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, 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.
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 not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) 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. 61/753831, 61/493344 & 61/102885, 12/573939 & 13/486980 fail 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.
Application Nos. 61/753831, 61/493344 & 61/102885, 12/573939 & 13/486980 fail to provide adequate support for at least “the heating chamber comprises a plurality of channels” (claims 7 & 21).
Accordingly, claims 7-9 & 21-22 are given the priority date of 1/17/2014.
Accordingly, claims 1-6, 10-20 & 23-24 are given the priority date of 10/6/2008.
The application is examined under AIA due the presence of claims with a priority date after March 16, 2013.
Specification
The abstract of the disclosure is objected to because it refers to “Methods of ablating endometrial tissue are disclosed”, but the claims pertain to a treatment system for Barrett’s esophagus. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: update Par. [0001] of the specification to reflect issued patents. Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: amend “is relayed” to -is configured to be relayed- in ll. 2. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “ablative vapor” to -the vapor- in ll. 3. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “area of the fluid” to -area for the fluid- in ll. 2. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “the channels” to -the plurality of channels- in ll. 1. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “and metal” to -or metal- in ll. 2. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “is heated’ to -is configured to be heated in ll. 1. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “the tissue” to -the target tissue- in ll. 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “of energy” to -of the energy- in ll. 4. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “the patient’s hollow organ” to -a hollow organ of the patient- in ll. 4. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “of energy” to -of the energy- in ll. 10. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “the patient’s esophagus’ to -an esophagus of the patient- in ll. 10-11. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “the at least one positioning element” to -the at least one expandable positioning element -in ll. 1. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “the fluid is heated” to -a fluid is configured to be heated- in ll. 2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “is relayed” to -is configured to be relayed- in ll. 2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “ablative vapor” to -the ablative vapor- in ll. 3. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “of the fluid” to -for a fluid- in ll. 2. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “the channels” to -the plurality of channels- in ll. 1. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “and metal” to -or metal- in ll. 2. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: amend “the at least one positioning element” to -the at least one expandable positioning element -in ll. 1. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hoey et al. (2009/0216220, with support in at least provisional application nos. 61/123384, 61/068049, 61/068130, 61/123417 & 61/123412).
Concerning claim 1, as illustrated in at least Figs. 2, 5, 6H, 7-8 & 10-15, Hoey et al. disclose an ablation catheter (vapor delivery tool 470; [0095]) comprising:
an elongate catheter body having a lumen, a proximal end, and a distal end (elongated member 472 comprising flexible inner sleeve 476 can comprise a working end such as in Fig. 6H and flow channel 410; [0089], [0095]);
a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (inductively heatable structure 480 is located within elongated member 472 and is configured to vaporize treatment media such as deionized water; [0092-0093], [0095-0096]);
at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (source 120 of a flowable liquid treatment media 121 communicates with a flow channel 124 extending through the probe body 102 to at last one outlet 125/425 on working end 110/410; [0068]; and
at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (expandable member 183 such as a balloon for positioning the heat applicator surface against targeted tissue; [0079]).
Concerning claim 2, Hoey et al. disclose a thermally insulated handle (104/452/477) attached to the catheter body (472) ([0093-0095]; Fig. 11-15).
Concerning claim 3, Hoey et al. disclose at least one sensor and a microprocessor (150), wherein information from the sensor is relayed to the microprocessor and the microprocessor is configured to determine a delivery rate of ablative vapor based upon the information ([0069-0070], [0072-0073]).
Concerning claim 4, Hoey et al. disclose the sensor is a temperature sensor ([0072-0073], [0082]).
Concerning claim 5, Hoey et al. disclose the sensor is a pressure sensor ([0072-0073], [0085]).
Concerning claim 6, Hoey et al. disclose comprising thermally insulating material (477) covering the catheter body (472/476) ([0095]; Fig. 13).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Hoey et al. (2009/0216220, with support in at least provisional application nos. 61/123384, 61/068049, 61/068130, 61/123417 & 61/123412).
Concerning claim 7, as illustrated in at least Figs. 2, 5, 6H, 7-8 & 10-15, Hoey et al. disclose an ablation catheter (vapor delivery tool 470; [0095]) comprising: an elongate catheter body having a lumen, a proximal end, and a distal end (elongated member 472 comprising flexible inner sleeve 476 can comprise a working end such as in Fig. 6H and flow channel 410; [0089], [0095]); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (inductively heatable structure 480 is located within elongated member 472 and is configured to vaporize treatment media such as deionized water; [0092-0093], [0095-0096]); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (source 120 of a flowable liquid treatment media 121 communicates with a flow channel 124 extending through the probe body 102 to at last one outlet 125/425 on working end 110/410; [0068]; and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (expandable member 183 such as a balloon for positioning the heat applicator surface against targeted tissue; [0079]). Hoey et al. further disclose the heating chamber (480) comprises a plurality of channels (455) that provide a contact surface area of the fluid with the heating chamber (480) ([0094]; Fig. 13).
Concerning claim 8, Hoey et al. disclose the channels comprise any one of metal tubes (458), metal beads, and metal filings ([0094]; Fig. 13).
Concerning claim 9, Hoey et al. disclose the fluid is heated in the heating chamber (480) using resistive heating ([0093]; Fig. 13).
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 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(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (2009/0216220, with support in at least provisional application nos. 61/123384, 61/068049, 61/068130, 61/123417 & 61/123412), as applied to claim 1, in further view of Shmulewitz et al. (WO2006/019728).
Concerning claim 12, Hoey et al. fail to disclose the at least one expandable positioning element to be disc or cone shaped. However, Shmulewitz discloses a medical device (100) having a positioning element (115) that is conical. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Hoey et al. '688 in view of Hoey et al. '846 and Ren et al. such that the first positioning element is conical shaped in order to provide the benefit of having a volume or area relatively near to the proximal end of the catheter be smaller and/or narrower than the volume or area relatively near to the distal end as taught by Shmulewitz et al. ([0038-0039]; Fig. 1)
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (2009/0216220, with support in at least provisional application nos. 61/123384, 61/068049, 61/068130, 61/123417 & 61/123412), as applied to claim 1, in further view of Shadduck et al. (2002/0156470).
Concerning claim 13, Hoey et al. fail to disclose the at least one positioning element is separated from the at least one delivery port by a distance of 1 mm to 10 cm. However, Shadduck disclose a device (10) to perform ablation that comprises an inflatable positioning element (50) having a diameter of 10-30 mm, used with a 20-120 mm diameter catheter and configured to use in an esophagus, which can range in diameter from 2.5-4 mm, which would then separate the wall of the inflatable positioning element from the at least one delivery port by a distance of 1 mm to 10 cm. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Hoey et al. such that the at least one positioning element separated from the at least one delivery port by a distance of 1 mm to 10 cm in order to provide the benefit of fixing the working end of the treatment device in position as taught by Shadduck '470 ([0064], [0079]; Fig. 1), and as Applicant appears to have placed no criticality on the claimed range (there is no specific reference to the claimed diameter range) and since it has been held that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 14, Hoey et al. fail to disclose a diameter of the at least one positioning element is between 0.01 mm and 100 mm. However, Shadduck '470 disclose a device (10) to perform ablation that comprises an inflatable positioning element (50) having a diameter of 10-30 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Hoey et al. such that the inflatable positioning element has a diameter between 0.01 mm and 100 mm in order to provide the benefit of fixing the working end of the treatment device in position as taught by Shadduck '470 ([0064], [0079]; Fig. 1) and as Applicant appears to have placed no criticality on the claimed range (there is no specific reference to the claimed diameter range) and since it has been held that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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 1-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,700,365 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite a device adapted to ablate tissue (device adapted to treat Barrett's esophagus in an esophagus of a patient by ablating esophageal tissue) comprising: an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a catheter having a hollow inner shaft through which steam can be transported); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (an input port at a second position and in fluid communication with said hollow inner shaft in order to receive said steam wherein the hollow inner shaft comprises a plurality of ports through which said steam can be released out of said hollow inner shaft, wherein each of said plurality of ports is positioned between the input port and the distal end along and circumferentially around said hollow inner shaft and separated from the inflatable balloon by a distance of at least 1 mm); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first positioning element attached to said catheter at a distal end of said catheter, wherein said first positioning element comprises an inflatable balloon configured to abut a gastroesophageal junction when placed in a gastric cardia) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s esophagus does not exceed 5 atm (a controller programmed to determine an amount of thermal energy needed to ablate said esophageal tissue, programmed to limit a maximum dose of said steam based on a type of disorder being treated, wherein said type of disorder comprises Barrett's esophagus, and programmed to limit the amount of thermal energy delivered such that a pressure within the patient's esophagus does not exceed 5 atm). The patent fails to specifically disclose a heating chamber within the catheter body. However, Hoey et al. disclose an ablation catheter (470) comprising a heating chamber (480) positioned within a catheter body and configured to convert fluid to vapor for ablation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to comprise the heating chamber in order to provide the benefit of a highly controlled energy source as taught by Hoey et al. ([0011]).
Claims 1-9 & 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,561,066 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter with a proximal end and a distal end and a lumen there between) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a catheter with a proximal end and a distal end and a lumen there between); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (a fluid heating chamber comprising ferromagnetic material, wherein said fluid heating chamber is connected to the catheter; a coil for receiving an alternating current and causing said ferromagnetic material in the fluid heating chamber to inductively heat, wherein said coil is coaxially positioned around the fluid heating chamber and separated from the fluid heating chamber); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (catheter comprising a plurality of ports at the distal end). The patent fails to disclose and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient. However, Hoey et al. further disclose a positioning element (183). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient in order to provide the benefit of positioning the applicator as taught by Hoey et al. ([0079).
Claims 1-9, 12 & 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,561,067 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter having a hollow shaft through which an ablative agent can travel) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a catheter having a hollow shaft through which an ablative agent can travel); at least one delivery port at the distal end of the catheter body, and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one infusion port on said catheter for delivery of said ablative agent to said endometrial tissue); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first positioning element attached to said catheter; a second positioning element attached to said catheter and positioned on said catheter distal to said first positioning element, wherein said second positioning element is a disc shaped wire mesh and has a diameter in a range of 0.1 mm to 10 cm). The patent fails to specifically disclose a heating chamber within the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port. However, Hoey et al. disclose an ablation catheter (470) comprising a heating chamber (480) within a catheter body configured to convert fluid to vapor for ablation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to comprise the heating chamber within the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port in order to provide the benefit of a highly controlled energy source as taught by Hoey et al. ([0011]).
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 10,064,697. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (an ablation catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (an elongate catheter body with a lumen within, a proximal end, and a distal end); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (a first inline chamber having an elongate body, a lumen within, a proximal end, and a distal end, wherein said lumen of said first inline chamber is in fluid communication with said lumen of said elongate catheter body); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one delivery port at said distal end of said catheter body; wherein said first inline chamber is configured to receive fluid from a fluid source where said fluid is converted to vapor therein, wherein said first inline chamber is configured to provide said vapor to said catheter body and said catheter body is configured to allow said vapor to exit said at least one delivery port to ablate a target tissue); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (at least one positioning element attached to said catheter body; wherein said at least one positioning element is configured to position said catheter body within a hollow organ of a patient) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s esophagus does not exceed 5 atm (a controller programmed to determine an amount of energy needed to ablate said target tissue, programmed to limit a maximum dose of said vapor based on a type of disorder being treated, and programmed to limit the amount of energy delivered such that a pressure within a body of the patient does not exceed 5 atm). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,842,548 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter in fluid communication with the heating component) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (the catheter comprises: a hollow shaft through which the vapor ablative agent can travel); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (a heating component in fluid communication with the source of fluid, wherein the heating component is configured to apply heat to the fluid to convert the fluid to a vapor ablative agent); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (more than one port distributed along circumferentially positioned around the shaft and configured to deliver the vapor ablative agent toward at least a portion of the GI tract); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first positioning element attached to the shaft at a proximal end of the shaft, wherein the first positioning element is configured to position the catheter at a first fixed distance from the tissue to be ablated, wherein the first positioning element is defined by a first disc shaped wire mesh structure and wherein the first disc shaped wire mesh structure is at least partially covered by a membrane; a second positioning element attached to the shaft at a distal end of the shaft and separated from the first positioning element by a length, wherein the second positioning element is configured to position the catheter at a second fixed distance from the tissue to be ablated and wherein the second positioning element is defined by a second disc shaped wire mesh structure and wherein the second disc shaped wire mesh structure is at least partially covered by a membrane) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s esophagus does not exceed 5 atm ( a controller in operable communication with the pump and the heating component; wherein the controller is programmed to limit an amount of the vapor ablative agent delivered through the more than one port such that a pressure within the patient's GI tract does not exceed 5 atm and programmed to generate the vapor ablative agent such that it is delivered from more than one port for a treatment period that is less than 1 minute). The patent fails to disclose the heating chamber positioned within the catheter body. However, Hoey et al. disclose an ablation catheter (470) comprising a heating chamber (480) positioned within a catheter body and configured to convert fluid to vapor for ablation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to comprise the heating chamber within the catheter body in order to provide the benefit of a highly controlled energy source as taught by Hoey et al. ([0011]).
Claims 1-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 & 18-31 of U.S. Patent No. 11,813,014. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (the catheter comprises: an elongate catheter body having a lumen, a proximal end, and a distal end); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (a heating component positioned within the catheter body and in fluid communication with the container, wherein the heating component is configured to apply energy to the fluid to convert the fluid to a vapor ablative agent; at least one delivery port at the distal end of the catheter body, wherein the at least one delivery port is configured to allow the vapor ablative agent to exit the catheter body to ablate the tissue); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one delivery port at the distal end of the catheter body, wherein the at least one delivery port is configured to allow the vapor ablative agent to exit the catheter body to ablate the tissue); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (an expandable positioning element attached to a distal end of the catheter body) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s esophagus does not exceed 5 atm ( a controller in operable communication with the pump and the heating component, wherein the controller is programmed to limit an amount of the vapor ablative agent delivered through the at least one delivery port such that a pressure within the GI tract of the patient does not exceed 5 atm). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-10 & 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-55 of U.S. Patent No. 10,842,557. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (the catheter comprises: an elongate catheter body having a lumen, a proximal end, and a distal end); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (a heating chamber positioned in-line with respect to the lumen of the catheter body and in fluid communication with the pump, wherein the heating chamber is configured to apply heat to the fluid to convert the fluid to a vapor ablative agent); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (more than one port distributed along the length and circumferentially positioned around the catheter body, wherein the more than one port is configured to release the vapor ablative agent toward at least a portion of the duodenum); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first expandable positioning element attached to the catheter body at a proximal end of the catheter body, wherein the first expandable positioning element is configured to position the catheter at a first fixed distance from the tissue to be ablated, wherein the first expandable positioning element is defined by a first conical shaped wire mesh structure and wherein the first conical shaped wire mesh structure is at least partially covered by a membrane) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s hollow organ does not exceed 5 atm (a controller in operable communication with the pump and the heating chamber, wherein the controller is programmed to limit an amount of the vapor ablative agent delivered through the more than one port such that a pressure within the patient's duodenum does not exceed 5 atm.). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-10 & 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,842,549 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter in fluid communication with the heating component) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a hollow shaft through which the vapor ablative agent can travel); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one port distributed along, and positioned around, the shaft and configured to release the vapor ablative agent toward at least a portion of the pulmonary tissue); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a positioning element attached to the shaft at a distal end of the shaft, wherein the positioning element is configured to position the catheter at a fixed distance from the pulmonary tissue to be ablated, wherein the positioning element is defined by a conical shaped wire mesh structure and wherein the conical shaped wire mesh structure is at least partially covered by a membrane) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s hollow organ does not exceed 5 atm (a controller in operable communication with the pump and the heating component, wherein the controller is programmed to limit an amount of the vapor ablative agent delivered through the at least one port such that a pressure within the patient's pulmonary system does not exceed 5 atm and programmed to generate the vapor ablative agent such that it is delivered from the at least one port for a treatment period that is less than 1 minute.). The patent fails to specifically disclose a heating chamber within the catheter body. However, Hoey et al. disclose an ablation catheter (470) comprising a heating chamber (480) within a catheter body configured to convert fluid to vapor for ablation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to comprise the heating chamber in order to provide the benefit of a highly controlled energy source as taught by Hoey et al. ([0011]).
Claims 1-10 & 12-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,020,175 in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a hollow shaft configured to transport fluid); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (activating a flow of fluid from a fluid source through a tube, wherein said tube is in fluid communication with the catheter; activating a heating element attached to the catheter to cause the fluid to be transformed into an ablative agent as it passes through the catheter for a first treatment period); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (directing the ablative agent onto the tissue through one or more ports positioned on the hollow shaft, wherein said one or more ports is positioned proximate the first positioning element); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first positioning element attached to the catheter at a distal tip of the hollow shaft, wherein the first positioning element comprises a wire mesh conical shaped structure configured to abut a region proximate the tissue) and/or an element to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s esophagus does not exceed 5 atm (wherein the transformation of the fluid into the ablative agent for the first treatment period is limited such that the ablative agent does not cause a pressure in the patient to exceed 5 atm). The patent fails to disclose the controlling done by a controller. However, Hoey et al. disclose a vapor ablation system comprising a controller (150) programmed to determine an amount of energy needed to ablate tissue. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the controlling is done by a controller in order to provide the benefit of automatically controlling operating parameters of the system as taught by Hoey et al. ([0069]).
Claims 1-10 & 12-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,779,430. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (an elongate catheter body with a lumen, a proximal end, and a distal end); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein ( wherein said first member is configured to receive fluid from a fluid source and convert the fluid to vapor, wherein said catheter body is configured to direct the vapor from the first member out of the at least one delivery port in order to ablate the endometrial tissue); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one delivery port positioned along a length of the catheter body between the first positioning element and the second positioning element); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient ( first positioning element attached to the catheter; a second positioning element attached to the catheter and positioned on the catheter distal to the first positioning element, wherein the second positioning element is at least one of a cone shaped wire mesh or a disc shaped wire mesh) and/or a controller programmed to determine an amount of energy needed to ablate the tissue, programmed to limit a maximum dose of an ablative vapor based on a type of disorder being treated, wherein the type of disorder comprises a gastrointestinal disorder, and programmed to limit the amount of energy delivered such that a pressure within the patient’s hollow organ does not exceed 5 atm (a controller programmed to limit a dose of the vapor directed out of the at least one delivery port, wherein the limited dose is a function of time, the controller is programmed to limit an amount of vapor delivered such that a pressure level does not exceed 5 atm within the uterine cavity). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-9 & 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,806,066. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a first catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (at least one lumen in the first catheter); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (the controller is configured to cause an electrical current to be delivered to at least one electrode positioned within the at least one lumen of the first catheter); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (delivering vapor through ports positioned in the first catheter between the at least first and second positioning elements); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (at least first and second positioning elements positioned at first and second attachment points, respectively, on the catheter and separated along a length of the first catheter and at least two ports positioned between the at least first and second positioning elements, wherein each of the at least first and second positioning elements are of wire mesh cone or disc, and wherein each of the at least first and second positioning elements has a first configuration and a second configuration, and wherein, in the first configuration, each of the at least first and second positioning elements is compressed within the first catheter and in the second configuration, each of the at least first and second positioning elements is expanded to be at least partially outside the first catheter). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-9 & 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,864,809. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a first catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (at least one lumen in the first catheter ); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (at least one electrode positioned within the at least one lumen of the first catheter at a place different from the at least first and second positioning elements to thereby generate said vapor from the saline at said vapor input flow rate); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (delivering the vapor through ports positioned in the first catheter between the at least two positioning elements and into the treatment volume); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (at least two positioning elements separated along a length of the catheter and at least two ports positioned between the at least two positioning elements, wherein each of the at least two positioning elements has a first configuration and a second configuration, and wherein, in the first configuration, each of the at least two positioning elements is compressed within the catheter and in the second configuration, each of the at least two positioning elements is expanded to be at least partially outside the catheter). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,279,803. Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (the catheter comprises: at least one lumen in fluid communication with the catheter connection port and configured to receive a fluid); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (at least one electrode coupled to the at least one lumen and configured to receive an electrical current from the control unit, wherein, upon the at least one electrode receiving the electrical current and the at least one lumen receiving the fluid, a vapor, having a first flow rate, is generated); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least two ports positioned between the first positioning element and the second positioning element, wherein the at least two ports are adapted to release the vapor into the treatment volume); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a first positioning element coupled to a surface of the catheter and adapted to expand from a compressed configuration to an expanded configuration). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent 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.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 17/005982 (reference application) in view of Hoey et al. (2009/0216220). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (a catheter having a handle and a length extending between a distal end of the handle and a distal tip); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (at least one electrode positioned within the first lumen and proximate the distal tip; the at least one electrode is adapted to receive the liquid and transform the liquid into an ablative vapor such that it is directed into a proximal end of the needle); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (a needle having a lumen and configured to be coupled to the distal tip of the catheter; a needle attachment component, wherein the needle comprises an internal channel in fluid communication with the first lumen and a port to allow a passage of the ablative vapor to an external environment from the internal channel). The co-pending application fails to disclose at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient. However, Hoey et al. further disclose a positioning element (183). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient in order to provide the benefit of positioning the applicator as taught by Hoey et al. ([0079).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 & 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/060543 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (ablation catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (an outer sheath having a first diameter and a length extending between a proximal end and a distal end, the outer sheath configured with at least one opening); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (an inner shaft having at least one lumen, wherein the lumen is configured to receive a volume of fluid; at least one heating component positioned within the lumen, wherein the at least one heating component comprises at least one electrode positioned circumferentially around a central core, and wherein the at least one heating component is configured to convert the volume of fluid received by the lumen to a vapor that exits from the at least one first port and the at least one second port); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (at least one heating component positioned within the lumen, wherein the at least one heating component comprises at least one electrode positioned circumferentially around a central core, and wherein the at least one heating component is configured to convert the volume of fluid received by the lumen to a vapor that exits from the at least one first port and the at least one second port); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (at least one positioning element positioned proximate a proximal or distal end of the inner shaft, wherein the at least one positioning element is configured to expand from a first compressed delivery configuration to a second expanded deployed configuration). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the co-pending application 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/593883 (reference application, now allowed). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter ) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (controller delivers a first fluid to the catheter); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (the controller delivers a first fluid to the catheter and causes the catheter to heat the first fluid to form a first ablative fluid such that the first ablative fluid leaves the catheter through the ports over a first period of time); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (ports are positioned on the catheter and are configured to direct ablative fluid from within the catheter out toward said first treatment zone); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (at least one positioning element configured to expand outward from the catheter). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the co-pending application 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 19/232563 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (causing fluid to be delivered into the distal end of the catheter); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (causing a fluid to be delivered into the distal end of the catheter, heating the fluid within the distal end of the catheter to generate ablative vapor); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (releasing the vapor through one or more ports positioned within an interior of the expanded structure); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (expanding a structure). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the co-pending application 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 & 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11, 17-19, 30-44, 49-57, 62-68, 73-76, 89-91, 102-106 & 119-120 of copending Application No. 19/232580 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they all recite an ablation catheter (a catheter) comprising an elongate catheter body having a lumen, a proximal end, and a distal end (causing a first volume of fluid to be delivered to the distal end of the catheter); a heating chamber positioned within said catheter body, wherein the heating chamber is configured to receive fluid from a fluid source and convert the fluid to vapor therein (causing a first volume of fluid to be delivered to the distal end of the catheter, heated); at least one delivery port at the distal end of the catheter body, wherein the heating chamber is configured to provide the vapor through the catheter body to the at least one delivery port and the at least one delivery port is configured to allow the vapor to exit the catheter body to ablate a target tissue (causing a first volume of fluid to be delivered to the distal end of the catheter, heated, and released as vapor from the distal end of the catheter); and at least one expandable positioning element attached to the catheter body, wherein the at least one expandable positioning element is configured to position the catheter body within a hollow organ of a patient (a wire mesh structure positioned on the distal end and is configured to transition from a compressed configuration when inside the sheath to an expanded configuration when outside the sheath). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the co-pending application 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794