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 .
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.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-14 of U.S. Patent No. 11,911,093. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the examined claims 1-20 would have been obvious over the reference claims 1-6 and 8-14.
Regarding claim 1, Patent ‘093 claims an apparatus, comprising: a catheter; a tip electrode, at a distal end of the catheter, shaped to define a plurality of fluid apertures; and a structure, within the tip electrode, configured such that fluid passed distally through a lumen of the catheter flows in a longitudinal direction through a space between the structure and an inner surface of the tip electrode, prior to exiting through the fluid apertures (see reference claim 1).
Regarding claim 2, Patent ‘093 claims wherein the structure is configured such that fluid flows through the space in a distal direction (see reference claim 2).
Regarding claim 3, Patent ‘093 claims wherein the structure is configured such that the fluid flows through the space in a proximal direction (see reference claim 3).
Regarding claim 4, Patent ‘093 claims wherein the structure comprises a conduit (see reference claim 1).
Regarding claim 5, Patent ‘093 claims wherein the conduit is configured such that the fluid exits a distal opening of the conduit, and is then deflected into the space by a distal face of the tip electrode (see reference claim 1).
Regarding claim 6, Patent ‘093 claims wherein a majority of the fluid apertures are in a circumferential face of the tip electrode (see reference claim 1).
Regarding claim 7, Patent ‘093 claims wherein the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode (see reference claim 5).
Regarding claim 8, Patent ‘093 claims wherein the structure is shaped to define one or more circumferential openings, such that the fluid flows into the space through the circumferential openings (see reference claim 4).
Regarding claim 9, Patent ‘093 claims wherein the space is less than 0.3 mm in a radial direction (see reference claim 5).
Regarding claim 10, Patent ‘093 claims wherein at least part of the space is less than 0.1 mm in a radial direction (see reference claim 6).
Regarding claim 11, Patent ‘093 claims a method, comprising: using a tip electrode at a distal end of a catheter, passing an ablating signal into tissue; and while passing the ablating signal into the tissue, causing fluid to flow in a longitudinal direction through a space between a structure and an inner surface of the tip electrode, and to subsequently exit the tip electrode through fluid apertures in the tip electrode (see reference claim 8).
Regarding claim 12, Patent ‘093 claims wherein causing the fluid to flow in the longitudinal direction comprises causing the fluid to flow in a distal direction (see reference claim 9).
Regarding claim 13, Patent ‘093 claims wherein causing the fluid to flow in the longitudinal direction comprises causing the fluid to flow in a proximal direction (see reference claim 10).
Regarding claim 14, Patent ‘093 claims wherein the structure includes a conduit, and wherein the method further comprises causing the fluid to flow through the conduit prior to flowing through the space (see reference claim 8).
Regarding claim 15, Patent ‘093 claims causing the fluid to exit a distal opening of the conduit, and to be deflected into the space by a distal face of the tip electrode (see reference claim 8).
Regarding claim 16, Patent ‘093 claims wherein the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode (see reference claim 13).
Regarding claim 17, Patent ‘093 claims causing the fluid to flow into the space through one or more circumferential openings in the structure (see reference claim 11).
Regarding claim 18, Patent ‘093 claims wherein a majority of the fluid apertures are in a circumferential face of the tip electrode (see reference claim 12).
Regarding claim 19, Patent ‘093 claims wherein the space is less than 0.3 mm in a radial direction (see reference claim 13).
Regarding claim 20, Patent ‘093 claims wherein at least part of the space is less than 0.1 mm in a radial direction (see reference claim 14).
Therefore, examined claims 1-20 are not patentably distinct from reference claims 1-6 and 8-14.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christian et al., (US 20120165809), hereinafter Christian.
Regarding claim 1, Christian discloses (Figure 8) an apparatus, comprising: a catheter (15); a tip electrode (216), at a distal end (210) of the catheter (15), shaped to define a plurality of fluid apertures (60); and a structure (214), within the tip electrode (216), configured such that fluid passed distally through a lumen (230) of the catheter (15) flows in a longitudinal direction through a space (252, 232) between the structure (214) and an inner surface of the tip electrode (216), prior to exiting through the fluid apertures (60) ([0058]-[0059]).
Regarding claim 2, Christian discloses (Figure 8) that the structure (214) is configured such that fluid flows through the space (252, 232) in a distal direction ([0058]).
Regarding claim 3, Christian discloses (Figure 8) that the structure (214) is configured such that the fluid flows through the space (252, 232) in a proximal direction ([0058]).
Regarding claim 4, Christian discloses (Figure 8) that the structure comprises a conduit (262), ([0058]).
Regarding claim 5, Christian discloses (Figure 8) that the conduit (262) is configured such that the fluid exits a distal opening (268) of the conduit (262), and is then deflected into the space by a distal face (236) of the tip electrode (216), ([0058]).
Regarding claim 11, Christian discloses (Figures 8 and 9) a method, comprising: using a tip electrode (216) at a distal end (210) of a catheter (15), passing an ablating signal into tissue; and while passing the ablating signal into the tissue, causing fluid to flow in a longitudinal direction through a space (252, 232) between a structure (214) and an inner surface of the tip electrode (216), and to subsequently exit the tip electrode (216) through fluid apertures (60) in the tip electrode (216), ([0059], [0060]-[0064]).
Regarding claim 12, Christian discloses (Figures 8 and 9) that causing the fluid to flow in the longitudinal direction comprises causing the fluid to flow in a distal direction ([0058]).
Regarding claim 13, Christian discloses (Figures 8 and 9) that causing the fluid to flow in the longitudinal direction comprises causing the fluid to flow in a proximal direction ([0058]).
Regarding claim 14, Christian discloses (Figure 8 and 9) that the structure (214) includes a conduit (262), and wherein the method further comprises causing the fluid to flow through the conduit (262) prior to flowing through the space (252, 232), ([0058]).
Regarding claim 15, Christian discloses (Figures 8 and 9) causing the fluid to exit a distal opening (268) of the conduit (262), and to be deflected into the space (252, 232) by a distal face (236) of the tip electrode ([0058]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claim 5 above, and further in view of Grunewald et al., (US 20130123775), hereinafter Grunewald.
Regarding claim 6, Christian discloses the apparatus of claim 5, but fails to disclose that a majority of the fluid apertures are in a circumferential face of the tip electrode. Rather, Christian discloses that all of the fluid apertures (60) are in a circumferential face of the tip electrode (210), ([0059]). However, Grunewald teaches (Figure 5) a catheter having a tip electrode (50) with fluid apertures (60) in both the distal face (64) and the circumferential face (62) of the tip electrode (50), with a majority of the fluid apertures (60) in the circumferential face (62) of the tip electrode (50), ([0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian such that a majority of the fluid apertures are in a circumferential face of the tip electrode, as taught by Grunewald, because the modification would provide fluid apertures in the distal face of the tip electrode as well (Grunewald, [0074]) to ensure fluid flows from apertures around the entire tip electrode for efficient cooling.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claims 1 and 5 above, and further in view of Ingle (US 20110160726).
Regarding claims 7 and 9, Christian discloses the apparatus of claims 1 and 5, but fails to disclose that the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space is less than 0.3 mm in a radial direction, wherein at least part of the space is less than 0.1mm in a radial direction. However, Ingle teaches (Figure 6) a catheter having a conduit (130) within a structure (140) inside a tip electrode (126), wherein the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space between the structure and the inner surface of the tip electrode is less than 0.3 mm in a radial direction ([0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian such that the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space is less than 0.3 mm in a radial direction, as taught by Ingle, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claim 1 above, and further in view of Skarda (US 20050055019).
Regarding claim 8, Christian discloses the apparatus of claim 1, but fails to disclose that the structure is shaped to define one or more circumferential openings, such that the fluid flows into the space through the circumferential openings. However, Skarda teaches (Figure 7) a catheter having a tip electrode (12) having a structure (50) within it that is shaped to define one or more circumferential openings (54), such that fluid flows into a space between the structure (50) and the inner surface of the shell (30) through the circumferential openings (54), ([0015]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian to include the circumferential openings on the structure taught by Skarda because the modification would allow the fluid to fill the chamber through the multiple openings (Skarda, [0015]) to efficiently facilitate flow of the fluid.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Christian.
Regarding claim 10, Christian discloses (Figure 8) that the space (252, 232) comprises one part (252) which is smaller than another part (232) such that the space between the first part (252) and the inner surface of the tip electrode (216) is smaller than the space between the second part (232) and the inner surface of the tip electrode (216). Christian fails to disclose that at least part of the space is specifically less than 0.1 mm in a radial direction. However, since it was disclosed that part of the space was smaller than another part of the space, it would have been obvious to modify Christian such that at least part of the space is specifically less than 0.1 mm in a radial direction since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claims 11 and 15 above, and further in view of Ingle.
Regarding claims 16 and 19, Christian discloses the method of claims 11 and 15, but fails to disclose that the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space is less than 0.3 mm in a radial direction, wherein at least part of the space is less than 0.1mm in a radial direction. However, Ingle teaches (Figure 6) a catheter having a conduit (130) within a structure (140) inside a tip electrode (126), wherein the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space between the structure and the inner surface of the tip electrode is less than 0.3 mm in a radial direction ([0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian such that the distal opening of the conduit is positioned within 0.3 mm of the distal face of the tip electrode and the space is less than 0.3 mm in a radial direction, as taught by Ingle, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claim 11 above, and further in view of Ingle.
Regarding claim 17, Christian discloses the method of claim 11, but fails to disclose causing the fluid to flow into the space through one or more circumferential openings in the structure. However, Skarda teaches (Figure 7) a catheter having a tip electrode (12) having a structure (50) within it that is shaped to define one or more circumferential openings (54), such that fluid flows into a space between the structure (50) and the inner surface of the shell (30) through the circumferential openings (54), ([0015]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian to include the step of causing the fluid to flow into the space through one or more circumferential openings in the structure, as taught by Skarda, because the modification would allow the fluid to fill the chamber through the multiple openings (Skarda, [0015]) to efficiently facilitate flow of the fluid.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Christian as applied to claim 11 above, and further in view of Grunewald.
Regarding claim 18, Christian discloses the method of claim 11, but fails to disclose that a majority of the fluid apertures are in a circumferential face of the tip electrode. Rather, Christian discloses that all of the fluid apertures (60) are in a circumferential face of the tip electrode (210), ([0059]). However, Grunewald teaches (Figure 5) a catheter having a tip electrode (50) with fluid apertures (60) in both the distal face (64) and the circumferential face (62) of the tip electrode (50), with a majority of the fluid apertures (60) in the circumferential face (62) of the tip electrode (50), ([0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Christian such that a majority of the fluid apertures are in a circumferential face of the tip electrode, as taught by Grunewald, because the modification would provide fluid apertures in the distal face of the tip electrode as well (Grunewald, [0074]) to ensure fluid flows from apertures around the entire tip electrode for efficient cooling.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Christian.
Regarding claim 20, Christian discloses (Figure 8) that the space (252, 232) comprises one part (252) which is smaller than another part (232) such that the space between the first part (252) and the inner surface of the tip electrode (216) is smaller than the space between the second part (232) and the inner surface of the tip electrode (216). Christian fails to disclose that at least part of the space is specifically less than 0.1 mm in a radial direction. However, since it was disclosed that part of the space was smaller than another part of the space, it would have been obvious to modify Christian such that at least part of the space is specifically less than 0.1 mm in a radial direction since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached on 9AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached on (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794