DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/23/2025 has been entered.
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 83-87 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 83 has been amended to recite that the delivery of ablative fluid forms “a ring of the ablative fluid causing circumferential damage only beyond an adventitial layer of the target vessel”. It is unclear whether the term “only” refer to the “ring of ablative fluid” or the “cicumferential damage”. That is, it is unclear if the claim requires the “ring of ablative fluid” to be “only beyond an adventitial layer of the target vessel” or the “circumferential damage” to be “only beyond an adventitial layer of the target vessel”. For the sake of examination, it is believed that the term “only” is intended to refer to the “ring of ablative fluid” since circumferential damage only beyond an adventitial layer does not appear to be supported by the original disclosure1. Therefore, this is the interpretation applied to the claim. In order to overcome this rejection, it is suggested to amend claim 83 to recite “delivering an ablative fluid through the first injection needle and the second injection needle only beyond an adventitial layer of the target vessel to form a ring of the ablative fluid causing circumferential damage the adventitial layer of the target vessel while causing minimal damage to an intimal layer and a medial layer of the target vessel”.
Claims 84-87 are rejected due to their dependence on claim 83.
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 73-87 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chow et al. (US Pat 6,692,466) in view of Seward et al. (PG PUB 2011/0104061).
Re claim 73, Chow discloses a method comprising: providing a system 10 (Fig 1A but with a second guide tube and a second injection needle as seen in Fig 4A and described in Col 8, Lines 41-48); it is noted that all reference characters cited below refer to Fig 1A and/or 4A unless otherwise noted) comprising a catheter body 12, a first guide tube 40 (above the balloon 20 in Fig 4A), a second guide tube 40 (below the balloon 20 in Fig 4A), a first injection needle 46 (above the balloon 20 in Fig 4A), and a second injection needle 46 (below the balloon 20 in Fig 4A), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4A; Col 4, Lines 65-66), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4A; Col 4, Lines 65-66); advancing the first guide tube and the second guide tube toward a wall of a target vessel (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 21-31); advancing the first injection needle and the second injection needle through the first guide tube and the second guide tube, respectively (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 32-33). Although Chow discloses that the advancing of the injection needles penetrates a wall of the target vessel (as seen in Fig 3C), Chow does not explicitly disclose that the penetration is into or through an internal elastic lamina of the target vessel; although Chow discloses delivering a fluid through the injection needles, Chow does not disclose that the fluid is an ablative fluid and that the delivery 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 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 target 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 Chow to include the injection needles with a length such that they 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, Chow 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, Chow 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, Chow 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, Chow 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 78, Chow discloses that the first injection needle and the second injection needle advance a preset depth (set by mechanical stop 80; Col 5, Lines 62-65).
Re claim 79, Chow 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 70, Chow 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, Chow discloses that the first injection needle comprises an injection egress 53 (Fig 3C) at or proximal to a tip of the first injection needle (Col 5, Lines 33-34).
Re claim 82, Chow 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, Chow discloses a method comprising: providing a system 10 (Fig 1A but with a second guide tube and a second injection needle as seen in Fig 4A and described in Col 8, Lines 41-48); it is noted that all reference characters cited below refer to Fig 1A and/or 4A unless otherwise noted) comprising a catheter body 12, a first guide tube 40 (above the balloon 20 in Fig 4A), a second guide tube 40 (below the balloon 20 in Fig 4A), a first injection needle 46 (above the balloon 20 in Fig 4A), and a second injection needle 46 (below the balloon 20 in Fig 4A), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4A; Col 4, Lines 65-66), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4A; Col 4, Lines 65-66); advancing the first guide tube and the second guide tube toward a wall of a target vessel (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 21-31); advancing the first injection needle and the second injection needle through the first guide tube and the second guide tube, respectively (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 32-33), to penetrate the wall of the target vessel (as seen in Fig 3C). Chow discloses delivering a fluid through the injection needles, but does not disclose that the fluid is an ablative fluid and that the delivery forms a ring of the ablative fluid causing circumferential damage only2 beyond an 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 target 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 causing circumferential damage only beyond an 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 Chow to include the injection needles with a length such that they penetrate entirely through the wall 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 causing circumferential damage only beyond an 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, Chow 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, Chow 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, Chow 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, Chow discloses that the first injection needle and the second injection needle only penetrate into tissue to a preset distance (set by mechanical stop 80; Col 5, Lines 62-65).
Claims 88 and 90-92 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chow et al. (US Pat 6,692,466)/Steward et al. (PG PUB 2011/0104061)3 in view of Seward et al. (US Pat 7,744,584)4.
Re claim 88, Chow discloses a method comprising: providing a system 10 (Fig 1A but with a second guide tube and a second injection needle as seen in Fig 4A and described in Col 8, Lines 41-48); it is noted that all reference characters cited below refer to Fig 1A and/or 4A unless otherwise noted) comprising a catheter body 12, a first guide tube 40 (above the balloon 20 in Fig 4A), a second guide tube 40 (below the balloon 20 in Fig 4A), a first injection needle 46 (above the balloon 20 in Fig 4A), and a second injection needle 46 (below the balloon 20 in Fig 4A), the first injection needle disposed within a lumen of the first guide tube (as seen in Fig 4A; Col 4, Lines 65-66), the second injection needle disposed within a lumen of the second guide tube (as seen in Fig 4A; Col 4, Lines 65-66); advancing the first guide tube and the second guide tube toward a wall of a target vessel (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 21-31); advancing the first injection needle and the second injection needle through the first guide tube and the second guide tube, respectively (as seen in moving from Fig 3B to Fig 3C; Col 5, Lines 32-33), to penetrate the wall of the target vessel (as seen in Fig 3C). Chow does not disclose a third guide tube having a third injection needle disposed and advanced therethrough. Although Chow discloses delivering a fluid only through the injection needles, Chow does not disclose that this fluid is an ablative fluid and that the delivery is for circumferential filling of a space outside of the 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 medical layers of the target vessel.
Seward ‘061, 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 through a wall of a target vessel (Para 45, Fig 11C), and delivering an ablative fluid through the injection needles for circumferential filling of 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 (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 Chow to include the injection needles with a length such that they penetrate through the entire width of the target vessel and to include the fluid as an ablative fluid for circumferential filling of 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, as taught by Seward ‘061, for the purpose of treating hypertension by delivering agents to reduce hyperactive sympathetic nerve activity (Para 3). Although Seward 2011 discloses “multiple” injection needles (Para 93), Seward ‘061 does not explicitly disclose that there are three needles.
However, Seward ‘584 teaches that a single injection from a single needle will result in the injected fluid circumferentially filling a space outside of an adventitial layer and forming a ring around the target vessel after an extended amount of time (as seen in Fig 8A; Col 13, Lines 42-59). One of ordinary skill in the art would recognize that increasing the number of needles around the circumference will reduce the amount of time needed for the fluid to circumferentially fill a space forming a ring around the target vessel (as a single plume has to travel the entire circumference to close the ring, while circumferentially spaced plumes would not have to travel as far to connect with each other to close the ring). Additionally, Seward ‘584 teaches a system (Fig 5) employing three needles 222,224A,224B (Fig 5) to penetrate through the wall of the target vessel and deliver fluid outside the target vessel (Col 13, Lines 27-33). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Chow to include a third injection needle within a corresponding third guide tube, as taught by Seward ‘584, for the purpose of decreasing the amount of time in which it would take to circumferentially fill the space forming a ring around the target vessel (Col 13, Lines 42-59).
Re claim 90, Chow as modified by Seward ‘061 in the rejection of claim 88 above discloses all the claimed features with Seward ‘061 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, Chow (as modified by Seward ‘584 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 (as the depth is set by mechanical stop 80; Co l5, Lines 62-65).
Re claim 92, Chow as modified by Seward ‘061 and Seward ‘584 in the rejection of claim 88 above discloses all the claimed features as Seward ‘584 teaching that delivering the ablative fluid comprises three points of simultaneous injection (as seen in Fig 5). The motivation set forth in the rejection of claim 88 also applied to this claim.
Response to Arguments
Applicant's arguments filed 9/23/2025 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.
Conclusion
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
1 Although Para [0158] discloses that injection of the ablative fluid can be “only into the volume outside the adventitia”, this does not require the damage caused by the ablative fluid to be “only beyond an adventitial layer”; since Para [0045] discloses that injection outside the adventitia allows “the ablative fluid to flow around and ‘bathe’ the outside of the artery”, one of ordinary skill in the art would be led to believe that the ablative fluid would cause damage to at least the outer surface of the adventitial layer.
2 See the 35 U.S.C. 112(b) rejection above for an explanation of the interpretation of this limitation.
3 Referred to as “Seward ‘061” in the rejections below.
4 Referred to as “Seward ‘584” in the rejections below.