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) 1-4 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. (US 2012/0277730 A1).
Regarding claim 1, Salahieh discloses an apparatus (steerable device; it is noted that the embodiment of Figs. 7a and 7b are being used for the current rejection but like parts are referred to in Figs. 2a and 2b for clarity of the rejection), comprising: an elongate sheath assembly (see for example, steerable device 30; Figs. 2a, 2b) configured to be advanced through a blood vessel of a patient body (the steerable device can be used to delivery, or guide, a medical device into bodily lumens or cavities such as a blood vessel; [0067]), wherein the elongate sheath assembly comprises an outer sheath (second tubular member/outer tubular member 128; Fig. 7b; [0093]) and an inner sheath (first tubular member/inner tubular member 112; Fig. 7a; [0093]), wherein the inner sheath (112) is received inside a lumen of the outer sheath (128; [0093]; Figs. 2a, 2b), wherein a lumen of the inner sheath is configured to receive an object (any type of suitable medical device or instrument therethrough; [0067]) separate from the elongate sheath assembly, wherein the elongate sheath assembly comprises a plurality of flexible segments (steerable portions 116, 132 and proximal portions 118, 134; Figs. 7a, 7b) comprising a plurality of cuts (slots 124, 140, 126, 142), wherein the outer sheath (128) comprises a first flexible segment (132 or 134) of the plurality of flexible segments and the inner sheath (112) comprises a second flexible segment (116 or 118) of the plurality of flexible segments, wherein the first flexible segment and the second flexible segment are unaligned along a length of the elongate sheath assembly to prevent kinking (when 132 is the first flexible segment and 116 is the second flexible segment, the two are unaligned as the slots in each of the tubular members 112 and 128 are offset relative to the adjacent slot in opposite helical patterns; [0094]; when 132 is the first flexible segment and 118 is the second flexible segment, the two are unaligned as a proximal end of the first flexible segment 132 is unaligned with a proximal end of the second flexible segment 118; Figs. 7a-7b; when 134 is the first flexible segment and 116 is the second flexible segment, the two are unaligned as a distal end of the first flexible segment 134 is unaligned with a distal end of the second flexible segment 116; Figs. 7a-7b).
Regarding claim 2, Salahieh discloses wherein at least one of: a distal end of the first flexible segment (132) is unaligned with a distal end of the second flexible segment (118; Figs. 7a-7b); or a proximal end of the first flexible segment (132) is unaligned with a proximal end of the second flexible segment (118; Figs. 7a-7b).
Regarding claim 3, Salahieh discloses wherein the outer sheath (128) further comprises a third flexible segment (other of 132 or 134) of the plurality of flexible segments and the inner sheath (112) comprises a fourth flexible segment (other of 116, 118) of the plurality of flexible segments (Figs. 7a-7b).
Regarding claim 4, Salahieh discloses wherein the third flexible segment (134) is proximal of the first flexible segment (132), wherein the fourth flexible segment (118) is proximal of the second flexible segment (116).
Regarding claim 6, Salahieh discloses wherein the third flexible segment (134) and the fourth flexible segment (116) are unaligned along the length of the elongate sheath assembly (Figs. 7a-7b).
Regarding claim 7, Salahieh discloses wherein a proximal end of the first flexible segment (132) is unaligned with a proximal end of the second flexible segment (118), and wherein a distal end of the third flexible segment (134) is unaligned with a distal end of the fourth flexible segment (116; Figs. 7a-7b).
Regarding claim 8, Salahieh discloses wherein a proximal end of the third flexible (134) segment is unaligned with a proximal end of the fourth flexible segment (116; Figs. 7a-7b).
Regarding claim 9, Salahieh discloses wherein the inner sheath is longer than the outer sheath (see for example, Figs. 2a-2b; wherein the inner tubular element 36 is longer than the outer tubular element 34 in order to move the outer tubular element axially relative to the inner tubular element to steer the device; [0069]).
Regarding claim 10, Salahieh discloses wherein the object comprises a medical lead implanted in the patient body (it is noted that the “object” is only functionally claimed; therefore, the apparatus needs only to be capable of receiving a medical lead and the lumen of the inner sheath 112 is considered capable of receiving a medical lead as it is used to deliver, or guide, any type of suitable medical device or instrument therethrough; [0067]), wherein the lumen of the inner sheath (112) is configured to receive the medical lead for removal of the medical lead from the patient body (as the inner sheath 112 is considered capable of receiving a medical lead as it is used to deliver, or guide, any type of suitable medical device or instrument therethrough; [0067]).
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 (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 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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2012/0277730 A1) in view of Mitelberg et al. (US 2008/0097398 A1).
Regarding claim 5, Salahieh discloses wherein at least one of: the plurality of cuts in the first flexible segment (132) is configured to provide a constant flexibility (as the slots 140 are equally spaced from one another; Fig. 7b); or the plurality of cuts in the second flexible segment (116) is configured to provide a constant flexibility (as the slots 124 are equally spaced from one another; Fig. 7a).
Salahieh fails to disclose the plurality of cuts in the third flexible segment (134) is configured to provide a variable flexibility or the plurality of cuts in the fourth flexible segment (118) is configured to provide a variable flexibility. While the third and fourth flexible segments (134, 118) have different flexibilities relative to the first and second flexible segments (132, 116) due to their slots (142, 126) being different from slots (140, 124), the third and fourth flexible segments (134, 118) have a constant flexibility.
However, Mitelberg teaches an elongate sheath assembly (Figs. 5-6) comprising a plurality of cuts (spiral cuts 16a), the elongate sheath assembly including a first segment (region 24) with first cuts (cuts 16a of region 24) arranged in a constant pitch to provide a constant flexibility (constant spacing between cuts 16a in region 24; Figs. 5-6), and a third segment (regions 22, 26, 28) with second cuts (cuts 16a of regions 22, 26, 28) arranged in a variable pitch to provide a variable flexibility (as the spacing between the cuts 16a of regions 22, 26, 28 varies; Figs. 5-6). The varying pitch results in pitch angle changes along a length of the elongate sheath assembly (Figs. 5-6). The varying flexibility of the elongate sheath assembly allows for improved column strength and pushability at the proximal portion and improved trackability and flexibility at the distal portion ([0032]).
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 slots of the third and/or fourth flexible segments to have a variable pitch to provide a variable flexibility as taught by Mitelberg in order to improve the column strength and pushability at the proximal portion (third and fourth flexible segments) while maintaining the trackability and flexibility at the distal portion (first and second flexible portions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Grace (US 5,651,781) is noted for teaching a flexible elongate sheath assembly for removing a pacemaker lead.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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