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 Objections
Claim 10 objected to because of the following informalities:
Claim 10 recites the limitation “wherein movement of the actuation wire a proximal direction” in lines 2-3 of the claim. It is suggested this limitation be changed to “wherein movement of the actuation wire in a proximal direction” for grammatical purposes.
Claim 13 recites the limitation “an articulation region of catheter” in line 2 of the claim. It is suggested this limitation be changed to “an articulation region of the catheter” for grammatical purposes.
Appropriate correction is required.
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 12 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.
Claim 12 recites the limitation “ the tubular member” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “a distal of the catheter” in line 2 of the claim. It is unclear what the limitation “a distal” modifies. The examiner interprets the limitation to be “a distal end of the catheter” for examination purposes.
Claim 13 recites the limitation “the distal end of the catheter” in line 2 of the claim. There is insufficient antecedent basis for the limitation “the distal end” since claim 12 only previously recites “a distal of the catheter” in line 2.
Claim 14 recites the limitation “the tubular member” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the shaft” in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Subsequently, there is also insufficient antecedent basis for the limitation “the shaft” in line 1 of claim 19.
Claim 19 recites the limitation “the distal end of the shaft” in line 2 and “the shaft” in lines 3 and 4 of the claim. There is insufficient antecedent basis for the limitations “the distal end” and “the shaft” in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malkowski et al (US 20130178712).
Regarding claim 1, Malkowski et al (hereafter Malkowski) discloses a medical device comprising: an actuator; a catheter (100); an end effector 310) assembly at a distal end of the catheter; and an actuation wire (610 or 630, the limitation “wire” is sufficiently broad to encompass “metal in the form of a usually very flexible thread or slender rod”) having a proximal portion coupled to the actuator (120) and a distal portion coupled to the catheter or the end effector assembly, such that actuation of the actuator articulates a distal portion of the catheter, wherein the distal portion of the actuation wire includes a hook or a loop (620, 620 is a loop) for coupling to the catheter or the end effector assembly.
Regarding claim 2, Malkowski discloses all of the limitations set forth in claim 1, wherein the medical device includes a cuff (200 or 620) removably coupled to the catheter, wherein the actuation wire (61, 630) is coupled to the cuff.
Regarding claim 3, Malkowski discloses all of the limitations set forth in claim 2, wherein the loop or the hook (630) wraps around a clevis (160) of the end effector assembly (figures 6, 7).
Regarding claim 4, Malkowski discloses all of the limitations set forth in claim 3, wherein the cuff includes a first opening and a second opening (206), wherein the first opening and the second opening are each proximal of the clevis (160), and wherein the actuation wire (630) extends through the first opening and the second opening (figures 6, 7).
Regarding claim 7, Malkowski discloses all of the limitations set forth in claim 1, wherein, the hook or the loop extends into an opening at a distalmost end of the catheter (630 passes through distalmost end of catheter 100 to section 140).
Regarding claim 8, Malkowski discloses all of the limitations set forth in claim 7, further comprising a sheath (200) that surrounds a portion of the catheter, wherein, between a distalmost end of the sheath and a distalmost end of the catheter, at least a portion of the actuation wire is external to the sheath and external to the catheter (figures 6, 7).
Regarding claim 9, Malkowski discloses all of the limitations set forth in claim 8, wherein, proximally of the distalmost end of the sheath, the actuation wire (610) is external to the catheter and inside of the sheath.
Regarding claim 10, Malkowski discloses all of the limitations set forth in claim 1, wherein movement of the actuation wire a proximal direction bends the distal portion of the catheter from a neutral position to an articulated position, and wherein movement of the at least one actuation wire in a distal direction moves the distal portion of the catheter from the articulated position toward the neutral position (paragraphs 0074-0076).
Regarding claim 11, Malkowski discloses a medical device comprising: a catheter (100); an end effector (310) assembly at a distal end of the catheter; and an accessory device, including: an actuator (120); a cylindrical member (620) removably positioned around at least a portion of the catheter; and an actuation wire (610, 630) having a proximal portion coupled to the actuator and a distal portion coupled to the catheter or the end effector assembly, such that actuation of the actuator articulates a distal portion of the catheter (paragraphs 0074-0076, figures 6, 7).
Regarding claim 14, Malkowski discloses all of the limitations set forth in claim 1, wherein a tubular member is a cuff (200), wherein the actuation wire is coupled to the cuff (the limitation “coupled” is sufficiently broad to encompass all of the components coupled to form the whole device), and wherein the actuation wire (630) includes a distal loop that wraps around a clevis (160) of the end effector assembly (630, wraps around clevis 160).
Regarding claim 15. The medical device of claim 14, wherein the cuff (200) includes a first opening and a second opening, wherein the first opening and the second opening are each proximal of the clevis, and wherein the actuation wire extends through the first opening and the second opening (figures 6, 7).
Regarding claim 16, Malkowski discloses a medical device comprising: an actuator (120); a catheter (100); an end effector assembly (310) at a distal end of the catheter; and an actuation wire (630) having a proximal portion coupled to the actuator and a distal portion that is hooked to a distalmost opening of the catheter (looped through distalmost end of 100) or wrapped around a portion of the end effector assembly, such that actuation of the actuator articulates a distal portion of the shaft (paragraph 0078).
Regarding claim 17, Malkowski discloses all of the limitations set forth in claim 16, further comprising a tubular member (200 or 620) that surrounds at least a portion of the catheter (figure 1).
Regarding claim 18, Malkowski discloses all of the limitations set forth in claim 17, wherein the tubular member is a sheath, wherein the sheath is disposed proximally of a distal end of the catheter (figures 1,2, 6, 7).
Regarding claim 19, Malkowski discloses all of the limitations set forth in claim 18, wherein a distance between a distal end of the sheath and a distal end of the catheter defines an articulation region of the shaft, wherein proximal movement of the sheath relative to the shaft increases an area of the articulation region( 140, 160), and wherein distal movement of the sheath relative to the shaft decreases the area of the articulation region (figures 6, 7).
Regarding claim 20, Malkowski discloses all of the limitations set forth in claim 17, wherein the tubular member is a cuff (200), wherein the actuation wire is coupled to the cuff, wherein the cuff includes a first opening and a second opening (distal and proximal openings 206), wherein the first opening and the second opening are each proximal of a clevis (160) of the end effector assembly, and wherein the actuation wire (630) extends through the first opening and the second opening and wraps around the clevis (figure 6).
Regarding claim 1-6, according to an alternate interpretation, Malkowski discloses a medical device comprising: an actuator; a catheter (100); an end effector (310) assembly at a distal end of the catheter; and an actuation wire (430, 450, 610 or 630, 910, the limitation “wire” is sufficiently broad to encompass “metal in the form of a usually very flexible thread or slender rod”) having a proximal portion coupled to the actuator (120) and a distal portion coupled to the catheter or the end effector assembly, such that actuation of the actuator articulates a distal portion of the catheter, wherein the distal portion of the actuation wire includes a hook or a loop (loop of actuation wire around 153) for coupling to the catheter or the end effector assembly, wherein the medical device includes a cuff (140) removably coupled to the catheter, wherein the actuation wire (450) is coupled to the cuff (all components of the device are coupled to one another to form the whole), wherein the loop or the hook (150) wraps around a clevis (144) of the end effector assembly (figures 6, 7), wherein the cuff includes a first opening and a second opening (206), wherein the first opening and the second opening are each proximal of the clevis (144), and wherein the actuation wire (450) extends through the first opening and the second opening (figures 4B, 8), wherein the second opening is C-shaped (clevis of 144 is C shaped) and affixed to a free end of the actuation wire via an adhesive (paragraph 0070, 0071), wherein a portion of the actuation wire that wraps around the clevis is distal of all other portions of the actuation wire (figure 8).
Regarding claim 11, according to an alternative interpretation, Malkowski discloses a medical device comprising: a catheter (100); an end effector (310) assembly at a distal end of the catheter; and an accessory device, including: an actuator (120); a cylindrical member (140) removably positioned around at least a portion of the catheter; and an actuation wire (450) having a proximal portion coupled to the actuator and a distal portion coupled to the catheter or the end effector assembly, such that actuation of the actuator articulates a distal portion of the catheter (paragraphs 0071).
Regarding claim 12, Malkowski discloses all of the limitations set forth in claim 11, wherein the cylindrical member is a sheath (200), wherein the sheath includes a distal end that is proximal of a distal of the catheter, and wherein the actuation wire (430) includes a distal hook (loop) configured to couple to a distalmost opening of the catheter (catheter can encompass only proximal section of 100 and thus meet the limitations).
Regarding claim 13, Malkowski discloses all of the limitations set forth in claim 12, wherein a distance between the distal end of the sheath (200) and the distal end of the catheter (100) defines an articulation region of catheter, wherein the sheath is movable relative to the catheter (paragraph 0050), and wherein movement of the sheath changes a size of the articulation region (paragraphs 0074-0076).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following references include articulating catheter shafts using actuation wires:
Remiszewski et al (US 20070282358), Spivey (US 20100056861), Fichera et al (US 20200289201)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771
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