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 Objections Claim 16 is objected to because of the following informalities: a word is missing to make the claim grammatically correct, such as “and”, before “respectively”. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 4, the terms “regular” and “irregular”, lacking any context or special definition, are indefinite. It is not clear what kind of shape would be considered “regular” or “irregular” from the claim. It is also not clear if claim 4 properly further limits parent claim 1 under 35 U.S.C. 112(d), as worded. For the purposes of examination, any shape whatsoever will read on claim 4, noting that any item that reads on the term “protrusion” will inherently possess a “shape”. Claim Rejections - 35 USC § 102 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, 6-18, 20 , and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti et al. (US 20140142509). Regarding claim 1, Bonutti et al. discloses a sheath 204 (fig. 13-57; par. 0083) for delivering a medical device (see at least par. 0092) , wherein the sheath has a proximal end (proximal end of 204) and a distal end (distal end of 204) and comprises: a variable diameter inner liner comprising a sheet (par. 0083) having a first longitudinal edge and a second longitudinal edge and is defined by an inner surface and an outer surface (edges and surfaces which are visible, for example, in fig. 22 in its wound configuration) , wherein the sheet is wound in a spiral configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet forming an overlapping portion (see at least fig. 22) , wherein at least a portion of the outer surface of the sheet abutting the first longitudinal edge comprises a first plurality of protrusions (protrusions 205 , in the embodiment where they are on the outer surface , fig. 21-26; par. 0098) , wherein the at least a portion of the first pluralit y of protrusions is disposed within the overlapping portion (“all or any portion” par. 0098) , thereby reducing the contact area between the inner surface and the outer surface of the sheet within the overlapping portion (structures 205 are fully capable of performing this claimed function) ; wherein the first longitudinal edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second longitudinal edge is slidable along at least a portion of the outer surface of the sheet (par. 0102) , wherein the inner surface of the sheet defines a lumen of the sheath having a longitudinal axis (see lumen variously illustrated at least in fig. 21-28) ; and wherein the variable diameter inner liner is configured to expand from a first rest diameter d r to a second expanded diameter d e by sliding the first edge of the sheet along at least a portion of the inner surface and sliding the second edge of the sheet along the at least a portion of the outer surface, during application of a radial outward force by passage of a medical device through the lumen of the inner liner (see at least par. 0092 and 0102) . Regarding claim 2, Bonutti et al. discloses the sheet has a predetermined thickness (see any of fig. 13-57, which illustrate a thickness, which inherently is predetermined as a result of design/manufacture; see also par. 0086 regarding configuration of shape and dimensions for a specific patient) . Regarding claim 3, Bonutti et al. discloses the first plurality of protrusions are disposed in a predetermined pattern to reduce the contact area between the inner surface and the outer surface of the sheet within the overlapping portion (see pattern illustrated in fig. 21, inherently predetermined as a result of design/manufacture, which are fully capable of performing this claimed function) . Regarding claim 4, as best understood, Bonutti et al. discloses the first plurality of protrusions comprise a regular shape, irregular shape, or any combination thereof (any shape or combination of shapes under the sun reads on this limitation – 205 are disclosed as having a shape and would also inherently have a shape) . Regarding claim 6, Bonutti et al. discloses the sheet comprises a first polymer composition (par. 0071, 0072, 0090) . Regarding claim 7, Bonutti et al. discloses the first polymer composition comprises high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof (par. 0071) . Regarding claims 8 and 9, Bonutti et al. discloses the sheet comprises a multilayer structure (when wound as illustrated in fig. 21-22, multiple layers result as illustrated) with each layer comprising the same polymer composition (par. 0071, 0072, 0090; see fig. 21-22). Regarding claim 10, Bonutti discloses the first plurality of protrusions comprise a second polymer composition that is the same or different from the first polymer composition (205 will inherently be either the same or different) . Regarding claim 11, Bonutti et al. disclose the second polymer composition is substantially identical to the first polymer composition (par. 0098 describes 205 as elements of the body 204) . Regarding claim 12, Bonuttii et al. discloses the at least a portion having the first plurality of protrusions is greater than the overlapping portion ( “all or any portion” par. 0098) . Regarding claim 13, Bonutti et al. discloses the at least a portion having the first plurality of protrusions is substantially identical to a circumference of the sheet in the spiral configuration (“all or any portion” par. 0098) . Regarding claim 14, Bonutti et al. discloses the first plurality of protrusions are disposed on the outer surface of the sheet, respectively, along at least a portion of a length of the sheath (see embodiment illustrated in fig. 21; see also “all or any portion” par. 0098) . Regarding claim 15, Bonutti et al. discloses the first plurality of protrusions are disposed on the outer surface of the sheet respectively abut the distal end of the sheath (see embodiment illustrated in fig. 21; see also “all or any portion” par. 0098) . Regarding claim 16, Bonutti et al. discloses the first plurality of protrusions are disposed on the outer surface of the sheet respectively abut the proximal end of the sheath (see embodiment illustrated in fig. 21; see also “all or any portion” par. 0098) . Regarding claim 17, Bonutti et al. discloses the first plurality of protrusions are disposed on the outer surface of the sheet, respectively, along a full length of the sheath (see embodiment illustrated in fig. 21; see also “all or any portion” par. 0098) . Regarding claim 18, Bonutti et al. discloses the internal surface of the inner liner is at least partially ribbed (par. 0098 describes placing protrusions on any portion including inner and outer surfaces, and describes ribbed embodiments such as those illustrated in fig. 23 and 24) . Regarding claim 20, Bonutti et al. discloses the sheath further comprises an outer layer (sheath 204 itself is, inherently during use, an “outer layer”, as described for example in par. 0092; additionally, sheath 204 when wound forms a plurality of layers including an outer layer as claimed, see fig. 22) . Regarding claim 21, Bonutti et al. discloses the outer layer comprises a polyether block amide, a styrene-based elastomer, polyurethane, latex, copolymers thereof, blends thereof, or extrudates of thereof (par. 0071, 0072, 0090) . 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. Regarding claim 5, Bonutti et al. discloses the sheath as claimed, except for the first plurality of protrusions have an average height up to about 20 % of the predetermined thickness. However, t here is no evidence of record that establishes that changing the average height of the protrusions relative to the predetermined thickness would result in a difference in function of the Bonutti et al. device. Further, a person having ordinary skill in the art, being faced with modifying the protrusions of Bonutti et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range of relative height . Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “ can ” be within the claimed range, and offering other acceptable ranges ( see par. 0199 of the specification ) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the protrusions of Bonutti et al. to have an average height up to about 20% of the predetermined thickness as an obvious matter of design choice within the skill of the art. Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. in view of Nguyen et al. (US 20100094392). Regarding claim 19, Bonutti et al. discloses the sheath as claimed, except for specifically disclosing the inner liner is lubricious and has a coefficient of friction less than about 0.5. However, Nguyen et al. teaches providing an inner polymeric tubular layer with a low coefficient of friction, such as 0.1 or less (par. 0073) . It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a liner having a coefficient of friction of 0.1 or less, as taught by Nguyen et al., in the invention of Bonutti et al. for the purpose of facilitating passage of devices through the lumen (par. 0073) Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NATHAN R PRICE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5421 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8:00am-4:00pm Eastern time . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Tsai can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5246 . 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. /NATHAN R PRICE/ Primary Examiner, Art Unit 3783