumen (Behl - - Ps. [0010], [0014], [0016]).
Behl further disclosing that in the embodiment of Figs. 12C, 12D, a flat sheet is heat-sealed around the core wire (184) forming the distal region (190) such that, when compressed, the expanded structure of the distal region (190) looks like a series of layered rectangular pieces, as shown in Fig. 12D (P. [0059]), but Modified Vale does not explicitly disclose
(claim 1, claim 2, claim 3 and 5) wherein the microcatheter has an elongate radiopaque indicator as claimed.
However, Behl further teaches that the embodiments in Figs. 4G and 4H disclose flat sheets (55, 59) that when compressed, the expanded structure look like a series of layered rectangular pieces (P. [0050]) including
(claim 1, claim 2 and claim 3) a distal portion elongate radiopaque indicator (57, 61) (Figs. 4G, 4H) configured to transform between a substantially straight non-indicating state and a substantially wavy indicating state (P. [0050] - - it will often be desirable to coat, imprint, laminate, or otherwise provide a layer or pattern of radiopaque material on at least one surface of the anchor. As shown in FIG. 4G, a length of material 55 is laminated to a layer of gold foil 57 over substantially its entire surface. It will be appreciated that when the length of material 55 folds into its compacted configuration, the gold foil will be layered to greatly enhance the radiopacity of the anchor structure. As shown in FIG. 4H, a similar length of material 59 has a radiopaque ink pattern 61 formed over a surface thereof…when the length of material is folded or otherwise compacted, the radiopacity of the resulting anchor structure will be greatly enhanced as the layers of radiopaque ink are superimposed upon one another);
(claim 5) wherein the elongate radiopaque indicator (57, 61) comprises a radiopaque coating (P. [0050] - - it will often be desirable to coat, imprint, laminate, or otherwise provide a layer or pattern of radiopaque material on at least one surface of the anchor).
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 modify Vale in view of the embodiment shown in Figs. 12C, 12D in order to include a radiopaque indicator taught in the embodiments of Fig. 4G or 4H because it would allow the folded and compacted configuration to greatly enhance the radiopacity in the substantially wavy indicating state of the microcatheter associated with Vale (Behl - - P. [0050]). Furthermore, 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 modify Vale in view of the embodiment of Figs. 12C, 12D to include the radiopaque indicator features of the embodiments of 4G or 4H because such modifications were contemplated by the Behl reference (P. [0065] - - While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used).
Modified Vale does not explicitly disclose
(claim 1) wherein the distal portion of the delivery microcatheter comprises a coiled core and the proximal portion of the delivery microcatheter comprises a braided core.
However, Macoviak teaches catheters (800) (Fig. 18) used in capturing emboli in the cerebral circulation (Abstract)
(claim 1) Wherein the elongated catheter shaft (802) (Fig. 18) of the catheter (800) is preferably formed of a flexible thermoplastic material, a thermoplastic elastomer, or a thermoset elastomer. Suitable materials for use in the elongated catheter shaft (802) include, but are not limited to, polyvinylchloride, polyurethane, polyethylene, polyamides, polyesters, silicone, latex, and alloys or copolymers thereof, as well as braided, coiled or counter wound wire or filament reinforced composites. Additionally or alternatively, the elongated catheter shaft 802 may be constructed using metallic tubing or a solid wire, for example stainless steel hypodermic tubing or wire or superelastic nickel-titanium alloy tubing or wire (Macoviak - - P. [0062]).
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 provide a composite of different reinforcing materials in different portions of the catheter according to the teachings of Macoviak (P. [0062]), since the modification would have yielded predictable results, namely, reinforcing the catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
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 a coiled filament wire reinforcement taught by Macoviak (P. [0062]) for the braid structure distal end associated with Vale in view of Behl, since the substitution would have yielded predictable results, namely, reinforcing the catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
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 a braided filament wire reinforcement taught by Macoviak (P. [0062]) for the outer coil proximal end associated with Vale in view of Behl, since the substitution would have yielded predictable results, namely, reinforcing the catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 4, Vale in view of Behl discloses the apparatus of claim 1, Behl further teaching that the elongate radiopaque indicator comprises gold (Behl - - P. [0050]), but Vale in view of Behl does not explicitly disclose
(claim 4) wherein the elongate radiopaque indicator comprises a tungsten doped portion of the distal portion.
However, Macoviak teaches catheters (800) (Fig. 18) used in capturing emboli in the cerebral circulation (Abstract)
(claim 4) wherein the elongate radiopaque indicator (816) (Fig. 18) comprises a tungsten doped portion of the distal portion (P. [0062] - - For example, in the illustrative embodiment shown in FIG. 18, a radiopaque location marker 816 is positioned near the distal end 806 of the catheter shaft 802, and another near the proximal end of the flow divider 810, to assist in positioning the flow divider 810 within the aortic arch. The radiopaque location markers 816 may be formed as a ring or disk of dense radiopaque metal such as gold, platinum, tantalum, tungsten, or compounds or alloys thereof, or a ring of a polymer or adhesive material heavily loaded with a radiopaque filler material).
The tungsten radiopaque indicator (816) taught by Macoviak performs the same function of enhancing imaging of the catheter during deployment using standard fluoroscopy, ultrasound, MRI, MRA, transesophageal echocardiography, or other techniques (Macoviak - - P. [0062]) as the gold radiopaque indicator associated with Vale in view of Behl (Behl - - P. [0050]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (tungsten radiopaque indicator) for another (gold radiopaque indicator) since the substitution would have yielded predictable results, namely, enhancing imaging of the catheter during deployment using standard fluoroscopy, ultrasound, MRI, MRA, transesophageal echocardiography, or other techniques. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 6, Vale in view of Behl and Macoviak discloses the apparatus of claim 1, Vale further disclosing wherein the cage structure (1200) further comprises a distal section (1201, 1250) (Figs. 34, 35a) and a proximal spiral section (1205, 1207) (Figs. 34) (Ps. [0178], [0179] - - device 1200 incorporates a helical tubular component 1205 which can be used to generate a pinch on the clot by partial resheathing with the microcatheter as described previously; proximal section of the helical tube 1207; it is noted that the proximal section 1207 of helical tube 1205 pinches on clot during partial resheathing with the microcatheter), the distal section (1201, 1250) comprising a first plurality of struts and the proximal spiral section (1207) comprising a second plurality of struts smaller than the first plurality of struts (See Figs. 34 and 35a - -showing smaller struts in the proximal section 1205, 1207).
Regarding claim 7, Vale in view of Behl and Macoviak discloses the apparatus of claim 6, Vale further disclosing wherein a first end of the first plurality of struts abuts the second plurality of struts (See Fig. 34) (P. [0178] - - helical component 1205 also provides additional radial force to the inner surface of the outer cage 1201; it is noted that spiral section (1205, 1207) pushes against or abuts the distal section (1201, 1250)) and a second end of the first plurality of struts terminates in a plurality of atraumatic unions (See Fig. 34 - - it is noted that the plurality of atraumatic unions disclosed by Vale is similar to applicant’s atraumatic unions 144 shown in applicant’s Fig. 2).
Regarding claim 8, Vale in view of Behl and Macoviak discloses the apparatus of claim 1, Vale further disclosing wherein the cage structure (1200) comprises a proximal spiral section (1205, 1207) (Fig. 34), a cylindrical body section (1201, 1250) (Figs. 34, 35a) distal of the proximal spiral section (1205, 1207) (Ps. [0178], [0179] - - device 1200 incorporates a helical tubular component 1205 which can be used to generate a pinch on the clot by partial resheathing with the microcatheter as described previously; proximal section of the helical tube 1207; it is noted that at least the proximal section 1207 of helical tube 1205 is proximal of the cylindrical body section (1201, 1250)), and an open distal end (See Figs. 34, 35a), wherein the proximal spiral section (1207) is configured to pinch a clot between struts of the proximal spiral section (1207) (Ps. [0178], [0179] - - the outer cage 1201 … can be positioned inside or outside of the proximal section of the helical tube 1207. To generate a pinch on the clot with this device, it can be partially resheathed with a microcatheter, diagnostic or intermediate catheter until the physician feels a resistance to pushing the catheter any further distal over the device. At this point the physician knows he has a successful pinch and the catheter and device can be removed with the clot as a unit; it is noted that Vale refers to the helical tubular component shown in FIGS. 29 to 33 and Ps. [0174]- [0177]) to describe generating a pinch on the clot by partial resheathing with the microcatheter).
Claim(s) 10- 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al. (US Pub. No. 2017/0071614 A1) in view of Behl et al. (US Pub. No. 2011/0172678 A1) and Macoviak et al. (US Pub. No. 2002/0143362 A1) as evidenced by Ju et al. (US Pat. No. 6,217,566).
Regarding claim 10 and claim 14, Vale discloses a method of treatment for an embolism, the method comprising:
deploying at least a part of a cage structure (1200) (Fig. 34) of a clot retrieval assembly across a clot (1052, 1101) (Figs. 30, 33) and distal in relation to a catheter (1053, 1103) (Figs. 30, 33) (Ps. [0175], [0177], [0178] - - microcatheter 1053 can be forwarded again to partially resheath the device 1051 and generate a pinch on the clot between the distal tip of the microcatheter and the struts; microcatheter 1103 can be forwarded to resheath the device 1102 until the physician feels a resistance to movement indicating that the clot has been pinched in the device; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200 in the manner shown in Figs. 29- 33);
applying a tension to a shaft (1002, 1210) (Figs. 29, 34) attached to a proximal section of the cage structure (1200) (P. [0178] - -The helical tubular component shown in FIGS. 29 to 33 is particularly good at generating a pinch on clots which are difficult to dislodge and retrieve from the vessel such as organised clots with a moderate to high fibrin content. FIG. 34 shows a device 1200 which can be used for dislodgement and retention of all clot types; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200 in the manner shown in Figs. 29- 33);
pinching the clot (1052, 1101) between the cage structure (1200) and a distal end of the catheter (1053, 1103) (Ps. [0175], [0177]- - microcatheter 1053 can be forwarded again to partially resheath the device 1051 and generate a pinch on the clot between the distal tip of the microcatheter and the struts; microcatheter 1103 can be forwarded to resheath the device 1102 until the physician feels a resistance to movement indicating that the clot has been pinched in the device); and
extracting the clot (1052, 1101), the cage structure (1200), and the catheter (1053, 1103) (P. [0177], [0178] - - The microcatheter 1103, device 1102 and clot 1101 can then be removed simultaneously while maintaining the pinch between the device and clot; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200 in the manner shown in Figs. 29- 33).
Vale further disclosing that the clot retrieval device is configured to provide a flow path for oxygenated, nutrient carrying blood to reach the ischaemic area distal of the clot (P. [0135]), but Vale does not explicitly disclose
(claim 10) wherein the microcatheter has substantially straight state and a substantially wavy state as claimed;
(claim 10 and 14) wherein the microcatheter has an elongate radiopaque indicator as claimed;
(claim 10) wherein the distal portion of the catheter comprises a coiled core and a proximal portion of the catheter comprises a braided core as claimed.
However, Behl teaches a catheter (182, 190) (Figs. 12C, 12D) for “decompressing” or creating a flow path through a blockage in a lumen (P. [0010])
(claim 10) transforming the catheter (182, 190) and tension member (184, 186) from a first substantially straight non-indicating state (Fig. 12C) to a second substantially wavy indicating state (12D) by impinging on the catheter (182, 190) (P. [0059] - - Apparatus 180 is a guidewire structure having an outer coil 182 and an inner core wire 184. The inner core wire 184 has an actuator grip 186 at its proximal end and is attached to a flexible tip 188, …A generally tubular film structure 190 is attached at its proximal end 192 to the shaft 182 and at its distal end 194 to the flexible tip 188. Thus, by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D).
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 modify the step of pinching the clot between the cage structure (1200) and a distal end of the catheter (1053, 1103) disclosed by Vale such that the microcatheter transforms from a first substantially straight non-indicating state to a second substantially wavy indicating state responsive to an impingement of the cage structure (via the shaft being pulled proximally or pushed distally) according to the teachings of Behl because it would decompress a blockage in the body lumen (Behl - - Ps. [0010], [0014], [0016]).
Behl further disclosing that in the embodiment of Figs. 12C, 12D, a flat sheet is heat-sealed around the core wire (184) forming the distal region (190) such that, when compressed, the expanded structure of the distal region (190) looks like a series of layered rectangular pieces, as shown in Fig. 12D (P. [0059]), but Modified Vale does not explicitly disclose
(claim 10 and claim 14) wherein the microcatheter has an elongate radiopaque indicator as claimed.
However, Behl further teaches that the embodiments in Figs. 4G and 4H disclose flat sheets (55, 59) that when compressed, the expanded structure look like a series of layered rectangular pieces (P. [0050]) including
(claim 10) a distal portion elongate radiopaque indicator (57, 61) (Figs. 4G, 4H) transforming from a first substantially straight non-indicating state to a second substantially wavy indicating state (P. [0050] - - it will often be desirable to coat, imprint, laminate, or otherwise provide a layer or pattern of radiopaque material on at least one surface of the anchor. As shown in FIG. 4G, a length of material 55 is laminated to a layer of gold foil 57 over substantially its entire surface. It will be appreciated that when the length of material 55 folds into its compacted configuration, the gold foil will be layered to greatly enhance the radiopacity of the anchor structure. As shown in FIG. 4H, a similar length of material 59 has a radiopaque ink pattern 61 formed over a surface thereof…when the length of material is folded or otherwise compacted, the radiopacity of the resulting anchor structure will be greatly enhanced as the layers of radiopaque ink are superimposed upon one another);
(claim 14) wherein the visualizing the second substantially wavy state comprises using fluoroscopic imaging techniques (Ps. [0006], [0050] - - an operating room where anesthesia and fluoroscopic imaging are available; It will be appreciated that when the length of material 55 folds into its compacted configuration, the gold foil will be layered to greatly enhance the radiopacity of the anchor structure. As shown in FIG. 4H, a similar length of material 59 has a radiopaque ink pattern 61 formed over a surface thereof…Again, when the length of material is folded or otherwise compacted, the radiopacity of the resulting anchor structure will be greatly enhanced as the layers of radiopaque ink are superimposed upon one another).
Given that the second substantially wavy state greatly enhances the radiopacity of the device and given that an operating room where fluoroscopic imaging is available is contemplated, 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 modify the method step of transforming the microcatheter to include the step of visualizing the second substantially wavy indicating state because it fluoroscopy is a known method for predictably imaging radiopaque indicators.
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 modify Vale in view of the embodiment shown in Figs. 12C, 12D in order to include a radiopaque indicator taught in the embodiments of Fig. 4G or 4H because it would allow the folded and compacted configuration to greatly enhance the radiopacity in the substantially wavy indicating state of the microcatheter associated with Vale (Behl - - P. [0050]). Furthermore, 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 modify Vale in view of the embodiment of Figs. 12C, 12D to include the radiopaque indicator features of the embodiments of 4G or 4H because such modifications were contemplated by the Behl reference (P. [0065] - - While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used).
Modified Vale does not explicitly disclose
(claim 10) wherein the distal portion of the catheter comprises a coiled core and a proximal portion of the catheter comprises a braided core as claimed.
However, Macoviak teaches catheters (800) (Fig. 18) used in capturing emboli in the cerebral circulation (Abstract)
(claim 10) wherein the distal portion of the catheter comprises a coiled core and a proximal portion of the catheter comprises a braided core as claimed (P. [0039] - - Suitable materials for the tubular body 104 include, but are not limited to, polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides (nylons), and alloys or copolymers thereof, as well as braided, coiled or counterwound wire or filament reinforced composites).
It is noted that the broadest reasonable interpretation of the third option of “counterwound wire or filament” is in fact a combination of being braided and coiled. In order to form a cylindrical tube of counterwoven wire or filament, a helical coil wire or filament must be wound in one direction and then wound in the opposite direction such that the overlapping helical coil wire or filament forms a non-woven braid.
Support for the broadest reasonable interpretation can be found in Ju et al. (US Pat. No. 6,217,566), which teaches a catheter reinforced with counterwoven wire: “ It is within the scope of this invention that braid (140) (in FIG. 4A) may be simply a pair of counter-woven helically wound coils such as described as a non-woven braid.” (See Fig. 4A below) (Col. 10, l. 5- 8):
PNG
media_image1.png
472
436
media_image1.png
Greyscale
Since braided and coiled wire extending along the entire length of the catheter allows for both a distal portion of the catheter comprising a coiled core and a proximal portion of the catheter comprising a braided core, the requirements of the claim have been met.
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 modify the catheter associated with Vale and Behl to include both a distal portion of the catheter comprising a coiled core and a proximal portion of the catheter comprising a braided core according to the teachings of Macoviak because it would provide for reinforcement of the catheter (Macoviak - - P. [0062]).
Regarding claim 11, Vale in view of Behl and Macoviak discloses the method of claim 10, Vale further disclosing further comprising: moving the cage structure (1200) to pin the clot (1052, 1101) between the cage structure (1200) and an inner wall of a blood vessel (See Figs. 30, 33) (Ps. [0175], [0177], [0178] - - the microcatheter 1053 can be forwarded again to partially resheath the device 1051 and generate a pinch on the clot between the distal tip of the microcatheter and the struts and crowns of the device 1051 as described elsewhere in this specification; FIG. 33 shows a helical tubular component 1102 deployed in a clot 1101 which is located in a bifurcation of the anatomical vessels 1100. The microcatheter 1103 can be forwarded to resheath the device 1102 until the physician feels a resistance to movement indicating that the clot has been pinched in the device; The helical tubular component shown in FIGS. 29 to 33 is particularly good at generating a pinch on clots which are difficult to dislodge and retrieve from the vessel such as organised clots with a moderate to high fibrin content. FIG. 34 shows a device 1200 which can be used for dislodgement and retention of all clot types).
Regarding claim 12, Vale in view of Behl and Macoviak discloses the method of claim 10, Vale further disclosing wherein the clot (1052, 1101) comprises a majority of fibrin (Ps. [0141], [0191] - - This invention is particularly suited to the dislodgement and retraction of clots which have a high fibrin content (typically higher than 40% fibrin content) ; the device is effective at dislodging and retaining fibrin rich and red blood cell rich clots; fibrin rich clots are broadly interpreted as a majority of fibrin).
Regarding claim 13, Vale in view of Behl and Macoviak discloses the method of claim 12, Vale further disclosing further comprising: extracting the clot (1052, 1101) from a distal M2, M3, M4, A2-5, or P2-P5 vessel (Ps. [0001], [0175], [0177], [0178] - - The invention is particularly suited to removing clot from cerebral arteries in patients suffering acute ischemic stroke (AIS); This is shown in FIG. 30 where the spiral device 1051 is deployed within the clot 1052 in the neurovascular vessels 1050; The microcatheter 1103, device 1102 and clot 1101 can then be removed simultaneously while maintaining the pinch between the device and clot; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200 in the manner shown in Figs. 29- 33; it is further noted that a distal M2, M3, M4, A2-5, or P2-P5 vessel are cerebral arteries and/or neurovasculature vessels).
Claim(s) 15- 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behl et al. (US Pub. No. 2011/0172678 A1) and Macoviak et al. (US Pub. No. 2002/0143362 A1) as evidenced by Ju et al. (US Pat. No. 6,217,566).
Regarding claim 15, Behl discloses a catheter (182, 190) (Figs. 12C, 12D) comprising:
a proximal region (182) extending over a majority of a length of the catheter (182, 190);
a distal region (190) extending distally from the proximal region (182); and
wherein the catheter (182, 190) is configured such that a compressive force applied at a distal end of the catheter results in a controlled movement of the distal region (190) from a substantially straight uncompressed configuration (Fig. 12C) to a wavy compressed configuration (Fig. 12D).
The embodiment in Figs. 12C and 12D does not explicitly disclose
(claim 15) wherein the microcatheter has an elongate radiopaque indicator as claimed;
(claim 15) wherein the distal region comprises a coiled core and the proximal region comprises a braided core as claimed.
However, Behl further teaches that the embodiments in Figs. 4G and 4H disclose flat sheets (55, 59) that when compressed, the expanded structure look like a series of layered rectangular pieces (P. [0050]) including
(claim 15) a radiopaque indicator (57, 61) (Figs. 4G, 4H) configured to transform between a substantially straight uncompressed configuration to a wavy compressed configuration (P. [0050] - - it will often be desirable to coat, imprint, laminate, or otherwise provide a layer or pattern of radiopaque material on at least one surface of the anchor. As shown in FIG. 4G, a length of material 55 is laminated to a layer of gold foil 57 over substantially its entire surface. It will be appreciated that when the length of material 55 folds into its compacted configuration, the gold foil will be layered to greatly enhance the radiopacity of the anchor structure. As shown in FIG. 4H, a similar length of material 59 has a radiopaque ink pattern 61 formed over a surface thereof…when the length of material is folded or otherwise compacted, the radiopacity of the resulting anchor structure will be greatly enhanced as the layers of radiopaque ink are superimposed upon one another).
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 modify the embodiment shown in Figs. 12C, 12D in order to include a radiopaque indicator taught in the embodiments of Fig. 4G or 4H such that the radiopaque indicator extends over at least a portion of a length of the distal region of the catheter wherein the radiopaque indicator is configured to indicate a configuration of the distal region because it would allow the folded and compacted configuration to greatly enhance the radiopacity in the substantially wavy indicating state of the microcatheter associated with the embodiment of Figs. 12C and 12D (Behl - - P. [0050]). Furthermore, 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 modify the embodiment of Figs. 12C, 12D to include the radiopaque indicator features of the embodiments of 4G or 4H because such modifications were contemplated by the Behl reference (P. [0065] - - While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used).
Modified Behl does not explicitly disclose
(claim 15) wherein the distal region comprises a coiled core and the proximal region comprises a braided core as claimed.
However, Macoviak teaches catheters (800) (Fig. 18) used in capturing emboli in the cerebral circulation (Abstract)
(claim 15) wherein the distal region comprises a coiled core and the proximal region comprises a braided core (P. [0039] - - Suitable materials for the tubular body 104 include, but are not limited to, polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides (nylons), and alloys or copolymers thereof, as well as braided, coiled or counterwound wire or filament reinforced composites).
It is noted that the broadest reasonable interpretation of the third option of “counterwound wire or filament” is in fact a combination of being braided and coiled. In order to form a cylindrical tube of counterwoven wire or filament, a helical coil wire or filament must be wound in one direction and then wound in the opposite direction such that the overlapping helical coil wire or filament forms a non-woven braid.
Support for the broadest reasonable interpretation can be found in Ju et al. (US Pat. No. 6,217,566), which teaches a catheter reinforced with counterwoven wire: “ It is within the scope of this invention that braid (140) (in FIG. 4A) may be simply a pair of counter-woven helically wound coils such as described as a non-woven braid.” (See Fig. 4A below) (Col. 10, l. 5- 8):
PNG
media_image1.png
472
436
media_image1.png
Greyscale
Since braided and coiled wire extending along the entire length of the catheter allows for both a distal region of the catheter comprising a coiled core and a proximal region of the catheter comprising a braided core, the requirements of the claim have been met.
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 modify the catheter associated with Vale and Behl to include both a distal region of the catheter comprising a coiled core and a proximal region of the catheter comprising a braided core according to the teachings of Macoviak because it would provide for reinforcement of the catheter (Macoviak - - P. [0062]).
Regarding claim 16, Behl in view of Macoviak discloses the apparatus of claim 15, Behl further disclosing wherein the proximal region (182) is configured to remain in a substantially straight configuration as the compressive force is applied at the distal end of the catheter (182, 190) and the distal region (190) is moved to the wavy compressed configuration (See Fig. 12D) (P. [0059] - - A generally tubular film structure 190 is attached at its proximal end 192 to the shaft 182 and at its distal end 194 to the flexible tip 188. Thus, by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D).
Regarding claim 17, Behl in view of Macoviak discloses the apparatus of claim 15, Behl further disclosing discloses wherein the catheter (182, 190) is configured such that the compressive force applied to a majority of the length of the catheter (182, 190) results in the proximal region (182) remaining in a substantially straight configuration and the distal region moving to the wavy compressed configuration (See Fig. 12D) (P. [0059] - - A generally tubular film structure 190 is attached at its proximal end 192 to the shaft 182 and at its distal end 194 to the flexible tip 188. Thus, by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in FIG. 12D).
Claim(s) 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behl et al. (US Pub. No. 2011/0172678 A1) and Macoviak et al. (US Pub. No. 2002/0143362 A1) as applied to claim 15 above, and in further view of Vale et al. (US Pub. No. 2017/0071614 A1).
Regarding claims 19- 20, Behl in view of Macoviak discloses the apparatus of claim 15, Behl further disclosing using the catheter for “decompressing” or creating a flow path through a blockage in a lumen (P. [0010]), Behl also disclosing an inner core wire 184 having an actuator grip 186 at its proximal end and is attached to a flexible tip 188, typically formed from polyurethane or other soft polymer, at its distal end wherein, by pulling proximally on the grip 186, the flexible tip 188 will be pulled toward the shaft 182, thus compressing the tubular structure 190, as shown in Fig. 12D (P. [0059]), but Behl does not disclose
(claim 19) wherein the catheter is configured to deliver a clot retrieval device across a clot;
(claim 20) wherein the catheter is configured to pinch the clot between a distal end of the catheter and the clot retrieval device.
However, Vale teaches a clot retrieval device configured to provide a flow path for oxygenated, nutrient carrying blood to reach the ischaemic area distal of the clot (P. [0135])
(claim 19) wherein the catheter (1053, 1103) (Figs. 30, 33) is configured to deliver a clot retrieval device (1200) (Fig. 34) across a clot (1052, 1101) (Figs. 30, 33) (Ps. [0177], [0182] - - The microcatheter 1103, device 1102 and clot 1101 can then be removed simultaneously while maintaining the pinch between the device and clot; In addition to the pinch capability of this component, it also provides inner channel functionality such as; immediate restoration of blood flow on deployment, breaking the pressure gradient across the clot, facilitating contrast flow and distal visualisation and acting as an aspiration channel for distal emboli);
(claim 20) wherein the catheter (1053, 1103) is configured to pinch the clot between a distal end of the catheter (1053, 1103) and the clot retrieval device (1200) (Fig. 34) (Ps. [0175], [0177], [0178] - - microcatheter 1053 can be forwarded again to partially resheath the device 1051 and generate a pinch on the clot between the distal tip of the microcatheter and the struts; microcatheter 1103 can be forwarded to resheath the device 1102 until the physician feels a resistance to movement indicating that the clot has been pinched in the device; it is noted that partial resheathing microcatheters 1053, 1103 can be similarly used with cage structure 1200, which is being used for this rejection).
The clot retrieval device taught by Vale performs the same function of “decompressing” or creating a flow path through a blockage in a lumen as the flexible tip 188 associated with Behl in view of Macoviak. Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (clot retrieval device) for another (flexible tip 188) since the substitution would have yielded predictable results, namely, creating a flow path through a blockage in a lumen. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Parker et al. (US Pub. No. 2010/0049168 A1) discloses a catheter having dual reinforcing elements. The first reinforcing element comprises a braid the second reinforcing element comprises a coil. The braid is positioned at the proximal portion of the inner liner and extends distally therefrom. The coil is positioned at the distal portion longitudinally adjacent the braid.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KANKINDI RWEGO/Primary Examiner, Art Unit 3771