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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 6, 2026 has been entered. Currently claims 1-13 are pending in this application.
Response to Arguments
As best the claims can be understood, Applicant's amendments filed March 6, 2026 have been fully considered but they are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims. Examiner notes that the amendments to the claims have required new rejections under 35 U.S.C. 112(a) and 112(b).
Applicant argues that Vrba does not disclose a "generator furthermore comprising a processing unit, comprising processing circuitry, configured to control to cause all three EM waves to be emitted at the same time and control interaction among them for the internal ablation of parenchymal organs, hollow anatomical conduits and/or blood vessels.” Examiner disagrees. As stated previously, Vrba discloses in [0179] wherein “Energy modalities include, but are not limited to . . . microwave energy, radiofrequency (RF) energy, . . . laser energy . . . or any combination thereof . . . . In various embodiments different energy modalities may be used in combination (either simultaneously or sequentially).” Vrba also discloses ablation of the pancreas as disclosed in [0186]).
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 1-13 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.
Claim 1, lines 12-14 recite the phrase “said generator furthermore comprising a processing unit, comprising processing circuitry, configured to . . . emit RF and MW in alternate switch modality of pulses at millisecond based intervals and control ablated tissue temperature and impedance.”
The term “at millisecond based intervals” is unclear, as all timing can be considered “millisecond based.” It is suggested to further limit the intervals desired to be claimed IF supported by the specification.
The phrase “and control ablated tissue temperature and impedance.” This phrase is unclear, as it is not known how the generator controls the temperature and the impedance, as there is no circuitry or hardware included to perform this function.
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 1-4, 8, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vrba (US 2017/0348049, as previously cited).
Regarding claim 1, Vrba discloses a tissue ablation system for the internal treatment of parenchymal organs hollow anatomical conduits or blood vessels (e.g. ablation system; [0002], said system comprising:
an Electromagnetic (EM) wave generator (e.g. generator as mention in [0186]) wherein said generator includes at least two EM wave outputs and is configured to provide three types of EM waves through said outputs comprising Radiofrequency (RF), Microwave (MW) and Laser (LS) (e.g. generator as mentioned in [0179] wherein “Energy modalities include, but are not limited to . . microwave energy, radiofrequency (RF) energy, . . . laser energy . . . . In various embodiments different energy modalities may be used in combination (either simultaneously or sequentially).”
wherein said generator furthermore comprising a processing unit comprising circuitry configured to control to cause all three EM waves to be emitted at the same time and control interaction among them including the ability to emit RF and and MW in alternate switch modalities (e.g. controller 23904 as shown in Figure 23 and described in [0308]) for the internal ablation of parenchymal organs, hollow anatomical conduits and/or blood vessels (e.g. stimulation of parenchymal organ, including pancreas, stomach, or small intestine as disclosed in [0186]) and control ablated tissue temperature and impedance (e.g. as disclosed in [0037]); and
a catheter with an active distal end (e.g. balloon catheter 400).
Regarding claim 2, Vrba further discloses wherein one of the outputs is a joint output that configured to provide two types of EM waves (e.g. multiple electrodes 403 that can be considered “joint outputs”).
Regarding claim 3, Vrba further discloses four outputs (e.g. multiple electrodes 403 that can be considered “joint outputs”).
Regarding claim 4, Vrba additionally disclose that said catheter comprises an internal shaft (e.g. shaft 1905 as shown in Figure 19A and 19B) and an external hollow shaft (e.g. shaft 1910 as shown in Figures 19A and 19B), both shafts being coaxial and movable relatively to each other (e.g. movable shafts; [0294]).
Regarding claim 8, Vrba discloses wherein said catheter comprises an anodic portion and a cathodic portion (e.g. bipolar electrode pairs will necessarily have anodic and cathodic portions; [0186]).
Regarding claim 13, Vrba additionally discloses a handle for a navigation catheter and a handle for the active catheter or a needle (e.g. handle as described in [0407]).
Claim Rejections - 35 USC § 103
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 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.
Claims 5-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Reever (US 2019/0374276, as previously cited).
Regarding claim 5, Vrba discloses the claimed invention but does not expressly disclose wherein the laser-based catheter includes an internal shaft that is an optic fiber with a free portion and wherein the amplitude of the laser ablation field dimension is telescopically regulated by the relative movement of the external shaft. Reever discloses that it is well known in the art of device that are capable of applying more than one type of stimulation (e.g. laser and RF stimulation) to include a optical fiber (e.g. laser fiber 90) and wherein the amplitude of the laser ablation field dimension is telescopically regulated by the relative movement of the external shaft (e.g. stop cocks 30 and 34 that regulate the movement of the shafts; [0030] – [0032]). It would have been obvious to one having ordinary skill at the time the invention was made to include the telescopic limits of Reever in the device of Vrba since such a modification would provide the system with the predictable results of a reliable means of controlling the laser field.
Regarding claim 6, Vrba further discloses wherein said laser-based catheter furthermore comprises coolant outlets configured to provide a coolant around the therapy delivery device (e.g. temperature coolant; [0193]).
Regarding claim 7, Vrba further discloses an expandable balloon fixed to the distal end of the external shaft, said balloon acting as an expansion chamber for the coolant.
Regarding claim 10, Vrba additionally discloses a metallic mesh being located around the catheter distal end in such a way as to conductively connect the two external shafts (e.g. stents, balloons, cages or baskets as disclosed in [0189]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Pasquino (US 2018/0280070, as previously cited).
Regarding claim 9, Vrba discloses the claimed invention except wherein said anodic portion is located on the internal shaft and wherein said cathodic portion is located on two external shafts. Pasquino discloses that it was well known in the art of ablation device to include opposite electrode arrangements on the inner and outer shafts; (e.g. Figure 2 and 3, wherein the inner shaft is a cathode and the outer shafter is an anode. The opposite arrangement would have been obvious to one having ordinary skill in the art. It would have been obvious to include the electrode arrangement of Pasquino in the device of Vrba since such a modification would provide the system with the predictable results of a reliable means of applying bipolar stimulation.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Wallace (US 2017/0215936, as previously cited).
Regarding claim 11, Vrba discloses the claimed invention except the inclusion of biopsy jaws that are linked to the internal shaft distal end. Wallace discloses that it was well known in the art of devices for apply multiple sources of energy to include forceps at the end of a distal shaft (e.g. forceps as described in [0110]). It would have been obvious to include forceps of Wallace in the device of Vrba since such a modification would provide the system with the predictable results of a reliable means performing stimulation.
Regarding claim 12, Vrba discloses the claimed invention including a catheter adapted to provide MW alone, RF alone or a combination of both [0176], but does not expressly disclose an antenna located within the internal shaft. Wallace discloses that the use of such antenna are well known in the art (e.g. antenna as disclosed in [0089]). It would have been obvious to include antenna of Wallace in the device of Vrba since such a modification would provide the system with the predictable results of a reliable means performing stimulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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