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 .
Status of Claims
This office action is responsive to the application filed 6 June 2024.
Claims 1-14 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
“when said received in” (ln 16 and 37-38) – the phrase “said” is improperly placed.
Appropriate correction is required.
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, 2, and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Barman et al. (US Patent Publication No. 20130289682 A1), hereinafter Barman, in view of Porter et al. (US Patent Publication No. 20200085453 A1), hereinafter Porter, in further view of Shih et al. (US Patent Publication No. 20220330969 A1), hereinafter Shih.
Regarding claim 1, Barman discloses a denervation system (Fig. 1, system 10) for percutaneous abatement of renal nerve activity (ablation of neural fibers; para. 0029), comprising:
a delivery catheter (Fig. 1, catheter 12), a first catheter apparatus (Fig. 3A, comprising first catheter 302a and therapeutic arm 306a), a second catheter apparatus (Fig. 3A, comprising second catheter 302b and therapeutic arm 306b) and a control system (Fig. 1, comprising energy system 26, algorithms 31, control algorithm 30, and control mechanism 32), said control system (26 and 30-32) in communication with said first and second catheter apparatus (system communicates with assembly 21; para. 0032),
said delivery catheter (12) comprising a first internal lumen (Fig. 3A, sheath 310), said first internal lumen (310) of said delivery catheter (12) configured to receive said first and second catheter apparatus therein (Fig. 3A, sheath 310 receives catheters 302a and b), said first catheter apparatus (302a and arm 306a) comprising a first core member (Fig. 3A, first catheter 302a), said first core member (302a) comprising a first proximal end region (Fig. 3A, region proximal to distal portion 304a), a first distal end region (Fig. 3A, distal portion 304a) and a first outer surface region (Fig. 3A, outer surface of arm 306a), a second internal lumen (Fig. 3A, lumen of 302a) of said first core member (302a) extending
from said first distal end (304a) of said first core member (302a) to said first proximal end (proximal of
304a) of said first core member (302a),
wherein said first core member (302a) is adapted to transition from a first pre-deployment configuration to a first deployed configuration (therapeutic assembly 21 moves from a pre-deployment arrangement to a deployed arrangement; para. 0036), said first deployed configuration (para. 0036) of said core member (302a) comprising a first catheter configuration (para. 0036), said first catheter configuration (para. 0036) conforming to a first extravascular surface region of said renal artery (conform to geometry of artery and flexible to navigate vasculature; para. 0041 and 0110), said second catheter apparatus (302b and 306b) comprising a second core member (Fig. 3A, second catheter 302b), said second core member (302b) comprising a second proximal end region (Fig. 3A, region proximal to distal portion 304b), a second distal end region (Fig. 3A, distal portion 304b) and a second outer surface region (Fig. 3A, outer surface of 306b), said second core member (302b) further comprising a third internal lumen (Fig. 3A, lumen of 302b) and,
said third internal lumen (lumen of 302b) of said second core member (302b) extending from said second distal end of said second core member (304b) to said second proximal end of said second core member (proximal of 304b),
wherein said second core member (302b) is adapted to transition from a second pre-deployment configuration to a second deployed configuration (therapeutic assembly 21 moves from a pre-deployment arrangement to a deployed arrangement; para. 0036), said second deployed configuration (para. 0036) of said second core member (302b) comprising a second catheter configuration (para. 0036), said second catheter configuration (para. 0036) conforming to a second extravascular surface region of said renal artery (para. 0041 and 0110),
said first core member (302a) and said second core member (302b) further adapted to receive and transmit at least first energy therethrough (energy delivery from elements 308; para. 0040),
said control system (26 and 30-32) comprising an energy delivery module (Fig. 1, source 26 with algorithm 30 and 31) and power supply means (Fig. 1, source 26 provides energy; para. 0034), said energy delivery module (Fig. 1, source 26 with algorithm 30 and 31) adapted to generate and transmit said at least first energy to said first and second core members (para. 0034, 0041, and 0110),
said power supply means (26) adapted to provide power to said control system (para. 0034).
Barman does not expressly disclose said first core member further comprising a first plurality of fenestrations, said second lumen adapted to receive a pharmacological agent therein, said first plurality of fenestrations disposed proximate said first distal end region of said first core member and in communication with said second internal lumen, said first plurality of fenestrations sized and adapted to allow said pharmacological agent, when received in said second internal lumen of said first core member, to be dispersed out of said second internal lumen and delivered proximate a renal artery when said first core member is disposed proximate said renal artery, said first core member comprising a superelastic shape-memory alloy a second plurality of fenestrations, said third internal lumen adapted to receive said pharmacological agent therein, said second plurality of fenestrations disposed proximate said second distal end region of said second core member and in communication with said third internal lumen, said second plurality of fenestrations sized and adapted to allow said pharmacological agent, when said received in said third internal lumen of said second core member, to be dispersed out of said third internal lumen and delivered proximate said renal artery when said second core member is disposed proximate said renal artery, said second core member comprising said superelastic shapememory alloy, said agent delivery module adapted to modulate delivery of said pharmacological agent to said first and second core members.
Porter teaches a first core member (Porter: Fig. 7A, one of arms 36) further comprising a first
plurality of fenestrations (Fig. 7A, ports 46), a second lumen (Fig. 7D, lumen 44) adapted to receive a pharmacological agent therein (rt-PA is a pharmacological agent fluidly received within a lumen 44; para. 0056-0057 and 0061),
said first plurality of fenestrations (46) disposed proximate a first distal end region of said first core member (Fig. 7A, ports 46 are disposed proximate to hub 42) and in communication with said second internal lumen (ports 46 in fluid communication with lumen 44; para. 0061), said first plurality of fenestrations (46) sized and adapted to allow said pharmacological agent (para. 0056-0057 and 0061), when received in said second internal lumen (44) of said first core member (para. 0056-0057 and 0061), to be dispersed out of said second internal lumen (44) and delivered proximate a renal artery (examiner interprets that, if the invention of Barman is combined with the invention of Porter, the pharmacological agent of Porter must delivered proximate a renal artery, which is the treatment site of Barman; Barman: para. 0032) when said first core member (36) is disposed proximate said delivery site (Barman: para. 0032), said first core member (36) comprising a super elastic shape-memory alloy (catheter 14 is comprised of an alloy, wherein the arms 36 are comprised of a super-elastic forming element; para. 0057 and 0063).
A second core member (Fig. 7A, one of arms 36) comprising a second plurality of fenestrations
(46) said third internal lumen (44) adapted to receive said pharmacological agent therein (para.
0056-0057 and 0061), said second plurality of fenestrations (46) disposed proximate of said second distal end region of said second core member (proximate to hub 42) and in communication with said third internal lumen (44), said second plurality of fenestrations (46) sized and adapted to allow said pharmacological agent (para. 0056-0057 and 0061), when received in said third internal lumen (44) of said second core member (36), to be dispersed out of said third internal lumen (44) and delivered proximate said renal artery when said second core member is disposed proximate said renal artery (examiner interprets that, if the invention of Barman is combined with the invention of Porter, the pharmacological agent of Porter must delivered proximate a renal artery, which is the treatment site of Barman; Barman: para. 0032).
said second core member (36) comprising said superelastic shape-memory alloy (para. 0057 and
0063).
an agent delivery module (fluid control system; para. 0066) adapted to modulate delivery of said pharmacological agent to said first and second core members (control flow of fluid from fluid source toe catheter 14; para. 0066).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barman such that said first core member further comprising a first plurality of fenestrations, said second lumen adapted to receive a pharmacological agent therein, said first plurality of fenestrations disposed proximate said first distal end region of said first core member and in communication with said second internal lumen, said first plurality of fenestrations sized and adapted to allow said pharmacological agent, when received in said second internal lumen of said first core member, to be dispersed out of said second internal lumen and delivered proximate a renal artery when said first core member is disposed proximate said renal artery, said first core member comprising a superelastic shape-memory alloy a second plurality of fenestrations, said third internal lumen adapted to receive said pharmacological agent therein, said second plurality of fenestrations disposed proximate said second distal end region of said second core member and in communication with said third internal lumen, said second plurality of fenestrations sized and adapted to allow said pharmacological agent, when said received in said third internal lumen of said second core member, to be dispersed out of said third internal lumen and delivered proximate said renal artery when said second core member is disposed proximate said renal artery, said second core member comprising said superelastic shapememory alloy, said agent delivery module adapted to modulate delivery of said pharmacological agent to said first and second core members as taught by Porter in order to allow a pharmaceutical agent during treatment to be delivered to a treatment site and provide a therapy (para. 0083).
Barman in view of Porter does not expressly disclose said first core member transitions from a first pre-deployment configuration to a first deployed configuration when said first core member is subjected to a first pre-defined critical temperature, said second core member transitions from a second pre-deployment configuration to a second deployed configuration when said second core member is subjected to a second pre-defined critical temperature.
Shih teaches a core member (Shih: Fig. 4C, transducer support 450) transitions from a first predeployment configuration (Fig. 4C) to a first deployed configuration (Fig. 4D) when said first core member (450) is subjected to a first pre-defined critical temperature (Fig. 4C to D, support 450 transitions to a different shape upon reaching a different pre-defined temperature; para. 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barman in view of Porter such that said first core member transitions from a first pre-deployment configuration to a first deployed configuration when said first core member is subjected to a first pre-defined critical temperature, said second core member transitions from a second predeployment configuration to a second deployed configuration when said second core member is subjected to a second pre-defined critical temperature as taught by Shih in order to allow the core members to take on different suitable shapes during use, allowing the core members to be controlled (para. 0078).
Regarding claim 2, Barman in view of Porter and Shih discloses the device above, wherein said first catheter configuration (Barman: para. 0036) of said first core member (302a) is in an opposite direction relative to said second catheter configuration (para. 0036) of said second core member (Fig.
3A-C, core members 302a and b are deployed in opposite directions from each other; para. 0036).
Regarding claim 4, Barman in view of Porter and Shih discloses the device above, wherein said at least first energy delivered to and transmitted through said first and second core members (para. 0034,
0041, and 0110) comprises electrical energy (RF electrical energy; para. 0044).
Regarding claim 5, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter does not expressly disclose said electrical energy provides said first and second pre-defined critical temperatures.
Shih teaches an electrical energy (Shih: current; para. 0078) provides a pre-defined critical temperature (different temperature; para. 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barman in view of Porter such that said electrical energy provides said first and second pre-defined critical temperatures as taught by Shih in order to allow the core members to take on different suitable shapes during use, allowing the core members to be controlled (para. 0078).
Regarding claim 6, Barman in view of Porter and Shih discloses the device above, wherein said first core member (Barman: 302a) and said second core member (302b) are further adapted to receive and transmit at least second energy therethrough (RF energy; para. 0044) and said energy delivery module (26 with 30 and 31) is further adapted to generate and transmit said at least second energy
(para. 0044) to said first and second core members (RF energy delivered to element 308; para. 0044).
Regarding claim 7, Barman in view of Porter and Shih discloses the device above, wherein said at least second energy comprises radiofrequency (RF) energy (Barman: para. 0044).
Regarding claim 8, Barman in view of Porter and Shih discloses the device above, wherein said
RF energy abates renal nerve activity (ablation and neuromodulation; para. 0044).
Regarding claim 9, Barman in view of Porter and Shih discloses the device above, wherein said first core member (302a) further comprises a first outer sheath (portion of shaft 302a proximate to distal portion 304a) disposed proximate said first outer surface region (outer surface of 302a) of said first core member (302a).
Regarding claim 10, Barman in view of Porter and Shih discloses the device above, wherein said second core member (302b) further comprises a second outer sheath (portion of shaft 302b proximate to distal portion 304b) disposed proximate said second outer surface region (outer surface of 302b) of said second core member (302b).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Barman in view of Porter and Shih, in further view of Urbanski et al. (US Patent Publication No. 20230042352 A1), hereinafter Urbanski.
Regarding claim 3, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter and Shih does not expressly disclose said superelastic shape-memory
alloy comprises a nickel-titanium (NiTi) alloy.
Urbanski teaches a core member (Urbanski: Fig. 4, flexible shaft section 102) a superelastic shape-memory alloy comprises a nickel-titanium (NiTi) alloy (Nitinol; para. 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the core member of Barman in view of Porter and Shih such that said superelastic shape-memory alloy comprises a nickel-titanium (NiTi) alloy as taught by Urbanski in order to provide a core member with superelasticity and shape memory effect, allowing the shape to recover (para. 0053).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Barman in view of Porter and Shih, in further view of Kelly et al. (US Patent Publication No. 20260077174 A1), hereinafter Kelly.
Regarding claim 11, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter and Shih does not expressly disclose said pharmacological agent is adapted to induce neutralization of a renal nerve.
Kelly teaches a pharmacological agent is adapted to induce neutralization of a renal nerve (therapeutic agent denervation; para. 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barman in view of Porter and Shih such that said pharmacological agent is adapted to induce neutralization of a renal nerve as taught by Kelly in order to further ablate nerve tissue and treat excessive activation of renal nerves (para. 0022).
Regarding claim 12, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter and Shih does not expressly disclose said pharmacological agent comprises a neurolytic agent selected from the group consisting of ethanol, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, amiodarone, flecainide, botulinum toxin (Botox®), digoxin, a cardiac glycoside, guanethidine, heated saline, heated hypertonic saline, heated hypotonic fluid, heated potassium chloride and liquid nitrogen.
Kelly teaches a pharmacological agent comprises a neurolytic agent selected from the group consisting of ethanol, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, amiodarone, flecainide, botulinum toxin (Botox®), digoxin, a cardiac glycoside, guanethidine, heated saline, heated hypertonic saline, heated hypotonic fluid, heated potassium chloride and liquid nitrogen (lidocaine; para. 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barman in view of Porter and Shih such that said pharmacological agent comprises a neurolytic agent selected from the group consisting of ethanol, phenol, glycerol, lidocaine, bupivacaine, tetracaine, benzocaine, amiodarone, flecainide, botulinum toxin (Botox®), digoxin, a cardiac glycoside, guanethidine, heated saline, heated hypertonic saline, heated hypotonic fluid, heated potassium chloride and liquid nitrogen as taught by Kelly in order to modulate activity of renal nerves and further ablate nerve tissue and treat excessive activation of renal nerves (para. 0022-0023).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Barman in view of Porter and Shih, in further view of Goshayeshgar et al. (US Patent Publication No. 20170266419 A1), hereinafter Goshayeshgar.
Regarding claim 13, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter and Shih does not expressly disclose said pharmacological agent comprises an anti-inflammatory agent selected from the group consisting of methylprednisolone, triamcinolone, betamethasone and dexamethasone.
Goshayeshgar teaches a pharmacological agent comprising an anti-inflammatory agent selected from the group consisting of methylprednisolone, triamcinolone, betamethasone and dexamethasone (Goshayeshgar: dexamethasone; para. 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the pharmacological agent of Barman in view of Porter and Shih such that said pharmacological agent comprises an anti-inflammatory agent selected from the group consisting of methylprednisolone, triamcinolone, betamethasone and dexamethasone as taught by Goshayeshgar in order to remedy pain to a treatment site (para. 0056).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barman in view of Porter and Shih, in further view of Novak et al. (US Patent Publication No. 20200222549 A1), hereinafter Novak.
Regarding claim 14, Barman in view of Porter and Shih discloses the device above.
Barman in view of Porter and Shih does not expressly disclose said pharmacological agent comprises an antibiotic selected from the group consisting of an aminoglycoside, a cephalosporin, chloramphenicol, clindamycin, an erythromycin, a fluoroquinolone, a macrolide, an azolide, metronidazole, a penicillin, a tetracycline, trimethoprim-sulfamethoxazole, gentamicin and vancomycin.
Novak teaches a pharmacological agent comprises an antibiotic selected from the group consisting of an aminoglycoside, a cephalosporin, chloramphenicol, clindamycin, an erythromycin, a fluoroquinolone, a macrolide, an azolide, metronidazole, a penicillin, a tetracycline, trimethoprim-sulfamethoxazole, gentamicin and vancomycin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the pharmacological agent of Barman in view of Porter and Shih such that said pharmacological agent comprises an antibiotic selected from the group consisting of an aminoglycoside, a cephalosporin, chloramphenicol, clindamycin, an erythromycin, a fluoroquinolone, a macrolide, an azolide as taught by Novak in order to prevent infection of a treatment site (para. 0175).
Conclusion
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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