DETAILED ACTION
The following is a 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.
Response to Amendment
Acknowledgment is made to the amendment received 2/11/2026.
Applicant’s amendments are sufficient to overcome the specification objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to and/or cancellation of the claims are sufficient to overcome the claim objections 35 USC 112(a)/first paragraph set forth in the previous office action except for claim 6.
Applicant’s amendments are sufficient to overcome the double patenting rejections set forth in the previous office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 recites the limitation “a total area of respective outer openings of the multiple channels being at least 30% of an area of the outer surface”; however, the originally filed disclosure only provides support for the second plurality of channels (46) to contribute to the “at least 30% of the area” (“the total area of the respective outer openings of channels 46—including the concave channels and any convex channels—may be at least 30% of the area of the outer surface”, Par. [0071]) Thus, there is no support in the originally filed disclosure for the claimed limitation.
Claim Interpretation
The Examiner notes that “close-packed pattern” (claim 12) is defined in at least Par. [0113]: “For example, as shown in FIG. 6A, a plurality of circular mask apertures may be arranged in a close-packed pattern, with a distance L3 of between 0.05 and 0.5 mm between the respective centers of neighboring mask apertures. In some embodiments, L3 is approximately twice L2.”
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-10, 12-13 & 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingle et al. (2011/0160726) in view of Govari et al. (2018/0110562), Sterrett et al. (2017/0112405), and Jensen et al. (2013/0090650).
Concerning claims 1 & 13, as illustrated in at least Figs. 1 & 5-6, Ingle et al. disclose an apparatus (catheter 102; [0032]), comprising: multiple channels extending between the inner surface and the outer surface, comprising: a first plurality of channels extending between the inner surface and the outer surface, each of the first plurality of channels being configured to direct an irrigation fluid therethrough (a plurality of fluid outlets 134 connected to the fluid heating space; [0034]); and an electrically-conductive metal, comprising an interior and exterior (tip electrode 106 comprises conductive inner and outer surfaces; [0029]), a surface of the interior being shaped to define a depression configured to increase turbulence of a flow of the irrigation fluid (a raised or indented spiral pattern may be formed on the inner surface of the electrode 106 and/or the outer surface of the insulation member hemispherical portion 140 in order to increase the heat transfer effectiveness within the fluid heating space 132; [0040]).
Ingle et al. fail to disclose the apparatus comprising a flexible electrically insulative substrate. However, Govari et al. disclose an apparatus (catheter 22; [0021]) comprising: a distal tip assembly (40) comprised of a flexible electrically insulative substrate assembly (multi-layered flexible printed circuit board (PCB) sheet 60; [0027-0028]) comprising: multiple channels comprising a first plurality of channels (irrigation holes 64; [0026], [0036]) extending between an interior and exterior surface of the distal end and each of the first plurality of channels being configured to direct an irrigation fluid therethrough and a second plurality of channels (inherent electrical connection vias; [0035-0036]); and an electrically-conductive metal (electrode(s) 62 can be disposed on the inside or outside; [0031], [0034-0035]). 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 Ingle et al. such that the apparatus comprises a flexible electrically insulative substrate comprising multiple channels comprising a first plurality of channels and a second plurality of channels in order to provide the benefit of an improved distal end assembly that provides various functionalities within a small volume such as: (i) forms a mechanical substrate for mounting or embedding electrical devices such as electrodes or sensors, (ii) comprises conducting traces that convey electrical signals to/from the electrical devices, and/or (iii) comprises irrigation tubes and holes for irrigating the tissue, thus enabling integration of electrical devices and interconnections in a flexible substrate wrapped around a low cost molded plastic assembly rather than producing expensive micro-machined metal tubes, wires and electrodes, and mounting them on the metal tube area as taught by Govari et al. ([0014-0015], [0020], [0027-0028], [0031]; Fig. 1-4).
Ingle et al. in view of Govari et al. fail to disclose the flexible electrically insulative substrate comprising an inner surface; an outer surface; and the multiple channels extending between the inner surface and the outer surface, comprising: the second plurality of channels extending between the inner surface and the outer surface, each of the second plurality of channels being concave; and the electrically-conductive metal, comprising: an outer layer at least partially covering the outer surface; an inner layer at least partially covering the inner surface; and a plurality of columns, each of the second plurality of channels being filled with a corresponding one of the plurality of columns to connect the outer layer to the inner layer. However, Sterrett et al. disclose an apparatus (Fig. 1) comprising a flexible electrically insulative substrate, comprising an inner surface and an outer surface (under structure 385 coated with dielectric 387 comprises two surfaces that can be considered inner and outer surfaces when flexed; [0160]); multiple channels extending between the inner surface and the outer surface, comprising: a second plurality of channels extending between the inner surface and the outer surface, each of the second plurality of channels being concave (vias 386 extend between exterior surfaces of understructure 385 coated with dielectric 387 and are concave in shape; [0160]); and an electrically-conductive metal, comprising: an outer layer at least partially covering the outer surface; an inner layer at least partially covering the inner surface; and a plurality of columns, each of the second plurality of channels being filled with a corresponding one of the plurality of columns to connect the outer layer to the inner layer (electrically conductive trace 391 covers all of understructure 385 coated with dielectric 387 and each surface is electrically interconnected via vias 386, thus electrically coupling portions of the second electrically conductive trace 391 extending along the top, or outer, portion and the bottom, or inner, portion of the processed understructure 392, where traces are connected to an electrode; [0151], [0161-0163]). 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 Ingle et al. in view of Govari et al. such that the flexible electrically insulative substrate comprises an inner surface; an outer surface; and the multiple channels extend between the inner surface and the outer surface, comprise: the second plurality of channels extending between the inner surface and the outer surface, each of the second plurality of channels being concave; and the electrically-conductive metal, comprises: an outer layer at least partially covering the outer surface; an inner layer at least partially covering the inner surface; and a plurality of columns, each of the second plurality of channels being filled with a corresponding one of the plurality of columns to connect the outer layer to the inner layer in order to provide the benefit of an integrated flexible electrode structure as taught by Sterrett et al. ([0007]).
Ingle et al. in view of Govari et al. and Sterrett et al. fail to disclose the depression to be a plurality of depressions. However, Jenson et al. disclose an apparatus comprising a surface shaped to define one or more spirals configured to increase turbulence of a flow of irrigation fluid to facilitate heat transfer. 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 Ingle et al. in view of Govari et al. and Sterrett et al. such that the depression to be a plurality of depressions since Jenson et al. teaches one or more spiral patterns to be equivalent in the art for the purposes of inducing turbulent flow to facilitate heat transfer via fluid ([0047]; Fig. 9B) and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. See also In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Concerning claim 6, Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. fail to specifically disclose a total area of respective outer openings of the multiple channels being at least 30%. 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 device of Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. such that the percentage of a total area of respective outer openings of the first plurality of channels and the second plurality of channels is at least 30% of an area of the outer surface 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 Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. would not operate differently with the claimed percentage. Further, Applicant places no criticality on the range claimed, indicating that the total area “may be at least 30% of the area of the outer surface” ([0071]).
Concerning claim 7, Ingle et al. disclose the electrically-conductive metal comprising gold ([0033, [0039]).
Concerning claims 8 & 16, Ingle et al. disclose a probe (112) configured for insertion into a body; and a supporting structure (128) attached to the interior of the electrically-conductive metal (106) and coupled to a distal end of the probe (112) ([0034]; Fig. 6-7). The modified invention of Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. teaches the supporting structure attached to the inner layer of the electrically-conductive metal.
Concerning claim 9, Ingle et al. disclose the supporting structure (128) comprising a plurality of ribs (178) surrounding a lumen (130) ([0053]; Fig. 12).
Concerning claim 10¸ Ingle et al. disclose successive ribs (178) separated form one another by an aperture that is wider than each of the ribs (178) ([0053]; Fig. 12).
Concerning claim 12¸ Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. fail to specifically disclose the plurality of depressions to be circular and arranged in a close-packed pattern. However, Jenson et al. further teaches various shapes for the depressions, including spiral or circular ([0047]; Fig. 9B-11B). 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 Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. such that the plurality of depressions are circular since Jenson et al. teaches or more spiral patterns and one or more dimples/indentations/bumps/protrusions to be equivalents in the art for the purposes of inducing turbulent flow to facilitate heat transfer via fluid ([0047-0048]; Fig. 9B-11B). Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. fail to specifically disclose a sizing of the pattern such that it is a closely packed pattern (see Claim Interpretation section above). 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 Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. such that the pattern is a closely packed pattern because it appears to be an arbitrary design consideration which fails to patentably distinguish over Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. and the modified invention of Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. would operate equally well with the claimed closely-packed pattern. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the pattern “may” be arranged in any suitable arrangement, such as a grid pattern (specification pp. [0113]).
Concerning claim 17, Ingle et al. disclose the apparatus (102) configured to conduct ablation currents ([0029]). The modified invention of Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. teaches the ablation currents configured to be conductive at least via the outer layer of the electrically-conductive material.
Concerning claims 18-19, Ingle et al. disclose a sensor (104 // or // 162/164) attached to, and electrically insulated from, the electrically-conductive metal interior and configured to acquire physiological readings from tissue ([0033], [0042-0043]; Fig. 1 & 6). The modified invention of Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. teaches the sensor attached to and electrically insulated from the inner layer.
Claim(s) 2-5 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingle et al. (2011/0160726) in view of Govari et al. (2018/0110562), Sterrett et al. (2017/0112405) and Jenson et al. (2013/0090650), as applied to claims 1 & 13, in further view of Mahanta et al. (2017/0171957).
Concerning claims 2 & 20, Sterrett et al. further disclose each of the second plurality of channels (386) comprising: a central channel portion (386) (Fig. 17A-F). Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. fail to disclose each of the second plurality of channels comprising: at least one peripheral channel portion opening into the central channel portion. However, Mahanta et al. disclose a flexible electrically insulative substrate (11) comprising a plurality of channels (14) extending between an inner surface and outer surface of the flexible electrically insulative substrate (11), each of the plurality of channels (14) comprising: at least one peripheral channel portion (16) opening into a central channel portion (15). 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 Ingle et al. in view of Govari et al., Sterrett et al. and Jenson et al. such that each of the second plurality of channels comprises at least one peripheral channel portion opening into the central channel portion in order to provide the benefit of improving thermal dissipation as taught by Mahanta et al. ([0018], [0032], [0035]; at least Fig. 2, 4, 7-8)
Concerning claim 3, Mahanta et al. further disclose the at least one peripheral channel portion (16) comprising an arch shape opening into the central channel portion (15) ([0029]).
Concerning claim 4, Mahanta et al. further disclose the at least one peripheral channel portion (16) comprising a rectangular shape opening into the central channel portion (15) ([0029]) (Fig. 2 & 4-6).
Concerning claim 5, Ingle et al. in view of Govari et al., Sterrett et al., Jenson et al. and Mahanta et al. fail to disclose the at least one peripheral channel portion comprising a triangular shape opening into the central channel portion. However, Mahanta et al. disclose that the peripheral channels can have various shapes that affect the degree of cooling ([0029]). 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 Ingle et al. in view of Govari et al., Sterrett et al., Jenson et al. and Mahanta et al. such that the at least one peripheral channel portion comprises a triangular shape opening into the central channel portion in order to provide the benefit of affecting the degree of cooling as taught by Mahanta et al. and 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.
Response to Arguments
Applicant’s arguments are moot in view of the new ground(s) of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kallback et al. (2016/0228061) teaches a flex circuit catheter having a substrate (150) having inner and outer surfaces, channels for irrigation (141) and channels for conductive vias (140) connecting inner and outer metal layers (125 and/or 130 and/or 110).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794