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 § 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 –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Claim(s) 1-5, 8, 10-20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Soltani et al (Pub. No.: US 2005/0192556)
Regarding claim 1, Soltani et al disclose a method of treating a vascular occlusion, the method comprising:
positioning an ultrasound catheter within a patient, the ultrasound catheter including a treatment zone (treatment site) [see abstract, claim 3];
an ultrasound radiating member positioned within the treatment zone [see abstract, claim 3];
a fluid delivery lumen hydraulically coupled to an exit port within the treatment zone [see abstract, 0047, 0069, 0094];
delivering, through the fluid delivery lumen and the exit port, a microbubble therapeutic compound to an internal portion of the vascular occlusion intermittently with ultrasonic energy [see 0047, 0069, 0094, 0122];
wherein delivering includes first and second treatment phases [see abstract, 0122];
wherein the first treatment phase includes delivering the microbubble therapeutic
compound without any of the ultrasonic energy [see 0122] by disclosing during a first treatment phase, the microbubble therapeutic compound is delivered without ultrasonic energy [see 0122];
wherein the second treatment phase includes delivering ultrasonic energy without
the microbubble therapeutic compound [see abstract] by disclosing the phases with ultrasonic energy correspond to the periods during which the therapeutic compound that does not contain microbubbles is applied [see 0122];
wherein the first and second treatment phases are alternately repeated a plurality of
times [see 0122] by disclosing the first and second treatment phases are alternately repeated several times [see 0122].
Regarding claim 2, Soltani et al disclose wherein the first and second treatment phases each have a duration of between 1 minute and 20 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 3, Soltani et al disclose wherein the duration of each of the first and second treatment phases is between 2 minutes and 7 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 4, Soltani et al disclose wherein the duration of each of the first and second treatment phases is between 3 minutes and 4 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 5, Soltani et al disclose wherein the first and second treatment phases have different durations [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122]. Since these phases can be few minutes each; therefore, they can inherently be different and/or equal (emphasis added).
Regarding claim 8, Soltani et al disclose wherein the microbubble therapeutic compound has microbubbles with an average diameter in a range of 0.01 µm to 0.4 µm [see claim 5].
Regarding claim 10, Soltani et al disclose positioning the ultrasound catheter within a patient's vasculature such that at least a portion of the treatment zone is located in the internal portion of the vascular occlusion [see 0005] by disclosing a method of treating a vascular occlusion located at a treatment site within a patient's vasculature comprises positioning an ultrasound catheter at the treatment site [see 0005].
Regarding claim 11, Soltani et al disclose wherein an exterior surface of the treatment zone includes a cavitation promoting surface (vessel wall and/or the clot material] [see 0065, 0117] by disclosing cavitation also promotes more effective diffusion and penetration of the therapeutic compound into surrounding tissues, such as the vessel wall and/or the clot material [see 0117].
Regarding claim 12, Soltani et al disclose wherein the cavitation promoting surface is patterned with features from an ablative laser [see 0065, 0117] by disclosing the fluid delivery ports 58 can be created in the tubular body 12 by punching, drilling, burning or ablating (such as with a laser) [see 0065].
Regarding claim 13, Soltani et al disclose wherein the microbubble therapeutic compound is selected from the group consisting of neuroprotection compounds, anti-thrombosis compounds, heparin, urokinase, streptokinase, tissue plasminogen activator (tPA), and recombinant tissue plasminogen activator (rtPA) [see 0033].
Regarding claim 14, Soltani et al disclose method of treating a vascular occlusion, the method comprising:
positioning an ultrasound catheter within a patient, the ultrasound catheter including a treatment zone [see abstract, claim 3, 0008];
an ultrasound radiating member positioned within the treatment zone [see abstract, claim 3, 0008, 0048];
a fluid delivery lumen hydraulically coupled to an exit port within the treatment zone [see abstract, 0047, 0069, 0094];
delivering, through the fluid delivery lumen and the exit port, a microbubble
therapeutic compound to an internal portion of the vascular occlusion during a first
treatment phase in the absence of any ultrasonic energy [see 0122] by disclosing during a first treatment phase, the microbubble therapeutic compound is delivered without ultrasonic energy [see 0122];
delivering ultrasonic energy during a second treatment phase in the absence of any
of the microbubble therapeutic compound [see abstract] by disclosing the phases with ultrasonic energy correspond to the periods during which the therapeutic compound that does not contain microbubbles is applied [see 0122];
wherein the ultrasonic energy causes cavitation to occur within the microbubble therapeutic compound delivered to the vascular occlusion during the first treatment phase [see 0005, 0117, 0122].
Regarding claim 15, Soltani et al disclose wherein the first and second treatment phases have different durations [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122]. Since these phases can be few minutes each; therefore, they can inherently be different and/or equal (emphasis added).
Regarding claim 16, Soltani et al disclose wherein the first and second treatment phases are alternately repeated a plurality of times [see 0122] by disclosing the first and second treatment phases are alternately repeated several times [see 0122].
Regarding claim 17, Soltani et al disclose wherein the first and second treatment phases each have a duration of between 1 minute and 20 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 18, Soltani et al disclose wherein the duration of each of the first and second treatment phases is between 2 minutes and 7 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 19, Soltani et al disclose wherein the duration of each of the first and second treatment phases is between 3 minutes and 4 minutes (few minutes could be 1, 2, 3, minutes, emphasis added) [see 0122] by disclosing the duration of the first and second phases are each on the order of approximately a few minutes [see 0122].
Regarding claim 20, Soltani et al disclose wherein the microbubble therapeutic compound has microbubbles with an average diameter in a range of 0.01 µm to 0.4 µm [see claim 5].
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 6-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soltani et al (Pub. No.: US 2005/0192556) in view of Hiejima et al (US Pat: 5, 531, 688).
Regarding claims 6-7, Soltani et al don’t disclose wherein the microbubble therapeutic compound is delivered at an infusion rate that is in a range of 10 mL per hour to 120 mL per hour and wherein the microbubble therapeutic compound is delivered at an infusion rate that is in a range of 100 mL per hour to 120 mL per hour.
Nonetheless, Hiejima et al disclose wherein the compound is delivered at an infusion rate that is in a range of 10 mL per hour to 120 mL per hour and wherein the compound is delivered at an infusion rate that is in a range of 100 mL per hour to 120 mL per hour [see column 8 lines 53-58].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Soltani et al and Hiejima et al by using an infusion rate that is in a range of 100 mL per hour to 120 mL per hour; Rapid infusion can help restore intravascular volume, which is crucial for patients experiencing shock or severe blood loss; to enhance cardiac output, improving blood flow to vital organs and tissues.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soltani et al (Pub. No.: US 2005/0192556) in view of Schneider et al (Pub. No.: US 2002/0077588).
Regarding claim 9, Soltani et al don’t disclose wherein the microbubble therapeutic compound has a microbubble concentration in a range of 4x10^7 to 10x10%9 microbubbles per milliliter.
Nonetheless, Schneider et al wherein the microbubble therapeutic compound has a microbubble concentration in a range of 4x107 to 10x109 microbubbles per milliliter [see 0033].
Therefore, it is obvious to one skilled in the art at the time the invention was made and would have been motivated to combine Soltani et al and Schneider et al by using a microbubble concentration in a range of 4x107 to 10x109 microbubbles per milliliter; can enhance the stability of microbubbles, allowing for longer use periods without the need for reconstitution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798