DETAILED CORRESPONDENCE
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 .
Election/Restrictions
Applicant’s election of invention and/or species, and corresponding claims (27-37) is acknowledged. The election has been made without traverse. Non-elected claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Allowable Subject Matter
Claims 29-32, 34-36 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 27, 28, 33, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20100059173 A1)
In reference to claim 27, Kampa discloses a method of fabrication of a … peel-away sheath, the method comprising the steps of: (Fig 1-2 and “a tubular body 10 of a catheter, sheath or lead (e.g., pacing lead) 15 and a method of manufacturing the tubular body” [0065]. See figures 1-2 and description thereof)
providing a tubular inner layer having a longitudinal axis and a lumen formed therethrough; (Fig 2 and [0069] and [0016], e.g., “sheath or lead comprising a tubular body that includes a longitudinally extending polymer core, a reinforcement layer, and an outer polymer layer. The polymer core includes a core wall, a longitudinally extending central lumen defined by the core wall, and at least one core wall lumen extending longitudinally through a radial thickness of the core wall. The reinforcement layer extends circumferentially about an outer circumferential surface of the core, and the polymer layer extends circumferentially about the reinforcement layer”)
providing an outer layer coaxially arranged with the inner layer;
providing a support layer laminated between the inner and outer layers to form a sheath body ; ([0086, 93, 99-100]; Claim 13)
reflowing the sheath body to fuse the inner, outer and support layers; ([0086, 93, 99-100]; Claim 1, e.g., “a reflow process” and “subjected to the aforementioned temperature conditions to bring about the reflow process [block 250]. This causes the polymer layer 60, which, in one embodiment, is formed of PEBAX, to melt, impregnate the reinforcement layer 55 (where present), and consolidate with the outer circumferential surface 65 of the core 20." [P0086])
forming at least one shear line positioned beneath an outer surface of the sheath body, and the at least one shear line configured to facilitate the longitudinal separation of the sheath body along the at least one shear line. (“The peeling/slitting of the tubular body begins at a score line aligned with the lumen.” [P0033])
Kampa does not describe the tube as kink resistant, however, it would be obvious to configure the tube as kink resistant in order to prevent obstruction through the tube, which is described as an intended goal in Kampa.
In reference to claim 28 see Fig 2
In reference to claim 33 “In one embodiment, the scoring of the core wall 25 occurs prior to being subjected to the reflow process. In one embodiment, the scoring of the core wall 25 occurs after the reflow process.” (P0093)
In reference to claim 37 see “the reinforcement layer (i.e., a cylindrical wire braid) 55 is pulled or woven over the outer circumferential surface 65 of the core 20 and tightened” (P0083). A braid, in this art, encompasses braid with s-shaped unit cells.
Conclusion
Any prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See references cited in applied prior art for further background. As a whole these references and appropriate secondary and tertiary references are believed sufficient to provide the skilled reader with the opportunity to learn about the technical background requisite to appreciate the body of knowledge needed to understand and communicate regarding the technology at issue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS KRASNOW whose telephone number is (571)270-1154. The examiner can normally be reached M-R: 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao Zhao can be reached on 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner has utilized USPTO approved search resources, such as EIC or external tools, beyond routine search tools and/or leveraged experts in the field. Examiner has cited and explained the relevance of prior art not used in rejections but pertinent to the claims or disclosure. Examiner has provided detailed search documentation through detailed Search Notes, such as annotated search results that identify which data sets were reviewed. When citing the prior art examiner has used annotations clearly in prior art rejections such as, using item-to-item matching to the prior art, pairing exact claim language to particular language used in the prior art, and/or clearly explaining examiner’s interpretation as to how a citation maps to claim language especially when there is not a one-to-one matching of terms.
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/NICHOLAS KRASNOW/Examiner, Art Unit 1744
