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 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.
Claim(s) 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2005/0251144 to Wilson et al. (Wilson hereinafter) in view of US Pre-Grant Publication 2007/0179456 to Glenn (Glenn) and US Pre-Grant Publication 2015/0265769 to Bratbak et al (Bratbak).
Regarding claim 17, Wilson teaches an implant assembly (100), the implant assembly configured to be received in a macroaperture (104) created in the cranial bone adjacent an outer table thereof and a connected microaperture (e.g. created by 321) of smaller diameter than the macroaperture created in the cranial bone and extending toward an inner table thereof, the implant assembly comprising: a generally cylindrical bone anchor (200) configured to be received in the macroaperture, the bone anchor having external threads (210) configured to engage the macroaperture, the bone anchor having a lumen (204) with internal threads (see paragraph 36); and an implant body (300) configured to be received in the lumen of the bone anchor and extend through the bone anchor into the microaperture (see e.g. Fig. 9), the implant body having external threads configured to be received by the internal threads (paragraph 36) to locate and secure the implant body in the bone anchor, the implant body having a lumen (312a) for providing access therethrough to the DVS. Furthermore, Wilson teaches an internal stop surface (202) configured to engage the implant body (see Fig. 6) which has a central opening (coaxial with 206) for the implant body therethrough and a proximal portion (310) and an elongated distal portion (302) of smaller diameter that is received in the bone anchor and engages the stop surface (via 309). Wilson does not teach a hollow needle and stop. Glenn teaches another bone anchor generally, and particularly teaches that a hollow needle with a stop may be provided (paragraph 38) so as to infuse medication through the anchor (paragraph 2). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a needle with a stop as taught by Glenn to the anchor of Wilson in order to allow for infusion of medication. Bratbak also teaches a surgical instrument having a sharp point (8) for penetration (paragraph 38) and depth markings (paragraph 38) to show depth of insertion. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a sharp point and markings to the needle of Wilson in order to facilitate penetration and to indicate depth of insertion. Such a modification will result in a needle dimensioned as claimed to result in a predetermined, limited distal protrusion. The examiner notes that the advancing steps are capable of being performed in any order, since the instant claim is directed to an apparatus, i.e. the order in which elements are inserted is a functional limitation which does not confer additional structure on the claimed invention.
Regarding claim 22, Wilson teaches ports at the lower end of each lumen (312a-c) at a distal tip.
Regarding claim 23, Wilson teaches providing a sensor (320) at a distal tip of the implant body.
Regarding claim 24, Wilson teaches the limitations of claim 17 from which claim 24 depends, as discussed above. Wilson does not teach a resealable membrane. Glenn teaches another bone anchor supported port generally, and particularly teaches a septum or membrane (60), which resealably connects the exterior and interior of the anchor (paragraph 28). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a membrane as taught by Glenn either in place of or in addition to the lumens thereof in order to provide sealed access to the interior.
Regarding claim 25, Wilson teaches a connector (312a) configured for connection to a catheter (321). The examiner notes that fluid connection is not required by this claim.
Regarding claim 26, Wilson teaches a fluid coupler (312a) configured to couple with a catheter (321).
Regarding claim 27, Wilson teaches the use of metal or plastic (paragraph 34).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Glenn and Bratbak as applied to claim 17 above, and further in view of US Pre-Grant Publication 2016/0074629 to Rosenberg et al. (Rosenberg).
Regarding claim 28, Wilson teaches the limitations of claim 17 from which claim 28 depends, as discussed above. Wilson does not teach the use of antithrombogenic materials. Rosenberg teaches another implant generally, and particularly teaches that antithrombogenic materials may prevent ingrowth and/or infection (paragraph 245) in that application. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use antithrombogenic materials as taught by Rosenberg with the anchor of Wilson in order to prevent ingrowth.
Response to Arguments
Applicant’s arguments, see page 10, filed 20 July 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Wilson in view of Glenn and Bratbak, as discussed 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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 12 September 2026
