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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2025 and 11/17/20254 are being considered by the examiner.
Response to Amendment
The amendment filed 08/25/2025 has been entered. Claims 1-9, 10-13 and 16 remain pending in the application. Applicant’s amendments to the claims 4-10 and 13 have overcome the 112(b) rejection previously set forth in the Non-final Office Action mailed 4/25/2025.
Response to Arguments
Regarding applicant’s arguments, see pages 5 lines 16-21 that, in view of amendments, Ditter does not explicitly disclose ablation electrodes in both loops of the apparatus is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Stewart et al. (US 20020111618 A1)
Applicant’s arguments, see pages 5 lines 22-25 that, in, view of amendments, Ditter teaches away from electrodes in the distal loop. While Ditter does not explicitly teach electrodes in the distal loop this is not grounds to view Ditter as teaching away from electrodes in the distal end. The following is a quotation of MPEP 2145(D)(01) regarding the nature of the teaching and what constitutes teaching away:
A prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness. However, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (Claims were directed to an epoxy resin based printed circuit material. A prior art reference disclosed a polyester-imide resin based printed circuit material, and taught that although epoxy resin based materials have acceptable stability and some degree of flexibility, they are inferior to polyester-imide resin based materials. The court held the claims would have been obvious over the prior art because the reference taught epoxy resin based material was useful for the inventor’s purpose, applicant did not distinguish the claimed epoxy from the prior art epoxy, and applicant asserted no discovery beyond what was known to the art.).
Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) ("Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination.").
Regarding applicant’s arguments, see pages 6 lines 1-3 that, Ditter does not explicitly disclose first loop diameter increasing toward the second loop section is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Stewart et al. (US 20020111618 A1)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ditter (presented in previous office action).
Regarding claim 11, Ditter teaches: An ablation catheter for treatment of a patient's tissue by delivery of high-voltage pulses comprising: a catheter shaft and an ablation portion being arranged at a distal end of the catheter shaft with a plurality of electrodes accommodated spaced from one another along the ablation portion ([Figure 2]; Specifically, Ditter teaches a catheter shaft 14 and ablation portion 22 at the distal end of the catheter shaft and a plurality of electrodes 19 along the ablation portion), wherein the plurality of electrodes comprises at least one first electrode of a first electrode type and at least one second electrode of a second electrode type ([Figure 11]; Specifically Ditter teaches use of AR and IR electrodes), wherein a first surface area of the first electrode type is smaller than a second surface area of the second electrode type. (Column 12 lines 37-40]; Specifically, Ditter teaches the IR electrodes are narrower than the AR electrodes which is seen as having a smaller surface area)
Regarding claim 12, Ditter teaches: The ablation catheter of claim 11. Ditter further teaches: wherein a sequence of accommodation of the electrodes along the ablation portion is such that one first electrode and one second electrode alternate. ([Figure 11] Specifically, Ditter teaches AR and IR electrodes alternating)
Regarding claim 13, Ditter teaches: The ablation catheter of claim 11, wherein the ablation portion forms a three- dimensional spiral ([Figure 2] Specifically, Ditter teaches the ablation portion 22 being a spiral) , wherein a sequence of accommodation of the electrodes along the ablation portion is such that a plurality of second the electrodes is accommodated along a spiral section having a greater inner diameter and that a plurality of the first electrodes is accommodated along a spiral section having a smaller inner diameter. ([Figure 16] Specifically, Ditter teaches second electrodes along a loop with a greater inner diameter and first electrodes along a loop having a smaller inner diameter)
Regarding claim 16, Ditter teaches: An ablation catheter for treatment of a patient's tissue by delivery of high-voltage pulses comprising: a catheter shaft having an ablation portion arranged at a distal end of the catheter shaft ([Figure 2]; Specifically, Ditter teaches a catheter shaft 14 and ablation portion 22 at the distal end of the catheter shaft and a plurality of electrodes 19 along the ablation portion. Shown in the picture shown below), the ablation portion comprising a plurality of ablation electrodes ([Figure 2]; Ditter teaches ablation electrodes 19 arranged on the ablation portion), wherein the ablation portion forms a spiral and comprises a first loop section and a neighboring second loop section, wherein an inner diameter of the first loop section decreases towards an inner diameter of the second loop section starting from a first end of the first loop section located opposite the second loop section ([Figure 2]; Ditter disclose neighboring loops wherein the diameter of the loops decreases toward the distal end), wherein the first loop section has a greater stiffness than the second loop section. ([Column 2 lines 52-58]; “Whereas the distal loop has a smaller radius, a softer structure with a greater flexibility, and a softer straight distal end section that helps guide the distal loop into the tubular region, the proximal loop has a stiffer structure and a larger radius to ensure contact between its electrodes and the ostium of the tubular region. “)
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.
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) 1-3 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Stewart et al. (US 20020111618 A1) herein referred to as “Stewart”.
Regarding claim 1, Ditter discloses: An ablation catheter for treatment of a patient's tissue by delivery of high-voltage pulses comprising: a catheter shaft and an ablation portion being arranged at a distal end of the catheter shaft with a plurality of electrodes accommodated along the ablation portion ([Figure 2]; Specifically, Ditter discloses a catheter shaft 14 and ablation portion 22 at the distal end of the catheter shaft and a plurality of electrodes 19 along the ablation portion. Shown in the picture shown below), wherein the ablation portion forms a spiral and comprises a first loop section and a neighboring second loop section, ([Figure 2]; Specifically, Ditter discloses the ablation portion made comprising a first spiral loop and neighboring loops see annotated figure below), wherein the first loop section has a greater stiffness than the second loop section. ([Column 2 lines 52-58] Specifically, Ditter discloses that the first loop has a greater stiffness than the second loop)
Ditter does not teach: Ablation electrodes along the ablation portion and wherein an inner diameter of the first loop section increases towards an inner diameter of the second loop section starting from a first end of the first loop section located opposite the second loop section.
However, Stewart discloses: Ablation electrodes along the ablation portion ([Figure 3B]; Stewart discloses ablation electrodes along the both the first and second loops) and wherein an inner diameter of the first loop section increases towards an inner diameter of the second loop section starting from a first end of the first loop section located opposite the second loop section. ([Figure 3B]; Stewart discloses the inner diameters of the loops increasing toward the second loop. As shown below)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter as disclosed by Ditter with the ablation electrodes and the increasing diameter geometry as disclosed by Stewart the motivation being to provide electrodes in each loop segment ([0087]) and the simple substitution of an ablation section of a catheter to obtain the predictable result of lesion ablation respectively.
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Regarding claim 2, Ditter in view of Stewart disclose: The catheter of claim 1. Ditter further discloses: wherein the ablation portion is connected to the catheter shaft by a transition joint. ([Figure 2]; Specifically, Ditter discloses the ablation portion 22 connected to catheter shaft 14 via transition joint 20)
Regarding claim 3, Ditter in view of Stewart disclose: The catheter of claim 1. Ditter further discloses: wherein the ablation catheter further comprises a third loop section which is a neighboring section to the second loop section ([Figure 2] Specifically, Ditter discloses a third loop 17D), section wherein the third loop section has a greater stiffness than the second loop (]Column 5 lines 35-40]; Ditter discloses a distal loop being more resilient than the proximal loop which is seen as stiffer)
Ditter does not disclose: wherein an inner diameter of the third loop section increases along the third loop section starting with the end that is closest to the second loop section wherein the third loop section has a greater stiffness than the second loop section.
However, Stewart discloses: herein an inner diameter of the third loop section increases along the third loop section starting with the end that is closest to the second loop section ([Figure 3B] As shown above).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter as disclosed by Ditter with the increasing diameter geometry as disclosed by Stewart the simple substitution of an ablation section of a catheter to obtain the predictable result of lesion ablation respectively.
Regarding claim 6, Ditter in view of Stewart discloses: The catheter of claim 4. Ditter further discloses: wherein the wire of the second loop section comprises at least one indentation and/or the wire of the first loop section ([Figure 2] Specifically, Ditter discloses indentations along a second loop that has indents)
Regarding claim 7, Ditter in view of Stewart disclose: The catheter of claim 1. Ditter further discloses: wherein a pitch and/or clearance is provided between the first loop section and the second loop section. ([Figure 2] Specifically, Ditter discloses a clearance between first loop and second loop)
Regarding claim 8, Ditter in view of Stewart disclose: The catheter of claim 7. Ditter further discloses: wherein the pitch and/or clearance between the first loop section and the second loop section is between 2 mm and 8 mm, in particular between 4 mm and 6 mm. ([Column 8 lines 5-11] Specifically, Ditter discloses a pitch of 7.2 mm which is within the range specified)
Regarding claim 9, “or” is seen as a coordinating conjunction that connects two or more possibilities for examination purposes “wherein the first end of the first loop section is directly attached to the distal end of the catheter shaft” the possibility being taught.
Ditter in view of Stewart disclose: The catheter of claim 1. Ditter further discloses: wherein the first end of the first loop section is directly attached to the distal end of the catheter shaft or a second end of the second loop section or, if applicable, a second end of the third loop section is directly attached to the distal end of the catheter shaft ([Figure 2] Specifically, Ditter discloses a first loop attached to a catheter shaft), wherein the second end of the second loop section and, if applicable, the second end of the third loop section is located opposite the first loop section ([Figure 2]; Specifically, Ditter discloses a second opposite the first loop).
Regarding claim 10, Ditter in view of Stewart disclose: The catheter of claim 7. Ditter further discloses: wherein the catheter shaft is located at or close to an axis of the spiral form of the ablation portion. ([Figure 3] Specifically, Ditter discloses the spiral ablation assembly on the same axis as the catheter shaft)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Stewart in view of further reasoning.
Regarding claim 4, Ditter in view of Stewart disclose: The catheter of claim 1. Ditter further discloses: wherein the respective stiffness of the first loop section and the second is provided by the form and/or the material of a wire, of the respective loop section. ([Column 8 lines 54 – 60] Specifically, Ditter discloses a support member 50 that gives stiffness and form to the loops of distal section 17)
Regarding claim 5, Ditter in view of Stewart disclose: The catheter of claim 4. Ditter further discloses essentially as claimed: wherein a first diameter of the wire, of the first loop section is greater than a second diameter of the wire, of the second loop section ([Figure 2] Specifically, Ditter discloses the diameter of the wire increasing from a first loop to a second loop) wherein the first diameter is between 350 um and 700 um and the second diameter is between 200 um and 349 um. ([Column 9 lines 6-11]; “Moreover, the support member can have a varying thickness along its length, for example, being thinner distally and thicker proximally so that a distal portion can be more readily contracted and a proximal portion can better withstand the load from an axial force that is applied when the distal assembly 17 comes into contact with target tissue.”)
However, Ditter does not expressly disclose: The first diameter between 350 up and 700 um and the second diameter is between 200 um and 349 um.
It appears that the device of Ditter would operate equally well with the claimed diameter since the both devices are directed to use within the confines of a patient’s heart. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the diameter “for example” be within the claimed ranges (specification page 6 pp 0006 and page 19 pp 0001.)
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 Ditter to have a first diameter between 350 up and 700 um and the second diameter is between 200 um and 349 um because it appears to be an arbitrary design consideration which fails to patentable distinguish over Ditter.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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