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 .
Claims 1-20 are pending.
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.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi et al. (US 5,993,379) in view of Brockmeier et al. (US 2008/0290605).
Regarding Claim 18, Ouchi discloses:
A biopsy cap configured to be secured to a port of a medical device and to accommodate one or more elongate members therethrough, the biopsy cap comprising:
an outer shell (case 62234) securable to a port on the medical device (see Fig. 82 showing case 62234 attached to port 10) and defining an interior volume (interior volume including part for holding 12134) between a proximal end of the outer shell and a distal end of the outer shell (see Fig. 82 showing the case extending from a proximal to a distal end) sized to accommodate two or more differently-configured elements (12134 and 11 having slit 11a) configured to reduce or prevent fluid flow through the biopsy cap and external to the one or more elongated members accommodated through the biopsy cap (12134 absorbs fluid and reduces flow through the cap; 11a is a slit that conforms to the inserted instrument to reduce flow through the cap);
an element disposed within the interior volume and configured to reduce or prevent fluid flow through the biopsy cap (12134 absorbs fluid and reduces flow through the cap);
a base member (11) formed separately from the outer shell and the two or more differently-configured elements (as shown in Fig. 82, the two are separate members) and defining a securing region (distal region of 11 engaging port 10) configured to frictionally engage the port of the medical device to secure the outer shell to the medical device (see Fig. 82 showing distal region of 11 engaging port 10 for attachment);
wherein the base member further comprises a recessed annular portion positioned proximal to a distal end of the base member and having a cross-sectional dimension less than a cross-sectional dimension of the base member at the distal end thereof (see Fig. 82 showing the proximal-most portion which is recessed and has a reduced cross-sectional dimension; see below).
Ouchi does not explicitly disclose two or more differently-configured elements disposed within the interior volume and configured to reduce or prevent fluid flow through the biopsy cap, the two or more differently-configured elements stacked within the interior volume and wherein at least one of the two or more differently-configured elements comprises a plurality of radially inwardly extending members, the plurality of radially inwardly extending members having a length configured to extend into and compress within a channel of the one or more elongate members.
Brockmeier teaches a similar sealing element with differently configured axial sections (see Fig. 12; 502 and 504 have different lengths creating different sections, see Fig. 13 showing the stacked nature of the seals; and see Fig. 16 with differently configured stacked seals, which can be the triangular-shaped elements as shown or bristles) for contacting an inserted instrument and reducing flow through the device. These brushes or stacked flexible components can be made from an elastomeric material (Paragraphs 0030 and 0040). The bristles or elements can extend into a channel of an inserted instrument (the instrument is not a structural element of the claim) because they extend into the interior space of the insertion channel. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Ouchi’s device to include Brockmeier’s seal. Such a modification is the simple substitution of one known seal for another to yield the predictable result of sealing the lumen. Furthermore, the different sizes of the elements and their offset nature prevents a continuous linear passage to be formed creating a better sealing element.
Regarding Claim 19, Ouchi as modified further discloses wherein the outer shell and/or the base member is formed of a flexible material to enable the outer shell and base to be snapped together into engagement (Col 25 Lines 40-43 indicating that the base member 11 is made of a resilient rubber material).
Regarding Claim 20, Ouchi as modified further discloses wherein outer shell includes a securement feature (see Fig. 82 showing a shoulder on the distal portion of 62234) contoured to provide a friction fit with a corresponding securement feature on the base member (see Fig. 82 showing the recessed portion of 11, the lines from 11a and 10 extend through the recessed portion in the figure and show the shoulder of the case 62234 engaging with the recessed portion).
Allowable Subject Matter
Claims 1-17 are allowed.
The following is an examiner’s statement of reasons for allowance:
The primary reason the claims are allowable over the prior art is that the prior art fails to disclose or render obvious the claimed biopsy cap with a shell, two or more differently configured sections within the shell, a base member, and the claimed space between the members of the sections. Brockmeier was used to teach the sealing elements, and as seen in Fig. 16, the space between the members is not tapered as claimed. Figs. 6 and 15 show triangular bristles, but the spaces between the bristles do not taper radially inward. Instead, they taper radially outward. Also, the substrate is formed in a ring shape such that the bristles converge to a point (see Paragraph 0033). The reference does not read on the claims. No reason was found in the art to make such a modification. Therefore, the claims are allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Claims 1-17 are allowed as set forth above in response to Applicant’s amendments. The Double Patenting rejection has also been removed in response to the amendments.
Claims 18-20 remain rejected based on the combination of Ouchi and Brockmeier as set forth above.
The application is not in condition for allowance at this time.
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 TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795