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 .
Claim Status
Claims 1-21 are currently pending and under exam herein.
Priority
This application is a continuation of U.S. Patent Application Serial No. 17/361,156, filed June 28, 2021, now U.S. Patent No. 11,331,149, which is a continuation of U.S. Patent Application Serial No. 17/003,653, filed August 26, 2020, now U.S. Patent No. 11,051,885, which is a continuation of U.S. Patent Application Serial No. 16/482,509, filed July 31, 2019, now U.S. Patent No. 11,045,256, which is a national phase application under 35 U.S.C. § 371 of PCT/EP2018/052701, filed February 2, 2018, which claims priority to European Patent Application Serial No. 17154648.4, filed February 3, 2017, and is also a continuation-in-part of U.S. Patent Application Serial No. 14/399,781, filed November 7, 2014, now U.S. Patent No. 10,789,772, which is a national phase application under 35 U.S.C. § 371 of PCT/EP2013/058392, filed April 23, 2013, which claims priority to PCT/EP2013/054276, filed March 4, 2013, and PCT/EP2012/059207, filed May 16, 2012, the entire contents of each of which are incorporated herein by reference. U.S. Patent Application 17/361,156, filed June 28, 2021, now U.S. Patent No. 11,331,149, is also a continuation-in-part of U.S. Patent Application Serial No. 15/570,976, filed October 31, 2017, now U.S. Patent No. 11,141,220, which is a national phase application under 35 U.S.C. § 371 of PCT/EP2016/059688, filed April 29, 2016, which claims priority to European Patent Application Serial No. 15166130.3, filed May 1, 2015.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been filed in parent Application No. 16/482,509, filed on 31 July 2019.
Priority for at least independent claims 1, 15, and 21 is granted to the EFD of 6 May 2012.
Information Disclosure Statement
The Information Disclosure Statement filed 15 May 2022 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings filed 14 May 2022 have been accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20220273369.
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.
(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.
Claims 1-3, 5-7, 9, 12-16, and 19-21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2011/0153286 to Zaeuner et al. (IDS document).
Claim 1 is directed to:
A computer-implemented method for pre-operative planning for delivery of a prosthetic cardiac implant to a patient's heart, the method comprising:
obtaining a plurality of digital images of a patient's heart;
obtaining a digital three-dimensional model of a prosthetic cardiac implant;
generating, from the plurality of digital images, a digital patient-specific anatomical model representing a patient-specific cardiac region including a deployment site for the prosthetic cardiac implant;
virtually deploying the digital three-dimensional model of the prosthetic cardiac implant at the deployment site;
calculating deformation of the digital three-dimensional model of the prosthetic cardiac implant, in the deployed state, within the deployment site of the patient-specific cardiac region; and
determining a measure of interaction between the digital three-dimensional model of the prosthetic cardiac implant and the patient-specific cardiac region of the digital patient-specific anatomical model.
With respect to claim 1 the prior art to Zaeuner et al. discloses virtual percutaneous valve implantation wherein patient-specific anatomical model of a heart valve is estimated based on 3D cardiac medical image data and an implant model representing a valve implant is virtually deployed into the patient-specific anatomical model of the heart valve. The implant models maintained in a library are virtually deployed into the patient specific anatomical model of the heart valve to select an implant type and size and deployment location and orientation for percutaneous valve implantation [abstract]. Further, Zaeuner et al. disclose doing so in a pre-operative framework [0018] and with computer implementation [0039].
Specifically, Zaeuner et al. disclose “transform[ing] a 3D medical image data representing a patient's anatomy to generate a patient-specific anatomical model and use[ing] the anatomical model to virtually simulate the implantation of one or more implants” [0019]. Zaeuner et al. further disclose “one or more implant models are virtually deployed into the patient-specific model of the valve” [0026] and “the expansion of a selected implant model is modeled by balancing external and internal forces as encountered in the actual procedure, using iterative optimization methods” [0028].
With respect to calculations of deformation, Zaeuner et al. disclose that “the internal forces… model the intrinsic properties of the stent and enforce deformation along its surface normals and long axis, as the device is self-expandable” [0028].
With respect to determining measures of interaction between the model and the implant at the region (herein fairly interpreted as the valve location), Zaeuner et al. disclose that “external forces… model the inter action of the stent and the aortic valve and aorta tissue, and guide the implant deformation by balancing the internal device forces…” [0028].
With respect to the system and non-transitory computer-readable medium of claims 15 and 21, respectively, the prior art to Zaeuner et al. disclose that “the methods may be implemented on a computer using well-known computer processors, memory units, storage devices, computer software, and other components” to perform the methods as described above [0039].
With respect to claim 2, Zaeuner et al. disclose that “hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis” [0031]. The claim does not define “blood flow path” and as such, Zaeuner et al. disclose assessment of leakage which is a hemodynamic component of backward blood flow.
With respect to claims 3 and 9, Zaeuner et al. disclose that “hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis” [0031].
With respect to claim 5, Zaeuner et al. disclose that “at step 708, the valve implantation procedure is assessed based on the segmented device. In one embodiment, the quality of the implantation can be assessed by calculating the distances of the segmented device to various anatomical landmarks of the patient-specific anatomical model. These distances can be compared with target distances corresponding to each anatomical landmark. The target distances can be based on the pro-operative virtual (in-silica) valve implantation performed using the method of FIG. 1” [0036] and also another embodiment disclosing “the post-operative segmented device (implant) can be used as a ground truth to validate the prediction generated by the pre-operative virtual deployment of the implant. In the post-operative volume, the ground truth implant can be manually placed and fit to the imaged stent, which is well visible in the post-operative image data, using a semi-automatic method based on the thin-plate-spline transformation. The ground truth can be compared to a corresponding virtually deployed implant to validate accuracy of the virtually deployed implant. The ground truth and corresponding virtually deployed implant can be compared by visualizing the ground truth and virtually deployed implant. The ground truth and corresponding virtu ally deployed implant can also be compared on the basis of internal precision, by comparing their shapes in isolation via symmetric point-to-point distance, and on the basis of external precision (e.g., using distances to anatomic landmarks)” [0037]. As the claim does not define the “prolonged presence” parameter, the prior art reads on said limitation herein.
With respect to claim 6, Zaeuner et al. disclose “hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis” [0031]. As the claim does not define “determining the degree of incomplete deployment”, the measure of leakage, for example is fairly interpreted as indicating incomplete deployment herein.
With respect to claims 7 and 16, Zaeuner et al. disclose prosthetic heart valve deployment [abstract].
With respect to claims 12 and 19, Zaeuner et al. disclose “for example, using the virtual-deployment framework various implants can be tested and compared to select the best implant and implant size. Further, the virtual implantation can provide an optimal position and orientation for the selected implant with respect to the patient-specific model. Quantitatively, the forces that hold the stent to the wall can be calculated after virtual deployment. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis. The virtual valve deployment results may be output as a visualization of the implant model in the patient-specific valve model. By simulating the procedure visually, physicians can predict complications of the procedure and minimize risks of the procedure” [0031].
With respect to claims 13 and 20, Zaeuner et al. disclose “...treatment options can be optimized by testing different hypotheses to select the best deployment options” [0031].
With respect to claim 14, Zaeuner et al. disclose “the computer 902 also includes other input/output devices 908 that enable user interaction with the computer 902 (e.g., display, keyboard, mouse, speakers, buttons, etc.)” [0039].
As such, the claims are obvious over the cited art.
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.
1. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0153286 to Zaeuner et al. (IDS document), as applied to claim 1 above and in view of Basari et al. (Journal of Medical Imaging and Health Informatics (2016) Vol. 6, No. 6:8 pages-IDS document).
Zaeuner et al. disclose the above limitations as applied to claim 1. Zaeuner et al. do not specifically disclose the patient-specific model of the cardiac region at a plurality of moments during a cardiac cycle.
However, the prior art to Basari et al. disclose a patient-specific model at a plurality of moments and measurements of hemodynamic compromise therein [page 4, Figure 6].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included modeling over a cardiac cycle, as taught by Basari et al. with the methods of Zaeuner et al. for more robust planning when assessing implant parameters over time for a complete picture of hemodynamics, vessel structure and function and the like. The prior art to Basari et al. and Zaeuner et al. are specifically concerned with optimal deployment to avoid high gradient, leakage, and suboptimal effective orifice (Zaeuner et al. at [0004]; Basari et al. [Figure 6]). Zaeuner et al. further include that image data may being taken over time for modeling purposes [0020]. One would have had motivation to combine said references wherein Basari et al. specifically teach that the improper fitting of implants (TAVI valve) leads to PVL issues [p. 5] and wherein a clear understanding of flow behavior is necessary. As such, the methods as combined with Zaeuner et al. for modeling implant behavior would have met with a reasonable expectation of success, and further both references are in the same filed of endeavor.
As such, the claims are obvious over the cited art.
2. Claims 8, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0153286 to Zaeuner et al. (IDS document), as applied to claims 1 and 15 above and in view of Mobius-Winkler et al. (Atrial Fibrillation. J. Vis. Exp. (60), e3671, DOI : 10.3791/3671 (2012); 7 pages).
With respect to claims 1 and 15, Zaeuner et al. disclose the above limitations. Zaeuner et al. do not specifically disclose the implant device for left atrial appendage (LAA) closure and blockage of clots. However, Mobius-Winkler et al. disclose closure of the LAA using the WATCHMAN™ implant device for the purpose of preventing clots to the bloodstream [abstract].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have also included the WATCHMAN™ device as one type of implant (which is designed to specifically address LAA closure) because both references are in the same fieled of endeavor and concerned with implant device methodology. Further, Zaeuner et al. motivate using said modeling technique wherein said methods include that “the virtual-deployment framework various implants can be tested and compared to select the best implant and implant size. Further, the virtual implantation can provide an optimal position and orientation for the selected implant with respect to the patient specific model. Quantitatively, the forces that hold the stent to the wall can be calculated after virtual deployment. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis” [0031]. As such, the device as disclosed by Mobius-Winkler et al. modeled as combined with Zaeuner et al. for implant behavior would have met with a reasonable expectation of success.
3. Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0153286 to Zaeuner et al. (IDS document), as applied to claims 1 and 15 above.
Zaeuner et al. disclose the methods and systems above as for claims 1 and 15. With respect to claims 11 and 18, Zaeuner et al. do not specifically disclose deployment at different locations and measurement of interactions at different locations. However, modeling different locations and interactions with a model as described by Zaeuner et al. would have been an obvious design choice to provide optimal location in a vessel for said implant. Zaeuner et al. motivate one to do so, teaching that “a misplaced implant can block the coronary ostia and induce a life threatening ischemic condition. Suboptimal deployment location can result in poor hemodynamic performance with severe paravalvular leakages and/or high gradients and suboptimal effective orifice. Incorrect implant sizing may require a re-operation and may damage the vessel tissue and cause catastrophic events, such as arterial dissection or rupture. Accordingly, improved techniques for percutaneous valve implantation planning, procedure guidance, and outcome assessment are desirable” [0004] and further that “…the present invention can be used pre-operatively for identification of optimal device type, size and deployment location and for treatment outcome prediction” [0005]. As such, one would have had a reasonable expectation of success in modeling at various locations to assess various interactions and the invention is prima facie obvious.
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.
1. Claims 1, 2, 9, 15, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 21 of US 11,069,136. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims in the ‘136 patent are directed to: a method, system and computer-readable medium for evaluating placement of a prosthetic device, comprising: obtaining a plurality of digital images of a patient's cardiac anatomy; obtaining a digital model of a prosthetic cardiac device; generating, from the plurality of digital images, a patient-specific digital depiction of the patient's cardiac anatomy including a cardiac anatomical structure in fluid communication with an adjacent anatomical structure, using a computer system; virtually placing the digital model of the prosthetic cardiac device within the cardiac anatomical structure of the patient-specific digital depiction; calculating, using the computer system, a measure of blood flow obstruction to the adjacent anatomical structure of the patient-specific digital depiction resulting from the placement of the digital model of the prosthetic cardiac device; and generating, using the computer system, information to indicate the measure of blood flow obstruction to the adjacent anatomical structure of the patient-specific digital depiction resulting from the placement of the digital model of the prosthetic cardiac device.
Claims of the instant application include a method, system and computer-readable medium directed to a computer-implemented method for pre-operative planning for delivery of a prosthetic cardiac implant to a patient's heart, the method comprising: obtaining a plurality of digital images of a patient's heart; obtaining a digital three-dimensional model of a prosthetic cardiac implant; generating, from the plurality of digital images, a digital patient-specific anatomical model representing a patient-specific cardiac region including a deployment site for the prosthetic cardiac implant; virtually deploying the digital three-dimensional model of the prosthetic cardiac implant at the deployment site; calculating deformation of the digital three-dimensional model of the prosthetic cardiac implant, in the deployed state, within the deployment site of the patient-specific cardiac region; and determining a measure of interaction between the digital three-dimensional model of the prosthetic cardiac implant and the patient-specific cardiac region of the digital patient-specific anatomical model (claim 1).
The claims of the ‘136 patent are directed further to obtaining digital images of a patient’s cardiac anatomy (the instant claims include obtaining digital images of a patient’s heart); obtaining a model of a prosthetic device and generating a patient-specific depiction (the instant claims include a model of a prosthetic cardiac implant); virtually placing the model of the device within the patient-specific anatomical structure (the instant claims include deploying the device model at the deployment site); calculating a measure of blood flow obstruction to adjacent structures as a result of placement of the prosthetic model (the instant claims include calculating a deformation of the model of the implant at the deployment site in the anatomical model-clm 1; the instant claims include determining a blood flow path-clm 2); generating information to indicate measure of blood flow obstruction (the instant claims include determining a measure of hemodynamic compromise-clm 9). The instant claims further include a step of determination of a pathway to deliver the device to the anatomical model. The instant claims would have been prima facie obvious to one of ordinary skill in the art over those of the ‘136 patent, wherein the when looking to the Specification for definition, the definition of a cardiac device as per the ‘136 patent is a valve implant (see for example, col. 2).
2. Claims 1, 15, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 21 of US 11,331,149 in view of Nucifora et al. (Circulation: Cardiovascular Imaging (2011) Vol. 4, Issue 5:514-523-IDS document). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the instant application include a method, system and computer-readable medium directed to a computer-implemented method for pre-operative planning for delivery of a prosthetic cardiac implant to a patient's heart, the method comprising: obtaining a plurality of digital images of a patient's heart; obtaining a digital three-dimensional model of a prosthetic cardiac implant; generating, from the plurality of digital images, a digital patient-specific anatomical model representing a patient-specific cardiac region including a deployment site for the prosthetic cardiac implant; virtually deploying the digital three-dimensional model of the prosthetic cardiac implant at the deployment site; calculating deformation of the digital three-dimensional model of the prosthetic cardiac implant, in the deployed state, within the deployment site of the patient-specific cardiac region; and determining a measure of interaction between the digital three-dimensional model of the prosthetic cardiac implant and the patient-specific cardiac region of the digital patient-specific anatomical model (claim 1).
Claims of the ‘149 patent are directed to a method, system and computer-readable medium directed to pre-operative planning for delivery of a left atrial appendage closure device in a patient's heart, the method comprising: obtaining a plurality of digital images of a patient's heart; obtaining a digital three-dimensional model of a left atrial appendage closure device; generating, from the plurality of digital images, and with a computer system, a patient-specific digital anatomical model of a patient's left atrium and left atrial appendage; determining, with the computer system, a pathway for delivering the left atrial appendage closure device into the patient-specific digital anatomical model of the patient's left atrium and left atrial appendage; virtually deploying, using the computer system, the digital three-dimensional model of the left atrial appendage closure device along the pathway and into the patient-specific digital anatomical model of the patient's left atrium and left atrial appendage; calculating, using the computer system, deformation of the digital three-dimensional model of the left atrial appendage closure device, in the deployed state, within the patient-specific digital anatomical model of the patient's left atrium and left atrial appendage; and determining, using the computer system, a measure of interaction between the digital three-dimensional model of the left atrial appendage closure device and the patient-specific digital anatomical model of the patient's left atrium and left atrial appendage.
The instant claims are genus claims and encompass said species whereby the instant claims further provide that the device is a LAA (claims 8). As such, the claims are obvious variants ones of the other.
3. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of US 11,051,885. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims in the ‘885 patent are directed to a method, system and computer-readable medium for predicting a measure of hemodynamic compromise resulting from transcatheter structural heart intervention including
A computer-based method for predicting a measure of hemodynamic compromise resulting from transcatheter structural heart intervention, comprising: providing an implant model representing a three-dimensional representation of a cardiac implant; providing a patient-specific anatomical model representing a patient-specific cardiac region including a first blood flow path and a deployment site for the cardiac implant in the first blood flow path; virtually deploying the implant model into the patient-specific anatomical model at the deployment site; calculating deformation of the implant model and of the patient-specific anatomical model caused by deployment of the implant model at the deployment site; and determining a measure of hemodynamic compromise corresponding to the deformation of the implant model and of the patient-specific anatomical model.
Claims of the instant application include a method, system and computer-readable medium directed to a computer-implemented method for pre-operative planning for delivery of a prosthetic cardiac implant to a patient's heart, the method comprising: obtaining a plurality of digital images of a patient's heart; obtaining a digital three-dimensional model of a prosthetic cardiac implant; generating, from the plurality of digital images, a digital patient-specific anatomical model representing a patient-specific cardiac region including a deployment site for the prosthetic cardiac implant; virtually deploying the digital three-dimensional model of the prosthetic cardiac implant at the deployment site; calculating deformation of the digital three-dimensional model of the prosthetic cardiac implant, in the deployed state, within the deployment site of the patient-specific cardiac region; and determining a measure of interaction between the digital three-dimensional model of the prosthetic cardiac implant and the patient-specific cardiac region of the digital patient-specific anatomical model (claim 1).
As such, the claims are obvious variants one of the other. Further, the Specification, when looked to for definition, indicates that said processes include application to aortic implants (TAVI) (see page 2 of the originally filed Specification).
4. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US 11,045,256. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims of the instant application include a method, system and computer-readable medium directed to a computer-implemented method for pre-operative planning for delivery of a prosthetic cardiac implant to a patient's heart, the method comprising: obtaining a plurality of digital images of a patient's heart; obtaining a digital three-dimensional model of a prosthetic cardiac implant; generating, from the plurality of digital images, a digital patient-specific anatomical model representing a patient-specific cardiac region including a deployment site for the prosthetic cardiac implant; virtually deploying the digital three-dimensional model of the prosthetic cardiac implant at the deployment site; calculating deformation of the digital three-dimensional model of the prosthetic cardiac implant, in the deployed state, within the deployment site of the patient-specific cardiac region; and determining a measure of interaction between the digital three-dimensional model of the prosthetic cardiac implant and the patient-specific cardiac region of the digital patient-specific anatomical model (claim 1).
Claims of the ‘256 patent are directed to a method, system and computer-readable medium directed to a computer-based method for predicting cardiac health resulting from a proposed transcatheter structural heart intervention, comprising: providing a calibration database configured to store data that correlates predicted measures of hemodynamic compromise to actual occurrences of post-operative hemodynamic compromise observed in a plurality of patients; providing an implant model representing a three-dimensional representation of a cardiac implant; providing a patient-specific anatomical model representing a patient-specific cardiac region including a first blood flow path and a deployment site for the cardiac implant in the first blood flow path; virtually deploying the implant model into the patient-specific anatomical model at the deployment site; calculating deformation of the implant model and of the patient-specific anatomical model caused by deployment of the implant model at the deployment site; determining a patient-specific measure of hemodynamic compromise corresponding to the deformation of the implant model and of the patient-specific anatomical model; and generating an indication of risk of likelihood of an actual hemodynamic compromise for the proposed transcatheter structural heart intervention arising from the patient-specific measure of hemodynamic compromise by comparing the patient-specific measure of hemodynamic compromise to the data associated with the actual occurrences of post-operative hemodynamic compromise observed in the plurality of patients stored in the calibration database. The ‘256 claims further include generation of a risk of compromise for TAVI. The claims are obvious variants one of the other and are prima facie obvious in view of Zaeuner et al., disclosing the need to minimize risk of procedures, making calculations thereof obvious.
Relevant Prior Art
With respect to relevant prior art, the prior art of Auricchio et al. (IDS document) teaches aspects of heart valve implantation in a patient (page 287) and estimates a patient-specific model of the aorta and aortic valve based on 2D and 3D medical image data (page 282). Auricchio et al. further disclose deployment of implant models at page 282. However, Auricchio et al. do not specifically disclose or suggest the calculation of a deformation of the three-dimensional model of a device within the patient-specific anatomical model as instantly claimed. Further, Auricchio et al. do not specifically teach or fairly suggest measurements of interactions between said device model and anatomical model, as instantly claimed.
Eligibility under 35 USC 101
With respect to claims 1-21, and patent eligibility under 35 USC 101, the instant claims are not subject to a rejection for being directed to a judicial exception without recitation of integration and/or significantly more because claims 1, 15 and 21 (the independent claims) and those claims dependent therefrom, include steps that cannot be said to reasonably include any of the judicial exceptions as provided for in the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”), and as outlined in the MPEP at 2106.04. That is, the instant claim neither recite abstract ideas [(1) mathematical processes; (2) methods of organizing human activity; or (3) mental processes] nor do they include natural products/natural phenomena. The steps of the claims include provision of three-dimensional models that can only fairly be interpreted as generated by computer-implementation using complex processes such as deployment of three-dimensional device models within three-dimensional patient-specific anatomical models for calculations of deformation in said context. The determinations of measured interactions as claimed cannot reasonably be interpreted as performed by a human or by mathematical calculation only.
Conclusion
No claims are allowed.
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Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 12:00PM to 10:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/Primary Examiner, Art Unit 1687