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 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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Mauch (US 2018/0126121, hereinafter “Mauch”).
Mauch 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— 22, 18, and 20 – 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 (tubular member 22) 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]), wherein the first dilator segment can be axially moved distally relative to the second dilator segment when nested within the third dilator segment (moving from position of Fig 6 to position of Fig 7), and
where the first dilator segment (22) can be releasably locked with the second dilator segment (18) into either a first compact locked configuration or a first extended locked configuration (can be locked in a first locked configuration para [0019]; twist/lock style coupling including protrusion 32 and channel 68 – para [0021-0023], Figs 2-3) (It is noted the claim recites the first and second dilator segments can be releasably locked in either a first compact locked configuration or a first extended locked configuration, but does not require both locked configurations); and
where the second dilator (18) segment can be axially moved distally relative to the third dilator segment (20) independent of whether the first dilator segment and the second dilator segment are in either the first compact locked configuration or the first extended locked configuration (each segment is fully capable of being independently locked/unlocked and fully capable of moving relative to one another when unlocked – para [0032]), and where the second dilator segment (18) can be releasably locked with the third dilator segment (20) into either a second compact locked configuration or a second extended locked configuration (can be locked in a second extended locked configuration – para [0019]; twist/lock style coupling including protrusion 52 and channel 68 – para [0021-0023], Figs 2-3) (It is noted the claim recites the second and third dilator segments can be releasably locked in either a second compact locked configuration or a second extended locked configuration, but does not require both locked configurations).
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Claim Rejections - 35 USC § 103
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (US 2018/0126121), as applied to claim 1 above, in view of LaPierre et al. (US 2021/0228198, hereinafter “LaPierre”).
Regarding claims 2-3, Mauch discloses at least a first groove (48) and protrusion (32) arrangement between the first dilator segment (22) and second dilator segment (18), wherein when the protrusion engages the first groove, the first dilator segment and the second dilator segment are in the first extended locked configuration.
Mauch fails to disclose at least a first groove on an outer surface of the first dilator segment; and a protrusion on an inner surface of the second dilator segment, wherein when the protrusion engages the first groove, the first dilator segment and the second dilator segment are in the first compact locked configuration or further comprising a plurality of grooves radially spaced apart on the outer surface of the first dilator segment, wherein the protrusion is configured to engage with any of the plurality of grooves, as claimed.
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 Mauch 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.
Furthermore, Mauch teaches the protrusion (32) is located on the outer surface of the first dilator segment (22) and the groove (48) is located on the second dilator segment (18), wherein when the protrusion engages the groove, the second dilator segment is locked with respect to the first dilator segment (para [0021-0023], Figs 2-3). 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 Mauch and LaPierre to rearrange the positions of the groove and protrusion of the locking mechanism such that groove was on the outer surface of the first dilator segment and the protrusion was on the inner surface of 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.
Regarding claim 4, Mauch discloses a groove (68) and protrusion (52) arrangement between the second dilator segment (18) and third dilator segment (20), wherein when the protrusion engages first groove, the first dilator segment and the second dilator segment are in the second extended locked configuration.
Mauch fails to disclose a groove on an outer surface of the second dilator segment and a protrusion on an inner surface of the third dilator segment, wherein when the protrusion of the third dilator segment engages the groove of the second dilator segment, the second dilator segment and the third dilator segment are in the second compact locked configuration.
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 Mauch such that the connection between the second and third 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.
Furthermore, Mauch teaches the protrusion (52) is located on the outer surface of the second dilator segment (18) and the groove (68) is located on the third dilator segment (20), wherein when the protrusion engages the groove, the second dilator segment is locked with respect to the third dilator segment (para [0021-0023], Figs 2-3). 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 Mauch and LaPierre to rearrange the positions of the groove and protrusion of the locking mechanism such that groove was on the outer surface of the second dilator segment and the protrusion was on the inner surface of the third 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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (US 2018/0126121), as applied to claim 1 above.
Regarding claims 5-7, Mauch discloses 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]).
It would have been obvious 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
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
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.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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