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 on 03/18/2026 has been entered. Claims 1, 9, 12-13, and 15-17 have been amended. Claims 2-8, 10-11, and 14 are in the original/ previously presented form. Claims 18-22 are cancelled. Claims 23-25 are newly presented. Thus, claims 1-17, and 23-25 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The amendment to the drawings were received on 03/18/2026. Applicant addressed all previous objections. These drawings are acceptable.
Specification
The amendments to the specifications were received on 03/18/2026. These amendments are acceptable.
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 1 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.
Regarding claim 1, the claim states “the intrabrain catheter is configured to always have a straight linear orientation in the brain” but is then followed with “while also being configured to angularly deflect in response to the deflection force applied by the brain tissue”. The use of the word “always” creates confusion as the examiner interprets if the intrabrain catheter was truly “always” in a straight linear orientation, the catheter would not be able to angularly deflect at all. The examiner suggest removal of the word “always”, or alternatively removing either “configured to always have a straight linear orientation in the brain” or “configured to angularly deflect in response to the deflection force applied by the brain tissue”. For the purposes of examination, the examiner will interpret the limitation without the use of the word always, so that the intrabrain catheter can be both configured to “have a straight linear orientation in the brain” and “angularly deflect in response to the deflection force applied by the brain tissue”.
Regarding claim 12, there is a lack of continuity concerning the use of the word “distal”. The claim states a distal end of a guide sheath, then states “wherein the guide sheath is configured to define a passage that slidably receives a distal end portion of the intrabrain catheter for placement at a target site in a brain of a subject” and “wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt”. With these limitations, it is interpreted that the guide sheath resides inside the both with the distal end of the guide sheath facing the brain of the patient, and the distal end portion of the intrabrain catheter is intended to move towards the distal end of the guide sheath. However, then the claim follows with “after the guide sheath is in position in the brain, with a distal end of the intrabrain catheter thereof residing external to the guide sheath”. It is confusing to the examiner why the distal end portion of the intrabrain catheter would be external to the placed guide sheath, when it was previously claimed the distal end portion of the intrabrain catheter would be slidingly received for placement by the guide sheath. Appropriate correction should be made to clarify the relationship with the guide sheath and the distal end portion of the intrabrain catheter.
Regarding claim 16, the claim states “the intrabrain catheter always has a straight linear orientation in the brain” but is then followed with “but is configured to angularly deflect in response to the deflection force applied by brain tissue”. The use of the word “always” creates confusion as the examiner interprets if the intrabrain catheter was truly “always” in a straight linear orientation, the catheter would not be able to angularly deflect at all. The examiner suggest removal of the word “always”, or alternatively removing either “has a straight linear orientation in the brain” or “configured to angularly deflect in response to the deflection force applied by brain tissue”. For the purposes of examination, the examiner will interpret the limitation without the use of the word “always”, so that the intrabrain catheter can be both configured to “have a straight linear orientation in the brain” and “angularly deflect in response to the deflection force applied by the brain tissue”.
Regarding claim 16, the claim states “the distal end portion has a constant stiffness”, but previously stated in the same claim “the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in concert with the guide sheath in response to a deflection force applied by brain tissue during brain shift associated with patient movement”. The use of the word “constant” creates confusion as the examiner interprets if the distal end portion of the intrabrain catheter truly had a “constant” stiffness, the distal end portion would have no flexibility at all. The examiner suggest removal of the amended addition “wherein the distal end portion has a constant stiffness” as it reads almost identical to a previous stated limitation of the claim “a distal end portion with sufficient rigidity to maintain a straight linear orientation for insertion through a tubular guide of a trajectory frame”. For the purpose of examination, the examiner will interpret the limitation without the use of the word “constant”, so that the distal end portion of the intrabrain catheter can be both sufficiently rigid and stiff, as well as have sufficient flexibility.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 7-11, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al. (United States Patent No. US 10,105,485 B2; herein, Piferi), and further in view of Knute et al. (United States Patent No. US 4,903,707 A; herein, Knute), Heruth et al. (United States Patent No. US 5,713,858 A; herein, Heruth), and Bose et al. (United States Patent Application Publication No. US 2009/0030400 A1; herein, Bose).
Regarding claim 1, Piferi discloses an intrabrain catheter (FIG. 12A, system 601), comprising: an elongate body (FIG. 12A, cannula 600) having a length in a range of 0.5-10 feet (col. 28 lines 28-30, 39-40, 49-50, 52-54; L1 of the exposed section 630A…is in the range of from about 1 mm to 50 mm; L4 of the exposed section 620A…is in the range of from about 1 mm to 75 mm; L7 of the support sleeve 610 is in the range of from about 0.5 inch to 20 inches; L8 of the tapered section 618B of the support sleeve 610 is in the range of from about 6 to 9 mm; each of the components and individual lengths add together to create the entire elongate body), the elongate body comprising a transfer tube that extends a full length of the elongate body (FIG. 12A, transfer tube 630) and that extends out a distal end portion thereof to define an exposed tip (FIG. 12E, distal exposed section of transfer tube 630A), wherein the intrabrain catheter has a proximal end portion (FIG. 12B, detail 12C) that is configured to be external to a patient (FIG. 5, cannula 100 near inlet port 114), wherein the intrabrain catheter has a distal end portion (FIG. 12B, detail 12E) with sufficient rigidity to maintain a straight linear orientation for insertion through a tubular guide of a trajectory frame (FIG. 5, col. 29 lines 7-14, rigid support sleeve 610 prevents or inhibits bending or flex of the large majority of the length of the cannula 600 as the cannula 600 is inserted through the targeting cannula 60), wherein the intrabrain catheter is configured to always have a straight linear orientation in the brain (FIG. 5, col. 29 lines 7-14, rigid support sleeve 610 prevents or inhibits bending or flex of the large majority of the length of the cannula 600 as the cannula 600 is inserted through the targeting cannula 60), and wherein the elongate body of the intrabrain catheter is configured so that with the distal end portion in position in the brain (col. 29 lines 9-11, cannula 600 inserted into patient’s brain).
Piferi does not disclose wherein the proximal end portion has sufficient flexibility to be able to bend at least 30 degrees relative to an axially extending straight linear axis in an unloaded, normal orientation, wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in response to a deflection force applied by brain tissue during brain shift associated with patient movement, and wherein the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue, wherein, in position, the intrabrain catheter is assembled to a guide sheath, a bolt and a bolt nut, wherein the bolt comprises an axially extending through channel and is configured to threadably attach to a skull of a patient prior to insertion of the guide sheath into the channel of the bolt, and wherein the bolt nut is configured to threadably attach to the bolt after the guide sheath is positioned in the channel of the bolt, wherein the guide sheath has a length defined between axially opposing proximal and distal ends thereof with the guide sheath defining a trajectory passage for the distal end portion of the elongate body of the intrabrain catheter to be slidably positioned through the guide sheath at a desired intrabrain target site after the guide sheath is positioned in the channel of the bolt and the bolt nut is attached to the bolt, and wherein the distal end of the guide sheath extends distal to the bolt, and a more proximal portion of the elongate body extends through the channel in the bolt with the proximal end portion of the elongate body bending at least 30 degrees relative to the axially extending straight linear axis to transversely exit the bolt nut while the bolt nut is attached to the bolt.
However, Heruth teaches wherein the proximal end portion has sufficient flexibility to be able to bend at least 30 degrees relative to an axially extending straight linear axis in an unloaded, normal orientation (FIG. 2, visual inspection of catheter 24 shows an angle of at least 30 degrees relative to an axially extending straight linear axis), wherein, in position, the intrabrain catheter is assembled to a guide sheath (FIG. 2, guiding catheter 16), wherein the guide sheath has a length defined between axially opposing proximal and distal ends (FIG. 2, guiding catheter 16 has distal end 15 and proximal end near annular collar portion 28) thereof with the guide sheath defining a trajectory passage for the distal end portion of the elongate body of the intrabrain catheter (FIG. 2), and the proximal end portion of the elongate body bending at least 30 degrees relative to the axially extending straight linear axis (FIG. 2, visual inspection of catheter 24 shows an angle of at least 30 degrees relative to an axially extending straight linear axis). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intrabrain catheter as disclosed by Piferi to include a relatively flexible catheter and guide sheath with a passage for a catheter as taught by Heruth in order to access a desired site within the patient's cranial cavity in support of neurological treatment of the patient (col. 5 lines 15-22) and provide outer protection for the catheter (col. 5 line 58-65).
Piferi in view of Heruth still does not disclose wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in response to a deflection force applied by brain tissue during brain shift associated with patient movement, and wherein the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue, and a bolt and a bolt nut, wherein the bolt comprises an axially extending through channel and is configured to threadably attach to a skull of a patient prior to insertion of the guide sheath into the channel of the bolt, and wherein the bolt nut is configured to threadably attach to the bolt after the guide sheath is positioned in the channel of the bolt, the distal end portion of the elongate body of the intrabrain catheter to be slidably positioned through the guide sheath at a desired intrabrain target site after the guide sheath is positioned in the channel of the bolt and the bolt nut is attached to the bolt, and wherein the distal end of the guide sheath extends distal to the bolt, and a more proximal portion of the elongate body extends through the channel in the bolt to transversely exit the bolt nut while the bolt nut is attached to the bolt.
However, Bose teaches wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in response to a deflection force applied by brain tissue during brain shift associated with patient movement ([0016], delivery catheter 12 contains regions with distal flexibility and kink resistance), and wherein the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue ([0016], [0024], delivery catheter 12 contains regions with distal flexibility and kink resistance that can absorb resistive forces of the neuroanatomy). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intrabrain catheter as disclosed by Piferi to have a sufficiently flexible distal portion as taught by Bose in order to allow for intervention to a treatment site that might otherwise be inaccessible ([0024]).
Piferi in view of Heruth and Bose still does not disclose a bolt and a bolt nut, wherein the bolt comprises an axially extending through channel and is configured to threadably attach to a skull of a patient prior to insertion of the guide sheath into the channel of the bolt, and wherein the bolt nut is configured to threadably attach to the bolt after the guide sheath is positioned in the channel of the bolt, the distal end portion of the elongate body of the intrabrain catheter to be slidably positioned through the guide sheath at a desired intrabrain target site after the guide sheath is positioned in the channel of the bolt and the bolt nut is attached to the bolt, and wherein the distal end of the guide sheath extends distal to the bolt, and a more proximal portion of the elongate body extends through the channel in the bolt to transversely exit the bolt nut while the bolt nut is attached to the bolt.
However, Knute teaches a bolt (Fig. 3, bolt means 17) and a bolt nut (Fig. 4, threaded cap 45), wherein the bolt comprises an axially extending through channel (Fig. 3, opening 29 in the bolt means 17) and is configured to threadably attach to a skull of a patient (Fig. 3, col. 3 lines 14-18) prior to insertion of the guide sheath into the channel of the bolt (Fig. 4, col. 3 lines 22-29, rigid portion 33 fits slidingly within the opening 29 in the bolt means 17), and wherein the bolt nut is configured to threadably attach to the bolt after the guide sheath is positioned in the channel of the bolt (Fig. 4, col. 3 lines 30-41, clamping means 21 clamps the rigid portion 33 of the catheter 19 in fixed relation to the bolt means 17), the distal end portion of the elongate body of the intrabrain catheter to be slidably positioned through the guide sheath at a desired intrabrain target site (Fig. 4, col. 3 lines 22-64, catheter 19 passes through rigid portion 33 and can be slidingly moved back and forth through the opening 29 in the bolt means 17 to control location of flexible portion 35) after the guide sheath is positioned in the channel of the bolt (Fig. 4, col. 3 lines 22-29, rigid portion 33 fits slidingly within the opening 29 in the bolt means 17) and the bolt nut is attached to the bolt (Fig. 4, col. 3 lines 42-44, threaded cap 45 which screws onto mating threads 47 on the second extremity 27 of the bolt means 17), and wherein the distal end of the guide sheath extends distal to the bolt (Fig. 4), and a more proximal portion of the elongate body extends through the channel in the bolt (Fig. 4, col. 3 lines 22-64, catheter 19 passes through rigid portion 33 and can be slidingly moved back and forth through the opening 29 in the bolt means 17) to transversely exit the bolt nut while the bolt nut is attached to the bolt (Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intrabrain catheter as disclosed by Piferi to consist a bolt with a channel and bolt nut that threadably attaches to the outer sides of the bolt as taught by Knute in order to create a fluid-tight mounting which provides isolation between the interior of the skull and the outside environment, thereby reducing the potential for infection (col. 1 line 62-col. 2 line 2). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi to function to be positioned and reside within the bolt after attaching the bolt to the head of the patient as taught by Knute in order to provide sterile access into the ventricle of the brain (col. 3 lines 22-29, 55-58).
Regarding claim 7, Piferi discloses wherein the intrabrain catheter is MRI compatible (col 26 lines 62-63).
Regarding claim 8, Piferi discloses wherein the proximal end portion of the elongate body is coupled to a connector (FIG. 12C, luer fitting 652) with an internal cavity surrounding an exposed sub-length of the transfer tube (FIG. 12C, col 27 lines 58-61, proximal extension section of transfer tube 630C surrounded).
Regarding claim 9, Piferi discloses wherein the elongate body comprises a first polymeric outer tube (FIG. 12D, connecting tube 660) coupled to a second polymeric outer tube (FIG. 12D, support sleeve 610) via an adapter member (FIG. 12D, tubing adapter 662), with the first polymeric outer tube extending longitudinally spaced apart from the second polymeric outer tube (FIG. 12B), and wherein the first polymeric outer tube resides closer to the proximal end portion than the second polymeric outer tube (FIG. 12B, detail 12C).
Regarding claim 10, Piferi discloses wherein the elongate body is provided by a polymeric outer tube with a constant outer diameter extending between a proximal end to a segment merging into a tapered distal end segment (FIG. 12B, connecting tube 660).
Regarding claim 11, Piferi discloses wherein the elongate body comprises a polymeric outer tube that is directly attached to a second tube extending about the transfer tube along a sub-length of the elongate body (col. 27 lines 25-27, the inner sleeve 620 is secured to the inner surface of the support sleeve 610), and wherein the second tube is directly attached to the transfer tube (col. 27 lines 46-48, the transfer tube 630 is secured to the inner surface of the inner sleeve 620).
Regarding claim 23, Piferi discloses the first polymeric outer tube has a greater outer diameter and wall thickness than the second polymeric outer tube (FIG. 12D, visual comparison between the outer diameter and wall thickness of connecting tube 660 versus support sleeve 610 shows the connecting tube 660 is greater than support sleeve 610 in both comparisons).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, and Bose as applied to claim 1 above, and further in view of Markel (United States Patent No. US 5,053,004 A).
Regarding claim 2, in the modified device of Piferi, Piferi discloses wherein the elongate body comprises an outer tube that is polymeric (FIG. 12E, col. 27 lines 20-21, polymeric outer sleeve 640 wraps around the entire support sleeve 610) and that surrounds a length of the transfer tube (FIG. 12B and FIG. 12E depict the transfer tube 630 being enclosed within support sleeve 610 and outer sleeve 640), wherein the outer tube has a wall thickness that is greater than the transfer tube (FIG. 12E, visual comparison between the wall thickness of support sleeve 610/outer sleeve 640 and transfer tube 630 shows the wall of support sleeve 610/outer sleeve 640 is greater in size), and wherein the transfer tube is indirectly coupled to the outer tube (FIG. 12E).
Piferi in view of Knute, Heruth, and Bose does not disclose the transfer tube as a non-extendable relative to the outer tube. However, Markel teaches the transfer tube as a non-extendable relative to the outer tube (FIG. 2, col. 4 lines 13-17, tubes 3 and 5 share cylindrical sleeve 7, in which the sleeve is bonded to both tubes, restricting the extension of tube 5 in regards to tube 3). The three components of Markel are similar to the three tubes of Piferi as both are arranged in a concentric manner, and the inner surface of the outer tube is bonded to the outer surface of the middle tube, same as the outer surface of the smallest tube is bonded to the inner surface of the middle tube. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the tubes of the modified intrabrain catheter of Piferi with the non-extendable bonded tubes of Markel in order to prevent the transfer tube from falling out of place in regards to the other concentric tubes (FIG.1, col. 4 lines 13-23).
Regarding claim 3, in the modified device of Piferi, Piferi discloses wherein a distal end portion of the outer tube tapers radially outward in an axial direction from the transfer tube to an outer diameter (FIG. 12E, support sleeve 610 tapers outward towards the proximal end of cannula 600), wherein the outer tube has a length that is less than a length of the elongate body (FIG. 12B, transfer tube 630 extends the entire length of the cannula 600, whereas support sleeve 610 does not) and is in a range of 6-36 inches (col. 28 lines 48-51, L7 of the support sleeve 610 is in the range of from about 0.5 inch to 20 inches), and wherein the transfer tube has a length that is longer than the outer tube (FIG. 12B, transfer tube 630 extends the entire length of the cannula 600, whereas support sleeve 610 does not).
Regarding claim 4, in the modified device of Piferi, Piferi discloses a second tube (FIG. 12E, inner sleeve 620) that is attached to the transfer tube (col. 27 lines 46-48) and that resides between the transfer tube and the outer tube (FIG. 12E, inner sleeve 620 separates support sleeve 610 and transfer tube 630), wherein the second tube is formed of the same material as the transfer tube (col. 27 lines 44-45, 64-65, inner sleeve 620 and transfer tube 630 are formed of fused silica) and terminates a distance outside the outer tube before the tip of the intrabrain catheter (FIG. 12E, end face 620B).
Regarding claim 5, in the modified device of Piferi, Piferi discloses the second tube and the transfer tube are both formed of fused silica (col. 27 lines 44-45, 64-65, inner sleeve 620 and transfer tube 630 are formed of fused silica).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, and Bose as applied to claim 1 above, and further in view of Lucas et al. (United States Patent No. US 5,795,332 A; herein, Lucas).
Regarding claim 6, Piferi in view of Knute, Heruth, and Bose does not disclose wherein at least a segment of the distal end portion of the elongate body of the intrabrain catheter is devoid of a support tube of rigid material such as ceramic. However, Lucas teaches wherein at least a segment of the distal end portion of the elongate body of the intrabrain catheter is devoid of a support tube of rigid material such as ceramic (col. 6 lines 29-32, catheter 20 is made of medical grade silicone). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the distal end portion of the modified intrabrain catheter of Piferi with the fully silicone catheter of Lucas, as it is known in the art that silicone is softer and more flexible, providing better durability for catheter use (col. 3 lines 11-18).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi, and further in view of Knute, Heruth, and Gill (United States Patent No. US 7,984,929 B2).
Regarding claim 12, Piferi discloses an intrabrain catheter (FIG. 12A, system 601).
Piferi does not disclose a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen, wherein the guide sheath is configured to define a passage that slidably receives a distal end portion of the intrabrain catheter for placement at a target site in a brain of a subject; a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt, and wherein a portion of the intrabrain catheter is configured to reside in the guide sheath, after the guide sheath is in position in the brain, with a distal end of the intrabrain catheter thereof residing external to the guide sheath; a seal member inside the bolt adjacent the shoulder of the guide sheath; and a bolt nut configured to couple to the bolt.
However, Heruth teaches a sheath assembly comprising a guide sheath (FIG. 2, guiding catheter 16) with a proximal end and an opposing distal end and with a lumen extending therethrough (FIG. 2, guiding catheter 16 has distal end 15 and proximal end near annular collar portion 28), and after the guide sheath is in position in the brain (FIG. 1, col. 5 line 50-52, guiding catheter has to be inserted and positioned), with a distal end of the intrabrain catheter thereof residing external to the guide sheath (FIG. 2, catheter 24 extends outside catheter/port assembly 10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intrabrain catheter disclosed by Piferi to include a guide sheath which can be positioned in the brain and encapsulate the catheter as taught by Heruth in order to access a desired site within the patient's cranial cavity in support of neurological treatment of the patient (col. 5 lines 15-22) and provide outer protection for the catheter (col. 5 line 58-65).
Piferi in view of Heruth still does not disclose wherein the proximal end comprises a shoulder that extends radially outward from the lumen, wherein the guide sheath is configured to define a passage that slidably receives a distal end portion of the intrabrain catheter for placement at a target site in a brain of a subject; a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt, and wherein a portion of the intrabrain catheter is configured to reside in the guide sheath; a seal member inside the bolt adjacent the shoulder of the guide sheath; and a bolt nut configured to couple to the bolt.
However, Knute teaches wherein the guide sheath is configured to define a passage that slidably receives a distal end portion of the intrabrain catheter for placement at a target site in a brain of a subject (Fig. 4, col. 3 lines 22-64, catheter 19 passes through rigid portion 33 and can be slidingly moved back and forth through the opening 29 in the bolt means 17 to control location of flexible portion 35); a bolt (Fig. 3, bolt means 17) configured to threadably engage a skull of a patient (Fig. 3, col 3 lines 14-18), wherein the bolt comprises an open channel that extends axially therethrough (Fig. 3, opening 29 in the bolt means 17), wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt (Fig. 4, col. 3 lines 22-29, rigid portion 33 fits slidingly within the opening 29 in the bolt means 17), and wherein a portion of the intrabrain catheter is configured to reside in the guide sheath (Fig. 4, col. 3 lines 22-64, catheter 19 passes through rigid portion 33 and can be slidingly moved back and forth through the opening 29 in the bolt means 17 to control location of flexible portion 35); a seal member inside the bolt adjacent the shoulder of the guide sheath (Fig. 4, O-ring 51); and a bolt nut configured to couple to the bolt (Fig. 4, threaded cap 45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intrabrain catheter as disclosed by Piferi to consist of a bolt with a channel and bolt nut that threadably attaches to the outer sides of the bolt as taught by Knute in order to create a fluid-tight mounting which provides isolation between the interior of the skull and the outside environment, thereby reducing the potential for infection (col. 1 line 62-col. 2 line 2). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi to function to be positioned and reside within the bolt after attaching the bolt to the head of the patient as taught by Knute in order to provide sterile access into the ventricle of the brain (col. 3 lines 22-29, 55-58).
Piferi in view of Heruth and Knute still does not disclose wherein the proximal end comprises a shoulder that extends radially outward from the lumen.
However, Gill teaches wherein the proximal end comprises a shoulder that extends radially outward from the lumen (Fig. 4, radially extending end portion 42). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi to include a radially extending shoulder as taught by Gill in order to prevent the guide sheath from being drawn back though the aperture of the bolt (col. 9 lines 9-12).
Regarding claim 13, in the modified system of Piferi, Piferi does not disclose the proximal end of the sheath assembly terminates inside the bolt with the shoulder of the guide sheath residing in the open channel of the bolt.
However, Knute teaches the proximal end of the sheath assembly terminates inside the bolt (Fig. 4, col. 3 lines 22-29, rigid portion 33 fits slidingly within the opening 29 in the bolt means 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi to terminate within the bolt as taught by Knute in order to form a sterile connection between the guide sheath and the bolt (col. 3 lines 55-58).
Further, Gill teaches the shoulder of the guide sheath residing in the open channel of the bolt (Fig. 4, radially extending end portion 42 flails out inside the end cap portion 46). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi to have the shoulder of the guide sheath inside the bolt in order to prevent the guide sheath from being drawn back though the aperture of the bolt (col. 9 lines 9-12).
Regarding claim 14, in the modified system of Piferi, Piferi does not disclose the bolt nut has a distal portion that is configured to apply a clamping force against the seal member. However, Knute teaches the bolt nut has a distal portion that is configured to apply a clamping force against the seal member (Fig. 4, col. 3 lines 47-58, as cap 45 is screwed into position, it engages with collet 49 and provides a compression force onto O-ring 51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intrabrain catheter of Piferi to include a distal portion in the bolt means that would provide a compression force against the sealing member as taught by Knute in order to form a sterile connection between the guide sheath and the inside of bolt (col. 3 lines 55-58).
Regarding claim 15, in the modified system of Piferi, Piferi does not disclose the seal member comprises an O-ring. However, Knute teaches the seal member comprises an O-ring (Fig. 4, O-ring 51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intrabrain catheter of Piferi to include an O-ring as taught by Knute due to the known ability of O-rings to offer flexibility over a long lifetime and provide reliable sealing functionality (col.3 lines 43-58).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, and Gill as applied to claim 12 above, and further in view of Bose.
Regarding claim 16, in the modified system of Piferi, Piferi discloses the intrabrain catheter (FIG. 12A, system 601) comprises an elongate body (FIG. 12A, cannula 600) having a length in a range of 0.5-5 feet (col. 28 lines 28-30, 39-40, 49-50, 52-54; L1 of the exposed section 630A…is in the range of from about 1 mm to 50 mm; L4 of the exposed section 620A…is in the range of from about 1 mm to 75 mm; L7 of the support sleeve 610 is in the range of from about 0.5 inch to 20 inches; L8 of the tapered section 618B of the support sleeve 610 is in the range of from about 6 to 9 mm; each of the components and individual lengths add together to create the entire elongate body), the elongate body comprising a transfer tube that extends a full length of the elongate body (FIG. 12A, transfer tube 630) and that extends out a distal end portion thereof to define an exposed tip (FIG. 12E, distal exposed section of transfer tube 630A), wherein the intrabrain catheter has a proximal end portion (FIG. 12B, detail 12C) that is configured to be external to a patient (FIG. 5, cannula 100 near inlet port 114), wherein the intrabrain catheter has a distal end portion (FIG. 12B, detail 12E) with sufficient rigidity to maintain a straight linear orientation for insertion through a tubular guide of a trajectory frame (FIG. 5, col. 29 lines 7-14, rigid support sleeve 610 prevents or inhibits bending or flex of the large majority of the length of the cannula 600 as the cannula 600 is inserted through the targeting cannula 60), wherein the distal end portion has a constant stiffness (FIG. 5, col. 29 lines 7-14, rigid support sleeve 610 prevents or inhibits bending or flex of the large majority of the length of the cannula 600 as the cannula 600 is inserted through the targeting cannula 60, 610 can also be made of ceramic), and wherein the intrabrain catheter always has a straight linear orientation in the brain (FIG. 5, col. 29 lines 7-14, rigid support sleeve 610 prevents or inhibits bending or flex of the large majority of the length of the cannula 600 as the cannula 600 is inserted through the targeting cannula 60).
Modified Piferi does not disclose wherein the proximal end portion has sufficient flexibility to be able to bend at least 30 degrees relative to an axially extending straight linear axis in an unloaded, normal orientation, wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in concert with the guide sheath in response to a deflection force applied by brain tissue during brain shift associated with patient movement, and the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue.
However, Heruth teaches wherein the proximal end portion has sufficient flexibility to be able to bend at least 30 degrees relative to an axially extending straight linear axis in an unloaded, normal orientation (FIG. 2, visual inspection of catheter 24 shows an angle of at least 30 degrees relative to an axially extending straight linear axis). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intrabrain catheter of Piferi to include a relatively flexible proximal end portion of the intrabrain catheter as taught by Heruth in order to access a desired site within the patient's cranial cavity in support of neurological treatment of the patient (col. 5 lines 15-22).
Modified Piferi in view of Heruth still does not disclose wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in concert with the guide sheath in response to a deflection force applied by brain tissue during brain shift associated with patient movement, and the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue.
However, Bose teaches wherein the distal end portion of the intrabrain catheter is configured to have sufficient flexibility to be able to deflect in concert with the guide sheath in response to a deflection force applied by brain tissue during brain shift associated with patient movement ([0016], delivery catheter 12 contains regions with distal flexibility and kink resistance), and the intrabrain catheter is configured to angularly deflect in response to the deflection force applied by brain tissue ([0016], [0024], delivery catheter 12 contains regions with distal flexibility and kink resistance that can absorb resistive forces of the neuroanatomy). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intrabrain catheter of Piferi to have a sufficiently flexible distal portion as taught by Bose in order to allow for intervention to a treatment site that might otherwise be inaccessible ([0024]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, and Gill as applied to claim 12 above, and further in view of Boston Scientific (Boston Scientific. (2020). Peripheral Interventions Product Catalog [Catalog]).
Regarding claim 17, in the modified system of Piferi, Piferi does not disclose the guide sheath is provided as a plurality of guide sheaths, each guide sheath comprising a respective shoulder and provided in a different length from the respective shoulder to a corresponding distal end of the guide sheath to thereby allow a user to select an appropriate guide sheath to use for a particular medical procedure.
However, Boston Scientific teaches the guide sheath is provided as a plurality of guide sheaths to thereby allow a user to select an appropriate guide sheath to use for a particular medical procedure (pg. 20-21, Introducer Sheaths come in a variety of sheath lengths). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth as part of the modified intrabrain catheter of Piferi with the various guide sheath lengths as taught by Boston Scientific in order to properly treat each patient. This means selecting a different length guide sheath depending on the size of the patient or how far from an access point on a patient the sheath would need to stretch.
Further, Gill teaches each guide sheath comprising a respective shoulder (Fig. 4, radially extending end portion 42) and provided in a different length from the respective shoulder to a corresponding distal end of the guide sheath (Fig. 4, radially extending end portion 42 is continuously connected to cable sheath 40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide sheath taught by Heruth and multiple guide sheaths as taught by Boston Scientific as part of the modified intrabrain catheter of Piferi with a radially extending shoulder as taught by Gill in order to prevent the guide sheath from being drawn back though the aperture of the bolt (col. 9 lines 9-12).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, and Gill as applied to claim 12 above, and further in view of Swann et al. (United States Patent No. US 4,646752 A; herein, Swann).
Regarding claim 24, in the modified system of Piferi, Piferi does not disclose the bolt nut comprises a proximal end portion with a neck that merges into a center projection having an open center channel, wherein the center projection has a distal end that faces the shoulder of the guide sheath in the open channel of the bolt, wherein the proximal end portion comprises an outer portion with an annular space between a wall of the center projection and the outer portion with a proximal end of the bolt residing in the annular space, and wherein an inner surface of the outer portion comprises threads that attach to external threads of the bolt to couple the bolt and bolt nut.
However Knute teaches the bolt nut comprises a proximal end portion (Fig. 4, threaded cap 45), wherein the proximal end portion comprises an outer portion (Fig. 4, threads 47 of threaded cap 45), and wherein an inner surface of the outer portion comprises threads that attach to external threads of the bolt to couple the bolt and bolt nut (Fig. 4, col. 3 lines 42-44, threaded cap 45 which screws onto mating threads 47 on the second extremity 27 of the bolt means 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified intrabrain catheter of Piferi to consist of a bolt nut that threadably attaches to the outer sides of the bolt as taught by Knute in order to create a fluid-tight mounting which provides isolation between the interior of the skull and the outside environment, thereby reducing the potential for infection (col. 1 line 62-col. 2 line 2).
Modified Piferi in view of Knute still does not disclose a neck that merges into a center projection having an open center channel, wherein the center projection has a distal end that faces the shoulder of the guide sheath in the open channel of the bolt, an annular space between a wall of the center projection and the outer portion with a proximal end of the bolt residing in the annular space.
However, Swann teaches a neck that merges into a center projection having an open center channel (Annotated on Fig. 4 below), wherein the center projection has a distal end that faces the shoulder of the guide sheath in the open channel of the bolt (Annotated on Fig. 4 below, distal end being the tapered end), an annular space between a wall of the center projection and the outer portion with a proximal end of the bolt residing in the annular space (Annotated on Fig. 4 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bolt and bolt nut taught by Knute as part of the modified intrabrain catheter of Piferi to have the bolt nut fit directly into the bolt and connect to the sides of the bolt in order to couple fluid tubing directly to the screw-type device (col. 1 lines 46-53), which would reduce the possibility of contamination and spills.
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Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Knute, Heruth, Gill, and Swann as applied to claim 24 above, and further in view of Osa (United States Patent No. US 10,786,325 B1).
Regarding claim 25, in the modified system of Piferi, Piferi does not disclose a cap that attaches to the proximal end portion of the bolt nut with a segment of the intrabrain catheter transversely exiting the bolt nut and cap. However, Osa teaches a cap that attaches to the proximal end portion of the bolt nut with a segment of the intrabrain catheter transversely exiting the bolt nut and cap (FIG. 1 and FIG. 2 anchor bolt cap 22). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bolt nut taught by Knute as part of the modified intrabrain catheter of Piferi to include a cap with a bore as taught by Osa in order to provide access to the lumen of the bolt as well as to guide the intrabrain catheter (col. 2 line 63 – col. 3 line 18).
Response to Arguments
Applicant’s arguments, see pages 1-15, with respect to claims 1, 6, 12, 13, and 17 under 35 U.S.C. 103 have been considered but are moot because the arguments do not apply in view of the new grounds of rejection.
Applicant argues on pg. 16 of the Remarks, regarding claim 6, that “Lucas describes a silicone balloon catheter. Piferi provides a transfer tube and an outer support tube to provide a rigid device to maintain a position at the target site in the brain. One of skill in the art would not modify at least a segment of the distal end portion of the catheter as alleged to ‘provide better durability for catheter use’.” However, it has been held that a prior art reference must be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the particular problem that is of concern is a segment of the distal end portion of the elongate body must be devoid of a support tube of rigid material for flexibility purposes. Lucas is applied for teachings regarding the use of silicone for a catheter body. Silicone is a known material used for the manufacturing of medical catheters/tube-like components of catheters (as taught and evidenced by Lucas, for one col. 3 lines 11-18), so it would not be beyond the skill of one of ordinary skill in the art to change the material to be "devoid of a rigid material such as ceramic”, and instead use a material such as silicone. Therefore, although the rejection of claim 6 was made moot by the new grounds of rejection made to claim 1, the use of Lucas still stands in the final rejection.
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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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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