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 6 is objected to because of the following informalities: Claim 6 recites “the intermediate second guide member” in line 4 which should read “the intermediary second guide member”. 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 15 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 15 recites the limitation "the guide member" in line 1. There is insufficient antecedent basis for this limitation in the claim as it is unclear if this refers to the “first guide member”, “the second guide member”, or in addition thereto. For the purposes of examination, the limitation has been interpreted to read “the first guide member”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matlock et al. (US 2017/0259048 A1) in view of Calomeni et al. (US 2017/0065406 A1).
Regarding claim 1, Matlock discloses an apparatus (dilation instrument 200 with actuating assembly 260 in place of actuating assembly 250; Figs. 14, 17-19; [0109]), comprising: (a) a body (handle 202; Fig. 14); (b) a first guide member (guide catheter 204; Fig. 14) extending distally from the body (Fig. 14); (c) a dilation catheter (dilation catheter 268; Fig. 17) slidably disposed relative to the first guide member (as dilation catheter 268 is slidably disposed in the lumen of guide catheter 204, similar to that of dilation catheter 208; [0101]; [0109]), the dilation catheter (268) being operable to translate relative to the body (202) along a first longitudinal range of motion from a first proximal-most position to a first distal-most position (as dilation catheter 268 is longitudinally advanced and retracted relative to handle 202 and through the lumen of the guide catheter 204 similar to that of dilation catheter 208; [0103]; [0109]), the dilation catheter including: (i) an expandable element (inflatable balloon 270) configured to dilate an anatomical passageway within a patient ([0114]), and (ii) a distal end (distal end of 268; Fig. 17); (d) a second guide member (guidewire 266; Fig. 17) slidably disposed relative to the dilation catheter (as guidewire 266 can be inserted into dilation catheter 268 to a desired length i.e., slide within dilation catheter 268; [0113]), the second guide member (266) being operable to translate relative to the body (202) along a second longitudinal range of motion from a second proximal-most position to a second distal-most position (when locked relative to unitary movement assembly 262, guidewire 266 translates with dilation catheter 268; [0111]); and (e) an actuator (unitary movement assembly 262; Fig. 17) operable to simultaneously drive translation of the dilation catheter (268) along the first longitudinal range of motion and the second guide member (266) along the second longitudinal range of motion (as guidewire 266 translates with dilation catheter 268 and unitary movement assembly 262; [0111]).
Matlock fails to explicitly teach the actuator comprises a rotary member operable to rotate relative to the body to thereby simultaneously drive translation of the dilation catheter along the first longitudinal range of motion and the second guide member along the second longitudinal range of motion.
However, Matlock teaches a second guide member (guidewire 206) can be translated by any suitable operation and in some variations, the actuator (guidewire movement assembly 212) is rotatable relative to the body (handle 202) to provide longitudinal advancement and retraction of the second guide member (206; [0107]) and various other suitable ways in which the second guide member may be longitudinally advanced and retracted relative to the body with be apparent to those of ordinary skill in the art ([0107]).
Calomeni teaches an apparatus (medical device system 10; Fig. 1), comprising: a body (handle 18; Figs. 1, 4-8); a catheter (outer sheath 12) being operable to translate relative to the body (18) along a fist longitudinal range of motion from a first proximal-most position (Fig. 8; as outer sheath 12 stops translating proximally in Fig 8 when sheath carriage 132 engages lost motion barrel 158; [0079]) to a first distal-most position (Fig. 6; as in Fig. 6 outer sheath 12 is extended distally relative to the inner catheter 14 and handle 18; [0077]); a second guide member (actuator members 84; Figs. 2-3) slidably disposed relative to the catheter (when carriage screw 132a unthreads from sheath carriage 132, additional rotation of the rotatable control knob 122 and the lead screw 134 causes continued proximal movement of the actuator member carriage 152, which moves actuator members 84, while motion of the sheath carriage 132 ceases; thus, 84 translates relative to 12; [0079]), the second guide member (84) being operable to translate relative to the body along a second longitudinal range of motion from a second proximal-most position (Fig. 8, as actuator members 84 stops translating proximally when actuator member carriage 152 is in its proximal most position; [0078]) to a second distal-most position (Fig. 6; as actuator member 84 is translated distally until actuator member carriage 152 is within lost motion barrel 158; [0077]); and an actuator (including at least 132, 152, 158, lead screw 134, control knob 122, rotatable ring 155), the actuator comprising a rotary member (lead screw 134) operable to rotate relative to the body (18) to thereby simultaneously drive translation of the catheter (12) along the first longitudinal range of motion and the second guide member (84) along the second longitudinal range of motion (as actuating the lead screw 134 by rotating control knob 122 simultaneously and/or sequentially actuates the actuator member carriage 152 and the sheath carriage 132 to translate both the outer sheath 12 and the actuation members 84; [0089]). Thus, both Matlock and Calomeni teach actuators operable to simultaneously drive translation of a catheter along a first longitudinal range of motion and a second guide member along a second longitudinal range of motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the unitary slidable actuator of Matlock the rotary actuator taught by Calomeni because the substitution of one known actuator for another would have yielded the predictable result of simultaneously driving translation of the dilation catheter along the first longitudinal range of motion and the second guide member along the second longitudinal range of motion i.e., a coordinated axial motion of two elongate members from a single rotary input to achieve synchronized translations.
Regarding claim 2, modified Matlock discloses the rotary member (134 of Calomeni) comprising a first fine threaded section (first portion 134a and second portion 134b; as the thread pitch of 134a and/or 134b may be fine or coarse; [0080] of Calomeni).
Regarding claim 3, modified Matlock discloses the actuator further comprising a dilation hub (sheath carriage 132 and sheath carriage screw 132a or 132, 132a and lost motion barrel 158 of Calomeni) attached to the dilation catheter (as sheath carriage 132 is attached to the outer sheath 12 i.e., dilation catheter 268 of Matlock), the dilation hub (132) having a second fine threaded section (internal threads of 132a of Calomeni) operatively engaged with the first fine threaded section of the rotary member (as 132a is threadedly engaged to 134a of 134 of Calomeni).
Regarding claim 4, modified Matlock discloses the dilation hub (132 of Calomeni) comprising an attachment rod (sheath adapter 130; Fig. 5; [0069] of Calomeni) affixed to the dilation catheter (as sheath adaptor 130 is attached to the outer sheath 12 i.e., dilation catheter 268 of Matlock).
Regarding claim 5, modified Matlock discloses the actuator further comprising a second guide member hub (lost motion barrel 158 or actuator member carriage 152 of Calomeni) attached to the second guide member (84 i.e., guidewire 266 of Matlock), the second guide member hub (158 or 152) comprising a first coarse threaded section (larger internal threaded section of 158; Fig. 6 of Calomeni or internal threaded section of 152 that rotates along 152b which may be coarse or fine; [0080] of Calomeni).
Regarding claim 6, modified Matlock discloses the actuator further comprising and an intermediary second guide member driver (actuator carriage screw 152a of Calomeni), the intermediary second guide member driver (152a) comprising a second coarse threaded section (external threads of actuator carriage screw 152a) operatively engaged with the first coarse threaded section of the second guide member hub (158; [0077] of Calomeni), the intermediate second guide member driver (152a) comprising a third fine threaded section (internal threads of 152a that engage with lead screw 134 of Calomeni) operatively engaged with the first fine threaded section (as second portion 134b may be coarse or fine and constant with 134a; [0080]).
Regarding claim 7, modified Matlock discloses the dilation hub (132 of Calomeni) being slidably disposed within the body (18; Figs. 6-8 of Calomeni).
Regarding claim 8, modified Matlock discloses the second guide member hub (152 of Calomeni) being slidably disposed within the dilation hub (as 152 is interpreted here to include 152a, which is slidably disposed within 158 when the dilation hub includes 132 and 158 of Calomeni; Figs. 6-8).
Regarding claim 9, modified Matlock discloses the second longitudinal range of motion being greater than the first longitudinal range of motion (as 152 of Calomeni, which is connected to the second guide member is proximal 132 which is connected to the catheter; Figs. 5-8 of Calomeni and the guidewire 266 of Matlock is longer than the dilation catheter 268; Fig. 17 of Matlock). Calomeni’s lost motion barrel 158 causes the sheath carriage 132 to halt while the actuator member carriage 152 continues to translate ([0079]–[0080]), inherently yielding a longer second range of motion than the first.
Regarding claim 10, modified Matlock discloses the first proximal-most position being distal relative to the second proximal-most position (as 132 of Calomeni, which is connected to the catheter is distal 152 which is connected to the second guide member; Figs. 5-8 of Calomeni and the proximal end of 268 of Matlock is distal to the proximal end of 266 as Matlock shows the guidewire extending beyond the dilation catheter at distal extension and the catheter’s proximal-most position being distal of the guidewire’s proximal-most position when co-translated; Figs. 17–19; [0109]–[0113]).
Regarding claim 11, modified Matlock discloses the invention as claimed above, and Matlock further discloses the first distal-most position being proximal relative to the second distal-most position (as 266 extends distally past 268 in the fully extended position; Fig. 17).
Regarding claim 12, modified Matlock discloses the invention as claimed above and further discloses the expandable element (270) comprising a balloon ([0112]; Fig. 17).
Regarding claim 13, modified Matlock discloses the rotary member comprising a proximal handle (control knob 122 of Calomeni; Fig. 4).
Regarding claim 14, modified Matlock discloses the body (18 of Calomeni) comprising a proximal collar (control knob 122 of Calomeni) rotationally housing the rotary member (134 of Calomeni; Figs. 4-5).
Regarding claim 15, modified Matlock discloses the invention as claimed above, and Matlock further discloses the first guide member (guide catheter 204; Fig. 14) comprising a guide catheter (Fig. 14).
Regarding claim 16, modified Matlock discloses the body (18 of Calomeni) comprising a handle (Fig. 4 of Calomeni).
Regarding claim 17, modified Matlock discloses the invention as claimed above, and Matlock further discloses the dilation catheter (268) being positioned within an interior region of the first guide member (204; similar to 208 of Figs. 14-16; [0109]).
Regarding claim 18, modified Matlock discloses the invention as claimed above, and Matlock further discloses the first guide member (204) comprising a hollow shaft (Fig. 14).
Regarding claim 19, Matlock discloses an apparatus (dilation instrument 200 with actuating assembly 260 in place of actuating assembly 250; Figs. 14, 17-19; [0109]), comprising: (a) a body (handle 202; Fig. 14), the body having a first longitudinal end (distal end of 202) and a second longitudinal end (proximal end of 202), the first longitudinal end defining an opening (opening through which 266 and 288 extend); (b) a first guide element (guide catheter 204; Fig. 14) extending distally from the body (Fig. 14); (c) a dilation catheter (dilation catheter 268; Fig. 17) slidably disposed relative to the first guide member (as dilation catheter 268 is slidably disposed in the lumen of guide catheter 204, similar to that of dilation catheter 208; [0101]; [0109]), the dilation catheter (268) being operable to translate relative to the body (202) along a first longitudinal range of motion from a first proximal-most position to a first distal-most position (as dilation catheter 268 is longitudinally advanced and retracted relative to handle 202 and through the lumen of the guide catheter 204 similar to that of dilation catheter 208; [0103]; [0109]), the dilation catheter including: (i) an expandable element (inflatable balloon 270) configured to dilate a passageway within a head of a patient ([0114]), and (ii) a distal end (distal end of 268; Fig. 17); (d) a second guide element (guidewire 266; Fig. 17) slidably disposed relative to the dilation catheter (as guidewire 266 can be inserted into dilation catheter 268 to a desired length i.e., slide within dilation catheter 268; [0113]), the second guide element (266) being operable to translate relative to the body (202) along a second longitudinal range of motion from a second proximal-most position to a second distal-most position (when locked relative to unitary movement assembly 262, guidewire 266 translates with dilation catheter 268; [0111]); and (e) an actuator assembly (unitary movement assembly 262; Fig. 17) operable to translate the dilation catheter and simultaneously drive translation of the dilation catheter (268) and the second guide element (266) (as guidewire 266 translates with dilation catheter 268 and unitary movement assembly 262; [0111]).
Matlock fails to explicitly teach the actuator comprises a rotary member comprising a first threaded section, the rotary member being rotatably coupled to the body, (ii) a dilation catheter hub comprising a second threaded section operatively engaged with the first threaded section of the rotary member, the dilation catheter hub being coupled to the dilation catheter, (iii) an intermediate second guide element driver comprising: (A) a third threaded section operatively engaged with the first threaded section of the rotary member, and (B) a fourth threaded section, and (iv) a second guide element hub comprising a fifth threaded section operatively engaged with the fourth threaded section of the intermediate second guide element driver, the rotary member being operable to translate the dilation catheter, the intermediate second guide element driver, and the second guide element hub in response to rotating relative to the body to thereby simultaneously translate the dilation catheter and the second guide element.
However, Matlock teaches a second guide member (guidewire 206) can be translated by any suitable operation and in some variations, the actuator (guidewire movement assembly 212) is rotatable relative to the body (handle 202) to provide longitudinal advancement and retraction of the second guide member (206; [0107]) and various other suitable ways in which the second guide member may be longitudinally advanced and retracted relative to the body with be apparent to those of ordinary skill in the art ([0107]).
Calomeni teaches an apparatus (medical device system 10; Fig. 1), comprising: a body (handle 18; Figs. 1, 4-8), the body (18) having a first longitudinal end (distal end) and a second longitudinal end (proximal end), the first longitudinal end defining an opening (Fig. 4); a catheter (outer sheath 12) being operable to translate relative to the body (18) along a fist longitudinal range of motion from a first proximal-most position (Fig. 8; as outer sheath 12 stops translating proximally in Fig 8 when sheath carriage 132 engages lost motion barrel 158; [0079]) to a first distal-most position (Fig. 6; as in Fig. 6 outer sheath 12 is extended distally relative to the inner catheter 14 and handle 18; [0077]); a second guide member (actuator members 84; Figs. 2-3) slidably disposed relative to the catheter (when carriage screw 132a unthreads from sheath carriage 132, additional rotation of the rotatable control knob 122 and the lead screw 134 causes continued proximal movement of the actuator member carriage 152, which moves actuator members 84, while motion of the sheath carriage 132 ceases; thus, 84 translates relative to 12; [0079]), the second guide member (84) being operable to translate relative to the body along a second longitudinal range of motion from a second proximal-most position (Fig. 8, as actuator members 84 stops translating proximally when actuator member carriage 152 is in its proximal most position; [0078]) to a second distal-most position (Fig. 6; as actuator member 84 is translated distally until actuator member carriage 152 is within lost motion barrel 158; [0077]); and an actuator (including at least 132, 152, 158, lead screw 134, control knob 122, rotatable ring 155), the actuator, comprising: (i) a rotary member (lead screw 134) comprising a first threaded section (134a, 134b; Fig. 6), the rotary member (134) being rotatably coupled to the body (Figs. 5-8), (ii) a catheter hub (sheath carriage 132, sheath carriage screw 132a) comprising a second threaded section (internal threads of 132a) operatively engaged with the first threaded section of the rotary member (Figs. 5-8), the catheter hub (132, 132a) being coupled to the catheter (via sheath adapter 130; [0069]), (iii) an intermediate second guide element driver (actuator carriage screw 152a) comprising: (A) a third threaded section (internal threads of 152a) operatively engaged with the first threaded section (134b) of the rotary member (134; Figs. 5-8), and (B) a fourth threaded section (external threads of actuator carriage screw 152a), and (iv) a second guide element hub (actuator member carriage 152) comprising a fifth threaded section (internal threads of 152) operatively engaged with the fourth threaded section (external threads of actuator carriage screw 152a) of the intermediate second guide element driver (152; Figs. 6-7), the rotary member (134) being operable to translate the catheter (12; [0077]-[0078]), the intermediate second guide element driver (152a), and the second guide element hub (152) in response to rotating relative to the body to thereby simultaneously translate the catheter and the second guide element (as actuating the lead screw 134 by rotating control knob 122 simultaneously and/or sequentially actuates the actuator member carriage 152 and the sheath carriage 132 to translate both the outer sheath 12 and the actuation members 84; [0089]). Thus, both Matlock and Calomeni teach actuators operable to simultaneously drive translation of a catheter along a first longitudinal range of motion and a second guide member along a second longitudinal range of motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the unitary slidable actuator of Matlock the rotary actuator taught by Calomeni because the substitution of one known actuator for another would have yielded the predictable result of simultaneously driving translation of the dilation catheter along the first longitudinal range of motion and the second guide element along the second longitudinal range of motion i.e., a coordinated axial motion of two elongate members from a single rotary input to achieve synchronized translations.
Regarding claim 20, Matlock discloses an apparatus (dilation instrument 200 with actuating assembly 260 in place of actuating assembly 250; Figs. 14, 17-19; [0109]), comprising: (a) a body (handle 202; Fig. 14); (b) a guide catheter (guide catheter 204; Fig. 14) extending distally from the body (Fig. 14); (c) a dilation catheter (dilation catheter 268; Fig. 17) slidably disposed within the guide catheter (as dilation catheter 268 is slidably disposed in the lumen of guide catheter 204, similar to that of dilation catheter 208; [0101]; [0109]), the dilation catheter (268) being operable to translate relative to the body (202) along a first longitudinal range of motion (as dilation catheter 268 is longitudinally advanced and retracted relative to handle 202 and through the lumen of the guide catheter 204 similar to that of dilation catheter 208; [0103]; [0109]), the dilation catheter including: (i) an expandable element (inflatable balloon 270) configured to dilate a passageway within a head of a patient ([0114]), and (ii) a distal end (distal end of 268; Fig. 17); (d) a guide element (guidewire 266; Fig. 17) slidably disposed relative to the dilation catheter (as guidewire 266 can be inserted into dilation catheter 268 to a desired length i.e., slide within dilation catheter 268; [0113]), the guide element (266) being operable to translate relative to the body (202) along a second longitudinal range of motion (when locked relative to unitary movement assembly 262, guidewire 266 translates with dilation catheter 268; [0111]); and (e) an actuator (unitary movement assembly 262; Fig. 17) operable to simultaneously drive translation of the dilation catheter (268) along the first longitudinal range of motion and the guide element (266) along the second longitudinal range of motion (as guidewire 266 translates with dilation catheter 268 and unitary movement assembly 262; [0111]).
Matlock fails to explicitly teach the actuator comprises a rotary member operable to rotate relative to the body to thereby simultaneously drive translation of the dilation catheter along the first longitudinal range of motion and the guide element along the second longitudinal range of motion.
However, Matlock teaches a second guide member (guidewire 206) can be translated by any suitable operation and in some variations, the actuator (guidewire movement assembly 212) is rotatable relative to the body (handle 202) to provide longitudinal advancement and retraction of the second guide member (206; [0107]) and various other suitable ways in which the second guide member may be longitudinally advanced and retracted relative to the body with be apparent to those of ordinary skill in the art ([0107]).
Calomeni teaches an apparatus (medical device system 10; Fig. 1), comprising: a body (handle 18; Figs. 1, 4-8); a catheter (outer sheath 12) being operable to translate relative to the body (18) along a fist longitudinal range of motion from a first proximal-most position (Fig. 8; as outer sheath 12 stops translating proximally in Fig 8 when sheath carriage 132 engages lost motion barrel 158; [0079]) to a first distal-most position (Fig. 6; as in Fig. 6 outer sheath 12 is extended distally relative to the inner catheter 14 and handle 18; [0077]); a second guide member (actuator members 84; Figs. 2-3) slidably disposed relative to the catheter (when carriage screw 132a unthreads from sheath carriage 132, additional rotation of the rotatable control knob 122 and the lead screw 134 causes continued proximal movement of the actuator member carriage 152, which moves actuator members 84, while motion of the sheath carriage 132 ceases; thus, 84 translates relative to 12; [0079]), the second guide member (84) being operable to translate relative to the body along a second longitudinal range of motion from a second proximal-most position (Fig. 8, as actuator members 84 stops translating proximally when actuator member carriage 152 is in its proximal most position; [0078]) to a second distal-most position (Fig. 6; as actuator member 84 is translated distally until actuator member carriage 152 is within lost motion barrel 158; [0077]); and an actuator (including at least 132, 152, 158, lead screw 134, control knob 122, rotatable ring 155), the actuator comprising a rotary member (lead screw 134) operable to rotate relative to the body (18) to thereby simultaneously drive translation of the catheter (12) along the first longitudinal range of motion and the second guide member (84) along the second longitudinal range of motion (as actuating the lead screw 134 by rotating control knob 122 simultaneously and/or sequentially actuates the actuator member carriage 152 and the sheath carriage 132 to translate both the outer sheath 12 and the actuation members 84; [0089]). Thus, both Matlock and Calomeni teach actuators operable to simultaneously drive translation of a catheter along a first longitudinal range of motion and a second guide member along a second longitudinal range of motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the unitary slidable actuator of Matlock the rotary actuator taught by Calomeni because the substitution of one known actuator for another would have yielded the predictable result of simultaneously driving translation of the dilation catheter along the first longitudinal range of motion and the guide element along the second longitudinal range of motion i.e., a coordinated axial motion of two elongate members from a single rotary input to achieve synchronized translations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gorlewicz et al. (US 2022/0183716 A1) and Weldon et al. (US 2003/0191516 A1) are noted for teaching rotary actuators.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771