DETAILED ACTION
This action is pursuant to claims filed on 12/2/2024. Claims 1-9 are pending. A first action on the merits of claims 1-9 is as follows.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Osa et al. (hereinafter “Osa”, US 10743927 B1).
Regarding independent claim 1, Osa discloses an anchor bolt (anchor bolt in Figs. 3 and 4) adapted to be screwed into a patient’s skull ([Abstract]: the anchor bolt is for the threading engagement with the skull of a patient) for the purpose of placing a depth electrode at a desired location within the patient’s cranium ([Col 1, lines 8-14]: the present invention relates to an anchor bolt driver device for placing an anchor bolt for subsequent neurosurgery electrode placement), the anchor bolt comprising:
a collar located at a proximal end of the anchor bolt (collar 25 in Fig. 3 and 4 highlighted below);
cap threads on an outer surface of the collar (threads on outer surface of the collar shown below);
a subdural stem located at a distal end of the anchor bolt (subdural stem 24 in Figs. 3 and 4 highlighted below);
skull threads on an outer surface of the subdural stem (skull threads on stem shown below);
an external stem (external stem highlighted below – the length and structure of the stem are not defined by the claim);
a recovery fitting section located between the external stem and the subdural stem (recovery fitting section highlighted below which is between the external stem and subdural stem – the “recovery fitting section” is provided with no structure or function in the claim and is interpreted as anywhere a fitting could be clamped and a fitting can be clamped to the stem highlighted below);
an internal lumen extending along a longitudinal axis through the anchor bolt (internal lumen 22 in Figs. 3 and 4 highlighted below) including through the collar, the external stem, the recovery fitting section, and the subdural stem (lumen penetrates through the collar, external stem, recovery fitting section, and subdural stem as shown below);
a controlled break point in the external stem or between the external stem and the recovery fitting (controlled break point is the thin portion of the bolt highlighted in Figs. 3 and 4 below which is between the external stem and recovery fitting – the claim does not provide any structure or function to this break point and a thin section in the walls of the bolt would break prior to other portions of the bolt if there was an impact);
an axial broach (broach 23 highlighted in Figs. 3 and 4 below) in the collar accessible from the proximal end of the anchor bolt (broach is in the collar and accessible on the proximal end of the bolt in Figs. 3 and 4), said broach adapted to enable a wrench or fitting ([Col 3, lines 25-36]: the formed end portion 23 receives a socket of the driver device) to turn the anchor bolt clockwise or counterclockwise around the longitudinal axis ([Col 4, line 53-Col 5, line4]: the end portion 23 receives the socket to screw the bolt into the skull);
wherein said anchor bolt is adapted to be screwed into a pre-drilled hole in the patient’s skull ([Col 4, line 53-Col 5, line4]: hole is pre-drilled into the skull) such that the subdural stem is embedded in the patient’s skull and the remaining parts of the anchor bolt remain external to the patient’s skull and skin ([Col 4, line 53-Col 5, line4]: the driver connects to end portion 23, thus it is inherent that threads 24 which are on the subdural stem are embedded in the patient’s skull as seen in Fig. 6F – ensuring only the subdural stem is embedded in the skull is simply a matter of stopping the driver before more of the bolt is embedded which the device is capable of doing as this is a functional limitation) with the recovery fitting section being closer to the subdural stem than the controlled break point (the recovery fitting section is closer to the subdural stem than the controlled break point as highlighted below), and the internal lumen permitting access for a depth electrode inside the patient's skull ([Col 1, lines 8-14]: the present invention relates to an anchor bolt driver device for placing an anchor bolt for subsequent neurosurgery electrode placement; thus a depth electrode can be inserted through the lumen since this is a functional limitation and the lumen allows for the electrode placement);
and further wherein the controlled break point comprises a portion of the anchor bolt that breaks preferentially when a lateral force is applied to the collar or external stem of the installed anchor bolt (this is a functional limitation and provides no specific structure to the break point; the limitation “preferentially” is imply interpreted as “first”; the thin portion that forms the controlled break point would break first when subject to a lateral force on the collar or external stem because it is thinner than the remainder of the bolt and thus forms the weakest point of the bolt).
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Regarding claim 8, Osa discloses the anchor bolt recited in claim 1 wherein the internal lumen has a constant diameter within tolerance through the external stem, the recovery fitting section, and the subdural stem (the lumen 22 has a constant diameter through the three sections as seen in Fig. 4).
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 nonobviousness.
Claim(s) 2, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Osa as applied to claim 1 and described above, in view of Osa (hereinafter “Osa ‘325”, US 10786325 B1).
Regarding claim 2, Osa discloses an assembly (assembly shown in Fig. 5) including the anchor bolt recited in claim 1 (anchor bolt 20 in Fig. 5) further comprising:
a cap (caps 29 in Fig. 5) with an axial opening that is adapted to be tighten onto the threaded collar of the anchor bolt with the depth electrode being placed through the axial opening of the threaded cap ([Col 5, lines 5-7]: the anchor bolts are positioned in the skull having caps through which electrode leads extend – the caps engage with the proximal end as seen in Fig. 5).
While it is the examiner’s opinion that the caps are inherently threaded in order to be compatible the threads 25, Osa is specifically silent to the caps having threads. Osa is also silent to the assembly comprising an internal gasket located within the cap and also having an opening through which the depth electrode is placed.
Osa ‘325 teaches an anchor bolt fixation system for catheter probes and electrodes having different diameters ([Abstract]). The system has a removable reducing tube that is provided for insertion into the lumen of an anchor bolt and anchor bolt cap ([Abstract]). The system can be used with a reducing tube for smaller diameter catheters as shown in Figs. 1 and 2, or without a reducing tube for larger diameter catheters as seen in Figs. 3 and 4 ([Col 2, lines 17-26], [Col 3, lines 42-50]). The latter configuration is similar to the one disclosed by Fig. 5 of Osa, since Osa does not disclose the use of a reducing tube. Osa ‘325 further teaches that the silicone gasket 15 and the anchor bolt cap 20 fixate the catheter in the anchor bolt ([Col 3, lines 42-50]). The gasket sits in the indentation 30 in the proximal end of the anchor bolt and provides a seal when the reducing tube is introduced into the lumen of the anchor bolt ([Col 2, lines 52-67]). In the case where no reducing tube is utilized, the same function would occur as the gasket forms a seal with the catheter since that is the tube that is inserted through the lumen of the seal, as seen in Figs. 3 and 4. Furthermore, the anchor bolt cap 20, as seen in Figs. 3 and 4, has threads which engage with the threads on the end of the anchor bolt ([Col 3, lines 5-23]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the cap threads and the gasket of Osa ‘325 with the system of Osa such that when assembled, the gasket and threaded cap fixate the depth electrode in place and provides a seal around it, thus arriving at the claimed invention.
Regarding claim 4, the Osa/Osa ‘325 combination discloses the assembly recited in claim 2 wherein the components are each made from a non-ferrous, biocompatible material that is conditionally suitable for magnetic resonance imaging (Osa ‘325 [Col 3, lines 30-41]: the anchor bolt cap is Grade 23 titanium; [Col 2, lines 34-42]: the gasket 15 is made of medical grade silicone – these are both known in the art to be non-ferrous and biocompatible materials suited for MRI).
Osa further discloses that typical bone screws and anchor bolts are typically made of nonferrous materials such as titanium or polymer such as PEEK ([Col 1, lines 45-51]).
However, Osa is silent to the specific material of the anchor bolt in Figs. 3 and 4.
Osa ‘325 further teaches that the anchor bolt may be made of Grade 23 titanium ([Col 3, lines 24-29]). Osa ‘325 further states that certain procedures may require the use of MRI guidance ([Col 1, lines 13-30]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize Grade 23 titanium for the anchor bolt, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331. Grade 23 titanium is a known material to utilize for depth electrodes, as taught by Osa ‘325 and disclosed by Osa, and it is also a non-ferrous, biocompatible material that is suitable for use in MRIs. Thus, utilizing Grade 23 titanium for the anchor bolt would result in the claimed invention.
Regarding claim 5, Osa discloses the anchor bolt recited in claim 1.
Osa further discloses that typical bone screws and anchor bolts are typically made of nonferrous materials such as titanium or polymer such as PEEK ([Col 1, lines 45-51]).
However, Osa is silent to the material of the anchor bolt being Grade 23 titanium.
Osa ‘325 further teaches that the anchor bolt may be made of Grade 23 titanium ([Col 3, lines 24-29]). Thus, Grade 23 titanium is a known material in the art to utilize for anchor bolts for depth electrodes. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize Grade 23 titanium for the anchor bolt, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the Osa/Osa ‘325 combination as applied to claim 2/1 and described above, in further view of Skakoon et al. (hereinafter “Skakoon”, US 7204840 B2).
Regarding claim 3, the Osa/Osa ‘325 combination discloses the assembly recited in claim 2 as described above.
However, the Osa/Osa ‘325 combination is silent to the assembly further comprising an elastomeric cap that covers the threaded cap and the tail of the depth electrode when the anchor bolt and the depth electrode are installed and in use.
Skakoon teaches devices and method to provide accurate targeting, placement, and stabilization of an electrode into the brain ([Abstract]). Fig. 1 of Skakoon shows an electrode inserted into the patient’s brain along with the anchoring system and an elastomeric cap which covers the burr hole, stabilizer, rigid cap, electrode tail, and base plate ([Col 4, lines 26-46]). The anchoring system has a stabilizer 110 and rigid cap 112 as seen in Fig. 1, which is similar to the fixation bolt and threaded cap of the Osa/Osa ‘325 combination ([Col 4, lines 26-46]). The elastomeric cap 114 is made of silicone or other elastomer and softens the profile of the implanted apparatuses and allows for contouring to more closely match the skull’s surface ([Col 4, lines 26-46]). The upturned portion of the electrode, which is the electrode tail as seen in Fig. 1, is directed to the outside of the cap and skin flap as seen in Fig. 1 ([Col 4, lines 47-52]). While the style of the stabilizer is different than the bolt of the Osa/Osa ‘325 combination, the benefit of a conformal cap is apparent to the combination. Combining an elastomeric cap with the combination would soften the exterior of the device for the patient and cover the implantation site. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the elastomeric cap of Skakoon with the anchor bolt system of the Osa/Osa ‘325 combination in order to provide a cap that covers the threaded cap and the tail of the electrode which would allow the system to better contour and conform to the surface of the patient’s head.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Osa as applied to claim 1 and described above, in view of Steele (US 20120197309 A1).
Regarding claim 6, Osa discloses the anchor bolt recited in claim 1. The break point of Osa is further defined by a step down in diameter as seen in Figs. 3 and 4.
However, Osa is silent to the controlled break point being constructed by tapering the outer diameter of the external stem narrower as the external stem approaches the recovery fitting.
Steele teaches a bone anchoring system for slidable engagement with an implant, similar to how the bone anchor of Osa slidably engages with a catheter or electrode ([Abstract]). The anchoring system has a break-region with a plurality of pre-defined fracture initiator zones to facilitate the initiation of a fracture upon application of sufficient force ([Abstract]). The break-region can have any number of initiator zones or grooves, from a single zone to six or more zones ([0029]). As seen in Fig. 3A, the fracture initiator zones have tapers which face each other to form a reduced outer diameter ([0028]). Modifying the controlled break point of Osa to include these tapers would be well within the ordinary level of skill in the art as it is simply a change in the shape of the region. Furthermore, including notches in the location in which the diameter of the bolt of Osa would form a taper that tapers from a larger diameter to a smaller diameter as it moves toward the recovery section, as the claimed invention requires. The claim does not limit the length or size of the taper or whether an opposite taper can be present on the opposite side of a notch. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the break point of Osa with the notches of Steele to form fracture initiation regions that comprise tapers and allow for the bolt to break at the fracture initiation points upon application of sufficient force.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Osa as applied to claim 1 and described above.
Regarding claim 7, Osa discloses the anchor bolt recited in claim 1.
However, Osa is silent to the failure torque of the anchor bolt at the controlled break point.
Osa also discloses that anchor bolts are typically made of titanium ([Col 1, lines 45-51]). Osa also discloses that the thickness of the walls decreases in the break point region as shown in Fig. 4. The material and thinning of the wall create are the structural features that determine the load at failure. The claim does not limit the materials, shape, or dimensions of the bolt that result in the failure point and the claim is written entirely functionally. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bolt such that the moment at failure is in the range of 12-18 pound-inches, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Osa as applied to claim 1 and described above, in view of Moorman et al. (hereinafter “Moorman”, US 20230346501 A1).
Regarding claim 9, Osa discloses the anchor bolt recited in claim 1 wherein the internal lumen in the external stem has a first diameter (diameter of lumen 22 that is on the proximal end as shown in Fig. 4).
However, Osa does not disclose the internal lumen in the subdural stem having a second diameter that is smaller than the diameter of the internal lumen in the external stem.
Moorman teaches a cranial access device that includes a cranial bolt that comprises a passageway for receiving a neurosurgical tool, similar to the device of Osa ([Abstract]). Moorman further teaches that the internal diameter can be uniform throughout its length, like in Osa, or the diameter of the central passageway may be increased from the distal end to the proximal end ([0030]). It would have been an obvious matter of design choice to modify the diameter of the lumen of Osa as taught by Moorman, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794