DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,517,725.
Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of claim 1 of the application are to be found in claim 1 of the patent.
Specifically, both claim 1 of the application and claim 1 of the patent recite the same limitations regarding a method of treating multiple diseases, comprising: delivering a therapeutic treatment to a first body lumen using a delivery catheter; withdrawing the delivery catheter from the first body lumen; delivering a therapeutic treatment to a second body lumen using the delivery catheter; withdrawing the delivery catheter from the second body lumen; wherein 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. Despite the slight variation between the language of claim 1 of the application and the language of claim 1 of the patent, claim 1 of the patent includes every limitation of claim 1 of the application.
The difference between claim 1 of the application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific, for example a balloon delivery catheter. Thus the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of U.S. Patent No. 11,517,725.
Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of claim 1 of the application are to be found in claim 27 of the patent.
Specifically, both claim 1 of the application and claim 27 of the patent recite the same limitations regarding a method of treating multiple diseases, comprising: delivering a therapeutic treatment to a first body lumen using a delivery catheter; withdrawing the delivery catheter from the first body lumen; delivering a therapeutic treatment to a second body lumen using the delivery catheter; withdrawing the delivery catheter from the second body lumen; wherein 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. Despite the slight variation between the language of claim 1 of the application and the language of claim 27 of the patent, claim 27 of the patent includes every limitation of claim 1 of the application.
The difference between claim 1 of the application and claim 27 of the patent lies in the fact that the patent claim includes more elements and is thus more specific, for example a balloon delivery catheter. Thus the invention of claim 27 of the patent is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 27 of the patent, it is not patentably distinct from claim 27 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11,517,725.
Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of claim 1 of the application are to be found in claim 28 of the patent.
Specifically, both claim 1 of the application and claim 28 of the patent recite the same limitations regarding a method of treating multiple diseases, comprising: delivering a therapeutic treatment to a first body lumen using a delivery catheter; withdrawing the delivery catheter from the first body lumen; delivering a therapeutic treatment to a second body lumen using the delivery catheter; withdrawing the delivery catheter from the second body lumen; wherein 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. Despite the slight variation between the language of claim 1 of the application and the language of claim 28 of the patent, claim 28 of the patent includes every limitation of claim 1 of the application.
The difference between claim 1 of the application and claim 28 of the patent lies in the fact that the patent claim includes more elements and is thus more specific, for example a balloon delivery catheter. Thus the invention of claim 28 of the patent is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 28 of the patent, it is not patentably distinct from claim 28 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,208,224
Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of claim 1 of the application are to be found in claim 10 of the patent.
Specifically, both claim 1 of the application and claim 10 of the patent recite the same limitations regarding a method of treating multiple diseases, comprising: delivering a therapeutic treatment to a first body lumen using a delivery catheter; withdrawing the delivery catheter from the first body lumen; delivering a therapeutic treatment to a second body lumen using the delivery catheter; withdrawing the delivery catheter from the second body lumen; wherein the therapeutic treatments are effective to treat diabetes and obesity. Despite the slight variation between the language of claim 1 of the application and the language of claim 10 of the patent, claim 10 of the patent includes every limitation of claim 1 of the application.
The difference between claim 1 of the application and claim 10 of the patent lies in the fact that the patent claim includes more elements and is thus more specific, for example a chemical formulation comprising ethanol. Thus the invention of claim 10 of the patent is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 10 of the patent, it is not patentably distinct from claim 10 of the patent.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1 – 4, 9, 10, 13, 15, and 19 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Azamian (U.S. 2013/0178910).
Regarding claim 1, Azamian teaches a method of treating multiple diseases (paragraph [0255] discloses that the system and methods as described can be used for treatment of diabetes and obesity), comprising:
delivering a therapeutic treatment to a first body lumen using a delivery catheter (catheter 1750, Figure 17), specifically see discussion of delivering electrical energy for ablation of a target treatment site in a body lumen such as celiac, common hepatic, and proper hepatic arteries in paragraph [0165];
withdrawing the delivery catheter from the first body lumen (the entire ablation system 1700 can be retracted upon completion as discussed in paragraph [0165]);
delivering a therapeutic treatment to a second body lumen using the delivery catheter (since multiple regions (organs, arteries, and nerve systems) can be modulated in sequentially as discussed in paragraph [0069], the ablation system 1700 can be used to deliver electrical energy for ablation of another target treatment site in another body lumen shown in Figures 1 and 2 and discussed in paragraphs [0066] and [0067]);
withdrawing the delivery catheter from the second body lumen (the entire ablation system 1700 can be retracted upon completion as discussed in paragraph [0165]);
wherein 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 (paragraph [0255] discloses that the system and methods as described can be used for treatment of diabetes and obesity).
Regarding claim 2, Azamian teaches that the first body lumen is a blood vessel (celiac, common hepatic, and proper hepatic arteries as discussed in paragraph [0165]); and the second body lumen is the same blood vessel or a different blood vessel (see discussions of different type of blood vessel that can be treated using the system and method as disclosed in paragraphs [0066] and [0067] and multiple arteries can be treated sequentially as discussed in paragraph [0069]); wherein 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 (paragraph [0255] discloses that the system and methods as described can be used for treatment of diabetes and obesity).
Regarding claim 3, Azamian teaches that the first body lumen is a renal artery (see discussion of renal arteries as an example of treatment site in paragraph [0011]); and the second body lumen is a different renal artery or a pulmonary artery (see discussion of multiple renal arteries in paragraph [0011] and multiple arteries can be treated sequentially as discussed in paragraph [0069]); wherein 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 (paragraph [0255] discloses that the system and methods as described can be used for treatment of diabetes and obesity).
Regarding claim 4, Azamian teaches that the first body lumen is a renal artery (see discussion of renal arteries as an example of treatment site in paragraph [0011]); and the second body lumen is a different renal artery (since renal arteries are disclosed as examples of treatment site in paragraph [0011] and multiple arteries can be treated sequentially as discussed in paragraph [0069]); wherein 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 (paragraph [0255] discloses that the system and methods as described can be used for treatment of diabetes and obesity).
Regarding claim 9, Azamian teaches that the delivery catheter is a needle-based delivery catheter (see discussion of a needle based catheter in paragraph [0126] and shown in Figure 10).
Regarding claim 10, Azamian teaches that the delivery catheter is a balloon delivery catheter (see discussion of balloon catheter in paragraph [0130] and shown in Figure 17).
Regarding claim 13, Azamian teaches that delivering the therapeutic treatment comprises delivering an effective amount of a formulation at a desired temperature to target tissue (see discussion of drugs that is capable of modulating nerve signals, in combination with energy modalities, being delivered for neuromodulation in paragraphs [0200] and [0201]). Examiner notes that since the claim does not specify any specific temperature, any temperature that the drugs being delivered for neuromodulation as discussed in paragraphs [0200] and [0201] can be understood as the desired temperature.
Regarding claim 15, Azamian teaches that the formulation comprises water (hot water as discussed in paragraphs [0015] and [0016]).
Regarding claim 19, Azamian teaches that delivering the therapeutic treatment comprises delivering energy from radiofrequency (paragraph [0079]).
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.
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Gnanashanmugam (U.S. 2013/0204068).
Regarding claim 5, Azamian teaches claim 1 as seen above.
Azamian further teaches that the first body lumen is a pulmonary artery (see discussion of pulmonary arteries as an example of target treatment area in paragraph [0009]); and the second body lumen is a different pulmonary artery (since pulmonary arteries can be a target treatment area as discussed in paragraph [0009] and multiple arteries can be treated sequentially as discussed in paragraph [0069]); wherein the therapeutic treatments are effective to treat hypertension (as discussed in paragraph [0007]).
However, Azamian does not specify that the therapeutic treatments are effective to treat heart failure and pulmonary arterial hypertension.
Gnanashanmugam teaches a method of ablating tissues (paragraph [0120]) similar to Azamian and the current application, further including that the therapeutic treatments are effective to treat heart failure and pulmonary arterial hypertension (as discussed in paragraphs [0078] and [0187]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Gnanashanmugam with the method of Azamian in order to prevent or treat congestive heart failure, hypertension, myocardial infarction, pulmonary disease, other pulmonary system diseases, and/or other pulmonary or cardio-pulmonary anomalies for a period of months or even years (Gnanashanmugam, paragraph [0187]).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Scandurra (U.S. 2013/0245665).
Regarding claim 6, Azamian teaches claim 1 as seen above.
Azamian further teaches that the first body lumen is a pulmonary artery (see discussion of pulmonary arteries as an example of target treatment area in paragraph [0009]); and the delivery catheter has balloons (see balloons 1725, Figure 17).
However, Azamian does not specify that delivering the therapeutic treatment to the pulmonary artery comprises positioning the front balloon of the delivery catheter at a pulmonary artery bifurcation.
Scandurra teaches a method for treatment within a body lumen (see abstract) similar to Azamian and the current application, further including that delivering the therapeutic treatment to the pulmonary artery comprises positioning a front balloon (compliant body 12, Figure 10E) of the delivery catheter at a pulmonary artery bifurcation (as shown in Figure 10E and discussed in paragraphs [0036] and [0039]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Scandurra with the device of Azamian in order to increases the compliance of the pulmonary artery and results in reduced systolic pressure in the pulmonary artery and right ventricle (Scandurra, paragraph [0040]).
Claims 7 and 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Askew (U.S. 2009/0192505).
Regarding claim 7, Azamian teaches claim 1 as seen above.
However, Azamian does not specify that the first body lumen is an airway; and the second body lumen is a different airway; wherein the therapeutic treatments are effective to treat asthma and chronic obstructive pulmonary disease.
Askew teaches a treatment method in a body lumen (see abstract) similar to Azamian and the current application, further including that the first body lumen is an airway (see discussion of applying treatment to the distal lobar in paragraph [0329]); and the second body lumen is a different airway (see discussion of applying treatment to segmental bronchi in paragraph [0329]); wherein the therapeutic treatments are effective to treat asthma (paragraph [0049]) and chronic obstructive pulmonary disease (paragraph [0220]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Askew with the method of Azamian in order to initiate a targeted immune response and allow the targeted tissue to be more permeable to therapeutic agents (Askew, paragraph [0193]).
Regarding claim 8, Azamian teaches claim 1 as seen above.
However, Azamian does not specify that the first body lumen comprises an airway; and delivering the therapeutic treatment to the airway comprises treating at least one of a main bronchus, a lobar bronchus, a segmental bronchus, and a subsegmental bronchus.
Askew teaches a treatment method in a body lumen (see abstract) similar to Azamian and the current application, further including that the first body lumen is an airway (see discussion of applying treatment to the distal lobar in paragraph [0329]); delivering the therapeutic treatment to the airway comprises treating at least one of a main bronchus, a lobar bronchus, a segmental bronchus, and a subsegmental bronchus (see discussion of applying treatment to the distal lobar and segmental bronchi in paragraph [0329]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Askew with the method of Azamian in order to initiate a targeted immune response and allow the targeted tissue to be more permeable to therapeutic agents (Askew, paragraph [0193]).
Claims 11 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Ogle (U.S. 2011/0093000).
Regarding claim 11, Azamian teaches claim 1 as seen above.
Azamian further teaches that the delivery catheter is a balloon delivery catheter (See balloon catheter as shown in Figure 17 an discussed in paragraph [0165]), wherein delivering the therapeutic treatments comprises positioning the balloon delivery catheter in the respective body lumen (See placement of balloon catheter system 1750 as shown in Figure 17 and discussed in paragraph [0165]); inflating a balloon of the balloon delivery catheter (see discussion of inflating occlusive balloons 1725 in paragraph [0165]), delivering energy through the balloon delivery catheter (see discussion of delivering energy with electrode 1740 in paragraph [0165]); and deflating the balloon prior to withdrawal (see discussion of deflating occlusive balloons 1725 prior to retracting in paragraph [0165]).
However, Azamian does not specify that the balloon has a diameter in an inflated state between 2 millimeters and 30 millimeters.
Ogle teaches a method of treating a body lumen (see abstract) similar to Azamian and the current application, further including that the balloon has a diameter in an inflated state between 2 millimeters and 30 millimeters (see discussion of the sealing balloon having an inflated diameter from 5 millimeter to 50 millimeter and that additional ranges within the explicit ranges are also contemplated in paragraph [0059]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Ogle with the method of Azamian in order to eliminate any trauma the sealing balloon may have on the vessel that it is sealed (Ogle, paragraph [0059]).
Regarding claim 12, Azamian teaches claim 1 as seen above.
Azamian further teaches that the delivery catheter is a balloon delivery catheter (See balloon catheter as shown in Figure 17 an discussed in paragraph [0165]), wherein the balloon delivery catheter comprises: an elongated shaft (shaft of catheter 1750, Figure 17); at least one balloon disposed along the elongated shaft (balloons 1725, Figure 17, paragraph [0165]); at least one marker band (radiopaque markers located at the distal end of the catheter or along the length of the catheter as discussed in paragraph [0211]).
However, Azamian does not specify that at least one marker band located adjacent to the balloon; and wherein the balloon comprises a material selected from polyamides, nylons, polyether block amides, polyesters, polyethylene terephthalate, and copolymers thereof.
Ogle teaches a method of treating a body lumen (see abstract) similar to Azamian and the current application, further including that at least one marker band (radiopaque marker band 106, Figure 1a and 1b, paragraph [0061]) located adjacent to the balloon (marker band 106 is adjacent to balloon 105 as shown in Figure 1b); and wherein the balloon comprises a material selected from polyamides, nylons, polyether block amides, polyesters, polyethylene terephthalate, and copolymers thereof (the device can be formed from polyether-amide block co-polymer (PEBAX.RTM.), nylon (polyamides) as discussed in paragraph [0067]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Ogle with the method of Azamian in order to eliminate any trauma the sealing balloon may have on the vessel that it is sealed (Ogle, paragraph [0059]).
Claims 14, and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Barry ‘233 (U.S. 2006/0161233)
Regarding claim 14, Azamian teaches claim 13 as seen above.
However, Azamian does not specify that the formulation comprises at least one of a gas, vapor, liquid, solution, emulsion or suspension; wherein the formulation is delivered at a temperature between -40 °C and 140 °C; and wherein the formulation is delivered at a pressure between 1 ATM and 12 ATM.
Barry ‘233 teaches a method of treatment in a body lumen (see abstract) similar to Azamian and the current application, further including that the formulation comprises vapor (vaper 12 as shown in Figure 1 and discussed in paragraph [0022]); wherein the formulation is delivered at a temperature between -40 °C and 140 °C (40 to 80 degrees Celsius as discussed in paragraph [0022]) ; and wherein the formulation is delivered at a pressure between 1 ATM and 12 ATM (at atmospheric pressure (1 ATM) as discussed in paragraph [0022]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Barry ‘233 with the method of Azamian in order to decrease a patient’s effective lung volume (Barry ‘233, paragraph [0007]).
Regarding claim 17, Azamian teaches claim 13 as seen above.
However, Azamian does not specify that the formulation comprises at least one therapeutic agent chosen from sodium channel blockers, tetrodotoxin, saxitoxin, decarbamoyl saxitoxin, vanilloids, neosaxitoxin, lidocaine, conotoxins, cardiac glycosides, digoxin, glutamate, staurosporine, amlodipine, verapamil, and guanethidine sulfate.
Barry ‘233 teaches a method of treatment in a body lumen (see abstract) similar to Azamian and the current application, further including that the formulation comprises lidocaine (paragraph [0030]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Barry ‘233 with the method of Azamian in order to alleviate patient discomfort and pain during treatment (Barry ‘233, paragraph [0030]).
Claims 16 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Arntzen (U.S. 6,444,233).
Regarding claim 16, Azamian teaches claim 13 as seen above.
Azamian further teaches that any chemical that is capable of disrupting nerve signals or ablating sympathetic nerve fibers may be used (paragraph [0205]).
However, Azamian does not specify that the formulation comprises at least one of 10 wt% to 100 wt% ethanol and 1 wt% to 100 wt% acetic acid.
Arntzen teaches a treatment method similar to Azamian and the current application, further including that the formulation comprises 100 wt% ethanol (100% ethanol as discussed in Col. 100, lines 49 – 55).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Arntzen with the method of Azamian in order to decrease the morbidity associated with high cholesterol in patient (Col. 69, lines 39 – 48).
Regarding claim 18, Azamian teaches claim 13 as seen above.
Azamian further teaches that any chemical that is capable of disrupting nerve signals or ablating sympathetic nerve fibers may be used (paragraph [0205]).
However, Azamian does not specify that the formulation comprises an azeotrope chosen from: ethanol/water, ethanol/water/contrast agent, ethanol/water/surfactant, propanol/water, iso-propanol/water, butanol/water, acetic acid/water, and combinations thereof.
Arntzen teaches a treatment method similar to Azamian and the current application, further including that the formulation comprises an azeotrope of ethanol/water (ethanol azeotrope with 5% water as discussed in Col. 100, lines 49 – 55).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Arntzen with the method of Azamian in order to decrease the morbidity associated with high cholesterol in patient (Col. 69, lines 39 – 48).
Claims 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Azamian (U.S. 2013/0178910) in view of Barry ‘483 (U.S. 2009/0301483)
Regarding claim 20, Azamian teaches claim 1 as seen above.
However, Azamian does not specify that delivering the therapeutic treatment comprises delivering energy at a flow rate between about 2 calories/second and about 500 calories/second, and wherein the treatment duration is between about 2 seconds and about 60 minutes.
Barry ‘483 teaches a method of treatment in a body lumen (see abstract) similar to Azamian and the current application, further including that delivering the therapeutic treatment comprises delivering energy at a flow rate between about 2 calories/second and about 500 calories/second (20 cal/s – 200 cal/s as discussed in paragraph [0024]) and wherein the treatment duration is between about 2 seconds and about 60 minutes (2 seconds to about 30 seconds as discussed in paragraph [0024]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the features of Barry ‘483 with the method of Azamian in order to cause the lung volume to be reduced and treat a variety of lung conditions (Barry ‘483, paragraphs [0020] and [0023]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783