DETAILED ACTION
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 (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, U.S. Application No. 12/979,803, 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 one or more claims of this application. More specifically, this application fails to disclose ‘determining a power rate delivery value’ and ‘delivering energy at a first/second power level in a first/second time period’.
The Examiner notes that support for the instant claims has been found in U.S. Application No. 13/151,750. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 6/2/2011, this being the filing date of U.S. Application No. 13/151,750.
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 11, 14, and 18 are objected to because of the following informalities: In claim 11, line 9, “targeted” should be replaced with -target-; In claim 14, line 2, “targeted” should be replaced with -target-; In claim 18, line 4, both occurrences of “targeted” should be replaced with -target-. 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 6, 8, 9, 14, 15, and 18 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 6 recites the limitation "a magnetic field" in lines 1-2. The antecedent basis for this limitation is confusing, since it’s already been recited. Appropriate correction is required.
Claim 8 recites the limitation "a flow rate" in line 1. The antecedent basis for this limitation is confusing, since it’s already been recited. Appropriate correction is required.
Claim 8 recites the limitation "a temperature" in line 3. The antecedent basis for this limitation is confusing, since it’s already been recited. Appropriate correction is required.
Claim 14 recites the limitation "a temperature" in line 2. The antecedent basis for this limitation is confusing, since it’s already been recited. Appropriate correction is required.
Claim 18 recites the limitation "a flow rate" in line 1. The antecedent basis for this limitation is confusing, since it’s unclear which previously-recited “flow rate” is being referred to. Appropriate correction is required.
Claim 18 recites the limitation "a temperature" in lines 3-4. The antecedent basis for this limitation is confusing, since it’s already been recited. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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, 7-9, 11, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, 13 of U.S. Patent No. 9,855,094. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims of 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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-3, 7-12, and 18-20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Marion, U.S. 2011/0270242 (hereinafter Marion).
Regarding claim 1, Marion discloses (note figs. 1-5, 7, and 13-16) a system comprising: an ablation generator (note paragraph 53); an electronic control unit (ECU) (necessarily composed of some of the components found within ‘110’); a control system (necessarily composed of some of the components found within ‘110’); and a catheter (see fig. 2) comprising: at least one ablation electrode (12/40); a catheter shaft (13) including a fluid lumen (20); and a plurality of thermal sensors communicatively coupled to the ECU, the plurality of thermal sensors (70) configured to measure a temperature of a targeted tissue (note paragraphs 73-74), the ECU necessarily configured to receive temperature measurement data from the plurality of thermal sensors, determine a ‘power rate delivery value’ based on the temperature measurement data, and output the power rate delivery value (note paragraph 91), the control system necessarily configured to receive the power rate delivery value and control energy delivery of the ablation generator based at least in part on the power rate delivery value (note paragraph 91).
Regarding claim 2, Marion discloses (see above) a system wherein the catheter includes at least one irrigation port (i.e., distal opening of lumen) configured to guide irrigation fluid from the fluid lumen to an ‘outer shell’ (i.e., distal face) of the catheter.
Regarding claim 3, Marion discloses (see above) a system wherein the plurality of thermal sensors are substantially equally spaced around a periphery of a distal end of the catheter (see fig. 7).
Regarding claim 7, Marion discloses (see above) a system wherein the control system is further configured to control a flow rate of irrigation fluid (note paragraphs 95-96).
Regarding claim 8, Marion discloses (see above) a system wherein a flow rate of the irrigation fluid is capable of being based at least in part on electrophysiological data obtained during cardiac ablation (note paragraphs 58 and 62) and wherein the electrophysiological data comprises a temperature of a tip of the catheter, a temperature of targeted tissue undergoing cardiac ablation, an electrical impedance of targeted tissue undergoing cardiac ablation, or a combination thereof (see above).
Regarding claim 9, Marion discloses (see above) a system wherein the flow rate of the irrigation fluid is a first flow rate during a first time period and a second flow rate during a second time period (note fig. 14B; paragraph 96).
Regarding claim 10, Marion discloses (see above) a system wherein the ablation generator is configured to generate radiofrequency (RF) energy and the at least one ablation electrode is configured to deliver RF energy (note paragraphs 58 and 90-91).
Regarding claim 11, Marion discloses (note figs. 1-5, 7, and 13-16) a system comprising: an irrigation catheter (see fig. 2) comprising at least one ablation electrode (12/40); an ablation generator (note paragraph 53) communicatively coupled to the irrigation catheter, the ablation generator configured to deliver energy to at least a portion of the irrigation catheter; a control system (necessarily composed of some of the components found within ‘110’) configured to control energy delivery of the ablation generator, wherein the control system is adapted to deliver energy at a first power level in a first time period and at a second power level in a second time period, wherein the first power level and the second power level are based on at least a temperature of a targeted tissue (note paragraph 91); and a source of irrigation fluid (224), wherein the control system is configured to deliver irrigation fluid to the irrigation catheter at a first flow rate during the first time period and at a second flow rate during the second time period (note paragraphs 95-96).
Regarding claim 12, Marion discloses (see above) a system wherein the irrigation catheter further comprises at least one ‘sensing electrode’ (i.e., temperature sensor ‘70’).
Regarding claim 18, Marion discloses (see above) a system wherein a flow rate of the irrigation fluid is based at least in part on electrophysiological data obtained during cardiac ablation (note paragraphs 58 and 62) and wherein the electrophysiological data comprises a temperature of a tip of the irrigation catheter, a temperature of targeted tissue undergoing cardiac ablation, an electrical impedance of targeted tissue undergoing cardiac ablation, or a combination thereof (see above).
Regarding claim 19, Marion discloses (see above) a system wherein the ablation generator is configured to generate RF energy and the at least one ablation electrode is configured to deliver RF energy (note paragraphs 58 and 90-91).
Regarding claim 20, Marion discloses (see above) a system wherein the irrigation catheter comprises a fluid lumen (20) and at least one irrigation port (i.e., distal opening of lumen).
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.
Claim 4-6 and 13-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marion in view of Ahmed, U.S. 2006/0106298 (hereinafter Ahmed).
Regarding claims 4-6, Marion discloses (see above) a system comprising a catheter having an ablation electrode and a plurality of thermal sensors. However, Marion fails to explicitly disclose a catheter further comprising at least one sensing electrode, wherein the at least one sensing electrode comprises a magnetic field sensing coil, wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system. Ahmed teaches (note abstract; fig. 1) a similar catheter for ablation and mapping comprising an ablation electrode and a sensing electrode (17), wherein the sensing electrode comprises a magnetic field sensing coil, wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system (note paragraphs 71-72). This configuration has been utilized in order to enable the location mapping of the catheter, thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the system of Marion to comprise a catheter further comprising a magnetic field sensing coil, wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system, in order to increase safety and efficiency.
Regarding claims 13, 16, and 17, Marion discloses (see above) a system comprising a catheter having an ablation electrode and a plurality of thermal sensors (i.e., sensing electrodes). However, Marion fails to explicitly disclose a catheter wherein the at least one sensing electrode further comprises a magnetic field sensing coil (i.e., mapping electrode), wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system. Ahmed teaches (note abstract; fig. 1) a similar catheter for ablation and mapping comprising an ablation electrode and a sensing/mapping electrode (17), wherein the sensing/mapping electrode comprises a magnetic field sensing coil, wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system (note paragraphs 71-72). This configuration has been utilized in order to enable the location mapping of the catheter, thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the system of Marion to comprise a catheter further comprising a magnetic field sensing coil (i.e., mapping electrode), wherein the magnetic field sensing coil is responsive to a magnetic field transmitted through a patient and is configured to sense a strength of the magnetic field at a particular location and transmit a representative signal to a magnetic field-based mapping system, in order to increase safety and efficiency.
Regarding claim 14, Marion discloses (see above) a system wherein the at least one thermal sensor (70) comprises a plurality of thermal sensors configured to measure a temperature of a targeted tissue (note paragraphs 73-74).
Regarding claim 15, Marion discloses (see above) a system wherein the plurality of thermal sensors are substantially equally spaced around a periphery of a distal end of the irrigation catheter (see fig. 7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2010/0168736 (Wang).
U.S. 2008/0167649 (Edwards).
U.S. 2008/0097422 (Edwards).
U.S. 6,056,745 (Panescu).
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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