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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Status of Claims
Claims 1-6 and 8-13 are pending and examined below.
Response to Arguments
The remarks of 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn't explicitly teach or disclose all of the elements of amended claims 1 and 9, in particular the following claim language:
“and wherein both ends in a lengthwise direction of the artificial esophageal scaffold have no pores and are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold.”
This argument is moot in light of the new 103 rejection below.
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.
Claim(s) 1, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi)
Regarding claim 1, Jae discloses an artificial esophageal scaffold of a multi-layered construct (Fig. 6), comprising:
a first layer (see annotated Fig. 6 below) in a hollow columnar shape with a circular cross section (see Fig. 6, wherein annotated first layer is a hollow columnar shape with circular cross section);
a second layer (see annotated Fig. 6 below) being disposed inside the first layer (see annotated Fig. 6, wherein second layer is inside the first layer) and in a columnar construct (Fig. 5, wherein second layer is formed of columns) mimicking a mucosa of an esophagus (Fig. 5, wherein the second layer is in a columnar construct is therefore configured for the claimed intended use); and
and an interlayer support (see annotated Fig. 6 below) being disposed between the first layer and the second layer (see annotated Fig. 6 below) and configured for maintaining the interlayer spacing (see annotated Fig. 6, wherein annotated interlayer support is configured for this intended use), wherein each of the first layer and the second layer comprises a plurality of columns disposed at regular intervals (Fig. 5, wherein first and second layer are formed of a plurality of columns, see also Lines 235-236 of translation, wherein the cell support is formed by repeating the dragging technique), and a plurality of strands (Fig. 3, strands 60) formed by a dragging technique between the plurality of columns (see Fig. 3, wherein this dragging technique between two columns is shown)
wherein a pore size of the pores varies according to a distance between the columns (See lines 185-187 of translation, wherein micropore size is based on distance d between pillars)
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Jae doesn't explicitly teach or disclose that both ends in a lengthwise direction of the artificial esophageal scaffold have no pores.
Lui discloses an artificial esophageal scaffold (Fig. 1, 1, see also ¶0051, wherein 1 can be inserted into an esophagus) of multi-layer construction (¶0072, wherein “three-dimensional additive means” corresponds to multi-layer constriction) wherein both ends in a lengthwise direction of the artificial esophageal scaffold have no pores (see annotated Fig. 1 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the ends of the artificial esophageal scaffold of Jae to have no pores, as taught by Lui, in order to create a more robust scaffold with more desirable mechanical properties.
Jae doesn't explicitly teach or disclose that both ends in a lengthwise direction are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold. Liu discloses two lengthwise ends that have no pores (see annotated Fig. 1 above) but doesn't explicitly teach or disclose that they are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold.
Cassivi discloses an artificial esophageal scaffold wherein both ends in a lengthwise direction (¶0007, wherein the “distal end portion” and “proximal end portion” correspond to both ends in a lengthwise direction) are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold (¶0007, wherein the “distal end portion” and “proximal end portion” are configured to be attached the “lower stump end” and the “upper stump end” of the esophagus respectively).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the ends of the artificial scaffold of Jae in view of Lui to be directly connected to portions of an esophagus during transplantation, as taught by Cassivi, in order to avoid leakage, stricture, failure of tissue regrowth, obstruction, migration and/or displacement (¶0022).
Regarding claim 6, Jae doesn't explicitly teach or disclose that both ends in a lengthwise direction of the artificial esophageal scaffold have no pores.
Lui discloses an artificial esophageal scaffold (Fig. 1, 1, see also ¶0051, wherein 1 can be inserted into an esophagus) wherein both ends in a lengthwise direction of the artificial esophageal scaffold have no pores (see annotated Fig. 1 below)
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The claimed phrase “manufactured…by a plotting technique” is being treated as a product by process limitation; that is, that the ends in a lengthwise direction of the artificial esophageal scaffold are formed by a plotting technique. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Regarding claim 8, Jae discloses columns (Fig. 3, 51a and 51b) which are related to the flexibility of the construct (see lines 200-201 where the pillars 51a and 51b are related to the flexibility of the construct because the main frame is made of pillars 51a and 51b).
The claimed phrase “formed by a four-point injection plotting technique” is being treated as a product by process limitation; that is, that the columns are formed by a four-point injection plotting technique. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of US 2016/0287419 (Nguyen)
Regarding claim 2, Jae discloses a columnar construct and a second layer (See rejection of claim 1) but doesn’t explicitly teach or disclose a star-shaped cross section with ridges and valleys. Liu doesn't explicitly teach or disclose a star-shaped cross section with ridges and valleys. Cassivi doesn't explicitly teach or disclose a star-shaped cross section with ridges and valleys
Nguyen discloses a columnar construct (Fig. 1, 12) comprising a star shaped cross section (Fig. 4, wherein 12 has a star shaped cross section) with a ridge (Fig. 4, 24, ¶0100) and a valley (Fig. 4, 26, ¶0100).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the columns of the second layer of Jae in view of Liu in view of Cassivi, to be formed at the ridges and valleys of the star-shaped cross section, as taught by Nguyen, in order to maintain luminal patency (Nguyen, ¶0098).
Regarding claim 3, Jae discloses an auxiliary column (Fig. 5, 210) but doesn't explicitly teach or disclose a star-shaped cross section a ridge and a valley. Liu doesn't explicitly teach or disclose a star-shaped cross section a ridge and a valley. Cassivi doesn't explicitly teach or disclose a star-shaped cross section a ridge and a valley.
Nguyen discloses a columnar construct (Fig. 1, 12) comprising a star shaped cross section (Fig. 4, wherein 12 has a star shaped cross section) with a ridge (Fig. 4, 24, ¶0100) and a valley (Fig. 4, 26, ¶0100).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the auxiliary column Jae in view of Liu in view of Cassivi to be formed between the ridges and valleys of the star-shaped cross section, as taught by Nguyen, in order to maintain luminal patency (Nguyen, ¶0098).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of US 2020/0163747 (Park)
Regarding claim 4, Jae discloses a first layer (see rejection of claim 1) but doesn’t explicitly teach or disclose an outer wrinkled construct. Liu doesn’t explicitly teach or disclose an outer wrinkled construct. Cassivi doesn’t explicitly teach or disclose an outer wrinkled construct.
Park discloses a columnar construct (Fig. 2) comprising an outer wrinkled construct (Fig. 2, see also ¶0020, wherein a surface concave-convex structure corresponds to an outer wrinkled construct).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the first layer of Jae in view of Liu in view of Cassivi, as an outer wrinkled construct, as taught by Park, in order to provide both flexibility and patency (Park, ¶0020).
The claimed phrase “by repeating an increase and a decrease of a diameter according to a height of a sliced horizontal layer” is being treated as a product by process limitation; that is, that the outer wrinkled construct is formed by repeating an increase and a decrease of a diameter according to a height of a sliced horizontal layer. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of CN 107164318 (Ye)
Regarding claim 5, Jae discloses a first and second layer (see rejection of claim 1) but doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Liu doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Cassivi doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer.
Ye discloses wherein a bioink (Fig. 2, biological ink 4) is printed in a space between the first layer and the second layer (see Fig. 2, wherein 4 is printed between the first and second layer of the biological framework)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the space in between the first layer and second layer of Jae in view of Liu in view of Cassivi with bioink, as taught by Ye, in order to form a functional vascular network within the scaffold.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of KR 1849948 (Cho) in view of US 2020/0086552 (Yarka) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi)
Regarding claim 9, Jae discloses a method of manufacturing an artificial esophageal scaffold of the multi-layered construct (Figs. 3-6) comprising:
having a first layer in a columnar shape with a circular cross section (see annotated Fig. 6 below) and a second layer being disposed inside the first layer (see annotated Fig. 6 below) and in a columnar construct mimicking a mucosa of an esophagus (see Fig. 6, wherein the second layer is configured for this intended use based on its arrangement within the first layer) and a dragging technique (Fig. 3, see also lines 157-161 of translation),
wherein, when each layer (lines 169-170, wherein strands 60 correspond to each layer) of the artificial esophageal scaffold is manufactured into the plurality of columns (see Lines 169-170 of translation, wherein strands 60 are formed between the columns), a resultant multi-layered construct has a porous construct having pores between strands (See Fig. 6, wherein micropores 330 correspond to pores between strands)
wherein a pore size of the pores varies according a distance between the columns (See lines 185-187 of translation, wherein micropore size is based on distance d between pillars)
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Jae doesn’t explicitly teach or disclose the steps of separately designing, generating G-code, manufacturing according to the G-code.
Cho discloses generating G-code (Fig. 2, S30) and manufacturing the columns and the strand according to the G-code (Fig. 2, S50),
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify with the process of Jae with steps to design, generate G code, and manufacture, as taught by Cho, in order to control the pore size to promote cell growth, cell attachment, and structural strength.
Jae doesn’t explicitly teach or disclose a fan to control a degree of stretch of the strand by discharging through the injection nozzle in a state in which forced convection is generated. Cho doesn't explicitly teach or disclose a fan to control a degree of stretch of the strand by discharging through the injection nozzle in a state in which forced convection is generated.
Yarka discloses a fan (Fig. 2, 244, see also ¶0056 wherein 244 may include a variable speed fan) of the apparatus of manufacturing (Fig. 3, 100) which is operated to control a degree of stretch of the strand (¶0034, wherein printer 100 is configured for this intended use because it controls the temperature of the build material) by discharging through the injection nozzle in a state in which forced convection is generated (¶0045, wherein “actively cooling an outlet portion of the extruder” corresponds to discharging through the injection nozzle in a state in which force convection is generated”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the process of Jae in view of Cho to include a step to control the degree of stretch via a fan, as taught by Yarka, in order to avoid issue related to undesirably heating of the extruder such as damage to the apparatus of manufacturing (¶Yarka, ¶0003) or fluctuations in the dimensions of the printed product.
Jae doesn't explicitly teach or disclose that both ends in a lengthwise direction of the artificial esophageal scaffold have no pores. Cho doesn't explicitly teach or disclose that both ends in a lengthwise direction of the artificial esophageal scaffold have no pores. Yarka doesn't explicitly teach or disclose that both ends in a lengthwise direction of the artificial esophageal scaffold have no pores
Lui discloses an artificial esophageal scaffold (Fig. 1, 1, see also ¶0051, wherein 1 can be inserted into an esophagus) of multi-layer construction (¶0072, wherein “three-dimensional additive means” corresponds to multi-layer constriction) wherein both ends in a lengthwise direction of the artificial esophageal scaffold have no pores (see annotated Fig. 1 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the ends of the artificial esophageal scaffold of Jae in view of Cho in view of Yarka to have no pores, as taught by Lui, in order to create a more structurally sound and robust frame for the scaffold.
Jae doesn't explicitly teach or disclose that both ends in a lengthwise direction are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold. Cho doesn't explicitly teach or disclose that both ends in a lengthwise direction are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold. Yarka doesn't explicitly teach or disclose doesn't explicitly teach or disclose that both ends in a lengthwise direction are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold. Liu discloses two lengthwise ends that have no pores (see annotated Fig. 1 above) but doesn't explicitly teach or disclose that they are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold.
Cassivi discloses an artificial esophageal scaffold wherein both ends in a lengthwise direction (¶0007, wherein the “distal end portion” and “proximal end portion” correspond to both ends in a lengthwise direction) are configured to be directly connected to portions of an esophagus during transplantation of the artificial esophageal scaffold (¶0007, wherein the “distal end portion” and “proximal end portion” are configured to be attached the “lower stump end” and the “upper stump end” of the esophagus respectively).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configure the ends of the artificial scaffold of Jae in view of Cho in view of Yarka in view of Lui to be directly connected to portions of an esophagus during transplantation, as taught by Cassivi, in order to avoid leakage, stricture, failure of tissue regrowth, obstruction, migration and/or displacement (¶0022).
Regarding claim 10, Jae discloses adjusting a distance between the columns by setting column arrangement at each layer (See line 174-176 of translation, wherein distance d between columns can be set). Jae doesn’t explicitly teach or disclose a design step or setting pore size of each layer.
Cho discloses wherein in the separately designing (Fig. 2, S10), a pore size is adjusted by setting pore sizes of each layer (Lines 199, “selecting one or more cell properties such as pore size”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Jae with a step to adjust the pore size of each layer, as taught by Cho, in order to design for cell growth, cell attachment, and structural strength (Cho, lines 13-14)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of KR 1849948 (Cho) in view of US 2020/0086552 (Yarka) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of US 2016/0287419 (Nguyen)
Regarding claim 11, Jae discloses a columnar construct with columns (see rejection of claim 9) but doesn’t explicitly teach or disclose a design step.
Cho discloses a separate design step (Fig. 2, S10)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the process of Jae with a step to separately design the structure, as taught by Cho, in order to in order to design for cell growth, cell attachment, and structural strength (Cho, lines 13-14)
Jae doesn't explicitly teach or disclose a star-shaped cross section comprising a ridge and a valley. Cho doesn't explicitly teach or disclose a star-shaped cross section comprising a ridge and a valley. Yarka doesn't explicitly teach or disclose a star-shaped cross section comprising a ridge and a valley. Liu doesn't explicitly teach or disclose a star-shaped cross section comprising a ridge and a valley. Cassivi doesn't explicitly teach or disclose a star-shaped cross section comprising a ridge and a valley.
Nguyen discloses a columnar construct (Fig. 1, 12) comprising a star shaped cross section (Fig. 4, wherein 12 has a star shaped cross section) with a ridge (Fig. 4, 24, ¶0100) and a valley (Fig. 4, 26, ¶0100).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to dispose the columns of Jae in view of Cho in view of Yarka in view of Lui in view of Cassivi at a ridge and of the star-shaped cross section, as taught by Nguyen, in order to maintain luminal patency (Nguyen, ¶0098).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of KR 1849948 (Cho) in view of US 2020/0086552 (Yarka) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of US 2020/0163747 (Park)
Regarding claim 12, Jae discloses a first layer (see rejection of claim 1) but doesn't explicitly teach or disclose forming an outer wrinkled construct. Cho doesn’t explicitly teach or disclose forming an outer wrinkled construct. Yarka doesn’t explicitly teach or disclose forming an outer wrinkled construct. Liu doesn’t explicitly teach or disclose forming an outer wrinkled construct. Cassivi doesn’t explicitly teach or disclose forming an outer wrinkled construct.
Park discloses forming an outer wrinkled construct (Fig. 2, see also ¶0020, wherein a surface concave-convex structure corresponds to an outer wrinkled construct) by repeating an increase and a decrease of a diameter according to a height of a sliced horizontal layer (see Fig. 16, wherein the diameter is increased and decreased according to height, ¶0036, wherein the numbers of materials used corresponds to an increase and decrease in diameter)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the design process of Jae in view of Cho in view of Yarka in view of Lui in view of Cassivi with an outer wrinkled construct, as taught by Park, in order to provide both flexibility and patency to the scaffold (Park, ¶0020)
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0032710A (Jae) in view of KR 1849948 (Cho) in view of US 2020/0086552 (Yarka) in view of US 2019/0350731 (Liu) in view of US 2013/0131827 (Cassivi), as applied to claims above, and further in view of CN 107164318 (Ye)
Regarding claim 13, Jae discloses a first and second layer (see rejection of claim 1) but doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Cho doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Yarka doesn't explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Lui doesn’t explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer. Cassivi doesn’t explicitly teach or disclose wherein a bioink is printed in a space between the first layer and the second layer
Ye discloses wherein a bioink (Fig. 2, biological ink 4) is printed in a space between the first layer and the second layer (see Fig. 2, wherein 4 is printed between the first and second layer of the biological framework)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the space in between the first layer and second layer of Jae in view of Cho in view of Yarka in view of Lui in view of Cassivi with bioink, as taught by Ye, in order to form a functional vascular network within the scaffold.
Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774