DETAILED ACTION
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 .
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,097,071. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 12,097,071 are directed to planning for left atrial appendage transseptal access point optimization comprising a processor configured to generating an anatomical map comprising a representation of at least part of a heart of a patient, identifying a septum of LAA of the heart of the patient in the anatomical map; defining on the anatomical map an entry surface over which a medical device, which is to be delivered via a sheath that penetrates the septum, is to engage with the LAA; calculate a plurality of curves that each include a first end extending to the entry surface, a second end extending to the septum, and comply with specified mechanical properties of the sheath; derive from the curves, multiple candidate locations on the septum for transseptal puncture with the sheath; and cause visualization the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve. Furthermore, the independent claims of U.S. Patent No. 12,097,071 are narrower than claim 1 of current application.
Claims 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,097,071. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 12,097,071 are directed to planning for left atrial appendage transseptal access point optimization comprising a processor configured to configured to cause the system to: calculate a plurality of curves that each (i) have a first end that is tangent to an entry surface over which a medical device is to engage with a Left Atrial Appendage (LAA) of a heart of a patient, (ii) have a second end touching a septum of the heart of the patient, and (iii) comply with specified mechanical properties of a sheath used to guide the medical device; derive, from the curves, multiple candidate locations on the septum for transseptal puncture with the sheath; and cause visualization the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve. Furthermore, the independent claims of U.S. Patent No. 12,097,071 are narrower than claim 12 of current application.
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.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0125581; hereinafter Wang), in view of Sone et al. (US 2019/0000551; hereinafter Sone), in view of Yasui (US 2011/0092811).
Regarding claim 1, Wang discloses a selecting a medical device for use in a medical procedure. Wang shows a non-transitory, computer-readable medium storing instructions thereon that (see par. [0007], when executed by one or more processors (see par. [0007]), cause a device to: generate an anatomical map comprising a representation of at least part of a heart of a patient (see par. [0031]; fig. 3 and 5); identify a septum and a Left Atrial Appendage (LAA) of the heart of the patient in the anatomical map (see par. [0031]); define on the anatomical map an entry surface over which a medical device, which is to be delivered via a sheath that penetrates the septum, is to engage with the LAA (see par. [0039]; fig. 3); comply with specified mechanical properties of the sheath (see par. [0084], [0091]); multiple candidate locations on the septum for transseptal puncture with the sheath (see par. [0031], [0082]); and cause visualization, for performance of a cardiac procedure on the patients, the multiple candidate locations overlaid on the anatomical map (see par. [0083]).
Wang fails to explicitly state calculate a plurality of curves that each include a first end extending to the entry surface, a second end extending to the septum, and that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Sone discloses a medical image processing apparatus. Sone teaches a plurality of curves that includes a first ending extending to entry surface (see fig. 3; 5, 7A-C and 9; par. [0085]); and have a second end touching the septum (see fig. 3; 5, 7A-C and 9; par. [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a plurality of curves that each include a first end extending to the entry surface, a second end extending to the septum in the invention of Wang, as taught by Sone, to be able to determine and provide a more accurate puncture location which would reduce a burden on the subject by avoiding further unnecessary surgery procedure.
But, Wang and Sone fail to explicitly state that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Yasui discloses a syringe needle guiding apparatus. Yasui teaches providing a circle indicating an appropriate insertion angle of the needle (see par. [0051], [0053], [0068], the examiner notes that claim merely limits a semicircular curve, and a circle comprises a semicircular curve).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claim invention, to have utilized the teaching a circle indicating an appropriate insertion angle of the needle in the invention of Wang and Sone, as taught by Yasui, to aid the user by providing a better estimate location for the insertion. The examiner notes that since Wang already shows presenting the multiple candidate locations to a user (see par. [0083]), and upon modification of prior arts Wang and Sone to incorporate the teaching of a circle indicating an appropriate insertion angle of the needle as taught by Yasui will provide that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Regarding claim 2, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows wherein the instructions, when executed by the one or more processors, are further configured to cause the device to calculate a normal to the entry surface (see par. [0049]).
Regarding claim 3, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Sone teaches wherein calculating a plurality of curves further includes the first end being tangent to the normal (see fig. 3; 5, 7A-C and 9; par. [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein calculating a plurality of curves further includes the first end being tangent to the normal in the invention of Wang, as taught by Sone, to be able to determine and provide a more accurate puncture location which would reduce a burden on the subject by avoiding further unnecessary surgery procedure.
Regarding claim 4, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Sone teaches wherein the instructions, when executed by the one or more processors, are further configured to cause the device to receive ultrasound data from an invasive ultrasound probe inserted into the heart of the patient (see abstract; par. [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the instructions, when executed by the one or more processors, are further configured to cause the device to receive ultrasound data from an invasive ultrasound probe inserted into the heart of the patient in the invention of Wang, as taught by Sone, to provide highly detailed images of the heart and its internal structure which would aid in determining of the accurate puncture location which would reduce a burden on the subject by avoiding further unnecessary surgery procedure.
Regarding claim 5, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Sone teaches wherein the anatomical map is calculated based at least in part on the ultrasound data (see par. [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the anatomical map is calculated based at least in part on the ultrasound data in the invention of Wang, as taught by Sone, to prove a safer imaging dur to absence of ionizing radiation.
Regarding claim 6, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows wherein the specified mechanical properties of the sheath comprise a minimal radius of curvature of the sheath obtainable inside the heart by external manipulation of the sheath (see par. [0084], [0091]).
Regarding claim 7, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows delineating an ostium of the LAA on the anatomical map (see par. [0039], [0040], [0041]); and best fitting a plane to the delineated ostium (see par. [0039], [0040], [0041]).
Regarding claim 8, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows an access position of the sheath to a RA of the heart is from the inferior vena cava (see par. [0018], fig. 1). Sone also teaches an access position of the sheath to a RA of the heart is from the inferior vena cava (see fig. 7A; par. [0076]).
Regarding claim 9, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows an LAA occlusion device (See par. [0017]).
Regarding claim 11, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows causing visualization the multiple candidate locations comprises presenting the sheath, the entry surface, using a 3D mapping system (see par. [0035], [0083]; fig. 2-3).
Regarding claim 12, Wang discloses a selecting a medical device for use in a medical procedure. Wang teaches a system (see fig. 2), comprising: a memory storing instructions thereon that (see par. [0007]), when executed by the one or more processors (see par. [0007]), are configured to cause the system to: access an anatomical map comprising a representation of at least part of a heart of a patient (see par. [0031]; fig. 3 and 5); identifying a septum and a LAA of a heart of a patient in an anatomical map of at least part of the heart (see par. [0031], fig. 3)) and comply with specified mechanical properties of a sheath used to guide the medical device (see par. [0084], [0091]); multiple candidate locations on the septum for transseptal puncture with the sheath (see par. [0031], [0082]); and cause visualization, for performance of a cardiac procedure on the patients, the multiple candidate locations overlaid on the anatomical map (see par. [0083]).
Furthermore, Wang shows an entry surface over which medical device is to engage with a Left Atrial Appendage (LAA) of a heart of a patient (see par. [0039]; fig. 3), but Wang fails to explicitly state calculating a plurality of curves that each have a first end that is tangent to an entry surface, (ii) have a second end touching a septum of the heart of the patient, and the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Sone discloses a medical image processing apparatus. Sone teaches a plurality of curves that each have one end that is tangent to entry surface (see fig. 3; 5, 7A-C and 9; par. [0085]); and have a second end touching the septum of the heart of the patient (see fig. 3; 5, 7A-C and 9; par. [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a plurality of curves that each have one end that is tangent to entry surface; and have a second end touching the septum of the heart of the patient in the invention of Wang, as taught by Sone, to be able to determine and provide a more accurate puncture location which would reduce a burden on the subject by avoiding further unnecessary surgery procedure.
But, Wang and Sone fail to explicitly state that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Yasui discloses a syringe needle guiding apparatus. Yasui teaches providing a circle indicating an appropriate insertion angle of the needle (see par. [0051], [0053], [0068], the examiner notes that claim merely limits a semicircular curve, and a circle comprises a semicircular curve).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claim invention, to have utilized the teaching a circle indicating an appropriate insertion angle of the needle in the invention of Wang and Sone, as taught by Yasui, to aid the user by providing a better estimate location for the insertion. The examiner notes that since Wang already shows presenting the multiple candidate locations to a user (see par. [0083]), and upon modification of prior arts Wang and Sone to incorporate the teaching of a circle indicating an appropriate insertion angle of the needle as taught by Yasui will provide that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Regarding claim 13, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Sone teaches wherein the instructions, when executed by the one or more processors, are further configured to cause the system to receive ultrasound data from an invasive ultrasound probe inserted into the heart of the patient (see abstract; par. [0035]), the ultrasound data comprising data indicative of at least part of the heart of the patient (see abstract; par. [00035]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the instructions, when executed by the one or more processors, are further configured to cause the system to receive ultrasound data from an invasive ultrasound probe inserted into the heart of the patient, the ultrasound data comprising data indicative of at least part of the heart of the patient in the invention of Wang, as taught by Sone, to provide highly detailed images of the heart and its internal structure which would aid in determining of the accurate puncture location which would reduce a burden on the subject by avoiding further unnecessary surgery procedure.
Regarding claim 14, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows wherein the instructions, when executed by the one or more processors, are further configured to cause the system to generate an anatomical map (see fig. 5), the anatomical map comprising a representation of at least part of the heart (see fig. 5), and Sone teaches ultrasound data comprising data (see abstract; par. [00035]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of utilizing ultrasound data in the invention of Wang, as taught by Sone, to prove a safer imaging dur to absence of ionizing radiation.
Regarding claim 15, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows wherein the instructions, when executed by the one or more processors, are further configured to cause the system to cause visualization, on the anatomical map, of the sheath and the entry surface over which the medical device, which is to be delivered via the sheath that penetrates the septum, is to engage with the LAA (see par. [0039], fig. 3).
Regarding claim 16, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows delineating an ostium of the LAA on the anatomical map (see par. [0039], [0040], [0041]); and best fitting a plane to the delineated ostium (see par. [0039], [0040], [0041]).
Regarding claim 17, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows calculating a normal to the entry surface (see par. [0049]).
Regarding claim 18, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows wherein the specified mechanical properties of the sheath comprise a minimal radius of curvature of the sheath obtainable inside the heart by external manipulation of the sheath (see par. [0084], [0091]).
Regarding claim 19, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows an access position of the sheath to a RA of the heart is from the inferior vena cava (see par. [0018], fig. 1). Sone also teaches an access position of the sheath to a RA of the heart is from the inferior vena cava (see fig. 7A; par. [0076]).
Regarding claim 20, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, furthermore, Wang shows an LAA occlusion device (See par. [0017]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0125581; hereinafter Wang), in view of Sone et al. (US 2019/0000551; hereinafter Sone), in view of Yasui (US 2011/0092811) as applied to claim 1 above, and furthermore in view of Kassab et al. (US 2010/0286718).
Regarding claim 10, Wang, Sone and Yasui disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a balloon catheter.
Kassab discloses a device and method for percutaneous trans-septal left atrial appendage occlusion. Kassab teaches a balloon catheter (see par. [0046]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized a balloon catheter in the invention of Wang, Sone and Yasui, as taught by Kassab, to be able to occlude the LAA ostium and to be able to perform suctioning.
Response to Arguments
The previous objection to claim 1 has been withdrawn in view of Applicant’s amendments to claim 1.
In view of Applicant’s amendments and remarks with respect to claim 1 and 12, and upon further consideration, the examiner has withdrawn the previous rejection under 35 USC 101.
Applicant's arguments filed 12/29/2025, pages 15-18, have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 15-17, with respect to prior art rejection of independent claims 1 and 12, the examiner respectfully disagrees. The examiner maintains that combined invention of Wang, Sone and Yasui disclose all the claim limitations set forth in independent claims 1 and 12, particularly the claim limitation of that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve. The examiner has relied on prior art Wang to show an anatomical map comprising a representation of at least part of a heart of a patient (see par. [0031]; fig. 3 and 5); identify a septum and a Left Atrial Appendage (LAA) of the heart of the patient in the anatomical map (see par. [0031]) and multiple candidate locations on the septum for transseptal puncture with the sheath (see par. [0031], [0082]); and cause visualization, for performance of a cardiac procedure on the patients, the multiple candidate locations overlaid on the anatomical map (see par. [0083]). The examiner has further relied on prior art Sone to teach a plurality of curves that includes a first ending extending to entry surface (see fig. 3; 5, 7A-C and 9; par. [0085]); and have a second end touching the septum (see fig. 3; 5, 7A-C and 9; par. [0085]).
The examiner has relied on prior art Yasui teaches providing a circle indicating an appropriate insertion angle of the needle (see par. [0051], [0053], [0068]). The Applicant argues that prior art Yasui teaches a representative of an angle of the needle and not a location where the needle could be inserted, the examiner respectfully disagrees. Claim 1 merely limits that the multiple candidate locations disposed along a semicircular curve and prior art Yasui teaches using a circle display to show the angle where a needle is going to intersects the target. In par. [0053], Yasui teaches displaying circle indicating an appropriate insertion angle of where the needle would be injected into the blood vessel. Furthermore, the examiner maintains that since Wang already shows presenting the multiple candidate locations to a user (see par. [0083]), and upon modification of prior arts Wang and Sone to incorporate the teaching of a circle indicating an appropriate insertion angle of the needle as taught by Yasui will provide that the multiple candidate locations being represented as multiple candidate locations disposed along a semicircular curve.
Applicant's remarks on bottom of page 17 to page 18 with regards to prior art Kassab have been fully considered but they are not persuasive as they are not directed to the content of the citations from prior art Kassab, but merely rely on the alleged deficiency with the primary combination of Wang, Sone and Yasui.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ward et al. (US2020/0261158) disclose system and method for cather-based intervention.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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, Anne M Kozak can be reached at (571)270-0552. 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.
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797