DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 12/08/2025 to claim 1 have been entered. Claims 4, 5, 8, 13-19, and 21 have been canceled. Claims 25-40 have been added. Claims 1-3, 6, 7, 9-12, 20, and 22-40 remain pending, of which claims 1-3, 6, 7, 9, 12, and 25-40 are being considered on their merits. Claims 10, 11, 20, and 22-24 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
The instant amendments to claim 1 have overcome the 35 U.S.C. § 112(a) rejections of record for new matter and 35 U.S.C. § 103 rejections of record over Wallin, which are withdrawn. New grounds of rejection are set forth below, necessitated by the instant claim amendments.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 1-3, 6, 7, 9, 12, and 25-40 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.
The term “about” in claims 1-3, 6, 27, 28, and 36 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Correction is required.
Because claims 6, 9, 12, 25, 26, 29-35, and 37-40 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
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.
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 1-3, 6, 12, and 25-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kolesky et al. (Advanced Materials (2014), 26, 3124-3130; Reference U)
Kolesky teaches a device for cell culture, the device comprising: a supporting fiber layer comprising 3-D printed fibers; and a suspended fiber layer comprising 3-D printed fibers supported at a defined interval by fibers of the supporting fiber layer, each of the fibers of the suspended fiber layer having an unsupported, suspended length, wherein the fibers of the suspended fiber layer are disposed in a parallel array, have a stiffness of between about 103 Pa and 2x104 Pa (i.e. 100 Pa and 2,000 Pa, and equivalent to 0.1 kPa and 2 kPa respectively), and have diameters between about 45-500 µm to 20 pm; and the unsupported, suspended length is of about 0.5 µm to about 1000 µm, is located between fibers of the supporting fiber layer, and is not supported by the supporting fiber layer or [[the]] a substrate (Fig. 2g, 2h, and 2i; paragraph starting “We take advantage of this…” through paragraph ending “…Movie 3)” on p3126; paragraph starting “To create the ECM…” on p3125 for the stiffness (e.g. elastic modulus) values); p3129, subheading “Multi-material 3D Bioprinting” for 3D printing methods; ), reading in-part on claims 1, 6, 33, and 35, and reading on claims 25-28, the embodiment of printed fibers as support beams for claim 29 and the embodiment of the diameter range of above for claim 30, claims 31-32, the embodiment of multiple suspended layers for claim 34, and the embodiment of empty gaps between the printed fibers for claim 38. Kolesky teaches that their 3D printing approach is scalable and is relevant for applications for such as drug screening, in which arrays of 3D tissues constructs could be printed in parallel within standard well plates (the paragraph spanning both columns on p3128), reading in-part on claims 1, 33, 35, and 36. Kolesky teaches loading the 3D printed fibers with human neonatal dermal fibroblasts (i.e. HNDFs), 10T1/2s mouse fibroblasts, or human umbilical cord vascular endothelial cells (i.e. HUVECs) (p3127, right column, the paragraph starting “To demonstrate patterning of multiple cell types…”), reading on a device capable of cell culture for the preamble of claim 1. Kolesky teaches further coating the device with fibronectin to improve cell adhesion (p3129, right column, subheading “Endothelialization of Vascular Networks”), reading on the embodiment of fibronectin coating for claims 12 and 37. Kolesky teaches wherein the unsupported, suspended length is of about 10 pm to about 1000 pm (Fig. 2i, noting the gap between the fibers is about 200 µm), reading on claims 2 and 3 and reading in-part on claim 39.
Regarding claims 1, 33, and 35, Kolesky does not teach the claimed fiber diameter thickness ranges. Regarding claim 36, Kolesky does not teach fiber spacing up to about 100 µm. Regarding claim 39, Kolesky does not teach wherein each printed field (e.g. the gaps between the printed fibers) up to 1 mm by 1 mm. However, see In re Rose 220 F.2d 463 (CCPA 1955) (holding that “differences in degree and/or size [are] not patentable distinctions”). Also, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the limitations towards fiber diameter, fiber spacing, and dimensions of the printed field (e.g. the gaps between the printed fibers) are known optimizable parameters as set forth by Kolesky based on the diameter of the nozzle used to dispense/print the fibers and the choice of 3D pattern by a person of ordinary skill in the art. Therefore, it would have been obvious before the invention was made to scale down the device of Kolesky absent evidence to the contrary of an unexpected result. A person of ordinary skill in the art might scale down the device of Kolesky when working with small quantities of cells such as standard well plates as envisioned by Kolesky in methods of drug screening 3D tissue constructs in standard well plates.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kolesky as applied to claim 1 above, and further in view of Shogbon et al. (US 2014/0134729; provided in the IDS dated 12/07/2022).
The teachings of Kolesky are relied upon as set forth above. Kolesky further teaches 3D printing on gelatin-methacrylate-coated surfaces (i.e. GelMA; see the 2nd paragraph under subheading “Multi-Material 3D Bioprinting” on p3129), reading in-part on claim 7.
Regarding claim 7, Kolesky does not teach the embodiment of 1, 6-hexanediol diacrylate as a species of HDDA derivative.
Shogbon teaches a well plate device coated with an acrylic copolymer selected from the group consisting in-part of hexanediol diacrylate, tetra(ethylene glycol) diacrylate, polyethylene glycol diacrylate (Mw ~ 258 or n ~ 7), 1, 6-hexanediol diacrylate, and di(ethylene glycol) diacrylate an capable of culturing human embryonic stem cells and oligodendrocyte progenitor cells (¶0024-0025 and Table 1; also see working Example 1), reading on the embodiment of 1, 6-hexanediol diacrylate as an HDDA derivative and polyethylene glycol diacrylate for the PEG derivative of claims 7 and 8.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the gelatin-methacrylate coating of Kolesky with the hexanediol diacrylate and polyethylene glycol diacrylate coating of Shogbon in Kolesky’s cell culture device. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Kolesky and Shogbon are directed towards cell devices for the culturing of mammalian cells. The skilled artisan would have been motivated to do so because Shogbon teaches that hexanediol diacrylate and polyethylene glycol diacrylate would be predictably advantageous for the culturing of oligodendritic progenitor cells and would thus improve the ability of Kolesky’s device to then culture oligodendritic progenitor cells, see M.P.E.P. § 2143(I)(A).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kolesky and Shogbon as applied to claims 1 and 7 above, and further in view of Kim et al. (Soft Matter (2016), 12, 2076-2085; provided in the IDS dated 12/07/2022).
The teachings of Kolesky and Shogbon are relied upon as set forth above.
Regarding claims 7 and 9, Kolesky and Shogbon do not teach the embodiment of a copolymer fiber comprising poly HDDA-co-starPEG (e.g. any multi-arm PEG). Regarding claim 12, Kolesky and Shogbon do not teach further modifying the suspended fiber layer with a surface ligand.
Kim teaches a composition and methods of making multi-arm PEG or PEG-acrylate hydrogels functionalized with RGD peptide (Abstract). Kim teaches RGD peptide is an integrin-binding sequence and the addition of this peptide to PEG hydrogels promotes cell adhesion (paragraph spanning 2076-2077, also subheading 1 on p2077 for RGD functionalization), reading on claims 7, 9, and 12. Kim teaches functionalized multi-arm PEG or PEG acrylates are used to crosslink said PEG monomers into hydrogels (paragraph spanning p2076-2077), reading in-part on claims 1-6. Kim teaches PEG hydrogels are useful as their physical properties can be tuned/adjusted independent of their biological activity (p2076, 1st paragraph under the Introduction), reading on claims 7, 9, and 12.
Regarding claims 7 and 9, it would have been obvious before the invention was filed to further substitute the PEG acrylate(s) of Shogbon with the multi-arm PEG acrylate of Kim in the device of Kolesky. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Shogbon and Kim are directed towards PEG acrylates. The skilled artisan would have been motivated to do so because multi-arm PEG acrylate of Kim would be advantageous to crosslinking the copolymer of Shogbon into a hydrogel, and said PEG hydrogel being advantageous as its physical properties are separately adjustable/tunable from its biological function in the device of Kolesky.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Kolesky as applied to claim 1 above, and further in view of Simon (US 8,486,692; Reference A).
The teachings of Kolesky are relied upon as set forth above. Kolesky further teaches a build volume of 725 x 650 x 150 mm (p3128, paragraph starting “Multi-Material 3D Bioprinting”), reading in-part on claim 40.
Regarding claim 40, Kolesky does not teach wherein the device has dimensions of up to 6 mm by 6 mm and a thickness of 70-100 µm.
Simon teaches a cell culture apparatus consisting of an array of vessels (Abstract and Fig. 2). Simon teaches the dimensions of the bottom and sides of the apparatus may be specified as required for specific tasks, and for a multiple vessel array teaches a bottom diameter of 2-50 mm (e.g. 2 x 2 mm to 50 x 50 mm; Col. 5, lines 47-54), and wall thicknesses of 0.1-0.3 mm (equating to 100-300 µm) to provide gas permeability and optical clarity while providing sufficient structural integrity to the vessel (Col. 5, line 62 through Col. 6, line 7), reading on claim 40.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the device holding the 3D printed fibers of Kolesky with the device of Simon. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Kolesky and Shogbon are directed towards cell devices for the culturing of mammalian cells. The skilled artisan would have been motivated to do so because Simon teaches that a bottom diameter of 2-50 mm is a predictably advantageous size for a multiple vessel array and teaches that a wall thickness of 0.1-0.3 mm (equating to 100-300 µm) is a predictably advantageous size to provide gas permeability and optical clarity while providing sufficient structural integrity to the vessel
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-10 of the reply have been fully considered, but not found persuasive of error over the new grounds of rejection set forth above and necessitated by the instant claim amendments.
Conclusion
No claims are allowed. No claims are free of the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653