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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species A in the reply filed on 1/2/2026 is acknowledged. Accordingly, claims 13-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claims 13-19) and invention (claim 20), there being no allowable generic or linking claim.
Information Disclosure Statement
It is noted that the non-patent literature listed in paragraph [0026] of the Specification has not been considered as it is not listed on an Information Disclosure Statement.
Specification
The disclosure is objected to because of the following informalities: The term “tacitly” is recited throughout the Specification (Para 8, 9, 27, 38, 41, 42), but this term appears to be used contrary to its ordinary meaning and has not been clearly redefined in the Specification in such a way as to set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the Applicant intended to so redefine that claim term. The term “tacitly” is used to mean “perceptible by touch”, while the accepted meaning is “without expressing something directly”. It appears that the correct term to use is “tactilely”. Therefore, it is suggested to replace each occurrence of the term “tacitly” with the term “tactilely”.
Appropriate correction is required.
Claim Objections
Claims 7 and 9 are objected to because of the following informalities: In each of claims 7 and 9, the term “the” should be inserted before the phrase “tactile vibration” on line 4 in order to ensure proper antecedent basis (since this vibration was introduced in the previous line). Appropriate correction is required.
Applicant is advised that should claim 6 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). If Applicant chooses to cancel one of claims 6 and 8, it is suggested to cancel claim 6 since claim 9 depends on claim 8 (and no claims depend on claim 6).
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.
Claims 4-12 are 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.
Claims 4, 6, 7, 8, 9 recite the term “tacitly” (“tacitly contacted” in claim 4 and “tacitly interact” in claims 6-9), but this term appears to be used contrary to its ordinary meaning. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term (Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999)). The term “tacitly” is used by the claim to mean “perceptible by touch”, while the accepted meaning is “without expressing something directly”. The term is indefinite because the specification does not clearly redefine the term. It appears that the correct term to use is “tactilely”.
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 1-12 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 medical device (it is noted that the italicized text constitutes functional language and, therefore, “an elongated medical device” 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 dilation catheter 220), the apparatus comprising: an elongated medical-conveyance assembly 100 (Fig 16A; “guide catheter”, Para 66) defining an elongated conveyance lumen (within which dilation catheter 220 resides in Fig 16A) 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; as seen in Fig 16A and Para 66-69, this limitation is met since the apparatus 100 can receive dilation catheter 220); and a tactile feature 125+125 (Fig 16A; “tactile markers”, Para 66) located at the elongated conveyance lumen (as seen in Fig 16A).
Re claim 2, Fernandez discloses that the elongated medical-conveyance assembly includes an 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) having 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); and the elongated medical device includes an elongated guidewire assembly (as set forth above, the “elongated medical device” is not a part of the claimed invention).
Re claim 3, Fernandez discloses that the elongated medical-conveyance assembly includes an elongated catheter assembly, an elongated dilator assembly, or an elongated sheath assembly (Para 66 sets forth that the assembly 100 is a “guide catheter” and, therefore, it is both a “catheter assembly” and a “sheath assembly”).
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 tacitly 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) located within the elongated conveyance lumen (as seen in Fig 16A).
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 6, Fernandez discloses that the tactile feature is configured to tacitly interact with the guidewire distal tip section of the elongated guidewire assembly in response to contact 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 7, Fernandez discloses that the tactile feature is configured to tacitly 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 tacitly 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 tacitly 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 11, Fernandez discloses that the tactile feature includes a recessed feature (as seen in Fig 16A, the markers 125 are “recessed” in that they are located inside the lumen (i.e. recessed in 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 1-12 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 medical device (it is noted that the italicized text constitutes functional language and, therefore, “an elongated medical device” 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), the apparatus comprising: an elongated medical-conveyance assembly 602 (Fig 6; “outer shaft-member tube”, Para 28) defining an elongated conveyance lumen (within which the inner tube 604 resides in Fig 6) 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; as seen in Fig 6 and Para 29, this limitation is met since the outer tube 602 can receive inner tube 604); and a tactile feature 612+613 (Fig 6, “ramp-like features”, Para 29) located at the elongated conveyance lumen (as seen in Fig 6).
Re claim 2, Gianotti discloses that the elongated medical-conveyance assembly includes an 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 Para 29 discloses that a guidewire can be received within lumen 608 which resides within the inner tube 604 that is received in the assembly 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 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); and the elongated medical device includes an elongated guidewire assembly (as set forth above, the “elongated medical device” is not a part of the claimed invention).
Re claim 3, Gianotti discloses that the elongated medical-conveyance assembly includes an elongated catheter assembly, an elongated dilator assembly, or an elongated sheath assembly (Para 27 sets forth that the arrangement seen in Fig 6 can be found in the catheter of Fig 3; therefore, the assembly 602 is both a “catheter assembly” and a “sheath assembly”).
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 tacitly 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) located within the elongated conveyance lumen (as seen in Fig 6).
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 6, Gianotti discloses that the tactile feature is configured to tacitly interact with the guidewire distal tip section of the elongated guidewire assembly in response to contact 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 7, Gianotti discloses that the tactile feature is configured to tacitly 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 tacitly 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 tacitly 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 11, Gianotti discloses that the tactile feature includes a recessed feature (as seen in Fig 6, a recess exists between the two ramp-like features 612,613).
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”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 6,059,759 to Mottola et al. discloses a catheter with a tactile feature for contact with a guidewire (Fig 12-15)
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783