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
The Amendment filed April 27, 2026 has been entered. Applicant’s amendments have overcome the 112(b) rejections previously set-forth in the Non-Final Office Action mailed on 01/28/2026. Currently claims 1, 10, 51, 54-57, 59, and 66 have been amended, and claims 1, 3-4, 6-8, 10-38, 41, 44-51, 54-59 and 61-68 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 6-8, 10-12, 51, 54-59, and 61-68 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 51, there is no support for the claim language “wherein the base is configured to not penetrate the brain tissue”.
Figure 4 shows a cross-sectional view of the cortical access system coupled to a patient's skull, wherein the intracranial apparatus 20 may be positioned near or on the patient's brain tissue 804. Similarly, the paragraph [0098] of filed Specification describes how “the base 128 or the distal end 112 of the turret frame 36 may be positioned significantly near or in contact with the brain tissue 804 at the cranial opening 806 when the cortical access system 24 is deployed”.
Therefore, while there is evidence for the base of the turret to be positioned significantly near or in contact with the brain tissue, there is not support for the base to be configured to not penetrate the brain tissue in either the Specification of the remaining of the filed Drawings, given that there is not clear description of any physical structure or other mechanism that specifically prevents the base from penetrating the brain tissue. Thus, since there is no support for the claim language, claims 1 and 51 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Claims 3-4, 6-8, 10-12, 54-59, and 61-68 are also rejectedbecause they are dependent on a respective one of claims 1 and 51.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 6-8, 10-12, 51, 54-59, and 61-68 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 51 recite the limitation "wherein the base is configured to not penetrate the brain tissue," in lines 7-8 and lines 8-9, respectively. The Examiner is of the position that this noted limitation renders the scope of each claim as indefinite because one of ordinary skill would not be reasonably apprised of the scope of the claim required by the requirement of “the base is configured to not penetrate the brain tissue”. In particular, the Examiner finds the scope of the claim as indefinite given that it is unclear what structure and/or function would be sufficient to ensure that base to be “configured to not penetrate the brain tissue” as claimed. The instant recitation is overly broad as claimed and attempts to define the base in terms of what structure/function the base is not, rather than clearly defining what the structure/function of the base actually is (See MPEP 2173.05(i)). Further, while the claims are routinely interpreted in light of the disclosure (while maintaining that limitations from the specification are not read into the claims), the disclosure fails to provide any insight as to the structure/function of the base that would reasonably apprise or otherwise render definite the at-issue limitation of “the base is configured to not penetrate the brain tissue. Claims 3-4, 6-8, 10-12, 54-59, and 61-68 are also rejectedbecause they are dependent on claims 1 and 51.
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.
(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.
Claims 1, 3, 6, 51, 54, 58-59, and 61-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liberman (U.S. Application No. 20060142782 A1).
Regarding independent claims 1 and 51, Liberman discloses a device (10) for positioning on a patient’s cranium (110) (pa. 0033 & Figs. 1-3) and for delivery a medical tool (e.g., a guide wire, catheter, stent, filter, needle, guide pin, or cannula) or one or more electrodes (i.e., a lead) (pa. 0043) into an epidural and/or subdural space (114) and to brain tissue (124) of the patient through an opening (i.e., burr hole 120) in the cranium (pa. 0040 & Figs. 5B-7), the device comprising:
a turret (combination of first elongate member 18 and second elongate member 30) including a proximal end portion (20, 32), a distal end portion (26, 40) (pa. 0035-0036), wherein the distal end portion includes a base (distalmost section of distal end portion 26) and a side surface (periphery wall surface of a substantially C-shaped section of the distal end portion 26, as seen in Fig. 3) between the base and the proximal end portion (pa. 0035), and a first channel (36) extending from an entrance opening (i.e., opening of the proximal end portion 32, as seen in Fig. 1) to an exit opening (28) (pa. 0036), wherein the base is configured to not penetrate the brain tissue (see Figs. 5B-6), and wherein the exit opening is on the side surface of the distal end portion (see Fig. 3), and wherein the turret and the exit opening are configured to locate the exit opening in the epidural and/or subdural space between the cranium and the brain tissue when the turret is positioned on the cranium with the base between the cranium and the brain tissue (pa. 0040-0041), and wherein the first channel is configured to guide the medical tool or the one or more electrodes from the entrance opening to the exit opening and out of the exit opening generally horizontally into the epidural and/or subdural space for positioning on the patient's brain tissue (see Fig. 5B), and wherein the first channel is curved along its length between the entrance opening and the exit opening (see Fig. 2).
Regarding claim 3, Liberman discloses the turret further comprising a second channel (distal portion of the first channel 36) configured for the one or more electrodes to be released from the turret (pa. 0036).
Examiner is interpreting the second channel as being a distal portion of the first channel given that the claim language is broad and does not specify the second channel has to be structurally different from the first channel. Furthermore, the claim language is not specific about which direction the one or more electrodes need to be released from the turret. Therefore, as long as the first channel 36 is configured to guide the one or more electrodes from an entrance opening to the exit opening into the epidural space, and the end portion of the first channel is configured to release the one or more electrodes from the turret, then portions of the same lumen/channel may be mapped as different channels.
Regarding claims 6 and 54, Liberman discloses the turret comprising a turret frame (22, 34) (pa. 0035-0036) and a turret insert/guide (46) removably mated to the turret frame (pa. 0037), and wherein the turret insert/guide defines the first channel (see Fig. 1).
Regarding claim 58, Liberman discloses a guide clamp (groove 54 of housing 46) configured to be coupled to the turret to help secure the medical tool received in the first channel (pa. 0037).
Regarding claim 59, Liberman discloses a clamp lock (snap-fit coupling of groove 54) configured to secure the guide clamp to a turret frame (22) (pa. 0037).
Regarding claims 61 and 63, Liberman discloses wherein:
the distal end portion includes a bottom surface (i.e., any surface on or directly adjacent to the distal end portion) and a periphery; and
the exit opening of the first channel is located on the periphery of the distal end portion (see Fig. 3),
between the proximal end portion and the bottom surface, and the channel is configured to guide the medical tool between the cranium and the brain tissue (pa. 0040).
Regarding claims 62 and 64, Liberman discloses wherein the first channel is configured to guide the medical tool/one or more electrodes out of the exit opening generally horizontally between the patient's cranium and brain tissue (see Fig. 5B).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Liberman as applied to claim 1 above, and further in view of Hua (U.S. Patent No. 9179875 B2).
Regarding claim 10, Liberman discloses the invention substantially as claimed in claim 1 and discussed above.
However, Liberman does not disclose a turret comprising an endoscope channel configured to receive an endoscope for imaging of an electrode being delivered by the device.
Hua, in the same field of endeavor, teaches the device including a camera which would allow for endoscopic guidance of electrodes into the epidural, subdural, or intraventricular structures (Col. 9, lines 29-32).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an endoscope channel of Hua to the device of Liberman for the purpose of providing the user further ways to visualize the proper placement of the electrodes.
Claims 4, 7-8, 55, and 68 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Henderson (U.S. Patent No. 6491699 B1).
Regarding claim 4, Liberman discloses the invention substantially as claimed in claims 1 and 3 and discussed above.
However, Liberman does not disclose the second channel being narrower than the first channel such that only a portion of each of the one or more electrodes is releasable via the second channel.
Henderson, in the same field of endeavor, teaches a channel with a narrower lower/distal portion opening (1064) compared to an upper/proximal portion opening (424) (Col. 9, lines 25-33 & Figs. 4A-4C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of the second channel to be narrower on the distal portion of the channel of Lieberman for the purpose of preventing a specific dimensioned-instrument from sliding entirely through the channel (Col. 9, lines 33-36). The resulting modification would lead to at least a portion of the second channel to be narrower than a portion of the first channel.
Regarding claims 7 and 55, Lieberman discloses creating a single burr hole (120) in the cranium (110) into the subdural space (114) (pa. 0003).
However, Lieberman does not explicitly teach a mounting plate configured to be secured to the opening in the patient's cranium via securing elements and to rotatably receive the turret, wherein the mounting plate includes at least one retaining structure configured to couple to at least one retaining structure of the turret.
Henderson, in the same field of endeavor, teaches a base plate (140), wherein the mounting plate is configured to be secured to an opening in a patient's cranium via securing elements (via screws that pass through mounting holes 416 of mounting tabs 422) (Col. 6, lines 62-65 & Fig. 4A) and to rotatably receive a medical instrument, wherein the mounting plate includes at least one retaining structure (1016) configured to couple to at least one retaining structure of the medical instrument (i.e., mounting thread on guidance mounting base 440 (Col. 8, lines 45-50 & Figs. 4B-4C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the securing elements and both the complementary retaining structure of the mounting plate and the retaining structure of the medical instrument (i.e., the corresponding mounting threaded surfaces) taught by Henderson to the turret structure of Lieberman in order to allow for further control and stabilization of the turret to the patient’s skull.
Regarding claims 8 and 68, Lieberman discloses the invention substantially as claimed in claims 1, 7, 51, and 55 discussed above.
However, Lieberman does not disclose a retaining ring configured to be coupled to the mounting plate such that the turret is rotatable while translational motion of the turret is limited, wherein the mounting plate includes one or more coupling members configured to couple to at least one coupling member of the retaining ring.
Henderson, in the same field of endeavor, teaches an a retaining ring (414) coupled to the mounting plate (140) such that the medical instrument is rotatable (Col. 6, lines 62-65), wherein the mounting plate includes one or more coupling members (i.e., guidance mounting base 440) configured to couple to at least one coupling member of the retaining ring (i.e., x-direction translation base 444a and y-direction translation base 444b) (Col. 7, lines 27-30 & Fig. 4A).
Examiner is interpreting “coupled to” as any two objections which may be directly or indirectly connected/touching/coupled to each other.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the retaining ring with its coupling member and the coupling members of the mounting plate taught by Henderson to the external portions of the turret structure of Lieberman which interact with the burr hole 120 in order to allow for further stabilization and more precise control of the medical device while attached to the patient’s skull.
Claims 11-12, and 57 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Flaherty (U.S. Application No. 20100023021 A1).
Regarding claims 11 and 57, Lieberman discloses the invention substantially as claimed in claims 1 and 51 and discussed above.
However, Lieberman does not disclose the turret with a bottom surface configured to atraumatically displace brain tissue and increase subdural space.
Flaherty, in the same field of endeavor, teaches a bottom surface of piston (180) configured to atraumatically displace brain tissue and increase subdural space (pa.
0033, 0062 & Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the method taught by Flaherty of atraumatically displacing brain tissue and increasing the subdural space to the device of Lieberman in order to allow for precise implantation of the electrode/medical tool while preventing improper implantation and trauma (Flaherty, pa. 0051, 0066).
Regarding claim 12, Lieberman discloses the invention substantially as claimed in claim 1 and discussed above.
However, Lieberman does not disclose a force sensor configured to monitor a force exerted onto the patient's brain tissue.
Flaherty, in the same field of endeavor, teaches a contact/force measurement
sensor (188) (pa. 0066 & Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the force sensor to the device of Lieberman in order to minimize the trauma to the target tissue or otherwise optimize the insertion process (Flaherty, pa. 0066).
Claims 65 and 67 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Skakoon (U.S. Application No. 20020156372 A1).
Regarding claims 65 and 67, Lieberman discloses the first channel (36) extending from an entrance opening (i.e., opening from the proximal end portion, as seen in Fig. 1) comprises a circular slot.
However, Lieberman does not disclose wherein the entrance opening comprises a rectangular slot.
Skakoon, in the same field of endeavor, teaches a base (104) comprising one or more grooves (202) (analogous to the entrance opening) for receiving the proximal end (100B) of electrode (100) (pa. 0052 & Fig. 1), wherein the grooves comprise a substantially rectangularly shaped-slot (see Fig. 2).
It would have been prima facie obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the entrance opening of the first channel of Lieberman to be rectangular since applicant has not disclosed that the particular shape of the opening solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any suitable shape which allows for controlled insertion and removal of the electrode from the turret.
Claims 56 and 66 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman and Henderson, as applied to claims 1 and 51 above, and further in view of Skakoon (U.S. Application No. 20020156372 A1).
Regarding claim 56, Lieberman/Henderson combination discloses the invention substantially as claimed in claims 51 and 55 and discussed above.
However, they do not disclose a turret lock configured to be coupled to the turret
base such that the turret is rotatable while translational motion of the turret is limited, wherein the turret lock comprises a cam lock.
Skakoon, in the same field of endeavor, teaches a deep brain access device (102) configured to allow an electrode (100) to access a target tissue within a patient’s brain (pa. 0049 & Fig. 1). The brain access device comprises a stabilizer (110) including a disk (310) coupled to a cam lock (312) (pa. 0054 & Fig. 3). The cam lock is able to rotate with respect to disk in order to open and close opening (314) in which the electrode is either passed freely (when open) or clamped (when closed) (pa. 0054-0055).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the turret locking feature of Skakoon in the surface of the turret base of Lieberman for the purpose of preventing unwanted movement of the electrode while in a deployed configuration.
Regarding claim 66, Lieberman/Henderson combination discloses the invention substantially as claimed in claims 1 and 7 and discussed above.
However, they do not disclose a turret lock configured to be coupled to the turret
base such that the turret is rotatable while translational motion of the turret is limited, wherein the turret lock comprises a cam lock.
Skakoon, in the same field of endeavor, teaches a deep brain access device (102) configured to allow an electrode (100) to access a target tissue within a patient’s brain (pa. 0049 & Fig. 1). The brain access device comprises a stabilizer (110) including a disk (310) coupled to a cam lock (312) (pa. 0054 & Fig. 3). The cam lock is able to rotate with respect to disk in order to open and close opening (314) in which the electrode is either passed freely (when open) or clamped (when closed) (pa. 0054-0055).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the turret locking feature of Skakoon in the surface of the turret base of Lieberman for the purpose of preventing unwanted movement of the electrode while in a deployed configuration.
Response to Arguments
Applicant' s arguments, see pages 12-13 of the Remarks filed 04/27/2026 with respect to the rejection of claims 1 and 51 under 35 U.S.C. 102 as unpatentable over Imran have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1 and 51 to further require the base to be configured to not penetrate the brain tissue and wherein the base is positioned between the cranium and the brain tissue is defined over Imran given that it does not contemplate this claimed structure. Therefore, the prior rejections based on the combination of Stratton and Hua have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1, 3, 6, 51, 54, 58-59, and 61-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liberman (U.S. Application No. 20060142782 A1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Liberman as applied to claim 1 above, and further in view of Hua (U.S. Patent No. 9179875 B2).
Claims 4, 7-8, 55, and 68 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Henderson (U.S. Patent No. 6491699 B1).
Claims 11-12, and 57 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Flaherty (U.S. Application No. 20100023021 A1).
Claims 65 and 67 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman, as applied to claims 1 and 51 above, and further in view of Skakoon (U.S. Application No. 20020156372 A1).
Claims 56 and 66 are rejected under 35 U.S.C. 103 as being
unpatentable over Lieberman and Henderson, as applied to claims 1 and 51 above, and further in view of Skakoon (U.S. Application No. 20020156372 A1).
It is the Examiner’s position that the newly filed rejections based on the Liberman reference is tenable for at least the reasoning set forth in the action 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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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