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 .
Claim Objections
Claim 15 objected to because of the following informalities: grammar. The claim recites “the one or more electrodes forming electrode pairs” and should be amended to recite “the one or more electrodes form electrode pairs”. Appropriate correction is required.
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.
Claims 1-17 are 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.
Regarding claim 1, the claim recites “a lead body” in the last line. It is unclear whether or not this limitation refers to the previously disclosed “a lead body” of ll. 2. For examination purposes, this limitation has been interpreted as “the lead body”.
As a result of dependence on claim 1, subsequent dependent claims 2-11 are also rejected as indefinite.
Regarding claim 2, the claim recites “a thickness of the ribbon wire in a radial direction”. It is unclear whether or not this limitation refers to the previously disclosed “a thickness of ribbon wire in a radial direction” of claim 1, ll. 7. For examination purposes, this limitation has been interpreted as “the thickness of the ribbon wire in the radial direction”.
Regarding claims 3-4, the claims recite “a ribbon wire” in ll. 2 of each claim. It is unclear whether or not this limitation refers to the “a ribbon wire” of claim 1, ll. 7. For examination purposes, this limitation has been interpreted as “the ribbon wire”.
Regarding claim 5, the claim recites “a length of the lead body” in ll. 2. It is unclear whether or not this limitation refers to the previously disclosed “a length of the lead body” of claim 1, ll. 5. For examination purposes, this limitation has been interpreted as “the length of the lead body”.
Regarding claim 11, the claim recites “one to six conductive paths arranged in parallel”. It is unclear how, in the case of one conductive path, the path can be arranged in parallel to itself. For examination purposes, this limitation has been interpreted as “two to six conductive paths arranged in parallel”.
Regarding claim 12, the claim recites “a patient” in ll. 2. It is unclear whether or not this limitation refers to the previously disclosed “a patient” of ll. 1. For examination purposes, this limitation has been interpreted as “the patient”.
As a result of dependence on claim 12, subsequent dependent claims 13-17 are also rejected as indefinite.
Regarding claim 13, the claim recites “a patient” in ll. 1-2. It is unclear whether or not this limitation refers to the previously disclosed “a patient” of claim 12, ll. 1. For examination purposes, this limitation has been interpreted as “the patient”.
Regarding claim 14, the claim recites “a treatment site” in ll. 2. It is unclear whether or not this limitation refers to the previously disclosed “a site of a cancerous tumor” of claim 12, ll. 12. For examination purposes, this limitation has been interpreted as “the treatment site”.
Regarding claim 16, the claim recites “two different electrical field vectors”. It is unclear whether or not this limitation refers to the previously disclosed “at least two different electrical field vectors” of claim 15. For examination purposes, this limitation has been interpreted as “the at least two different electrical field vectors”.
Regarding claim 17, the claim recites “a cancerous tumor” in ll. 2. It is unclear whether or not this limitation refers to the previously disclosed “a cancerous tumor” of claim 12, ll. 12. For examination purposes, this limitation has been interpreted as “the cancerous tumor”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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.
Claim(s) 1-5 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zarembo (US 2007/0038278).
Regarding claim 1, Zarembo discloses a lead (Abstract) comprising: a lead body having a proximal end and a distal end (Fig. 1, lead 100), the lead body defining a lumen (Abstract); and one or more electric field generating electrodes, wherein the one or more electric field generating electrodes are disposed along a length of the lead body (Fig. 1, electrodes 115, 120); wherein the one or more electric field generating electrodes comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches (para. 55, last sentence).
Although Zarembo does not explicitly disclose that the lead is for a cancer treatment system as recite in the preamble, Examiner submits that when reading the preamble in the context of the entire claim, the recitation “for a cancer treatment system” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claims 2-4, Examiner submits that these limitations are bound to the optional limitation of claim 1, “wherein the one or more electric field generating electrodes comprise a ribbon wire, wherein a thickness of the ribbon wire in a radial direction with respect to the lead body is less than 0.005 inches; or a walled tube, wherein a thickness of the walled tube is less than 0.005 inches; or a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to a lead body is less than 0.005 inches”. Since the prior art rejection is based on the option of “a walled tube…” as set forth above, Examiner submits that claims 2-4 are met by the rejection of claim 1 above as these limitations are not required by the claim language.
Regarding claim 5, Zarembo discloses two electric field generating electrodes disposed along the length of the lead body (Fig. 1, electrodes 115, 120).
Regarding claim 8, Zarembo discloses the one or more electric field generating electrodes comprise platinum, titanium, nickel, or a metal alloy (para. 52).
Regarding claim 9, Zarembo discloses the walled tube comprising a helical conductor pattern (Abstract; Fig. 1, 2A, 2C depict helical arrangement of electrodes).
Regarding claim 10, Zarembo discloses the helical conductor pattern has an outside diameter of 1 to 3 millimeters (para. 62 discloses the helix outer diameter is 0.053 inches, which is equivalent to 1.346 mm).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zarembo in view of Trailer (US 5154387).
Regarding claim 6, Zarembo does not disclose the two electric field generating electrodes are each independently from 1 cm to 4 cm in length.
Trailer, however, teaches an apparatus for emergency pacing of a patient’s heart (Abstract) wherein pacing electrodes 14 and 20 must allow sufficient current flow to cause ventricular and atrial pacing. It has been found by the inventors that the pacing electrodes should have a minimum surface area of approximately 1.5 square centimeters to achieve these results. For a standard size catheter of 2.5 millimeters diameter, this means that the pacing electrodes should be approximately 2.0 centimeters long to achieve these results (Col. 4, ll. 45-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Zarembo such that the two electric field generating electrodes are each independently 2 cm in length. Making this modification would be useful for facilitating sufficient current flow to cause ventricular and atrial pacing, as taught by Trailer.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zarembo in view of Fine et al. (US 4922927) (hereinafter Fine).
Regarding claim 7, Zarembo does not disclose the two electric field generating electrodes are separated by a non-conducting gap portion of from 0.1 cm to 2 cm.
Fine, however, teaches a defibrillating lead (Abstract) wherein the pacing electrode is separated from the closest end of the coil electrode by a distance of approximately one centimeter and is electrically insulated thereform (Col. 4, ll. 53-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Zarembo such that the two electric field generating electrodes are separated by a non-conducting gap portion of 1 cm. Making this modification would be useful for providing sufficient insulation between electrodes, as suggested by Fine.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zarembo in view of Williams et al. (US 5016645) (hereinafter Williams).
Regarding claim 11, Zarembo does not disclose the one or more electric field generating electrodes comprise from two to six conductive paths arranged in parallel.
Williams, hwoever, teaches a medical electrode lead (Abstract) wherein although in the context of a defibrillation electrode, it is believed that the electrode coils illustrated provide an appropriate electrode surface, in other applications, other conductive metallic or nonmetallic materials may be used to provide corresponding electrode surfaces. For example, conductive polymers, metallization layers, braided or tinsel wires, wire mesh or carbon fibers may be appropriate, provided that the electrode surfaces define a plurality of parallel electrode paths, and that means for increasing the flexibility of the electrode, such as grooves, are located between the electrode paths (Col. 6, ll. 57-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Zarembo such that disclose the one or more electric field generating electrodes comprise from two to six conductive paths arranged in parallel. Making this modification would be useful for providing an electrode surface which is appropriate for a particular application, as well as increasing the flexibility of the electrode, as taught by Williams.
Claim(s) 12-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba et al. (US 2017/0348049) (hereinafter Vrba) in view of Zarembo.
Regarding claim 12, Vrba discloses a method of treating a patient previously diagnosed with cancer (para. 195, last sentence discloses treating prostate cancer) comprising: implanting a first lead within a patient; the first lead comprising a first lead body comprising a proximal end and a distal end; and one or more electric field generating electrodes disposed along a length of the lead body (Fig. 24 depicts lead catheter 24002 implanted within a blood vessel and electrode 24003 disposed at distal end of lead body; para. 310); positioning the lead at or near a site of a cancerous tumor (para. 195, last sentence discloses treating prostate cancer); and generating one or more electric fields with the one or more electric field generating electrodes (para. 17, last sentence discloses applying various types of electromagnetic energy; para. 397, 2nd sentence discloses electric field).
Vrba does not disclose wherein the one or more electric field generating electrodes comprise a ribbon wire, wherein a thickness of the ribbon wire in a radial direction with respect to the lead body is less than 0.005 inches; or a walled tube, wherein a thickness of the walled tube is less than 0.005 inches; or a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to the lead body is less than 0.005 inches.
Zarembo, however, teaches tubular lead electrodes and methods (Abstract) wherein the one or more electric field generating electrodes comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches (para. 55, last sentence). Zarembo further teaches one advantage of tubular electrodes is the increased strength provided by a tube compared to a solid electrode of equal cross-sectional area. Another advantage is the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending at least partially into the tube (para. 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Vrba such that the one or more electric field generating electrodes comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches. Making this modification would be useful for providing a tube electrode which has increased strength compared to a solid electrode of equal cross-sectional area, and the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending at least partially into the tube, as taught by Zarembo.
Regarding claim 13, modified Vrba does not explicitly disclose implanting a second lead within the patient, wherein the second lead comprises a second lead body comprising a proximal end and a distal end; and wherein the one or more electric field generating electrodes comprise a ribbon wire, wherein a thickness of the ribbon wire in a radial direction with respect to the lead body is less than 0.005 inches; or a walled tube, wherein a thickness of the walled tube is less than 0.005 inches.
Examiner submits that modifying modified Vrba to implant a second lead within the patient, wherein the second lead comprises all of the same structural limitations as the first lead of claim 12 would amount to a mere duplication of parts (see MPEP 2144.04(VI)(B)), and thus claim 13 is obvious. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced, and the application as originally filed does not appear to provide criticality for the duplicated second lead.
Regarding claim 18, Vrba discloses a medical device system for treating a cancerous tissue (Fig. 23; para. 195 discloses treating prostate cancer) comprising: an electric field generating circuit configured to generate one or more electric fields at or near a site of the cancerous tissue; control circuitry in communication with the electric field generating circuit, the control circuitry configured to control delivery of the one or more electric fields from the electric field generating circuit to the site of the cancerous tissue (Fig. 23, controller 23904 comprises both generator and control circuitry; para. 308: “The treatment system further comprises a controller 23904 (e.g., RF generator having one or more processing devices) configured to regulate power delivery to the ablation catheter 23902”); and an implantable first lead, the implantable first lead comprising a lead body having a proximal end and a distal end (lead 23902), the lead body defining a lumen (para. 11, 2nd sentence discloses the catheter may have a lumen); and one or more electric field generating electrodes disposed along a length of the lead body (electrode 23903)
Vrba does not disclose wherein the one or more electric field generating electrodes comprise a ribbon wire, wherein a thickness of the ribbon wire in a radial direction with respect to the lead body is less than 0.005 inches; or a walled tube, wherein a thickness of the walled tube is less than 0.005 inches; or a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to the lead body is less than 0.005 inches.
Zarembo, however, teaches tubular lead electrodes and methods (Abstract) wherein the one or more electric field generating electrodes comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches (para. 55, last sentence). Zarembo further teaches one advantage of tubular electrodes is the increased strength provided by a tube compared to a solid electrode of equal cross-sectional area. Another advantage is the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending at least partially into the tube (para. 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Vrba such that the one or more electric field generating electrodes comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches. Making this modification would be useful for providing a tube electrode which has increased strength compared to a solid electrode of equal cross-sectional area, and the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending at least partially into the tube, as taught by Zarembo.
Regarding claim 19, modified Vrba does not explicitly disclose a second implantable lead comprising the same limitations as the first implantable lead of claim 18.
Examiner submits that modifying modified Vrba to include a second implantable lead, wherein the second lead comprises all of the same structural limitations as the first lead of claim 18 would amount to a mere duplication of parts (see MPEP 2144.04(VI)(B)), and thus claim 19 is obvious. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced, and the application as originally filed does not appear to provide criticality for the duplicated second lead.
Regarding claim 20, modified Vrba teaches the control circuitry causes the electric field generating circuit to generate one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz (Vrba para. 388).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba in view of Palti (US 2006/0282122).
Regarding claim 14, modified Vrba teaches generating one or more electric fields with the one or more electrodes comprises generating an electrical field at the treatment site at one or more frequencies selected from a range of between 100 kHz to 300 kHz (Vrba para. 388), using currents ranging from 20 mAmp to 500 mAmp (Vrba para. 389).
Modified Vrba does not disclose the electric field having a field strength of between 1 V/cm to 10 V/cm.
Palti, however, teaches treating cancer with electric field (Abstract) wherein for many types of cancers, frequencies between 100 kHz and 300 kHz at field strengths between 1 and 10 V/cm have been shown to be helpful (para. 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Vrba such that the electric field having a field strength of between 1 V/cm to 10 V/cm. Making this modification would be useful for treating many types of cancers, as taught by Palti.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba in view of Schmidt et al. (US 2019/0117971) (hereinafter Schmidt).
Regarding claims 15-16, modified Vrba does not teach the one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another.
Schmidt, however, teaches leads for treatment of cancer with electric fields (Abstract) wherein one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another (para. 18-19; claims 15-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Vrba such that the one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another. Making this modification would be useful for treating cancer with electric fields, as taught by Schmidt.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba in view of Trikha et al. (US 2020/0085789) (hereinafter Trikha).
Regarding claim 17, modified Vrba does not teach obtaining MRI of the cancerous tumor to determine a progression or regression of the cancerous tumor.
Trikha, however, teaches that MRI assessment may indicate tumor progression (para. 478). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Vrba to include obtaining MRI of the cancerous tumor to determine a progression or regression of the cancerous tumor. Making this modification would be useful for providing an indication of tumor progression, as taught by Trikha.
Conclusion
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792