DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 16/748480 & 13/3 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 16/748480 & 13/736794 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 one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 1/8/2013.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph to include patent numbers for the priority applications.
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because of the following informalities: amend “telescopically” to -telescopic- in ll. 2. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “trace a generally helical pattern” to -are configured to trace a first and second generally helical pattern- in ll. 2 (two patterns are traced as discussed in Par. [0088] & Fig. 15). Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the spines” to -the at least two spines- in ll. 1 & 3 (twice). Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “trace the generically helical pattern” to -are configured to trace a first generally helical pattern - in ll. 2. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “trace the generally helical pattern” to -are configured to trace a second generally helical pattern- in ll. 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the generally straight proximal portion" in ll. 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 7 will be interpreted as being dependent on claim 2.
Claim 8 recites the limitation “each of the first and second distal assemblies has at least five spines in total”; however, claim 1, upon which claim 8 depends, recites “each of the first and second distal assemblies comprising…at least two spines”. It is unclear if the “at least five spines” is in addition to the “at least two spines” previously recited. For purposes of examination, claim 8 will be interpreted as -wherein the at least two spines of the first and second distal assemblies comprises at least five spines-.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-6 & 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fuimaono et al. (2003/0125614) in view of Young et al. (2006/0095029) and Gough et al. (5,980,517).
Concerning claims 1 & 8, as illustrated in at least Figs. 1-4 & 7, Fuimaono et al. disclose a catheter (catheter 10; [0013]), comprising:
an elongated catheter body (elongated catheter body 12; [0018]); and
a first distal assembly distal of the catheter body (mapping assembly 18 mounted at the distal end of the catheter body 12; [0013]) and a second distal assembly distal of the first assembly (Fuimaono et al. fail to disclose a second distal assembly distal of the first assembly. However, Young et al. disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al.. ([0055-0057], [0061-0063], [0068]; Fig. 8-13)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (plurality of spines 14, totaling at least 5 spines, have proximal ends mounted at the distal end of catheter body 12 via mounting assembly 31 and free distal ends; [0018], [0031-0034], Fig. 2),
wherein each of the at least two spines comprises:
a support arm having shape memory (support arm 24 comprising a metal or plastic material having shape memory; [0016]);
a non-conductive covering in surrounding relation to the support arm (non-conductive coating 26 in surrounding relation to the support arm 24; [0016]); and
at least one electrode (ring electrode 28 mounted on each non-conductive covering 26; [0020]);
wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (While Fuimaono et al. disclose what appears to be spines of different lengths forming a cup-shape ([0037]; Fig. 7), Fuimaono et al. in view of Young et al. fail to disclose a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region. However, Gough et al. disclose a catheter (12) comprising an elongated catheter body (14) and a distal assembly comprising a plurality of spines (16). Gough et al. further disclose that any number of cell necrosis geometries can be achieved via at least the adjustable length of each spine and the number of energy delivery devices. Gough et al. further gives various examples of cell necrosis geometries, including, but not limited to: spherical, semi-spherical, spheroid, triangular, semi-triangular, square, semi-square, rectangular, semi-rectangular, conical, semi-conical, quadrilateral, semi-quadrilateral, semi-quadrilateral, rhomboidal, semi-rhomboidal, trapezoidal, semi-trapezoidal, combinations of the preceding, geometries with non-planar sections or sides, free-form and the like. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. in view of Young et al. such that a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region in order to provide the benefit defining the periphery or boundary of a selected tissue mass for treatment to thus provide a variety of different geometries, not always symmetrical, that can be ablated as taught by Gough et al. (Col. 3, ll. 51-56, Col. 4, ll. 17-43, Col. 6, ll. 17-25; Fig. 1)
Concerning claim 2, Young et al. further disclose the second distal assembly (250) has a generally straight proximal portion (proximal end of spine 256) extending from the mounting assembly (220) of the first distal assembly (225) ([0054]; Fig. 8).
Concerning claim 3, Young et al. further disclose the generally straight proximal portion (proximal end of spine 256) has a fixed relationship to the mounting assembly (220) of the first distal assembly (225) ([0054]; Fig. 8).
Concerning claim 4, Young et al. further disclose the generally straight proximal portion (proximal end of spine 256) is adapted for telescopically movement relative to the mounting assembly of the first distal assembly(225) ([0057]; Fig. 9).
Concerning claim 5-6, the modified invention of Fuimaono et al. in view of Young et al. and Gough et al. disclose the distal ends of the at least two-spines of the first and second distal assemblies are configured to trace a generally helical pattern from about 0 degrees to about 360 degrees and the distal ends of the spines of the second distal assembly are configured to trace the generally helical pattern from about 360 degrees to about 720 degrees when the distal assemblies are manipulated in an appropriate manner to achieve the desired pattern (see rejection of claim 1).
Concerning claim 9, Fuimaono et al. disclose at least one of the first or second distal assemblies has a unibody support structure (24) ([0021]; Fig. 4).
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fuimaono et al. (2003/0125614) in view of Pham et al. (2006/0095029) and Gough et al. (5,980,517), as applied to claim 1, in further view of Morris et al. (2002/0120261).
Concerning claim 7, Fuimaono et al. in view of Young et al. and Gough et al. fail to disclose the generally straight proximal portion of the second distal assembly includes a plunger having a cam surface adapted to deflect the at least two spines of the first distal assembly. However, Morris et al. disclose a catheter (10) comprising an elongated catheter body (24e) and a distal assembly comprising at least two spines (18) deployable from the catheter body (24e), where the spines (18) are deflected by a plunger having a cam surface (16). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. in view of Young et al. and Gough et al. such that the generally straight proximal portion of the second distal assembly includes a plunger having a cam surface adapted to deflect the at least two spines of the first distal assembly in order to provide the benefit of controllably advancing the spines from the catheter body as taught by Morris et al. ([(0104-0105]; Fig. 32A & 36B)
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,537,286 in view of Young et al. (2006/0095029). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a catheter (a catheter), comprising: an elongated catheter body (an elongated catheter body); and a first distal assembly distal of the catheter body (a distal assembly distal of the elongated catheter body) and a second distal assembly distal of the first assembly (The patent fails to disclose a second distal assembly distal of the first assembly. However, Young et al. disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al.. ([0055-0057], [0061-0063], [0068]; Fig. 8-13)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (each of the at least four spines having a proximal end fixedly attached to a distal end of the elongated catheter body and a free distal end), wherein each of the at least two spines comprises: a support arm having shape memory (a support arm having shape memory); a non-conductive covering in surrounding relation to the support arm (a non-conductive covering in surrounding relation to the support arm); and at least one electrode (at least one electrode); wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (wherein the at least four spines are arranged in a radial pattern about a longitudinal axis of the distal assembly and a length of each of the at least four spines increases in radial progression about the longitudinal axis, and when the distal assembly is in an expanded arrangement, each of the at least four spines extends radially outward from the catheter body).
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,537,286 in view of Young et al. (2006/0095029). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a catheter (a catheter), comprising: an elongated catheter body (an elongated catheter body); and a first distal assembly distal of the catheter body (a distal assembly distal of the elongated catheter body) and a second distal assembly distal of the first assembly (The patent fails to disclose a second distal assembly distal of the first assembly. However, Young et al. disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al.. ([0055-0057], [0061-0063], [0068]; Fig. 8-13)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (each of the at least four spines having a proximal end fixedly attached to a distal end of the elongated catheter body and a free distal end), wherein each of the at least two spines comprises: a support arm having shape memory (a support arm having shape memory); a non-conductive covering in surrounding relation to the support arm (a non-conductive covering in surrounding relation to the support arm); and at least one electrode (at least one electrode); wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (wherein the at least four spines are arranged in a radial pattern about a longitudinal axis of the distal assembly and a length of each of the at least four spines increases in radial progression about the longitudinal axis, and when the distal assembly is in an expanded arrangement, each of the at least four spines extends radially outward from the catheter body, and wherein the distal assembly is moveable between the expanded arrangement, in which each of the at least four spines extends radially outward from the catheter body, and a collapsed arrangement, in which each of the at least four spines is disposed generally along a longitudinal axis of the catheter body).
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights