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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/30/22 and 12/30/21 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on October 14, 2025, amended claim 40 has been entered.
Response to Arguments
Applicant’s arguments and amendments filed with respect to the prior art rejections raised in the previous office action were fully considered, but were not persuasive. Applicant argues Marchand does not teach a cam or cam barrel. Applicant further adds that Marchand teaches a pin that is fixed in place in a slot and is non-moveably secured in the slot. Examiner disagrees and notes that Marchand’s pin and slot do in fact act as the cam and cam channel as claimed in the present Application. Examiner notes that since the pin is also attached to a slide nut in the slot, the pin moves in the slot [par. 72, 73], which would infer the pin is not fixed in place. Therefore, this equates to a cam and cam channel, when taking into consideration broadest reasonable interpretation. It is further noted that the claim language also requires the cam to travel along the cam channel so clarification in the claim language would be requested in terms of when the cam should be fixably coupled versus capable of traveling along the cam channel.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-29 and 32 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Marchand (U.S. Patent Application Publication 2008/0065011 A1)
Marchand was applied in the previous office action
Regarding claim 21, Marchand teaches an apparatus comprising:(a) a body [fig. 1, element 20]; (b) a shaft assembly extending distally from the body and defining a longitudinal axis, wherein the shaft assembly comprises: (i) a rigid proximal portion [fig. 7A, element 114; par. 79], and (ii) a flexible distal portion [fig. 7A, element 56; par. 79], (c) a dilation catheter slidable relative to the shaft assembly; wherein the dilation catheter comprises an expandable dilator [fig. 1, element 28; par. 60, 61]: and (d) a deflection actuation assembly comprising: (i) a first rotary actuator [fig. 1, element 70; par. 70], (ii) a first translatable actuation member operatively coupled with the first rotary actuator [fig. 3A, 3B, element 68; par. 70, 71], wherein the first translatable actuation member includes a cam channel [fig. 5A, element 82; par. 72, 73], (iii) a second translatable actuation member extending through the shaft assembly, wherein the second translatable actuation member couples the first translatable actuation member with the flexible distal portion of the shaft assembly [fig. 3A, 3B, element 74; par. 72, 73], wherein the first rotary actuator is configured to drive the first and second translatable actuation members longitudinally, wherein the flexible distal portion is configured to deflect away from the longitudinal axis in response to translation of the first and second translatable actuation members longitudinally [par. 70-73], and (iv) a cam fixably coupled with the first rotary actuator, wherein the cam is configured to travel along the cam channel [fig. 5A, element 80; par. 72, 73].
Regarding claim 22, Marchand further teaches the first translatable actuation member comprises a cam barrel, wherein the cam barrel includes the cam channel [fig. 5A, element 68, 82; Examiner notes the cam barrel is interpreted to be the portion of the first actuation member (slide nut 68) that comprises the cam channel]
Regarding claim 23, Marchand further teaches the cam barrel is configured to translate the second translatable actuation member to cause straightening or bending of the flexible distal portion in response to translation of the cam barrel [par. 72, 73; Examiner notes the second translatable actuation member 74 moves through the cam channel and connects to the flexible distal portion 56 to pull the flexible distal portion].
Regarding claim 24, Marchand further teaches the second translatable actuation member comprises a pull-wire having proximal and distal ends, wherein the distal end of the pull-wire is secured with a distal end of the flexible distal portion [fig. 3A, 3B, element 74; par. 72, 23; Examiner notes the second translatable actuation member consists of the pull-wire].
Regarding claim 25, Marchand further teaches 24, wherein the pull-wire is configured to translate with the cam barrel relative to the rigid proximal portion in response to rotation of the first rotary actuator relative to rigid proximal portion [par. 79, 80; Examiner notes the rigid proximal portion 114 is connected to the pull-wire].
Regarding claim 26, Marchand further teaches the cam channel has a plurality of channel portions, wherein the channel portions are in communication with each other [fig. 5A, elements 82, 98; par. 72].
Regarding claim 27, Marchand further teaches the cam channel includes at least one detent feature providing transitions between the channel portions [par. 73, 74; Examiner notes the pull-wire transitions between the channel portions (slots in the slide nut)]
Regarding claim 28, Marchand further teaches the at least one detent feature of the cam channel is positioned at a location corresponding to at least one predetermined deflection angle of the flexible distal portion of the shaft assembly [par. 72, 73; Examiner notes when the adjustment knob is rotated, the pull wire bends the flexible distal portion 56].
Regarding claim 29, Marchand further teaches the first rotary actuator is configured to provide tactile feedback corresponding to the at least one predetermined deflection angle in response to rotation of the first rotary actuator [par. 72, 73; “the pin 80 is allowed to float within slot 82 of the slide nut 68 when the knob 70 is adjusted to reduce tension in the pull wire, preventing buckling of the pull wire.”].
Regarding claim 32, Marchand further teaches (a) a guidewire slidably disposed in the dilation catheter; and (b) a guidewire actuation assembly, wherein the guidewire actuation assembly is operable to translate the guidewire relative to the body, wherein the guidewire actuation assembly is operable to rotate the guidewire about the longitudinal axis [fig. 4A, 4B, element 140; par. 85, 94, 95]
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 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 30, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Marchand and in further view of Khuu (U.S. Patent Application Publication 2017/0266413 A1)
Khuu was applied in Applicant’s IDS submitted on 12/30/21 and the previous office action
Regarding claim 30, Marchand teaches an apparatus comprising a body and a shaft assembly, as disclosed above
However, Marchand does not teach the at least one predetermined deflection angle includes a first angle, a second angle, and a third angle, wherein the first angle is in a range from approximately 50 degrees to approximately 60 degrees, wherein the second angle is in a range from approximately 65 degrees to approximately 70 degrees, wherein the third angle is in a range from approximately 105 degrees to approximately 115 degrees.
Khuu teaches the at least one predetermined deflection angle includes a first angle, a second angle, and a third angle, wherein the first angle is in a range from approximately 50 degrees to approximately 60 degrees, wherein the second angle is in a range from approximately 65 degrees to approximately 70 degrees, wherein the third angle is in a range from approximately 105 degrees to approximately 115 degrees [fig. 21; par. 42, 43]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate the at least one predetermined deflection angle includes a first angle, a second angle, and a third angle, wherein the first angle is in a range from approximately 50 degrees to approximately 60 degrees, wherein the second angle is in a range from approximately 65 degrees to approximately 70 degrees, wherein the third angle is in a range from approximately 105 degrees to approximately 115 degrees, for selecting a desired flexion position of the distal tip of an attached catheter, as evidence by Khuu [par. 42].
Regarding claim 31, Khuu further teaches the first angle is approximately 55 degrees, wherein the second angle is approximately 70 degrees, wherein the third angle is approximately 110 degrees [fig. 21; par. 42, 43 “The use of a cam feature in the disclosed control handles can provide an infinite degree of choice in selecting a desired flexion position of the distal tip of an attached catheter”].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate the first angle is approximately 55 degrees, wherein the second angle is approximately 70 degrees, wherein the third angle is approximately 110 degrees, for selecting a desired flexion position of the distal tip of an attached catheter, as evidence by Khuu [par. 42].
Regarding claim 33, Khuu further teaches the body comprises a body portion and a grip portion, wherein the grip portion is selectively removable from the body portion [fig. 2, elements 34, 64]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate the body comprises a body portion and a grip portion, wherein the grip portion is selectively removable from the body portion, for controlling the circumferential angle of distal tip, as evidence by Khuu [par. 36].
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand and Khuu and in further view of Suehara (U.S. Patent Application Publication 2016/0015250 A1)
Suehara was applied in the previous office action
Regarding claim 34, Marchand and Khuu teach an apparatus comprising a body and a shaft assembly, as disclosed above
However, Marchand and Khuu do not teach the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion
Suehara teaches the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion [fig. 6, elements 30, 62; Examiner notes element 30 slides longitudinally relative to grip portion 62; par. 80-82]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand and Khuu, to incorporate the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion, for allowing the elongate member perform an advance/retraction action and a bending action, as evidence by Suehara [par. 81].
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand and in further view of Suehara
Regarding claim 35, Marchand teaches an apparatus comprising a body and a shaft assembly, as disclosed above
However, Marchand does not teach the flexible distal portion includes a flex section that is formed by a series of ribs that are separated by a series of V-shaped notches.
Suehara teaches the flexible distal portion includes a flex section that is formed by a series of ribs that are separated by a series of V-shaped notches [fig. 6, elements 11, 35; par. 55, 64].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate the flexible distal portion includes a flex section that is formed by a series of ribs that are separated by a series of V-shaped notches, for allowing the elongate member to perform a bending action, as evidence by Suehara [par. 64].
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Marchand and in further view of Khuu and Suehara
Regarding claim 40, Marchand teaches an apparatus comprising: (a) a body comprising: (i) body portion [fig. 1, element 20], (b) a shaft assembly extending distally from the body and defining a longitudinal axis, wherein the shaft assembly comprises: (i) a rigid proximal portion [fig. 7A, element 114; par. 79], and (ii) a flexible distal portion [fig. 7A, element 56; par. 79]; and (c) a deflection actuation assembly comprising: (i) a first rotary actuator [fig. 1, element 70; par. 70] having a cam secured thereto [par. 72, 73; Examiner notes the pin is connected to slide nut which is connected to the first rotary actuator], (ii) a cam barrel operatively coupled with the first rotary actuator, the cam barrel having a cam channel into which the cam of the first rotary actuator is received [fig. 5A, element 68, 82; Examiner notes the cam barrel is interpreted to be the portion of the first actuation member (slide nut 68) that comprises the cam channel], and (iii) a pull-wire [fig. 3B, element 74] extending through the shaft assembly [fig. 3B element 74], wherein the pull-wire couples the cam barrel with the flexible distal portion of the shaft assembly [par. 72, 73; Examiner notes the pull-wire is connected to the slide nut and pin located in the slot], wherein rotation of the first rotary actuator moves the cam within the cam channel so as to move the cam barrel and the pull-wire longitudinally [par. 72, 73, 79, 80; Examiner notes the knob, which rotates, moves the slide nut with the pin, further moving the wire], wherein the flexible distal portion is configured to deflect away from the longitudinal axis in response to translation of the cam barrel and the pull-wire longitudinally [par. 72, 73].
However, Marchand does not teach a grip portion that is selectively removable from the body portion, wherein the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion.
Khuu teaches a grip portion that is selectively removable from the body portion [fig. 2, elements 34, 64]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate a grip portion that is selectively removable from the body portion, for controlling the circumferential angle of distal tip, as evidence by Khuu [par. 36].
Suehara teaches the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion [fig. 6, elements 30, 62; Examiner notes element 30 slides longitudinally relative to grip portion 62; par. 80-82]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Marchand, to incorporate the body portion and the grip portion include complementary rail and recess features that are configured to provide sliding longitudinal engagement between the body portion and the grip portion, wherein the body portion and the grip portion further include complementary detent features that are configured to selectively maintain a longitudinal position of the grip portion relative to the body portion, for allowing the elongate member perform an advance/retraction action and a bending action, as evidence by Suehara [par. 81]
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of US Patent No. 10874839. Although the claims at issue are not identical, they are not patentably distinct from each other as they are understood to be obvious variants of one another. Dependent claims 22-35 are also substantially claimed in 10874839.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13 and 14 of US Patent No. 10874839. Although the claims at issue are not identical, they are not patentably distinct from each other as they are understood to be obvious variants of one another.
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 extension fee 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 date of this final action.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791