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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 11/10/2025.
Acknowledgement is made to the amendment of claims 8-9.
Acknowledgement is made to the withdrawal of claims 1-9 and 20-28.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 10-19 are pending as rejected below. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nair (US-20170215952-A1).
Regarding claim 13, Nair teaches a tissue treatment system ([0049]) comprising:
an ablation device ([0052]) configured to ablate one or more nerves innervating a kidney ([0109]- [0110];
a non-transitory computer readable memory storing instructions ([0056], [0062]); and
one or more processors ([0062]) configured to execute the stored instructions to cause the tissue treatment system to:
detect an amount of calcification ([0082], [0087], [0127]) at one or more target locations along a main renal artery and at one or more target locations along at least one of an accessory renal artery or a renal artery branch ([0117]- [0118]);
determine whether the calcification amount is lower at the one or more target locations along the main renal artery or at the one or more target locations along at least one of the accessory renal artery or the renal artery branch ([0105]- [0107] teach the system as determining if the target area is harder or softer, therefore teaching the claim limitation as broadly as is currently claimed); and
prompt a user, using a graphic user interface, to perform an ablation at the one or more target locations along the main renal artery or, alternatively, at the one or more target locations along at least one of the accessory renal artery or the renal artery branch based on whether the calcification amount is lower at the one or more target locations along the main renal artery or at the one or more target locations along at least one of the accessory renal artery or the renal artery branch ([0105]- [0107] teach ablating the patient tissue based on the level of calcification, therefore teaching the claim limitation as broadly as is currently claimed).
Regarding claim 14, Nair teaches the tissue treatment system of claim 13, wherein the one or more processors are further configured to execute the stored instructions to cause the tissue treatment system to: increase a default treatment duration, while maintaining a default flow rate and acoustic entry power level setting ([0082] teaches this claim limitation as broadly as claimed without further limitations relative to the specific or relative calcification levels which are being specifically being discussed as being treated) in order to create a lesion beginning about 1 mm from a lumen of the main renal artery to about 1 mm from the lumen of at least one of the accessory renal artery or the renal artery branch (In accordance with MPEP 2114 this currently taught structure of an ablation device, would perform the function of creating a lesion at this specific position, as this limitation is a recitation of the intended use of the claimed invention, as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics).
Regarding claim 15, Nair teaches the tissue treatment system of claim 13, wherein the one or more processors are further configured to execute the stored instructions to cause the tissue treatment system to decrease acoustic entry power below a default setting while increasing a treatment duration setting ([0082] teaches this claim limitation as broadly as claimed without further limitations relative to the specific or relative calcification levels which are being specifically being discussed as being treated) in order to create a lesion beginning about 1 mm from a lumen of the main renal artery to about 1 mm from the lumen of at least one of the accessory renal artery or the renal artery branch, while still compensating for calcification within the treated main renal artery or at least one of the accessory renal artery or the renal artery branch (In accordance with MPEP 2114 this currently taught structure of an ablation device, would perform the function of creating a lesion at this specific position, as this limitation is a recitation of the intended use of the claimed invention, as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics).
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 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nair (US-20170215952-A1) in view of Stone (US-20080188912-A1).
Regarding claim 10, Nair teaches a tissue treatment system configured to ablate one or more nerves about, within, or surrounding a calcified region of a renal artery ([0049], [0111]) comprising:
a non-transitory computer readable memory storing instructions ([0056], [0062]); and
one or more processors ([0062]) configured to execute the stored instructions to cause the tissue treatment system to:
detect calcification ([0082], [0087], [0127]) within the renal artery in a target area ([0117]- [0118]).
However, Nair fails to teach lowering a default acoustic entry power setting and increase a duration of ablation setting based on the detected calcification.
Nair does however further teach that different types of plaque, such as fatty plaque in comparison to hardened, calcified plaque, may possess different properties which affect the amount and duration of energy that may be required to effectively modulate the nerves overlying the vessels in the region of the plaques ([0105]- [0106], [0127]).
Stone teaches a catheter and catheter system used to treat diseased tissue, such as that of lipid-rich vulnerable plaque, by gentle heating (Abstract). This gentle heating allows for the heating to treat the vulnerable plaque while inhibiting heating of undesirable tissue ([0047]).
Stone further teaches the gentle heating as occurring by a variety of known means, such as the addition of fluid delivery when necessary or applying very low power for longer durations ([0046], [0056], [0074]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the application of energy as being of low power for a longer duration while treating plaque, as is taught by Stone, into the system which varies the treatment of the plaque based on the type of plaque as is taught by Nair, to produce the predictable result of treating plaque while inhibiting heating of undesirable tissue, as is taught by Stone, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 11, Stone further teaches the tissue treatment system of claim 10, wherein the one or more processors are configured to lower the acoustic entry power by 30% and increases the treatment duration by 35- 45% ([0082]).
Regarding claim 12, Stone further teaches the tissue treatment system of claim 11, wherein the one or more processors are configured to additionally increase a flow rate by 5% or more based on the detected calcification ([0055]- [0056] teach providing fluid to the treatment site during the treatment of tissue by mild heating, additionally, there does not appear to be any disclosed criticality for this recited range. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art).
Claim 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lawinger (US-20190117242-A1) in view of Nair (US-20170215952-A1) and (Cope US-20200129742-A1).
Regarding claim 16, Lawinger teaches a method(Abstract, [0021]), comprising:
delivering a catheter to a calcified region of a body lumen wall ([0051]), wherein the catheter includes a proximal balloon, a middle balloon, and a distal balloon mounted on a catheter shaft (Fig. 6-7; distal portion 130 of a catheter, e.g. catheter 10 of Fig. 1, contains first balloon 136, second balloon 138, and treatment balloon 144 positioned between first and second balloons), and wherein the catheter includes a laser fiber disposed between the distal and proximal balloons (Fig. 6-7; cavitation generator 140 is taught in [0090] as being an optical fiber laser);
generating, by the laser fiber, one or more bubbles to at least partially fragment the calcified region of the body lumen wall ([0042], [0062], [0081]- [0083]) and;
treating tissue about, within, or surrounding the calcified region of the body lumen wall after the calcified region has been at least partially fragmented ([0144]).
However, Lawinger fails to teach the method as being a method of renal denervation, and the treating of tissue as specifically being ablating one or more nerves.
Nair teaches the known problem of calcification along a body lumen wall as being a known problem within treatments occurring throughout the renal system ([0111]- [0116]).
Nair further teaches using a system which treats, by ablation, along a calcified vasculature wall of the renal system during renal denervation ([0111]- [0116]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have utilized the known treatment of renal denervation by treating by ablation calcified vasculature walls of the renal system, as is taught by Nair, into the method of treating a calcified region of a body lumen wall, as is taught by Lawinger, to produce the predictable result of treating diseases which have a known treatment through a method of ablating calcified lumen walls, as is taught by Nair, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Lawinger further fails to teach the laser fiber being disposed on a surface of a balloon.
Lawinger does however teach the cavitation generator, which is taught as being a variety of treatment elements, such as an optical fiber laser, a plurality of electrodes, one or more piezoelectric transducers, etc. as being located at a position in the middle of the distal and proximal balloons.
Cope teaches a catheter having at least one balloon to form a portion of a cavity with a wall of a vessel of a patient when in an expanded state (Abstract). This expandable balloon further having an element, such as an electrode, for treating tissue by delivering energy to fluid ([0126]).
Cope further teaches the electrode for treating tissue as being located on a surface of a balloon portion which is located between the distal balloon portion and the proximal balloon portions ([0110], [0125]) so as to contact exposed surfaces and deliver energy (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the treatment element as being positioned on a surface of a balloon of the catheter between the distal portion and the proximal portion, as is taught by Cope, into the balloon catheter having a treatment element as is taught by Lawinger, to produce the predictable result of treating the patient tissue by contact exposed surfaces and delivering energy, as is taught by Cope, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 17, Lawinger teaches the method of claim 16, further comprising inflating the proximal balloon and the distal balloon to substantially appose the body lumen wall to block calcified fragments from embolizing (Fig. 6-7; first and second balloons 136, 138 are positioned on either side of calcified lesion 34 [0020]- [0024]).
Regarding claim 18, Cope teaches the method of claim 16, further comprising inflating the middle balloon to position the treatment element adjacent to the calcified region when generating the one or more bubbles ([0110], [0125]).
In accordance with the above rejection of claim 16, Lawinger further teaches the treatment element as being a laser fiber ([0090]).
Regarding claim 19, Lawinger teaches the method of any of claim 16, further comprising removing blocked calcified fragments with holes located on the catheter shaft ([0031]- [032], [0060]).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794