DETAILED ACTION
This action is responsive to the RCE filed 8/8/25.
Claims 55, 57-69 and 71 are rejected.
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.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 55, 57-69 and 71 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 55, the claim has been amended to recite that the control device is ‘configured to control the temperature of the heating surface to avoid damage of tissue of the renal artery’. There is no support in the specification for this limitation. Therefore, the claim contains new matter.
Applicant argues that par. 4 of the specification (See US 20180256390), provides support for the claim language. However, par. 4 does not disclose ‘a control device’, let alone one which is ‘configured to control the temperature of a heating surface to avoid damage of tissue of the renal artery’.
While, par. 4 does state ‘To avoid any kind of damage to the blood vessel a system using heat or cold could be used to regulate the constriction or dilatation of the blood vessel,’ based on the context of the citation it appears that this disclosure is related to avoiding damage sustained from chronic hypertension not from thermal injury. Further, it is clear from the Remarks that applicant intends the claim to refer to avoiding thermal injury. For instance, pg. 5 of the Remarks states:
Thus, it is clear that the neuromodulation taught by Demarais involves a “thermal injury” (irrespective of whether the heating is performed in the ablative or non-ablative temperature range) on target tissue. The fact that Demarais further teaches that the temperature can be controlled below a threshold which could cause injury of non-target tissue of the renal artery does not change the fact that the whole purpose of the device of Demarais is to injure target tissue to reduce neuromodulation.
Thus, while par. 4 might support the concept of avoiding damage caused by hypotension/hypertension by controlling dilation and constriction of the blood vessel using heating/cooling devices, in the examiner’s opinion it does not support a controller configured to control a heating surface to avoid any type of thermal damage to the tissue of the renal artery, as claimed and argued in the Remarks.
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 71 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 71 recites the limitation "the cooling system". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 negatived by the manner in which the invention was made.
Claims 55, 57, 59 and 68-69 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Levin et al. (US 8150518, “Levin”) in view of Demarais et al. (US 7617005, “Demarais”).
Regarding claim 55 Levin teaches a system for treating a patient with general hypertension by increasing a blood flow in the renal artery (Abstract and col. 9, lines 30-49), the system comprising: a hypertension treatment device adapted to have at least one surface of the device placed on the outside of the renal artery to increase the blood flow in the patient’s renal region (Fig. 15, renal artery cuff 1401), wherein said surface comprises a vasodilation device able to deliver energy to said renal artery to dilate said renal artery (Col. 5, line 66-col. 6, line 20 and col. 9, line 22-col. 10, line 55, suppression of sympathetic nerve stimulation of the kidney results in vasodilation of the renal artery) and thereby increase the blood flow distal to said dilated renal artery (Although Levin does not explicitly teach this, the examiner maintains that the vasodilation of the renal artery would inherently result in an increase in local blood flow distal to the renal artery), causing the kidney to reduce the general blood pressure and thereby treat general hypertension (Col. 9, lines 45-49), a control device adapted to be implanted in the patient (Fig. 2 and col. 13, lines 66-67-col. 14, line 1, ‘The blood pressure is monitored by the computer controlled implanted device 202 (FIG. 2) using the implanted sensor 210.’) and to: control the hypertension treatment device by: increasing suppression for increasing the dilation of said renal artery and thereby control the lowering of the patient's general blood pressure (Fig. 5).
Levin fails to teach that the first surface comprises a heating surface able to heat said renal artery; that increasing suppression of renal sympathetic nerve activity includes increasing the temperature of the first surface adapted to be in contact with outside of the renal artery; and that the control device is adapted to control the temperature of the heating surface to avoid damage of tissue of the renal artery.
Regarding the heating aspect, Demarais teaches an apparatus for thermally-induced renal neuro-modulation (Abstract), which comprises a renal artery cuff (Fig. 10, cuff 342) with multiple surfaces configured to contact the renal artery (Col. 13, lines 36-43, ‘FIG. 10 shows another method and apparatus for thermal renal neuromodulation via direct application of thermal energy to the target neural fibers. The apparatus 340 comprises renal artery cuff 342 having one or more integrated thermoelectric elements’); each surface adapted for both heating and cooling (Col. 13, lines 36-62 and fig. 10, ‘Either the hot side or the cold side of the thermoelectric element faces radially inward in order to heat or cool, respectively, the target neural fibers that travel along the renal artery to achieve thermal renal neuromodulation […] Reversal of the polarity of the voltage applied across the two junctions reverses the direction of the thermal gradient.’).
Demarais further teaches that that increasing suppression of renal sympathetic nerve activity includes increasing the temperature of the surface adapted to be in contact with outside of the renal artery (Col. 15, lines 5-24 and fig. 14a); and wherein the control device is adapted to control the temperature of the heating surface (Col. 14, lines 9-13) to avoid damage of tissue of the renal artery (Col. 9, lines 21-25, ‘The thermal neuromodulation may be controlled using the measured parameter(s) as feedback. This feedback may be used, for example, to maintain the parameter(s) below a desired threshold. For example, the parameter(s) may be maintained below a threshold that may cause injury to the non-target tissues.’).
Therefore, since both Levin and Demarais teach different mechanisms for suppressing sympathetic nerve stimulation, it would have been obvious to POSITA at the time that the invention was made to substitute one known means of suppression of sympathetic nerve activation (e.g. the heating of the renal nerve taught by Demarais) for the other (e.g. the methods of suppression taught by Levin) in order to achieve the predictable result of a means for suppressing sympathetic nerve activation. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Further, it would have been obvious to POSITA to further modify Levin, as modified, by configuring the controller to provide feedback temperature control of the heating surfaces of Levin, as modified, in order to maintain the temperature below a threshold which could cause injury of non-target tissue of the renal artery, as taught by Demarais.
Regarding claim 57, Levin, as modified, further teaches a power supply and electronic circuitry adapted to power the heating surface (Levin has previously been modified in view of Demarais to include a heating surface; See Demarais, fig. 10, power supply 344).
Regarding claim 59, Levin, as modified, further teaches wherein the implantable element is a Peltier element (Levin has previously been modified in view of Demarais to include the thermal element of Demarais which can comprise a Peltier element; See Demarais, col. 13, lines 41-62).
Regarding claim 68, Levin, as modified, further teaches wherein the system comprises a blood pressure sensor (Col. 12, lines 64-66, ‘The sensor can be a pressure sensor or an oxygen saturation sensor.’).
Regarding claim 69, Levin, as modified, further teaches wherein said blood pressure sensor is an implantable sensor (Col. 12, lines 64-66, ‘The implantable device 202 is also equipped with the sensor lead 209 terminated with the sensor 210. The sensor can be a pressure sensor or an oxygen saturation sensor.’; fig. 2, implanted sensor 210).
Claims 58, 60-63, 65 and 71 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Levin in view of Demarais, as applied to claims 55, 57, 59 68-69 above, and further in view of Saadat (US 20070225781).
Regarding claim 58, Levin, as modified, teaches an implantable device wherein said power supply is a battery, but fails to explicitly teach that the battery is rechargeable.
Saadat teaches an implantable system that is used to cool or heat nerve bodies to diminish nerve impulses (Abstract and fig. 1), which includes a rechargeable power supply (Par. 16).
In view of Saadat, it would have been obvious to POSITA at the time that the invention was made to further modify Levin, as modified, by including a rechargeable power supply in order to prolong the operating life of the implantable device.
Regarding claims 60 and 62, Levin, as modified, further teaches a wireless energy transmitter for wireless charging of the power supply from outside the patient’s body; or a wireless energy transmitter for non-invasively energizing implantable energy consuming components of the device with wireless energy (Levin has previously been modified in view of Saadat to include a rechargeable power supply; See Saadat, pars. 16 and 86, ‘external charging unit’).
Regarding claim 61, Levin, as modified, fails to explicitly teach at least one of the following: at least one push button with a switch implantable in the patient for manually and non-invasively controlling the device, and a wireless remote control for non-invasively controlling the device.
Saadat teaches a remote control which is provided to manually activate the implantable device (See Saadat, par. 125).
In view of Saadat, it would have been obvious to POSITA at the time that the invention was made to further modify Levin, as modified, by providing a wireless remote control for non-invasively controlling the device in order to allow the device to be activated manually by a user, as taught by Saadat.
Regarding claim 63, Levin, as modified, further teaches an energy-transforming device for transforming the wireless energy transmitted by the energy transmission transmitter from a first form into a different form of energy, wherein the energy- transforming device is adapted to perform at least one of the following: a) directly power implantable energy consuming components of the device with the different form of energy, and b) with the system further comprising, an implantable source of energy for powering implantable energy consuming components of the device, chargeable by the wireless energy, power the implantable energy source with the different form of energy, as the energy-transforming device transforms the first form of energy transmitted by the energy transmitter into the different form of energy (Levin has previously been modified in view of Saadat to include a rechargeable power supply; see Saadat, pars. 16 and 86 and fig. 2, charger 66).
Regarding claim 65, Levin, as modified, further teaches wherein the control device comprises an external control unit, intended to be outside the patient’s body (Levin has previously been modified in view of Saadat to include a remote controller; See Saadat, par. 148).
Regarding claim 71, Levin, as modified, teaches a cooling system adapted to transport away heat (Levin has previously been modified in view of Demarais to include thermoelectric heaters/coolers, which inherently are capable of transporting heat away from the a cold side of the thermoelectric element to a hot side of a thermoelectric element; see Demarais, col. 13, lines 36-62 and fig. 10, ‘Either the hot side or the cold side of the thermoelectric element faces radially inward in order to heat or cool, respectively, the target neural fibers that travel along the renal artery to achieve thermal renal neuromodulation.’), but fails to teach wherein the cooling system is configured to use water.
Saadat teaches an analogous implantable Peltier device that is used to cool or heat nerve bodies to diminish nerve impulses (Abstract and fig. 1), wherein the cooling system is further configured to use a fluid loop (Fig. 1, coolant lines 54/56) to cool the hot side of the Peltier element and transfer heat away from the hot side of the thermoelectric element towards a heat exchanger (Fig. 1 and par. 83, ‘As heat transfer medium 58 absorbs the heat from heated region 44, medium 58 can be urged to pass through a controllable outlet 50 through the feedline 54 and through the implantable unit 14 by the pump 48. From the pump 48, the heated medium 58 can travel through the feedline 54 to the heat exchanger 26, where the absorbed heat may be transferred to the body organ (e.g., SVC 24), against or near the body surface (not shown) or external to the body (not shown).’). Saadat further teaches that the fluid in the fluid loop can comprise water (Par. 83, ‘The liquid heat transfer medium 58 can be a fluid that can have a high specific heat capacity. The liquid heat transfer medium 58 can be biocompatible. The liquid heat transfer medium 58 can be chilled saline, fluorinated hydrocarbon (Fluorinert.TM.), liquid chlorodifluoromethane, water, air, or combinations thereof.’)
Therefore, in view of Sadaat, it would have been obvious to POSITA at the time that the invention was made to implement cooling fluid loops in thermal communication with the hot sides of the Peltier elements, in order to transport heat away from the hot side of the Peltier elements, when the Peltier elements are used in a cooling mode, as disclosed by Sadaat.
Claims 64 and 66 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Levin in view of Demarais, as applied to claims 55, 57, 59 and 68-69 above, and further in view of Snell et al. (US 5759199, “Snell”).
Regarding claim 64, Levin, as modified, fails to teach a wireless remote control that is adapted to send a wireless control signal, and wherein the signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof.
Snell teaches a remote control for sending a wireless control signal to an implanted device (Abstract), wherein the signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof (Col. 9, lines 25-32).
In view of Snell, it would have been obvious to POSITA at the time that the invention was made to further modify Levin, as modified, by configuring the implantable device to be controlled by a remote controller through either an amplitude modulated or a frequency modulated wireless signal, in order to allow the implantable device to be activated manually by a user.
Regarding claim 66, Levin, as modified, teaches that the control device comprises an internal control unit (Fig. 2, computer-controlled implant device 202), but fails to teach wherein the internal control unit is adapted to be programmable by an external control unit.
Snell teaches an external controller for an implantable device which is configured to program an internal controller for the implantable device (Col. 2, line 59-col. 3, line 12).
In view of Snell, it would have been obvious to POSITA at the time that the invention was made to further modify Levin, as modified, by configuring an internal controller to be programmable by an external controller, in order to allow the implant to be reprogramed subsequent to implantation, as taught by Snell.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 55, 57-69 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9968482 (‘482) in view of Demarais.
As a matter of example, the following is a comparison between application claim 55 and claim 2 of ‘482.
Application claim 55
Claim 2 of ‘482
55. A system for treating a patient with general hypertension by increasing a blood flow in the renal artery, the system comprising:
a hypertension treatment device adapted to have a first surface of the device placed on the outside of the renal artery to increase the blood flow in the patient’s renal region, wherein said first surface comprises a heating surface able to heat said renal artery to dilate said renal artery and thereby increase the blood flow distal to said dilated renal artery, causing the kidney to reduce the general blood pressure and thereby treat general hypertension,
a control device adapted to be implanted in the patient and to:
-control the hypertension treatment device by:
increasing the temperature of the first surface adapted to be in contact with the outside of the renal artery for increasing the dilation of said renal artery and thereby control the lowering of the patient’s general blood pressure, or
wherein the control unit is configured to produce control the temperature of the heating surface to avoid damage of tissue of the renal artery.
1. A system for treating a patient with general hypertension by increasing a blood flow in the renal artery, the system comprising:
a hypertension treatment device adapted to: have at least one surface of the device placed on the outside of the renal artery to increase the blood flow in the patient's renal region, wherein said surface comprises a heating surface able to heat said renal artery to dilate said renal artery and thereby increase the blood flow distal to said dilated renal artery, causing the kidney to reduce the general blood pressure and thereby treat general hypertension, and to be used in combination with a constriction device, when thermally stimulating the wall portion of the blood vessel;
the system further comprising: a control device adapted to control the hypertension treatment device to heat the wall portion of the renal artery to cause expansion thereof and control the temperature of said heating surface based on the patient's general blood pressure, to:
increase the temperature for increasing the dilation of said renal artery and thereby control the lowering of the patient's general blood pressure, or
decrease the temperature for reducing the dilation to thereby control the increasing of the patient's general blood pressure,
wherein the control device comprises an implantable internal control unit adapted to, in response to signals from a sensor, directly control the hypertension device over time, in accordance with an activity schedule program, and to directly control the constriction device, wherein the sensor is adapted to sense at least the temperature of the heating surface and the general blood pressure of the patient.
‘wherein the temperature of said heating surface is controlled by the internal control unit.’
As can be seen from the above comparison, patent claim 2 teaches all aspects of application claim 55 except for the limitation related to providing temperature control to avoid damage of tissue of the renal artery. However, this feature is obvious over Demarais, as discussed above with respect to the prior art rejection of claim 55.
Response to Arguments
Applicant's arguments filed 8/8/25 with respect to the rejection of the claims under 35 U.S.C. 112, 1st have been fully considered but they are not persuasive.
Applicant cites par. 4 of the original disclosure (See US 20180256390) as support for the limitation ‘wherein the control device is configured to control the temperature of the heating surface to avoid damage of tissue of the renal artery.’ The examiner disagrees. Par. 4 states:
Hypertension or hypotension is not something that only affects the whole vascular system, sometimes it is a local part of the vascular system that is affected. By locally dilate or constrict the blood vessel creating the local problem of hypo- or hypertension this problem could be treated. To avoid any kind of damage to the blood vessel a system using heat or cold could be used to regulate the constriction or dilatation of the blood vessel.
Par. 4 does not provide any mention of a ‘control device’, let alone a control device ‘configured to control the temperature of a heating surface to avoid damage of tissue of the renal artery’. Therefore, par. 4 does not support the claim limitation, as written. Further, while par. 4 does broadly disclose avoiding damage to the vascular system, it is clear from the context of the disclosure that the citation is referring to avoiding damage sustained from chronic hypertension, not from thermal damage.
For instance, the citation occurs in a section of the disclosure which is discussing damage to vasculature sustained from chronic hypertension, as demonstrated by par. 2 of the PGPUB:
Although the body may tolerate short periods of increased blood pressure, sustained hypertension may eventually result in damage to multiple body organs, including the kidneys, brain, eyes and other tissues, causing a variety of maladies associated therewith. The elevated blood pressure may also damage the lining of the blood vessels, accelerating the process of atherosclerosis and increasing the likelihood that a blood clot may develop. This could lead to a heart attack and/or stroke. Sustained high blood pressure may eventually result in an enlarged and damaged heart (hypertrophy), which may lead to heart failure.
Therefore, when understood in context, par. 4 is not disclosing a controller which controls the temperature of a heating surface to avoid any thermal damage to any tissue of the renal artery, as alleged by applicant, but instead is disclosing avoiding damage to the vasculature as a result of chronic hypertension through the constriction and dilation of the blood vessel mediated by heating/cooling. Therefore, the examiner rejects applicant’s assertion that par. 4 supports a controller configured to control the temperature of a heating surface to avoid thermal damage to the renal artery. In the examiner’s opinion this is not the intended meaning of par. 4.
Applicant's arguments filed 8/8/25 with respect to the rejection of the clams under 35 U.S.C. 103(a) have been fully considered but they are not persuasive.
Applicant argues:
The last limitation of claim 55 added in response to the previous Office Action specifies a control unit configured to control the temperature of the heating surface to avoid damage of tissue of the renal artery. ¶ This means that the tissue of the renal artery should not be at all damaged by the heating surface, irrespective of whether such damage would occur to “target tissue” or “non-target tissue” of the renal artery. This must be the broadest reasonable interpretation of this limitation, which clearly specifies that the heating should be controlled to avoid damage of the renal artery. Since no specific part of the renal artery is being mentioned in the claimed, it must be interpreted as to refer to all of the renal artery
The examiner disagrees and maintains that the disclosure of Demarais which configures the controller to control the temperature of the heating surface to avoid damage to non-target tissues of the renal artery (Col. 9, lines 21-25), is sufficient to satisfy the limitation of ‘avoiding damage of tissue of the renal artery’, according to its broadest reasonable interpretation. For instance, ‘non-target tissue of the renal artery’ is broadly within the category of ‘tissue of the renal artery’. Therefore, avoiding damage to non-target tissue of the renal artery is ‘avoiding damage to tissue of the renal artery’, according to its broadest reasonable interpretation. Further, the examiner rejects applicant’s assertion that the claim language is limiting enough to preclude any degree of damage to any tissue of the renal artery even if the controller is explicitly configured to avoid damage to some tissues of the renal artery. Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794