DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-23 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/27/2025 has been entered.
Information Disclosure Statement
The information disclosure statement filed 08/27/2025 has been considered.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
Applicant argues that Miller teaches away from the recited steps of 3D-printing, by emphasizing advantages of its stereolithography in multiple places and repeatedly denigrating a 3D-printing approach (Remarks, pages 6-7). This argument is not persuasive, because Miller teaches stereolithography as the fabrication of 3D objects using a 3D printer (Miller, page 6, paragraph 0070). Therefore, Miller does not teach away from 3D-printing, and rather discusses advantages to one specific type of 3D printing.
Applicant argues that Miller teaches away from the 3D-printing of separate freestanding (non-entangled) tubes (Remarks, page 7). This argument is not persuasive, because there is no limitation in the claims requiring “separate freestanding (non-entangled) tubes” as stated in the Remarks. Further, Miller teaches the shape of a blood vessel (Miller, claim 9), which is a suitable shape of the hydrogel construct according to the instant claim 12.
Modified/Maintained 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.
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.
Claims 1, 3-6, 8, 10-12, and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20200339925 A1; IDS reference, 10/25/2022), further in view of Ma (Industrial & Engineering Chemistry Research, 2017) and evidenced by MilliporeSigma. The references were previously cited by the Examiner.
Regarding claim 1, Miller teaches a method for preparing a hydrogel matrix with a first and second tubular architecture (i.e., two tubular hydrogel constructs; Miller, claim 37) utilizing a pre-polymerization solution comprising a photosensitive polymer (i.e., bio-ink composition comprising a polymer; Miller, claim 62) in a vat (Miller, page 6, paragraph 0070). Miller further teaches the 3D hydrogel matrix is printed via photopolymerization (i.e., electromagnetic radiation is applied; Miller, page 2, paragraph 0013) in a sequential, layer-by-layer manner (i.e., the constructs are manufactured simultaneously; Miller, page 6, paragraph 0070) using a light source at 405 nm (i.e., UV radiation source; Miller, page 7, paragraph 0078). Miller does not specifically teach the outer cylindrical surface coaxial to the inner cylindrical surface as stated in the amended claim, but does teach the shape of a blood vessel (Miller, claim 9). Ma teaches a polymer containing hydrogel (Ma, abstract) which can be used as an artificial blood vessel (Ma, page 7971, introduction, paragraph 1) and teaches a tubular shape wherein the tubes comprise an inner and outer cylindrical surface which are coaxial and are in the shape of a cylindrical wall (Ma, figure 10).
Miller and Ma are considered to be analogous to the claimed invention, because all are in the same field of synthetic blood vessel engineering. It would have been prima facie obvious to one of ordinary skill in the field to have utilized the method taught by Miller to produce the simple tubular shape taught by Ma, because Ma teaches cylindrical shaped tube to be useful as artificial blood vessels (Ma, page 7971, introduction, paragraph 1).
Regarding claim 3, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller further teaches the hydrogel to comprise poly(ethylene diacrylate), a polymer (Miller, page 3, paragraph 0047).
Regarding claim 4, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller further teaches a light source at 405 nm (i.e., UV radiation; Miller, page 7, paragraph 0078).
Regarding claim 5, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller further teaches three or more independent vessel architectures (Miller, page 9, paragraph 0100), which overlaps the claimed range of 10 or more constructs. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 6, Miller and Ma together teach the pre-hydrogel solution to be aqueous (Miller, page 6, paragraph 0076) and teaches methylene chloride may be used as the photoabsorber additive material (Miller, page 10, paragraph 0110). Water and methylene chloride are known to be immiscible, as evidenced by MilliporeSigma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have arrived at the use of a liquid that is immiscible with the bio-ink when producing the solution taught by Miller.
Regarding claim 8, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches an LAP photoinitiator (Miller, page 7, paragraph 0078).
Regarding claim 10, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches the pre-polymerization solution includes one or more types of bacterial, mammalian, and plant cells (i.e., biologics; Miller, claim 41).
Regarding claim 11, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches a scalable lung-mimetic model (Miller, page 5, paragraph 0066).
Regarding claim 12, Miller and Ma together teach all the elements of the current invention as applied to claim 11. Miller further teaches the shape of a blood vessel (Miller, claim 9).
Regarding claim 15, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller further teaches the vascular compartment (i.e., inner lumen) can be seeded with endothelial cells (i.e., endothelialization; Miller, page 4, paragraph 0055) and the channel network can be lined with cells (i.e., cellularization; Miller, page 8, paragraph 0087).
Regarding claim 16, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller demonstrates a patterned inner surface of the vessel (Miller, figure 1A).
Regarding claim 17, Miller and Ma together teach all the elements of the current invention as applied to claim 16. Miller demonstrates a patterned hydrogel that permits unidirectional flow (Miller, figure 1B).
Regarding claim 18, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches each vessel architecture is branching (i.e., one or more bifurcations; Miller, claim 1).
Regarding claim 19, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller further teaches fibrin gel (Miller, page 4, paragraph 0055).
Regarding claim 20, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches three or more vessel architectures (i.e., a batch; Miller, page 9, paragraph 0100) manufactured as discussed above.
Regarding claim 21, Miller and Ma together teach all the elements of the current invention as applied to claim 20. Miller further teaches the two tubular channel networks are independent and produced by different algorithms (Miller, claim 37), which Miller exemplifies may result in different shapes being produced (Miller, page 2, paragraph 0011, “a torus and a torus knot”).
Regarding claim 22, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller does not specifically teach the tube is non-branching as stated in the amended claim, but does teach the shape of blood vessels (Miller, claim 9). Ma teaches a polymer containing hydrogel (Ma, abstract) which can be used as an artificial blood vessel (Ma, page 7971, introduction, paragraph 1) and teaches the hydrogel is a non-branched tubular shape wherein the two separate tubes comprise an inner and outer cylindrical surface which are coaxial and are in the shape of a cylindrical wall (Ma, figure 10), suggesting an individual blood vessel shape is non-branched. It would have been prima facie obvious to one of ordinary skill in the field to have utilized the method taught by Miller to produce the simple tubular shape taught by Ma, because Ma teaches the cylindrical shaped tube to be useful as an artificial blood vessel (Ma, page 7971, introduction, paragraph 1), when individual diseased vessels need to be replaced (Ma, page 7974, section 3.6), and Miller teaches embodiments can include only a portion of the taught components (i.e., an individual blood vessel) as necessary (Miller, page 12, paragraph 0128).
Regarding claim 23, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller does not specifically teach the cylindrical tube as stated in the amended claim, but does teach the shape of a blood vessel (Miller, claim 9). Ma teaches a polymer containing hydrogel (Ma, abstract) which can be used as an artificial blood vessel (Ma, page 7971, introduction, paragraph 1) and teaches a cylindrical tubular shape (Ma, figure 10) with a thickness of 1.4 mm (Ma, page 7972, paragraph 2.4.2.). It would have been prima facie obvious to one of ordinary skill in the field to have utilized the method taught by Miller to produce the simple tubular shape taught by Ma, because Ma teaches cylindrical shaped tube to be useful as artificial blood vessels (Ma, page 7971, introduction, paragraph 1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20200339925 A1; IDS reference, 10/25/2022) and Ma (Industrial & Engineering Chemistry Research, 2017) as applied to claims 1, 3-6, 8, 10-12, and 15-23, further in view of by Nelson (US 20210069378 A1). The references were previously cited by the Examiner.
Regarding claim 2, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches the bio-ink composition to comprises polymers, but does not teach monomers. Nelson, however teaches bioink compositions for 3D bioprinting (Nelson, claim 1) comprising polymers (Nelson, page 8, paragraph 0162) or monomers (Nelson, page 17, paragraph 0295), an example being glucose (Nelson, page 9, paragraph 0150). Miller, Ma, and Nelson are considered to be analogous to the claimed invention, because all are in the same field of synthetic tissue production. It would have been prima facie obvious to one of ordinary skill in the art to utilize the monomer glucose in the method taught by Miller in order to promote cellular growth in the intended 3D biostructure, as taught by Nelson (Nelson, page 8, paragraph 0150).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20200339925 A1; IDS reference, 10/25/2022) and Ma (Industrial & Engineering Chemistry Research, 2017) as applied to claims 1, 3-6, 8, 10-12, and 15-23, further in view of by Kim (Journal of International Society for Simulation Surgery, 2016). The references were previously cited by the Examiner.
Regarding claim 7, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches the composition to comprise poly(ethylene glycol) diacrylate polymer, but does not teach the methylacrylated derivative poly(ethylene glycol) di(meth)acrylate. Kim, however, teaches various materials for producing bio-inks, and states poly(ethylene glycol) di(meth)acrylate as an alternative for poly(ethylene glycol) diacrylate polymer, which forms unstable esters (Kim, page 56, “Synthetic bioinks”). Miller and Kim are considered to be analogous to the claimed invention, because all are in the same field of synthetic tissue production. It would have been prima facie obvious to one of ordinary skill in the art to employ the alternative polymer poly(ethylene glycol) di(meth)acrylate taught by Kim to the method taught by Miller in order to increase ester stability as suggested by Kim.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20200339925 A1; IDS reference, 10/25/2022) as applied to claims 1, 3-6, 8, 10-12, and 15-23, further in view of Fan (Journal of Biomaterials Applications, 2016). The references were previously cited by the Examiner.
Regarding claim 9, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller teaches the pre-hydrogel solution to be aqueous (Miller, page 6, paragraph 0076), but does not specify the type of water used to form the aqueous solution. Fan, however, teaches an aqueous bio-ink composition comprising DI water (Fan, page 685, “hydrogel preparation”). Miller and Fan are both considered to be analogous to the claimed invention, because all are in the same field of 3D bioprinting. It would have been prima facie obvious to one of ordinary skill in the art to utilize DI water as the specific type of water when forming the aqueous hydrogel solution for the bio-ink, as taught by Fan, with a reasonable expectation for success.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20200339925 A1; IDS reference, 10/25/2022) and Ma (Industrial & Engineering Chemistry Research, 2017) as applied to claims 1, 3-6, 8, 10-12, and 15-23, further in view of by Tan (US 20100221304 A1). The references were previously cited by the Examiner.
Regarding claim 13, Miller and Ma together teach all the elements of the current invention as applied to claim 12. Miller does not teach the vessel comprises a vein or artery from the claimed list. Tan, however, teaches a tubular biocomposite material (Tan, claim 2) which can be used as a vascular graft material for coronary artery grafts (Tan, page 1, paragraph 0002).
Miller, Ma, and Tan are all considered to be analogous to the claimed invention, because all are in the same field of synthetic tissue production. It would have been prima facie obvious to one of ordinary skill in the field to have applied the teachings of Miller, which can produce a variety of organ-based constructs, to create a coronary artery graft to address graft-associated dysfunction, a serious health concern according to Tan (Tan, page 1, paragraph 0003).
Regarding claim 14, Miller and Ma together teach all the elements of the current invention as applied to claim 1. Miller does not teach the construct comprises a hemodialysis graft. Tan, however, teaches a tubular biocomposite material (Tan, claim 2) which can be used as a vascular graft material for hemodialysis (Tan, page 5, paragraph 0074). As above, it would have been prima facie obvious to one of ordinary skill in the field to have applied the teachings of Miller, which can produce a variety of organ-based constructs, to create a hemodialysis graft to address graft-associated dysfunction, a serious health concern according to Tan (Tan, page 1, paragraph 0003).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613