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 .
Response to Amendment
This office action is responsive to the amendment filed on 6/20/26. As directed by the amendment: claims 1, 4, 15, 16, and 18 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-21 are presently pending in this application.
Applicant’s amendments are sufficient to overcome the claim objection from the prior action and the rejection under 35 U.S.C. 112(b) from the prior action.
Claim Objections
Claim 15 is objected to because of the following informalities: “distal end of the sheath” lacks a preceding article, such as “a” or “the/said” as appropriate. 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 applicant regards as his invention.
Claims 15 and 18 are 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 15, “distal end of the sheath” is indefinite, as it is not clear how it relates to any of the “distal” limitations earlier recited in claim 1.
Regarding claim 18, it is unclear how “an internal surface” of the inner liner relates to the previously recited “inner surface” in claim 1.
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) 1-4, 6-18, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 20140142509) in view of (Goldberg et al. (US 20190307589).
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 section (proximal end of 204) and a distal section (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 plurality 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 dr to a second expanded diameter de 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), the reduce contact area of the plurality of protrusions is configured to reduce the radial outward force required to expand the variable diameter inner liner (structures 205 reduce the contact area as claimed, see fig. 21-26, and are thus fully capable of reducing the radial outward force required to expand the liner due at least to contact area), except for specifically disclosing the distal section comprises a tip section, the tip section extending from a distal end of the proximal section and comprises a slit, the slit extending along a portion of the tip section, and wherein the tip section is configured to split to facilitate retrieval of the medical device. However, Goldberg et al. teaches an expandable sheath (comprised at least of 904 and 906 in fig. 34) which comprises a tip section 902 at the distal section (see fig. 34) comprising a slit extending along a portion of the tip section for splitting the tip section as claimed (scoring, par. 0129). 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 Bonutti et al. sheath to utilize a distal tip with slit as taught by Goldberg et al. in order to provide sufficient structure to improve insertion characteristics of the sheath without hindering necessary expansion (par. 0129).
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 , Bonutti et al. discloses the first plurality of protrusions comprise a at least a circular shape (see fig. 21).
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, as best understood, 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 and 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, as best understood, Bonutti et al. discloses an 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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. in view of Goldberg et al.
Regarding claim 5, Bonutti et al., as modified by Goldberg et al. above, teaches the sheath as claimed, except for the first plurality of protrusions have an average height up to about 20 % of the predetermined thickness. However, there 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. in view of Goldberg 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 Goldberg et al., and further in view of Nguyen et al. (US 20100094392).
Regarding claim 19, Bonutti et al. in view of Goldberg et al. teaches 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. in view of Goldberg et al. for the purpose of facilitating passage of devices through the lumen (par. 0073).
Response to Arguments
Applicant's arguments filed 6/20/26 have been fully considered but they are not persuasive.
Applicant argues on pg. 9 of the Remarks that Bonutti et al., in par. 0098, discloses performing a function incompatible with that of amended claim 1. Examiner respectfully disagrees. First, the cited passage from par. 0098 is notably describing one possible configuration result for those elements, noting that a variety of possible configurations of the elements are disclosed. Second, the claimed reduction in radial outward force is recited to be the result of reduced contact area by the inclusion of the protrusions. As noted in the rejection of claim 1 above, the cited protrusions of Bonutti et al. would result in a reduced contact area, thus resulting in the radial outward force related to contact area to be reduced as claimed.
Applicant’s remaining arguments with respect to the remaining amendments to claim 1 have been addressed by modifying Bonutti et al. with Goldberg et al. as set forth in the rejections under 35 U.S.C. 103(a) above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached 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, Michael Tsai can be reached at 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
Prosecution Insights