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 .
Response to Amendment
This office action is responsive to the amendment filed on 03/30/2026. As directed by the amendment: claims 1, 8 & 38 have been amended. Claims 2 1-37 have been cancelled.
Thus, claims 1-20 & 38 are pending in this application.
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.
Claims 1-3, 6, 7, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Errico et al (US 6356792 B1).
Regarding claim 1, Errico et al disclose a device (100) for providing cranial access (abstract), the device comprising: a hollow shaft (100) sized to fit within a hole (140) extending through a skull bone (fig 5) and defining a passaging (102) having opposite open ends (fig 3), the hollow shaft having a length of at least a thickness of the skull bone (fig 5); at least one connector (110) extending laterally from a first end of the hollow shaft for abutting the skull bone around the hole (fig 5 and col 4, lines 40-44); and, a plug (120) sized to fit into the hollow shaft (fig 5), the plug extending at least the length of the hollow shaft (fig 5) and configured to be removably secured within the hollow shaft (col 3, lines 51-55), the plug completely closing the passage of the hollow shaft (fig 5).
Regarding claim 2, Errico et al disclose the device of claim 1 wherein an inner surface (102) of the hollow shaft and outer surface of the plug have corresponding threads (124) formed thereon (col 4, lines 48-56).
Regarding claim 3, Errico et al disclose the device of claim 1 wherein one of an inner surface of the hollow shaft and an outer surface of the plug has two or more radial protrusions extending therefrom, and the other of the inner surface of the hollow shaft and the outer surface of the plug has two or more corresponding L-shaped grooves formed therein (figs 3-4, inner of 100 comprise a L shaped groove and outer surface of 120 comprises protrusion 122 and 124).
Regarding claim 6, Errico et al disclose the device of claim 1 wherein the plug (120) has a central channel (126) configured to receive a portion of an implanted device (fig 5, col 5, lines 43-55).
Regarding claim 7, Errico et al disclose the device of claim 6 wherein the implanted device is secured within the plug (fig 5).
Regarding claim 12, Errico et al disclose the device of claim 1 wherein the connector (110) is a flange, a flat surface of the flange configured to abut the skull bone around the hole (col 4, lines 40-44).
Claim Rejections - 35 USC § 103
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 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Wingeier et al (US 20090112278 A1).
Regarding claim 4, Errico et al disclose the limitations of claim 1 but fail to teach wherein a second end of the hollow shaft has an inwardly tapered outer surface to facilitate insertion of the hollow shaft into the hole.
However, Wingeier et al disclose a device for a skull (abstract) comprising a hollow shaft (see figs 6-7, channel 100) wherein a second end (108) of the hollow shaft has an inwardly tapered outer surface to facilitate insertion of the hollow shaft into the hole of the skull (para 0163).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hollow shaft of Errico et al and incorporate the teachings of Wingeier et al to have a second end of the hollow shaft has an inwardly tapered outer surface to facilitate insertion of the hollow shaft into the hole. This would facilitate easier insertion of said hollow shaft into the skull and prevents said shaft from being pushed into the skull to a greater degree than intended (see para 0163).
Claim 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Abrahams (US 20120323217 A1).
Regarding claim 5, Errico et al disclose the limitations of claim 1 but fail to teach wherein the plug comprises an inflatable extension.
However, Abrahams discloses a cranial access device (10) comprising a plug (14, see fig 9D) wherein the plug comprises an inflatable extension (52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plug of Errico et al and incorporate the teachings of Abrahams to have said plug comprises an inflatable extension. This would protect against overinflation that may damage the surrounding brain tissue (see para 0050).
Regarding claim 10, Errico et al disclose the limitations of claim 1 but fail to teach wherein the plug includes a drainage device.
However, Abrahams discloses a cranial access device (10) comprising a plug (14, see fig 9D) wherein the plug comprises includes a drainage device (44).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plug of Errico et al and incorporate the teachings of Abrahams to have said plug comprises includes a drainage device. This would facilitate the removal of any unwanted fluid buildup at the surgical site during and after a surgery (para 0042).
Claims 8 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Boner et al (US 4681103 A).
Regarding claim 8, Errico et al disclose the limitations of claim 1 but fail to teach said device further includes a biopsy trajectory guide.
However, Boner et al teach a surgical instrument guide (see fig 9) comprises a plug (44) wherein the plug includes a biopsy trajectory guide (40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Errico et al and incorporate the teachings of Boner et al to have the device further includes a biopsy trajectory guide. This allows said device to also be able to take tissue from a target area in the brain (col 3, lines 47-52).
Regarding claim 15, Errico et al disclose the limitations of claim 1 and further teach an assembly comprising the device of claim 1, and: a retaining ring (120) secured within and generally concentric with the hollow shaft (fig 5) but fail to disclose a guide defining a central channel, the guide passing through the retaining ring, the retaining ring configured to at least partially obstruct movement of the guide through the hollow shaft.
However, Boner et al teach a surgical instrument guide (20, see fig 4) comprises a hollow shaft (22), a retaining ring (28) and a guide (14) defining a central channel (fig 4), the guide passing through the retaining ring, the retaining ring configured to at least partially obstruct movement of the guide through the hollow shaft (fig 4, col 4, lines 21-28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Errico et al and incorporate the teachings of Boner et al to have said device further comprises a guide defining a central channel, the guide passing through the retaining ring, the retaining ring configured to at least partially obstruct movement of the guide through the hollow shaft. This would provide the benefit of having a trajectory system for biopsies, electrically stimulating target areas of brain, muscle, nerves, etc., with a locking mechanism to guide the proper placement of a surgical instrument into the brain or other tissue (col 3, lines 31-42).
Regarding claim 16, Errico et al in view of Boner et al disclose the assembly of claim 15,
Boner et al further disclose wherein the guide is rotatably pivoted in the hollow shaft about the retaining ring (col 4, lines 12-17 and col 5, lines 36-42).
Regarding claim 17, Errico et al in view of Boner et al disclose the assembly of claim 15,
Boner et al further disclose wherein the retaining ring (28) includes a seating surface configured to abut the guide (fig 4).
Regarding claim 18, Errico et al in view of Boner et al disclose the assembly of claim 15,
Boner et al further disclose wherein the retaining ring (28) includes a seating surface complementary to an at least partially spherical surface of the guide (fig 4, surface abutting ball 26).
Regarding claim 19, Errico et al in view of Boner et al disclose the assembly of claim 15,
Boner et al further disclose said assembly comprising locking ring (36) secured within and generically concentric with the hollow shaft (22), the locking ring being configured to abut the guide to hinder movement of the guide along the hollow shaft (claim 1, ring locking 36 locks ball 26 in place to prevent movement of guide 44, see figs 8-9 and col 6, lines 1-3).
Regarding claim 20, Errico et al in view of Boner et al disclose the assembly of claim 19,
Boner et al further disclose wherein the locking ring (36) includes a seating surface (fig 4) configured to abut the guide to hinder movement of the guide (see fig 4, lower surface of 36 abutting top 49 of 14 and col 6, lines 1-3).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Begemann et al (US 20100145142 A1).
Regarding claim 9, Errico et al disclose the limitations of claim 1 but fail to teach wherein the plug includes a pressure sensor.
However, Begemann et al disclose a neurosurgery device (abstract) comprising a plug (212) wherein the plug includes a pressure sensor (220, see fig 23b and para 0102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plug of Errico et al and incorporate the teachings of Begemann et al to have the plug includes a pressure sensor. This would allow said device to monitor pressure inside the brain by measuring the pressure of the fluid (see para 0102).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Hu et al (US 20160066803 A1).
Regarding claim 11, Errico et al disclose the limitations of claim 1 but fail to teach wherein the hollow shaft and the connector are constructed from titanium and the plug is constructed from PEEK.
However, Hu et al disclose an intracranial device (see fig 10A-B) having a shaft (850) and a connector (808) made of titanium and a plug (812) made from peek (see para 0088).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Errico et al and incorporate the teachings of Hu et al to have the hollow shaft and the connector constructed from titanium and the plug constructed from PEEK. These are known to be biocompatible materials that are robust, and hydrophobic material (para 0059) and said plug made of Peek would be advantageous as it is known for its mechanical strength, chemical resistance, and dimensional stability.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 6356792 B1) in view of Solar et al (US 20130096570 A1).
Regarding claim 13, Errico et al disclose the limitations of claims 1 and 12 but fail to teach wherein fastener holes are circumferentially distributed along the flange and though the surface of the flange configured to abut the skull bone, in the at least one connector.
However, Solar et al disclose a cranial access device (see fig 2, para 0034) comprising a hollow shaft (104) with a connector (114) having fastening holes (118A-B) wherein fastener holes are circumferentially distributed along the flange and though the surface of the flange configured to abut the skull bone, in the at least one connector (para 0035).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the connector of Errico et al and incorporate the teachings of Solar et al to have fastener holes are circumferentially distributed along the flange and though the surface of the flange configured to abut the skull bone, in the at least one connector. This would provide the benefit of ensuring that said connector and said hollow shaft are properly secured in place (see para 0035).
Regarding claim 14, Errico et al in view of Solar et al disclose the device according to claim 13,
Solar et al further disclose the device including bone screws (116A-B) sized to be received through the fastener holes (see fig 2 and para 0035).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Pretre et al (US 20130072876 A1) in view of Shimko (US 20110282396 A1).
Regarding claim 38, Pretre et al disclose a device (500, see fig 18) for providing cranial access (para 0032), the device comprising: a hollow shaft (shaft extending from 504) sized to fit within a hole (52) extending through a skull bone (50); at least one connector (see annotated figure below) extending laterally from a first end of the hollow shaft for abutting the skull bone around the hole (see fig 18 and annotated figure below, head portion abuts the skull 50 around hole 52); and, a plug (506) sized to fit into the
hollow shaft (fig 18), the plug extending at least the length of the hollow shaft and configured to be removably secured within the hollow shaft (para 0050-52, fig 18).
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Pretre et al fail to teach wherein a top surface of the plug is coplanar with a top surface of the first end of the hollow shaft, when the plug is removably secured within the hollow shaft.
However, Shimko discloses an implant (100) comprising a hollow shaft (110) and a plug (120) wherein a top surface (125) of the plug is coplanar with a top surface (111a) of the first end of the hollow shaft, when the plug is removably secured within the hollow shaft (fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Pretre et al and incorporate the teachings of Shimko to have a top surface of the plug is coplanar with a top surface of the first end of the hollow shaft, when the plug is removably secured within the hollow shaft. This would provide of the benefit of preventing further insertion of said plug (para 0040).
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/30/2026, with respect to the rejections of claims 1-20 & 38 have been fully considered.
Applicant’s arguments, see Remarks, filed 03/30/2026, with respect to the rejections of claims 1-20 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 in view of Errico et al (US 6356792 B1).
With regard to the arguments for claim 38 that Pretre fails to teach a "top surface of the plug is coplanar with a top surface of the first end of the hollow shaft, when the plug is removably secured within the hollow shaft and the Office's stated motivation to combine - "preventing further insertion of said plug" - is improper for at least two independent reasons", examiner respectfully disagrees. The claim states that the plug is configured to be removably secured within the hollow shaft, thus it is obvious that the plug of Pretre can be removed and be replaced with another type of plus where the top surface of the plug is coplanar with a top surface of the first end of the hollow shaft as an indication that said plug is properly inserted and prevent further insertion into dura mater when using hollow shaft of Pretre.
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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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