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 . Claims 1-20 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities; appropriate correction is required.
Regarding page 33, line 19, “reinforcing elements 201” should be corrected to “reinforcing elements 210.”
Regarding pages 32, 33, and 34, “Shore A hardness from about 25 MPa to about 35 MPa according to ASTM D-224D” should be corrected as Shore A hardness is a dimensionless value and is not expressed in units of pressure (MPa), and “ASTM D-224D” does not correspond to a recognized ASTM standard.
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 9, 16, 19, and 20 are 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 9 recites “being according to claim 1.” It is unclear what part of claim 1 is being incorporated into claim 9.
Claim 16 recites “having a Shore A hardness from about 25MPa to about 35MPa according to ASTM D-224D.” Shore A hardness is a dimensionless value and is not expressed in units of pressure (MPa). In addition, “ASTM D-224D” does not correspond to a recognized ASTM standard.
Claim 19 recites the limitation "object" and “said liner layer” in line 1. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution and as best understood, claim 19 will be interpreted to mean according to claim 18 where “a liner layer” was first introduced, instead of claim 15.
Claim 20 recites the limitation "object" and “said liner layer” in line 1. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution and as best understood, claim 19 will be interpreted to mean according to claim 18 where “a liner layer” was first introduced, instead of claim 15.
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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”).
Regarding claim 1, a first embodiment (Fig. 11) of Ooba discloses a tubular structure (cylindrical (tubular) modeled article 13, see [0115]) fabricated by additive manufacturing (see [0002]) from non-biological building material formulations (object built from materials such as photocurable resin, powder, jelly, or sol, see [0017] and [0059]), and comprising:
an elongated core (support 28, see Fig. 11C), a shell (cylindrical modeled article 13) encapsulating said core (see Fig. 11C) and an intermediate shell (predetermined gap d comprise a powder layer, see [0059], [0119], and Fig. 11C) between said core and said shell (interposed between the inner support 28 and the inner surface of the tube wall, see Fig. 11C), each of said core, said shell and said intermediate shell being made of a different material or a different combination of materials (tube wall being formed of the modeling material, inner support 28 of the support material, and gap d of the powder material, see [0024] and [0025]), wherein both said core and said intermediate shell are sacrificial (support 28 and the gap-filling material are both removed from the three-dimensional modeled object after fabrication, see [0024] and [0025]), and wherein one of said intermediate shell and said core is made of a hardened support material (support 28 is a solidified support member with shape corresponding to the inner surface of the cylindrical model to support it, see [0117]).
The first embodiment of Ooba does not disclose that another one of said intermediate shell and said core is made of a liquid or liquid-like material, however a second embodiment (see [0004]-[0007] for laser beam lithography method) of Ooba discloses a laser beam lithography method wherein said intermediate shell is made of a liquid or liquid-like material (build material surrounding the modeled article and remaining in the three-dimensional structure is a liquid photocurable resin that is left uncured by the light, and that the modeled article is obtained by removing that fluid shaping material, see [0004] and [0025]).
The second embodiment of Ooba teaches that the surrounding or gap material in the region between the modeled article and its support is an uncured liquid photocurable resin which is removed after fabrication (see [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gap d disclosed by the first embodiment of Ooba to include uncured liquid photocurable resin by the laser beam lithography method, as taught by the second embodiment, in order to easily remove the sacrificial material from the tube and to avoid leaving any traces of support on the inner walls.
Regarding claim 2, the first embodiment of Ooba further discloses an intermediate shell (predetermined gap d comprise a powder layer, see [0059], [0119], and Fig. 11C) and core (support 28, see Fig. 11C) but does not disclose that the intermediate shell is made of said hardened support material, and said core is made of said liquid or liquid-like material. However, a second embodiment of Ooba further discloses a hardened support material (non-fluid shaping materials including powder, wax, jelly, and sol, see [0017] and [0059]), and liquid or liquid-like material (fluid shaping material identifies as a liquid, including the liquid photocurable resin used in the laser beam lithography method that remains uncured, see [0004], [0017], and [0025]). The second embodiment of Ooba teaches that both the non-fluid and fluid shaping materials are used in forming the object together with the support, and that both are removed from the desired modeled article after fabrication (see [0025]). Ooba’s non-fluid shaping material indicated a solid state and corresponds to the recited “hardened support material,” while the fluid shaping material corresponds to the recited “liquid or liquid-like material.”
Thus, Ooba presents one of ordinary skill in the art with a recognized need to fill each of
the two sacrificial regions of the hollow tube (the core and intermediate shell) with a shaping material that supports the structure during fabrication and subsequently removed (see [0115] and [0119]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try the arrangement recited wherein the intermediate shell is provided with the non-fluid (hardened support) shaping material and the core is provided with the fluid (liquid or liquid-like) shaping material because this is one of the finite number of identified, predictable solutions that Ooba discloses for filling the two sacrificial regions of its tubular structure (see MPEP 2143(I)(E)). One of ordinary skill in the art would have had a reasonable expectation of success in doing so, as Ooba describes that both the non-fluid and fluid material are suitable for forming and supporting the sacrificial regions of the structure, and that both are removed to obtain the finished object.
Regarding claim 3, the first embodiment of Ooba further discloses that the core is made of said hardened support material (support 28 is a solidified support member with shape corresponding to the inner surface of the cylindrical model to support it, see [0117]).
The first embodiment of Ooba does not disclose that said intermediate shell is made of said liquid or liquid-like material, however the second embodiment of Ooba further discloses that said intermediate shell is made of said liquid or liquid-like material (build material surrounding the modeled article and remaining in the three-dimensional structure is a liquid photocurable resin that is left uncured by the light, and that the modeled article is obtained by removing that fluid shaping material, see [0004] and [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gap d disclosed by the first embodiment of Ooba to include uncured liquid photocurable resin by the laser beam lithography method, as taught by the second embodiment, in order to easily remove the sacrificial material from the tube and to avoid leaving any traces of support on the inner walls.
Regarding claim 4, the first embodiment of Ooba does not disclose wherein said liquid or liquid-like material is characterized by a flowability, however the second embodiment of Ooba further discloses wherein said liquid or liquid-like material is characterized by a flowability when subjected to a positive pressure of no more than 1 bar (Ooba discloses an uncured liquid light curable resin that self-levels into planar layers and remains uncured and flowable after fabrication, see [0025]). As the resin is flowable at atmospheric pressure, it necessarily flows under applied pressures no more than 1 bar. Accordingly, Ooba’s liquid resin inherently exhibits flowability when subjected to a positive pressure of no more than 1 bar.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the core disclosed by the first embodiment of Ooba to be made of a liquid or liquid-like material with flowability when subjected to a positive pressure, as taught by the second embodiment of Ooba, in order to form and support the sacrificial regions of the structure and be easily removable after fabrication.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of CN 1654028 A (“Lin”).
Regarding claim 5, the first and second embodiments of Ooba do not disclose having a shape of a blood vessel, however Lin discloses a method of forming a tubular tissue-engineering scaffold by additive manufacturing wherein the tubular structure has a shape of a blood vessel (see [0010] and Figs. 2 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular structure of Ooba to have a shape of a blood vessel, as taught by Lin, for use as vascular scaffolds. One of ordinary skill would have a reasonable expectation of success, as both references are directed to forming tubular structures by additive manufacturing. Such a selection of a particular art-recognized shape would have been obvious.
Regarding claim 6, the first embodiment of Ooba further discloses wherein said shell is embedded in a supporting structure (modeled article 13 is supported on its exterior and embedded in support 27, which has a shape corresponding to the outer surface, see Fig. 11C).
Regarding claim 7, the first embodiment of Ooba further discloses wherein said supporting structure is sacrificial (support 27 is removed when the completed modeled article is extracted, see [0119]).
Regarding claim 8, the first embodiment of Ooba further discloses an object (cylindrical (tubular) modeled article 13, see Fig. 11C) fabricated by additive manufacturing (see [0002]) from non-biological building material formulations (object built from materials such as photocurable resin, powder, jelly, or sol, see [0017] and [0059]).
The first embodiment of Ooba does not disclose that the object has a shape of an organ, however Lin further discloses that the object has a shape of an organ (bodily structures may be formed for neural conduit, blood vessel, salivary gland, alimentary tracts, air passage, urethra, genital tract, liver, and kidney, see [0004]) and comprising: at least one structure having a shape of a blood vessel (see [0010] and Figs. 2 and 3) and at least one structure having a shape of a bodily structure other than a blood vessel (bodily structures capable of being shaped for neural conduit, salivary gland, alimentary tracts, air passage, urethra, genital tract, liver, and kidney, see [0004]), wherein said structure having said shape of said blood vessel is the tubular structure according to claim 1 (Ooba discloses the tubular structure of claim 1, see claim 1 above).
Lin teaches that for complicated organs like the liver and kidney, the scaffold is formed as an organ body having a specified interior runner or internal vessel, and that the macroscopical form of the support has basically determined the final form of the artificial organ or organ (see [0004] and [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular structure disclosed by Ooba to have a shape of a blood vessel and a bodily structure having a shape other than a blood vessel, as taught by Lin, in order to produce an anatomical organ model representing the vasculature and the non-vessel anatomy of the organ. Additionally, the recited organ shape and non-vessel bodily structure constitutes an obvious matter of design choice; the Specification of the current application showing no criticality to any particular organ shape or non-vessel structure (see Specification [0250]).
Regarding claim 9, the first embodiment of Ooba further discloses an object (cylindrical (tubular) modeled article 13, see Fig. 11C) fabricated by additive manufacturing (see [0002]) from non-biological building material formulations (object built from materials such as photocurable resin, powder, jelly, or sol, see [0017] and [0059]).
The first embodiment of Ooba does not disclose that the object comprises an interconnected network of elongated structures, however Lin further discloses that the object comprises an interconnected network of elongated structures (three-dimensional block scaffold with an internal pipe network, see [0058]-[0060] and Fig. 4), each having a shape of a blood vessel (three-dimensional block with an internal pipe network has interior tubular mesh shape as shown in Fig. 3 correlating to the shape of a blood vessel, see [0058] and Figs. 2-4) and being according to claim 1 (Ooba discloses the tubular structure of claim 1, see claim 1 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular structure disclosed by Ooba to have an interconnected network of elongated structures in a shape of a blood vessel, as taught by Lin, in order to produce an anatomical organ model representing the vasculature anatomy of the organ.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of US 2014/0328963 A1 (“Mark”).
Regarding claim 10, the first and second embodiments of Ooba do not disclose reinforcing elements embedded in said shell, however Mark discloses fiber reinforced additive manufacturing in which one or more reinforcing fiber strands are embedded within a surrounding matrix material, and that the core or strands of the core may reinforce structurally (see [0034]). Mark teaches that the reinforced filament may be used in forming a solid shell (see [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular structure disclosed by Ooba to have reinforcing elements embedded in the shell, as taught by Mark, in order to structurally reinforce the additively-manufactured shell wall (see [0027] and [0034]).
Regarding claim 11, the first and second embodiments of Ooba do not disclose wherein said reinforcing elements are oriented to effect anisotropic mechanical properties of said shell, however Mark further discloses that said reinforcing elements are oriented to effect anisotropic mechanical properties of said shell (when the reinforcing filaments is laid down in bonded ranks with a dominant direction or directions, these directions may optionally exhibit anisotropic strength both locally and overall, see [0033]). Mark teaches that directionality or anisotropy of reinforcement within a structure can optionally provide enhanced part strength in desired locations and directions (see [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the tubular structure disclosed by Ooba to orient the reinforcing elements embedded in the shell to affect its anisotropic mechanical properties, as taught by Mark, in order to tailor the directional strength of the shell to meet the mechanical requirements of the structure (see [0033]).
Regarding claim 12, the first and second embodiments of Ooba do not disclose wherein said reinforcing elements comprise at least one elongated reinforcing element embedded in said shell parallel along the longitudinal axis, however Mark further discloses said reinforcing elements comprise at least one elongated reinforcing element embedded in said shell parallel to a longitudinal axis of said shell (deposited reinforcing ranks may be laid as straight, boustrophedon ranks, see [0129]). Mark teaches that the reinforcement is laid down with a dominant direction or directions to provide reinforcement in desired locations and directions (see [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the tubular structure disclosed by Ooba to orient the reinforcing elements embedded in the shell parallel to a longitudinal axis of the shell, as taught by Mark, in order to provide longitudinal reinforcement of the wall.
Regarding claim 13, the first and second embodiments of Ooba do not disclose wherein said reinforcing elements comprise at least one annular reinforcing element embedded in said shell along an azimuthal direction, however Mark further discloses said reinforcing elements comprise at least one annular reinforcing element embedded in said shell along an azimuthal direction defining said shell (deposited reinforcing ranks may be laid as circular, oval, or oblate loops (e.g., racetrack shapes for long parts), see [0129]). Mark teaches that the reinforcement is laid down with a dominant direction or directions to provide reinforcement in desired locations and directions (see [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the tubular structure disclosed by Ooba to orient the reinforcing elements embedded in the shell along an azimuthal direction, as taught by Mark, in order to provide circumferential reinforcement of the wall.
Regarding claim 14, the first and second embodiments of Ooba do not disclose wherein said reinforcing elements comprise at least one elongated reinforcing element embedded in said shell parallel along the longitudinal axis, however Mark further discloses wherein said reinforcing elements comprise at least one elongated reinforcing element embedded in said shell parallel to a longitudinal axis of said shell (deposited reinforcing ranks may be laid as boustrophedon ranks, and that successive layers may be laid parallel with or overlapping the layer below, see [0129]). Mark teaches that the reinforcement is laid down with a dominant direction or directions to provide reinforcement in desired locations and directions (see [0033]), and expressly permits combining its directional options in any operable permutation (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the tubular structure disclosed by Ooba to orient the reinforcing elements embedded in the shell parallel to a longitudinal axis of the shell, as taught by Mark, in order to provide longitudinal and circumferential reinforcement of the wall.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of US 2014/0328963 A1 (“Mark”), and further in view of Stratasys PolyJet Materials Data Sheet (“Stratasys Data Sheet”).
Regarding claim 15, the first and second embodiments of Ooba in view of Mark do not disclose that the reinforcing elements are made of a material having a tensile strength of from about 2 to about 4 MPa, however the Stratasys Data Sheet discloses rubber-like materials usable in PolyJet (inkjet) additive manufacturing known as the TangoTM family, including a material (TangoGray FLX950) having a tensile strength of from about 2 to about 4 MPa according to ASTM D-412 (TangoGray FLX950 has a tensile strength of 3-5 MPA per ASTM D-412, see pg. 2, TANGOGRAY FLX950 table).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the reinforcing elements disclosed by Ooba in view of Mark to be of a rubber-like PolyJet material having a tensile strength of from about 2 to about 4 MPa, as taught by the Stratasys Data Sheet. Where a claimed range lies within or overlaps a range disclosed in the prior art, a prima facie case of obviousness exists. One of ordinary skill setting out to construct a model of a blood vessel would have recognized that the model must be flexible and compliant in order to mimic a native vessel, and would have been motivated to select such a known rubber-like PolyJet material that is stiffer than the soft shell yet still elastomeric in order to provide reinforcement while maintaining its flexibility. The selection yields no more than the predictable result of a reinforced but flexible shell with a reasonable expectation of success.
Regarding claim 16, the first and second embodiments of Ooba in view of Mark do not disclose wherein said reinforcing elements are made of a material having a Shore A hardness from about 25MPa to about 35MPa, however the Stratasys Data Sheet further discloses a material (TangoBlackPlus FLX980 and TangoPlus FLX930) having a Shore A hardness from about 25MPa to about 35MPa (TangoBlackPlus FLX980 and TangoPlus FLX930 have a Shore A hardness of 26-28 per ASTM D-2240, see pg. 2, TANGOBLACKPLUS FLX980 AND TANGOPLUS FLX930 table). Under broadest reasonable interpretation in light of the specification, the limitation of ASTM D-224D is treated as requiring a Shore A hardness measured according to ASTM D-2240.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the reinforcing elements disclosed by Ooba in view of Mark to be of a known rubber-like PolyJet material having a Shore A hardness of from about 25 to about 35, as taught by the Stratasys Data Sheet. Where a claimed range lies within or overlaps a range disclosed in the prior art, a prima facie case of obviousness exists. The Specification of the current application shows no criticality to the recited hardness range, characterizing it as a property a suitable material can have, recited optionally and preferably (see Specification pg. 33, lines 30-33). One of ordinary skill setting out to construct a model of a blood vessel would have recognized that the model must be flexible and compliant in order to mimic a native vessel, and would have been motivated to select such a known rubber-like PolyJet material that is stiffer than the soft shell yet still elastomeric in order to provide reinforcement while maintain its flexibility. The selection yields no more than the predictable result of a reinforced but flexible shell with a reasonable expectation of success.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of US 2014/0328963 A1 (“Mark”), and further in view of Stratasys PolyJet Materials Data Sheet (“Stratasys Data Sheet”) and US 2014/0167300 A1 (Lee).
Regarding claim 17, the first and second embodiments of Ooba in view of Mark do not disclose wherein said reinforcing elements are made of a material which comprises an elastomeric curable material, however the Stratasys Data Sheet further discloses a material which comprises an elastomeric curable material (TangoBlackPlus FLX980, TangoPlus FLX930, TangoBlack FLX973, and TangoGray FLX950 are elastomeric curable materials that are usable in PolyJet (inkjet) additive manufacturing, see pg. 2 for rubber-like materials).
The Specification of the current application states that rubber-like PolyJet materials (e.g. Tango family) are formulated to have relatively low viscosity permitting dispensing, for example by inkjet, and are obtained by using monomers and oligomers with intrinsic flexible molecular structure (e.g., acrylic elastomers), and thus are elastomeric curable materials (see Specification pg. 4, lines 22-31).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the reinforcing elements disclosed by Ooba in view of Mark, in order to be durable yet flexible. One of ordinary skill setting out to construct a model of a blood vessel would have recognized that the model must be flexible and compliant in order to mimic a native vessel, and would have been motivated to form the reinforcing element from an elastomeric (rubber-like) curable material of the type known for the PolyJet system.
The first and second embodiments of Ooba in view of Mark and the Stratasys Data
Sheet do not disclose wherein said reinforcing elements are made of a material which comprises silica particles, however Lee discloses curable photopolymer compositions used to build three-dimensional articles by inkjet and digital light processing additive manufacturing, including a material which comprises silica particles (silica-based fine particles, see Abstract and [0021]). Lee teaches that the silica particles provide stable dispersion and improved mechanical properties to the photo-curable composition (see [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the reinforcing elements disclosed by Ooba in view of Mark and the Stratasys Data Sheet to include silica particles in the elastomeric curable (rubber-like PolyJet) material, as taught by Lee, in order to provide stable particle dispersion and to control the mechanical properties of the material.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of CN 1654028 A (“Lin”) and US 2011/0241240 A1 (“Gothait”).
Regarding claim 18, the first and second embodiments of Ooba do not disclose a liner layer at least partially coating an inner surface of said shell, however Lin further discloses a liner layer at least partially coating an inner surface of said shell (layer b covering the inner surface of outer layer c, see Example 1 [0039]-[0056] describing a tube wall with multi-ply structure and Fig. 3), between said intermediate shell and said inner surface (layer b is between layer a and inner surface of outer layer c, see Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shell of the tubular structure disclosed by Ooba to have a liner layer at least partially coating its inner surface, as taught by Lin, in order to provide an inner lining and support for the tube wall, which is a predictable provision of multi-layer vessel-wall construction.
The first and second embodiments of Ooba in view of Lin do not disclose a stronger attachment between said liner layer and said shell, however Gothait discloses additive manufacturing of objects, including through inkjet, wherein an attachment between said liner layer and said shell is stronger than an attachment between said intermediate shell and said liner layer (Gothait teaches a release construction between a modeling construction and an adjacent support construction, and forms a relatively soft layer or layers of material to enable easy release of the support construction from the object after printing, see [0062]-[0064]). Thus, Gothait teaches fabricating the interface between the modeled object and the supporting construction such that the sacrificial portion is more weakly attached and releases cleanly from the modeled object.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interface between the intermediate shell and the liner layer disclosed by Ooba in view of Lin to have a weaker attachment than the attachment between the liner layer and the shell, as taught by Gothait, so that the sacrificial intermediate shell easily separates from the liner layer for a clean removal while keeping the liner layer attached to the shell.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0368224 A1 (“Ooba”) in view of CN 1654028 A (“Lin”) and US 2011/0241240 A1 (“Gothait”), and further in view of 3D Printed Cardiac Phantom for Procedural Planning of a Transcatheter Native Mitral Valve Replacement (“Izzo”).
Regarding claim 19 and noting the 112(b) rejection above, the first and second embodiments of Ooba in view of Lin and Gothait do not disclose that the liner layer is harder than said shell, however Izzo discloses the additive manufacturing of a tubular cardiovascular structure modeling a diseased vessel by a Stratasys Objet 500 Connex3 multi-material printer (see Abstract), wherein said liner layer is harder than said shell (calcified region is printed from DM_9770 having a durometer of 68-72 Shore A, and thus harder than the vascular anatomy that was printed from Tango+, having a durometer of 26-28 Shore A, see Table 1).
Izzo teaches that the materials were chosen to mimic vascular tissue (for the anatomy),
and bone (for the calcified region), and that the location and material properties of both the mitral calcification and left heart anatomy were replicated accurately (see Section 2.4 and 4.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liner layer disclosed by Ooba in view of Lin and Gothait to be harder than the shell, as taught by Izzo, to create an anatomically accurate model of a vasculature. Atherosclerotic plaque forms on the inner luminal surface of a vessel, which is the same location as the claimed inner layer, and as such, the plaque is harder than the surrounding soft vascular tissue. One of ordinary skill looking to model a diseased vessel with plaque with the tubular structure disclosed by Ooba in view of Lin and Gothait, would therefore have selected the material of the inner layer to be harder than the shell. This is the application of a known technique to improve a similar additively manufactured anatomical model in the same predictable manner.
Regarding claim 20 and noting the 112(b) rejection above, the first and second embodiments of Ooba in view of Lin and Gothait do not disclose wherein said liner layer has mechanical properties of plaque tissue, however Izzo further discloses wherein said liner layer has mechanical properties of plaque tissue (calcified plaque region (mitral annular calcification) is selectively segmented and printed from a different material than the surrounding soft vascular tissue, corresponding to the mechanical properties of that tissue, see Section 2.3.1-2.4 and Fig. 4).
Izzo teaches that the materials were chosen to mimic vascular tissue (for the anatomy),
and bone (for the calcified region), and that the location and material properties of both the mitral calcification and left heart anatomy were replicated accurately (see Section 2.4 and 4.1). The calcified-plaque region was printed from DM_9770 that is distinct and harder than the vascular tissue made of Tango+, and thus Izzo discloses a layer or region of an additively manufactured vessel model that has the mechanical properties of plaque (calcified) tissue (see Section 2.4 and Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liner layer disclosed by Ooba in view of Lin and Gothait to have the mechanical properties of plaque tissue, as taught by Izzo, to create an anatomically accurate model of a vasculature. Atherosclerotic plaque forms on the inner luminal surface of a vessel, which is the same location as the claimed inner layer, and thus one of ordinary skill looking to model a diseased vessel with plaque with the tubular structure disclosed by Ooba in view of Lin and Gothait, would have looked to the inner liner layer as the plaque-associated region and following Izzo, would have selected its material to have the same mechanical properties of plaque tissues. This is the application of a known technique to improve a similar additively manufactured anatomical model in the same predictable manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm.
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/N.C.N./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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