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, 5-7, 9-12, 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.
4. In regards to Claim 8, due to the lack of rejection in the previous office action, and the amendment to make Claim 8 independent, a new rejection on the merits is warranted. Therefore, the current office action is non-final.
5. Claims 4, 13, and 17 are presently cancelled.
Claim Rejections - 35 USC § 112
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 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. The term “relatively stiff” in Claim 18 is a relative term which renders the claim indefinite. The term “relatively stiff” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term lacks definition as to how much ‘relatively stiff’ the elongate member is compared to the other structure, the shape-changing section. Therefore, any degree of stiffness defined compared to the shape-changing section will be interpreted to read on the claim language. Proper correction is required.
9. Claim 13 was previously rejected under 35 U.S.C. 112(b) as being indefinite and 35 U.S.C. 112(d) of being in improper dependent form for failing to further limit the subject matter. However, Claim 13 has been cancelled. Therefore, these rejections have been withdrawn.
Claim Rejections - 35 USC § 103
10. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claims 1-3, 5-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Willems U.S. 6,002,955 (herein referred to as “Willems”) and in view of Visram U.S. 2005/0159738 (herein referred to as “Visram”).
12. Regarding Claim 1, Willems teaches a method for carrying out a medical procedure (Figs. 1, 9A, 9B; Col. 7, lines 12-26) , comprising:
a. advancing a medical device (Figs. 1, 9A, 9B, ref nums 6, 18) towards a puncture site in a patient’s body (Fig. 9A, ref num 80) and positioning a radiofrequency puncture electrode (Fig. 4A, 10, ref num 26; Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”) of the medical device adjacent the puncture site (Col. 7, lines 13-14, “tip portion 18 is introduced into right atrium 42”);
b. the radiofrequency puncture electrode creates a puncture in the puncture site (Col. 7, lines 13-15, “tip portion 18 is introduced into right atrium 42 and delivered through a transseptal puncture 80 into left atrium 78”);
c. advancing the medical device through the puncture to position an auxiliary electrode (Figs. 4A, 10, ref num 24; see Figs. 9A-9B for the advancement of the device) of the medical device at a target site in the patient’s body (Col. 7, lines 21-26, “Manipulation of tip section 18 into various positions in left atrium 78 can be facilitated by anchoring anchor section 22 into a pulmonary vein opening 82 as shown. The resulting improved contact between the electrodes and left atrial tissue can facilitate the mapping and ablation of atrial fibrillation and other atrial tachycardias”);
d. changing the shape of a shape-changing section (Figs. 1, 4A, 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 and anchor to a 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); and,
e. using the auxiliary electrode for diagnosis, mapping, or treatment at the target site (Col. 7, lines 25-26, “facilitate the mapping and ablation of atrial fibrillation and other atrial tachycardias”: Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”).
Willems fails to teach that the radiofrequency puncture electrode delivers radiofrequency energy to create the puncture.
Visram teaches a method of analogous art (Fig. 9A), wherein the method comprises delivering radiofrequency energy from a radiofrequency puncture electrode to create a puncture in the puncture site (Fig. 9A, ref num 910; para 0061). This is a commonly used method when creating the puncture site (para 0002). 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 Willems to use radiofrequency energy to create puncture, as this is a widely accepted method within the known field.
13. Regarding Claim 2, 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).
14. Regarding Claim 3, Willems teaches advancing the medical device through the puncture comprises using the auxiliary electrode for pulmonary vein isolation (Col. 6, lines 39-46, “In the left atrium, evidence has shown that pulmonary veins 56 are anatomical barriers to conduction which may play an important role. Therefore, catheter assembly 2 could prove useful in mapping and pacing to assess conduction block in the left atrium. In such cases, anchor section 22 would be placed in the openings to one of the four pulmonary veins 56”; Col. 7, lines 25-26, “facilitate the mapping and ablation of atrial fibrillation and other atrial tachycardias”: Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”).
15. Regarding Claim 5, 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”).
16. Regarding Claim 6, Willems teaches using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to ablate the target site (Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”).
17. Regarding Claim 7, Willems 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. 6, lines 41-45, “catheter assembly 2 could prove useful in mapping and pacing to assess conduction block in the left atrium. In such cases, anchor section 22 would be placed in the openings to one of the four pulmonary veins 56”; Col. 6, lines 13-16, “Positioning tip portion 18 so that electrodes 24 circle the tricuspid valve allows a physician to assess conduction around the structure to look for zones of slowed conduction, which are typically targets for ablation”).
18. Regarding Claim 8, Willems teaches a method for carrying out a medical procedure (Figs. 1, 9A, 9B; Col. 7, lines 12-26) , comprising:
a. advancing a medical device (Figs. 1, 9A, 9B, ref nums 6, 18) towards a puncture site in a patient’s body (Fig. 9A, ref num 80) and positioning a radiofrequency puncture electrode (Fig. 4A, 10, ref num 26; Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”) of the medical device adjacent the puncture site (Col. 7, lines 13-14, “tip portion 18 is introduced into right atrium 42”);
b. the radiofrequency puncture electrode creates a puncture in the puncture site (Col. 7, lines 13-15, “tip portion 18 is introduced into right atrium 42 and delivered through a transseptal puncture 80 into left atrium 78”);
c. advancing the medical device through the puncture to position an auxiliary electrode (Figs. 4A, 10, ref num 24; see Figs. 9A-9B for the advancement of the device) of the medical device at a target site in the patient’s body (Col. 7, lines 21-26, “Manipulation of tip section 18 into various positions in left atrium 78 can be facilitated by anchoring anchor section 22 into a pulmonary vein opening 82 as shown. The resulting improved contact between the electrodes and left atrial tissue can facilitate the mapping and ablation of atrial fibrillation and other atrial tachycardias”); and,
d. using the auxiliary electrode for diagnosis, mapping, or treatment at the target site (Col. 7, lines 25-26, “facilitate the mapping and ablation of atrial fibrillation and other atrial tachycardias”: Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”), wherein using the auxiliary electrode for diagnosis, mapping, or treatment at the target site comprises using the auxiliary electrode to pace the target site (Col. 6, lines 3,-31 and 41-43 “pacing from the coronary sinus and recording from electrodes 24… catheter assembly 2 could prove useful in mapping and pacing to assess conduction block in the left atrium”).
Willems fails to teach that the radiofrequency puncture electrode delivers radiofrequency energy to create the puncture.
Visram teaches a method of analogous art (Fig. 9A), wherein the method comprises delivering radiofrequency energy from a radiofrequency puncture electrode to create a puncture in the puncture site (Fig. 9A, ref num 910; para 0061). This is a commonly used method when creating the puncture site (para 0002). 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 Willems to use radiofrequency energy to create puncture, as this is a widely accepted method within the known field.
19. Regarding Claim 9, Willems teaches the auxiliary electrode is positioned in a shape-changing section of the medical device (Fig. 4A, ref num 24 is located in ref num 22).
20. Regarding Claim 11, Willems fails to teach using the medical device as a rail to advance a secondary device towards the target site.
Visram teaches using the medical device as a rail to advance a second 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 a 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 Willems to use the medical device as a rail to guide a secondary device to the target site to complete the treatment, as this produces the same expected result of ablating the target site.
21. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Willems and Visram, and further in view of Haissaguerre U.S. 6,064,902 (herein referred to as “Haissaguerre”).
22. Regarding Claim 10, Willems 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.
Haissaguerre teaches a method of analogous art (Figs. 1A, 6; Col. 8, lines 13-21), such that the method comprises that the target site comprises a wall of the vessel (Fig. 6, ref num 20 of vessel, ref num 13; Col. 9, lines 12-14), such that changing the shape of the shape-changing section positions the auxiliary electrode in contact with the target site (Fig. 6, ref num 12 changes shape at ref num 43, placing ref num 18 and 19 in contact with the wall, ref num 20). This provides feedback to the user to ensure that the proper target site is ablated (Col. 9, lines 29-31, “Based on the outputs from mapping electrodes 18 and 19, the surgeon locates sites on wall surface 20 requiring ablation treatment”). 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 Willems to have the target site be a wall of the vessel and have the auxiliary electrode in contact with the wall to ensure that the target site is engaged for ablation/treatment.
23. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Willems and Visram, and further in view of Starksen U.S. 2009/0209950 (herein referred to as “Starksen”).
24. Regarding Claim 12, Willems 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 (Col. 4, lines 56-57, “Electrodes 24, 26 may be constructed for both mapping and ablation”).
Willems fails to teach using the auxiliary electrode to confirm the treatment.
Starksen teaches a method of analogous art (Fig. 4; para 0071), wherein the method uses an auxiliary electrode to confirm treatment (Fig. 30, ref nums 398 = auxiliary electrodes; para 0140, “the ablation electrode(s) 400 at or closest to the detected bypass tract may be activated to ablate the tissue about the bypass tract and then the activation data may be reacquired from mapping electrodes 398 to confirm destruction of the tract”). This ensures that ablation is successful (para 0140). 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 method of Willems to use the auxiliary electrode to confirm treatment in order to ensure that the treatment is completed and successful.
25. Claims 14-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Willems and in view of Panescu U.S. 2021/0128229 (herein referred to as “Panescu”).
26. Regarding Claim 14, Willems teaches a medical device (Fig. 1, ref num 6) comprising:
a. a. an elongate member (Fig. 1, ref num 16) having a distal portion (Fig. 1, ref num 18) defining a distal end (Fig. 1, ref num 22), and a proximal portion (Fig. 1, ref num 20) defining a proximal end (proximal end is defined by ref num 20), the elongate member comprising an inner mandrel (Fig. 2B, ref num 16 has shaft, ref num 28 with inner lumen, ref num 30) and an outer liner (implicit that the elongate member would have an outer liner, ref num 28);
b. a radiofrequency puncture electrode at the distal end (Fig. 4A, ref num 26), and a first electrical connector (Fig. 2B, ref num 32) extending proximally from the radiofrequency puncture electrode towards the proximal end (Col. 4, lines 60-63, “Catheter shaft 28 defines a main lumen 30 through which a plurality of electric wires 32, one for each electrode 24, 26, extend between the electrodes and electrical connector 10”), for electrically connecting the radiofrequency puncture electrode to a radiofrequency generator (Col. 4, lines 60-63; understood ref num 10 connects to radiofrequency generator); and
c. at least a first auxiliary electrode (Fig. 4A, ref num 24) in the distal portion (see Fig. 4A, ref num 24 is in ref num 22), positioned proximally of the radiofrequency puncture electrode (Fig. 4A, ref num 24 is positioned proximal to ref num 26), and a second electrical connector (Fig. 2B, ref num 32) extending proximally from the auxiliary electrode towards the proximal end (Col. 4, lines 60-63, “Catheter shaft 28 defines a main lumen 30 through which a plurality of electric wires 32, one for each electrode 24, 26, extend between the electrodes and electrical connector 10”), for electrically connecting the auxiliary electrode to a diagnostic system, a mapping system, and/or a treatment system (Col. 4, lines 60-63).
Willems fails to teach the elongate member includes an intermediate section located between the radiofrequency electrode and the shape-changing section, the intermediate section being co-linear with a section of the elongated member proximal of the shape-changing section when the shape-changing section defines a loop shape.
Panescu teaches a medical device of analogous art (Figs. 1 and 27), wherein the device comprises an elongate member (Fig. 27, ref num 200) and a radiofrequency puncture electrode (Fig. 27, ref num 201) such that the elongate member includes an intermediate section located between the radiofrequency electrode and a shape-changing section (Fig. 27, ref num 58 indicates the intermediate section between the distal-most ref num 201 and ref num 210, shape-changing section), such that the intermediate section is straight like a section of the elongated member proximal of the shape-changing section when the shape changing section define a loop shape (see Fig. 27, ref num 58 is straight and so is reef num 200 proximal to ref num 210). While Panescu fails to explicitly teach that they are co-linear with one another, It would have been an obvious matter of design choice to make the different portions of the intermediate section be co-linear with a proximal portion of the elongate member, such that it is whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
27. Regarding Claim 15, Willems teaches the first auxiliary electrode is one of a plurality of auxiliary electrodes that are longitudinally spaced apart in the distal portion (see Figs. 4A and 10, plurality of ref num 24 spaced apart).
28. Regarding Claim 16, Willems teaches the auxiliary electrode is in the shape-changing section (see Fig. 4A, ref num 24 is in ref num 22).
29. Regarding Claim 18, Willems teaches the elongate member is relatively stiff proximal of the shape-changing section (Col. 4, lines 45-47, “While both main body portion 16 and tip portion 18 are flexible, tip portion 18 is preferably more flexible (less stiff) than main body portion 16”).
30. Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Willems and Panescu, and further in view of Visram.
31. Regarding Claim 19, Willems fails to teach the medical device is a guidewire and the elongate member has an outer diameter of between about 0.014 inches to about 0.060 inches.
Visram teaches a medical device of analogous art, such that the medical device is a guidewire (Figs. 7A and 8, ref num 700; para 0036, 0057) and the elongate member has an outer diameter of between about 0.014 inches to about 0.060 inches (Fig. 1, ref num 104 is the same elongate member as Fig. 6, ref num 602, see para 0072; para 0037, “elongate member 104 is preferably no larger than 0.050” (1.282 mm)”). It would have been an obvious matter of design choice to make the outer diameter of the elongate member between 0.014 to 0.060 inches, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
32. Regarding Claim 20, Willems fails to teach the medical device is a microcatheter and the elongate member has an outer diameter of between about 0.02 inches to about 0.079 inches.
Visram teaches a medical device of analogous art, such that the device is a microcatheter (para 0039, 0066) and the elongate member has an outer diameter of between 0.02 inches to about 0.079 inches (Fig. 1, ref num 104 is the same elongate member as Fig. 6, ref num 602, see para 0072; para 0037, “elongate member 104 is preferably no larger than 0.050” (1.282 mm)”). It would have been an obvious matter of design choice to make the outer diameter of the elongate member between 0.02 to 0.079 inches, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794