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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 136-146, 148-150 and 156-160 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the examiner found support for a helical corrugation with a varying depth (PG Pug ¶157), no support was found for a plurality of helical corrugations, only a singular helical corrugation.
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) 136- 141 and 156-160 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randolph et al (US 6,021,340) in view of Kaufman et al (US 4,516,970) and Berg (US 6,858,024).
Regarding claim 136, Randolph discloses a catheter (fig 9), comprising: a sheath 13 having a smooth outer surface (fig 9) and having a first stiffness (reference claim 6); an expandable member 36 attached to a distal end of the sheath (fig 9; intermediate section is 64 and the expandable member is in the intermediate section as per claim 11; intermediate section is considered part of distal end as per fig 9); and a distal tip (18 and whatever section of intermediate section 64 extends distally from the balloon, if any) extending from a distal end of the expandable member, wherein the distal tip includes a distal section having a second stiffness that is less than the first stiffness (reference claim 8 – the intermediate section has a flexibility that is greater than the proximal shaft section and distal section is even more flexible than intermediate section), wherein a length of the distal tip is essentially approximately 3 cm to approximately 15 cm (distal end/section being 5-13 cm as per claim 5 and the intermediate section being about 1-8 cm as per claim 10; such that it is considered to significantly overlap with “approximately” 3 cm to “approximately” 15 cm) wherein the expandable member is attached to the sheath and to the distal section of the distal tip (fig 9, when the expandable member is part of the intermediate section), and wherein the expandable member is configured to inflate to block blood flow (Col.3 ll 27-30) before aspiration of a clot via the catheter (intended use, device is capable of such).
While Randolph substantially discloses the invention as claimed, it does not disclose the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section.
Kaufman disclose a medical device (such as a catheter – abstract) which has a helical corrugation in the distal section (fig 4), the length and depth of the corrugation are chosen to customize the desired flexibility (Col.7 ll 42-51). It is unclear if “may have different depths” refers to a singular groove or different helical grooves as they vary among different devices.
Berg discloses a depth of a plurality of corrugations is different along a length of a catheter shaft to customize the flexibility (fig 11C and Col.9 ll 49-52).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section as taught by Kaufman (and reinforced by Berg) to further customize the flexibility/pushability of the device.
Regarding claim 137, wherein an outer diameter of the distal tip is different than an outer diameter of the sheath (a taper at the end 18).
Regarding claim 138, wherein an outer diameter of the distal tip is less than an outer diameter of the sheath (a taper on end of 18 is less than the end of the sheath).
Regarding claim 139, while Randolph substantially discloses the invention as claimed, it does not disclose a jacket including a first material; and an inner liner including a second material different from the first material, wherein the jacket and the inner liner each extend from the sheath to the distal tip.
Berg discloses a jacket/outer layer 74 formed over a support layer/sheath 72 and a liner/inner layer 70, the jacket being different material than the inner liner (Col.8 ll 66 – Col.9 ll 11).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that it comprises a jacket including a first material; and an inner liner including a second material different from the first material, wherein the jacket and the inner liner each extend from the sheath to the distal tip as taught by Berg to customize the flexibility and pushability of the device and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claim 140, while Randolph substantially discloses the invention as claimed, it does not disclose the sheath is formed of a first material and the corrugated proximal section is formed of a second material, and wherein the first material and the second material. The examiner takes the position that one of ordinary skill in the art that one of ordinary skill in the art would determine an appropriate material for each section as is consistent with the desire for decreased flexibility as one moves distally. It would have been obvious to one of ordinary skill in the art, at the time of filing, to utilize different materials for the sections with different flexibilites, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claim 141, while Randolph substantially discloses the invention as claimed, it is unclear if the expandable member is configured to remain in or proximal to a C1 segment of an internal carotid artery (ICA) while inflated, and the distal tip is configured to reach a distal ICA, a terminus of the ICA, a proximal M1 segment, a distal M1 segment, a proximal M2 segment, or a distal M2 segment while the expandable member is inflated.
The diameter of the catheter is less than 8 mm (being less than the diameter of the inflated balloon – Col.4 ll 42) and according to the American Heart Association the diameter of the ICA is about 4-6 mm.
Regardless, Randolph is drawn to a device which is customized to reach a specific body part.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that the expandable member is configured to remain in or proximal to a C1 segment of an internal carotid artery (ICA) while inflated, and the distal tip is configured to reach a distal ICA, a terminus of the ICA, a proximal M1 segment, a distal M1 segment, a proximal M2 segment, or a distal M2 segment while the expandable member is inflated as suggested by Randolph itself as part of design choice on customizing the device to reach a particular location.
Alternatively, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that the diameter of the catheter to be small (including less than 6 mm) to allow it to be used on smaller vasculature and further reduce the damage it inflicts as it is introduced.
Regarding claim 156, Randolph discloses a catheter (fig 9), comprising: a sheath 13 having a smooth outer surface (fig 7) and having a first stiffness (reference claim 5); an expandable member 36 attached to a distal end of the sheath (fig 9, expandable member is part of intermediate section 64 as per claim 11); and a distal tip 18 extending from a distal end of the expandable member (fig 9, expandable member is part of intermediate section 64 as per claim 11), wherein the distal tip includes a distal section and having a second stiffness that is less than the first stiffness (reference claim 8), wherein a length of the distal tip is approximately 3 cm to approximately 15 cm (distal end/section being 5-13 cm as per claim 5 and the intermediate section being about 1-8 cm as per claim 10; such that it is considered to significantly overlap with “approximately” 3 cm to “approximately” 15 cm), wherein the expandable member is attached to the sheath and to the corrugated distal section of the distal tip (fig 9, expandable member is part of intermediate section 64 as per claim 11), and wherein the expandable member is configured to inflate to block blood flow (Col.3 ll 27-30) before aspiration of a clot via the catheter (intended use, device is capable of such via lumen).
While Randolph substantially discloses the invention as claimed, it does not disclose the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section.
Kaufman disclose a medical device (such as a catheter – abstract) which has a helical corrugation in the distal section (fig 4), the length and depth of the corrugation are chosen to customize the desired flexibility (Col.7 ll 42-51). It is unclear if “may have different depths” refers to a singular groove or different helical grooves as they vary among different devices.
Berg discloses a depth of a plurality of corrugations is different along a length of a catheter shaft to customize the flexibility (fig 11C and Col.9 ll 49-52).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section as taught by Kaufman (and reinforced by Berg) to further customize the flexibility/pushability of the device.
Regarding claims 157-160, see claims 137, 138, 141 and 140 above.
Claim(s) 142-146 and 148-150 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randolph et al (US 6,021,340) in view of Kaufman et al (US 4,516,970), Berg (US 6,858,024) and Cribier et al (US 4,777,951).
Regarding claim 142, Randolph discloses a catheter (fig 9), comprising: a sheath 13 having a longitudinal axis, having a first stiffness (reference claim 5), and defining a lumen 34/62; an expandable member 36 (fig 9; intermediate section is 64 and the expandable member is in the intermediate section as per claim 11) that is configured to inflate to block blood flow (Col.3 ll 27-30) before aspiration of a clot via the catheter (intended use); a distal tip (18 and whatever section of intermediate section 64 extends from the balloon) extending from a distal end of the expandable member and including a distal section having a second stiffness that is less than the first stiffness (reference claim 8 – the intermediate section has a flexibility that is greater than the proximal shaft section and intermediate section has a flexibility less than the distal shaft section), wherein the expandable member is attached to the sheath and to the distal section of the distal tip (fig 9, expandable member is part of intermediate section 64 as per claim 11); wherein the expandable member includes a radially inner member and a radially outer member (fig 4), wherein the radially inner member is a portion of the sheath (fig 4), wherein the radially outer member includes a material having a flexibility greater than a flexibility of a material of the sheath (the expandable member is a balloon and designed to expand while the catheter does not collapse).
While Randolph substantially discloses the invention as claimed, it does not disclose the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section.
Kaufman disclose a medical device (such as a catheter – abstract) which has a helical corrugation in the distal section (fig 4), the length and depth of the corrugation are chosen to customize the desired flexibility (Col.7 ll 42-51). It is unclear if “may have different depths” refers to a singular groove or different helical grooves as they vary among different devices.
Berg discloses a depth of a plurality of corrugations is different along a length of a catheter shaft to customize the flexibility (fig 11C and Col.9 ll 49-52).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Randolph such that the distal tip includes a corrugated distal section including a plurality of helical corrugations, wherein a depth of the plurality of helical corrugations varies along the corrugated distal section as taught by Kaufman (and reinforced by Berg) to further customize the flexibility/pushability of the device.
Regarding claim 143, wherein an outer diameter of the sheath distal of the expandable member is different than an outer diameter of the sheath proximal of the expandable member (due to taper on end of 18).
Regarding claim 144, wherein an outer diameter of the sheath distal of the expandable member is less than an outer diameter of the sheath proximal of the expandable member (due to taper on end of 18).
Regarding claim 145, wherein the plurality of corrugations (see combination above), wherein the plurality of corrugations includes a plurality of peaks and a plurality of valleys (fig 4 of Kaufman), and wherein a length of the radially outer surface of the sheath distal of the expandable member is approximately 3 cm to approximately 15 cm (see claim 142 above and how claimed range and reference range are considered to significantly overlap).
Regarding claim 146, wherein the sheath distal of the expandable member is configured to directly aspirate the clot (capable of such via the lumen).
Regarding claim 148, see claim 141 above.
Regarding claim 149, further comprising a chamber defined between the radially inner member and the radially outer member of the expandable member (fig 4), wherein the chamber is configured to receive a fluid to expand the expandable member from an unexpanded configuration to an expanded configuration (Col.4 ll 20-26).
Regarding claim 150, wherein the sheath proximal of the expandable member is configured to be less flexible than the sheath distal of the expandable member (Col.2 ll 13-18).
Response to Arguments
Applicant’s amendments overcome the previous rejection. New art Kaufman replaces Schweich as Kaufman discloses using helical corrugations.
Conclusion
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783