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 .
Notice of Amendment
In response to the amendment filed on 2/24/2026, amended claims 1, 3, 8, 14, 16-17, and 19, cancelled claims 9 and 15, and new claims 21-22 are acknowledged. Claims 1-8, 10-14, and 16-22 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 16 recites the limitations “a proximal end of the first articulation wire is removably received within the first slot, such that the first articulation wire is replaceable with a third articulation wire following a use of the medical device in a medical procedure” and “a proximal end of the second articulation wire is removably received within the second slot, such that the second articulation wire is replaceable with a fourth articulation wire following a use of the medical device in a medical procedure” which do not appear to be supported by the disclosure as originally filed. Moreover, Applicant has failed to clearly point out where these new limitations are supported in the original disclosure. There does not appear to be any description of
the first and second articulation wires being replaceable with third and fourth articulation wires following a use of the medical device in a medical procedure.
Claims 17-18 are rejected based on their dependence from independent claim 16.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Florio et al. (US Patent No. 7,056,314 B1) (previously cited).
Regarding claim 1, Florio et al. discloses a medical device comprising:
a shaft (42);
an articulation wire (70, 71, 72, 73) extending through at least a portion of the shaft (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”); and
a handle (54), including:
a handle body (80) having an outer surface that defines a channel (see Figures 3 and 8), wherein the channel has an opening extending along a radially outer side of the channel (see Figure 3), wherein the opening is formed through the outer surface of the handle body (see Figure 3), wherein the outer surface is between a proximal end of the handle body and a distal end of the handle body, wherein a proximal portion (55) of the shaft is received within a first portion of the channel (see Figure 8), and wherein a proximal portion of the articulation wire is received within a second portion of the channel (see Figure 8); and
a control member (92, 93, 94, 95) that is movable relative to the handle body to move the distal portion of the articulation wire relative to the distal portion of the shaft (see col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion. Thus, each knob may be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46 of the obturator body to guide and steer the tip of the obturator around obstructions and ultimately into the coronary sinus os”).
Regarding claim 2, Florio et al. discloses wherein the articulation wire is a first articulation wire (70), and the control member is a first control member (92), and further comprising:
a second articulation wire (71, 72, 73) extending through the at least the portion of the shaft, and wherein a proximal portion of the second articulation wire is removably received within a third portion of the channel (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”); and
a second control member (93, 94, 95) that is movable relative to the handle body to move the distal portion of the second articulation wire relative to the distal portion of the shaft (see col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion. Thus, each knob may be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46 of the obturator body to guide and steer the tip of the obturator around obstructions and ultimately into the coronary sinus os”).
Regarding claim 3, Florio et al. discloses each of the second portion of the channel and the third portion of the channel is proximal to the first portion of the channel (see Figure 8), wherein the opening extends along at least a portion of the first channel, the second channel, and the third channel, such that each of the first channel, the second channel, and the third channel have an open radially outer side.
Regarding claim 5, Florio et al. discloses a wire fixation body (see Figure 8 near element 102 where wire attaches to knob) connected to the control member, wherein the wire fixation body defines a first slot in communication with the second portion of the channel, and wherein the articulation wire is removably received within the first slot (see col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion”).
Regarding claim 21, Florio et al. discloses the first slot extends from a proximal end of the wire fixation body to a distal end of the wire fixation body (see Figure 8).
Regarding claim 22, Florio et al. discloses the opening extends along an entire longitudinal length of the channel (see Figures 3 and 8).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio et al.
Regarding claim 4, it is noted Florio et al. does not specifically teach the channel has an approximately Y-shape. However, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the channel to have an approximately Y-shape, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of receiving the shaft and articulation wires. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim(s) 6 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio et al., further in view of Tegg (US Publication No. 2008/0159825 A1) (previously cited).
Regarding claim 6, it is noted Florio et al. does not specifically teach the control member is a first control member, and further comprising a second control member, wherein movement of the second control member relative to the handle body changes a width of the first slot. However, Tegg teaches the control member is a first control member, and further comprising a second control member (58), wherein movement of the second control member relative to the handle body changes a width of the first slot (56) (see Figures 5-6 and [0038] – “In order to restrain a wire passing through opening 54 in at least one axial direction, one end of slot 56--in particular, proximal end 62 against which biasing device 60 biases locking pin 58--is narrower than a distal end 66 of slot 56. Slot 56 is preferably an elongate slot defined by an axial surface 68, an inclined surface 70 opposite axial surface 68, and proximal and distal ends 62, 66, which join axial surface 68 and inclined surface 70”, [0039] – “To facilitate loading, the operator compresses biasing device 60 into the configuration shown in phantom in FIGS. 5 and 6 by moving locking pin 58 distally. This permits downward movement of locking pin 58 along inclined surface 70, increasing the gap between locking pin 58 and axial surface 68, and thereby permitting wire 72 to pass between locking pin 58 and axial surface 68 and move freely in the direction of arrow 76”, and [0040] – “Once locking pin 58 is released, however, biasing device 60 re-expands, its restorative force urging locking pin 58 upwards along inclined surface 70 towards proximal end 62 of slot 56. Wire 72 is now secured between locking pin 58 and axial surface 68”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Florio et al. to include the control member is a first control member, and further comprising a second control member, wherein movement of the second control member relative to the handle body changes a width of the first slot, as disclosed in Tegg, so as to permit articulation wire to move freely within the slot in a first position and lock wire within the slot in a second position.
Regarding claim 12, Tegg teaches the second control member includes a slider (58) (see [0039] – “To facilitate loading, the operator compresses biasing device 60 into the configuration shown in phantom in FIGS. 5 and 6 by moving locking pin 58 distally”).
Regarding claim 13, the combination of Florio et al. in view of Tegg teaches the first control member is disposed on a first side of the handle, and wherein the second control member is disposed on a second side of the handle, wherein the second side is different from the first side (see Florio et al.: Figures 3 and 8).
Regarding claim 14, the combination of Florio et al. in view of Tegg teaches the opening of the channel is on the first side of the handle (see Florio et al.: Figures 3 and 8).
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio et al., further in view of Tegg and Meduri et al. (US Publication No. 2020/0337683 A1).
Regarding claim 16 as best understood, Florio et al. teaches a medical device comprising:
a shaft (42);
a first articulation wire (70) extending through at least a portion of the shaft (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”);
a second articulation wire (71, 72, 73) extending through at least the portion of the shaft (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”); and
a handle (54), including:
a first wire fixation body (see Figure 8 near element 102 where wire attaches to knob) defining a first slot, wherein a proximal end of the first articulation wire is received within the first slot (see col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion”); and
a second wire fixation body (see Figure 8 near element 102 where wire attaches to knob) defining a second slot, wherein a proximal end of the second articulation wire is received within the second slot (see col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion”).
It is noted Florio et al. does not specifically teach a proximal end of the first articulation wire is removably received within the first slot, such that the first articulation wire is replaceable with a third articulation wire following a use of the medical device in a medical procedure, a proximal end of the second articulation wire is removably received within the second slot, such that the second articulation wire is replaceable with a fourth articulation wire following a use of the medical device in a medical procedure, or a control member, wherein movement of the control member changes a first width of the first slot and a second width of the second slot. However, Meduri et al. teaches a proximal end of the first articulation wire is removably received within the first slot, such that the first articulation wire is replaceable with a third articulation wire following a use of the medical device in a medical procedure, a proximal end of the second articulation wire is removably received within the second slot, such that the second articulation wire is replaceable with a fourth articulation wire following a use of the medical device in a medical procedure (see Figure 11 and [0035] – “It is advantageous to permit a portion of the catheter 12 to be detached from the assembly 10. This detachability permits portions of the assembly to be discarded after use, while portions of the assembly, such as the control handle 20, may be reused. In the example embodiment shown in FIG. 11, a first length 110 of catheter 12 comprising the proximal end 18 is permanently affixed to the control handle 20, and a second length 112, comprising the majority of the catheter 12 and including the distal end 16 (not shown) is removably attached to the first length 110. Attachment may be via a coupling 114, which could use friction to secure the lengths 110 and 112 to one another. Other types of couplings including compression couplings and bayonet couplings are also feasible. Additional fittings 116, such as spring biased clips, may be used to removably attach the articulation wires 36 and 50 to the traction mechanism 22. FIG. 11A shows an alternate embodiment of the catheter assembly having a unitary (i.e., single piece) disposable catheter 12 whose proximal end 18 (shown disconnected) is removably attached to the luer fitting 106. In this embodiment both the first and second articulation wires 36 and 50 extend through the lumen 14 and exit the catheter short of its proximal end 18. The control handle 20 may be partially disassembled to connect the articulation wires 36 and 50 to the traction mechanism 22. Luer fitting 106 is also removably attached to handle 20, for example, using screw threads. Any portion of the catheter assembly exposed to a patient's fluids must be removable from handle 20 and disposable”). Tegg teaches a control member (58), wherein movement of the control member changes a first width of the first slot (56) and a second width of the second slot (56) (see Figures 5-6 and [0038] – “In order to restrain a wire passing through opening 54 in at least one axial direction, one end of slot 56--in particular, proximal end 62 against which biasing device 60 biases locking pin 58--is narrower than a distal end 66 of slot 56. Slot 56 is preferably an elongate slot defined by an axial surface 68, an inclined surface 70 opposite axial surface 68, and proximal and distal ends 62, 66, which join axial surface 68 and inclined surface 70”, [0039] – “To facilitate loading, the operator compresses biasing device 60 into the configuration shown in phantom in FIGS. 5 and 6 by moving locking pin 58 distally. This permits downward movement of locking pin 58 along inclined surface 70, increasing the gap between locking pin 58 and axial surface 68, and thereby permitting wire 72 to pass between locking pin 58 and axial surface 68 and move freely in the direction of arrow 76”, and [0040] – “Once locking pin 58 is released, however, biasing device 60 re-expands, its restorative force urging locking pin 58 upwards along inclined surface 70 towards proximal end 62 of slot 56. Wire 72 is now secured between locking pin 58 and axial surface 68”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Florio et al. to include a proximal end of the first articulation wire is removably received within the first slot, such that the first articulation wire is replaceable with a third articulation wire following a use of the medical device in a medical procedure, a proximal end of the second articulation wire is removably received within the second slot, such that the second articulation wire is replaceable with a fourth articulation wire following a use of the medical device in a medical procedure, as disclosed in Meduri et al., so as to allow portions of the medical device that are exposed to patient’s fluids to be removable from handle and discarded after use, while other portions of the device, such as the handle, may be reused (see Meduri et al.: [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Florio et al. to include a control member, wherein movement of the control member changes a first width of the first slot and a second width of the second slot, as disclosed in Tegg, so as to permit articulation wires to move freely within the slot in a first position and lock wires within the slot in a second position.
Regarding claim 18, the combination of Florio et al. and Tegg teaches the control member is a first control member (see Tegg as referenced above), wherein the medical device further comprises:
a second control member (92, 93, 94, 95) configured to move the first wire fixation body, thereby moving the proximal end of first articulation wire relative to the shaft (see Florio et al.: col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion. Thus, each knob may be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46 of the obturator body to guide and steer the tip of the obturator around obstructions and ultimately into the coronary sinus os”).; and
a third control member (92, 93, 94, 95) configured to move the second wire fixation body, thereby moving the proximal end of the second articulation wire relative to the shaft (see Florio et al.: col. 6, lines 24-34 – “The actuation members 70 73 are attached at their proximal ends to displacement control members, for example, knobs 92 95, respectively, longitudinally slidable along the length of the tubular portion 82 of the handle 54 within slots 96 98, respectively, formed in the tubular portion. Thus, each knob may be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46 of the obturator body to guide and steer the tip of the obturator around obstructions and ultimately into the coronary sinus os”).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio et al., further in view of Suon et al. (US Publication No. 2012/0197190 A1).
Regarding claim 19, Florio et al. discloses a method of using a medical device, the method comprising:
inserting a proximal end of a shaft (42) into a first portion of a channel defined by a body of a handle (54) of the medical device (see Figure 8);
inserting a proximal end of a first articulation wire (70) into a second portion of the channel (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”); and
inserting a proximal end of a second articulation wire (71, 72, 73) into a third portion of the channel (see Figures 5-8 and col. 5, lines 45-48 – “The actuator 52 further includes elongated actuation members 70 73, which may comprise pull wires or cables, that extend from the control handle 54 through the outer lumens 58 61, respectively, in the obturator body”).
It is noted Florio et al. does not specifically teach moving a single control member in a first direction relative to the body, thereby securing each of the shaft, the first articulation wire, and the second articulation wire to the handle. However, Suon et al. teaches moving a single control member (60) in a first direction relative to the body, thereby securing each of the shaft, the first articulation wire, and the second articulation wire to the handle (see Figures 4A-B and [0042] – “In some embodiments, a securing member 60 can be configured to move to releasably couple handle control members 250 and catheter control members 255” and [0056] – “Securing member 60 can be moved to releasably couple a plurality of handle control members 250 and a plurality of catheter control member 255. Securing member 60 can be configured to move relative to handle 50 or catheter 70. For example, securing member 60 can move rotationally or longitudinally relative to handle 50. In particular, securing member 60 may move distally from a first position 62 (as shown in FIG. 4A) to a second position 64 (as shown in FIG. 4B). Handle control member 250 may remain in a fixed position relative to handle 50 as securing member 60 is moved from first position 62 to second position 64. Securing member 60 can also move proximally from second position 64 to first position 62. Such movements can couple and decouple handle 50 and catheter 70”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Florio et al. to include moving a single control member in a first direction relative to the body, thereby securing each of the shaft, the first articulation wire, and the second articulation wire to the handle, as disclosed in Suon et al., so as to easily couple and decouple the handle and the shaft (see Suon et al.: [0056]).
Regarding claim 20, Suon et al. teaches moving a control wire in a second direction relative to the body, thereby releasing the shaft, the first articulation wire, and the second articulation wire from the handle; removing the shaft, the first articulation wire, and the second articulation wire from the handle (see Figures 4A-B and [0042] – “In some embodiments, a securing member 60 can be configured to move to releasably couple handle control members 250 and catheter control members 255” and [0056] – “Securing member 60 can be moved to releasably couple a plurality of handle control members 250 and a plurality of catheter control member 255. Securing member 60 can be configured to move relative to handle 50 or catheter 70. For example, securing member 60 can move rotationally or longitudinally relative to handle 50. In particular, securing member 60 may move distally from a first position 62 (as shown in FIG. 4A) to a second position 64 (as shown in FIG. 4B). Handle control member 250 may remain in a fixed position relative to handle 50 as securing member 60 is moved from first position 62 to second position 64. Securing member 60 can also move proximally from second position 64 to first position 62. Such movements can couple and decouple handle 50 and catheter 70”).
Allowable Subject Matter
Claims 7-8, 10-11, and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
A reason for indicating allowable subject matter will be provided in a future Office Action.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
Applicant argues that Florio does not disclose at least “a handle body having an outer surface that defines a channel, wherein the channel has an opening extending along a radially outer side channel, wherein the opening is formed through the outer surface of the handle body, wherein the outer surface is between a proximal end of the handle body and a distal end of the handle body”. The Examiner respectfully disagrees and notes that Figures 3 and 8 of Florio show a handle body (54, 80, 82) with a central lumen (86) that extends to an outer surface defining at least three openings (96, 97, 98) that are along a radial outer side and are formed through the outer surface of the handle body that extends between a proximal end and a distal end of the handle body. Thus, Florio still reasonably maps to the claim language of amended claim 1.
Applicant’s arguments with respect to claim(s) 16 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
Prosecution Insights