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 § 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 22, 23, 29 and 30 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. Claims 22, 23, 29 and 30 each recite the limitation "each finger" in line 2. There is insufficient antecedent basis for this limitation in the 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 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 non-obviousness.
Claims 1, 2, 10, 12-15, 17, 21, 24-28, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Mongrain et al. (US 2007/0276465) in view of Euteneuer et al. (US 5,989,280).
Regarding claim 1, Mongrain et al. disclose a delivery sheath (Figure 9; can be regarded as a sheath as evident from, e.g., Figure 39) comprising: inter-connected appendages (810) extending around a cylindrical inner lumen (14) and forming one or more gaps (between adjacent members 810); a spine (812) coupled to the inter-connected appendages, wherein a first set of the inter-connected appendages (top row) couple to a first side of the spine and extend from the first side of the spine at a less than 90-degree angle relative to a first end (left end) of the spine, and wherein a second set (bottom row) of the inter-connected appendages couple to a second side of the spine and extend from the second side of the spine at a greater than 90-degree angle relative to the first end of the spine (evident from Figure 9).
Mongrain et al. fail to explicitly state that the inter-connected appendages are configured to: assume a default form in which the inner lumen has a first width; bend in response to an implant passing through the inner lumen to cause at least a portion of the inner lumen to increase beyond the first width; and elastically return to the default form following removal of the implant from the inner lumen. However, Mongrain et al. disclose that the sheath is a stent and may be made from a shape-memory alloy and self-expand (¶[0099]).
Euteneuer et al. teach that nitinol is a well-known, resilient, shape-memory material used for making self-expanding stents (col. 11, lines 10-15). Stents, due to their very similar structure to Applicant’s scaffolding, would be reasonably pertinent to the problem addressed by Applicant and are considered analogous art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used resilient nitinol (resilient in at least the expanded, austenitic state - see for example US 6,315,791, col. 7 lines 19-25, as further evidence) to construct the sheath of Mongrain et al. in order to take advantage of this well-known material suitable for constructing self-expanding stents. With this modification, the sheath would be capable of performing the claimed functions when at least some implants are passed therethrough.
Regarding claim 2, an expandable coating (60) encloses at least a portion of the one or more gaps.
Regarding claims 10 and 12, Mongrain et al. disclose a delivery sheath (Figure 9; can be regarded as a sheath as evident from, e.g., Figure 39) comprising: a spine (812); and one or more appendages (810)
Mongrain et al. fail to explicitly state that the one or more appendages are configured to bend to increase a width of the inner lumen in response to an implant being passed through the inner lumen. However, Mongrain et al. disclose that the sheath is a stent and may be made from a shape-memory alloy and self-expand (¶[0099]).
Euteneuer et al. teach that nitinol is a well-known, resilient, shape-memory material used for making self-expanding stents (col. 11, lines 10-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used resilient nitinol to construct the sheath of Mongrain et al. in order to take advantage of this well-known material suitable for constructing self-expanding stents. With this modification, the sheath would be capable of performing the claimed function when at least some implants are passed therethrough.
Regarding claim 13, a covering (60) at least partially enclosing the spine and the one or more appendages.
Regarding claim 14, the spine has uneven sides forming peaks and troughs and the one or more appendages extend from peaks of the spine (the arrangement of Figure 12 is considered fully disclosed for the Figure 9 embodiment - the appendages at “18” in Figure 12 can be considered as extending from the bottom of a peak structure).
Regarding claim 15, the one or more appendages form partial helical coils (¶[0074] - appendages 810 are an embodiment of appendages 18).
Regarding claim 17, a first portion of the spine at or near a first end of the spine attaches to one or more of the first set of the one or more appendages at a first side of the spine and does not attach to any appendages of the one or more appendages at a second side of the spine (evident from Figure 9).
Regarding claim 21, each appendage of the first set of the inter-connected appendages comprises a free end disconnected from the second set of the inter-connected appendages and from the spine (evident from Figure 9).
Regarding claim 24, the inter-connected appendages are arranged in an alternating manner along the cylindrical inner lumen in which each appendage of the first set of the inter-connected appendages is disposed directly between two appendages of the second set of the inter-connected appendages (the arrangements of Figures 10 and 11 are considered fully disclosed for the embodiment of Figure 9).
Regarding claim 25, each appendage of the inter- connected appendages has a curved semi-circular shape (members 810 form a curve as shown for members 18 in Figure 3 and elsewhere).
Regarding claim 26, each appendage of the inter- connected appendages has a curved helical shape (¶[0074] - appendages 810 are an embodiment of appendages 18).
Regarding claim 27, Mongrain et al. disclose a delivery sheath (Figure 9; can be regarded as a sheath as evident from, e.g., Figure 39) comprising: a spine (812); a first set of appendages (top row of members 810) coupled to a first side (top side) of the spine and extending from the first side of the spine at a less than 90-degree angle relative to a first end (left end) of the spine; and a second set of appendages (bottom row of members 810) coupled to a second side (bottom side) of the spine and extending from the second side of the spine at a greater than 90-degree angle relative to the first end of the spine (evident from Figure 9), the first set of appendages and the second set of appendages extending around and forming a cylindrical inner lumen (14) along the spine, each appendage of the first set of appendages and the second set of appendages being shape-set in a curved form (¶[0099]).
Mongrain et al. fail to explicitly state that the cylindrical inner lumen has a first width and is adapted to: bend in response to an implant passing through the cylindrical inner lumen to cause at least a portion of the cylindrical inner lumen to increase beyond the first width; and elastically return to the shape-set curved form following removal of the implant from the cylindrical inner lumen. However, Mongrain et al. disclose that the sheath is a stent and may be made from a shape-memory alloy and self-expand (¶[0099]).
Euteneuer et al. teach that nitinol is a well-known, resilient, shape-memory material used for making self-expanding stents (col. 11, lines 10-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used resilient nitinol to construct the sheath of Mongrain et al. in order to take advantage of this well-known material suitable for constructing self-expanding stents. With this modification, the sheath would be capable of performing the claimed functions when at least some implants are passed therethrough.
Regarding claim 28, each appendage of the first set of appendages comprises a free end disconnected from the second set of appendages and from the spine (evident from Figure 9).
Regarding claim 31, the first set of appendages and the second set of appendages are arranged in an alternating manner along the cylindrical inner lumen in which each appendage of the first set of appendages is disposed directly between two appendages of the second set of appendages (the arrangements of Figures 10 and 11 are considered fully disclosed for the embodiment of Figure 9).
Regarding claim 32, each appendage of the first set of appendages and the second set of appendages has a curved helical shape (¶[0074] - appendages 810 are an embodiment of appendages 18).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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