DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1-20 are pending in the application. Claims 1-20 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/3/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: in line 2, the Examiner suggests deleting “when.” Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in line 5, “the cage” should read --the helical cage--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: in line 4, “the cage” should read --the helical cage--. Appropriate correction is required.
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.
Claims 1, 4-7, 14, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eckhouse et al. (US 2011/0152920 A1) (“Eckhouse”).
Regarding claim 1, Eckhouse discloses (Figures 16A1-17C) an intravascular therapy device comprising: an intravascular catheter (305; paragraph 0310); a helical cage (302/307) configured to be rotated by the intravascular catheter (paragraphs 0300, 0310) into a vascular occlusion disposed in a blood vessel of an associated patient; and a treatment device (308) configured to be moved to a position inside the helical cage while the helical cage is rotated into the vascular occlusion and further configured to be operated to treat the vascular occlusion while positioned inside the helical cage (paragraphs 0301-0303).
Regarding claim 4, Eckhouse discloses (Figures 16A2) that the treatment device (308) is sized to fit within a diameter of the helical cage (302).
Regarding claim 5, Eckhouse discloses the that the helical cage comprises stainless steel (paragraph 0310).
Regarding claim 6, Eckhouse discloses that the helical cage comprises Nitinol (paragraph 0310).
Regarding claim 7, Eckhouse discloses that the helical cage comprises a shape memory polymer (paragraph 0310).
Regarding claim 14, Eckhouse discloses (Figures 16A1-17C) a vascular therapy system comprising: a treatment device (308); and a helical cage (302/307) configured to be rotated into a vascular occlusion disposed in a blood vessel of an associated patient (paragraphs 0300, 0310), the cage having a diameter smaller than a diameter of the blood vessel and having a size to accommodate the treatment device (Figure 16A2).
Regarding claim 17, Eckhouse discloses that the helical cage comprises one of stainless steel, Nitinol, or a shape memory polymer (paragraph 0310).
Regarding claim 18, Eckhouse discloses (Figure 16C) an intravascular catheter (309); wherein the helical cage (302/307) is configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient (paragraph 0300); and the treatment device (308) is capable of being moved to a position inside the helical cage while the helical cage is rotated into the vascular occlusion and further capable of being operated to treat the vascular occlusion while positioned inside the helical cage (paragraphs 0301-0303).
Claims 1, 2, 4, 8, 14, 16, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malhi et al. (US 2018/0280045 A1) (“Malhi”).
Regarding claim 1, Malhi discloses (Figure 9) an intravascular therapy device comprising: an intravascular catheter (400; paragraph 0051); a helical cage (460) configured to be rotated by the intravascular catheter (via inner tubular body 430 of internal cutting mechanism 420 of catheter 400) into a vascular occlusion disposed in a blood vessel of an associated patient; and a treatment device (450) configured to be moved to a position inside the helical cage while the helical cage is rotated into the vascular occlusion and further configured to be operated to treat the vascular occlusion while positioned inside the helical cage (Figure 9; paragraphs 0057-0058).
Regarding claim 2, Malhi discloses (Figure 9) that the treatment device (450) is configured to be moved to the position inside the helical cage (460) while the helical cage is rotated into the vascular occlusion and operated to treat the vascular occlusion using the same intravascular catheter (400) that is used to rotate the helical cage into the vascular occlusion (treatment device is attached to inner tubular body 440 of the internal cutting mechanism 420 of catheter 400).
Regarding claim 4, Malhi discloses (Figure 9) that the treatment device (450) is sized to fit within a diameter of the helical cage (460).
Regarding claim 8, Malhi discloses (Figure 9) that the treatment device (450) includes an occlusion debulking tool (452, 456) configured to fit within the helical cage to debulk the vascular occlusion (paragraph 0057).
Regarding claim 14, Malhi discloses (Figure 9) a vascular therapy system comprising: a treatment device (450); and a helical cage (460) configured to be rotated into a vascular occlusion disposed in a blood vessel of an associated patient (paragraph 0058), the cage having a diameter smaller than a diameter of the blood vessel and having a size to accommodate the treatment device (Figure 9).
Regarding claim 16, Malhi discloses the treatment device (450) includes an occlusion debulking tool (452, 456) configured to fit within the helical cage (460) to debulk the vascular occlusion (paragraph 0057).
Regarding claim 18, Malhi discloses (Figure 9) an intravascular catheter (400); wherein the helical cage (460) is configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient (via inner tubular body 430 of internal cutting mechanism 420 of catheter 400; paragraph 0058); and the treatment device (450) is configured to be moved to a position inside the helical cage while the helical cage is rotated into the vascular occlusion and further configured to be operated to treat the vascular occlusion while positioned inside the helical cage (treatment device is attached to inner tubular body 440 of the internal cutting mechanism 420 of catheter 400; paragraph 0058).
Regarding claim 19, Malhi discloses (Figure 9) that the treatment device (450) is configured to be moved to the position inside the helical cage (460) while the helical cage is rotated into the vascular occlusion and operated to treat the vascular occlusion using the same intravascular catheter (400) that is used to rotate the helical cage into the vascular occlusion (treatment device is attached to inner tubular body 440 of the internal cutting mechanism 420 of catheter 400).
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticiapted by Tsukernik (US 2009/0138031 A1).
Regarding claim 14, Tsukernik discloses (Figures 1-15) a vascular therapy system (10) comprising: a treatment device (42); and a helical cage (28) configured to be rotated into a vascular occlusion disposed in a blood vessel of an associated patient (paragraph 0052), the cage having a diameter smaller than a diameter of the blood vessel and having a size to accommodate the treatment device (Figures 8-12).
Regarding claim 15, Tsukernik discloses (Figure 6e) that the helical cage has a distal end (46) that is turned inward toward an axis of the helical cage (paragraph 0046).
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.
Claims 1, 3, 11, 12, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shaltis (US 2015/0216650 A1) in view of Eckhouse et al. (US 2011/0152920 A1) (“Eckhouse”).
Regarding claim 1, Shaltis discloses (Figures 1-10) an intravascular therapy device, comprising: an intravascular catheter (118); a helical cage (120); and a treatment device (130) configured to be moved to a position inside the helical cage and further configured to be operated to treat the vascular occlusion while positioned inside the helical cage (paragraphs 0057, 0058, 0062). Shaltis discloses that the helical cage contains radiopaque material and the therapy method utilizes x-ray imaging in order to provide an indication of progress or removal of the occlusion. However, Shaltis fails to disclose that the helical cage is configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient.
In the same field of endeavor, Eckhouse teaches (Figures 16A1-18B) an intravascular therapy device comprising an intravascular catheter (309) and a helical cage (302/307) configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient. Eckhouse teaches that the helical cage is adapted to grasp and separate the vascular occlusion from the vessel wall as it is rotated into the vascular occlusion (paragraphs 0181, 0300). Further, Eckhouse teaches that the helical cage can be used in conjunction with radiopaque material so that the location of the helical cage may be visualized within the body (paragraphs 0265, 310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the intravascular catheter and helical cage taught by Eckhouse, wherein the helical cage is configured to be rotated by the intravascular catheter into a vascular occlusion, for the intravascular catheter and helical cage disclosed by Shaltis. Eckhouse shows that an intravascular catheter with a helical cage that is rotated into the vascular occlusion is an equivalent structure known in the art, because both helical cages have radiopaque material, allowing the helical cage to visualized within the body during the procedure. Substitution of one known element (the intravascular catheter and helical cage taught by Eckhouse, that is rotated into the vascular occlusion) for another element (the intravascular catheter and helical cage disclosed by Shaltis) providing the same function to yield predictable results (visualizing the helical cage to provide an indication of progress or removal of the occlusion) would have been obvious to one of ordinary skill in the art at the time of the invention. Additionally, the intravascular catheter and helical cage taught by Eckhouse provides the additional benefit of grasping and separating the vascular occlusion from the vessel wall as the helical cage is rotated into the vascular occlusion (Eckhouse, paragraphs 0181, 0300).
Regarding claim 3, Shaltis as modified by Eckhouse teaches (Shaltis, Figures 1-10) a second intravascular catheter (126) different from the intravascular catheter; wherein the second intravascular catheter is configured to move the treatment device (130) to the position inside the helical cage while the helical cage is rotated into the vascular occlusion and to operate the treatment device to treat the vascular occlusion (Shaltis, paragraphs 0057 and 0060).
Regarding claim 11, Shaltis discloses (Figures 1-10) a vascular therapy method, comprising: inserting a helical cage (120) into a blood vessel of an associated patient at a blood occlusion (“O”) disposed in the blood vessel (206); after inserting the helical cage into the blood vessel, inserting a treatment device (114) inside the helical cage (210; Figures 4, 6, 8); operating the treatment device while inserted inside the helical cage to apply therapy to treat the vascular occlusion (paragraphs 0057, 0058, 0062); removing the treatment device from the helical cage (paragraph 0065); and removing the helical cage from the blood vessel (paragraph 0065). Shaltis discloses that the helical cage contains radiopaque material and the therapy method utilizes x-ray imaging in order to provide an indication of progress or removal of the occlusion. However, Shaltis fails to disclose that the helical cage is screwed into the occlusion.
In the same field of endeavor, Eckhouse teaches (Figures 16A1-18B) a helical cage (302/307) that is inserted into a blood vessel at a blood occlusion disposed in the blood vessel and screwing the helical cage into a vascular occlusion disposed within the blood vessel. Eckhouse teaches that the helical cage is adapted to grasp and separate the vascular occlusion from the vessel wall as it is screwed into the vascular occlusion (paragraphs 0181, 0300). Further, Eckhouse teaches that the helical cage can be used in conjunction with radiopaque material so that the location of the helical cage may be visualized within the body (paragraphs 0265, 310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the helical cage taught by Eckhouse, that is rotated and screwed into the vascular occlusion, for the helical cage disclosed by Shaltis. Eckhouse shows that the helical cage that is screwed into the vascular occlusion is an equivalent structure known in the art, because both helical cages have radiopaque material, allowing the helical cage to visualized within the body during the procedure. Substitution of one known element (the helical cage taught by Eckhouse, that is screwed into the vascular occlusion) for another element (the helical cage disclosed by Shaltis) providing the same function to yield predictable results (visualizing the helical cage to provide an indication of progress or removal of the occlusion) would have been obvious to one of ordinary skill in the art at the time of the invention. Additionally, the helical cage taught by Eckhouse provides the additional benefit of grasping and separating the vascular occlusion from the vessel wall as it is screwed into the vascular occlusion (Eckhouse, paragraphs 0181, 0300).
Regarding claim 12, Shaltis as modified by Eckhouse teaches that applying therapy comprises: applying the therapy with the treatment device comprising an occlusion debulking tool (Shaltis, paragraph 0057).
Regarding claims 14 and 18, Shaltis discloses (Figures 1-10) a vascular therapy system, comprising: an intravascular catheter (118); a treatment device (130); and a helical cage (120), the cage having a diameter smaller than a diameter of the blood vessel (Figures 6-10) and having a size to accommodate the treatment device (Figures 4 and 6-10); and the treatment device is configured to be moved to a position inside the helical cage and further configured to be operated to treat the vascular occlusion while positioned inside the helical cage (paragraphs 0057, 0058, 0062). Shaltis discloses that the helical cage contains radiopaque material and the therapy method utilizes x-ray imaging in order to provide an indication of progress or removal of the occlusion. However, Shaltis fails to disclose that the helical cage is configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient.
In the same field of endeavor, Eckhouse teaches (Figures 16A1-18B) an intravascular therapy device comprising an intravascular catheter (309) and a helical cage (302/307) configured to be rotated by the intravascular catheter into a vascular occlusion disposed in a blood vessel of an associated patient. Eckhouse teaches that the helical cage is adapted to grasp and separate the vascular occlusion from the vessel wall as it is rotated into the vascular occlusion (paragraphs 0181, 0300). Further, Eckhouse teaches that the helical cage can be used in conjunction with radiopaque material so that the location of the helical cage may be visualized within the body (paragraphs 0265, 310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the intravascular catheter and helical cage taught by Eckhouse, wherein the helical cage is configured to be rotated by the intravascular catheter into a vascular occlusion, for the intravascular catheter and helical cage disclosed by Shaltis. Eckhouse shows that an intravascular catheter with a helical cage that is rotated into the vascular occlusion is an equivalent structure known in the art, because both helical cages have radiopaque material, allowing the helical cage to visualized within the body during the procedure. Substitution of one known element (the intravascular catheter and helical cage taught by Eckhouse, that is rotated into the vascular occlusion) for another element (the intravascular catheter and helical cage disclosed by Shaltis) providing the same function to yield predictable results (visualizing the helical cage to provide an indication of progress or removal of the occlusion) would have been obvious to one of ordinary skill in the art at the time of the invention. Additionally, the intravascular catheter and helical cage taught by Eckhouse provides the additional benefit of grasping and separating the vascular occlusion from the vessel wall as the helical cage is rotated into the vascular occlusion (Eckhouse, paragraphs 0181, 0300).
Regarding claim 20, Shaltis as modified by Eckhouse teaches (Figures 1-10) a second intravascular catheter (126) different from the intravascular catheter; wherein the second intravascular catheter (126) is configured to move the treatment device (130) to the position inside the helical cage while the helical cage is rotated into the vascular occlusion and to operate the treatment device to treat the vascular occlusion (Shaltis, paragraphs 0057 and 0060).
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shaltis (US 2015/0216650 A1) in view of Eckhouse et al. (US 2011/0152920 A1) (“Eckhouse”) as applied to claims 1 and 11 respectively, above, and further in view of Celliers et al. (US 2002/0045890 A1) (“Celliers”).
Regarding claim 9, Shaltis as modified by Eckhouse teaches the invention substantially as claimed in that the treatment device is configured to fit within the helical cage. The combined teaching fails to teach that the treatment device includes a laser ablation catheter to provide ablation therapy to the vascular occlusion. However, Shaltis discloses that devices for removing occlusions from a body lumen, such as a vasculature of a patient, to reestablish patency of the body lumen are well known in the art (paragraph 0002).
Celliers (US 2002/0045890 A1) teaches (Figures 1A and 1B) that a laser ablation catheter (14) is a treatment device that is well known in the art to apply therapy to a vascular occlusion (paragraphs 0009 and 0020).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the laser ablation catheter taught by Celliers for the treatment device taught by Shaltis in view of Eckhouse. Celliers shows that a laser ablation catheter is an equivalent structure known in the art for applying therapy to a vascular occlusion. Substitution of one known element (the laser ablation catheter taught by Celliers) for another element (the treatment device taught by Shaltis in view of Eckhouse) providing the same function to yield predictable results (applying therapy to the vascular occlusion) would have been obvious to one of ordinary skill in the art at the time of the invention. Additionally, the laser ablation catheter taught by Celliers provides the additional benefit of removing and/or emulsifying the vascular occlusion with less damage to the underlying tissue and less chance of perforating the blood vessel wall than prior art devices (Celliers, paragraph 0034).
Regarding claim 13, Shaltis as modified by Eckhouse teaches the invention substantially as claimed. The combined teaching fails to teach applying the therapy with the treatment device comprising a laser ablation catheter. However, Shaltis discloses that devices for removing occlusions from a body lumen, such as a vasculature of a patient, to reestablish patency of the body lumen are well known in the art (paragraph 0002).
Celliers (US 2002/0045890 A1) teaches (Figures 1A and 1B) that a laser ablation catheter (14) is a treatment device that is well known in the art to apply therapy to a vascular occlusion (paragraphs 0009 and 0020).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the laser ablation catheter taught by Celliers for the treatment device taught by Shaltis in view of Eckhouse. Celliers shows that a laser ablation catheter is an equivalent structure known in the art for applying therapy to a vascular occlusion. Substitution of one known element (the laser ablation catheter taught by Celliers) for another element (the treatment device taught by Shaltis in view of Eckhouse) providing the same function to yield predictable results (applying therapy to the vascular occlusion) would have been obvious to one of ordinary skill in the art at the time of the invention. Additionally, the laser ablation catheter taught by Celliers provides the additional benefit of removing and/or emulsifying the vascular occlusion with less damage to the underlying tissue and less chance of perforating the blood vessel wall than prior art devices (Celliers, paragraph 0034).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Malhi et al. (US 2018/0280045 A1) (“Malhi”) in view of Murphy et al. (US 2014/0309658 A1) (“Murphy”).
Regarding claim 10, Malhi discloses the invention substantially as claimed. However, Malhi fails to disclose that the helical cage has a distal end that is turned inward toward an axis of the helical cage.
In the same field of endeavor, Murphy teaches (Figures 5-7A) a helical cage (86) that has a distal end (88) that is turned inward toward and axis of the helical cage (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a distal end of the helical cage disclosed by Malhi to be inward toward an axis of the helical cage, as taught by Murphy. This modification would provide a helical cage with a shape that facilitates traversing or boring through a vascular occlusion (Murphy, paragraphs 0060 and 0065).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Osborne et al. (US 8,246,641 B2) disclose (Figure 5) an intravascular therapy device comprising an intravascular catheter (212) and a helical cage (218) configured to be rotated by the intravascular catheter into a vascular occlusion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771