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 § 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 6 and 20 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 6 recites “positioning a front balloon of the delivery catheter at a pulmonary artery bifurcation.” Claim 1 recites only “a delivery catheter” and does not previously introduce a balloon, a balloon delivery catheter, multiple balloons, or any “front” balloon. The phrase “a front balloon” lacks antecedent basis and renders the scope unclear because it is unclear whether the delivery catheter must include multiple balloons, a distal/front balloon, or some other balloon structure.
Claim 20 recites “wherein delivering the therapeutic treatment comprises delivery energy at a flow rate…” The phrase appears to contain a grammatical error and does not clearly define whether the method requires “delivering energy,” “delivering thermal energy,” or “delivering a formulation carrying energy.” Further, “energy at a flow rate” is ambiguous because calories/second is a power/energy-delivery rate, not a conventional “flow rate” of a material. The metes and bounds are unclear.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 2, 4, 9, 10, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”).
In relation to independent claim 1, this claim recites a method of treating multiple diseases by delivering a therapeutic treatment to a first body lumen using a delivery catheter, withdrawing the catheter, delivering therapeutic treatment to a second body lumen using the same catheter, and withdrawing the catheter, where the therapeutic treatments are effective to treat at least two diseases selected from hypertension, diabetes, obesity, heart failure, end-stage renal disease, digestive disease, asthma, pulmonary arterial hypertension, and chronic obstructive pulmonary disease.
Delivering a therapeutic treatment to a first body lumen using a delivery catheter.
Fischell-277 discloses a catheter configured for delivery into a target vessel, stating that “the distal end of the CAS 10 is inserted into the target vessel over the guide wire 20” (Fischell-277 ¶ [0085]). Fischell-277 further discloses delivering treatment through the catheter, stating that “an ablative substance such as ethanol is injected into the ostial wall through the needles 19” (Fischell-277 ¶ [0087]).
Withdrawing the delivery catheter from the first body lumen.
Fischell-277 discloses withdrawal after treatment, stating that “the balloon 16′ is then deflated and the CAS 10 is pulled back in the proximal direction until the needles 19 are no longer penetrating the ostial wall,” and that “the CAS 10 is then pulled back more in the proximal direction into the distal end of the guiding catheter 30” (Fischell-277 ¶ [0087]).
Delivering therapeutic treatment to a second body lumen using the same delivery catheter and withdrawing the catheter.
Fischell-277 discloses repeating the procedure in another target vessel, stating that “the guide wire 20 may be advanced into another target vessel and the ablation procedure repeated,” and that “[a]fter the last target vessel is treated, the CAS 10 can then be removed from the patient’s body” (Fischell-277 ¶ [0087]).
Therapeutic treatments effective to treat at least two selected diseases.
Fischell-277 discloses hypertension treatment, stating that “[a] similar approach can be used with the CAS, via access from a peripheral artery such as the femoral artery, to treat hypertension, via ablation of tissue in the periostial aortic wall tissue surrounding one or both of the renal arteries” (Fischell-277 ¶ [0117]). Fischell-277 does not expressly disclose that the same repeatable treatment method is effective for a second claimed disease such as congestive heart failure or end-stage renal disease. Evans fills this gap by disclosing that “[n]erve denervation may be used to manage hypertension, congestive heart failure, endstage renal disease, and other conditions.” (Evans ¶ [0004].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Fischell-277’s repeatable catheter-based renal periostial ablation method with Evans’s renal-denervation disease teachings because both references address catheter-based or localized denervation/neuromodulation to treat diseases mediated by sympathetic nerve activity. Fischell-277 states that the procedure treats hypertension by “ablating afferent and/or efferent sympathetic nerve fibers entering or exiting the kidney” (Fischell-277 ¶ [0117]). Evans similarly identifies denervation for hypertension, congestive heart failure, and end-stage renal disease (Evans ¶ [0004]).
In relation to claim 2, this claim depends from claim 1 and further recites that the first body lumen is a blood vessel, the second body lumen is the same blood vessel or a different blood vessel, and the therapeutic treatments are effective to treat at least two diseases selected from hypertension, diabetes, obesity, heart failure, end-stage renal disease, and pulmonary arterial hypertension.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans is incorporated into this rejection.
Blood-vessel lumens and repeated treatment.
Fischell-277 discloses treatment of target vessels and identifies renal arteries, stating that the CAS can be used “to treat hypertension, via ablation of tissue in the periostial aortic wall tissue surrounding one or both of the renal arteries” (Fischell-277 ¶ [0117]). Fischell-277 also discloses repeated treatment after withdrawal, stating that “the guide wire 20 may be advanced into another target vessel and the ablation procedure repeated” (Fischell-277 ¶ [0087]).
Disease subset.
Fischell-277 discloses hypertension treatment (Fischell-277 ¶ [0117]). To the extent the claim requires at least one additional disease from the narrowed subset, Evans discloses “congestive heart failure” and “endstage renal disease” as denervation-manageable conditions (Evans ¶ [0004]).
The motivation stated for claim 1 applies. A person of ordinary skill would have used the repeatable blood-vessel catheter ablation method of Fischell-277 with Evans’s disease teachings to treat multiple sympathetic-mediated diseases in a predictable catheter-denervation workflow.
In relation to claim 4, this claim depends from claim 1 and recites that the first body lumen is a renal artery and the second body lumen is a different renal artery, with treatments effective to treat at least two diseases selected from hypertension, diabetes, obesity, heart failure, end-stage renal disease, and pulmonary arterial hypertension.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans is incorporated.
Different renal arteries.
Fischell-277 expressly discloses using the CAS “to treat hypertension, via ablation of tissue in the periostial aortic wall tissue surrounding one or both of the renal arteries” (Fischell-277 ¶ [0117]). Fischell-277 also teaches repeated treatment in another target vessel after withdrawal. (Fischell-277 ¶ [0087]).
Disease subset and motivation.
The disease mapping and motivation stated for claim 2 apply here. Evans fills the additional claimed disease indications by disclosing denervation for “congestive heart failure” and “endstage renal disease.” (Evans ¶ [0004].)
Therefore, in view of the demonstrated conventionality of the enhancement(s), its implementation in the invention of this application would have been considered an obvious alternative in the design of the process.
In relation to claim 9, this claim depends from claim 1 and recites that the delivery catheter is a needle-based delivery catheter.
Base rejection incorporated.
The rejection of claim 1 is incorporated.
Needle-based delivery catheter.
Fischell-277 discloses that “each hub 17 acts as a penetration limiting member to limit the penetration of the distally attached needle 19 into the ostial wall of the target vessel” (Fischell-277 ¶ [0078]). Fischell-277 further states that “an ablative substance such as ethanol is injected into the ostial wall through the needles 19” (Fischell-277 ¶ [0087]).
Based on the above teachings, the motivation stated for claim 1 applies because Fischell-277 already provides the needle-based catheter structure and Evans provides additional disease indications. Therefore, in view of the demonstrated conventionality of the enhancement(s), its implementation in the invention of this application would have been considered an obvious alternative in the design of the process.
In relation to claim 10, this claim depends from claim 1 and recites that the delivery catheter is a balloon delivery catheter.
Base rejection incorporated.
The rejection of claim 1 is incorporated.
Balloon delivery catheter.
Fischell-277 discloses that “[a]n expandable cylindrical balloon 16 is attached at its proximal end to the middle tube 14 and at its distal end to the inner tube 18.” (Fischell-277 ¶ [0077].) Fischell-277 further discloses that “the balloon 16 can be inflated by injection of a fluid through the balloon inflation lumen and deflated by applying suction to the balloon inflation lumen.” (Fischell-277 ¶ [0077].)
The motivation stated for claim 1 applies. Fischell-277 already uses a balloon to center and operate the catheter in a vessel, and Evans supplies additional denervation disease targets. Therefore, in view of the demonstrated conventionality of the enhancement(s), its implementation in the invention of this application would have been considered an obvious alternative in the design of the process.
In relation to claim 21, this claim depends from claim 1 and recites that the therapeutic treatment delivered to the first body lumen is effective to treat a first disease of the at least two diseases, and the therapeutic treatment delivered to the second body lumen is effective to treat a second disease of the at least two diseases, the second disease being different from the first
disease.
Base rejection incorporated.
The rejection of claim 1 is incorporated into this rejection.
Different first and second diseases.
Fischell-277 discloses treatment of hypertension by renal periostial ablation (Fischell-277 ¶ [0117]). Fischell-277 does not expressly disclose using different lumen treatments for different claimed diseases. Evans fills the disease target gap by disclosing that “[n]erve denervation may be used to manage hypertension, congestive heart failure, endstage renal disease, and other conditions” (Evans ¶ [0004]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to apply Fischell-277’s repeatable renal-denervation catheter method to different denervation disease indications disclosed by Evans because both references identify sympathetic nerve modulation as the therapeutic mechanism.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Gnanashanmugam et al. (WO2013090848A1; hereinafter “Gnanashanmugam”).
In relation to claim 3, this claim depends from claim 1 and further recites that the first body lumen is a renal artery and the second body lumen is a different renal artery or a pulmonary artery, with treatments effective to treat at least two diseases selected from hypertension, diabetes, obesity, heart failure, end-stage renal disease, and pulmonary arterial hypertension.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans is incorporated into this rejection.
Renal artery and different renal artery.
Fischell-277 discloses ablation surrounding “one or both of the renal arteries” (Fischell-277 ¶ [0117]). Fischell-277 further teaches that after one target vessel is treated, “the guide wire 20 may be advanced into another target vessel and the ablation procedure repeated” (Fischell-277 ¶ [0087]).
Pulmonary artery alternative.
To the extent the second lumen is a pulmonary artery, Gnanashanmugam discloses pulmonary vasculature target vessels including “a pulmonary trunk, a right pulmonary artery, a left pulmonary artery, an artery branching from the right pulmonary artery, an artery branching from the left pulmonary artery, and/or any artery branching from the branching arteries.” (Gnanashanmugam, pages 3 and 4, starting in line 27 of page 3).
Disease subset.
Fischell-277 discloses hypertension treatment by renal-artery-associated ablation (Fischell-277 ¶ [0117]). Evans discloses denervation for “congestive heart failure” and “endstage renal disease” (Evans ¶ [0004]). Gnanashanmugam discloses treatment to “ameliorate pulmonary hypertension” (Gnanashanmugam, page 4, line 24).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to apply Fischell-277’s repeatable catheter-denervation method to renal arteries as expressly taught by Fischell-277, and to use Gnanashanmugam’s pulmonary-artery targets where the second body lumen is
pulmonary, because the references teach analogous intravascular denervation/neuromodulation for sympathetic-mediated vascular disease.
Claims 5 and 6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”) and Gnanashanmugam et al. (WO2013090848A1; hereinafter “Gnanashanmucam”), as discussed above, and in further view of Azamian et al. (US 20130178910A1; hereinafter “Azamian”).
In relation to claim 5, this claim depends from claim 1 and recites that the first body lumen is a pulmonary artery and the second body lumen is a different pulmonary artery, with the therapeutic treatments effective to treat heart failure and pulmonary arterial hypertension.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans is incorporated into this rejection for the underlying delivery, withdrawal, repeat-treatment, and multi-disease framework.
Pulmonary arterial hypertension and pulmonary arteries.
Gnanashanmucam discloses “devices, systems and methods for treating one or more nerves, nerve fibers or neurons to treat pulmonary hypertension and/or other pulmonary vascular disorders.” (Gnanashanmugam, page 1, lines 6-9). Gnanashanmugam further discloses “advancing an intravascular treatment device to a target location in a target blood vessel within the pulmonary vasculature” and using it “to ameliorate pulmonary hypertension” (Gnanashanmugam, page 2, lines 7-11).
First and second pulmonary arteries.
Gnanashanmugam discloses pulmonary vasculature including “a pulmonary trunk, a right pulmonary artery, a left pulmonary artery,” and arteries branching therefrom (Gnanashanmugam, page 3, starting in line 28). Gnanashanmugam further discloses sequential treatment: after right-side therapy, “the catheter 302 may be retracted from the right pulmonary artery RPA,” the guide catheter may be “repositioned,” and the guidewire “may be re-advanced ... to a position within the left pulmonary artery LPA.” (Gnanashanmugam, page 48, lines 23-30). The catheter is then “re-advanced ... into position within the left pulmonary artery” to achieve left pulmonary neuromodulation (Gnanashanmugam, page 49, starting in line 6).
Heart failure.
Gnanashanmugam discloses that pulmonary hypertension “causes increased work for the right side of the heart and eventually hypertrophy and dysfunction of not only the right side of the heart, but often the left side as well” (Gnanashanmugam, page 1, lines 12-14). Evans further discloses that “[n]erve denervation may be used to manage hypertension, congestive heart failure, endstage renal disease, and other conditions” (Evans ¶ [0004]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to add Gnanashanmugam and Azamian to the Fischell-277/Evans base combination because the base combination already teaches repeatable catheter-based denervation/ablation and Evans expressly teaches denervation for congestive heart failure. Gnanashanmugam provides the pulmonary-artery
implementation and states that reducing sympathetic tone produces “a reduction in pulmonary pressure and pulmonary hypertension” (Gnanashanmugam, page 10, lines 22-23). Azamian confirms that neuromodulation may be used for cardiovascular and metabolic conditions including “hypertension” and “obesity” (Azamian ¶ [0007]).
In relation to claim 6, this claim depends from claim 1 and recites that the first body lumen comprises a pulmonary artery and that delivering the therapeutic treatment to the pulmonary artery comprises positioning a front balloon of the delivery catheter at a pulmonary artery bifurcation.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans and the additional rejection of claim 5 over Gnanashanmugam and Azamian are incorporated.
Pulmonary artery and pulmonary artery bifurcation.
Gnanashanmugam discloses that “the pulmonary artery bifurcation and adjacent portions of the right and left pulmonary arteries receive a very rich innervation” (Gnanashanmugam, page 15, lines 7-8). Gnanashanmugam further states that “a large concentration of nerve endings are found at the bifurcation of the pulmonary artery, as well as in parts of the adjacent pulmonary artery and its right and left main branches” (Gnanashanmugam, page 16, lines 9-11).
Balloon catheter / front balloon.
Gnanashanmugam discloses an “apparatus 240” comprising “a balloon catheter 242 having an expandable balloon 244,” and further states that “after positioning the catheter 242 in a target vessel (e.g. pulmonary artery PA), the balloon 244 is inflated until it contacts the wall of the vessel” (Gnanashanmugam, page 42, lines 3-11). To the extent the term “front balloon” is not used verbatim, positioning the expandable balloon on the catheter at the known nerve-rich pulmonary artery bifurcation would have been an obvious implementation of the disclosed pulmonary-artery balloon catheter for the disclosed target region.
The motivation stated for claim 5 applies. A person of ordinary skill would have used Gnanashanmugam’s balloon catheter at the pulmonary artery bifurcation because Gnanashanmugam identifies that bifurcation and the adjacent pulmonary arteries as richly innervated target regions for pulmonary denervation (Gnanashanmugam, page 15, lines 7-8).
Claims 7 and 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Askew et al. (US 2009/0192505A1; hereinafter “Askew”).
In relation to claim 7, this claim depends from claim 1 and recites first and second body lumens that are different airways, with treatments effective to treat asthma and chronic obstructive pulmonary disease.
Base rejection incorporated.
The rejection of claim 1 over Fischell-277 in view of Evans is incorporated into this rejection.
Airways and asthma/COPD.
Fischell-277 does not expressly disclose airway lumens, asthma, or chronic obstructive pulmonary disease. Askew fills this gap by disclosing “methods of cryospray therapy and drug delivery for airway and thoracic applications” (Askew ¶ [0001]). Askew also states that “a wide variety of conditions may be treated using the methods of the invention including asthma,” and separately explains that “[c]hronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema.” (Askew ¶¶ [0000/Abstract], [0004].)
Repeated airway treatment.
Askew discloses that cryogen or an isotherm can be applied “a plurality of times,” with intervals “from about 1 second to about 10 minutes” (Askew ¶ [0012]). Applying Fischell-277’s repeated catheter-treatment workflow to different airway targets would have been an ordinary use of catheter repositioning for multiple lumen treatments.
Based on the above teachings, it would have been obvious to add Askew’s airway treatment to
the Fischell-277/Evans base framework because both Fischell-277 and Askew use catheter delivered therapy to injure or ablate target tissue. Askew teaches catheter-guided cryogen delivery to thoracic/airway tissue, while Fischell-277 teaches repeating treatment after catheter withdrawal and repositioning (Askew ¶ [0014]; Fischell-277 ¶ [0087]).
In relation to claim 8, this claim depends from claim 1 and recites that the first body lumen comprises an airway and delivering the therapeutic treatment comprises treating at least one of a main bronchus, lobar bronchus, segmental bronchus, and subsegmental bronchus.
Base rejection incorporated.
The rejection of claim 1 and the airway rejection of claim 7 are incorporated.
Bronchial airway treatment.
Askew discloses catheter treatment of lung tissue, stating that “a proximal end of a catheter may be connected to a cryogen source and a distal end of the catheter may be guided to a tissue to be treated using a guiding device and cryogen flows from the source through the distal end to the tissue” (Askew ¶ [0014]). Askew further identifies bronchial airway targets, stating that lesions may occur in the “trachea or bronchus” (Askew ¶ [0005]).
The motivation stated for claim 7 applies; a person of ordinary skill would have treated bronchial airways with Askew’s catheter-based cryospray therapy to address asthma/COPD airway pathology. In view of the demonstrated conventionality of the enhancement(s), its implementation in the invention of this application would have been considered an obvious alternative in the design of the process.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Campbell et al. (US 2006/0271091A1; hereinafter “Campbell”) and Alex et al. (US 2010/0234875A1; hereinafter “Alex”).
In relation to claim 11, this claim depends from claim 1 and recites a balloon delivery catheter, positioning in the respective body lumen, inflating a balloon having a diameter in an inflated state between 2 mm and 30 mm, delivering energy, heat, or a chemical formulation through the balloon delivery catheter, and deflating the balloon prior to withdrawal.
Base rejection incorporated.
The rejection of claim 1 and the balloon-catheter rejection of claim 10 are incorporated.
Positioning, inflating, and deflating.
Fischell-277 discloses that the catheter is inserted “into the target vessel over the guide wire 20,” and that after retraction of the guiding catheter, “the inflatable balloon 16′ has been expanded with the guide wire 20 still lying within the target vessel” (Fischell-277 ¶¶ [0085]–[0086]). Fischell-277 further states that “the balloon 16′ is then deflated and the CAS 10 is pulled back in the proximal direction” (Fischell-277 ¶ [0087]).
Balloon diameter.
Fischell-277 does not expressly disclose the claimed 2–30 mm numerical range. Alex fills this gap by disclosing “5-10 mm diameter balloons” and “12-20 mm diameter balloons,” which fall within the claimed range. (Alex ¶ [0071].)
Energy, heat, or chemical formulation delivery.
Fischell-277 discloses chemical delivery of ethanol through the catheter and also discloses that injector tubes may be connected “to an electrical or RF field source to allow for electrical discharge or RF ablation.” (Fischell-277 ¶¶ [0087], [0043].)
Based on the above teachings, it would have been obvious to use Alex’s known balloon diameters and Campbell’s conventional deflation-before-withdrawal practices in Fischell-277’s balloon-centered catheter because Fischell-277 already states that balloon diameter is adjusted by inflation pressure. (Fischell-277 ¶ [0084]; Campbell ¶ [0004]; Alex ¶ [0071].)
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Lentz et al. (EP0987042A2; hereinafter “Lentz”) and Alex et al. (US 2010/0234875A1; hereinafter “Alex”).
In relation to claim 12, this claim depends from claim 1 and recites a balloon delivery catheter comprising an elongated shaft, at least one balloon along the shaft, at least one marker band adjacent to the balloon, and a balloon material selected from polyamides, nylons, polyether block amides, polyesters, polyethylene terephthalate, and copolymers thereof.
Elongated shaft and balloon. Fischell-277 discloses the catheter body and balloon relationship, stating that “the proximal portion of the CAS 10 includes three tubes, an outer tube 12, a middle tube 14 and an inner tube 18” and that “[a]n expandable cylindrical balloon 16 is attached at its proximal end to the middle tube 14 and at its distal end to the inner tube 18” (Fischell-277 ¶ [0077]).
Marker band adjacent to the balloon. Lentz discloses “radiopaque marker bands which can be positioned on a medical catheter to identify the location of the catheter during surgical procedures using fluoroscopic techniques” (Lentz ¶ [0001]). Lentz further discloses that marker bands “are located, respectively, under the proximal end 44 and the distal end 46 of the balloon 36” (Lentz ¶ [0020]).
Balloon material. Lentz discloses that “the balloon 36 is preferably made of Pebax® 7033,” and that other materials including “a Nylon 12 material” may be used (Lentz ¶¶ [0013], [0015]). Alex further discloses compliant materials including “nylon” and “polyether block amides (PEBAX)” (Alex ¶ [0029]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to add Lentz marker bands and known balloon materials to Fischell-277’s balloon catheter to improve fluoroscopic positioning and use known compatible catheter polymers, particularly because Fischell-277 already contemplates radiopaque visualization of catheter components (Fischell-277 ¶ [0017]).
Claims 13, 15, 16, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Cressman (US 2012/0253192A1).
In relation to claim 13, this claim depends from claim 1 and recites delivering an effective amount of a formulation at a desired temperature to target tissue.
Base rejection incorporated. The rejection of claim 1 is incorporated into this rejection.
Formulation delivery to target tissue.
Fischell-277 discloses delivery of an ablative formulation to tissue, stating that “an ablative substance such as ethanol is injected into the ostial wall through the needles 19” (Fischell-277 ¶ [0087]).
Desired temperature.
Cressman discloses chemical ablation and thermochemical temperature effects, stating that chemical reactions may provide “a heated solution, suspension, colloid, gel, or the like,” and that a delivered reagent may react with “water at the targeted tissue location to locally generate ablation heat at the targeted tissue site” (Cressman ¶¶ [0005], [0027]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to use Cressman’s known chemical-ablation formulations and thermochemical temperature control with Fischell-277’s catheter injection system because Fischell-277 already injects ethanol as an ablative substance and Cressman identifies ethanol, acetic acid, hot saline, and thermochemical heat generation as ablation techniques (Fischell-277 ¶ [0087]; Cressman¶¶ [0004], [0027]).
In relation to claim 15, this claim depends from claim 13 and recites that the formulation comprises at least one ingredient selected from water, saline, hypertonic saline, phenol, methanol, ethanol, absolute alcohol, isopropanol, propanol, butanol, isobutanol, ethylene glycol, glycerol, acetic acid, lactic acid, propyl iodide, isopropyl iodide, ethyl iodide, methyl acetate, ethyl acetate, ethyl nitrate, isopropyl acetate, ethyl lactate, urea, lipiodol, and surfactant.
Base rejection incorporated.
The rejection of claim 13 is incorporated into this rejection.
Claimed ingredients.
Fischell-277 discloses ethanol by stating that “an ablative substance such as ethanol is injected into the ostial wall through the needles 19” (Fischell-277 ¶ [0087]). Cressman discloses “direct injection of a single agent (e.g., ethanol, acetic acid, hydrochloric acid, hot saline, or sodium hydroxide),” and further discloses reducing agents including “glycerol” for thermochemical ablation (Cressman ¶¶ [0004], [0021]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to select known ablation ingredients such as ethanol, acetic acid, hot saline, or glycerol-containing thermochemical mixtures from Cressman for use in Fischell-277’s injection catheter because both references teach targeted chemical ablation.
In relation to claim 16, this claim depends from claim 13 and recites that the formulation comprises at least one of 10 wt% to 100 wt% ethanol and 1 wt% to 100 wt% acetic acid.
Base rejection incorporated.
The rejection of claim 13 is incorporated into this rejection.
Ethanol and acetic acid.
Fischell-277 discloses ethanol injection for ablation (Fischell-277 ¶ [0087]). Cressman discloses ethanol and acetic acid as ablation agents, stating that direct injection agents include “ethanol” and “acetic acid” (Cressman ¶ [0004]).
Concentration range.
Cressman discloses ethanol and acetic acid chemical-ablation agents but does not expressly disclose the entire claimed 10 wt% to 100 wt% ethanol or 1 wt% to 100 wt% acetic-acid ranges. However, as discussed above, Fischell-277 already uses ethanol for ablation, and Cressman teaches ethanol and acetic acid as direct-injection chemical-ablation agents. Therefore, an artisan skilled in the art would have recognized that the claimed ranges for ethanol and acetic acid are directly related to the effects of these chemicals in the human body and the safety standards/limitations of the procedure; therefore, after experimentation with the use of these chemical agent in the procedure, the claimed ranges would have been considered obvious alternatives imposed by the limitations of the human body and the effects of these chemicals on tissue.
In relation to claim 17, this claim depends from claim 13 and recites therapeutic agents including sodium channel blockers, tetrodotoxin, saxitoxin, decarbamoyl saxitoxin, vanilloids, neosaxitoxin, lidocaine, conotoxins, cardiac glycosides, digoxin, glutamate, staurosporine, amlodipine, verapamil, and guanethidine sulfate.
Base rejection incorporated.
The rejection of claim 13 is incorporated into this rejection.
Therapeutic agents.
Evans discloses many of the claimed therapeutic-agent categories, stating that “site 1 sodium channel blockers such as tetrodotoxin (TTX), saxitoxin (STX), decarbamoyl saxitoxin, vanilloids, and neosaxitoxin are used as local anesthetic formulations” (Evans ¶ [0019]). Evans also states that “lidocaine may be used as temporary nerve blockage agents,” that “conotoxins may also provide temporary nerve blockade,” that “cardiac glycosides” have been used to treat congestive heart failure and arrhythmias, and that “glutamate” and “verapamil” may be used in nerve-cell damage/blockade approaches (Evans ¶ [0019]).
Based on the above teachings, it would have been obvious to use Evans’s neural agents in Fischell-277’s injection catheter because Evans states that delivery systems “provide site-specific treatment and control so that the controlling effects are localized,” and Fischell-277 provides an ostial-wall catheter injection platform for ablating nerves around renal arteries (Evans ¶ [0018]; Fischell-277 ¶ [0117]).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), and Cressman (US 2012/0253192A1), as discussed above, and in further view of Askew et al. (US 2009/0192505A1; hereinafter “Askew”) and Campbell et al. (US 2006/0271091; hereinafter “Campbell”).
In relation to claim 14, this claim depends from claim 13 and recites that the formulation comprises at least one of a gas, vapor, liquid, solution, emulsion, or suspension, is delivered at a temperature between −40 °C and 140 °C, and is delivered at a pressure between 1 ATM and 12 ATM.
Base rejection incorporated.
The rejection of claim 13 is incorporated into this rejection.
Liquid/solution/suspension formulation.
Cressman discloses “a heated solution, suspension, colloid, gel, or the like,” and also discloses “direct injection of a single agent (e.g., ethanol, acetic acid, hydrochloric acid, hot saline, or sodium hydroxide)” (Cressman ¶¶ [0005], [0004]).
Temperature.
Askew discloses temperature-controlled cryogenic therapy, stating that “[s]uitable examples of temperatures may include, but are not limited to, from about 4° C to about the boiling point of the cryogen.” (Askew ¶ [0012].) A temperature of about 4 °C is within the claimed −40 °C to 140 °C range.
Pressure.
Campbell discloses balloon-catheter pressure ranges, stating that angioplasty balloon devices “are rated to high pressures, usually up to about 8 to 12 atmospheres depending on rated diameter” (Campbell ¶ [0005]). This supports a catheter pressure range overlapping the claimed 1–12 ATM range.
Based on the above comments, it would have been obvious to apply Cressman solution/suspension chemical-ablation formulations and Askew’s temperature-controlled catheter therapy to Fischell-277’s ethanol injection catheter because each reference uses a catheter or cannula to deliver ablative therapy to target tissue. Moreover, Campbell supplies known balloon-catheter pressure practices for the balloon-catheter environment.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), and Cressman (US 2012/0253192A1), as discussed above, and in further view of Lee et al. (WO2012148459A1; hereinafter “Lee”) and the publication Ansari et al. (“Radiofrequency ablation or percutaneous ethanol injection for the treatment of liver tumors”; hereinafter “Ansari”).
In relation to claim 18, this claim depends from claim 13 and recites an azeotrope chosen from ethanol/water, ethanol/water/contrast agent, ethanol/water/surfactant, propanol/water, isopropanol/water, butanol/water, acetic acid/water, and combinations thereof.
Base rejection incorporated.
The rejection of claim 13 is incorporated into this rejection.
Ethanol as an ablative formulation.
Fischell-277 discloses ethanol ablation, stating that “an ablative substance such as ethanol is injected into the ostial wall through the needles 19” (Fischell-277 ¶ [0087]). Ansari supplies medical-context support for ethanol and acetic-acid ablation by stating that local ablative therapies include “percutaneous ethanol injection (PEI), percutaneous acetic acid injection, radiofrequency ablation (RFA), cryoablation, microwave ablation, laser-induced thermotherapy, and high-intensity focused ultrasound” (Ansari, Abstract, p. 1003).
Ethanol/water azeotrope.
Fischell-277 does not expressly disclose that the ethanol formulation is an ethanol/water azeotrope. Lee fills the azeotrope gap by disclosing that “[w]ater and ethanol form an azeotrope that is difficult to separate in a distillation column,” and that “[t]he ethanol-water azeotrope limits the recoverable ethanol in distillation columns to an ethanol product comprising about 92-96 wt.% of ethanol” (Lee ¶ [0016]).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use known ethanol/water compositions, including azeotropic ethanol/water compositions, as predictable ethanol-based ablative formulations in Fischell-277’s ethanol-injection ablation catheter because Fischell-277 already identifies ethanol as the ablative substance and Lee establishes that ethanol/water azeotropic ethanol products were known compositions in the art.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Gnanashanmugam et al. (WO2013090848A1; hereinafter “Gnanashanmucam”), Demarais et al. (US 8774913B2; hereinafter “Demarais”), Askew et al. (US 2009/0192505A1; hereinafter “Askew”), and Azamian et al. (US 20130178910A1; hereinafter “Azamian”).
In relation to claim 19, this claim depends from claim 1 and recites delivering energy selected from radiofrequency, cryoablation, microwave, laser, ultrasound, and high-intensity focused ultrasound energies.
Base rejection incorporated.
The rejection of claim 1 is incorporated.
Radiofrequency energy.
Fischell-277 discloses that “two or more of the legs/injector tubes may be connected to an electrical or RF field source to allow for electrical discharge or RF ablation” (Fischell-277 ¶ [0043]). Gnanashanmugam also discloses energy sources including “monopolar radiofrequency, bipolar radiofrequency, other forms of radiofrequency” (Gnanashanmugam, page 2, lines 12-19).
Cryoablation / cold energy.
Askew discloses cryogenic treatment, stating that methods may comprise “contacting the tissue with a cryogen, for example, with a liquefied gas such as liquid nitrogen” (Askew ¶ [0012]). Askew also discloses that “cryogen flows from the source through the distal end to the tissue.” (Askew ¶ [0014]).
Microwave, laser/light, ultrasound, and HIFU.
Gnanashanmugam discloses “high intensity focused ultrasound, low frequency ultrasound, other forms of ultrasound, microwave, light, heat, cold radiation, phototherapy, magnetic, electrical, electromagnetic, cryotherapy, plasma, mechanical, chemical, kinetic, potential, nuclear, elastic and/or hydrodynamic energy” (Gnanashanmugam, page 2, lines 15-18). Azamian similarly discloses “RF energy, ultrasonic energy, focused ultrasound (e.g., HIFU, LIFU) energy ... chemoablation, cryoablation ... or any other modality” (Azamian ¶ [0010]).
Additional support.
Demarais discloses that neuromodulation may be induced “via electrical energy application, via thermal energy application (either heating or cooling), via mechanical energy application, via chemical energy application, via radiation energy application.” (Demarais, col. 3, starting in line 65). Demarais further teaches “localized drug delivery,” “high intensity focused ultrasound,” “thermal techniques,” and “athermal techniques” (US8774913B2, col. 4, lines 4-6).
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to select among the known energy modalities disclosed by the secondary references because Fischell-277 already teaches RF/electrical ablation in the claimed catheter-treatment environment, and the secondary references disclose predictable alternative ablation/neuromodulation modalities for target tissue or nerves.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischell et al. (US 2012/0271277A1; hereinafter “Fischell-277”) in view of Evans et al. (US 2011/0182912; hereinafter “Evans”), as discussed above, and in further view of Askew et al. (US 2009/0192505A1; hereinafter “Askew”).
In relation to claim 20, this claim depends from claim 1 and recites delivering energy at a flow rate between about 2 calories/second and about 500 calories/second and treatment duration between about 2 seconds and about 60 minutes.
Base rejection incorporated.
The rejection of claim 1 is incorporated.
Energy delivery and treatment duration.
Fischell-277 discloses RF/electrical ablation, stating that injector tubes may be connected “to an electrical or RF field source to allow for electrical discharge or RF ablation” (Fischell-277 ¶ [0043]). Askew discloses timed repeated treatment intervals, stating that target tissue may be contacted with cryogen “a plurality of times” and that the period between treatments “may be from about 1 second to about 10 minutes” (Askew ¶ [0012]).
Based on the above teachings, it would have been obvious to use timed ablation exposures from Askew with Fischell-277’s catheter-based RF or chemical ablation because both references deliver ablative therapy through catheters and teach controlling treatment application to achieve tissue effects.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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