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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 3/6/26 is acknowledged.
Claim 57 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/6/26.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1-34, 46, 47, 50-56 and 58 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 discloses “A medical device for placement in a biological space” on line 1. This should be changed to “A medical device configured for placement in a biological space”.
Claim 1 discloses “the expandable device can be placed through the lumen of the second catheter into a biological space” on line 47-48. This should be changed to “the expandable device configured to be placed through the lumen of the second catheter into a biological space”.
Claim 1 discloses “removed from the patient” on line 63. This should be changed to “configured to be removed from the patient”.
Claim 12 discloses “anchors the balloon-like implant by contacting a portion of the biological space” on line 2. This should be changed to “configured to anchor the balloon-like implant by contacting a portion of the biological space”.
Claim 15 discloses “expandable device material is in the biological space” on line 6-7. This should be changed to “expandable device material is configured to be in the biological space”.
Claim 17 discloses “the guidewire tracks” on line 1. This should be changed to “the guidewire is configured to track”.
Claim 46 discloses “the distal portion anchors the balloon-like implant and proximal portion in a desired position in biological space”. This should be changed to “the distal portion is configured to anchor the balloon-like implant and proximal portion in a desired position in biological space”.
Claim 50 discloses “A medical device for placement in a biological space” on line 1. This should be changed to “A medical device configured for placement in a biological space”.
Claim 58 discloses “A kit for occluding a biological space” on line 1. This should be changed to “A kit configured for occluding a biological space”.
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 1-24, 54 and 55 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 1 recites the limitation “the first catheter which, along with the second catheter, defines a first lumen” lines 19. This language is unclear as to whether the first catheter or second catheter, or both, comprise the first lumen, as a second lumen in the second catheter is also disclosed in line 26.
Claim 1 recites the limitation "”the proximal hub of the first catheter" in line 29. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the first catheter comprises “a first proximal hub” while the second catheter comprises “a proximal hub”. Examiner further suggests changing the second catheter to comprise “a second proximal hub” for the sake of clarity.
Claim 1 recites the limitation "the proximal opening" in line 30. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 discloses “a distal portion” on lines 30, 31 and 32. This language is unclear as to whether it is referring to the same or different distal portions of the second catheter.
Claim 1 recites the limitation "the distal end of the expandable device" in line 38. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the proximal end of the expandable device" in line 40. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the opening in the wall of the distal region" in line 44. There is insufficient antecedent basis for this limitation in the claim. Examiner believes this should is referring to “the opening in the wall at a distal end of the distal region” of the balloon-like implant.
Claim 1 recites the limitation “a biological space” on line 48. This language is unclear as to whether it is referring to the same or different biological space as disclosed in the preamble and previously in the claim.
Claim 1 recites the limitation "the distal opening of the balloon-like implant" in line 53. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "second portion of the expandable device" in line 56-57. This language is unclear as to whether it is referring to the same or different second portion of the expandable device.
Claim 1 recites the limitation "the lumen of the second catheter" in line 57. This language is unclear as to whether it is referring to the same or different second portion of the expandable device.
Claim 2 recites the limitation “an expandable device” in line 2. This language is unclear as to whether it is referring to the same or different expandable device than disclosed in claim 1.
Claim 4 recites the limitation "the flexible non-metal polymer material" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “adjacent first portion of the expandable device” on line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the front and back stop” on line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the language front stop should be “a distal front stop and back stop” to be consistent with “a distal front stop” on line 3, alternatively line 3, “a distal front stop” should be changed to “a front stop”.
Claim 16, recites the limitation “the opening” on lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “a guidewire” on line 2. This language is unclear as to whether it is referring to the same or different guidewire as disclosed in claim 1.
Claim 36 recites the limitation “second portion diameters” on line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes there is inconsistency regarding the “the second proximal portion diameter, the second distal portion diameter, and the second portion diameters”.
Claim 37 recites the limitation “the first and second diameters of the proximal portion of the first and second diameters of the distal portion are equal”. This language is indefinite as claim 36 discloses the second proximal diameters being larger than the first portion diameter, but claim 37 discloses the diameters being equal. Examiner further notes there is inconsistency regarding the language including “the diameters of the proximal portion” verses “the proximal portion diameter”.
Clam 51 recites the limitation “the balloon-like implant is a pair of opposed caps” on line 1. This language is unclear as to how a pair of opposed caps are “balloon like” or further comprises a wall as disclosed in claim 50. Examiner is interpreting the balloon like implant further comprising a pair of opposed caps.
Claim 54 recites the limitation “the intermediate region” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 recites the limitation “the second portion” on line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-34, 50, 54 and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franano et al. WO 2018/176064.
Regarding claim 1, Franano et al. discloses medical device for placement in a biological space (paragraph 0032), the medical device comprising: a compressed balloon-like implant (for example, detachable balloon 10, paragraph 0213, figure 1A) configured for implantation in the biological space (paragraph 0032), the balloon-like implant comprising: a distal region (figure 1A, paragraph 0213), a proximal region generally opposite the distal region (figure 1A), an intermediate region transitioning from the distal region to the proximal region (figure 1A, paragraph 0213), a first axis 706 extending proximal- distal between the proximal region and distal region (figure 1A, paragraph 0213), and a second axis 708 perpendicular to the first axis (figure 1A, paragraph 0213); a wall 30 extending generally continuously from the proximal region through the intermediate region, to the distal region, with an exterior surface and an interior surface (paragraph 0216), the interior surface defining a central void or interior volume (paragraph 0216), wherein the central void or interior volume is configured to be modified based on deployment (may be inflated or expanded with fluid, paragraph 0214);
an opening in the wall 30 at a proximal end of the proximal region 110 that allows for the passage of fluid from a first catheter 173 into the central void or interior volume 115 of the balloon-like implant (paragraph 0216, figures 30A-D, 32A-D) and also allows for passage of a portion of a second catheter 174 into the central void or interior volume 115 of the balloon-like implant (paragraph 0216, figures 32A-D); an opening in the wall at a distal end of the distal region that allows for the passage of a portion of the second catheter out of the central void or interior volume of the balloon-like implant (figures 37A-E); the first catheter 173 which, along with the second catheter 174, defines a first lumen 162 to allow for passage of fluid from a proximal end of the first catheter to a distal end of the first catheter, and into the central void or interior volume of the balloon-like implant figures (paragraph 0217); the first catheter 173 comprising: a proximal end that is coupled to a first proximal hub 179 (paragraph 0217); and a distal portion that is operably coupled or joined to the opening in the wall of the proximal region 110 of the balloon-like implant 10 (paragraph 0217), the distal portion including a port configured to accept a guidewire 40 (figure 16, guidewire extends through to distal end through port of lumen); the second catheter 174 defines a second lumen 163 configured to accept at least one of the guidewire 40 and an expandable device 720 or combinations thereof (paragraph 0217), the second catheter comprising: a proximal end that is coupled to a second proximal hub 178; a proximal portion that passes through the proximal hub 179 of the first catheter 173 (paragraph 0217); a distal portion that passes through the proximal opening of the balloon-like implant (paragraph 0217); a distal portion that passes through the central void or interior volume of the balloon-like implant (paragraph 0217); a distal portion that engages or passes through the distal opening in the balloon-like implant 10 (paragraph 0217); a distal end that is open (paragraph 0217); the expandable device 720 anchoring and supporting the balloon-like implant after being deployed (paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration) , the expandable device comprising: a first portion located at the distal end of expandable device (for example, distal end 720, figure 41A-H), the first portion configured to anchor the balloon-like implant 10 when fully deployed paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration); a second portion located at the proximal end of the expandable device (proximal end of 720, figure 41A-H), the second portion of 720 configured to expand within the balloon-like implant 10 when fully deployed thereby providing support to the balloon-like implant (figures 41A-H); a waist located between the first portion and second portion (portion between the first and second portion transitioning out of the balloon, figure 41E), the waist configured to engage with the opening in the wall of the distal region when fully deployed (figure 41E); and wherein: the second catheter can be moved forward or backward while the balloon-like implant remains fixed in position (paragraph 0051, 0220); all, or a portion of, the expandable device can be placed through the lumen of the second catheter into a biological space wherein the first portion of the expandable device is adjacent to the balloon-like implant (figures 41A-H), passing through the second catheter until the waist is exposed into the biological space 904 (figure 41E); after the waist is exposed, the balloon-like implant or the first portion of the expandable device is positioned with the first or second catheter (figure 41E), respectively, until the waist of the expandable device is adjacent yet distal to the distal opening of the balloon-like implant (figure 41D-41E) and the second catheter is adjacent yet distal to the distal opening of the balloon-like implant (figure 41D); the second catheter can be pulled back proximally until a distal tip of the second catheter is located in the central void or interior volume of the balloon-like implant (figure 41E-G, paragraphs 0220), and a second portion of the expandable device can be deployed through the lumen of the second catheter and placed into the central void or interior volume of the balloon-like implant (paragraph 0220); the passage of fluid through the first catheter into the central void or interior volume of the balloon-like implant can result in expansion of the balloon-like implant (paragraph 0217); and after expansion of the balloon-like implant and placement of the second portion of the expandable device, the second catheter can be withdrawn proximally and the first catheter can be separated from the expanded balloon-like implant and removed from the patient while the balloon- like implant and the first and second portions of the expandable device remain in the patient (figures 41A-H, first and second catheters disengaged and withdrawn leaving the balloon and expandable members). Regarding claim 2, Franano et al. discloses wherein the balloon-like implant is a permanent implant (paragraph 0216) and is configured to receive an expandable device 720 within (figures 41A-H) and the wall of the balloon-like implant comprises a flexible non-metal polymer material (paragraph 0037).
Regarding claims 3 and 4, Franano et al. discloses wherein the wherein flexible non-metal polymer material comprises a single layer of a non-compliant polymer (paragraph 0037, 00253), wherein the flexible non-metal polymer material is non-compliant comprising at least one of polyamide (nylon) or polyether block amide (Pebax) (paragraph 0079, 00252).
Regarding claims 5 and 6, Franano et al. discloses wherein the expandable device is an open cell laser cut structure comprising nitinol or any rigid material that can be collapsed and then expanded (expandable bodies 700, collapsed and expanded during placement, may be considered a partially rigid material that is configured to perform the function as claimed; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 7, Franano et al. discloses wherein at least a portion of the wall of the balloon-like implant comprises two or more polymer layers (paragraph 0043, one more polymer coatings or layers).
Regarding claim 8, Franano et al. discloses wherein the balloon-like implant possesses sufficient strength to maintain itself in an expanded or partially expanded configuration in vivo after separation from the first and second catheters (paragraph 0252).
Regarding claim 9, Franano et al. discloses wherein the opening in the wall at the proximal region of the balloon-like implant is a proximal neck 130 (figure 1A, claim 312).
Regarding claim 10, Franano et al. discloses the proximal neck further comprising: a buffer region 204 having a buffer region diameter (figure 30A-D, 33A) and a tapered proximal end (proximal end of 204, figure 30A-D) configured to receive at least a portion of the first catheter and the second catheter (figure 30A-D, 33A); and wherein the buffer region diameter is larger than a diameter of the proximal neck of the opening in the wall of the balloon-like implant at the proximal region (see annotated figure 30A below, 33A), at least a portion of the buffer region configured to allow the expandable device to expand thereby preventing a push back force from prematurely or unintentionally disengaging the balloon-like implant from the first catheter (expands as shown in figures 33A, or 30A, compared to figure 30D without the catheter being engaged, buffer regio is a elastomeric friction fit with catheters, paragraph 0215).
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Regarding claim 11, Franano et al. disclose, wherein the buffer region allows for movement of the distal tip of the second catheter within the buffer region (paragraph 00220, 0221, second catheter tip can be pulled back in the central void and removed proximally) thereby moderating movement of the distal tip proximal to a latch mechanism (for example, 510) of the first catheter when the expandable device is expanded (paragraph 0035, 0215, figures 21-26A).
Regarding claim 12, Franano et al. discloses wherein the adjacent first portion of the expandable device anchors the balloon-like implant by contacting a portion of the biological space outside of the balloon-like implant when deployed thereby bracing the first portion of the expandable device against the biological space (paragraph 0033, 0053, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration, distal portion of expandable member inserted through lumen into the aneurysm sac and contact outer surface of the balloon, exerting a force toward the aneurysm neck to aid in sealing, figure 41A-H, distal adjacent portion of 720 in biological space 904; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 13, Franano et al. discloses wherein the second portion of the expandable device is positioned inside of the balloon-like implant and expanded to support the balloon-like implant by providing a rigid support structure that contacts at least a portion of the interior surface of the wall of at least the intermediate region of the balloon-like implant when deployed (paragraph 0033, 0053, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration, portion of expandable member inserted into the central void of the balloon, contacting the inner surface of the wall of the balloon and exerting an outward force to help resist collapse, compression or contraction, figure 41A-H, portion of 720 in balloon 10; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 14, Franano et al. discloses wherein by providing the rigid support structure the expandable device maximizes compression with respect to the rigid support structure providing an increased localized radial force when contacting at least the portion of the interior surface of the wall (paragraph 0053, expandable member placed inside the central void of the expandable balloon, some segments of the proximal portion of the vascular coil contact the inner surface of the wall of the expanded balloon, and exert an outward force on the inner surface of the wall of the expanded balloon to help the expanded balloon resist collapse, compression, or compaction; to maintain closure of the aneurysm neck; and to reduce the risk of balloon movement or migration; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 15, Franano et al. discloses wherein the second portion of the expandable device 720 is positioned inside of the balloon-like implant (figure 41E-H) and expanded to support the balloon-like implant by providing a rigid support structure that includes a distal front stop located on the first portion and a back stop located on the second portion (figures 41E-H), the front and back stop resist lateral movement by engaging a portion of distal region of the balloon-like implant allowing for the expandable device to be positioned such that a known amount of expandable device material is in the biological space and in the balloon-like implant (paragraph 0053, distal portion contact outer surface of the wall of the expanded balloon, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 16, Franano et al. discloses wherein a third catheter is engaged to the first catheter and includes a distal opening configured to accept a guidewire to pass through the opening to an area outside of the first and third catheter within the biological space (paragraph 0076, 0097, for example, figure 15).
Regarding claim 17, Franano et al. discloses wherein the guidewire 40 tracks the balloon- like implant 10 and the expandable device through a portion of the biological space 904 (figures 41A-B), and the balloon- like implant 10 and the expandable device are positioned within the biological space at the same time (figures 41E-H).
Regarding claim 18, Franano et al. discloses wherein the guidewire tracks the balloon- like implant and the expandable device through a portion of the biological space (figures 41A-B), and the balloon- like implant and the first portion of the expandable device are positioned at the same time (figures 41E-H).
Regarding claim 19, Franano et al. discloses wherein the expandable device is an expandable braid device (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 20, Franano et al. discloses wherein the expandable braid device includes wires in the first portion, second portion, and the waist, the first portion of the expandable braid device having a plurality of first portion regions, the second portion of the expandable braid device having a plurality of second portion regions, the braid waist located between the first portion and second portion, the waist connecting the first and second portions of the expandable braid device (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, may consider any portions of the first portion outside the balloon, any portions of the second portion within the balloon, waist between the portions, for example, figure 41E-H, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen).
Regarding claim 21, Franano et al. discloses wherein at least one of the plurality of first portion regions has a first diameter (portions of 720 outside balloon, figures 41H) and at least one other first portion region has a second diameter when deployed (another portion of 720 outside balloon, figure 41H, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 22, wherein at least one of the plurality of second portion regions has a first diameter (portions of 720 inside balloon, figures 41H) and at least one other second portion region has a second diameter when deployed (another portion of 720 inside balloon, figure 41H, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 23, Franano et al. discloses wherein the wires of at least one of the plurality of first portion regions has a first pitch and the wires of at least one other first portion region has a second pitch when deployed (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, pitch of the first portion and second portions outside the balloon, any portions outside the balloon may be considered, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, , the expandable device may be provided with a structure as claimed).
Regarding claim 24, Franano et al. discloses wherein the wires of at least one of the plurality of second portion regions has a first pitch and the wires of at least one other second portion region has a second pitch when deployed (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, pitch of the first portion and second portions inside the balloon, any portions of the second portion within the balloon may be considered, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, , the expandable device may be provided with a structure as claimed).
Regarding claim 25, Franano et al. discloses wherein the waist includes a dense braid of twisted wires defining a waist lumen (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, may consider any portions of the first portion outside the balloon, any portions of the second portion within the balloon, waist between the portions, for example, figure 41E-H, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, , the expandable device may be provided with a structure as claimed).
Regarding claim 26, Franano et al. discloses wherein at least one wire runs through the waist lumen of the expandable braid device to reduce blood flow (paragraph 0469, expandable bodies may be braided wires or assembly of braided strands, may consider any portions of the first portion outside the balloon, any portions of the second portion within the balloon, waist between the portions, for example, figure 41E-H, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, , the expandable device may be provided with a structure as claimed).
Regarding claim 27, Franano et al. discloses wherein the waist is used in part to position the second portion of the expandable braid device within the balloon-like implant (figures 41A-H; Examiner notes the waist extends through the distal portion of the balloon and would be configured to at least in part position the expandable braid device within the balloon like implant; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claims 28-30, Franano et al. discloses wherein the waist is surrounded by a tube, the tube used in part to compress the dense braid of wires and to position the second portion of the expandable braid device within the balloon-like implant, wherein the tube surrounding the waist is a marker tube, the marker tube visible when viewed with an imaging device, wherein the tube surrounding the waist is configured to engage with the opening in the wall of the distal region of the balloon-like implant when fully deployed (paragraph 0469, 00473, 00474, expandable bodies may comprise radiopaque marker bands 612 expandable bodies may be braided wires or assembly of braided strands, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed). Regarding claim 31, Franano et al. further comprises a valve mating feature (paragraph 0058, 0063, valve for attaching the balloon to the second catheter, first catheter, or assembly of the first and second catheters), wherein the balloon-like implant includes a valve (paragraph 0063) for interacting with the waist by securing a waist of the expandable device to the balloon-like implant allowing for the second portion of the expandable device to be positioned inside the balloon-like implant without shifting the first portion of the expandable device (paragraph 0063, valve in the distal neck assembly to close the opening after retraction of the guidewire and second catheter, allows for shifting of the expandable device outside the balloon, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 32, Franano et al. discloses wherein the expandable device includes a radiopaque material visible when viewed with an imaging device (paragraph 0469, 00473, 00474, expandable bodies may comprise radiopaque marker bands 612 expandable bodies may be braided wires or assembly of braided strands, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 33, Franano et al. discloses wherein the expandable device includes at least one single wire marker tube, a radiopaque coupler, and at least one drawn filled tube (DFT) wire with a radiopaque core (paragraph 0469, 00473, 00474, expandable bodies may comprise radiopaque marker bands 612 expandable bodies may be braided wires or assembly of braided strands, Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 34, Franano et al. discloses wherein the plurality of second portion regions has a conical shape tapering from a larger distal diameter to a smaller proximal diameter (Figures 41A-H, expandable device 720 configured to be a conical shape tapering as exits the balloon as coiled; Examiner further notes the expandable device is not positively claimed, but only required to be received by the second lumen, the expandable device may be provided with a structure as claimed).
Regarding claim 50, Franano et al. discloses a device placed in a biological space, the medical device comprising: an expanded support device (expandable bodies 720, paragraph 0214, 218, 219) having proximal and distal portions (proximal and distal ends of bodies 720); a balloon-like implant 10 having a wall in contact with at least a portion of the expanded support device (figures 41E-H); and wherein the expanded support device and the balloon-like implant are configured to resist the flow of fluid within the biological space (paragraph 0002, 0032, reduce the flow of blood or other biological fluids in saccular aneurysms, arteries, veins, left atrial appendages, paravalvular leaks, other blood-containing structures, biological conduits, and biological spaces).
Regarding claims 54 and 55, Franano et al. discloses wherein at least a portion of the expanded support device supports the balloon-like implant from collapsing by contacting at least a portion of the wall (paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration), wherein the wall extends generally continuously from the proximal region through the intermediate region, to the distal region (figure 1A), wherein the second portion of the expanded support device supports the balloon-like implant device by providing a scaffolding structure protecting the expanded balloon-like implant from being compressed (scaffolding structure portion within balloon, paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, Examiner notes “scaffolding” may be defined as “anything that forms a support or basis for something else” – dictinary.com).
Claim(s) 35-38 and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kariniemi et al. US 2012/0245623.
Regarding claim 35, Kariniemi et al. discloses an expandable braid device configured for permanent implantation in a biological space (occlusion device 100, paragraph 0051), the expandable braid device 100 comprising: a distal portion having a first distal diameter (distal portion 105, figure 4), a proximal portion having a first proximal diameter (proximal portion 110, figure 4) and generally opposite the distal portion (figure 4), a waist 115 transitioning from the distal portion to the proximal portion (figure 4), a first axis extending proximal-distal between the proximal portion and distal portion (longitudinal axis through portions 110, 115, 105), and a second axis perpendicular to the first axis (axis perpendicular to the longitudinal axis through portions 110, 115, 105), an attachment coupler located at a proximal end of the proximal portion (paragraph 0017), the attachment coupler configured to releasably engage the expandable braid device to a delivery structure (paragraph 0017, proximal or distal features configured to releasably attach to a delivery device); and a plurality of wires extending generally continuously from the proximal portion to the distal portion (figure 4), the plurality of wires including a first pitch region having a first pitch (paragraph 0051, wires strands of the braided occlusion device have a predetermined pitch to define openings and vary impedance or blood flow therethrough).
Regarding claim 36, Kariniemi et al. further comprising a second proximal portion diameter, and a second distal portion diameter, wherein the second portion diameters are larger than the first portion diameters (see annotated figure 4 below, Examiner notes any portion of the distal or proximal portion may be considered).
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Regarding claim 37, Kariniemi et al. discloses wherein the first and second diameters of the proximal portion and the first and second diameters of the distal portion are equal (see annotated figure 4 below, Examiner notes any portion of the distal or proximal portion may be considered).
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Regarding claim 38, Kariniemi et al. discloses further comprising a second pitch region having a second pitch, wherein the second pitch is tighter than the first pitch (paragraph 0082, pitch angle of the portions 105, 110, 115 may be different to accommodate the overall shape and changes in diameter as desired).
Regarding claim 45, Kariniemi et al. further comprising radiopaque materials, wherein the radiopaque materials are visible on an imaging device (paragraph 0072).
Claim(s) 35-37 and 39-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thornton US 2022/0287831.
Regarding claim 35, Thornton discloses an expandable braid device configured for permanent implantation in a biological space (device 100, paragraph 0063), the expandable braid device (paragraph 0071, figures 1-3 and 6C), comprising: a distal portion having a first distal diameter (figure 1, diameter of distal portion as annotated in figure 1 below), a proximal portion having a first proximal diameter (figure 1, diameter of proximal portion as annotated in figure 1 below) and generally opposite the distal portion (figure 1), a waist transitioning from the distal portion to the proximal portion ((see annotated figure 1 below), a first axis extending proximal-distal between the proximal portion and distal portion (longitudinal axis through proximal and distal portions), and a second axis perpendicular to the first axis (axis perpendicular to the longitudinal axis), an attachment coupler located at a proximal end of the proximal portion (paragraph 0017), the attachment coupler 150 (figure 6A) configured to releasably engage the expandable braid device to a delivery structure (paragraph 0017, proximal or distal features configured to releasably attach to a delivery device); and a plurality of wires extending generally continuously from the proximal portion to the distal portion (figure 6C, wires along frame 129), the plurality of wires including a first pitch region having a first pitch (wires strands or struts of the device have a first pitch, figure 6C).
Regarding claim 36, Thornton further comprising a second proximal portion diameter, and a second distal portion diameter, wherein the second portion diameters are larger than the first portion diameters (see annotated figure 1 below, Examiner notes any portion of the distal or proximal portion may be considered).
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Regarding claim 37, Thornton discloses wherein the first and second diameters of the proximal portion and the first and second diameters of the distal portion are equal (see annotated figure 1 below, Examiner notes any portion of the distal or proximal portion may be considered).
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Regarding claim 39, 40 and 41, Thornton discloses wherein the plurality of wires includes a distal loop (see annotated figure 1 below, or 9B or loop within 152, figure 6C, line 178 may be slidingly attached to distal cells of stent 174, paragraph 0080), the distal loop extending distally away from the distal portion of the expandable braid device (figures 1, 9B) and configured to lead the expandable braid device over a guide path whereby a guidewire engages with the distal loop and tracks along the guide path to deploy the expandable braid device (configured to put the device over a guidewire to track along a guide path to deploy, as the device has the same structure as claimed, alternatively line 178 may be attached to distal end cells for placement and changing the shape for deployment), wherein the guidewire is a microcatheter or a tube having a tube lumen (attachment elements 152 with catheter 128, the attachment elements utilizing loops or holes within 154, attachment elements may be fixedly attached to the lumen 166 of catheter; alternatively tube 180 may be configured to extend through distal loops with cinch 178, figure 13; Examiner further notes the guidewire is not being positively claimed and must only be configured or capable of engaging with the distal loop and tracks along) wherein the distal loop includes a flared tip, the flared tip extending distal and away from the first axis (for example, distal end of cell, flared away from device, figures 1, 9B).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton US 2022/0287831.
Regarding claim 42, Thornton discloses wherein the distal loop is angled with respect to the first axis (for example, figures 4, 9B angled outward, or alternatively, angled inward when cinched with cinch wire 178, wherein the angle may be adjusted with the cinch wire extending through the distal loops from essentially along the longitudinal axis in the unconstrained configuration, figure 11, to an inward collapsed angle relative to the longitudinal axis, figure 13), but fails to explicitly disclose the distal loop is angled between 10 and 30 degrees with respect to the first axis.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Thornton to comprise a distal loop being angled between 10 and 30 degrees with respect to the first axis, since it has been held that discovering an optimum value (or range of values) of a result effective variable involves only routine skill in the art. In this case, the distal loop may be configured or arranged with the cinch wire or along the delivery catheter to be within the claimed range of angles for delivery (as shown for example, in figures 4, 9B, or between configuration as shown in figures 11 and 13).
Claim(s) 43 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kariniemi et al. US 2012/0245623 in view of Thornton US 2022/0287831.
Regarding claim 43, Kariniemi et al. discloses wherein the waist 115 includes a dense braid defining a waist lumen (figure 4, formed by braiding, paragraph 0051), but fails to disclose the waist being twisted wires.
Thornton discloses wherein an expandable device having a proximal section 801 and a distal section (opposite end) and a waist 861, the waist includes (figure 22), the waist being twisted resulting in the narrowing of flexible section 861 forming the waist, the waist having a waist lumen (within 861 to receive catheter, figure 22).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kariniemi et al. with a twisted waist portion, as taught by Thornton, as known in the art to twist the center waist or braid portion to allow for a narrowing flexible section that may be positioned within the tissue and close openings as necessary.
Regarding claim 44, Kariniemi et al. wherein the waist lumen may be collapsed to fit within a delivery catheter (paragraph 0049), but fails to explicitly disclose the inner diameter of 0 mm to 0.7 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an inner diameter of between 0mm and .7mm in the collapsed configuration within a delivery catheter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 46-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton US 2022/0287831 in view of Franano et al. WO 2018/176064.
Regarding claims 46-49, Thornton discloses the expandable braid device essentially as claimed as discussed above, but fail to disclose the braid device interacting with a balloon-like implant, the balloon-like implant comprising: a distal region, a proximal region generally opposite the distal region, and an intermediate region transitioning from the distal region to the proximal region; a wall extending generally continuously from the proximal region through the intermediate region, to the distal region, with an exterior surface and an interior surface, the interior surface defining a central void or interior volume; an opening in the wall at a proximal end of the proximal region that allows for the passage of fluid from a first catheter into the central void or interior volume of the balloon-like implant and also allows for passage of a portion of a second catheter into the central void or interior volume of the balloon-like implant; an opening in the wall at a distal end of the distal region that allows for the passage of a portion of the second catheter out of the central void or interior volume of the balloon-like implant; wherein the expandable braid device passes through the opening in the wall at the proximal region, the distal portion passing though the central void to an area outside of the balloon-like implant and the proximal portion remaining in the central void of the balloon-like implant; wherein the proximal portion supports the balloon-like implant by contacting the interior surface of the wall in at least the intermediate region; and, wherein the distal portion anchors the balloon-like implant and proximal portion in a desired position in biological space, wherein the waist is configured to engage with the opening in the wall of the distal region of the balloon-like implant when fully deployed, wherein a second catheter passes through a lumen of a first catheter, the first catheter comprising: an opening located at a distal end of the first catheter; the second catheter, wherein the expandable braid device passes through a lumen of the second catheter and the opening located at the distal end of the first catheter; and a balloon-like implant, wherein the balloon-like implant is advanced by the first catheter through a delivery catheter, wherein the delivery catheter further comprises a third catheter engaged to and adjacent to the delivery catheter, the third catheter comprising a distal third catheter opening, wherein the third catheter is configured to receive the guidewire; and wherein the expandable braid device and the balloon-like implant are guided over the guide path to a deployable position by the guidewire.
Franano et al. discloses medical device for placement in a biological space (paragraph 0032), the medical device comprising: an expandable device 720 interacting with a balloon like implant (detachable balloon 10, paragraph 0213, figure 1A) configured for implantation in the biological space (paragraph 0032), the balloon-like implant comprising: a distal region (figure 1A, paragraph 0213), a proximal region generally opposite the distal region (figure 1A), an intermediate region transitioning from the distal region to the proximal region (figure 1A, paragraph 0213), a wall 30 extending generally continuously from the proximal region through the intermediate region, to the distal region, with an exterior surface and an interior surface (paragraph 0216), the interior surface defining a central void or interior volume (paragraph 0216), an opening in the wall 30 at a proximal end of the proximal region 110 that allows for the passage of fluid from a first catheter 173 into the central void or interior volume 115 of the balloon-like implant (paragraph 0216, figures 30A-D, 32A-D) and also allows for passage of a portion of a second catheter 174 into the central void or interior volume 115 of the balloon-like implant (paragraph 0216, figures 32A-D); an opening in the wall at a distal end of the distal region that allows for the passage of a portion of the second catheter out of the central void or interior volume of the balloon-like implant (figures 37A-E); wherein the expandable device 720 passes through the opening in the wall at the proximal region (figures 41D-H, expandable member extends through balloon 10 from proximal end), the distal portion passing though the central void to an area outside of the balloon-like implant and the proximal portion remaining in the central void of the balloon-like implant (figures 41D-H); wherein the proximal portion supports the balloon-like implant by contacting the interior surface of the wall in at least the intermediate region (paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration); and, wherein the distal portion anchors the balloon-like implant and proximal portion in a desired position in biological space (paragraph 0033, 0053, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration, distal portion of expandable member inserted through lumen into the aneurysm sac and contact outer surface of the balloon, exerting a force toward the aneurysm neck to aid in sealing, figure 41A-H, distal adjacent portion of 720 in biological space 904), wherein the waist is configured to engage with the opening in the wall of the distal region of the balloon-like implant when fully deployed (figures 41D-H), wherein a second catheter 174 passes through a lumen of a first catheter 173 (for example, figure 32B) the first catheter comprising: an opening located at a distal end of the first catheter (figure 32A, at end of catheter lumen); the second catheter 174, wherein the expandable braid device passes through a lumen of the second catheter and the opening located at the distal end of the first catheter (figures 41A-H); and a balloon-like implant 10, wherein the balloon-like implant is advanced by the first catheter through a delivery catheter 173 (paragraph 0034), wherein the delivery catheter further comprises a third catheter engaged to and adjacent to the delivery catheter (figures 15, 16), the third catheter 175 comprising a distal third catheter opening (end of third catheter to receive guidewire 40 (figure 16), wherein the third catheter is configured to receive the guidewire (paragraph 0076, for example, figure 15C); and wherein the expandable device and the balloon-like implant are guided over the guide path to a deployable position by the guidewire (figures 41A-H) within the biological space 904.
Therefore, it would have been obvious to one having ordinary skill in the art to provide an expandable device interacting with a balloon-like implant as claimed, as taught by Franano et al., as known in the art for providing a balloon-like implant comprising an expandable member and a catheter system for delivering the expandable device and the balloon-like implant into the biological space. Examiner notes Franano et al. teaches a variety of shapes of expandable members (paragraph 00218) and in combination with the expandable device of Thornton, reads on the claimed invention.
Claim(s) 51, 56 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. WO 2018/176064 in view of Franano et al. US 2017/0245864 (hereafter Franano et al. ‘864).
Regarding claims 51 and 56, Franano et al. discloses wherein the balloon-like implant, but fails to disclose a balloon-like implant comprising a pair of opposed caps, the pair of opposed caps sealing the proximal and distal portions of the expanded support device , respectively, wherein the wall and the caps are comprised of a non-porous material.
Franano et al. ‘864 teaches a balloon-like implant comprising a pair of opposed caps (360 or 362, figures 2A-2Q, or caps on expandable member 162 with end cap 163 at distal end of wall 102), the pair of opposed caps sealing the proximal and distal portions of the expanded support device , respectively, wherein the wall and the caps are comprised of a non-porous material (paragraph 0033, 0233, caps comprising a polymer material and coating or sheath, and wall may be uniform or porous or combinations) to improve trackability of the device during delivery and placement and protect necks during positioning and reducing the risk of damage to the walls or lining of vessels during placement (paragraph 0268).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Franano et al. with a balloon-like implant comprising a pair of opposed caps, the pair of opposed caps sealing the proximal and distal portions of the expanded support device , respectively, wherein the wall and the caps are comprised of a non-porous material, as taught by Franano et al. ‘864, to improve trackability of the device during delivery and placement and protect necks during positioning and reducing the risk of damage to the walls or lining of vessels during placement.
Regarding claim 58, Franano et al. discloses a device a collapsed balloon-like implant 10 (figure 1A), the balloon-like implant 10 configured to be permanently placed and expanded in the biological space (paragraph 00216); an expandable device (720, paragraph 00217, 00218), the expandable device configured to anchor and support the balloon- like implant in the biological space (paragraph 0033, expandable bodies provide support to the balloon to maintain the size and shape and resisting collapse, compression or compaction, and help maintain position to prevent migration); a first , second, and third catheter, wherein the first 173, second 174, and third catheters 175 are configured to deploy the balloon-like implant and the expandable device in the biological space (figure 15, figure 20, biological space 904), respectively; a guide 185, wherein the guide is configured to position at least one of the balloon-like implant and the expandable device in the biological space (paragraph 0247, guide 185 may comprise a marker band 612 to help position the device); a guidewire 40, wherein the guidewire is operably interconnected with at least one of the balloon-like implant and expandable device (figure 20), but fails to disclose an instruction set, wherein the instruction set is configured to instruct a user on how to use the components of the system to occlude at least a portion of the biological space.
Franano et al. ‘864 teaches a kit for occluding a biological space (paragraph 0018), the kit comprising: a collapsed balloon-like implant 100 (figure 1A-1D), the balloon-like implant configured to be permanently placed and expanded in the biological space (paragraph 0010, 0331); an expandable device (coil 162, figures 12A, 12B, paragraph 0220), the expandable device configured to anchor and support the balloon- like implant in the biological space (figure 15E, paragraph 0002, coiled wires exert force on the ballon to aid in sealing the aneurysm neck); wherein the instruction set is configured to instruct a user on how to use the components of the system to occlude at least a portion of the biological space (paragraph 0470, medical kit may be provided for treating a patient with the medical device, the kit comprising the medical device, guidewire, one or more guide catheters, one or more expandable support structure, one or more accessory coils and instructions).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Franano et al. with an instruction set, as taught by Franano et al. ‘864, to instruct a user on how to use the components of the system to occlude at least a portion of the biological space.
Claim(s) 52 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. WO 2018/176064 in view of Thornton US 2022/0287831.
Regarding claims 52 and 53, Franano et al. discloses the device essentially as claimed, wherein the expanded support device further comprises a plurality of wires extending generally continuously from the proximal portion to the distal portion (plurality of wires or expandable bodies 720, paragraph 00218 figures 23), but fails to disclose the plurality of wires including a first pitch region having a first pitch and a first diameter, or wherein the expanded support device further comprises an attachment coupler mechanism located at a proximal end of the proximal portion, the attachment coupler mechanism configured to releasably engage the expanded support device to a catheter during deployment.
Thornton discloses a device 100 placed in a biological space (paragraph 0063) comprising a plurality of wires extending generally continuously from the proximal portion to the distal portion (figure 6C, wires along frame 129), the plurality of wires including a first pitch region having a first pitch (wires strands or struts of the device have a first pitch, figure 6C), and an expanded support device 100 an attachment coupler located at a proximal end of the proximal portion (paragraph 0017), the attachment coupler 150 (figure 6A) configured to releasably engage the expandable device to a delivery structure (paragraph 0017, proximal or distal features configured to releasably attach to a delivery device).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Franano et al. with disclose the plurality of wires including a first pitch region having a first pitch and a first diameter, as taught by Thornton, as a known substitute for an expandable support device within a biological space, and wherein the expanded support device further comprises an attachment coupler mechanism located at a proximal end of the proximal portion, the attachment coupler mechanism configured to releasably engage the expanded support device to a catheter during deployment, as taught by Thronton, as known in the art to provide a latch or attachment mechanism for advancing and then releasing or delivering an expandable device for occlusion within the target biological space.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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