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 action is in response to the amendment filed on 1/8/2026. In the amendment, claim 5 has been amended and claims 12-20 have been added.
Response to Arguments
Applicant's arguments filed 1/8/2026 have been fully considered but they are not persuasive. Applicant argues the differences between the claimed invention and the prior art are solely based on intended use of the structures. Examiner disagrees with this analysis. The main structural argument is that ‘D1 comprises a sharpened needle’. Examiner relies on the ‘sharpened needle’ to read on the claimed structure ‘stylet’. The claim is not defining the stylet as being ‘blunt’. It is a reasonable interpretation to equate a sharpened needle with a claimed structure ‘stylet’. There is no further definition of the stylet to support applicant’s arguments that the sharpened needle would be incapable of reading thereon. Further limitations/specifications must be provided in association with the claimed features to distinguish the structures as being only used for subdural procedures over the prior art’s similar features.
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, 4, 19, & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otten (US Pat. No. 5,255,691).
Regarding claim 1, Otten discloses an apparatus comprising a subdural sound
system comprising a sound (introducer needle 10 for introducing a lead into the epidural space, and so is capable of functioning as a sound; figure 1; column 4, lines 60-68), wherein said sound is a hypotube sound (needle 10; figure 1; column 4, lines 60-68) that comprises: a body (as shown; figure 3), said body being an elongated body that is configured to be placed into a subdural space of a patient (needle 10 is shown comprising a body capable of being placed into the subdural space of a patient; figures 1, 3) and that comprises a trailing end that has a proximal opening (introducer hub 16 located at a proximal end and comprising an opening 18 for receiving stylet 20; figures 3, 5; column 5, lines 55-65), a leading end that has a distal opening (distal tip 14 comprising an opening 19; figures 3, 7; column 6, lines 3-10), and a channel that extends from said trailing end to said leading end (lumen that extend from proximal end to the distal end for insertion of stylet 20; figure 5; column 6, lines 3-15), said channel being a receiving channel (the lumen receives the stylet 20; figure 5; column 6, lines 3-15); a curved tip (curved tip 14; figure 7; column 6, lines 5-17), said curved tip being disposed at said leading end (as shown; figure 7) and being configured for angled insertion into said subdural space to advance said body to a target site in said subdural space (the curved tip 14 is capable of angled insertion into said subdural space to advance to a target site in said subdural space; figure 1; column 6, lines 5-17); a stylet (stylet 20; figure 4; column 5, lines 55-65), said stylet being configured to fit into said channel and to be advanced to said distal opening (stylet 20 which may be constructed of a length of solid stainless steel 22 having a beveled sharpened tip 26 at its distal end for matching with the beveled opening Huber point of the distal tip 14 of the needle 12; figure 5; column 5, lines 35-50) to seal said distal opening (a pointed tip adapted to be positioned in the lumen of said needle to block the passage of fluids therethrough and to stiffen the needle; column 3, lines 45-55); and an electrode that is configured to be advanced through said distal opening (epidural stimulating lead 40 and its associated electrodes advanced through the opening; figure 2; column 5, lines 15-20; column 6, lines 10-17) for placement in contact with dura tissue in said subdural space after having been inserted into and through said channel (the lead 40 is advanced into the epidural space, and so is capable of being placed in contact with dura tissue in the subdural space; column 6, lines 10-17).
Regarding claim 3, Otten further discloses wherein said body comprises a first region (the proximal elongated portion of the body; figure 7) and a second region that is adjacent to said second region (the distal end region adjacent the elongated portion; figure 7), wherein said first region has a first rigidity (the first region is made of stainless steel; column 5, lines 25-30) and said second region has a second rigidity (the distal end is made of a flexible alloy; column 6, lines 5-10), and wherein said first rigidity is greater than said second rigidity (the first region is made of stainless steel and the second region is made of a flexible alloy; column 5, lines 25-30; column 6, lines 5-10).
Regarding claim 4, Otten further discloses wherein said body comprises a first region (the proximal elongated portion of the body; figure 7) and a second region that is adjacent to said first region (the distal end region adjacent the elongated straight portion; figure 7), wherein said second region includes said leading end (as shown; figure 7) and said second region is more flexible than said first region (the second region is made of a flexible alloy and the first region is made of stainless steel; column 5, lines 25-30; column 6, lines 5-10).
Regarding claim 19, Otten further discloses wherein said body has a varying flexibility profile (tip is flexible compared to remaining structure).
Regarding claim 20, Otten further discloses wherein said sound is configured such that a flexibility of said sound in response to an applied force depends on a direction in which said applied force is applied (since the tip is the more flexible structure of the device, it is considered that a direction to which force is applied will affect how the tip flexes; it is noted that a flexible element will generally respond to forces based on the direction in which they are applied)
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691) in view of Taha (US Pub. No. 2016/0008007 A1).
Regarding claim 2, Otten further discloses wherein said body comprises a circular lumen that defines said channel (elongated needle comprising an outside and inside lumen comprising a diameter and thus comprises a circular lumen defining a channel; column 5. lines 24-28). Otten fails to explicitly disclose, teach, or suggest wherein said circular lumen is flexible. However, Taha teaches a similar device having a flexible lumen (a flexible introducer epidural needle; paragraph [0056]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Otten’s needle to be flexible, as suggested and taught by Taha, for the purpose/benefit of increasing the maneuverability of the introducer. Furthermore, such a modification involves a mere change in flexibility of the introducer and thus would have required only routine skill in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691).
Regarding claim 5, Otten fails to further disclose, teach, or suggest wherein said curved tip comprises first, second, third, and fourth sides, wherein said first side has a curved profile in relation to a first axis of said body, wherein said second side has a flat profile in relation to said first axis, and wherein said third and fourth sides define a tapering profile in relation to a second axis of said body. However, since Otten discloses wherein the needle tip comprises a curved needle tip with a Huber point (column 5, lines 35-40), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Otten’s device such that said curved tip comprises first, second, third, and fourth sides, wherein said first side has a curved profile in relation to a first axis of said body, wherein said second side has a flat profile in relation to said first axis, and wherein said third and fourth sides define a tapering profile in relation to a second axis of said body, since the tip of the needle is curved and a Huber point is known as having a side having a flat profile and sides comprising a tapering profile. Furthermore, such profile would facilitate improved penetration into the tissue. Moreover, Otten discloses that other tip configurations may also be used (column 6, lines 20-27) and since such a modification involves a mere change in a shape of the tip the modification would have required only routine skill in the art.
Claims 6, 7, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691) in view of Kryzanski (US Pub. No. 2019/0308008 A1).
Regarding claim 6, Otten fails to further disclose, teach, or suggest wherein said stylet comprises an internal lumen that is configured to deliver irrigation fluid that passes through said channel. However, Kryzanski teaches a stylet having an internal lumen that is configured to deliver irrigation fluid that passes through said channel (guidewire comprises a channel for delivering irrigation fluid; paragraph [0063)). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the Otten’s stylet to include an internal lumen that is configured to deliver irrigation fluid that passes through said channel, as suggested and taught by Kryzanski, for the purpose/benefit of being able to deliver irrigation fluid to the channel as well as the target site, as is well-known in the art.
Regarding claim 7, Otten fails to further disclose, teach, or suggest wherein said system further comprises an irrigation adapter that is coupled to a proximal end of said stylet, wherein said irrigation adapter is configured to direct irrigation through said channel. However, Kryzanski teaches wherein a system comprising an irrigation adapter that is coupled to a proximal end of said stylet, wherein said irrigation adapter is configured to direct irrigation through said channel (the guiding mechanism terminates in an adapter, such as luer-lock, that allows use of a syringe to irrigate the guiding mechanism; paragraphs [0057], [0073]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the Otten’s device to include an irrigation adapter that is coupled to a proximal end of said stylet, wherein said irrigation adapter is configured to direct irrigation through said channel, as suggested and taught by Kryzanski, for the advantage of being able to deliver irrigation fluid to the channel as well as the target site, as is well-known in the art.
Regarding claim 11, Otten discloses a method comprising: fitting a stylet into a channel defined in a body of a sound (fitting a stylet 20 in a lumen defined in a body 12 of an introducer 10 (sound); figure 5; column 5, lines 55-65), said channel being a receiving channel that extends from a proximal opening at a trailing end of said sound to a distal opening at a leading end of said sound (the lumen receives the stylet 20 and extends from a proximal opening to a distal opening; figure 5; column 5, lines 55-65), said sound being a hypotube sound (the introducer is in the form of a hypotube needle; figure 3; column 4, lines 60-68), said body being an elongated body having a curved tip at said leading end (the introducer 10 is an elongated body with a curved tip; figure 7; column 6, lines 5-15), causing said stylet to seal said distal opening (pointed tip adapted to be positioned in the lumen of said needle to block the passage of fluids therethrough and to stiffen the needle; column 3, lines 45-55), directing said sound to a target site (as shown; figure 1), upon reaching said target site, removing the stylet from said receiving channel (as shown; figure 2), after having removed said stylet, fitting an electrode into said receiving channel (fitting a lead 40 comprising electrodes into the lumen of the introducer 10; figure 2; column 5, lines 15-20; column 6, lines 10-17), and advancing said electrode through said channel towards said leading end for placement thereof in contact with target tissue (advancing said lead 40 through said lumen towards said distal end for placement thereof in contact with target tissue; figure 2; column 6, lines 10-17). Otten fails to further disclose, teach, or suggest forming a hole in a skull of a patient to access target tissue in a subdural space in a brain area of said patient; a target site in said subdural space. However, Kryzanski teaches a similar method to include the step of forming a hole in a skull of a patient to access target tissue in a subdural space in a brain area of said patient (forming a small drill hole in the skill to access the subdural space in a brain area of the patient; paragraph [0050)); a target site in said subdural space (target site in said subdural space; paragraphs [0050], [0052]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the Otten’s method to include the step of forming a hole in a skull of a patient to access target tissue in a subdural space in a brain area of said patient, as suggested and taught by Kryzanski, for the purpose/benefit of expanding use of the delivery device to deliver leads to the brain area of a patient.
Regarding claim 12, Otten further discloses visually inspecting markings on said sound and determining an extent to which said sound has entered said patient's body based at least in part on having visually inspected said markings (column 5, lines 27-32).
Regarding claim 13, as modified to be used in the subdural space, Otten’s method meets the limitation ‘wherein directing said sound to said target site comprises forming said subdural space’ - see rejection of claim 11 above.
Regarding claim 14, Kryzanski further teaches selecting said patient to be an epileptic patient (intended use of the method is in epileptic patients - paragraphs [0001]-[0002]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691) in view of Leven et al. (US Pub. No. 2018/0126152 A1).
Regarding claim 8, Otten fails to further disclose, teach, or suggest wherein said electrode comprises a cylindrical electrode. However, Leven et al. teach an electrode to be cylindrical (ring electrode 120 is cylindrical as shown; figure 4A; paragraph [0077]). It would have been obvious to one of ordinary skill in the art, before the relevant date, to have modified Otten’s electrode to be cylindrical, as suggested and taught by Leven et al., for the purpose/benefit of using a lead configuration that is well known and widely used in the art.
Regarding claim 9, Otten fails to further disclose, teach, or suggest wherein said electrode comprises multiple ring electrodes extending along a cylindrical body. However, Leven et al. further teach wherein said electrode comprises multiple ring electrodes extending along a cylindrical body (ring electrodes 120 extending along a cylindrical lead; figure 4A; paragraph [0077]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Otten’s electrode to comprise of multiple ring electrodes extending along a cylindrical body, as suggested and taught by Leven et al., for the purpose/benefit of using a lead configuration that is well known and widely used in the art.
Regarding claim 10, Otten fails to further disclose, teach, or suggest wherein said electrode comprises an elongated structure with electrical contacts disposed on a flat side thereof. Leven et al. further teach wherein said electrode comprises an elongated structure with electrical contacts disposed on a flat side thereof (lead,503 comprising a flat distal end with electrodes disposed on the flat distal end; paragraph [0082)). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Otten’s electrode to comprise of an elongated structure with electrical contacts disposed on a flat side thereof, as suggested and taught by Leven et al., for the purpose/benefit of using a paddle-style electrode which provides an alternate contact area for specific uses.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691) in view of Ditto (US Pat. No. 7,022,109 B1).
Regarding claim 17, Otten fails to explicitly disclose wherein said sound is constructed from lubricious material. However, Ditto teaches a similar cannula system for similar intended use, wherein the cannula has a lubricious outer coating to allow to ease of insertion while reducing puncture site trauma (column 5, lines 34-39). It would have been found beneficial by one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a lubricious material within the Otten device, as suggested and taught by Ditto, for the purpose of reducing puncture site trauma by creating ease of insertion.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Otten (US Pat. No. 5,255,691) in view of Lavy et al. (WO 2014/016765 A2).
Regarding claim 18, Otten further discloses wherein the installation of the device is greatly facilitated by using x-ray fluoroscopy, ultrasonic imaging and other known techniques during the installation (column 6, lines 28-34), but fails to explicitly disclose a sensor to confirm a location of said sound in said subdural space, said sensor being selected from the group consisting of an optical sensor, a chemical sensor, and an electrical sensor.
However, Lavy et al. teach the use of an electrical impedance-difference sensor for positioning an epidural needle within different tissues or within the epidural space (paragraph [00147]). Since Otten discloses that ‘other known techniques’ are utilized for the installation of the device, one of ordinary skill in the art would have found it obvious to utilize the other known technique of an electrical sensor, as suggested and taught by Lavy et al., for the purpose of positioning the device.
Allowable Subject Matter
Claims 15 & 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to further disclose, teach, or suggest introducing a different sound through said hole and guiding said different sound to a different target site, wherein said different target site differs from said target site [claim 15]; and using a nudging motion to negotiate an initial entry at an angle to place said curved tip into a position to open up said subdural space [claim 16].
Conclusion
THIS ACTION IS MADE FINAL. 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 ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 April 1, 2026