CTNF 18/793,009 CTNF 96707 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. In light of the preliminary amendments to the claims filed 02/19/2025 in which claims 1-20 were cancelled and claims 21-40 were added, claims 21-40 are pending in the instant application and are examined on the merits herein. Priority The instant application is a continuation of 18/365,897 filed 08/04/2023 and 16/785,501 filed 02/07/2020 which claim priority to U.S. Provisional App. no. 62/942,631 filed 12/02/2019, 62/896,144 filed 09/05/2019, and 62/802,656 filed 02/07/2019. 02-09 AIA 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. 112(a) as follows: 02-10 AIA 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 No. 62/542,615 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed provisional applications do not provide support for claims 21-40 of the instant application. Regarding claim 21, the provisional applications fail to provide support for the specific method as claimed; therefore, claims 22-40 are not supported by the provisional applications . Claims 21-40 receive priority to the prior-filed application, filed on 02/07/2020 . Claim Objections 07-29-01 AIA Claim s 27 and 31 are objected to because of the following informalities: Claim 27 recites the limitation “in relation the first tissue wall and the second tissue wall” in ln. 3. This should read “in relation to the first tissue wall and the second tissue wall”. Claim 31 recites the limitation “opposite end regions of shunt device” in ln. 4. This should read “opposite end regions of the shunt device” . Appropriate correction is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 21-26, 28-30, and 34-36 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by US/2017/0113026 A1 to Finch . Regarding claim 21, Finch discloses a method for positioning and deploying a shunt device for connecting a first vascular cavity and a second vascular cavity that each form parts of a circulatory system of a patient (para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10; Fig. 14A-14E), the method comprising: puncturing an opening across a first tissue wall of the first vascular cavity and a second tissue wall of the second vascular cavity to form a first aperture in the first tissue wall and a second aperture in the second tissue wall (Fig. 14A-14B, puncturing an opening across the common wall 2 between right atrium 4 and left atrium 6 thus creating a first aperture in the tissue wall of right atrium 4 and a second aperture in the tissue wall of left atrium 6; para. 0119-0126); passing the shunt device through the first aperture and the second aperture (Fig. 14B-14E; para. 0119-0126); and, causing the shunt device to axially shorten and radially flare to form an hourglass shape in which radially flaring opposite end regions of the shunt device engage tissue surrounding the first aperture and the second aperture creating a smooth transition with the first tissue wall, the second tissue wall, and a lumen of the shunt device (para. 0075; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Regarding claim 22, Finch discloses the method of claim 21. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape includes compressing tissue of the first tissue wall and the second tissue wall (para. 0075). Regarding claim 23, Finch discloses the method of claim 22. Finch further discloses wherein compressing tissue is accomplished by axial foreshortening of the shunt device causing the radially flaring opposite end regions of the shunt device to move axially toward each other (para. 0061; para. 0075, compression occurs in a deployed state of shunt 10). Regarding claim 24, Finch discloses the method of claim 23. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form an hourglass shape is achieved by inflating a balloon within the lumen of the shunt device (para. 0061; para. 0111-0112). Regarding claim 25, Finch discloses the method of claim 21. Finch further discloses wherein the first vascular cavity and the second vascular cavity are blood vessels or chambers of a heart of the patient (Fig. 14A-14E, first and second vascular cavities as right atrium 4 and left atrium 6). Regarding claim 26, Finch discloses the method of claim 21. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form an hourglass shape is achieved by a preset shape of a shape memory alloy comprising the shunt device (para. 0101; para. 0111; para. 0119-0126). Regarding claim 28, Finch discloses the method of claim 21. Finch further discloses wherein positioning and deploying the shunt device is intended to improve a diseased state of the patient; and wherein the diseased state is one of a group consisting of: pulmonary hypertension, heart failure, hypertension, kidney failure, volume overload, hypertrophic cardiomyopathy, and valve regurgitation (para. 0002-0008). Regarding claim 29, Finch discloses the method of claim 21. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape includes: radially expanding the radially flaring opposite end regions of the shunt device to a greater degree than a central region of the shunt device (Fig. 1 showing undeployed state of shunt 10; Fig. 2 showing deployed and radially expanded state of shunt 10 such that radially flared regions 21/31 expand more than central shunt portion 40); and circumferentially engaging the tissue surrounding the first aperture and circumferentially engaging the tissue surrounding the second aperture (para. 0075; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Regarding claim 30, Finch discloses the method of claim 29. Finch further discloses wherein creating the smooth transition with the first tissue wall, the second tissue wall, and the lumen of the shunt device includes forming a first funnel-shaped transition region between the first tissue wall and the central region of the shunt device and forming a second funnel-shaped transition region between the second tissue wall and the central region of the shunt device (para. 0063, radially flared regions 21/31 have a funnel-shaped profile; para. 0075; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2 and in contact with common wall 2). Regarding claim 34, Finch discloses the method of claim 29. Finch further discloses wherein passing the shunt device through the first aperture and the second aperture includes receiving tactile resistance indicative of the shunt device being located at a desired alignment position; and wherein the tactile resistance is achieved by contact of a plurality of structures of the shunt device that are heat-set to radially expand upon deployment from a delivery device (para. 0101; para. 0111; para. 0123-0124, radially flared region 21 is pulled against the left atrial side of common wall 2). Regarding claim 35, Finch discloses the method of claim 29. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape results in a reduction in blood pressure in the first vascular cavity or the second vascular cavity (para. 0002; para. 0119-0126). Regarding claim 36, Finch discloses the method of claim 21. Finch further discloses wherein the first tissue wall and the second tissue wall represent a common wall separating the first vascular cavity from the second vascular cavity (Fig. 14A-14B, puncturing an opening across the common wall 2 between right atrium 4 and left atrium 6 thus creating a first aperture in the tissue wall of right atrium 4 and a second aperture in the tissue wall of left atrium 6; para. 0119-0126) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Finch as applied above . Regarding claim 27, Finch discloses the method of claim 21. Finch further discloses causing the shunt device to axially shorten and radially flare to form the hourglass shape (para. 0075; para. 0111- 0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Finch differs from the instantly claimed invention in that Finch fails to explicitly disclose wherein the shortening and flaring result in self-centering of the shunt device in relation to the first tissue wall and the second tissue wall; however, because Finch discloses a substantially identical structure and implantation method, it follows naturally that deployment of the Finch device would generate the same results as applicant, as supported in MPEP section 2112.02. By the principles of the device as comprising two equally spaced funnel-shaped regions, the device would center itself between said funnel-shaped regions. Regarding claim 31, Finch discloses the method of claim 29. Finch further discloses wherein radially expanding the radially flaring opposite end regions of the shunt device to a greater degree than the central region of the shunt device includes radially expanding an outer circumference of the radially flaring opposite end regions of shunt device to a circumference measuring greater than a circumference of the central region (Abstract, radially flared regions [proximal/distal retention flanges] have a diameter greater than the shunt portion in a deployed state; para. 0077, radially flared regions 21/31 have a deployed diameter between 7-40 mm and shunt portion 40 has a deployed diameter between 5-30 mm; circumference of radially flared regions may be 33-700% greater dependent upon deployed diameter; Fig. 1 showing undeployed state of shunt 10; Fig. 2 showing deployed and radially expanded state of shunt 10 such that radially flared regions 21/31 expand more than central shunt portion 40). Finch differs from the instantly claimed invention in that Finch fails to explicitly disclose wherein the outer circumference of the flaring opposite end regions of the shunt device measure at least 50 percent greater than a circumference of the central region in a radially expanded state. 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 outer circumference of the flaring opposite end regions of Finch from between 33-700% greater than the outer circumference of the central region in a radially expanded state to at least 50% greater than the outer circumference of the central region in a radially expanded state 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 0046-0049 indicating exemplary deployed diameters) . 07-21-aia AIA Claim s 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Finch as applied above, and further in view of US/2002/0035374 A1 to Borillo . Regarding claims 32-33, Finch discloses the method of claim 21. Finch further discloses (Claims 32-33) wherein passing the shunt device through the first aperture and the second aperture includes receiving tactile resistance indicative of the shunt device being located at a desired alignment position (para. 0101; para. 0111; para. 0123-0124, radially flared region 21 is pulled against the left atrial side of common wall 2). Finch differs from the instantly claimed invention in that Finch fails to disclose wherein the tactile resistance is achieved by contact of (Claim 32) a plurality of arms of a delivery device with the second tissue wall or (Claim 33) an annular ring of a delivery device with the second tissue wall. Borillo teaches a delivery device for a heart implant comprising (Claim 32) a plurality of arms of a delivery device or (Claim 33) an annular ring of a delivery device to act as a positioning guide and provide mechanical support during implant deployment (para. 0031; para. 0034; para. 0055; Fig. 2B, positioning guide 550 comprising arms 510; Fig. 2C, positioning guide 560 as an annular ring; Fig. 5, positioning guide 220). It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the delivery device of Finch to further comprise the positioning guide of Borillo, because Borillo teaches that the positioning guide of their invention can provide mechanical support during deployment of an implant (para. 0055) . 07-21-aia AIA Claim s 37-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Finch as applied above, and further in view of US/2014/0343348 A1 to Kaplan and US/2015/0313598 A1 to Todd . Regarding claim 37, Finch discloses the method of claim 21. Finch further discloses wherein passing the shunt device through the first aperture and the second aperture includes passing a wire-wound structure into the first vascular cavity and the second vascular cavity; and wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape includes inflating a balloon within the lumen to cause the shunt device to transition from a cylindrical shape to the hourglass shape (para. 0075; para. 0095, shunt 10 manufactured by braiding wires; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Finch differs from the instantly claimed invention in that Finch fails to disclose a laser cut structure and a cylindrical balloon. Kaplan teaches a shunt comprising first and second radially flared ends, wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape includes inflating a cylindrical balloon within the lumen to cause the shunt device to transition from a cylindrical shape to the hourglass shape (para. 0186; Fig. 5A-5B showing flaring and shortening of shunt 200 to an hourglass shape comprising first and second radially flared end in response to balloon dilation). Todd teaches a shunt comprising first and second radially flared ends that can be wire-wound or laser cut (para. 0074-0083; Fig. 3A, shunt 300 comprising radially flareable regions 302/304 with shunt portion 306) and further discloses that a balloon can be used to provide supplemental expansion forces to a self-expandable device by balloon dilation (para. 0147), such that a user can be certain that the shunt has fully expanded. The shunt of Todd is considered to be functionally equivalent to the shunt of Finch in that Todd’s shunt comprises first and second radially flared ends with a shunt portion in between the radially flared ends (para. 0074-0083; Fig. 3A, shunt 300 comprising radially flareable regions 302/304 with shunt portion 306), Todd’s shunt axially shortens and radially flares to an hourglass shape (para. 0074-0083; Fig. 3A, shunt 300 comprising radially flareable regions 302/304 with shunt portion 306), and Todd’s shunt can be used as an anastomosis device between two tissue structures (para. 0002), such as those within the heart. As Todd teaches a functionally equivalent structure to that of Finch that can be either wire-wound or laser cut, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shunt of Finch to be laser cut. Further, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Finch to comprise axially shortening and radial flaring by a cylindrical balloon, because Kaplan teaches that a shunt that is self-expandable can be shortened and flared with the use of a cylindrical balloon (para. 0186), and Todd teaches that a balloon can be used to provide supplemental expansion forces to a self-expandable device by balloon dilation (para. 0147). Regarding claim 38, the cited prior art suggests the method of claim 37. Finch further discloses wherein causing the shunt device to axially shorten and radially flare to form the hourglass shape includes compressing tissue of the first tissue wall and the second tissue wall; and wherein compressing tissue of the first tissue wall includes contacting the first tissue wall with a first plurality of rings comprising one of the radially flaring opposite end regions and a second plurality of rings comprising another of the radially flaring opposite end regions, wherein each ring of the first plurality of rings and the second plurality of rings extends concentrically around, and defines an inner diameter greater than a diameter of, the lumen of the shunt device (para. 0075; Abstract, radially flared regions [proximal/distal retention flanges] have a diameter greater than the shunt portion in a deployed state; para. 0077, radially flared regions 21/31 have a deployed diameter between 7-40 mm and shunt portion 40 has a deployed diameter between 5-30 mm; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31 comprised of plurality of rings that extend around and define a greater inner diameter than the lumen of the shunt device; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Regarding claim 40, the cited prior art suggests the method of claim 38. Finch further discloses wherein the cylindrical shape is achieved by the shunt device defining a radially compressed diameter of about 1-10 mm uniformly across the shunt device; and wherein the hourglass shape is achieved through (1) radial expansion of one ring of the first plurality of rings and one ring of the second plurality of rings from about 1-10 mm to about 7-40 mm, and (2) radial expansion of a central region of the shunt device from about 1-10 mm to about 5-30 mm (para. 0059, delivery configured of the shunt has a diameter from 1-10 mm; para. 0075; Abstract, radially flared regions [proximal/distal retention flanges] have a diameter greater than the shunt portion in a deployed state; para. 0077, radially flared regions 21/31 have a deployed diameter between 7-40 mm and shunt portion 40 has a deployed diameter between 5-30 mm; para. 0111-0112; para. 0119-0126; Fig. 1-7, shunt 10 comprising radially flared regions 21/31 comprised of plurality of rings that extend around and define a greater inner diameter than the lumen of the shunt device; Fig. 14A-14E, radially flared regions 21/31 disposed on either side of common wall 2). Finch differs from the instantly claimed invention in that Finch fails to explicitly disclose wherein the cylindrical shape is achieved by the shunt device defining a radially compressed diameter of about 2.2 mm uniformly across the shunt device; and wherein the hourglass shape is achieved through (1) radial expansion of one ring of the first plurality of rings and one ring of the second plurality of rings from about 2.2mm to about 8 mm, and (2) radial expansion of a central region of the shunt device from about 2.2mm to about 4 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 radially compressed diameter of the shunt of Finch from between 1-10 mm to about 2.2 mm, the radial expansion of one ring of each of the first and second plurality of rings from 1-10 mm to 7-40 mm of Finch to 2.2 mm to about 8 mm, and the radial expansion of the central region of the shunt device from 1-10 mm to 5-30 mm of Finch to 2.2 mm to about 8 mm 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 0046-0049 indicating exemplary diameters) . 07-21-aia AIA Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Finch, Kaplan, and Todd as applied above, and further in view of U.S. Patent no. 6,036,702 A to Bachinski . Regarding claim 39, the cited prior art suggests the invention of claim 38. The prior art differs from the instantly claimed invention in that Finch fails to disclose wherein engaging tissue surrounding the first and the second aperture includes engaging the first tissue wall and the second tissue wall with a plurality of barbs extending radially outward from the first plurality of rings and the second plurality of rings. Bachinski teaches a shunt comprising a plurality of barbs extending radially outward from a radially extending flared end for an even more secure attachment to tissue (col. 14:5-12; Fig. 34, shunt 430 comprising barbs 1467 on radially extending struts 1436). It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the cited prior art to further comprise a plurality of barbs extending radially outward from the first and second plurality of rings as taught by Bachinski, because Bachinski teaches that providing barbs creates an even more secure attachment to tissue at the flared ends (col. 14:5-12) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 6,926,690 B2 to Renati discloses a shunt comprising first and second flared regions. US/2016/0095705 A1 to Keränen discloses an annuloplasty system comprising positioning structures on the delivery device . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Linnae E. Raymond/Examiner, Art Unit 3781 /LESLIE R DEAK/Primary Examiner, Art Unit 3799 16 April 2026 Application/Control Number: 18/793,009 Page 2 Art Unit: 3781 Application/Control Number: 18/793,009 Page 3 Art Unit: 3781 Application/Control Number: 18/793,009 Page 5 Art Unit: 3781 Application/Control Number: 18/793,009 Page 6 Art Unit: 3781 Application/Control Number: 18/793,009 Page 7 Art Unit: 3781 Application/Control Number: 18/793,009 Page 8 Art Unit: 3781 Application/Control Number: 18/793,009 Page 9 Art Unit: 3781 Application/Control Number: 18/793,009 Page 11 Art Unit: 3781 Application/Control Number: 18/793,009 Page 12 Art Unit: 3781 Application/Control Number: 18/793,009 Page 13 Art Unit: 3781 Application/Control Number: 18/793,009 Page 14 Art Unit: 3781
