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
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.
Claims 1, 2, 4-8, 11-14, 17, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Graffam et al. (US 2011/0106059).
Regarding claim 1, Graffam et al. disclose a delivery device comprising: a handle (1200/1300; Figure 7) having an interior mounting shaft (1300; within interior of 1200 - Figures 12 and 13) having a proximal end and a distal end; a flexible catheter sheath (1400) extending distally from the handle (as in previous embodiment - Figure 5), the flexible catheter sheath extending at least partially through the handle (as in Figures 1 and 5); and a sheath hub (1100) coupled to the flexible catheter sheath (¶[0038]), the sheath hub being mateable with the proximal end of the handle (¶[0039]; Figure 9) and having a body including at least one of a keyed feature (195 - Figures 4, 7 and 8; or 1195 - Figure 9; or 1125 - Figure 10) for preventing rotation of the sheath hub relative to the handle (¶[0033], [0039], [0040]), and a snap feature (1190 and adjacent annular recess - Figure 9) for preventing translation of the sheath hub relative to the handle (¶[0040]), wherein the snap feature includes an annular recess formed in an outer surface of the body (see annular recess adjacent and proximal to 1190 in Figure 9).
Regarding claim 2, the keyed feature includes a generally rectangular projection extending from an outer surface of the body (e.g. see Figure 10).
Regarding claim 4, the keyed feature includes a single projection extending from an outer surface of the body (only 125 or 195 can be considered as the keyed feature).
Regarding claim 5, the keyed feature includes multiple projections (125, 195) extending from an outer surface of the body.
Regarding claim 6, the flexible catheter sheath includes at least one pull wire (500; ¶[0034]), and wherein the keyed feature is disposed in a same plane as the at least one pull wire (evident from Figure 1; wire 500 would pass through a plane of the keyed feature).
Regarding claim 7, the flexible catheter sheath includes at least one pull wire (500), and wherein the keyed feature is disposed in a different plane than the at least one pull wire (e.g. where it exits 1150).
Regarding claim 8, the interior mounting shaft includes a slot (analogous to 395) configured and arranged to receive the keyed feature.
Regarding claim 11, the snap feature is continuous about a circumference of the body (it has portions which extend continuously; the claim does not require the snap feature to extend around an entire circumference of the body).
Regarding claim 12, the snap feature is discontinuous about a circumference of the body (where it is interrupted by 195).
Regarding claim 13, the snap feature is interrupted by the keyed feature (Figure 9).
Regarding claim 14, the interior mounting shaft includes a complementary rim suitable for engaging with the snap feature (the groove 390 must have an adjacent rim for engagement with 1190).
Regarding claim 17, the sheath hub includes both the keyed feature and the snap feature (evident from Figure 9).
Regarding claim 18, the keyed feature (195) and the snap feature (1190) are at least partially overlapping in an axial direction of the sheath hub (Figure 9).
Regarding claim 20, the body, the snap feature and the keyed feature are unitarily formed (1100 is a single component; the claim does not require these elements to be monolithically formed).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Graffam et al. (US 2011/0106059) in view of Swenson (US 2008/0319345).
Regarding claim 3, Graffam et al. disclose that the keyed feature has a ridge of constant height (top surface of 195 - Figure 9) but fail to disclose that the keyed feature includes a ramp having a gradually increasing height.
Swenson discloses a similar keyed feature (66) for aligning a hub with a handle of a medical device (alignment means for any hub of any medical device being reasonably pertinent to Applicant’s problem). Swenson depicts the feature having a ramp (proximal to 70 - Figure 4). One skilled in any mechanical art would recognize that the ramped feature would allow easier insertion of the key into the mating feature since it eliminates the need for vertical alignment of the keyed feature with the mating feature during insertion; requiring only circumferential alignment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the keyed feature of Graffam et al. with the ramped leading surface of Swenson in order to allow easier insertion of the keyed feature into its mating slot.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Graffam et al. (US 2011/0106059) in view of Gray et al. (US 2013/0103004).
Regarding claim 10, Graffam et al. fail to disclose that the snap feature further includes a leading taper disposed adjacent a ledge with a constant diameter and a drop-off adjacent the annular recess. Graffam et al. are silent as to any particular importance of the keyed feature shape.
Gray et al. disclose a similar snap feature (528) for mating a sheath hub (510) to a handle (512), where the snap feature includes a leading taper disposed adjacent a ledge with a constant diameter and a drop-off (evident from Figure 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the snap feature (1190) of Graffam et al. with the shape of Gray et al. as a suitable alternative shape for a similar snap feature which may allow easier removal from the groove due to the tapered sides. With this modification, the drop-off of Gray et al. would be adjacent to the groove of Graffam et al.
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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