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 .
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be amended to include any updated patent information.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 12-13 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Van Dam (US 2009/0143760).
Regarding claim 1, Van Dam discloses a gallbladder ablation device comprising:(a) an elongate body (420); (b) an ablation component (distal end 404) associated with the elongate body, wherein the ablation component is configured to be positionable within an interior of a gallbladder (view figures 5 and 6); and (c) at least one first suction opening associated with the elongate body, wherein the at least one first suction opening is configured to apply suction to the interior of the gallbladder when the ablation component is positioned in the interior of the gallbladder such that the gallbladder contracts around the ablation component [Para 0023-0024 discuss applying a vacuum to area, Para 0044-0046 discusses cryoablation to flood the gallbladder and applying a vacuum].
Regarding claim 12, Van Dam discloses the ablation device of claim 1, wherein the ablation fluid is a cryogen [Para 0024 and 0042].
Regarding claim 13, Van Dam discloses the ablation device of claim 12, wherein the cryogen is liquid cryogen or gas cryogen [Para 0024 and 0042].
Claim(s) 18 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Van Dam (US 2009/0143760).
Regarding claim 18, Saab discloses a cryoablation device comprising:(a) a cryogen probe comprising an elongate probe body (catheter 10; multiple lumens within catheter tube 12 can be used to circulate a cryogenic fluid; column 11, 36-57); (b) an elongate slidable body comprising (catheter tube 12 configured to be open at both ends to fit over a wire guide 13; column 8, lines 50-53): (i) a probe lumen defined within the elongate slidable body (central conduit 11 within catheter tube 12 receives wire guide 13, view figures 1-2), wherein the elongate slidable body is slidably positioned over the elongate probe body such that the elongate probe body is disposed within the probe lumen (catheter tube 12 configured to be open at both ends to fit over a wire guide 13 and is capable of sliding; column 8, lines 50-53); and (ii) a suction lumen defined within the elongate slidable body (suction lumen 22 supplying fluid to exit port 50, where suction lumen 22 is defined by sleeves 14 and 20 that are readily collapsible under vacuum, column 10, lines 5-10 and 55-58); (c) at least one suction opening defined in an outer wall of the elongate slidable body, wherein the at least one suction opening is in fluid communication with the suction lumen (exit port 50 on manifold 32 receives fluid from outlet suction fluid lumen 22; column 10, lines 5-10); and (d) a fluid tube coupled with the elongate slidable body (fluid inlet port 42 attached to fluid lumen 16; column 9, lines 15-20), the fluid tube comprising a fluid tube lumen in fluid communication with the suction lumen of the elongate slidable body (fluid connection means 18 places end of fluid lumen 16 in direct fluid communication with suction lumen 22; column 9. Lines 13- 16). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the device of Van Dam include the additionally slidable body capabilities as taught by Saab. Doing so allows for positioning of the main device and treatment into various other anatomical features without removing the main body thereby reducing trauma and risk of infection to the targeted area by eliminating the need for multiple device insertions.
Claim Rejections - 35 USC § 103
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.
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) 2-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Dam (US 2009/0143760) in view of Sahota (US 5,951,514).
Regarding claims 2-4, 6-7 and 9, Van Dam discloses the ablation device of claim 1, but fails to explicitly disclose wherein the elongate body is a catheter body, and wherein the ablation component comprises an expandable balloon attached to the elongate body, wherein the expandable balloon is configured to receive an ablation fluid, wherein the at least one first suction opening is defined in the elongate body distal or proximal to the ablation component, at least one second suction opening defined in the elongate body, wherein the at least one first suction opening is defined in the elongate body distal to the ablation component and the at least one second suction opening is defined in the elongate body proximal to the ablation component, wherein the expandable balloon comprises at least two lobes, wherein the two lobes are disposed radially adjacent to each other along a length of the elongate body, wherein the at least two lobes define gaps disposed therebetween, wherein the at least one first suction opening comprises a plurality of at least one first suction openings defined along the length of the elongate body and within the gaps, wherein the at least one first suction opening comprises a plurality of at least one first suction openings defined along the length of the elongate body and within the gaps, wherein the expandable balloon comprises at least two lobes, wherein the two lobes are disposed axially adjacent to each other along a length of the elongate body. While Van Dam is silent as to the specific position of the expandable balloon, the suction openings or details of the expandable balloon it does contemplate balloon inflation/deflation accessories and other kit attachments [Para 0050]. However, Sahota discloses multi-lobed balloon catheter 62 includes one or more balloons 54 shown adjacent along the body of the catheter 62, with delivery apertures 56 providing suction when suction is applied to delivery lumen 72, are positioned in gaps between one or more balloons 54, with at least one aperture 56 on located proximally from at least one balloon lobe 54; annotated figure 10; figures 9, 10; column 8, lines 30-40, lines 54-58). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the cryoablation device of Lalonde incorporate multiple suction source locations and balloons as taught by Sahota. Doing so would allow for removal of fluid before treatment if needed as well as to ensure clear areas along the catheter to remove fluid during treatment.
Regarding claim 5, Van Dam discloses wherein the elongate body comprises a suction lumen defined therein, wherein the suction lumen is in fluidic communication with the at least one first suction opening (view figure 5).
Regarding claim 8, Van Dam discloses the ablation device of claim 2, wherein the elongate body comprises a guidewire lumen defined within the elongate body [Para 0043 and figure 6].
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Dam (US 2009/0143760) in view of Saab (US 6,623,516).
Regarding claims 10 and 11, Van Dam discloses the ablation device of claim 1, but fails to disclose wherein the elongate body is a probe body, and wherein the ablation component comprises an elongate slidable body slidably positioned over the probe body, wherein the at least one first suction opening is defined in the elongate slidable body and further comprising a suction lumen defined within the elongate slidable body, wherein the at least one suction opening is in fluidic communication with the suction lumen. However, Saab discloses a cryoablation device comprising:(a) a cryogen probe comprising an elongate probe body (catheter 10; multiple lumens within catheter tube 12 can be used to circulate a cryogenic fluid; column 11, 36-57); (b) an elongate slidable body comprising (catheter tube 12 configured to be open at both ends to fit over a wire guide 13; column 8, lines 50-53): (i) a probe lumen defined within the elongate slidable body (central conduit 11 within catheter tube 12 receives wire guide 13, view figures 1-2), wherein the elongate slidable body is slidably positioned over the elongate probe body such that the elongate probe body is disposed within the probe lumen (catheter tube 12 configured to be open at both ends to fit over a wire guide 13 and is capable of sliding; column 8, lines 50-53); and (ii) a suction lumen defined within the elongate slidable body (suction lumen 22 supplying fluid to exit port 50, where suction lumen 22 is defined by sleeves 14 and 20 that are readily collapsible under vacuum, column 10, lines 5-10 and 55-58); (c) at least one suction opening defined in an outer wall of the elongate slidable body, wherein the at least one suction opening is in fluid communication with the suction lumen (exit port 50 on manifold 32 receives fluid from outlet suction fluid lumen 22; column 10, lines 5-10); and (d) a fluid tube coupled with the elongate slidable body (fluid inlet port 42 attached to fluid lumen 16; column 9, lines 15-20), the fluid tube comprising a fluid tube lumen in fluid communication with the suction lumen of the elongate slidable body (fluid connection means 18 places end of fluid lumen 16 in direct fluid communication with suction lumen 22; column 9. Lines 13- 16). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the device of Van Dam include the additionally slidable body capabilities as taught by Saab. Doing so allows for positioning of the main device and treatment into various other anatomical features without removing the main body thereby reducing trauma and risk of infection to the targeted area by eliminating the need for multiple device insertions.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saab (US 6,623,516) in view of Sahota(US 5,951,514).
Regarding claim 19, Saab discloses the cryoablation device of claim 19, but fails to disclose wherein the at least one suction opening comprises a plurality of suction openings defined in the outer wall of the elongate slidable body. However, Sahota discloses multi-lobed balloon catheter 62 includes one or more balloons 54 shown adjacent along the body of the catheter 62, with delivery apertures 56 providing suction when suction is applied to delivery lumen 72, are positioned in gaps between one or more balloons 54, with at least one aperture 56 on located proximally from at least one balloon lobe 54; annotated figure 10; figures 9, 10; column 8, lines 30-40, lines 54-58). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the cryoablation device of Lalonde incorporate multiple suction source locations and balloons as taught by Sahota. Doing so would allow for removal of fluid before treatment if needed as well as to ensure clear areas along the catheter to remove fluid during treatment.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saab (US 6,623,516) in view of Xiao (US 7,101,367).
Regarding claim 20, Saab discloses the cryoablation device of claim 19, but fails to disclose further comprising a deployable retention structure disposed along a length of the elongate slidable body; the deployable retention structure comprises a deployed configuration and an undeployed configuration; and wherein the deployable retention structure comprises at least two hinged sections hingedly coupled to the outer wall of the elongate slidable body, wherein the at least two hinged sections are moveable between a deployed configuration and an undeployed configuration. However, Xiao discloses wherein the deployable retention structure comprises a deployed configuration and an undeployed configuration comprising at least two hinged sections (deployable catheter 10; column 3, lines 30-40; column 2, lines 34-45). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have the catheter of Saab be made of a retention structure as taught by Xiao. Doing so allows for better manipulation of the treatment end and increased placement support which allows for prevention of unintentional damage to healthy tissue.
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 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 3 and 8-9 of U.S. Patent No. 11,737,805. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the previously patented invention are directed towards a device (method using device from patent 11,737,805) comprising a body, an expandable balloon, an ablation (cryogen) conduit, a suction opening, a suction lumen, and when applying suction to an interior of a gallbladder to cause the gallbladder to contract around the device (claim 14 of application over claims 1 and 8 of patent); first suction opening defined distal or proximal to the ablation component (claim 15 of application to claims 2-3 and 9 of patent); at least one second suction opening defined in the elongate body, wherein the at least one first suction opening is defined in the elongate body distal to the ablation component and the at least one second suction opening is defined in the elongate body proximal to the ablation component (claim 16 of application and claims 8-9 of patent), and the catheter body comprises a guidewire lumen defined within the catheter body (claim 17 of application and claims 3 and 9 of patent).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Saadat (US 2007/0293724) discloses luminal access and suction within body structures.
LaLonde (US 6,270,493 discloses cryoablation structures and methods.
Behl (US 5,100,388) discloses ablation in hollow body organs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L ZINK whose telephone number is (571)270-7103. The examiner can normally be reached Monday-Friday 7-12 EST.
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/A.L.Z/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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