DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-3, 5-12, 14-16, and 18-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
4. Claim 18 is objected to because of the following informalities: in the amended section of the claim, the term “shape changing section” is missing a hyphen. It should recite, “the shape-changing section”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. Claim 18 was previously rejected under 35 U.S.C 112(b) as being indefinite. However, Claim 18 has been amended to overcome these rejections; therefore, the rejection is withdrawn.
6. 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.
7. Claim 14, as well as Claims 15, 16, and 18-20 based on their dependency to Claim 18, 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.
8. Claim 14 recites the limitation "the radiofrequency puncture electrode" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 later recites “a radiofrequency puncture electrode” in line 7, but fails to introduce the radiofrequency puncture electrode properly before line 3. This renders the claim indefinite. Proper correction is required.
Claim Rejections - 35 USC § 103
9. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
10. Claims 1-3, 5-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tandri U.S. 10,842,556 (herein referred to as “Tandri”) and in view of Leung U.S. 2021/0330355 (herein referred to as “Leung”) and Willems U.S. 6,002,955 (herein referred to as “Willems”).
11. Regarding Claim 1, Tandri teaches a method for carrying out a medical procedure (Figs. 6A, 6B, 7), comprising:
a. providing a medical device (Fig. 6A, ref num 110) comprising a single elongate member (Fig. 6A, ref num 120) carrying both a radiofrequency puncture electrode (Fig. 6A, ref num 124; Col. 13, lines 23-25, “The ablation generator 142 may emit energy, for example ablation energy selected from a group consisting of radiofrequency”; Col. 13, lines 52-53, “The ablation device 120 includes at least one ablation element 124”) and an auxiliary electrode (Fig. 6A, ref num 126);
b. advancing the single elongate member towards a puncture site in a patient's body (Fig. 6A, ref num 120 is advanced to a puncture site; Col. 14, lines 65-67 – Col. 15, lines 1-7) and positioning the radiofrequency puncture electrode adjacent the puncture site (Fig. 6A, ref num 126 is adjacent to the puncture site);
d. advancing the single elongate member through the puncture to position the auxiliary electrode of the medical device at a target site in the patient's body (Fig. 6B, ref num 120 is advanced through puncture to target site, ref num 80, positioning ref num 126 at target site; Col. 14, lines 65-67 – Col. 15, lines 1-7);
f. using the auxiliary electrode for diagnosis, mapping, or treatment at the target site (Col. 14, lines 39-42, “a temperature sensor 126 may be used to monitor the temperature of the target tissue… to confirm therapeutic delivery of RF”).
Tandri teaches that the puncture electrode creates the puncture at the puncture site (Claim 1, “an ablative energy delivery element of the treatment apparatus through a wall of the trachea at a level of the trachea proximate a tracheal bifurcation by penetrating the wall of the trachea, wherein the penetration includes puncturing and traversing the wall of the trachea”), but fails to explicitly teach (c) delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture in the puncture site. Tandri also fails to teach (e) changing the shape of a shape-changing section to anchor the shape-changing section in a vessel, wherein the shape-changing section is anchored in the vessel while the radiofrequency puncture electrode is located in the vessel.
Leung teaches a method of analogous art (Figs. 1-5), wherein the method comprises delivering radiofrequency energy from a radiofrequency puncture electrode to create a puncture in the puncture site (para 0028, “The first cutting element 601 is configured to form the puncture site 105 through the second biological feature 912 (once the elongated puncture device 106 is moved and activated accordingly). The first cutting element 601 may include, for instance, a first electrode portion configured to be electrically actuated, such as with an amount of radio frequency energy of sufficient magnitude for cutting tissue”; Fig. 4, ref num 105 = puncture, ref num 601 = rf puncture electrode; para 0007). Tandri teaches utilizing electrode to create the puncture, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to energize the electrode to create the puncture, like taught in Leung, as this produces the same expected result of creating the puncture at the puncture site to then advance the device through the puncture.
Willems teaches a method of analogous (Figs. 1, 9A, 9B), wherein the method comprises changing the shape of a shape-changing section (Fig. 1, 10, ref num 22) to anchor the shape-changing section in a vessel (Col. 2, lines 54-56, “the anchor section is configured to engage with an anchor to the cardiac structure, such as the ostium or opening of a vessel”), wherein the shape-changing section is anchored in the vessel while the radiofrequency puncture electrode is located in the vessel (see Figs. 4A and 10, ref num 26 is in the shape-changing section, therefore, when ref num 22 is anchored in the vessel, the electrode would also be located in the vessel). This aids with positioning the tip portion of the device at the target site, improving the contact between the treatment electrodes and the target tissue (Col. 7, lines, 21-26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to include a shape-changing section that anchors in a vessel in order to facilitate contact between the treatment electrode and the target tissue for treatment.
12. Regarding Claim 2, Tandri fails to teach the puncture site is a fossa ovalis of the patient’s heart, and the target site is a structure of a left side of the patient’s heart.
Willems teaches the puncture site is a fossa ovalis of the patient’s heart, and the target site is a structure of a left side of the patient’s heart (see Figs. 9A and 9B, ref num 80 is located at the fossa ovalis, ref num 42 = right atrium, ref num 78 = left atrium; the target is vessel, ref num 82). Since Tandri teaches treating a cardiopulmonary disease, and entering the heart via vessels (Col. 5, lines 15-23), then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the method of Tandri to an appropriate puncture site, such as the fossa ovalis and left side of the patients heart, like taught in Willems, in order to achieve the expected result.
13. Regarding Claim 3, Tandri fails to teach advancing the medical device through the puncture comprises using the auxiliary electrode for pulmonary vein isolation.
Willems teaches advancing the medical device through the puncture comprises using the auxiliary electrode for pulmonary vein isolation (Col. 6, lines 39-46; Col. 7, lines 25-26; Col. 4, lines 56-57”). Since Tandri teaches a plurality of electrodes (Col. 13, lines 60-67 – Col. 14, lines 1-2, “the ablation element 124… The term element within the context of “ablation element” includes a discrete element, such as an electrode, or a plurality of discrete elements, such as a plurality of spaced apart electrodes, which are positioned so as to collectively treat a region of tissue or discrete sites”), then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to utilize one of the electrodes to perform pulmonary vein isolation, since there are multiple electrodes available to ablate the target tissue.
14. Regarding Claim 5, Tandri fails to teach using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode for electroanatomic mapping of the target site.
Willems teaches using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode for electroanatomic mapping of the target site (Col. 4, lines 56-57, “electrodes 24, 26 may be constructed for both mapping and ablation”). It is widely known in the art that mapping the target site improves the efficacy of the treatment since the target locations are properly identified (Col. 1, lines 46-52). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to have the auxiliary electrode configured to map the target site in order to improve the treatment of the target area.
15. Regarding Claim 6, Tandri fails to explicitly teach using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to ablate the target site. However, Tandri does teach utilizing multiple electrodes for ablation of the target site (Col. 13, lines 60-67 – Col. 14, lines 1-2, “the ablation element 124… The term element within the context of “ablation element” includes a discrete element, such as an electrode, or a plurality of discrete elements, such as a plurality of spaced apart electrodes, which are positioned so as to collectively treat a region of tissue or discrete sites”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the auxiliary electrode to ablate the target site, as using multiple electrodes for treatment of the site is taught by Tandri.
16. Regarding Claim 7, Tandri teaches using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to collect electrical signals from the target site (Col. 21, lines 37-38, “Physiological sensors 126 may be used to evaluate therapy success 190”; Col. 18, lines 63-67 – Col. 19, lines 1-3, “The signal conditioning circuitry 150 may be selectively coupled to physiologic sensors 126 through the switch 148. The signal conditioning circuitry 150 may include dedicated sense amplifiers, multiplexed amplifiers, or shared amplifiers. Each sensing circuit may employ one or more low power precision amplifiers with programmable gain or automatic gain control, bandpass filtering, or a threshold detection circuit to sense the physiologic parameter of interest”).
17. Regarding Claim 8, Tandri teaches a method for carrying out a medical procedure (Figs. 6A, 6B, 7), comprising:
a. providing a medical device (Fig. 6A, ref num 110) comprising a single elongate member (Fig. 6A, ref num 120) carrying both a radiofrequency puncture electrode (Fig. 6A, ref num 124; Col. 13, lines 23-25, “The ablation generator 142 may emit energy, for example ablation energy selected from a group consisting of radiofrequency”; Col. 13, lines 52-53, “The ablation device 120 includes at least one ablation element 124”) and an auxiliary electrode (Fig. 6A, ref num 126);
b. advancing the single elongate member towards a puncture site in a patient's body (Fig. 6A, ref num 120 is advanced to a puncture site; Col. 14, lines 65-67 – Col. 15, lines 1-7) and positioning the radiofrequency puncture electrode adjacent the puncture site (Fig. 6A, ref num 126 is adjacent to the puncture site);
d. advancing the single elongate member through the puncture to position the auxiliary electrode of the medical device at a target site in the patient's body (Fig. 6B, ref num 120 is advanced through puncture to target site, ref num 80, positioning ref num 126 at target site; Col. 14, lines 65-67 – Col. 15, lines 1-7);
e. using the auxiliary electrode for diagnosis, mapping, or treatment at the target site (Fig. 14, lines 39-42, “a temperature sensor 126 may be used to monitor the temperature of the target tissue… to confirm therapeutic delivery of RF”).
Tandri teaches that the puncture electrode creates the puncture at the puncture site (Claim 1, “an ablative energy delivery element of the treatment apparatus through a wall of the trachea at a level of the trachea proximate a tracheal bifurcation by penetrating the wall of the trachea, wherein the penetration includes puncturing and traversing the wall of the trachea”), but fails to explicitly teach (c) delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture in the puncture site. Tandri also fails to teach (e) using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to pace the target site.
Leung teaches a method of analogous art (Figs. 1-5), wherein the method comprises delivering radiofrequency energy from a radiofrequency puncture electrode to create a puncture in the puncture site (para 0028, “The first cutting element 601 is configured to form the puncture site 105 through the second biological feature 912 (once the elongated puncture device 106 is moved and activated accordingly). The first cutting element 601 may include, for instance, a first electrode portion configured to be electrically actuated, such as with an amount of radio frequency energy of sufficient magnitude for cutting tissue”; Fig. 4, ref num 105 = puncture, ref num 601 = rf puncture electrode; para 0007). Tandri teaches utilizing electrode to create the puncture, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to energize the electrode to create the puncture, like taught in Leung, as this produces the same expected result of creating the puncture at the puncture site to then advance the device through the puncture.
Willems teaches a method of analogous (Figs. 1, 9A, 9B), wherein the method comprises an electrode used to pace the target site (Col. 6, lines 30-31, “pacing from the coronary sinus and recording from electrodes 24”). This assesses the target site for treatment (Col. 6, lines 41-46). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to use the auxiliary electrode to pace the target site in order to assess the target site for treatment.
18. Regarding Claim 9, Tandri fails to teach the auxiliary electrode is positioned in a shape-changing section of the single-elongate member.
Willems teaches the auxiliary electrode is positioned in a shape-changing section of the single-elongate member (Fig. 4A, ref num 24 is located in shape-changing section, ref num 22). This section is more easily navigated to the target site (Col. 2, lines 54-56); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to have the auxiliary electrode positioned on a shape-changing section in order to properly position the auxiliary electrode through the puncture site to the target site.
19. Regarding Claim 10, Tandri fails to teach the target site comprises a wall of the vessel, and changing the shape of the shape-changing section positions the auxiliary electrode in contact with the target site.
20. Regarding Claim 12, Tandri teaches using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to perform a treatment at the target site, and then using the auxiliary electrode to confirm the treatment (Col. 13, lines 55-59, “one or more ablation elements 124 and temperature sensors 126 that cooperate to provide localized delivery of energy to minimize, limit, or substantially eliminate unwanted ancillary trauma associated with the applied energy”; Col. 14, lines 39-42, “a temperature sensor 126 may be used to monitor the temperature of the target tissue… to confirm therapeutic delivery of RF”).
21. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tandri, Leung, and Willems, and further in view of Visram U.S. 2005/0159738 (herein referred to as “Visram”).
22. Regarding Claim 11, Tandri fails to teach using the single elongate member as a rail to advance a secondary device towards the target site.
Visram teaches a single elongate member as a rail to advance a secondary device towards the target site (Fig. 8, ref num 700 is used to guide secondary device to target site, para 0058). This provides access to the target site, and guides the second device to the target site for treatment, producing the same expected result of ablating the target site (para 0058). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tandri to use the single elongate member as a rail to guide a secondary device to complete the treatment, as this produces the same expected result of ablating the target site.
Allowable Subject Matter
23. Claims 14-16 and 18-20 contain allowable subject matter.
24. The following is an examiner’s statement of reasons for allowable subject matter: a medical device comprising an elongate member having a distal portion defining a distal end and having shape-changing section, a radiofrequency puncture electrode, and at least a first auxiliary electrode, as mentioned in Claim 14, is well known in the art. This is supported by at least the references cited during the prosecution of this case, as well as other references in the general area that could be located with minimal effort. However, after reviewing the applicant’s remarks (filed 4/16/2026), as well as reviewing the amendments made to the independent claim, the prior art of record fails to specifically teach the single elongate member configured to be advanced through a puncture created by the radiofrequency puncture electrode, such that both the radiofrequency puncture electrode and first auxiliary electrode are at the distal end of the single elongate member, as well as the single elongate member includes an intermediate section located between the radiofrequency electrode and a shape-changing section, the intermediate section being co-linear with a section of the single elongate member proximal of the shape-changing section when the shape-changing section defines a loop shape. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
25. However, Claim 14, as well as its dependents, still stand rejected due to the 35 U.S.C. 112(b) rejections outlined above in the present office action.
Conclusion
26. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights