DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 2. 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. Claim Rejections - 35 USC § 103 3. 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 . 4. Claims 1, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Trayanova U.S. 2015/0150643 (herein referred to as “ Trayanova ”) and in view of Squire U.S. 2015/0148794 (herein referred to as “Squire”). 5. Regarding Claim 1, Trayanova teaches a method of manufacturing a personalized atrial fibrillation ablation device (para 0009), comprising: obtaining a three-dimensional image of a left atrium of a patient’s heart (para 0009); determining a three-dimensional configuration for an ablation device to create a desired ablation pattern within the patient’s left atrium based on the three-dimensional image obtained (para 0009-0011). Trayanova fails to teach manufacturing an ablation device according to the three-dimensional configuration that was determined. Squire teaches a method of analogous art (para 0002, 0030, 0033), wherein the method comprises manufacturing an ablation device based on specific parameters/configurations from a target area (para 0036-0037, “the three dimensional structure of the tubular member can be manufactured to have essentially any suitable shape including relatively complex three-dimensional shapes…”; para 0033, “…the devices and methods described herein can be applied to hyperplastic tissue ablation, cardiac ablation…”). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have combined the teachings of Squire with Trayanova in order to manufacture an ablation device according to the three- dimensional configuration that was determined since one would infer this is for the predictable benefit of manufacturing an ablation device that would be personalized for the specific left atrium that is being treated using said ablation device. 6. Regarding Claim 4, Trayanova as modified teaches the method of claim 1, as well as the step of determining a three-dimensional configuration for an ablation device is performed with assistance from a computer (para 0010). 7. Regarding Claim 5, Trayanova as modified teaches the method of claim 1, as well as the step of determining a three-dimensional configuration for an ablation device is performed by an automated design process on a computer (para 0010). 8 . Claims 2, 8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Trayanova and Squire, and further in view of Hall U.S. 2003/0060821 (herein referred to as “Hall”). 9. Regarding Claim 2, Trayanova as modified teaches the method of claim 1. However, Trayanova fails to teach that the method further comprises the ablation device is configured to create a lesion encircling at least one pulmonary vein connected to the patient’s left atrium. Hall teaches an ablation device (Fig. 8) wherein the device is configured to create a lesion encircling at least one pulmonary vein connected to the patient’s left atrium (para 0078, “ablation element 53 is then opened, expanded, or allowed to expand…within the left atrium 122 in preparation for contacting to the target site for ablation 110 (a region on the atrial wall outside of the pulmonary vein and surrounding and encircling the opening to the pulmonary vein)…”). This ensures ablation to the target tissue (para 0078). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trayanova to create a lesion encircling a pulmonary vein connected to the left atrium as this produces the same expected result of ablating the target tissue. 10. Regarding Claim 8, Trayanova as modified teaches the method of claim 1, but fails to teach based on the three-dimensional image obtained, determining a configuration for at least one alignment member that will engage at least one pulmonary vein to hold the ablation device in alignment with the patient’s atrium; and manufacturing the ablation device with the at least one alignment member extending from the ablation device. Hall teaches a device comprising at least one alignment member (Fig. 8, ref num 62) that will engage at least one pulmonary vein (Fig. 8, ref num 62 engages with pulmonary vein, ref num 111) to hold the ablation device in alignment with the patient’s atrium (para 0076, “centering balloon [62] is then expanded within the pulmonary vein to secure the centering catheter”’ para 0078, “once the centering catheter is fixed in place, an ablation catheter 50 is advanced over the centering catheter 60 and into the left atrium 122”; see Figs. 9 and 10). By securing the ablation device within the atrium, the device then contacts its target site, which then allows for ablation to be achieved via the ablation device (para 0079). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trayanova to include an alignment member that engages a pulmonary vein to hold the ablation device in alignment in order to produces the same expected result of ablating the target region. While Trayanova as modified by Hall fails to teach manufacturing the ablation device with the at least one alignment member extending from the ablation device, as well as even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe , 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985). Therefore, since Trayanova as modified by Hall teaches an alignment member extending from the ablation device (Figs. 8-10, ref num 62), then this reads on the manufacturing limitations of the claim. Squire teaches a method of analogous art (para 0002, 0030, 0033), wherein the method comprises manufacturing an ablation device based on specific parameters/configurations from a target area (para 0036-0037, “the three dimensional structure of the tubular member can be manufactured to have essentially any suitable shape including relatively complex three-dimensional shapes…”; para 0033, “…the devices and methods described herein can be applied to hyperplastic tissue ablation, cardiac ablation…”). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have combined the teachings of Squire with Trayanova in order to manufacture an ablation device according to the three- dimensional configuration that was determined since one would infer this is for the predictable benefit of manufacturing an ablation device that would be personalized for the specific left atrium that is being treated using said ablation device. 11. Regarding Claim 10, Trayanova teaches the method of claim 1, but fails to teach the ablation device includes at least one electrical conductor. Hall teaches an ablation device of analogous art (Figs. 1 and 8), wherein the device comprises at least one electrical conductor (Fig. 1, ref num 54). This provides the ablation to the target site (para 0075). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as taught by Trayanova and included an electrical conductor in order to ablate the target tissue. 12. Regarding Claim 11, Trayanova teaches the method of claim 10, but fails to teach the ablation device includes a multiplicity of electrical conductors. Hall teaches an ablation device of analogous art (Figs. 1 and 8), wherein the device includes a multiplicity of electrical conductors (Fig. 1, ref nums 54, para 0062 and 0074). This provides the ablation to the target site (para 00765). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as taught by Trayanova and included a multiplicity of electrical conductors in order to ablate the target tissue. 13. Regarding Claim 12, Trayanova teaches the method of claim 1, but fails to teach collapsing the ablation device into a lumen of a delivery catheter. Hall teaches an ablation device of analogous art (Figs. 1 and 8), wherein the device includes collapsing the ablation device into a lumen of a delivery catheter (para 0062, “the expandable ablatio element is collapsed when introduced into the atrium through an introducer sheath”). This provides the ease of delivering the ablation device to the desired target tissue (para 0069). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trayanova to collapse the ablation device in a delivery catheter to provide ease of delivering the device to the target tissue. 14. Regarding Claim 13, Trayanova teaches the method of claim 1, but fails to teach the ablation device is manufactured with at least one trigger electrode configured to contact tissue on one side of the ablation pattern created by the ablation device and a sensing electrode configured to contact tissue on another side of the ablation pattern created by the ablation device. Hall teaches an ablation device of analogous art (Figs. 1 and 8), wherein the device comprises at least one trigger electrode configured to contact tissue on one side of an ablation pattern (Fig. 8 and 11, ref num 54) and a sensing electrode configuration to contact tissue on another side of the ablation pattern (Fig. 8, ref num 105). The trigger electrode provides ablation to the target site (para 0075) while the sensing electrode provides feedback to the operator (para 0072). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as taught by Trayanova and included a trigger electrode in order to ablate the target tissue, as well as a sensing electrode to provide feedback to the operator. 15 . Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Trayanova and Squire, and further in view of Hall and Belson U.S. 2014/0046324 (herein referred to as “Belson”). 16. Regarding Claim 3, Trayanova as modified teaches the method of claim 2, but fails to teach the ablation device is configured to create lesions encircling each of the patient’s pulmonary veins connected to the left atrium. Belson teaches an ablation device (Fig. 5, ref num 212) that is configured to create lesions encircling each of the patient’s pulmonary veins connected to the left atrium (Figs. 7A-7D; para 0069, “may be utilized for the treatment of atrial fibrillation…place segmented or continuous lesions near and around the pulmonary veins”). This treats atrial fibrillation by re-synchronizing the atria (para 0064, 0069). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trayanova to create lesions encircling each of the patient’s pulmonary veins connected to the left atrium as this produces the same expected result of treating atrial fibrillation. 17 . Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Trayanova and Squire, and further in view of Hall and Avitall U.S. 2012/0143179 (herein referred to as “ Avitall ”). 18. Regarding Claim 9, Trayanova teaches the method of claim 8, but fails to teach the ablation device is configured with alignment members that will engage each of the patient’s pulmonary veins connected to the left atrium. Avitall teaches an ablation device (Fig. 9) configured with alignment members (Fig. 9, ref nums 304 and 306). These alignment members engage each of the patient’s pulmonary veins connected to the left atrium (Fig. 11, ref nums 334 and 338 are the left superior and left inferior pulmonary veins, respectively, such that ref nums 304 and 306 engage them). This holds the ablation device (Fig. 9, ref num 302) in alignment with the patient’s atrium (see Fig. 11; para 0069, “stabilizing and supporting guide sheaths 304 and 306). This promotes good catheter contact with the desired target tissue to ensure ablation (para 0070). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Trayanova to have multiple alignment members that engage each of the pulmonary veins in order to promote tissue contact with the ablation members to ensure ablation of the target tissue. 20 . Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Trayanova and Squire, and further in view of Hunter U.S. 2016/0310077 (herein referred to as “Hunter”). 21. Regarding Claim 14, Trayanova teaches the method of claim 1, but fails to teach the ablation device is manufactured using three-dimensional printing. Hunter teaches an ablation device (para 0279, “catheter-based ablation”), such that the device is manufactured using three-dimensional printing (para 0614, “a method of making a medical device by 3D printing”). Manufacturing a medical device using 3D printing is a commonly used in the medical field (para 0619). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Trayanova to manufacture the ablation device using three-dimensional printing since this is a commonly used method in the field. Double Patenting 22. 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). 23. 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). 24. 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. 25. 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 . 26 . Claim s 1, 6, 7, and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 6-10, and 12 of U.S. Patent No. 11,857,263 (herein referred to as “ Patent ‘263 ”) in view of Trayanova U.S. 2015/0150643 and Squire U.S. 2015/0148794 . Patent ‘ 263 teaches a personalized atrial fibrillation ablation device, comprising : an ablation panel configured to create a desired ablation pattern within a wall of a patient’s left atrium to eliminate atrial fibrillation; wherein the ablation panel includes a first ablation element configured to encircle an ostium of a first pulmonary vein, a second ablation element configured to encircle an ostium of a second pulmonary vein, and a third ablation element configured to encircle an ostium of a third pulmonary vein, a first connecting member connecting the first ablation element to the second ablation element, and a second connecting member connecting the second ablation element to the third ablation element; a base ring configured to seat around a periphery of the patient’s mitral valve; and at least one spring member connected between the ablation panel and the base ring and configured to urge the ablation elements of the ablation panel into contact with a portion of the wall of the patient’s left atrium to be ablated (Claim 1 of Patent ’263 and Claim 15 of present application); wherein the ablation panel is manufactured with a fourth ablation element configured to encircle an ostium of a fourth pulmonary vein, and a third connecting member connecting the third ablation element to the fourth ablation element (Claim 6 of Patent ‘263 and Claim 16 of present application); configuring the first ablation element, the second ablation element, and the third ablation element of the ablation panel to deliver radiofrequency ablation energy to create a desired ablation pattern within a wall of a patient’s left atrium to eliminate atrial fibrillation; and connecting the first ablation element, the second ablation element, and the third ablation element of the ablation panel to a source of radiofrequency ablation energy (Claim s 7 and 8 of Patent ‘263 and Claim 17 of present application); or that each ablation element can be energized selectively (Claim s 9 and 10 of Patent ‘263 and C laim 18 of present application); further that the re is a base ring that will engage a periphery of the patient’s mitral valve and at least one spring element that will hold the ablation device in contact with a portion of the atrial wall to be ablated; manufacturing the base ring and the at least one spring element; and connecting the at least one spring element between the base ring and the ablation device (Claim 12 of Patent ‘263 and Claim 6 of present application); such that the ablation device has a mesh material attached to the base ring and configured to cover an opening within the base ring (Claim 12 of Patent ‘263 and Claim 7 of present application). 27. However, Patent ‘ 263 fails to tea ch a method of manufacturing a personalized atrial fibrillation ablation device, comprising: obtaining a three-dimensional image of a left atrium of a patient’s heart; determining a three-dimensional configuration for an ablation device to create a desired ablation pattern within the patient’s left atrium based on the three-dimensional image obtained; and manufacturing an ablation device according to the three-dimensional configuration that was determined. 28 . Trayanova teaches a method of manufacturing a personalized atrial fibrillation ablation device ( Trayanova , para 0009), comprising: obtaining a three-dimensional image of a left atrium of a patient’s heart ( Trayanova , para 0009); determining a three-dimensional configuration for an ablation device to create a desired ablation pattern within the patient’s left atrium based on the three-dimensional image obtained ( Trayanova , para 0009-0011). Squire teaches a method of analogous art ( Squire, para 0002, 0030, 0033), wherein the method comprises manufacturing an ablation device based on specific parameters/configurations from a target area ( Squire, para 0036-0037, “the three dimensional structure of the tubular member can be manufactured to have essentially any suitable shape including relatively complex three-dimensional shapes…”; para 0033, “…the devices and methods described herein can be applied to hyperplastic tissue ablation, cardiac ablation…”) . It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have combined the se teachings of Trayanova and Squire with Patent ‘263 in order to manufacture an ablation device according to the three-dimensional configuration that was determined since one would infer this is for the predictable benefit of manufacturing an ablation device that would be personalized for the specific left atrium that is being treated using said ablation device. 29. This is a provisional nonstatutory double patenting rejection. Allowable Subject Matter 30. Claims 6, 7, and 15-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, or would be allowable if the applicant's reply complies with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Conclusion 31 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ANNIE L SHOULDERS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3846 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday (alternate Fridays) 8AM-5PM EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Joseph Stoklosa can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-1213 . 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