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 .
Applicant’s Response
In the Applicant’s Response dated 2/23/26, the Applicant argued Claims 1-20 previously rejected in the Office Action dated 10/22/25.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/23/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 13 and 14 are objected to because of the following informalities:
The claims do not end in the correct punctuation.
Appropriate correction is required.
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 1-10, 12-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Assmann et al., United States Patent Publication 2016/0310259 (hereinafter “Assmann”), in view of Nappi, United States Patent Publication 2017/0326274.
Claim 1:
Assmann discloses:
A method of modelling an external support for a prospective pulmonary autograft attached to patient’s heart using an imaging scanner, the method comprising:
(i) obtaining, using the scanner, at least one scan of the vasculature of the heart during systole of the heart (see paragraph [0008] and [0055]). Assmann teaches at least one first 3D image data set is received via a first interface, wherein the first 3D image data set comprises 3D images of a vascular segment of a patient at different time points;
(ii) processing each scan using a processor to construct a model of the prospective graft (see paragraph [0008]). Assmann teaches processing the data from the 3D images to construct a model of the graft needed based on the analysis of data; and
Assmann fails to teach creating a support for a pulmonary autograft.
Nappi discloses:
pulmonary autograft (see paragraphs [0016] and [0024]). Nappi teaches processing the data from the angiographs to construct a model of the pulmonary autograft based on the analysis of data; and
(iii) processing the model of the pulmonary autograft to generate a model of the external support (see paragraphs [0020], [0088], [0094], [0124]). Nappi teaches processing the data from the model and analyze to generate a prosthesis to provide external support for the autograft.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include generating a model for support of a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the neoaortic root or vessel to which it is applied, conferring resistance to dilatation and behavior of conformability and compliance (see paragraph [0021]), as taught by Nappi.
Claim 2:
Assmann discloses:
obtaining, using the scanner, at least one scan of the heart vasculature during systole of the heart comprises obtaining at least one scan including at least one of the pulmonary valve (PV), the pulmonary trunk (PT), the aortic root and ascending aorta, the aortic valve (AV), the left ventricular outflow tract (LVOT) and the right ventricular outflow tract (RVOT) (see paragraphs [0008], [0047]-[0051], [0068], [0069]). Assmann teaches obtaining images of the aorta during a beating heart.
Claim 3:
Assmann discloses:
generating at least one aligned image in a plane aligned with the vasculature and in particular the prospective graft (see paragraphs [0080]). Assmann generating aligned the 3D images with the prospective graft.
Claim 4:
Assmann discloses:
in which each aligned image is aligned with the valve or the trunk (see paragraph [0080]). Assmann teaches aligning the images with the trunk.
Assmann fails to teach aligning images with pulmonary valve or pulmonary trunk.
Nappi discloses:
pulmonary valve or the pulmonary trunk (see paragraph [0004). Nappi teaches a pulmonary valve or pulmonary trunk; and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the neoaortic root or vessel to which it is applied, conferring resistance to dilatation and behavior of conformability and compliance (see paragraph [0021]), as taught by Nappi.
Claim 5:
Assman discloses:
in which the aligned images include a trans-axial aligned image parallel to a plane of the pulmonary valve or perpendicular to the pulmonary trunk, and/or a sagittal aligned image perpendicular to the plane of the pulmonary valve or parallel to the pulmonary trunk (see paragraphs [0074] and [0075]). Assman teaches aligning image to a plane parallel to the vascular segment such as the valve or the trunk.
Assmann fails to teach aligning images with pulmonary valve or pulmonary trunk.
Nappi discloses:
pulmonary valve or the pulmonary trunk (see paragraph [0004). Nappi teaches a pulmonary valve or pulmonary trunk; and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the neoaortic root or vessel to which it is applied, conferring resistance to dilatation and behavior of conformability and compliance (see paragraph [0021]), as taught by Nappi.
Claim 6:
Assmann discloses:
step of obtaining at least one scan of the heart vasculature during systole of the heart comprises obtaining at least one scan of the heart vasculature in a temporal window during systole in the cardiac cycle of the patient’s heart, typically between 10% R-R and 25% R-R (see paragraph [0042]). Assman teaches obtaining 3D images during a full cardiac cycle.
Claim 7:
Assmann discloses:
processing each scan using a processor to construct a model of the prospective graft comprises measuring one or more parameters, or at least four parameters, from the at least one scan obtained of the heart vasculature during systole of the heart (see paragraphs [0039], [0042] and [0058]). Assmann teaches processing the images to measure parameters of the heart including parameter during a complete cardiac cycle.
Claim 8:
Assmann discloses:
in which the parameters include at least one of: a) the base diameter of the left ventricular outflow tract LVOT, typically measured at the aorto-ventricular junction b) the diameter of each lobe of the sinuses of the prospective pulmonary autograft, the relative rotational spacings of the lobes and the distance of the circular centre of the lobes from the centreline of the lumen of the prospective pulmonary autograft c) the perimeter of the pulmonary valve d) the diameter of the pulmonary sinotubular junction (STJ) e) the aortic diameter (see paragraph [0080]). Assman discloses determining the aortic diameter f) a height of the pulmonary valve from a plane of the pulmonary ventricular junction PVJ to a plane of the pulmonary sinotubular junction.
Claim 9:
Assmann fails to disclose generating a model for the external support.
Nappi discloses:
in which, in order to generate the model of the external support, the method may take the model of the prospective pulmonary autograft and apply at least one transformation (see paragraphs [0105] and [0106]); Nappi teaches generating an external support by transforming the model and using different material to reinforce the graft. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the neoaortic root or vessel to which it is applied, conferring resistance to dilatation and behavior of conformability and compliance (see paragraph [0021]), as taught by Nappi.
Claim 10:
Assmann fails to disclose generating a model for the external support.
Nappi discloses:
in which the at least one transformation comprises a shape transformation comprising equalising the diameters of the lobes (see paragraphs [0065]- [0068], [0094]-[0095]); Nappi teaches generating an external support by transforming the shape and diameters. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the neoaortic root or vessel to which it is applied, conferring resistance to dilatation and behavior of conformability and compliance (see paragraph [0021]), as taught by Nappi.
Claim 12:
Assmann fails to disclose a support for a pulmonary autograft including a shape transformation by scaling.
Nappi discloses:
in which the shape transformation preserves the perimeter of the pulmonary valve (see paragraphs [0011] and [0078]); Nappi teaches the perimeter of the pulmonary valve does not change, only the size of the support is changed. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claims 13-15:
Assmann fails to disclose a support for a pulmonary autograft including a shape transformation by scaling.
Nappi discloses:
in which the at least one transformation comprises a scaling transformation; in which the scaling transformation increases the size of the model of the external support as compared to the model of the prospective pulmonary autograft; in which the scaling transformation increases the size of the model of the external support by a scaling factor of between 1 and 1.2, typically between 1.05 and 1.15 (see paragraphs [0011], [0078] and [0152]); Nappi teaches the ability to provide a scaling transformation to the model by increasing/decreasing the size of the support for best success of the pulmonary autograft. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claim 16:
Assmann fails to disclose manufacturing a former by the model.
Nappi discloses:
comprising using the model of the support to manufacture a former from which the support for a pulmonary autograft can be made (see claim 13); Nappi teaches manufacturing the former from the support model. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claim 17:
Assmann fails to disclose applying a former by the model.
Nappi discloses:
forming the support using the former (see paragraph [0088]); Nappi teaches manufacturing the former from the support model and applying the support. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claim 19:
Assmann fails to disclose a support for a pulmonary autograft.
Nappi discloses:
A support adapted for location exteriorly of a pulmonary autograft, the support being locatable around the pulmonary autograft and shaped to be in morphological relationship with the pulmonary autograft when placed in the aortic position, the support being manufactured in accordance with claim 17 or claim 18 (see paragraphs [0016] and [0088]); Nappi teaches manufacturing the former from the support model and applying the support to the pulmonary autograft of a patient. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claim 20:
Assmann fails to disclose a support for a pulmonary autograft.
Nappi discloses:
A method of supporting a pulmonary autograft comprising:
applying a support in accordance with claim 19 to a pulmonary autograft of a patient (see paragraphs [0016] and [0088]); Nappi teaches manufacturing the former from the support model and applying the support to the pulmonary autograft of a patient. and
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann to include a pulmonary autograft for the purpose of propose a prosthesis provided with a suitable reinforcement, capable of influencing the elastomechanical properties of the aortic root or vessel to which it is applied (see paragraph [0021]), as taught by Nappi.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Assmann, in view of Nappi, in further view of CARRERO VILLARROEL, United States Patent Publication 20220313400.
Claim 11:
Assmann and Nappi fails to teach translating the center lobes to equilateral triangles.
CARRERO VILLARROEL discloses:
in which the shape transformation acts to translate the centres of the lobes from forming an isosceles triangle to an equilateral triangle (see paragraph [0048]). CARRERO VILLARROEL teaches a shape transformation of the prosthetic by translating the lobes to equilateral triangle.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann and Nappi to include a shape transformation for the purpose of efficiently forming the correct prosthetic shape, as taught by CARRERO VILLARROEL.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Assmann, in view of Nappi, in further view of Marquez, United States Patent Publication 20060229718.
Claim 18:
Assmann and Nappi fails to teach a blank settable support to form the former.
Marquez discloses:
in which to form the support, a blank settable support is drawn over the former (see paragraph [0089]). Marquez teaches using a blank settable support to create the support.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Assmann and Nappi to include a blank setting support to create for the former for the purpose of creating the proper support for the prosthetic, as taught by Marquez.
Response to Arguments
Applicant's arguments filed 2/23/26 have been fully considered but they are not persuasive.
Applicant argues Assman nowhere discloses or suggests imaging a prospective
pulmonary autograft. All Assman teaches is the imaging of blood vessels per se (a "vascular segment" in the words of paragraph [0038]) that need some support with a stent. There is no consideration of autografting heart valves.
Although Assman does not teach pulmonary autografts in particular, Assman does teach imaging the heart during systole (see paragraph [0008] and [0055]). Assmann teaches at least one first 3D image data set is received via a first interface, wherein the first 3D image data set comprises 3D images of a vascular segment of a patient at different time points. Assman uses the model to create a stent graft.
Nappi teaches processing the data from the angiograph imaging to construct a model of the pulmonary autograft based on the analysis of data and model (see paragraph [0016]). Although Assman generate a model to create a stent graft, Nappi uses the model to create a pulmonary autograft. Thus, the combination of Assman and Nappi combined teaches the limitations of Claim 1.
The claim does not provide more detail how the model is created or used to create the autograft to differentiate it from the combined art.
Applicant argues This deficiency is not remedied by Nappi, or by any combination of Assman and Nappi. Nappi discloses a stent for providing support, wherein the stent has elasto-mechanical properties suitable for providing structural support to a pulmonary autograph. But the method of Nappi does not involve obtaining and processing scans "to construct a model of the prospective pulmonary autograph." Rather, it simply involves layering of bioabsorbable material and strips
of auxetic material.
The Examiner disagrees.
A pulmonary autograft is created based on a model generated and the measurements obtained. Nappi teaches processing the data from the model and analyze to generate a prosthesis to provide external support for the autograft (see paragraphs [0020], [0088], [0094], [0124]). The prosthesis of the invention allows a process of guided remodeling of the vessel the prosthesis is applied to, the attainment of optimal growth results of such vessel as well as an improvement in the elasto-mechanical properties of both the vessel per se and the composite body formed by vessel plus prosthesis. The autograft is configured based on the current stent. Thus, the model/configuration is processed to create the autograft. Thus, the rejections to these limitations are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 TIONNA M BURKE whose telephone number is (571)270-7259. The examiner can normally be reached M-F 8a-4p.
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/TIONNA M BURKE/Examiner, Art Unit 2178 5/27/26
/STEPHEN S HONG/Supervisory Patent Examiner, Art Unit 2178
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