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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/15/2025 has been entered.
Response to Amendment
The amendments filed 03/25/2024 have been entered. Claim 1 has been amended. Claim 8 has been cancelled. Claims 9-12 have been added. Claims 1-7 and 9-12 are currently pending on the application.
Response to Arguments
Applicant’s arguments filed 07/15/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended claim 1 to overcome the previous claim objections and 112 rejections. Applicant further distinguishes the invention from the prior art by including the limitation “a screw thread portion having the screw thread formed thereon, the screw thread portion having a length corresponding to a skull thickness of the patient, and a smooth part having no screw thread formed thereon, the smooth part having a length corresponding to a scalp thickness of the patient”. Olson does not disclose this limitation. Thus, a new prior art rejection has been made in light of the amendments.
Claim Objections
Claims 9-11 objected to because of the following informalities:
Regarding claim 9, the claim recites the limitation “wherein the length of the screw thread portion ranges from 9.6 mm to 13mm”. It is suggested to say that the length may be a value within that range, or some other similar precise wording, as the current wording makes it sound like the screw thread portion is extendable and retractable.
Regarding claim 10, the claim recites the limitation “wherein a length of the first part ranges from 13 mm to 21mm”. It is suggested to say that the length may be a value within that range, or some other similar precise wording, as the current wording makes it sound like the first part is extendable and retractable.
Regarding claim 11, the claim recites the limitation “wherein the screw type electrode has a length ranging from 22.8mm to 30.8mm”. It is suggested to say that the length may be a value within that range, or some other similar precise wording, as the current wording makes it sound like the device may change length.
Appropriate correction is required.
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.
Claims 1-7 and 9-12 are rejected under 35 U.S.C. 112(b) 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.
Regarding claim 1, the recitation “the screw thread portion having a length corresponding to a skull thickness of the patient” is indefinite as the metes and bounds of the claim are unclear until the device (herein the screw) engages the user. See In re Brummer.
Regarding claim 9, the claim recites the limitation “wherein the length of the screw thread portion ranges from 9.6 mm to 13mm.” However, claim 1, which claim 9 depends from, recites “the screw thread portion having a length corresponding to a skull thickness of the patient”. Thus, it is unclear what the actual measurement for the screw thread portion is, and the claim is considered indefinite.
The remaining claims are necessarily rejected as being dependent upon a rejected base claim.
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.
Claims 1-3, 5-6, and 9-11 rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20040243207 A1) in view of Laakkonen (US 20150272466 A1) and Kennedy (US 20050070810 A1) and Piferi (US 20140066750 A1).
Regarding Claim 1, Olson discloses
A screw-type electrode capable of being coupled to a plug-type wire (Olson, Fig 1A-B screw electrode (10,12) wire (18b), par [0040-0041]), the screw-type electrode comprising:
a first part having a screw thread configured to insert the screw-type electrode into a bone of a patient (Olson, Fig 1A-B screw (10) with first part denoted by threads, par [0040-0041]), the first part comprising:
a screw thread portion having the screw thread formed thereon (Olson, Fig 1A-B screw (10) with first part denoted by threads, par [0040-0041]), and
a second part connected to the first part and having a predetermined length, the second part having a groove configured to receive a terminal of the plug-type wire (Olson, Fig 1A-B screw (10) second part (28) with groove (22) to receive terminal (30) of plug-type wire, par [0043]), one or more holes positioned on an inner wall of the groove (Olson, Fig 1A-B hole (22), par [0040]), and the terminal having one or more corresponding protrusions coupled to and extending outwardly from the terminal (Olson, Fig 1A-B corresponding protrusion (24), par [0040]).
Olson discloses that the screw may be screwed into a spinal bone (Olson, par [0040]), as well as that the screw may go through an exterior hard bone into a softer interior while maintaining electrical conductivity (Olson par [0046]). Olson does not explicitly disclose wherein the bone is a skull. However, 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 (see MPEP 2114). For examination purposes the insertion of the electrode into the skull is seen as intended use. Therefore, Olson’s screw electrode would be capable of being inserted into the skull and scalp of a patient.
Olson does not explicitly disclose the screw thread portion having a length corresponding to a skull thickness of the patient;
a smooth part having no screw thread formed thereon, the smooth part having a length corresponding to a scalp thickness of the patient;
holes positioned on an inner side wall of the groove,
wherein, when the terminal of the plug-type wire is inserted into the groove of the second part of the screw-type electrode, the one or more protrusions of the terminal are configured to deflect such that they can be received by the corresponding one or more holes of the second part, thereby coupling the plug-type wire to the screw-type electrode.
However, Laakkonen discloses a medical electrical connector (Laakkonen par [0035]) wherein an inner side wall of the groove having one or more holes (Laakkonen Fig 7AB hole (52) in inner side wall of groove (74) of second part (11) par [0057]) and the terminal having one or more corresponding protrusions coupled to and extending outwardly from the terminal (Laakkonen Fig 7AB terminal (12) having protrusions (47) coupled to and extending outwardly from (20) par [0057]), wherein, when the terminal of the plug-type wire is inserted into the groove of the second part of the screw-type electrode, the one or more protrusions of the terminal are configured to deflect such that they can be received by the corresponding one or more holes of the second part, thereby coupling the pieces (Laakkonen par [0057] protrusions are flexible).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Olson with a secure shape-locking connector piece such as disclosed by Laakkonen, as such a method of connection allows for the plug be locked in such a manner as incorrect positioning of the plug is impossible (Laakkonen par [0057]), making up for the deficiency of Olson where the groove and terminal have no direct manner of locking.
Furthermore, Kennedy discloses screws for insertion into a skull wherein the length corresponds to the thickness of the cranium (Kennedy Fig 1 (102) par [0020], see also par [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used a screw with a length corresponding to the cranium thickness, as this allows penetration of the skull without damaging the brain (Kennedy par [0008]).
Furthermore, Piferi discloses a screw for screwing into a skull (Piferi Fig 3 (1440) par [0048]) having a threaded part and a smooth part having no screw thread formed thereon (Piferi Fig 3 screw (1440) threaded part (1446) smooth part (1448) par [0048]), the smooth part having a length corresponding to a scalp thickness of the patient (Piferi par [0067] smooth part may be 7mm, which is a typical scalp thickness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Olson to have a smooth part outside of the skull bone to leave a portion of the screw outside of the bone for use during procedures (Piferi par [0048]).
Regarding Claim 2, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 1, and further discloses wherein all or part of the first part is configured to be inserted into the bone of the patient (Olson, par [0040] screw is installed in bone), and is configured to detect a signal on the surface of the nervous system of the patient or to deliver a stimulus to the nervous system of the patient (Olson, par [0039] stimulation or detection of nerve tissue, par [0045]).
Olson does not explicitly disclose wherein the bone is a skull, or wherein the section of the nervous system is particularly the brain. However, Olson mentions that most body tissue may be electrically responsive and thus able to be interfaced with the disclosed device (Olson, par [0039]). 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 (see MPEP 2114).
Regarding Claim 3, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 1, and further discloses wherein the groove formed in the second part has a polygonal shape (Olson, par [0043] for description of groove in second part (28), see Fig 9-10 for analogous polygonal structures from other embodiments), and a separate insertion tool is configured to insert the screw-type electrode into the skull of the patient (Olson, par [0040] driver used to insert screw into patient).
Regarding Claim 5, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 3, and further discloses wherein the terminal of the plug-type wire has a polygonal shape corresponding to the groove of the second part (Olson, Fig 1A terminal (30) with polygonal shape corresponding to groove in (28), par [0043]).
Regarding Claim 6, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 5. Laakkonen further discloses wherein the one or more protrusions include an elastic member having a convex shape (Laakkonen Fig 7AB terminal (12) having protrusions (47) are convex and elastic par [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Olson with a secure shape-locking connector piece such as disclosed by Laakkonen, as such a method of connection allows for the plug be locked in such a manner as incorrect positioning of the plug is impossible (Laakkonen par [0057]), making up for the deficiency of Olson where the groove and terminal have no direct manner of locking.
Regarding Claim 9, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 5. Kennedy further discloses wherein the length of a screw thread portion is in a range between 9.6 mm to 13 mm (Kennedy Fig 1 (102), par [0021] screw may be ~6 to ~38 mm in length).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used a length of screw threads in such a range as disclosed by Kennedy, as such a range is suitable for screwing into a skull (Kennedy par [0020-0021]).
Regarding Claim 10, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 5. Kennedy further discloses wherein the length of a first part is in a range between 13 mm to 21 mm (Kennedy Fig 1 (102), par [0021] screw may be ~6 to ~38 mm in length).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used a length of screw threads in such a range as disclosed by Kennedy, as such a range is suitable for screwing into a skull (Kennedy par [0020-0021]).
Regarding Claim 11, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 5. Kennedy further discloses wherein the length of a screw is in a range between 22.8 mm to 30.8 mm (Kennedy Fig 1 (102), par [0021] screw may be ~6 to ~38 mm in length).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used a length of screw threads in such a range as disclosed by Kennedy, as such a range is suitable for screwing into a skull (Kennedy par [0020-0021]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20040243207 A1) in view of Laakkonen (US 20150272466 A1) and Kennedy (US 20050070810 A1) and Piferi (US 20140066750 A1) and further in view of Jones (US 20110112436 A1) and Mathonnet (US 8231620 B2).
Regarding Claim 4, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 1. Olson does not explicitly disclose wherein outer walls of the first and second parts have gradations marked thereon and are divided in predetermined units.
However, Jones discloses a similar screw for insertion into bone (Jones, par [0006]) comprising a first part with threads and a second part meant for connection (Jones, Fig 3, screw (10) with first part (24) and second part (30)) wherein outer walls of the second part has gradations marked thereon and are divided in predetermined units (Jones, Fig 3 gradations (30), par [0038,0042] shaft markings allows surgeon to see depth of screw insertion).
Mathonnet discloses an electrosurgical device comprising a screw with gradations on the screw threads (first part) indicate the depth of screw insertion (Mathonnet, Fig 7 screw (605) with markings (602), col 5 line 57-58 thread markings allow for depth indication during insertion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the markings of Jones with the device of Olson, as such markings allow for indication of the depth of the screw insertion (Jones, par [0038,0042] markings serve to inform surgeon how deep a pin has been positioned within the bone at any given time), and to have incorporated the markings of Mathonnet with the device of Olson, as the marked threads can be used to indicate depth of the screw (Mathonnet col 5 line 57-58). Combining the thread markings of Mathonnet with the shaft markings of Jones would allow for an indication of insertion depth both during the insertion process as well as after insertion has been performed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20040243207 A1) in view of Laakkonen (US 20150272466 A1) and Kennedy (US 20050070810 A1) and Piferi (US 20140066750 A1) and further in view of Kendricks (US 9226680 B1).
Regarding Claim 7, Olson in view of Laakkonen and Kennedy and Piferi discloses the device of claim 1. Olson fails to explicitly disclose a knob for attaching/detaching the one or more protrusions coupled to the respective one or more holes of the groove;
wherein, when pressed by a user, the knob forms a gap between the one or more protrusions and the respective one or more holes, thereby allowing the user to remove the second part from the first part.
However, Kendricks discloses a medical electrical connector comprising a knob (Kendricks Fig 5 knob (14)) for attaching or detaching one or more protrusions coupled to a respective one or more holes (Kendricks Fig 9AB protrusion (26) hole (4)), wherein, when pressed by a user (Kendricks col 5 line 64-col 6 line 1), the knob forms a gap between the one or more protrusions and the respective one or more holes, thereby allowing the user to remove the terminal from the second part (Kendricks Fig 5A-B, Fig 9A-B, col 6 line 46-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the connecting protrusions disclosed by Olson in view of Laakkonen to be actuated by a knob in a manner similar to that disclosed by Kendricks, as such a resiliently biased structure with a knob for manual manipulation allows for secure, yet easily removable, connection between electrical contacts of medical devices (Kendricks col 6 line 46-49)
Claims 12 rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20040243207 A1) in view of Laakkonen (US 20150272466 A1) and Kennedy (US 20050070810 A1) and Piferi (US 20140066750 A1), and further in view of Sexson (US 20170348037 A1).
Regarding claim 12, Olson in view of Laakkonen and Kennedy and Piferi discloses the invention of claim 1. However, Olson does not explicitly disclose
Furthermore, Sexson discloses screws designed for insertion into bone (Sexson par [0081]) wherein at least one of the first part and the second part are coated in different colors according to depth values (Sexson Fig 16 par [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Olson to include colored depth indication, as such an indication allows for visual inspection of insertion progress (Sexson par [0188]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liebrecht (US 6778861 B1) discloses a very similar electrically conductive bone screw (Liebrecht Fig 1-5 (311)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Monday-Friday 9am-5pm ET.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/MATTHEW DAVID BECTON/Examiner, Art Unit 3794