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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/07/2025 has been entered.
Response to Amendment
The Amendment filed October 16, 2025 has been entered. Currently claims 1, 7-8, 51, 55-56, 62, and 64 have been amended, claims 5, 9, 53, and 60 have been cancelled, claims 65-68 have been newly added, 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 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 10, 55-56, 59, and 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.
Claim 10 recites the limitation "an electrode" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this electrode is different from the one or more electrodes already cited in claim 1, or if this electrode is part of the array of the one or more electrodes. For examination purposes, Examiner will treat both the electrode in claim 10 as being part of the one or more electrodes of claim 1.
Claim 55 recites the limitation "a turret base" in line 1. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this turret base is different from “a turret including … a distal end portion, wherein the distal end portion includes a base” already cited in dependent claim 51, or if they are the same structure. For examination purposes, Examiner will treat both turret bases as the same structure on the apparatus of claim 51. Claims 56, 68 are also rejected because they are dependent on claim 51. Appropriate correction is required.
Claim 59 recites the limitation "the turret guide" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 Imran (U.S. Application No. 20100191305 A1).
Regarding claims 1, 51 Imran discloses a device (5) (pa. 0039 & Figs. 1-3) for positioning on a patient’s cranium (pa. 0040) and for delivery a medical tool or one or more electrodes (30, pa. 000043) into an epidural and/or subdural space and to brain tissue (TS) of the patient through an opening (i.e., burr hole) in the cranium (pa. 0041), the device comprising:
a turret (10) including a proximal end portion (21), a distal end portion (22) (pa. 0040), wherein the distal end portion includes a base (20 dp, pa. 0043) and a side surface (periphery wall surfaces adjacent to the base surface) between the base and the proximal end portion, and a first channel (25) extending from an entrance opening (i.e., opening from the proximal end portion, as seen in Fig. 2B) to an exit opening (27) (pa. 0043), 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, and wherein the first channel is configured to guide the one or more electrodes (with the aid of deflector 50, pa. 0044) 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 (pa. 0043), and wherein the first channel is curved along its length (25d) between the entrance opening and the exit opening (pa. 0043).
Examiner is interpreting the claim language directed at delivering the one or more electrodes into an epidural and/or subdural space 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 as a functional limitation. A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987. In this case, the device disclosed by the Imran reference is physically capable of deploying its electrodes in the epidural and/or subdural space since the distal portion of the turret must cross the epidural/subdural space in order to the reach the target tissue inside the brain tissue, as seen in Fig. 2A, and the electrodes are controllably deployable by the user once the distal portion of the turret reaches the target tissue (pa. 0045). Therefore, in a scenario where the user does not insert the distal portion of the turret all the way to reach the target tissue (TS) but instead partially inserts the turret to only reach the epidural/subdural space and then controllably advances the electrodes to be in the deployed state, then the prior art would meet the functional limitation of the claim.
Regarding claim 3, Imran discloses the turret further comprising a second channel (i.e., an additional channel 25; see the plurality of channels on Fig. 3) configured for the one or more electrodes to be released from the turret (pa. 0043).
Examiner is interpreting the second channel, or any channel in the turret device of Imran, to essentially function as both introduction and removal lumens where the user is able to insert and remove the electrodes when deemed necessary throughout the procedure. Although the Imran does not specifically describe methods for removing the electrodes from the turret, it does not teach against removing the electrodes, nor does it teach any structural components which prevents the user from removing the electrodes from the turret.
Regarding claims 6 and 54, Imran discloses the turret comprising a turret frame (60, 61) and a turret insert/guide (20) removably mated to the turret frame, and wherein the turret insert/guide defines the first channel (pa. 0041 & Figs. 6a-6b).
Regarding claim 58, Imran discloses a guide clamp (60, 61) configured to be coupled to the turret to help secure the medical tool received in the first channel (pa. 0041).
Regarding claim 59, Imran discloses a clamp lock (62) configured to secure the guide clamp to the turret guide (20) (pa. 0041).
Regarding claims 61 and 63, Imran discloses wherein the distal end portion includes a bottom surface (i.e., any surface on or directly adjacent to the tip region of the base) 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. 0043).
Regarding claims 62 and 64, Imran 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 (pa. 0043).
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 Imran, as applied to claim 1 above, and further in view of Hua (U.S. Patent No. 9179875 B2).
Regarding claim 10, Imran discloses the invention substantially as claimed in claim 1 and discussed above.
However, Imran 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 Imran for the purpose of providing the user further ways to visualize the placement of the electrodes.
Claims 4, 7-8, 55, and 68 are rejected under 35 U.S.C. 103 as being
unpatentable over Imran, as applied to claims 1 and 51 above, and further in view of Henderson (U.S. Patent No. 6491699 B1).
Regarding claim 4, Imran discloses the invention substantially as claimed in claims 1 and 3 and discussed above.
However, Imran 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 portion opening (1064) compared to an upper potion opening (1060) (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 lower portion of the device of Imran for the purpose of preventing a specific sized-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 claim 7, Imran discloses a mounting plate (64) on plug (60) configured to be secured to the opening in the patient's cranium (pa. 0041).
However, Imran does not explicitly teach the mounting plate is 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) (analogous to the mounting plate of Imran), wherein the mounting plate is configured to be secured to the opening in the 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 the turret, wherein the mounting plate includes at least one retaining structure (1016) configured to couple to at least one retaining structure of the turret (i.e., mounting thread on guidance mounting base 440, which is analogous to the turret plug structure of Imran) (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 (i.e., screw) and both the retaining structure of the mounting plate and the retaining structure of the turret (i.e., the corresponding mounting threaded surfaces) to the mounting plate and turret structure of Imran in order to allow for further stabilization of the medical device to the patient’s skull.
Regarding claims 8 and 68, Imran discloses a retaining ring (62) configured to be coupled to the mounting plate (pa. 0041).
Examiner is interpreting “coupled to” as any two objections which may be directly or indirectly connected/touching/coupled to each other. Therefore, the retaining ring of Imran does not necessarily have to be directly touching in order to be “coupled to” the mounting plate.
However, Imran does not disclose the 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 adjustable guidance base (414) (analogous to the retaining ring of Imran) coupled to the mounting plate (140) such that the turret 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).
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 coupling members of the mounting plate and the coupling member of the retaining ring of Henderson to the mounting plate and retaining ring structures of Imran in order to allow for further stabilization and more precise control of the medical device while attached to the patient’s skull.
Regarding claim 55, as best understood, Imran discloses a turret base (20 dp, pa. 0043) configured to be secured to the patient's cranium at the cranial opening via a securing means (i.e., flange 64) (pa. 0041).
However, Imran does not disclose wherein the turret base is configured to be rotatably received in the turret, wherein the turret base 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) (analogous to the turret base) comprising a lower screw portion (1010, 1016) (i.e., the retaining structure) configured to couple to at least one retaining structure (i.e., mounting thread on guidance mounting base 440, which is analogous to the turret structure of Imran) (Col. 8, lines 40-50 & 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 retaining structures of the turret base and the retaining structure of the turret (i.e., the corresponding mounting threaded surfaces) to the turret base and turret structure of Imran in order to allow for further stabilization of the medical device to the patient’s skull.
Claims 11-12, and 57 are rejected under 35 U.S.C. 103 as being
unpatentable over Imran, 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, Imran discloses the invention substantially as claimed in claims 1 and 51 and discussed above.
However, Imran 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 (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 piston of Flaherty to the device of Imran in order to allow for precise implantation of the electrode while preventing improper implantation and trauma (Flaherty, pa. 0051, 0066).
Regarding claim 12, Imran discloses the invention substantially as claimed in claim 1 and discussed above.
However, Imran 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 Imran 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 Imran, 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, Imran discloses the first channel (25) extending from an entrance opening (i.e., opening from the proximal end portion, as seen in Fig. 6a) comprising a circular slot.
However, Imran 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 Imran 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 Imran 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, Imran/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 interior of the turret base of Imran for the purpose of preventing unwanted movement of the electrode while in a deployed configuration.
Regarding claim 66, Imran/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 interior of the turret base of Imran for the purpose of preventing unwanted movement of the electrode while in a deployed configuration.
Response to Arguments
Applicant' s arguments, see pages 12-17 of the Remarks filed October 16, 2025 with respect to the rejection of claims 1 and 51 under 35 U.S.C. 102 as unpatentable over Stratton in view of Hua have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1 and 51 to further require the first channel to be curved along its length between the entrance opening and the exit opening is defined over each of Stratton and Hua given that neither contemplates 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 Imran (U.S. Application No. 20100191305 A1).
It is the Examiner’s position that the newly filed rejections based on the Imran reference is tenable for at least the reasoning set forth in the action above.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794