DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 37 and 46 are objected to because of the following informalities: claim 37 recites “the injector tubes” in line 17 this should be” the at least three injector tubes” for consistency. Claim 46 recites “the injector tubes” in line 16 this should be” the at least three injector tubes” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37-45 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 37 recites “wherein the at least three structures are connected at the proximal end of the at least three structures” it is not clear what the structures are connected to, if they are connected to each other or another device structure. For, purposes of examination it is considered as the structures are connected to any component of the system at their proximal ends.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 37-40 and 42-45 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337) in view of Tekbuchava (US 2007/0005018 A1) and Jacobsen et al. (US 6,302,870 B1).
With regard to claims 37, 39, and 44, Evans et al. teach a method of using an ablative system, the method including: advancing a portion of a catheter having an injection lumen (Fig. 2E member 310), and at least three injector tubes with distal needles within a target vessel (Fig. 2E tube is shaft portion of 320, needle is tip 326, at least three circumferentially arranged members); advancing at least three injector tubes with distal needles beyond an inside wall of the target vessel (Fig. 2E); limiting the penetration depth of the at least three injector tubes with distal needles to a preset distance beyond the inside wall of the target vessel ([0042], inserted to a preset depth to reach a predetermined target site, additionally see [0068], [0074]); and injecting an ablative fluid through the injection lumen, and the injector tubes to exit the distal needles located beyond the inside wall of the target vessel via an opening in the at least three distal needles ([0091], ethanol may be delivered). Evans et al. do not explicitly disclose advancement means for the injectors or show fluid supply to the injectors. However, Tekbuchava teaches a device for delivery of ablative fluid in which injector tubes with distal needles are connected to a manifold for advancement of injectors which fluidly connects fluid delivered through the catheter to the injectors (Fig. 4 member 474, 476, 478, actuated via 152, [0044], lumens connected through 160 of the catheter delivery fluid to the needles). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a manifold in Evans et al. and provide fluid to the injectors as in Tekbuchava as this would allow the injectors to be reliably advanced and retracted and would yield the same predictable result of advancing the injection members. Evans et al. do not disclose flattened distal end which limit penetration depth. However, Jacobsen et al. teach hilts (structures with flattened distal ends) which can be used on injection members to control the depth (abstract, Col. 3 lines 20-30, Fig. 6 members 136). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use structures on the injection tubes in Evans et al. as Jacobsen et al. teach this is beneficial for controlling depth. As combined the structures are connected at their proximal ends to the overall device.
With regard to claim 38, see [0086].
With regard to claim 40, see at least the abstract.
With regard to claim 42, see [0126].
With regard to claim 43, the embodiment of Fig. 2E does not explicitly disclose a radiopaque marker. However, Figs. 4 show radiopaque markers may be used to ensure proper depth penetration ([0067], [0068]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a radiopaque marker in the embodiment of Fig. 2E as Evans et al. discloses this is beneficial to ensure proper depth of delivery. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
With regard to claim 45, see [0041].
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337), Tekbuchava (US 2007/0005018 A1), and Jacobsen et al. (US 6,302,870 B1) as applied to claim 37 above, and further in view of Demarais et al. (US 2006/0212076 A1).
With regard to claim 41, Evans et al. teach denervating renal nerves but does not explicitly disclose the sympathetic nerve fibers. However, Demarais et al. teach denervating sympathetic renal nerves as this is beneficial to reverse processes which lead to vasoconstriction ([0013]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to ablate the sympathetic nerve fibers in Evans et al. as Demarais et al. teach this is beneficial for treating blood vessels.
Claims 46-48 and 51 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337) in view of Tekbuchava (US 2007/0005018 A1).
With regard to claim 46, Evans et al. teach a method of using an ablative system, the method including: advancing a distal tip of a catheter within a target vessel (Fig. 2F member 310); causing at least three injector tubes with distal needles to be advanced to penetrate an inside wall of the target vessel (Fig. 2F tube is shaft portion of 320, exemplary Fig. 2E needle is tip 326, at least three circumferentially arranged members), wherein the at least three injector tubes with distal needles are proximal to the distal tip of the catheter when the at least three injector tubes with distal needles penetrate the inside wall of the target vessel (exemplary Fig. 2E, at least three needle may be proximal to the distal tip); limiting the penetration depth of the at least three injector tubes with distal needles beyond the inside wall of the target vessel so that the at least three injector tubes with distal needles only penetrate to a preset distance ([0042], inserted to a preset depth to reach a predetermined target site, additionally see [0068], [0074]); and injecting an ablative fluid through the injector tubes with distal needles to exit at a location outside of the inside wall of the target vessel to cause a compete circular ablation of the tissue ([0042], inserted to a preset depth to reach a predetermined target site, additionally see [0068], [0074], needle would be retracted after injection to a position outside the inside wall, [0091], ethanol may be delivered, needles are around the complete circumference). Additionally, regarding the arrangement of the needles, Evans et al. teach needles may be placed in a pattern corresponding to the longitudinal, radial, and depth of renal nerve target sets. If the illustrated positions were not found to result in complete circular ablation of the tissue, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to arrange the needles as needed for treatment as Evans et al. teach placement to reach a desired target. Evans et al. teach the catheter may be anchored prior to inserting the injectors (see at least ([0065]) but do not explicitly disclose if the injectors are advanced simultaneously. However, Tekbuchava teaches a device for delivery of ablative fluid in which injector tubes with distal needles are connected to a manifold for simultaneous or individual advancement of injectors while a catheter remains in place which fluidly connects fluid delivered through the catheter to the injectors (Fig. 4 member 474, 476, 478, actuated via 152, [0044]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a manifold in Evans et al. as in Tekbuchava to simultaneously move the injectors as Tekbuchava teaches this to be equivalent to individual/sequential actuation and this would allow the injectors to be reliably advanced and retracted and would yield the same predictable result of advancing the injection members.
With regard to claim 47, the embodiment of Fig. 2E does not explicitly disclose a radiopaque marker. However, Figs. 4 show radiopaque markers may be used to ensure proper depth penetration ([0067], [0068]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a radiopaque marker in the embodiment of Fig. 2E as Evans et al. discloses this is beneficial to ensure proper depth of delivery. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
With regard to claim 48, the embodiment of Fig. 2E does not explicitly disclose a structure for uniform deployment. However, Figs. 3 show balloons about which the injectors are inserted to anchor the catheter ([0065]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a balloon in the embodiment of Fig. 2E as Evans et al. discloses this is beneficial to anchor the catheter. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Anchoring the catheter would aid in uniform deployment as it would prevent the catheter from moving and disrupting deployment.
With regard to claim 51, see [0004].
Claim 49 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337) and Tekbuchava (US 2007/0005018 A1) as applied to claim 46, above, and further in view of Demarais et al. (US 2006/0212076 A1).
With regard to claim 49, Evans et al. teach a method substantially as claimed but do not explicitly disclose treating both arteries. However, Demarais et al. teach bilateral artery treatment is beneficial for providing an enhanced effect over unilateral treatment (abstract, [0059]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use bilateral denervation in Evans et al. as Demarais et al. teach this is beneficial for providing enhanced treatment.
Claim 50 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337) and Tekbuchava (US 2007/0005018 A1) as applied to claim 46 above, and further in view of Deem et al. (US 2010/00222851 A1).
With regard to claim 50, Evans et al. teach a method substantially as claimed. Evans et al. do not specifically disclose using a guidewire. However, Deem et al. teach delivering an ablation device over a guidewire or through a sheath ([0038]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a guidewire in Evans et al. as Deem et al. teach this is an art effective means for delivering a catheter to a site within a vessel and ensures proper insertion which would yield the same predictable result.
Claims 52-55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337) in view of Hinchcliffe et al. (US 2002/0143302 A1), Deem et al. (US 2010/00222851 A1), and Tekbuchava (US 2007/0005018 A1).
With regard to claim 52, Evans et al. teach a method of ablating tissue outside of an inside wall of a target vessel, the method including: advancing a distal end of a catheter (Fig. 2E member 310) having injector tubes with distal needles to penetrate the inside wall of a target vessel (Fig. 2E tube is shaft portion of 320, needle is tip 326, at least three circumferentially arranged members); advancing the injector tubes with distal needles to a preset distance beyond the inside wall of the target vessel, wherein all distal ends of all injector tubes with distal needles are proximal to the distal tip of the catheter when the injector tubes with distal needles are advanced to the preset distance beyond the inside wall of the target vessel (Fig. 2E, [0042], inserted to a preset depth to reach a predetermined target site, additionally see [0068], [0074], injector tube with needles are considered for the claim except for the most distal member), and injecting an ablative fluid beyond the inside wall of the target vessel ([0091], ethanol may be delivered). Evans et al. does not disclose the tip to be tapered. However, Hinchcliffe et al. teach using a tapered distal tup for penetration ([0013]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a tapered tip in Evans et al. as Hinchcliffe et al. teach this is beneficial for penetration. Further, if Evans et al. is not found to teach all distal ends to be proximal of the tip, Evans et al. teach needles may be placed in a pattern corresponding to the longitudinal, radial, and depth of renal nerve target sets. Hinchcliffe et al. further teach the tips of the needles remain proximal the tip of the catheter to control the ablation zone ([0043]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to have all needle distal tip proximal of the catheter tip as Evans et al. teach placement can be decided based on treatment location and Hinchcliffe et al. teach such placement is beneficial to control the ablation zone. Evans et al. do not specifically disclose using a guidewire. However, Deem et al. teach delivering an ablation device over a guidewire or through a sheath ([0038]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a guidewire in Evans et al. as Deem et al. teach this is an art effective means for delivering a catheter to a site within a vessel and ensures proper insertion which would yield the same predictable result. Evans et al. but do not explicitly disclose if the injectors are advanced simultaneously. However, Tekbuchava teaches a device for delivery of ablative fluid in which injector tubes with distal needles are connected to a manifold for simultaneous or individual advancement of injectors while a catheter remains in place which fluidly connects fluid delivered through the catheter to the injectors (Fig. 4 member 474, 476, 478, actuated via 152, [0044]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a manifold in Evans et al. as in Tekbuchava to simultaneously move the injectors as Tekbuchava teaches this to be equivalent to individual/sequential actuation and this would allow the injectors to be reliably advanced and retracted and would yield the same predictable result of advancing the injection members. the embodiment of Fig. 2E does not explicitly disclose a non-penetrating surface engaged with the inside wall of the target vessel. However, Figs. 3 show balloons about which the injectors are inserted to anchor the catheter ([0065]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a balloon in the embodiment of Fig. 2E as Evans et al. discloses this is beneficial to anchor the catheter. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Anchoring the catheter would aid in uniform deployment as it would prevent the catheter from moving and disrupting deployment.
With regard to claim 53, see [0066].
With regard to claim 54, the embodiment of Fig. 2E does not explicitly disclose a radiopaque marker. However, Figs. 4 show radiopaque markers may be used to ensure proper depth penetration ([0067], [0068]) and Evans et al. disclose fluoroscopy may be used ([0027]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a radiopaque marker in the embodiment of Fig. 2E as Evans et al. discloses this is beneficial to ensure proper depth of delivery. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
With regard to claim 55, see [0004].
Claim 56 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans et al. (US 2011/0184337), Hinchcliffe et al. (US 2002/0143302 A1), Deem et al. (US 2010/00222851 A1), and Tekbuchava (US 2007/0005018 A1), as applied to claim 52 above, and further in view of Demarais et al. (US 2006/0212076 A1).
With regard to claim 56, Evans et al. teach denervating renal nerves but does not explicitly disclose the sympathetic nerve fibers. However, Demarais et al. teach denervating sympathetic renal nerves as this is beneficial to reverse processes which lead to vasoconstriction ([0013]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to ablate the sympathetic nerve fibers in Evans et al. as Demarais et al. teach this is beneficial for treating blood vessels.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are addressed as above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783