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 INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim(s) 4 objected to because of the following informalities: please change “actuating device engaging with the guidewire to move” to “actuating device engaging with the guidewire to be configured to move” since the claim is directed to a device as opposed to a method. Appropriate correction is required.
Claim(s) 5 objected to because of the following informalities: please change “actuating device moves” to “actuating device is configured to move” since the claim is directed to a device as opposed to a method. Appropriate correction is required.
Claim(s) 6 objected to because of the following informalities: please change “actuating device moves” to “actuating device is configured to move” since the claim is directed to a device as opposed to a method. Appropriate correction is required.
Claim(s) 7 objected to because of the following informalities: please change “actuating device transmits” to “actuating device is configured to transmit” since the claim is directed to a device as opposed to a method. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “tip portion proximal end positioned distal to the outlet port of the elongate tubular body” in claim 3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the claim is indefinite since it is unclear if “an elongate tubular body” is the same elongate tubular body as claimed in claim 1 or an additional elongate tubular body.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eder (US 2005/0234427A1) in view of Cully et al. (US 2003/0187495A1, “Cully”).
Regarding claim 1, Eder discloses a microcatheter system including an elongate tubular body (24; Fig. 1) having a body proximal end and a body distal end [0016]. The body distal end has a most distal tip having a length. An inflatable angioplasty balloon having a balloon proximal end and balloon distal end. The balloon proximal end is attached the length of the most distal tip at a first position. The balloon distal end is attached the length of the most distal tip at a second position. A guidewire (28) having proximal and distal ends. The distal end of the guidewire is capable of being threaded through an opening of the most distal tip. However, Eder does not disclose that the distal end of the guidewire includes a surgical tool locus that is capable of delivering a vascular occlusion tool to an occlusion.
In the same field of endeavor, devices treating occlusions, Cully teaches a device including a catheter (10), a balloon (20) disposed on a distal tip length and a guidewire (2180). The guidewire including a surgical tool locus (2181) that is capable of delivering a vascular occlusion tool to the occlusion [0110], wherein the locus includes any design for detachment from or reattachment to a proximal connector (2170). The connector of Cully is shown as a filter capable of shearing obstructions from a vessel, capturing or collecting debris. However, it is noted that the vascular occlusion tool is not positively recited. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the guidewire of Eder with a distal end having a surgical tool locus, as taught by Cully, to provide means for detachment and attachment of vascular occlusion tools.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eder in view of Cully, as applied to claim 1 above, and further in view of Fisher (US 2005/0197669A1).
Regarding claim 2, the combination of Eder and Cully does not disclose that the external surface of the elongate tubular body includes a reinforced material or braided material. In the same field of endeavor, catheters, Fisher teaches a catheter including a braided shaft (52) extending substantially the entire length of the catheter shaft [0019]. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have substituted the catheter shaft material of the combination of Eder and Cully with a braided material, as taught by Fisher, to provide flexibility, added pushability and kink resistance [0021].
Claim(s) 4-6, 8-11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eder in view of Cully, as applied to claim 1 above, and further in view of Stevens (US 6,193,735).
Regarding claims 4-6, the combination of Eder and Cully does not disclose an actuating device that is in communication with the guidewire at the proximal end of the guidewire, engaging with the guidewire to be capable of moving the guidewire relative to the most distal tip of the elongate tubular body.
In the same field of endeavor, balloon catheters and guidewires used to treat occlusions, Stevens teaches a device including a balloon (22) catheter (18) and a guidewire (12), wherein an actuating device (20) engages with the guidewire to be capable of moving the guidewire relative to the most distal tip of the catheter, moving the guidewire in a reciprocating manner backwards and forward, rotating (circular motion) the guidewire (C2;L1-27). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal end of the guidewire of the combination of Eder and Cully with an actuating device, as taught by Stevens, to provide means to facilitate opening obstructions in a blood vessel.
Regarding claims 8-11, the combination of Eder, Cully and Stevens discloses that the vascular occlusion tool is capable of being a microdrill bit, sanding end face, welding tip or lithotripter. It is noted that the vascular occlusion tool has not been positively recited, wherein the claimed limitations states that the “guidewire includes a surgical tool locus for (capable of) delivering a vascular occlusion tool”. For example, “the surgical tool locus comprises a vascular occlusion tool”.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eder in view of Cully and Stevens, as applied to claim 4 above, and further in view of Mendez et al. (US 2016/0256141A1, “Mendez”).
Regarding claim 7, the combination of Eder, Cully and Stevens does not disclose that the actuating device is capable of transmitting a cautery impulse to the distal end of the guidewire.
In the same field of endeavor, guidewires to treat occlusions, Mendez teaches an actuating device that is capable of transmitting a cautery impulse to a distal end of a guidewire [0230]. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the actuating device of the combination of Eder, Cully and Stevens with means to transmit a cautery impulse to the distal end of the guidewire, as taught by Mendez, to provide means for the predictable result of providing means to remove occlusions.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser (US 2009/0093791A1) in view of Eder in view of Cully.
Regarding claim 12, Heuser discloses a method for opening an occlusion in a vascular bed including inserting a catheter(10; Fig. 16) into a blood vessel in a body. The catheter includes an elongate tubular body having a body proximal end and a body distal end (Fig. 16). The body distal end has a most distal tip having a length. An inflatable angioplasty balloon(20) having a balloon proximal end and balloon distal end. The balloon proximal end is attached the length of the most distal tip at a first position. The balloon distal end is attached the length of the most distal tip at a second position. Upon reaching a treatment location (Fig. 16A) for the occlusion, inflating the inflatable angioplasty balloon [0038, 0057] to secure the catheter in position relative to an inner wall of the blood vessel such that the catheter has substantially no motion relative to the inner wall of the blood vessel. Inserting a guidewire (Fig. 16C) having proximal and distal ends into an inner chamber of the catheter. The distal end of the guidewire is capable of being threaded through an opening of the most distal tip. However, Heuser does not disclose that the catheter is a microcatheter or that the distal end of the guidewire includes a surgical tool locus that is capable of delivering a vascular occlusion tool to an occlusion.
In the same field of endeavor, devices treating occlusions, Eder teaches a microcatheter system including an elongate tubular body (24; Fig. 1) having a body proximal end and a body distal end [0016]. The body distal end has a most distal tip having a length. An inflatable angioplasty balloon having a balloon proximal end and balloon distal end. The balloon proximal end is attached the length of the most distal tip at a first position. The balloon distal end is attached the length of the most distal tip at a second position. A guidewire (28) having proximal and distal ends. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the catheter of Heuser with a microcatheter, as taught by Eder, as this modification involves the simples substitution of one type of catheter for another for the predictable result of treating small blood vessels.
In the same field of endeavor, devices treating occlusions, Cully teaches a device including a catheter (10), a balloon (20) disposed on a distal tip length and a guidewire (2180). The guidewire including a surgical tool locus (2181) that is capable of delivering a vascular occlusion tool to the occlusion [0110], wherein the locus includes any design for detachment from or reattachment to a proximal connector (2170). The connector of Cully is shown as a filter capable of shearing obstructions from a vessel, capturing or collecting debris. However, it is noted that the vascular occlusion tool is not positively recited. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the guidewire of the combination of Heuser and Eder with a distal end having a surgical tool locus, as taught by Cully, to provide means for detachment and attachment of vascular occlusion tools.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser in view of Eder and Cully, as applied to claim 12 above, and further in view of Stevens (US 6,193,735).
Regarding claims 13-15, the combination of Eder and Cully does not disclose an actuating device that is in communication with the guidewire at the proximal end of the guidewire, engaging with the guidewire to be capable of moving the guidewire relative to the most distal tip of the elongate tubular body.
In the same field of endeavor, balloon catheters and guidewires used to treat occlusions, Stevens teaches a device including a balloon (22) catheter (18) and a guidewire (12), wherein an actuating device (20) engages with the guidewire to move the guidewire relative to the most distal tip of the catheter, moving the guidewire in a reciprocating manner backwards and forward, rotating (circular motion) the guidewire (C2;L1-27, C4:L10-30). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal end of the guidewire of the combination of Heuser, Eder and Cully with an actuating device, as taught by Stevens, to provide means to facilitate opening obstructions in a blood vessel.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser in view of Eder, Cully and Stevens, as applied to claim 13 above, and further in view of Mendez et al. (US 2016/0256141A1, “Mendez”).
Regarding claim 16, the combination of Heuser, Eder, Cully and Stevens does not disclose that the actuating device transmits a cautery impulse to the distal end of the guidewire.
In the same field of endeavor, guidewires to treat occlusions, Mendez teaches an actuating device transmits a cautery impulse to a distal end of a guidewire [0230]. Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have provided the actuating device of the combination of Heuser, Eder, Cully and Stevens with means to transmit a cautery impulse to the distal end of the guidewire, as taught by Mendez, to provide means for the predictable result of providing means to remove occlusions.
Regarding claims 17-19, the combination of Heuser, Eder, Cully and Stevens discloses that the vascular occlusion tool is capable of being a microdrill bit, sanding end face, and a welding tip. It is noted that the vascular occlusion tool has not been positively recited, wherein the claimed limitations states that the “guidewire includes a surgical tool locus for (capable of) delivering a vascular occlusion tool”. For example, “the surgical tool locus comprises a vascular occlusion tool, the vascular occlusion tool is delivered to the occlusion”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Garrison et al. (US 2013/0035628A1) discloses a microcatheter having a balloon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771