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 .
Response to Amendment
The amendment filed June 10, 2026 has been entered. Claims 1-10 are currently pending.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Williams et al. (US 2024/0261537, hereinafter “Williams”).
Regarding claim 1, Williams discloses a sequential dilator assembly for a vessel; the sequential dilator assembly comprising:
a first dilator segment (120) at least partially nested in a second dilator segment (115) that is at least partially nested within a third dilator segment (110), wherein the first dilator segment (120) is configured to be axially moved distally relative to the second dilator segment (115) when the second dilator segment (115) is nested within the third dilator segment (110) (para [0014] – “the inner tube, 115 and innermost member 120 can co-axially slide relative to one another and relative to the outer sheath 110”), and where the first dilator segment (120) is configured to be releasably locked with the second dilator (115) segment into both a first compact locked configuration (Fig 3) and a first extended locked configuration (Fig 4) (locked positions controlled by control system 505 – para [0020-0025]; para [0023] – “the stages may also include locking mechanisms to ensure they do not move unintentionally”); and
where the second dilator segment (115) is configured to be axially moved distally relative to the third dilator segment (110) independent of whether the first dilator segment (120) and the second dilator segment (115) are in either the first compact locked configuration or the first extended locked configuration (Figs 2-4; locked positions controlled by control system 505, wherein each dilator segment is configured to be controlled independently of the other – para [0020-0025]), and where the second dilator segment (115) is configured to be releasably locked with the third dilator segment (110) into both a second compact locked configuration (Fig 2) and a second extended locked configuration (Fig 3 or 4).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lobo et al. (US 2021/0386454, hereinafter “Lobo”).
Regarding claim 1, Lobo discloses a sequential dilator assembly for a vessel (A dilator is well known to be a tube-shaped device inserted in a tissue opening to expand the opening. First, second and third tubular members – 260, 240, and 220 - are fully capable of sequentially being extended to dilate a vessel and thus is interpreted as a sequential dilator assembly.); the sequential dilator assembly comprising:
a first dilator segment (260) at least partially nested in a second dilator segment (240) that is at least partially nested within a third dilator segment (220), wherein the first dilator segment (260) is configured to be axially moved distally relative to the second dilator segment (240) when the second dilator segment (240) is nested within the third dilator segment (220) (para [0045]), and where the first dilator segment (260) is configured to be releasably locked with the second dilator segment (240) into both a first compact locked configuration (Figs 7-9, 11 – second protrusion 248 of second segment 240 locked within distal circular groove 269 of first segment 260; para [0047, 0050]) and a first extended locked configuration (Figs 15, 17 – second protrusion 248 of second segment 240 locked within proximal circular groove 267 of first segment 260; para [0052]); and
where the second dilator segment (240) is configured to be axially moved distally relative to the third dilator segment (220) independent of whether the first dilator segment (260) and the second dilator segment (240) are in either the first compact locked configuration or the first extended locked configuration (para [0045]), and where the second dilator segment (240) is configured to be releasably locked with the third dilator segment (220) into both a second compact locked configuration (Figs 9-11 – first protrusion 224 of first segment 220 received in distal groove 249 of second segment 240; para [0050]) and a second extended locked configuration (Figs 15-16 – first protrusion 224 of first segment 220 received in proximal groove 247 of second segment 240; para [0051-0052]).
Regarding claim 2, further comprising: at least a first circumferential groove (269) on an outer surface of the first dilator segment (260); and a protrusion (248) on an inner surface of the second dilator segment (240), wherein when the protrusion engages the first circumferential groove, the first dilator segment and the second dilator segment are in the first compact locked configuration (Figs 7-9, 11 – second protrusion 248 of second segment 240 locked within distal circular groove 269 of first segment 260; para [0047, 0050]).
Regarding claim 3, further comprising a plurality of grooves (distal circular groove 269 and proximal circular groove 267) radially spaced apart on the outer surface of the first dilator segment (260), wherein the protrusion is configured to engage with any of the plurality of grooves (para [0047]).
Regarding claim 4, further comprising a second circumferential groove (249) on an outer surface of the second dilator segment (240) and a protrusion (224) on an inner surface of the third dilator segment (220), wherein when the protrusion of the third dilator segment engages the second circumferential groove of the second dilator segment, the second dilator segment and the third dilator segment are in the second compact locked configuration (Figs 9-11 – first protrusion 224 of first segment 220 received in distal groove 249 of second segment 240; para [0050]).
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Lobo et al. (US 2021/0386454, hereinafter “Lobo”) in view of Mauch (US 2018/0126121, hereinafter “Mauch”). Lobo discloses the invention substantially as claimed, as shown above, but fails to disclose the claimed alignment markers. Mauch discloses a similar dilator assembly or assembly of nested tubular members, wherein a first dilator segment (tubular member 22) is at least partially nested in a second dilator segment (tubular member 18) that is at least partially nested within a third dilator segment (tubular member 20) (telescoping arrangement - Figs 6-7; para [0018-0019; 0032]). Mauch teaches the first dilator segment (22) comprises a first alignment marker (66) and the second dilator segment (18) comprises a second alignment marker (66), wherein the first alignment marker and the second alignment marker are used as indicators to indicate positional coupling and alignment of the tubular segments, or dilator segments (22, 18) respectively when extended and selectively coupled or locked (para [0027]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lobo to include alignment markers, as taught by Mauch, to indicate a positional coupling and alignment of the tubular or dilator segments. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Lobo and Mauch to position the alignment markers such that they were longitudinally aligned when the first dilator segment was axially moveable relative to the second dilator segment or such that the alignment markers were longitudinally misaligned when the first dilator segment was axially locked relative to the second dilator segment or such that the alignment markers were longitudinally misaligned when the first dilator segment was rotatable relative to the second dilator segment, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Lobo et al. (US 2021/0386454, hereinafter “Lobo”), as applied to claim 2 above, in view of LaPierre et al. (US 2021/0228198, hereinafter “LaPierre”). Lobo discloses the invention substantially as claimed, as shown above, including a sequential dilator assembly for a vessel (A dilator is well known to be a tube-shaped device inserted in a tissue opening to expand the opening. First, second and third tubular members – 260, 240, and 220 - are fully capable of sequentially being extended to dilate a vessel and thus is interpreted as a sequential dilator assembly.); the sequential dilator assembly comprising:
a first dilator segment (260) at least partially nested in a second dilator segment (240) that is at least partially nested within a third dilator segment (220), wherein the first dilator segment (260) is configured to be axially moved distally relative to the second dilator segment (240) when the second dilator segment (240) is nested within the third dilator segment (220) (para [0045]), and where the first dilator segment (260) is configured to be releasably locked with the second dilator segment (240) into both a first compact locked configuration (Figs 7-9, 11 – second protrusion 248 of second segment 240 locked within distal circular groove 269 of first segment 260; para [0047, 0050]) and a first extended locked configuration (Figs 15, 17 – second protrusion 248 of second segment 240 locked within proximal circular groove 267 of first segment 260; para [0052]); and
where the second dilator segment (240) is configured to be axially moved distally relative to the third dilator segment (220) independent of whether the first dilator segment (260) and the second dilator segment (240) are in either the first compact locked configuration or the first extended locked configuration (para [0045]), and where the second dilator segment (240) is configured to be releasably locked with the third dilator segment (220) into both a second compact locked configuration (Figs 9-11 – first protrusion 224 of first segment 220 received in distal groove 249 of second segment 240; para [0050]) and a second extended locked configuration (Figs 15-16 – first protrusion 224 of first segment 220 received in proximal groove 247 of second segment 240; para [0051-0052]).
However, Lobo fails to disclose the first dilator segment (260) comprises a longitudinal groove on an outer surface of the first dilator segment, where the protrusion (224) of the second dilator segment (240) is configured to slide along the longitudinal groove when transitioning the first dilator segment between the first compact locked configuration (Figs 7-9, 11 – second protrusion 248 of second segment 240 locked within distal circular groove 269 of first segment 260; para [0047, 0050]) and the first extended locked configuration (Figs 15, 17 – second protrusion 248 of second segment 240 locked within proximal circular groove 267 of first segment 260; para [0052]).
LaPierre discloses a similar device having inner (140) and outer (200) tubes mate with
each other along their length (Figs 1-2), wherein the outer tube comprises a plurality of grooves 230a-k) radially spaced apart on the outer surface of the outer tube and joined by longitudinal channel (220) extending along the length of the outer tube and wherein the inner tube comprises at least one protrusion (160) that engages with any of the plurality of grooves to lock along different lengths of the outer tube (para [0028-0029]). Thus, the outer tube may be locked to the inner tube in a compact locked configuration (for example protrusion 160 engaged to grooves 230a or 230b) or in an extended locked configuration (for example protrusion 160 engaged to grooves 230j or 230k, see Fig 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lobo such that the connection between the first and second dilator segments comprised a plurality of grooves joined by a longitudinal channel on one dilator segment such that the protrusion on the other dilator segment can selectively engage a distal groove or a proximal groove to move between a compact locked configuration and an extended locked configuration, as taught by LaPierre, and provide more precise control.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gephart (US 2008/0051821) teaches a sequential dilator with a plurality of operably connected, coaxial sleeves
Smith (US 4,862,891) teaches a generic sequential dilator comprising at least three
dilator segments
Bar et al. (US 2016/0206347) teaches a sequential dilator with a screw type mechanism
between at least three dilator segments
THIS ACTION IS MADE FINAL. 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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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, 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.
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.
/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
Prosecution Insights