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 .
Applicant’s amendment and response filed on 12/14/2025 has been received and entered into the case.
Claims 11-18 are newly added, and claims 1-18 have been considered on the merits. All arguments have been considered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/312,042 (now US PAT 11,419,962), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claims disclose a step of depositing a composition comprising triblock copolymer in a pattern onto a super-hydrophobic surface to form a hydrophilic surface on the super-hydrophobic surface, and the pattern is modeled after a biological structure. The “pattern”, “modeled after a biological structure” and “the 3D structure made using rods” disclosed in the instant claims are not supported by the disclosure of the ‘042 application in the manner under 35 U.S.C. 112(a). Thus, the priority claim for the earlier filed application is not granted, and the earliest filing date of the instant application is determined as 7/12/2022.
Claim Rejections - 35 USC § 112 (New Rejection)
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 1-18 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 1 discloses a new limitation directed to the 3-D structure being made using rods. It is not clear what subject matter this wherein clause intends to point out. The claimed method is directed to making a 3D structure and then the wherein clause discloses that the 3D structure is made using rods. It is vague if the rods are the 3D structure or the rods are used in steps of making the 3D structure. Do the steps disclosed in claim 1 somehow utilize rods in the steps or the wherein clause refers to additional step? According to the instant specification, hydrogel rods and a thin rod of Pluronic are disclosed (para. 47; Fig. 1). Is this limitation referring to either one or something else? Clarification is required.
If the wherein clause is meant to be the shape of the composition deposited onto a super-hydrophobic surface, applicant is advised to amend the claims to disclose that the 3D structure is in a rod shape.
For search purpose, the wherein clause is interpreted that the 3D structure is in a shape of rod.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 13: “the pattern replicates an image from imaging scan”
The limitation of claim 13 is not supported by the originally filed application. The specification discloses “biologic image” (para. 48) or “angiogram script” (para. 19), however, this does not support the broader scope of “an image from imaging scan”.
Claim 15: “pattern replicates a ventricular system or a recognizable portion of the ventricular system”
The instant specification discloses only “ventricular Purkinje system”, which is understood to limited to heart. The claimed “ventricular system” refers to brain. There is no support for “ventricular system” in the instant specification.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-12 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US2017/0216498) in view of Williams et al. (US 2019/0381213) and Neto et al. (2018, Mater. Horiz.)
Kang et al. teach a method of generating a cell-based 3D construct by bioprinting in a pre-determined pattern or model (e.g. digital model) and the method further comprises designing a model of the multi-dimensional construct according to the natural shape and/or cell distribution pattern of a tissue or an organ (para. 371 and 399; Example 13; Fig. 16). Kang et al. teach the multi-dimensional constructs can be any pre-determined pattern including a circular sheet, a hollow tube, a solid cylinder (para. 369). The shape of a hollow tube or a solid cylinder is considered to meet the “rods” as claimed. Kang et al. teach that the bioprinting involves a step of deposit the bio-blocks or bio-ink composition in a three-dimensional, automated, computer-aided fashion using a computer-aided device (para. 362).
Kang et al. do not teach the steps of depositing a composition comprising triblock copolymer in a pattern onto a super-hydrophobic surface to form a hydrophilic surface on the super-hydrophobic surface, and bioprinting the composition comprising a biologically-relevant materials dispersed within a biocompatible medium atop of the hydrophilic surface to form a 3D structure.
Williams et al. teach a method of making a 3D structure (spheroids) including a step of providing a suspension having biologically-relevant materials dispersed within a biocompatible medium onto the hydrophilic surface formed by depositing triblock copolymer onto a super-hydrophobic surface, and the triblock copolymer has an amphiphilic block structure having hydrophilic and hydrophobic properties, and the droplet of the suspension is bioprinted onto the hydrophilic material (triblock copolymer) on the super-hydrophobic surface (Abstract; para. 9, 10, 35, 71).
It would have been obvious to a person skilled in the art to use the steps of making a 3D structure taught by Williams et al. for the method of Kang et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the method of Williams et al. is one of bioprinting technology known in the art and one skilled in the art would recognize that the method of Williams et al. provide the 3D structure being easily released (minimally disruptive removal) from the triblock copolymer (e.g. Pluronic) by adjusting the temperature (para. 63 and 76).
By combining the teachings of Kang et al. and Williams et al., one skilled in the art would deposit a triblock copolymer, such as Pluronic, onto a super-hydrophobic surface in the pattern consistent with a desired shape and then bioprinting a suspension having biologically-relevant materials dispersed within a biocompatible medium onto the hydrophilic surface formed by depositing triblock copolymer onto a super-hydrophobic surface. The desired shape of the 3D structure can be solid cylinder as taught by Kang et al., and thus, the patten of the deposited triblock copolymer would be the same pattern as the 3D construct for adhering the bioprinted biologically-relevant material onto the hydrophilic surface formed by the copolymer.
In addition, Neto et al. teach a method of forming a patterned superhydrophobic surface for 3D cell culture to exhibit complex biological environments for tissue engineering, diagnostics and disease models (Abstract), and they teach that in soft-lithography, polydimethylsiloxane (PDMS) is applied in a pre-designed mold and further crosslinked, producing a pattern consistent with the geometrical features of the template (p.381, 2nd col.). According to Figure 2 of Neto et al., the superhydrophobic surface is treated to create hydrophilic pattern on the superhydrophobic surface (i.e. indirect photo-lithography micropatterning), and the shape of the hydrophilic surface is considered as a model. Neto et al. teach the robotic printing (bioprinting) along with photolithography to generate structured 3D culture environments (p.382). Neto et al. also teach the use of patterned superhydrophobic surface in order to produce more relevant tissue-like 3D models (Fig. 4).
Based on the teachings of Williams et al. and Neto et al., it would have been obvious to produce a 3D construct having a pre-designed model taught by Kang et al. using the method of Williams et al. with a reasonable expectation of success.
Regarding claims 2-3, Kang et al. teach the bio-ink composition comprising plurality of cells and collagen type I, and the biocompatible material being in a hydrogel state (para. 18, 64, 220 and 249). Furthermore, Williams et al. teach a hydrogel comprising collagen type 1 (p.15, claims 3 and 5).
Regarding claim 5, Kang et al. teach the cell in the bio-block includes stem cells (para. 281). Furthermore, Williams et al. teach stromal vascular fraction cells or microvascular fragment (p.15, claims 6-7).
Regarding claim 6, Kang et al. teach pluripotent stem cells (para. 278, 281). Furthermore, Williams et al. teach that the stem cells can be embryonic stem cell, pluripotent stem cells or adult stem cells (para. 43).
Regarding claims 7-8, Kang et al. teach cardiomyocyte in the bio-block or other cell types including endothelial cells, fibroblasts, etc. (para. 282). Furthermore, Williams et al. teach a step of bioprinting spheroids comprising a desired type of cells appropriate for the repair, restructuring, or repopulation of a tissue or organ including neurons, cardiomyocytes, myocytes, chondrocytes, pancreatic acinar cells, islets of Langerhans, osteocytes, hepatocytes, Kupffer cells, fibroblasts, myoblasts, satellite cells, endothelial cells, adipocytes, preadipocytes, biliary epithelial cells, and the like (para 44).
Regarding claims 9-10, Kang et al. teach the step of culturing the 3D construct in a 3D culturing incubator and the multi-dimensional construct is cultured in a bioreactor at about 37°C (para. 375), and this teaching would meet the limitation of claims 9-10. Furthermore, Williams et al. teach that subsequent to bioprinting the suspension, the resulting spheroids can then be incubated at physiological temperatures for a period of time while maintaining their spheroid shape, or the spheroids can then be further cultured in a cell culture medium (para. 10).
Regarding claims 11-12 directed to the step of implanting the 3D structure into an animal without culturing the 3D construct or adding additives to support formation, Kang et al. do not teach the limitation. However, Williams et al. teach that their method would allow for the production of a device that can be formed and implanted immediately without the need to subject material to tissue culture and without the need to utilize other additives (para. 48). Thus, it would have been obvious to a person skilled in the art that the combined teachings of Kang et al. in view of Williams et al. would produce a 3D construct that does not need additional tissue culturing or additives as taught by Williams et al. with a reasonable expectation of success.
Regarding claims 16-17 directed to the bioprinting using a pen tip of 15-33 gauge, or a pressure of 2-20 psi, Kang et al. do not teach the limitation. However, Williams et al. teach the use of a pen for bioprinting, and the tip is about 15-25 gauge, the pressure being 2-7 psi (par. 37). It would have been obvious to a person skilled in the art to use the bioprinting device, a pen, taught by Williams et al. for the method of Kang et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because, the bioprinting device of Williams is suitable in order to carry out the combined teachings of Kang et al. and Williams et al.
Regarding the linear speed of a pen at 10-20 mm/s (claim 18), Kang et al. in view of Williams et al. do not teach the limitation. However, it would have been obvious to modify the speed of the pen for the bioprinting the various biostructure as desired including the tube or cylinder structure. Furthermore, Kang et al. teach the speed of the bioprinting is about 500 mm/min or more (para. 366), and the claimed speed is converted to 600-1200 mm/min. The teaching of Kang et al. is overlapping with the claimed speed. Thus, based on the teaching of Kang et al., one skilled in the art would try to modify the speed of bioprinting (i.e. the linear speed of the pen) within the range known in the art for the desired outcome of bioprinting a 3D construct.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. in view of Williams et al. and Neto et al. as applied to claim 1 above, and further in view of Sun et al. (US2009/0263849; of record).
Regarding claim 4 directed to the modeling comprising computer-aided design (CAD), Kang et al. Williams et al. in view of Neto et al. do not particularly teach the limitation. However, the wherein clause does not require any active step to be carried out for the claimed method of making a 3D structure, and it is considered as a product-by-process limitation and thus, the limitation does not provide any patentable weight in determining the patentability of the claimed method.
Nevertheless, it is well known in the art that the production of a 3D tissue structure mimicking a naturally occurring tissue can be carried out by bioprinting integrated with computer-aided design (CAD) according to Sun et al. (see para. 17, 43, 74, 79, 92, 110). Figure 1B of Sun et al. shows a step of designing tissue construct using CAD followed by a step of bioprinting tissue construct into microfluidic system.
It would have been obvious to a person skilled in the art to use CAD in designing for fabricating the 3D tissue for the method of Williams et al. in view of Neto et al. A person of ordinary skilled in the art would have been motivated to do so because it is a well-known option available in the art and one skilled in the art would try the CAD as Sun et al. teach the benefit of structural reproducibility in producing cell/biomaterial construct (para. 43 and 110).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. in view of Williams et al. and Neto et al. as applied to claim 1 above, and further in view of Tracy et al. (2020, Cardiovascular Engineering and Technology) and Bartel et al. (2018, Eur. Heart J.)
Regarding claim 15, Kang et al. in view of Williams et al. and Neto et al. do not particularly that that the pattern replicates a ventricular Purkinje system.
Tracy et al. teach a method of 3D bioprinting the cardiac Purkinje system using human adipogenic mesenchymal stem cell derived Purkinje cells. Tracy et al. teach that using a reference anatomical Purkinje system (i.e. anatomical image) for CAD software design of a negative mold, Purkinje bioink was bioprinted as Purkinje network (Fig. 1).
It would have been obvious to a person skilled in the art to use the method of Kang et al. in view of Williams et al. to produce the 3D bioprinted Purkinje system (i.e. ventricular system as claimed). One skilled in the art would recognize that the process taught by Tracy et al. is substantially similar to the method of Williams et al. to prepare the mold by depositing Pluronic, and then bioink was performed into the mold, and then Pluronic is dissolved by changing temperature. This is consistent with the method of Williams et al. Thus, it is considered that the method of Kang et al. in view of Williams et al. would be expected to produce the Purkinje network with a reasonable expectation of success.
It is also noted that Tracy et al. teach “Purkinje rods” being bioprinted (p.590, 2nd col., last para.; Fig. 1). Thus, this teaching would meet the claimed 3D construct made using rods.
Regarding claims 13-14 directed to the imaging scan or angiogram, Tracy et al. do not particularly disclose the limitation. However, it is extremely well known in the art that the reference anatomical image or digital 3D models would be obtained from various scanning technology known in the art. Bartel et al. teach a medical 3D printing and the 3D data obtained by 3D Echo or CT and MRI-based angiographic acquisition protocol with intravenous contrast material would be used for producing a digital/virtual 3D model for bioprinting a cardiac tissue (see p.1247, 2nd col.; Fig. 1).
It would have been obvious to a person skilled in the art to use CT and MRI-based angiographic acquisition protocol taught by Bartel et al. for acquiring a reference anatomical Purkinje system with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the CT- and MRI-based angiography with a contrast is one of well known technologies for obtaining a digital 3D image for 3D printing.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,059,921 in view of Williams et al. (supra), Kang et al. (supra), Neto et al. (supra), Sun et al. (supra), Tracy et al. (supra) and Bartel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘921 patent disclose a method of making a pre-vascularized spheroid by bioprinting a suspension comprising a biocompatible medium including a hydrogel comprising collagen type I and a biologically-relevant materials including stromal vascular fraction cells. The claims of the ‘921 patent are silent in the step of depositing a triblock copolymer having amphiphilic properties onto a super-hydrophobic surface to form a hydrophilic surface in a pattern modeled after a biological structure, and the pattern is designed by CAD. However, it is known in the art according to Williams et al. that a spheroid can be bioprinted onto a hydrophilic surface formed onto a super-hydrophobic surface of the substrate (Abstract; para. 9, 10, 35, 71).
Regarding the pattern and the rods being used for making the 3D construct, the claims of the ‘921 patent do not disclose the limitation. However, Kang et al. teach a method of generating a cell-based 3D construct by bioprinting in a pre-determined pattern or model (e.g. digital model) and the method further comprises designing a model of the multi-dimensional construct according to the natural shape and/or cell distribution pattern of a tissue or an organ (para. 371 and 399; Example 13; Fig. 16). Kang et al. teach that the bioprinting involves a step of deposit the bio-blocks or bio-ink composition in a three-dimensional, automated, computer-aided fashion using a computer-aided device (para. 362).
Furthermore, Neto et al. teach a method of forming a patterned superhydrophobic surface for 3D cell culture to exhibit complex biological environments for tissue engineering, diagnostics and disease models (Abstract), and they teach that in soft-lithography, polydimethylsiloxane (PDMS) is applied in a pre-designed mold and further crosslinked, producing a pattern consistent with the geometrical features of the template (p.381, 2nd col.). According to Figure 2 of Neto et al., the superhydrophobic surface is treated to create hydrophilic pattern on the superhydrophobic surface (i.e. indirect photo-lithography micropatterning), and the shape of the hydrophilic surface is considered as a model. Neto et al. teach the robotic printing (bioprinting) along with photolithography to generate structured 3D culture environments (p.382). Neto et al. also teach the use of patterned superhydrophobic surface in order to produce more relevant tissue-like 3D models (Fig. 4).
Thus, it would have been obvious to a person skilled in the art to use the method of the ‘921 patent in combination of the teaching of Kang et al. to produce any desired pattern including rods with a reasonable expectation of success. One skilled in the art would recognize the method of the ‘921 patent would not be limited to form a spheroid, rather it can be used to produce any desired shape by extruding the suspension of cells in the biocompatible medium using the delivery pen.
Regarding the CAD, it is well known in the art that the production of a 3D tissue structure mimicking a naturally occurring tissue can be carried out by bioprinting integrated with computer-aided design (CAD) according to Sun et al. (see para. 17, 43, 74, 79, 92, 110). Figure 1B of Sun et al. shows a step of designing tissue construct using CAD followed by a step of bioprinting tissue construct into microfluidic system. As Kang et al. teach the bioprinting of the pre-determined pattern in a computer-aided fashion, this pre-determined pattern/design can be carried out by CAD of Sun et al.
Regarding the limitation of claims 11-12 and 16-18, the limitations are taught by Williams et al. as discussed in the 103 rejection above. The claims of ‘921 patent combined with the teachings of the cited references would render the subject matter of claims 11-12 and 16-18 obvious.
Regarding claims 13-15, as discussed above in the 103 rejection, the teachings of Tracy et al. and Bartel et al. would render the claims obvious.
It would have been obvious to a person skilled in the art to combine the teachings of the cited references with the claims of the ‘921 patent to arrive the claims of the instant application.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,419,962 in view of Kang et al. (supra), Williams et al. (supra), Neto et al. (supra), Sun et al. (supra), Tracy et al. (supra) and Bartel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘962 patent disclose a method of making a spheroid by bioprinting a suspension comprising a biocompatible medium including a hydrogel comprising collagen type I and a biologically-relevant materials including stromal vascular fraction cells, or stem cells derived from adipose tissue (i.e. adult stem cell). The claims of the ‘962 patent also disclose the cells appropriate for repair, restructure or repopulation of a tissue or organ and the types of cells as claimed in the instant application. The claims of the ‘962 patent teach the step of depositing a triblock copolymer having amphiphilic properties onto a super-hydrophobic surface to form a hydrophilic surface, however, they do not teach a pattern modeled after a biological structure, and the pattern is designed by CAD.
Regarding the pattern and the 3D construct is made using rods, Kang et al. teach a method of generating a cell-based 3D construct by bioprinting in a pre-determined pattern or model (e.g. digital model) and the method further comprises designing a model of the multi-dimensional construct according to the natural shape and/or cell distribution pattern of a tissue or an organ (para. 371 and 399; Example 13; Fig. 16). Kang et al. teach that the bioprinting involves a step of deposit the bio-blocks or bio-ink composition in a three-dimensional, automated, computer-aided fashion using a computer-aided device (para. 362). Neto et al. teach a method of forming a patterned superhydrophobic surface for 3D cell culture to exhibit complex biological environments for tissue engineering, diagnostics and disease models (Abstract), and they teach that in soft-lithography, polydimethylsiloxane (PDMS) is applied in a pre-designed mold and further crosslinked, producing a pattern consistent with the geometrical features of the template (p.381, 2nd col.). According to Figure 2 of Neto et al., the superhydrophobic surface is treated to create hydrophilic pattern on the superhydrophobic surface (i.e. indirect photo-lithography micropatterning), and the shape of the hydrophilic surface is considered as a model. Neto et al. teach the robotic printing (bioprinting) along with photolithography to generate structured 3D culture environments (p.382). Neto et al. also teach the use of patterned superhydrophobic surface in order to produce more relevant tissue-like 3D models (Fig. 4).
Regarding the CAD, it is well known in the art that the production of a 3D tissue structure mimicking a naturally occurring tissue can be carried out by bioprinting integrated with computer-aided design (CAD) according to Sun et al. (see para. 17, 43, 74, 79, 92, 110). Figure 1B of Sun et al. shows a step of designing tissue construct using CAD followed by a step of bioprinting tissue construct into microfluidic system. As Kang et al. teach the bioprinting of the pre-determined pattern in a computer-aided fashion, this pre-determined pattern/design can be carried out by CAD of Sun et al.
Regarding the limitation of claims 11-12 and 16-18, the limitations are taught by Williams et al. as discussed in the 103 rejection above. The claims of ‘962 patent combined with the teachings of the cited references would render the subject matter of claims 11-12 and 16-18 obvious.
Regarding claims 13-15, as discussed above in the 103 rejection, the teachings of Tracy et al. and Bartel et al. would render the claims obvious.
It would have been obvious to a person skilled in the art to combine the teachings of Kang et al., Neto et al. and Sun et al. with the claims of the ‘962 patent to arrive the claims of the instant application.
Response to Arguments
Applicant’s arguments with respect to the claim rejection under 112(b) have been fully considered and are persuasive based on the instant amendment. The claim rejection has been withdrawn.
The claim rejection under 35 USC 103 has been withdrawn due to the instant amendment. However, new claim rejections under 103 are presented above as new ground of rejections are necessitated by the instant amendment.
Regarding the double patenting rejections, the rejections have been modified in order to address the instant amendment including new claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631