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 2 is objected to because of the following informalities: Due to the amendments made to claim 2, the term “having” on line 3 should be replaced with the term “has” in order to be grammatically correct. Due to the amendments made to claim 1, the phrase “the elongated medical device” on lines 5-6 lack antecedent basis; this phrase should be replaced with the phrase “the elongated guidewire assembly” to match the amended language of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 7-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fernandez et al. (PG PUB 2017/0000991).
Re claim 1, Fernandez discloses an apparatus 100 (Fig 16A) for use with an elongated guidewire assembly having a guidewire distal tip section and a guidewire proximal section (it is noted that the italicized text constitutes functional language and, therefore, “an guidewire assembly having a guidewire distal tip section and a guidewire proximal section” is not a part of the claimed invention; rather, in order to read on this functional limitation, the apparatus only has to be structurally capable of being used with an elongated guidewire assembly having a guidewire distal tip and a guidewire proximal section; Fig 16A and Para 66-69 disclose that the apparatus 100 is used with a dilatation catheter 220; since one of ordinary skill in the art would recognize that assembly 100 can receive a guidewire having the structural configuration of dilation catheter 220, this limitation is met), the apparatus comprising: an elongated guidewire-conveyance assembly 100 (Fig 16A; “guide catheter”, Para 66; it is noted that the characterization of the assembly as a “guidewire-conveyance assembly” does not require the assembly to be used with a guidewire, but rather only requires that the assembly be structurally capable of being used with a guidewire; as set forth above, the limitation is met since the apparatus 100 can receive a guidewire having the structural configuration of dilatation catheter 220) defining an elongated conveyance lumen (within which dilation catheter 220 resides in Fig 16A) configured to receive the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated medical device” is not a part of the claimed invention; as seen in Fig 16A and Para 66-69, this limitation is met since the apparatus 100 can receive dilation catheter 220 and one of ordinary skill in the art would recognize that assembly 100 can receive a guidewire having the structural configuration of dilation catheter 220); and a tactile feature 125+125 (Fig 16A; “tactile markers”, Para 66) including a recessed surface feature (as seen in Fig 16A, markers 125 are “recessed” in that they are located inside the lumen (i.e. recessed within the lumen) and are “surface features” in that they are attached to the inner surface of the elongated conveyance lumen) located within the elongated conveyance lumen (as seen in Fig 16A), the surface feature configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; rather, in order to read on this limitation, the surface feature only has to be structurally capable of producing a tactile response when it interacts with a guidewire distal tip section of an elongated guidewire assembly; since Para 69 discloses that markers 125 produce a tactile response by interacting with the distal tip section of dilation catheter (“tactile markers (206) engaged tactile markers (125), providing a slight and temporary interference that triggered a vibration that was communicated along the lengths of catheters (100,220)”), one of ordinary skill in the art would recognize that the same tactile response would be produced with a guidewire having the structural configuration of the distal tip section of dilation catheter 220).
Re claim 2, Fernandez discloses that the elongated guidewire-conveyance assembly (it is noted that the characterization of the assembly as a “guidewire-conveyance assembly” does not require the assembly to be used with a guidewire; it only requires that the assembly be structurally capable of being used with a guidewire; since one of ordinary skill in the art would recognize that the assembly 100 can receive a guidewire having the structural configuration of dilation catheter 220 (with marker 206), this limitation is met) has a distal section (to the right in Fig 16A) and a proximal section (to the left in Fig 16A), with the elongated conveyance lumen extending between the distal section and the proximal section (as seen in Fig 16A), and with the elongated conveyance lumen configured to receive the elongated medical device (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated medical device” is not a part of the claimed invention; this limitation is met in view of Fig 16A).
Re claim 4, Fernandez discloses an apparatus 100 (Fig 16A) for use with an elongated guidewire assembly having a guidewire distal tip section and a guidewire proximal section configured to be tactilely contacted by a user (it is noted that the italicized text constitutes functional language and, therefore, “an elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Fig 16A and Para 66-69 that discloses that the apparatus 100 is used with a dilation catheter 220 and one of ordinary skill in the art would recognize that the apparatus 100 could interact in the manner claimed with a guidewire having structure of dilation catheter 220 (with marker 206)), the apparatus comprising: an elongated guidewire-conveyance assembly 100 (Fig 16A; “guide catheter”, Para 66; it is noted that the characterization of the assembly as a “guidewire-conveyance assembly” does not require the assembly to be used with a guidewire; it only requires that the assembly be structurally capable of being used with a guidewire; since one of ordinary skill in the art would recognize that a guidewire having the structure of dilation catheter 220 (with marker 206) could be used with the apparatus 100, this limitation is met) having a distal section (to the right in Fig 16A) and a proximal section (to the left in Fig 16A), with an elongated conveyance lumen (within which the dilation catheter 220 resides in Fig 16A) extending between the distal section and the proximal section (as seen in Fig 16A), and with the elongated conveyance lumen configured to receive the guidewire distal tip section of the elongated guidewire assembly from the proximal section (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 67,69 which explains how a guidewire having the structure of the dilation catheter 220 (with marker 206) would interact with the assembly 100 in the claimed way); and a tactile feature 125 (Fig 16A; “tactile markers”, Para 66; as seen in Fig 16A, markers 125 are “recessed” in that they are located inside the lumen (i.e. recessed within the lumen) and are “surface features” in that they are attached to the inner surface of the elongated conveyance lumen) located within the elongated conveyance lumen (as seen in Fig 16A), the surface feature configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; rather, in order to read on this limitation, the surface feature only has to be structurally capable of producing a tactile response when it interacts with a guidewire distal tip section of an elongated guidewire assembly; since Para 69 discloses that markers 125 produce a tactile response by interacting with the distal tip section of dilation catheter (“tactile markers (206) engaged tactile markers (125), providing a slight and temporary interference that triggered a vibration that was communicated along the lengths of catheters (110,220)”), one of ordinary skill in the art would recognize that the same tactile response would be produced with a guidewire having the structural configuration of the distal tip section of dilation catheter 220).
Re claim 5, Fernandez discloses that the tactile feature extends toward an interior of the elongated conveyance lumen (as seen in Fig 16A).
Re claim 7, Fernandez discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in such a way that the tactile feature, in use, imparts a tactile vibration into the guidewire distal tip section, and tactile vibration, in use, travels along the elongated guidewire assembly toward the guidewire proximal section and then to the user who is in tactile contact with the guidewire proximal section in response to tactile contact between the guidewire distal tip section and the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 67,69 which explains how a guidewire having the structure of the dilation catheter 220 (with marker 206) would interact with the assembly 100 in the claimed way).
Re claim 8, Fernandez discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in response to contact being made between the guidewire distal tip section and the tactile feature while the guidewire distal tip section is moved past the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 67,69 which explains how a guidewire having the structure of the dilation catheter 220 (with marker 206) would interact with the assembly 100 in the claimed way).
Re claim 9, Fernandez discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in such a way that the tactile feature, in use, imparts tactile vibration into the guidewire distal tip section, and tactile vibration, in use, travels along the elongated guidewire assembly toward the guidewire proximal section and then to the user who is in tactile contact with the guidewire proximal section in response to tactile contact between the guidewire distal tip section and the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 67,69 which explains how a guidewire having the structure of the dilation catheter 220 (with marker 206) would interact with the assembly 100 in the claimed way).
Re claim 10, Fernandez discloses that the tactile feature includes a raised feature (as seen in Fig 16A, the markers 125 are “raised” in that they project into the lumen).
Re claim 12, Fernandez discloses that the tactile feature is configured to interact with the guidewire distal tip section of the elongated guidewire assembly in response to the guidewire distal tip section making physical contact with the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 67,69 which explains how a guidewire having the structure of the dilation catheter 220 (with marker 206) would interact with the assembly 100 in the claimed way); and the tactile feature is configured to provide tactile feedback to the user of the guidewire distal tip section (Para 67, “interference may be felt by the hand of the operator grasping the dilation catheter (220) and/or guide catheter (120) thereby providing tactile feedback”; Para 69, “a vibration that was communicated along the lengths of catheters (100,220)”).
Claims 1, 2, 4, 5, 7-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gianotti et al. (PG PUB 2018/0154110).
Re claim 1, Gianotti discloses an apparatus 602 (Fig 6) for use with an elongated guidewire assembly having a guidewire distal tip section and a guidewire proximal section (it is noted that the italicized text constitutes functional language and, therefore, “an elongated guidewire assembly having a guidewire distal tip section and a guidewire proximal section” is not a part of the claimed invention; this limitation is met in view of Fig 6 and Para 29 that discloses that the apparatus 602 is used with inner tube 604 and one of ordinary skill in the art would recognize that the apparatus can be used with a guidewire having the structural configuration of inner tube 604), the apparatus comprising: an elongated guidewire-conveyance assembly 602 (Fig 6; “outer shaft-member tube”, Para 28; it is noted that the characterization of the assembly as a “guidewire-conveyance assembly” does not require the assembly to be used with a guidewire; it only requires that the assembly be structurally capable of being used with a guidewire; Para 29 discloses that the outer tube 602 conveys an inner tube 604; since one of ordinary skill in the art would recognize that the outer tube 602 is structurally capable of operating with a guidewire having the structure of inner tube 604, this limitation is met)) defining an elongated conveyance lumen (within which the inner tube 604 resides in Fig 6) configured to receive the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; as seen in Fig 6 and Para 29, this limitation is met since the outer tube 602 can receive the distal tip section of inner tube 604 and one of ordinary skill in the art would recognize that the outer tube 602 can, therefore, receive the distal tip section of a guidewire having the same structural configuration of inner tube 604); and a tactile feature 612+613 (Fig 6, “ramp-like features”, Para 29) including a recessed surface feature (as seen in Fig 6, a recess exists between the two ramp-like features and is formed in the inner surface forming the elongated conveyance lumen – “ramp-like features inscribed in the inner surface of the outer tube”, Para 29) located within the elongated conveyance lumen (as seen in Fig 6), the surface feature configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way (“When the inner tube is translated in the direction of arrow 616 with respect to the other tube, sliding of the surfaces of the ramp-like features followed by the steep descent of the tips 620 and 621 of the ramp-like features inscribed in the inner surface of the outer tube to a next, locked position provide a haptic, tactile, or sensory signal to a treatment provider”)).
Re claim 2, Gianotti discloses that the elongated guidewire-conveyance assembly has a distal section (Para 27 sets forth that the arrangement seen in Fig 6 can be found in the catheter of Fig 3; since Para 24 discloses the outer tube 316 moves distal to the inner tube 314 and Para 29 discloses that the outer tube 602 moves to the left in Fig 6, the distal section of the outer tube 602 is to the left in Fig 6) and a proximal section (for the same logic set forth immediately above, the proximal section of the outer tube is to the right in Fig 6), with the elongated conveyance lumen extending between the distal section and the proximal section (as seen in Fig 6), and with the elongated conveyance lumen configured to receive the elongated medical device (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated medical device” is not a part of the claimed invention; this limitation is met in view of Fig 6).
Re claim 4, Gianotti discloses an apparatus 602 (Fig 6) for use with an elongated guidewire assembly having a guidewire distal tip section and a guidewire proximal section configured to be tactilely contacted by a user (it is noted that the italicized text constitutes functional language and, therefore, “an elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Fig 6 and Para 29 that discloses that the apparatus 602 is used with inner tube 604 and one of ordinary skill in the art would recognize that the apparatus 602 could interact in the manner claimed with a guidewire having structure of inner tube 604 (with features 610,611)), the apparatus comprising: an elongated guidewire-conveyance assembly 602 (Fig 6; “outer shaft-member tube”, Para 28; (it is noted that the characterization of the assembly as a “guidewire-conveyance assembly” does not require the assembly to be used with a guidewire; it only requires that the assembly be structurally capable of being used with a guidewire; since one of ordinary skill in the art would recognize that a guidewire having the structure of inner tube 604 (with features 610,611) could be used with the apparatus 602, this limitation is met) having a distal section (Para 27 sets forth that the arrangement seen in Fig 6 can be found in the catheter of Fig 3; since Para 24 discloses the outer tube 316 moves distal to the inner tube 314 and Para 29 discloses that the outer tube 602 moves to the left in Fig 6, the distal section of the outer tube 602 is to the left in Fig 6) and a proximal section (for the same logic set forth immediately above, the proximal section of the outer tube is to the right in Fig 6), with an elongated conveyance lumen (within which the inner tube 604 resides in Fig 6) extending between the distal section and the proximal section (as seen in Fig 6), and with the elongated conveyance lumen configured to receive the guidewire distal tip section of the elongated guidewire assembly from the proximal section (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way); and a tactile feature 612+613 (Fig 6, “ramp-like features”, Para 29) including a recessed surface feature (as seen in Fig 6, a recess exists between the two ramp-like features and is formed in the inner surface forming the elongated conveyance lumen – “ramp-like features inscribed in the inner surface of the outer tube”, Para 29) located within the elongated conveyance lumen (as seen in Fig 6), the surface feature configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way (“When the inner tube is translated in the direction of arrow 616 with respect to the other tube, sliding of the surfaces of the ramp-like features followed by the steep descent of the tips 620 and 621 of the ramp-like features inscribed in the inner surface of the outer tube to a next, locked position provide a haptic, tactile, or sensory signal to a treatment provider”)).
Re claim 5, Gianotti discloses that the tactile feature extends toward an interior of the elongated conveyance lumen (as seen in Fig 6, each of the ramp-like features 612,613 extend toward an interior of the lumen).
Re claim 7, Gianotti discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in such a way that the tactile feature, in use, imparts a tactile vibration into the guidewire distal tip section, and tactile vibration, in use, travels along the elongated guidewire assembly toward the guidewire proximal section and then to the user who is in tactile contact with the guidewire proximal section in response to tactile contact between the guidewire distal tip section and the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way).
Re claim 8, Gianotti discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in response to contact being made between the guidewire distal tip section and the tactile feature while the guidewire distal tip section is moved past the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way).
Re claim 9, Gianotti discloses that the tactile feature is configured to tactilely interact with the guidewire distal tip section of the elongated guidewire assembly in such a way that the tactile feature, in use, imparts tactile vibration into the guidewire distal tip section, and tactile vibration, in use, travels along the elongated guidewire assembly toward the guidewire proximal section and then to the user who is in tactile contact with the guidewire proximal section in response to tactile contact between the guidewire distal tip section and the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way).
Re claim 10, Gianotti discloses that the tactile feature includes a raised feature (as seen in Fig 6, each ramp-like feature 612,613 is raised).
Re claim 12, Gianotti discloses that the tactile feature is configured to interact with the guidewire distal tip section of the elongated guidewire assembly in response to the guidewire distal tip section making physical contact with the tactile feature (it is noted that the italicized text constitutes functional language and, as set forth above, the “elongated guidewire assembly” is not a part of the claimed invention; this limitation is met in view of Para 29 which explains how a guidewire having the structure of the inner tube 604 (with features 610,611) would interact with the assembly 602 in the claimed way); and the tactile feature is configured to provide tactile feedback to the user of the guidewire distal tip section (Para 29, “provide a haptic, tactile, or sensory signal to a treatment provider”).
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive.
Applicant argues that Fernandez and Gianotti do not each disclose “a recessed tactile surface feature located within the elongated conveyance lumen that is configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly” as recited in independent claims 1 and 4. This argument is not persuasive. As set forth in the rejections of claim 1 and 4 above, Fernandez discloses that tactile feature 125 is “a recessed surface feature” because marker 125 is located inside the lumen (i.e. recessed within the lumen) and is attached to the inner surface of the elongated conveyance lumen (i.e. features of the inner surface) and is “configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly” based on Para 69 that discloses that markers 125 can produce a tactile response by interacting with a distal tip section having the shape of that of dilation catheter 220. As set forth in the rejections of claim 1 and 4 above, Gianotti discloses that tactile feature 612+613 is a “recessed surface feature” because a recess exists between the two ramp-like features 612,613 and is formed in the inner surface forming the elongated conveyance lumen and is “configured to produce a tactile response by interacting with the guidewire distal tip section of the elongated guidewire assembly” based on Para 29 that discloses that ramp-like features 612+613 can produce a tactile response by interacting with a distal tip section having the shape of that of inner tube 604.
Applicant argues that anticipation by each of Fernandez and Gianotti is not met because neither of Fernandez and Gianotti explicitly discloses operation with a guidewire. This argument is not persuasive since the “guidewire assembly” is only functionally recited and not a part of the claimed invention. Rather, in order for the prior art to anticipate the functional recitations that refer to the guidewire assembly, it only has to be established that the prior art is structurally capable of performing the functional recitations; the prior art does not have to explicitly disclose that the functional are performed.
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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