DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/470751 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 17/470751 provides adequate support for “the axial electrode comprising: a diameter of…less than 3.33 mm” in Par. [0056] (“diameter 90 of axial electrode 40A is less than lumen diameter 110” which can be “between 3.0 and 3.33 mm”).
Accordingly, the claims are given the priority date of 9/9/2021.
Specification
The disclosure is objected to because of the following informalities: update Par. [0001] with appropriate patent information.
Appropriate correction is required.
Claim Objections
Claim 8 is objected to because of the following informalities: amend “IRE” to -irreversible electroporation (IRE)- in ll. 2. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “the radial electrodes” to -the plurality of radial electrodes- in ll. 2. 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 15-17 & 20 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 15 recites “the electrical signal generator is configured to deliver irreversible electroporation (IRE) pulses to the axial electrode”; however, claim 12, upon which claim 15 depends, recites “conveying ablation energy to the axial electrode”. It is unclear if the IRE pulses are also the ablation energy. For purposes of examination, the claim will be interpreted as -the electrical signal generator conveys the ablation energy as irreversible electroporation (IRE) pulses to the axial electrode-.
Claim 16 recites “the electrical signal generator is configured to deliver IRE energy to the axial electrode”; however, claim 12, upon which claim 16 depends, recites “conveying ablation energy to the axial electrode”. It is unclear if the IRE energy is also the ablation energy. For purposes of examination, the claim will be interpreted as -the electrical signal generator conveys the ablation energy as irreversible electroporation energy to the axial electrode-.
Claim 17 recites “the electrical signal generator is configured to deliver radio frequency energy to the axial electrode”; however, claim 12, upon which claim 17 depends, recites “conveying ablation energy to the axial electrode”. It is unclear if the radio frequency energy is also the ablation energy. For purposes of examination, the claim will be interpreted as -the electrical signal generator conveys the ablation energy as radio frequency energy to the axial electrode-.
Claim 20 recites “the electric signal generator is configured to deliver IRE energy simultaneously to the axial electrode and at least one of the plurality of radial electrodes”; however, claim 12, upon which claim 20 depends, recites “conveying ablation energy to the axial electrode”. It is unclear if the IRE energy is also the ablation energy. For purposes of examination, the claim will be interpreted as -the electrical signal generator conveys the ablation energy as deliver IRE energy simultaneously to the axial electrode and at least one of the plurality of radial electrodes-.
Claim Interpretation
Claims 1 & 12 recites “a thickness of at least 20% of the diameter at a center of the axial electrode”. This is not regarded as an unbounded range, since one of ordinary skill in the art would recognize from the originally filed disclosure at Figs. 2-4 the thickness (100) is less than 100% of the diameter (90) of the axial electrode.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7-10, 12-16 & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (2019/0069950).
Concerning claim 1, as illustrated in at least Fig. 1 & 33A-E, Viswanathan et al. disclose a medical probe (ablation device/apparatus 300; [0167]) comprising:
an insertion tube extending along a longitudinal axis (outer shaft 3310; [0167]); and
a basket assembly comprising: a proximal end connected to a distal end of the insertion tube; a distal end (set of splines 3330 form a basket assembly having a proximal end connected to outer shaft 3310 and a distal end; [0167], [0176]) comprising
an axial electrode, the axial electrode comprising: a diameter of at least 1.5 mm, the diameter being substantially perpendicular to the longitudinal axis; and a thickness (cap electrode 3322 is disposed at a distal end of splines 3330 and has a diameter of at least 1.5 mm and has a thickness; [0167], [0176]); and
a plurality of spines extending from the proximal end of the basket assembly and conjoined at the axial electrode, the plurality of spines configured to bow radially outward from the longitudinal axis (set of splines 3330 form a basket assembly and are at least indirectly connected to outer shaft 3310 and are configured to bow radially outward form the basket assembly axis and conjoin/join together at its distal end at cap electrode 3322; [0167], [0171]).
Viswanathan et al. fail to disclose the axial electrode having a diameter that is also less than 3 mm. However, Viswanathan et al. disclose a medical probe comprising an axial electrode (3322) disposed at a distal end of a plurality of splines (3330) of a basket assembly, the axial electrode having a cross-sectional diameter of between about 1 mm and about 5 mm and capable of being withdrawn into an outer shaft (3310) having a diameter of between about 1.5 mm and about 6 mm ([0176]; Fig. 33A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the patent such that the cross-sectional diameter is at least 1.5 mm and less than 3.33 mm as Applicant appears to have placed no criticality on the claimed range (see pp. [0052] indicating “[t]ypical values of diameter 90 are 1.5, 1.75, 2.0, 2.25, 2.5 mm and 3.0 mm” and noting that in Par. [0057] “diameter 90 of axial electrode 40A is less than lumen diameter 110 so as to enable basket assembly 38 to traverse lumen 70”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
While Viswanathan et al. illustrate the thickness of the axial electrode (3322) to be less than the diameter (Fig. 33A), Viswanathan et al. fail to disclose the axial electrode having a thickness of at least 20% of the diameter at a center of the axial electrode. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Viswanathan et al. such that the axial electrode has a thickness of at least 20% of the diameter at a center of the axial electrode since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Viswanathan et al. would not operate differently with the claimed diameter since it would still be operable to deliver energy to tissue. Further, Applicant places no criticality on the 20% thickness claimed, indicating simply that the thickness may be “[i]n some embodiments, axial electrode 40A has a minimum thickness 100 (i.e., due to the rounded surface of the axial electrode) that is at least 20% of diameter 90.” ([0053]).
Concerning claim 2, while Viswanathan et al. illustrate the axial electrode (3322) to have a radius of curvature (Fig. 33A), Viswanathan et al. fail to disclose the axial electrode further comprising a radius of curvature of at least 25% and at most 50% of the thickness. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Viswanathan et al. to comprising a radius of curvature of at least 25% and at most 50% of the thickness since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Viswanathan et al. would not operate differently with the claimed radius of curvature range. Further, Applicant places no criticality on the range claimed, indicating simply that the “[i]n some embodiments, sides 92 are typically rounded so as to have a largest possible radius of curvature 107, while not creating an edge [and t]herefore, radius of curvature 107 can be between (at least) one-quarter (25%) of thickness 100 and (at most) one-half (50%) of thickness 100” ([0054]).
Concerning claim 3, Viswanathan et al. disclose comprising a plurality of radial electrodes (3332, 3334) disposed on the plurality of spines (3330), wherein each radial electrode of the plurality of radial electrodes comprises a geometric bias (electrodes 3332 comprise outward-facing exposed portion or “window” of electrode is exposed and thus presents a geometric bias) towards an outer side of a respective spine of the plurality of spines (3330) on which it is disposed ([0168]).
Concerning claim 4, Viswanathan et al. disclose comprising a sheath (3310) ([0167]; Fig. 33A). Viswanathan et al. fail to disclose the geometric bias enables the plurality of spines to lay flush with the insertion tube when the basket assembly is in a collapsed configuration within the sheath. However, in alternative embodiments, Viswanathan et al. disclose the spline electrodes (2630) may have an atraumatic shape including a rounded, flat, curved, and/or blunted portion configured to contact endocardial tissue (Fig. 26B). Those electrodes that are flat are configured to be withdrawn into an outer sheath (506) in a collapsed configuration, where the shape of the electrodes (154) naturally are configured to lay flush with the outer sheath (506) when withdrawn ([0022]; Fig. 1-2, 3, 5a-6c). At the time It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Viswanathan such that the geometric bias enables the plurality of spines to lay flush with the insertion tube when the basket assembly is in a collapsed configuration within the sheath and thus the electrodes are of whatever desired or expedient form or shape, since 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.
Concerning claim 7, Viswanathan et al. disclose further comprising an electric signal generator (122) coupled to the axial electrode (3322) and the plurality of radial electrodes (3332, 3334) ([0053], [0175]; Fig. 1).
Concerning claim 8, Viswanathan et al. disclose wherein the electric signal generator (122) is configured to deliver IRE energy simultaneously to the axial electrode (3322) and at least one the radial electrodes (3332, 3334) ([0053], [0175]; Fig. 1).
Concerning claim 9, Viswanathan et al. disclose comprising an electric signal generator (122) coupled to the axial electrode (3322) ([0053], [0175]; Fig. 1).
Concerning claim 10, Viswanathan et al. disclose the electrical signal generator (122) is configured to deliver irreversible electroporation (IRE) pulses to the axial electrode (3322) ([0053], [0179]; Fig. 1).
Concerning claim 12, as illustrated in at least Fig. 1 & 33A-E, Viswanathan et al. disclose a method of using a medical probe to perform a tissue ablation (method for ablating tissue; [0004]) comprising:
deploying the medical probe into a chamber of a heart (ablation device/apparatus 3300 in the form of a catheter including an outer shaft 3310 having an inner lumen 3312 is passed into body; [0167]), the medical probe comprising:
an insertion tube extending along a longitudinal axis (outer shaft 3310; [0167]); and
a basket assembly comprising: a proximal end connected to a distal end of the insertion tube; a distal end (set of splines 3330 form a basket assembly having a proximal end connected to outer shaft 3310 and a distal end; [0167], [0176]) comprising
an axial electrode, the axial electrode comprising: a rounded distal surface; a diameter of at least 1.5 mm, the diameter being substantially perpendicular to the longitudinal axis of the insertion tube; and a thickness; (cap electrode 3322 is disposed at a distal end of splines 3330 and has a diameter of at least 1.5 mm and has a thickness and a rounded profile; [0167], [0176]) and
a plurality of spines extending from the proximal end of the basket assembly and conjoined at the axial electrode, the plurality of spines configured to bow radially outward from the longitudinal axis (set of splines 3330 form a basket assembly and are at least indirectly connected to outer shaft 3310 and are configured to bow radially outward form the basket assembly axis and conjoin/join together at its distal end at cap electrode 3322; [0167], [0171]);
pressing the rounded distal surface of the axial electrode against tissue (cap electrode 3322 is placed in contact against tissue wall 3350; [0180]); and
conveying ablation energy to the axial electrode (focal lesion can be generated at desired depth; [0175], [0180]).
Viswanathan et al. fail to disclose the axial electrode having a diameter that is also less than 3 mm. However, Viswanathan et al. disclose a medical probe comprising an axial electrode (3322) disposed at a distal end of a plurality of splines (3330) of a basket assembly, the axial electrode having a cross-sectional diameter of between about 1 mm and about 5 mm and capable of being withdrawn into an outer shaft (3310) having a diameter of between about 1.5 mm and about 6 mm ([0176]; Fig. 33A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the patent such that the cross-sectional diameter is at least 1.5 mm and less than 3.33 mm as Applicant appears to have placed no criticality on the claimed range (see pp. [0052] indicating “[t]ypical values of diameter 90 are 1.5, 1.75, 2.0, 2.25, 2.5 mm and 3.0 mm” and noting that in Par. [0057] “diameter 90 of axial electrode 40A is less than lumen diameter 110 so as to enable basket assembly 38 to traverse lumen 70”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
While Viswanathan et al. illustrate the thickness of the axial electrode (3322) to be less than the diameter (Fig. 33A), Viswanathan et al. fail to disclose the axial electrode having a thickness of at least 20% of the diameter at a center of the axial electrode. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Viswanathan et al. such that the axial electrode has a thickness of at least 20% of the diameter at a center of the axial electrode since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Viswanathan et al. would not operate differently with the claimed diameter since it would still be operable to deliver energy to tissue. Further, Applicant places no criticality on the 20% thickness claimed, indicating simply that the thickness may be “[i]n some embodiments, axial electrode 40A has a minimum thickness 100 (i.e., due to the rounded surface of the axial electrode) that is at least 20% of diameter 90.” ([0053]).
Claim 13 is rejected upon the same rationale as applied to claim 2.
Claim 14 is rejected upon the same rationale as applied to claim 9.
Claim 15 is rejected upon the same rationale as applied to claim 10.
Claim 16 is rejected upon the same rationale as applied to claim 8.
Claim 18 is rejected upon the same rationale as applied to claim 3.
Claim 19 is rejected upon the same rationale as applied to claim 7.
Claim 20 is rejected upon the same rationale as applied to claim 8.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (2019/0069950), as applied to claim 4, in further view of Harlev et al. (2017/0312012).
Concerning claim 5, Viswanathan et al. fail to disclose a stem that extends longitudinally from a distal end of the insertion tube along a longitudinal axis, wherein a distance from the stem to the axial electrode decreases as the basket assembly moves from a collapsed configuration to an expanded configuration. However, Harlev et al. disclose a medical probe (104) comprising a basket assembly (124) and a stem (128) that extends longitudinally from a distal end of an insertion tube (140) along a longitudinal axis of the basket assembly (124), wherein a distance from the stem (128) to an axial tip (141b) decreases as the basket assembly moves from a collapsed configuration to an expanded configuration. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Viswanathan et al. to further comprise a stem that extends longitudinally from a distal end of the insertion tube along a longitudinal axis, wherein a distance from the stem to the axial electrode decreases as the basket assembly moves from a collapsed configuration to an expanded configuration in order to provide the benefit of an irrigation element that is directed toward an inner portion of the basket electrodes to facilitate heat transfer between the irrigation fluid and electrodes as taught by Harlev et al. ([0174]).
31. Concerning claim 6¸ Harlev et al. further disclose the stem (128) comprises one or more spray ports (134) to deliver irrigation fluid to the tissue in the body cavity ([0174]). The modified invention of Viswanathan et al. in view of Harlev et al. teach the stem spray ports for delivering irrigation fluid to the axial electrode, an electrode of the plurality of radial electrodes, or a combination thereof.
Claim(s) 11 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (2019/0069950), as applied to claims 3 & 14, in further view of Sherman (2014/0066913).
Concerning claims 11 & 17, Viswanathan et al. fail to disclose the electrical signal generator is configured to deliver radio frequency energy to the axial electrode. However, Sherman discloses a medical apparatus (10) comprising a probe having a plurality of electrodes (26) and an electrical signal generator (16) configured to apply both IRE and RF signals to the electrodes (26). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Viswanathan et al. such that the electrical signal generator is configured to deliver radio frequency energy to the axial electrode in order to provide the benefit of a more effective and efficient ablation since electroporation may not result in immediate ablation of the treated tissue (that is, the treated cells may continue to function somewhat normally for a time after electroporation) and thus immediate current blockage as taught by Sherman ([0021-0022], [0026-0028]).
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,004,804. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a medical probe (medical probe) comprising: an insertion tube extending along a longitudinal axis (an insertion tube configured for insertion into a body cavity of a patient); and a basket assembly (a basket assembly) comprising: a proximal end connected to a distal end of the insertion tube (a proximal end that is connected distally to the insertion tube); a distal end comprising an axial electrode (an axial electrode attached to the plurality of resilient spines), the axial electrode comprising: a diameter of at least 1.5, the diameter being substantially perpendicular to the longitudinal axis mm (a diameter of at least 1.5 millimeters); and a thickness of at least 20% of the diameter at a center of the axial electrode a thickness of at least 20% of the diameter; and a plurality of spines extending from the proximal end of the basket assembly and conjoined at the axial electrode, the plurality of spines configured to bow radially outward from the longitudinal axis (a plurality of resilient spines, which are configured to bow radially outward from an axis of the basket assembly and are conjoined at a distal end of the basket assembly; an axial electrode attached to the plurality of resilient spines). The patent fails to disclose the diameter to be less than 3.33 mm. However, Viswanathan et al. disclose a medical probe comprising an axial electrode (3322) disposed at a distal end of a plurality of splines (3330) of a basket assembly, the axial electrode having a cross-sectional diameter of between about 1 mm and about 5 mm and capable of being withdrawn into an outer shaft (3310) having a diameter of between about 1.5 mm and about 6 mm ([0176]; Fig. 33A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the patent such that the cross-sectional diameter is at least 1.5 mm and less than 3.33 mm as Applicant appears to have placed no criticality on the claimed range (see pp. [0052] indicating “[t]ypical values of diameter 90 are 1.5, 1.75, 2.0, 2.25, 2.5 mm and 3.0 mm” and noting that in Par. [0057] “diameter 90 of axial electrode 40A is less than lumen diameter 110 so as to enable basket assembly 38 to traverse lumen 70”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a method using the probe comprising: a method of using a medical probe to perform a tissue ablation, comprising: deploying the medical probe into a chamber of a heart (inserting, into a body cavity, an insertion tube having a distal end containing a lumen passing through the insertion tube; deploying, into the body cavity from the distal end,), the medical probe comprising: an insertion tube extending along a longitudinal axis; and a basket assembly comprising: a proximal end connected to a distal end of the insertion tube; a distal end comprising an axial electrode, the axial electrode comprising: a rounded distal surface; a diameter of at least 1.5 mm and less than 3.33 mm, the diameter being substantially perpendicular to the longitudinal axis of the insertion tube; and a thickness of at least 20% of the diameter at a center of the axial electrode; and a plurality of spines extending from the proximal end of the basket assembly and conjoined at the axial electrode, the plurality of spines configured to bow radially outward from the longitudinal axis (see above); pressing the rounded distal surface of the axial electrode against tissue; and conveying ablation energy to the axial electrode (positioning the basket assembly so that the axial electrode presses against the tissue in the body cavity; and conveying, via the axial electrode, ablation energy to the tissue).
Conclusion
The Examiner notes: Par. [0052-0055] of the originally filed disclosure provides criticality for the combination of the shape, diameter, thickness, and radius of curvature of the axial electrode: “axial electrode 40A has a mushroom-like shape (or a biscuit-like shape) whose rounded surface 102 and thickness constraints (a) make the axial electrode atraumatic to an engaged tissue in heart 26 (or tissue in any other body cavity in patient 28), (b) prevents high current density that can cause arcing during IRE ablation, (c) provides the axial electrode with sufficient surface area to dissipate heat during ablation, and (d) provides greater maneuverability for the axial electrode." Further, claim 13 only recites a surface contour (rounded) and fails to recite the shape of the axial electrode in combination with the rounded surface, diameter, thickness, and radius of curvature.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights