DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 73-77 and 79-87 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US Pat 5,588,960) in view of Seward et al. (PG PUB 2011/0104061).
Re claim 73, Edwards discloses a method comprising: providing a system 20 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted) comprising a catheter body 22, a first guide tube 52 (to the left in Fig 2), a second guide tube 52 (to the right in Fig 2), a first injection needle 41 (to the left in Fig 2), and a second injection needle 41 (to the right in Fig 2), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4; Col 3 Lines 36-39), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4; Col 3, Lines 36-39); advancing the first guide tube and the second guide tube toward a wall of a target vessel (via actuator 91; Col 6, Lines 26-44); advancing the first injection needle and the second injection needle through the first guide tube and the second guide tube, respectively (via actuator 72; Col 6, Lines 26-44), wherein the first injection needle and the second injection needle simultaneously advance until the first injection needle and the second injection needle simultaneously stop at the same depth of penetration to selectively target a specific layer in the vessel (since both needles are controlled by actuator 72; “preselected length” – Col 6, Lines 31-40). Although Edwards discloses ablating the target tissue with the injection needles (Col 6, Lines 62-65) and delivering fluid through the injection needles (Col 7, Lines 14-17), this fluid is not ablative fluid; additionally, Edwards does not disclose that the tissue of the target vessel that is penetrated is the internal elastic lamina and does not disclose that the injection needles deliver a ring of the ablative fluid spaced apart from the internal elastic lamina and beyond an adventitial plane of the wall of the target vessel to minimize intimal and medial injury.
Seward, however, teaches a method comprising providing a system (Fig 6) having a plurality of injection needles 330 (although only one is shown in Fig 6, Para 93 discloses that the system can employ “multiple microneedles” instead of a single microneedle 330) penetrating an internal elastic lamina of a blood vessel with the injection needles (Para 45, Fig 11C), and delivering an ablative fluid through the injection needles to deliver a ring of the ablative fluid spaced apart from the internal elastic lamina and beyond an adventitial plane of the wall of the target vessel to minimize intimal and medial injury (as seen in Fig 11C; Para 119) for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to utilize the system in a blood vessel such that the injection needles penetrate an internal elastic lamina of the target vessel and to include the fluid as an ablative fluid such that the delivery of the ablative fluid results in a ring of the ablative fluid spaced apart from the internal elastic lamina and beyond an adventitial plane of the wall of the target vessel to minimize intimal and medical injury, as taught by Seward, for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3).
Re claim 74, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the ablative fluid fills a layer containing sympathetic nerves (as seen in Fig 11C; Para 28,117). The motivation cited in the rejection of claim 73 above also applies to this claim.
Re claim 75, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the ablative fluid flows circumferentially (as seen in Fig 11C; Para 119). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 76, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the ablative fluid comprises ethanol (Para 17,18). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 77, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the target vessel is a renal artery (Para 28). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 79, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the first injection needle advances at least 0.5 mm beyond the internal elastic lamina (Para 105 sets forth that the wall has a thickness of between 0.05 mm and 1 mm and Para 17 sets forth that the needle is advanced to a depth of 3 mm). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 80, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that the first injection needle advances between 0.5 mm and 4 mm beyond the internal elastic lamina (Para 105 sets forth that the wall has a thickness of between 0.05 mm and 1 mm and Para 17 sets forth that the needle is advanced to a depth of 3 mm). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 81, Edwards discloses that the first injection needle comprises an injection egress 43 (Fig 4) at or proximal to a tip of the first injection needle (as seen in Fig 4; Col 3, Lines 29-34).
Re claim 82, Edwards as modified by Seward in the rejection of claim 73 above discloses all the claimed features with Seward teaching that between 0.1 ml and 5 ml of the ablative fluid is delivered (“1 ml”, Para 119). The motivation cited in the rejection of claim 73 also applies to this claim.
Re claim 83, Edwards discloses a method comprising: providing a system 20 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted) comprising a catheter body 22, a first guide tube 52 (to the left in Fig 2), a second guide tube 52 (to the right in Fig 2), a first injection needle 41 (to the left in Fig 2), and a second injection needle 41 (to the right in Fig 2), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4; Col 3 Lines 36-39), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4; Col 3, Lines 36-39); advancing the first guide tube and the second guide tube toward a wall of a target vessel within inflating a balloon(no balloon is discloses; advancement is via actuator 91 – Col 6, Lines 26-44); advancing the first injection needle and the second injection needle through the first guide tube and the second guide tube, respectively, to penetrate the wall of the target vessel (via actuator 72; Col 6, Lines 26-44). Although Edwards discloses ablating the target tissue with the injection needles (Col 6, Lines 62-65) and delivering fluid through the injection needles (Col 7, Lines 14-17), this fluid is not ablative fluid; additionally, Edwards does not disclose that the injection needles deliver ablative fluid only beyond an adventitial layer to form a ring of ablative fluid causing circumferential damage beyond the adventitial layer of the target vessel while causing minimal damage to an intimal layer and a medial layer of the target vessel.
Seward, however, teaches a method comprising providing a system (Fig 6) having a plurality of injection needles 330 (although only one is shown in Fig 6, Para 93 discloses that the system can employ “multiple microneedles” instead of a single microneedle 330) penetrating a wall of a blood vessel with the injection needles (Para 45, Fig 11C), and delivering an ablative fluid through the injection needles only beyond an adventitial layer of the target vessel to form a ring of the ablative fluid causing circumferential damage beyond the adventitial layer of the target vessel while causing minimal damage to an intimal layer and a medial layer of the target vessel (as seen in Fig 11C; Para 119) for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to include using the system in a blood vessel to deliver ablative fluid only beyond an adventitial layer of the target vessel to form a ring of the ablative fluid causing circumferential damage beyond the adventitial layer of the target vessel while causing minimal damage to an intimal layer and a medial layer of the target vessel, as taught by Seward, for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3).
Re claim 84, Edwards as modified by Seward in the rejection of claim 83 above discloses all the claimed features with Seward teaching that the ablative fluid is delivered around an entire circumference of the target vessel (as seen in Fig 11C; Para 119). The motivation cited in the rejection of claim 83 also applies to this claim.
Re claim 85, Edwards as modified by Seward in the rejection of claim 83 above discloses all the claimed features with Seward teaching the ablative fluid ablates nerves that run outside of an adventitial plane of the target vessel (as seen in Fig 11C; Para 119). The motivation cited in the rejection of claim 83 also applies to this claim.
Re claim 86, Edwards as modified by Seward in the rejection of claim 83 above discloses all the claimed features with Seward teaching that the ablative fluid ablates nerves while minimizing intimal medial injury (as seen in Fig 11C; Para 119). The motivation cited in the rejection of claim 83 also applies to this claim.
Re claim 87, Edwards discloses that the first injection needle and the second injection needle only penetrate into tissue to a preset distance (“preselected length” – Col 6, Lines 34-40).
Claims 88 and 90-94 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US Pat 5,588,960) in view of Seward et al. (PG PUB 2011/0104061) and Morris et al. (PG PUB 2006/0224118).
Re claim 88, Edwards discloses a method comprising: providing a system 20 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted) comprising a catheter body 22, a first guide tube 52 (to the back left in Fig 2), a second guide tube 52 (to the back right in Fig 2), a third guide tube (to the front right in Fig 2), a first injection needle 41 (to the back left in Fig 2), a second injection needle 41 (to the back right in Fig 2), and a third injection needle 41 (to the front right in Fig 2), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4; Col 3 Lines 36-39), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4; Col 3, Lines 36-39), the third injection needle disposed within a lumen of the third guide tube (as seen in Fig 4; Col 3, Lines 36-39); advancing the first guide tube, the second guide tube and the third guide tube toward a wall of a target vessel (via actuator 91; Col 6, Lines 26-44); advancing the first injection needle, the second injection needle, and the third injection needle through the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate the wall of the target vessel (via actuator 72; Col 6, Lines 26-44). Although Edwards discloses ablating the target tissue with the injection needles (Col 6, Lines 62-65) and delivering fluid only through the injection needles (Col 7, Lines 14-17), this fluid is not ablative fluid; additionally, Edwards does not disclose that the delivery is for circumferentially filling a space outside of an adventitial layer of the target vessel to form an ablative ring beyond the adventitial layer of the target vessel while causing minimal injury to intimal and medial layers of the target vessel. Lastly, although Edwards discloses that the device can have only three needles instead of four (Col 10,, Lines 54-57) and that the four needles are evenly spaced along the circumference (as seen in Fig 3), Edwards does not explicitly disclose that the three needles would be equally spaced along the circumference.
Seward, however, teaches a method comprising providing a system (Fig 6) having a plurality of injection needles 330 (although only one is shown in Fig 6, Para 93 discloses that the system can employ “multiple microneedles” instead of a single microneedle 330) penetrating a blood vessel with the injection needles (Para 45, Fig 11C) and circumferentially filling a space outside of an adventitial layer of the target wall by injecting an ablative fluid through the injection needles to deliver a ring of the ablative fluid beyond the adventitial plane of the target vessel to minimize intimal and medial injury (as seen in Fig 11C; Para 119) for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to utilize the system in a blood vessel and to include the delivery of ablative fluid such that it circumferentially fills a space outside of the adventitial layer of the vessel to form an ablative ring beyond the adventitial layer of the target vessel to minimize intimal and medical injury, as taught by Seward, for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3).
Additionally, Morris teaches equally spacing three injection needles 120,122,124 (Fig 8,9) around a circumference of a catheter body 112 (Fig 8,9) (as seen in Fig 8) to provide an even distance between delivery sites (Para 40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Morris to include the three injection needles such that they are equally spaced along a circumference, as taught by Morris, for the purpose of providing an even distance between delivery sites (Para 40).
Re claim 90, Edwards as modified by Seward and Morris in the rejection of claim 88 above discloses all the claimed features with Seward teaching that the ablative fluid ablates sympathetic nerve fibers (as seen in Fig 11C; Para 28,117). The motivation cited in the rejection of claim 83 also applies to this claim.
Re claim 91, Edwards (as modified by Morris in the rejection of claim 88 above to include a third injection needle) discloses that a depth setting for penetration of the first injection needle, the second injection needle, and the third injection needle is known prior to advancing the first injection needle, the second injection needle, and the third injection needle (“preselected length” – Col 6, Lines 34-40).
Re claim 92, Edwards as modified by Seward and Morris in the rejection of claim 88 above discloses all the claimed features with Morris teaching that delivering the ablative fluid comprises three points of simultaneous injection (as seen in Fig 8,9; Para 45). The motivation set forth in the rejection of claim 88 also applied to this claim.
Re claim 93, Edwards (as modified by Morris in the rejection of claim 88 above to include a third injection needle) discloses that advancing the first injection needle, the second injection needle, and the third injection needle further comprises advancing the first injection needle, the second injection needle, and the third injection needle without inflating a balloon (as no balloon is disclosed in Edwards; advancement of all needles is controlled by a single actuator 71+72 – Col 9, Lines 26-40).
Re claim 94, Edwards (as modified by Morris in the rejection of claim 88 above to include a third injection needle) discloses that advancing the first injection needle, the second injection needle, and the third injection needle further comprises advancing the first injection needle, the second injection needle, and the third injection needle to penetrate to the same depth (due to the depth of all needles being controlled by a single actuator 71+72 – Col 9, Lines 26-40).
Response to Arguments
Applicant's arguments filed 5/5/2026 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. Although the Seward reference applied in the present rejections was applied in the rejections set forth in the last Office Action, no specific arguments were directed to this reference.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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