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.
Response to Amendment
Acknowledgement is made to the amendment received 06/12/2026.
Acknowledgement is made to the amendment of claim 13.
Acknowledgement is made to the cancellation of claims 1-9 and 20-28.
Acknowledgement is made to the newly added claims 29-38.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 13-19 and 29-38 are pending. A complete action on the merits appears below.
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).
Claims 13-15 and 29-31 are rejected under 35 U.S.C. 103 as being obvious over Nair (US-20170215952-A1) in view of Bates (US-20130325000-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), wherein the one or more processors are further configured to prompt the user to perform the ablation from within the main renal artery ([0117], [0188]) or said at least one of the accessory renal artery or the renal artery branch having the lower calcification amount so as to create a lesion ([0052]).
However, Nair fails to teach the lesion beginning about 1 mm from a lumen of the main renal artery or said at least one of the accessory renal artery or the renal artery branch in which the ablation is performed to about 1 mm from a lumen of the other of the main renal arty or said at least one of the accessory renal arty or the renal artery branch.
Bates teaches a system for renal denervation by providing ablation energy to patient tissue (Abstract, [0046]). The energy is delivered to a point which is likely that renal sympathetic nerves pass while reducing the heating of the walls of the artery ([0046]- [0047]).
Bates further teaches providing the lesion at a position which is separate from a renal artery and an artery which is branched off of said renal artery, this position being a position which is likely that renal nerves pass ([0046]). Additionally, it should be noted that it is known in the art that the position of human renal nerves lie offset from the lumen walls they surround by about 1 mm (an additional reference has been provided in the conclusion for further information on this known feature of human anatomy).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of providing a lesion which treats renal nerves where the lesion begins at a position which is about 1 mm from the lumens they surround, as is taught by Bates, into the system for treating renal nerves as is taught by Nair, to produce the predictable result of treating patient nerves at a known position of that tissue type, as is taught by Bates, 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 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).
Regarding claim 29, Nair teaches the tissue treatment system of claim 13, wherein the ablation device comprises an ultrasound transducer ([0053]- [0054], [0058]).
Regarding claim 30, Nair teaches the tissue treatment system of claim 13, further comprising an imaging device configured to provide an image from which the amount of calcification is detected ([0082], [0095], [0105]- [0107]).
Regarding claim 31, Nair teaches the tissue treatment system of claim 30, wherein the imaging device comprises an intravascular ultrasound (IVUS) imaging transducer ([0053]- [0054], [0058]).
Claim 16-19, 33-35, and 37-38 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 ([0044], [0091]).
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]).
Regarding claim 33, Lawinger teaches the method of claim 16, further comprising removing fragments of the calcified region through one or more holes located on the catheter shaft ([0060]).
Regarding claim 34, Lawinger teaches the method of claim 33, wherein removing the fragments comprises applying suction through the one or more holes ([0060]).
Regarding claim 35, Lawinger as modified teaches the method of claim 16.
Lawinger further teaches generating before treating to produce the calcified region that has been at least partially fragmented ([0090]- [0091]).
In accordance with the above rejection, Nair teaches the treating as being ablating ([0111]- [0116]).
Nair further teaches determining a characteristic of the target tissue as being the level of calcification of the tissue ([0082]) after energy has been applied to the tissue and prior to treatment ([0188], [0195]- [0196]) such as ablation ([0197]- [0198]) so as to refine the treatment plan immediately prior to treatment ([0197]- [0198]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated determining the level of the application of energy after applying energy to tissue based on tissue characteristics, such as the calcification level, as is taught by Nair, into the method which delivers energy to a calcified region prior to applying a treatment to the region as is taught by Lawinger, to produce the predictable result of refining the treatment plan immediately prior to treatment, 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).
Regarding claim 37, Lawinger teaches the method of claim 16, wherein a flow rate of fluid through the middle balloon during generation of the one or more bubbles to at least partially fragment the calcified region is lower than a flow rate of fluid through the middle balloon during said treatment ([0090]- [0091]).
In accordance with the above rejection of claim 16 Nair teaches the treatment as being ablation ([0111]- [0116]).
Regarding claim 38, Lawinger teaches the method of claim 37, where the flow rate during generation of the one or more bubbles is stagnant or less than 2 mL/min ([0090]- [0091]).
Claim 32 is rejected under 35 U.S.C. 103 as being obvious over Nair (US-20170215952-A1) in view of Bates (US-20130325000-A1) further in view of Li (US-20070036404-A1).
Regarding claim 32, Nair teaches the tissue treatment system of claim 31, wherein the one or more processors are configured to determine the amount of calcification at a target location in an image provided by the intravascular ultrasound (IVUS) imaging transducer ([0058]), and to prompt the user to perform the ablation at the target location based at least in part on that determination ([0052], [0117], [0188]).
However, Nair fails to teach determining the amount of calcification as being lower when a media-adventitia border is detectable in an image.
Li teaches a method of analysis for intravascular ultrasound (IVUS) images ([0006]).
Li further teaches the known relationship of calcified lesions or plaque within the vessel as obscuring the medial-adventitia border ([0032]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known relationship between plaque and the medial-adventitia border of a vessel on an IVUS image, as is taught by Li, into the system which determines the amount of calcification of an image provided by an IVUS transducer as is taught by Nair, to produce the predictable result of using a known image feature as an indication of plaque, as is taught by Li, 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).
Claim 36 is 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) further in view of Torrance (US-20080103439-A1).
Regarding claim 36, Lawinger as modified teaches the method of claim 16.
However, Lawinger as modified fails to teach the method further comprising, after said generating and before said ablating, scraping at least a portion of the calcified region using a scraping unit carried by the catheter shaft, and collecting resulting calcification debris with a tissue collection unit adjacent to the scraping unit.
Lawinger as modified further teaches aspirating a cavity post cavitation ([0060]) and the treatment, the treatment being ablation in view of the above incorporation of Nair, as occurring after the cavitation has been completed ([0091]).
Torrance teaches a material removal system for plaque excision ([0008]).
Torrence further teaches the material removal system as including a blade that traverses a distal end of a catheter to scrape plaque from a vessel wall and collect it in an internal collection space ([0008]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the aspiration for removing elements from the calcified region, as is taught by Lawinger as currently modified with the material removal system having a blade which scrapes plaque from a vessel wall and collects it in a collection space as is taught by Torrence, to produce the predictable result removing plaque from a region having calcified tissue, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s arguments with respect to the claims which have been amended have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Nair reference are moot in view of the new rejections under Nair and Bates.
Applicant’s arguments regarding claim 10 that Nair does not teach the limitation of “lowering a default acoustic entry power setting and increasing a duration of ablation setting based on the detected calcification” as Nair teaches “ the processor may increase the level of ablative energy” is currently unpersuasive as 1) the prior art’s mere disclosure of more than one alternative does not constitute a teaching away (MPEP 2145(xi)(d)(1)) and 2) Nair further teaches in the section cited for this limitation ([0105]- [0106]) “the ablation assessment can indicate that the ablative element is now positioned adjacent to a softer area … based on this information, the user and/or the processor can decrease the level of ablative energy.” Which directly teaches a reason to decrease the power setting based on the detected calcification as broadly as is currently claimed in view of the limitation being “based on the detected calcification” which does not include specific limitations regarding the calcification such as, for example the degree, form, or type of calcification.
Applicant’s arguments regarding claim 10 that Stone does not teach the limitation which is not taught by Nair as Stone is trying to accomplish a different treatment objective is currently unpersuasive as 1) the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) and 2) while the examiner does not agree that the two references are different areas for different objectives, the more relevant aspect is what a PHOSITA would be capable of understanding from this combination. Specifically, the fact that Stone is performing this treatment to achieve renal nerve ablation does not provide that a person having ordinary skill in the art would not have the capability to understand that a type of tissue which is being treated, such as plaque may have varied types of treatment based on the specific types of plaque, as is taught in Nair ([0105]- [0106], [0127]).
Applicant’s arguments regarding claim 16, that Lawinger in view of Cope does not teach the claim limitation of “the catheter includes a laser fiber disposed on a surface of the middle balloon” are currently unpersuasive. First, applicant states that Lawinger teaches the cavitation generator as being “located on the catheter shaft” however attention is being brought to the fact that it is not located on the catheter shaft but is instead disposed within the catheter shaft at a position between the first and second balloons. Second, applicant states that the electrodes is carried by the elongate member and at least in part functions to restrict the expansion of the balloon, however, this teaching is merely cited as teaching the known ability for an element which delivers energy, such as a laser fiber or an electrode, to be positioned on a surface of a balloon. This obviousness rejection is not provided as an incorporation of additional limitations, such as the function of restricting the position of a balloon and the argument that this therefore cannot teach this known use of an element for delivering energy on a surface of a balloon in some manner is an argument of bodily incorporation as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. (MPEP 2145(III)).
Further, in response to applicant’s argument regarding claim 16 that the combination of “Nair, Lawinger, and Cope” fails to teach “generating, by the laser fiber, one or more bubbles to at least partially fragment the calcified region of the body lumen wall; and ablating one or more nerves about, within, or surrounding the calcified region of the body wall after the calcified region has been at least partially fragmented” clarification is brought to the current rejection. First, the rejection is of Lawinger, Nair, and Cope, not “Nair, Lawinger, and Cope” as the base reference of Lawinger teaches this majority of this provided limitation, with the feature which Lawinger does not teach of this limitation being the treatment as being ablation. Specifically, the rejection teaches the treatment as being the treatment of the vessel wall by the treatment balloon (Lawinger [0101]), this treatment by the treatment balloon is taught as occurring after the cavitation by the cavitation generator, such as the optical fiber (Lawinger, [0090]- [0091]). Therefore, when the treatment is taught by Nair as being ablation, the modification teaches the ablation as occurring after the laser fiber has fragmented the calcified region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20120123243 A1- [0025], [0034], [0079] teach the known position of human renal nerves as lying offset from the lumen walls they surround by about 1 mm
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
