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 (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.
Priority
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, PCT Application No. PCT/US2017/012099, fails to provide 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 the claims (note the specifically-claimed ‘looped spline’ and ‘inner shaft-spline’ arrangements).
The Examiner notes that support for the claims has been found in U.S. Provisional Application No. 62/491,910 (dated 4/28/17). As such, the Examiner will be taking this priority date for the purpose of examination.
Information Disclosure Statement
The information disclosure statement filed 9/3/26 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the cited reference lacked an English translation. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related application. That is, the parent application is referenced as a U.S. application even though it has issued as a patent. The paragraph should be amended to include the appropriate patent number.
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 10, 19, 20, 22, and 26 are objected to because of the following informalities: In claim 1, line 18, “at a second distance” should be deleted; In claim 10, line 19, “extends” should be replaced with -extending-; In claims 19 (lines 1 and 2), 20 (line 3), 22 (line 1), and 26, “first electrodes” should be replaced with -first ablation electrodes-. 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.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation "each loop" in line. There is insufficient antecedent basis for this limitation in the claim, since no loops have been previously claimed.
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 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,727,940. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patented claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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, 2, 4-5, 7-16, 18-23, 26, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliason, U.S. 2014/0257069 (hereinafter Eliason).
Regarding claim 1, Eliason discloses (note figs. 2-5; paragraphs 32 and 34) a catheter comprising: a catheter shaft (24) defining a longitudinal axis and having a proximal end, a distal end opposite the proximal end, and at least one shaft lumen therethrough; an inner shaft (54) disposed within the at least one shaft lumen; a set of splines (36) coupled with the catheter shaft, each spline of the set of splines including a set of ablation electrodes (‘42’ – note paragraph 32) disposed thereon, wherein each spline of the set of splines has a proximal end attached to the distal end of the catheter shaft and a distal end attached to a distal end of the inner shaft (necessarily – note paragraph 35); wherein the inner shaft is movable within the at least one shaft lumen along the longitudinal axis from a first inner shaft position defining a first (initial, compressed) configuration of the set of splines to a second inner shaft position defining a second expanded configuration of the set of splines (note abstract; paragraph 35); wherein in the first configuration each spline of the set of splines necessarily extends ‘substantially’ parallel to the longitudinal axis (i.e., at least a portion of each spline necessarily extends in this manner – note paragraph 29) and the distal end of each spline is located at a first distance from the distal end of the catheter shaft (necessarily – note paragraph 29); and wherein in the second configuration the distal end of each spline is located at a second distance from the distal end of the catheter shaft, wherein the second distance is less than the first distance, and wherein the ablation electrodes along each spline are positioned such that none of the ablation electrodes overlap with an ablation electrode on an adjacent spline (necessarily – note fig. 5).
Regarding claim 2, Eliason discloses (see above) a catheter further comprising a distal cap (52) coupled with the distal end of each spline, the distal cap defining a cap lumen therethrough and configured to receive a guidewire (note paragraphs 27-28).
Regarding claim 4, Eliason discloses (see above) a catheter wherein in the second configuration the set of splines are arranged as a set of loops, wherein each loop of the set of loops partially overlaps with an adjacent loop (note fig. 5).
Regarding claim 5, Eliason discloses (see above) a catheter wherein the set of splines are configured to helically rotate about the longitudinal axis (note paragraph 35).
Regarding claim 7, Eliason discloses (see above) a catheter wherein the set of splines comprises five (5) splines (note paragraph 34).
Regarding claims 8 and 9, Eliason discloses (see above) a catheter capable of being used in the claimed manner (note paragraphs 29, 32, and 33). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10, Eliason discloses (note figs. 2-5; paragraphs 32 and 34) a catheter comprising: a catheter shaft (24) defining a longitudinal axis and having a proximal end, a distal end opposite the proximal end, and at least one shaft lumen therethrough; an inner shaft (54) disposed within the at least one shaft lumen; a set of splines (36) coupled with the catheter shaft, each spline of the set of splines including a set of ablation electrodes (‘42’ – note paragraph 32) disposed thereon, wherein each spline of the set of splines has a proximal end attached to the distal end of the catheter shaft, a distal end attached to a distal end of the inner shaft, and an intermediate portion adapted to be radially displaceable away from the longitudinal axis (necessarily – note paragraph 35); wherein the inner shaft is movable within the at least one shaft lumen along the longitudinal axis from a first inner shaft position defining a first (initial, compressed) configuration of the set of splines to a second inner shaft position defining a second expanded configuration of the set of splines (note abstract; paragraph 35); wherein in the first configuration the set of splines necessarily define a longitudinally extending ‘cylinder’ (note paragraph 29); and wherein in the second configuration the set of splines are necessarily arranged as a set of loops with the intermediate portion of each spline extending radially away from the catheter shaft and the inner shaft, and wherein the ablation electrodes along each spline are necessarily ‘angularly offset’ from the ablation electrodes on an adjacent spline (note figs. 3 and 5).
Regarding claim 11-14, Eliason discloses (see above) a catheter capable of being used in the claimed manner (note paragraphs 29, 32, and 33). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 15, Eliason discloses (see above) a catheter wherein each set of electrodes includes at least one proximal electrode and at least one distal electrode, and wherein the distal electrodes intersect a plane that is substantially orthogonal to the longitudinal axis (note fig. 3).
Regarding claim 16, Eliason discloses (see above) a catheter wherein in the first configuration the distal end of each spline is located at a first distance from the distal end of the catheter shaft and, in the second configuration, the distal end of each spline is located at a second distance from the distal end of the catheter shaft, wherein the second distance is less than the first distance (note figs. 3 and 5; paragraph 35).
Regarding claim 18, Eliason discloses (note figs. 2-5; paragraphs 32 and 34) a catheter comprising: a catheter shaft (24) defining a longitudinal axis and having a proximal end, a distal end opposite the proximal end, and at least one shaft lumen therethrough; an inner shaft (54) disposed within the at least one shaft lumen; a set of splines (36) coupled with the catheter shaft, each spline of the set of splines including one or more first ablation electrodes (‘42’ – note paragraph 32) disposed thereon, wherein each spline of the set of splines has a proximal end attached to the distal end of the catheter shaft, a distal end attached to a distal end of the inner shaft, and an intermediate portion extending between the proximal end and the distal end (necessarily – note paragraph 35); wherein the inner shaft is movable within the at least one shaft lumen along the longitudinal axis from a first inner shaft position defining a first (initial, compressed) configuration of the set of splines to a second inner shaft position defining a second expanded configuration of the set of splines (note abstract; paragraph 35); wherein in the first configuration each spline of the set of splines necessarily extends ‘substantially’ parallel to the longitudinal axis (i.e., at least a portion of each spline necessarily extends in this manner – note paragraph 29); and wherein in the second configuration the distal ends of each spline are necessarily positioned ‘adjacent’ (i.e., near) the distal end of the catheter shaft and each spline necessarily forms a ‘petal-shaped curve’, and wherein the ‘intermediate portion’ of each spline does not overlap with the ‘intermediate portion’ of an adjacent spline (note fig. 5).
Regarding claim 19, Eliason discloses (see above) a catheter wherein the first electrodes on each spline are ‘electrically interconnected’ (i.e., connected to the same power source/generator) such that the catheter is capable of being used in the claimed manner (note paragraphs 29, 32, and 33). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 20, Eliason discloses (see above) a catheter wherein at least one spline of the set of splines includes one or more second electrodes (note figs. 3 and 5), wherein the one or more second electrodes are electrically addressable independent of the first electrodes on that spline (note paragraphs 29, 32, and 33).
Regarding claim 21, Eliason discloses (see above) a catheter wherein the one or more second electrodes are capable of receiving an ECG signal (note paragraph 32). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 22, Eliason discloses (see above) a catheter wherein each of the first electrodes are independently electrically addressable (note paragraphs 29, 32, and 33).
Regarding claim 23, Eliason discloses (see above) a catheter wherein each spline of the set of splines defines a spline lumen, each spline lumen receiving at least one electrical lead extending from the at least one shaft lumen, and wherein the at least one electrical lead is electrically connected with the one or more first ablation electrodes (note paragraphs 29, 32, and 33).
Regarding claim 26, Eliason discloses (see above) a catheter comprising: wherein each spline includes at least three (3) first electrodes (note figs. 3 and 5).
Regarding claim 27, Eliason discloses (see above) a catheter comprising: wherein each spline is necessarily configured to ‘twist away’ from the longitudinal axis as the inner shaft is moved from the first inner shaft position to the second inner shaft position (note figs. 3 and 5; paragraph 35).
Claim(s) 1, 3, 8, 9, 18-22, 24, 26, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swanson, U.S. 2002/0183638 (hereinafter Swanson).
Regarding claim 1, Swanson discloses (note figs. 12A-B) a catheter comprising: a catheter shaft (140) defining a longitudinal axis and having a proximal end, a distal end opposite the proximal end, and at least one shaft lumen therethrough; an inner shaft (142) disposed within the at least one shaft lumen; a set of splines (132) coupled with the catheter shaft, each spline of the set of splines including a set of ablation electrodes (‘130’ – note abstract) disposed thereon, wherein each spline of the set of splines has a proximal end attached to the distal end of the catheter shaft and a distal end attached to a distal end of the inner shaft (note paragraph 170); wherein the inner shaft is movable within the at least one shaft lumen along the longitudinal axis from a first inner shaft position defining a first configuration of the set of splines to a second inner shaft position defining a second configuration of the set of splines (note paragraph 172); wherein in the first configuration each spline of the set of splines necessarily extends ‘substantially’ parallel to the longitudinal axis (i.e., at least a portion of each spline necessarily extends in this manner) and the distal end of each spline is located at a first distance from the distal end of the catheter shaft (note fig. 12A); and wherein in the second configuration the distal end of each spline is located at a second distance from the distal end of the catheter shaft, wherein the second distance is less than the first distance, and wherein the ablation electrodes along each spline are positioned such that none of the ablation electrodes overlap with an ablation electrode on an adjacent spline (note fig. 12B).
Regarding claim 3, Swanson discloses (see above) a catheter wherein in the second configuration the set of splines are arranged as a set of non-overlapping loops (note fig. 12B).
Regarding claims 8 and 9, Swanson discloses (see above) a catheter capable of being used in the claimed manner (note paragraphs 134 and 150). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 18, Swanson discloses (note figs. 12A-B) a catheter comprising: a catheter shaft (140) defining a longitudinal axis and having a proximal end, a distal end opposite the proximal end, and at least one shaft lumen therethrough; an inner shaft (142) disposed within the at least one shaft lumen; a set of splines (132) coupled with the catheter shaft, each spline of the set of splines including one or more first ablation electrodes (‘130’ – note abstract) disposed thereon, wherein each spline of the set of splines has a proximal end attached to the distal end of the catheter shaft, a distal end attached to a distal end of the inner shaft, and an intermediate portion extending between the proximal end and the distal end (necessarily – note paragraph 170); wherein the inner shaft is movable within the at least one shaft lumen along the longitudinal axis from a first inner shaft position defining a first configuration of the set of splines to a second inner shaft position defining a second configuration of the set of splines (note paragraph 172); wherein in the first configuration each spline of the set of splines necessarily extends ‘substantially’ parallel to the longitudinal axis (i.e., at least a portion of each spline necessarily extends in this manner – note fig. 12A); and wherein in the second configuration the distal ends of each spline are necessarily positioned ‘adjacent’ (i.e., near) the distal end of the catheter shaft and each spline necessarily forms a ‘petal-shaped curve’, and wherein the ‘intermediate portion’ of each spline does not overlap with the ‘intermediate portion’ of an adjacent spline (note fig. 12B).
Regarding claim 19, Swanson discloses (see above) a catheter wherein the first electrodes on each spline are ‘electrically interconnected’ (i.e., connected to the same power source/generator) such that the catheter is capable of being used in the claimed manner (note paragraphs 134 and 150). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 20, Swanson discloses (see above) a catheter wherein at least one spline of the set of splines includes one or more second electrodes (note figs. 12A-B), wherein the one or more second electrodes are electrically addressable independent of the first electrodes on that spline (note paragraphs 134 and 150).
Regarding claim 21, Swanson discloses (see above) a catheter wherein the one or more second electrodes are capable of receiving an ECG signal (note paragraph 287). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 22, Swanson discloses (see above) a catheter wherein each of the first electrodes are independently electrically addressable (note paragraphs 134 and 150).
Regarding claim 24, Swanson discloses (see above) a catheter wherein in the second configuration each loop does not overlap with any other loop (note fig. 12B).
Regarding claim 26, Swanson discloses (see above) a catheter comprising: wherein each spline includes at least three (3) first electrodes (note figs. 12A-B).
Regarding claim 27, Swanson discloses (see above) a catheter comprising: wherein each spline is necessarily configured to ‘twist away’ from the longitudinal axis as the inner shaft is moved from the first inner shaft position to the second inner shaft position (note figs. 12A-B).
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.
Claim(s) 6, 17, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eliason.
Regarding claims 6, 17, and 25, Eliason discloses (see above) a catheter comprising splines with ablation electrodes thereon. However, Eliason fails to explicitly disclose the specific size/orientation of these splines. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the splines to have a wide range of dimensions/orientations (including the claimed ones), 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. In re Aller, 105 USPQ 233. It should also be noted that such a modification would have involved a mere change in the size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swanson.
Regarding claim 25, Swanson discloses (see above) a catheter comprising splines with ablation electrodes thereon. However, Swanson fails to explicitly disclose the specific dimensions of these splines. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the splines to have a wide range of dimensions (including the claimed ones), 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. In re Aller, 105 USPQ 233. It should also be noted that such a modification would have involved a mere change in the size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2017/0071543 (Basu).
U.S. 2013/0172715 (Just).
U.S. 2011/0213231 (Hall).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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