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 .
Election/Restrictions
Claims 1-16, 20, and 29-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 January 2026.
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 –
Claim(s) 17-19, 22-23 and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2005/0251144 to Wilson et al. (Wilson hereinafter).
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.
Regarding claim 18, 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.
Regarding claim 19, Wilson teaches 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).
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 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 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 Wilson in view of US Pre-Grant Publication 2007/0179456 to Glenn (Glenn).
Regarding claim 21, Wilson teaches the limitations of claim 17 from which claim 21 depends as discussed above. Wilson does not teach a hollow needle and stop. Glenn teaches another bone anchor generally, and particularly teaches that a 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. The examiner takes official notice that needles having sharp tips and depth markings are well known in the art, based on their commercial availability at the time of the effective filing date of the invention. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide those features as part of the needle in order to allow for better piercing and insertion depth control.
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.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson 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.
Conclusion
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 6 March 2026