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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-23 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "each notch" in the patch. It appears the dependency should be on claim 18 since “one or more notches” is not in claim 16. Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 rejected under 35 U.S.C. 101 because
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-9 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-9 recites a series of steps or acts for reconstructing the cardiovascular structure. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-9 recites at least one step or instruction for reconstructing the cardiovascular system, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The step of “creating a model” can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. The other limitations recite insignificant extra-solution activity in the form of data-gathering. Accordingly, each of Claims 1-9 recites an abstract idea.
Specifically, Claim 1 recites:
obtaining a three-dimensional model of the cardiovascular structure based on information regarding the cardiovascular structure; and
creating a three-dimensional model of a patch corresponding to the three- dimensional model of the cardiovascular structure, wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry.
The claimed steps creating a model of a patch based on cardiovascular data can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Further, dependent Claims 2-9 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implement the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-9 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, The method may also include producing a three-dimensional model of the cardiovascular structure based on the one or more images. For example, in some embodiments, the one or more images may be sent to a processor (e.g., via a wired or wireless communication protocol) which is configured to process the one or more images into a three-dimensional computer model of the cardiovascular structure. In some embodiments, a doctor (e.g., a surgeon), medical engineer or other medical professional may create the three-dimensional model with the assistance of computer aided design (CAD) software (e.g., at a user interface). In some embodiments, the method may also include creating a three-dimensional model of a patch corresponding to the three-dimensional model of the cardiovascular structure, where the patch is configured to reconstruct the cardiovascular structure to a normal geometry. In some embodiments, the three-dimensional model of the patch may be based at least in part in a stress strain curve of an anisotropic material of the patch. That is, the three-dimensional model of the patch may be configured to achieve a normal geometry of the cardiovascular structure when accounting for the deformation and strength of the patch. In some embodiments, the three-dimensional model of the patch may be created automatically by a processor based on the three- dimensional model of the cardiovascular structure. In some such embodiments, the processor may create the three-dimensional model of the patch based on a known normal cardiovascular structure geometry (Paragraph 0023 of the Applicant’s Specification).
Accordingly, in light of Applicant’s specification, the term “processor” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Examiner further notes that the claims do not recite said “processor”. The claims imply that there may be a “processor” to complete the method steps, but there is no formal recitation within the claim language.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processor”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-9 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 1-9 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-9 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Therefore, none of the Claims 1-9 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-9 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claim(s) 1-4 & 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0078356 hereinafter Pekkan.
In regards to Claim 1: A method of reconstructing a cardiovascular structure (Pekkan, Paragraph 0029; Figure 1), the method comprising:
obtaining a three-dimensional model of the cardiovascular structure based on information regarding the cardiovascular structure (Pekkan, Paragraph 33; Figure 1 Item 2); and
creating a three-dimensional model of a patch corresponding to the three- dimensional model of the cardiovascular structure, wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry (Pekkan, Paragraphs 34 & 37; Figure 1 Item 4).
In regards to Claim 2: The method of claim 1, further comprising characterizing the cardiovascular structure (Pekkan, Paragraph 33; MRI and CT scans described are used to characterize the cardiovascular structure).
In regards to Claim 3: wherein characterizing the cardiovascular structure includes producing one or more images of the cardiovascular structure (Pekkan, Paragraph 33; MRI and CTs are imaging system).
In regards to Claim 4: wherein obtaining a three-dimensional model of the cardiovascular structure includes producing the three-dimensional model based on the information regarding the cardiovascular structure (Pekkan, Paragraph 29; Figure 1 Item 5).
In regards to Claim 15: A non-transitory computer readable memory including processor executable instructions that when executed perform the method of claim 1 (Pekkan, Paragraph 95 & 96; Figure 1 Item 7).
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.
Claim(s) 5, 6, & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of 2008/0049991 hereinafter Gering.
In regards to Claim 5: Pekkan teaches all of claim 1, but does not teach flattening the three-dimensional model of the patch to a two-dimensional plan.
Gering teaches flattening the three-dimensional model of the patch to a two-dimensional plan (Gering, Paragraph 59, 60, & 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the flattening of the model taught in Gering to the system if cardiovascular patch construction taught in Pekkan, the motivation being to provide a simpler model of the structure for easier interaction.
In regards to Claim 6: A modified Pekkan teaches wherein the three-dimensional model of the patch includes an outermost perimeter, wherein flattening the three-dimensional model of the patch includes identifying one or more cutouts in the patch (Gering, Paragraphs 63 & 64, Figure 12).
In regards to Claim 9: A modified Pekkan teaches wherein the one or more cutouts are interior cutouts (Gering, Paragraph 64).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of WO 2018/148714 hereinafter Azakie.
In regards to Claim 14: Pekkan teaches all of claim 1, and printing the three-dimensional model of the patch (Pekkan, Paragraph 63), but does not disclose using an anisotropic material.
Azakie teaches printing the three-dimensional model of the patch using an anisotropic material (Azakie, Figure 1; Abstract, Page 4 Line 25 – Page 6 Line 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the anisotropic material taught in Azakie to the System taught in Pekkan, the motivation being to allow for stretching of the material to accommodate the different movements of the heart.
Claim(s) 10, 11, & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of 2008/0049991 hereinafter Gering in further view of WO 2018/148714 hereinafter Azakie.
In regards to Claim 10: A modified Pekkan teaches all of claims 6, 5, & 1; but does not teach projecting the two-dimensional plan onto at least one layer of anisotropic material.
Gering teaches projecting the two-dimensional plan onto at least one layer of material (Gering, Figure 10 Item 1000; Paragraph 61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add projecting the two-dimensional plan taught in Gering to the system of a modified Pekkan, the motivation being to provide an easily handled projection of the biological structure that physicians can use in a presentation to the patient.
Azakie teaches at least one layer of anisotropic material (Azakie, Page 4 Line 25 – Page 6 Line 22.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the use of an anisotropic material taught in Azakie to the system of a modified Pekkan, the motivation being to provide a material that allows for stretching and deformation to occur to suit any size needed for cardiovascular repair.
In regards to Claim 11: A modified Pekkan teaches all of claims 10, 6, 5, & 1, but does not teach cutting the at least one layer of the anisotropic material along a border formed by the outermost perimeter and the one or more cutouts.
Azakie teaches cutting the at least one layer of the anisotropic material along a border formed by the outermost perimeter and the one or more cutouts (Azakie, Figure 6 Item 620; Page 11 Line 26-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts of anisotropic material taught in Azakie to the system of a modified Pekkan, the motivation being to allow for the user to cut the material down to a desired size.
In regards to Claim 13: A modified Pekkan teaches claims 5 & 1, and selecting a patch template corresponding to the two-dimensional plan from a plurality of templates (Pekkan, Paragraph 60; multiple different prototypes are fabricated to be selected from).
Azakie teaches cutting at least one layer of an anisotropic material along a border formed by the patch template (Azakie, Page 11 Lines 26-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutting of the anisotropic material taught in Azakie to the system of a modified Pekkan, the motivation being to provide a allow for the material to be cut and shaped to fit into any cardiovascular space needed.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of US 2008/0049991 hereinafter Gering in further view of WO2018/148714 hereinafter Azakie in furthest view of US 2017/0027683 hereinafter Douthitt.
In regards to Claim 12: A modified Pekkan teaches claims 10, 6, 5, & 1, but does not teach projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector.
Douthitt teaches projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector (Douthitt, Paragraphs 51 & 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the laser projection of the two-dimensional plan taught in Douthitt to the system of a modified Pekkan, the motivation being to provide a template that can be followed for cutting the material to size.
Claim(s) 7 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of 2008/0049991 hereinafter Gering in further view of US 2008/0183275 hereinafter Schmid.
In regards to Claim 7: A modified Pekkan teaches all of claims 6, 5 & 1, but does not teach wherein the one or more cutouts include one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts include one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraph 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts in the material taught in Schmid to the system described in a modified Pekkan, the motivation being to provide more flexibility and allow access to veins and arteries.
In regards to Claim 8: A modified Pekkan teaches all of claims 7, 6, 5, 1, and wherein each of the one or more notches is triangular (Schmid, Paragraph 253 & 254).
Claim(s) 16, 25, 26 & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering.
In regards to Claim 16: Azakie teaches a patch for a cardiovascular structure (Azakie, Page 4 Lines 17-24), comprising: at least one layer of anisotropic material including an outermost perimeter (Azakie, Page 4 Line 25 – Page 6 Line 22)
Gering teaches one or more cutouts formed in the at least one layer of material (Gering, Paragraph 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts into the layer of material taught in Gering to the conduit taught in Azakie, the motivation being to preserve the contours of the cardiovascular structure.
In regards to Claim 25: Azakie teaches A method of forming a patch for a cardiovascular structure (Azakie, Page 4 Lines 17-24), and projecting a two-dimensional plan of the patch onto at least one layer of anisotropic material (Azakie, Page 4 Line 25 – Page 6 Line 22). Azakie does not teach the method comprising: wherein the two-dimensional plan is a flattened three-dimensional model of the patch, wherein the two-dimensional plan of the patch includes an outermost perimeter and one or more cutouts in the patch.
Gering Teaches the method comprising: wherein the two-dimensional plan is a flattened three-dimensional model of the patch (Gering, Paragraphs 59, 60, & 68), wherein the two-dimensional plan of the patch includes an outermost perimeter and one or more cutouts in the patch (Gering, Paragraph 63 & 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the two-dimensional plan including cutouts taught in Gering to the conduit taught in Azakie, the motivation being to provide an easily handled template of the biological structure that physicians can maneuver into place during a procedure.
In regards to Claim 26: A modified Azakie teaches wherein the one or more cutouts are interior cutouts (Gering, Paragraph 64).
In regards to Claim 28: A modified Azakie teaches further comprising cutting the at least one layer of the anisotropic material along a border formed by the outermost perimeter and one or more cutouts (Azakie, Page 11 Lines 26-28).
Claim(s) 17, 18, 19, 20, 21, 23, & 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in further view of US 2008/0183275 hereinafter Schmid.
In regards to Claim 17: A modified Azakie teaches all of claim 16, but does not teach wherein the one or more cutouts are interior cutouts.
Schmid teaches wherein the one or more cutouts are interior cutouts (Schmid, Paragraphs 253 &254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts taught in Schmid to the conduit taught in a modified Azakie, the motivation being to provide more flexibility to the patch and allow access for branching arteries and veins.
In regards to Claim 18: A modified Azakie teaches all of claim 16, but does not teach wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraphs 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts taught in Schmid to the conduit taught in a modified Azakie, the motivation being to provide greater flexibility to the patch to better match the contours of the cardiovascular structure that is being repairs.
In regards to Claim 19: A modified Azakie teaches all of claim 16, but does not teach wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the first edge and the second edge of each notch are joined together.
Schmid teaches wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the first edge and the second edge of each notch are joined together (Schmid, Paragraphs 253 & 254; Triangular cutouts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the triangular cutouts taught in Schmid to the conduits taught by a modified Azakie, the motivation being to provide greater flexibility to the patch to better match the contours of the cardiovascular structure that is being repairs.
In regards to Claim 20: A modified Azakie teaches all of claims 19 & 16, and wherein the joined first edge and second edge of each of the one or more cutouts are configured to apply tension to the least one layer of anisotropic material (Azakie, Page 4 Line 25 – Page 6 Line 22) to curve the at least one layer of anisotropic material (Schmid Paragraphs 253 & 254) (The edges being described in the prior art that make up the cutouts come into contact with the anisotropic material and are therefore configured to apply tension).
In regards to Claim 21: A modified Azakie teaches wherein the one or more cutouts are sized and shaped such that the at least one layer has a curvature corresponding to the cardiovascular structure (Schmid, Paragraph 253 & 254) (Cutouts increase flexibility to follow the contours of the cardiovascular structure and allow access to branches off of the artery or vein).
In regards to Claim 23: A modified Azakie teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter, and wherein the joined first edge and second edge of each of the one or more notches are configured to remove the discontinuities in the outermost perimeter (Gering, Paragraph 64; when edges are brought together, the material takes a form including the angular relationships of the cardiovascular structure involved).
In regards to Claim 27: A modified Azakie teaches all of claim 15 but does not teach wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraphs 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts in the material taught in Schmid to the conduit taught in a modified Azakie, the motivation being to increase the flexibility of the material and allow access to arteries that branch off.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in further view of US 2008/0183275 hereinafter Schmid in furthest view of US 2005/0049667 hereinafter Ardefeuille.
In regards to Claim 22: A modified Azakie teaches all of claims 22, 21, 20, 19, & 16; but does not teach wherein the cardiovascular structure is an aortic transverse arch.
Ardefeuille teaches wherein the cardiovascular structure is an aortic transverse arch (Ardefeuille, Paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the area of interest in the cardiovascular system as taught in Ardefeuille with the conduit system taught in a modified Azakie, the motivation being to further specialize the device allowing it to focus on solving specific problems associated with the region in question.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 5,480,424 hereinafter Cox.
In regards to Claim 24: A modified Azakie teaches all of claim 16, but does not teach wherein the anisotropic material is one selected from the group of human cardiovascular homograft and autologous pericardium.
Cox teaches wherein the anisotropic material is one selected from the group of human cardiovascular homograft and autologous pericardium (Cox, Column 3 Lines 54-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the homograft taught in Cox to the conduit taught in a modified Azakie, the motivation being to use a material that is proven to work under the same stress as what is needed for repairing the cardiovascular system.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2017/0027683 hereinafter Douthitt.
In regards to Claim 29: A modified Azakie teaches all of claim 25, but does not teach wherein projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector.
Douthitt teaches wherein projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector (Douthitt, Paragraphs 51 & 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the projection by a laser projector taught in Douthitt to the conduit taught in a modified Azakie, the motivation being to provide a template that can be followed when cutting the material to the desired size.
Claim(s) 30, 31, & 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2005/0070994 hereinafter Sievers.
In regards to Claim 30: A modified Azakie teaches Claim 25, but does not teach wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the method further comprising sewing the first edge to the second opposing edge of each of the one or more cutouts.
Sievers teaches wherein each of the one or more cutouts includes a first edge and a second opposing edge, the method further comprising sewing the first edge to the second opposing edge of each of the one or more cutouts (Sievers, Paragraph 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add sewing the edges of the cutouts together as taught in Sievers to the conduit taught in a modified Azakie, the motivation being to form the material into a three-dimensional shape that follows the contours of the area that is being repaired.
In regards to Claim 31: A modified Azakie teaches wherein sewing the first edge to the second opposing edge of each of the one or more cutouts includes applying tension to the least one layer of anisotropic material to curve the at least one layer of anisotropic material (Sievers, Paragraph 53; the sewing fixes the material into a shape, therefore must be applying tension to the edges).
In regards to Claim 32: A modified Azakie teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter, and wherein sewing the first edge to the second opposing edge of each of the one or more notches includes removing the discontinuities in the outermost perimeter (Sievers, Paragraph 53; By sewing the edges of the cutout together, there perimeter of the material would become continuous).
Conclusion
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791