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 .
Claim Objections
Claim 28 is objected to because of the following informalities: Claim 28 recites “a distal end of the stent” in line 2 which should read “the distal end of the stent”. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: Claim 41 recites “the deployed length” which should read “a deployed length” for consistency purposes. 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.
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 28 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites “wherein a tip is disposed on a guidewire and protrudes from a distal end of the stent prior to deployment of the stent”, where the tip and guidewire are positively claimed as part of the invention. Claim 28 depends from claim 21 which recites “A stent”, where the delivery catheter is functionally recited. As such, it is unclear if claim 28 is directed to the sub-combination of the stent or if it is directed to the combination of the tip/guidewire and the stent. For the purposes of examination, the limitation is interpreted to be directed to the sub-combination of the stent. Therefore, as long as the prior art discloses wherein the stent is configured to extend over a tip/guidewire, additional limitations directed to the guidewire are irrelevant.
Claim 39 recites the limitation "the surrounding narrowed segment" in line 3. There is insufficient antecedent basis for this limitation in the 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.
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.
Claim(s) 21, 26-30 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heilman et al. (US 2019/0298977 A1).
Regarding claim 21, Heilman discloses a stent (stent 900; Fig. 9) for permanent implantation into a cerebral venous sinus (Fig. 9) having a stenosis (some patients may have a stenosis; [0121]), the stent comprising: a proximal end, a distal end, and a tubular flexible body extending between the proximal end and the distal end (Fig. 9), the tubular flexible body comprising a wire (mesh of fine platinum or nitinol wire; [0066]) having a variable cell size between the proximal end and the distal end (as the cell size of the stent 900 is larger to the left when viewing Fig. 9 and smaller to the right), the tubular flexible body having the same diameter at the proximal end and the distal end (as the stent is a tube; Fig. 9); wherein the stent (900) is configured for insertion and permanent implantation into the cerebral venous sinus (Fig. 9), the stent (900) is configured to be constrained within a lumen of a delivery catheter (delivery catheter; [0068]) until the stent is positioned and deployed in the cerebral venous sinus (Fig. 9), wherein the stent is configured to self-expand (the stent 900 is implemented as a self-expanding circumferential type stent; [0065]) and capable of open a stenosis after being deployed (as the expanded stent 900 applies a constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place within the sigmoid sinus 904 by compressive force and further anchor device 902 in place against the wall of the sigmoid sinus; [0066]; thus, capable of opening a stenosis), and wherein the stent is configured to secure itself to a surrounding wall of the cerebral venous sinus ([0066]), and wherein the stent is configured to be permanently implanted in the cerebral venous sinus at a location of the stenosis (Fig. 9).
Heilman fails to explicitly disclose the diameter being between about 6 mm and about 10 mm at the proximal end and the distal end.
However, Heilman teaches the dural venous sinuses described in this application (i.e., sigmoid, transverse, straight, or sagittal sinus) can have a relatively large diameter (e.g., 7 mm, 8 mm, 9 mm or more; [0132]) and that expanded stent (900) applies a constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place within the sigmoid sinus by compressive force ([0066]). The stent would need to expand to at least the diameter of the sigmoid sinus in order to apply a constant outward radial force against the sigmoid sinus.
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 stent of Heilman to have the same diameter of between about 6 mm and about 10 mm at the proximal end and the distal end in light of the teachings of Heilman in order to effectively apply constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place.
Regarding claim 26, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the stent (900) is collapsible within the delivery catheter ([0068]).
Regarding claim 27, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the cells have different sizes in different sections of the stent (Fig. 9).
Regarding claim 28, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein a tip is disposed on a guidewire and protrudes from a distal end of the stent prior to deployment of the stent (as the stent 900 is compressed to reduce its diameter and fitted onto a balloon catheter; [0068]; thus, capable of receiving a tip/guidewire as claimed).
Regarding claim 29, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the stent is capable of transitioning between a collapsed configuration (compressed) and an expanded configuration (expanded; [0066]-[0068]).
Regarding claim 30, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the cerebral venous sinus is a member selected from the group consisting of the superior sagittal venous sinus, the transverse venous sinus, the sigmoid venous sinus, and the straight venous sinus (sigmoid sinus 904; [0066]; Fig. 9).
Regarding claim 44, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the wire is arrayed in a closed cell pattern (Fig. 9).
Claim(s) 22 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heilman et al. (US 2019/0298977 A1) in view of You et al. (US 2020/0368388 A1).
Regarding claims 22 and 33, Heilman modified discloses the invention as claimed above, and Heilman further discloses the stent (900) having variable cell size to adapt to a non-cylindrical shape of the cerebral venous sinus (Fig. 9), but fails to explicitly disclose wherein the stent has different zones that apply different respective chronic outward forces, wherein the stent can have a customized, variable cell size.
However, You teaches a stent (100) sized for permanent implantation into a cerebral venous sinus (having a diameter of 5 to 25 mm; [0164]), the stent comprising a tubular flexible body of braided wire ([0028]), the braided wire may comprise cells of differing size ([0028]). The different sized cells improve conformability of the stent ([0495]). The different sized cells would make up different zones that would apply different respect chronic outward forces.
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 closed cell pattern of modified Heilman to have to have customized variable cell size causing different zones that apply different respective chronic outward forces as taught by You in order to improve the conformability of the stent.
Claim(s) 23-25, 31-32, 34-35, 37-40, 42-43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heilman et al. (US 2019/0298977 A1) in view of Amans (US 2023/0097980 A1).
Regarding claims 23-25 and 45, Heilman modified fails to disclose wherein the stent is repositionable after deployment, wherein the stent can be retrieved when the tubular flexible body is expanded by up to about 85%, and wherein the stent can be re-sheathed within the lumen of the delivery catheter when the tubular flexible body is expanded by up to about 85%.
However, Amans teaches a stent (stent 2; Fig. 1) for permanent implantation into a cerebral venous sinus having a stenosis (stent for the unique environment of the venous sinuses to open a venous sinus stenosis; [0007]), comprising: a proximal end (proximal end portion 16), a distal end (distal end portion 14), and a tubular flexible body (tubular member 10) of braided wire (braided design; Fig. 1; [0013]), providing a closed cell pattern (closed cell; Fig. 1; [0013]); between the proximal end and the distal end (Fig. 1), wherein the tubular flexible body (10) has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]); wherein the stent is configured for insertion and permanent implantation into a cerebral venous sinus (i.e. sigmoid sinus; [0007]), the stent being constrained within a lumen of a delivery catheter until the stent is positioned and deployed in the cerebral venous sinus wherein the stent self-expands to open the stenosis after being deployed (as the stent may be constrained in a catheter and when un-sheathed at the target location, self-expand; [0037]), and wherein the stent is configured to secure itself to surrounding venous sinus walls to be retrievable or re-sheathable (as the closed cell or braided design allows for the stent to be retrievable; [0013]), and to be permanently implanted in a desired location in the cerebral venous sinus (as the stent remains in place after deployment). Amans further discloses wherein the stent (2) is capable of being retrieved or re-sheathed even when the stent is between about seventy and eighty-five percent expanded (as the closed cell braided design allows the stent to be retrievable; [0013]; further, the stent may have a hook 24 and/or attachment elements 22 that allow the stent to be retrieved or re-sheathed at any point during and/or after expansion, which would include at about seventy and eighty-five percent expanded; [0013]).
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 stent of modified Heilman to be repositionable after deployment, retrieved and re-sheathed when the tubular flexible body is expanded by up to about 85% as taught by Amans in order to allow the stent to be repositioned if not deployed in the desired position initially.
Regarding claim 31-32 and 38, Heilman modified fails to explicitly disclose wherein the stent is used to treat a medical condition selected from the group consisting of idiopathic intracranial hypertension, pulsatile tinnitus, cerebral venous insufficiency, intracranial venous thrombosis, and intracranial venous stenosis, wherein intracranial venous stenosis comprises a medical condition resulting from compression from a tumor, compression from brain parenchyma, compression from arachnoid granulation, or from thrombus, and/or wherein the medical condition is pulsatile tinnitus.
However, Amans teaches wherein the stent is used to treat a medical condition selected from the group consisting of idiopathic intracranial hypertension, pulsatile tinnitus, cerebral venous insufficiency, intracranial venous thrombosis, and intracranial venous stenosis (pulsatile tinnitus; [0002]; stenosis; [0007]), wherein intracranial venous stenosis comprises a medical condition resulting from compression from tumor, compression from brain parenchyma, compression from arachnoid granulation, or thrombus (“used to treat a medical condition resulting from” as recited in claim 11 is interpreted as functional language reciting an intended use of the device. Therefore, the device need only be capable of achieving the intended function. In the device of Amans, the stent is at least sized and shaped such that the stent is capable of treating an intracranial venous stenosis of which is a resultant of a thrombus obstruction). Amans further teaches wherein the medical condition is pulsatile tinnitus (PT; [0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the stent of modified Hielman to treat a medical condition selected from the group consisting of idiopathic intracranial hypertension, pulsatile tinnitus, cerebral venous insufficiency, intracranial venous thrombosis, and intracranial venous stenosis, wherein intracranial venous stenosis comprises a medical condition resulting from compression from a tumor, compression from brain parenchyma, compression from arachnoid granulation, or from thrombus in light of the teachings of Amans in order to treat more patients with different afflictions.
Regarding claim 34, Hielman discloses a stent (stent 900; Fig. 9) for permanent implantation into a cerebral venous sinus (Fig. 9) having a stenosis (some patients may have a stenosis; [0121]), the stent comprising: a proximal end, a distal end, and a tubular flexible body extending between the proximal end and the distal end (Fig. 9), the tubular flexible body comprising a wire (mesh of fine platinum or nitinol wire; [0066]) having a variable cell size between the proximal end and the distal end (as the cell size of the stent 900 is larger to the left when viewing Fig. 9 and smaller to the right), the tubular flexible body having the same diameter at the proximal end and the distal end (as the stent is a tube; Fig. 9); wherein the stent (900) is configured for insertion and permanent implantation into the cerebral venous sinus (Fig. 9), the stent (900) is configured to be constrained within a lumen of a delivery catheter (delivery catheter; [0068]) until the stent is positioned and deployed in the cerebral venous sinus (Fig. 9), wherein the stent is configured to self-expand (the stent 900 is implemented as a self-expanding circumferential type stent; [0065]) and capable of open a stenosis after being deployed (as the expanded stent 900 applies a constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place within the sigmoid sinus 904 by compressive force and further anchor device 902 in place against the wall of the sigmoid sinus; [0066]; thus, capable of opening a stenosis), and wherein the stent is configured to secure itself to a surrounding wall of the cerebral venous sinus ([0066]), and wherein the stent is configured to be permanently implanted in the cerebral venous sinus at a location of the stenosis (Fig. 9).
Heilman fails to explicitly disclose the diameter being between about 6 mm and about 10 mm at the proximal end and the distal end.
However, Heilman teaches the dural venous sinuses described in this application (i.e., sigmoid, transverse, straight, or sagittal sinus) can have a relatively large diameter (e.g., 7 mm, 8 mm, 9 mm or more; [0132]) and that expanded stent (900) applies a constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place within the sigmoid sinus by compressive force ([0066]). The stent would need to expand to at least the diameter of the sigmoid sinus in order to apply a constant outward radial force against the sigmoid sinus.
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 stent of Heilman to have the same diameter of between about 6 mm and about 10 mm at the proximal end and the distal end in light of the teachings of Heilman in order to effectively apply constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place.
Heilman discloses the stent may be used with a delivery catheter ([0068]), but fails to explicitly disclose an intracranial implant delivery system for implanting a stent into a cerebral venous sinus, the intracranial implant delivery system comprising: a catheter comprising a distal catheter end, a proximal catheter end, and a lumen extending between the distal catheter end and the proximal catheter end; a tip located at the distal catheter end; wherein the stent is configured to be constrained within a lumen of the catheter until the stent is positioned and deployed in the cerebral venous sinus, wherein the stent is configured to be re-sheathable, to expand after deployment, to alleviate the stenosis in the cerebral venous sinus by forcing a surrounding narrowed segment of the cerebral venous sinus to expand, and wherein the stent is configured to secure itself to the surrounding narrowed segment and to be implanted in the cerebral venous sinus at the surrounding narrowed segment.
However, Amans teaches an intracranial implant delivery system (stent 2 and catheter; Fig. 1; [0037]) for implanting a stent (stent 2) into a cerebral venous sinus (stent for the unique environment of the venous sinuses to open a venous sinus stenosis; [0007]), comprising: a catheter (catheter; [0037]) comprising a distal end (distal end of catheter), a proximal end (proximal end of catheter), and a lumen (lumen in which the stent is sheathed) extending between the distal end and the proximal end ([0037]); a tip located at the distal end of the catheter (a catheter inherently has a distal-most end i.e. tip; [0037]); and the stent (2; Fig. 1) comprising: a proximal end (proximal end portion 16), a distal end (distal end portion 14), and a tubular flexible body (tubular body 10) of braided wire (braided design; [0013]), providing a closed cell pattern (closed cell design; Fig. 1; [0013]), between the proximal end and the distal end (Fig. 1) wherein the tubular flexible body has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]); wherein the stent is configured for insertion into a cerebral venous sinus (at least the sigmoid sinus) to alleviate a stenosis (to open a stenosis; [0007]), the stent being constrained within a lumen of a delivery catheter until the stent is positioned and deployed in the cerebral venous sinus (as the stent may be constrained in a catheter and when un-sheathed at the target location, self-expand; [0037]), and wherein the stent is configured to be re-sheathable (as the closed cell or braided design allows for the stent to be retrievable; [0013]), to expand after deployment (self-expand; [0037]), to alleviate a stenosis in the venous sinus by forcing a narrowed segment of the vein to expand, and to secure itself to surrounding venous sinus walls and to be implanted in a desired location in the cerebral venous sinus (as the stent self-expands to contact and push against the vessel walls; [0037]).
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 stent of modified Heilman to include the intracranial implant delivery system as claimed, as taught by Amans. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of effectively delivering the stent to the sigmoid venous sinus.
Regarding claim 35, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the stent (900) can adapt its shape to a non-cylindrical shape of the cerebral venous sinus (Fig. 9).
Regarding claim 37, Heilman modified fails to explicitly disclose wherein the stent further comprises a coating of one or more therapeutic agents.
However, Amans teaches wherein the stent further comprises a coating of one or more therapeutic agents (stent 2 can be coated with a therapeutic agent; [0066]).
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 stent of modified Heilman to be coated with one or more therapeutic agents as taught by Amans in order to reduce the probability of undesired side effects, provide an antineoplastic agent, an antiproliferative agent, an antibiotic, an antithrombogenic agent, an anticoagulant, an antiplatelet agent, and/or an anti-inflammatory agent, improving healing at the treatment site.
Regarding claim 39, Heilman modified discloses the invention as claimed above, and Heilman further discloses wherein the stent (900) is formed of struts having a diameter that provides radial stiffness in a deployed condition to enable apposition of the stent to the surrounding narrowed segment (as the stent 900 applies a constant outward radial force against the sigmoid sinus wall such that the stent 900 is anchored in place within the sigmoid sinus 904 by compressive force; [0066]).
Regarding claim 40, Heilman modified fails to disclose wherein the stent is capable of being retrieved or re-sheathed even when the stent is between about seventy and eighty-five percent expanded.
However, Amans teaches a stent (stent 2; Fig. 1) for permanent implantation into a cerebral venous sinus having a stenosis (stent for the unique environment of the venous sinuses to open a venous sinus stenosis; [0007]), comprising: a proximal end (proximal end portion 16), a distal end (distal end portion 14), and a tubular flexible body (tubular member 10) of braided wire (braided design; Fig. 1; [0013]), providing a closed cell pattern (closed cell; Fig. 1; [0013]); between the proximal end and the distal end (Fig. 1), wherein the tubular flexible body (10) has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]); wherein the stent is configured for insertion and permanent implantation into a cerebral venous sinus (i.e. sigmoid sinus; [0007]), the stent being constrained within a lumen of a delivery catheter until the stent is positioned and deployed in the cerebral venous sinus wherein the stent self-expands to open the stenosis after being deployed (as the stent may be constrained in a catheter and when un-sheathed at the target location, self-expand; [0037]), and wherein the stent is configured to secure itself to surrounding venous sinus walls to be retrievable or re-sheathable (as the closed cell or braided design allows for the stent to be retrievable; [0013]), and to be permanently implanted in a desired location in the cerebral venous sinus (as the stent remains in place after deployment). Amans further discloses wherein the stent (2) is capable of being retrieved or re-sheathed even when the stent is between about seventy and eighty-five percent expanded (as the closed cell braided design allows the stent to be retrievable; [0013]; further, the stent may have a hook 24 and/or attachment elements 22 that allow the stent to be retrieved or re-sheathed at any point during and/or after expansion, which would include at about seventy and eighty-five percent expanded; [0013]).
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 stent of modified Heilman to be repositionable after deployment, retrieved and re-sheathed when the tubular flexible body is expanded by up to about 85% as taught by Amans in order to allow the stent to be repositioned if not deployed in the desired position initially.
Regarding claims 42-43, Heilman modified fails to explicitly disclose wherein the wire of the tubular flexible body is braided wire.
However, Amans teaches a stent (stent 2; Fig. 1) for permanent implantation into a cerebral venous sinus having a stenosis (stent for the unique environment of the venous sinuses to open a venous sinus stenosis; [0007]), comprising: a proximal end (proximal end portion 16), a distal end (distal end portion 14), and a tubular flexible body (tubular member 10) of braided wire (braided design; Fig. 1; [0013]), providing a closed cell pattern (closed cell; Fig. 1; [0013]); between the proximal end and the distal end (Fig. 1), wherein the tubular flexible body (10) has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]); wherein the stent is configured for insertion and permanent implantation into a cerebral venous sinus (i.e. sigmoid sinus; [0007]).
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 wire of the tubular flexible body of modified Heilman to be a braided wire as taught by Amans in order to allow for the stent to be retrievable since such a structure allows for reversible expansion and collapse of the stent ([0013] of Amans).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heilman et al. (US 2019/0298977 A1) in view of Amans (US 2023/0097980 A1), as applied to claim 34 above, and further in view of You et al. (US 2020/0368388 A1).
Regarding claim 36, Heilman modified fails to explicitly disclose wherein the stent can have customized, variable cell size to prevent obstruction of flow from a tributary vein into the cerebral venous sinus.
However, You teaches a stent (100) sized for permanent implantation into a cerebral venous sinus (having a diameter of 5 to 25 mm; [0164]), the stent comprising a tubular flexible body of braided wire ([0028]), the braided wire may comprise cells of differing size ([0028]). The different sized cells improve conformability of the stent ([0495]). The different sized cells would make up different zones that would apply different respect chronic outward forces.
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 closed cell pattern of modified Heilman to have to have customized variable cell size as taught by You in order to improve the conformability of the stent.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-22, 26-27, 41-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1).
Regarding claim 21, U.S. Patent No. 12,285,347 B2 claims a stent for permanent implantation into a cerebral venous sinus having a stenosis (claim 1, lines 1-2), the stent comprising: a proximal end, a distal end, and a tubular flexible body extending between the proximal end and the distal end, the tubular flexible body comprising a wire having a variable cell size between the proximal end and the distal end, the tubular flexible body having the same diameter at the proximal end and the distal end (claim 1, lines 4-8); wherein the stent is configured for insertion and permanent implantation into the cerebral venous sinus (claim 1, lines 9-11), the stent is configured to be constrained within a lumen of a delivery catheter until the stent is positioned and deployed in the cerebral venous sinus (claim 1, lines 11-13), wherein the stent is configured to self-expand to open the stenosis after being deployed (claim 1, lines 14-15), and wherein the stent is configured to secure itself to a surrounding wall of the cerebral venous sinus, and wherein the stent is configured to be permanently implanted in the cerebral venous sinus at a location of the stenosis (claim 1, lines 17-20).
U.S. Patent No. 12,285,347 B2 fails to explicitly claim the diameter being between about 6 mm and about 10 mm.
However, Heilman teaches the dural venous sinuses (i.e., sigmoid, transverse, straight, or sagittal sinus) can have a relatively large diameter (e.g., 7 mm, 8 mm, 9 mm or more; [0132]) and that expanded stent (900) applies a constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place within the sigmoid sinus by compressive force ([0066]). The stent would need to expand to at least the diameter of the sigmoid sinus in order to apply a constant outward radial force against the sigmoid sinus.
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 stent of U.S. Patent No. 12,285,347 B2 to have the same diameter of between about 6 mm and about 10 mm at the proximal end and the distal end in light of the teachings of Heilman in order to effectively apply constant outward radial force against the sigmoid sinus wall such that the stent is anchored in place.
Regarding claim 22, U.S. Patent No. 12,285,347 B2 claims wherein the stent has different zones that apply different respective chronic outward forces (claim 1, lines 15-16).
Regarding claim 26, U.S. Patent No. 12,285,347 B2 claims wherein the stent is collapsible within the delivery catheter (claim 1, line 11-12).
Regarding claim 27, U.S. Patent No. 12,285,347 B2 claims wherein the cells have different sizes in different sections of the stent (claim 1, line 5).
Regarding claim 41, U.S. Patent No. 12,285,347 B2 claims wherein the deployed length of the tubular flexible body is between about 40 mm and about 80 mm (claim 1, lines 8-9).
Regarding claim 42, U.S. Patent No. 12,285,347 B2 claims wherein the wire of the tubular flexible body is braided wire (claim 1, line 4).
Regarding claim 44, U.S. Patent No. 12,285,347 B2 claims wherein the wire is arrayed in a closed cell pattern (claim 1, lines 4-5).
Regarding claim 45, U.S. Patent No. 12,285,347 B2 claims wherein the stent is configured to be retrievable or re-sheathable (claim 1, line 18).
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 23, U.S. Patent No. 12,285,347 B2 claims wherein the stent is repositionable after deployment (claim 2, lines 1-3).
Claims 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 24, U.S. Patent No. 12,285,347 B2 claims wherein the stent can be retrieved when the tubular flexible body is expanded by up to about 85% (claim 14, lines 1-3).
Regarding claim 25, U.S. Patent No. 12,285,347 B2 claims wherein the stent can be re- sheathed within the lumen of the delivery catheter when the tubular flexible body is expanded by up to about 85% (claim 14, lines 1-3).
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 29, U.S. Patent No. 12,285,347 B2 claims wherein the stent is capable of transitioning between a collapsed configuration and an expanded configuration (claim 5, lines 1-3).
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 30, U.S. Patent No. 12,285,347 B2 claims wherein the cerebral venous sinus is a member selected from the group consisting of the superior sagittal venous sinus, the transverse venous sinus, the sigmoid venous sinus, and the straight venous sinus (claim 6, lines 1-4).
Claims 31, 39 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 31, U.S. Patent No. 12,285,347 B2 claims wherein the stent is used to treat a medical condition selected from the group consisting of idiopathic intracranial hypertension, pulsatile tinnitus, cerebral venous insufficiency, intracranial venous thrombosis, and intracranial venous stenosis (claim 7, lines 1-5).
Regarding claim 39, U.S. Patent No. 12,285,347 B2 fails to claim wherein the stent is formed of struts having a diameter that provides radial stiffness in a deployed condition to enable apposition of the stent to the surrounding narrowed segment.
However, Heilman teaches wherein the stent (900) is formed of struts having a diameter that provides radial stiffness in a deployed condition to enable apposition of the stent to the surrounding narrowed segment (as the stent 900 applies a constant outward radial force against the sigmoid sinus wall such that the stent 900 is anchored in place within the sigmoid sinus 904 by compressive force; [0066]).
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 stent of modified U.S. Patent No. 12,285,347 B2 to be formed of struts having a diameter that provides radial stiffness in a deployed condition to enable apposition of the stent to the surrounding narrowed segment in order to effectively apply an outward radial force to anchor the stent in place.
Regarding claim 43, U.S. Patent No. 12,285,347 B2 claims wherein the wire of the tubular flexible body is a braided wire (claim 1, line 4).
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 31 above.
Regarding claim 32, U.S. Patent No. 12,285,347 B2 claims wherein intracranial venous stenosis comprises a medical condition resulting from compression from a tumor, compression from brain parenchyma, compression from arachnoid granulation, or from thrombus (claim 8, lines 1-4).
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 21 above.
Regarding claim 33, U.S. Patent No. 12,285,347 B2 claims wherein the stent can have a customized, variable cell size to adapt to a non-cylindrical shape of the cerebral venous sinus (claim 10, lines 1-3).
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. U.S. Patent No. 12,285,347 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 34, U.S. Patent No. 12,285,347 B2 claims an intracranial implant delivery system for implanting a stent into a cerebral venous sinus (claim 15, lines 1-2), the intracranial implant delivery system comprising: a catheter comprising a distal catheter end, a proximal catheter end, and a lumen extending between the distal catheter end and the proximal catheter end (claim 15, lines 3-5); a tip located at the distal catheter end (claim 15, line 6); and a stent comprising: a proximal end, a distal end, and a tubular flexible body comprising a braided wire that provides a closed cell pattern and has variable cell size between the proximal end and the distal end of the stent, the tubular flexible body having the same diameter of between about 6 mm and about 10 mm at the proximal end and the distal end of the stent (claim 15, lines 6-14); and wherein the stent is configured for insertion into a cerebral venous sinus to alleviate a stenosis within the cerebral venous sinus, wherein the stent is configured to be constrained within a lumen of the catheter until the stent is positioned and deployed in the cerebral venous sinus, wherein the stent is configured to be re-sheathable, to expand after deployment, to alleviate the stenosis in the cerebral venous sinus by forcing a surrounding narrowed segment of the cerebral venous sinus to expand, and wherein the stent is configured to secure itself to the surrounding narrowed segment and to be implanted in the cerebral venous sinus at the surrounding narrowed segment (claim 15, lines 17-26).
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. U.S. Patent No. 12,285,347 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 35, U.S. Patent No. 12,285,347 B2 claims wherein the stent can adapt its shape to a non-cylindrical shape of the cerebral venous sinus (claim 17, lines 1-3).
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. U.S. Patent No. 12,285,347 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 36, U.S. Patent No. 12,285,347 B2 claims wherein the stent can have customized, variable cell size to prevent obstruction of flow from a tributary vein into the cerebral venous sinus (claim 18, lines 1-3).
Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 31 above, and further in view of Amans (US 2023/0097980 A1).
Regarding claim 37, U.S. Patent No. 12,285,347 B2 fails to claim wherein the stent further comprises a coating of one or more therapeutic agents.
However, Amans teaches wherein the stent further comprises a coating of one or more therapeutic agents (stent 2 can be coated with a therapeutic agent; [0066]).
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 stent of modified U.S. Patent No. 12,285,347 B2 to be coated with one or more therapeutic agents as taught by Amans in order to reduce the probability of undesired side effects, provide an antineoplastic agent, an antiproliferative agent, an antibiotic, an antithrombogenic agent, an anticoagulant, an antiplatelet agent, and/or an anti-inflammatory agent, improving healing at the treatment site.
Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,285,347 B2 in view of Heilman et al. (US 2019/0298977 A1), as applied to claim 31 above.
Regarding claim 38, U.S. Patent No. 12,285,347 B2 claims wherein the medical condition is pulsatile tinnitus (claim 9, lines 1-2).
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,285,347 B2 in view of Amans (US 2023/0097980 A1).
Regarding claim 40, U.S. Patent No. 12,285,347 B2 fails to claim wherein the stent is capable of being retrieved or re-sheathed even when the stent is between about seventy and eighty-five percent expanded.
However, Amans teaches a stent (stent 2; Fig. 1) for permanent implantation into a cerebral venous sinus having a stenosis (stent for the unique environment of the venous sinuses to open a venous sinus stenosis; [0007]), comprising: a proximal end (proximal end portion 16), a distal end (distal end portion 14), and a tubular flexible body (tubular member 10) of braided wire (braided design; Fig. 1; [0013]), providing a closed cell pattern (closed cell; Fig. 1; [0013]); between the proximal end and the distal end (Fig. 1), wherein the tubular flexible body (10) has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]); wherein the stent is configured for insertion and permanent implantation into a cerebral venous sinus (i.e. sigmoid sinus; [0007]), the stent being constrained within a lumen of a delivery catheter until the stent is positioned and deployed in the cerebral venous sinus wherein the stent self-expands to open the stenosis after being deployed (as the stent may be constrained in a catheter and when un-sheathed at the target location, self-expand; [0037]), and wherein the stent is configured to secure itself to surrounding venous sinus walls to be retrievable or re-sheathable (as the closed cell or braided design allows for the stent to be retrievable; [0013]), and to be permanently implanted in a desired location in the cerebral venous sinus (as the stent remains in place after deployment). Amans further discloses wherein the stent (2) is capable of being retrieved or re-sheathed even when the stent is between about seventy and eighty-five percent expanded (as the closed cell braided design allows the stent to be retrievable; [0013]; further, the stent may have a hook 24 and/or attachment elements 22 that allow the stent to be retrieved or re-sheathed at any point during and/or after expansion, which would include at about seventy and eighty-five percent expanded; [0013]).
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 stent of U.S. Patent No. 12,285,347 B2 to be repositionable after deployment, retrieved and re-sheathed when the tubular flexible body is expanded by up to about 85% as taught by Amans in order to allow the stent to be repositioned if not deployed in the desired position initially.
Prior Art
Claim 41 is 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.
Heilman is silent to the length of the stent. While Amans teaches a tubular flexible body (tubular body 10) of braided wire (braided design; [0013]), providing a closed cell pattern (closed cell design; Fig. 1; [0013]), between the proximal end and the distal end (Fig. 1) wherein the tubular flexible body has a diameter of between about 6 mm and 10 mm (as the diameter of the proximal portion may be 8 mm to 14 mm and the diameter of the distal portion may be 4 mm to 8 mm; [0011]), and a length of between about 60 mm and about 80 mm (length from about 30 mm to about 200 mm; [0011]), the diameter of the proximal end is larger than the diameter at the distal end for such that the tapering of the stent is essential to minimize the change in blood vessel shape and cross-sectional area, thereby limiting the generation of turbulent flow. Callister (US 2018/0256378 A1) teaches a stent for the venous sinuses that also includes different diameters because stent diameters positioned in both the sigmoid and transverse sinuses may be inadequate for at least one of the sinuses ([0008]). Thus, a longer stent would require different diameters at the proximal and distal ends in order to anchor in the venous sinuses.
Walzman (US 9,775,730 B1) is noted for teaching a stent 300 that is a flow-diverting stent for an artery. Therefore, the stent is not configured for permanent implantation into a cerebral venous sinus having a stenosis and the stent would lack any meaningful outward force to expand a narrowed blood vessel. Therefore, the stent of Walzman would not be capable of opening the stenosis after being deployed as claimed.
Conclusion
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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