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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation of “wherein the attachment line comprises a ring connecting the first member with the second member” in claim 15 and “wherein the attachment line comprises a coil that connects the first member and the second member” in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti (US Pub No. 2003/0032975).
Regarding claim 1, Bonutti discloses (Figures 1-5) an arthroscopic retractor (10) that is fully capable in being used as an introducer sheath system including: a handle (proximal portion of 10 as shown in Figures 1-2) comprising a translation mechanism (16); and a sheath (12, 14) comprising: a first member (12) extending longitudinally along a length of the sheath, a proximal portion of the first member coupled to the handle (Figures 1-2) (Paragraph 0064); and a second member (14) extending longitudinally along a length of the sheath, a proximal portion (46) of the second member coupled to the translation mechanism (Paragraph 0065) such that rotation of the translation mechanism moves the second member in an axial direction (Paragraph 0069); wherein the first member and the second member are coupled such that activation of the translation mechanism causes the second member to move axially with respect to the first member (Paragraph 0069), thereby changing a diameter of the sheath from a first diameter (Figure 1) to a second diameter (Figure 2), wherein the second diameter is different from the first diameter (Figures 1-2).
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 of this title, 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.
Claims 1, 12, 14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Drasler (US Pub No. 2009/0240202) in view of Johnson (US Pub No. 2009/0312748).
Regarding claim 1, Drasler discloses (Figures 1-4B) an introducer sheath system (Figures 2A-2B) including: a handle (70) comprising a translation mechanism (85); and a sheath (20) comprising: a first member (40) extending longitudinally along a length of the sheath, a proximal portion of the first member coupled to the handle (Figures 2A-2B); and a second member (75) extending longitudinally along a length of the sheath (Figures 2A-2B), a proximal portion of the second member coupled to the translation mechanism (Paragraph 0041) such that movement of the translation mechanism moves the second member in an axial direction (Paragraph 0041); wherein the first member and the second member are coupled such that activation of the translation mechanism causes the second member to move axially with respect to the first member (Paragraph 0041), thereby changing a diameter of the sheath from a first diameter (Figure 2A) to a second diameter (Figure 2B), wherein the second diameter is different from the first diameter (Figures 2A-2B).
Drasler fails to disclose the proximal portion of the second member coupled to the translation mechanism such that rotation of the translation mechanism moves the second member in the axial direction.
Johnson, in the analogous art of medical devices for causing a rod to translate axially, teaches (Figures 1-3) a rotational detachment mechanism (10) that includes a handle (12) that includes a translation mechanism (48) and wherein rotation of the translation mechanism moves a control member (26) in an axial direction (Figures 1 and 3) (Paragraphs 0037-0039). Since both Drasler and Johnson are concerned with activation of a translation mechanism on the handle to cause movement of a member in an axial direction that is attached to the translation mechanism, then it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the translation mechanism of Drasler that slides with the translation mechanism of Johnson that is rotated, in order to achieve a predictable result of causing movement of a member in an axial direction that is attached to the translation mechanism (MPEP 2143).
Regarding claim 12, Drasler modified by Johnson further discloses wherein the first member is coupled to the second member with an attachment line (Drasler, 80) (Paragraph 0035).
Regarding claim 14, Drasler modified by Johnson further discloses wherein axial movement of the second member in a direction decreases tension on the attachment line such that a spacing between the second member and first member is reduced, changing a radial location of second member with respect to the first member and reducing the diameter of the sheath (Drasler, Paragraph 0041) (Figures 2A-2B).
Regarding claim 17, Drasler modified by Johnson further discloses wherein the attachment line attaches to the first member and the second member at a series of connection points (Drasler, Figures 2A-2B).
Regarding claim 18, Drasler modified by Johnson further discloses further comprising an outer cover (see annotated figure below for Drasler) extending around the sheath, where the first member is coupled to the outer cover.
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Regarding claim 19, Drasler modified by Johnson further discloses a set of elongate first members (Drasler, 40), wherein each first member of the set of elongate first members comprises a proximal portion that is fixedly attached to the handle (Drasler, Figures 2A-2B); further including a set of elongate second members (Drasler, 75) and comingled with the set of elongate first members (Drasler, Figures 2A-2B), wherein each second member of the set of elongate second members comprises a proximal portion that is attached to the translation mechanism (Drasler, Paragraph 0036); wherein the set of elongate first members and the set of elongate second members are coupled such that activation of the translation mechanism causes the set of elongate second members to move axially with respect to the set of elongate first members, thereby changing the diameter of the sheath from the first diameter to the second diameter (Drasler, Figures 2A-2B).
Regarding claim 20, Drasler modified by Johnson further discloses wherein each first member of the set of elongate first members is positioned adjacent to a second member of the set of elongate second members in a circumferential direction around the sheath (Drasler, Figures 2A-2B).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Drasler (US Pub No. 2009/0240202) in view of Johnson (US Pub No. 2009/0312748) as applied to claim 12 above, and further in view of Kunis (US Pub No. 2007/0083194).
Regarding claim 15, Drasler modified by Johnson discloses the invention above except for wherein the attachment line comprises a ring connecting the first member with the second member.
Kunis, in the analogous art of medical catheters with an attachment line, teaches (Figures 15a-15c) an attachment line comprising a ring (194) for connecting two elements together (Paragraph 0110). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Drasler modified by Johnson to have the attachment line to comprise a ring connecting the first member with the second member as taught by Kunis, in order to provide a better attachment mechanism to fixedly attach two elements together (Kunis, Paragraph 0110).
Allowable Subject Matter
Claims 2-11, 13 and 16 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.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein the translation mechanism further includes: a rotating nut threadably engaged with the handle and axially movable along the handle upon rotation, where rotation of the rotating nut moves the second member in an axial direction; and a sliding ring rotatably coupled to the rotating nut, wherein the rotating nut is positioned proximally of the sliding ring and engages the sliding ring to translate axially along the handle (claim 2), wherein axial movement of the second member in a direction increases tension on the attachment line such that a spacing between the second member and first member is reduced, changing a radial location of second member with respect to the first member and reducing the diameter of the sheath (claim 13) and wherein the attachment line comprises a coil that connects the first member and the second member (claim 16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771