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
Applicant’s election without traverse of Invention I (Claims 35-44) and Species G (Figures 23-25) in the reply filed on 1/22/2026 is acknowledged.
Claim 45 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 40 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vadivelu et al. (US 2016/0263361).
With respect to Claim 40, Vadivelu teaches a cranial implant 30 comprising a housing (34, 70) including a first recess (the interior channel of housing element 70) and a second recess 32 formed therein (Figures 1-3);
the first recess (the interior channel of housing element 70) is defined by recessed surfaces (see Figure 3) formed along the housing, the first recess is in communication with an exterior surface 52 of the housing via access passageways (73, 75) extending from the exterior surface of element 70 to the first recess;
the second recess 32 includes an access hole (see Figures 1-3) and is shaped and dimensioned such that it is fully capable of receiving an intracranial monitoring device including a probe, wherein the second recess 32 is separate and distinct from the first recess.
With respect to Claim 44, Vadivelu teaches that the access passageways (73, 75) are defined by recessed surfaces formed along the housing (34, 70). See Figures 1-3.
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 41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Vadivelu in view of Schorn (US 2014/0073859).
With respect to Claims 41 and 43, Vadivelu does not specifically teach that the cranial implant further includes an intracranial monitoring device including a probe shaped and dimensioned for passage through the access hole of the second recess.
Schorn teaches a similar intracranial implant 60 comprising an opening 34 for inserting an element into the patient’s cranium. Specifically, Schorn teaches an intracranial monitoring device comprising a probe 50 (Figures 1-5; paragraphs [0006-0007]) that is configured to sense pressure and other parameters of the patient [0004]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Vadivelu’s cranial implant to be used to insert an intracranial monitoring device comprising a probe through the intracranial opening 32, as suggested Schorn, in order to provide a well-known means for monitoring pressure in a patient’s cranium. Specifically, Schorn’s monitoring probe could be provided either as part of Vanivelu’s shunt 71 or as a separate monitoring element to be inserted through opening 32.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Vanivelu and Schorn as applied to claim 41 above, and further in view of Orosio (US 2006/0173522).
With respect to Claim 42, Vanivelu and Schorn reasonably suggest the cranial implant and intracranial monitoring device of Claim 41, but do not specifically teach that the intracranial monitoring device is wireless.
However, it is extraordinarily well known in the art to use wireless communication to transmit data from patient monitoring device to an external controller. For example, Orosio teaches a cranial implant comprising an intracranial monitoring device 140 that communicates with an external controller 123 via wireless telemetry (Figure 1; paragraph [0036]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the cranial implant and intracranial monitoring device of Vanivelu and Schorn to use wireless communication to communicate the intracranial monitoring device with an external controller, as suggested by Orosio, in order to provide a well known communication means for a monitoring implant, thereby reducing wires and physical connection between the patient and the controller.
Allowable Subject Matter
Claims 35-39 are allowed.
The following is an examiner’s statement of reasons for allowance
The closest prior art is Vanivelu (cited above), which teaches an intracranial implant comprising a plurality of recesses. The first recess is configured to hold a CSF shunt, and the second opening is fully capable of holding an intracranial monitoring device including a probe. However, Vanivelu does not teach or suggest that the second recess comprises a recess extending to a lower surface and an access hole extending from the lower surface. This configuration, as illustrated in Figures 23-25 of the instant application, allows the head of a wireless intracranial monitoring device to be received in the recess while a probe passes from the distal end of the monitoring device into the cranium of the patient. It is unclear why one of ordinary skill in the art would have modified Vanivelu’s device to have the claimed configuration.
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.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bedenbaugh (US 8,038,685) teaches an intracranial implant and anchoring mechanism for anchoring a probe.
Sampath (US 2020/0375745) teaches a cranial implant for allowing insertion of a plurality of diagnostic instruments.
Ericson (US 6,533,733) teaches an implantable device for in vivo intracranial pressure monitoring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781