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 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) 1-4, 6, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dholakia et al. [US 2020/0289125 A1, hereinafter “Dholakia”].
Re. claim 1, Dholakia discloses a medical device [Figs. 15 and 16A-E] comprising:
a basket [240] having a plurality of wires [Par. 0100]; a connection member [237a, 222, and 252a, together] disposed on a proximal side with respect to the basket [Fig. 15]; and a basket pusher [243] disposed on the proximal side with respect to the connection member [Fig. 15], so that the basket is connected to the basket pusher via the connection member [Fig. 15],
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wherein the basket, the connection member, and the basket pusher are configured so that the connection member is capable of bending due to a weight of the basket [see Figs. 16C-D. The connection member is capable of bending due to an applied force and thus is capable of bending due to a weight of the basket], and an angle, on the proximal side between an extending direction of the basket pusher and a straight line passing through a distal end of the basket and a proximal end of the basket is 150 degrees or less [“the flexible joint 237a…allows for the first occlusive element 240 to deflect, bend, or flex at an angle of up to…about 150.deg.,” Par. 0107].
Dholakia fails to disclose the bending occurring under the condition where, after the basket and the connection member have been immersed in 37°C warm water for two minutes, a 0.1 g weight is connected, in the 37°C warm water, on a distal side with respect to a middle point of a length from the distal end of the basket to the proximal end of the basket, an angle on the proximal side between the extending direction of the basket pusher in a state where the basket pusher is horizontally fixed and the straight line passing through the distal end of the basket and the proximal end of the basket, is measured.
These specific testing conditions and associating bending angle limit the device to a specific range of bending stiffness or compliance. Because Dholakia fails to disclose identical testing conditions, it is unclear whether or not Dholakia’s device has the same bending stiffness, or a stiffness falling within the claimed range. However, Dholakia explains the importance of bending stiffness/compliance: “an outward radial force exerted by an outside surface of the filaments 14 of the device 10 against a constraining force when inserted into a vascular site such as blood vessel or aneurysm is lower [due to increased compliance with the increased size of the device] for a given amount of device compression or over-sizing. This force may be important in some applications to assure device stability and to reduce the risk of migration of the device and potential distal embolization” [Par. 0069]. That is, the “constraining force,” which is affected by compliance/bending stiffness of the device, is an important quantity which affects device stability and the risk of migration or embolization. As disclosed in Pars. 0062-0069, the bending stiffness or compliance of the connection member with respect to the basket determines the constraining force of the device when inserted. Thus, Dholakia recognizes the bending stiffness as a result-effective variable which achieves a recognized result of determining the constraining force of the inserted device, and there is motivation to optimize the bending stiffness to achieve the desired result regarding the size and constraining force of the device. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to conduct routine experimentation to reach another workable product with the desired result and thus desired bending angle under the claimed “condition.” See MPEP 2144.05.II.
Re. claim 2. Dholakia discloses the medical device according to claim 1, further comprising an outer tube [61] having a distal end [Fig. 16D] and a proximal end [the tube inherently has an opposite end, herein defined as the proximal end], wherein the basket is disposed in an inner cavity of the outer tube and is expandable when having come out of the outer tube [Par. 0116, Figs. 16A-D].
Re. claim 3. Dholakia discloses the connection member is configured to be separable so that the basket is detachable from the basket pusher [Figs. 16D-E; Par. 0107].
Re. claim 4. Dholakia discloses a length of the connection member in the extending direction of the basket pusher [see Annotated Fig. 15 above] is shorter than a length of the basket pusher and a length of the basket [Fig. 15 shows the length of the basket being greater than that of the connection member, and the pusher is described in Par. 0106 as being manipulated by the user, extending through 61, so Fig. 16D shows a pusher which is longer than the connection member].
Regarding a three-point bending stress of a material forming the connection member being lower than a three-point bending stress of a material forming the basket pusher and a three-point bending stress of a material forming the basket: It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Dholakia to have the claimed relative three-point bending stresses as claimed, because these bending stresses determine the constraining force and the angle of insertion and ability to navigate tortuous pathways [Par. 0062], and thus are result-effective variables which may be optimized through routine experimentation.
Re. claim 6. Dholakia discloses at a distal end of the basket pusher, the basket pusher is positioned inside the connection member, and in a dry state, an outer diameter of the connection member is larger than an outer diameter of the distal end of the basket pusher and is smaller than an outer diameter of the proximal end of the basket [Fig. 15].
Re. claim 9. Dholakia discloses the basket includes a first bundling portion at which the plurality of wires are bundled and fixed at a distal portion of the basket, and a second bundling portion at which the plurality of wires are bundled and fixed at a proximal portion of the basket, in a cross-section perpendicular to the extending direction of the basket pusher, the connection member is disposed inside the second bundling portion, and the wires are disposed outside the connection member [Annotated Fig. 15 below].
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Re. claim 10. Dholakia discloses the first bundling portion and the second bundling portion [Par. 0102] include a radiopaque material [“Markers, such as radiopaque markers, on the device 10, 110, 210 or delivery system 112 may be used in conjunction with external imaging equipment (e.g. x-ray) to facilitate positioning of the device or delivery system during deployment.,” Par. 0130].
Re. claim 11. Dholakia discloses the device as set forth with respect to claim 1 above. Dholakia further discloses an aneurysm treatment method [Figs. 16A-E] using the medical device of claim 1 [Par. 0003], the aneurysm treatment method comprising:
a step of inserting the basket into an artery and expanding the basket in an aneurysm of the artery [Figs. 16A-C; see Par. 0116]; and
a step of pushing the basket pusher in the extending direction thereof to cause an angle on the proximal side between the extending direction of the basket pusher and the straight line passing through the distal end of the basket and the proximal end of the basket, to be 150 degrees or less [Fig. 16D; Par. 0107
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dholakia in view of Liang et al. [US 20130085520 A1, hereinafter “Liang”].
Re. claim 5. Dholakia discloses the device as set forth with respect to claim 1 above, including the outer diameter of the connection member being smaller than an outer diameter of the proximal end of the basket [Fig. 15], and the connection member being attached to the basket pusher, but fails to teach the connection member positioned inside and with a smaller diameter than the basket pusher. However, Liang teaches, in a medical device, the connection member [312 and 313, Fig 3B] is positioned inside the basket pusher [308], and in a dry state, an outer diameter of the connection member is smaller than an outer diameter of the distal end of the basket pusher [Fig. 3B]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Dholakia by configuring the connection member to be of the type taught by Liang, which fits inside the basket pusher of Dholakia, because this amounts to a simple substitution of one connection type known in the art for another with predictable results.
Re. claim 7. Dholakia discloses a material forming the basket is a metal [Par. 0110], but is silent regarding the material of the connection member and basket pusher. However, Liang teaches a medical device wherein a material forming the connection member [313] is a synthetic resin [polypropylene, Par. 0039], and a material forming the basket pusher is metal [Par. 0006]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Dholakia such that the connection member is a synthetic resin and the pusher is made of metal because these respectively amount to a simple substitution of one material recognized as suitable in the art for another with predictable results.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dholakia in view of Hewitt et al. [US 9078658 B2, hereinafter “Hewitt”].
Re. claim 8. Dholakia teaches that the connection member may be separated by heat: the “detachment of the device 10, 110, 210 from the delivery apparatus 111 of the delivery system 112 may be affected by the delivery of energy (e.g. heat, radiofrequency, ultrasound, vibrational, or laser) to a junction or release mechanism between the device 10 and the delivery apparatus 111,” [Par. 0130], but fails to specifically disclose melting, or a heater. However, Hewitt teaches, in a medical device for treatment of aneurysm, a material forming the connection member has a property of melting due to heat, and the medical device further comprises a heater configured to heat the connection member so that the basket is detachable from the basket pusher [“The heater coil 124 may be configured to receive electric current supplied through the first conductor 126 and second conductor 128 from an electrical energy source 142 coupled to the first contact 138 and second contact 140 at the proximal section 136 of the apparatus 110. The electrical current passed through the heater coil 124 heats the heater coil to a temperature above the melting point of the tether material 72 so as to melt the tether 72 and sever it upon deployment of the device 10.,” Col. 15 lines 35-43]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Dholakia by forming the connection member to have a property of melting due to heat and further comprising a heater as taught by Hewitt in order to allow the basket to readily be detached from the pusher in a specific and controllable manner.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dholakia in view of Greenhalgh [US 6346117 B1].
Re. claim 12. Dholakia discloses the method set forth above but fails to teach the step of disposing a medical long object into the basket. However, Greenhalgh teaches, in a method of treating an aneurysm, disposing a medical long object [wire 32] into a basket [42, Fig. 6]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Dholakia by adding a step of disposing a medical long object into a basket as taught by Greenhalgh because this causes “[b]lood which would normally circulate under pressure into the aneurysm, causing it to enlarge, weaken and rupture, begins to form clots 36 on the platinum wire tangle and eventually the clots merge and enlarge to form an occlusion 38 (see FIG. 2) which seals off the aneurysm from the blood flow, preventing further enlargement and rupture,” [Greenhalgh Col. 1 lines 44-49].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771