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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is only 35 words. Correction is required. See MPEP § 608.01(b).
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.
Claim 9 is 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 9 recites “delivering the vapor of a quality greater than 25%”. It is unclear what the vapor quality is greater than (vapor quality greater than 25% of what). The specification discloses wherein the vapor quality is dependent on the water content (Page 11, lines 19-21), however the claim language does not reflect this, therefore making it unclear what the vapor quality is and how the vapor quality can be greater than 25% as compared to what.
Claim 19 recites “treating sleep apnea by at least one of ablation of a palate and ablation of a tongue”. It is unclear whether the applicant is trying to claim that sleep apnea is treated by ablating at least one of a palate or a tongue or if the applicant is trying to claim sleep apnea is treated by ablating both a palate and a tongue. For examination purposes, the examiner interprets this as “sleep apnea is treated by ablating at least one of a palate or a tongue”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-8, 10-11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (US 20100204688) herein referred to as “Hoey” further in view of Sharma et al. (US 20100094270) herein referred to as “Sharma”.
Regarding claim 1, Hoey discloses a method for selectively ablating at least one of a target tissue area of a patient (method includes selectively treating a target region of tissue, Paragraph [0017]), the method comprising:
providing an ablation system comprising (ablation system, Figure 2):
a coaxial catheter for inserting into the patient (coaxial catheter, Figures 6A-6M), the coaxial catheter comprising:
an outer catheter for advancing to the target tissue of the patient (outer sheath 180, 182, Figures 6A-6B, and Figure 6F);
an inner catheter for advancing into the target tissue of the patient, concentric and slidable within the outer catheter (inner catheter 102, 181, wherein inner sleeve 181 rotates within outer sleeve 182, Figure 6A-6F, Paragraph [0104]),
through a catheter connection port with the at least one pump (source 120 of flowable liquid treatment media 121 that communicates with flow channel 124 extending through the probe body 102, Figure 2, Paragraph [0094]),
wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter (vapor flows within channel 124 wherein the proximal end of the inner catheter is connected to the vapor generation components, Figure 8, Paragraph [0110]),
wherein the inner catheter comprises: at least one lumen to transport an ablative agent delivered from the at least one pump (channel 124 transports vapor, Figure 8, Paragraph [0110]);
at least one electrode positioned within the at least one lumen (electrodes 190a and 190b within lumen 124, Figure 8, Paragraph [0110]);
at least one positioning element along a length of the inner catheter (at least one expandable member 183 for positioning the heat applicator surface against targeted tissue, Figure 6H, Paragraph [0105];
and at least one opening proximate to the positioning element of the inner catheter (at least one opening 125, proximate to the positioning element 183, Figure 6H, Paragraph [0105]);
a controller having at least one processor in data communication with the at least one pump (controller 150 is capable of all operational parameters of system 100, including modulating an operational parameter comprising a flow rate of liquid phase treatment media 122 from pressurized source 120, Figures 2 and 3, Paragraph [0099]),
wherein, upon activating, the controller is configured to: control the delivery of the ablative agent into the at least one lumen in the coaxial catheter (the controller 150 is capable of providing or modulating an operational parameter comprising a flow rate of liquid phase treatment media 122 from pressurized source 120, Paragraph [0099]);
control the delivery of an electrical current to the at least one electrode positioned within the at least one lumen of the inner catheter (controller 150 capable of applying the selected level of energy to provide the phase conversion in the treatment media, Paragraph [0099]);
and control vapor generated from the ablative agent (controller 150 capable of applying the selected level of energy to provide the phase conversion in the treatment media, Paragraph [0099]);
inserting the coaxial catheter into the target tissue of the patient (positioning a probe in an interface with a targeted tissue, Paragraph [0033]);
applying the positioning element proximate the target tissue area enclosing at least a portion of the target tissue (expandable member 183 is expanded to position the heat applicator surface against targeted tissue, Figure 6H, Paragraph [0105]);
and programming the controller to control a delivery of the vapor such that the target tissue is ablated to cause differential damage to different cellular components in the target tissue (controller 150 is capable of all operational parameters of system 100, including modulating the operational parameters in response to preset values of in response to feedback signals FS from sensor system(s) 175, Paragraph [0099], the controlled vapor-to-liquid phase transition and vapor exit pressure to thereby control the interaction of a selected volume of vapor at the interface with tissue, Figure 1A, Paragraph [0091]).
However, Hoey does not explicitly disclose at least one pump nor wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump.
Sharma discloses wherein the system comprises at least one pump and wherein a proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump (pump 49, Figure 13, wherein the catheter 16 is connected to vessel 42 of pump 49 via a fluid connector 56, Paragraph [0112] and [0113]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Hoey to incorporate the teachings of Sharma by including a pump wherein the proximal end of the inner catheter is connected to the catheter connection port to place the inner catheter in fluid communication with the at least one pump. The motivation to do so being to pump additional liquid into the catheter upon sensing a fall in pressure or temperature in the vessel connected to the catheter to ensure there is a sufficient amount of vapor available for treatment (Sharma, Paragraph [0109]).
Regarding claim 2, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein the at least one positioning element is advanced until the distal end of the positioning element encloses the target tissue area (expandable member 183 such as a balloon is used for positioning the heat applicator surface against targeted tissue (seen as enclosing the target tissue area by covering the surface of the target tissue), Figure 6H, Paragraph [0105]).
Regarding claim 3, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein the at least one positioning element is advanced until the distal end of the positioning element is proximate the target tissue area (expandable member 183 is expanded until the heat applicator surface is against the target tissue, Paragraph [0105]).
Regarding claim 4, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein programming the controller to control a delivery of the vapor such that the target tissue is ablated to cause differential damage comprises damaging more cellular structure relative to extra cellular matrix (ECM) (controller 150 capable of applying the selected level of energy to provide the phase conversion in the treatment media, Paragraph [0099], the controlled vapor-to-liquid phase transition and vapor exit pressure to thereby control the interaction of a selected volume of vapor at the interface with tissue, Figure 1A, Paragraph [0091]).
Regarding claim 5, Hoey in view of Sharma discloses the method of claim 4.
Hoey further discloses wherein the target tissue is ablated for a time period at a temperature of up to 600C (a vapor media can have a temperature of at least 600C, Paragraph [0145], wherein the vapor delivery time ranging between 60 seconds and 120 seconds, Paragraph [0136]).
Regarding claim 7, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein programming the controller comprises maintaining pressure at the target tissue area less than 5 atm (the controller 150 is capable of controlling parameters of the vapor phase media including the pressure of the vapor media 122 at the outlet which is placed at the target tissue, Paragraph [0099], wherein various pressures are needed for various tissues and body cavities for ablating body cavities ranging from about 0.1 to 20 psi (0.0068 atm to 1.3609 atm which is less than 5 atm) for ablating body cavities or lumens and about 1 psi to 100 psi (0.068 atm to 6.8 atm) for intestinal ablations, Paragraph [0118]).
Regarding claim 8, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein programming the controller comprises delivering the vapor at a temperature between 990C and 1100C (vapor media can have a temperature of at least 90 or 1000C, Paragraph [0145]).
Regarding claim 10, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein programming the controller to control a delivery of the vapor such that the target tissue is ablated to cause differential damage comprises damaging more cellular structure relative of tumor relative to normal cellular structure (the controller 150 is capable of controlling parameters of the vapor phase media including the pressure of the vapor media 122 at the outlet which is placed at the target tissue, Paragraph [0099], the vapor can propagate extracellularly in soft tissue to provide intense congestive heating as the vapor collapses into water droplets, which results in effective tissue ablation and cell death, Paragraph [0102], wherein the tissue is treated to provide an effective tissue margin 179 around a targeted tumorous volume, Paragraph [0102]).
Regarding claim 11, Hoey in view of Sharma discloses the method of claim 1.
Hoey discloses treating a tumor proximate one of a blood vessel and a bowel wall (delivering vapor to a wall of the of the digestive tract, Paragraph [0019], the device can treat tumors in a patient’s breast, uterus, lung, liver, kidney, gall bladder, stomach, pancreas, colon, GI tract, bladder, prostate, bone, vertebrae, eye, brain or other tissue, Paragraph [0100]), wherein the region containing the target tissue includes any space, cavity, passage, opening, lumen or potential space in a body such as a sinus, airway, blood vessel, uterus, joint capsule, GI tract lumen or respiratory lumen, Paragraph [0120]).
Regarding claim 18, Hoey in view of Sharma discloses the method of claim 1.
Hoey further discloses wherein the method comprising treating a focal lesion in the brain (the device can be used to treat tumors (seen as a focal lesion) in the brain, Paragraph [0100]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Maor (US 20160113709) herein referred to as “Maor”.
Regarding claim 6, Hoey in view of Sharma discloses the method of claim 4.
Hoey discloses wherein greater than 50% of the cellular structure undergoes irreversible damage (the tissue is treated to provide an effective treatment margin 179 around a targeted tumorous volume (50% or greater of the cellular structure (the tumor) undergoes irreversible damage as seen in the figure), Figure 4B, Paragraph [102]).
However Hoey does not explicitly disclose wherein less than 50% of the ECM is damaged.
Maor discloses wherein less than 50% of the ECM is damaged (results demonstrate that NTIRE efficiently ablates vessel wall (cardiovascular muscle) within second, with no damage to extra-cellular structures (i.e. 0%), Paragraph [0187]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Hoey and Sharma to incorporate the teachings of Maor by including wherein less than 50% of the ECM is damaged. The motivation to do so being to ensure the targeted is area without damaging the surrounding tissue (Maor, [0187]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Sharma 2 (US 20160354140) herein referred to as “Sharma 2”.
Regarding claim 9, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein programming the controller comprises delivering the vapor of a quality greater than 25%.
Sharma 2 discloses wherein programming the controller comprises delivering the vapor of a quality greater than 25% (the steam may have a water content in a range of 1% to 95% when it exits from said catheter, Paragraph [0038], wherein the water vapor content ranges from 1%-99% and more preferably from 5%-95% water vapor, Paragraph [0722]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Sharma 3 by including wherein programming the controller comprises delivering the vapor of a quality greater than 25%. The motivation to do so being to use wet steam which contains water droplets for the use of the vapor delivery system (Sharma 3, Paragraph [0722]).
Claims 12, 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Sharma et al. (US 20200085496) herein referred to as “Sharma 3”.
Regarding claim 12, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method further comprises performing trans-arterial vapor ablation of tumors.
Sharma 3 discloses wherein the method further comprises performing trans-arterial vapor ablation of tumors (trans-arterial vapor ablation of a tumor being performed in a liver, Figure 41B, Paragraph [0259]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Sharma 3 by including wherein the method includes performing trans-arterial vapor ablation of tumors. The motivation to do so being to use a common technique such as ablation to eliminated diseased or unwanted tissues such as tumors (Sharma 3, Paragraph [0005]).
Regarding claim 13, Hoey in view of Sharma discloses the method of claim 12.
However Hoey does not explicitly disclose wherein the method comprises providing the ablation system positioned within a hepatic artery that feeds a tumor in a liver.
Sharma 3 discloses providing the ablation system positioned within a hepatic artery that feeds a tumor in a liver (the ablation device can be used for the treatment of focal or circumferential mucosal or submucosal lesions of any hollow organ or hollow body passage in the body wherein the hollow organ can include the hepatic artery, Paragraph [0279]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Sharma 3 by including wherein the method includes providing the ablation system positioned within a hepatic artery that feeds a tumor in the liver. The motivation to do so being to use a common technique such as ablation to eliminated diseased or unwanted tissues such as tumors in the liver (Sharma 3, Paragraph [0005]).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Hoey et al. (US 20110077628) herein referred to as “Hoey 2”.
Regarding claims 14, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method further comprises treating pain in at least one of a back, a neck, a sacroiliac joint, a knee pain, and a hip joint.
Hoey 2 discloses a method for treating pain in at least the back (another method of invention comprises utilizing a vapor delivery tool or needle to access a zygapophyseal joint, or a paravertebral region and delivering vapor to ablate such tissue and nerves therein to treat spinal pain (i.e. back pain), Paragraphs [0130] and [0137].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Hoey 2 by including wherein the method includes treating pain in at least the back. The motivation to do so being to use a common technique such as ablation to ablate nerves within the center of the vertebral body to alleviate back pain within a patient (Hoey 2, Paragraph [0130]).
Regarding claim 15, Hoey in view of Sharma and Hoey 2 discloses the method of claim 14.
However Hoey does not explicitly disclose wherein the method comprises treating pain transmitted by a nerve proximate a facet joint in a spinal motion segment of a patient.
Hoey 2 discloses treating pain transmitted by a nerve proximate a facet joint in a spinal motion segment of a patient (another method of invention comprises utilizing a vapor delivery tool or needle to access a zygapophyseal joint, or a paravertebral region and delivering vapor to ablate such tissue and nerves therein to treat spinal pain (i.e. back pain), Paragraphs [0130] and [0137].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Hoey 2 by including wherein the method includes treating pain in at least the back. The motivation to do so being to use a common technique such as ablation to ablate nerves within the center of the vertebral body to alleviate back pain within a patient (Hoey 2, Paragraph [0130]).
Regarding claim 16, Hoey in view of Sharma and Hoey 2 discloses the method of claim 14.
However Hoey does not explicitly disclose wherein the method comprises administering vapor for basivertebral nerve ablation.
Hoey 2 discloses administering vapor for basivertebral nerve ablation (a method corresponding to the invention utilizing the vapor delivery tool of Figure 19, wherein vapor is directed to a central region of the vertebral body to ablate the basivertebral nerve, Figure 20, Paragraph [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Hoey 2 by including wherein the method includes administering vapor for basivertebral nerve ablation. The motivation to do so being to use a common technique such as ablation to ablate nerves within the center of the vertebral body to alleviate back pain within a patient (Hoey 2, Paragraph [0130]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Warner et al. (US 20180221075) herein referred to as “Warner”.
Regarding claim 17, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method comprises treating arthritis pain.
Warner discloses wherein the method comprises treating arthritis pain (EP ablation may be used for treating arthritis, neck pain, and back pain, Paragraph [0002]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Warner by including wherein the method includes treating arthritis pain. The motivation to do so being to use a common technique such as ablation to ablate nerves and alleviate pain associated with arthritis (Warner, Paragraph [0002]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Underwood et al. (US 20040006339) herein referred to as “Underwood”.
Regarding claim 19, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method comprises treating sleep apnea by at least one of ablation of a palate and ablation of a tongue.
Underwood discloses treating sleep apnea by at least one of ablation of a palate and ablation of a tongue (for treating obstructive sleep disorders, the electrosurgical probe can be used to ablate target masses including, but not limited to, the tongue and soft palate tissue, wherein selected portions of the tongue are removed to treat sleep apnea or snoring, Figures 18-21, Paragraph [0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Underwood by including wherein the method includes treating sleep apnea by ablating at least one of a palate or ablation of a tongue. The motivation to do so being to use a common technique such as ablation of the palate or tongue to treat sleep apnea (Underwood, Paragraph [0169]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Hovda et al. (US Pat. No. 6053172) herein referred to as “Hovda”.
Regarding claim 20, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method comprises ablating an inferior turbinate in a submucosal space to relieve chronic nasal obstruction.
Hovda discloses a method which comprises ablating an inferior turbinate in a submucosal space to relieve chronic nasal obstruction (a method for treating nasal or sinus blockages including ablating the inferior turbinate in a submucosal space, Col. 22, lines 29-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Hovda by including wherein the method includes ablating an inferior turbinate in a submucosal space to relieve chronic nasal obstruction. The motivation to do so being to ablate the inferior turbinate to clear the blockage and/or enlarge the sinus cavity to reestablish normal sinus function (Hovda, Col. 22, lines 29-49).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Sharma further in view of Branovan et al. (US 20170360501) herein referred to as “Branovan”.
Regarding claim 21, Hoey in view of Sharma discloses the method of claim 1.
However Hoey does not explicitly disclose wherein the method comprises ablating a solitary thyroid nodule to improve thyroid function.
Branovan discloses ablating a solitary thyroid nodule to improve thyroid function (bipolar radio frequency (RF) ablation or electrocautery instrument designed for percutaneous ablation of tissue in a human cavity such as a thyroid nodule, Paragraph [0034]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of Sharma to incorporate the teachings of Branovan by including wherein the method includes ablating a solitary thyroid nodule to improve thyroid function. The motivation to do so being to ablate a thyroid nodule for the purposes of avoiding risks such as nerve damage or damage to parathyroid glands from a typical thyroidectomy (Branovan, Paragraph [0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 7:30-4:30 pm (CT), M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights