DETAILED ACTION
Note that the Examiner for this application has changed.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/18/2025 has been entered.
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 .
Status of the Claims
Claims 1, 3-10, 12, 14-16, and 18-32 are pending (claim set as filed on 12/18/2025).
Applicant’s election of Group I, method claims, is again acknowledged. Claims 21-32 are drawn to the product stand withdrawn as being directed to the non-elected invention.
Priority
This application is a CON of PCT/JP2020/011554, which has foreign applications to: (a) JP 2019-053871 filed on 03/20/2019; (b) JP 2019-186411 filed on 10/09/2019; and (c) JP 2019-217131 filed on 11/29/2019.
Withdrawal of Rejections
The response and amendments filed on 12/18/2025 are acknowledged. Any previously applied minor objections and/or minor rejections, not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formal corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the essential claim rejections are detailed below in the Examiner’s response to arguments section.
Briefly, the previous obviousness rejection over Headen in view of Southan has been withdrawn. Headen’s teaching of mineral oil SPAN80 with an emulsion of aqueous DTT solution is not a dispersion medium. However, a new ground of rejection is set below where the newly cited references teach the limitation of a dispersion medium that includes phosphate buffered saline (PBS).
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-10, 12, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tei (US 2012/0122949 A1) in view of Tanaka (WO 2015/147147 A1, an English translation is provided herewith) and Lin (US 2019/0177688 A1) – all references cited in the IDS filed on 09/20/2021.
Tei’s general disclosure relates to hydrogels of three-dimensional network structure and method for fabricating the same (see ¶ [0001]). Tei discloses that gels fabricated by mixing many branched polymers (see ¶ [0002]) and the hydrogel is high strength and form shape fitting (see ¶ [0066], [0071]). Examiner’s note: an objective of the present application is a hydrogel with high shape-retainability, see instant pre-grant publication at ¶ [0035] and abstract.
Regarding the solution branching polymers, Tei teaches “the method for manufacturing the hydrogels in the present invention comprises a step of mixing a first solution, which comprises a first four branching compound and a first buffer solution, and a second solution, which comprises a second four-branching compound and a second buffer solution” (see ¶ [0009]-[0010]). Tei teaches “the four-branching compound with an electrophilic functional group at each end and the four branching compound with a nucleophilic functional group at each end” and “two four-branching compounds, TAPEG (tetraamine-polyethylene glycol) and TNPEG (N-hydroxy-succinimidyl-polyethylene glycol (NHS-PEG)) were obtained” (see ¶ [0059], [0075]-[0087]).
Regarding the dispersion medium, Tei teaches the “first buffer solution comprises one or more of phosphate buffer or phosphate buffered saline. The said second buffer solution comprises one or more of the phosphate buffer, citric acid/phosphate buffer, the phosphate buffered saline, or citric acid/phosphate buffered saline” (see ¶ [0017], [0021]).
Regarding claims 14 and 18-19 pertaining to the cell culture, Tei teaches culturing of different cells types including fibroblasts, cell lines, osteoblast, et. al. in a culture medium and the hydrogels of the culture medium were cultured for 24 hours (see ¶ [0124]-[0125]).
However, Tei does not teach: discharged into air from a droplet discharge device is an inkjet method (claim 1’s limitation and claim 20); or a cell acting additive (claim 12).
Tanaka’s general disclosure relates to a method for fixing protein crystals, cells, biological tissues and other biological samples at high speed with a hydrogel and an apparatus for performing the method (see page 1: Description).
Tanaka teaches a method in which a biological sample is fixed with a hydrogel, which comprises preparing a solution 1 and a solution 2 that form a hydrogel, where droplets of solution 1 and solution 2 are discharged from two liquid discharge nozzles (see page 2: Methods steps 1-11 and the inkjet apparatus device which comprises discharge nozzles, retaining support material).
Regarding the solution branching polymers, Tanaka also teaches monomer combination that includes multi-branched PEG derivative, for example, a combination of the SUNBRIGHT series SH series (see page 3).
Regarding the dispersion medium, Tanaka teaches a suitable solvent such as phosphate buffered saline, and optional components such as stabilizers and preservatives may be added as necessary (see page 4).
Regarding claims 3-4 pertaining to the volume, Tanaka teaches the solution is preferably ejected from a suitable liquid ejection nozzle as a droplet having a volume ranging from several tens of pico-liters (pL) to 1 µL (a liquid having a volume per drop of 50-200 pL) (see page 4).
Regarding claims 5-6, 8-10, and 15-16 pertaining to a three-dimensional structure via stacking and seeding, Tanaka teaches the method can easily be performed by utilizing an additive manufacturing type three-dimensional printer to obtain a desired biological material. By controlling the discharge together with the solution containing the sample, a three-dimensional molded product in which the biological sample is fixed with a hydrogel can be produced (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or use a droplet discharge device such as taught by Tanaka for the hydrogel fabrication method of Tei. The disclosure of Tei notes that the fabrication method is not particularly limited and can be appropriately adjusted by a person skilled in the art (see Tei at ¶ [0061]-[0062]) and therefore, the ordinary artisan would have been motivated to combine with Tanaka’s apparatus because it would allow for high speed and precision production of the hydrogel structure. The ordinary artisan would have had a reasonable expectation of success is because both the references are directed to the production of hydrogels comprising multi-branched polymer comprising polyethylene glycol.
Regarding the cell additive, it would have been further obvious to employ or use a cell additive such as taught by Lin for the method of Tei-Tanaka. Lin teaches “a fixative may be needed in some cases in order to fix the cells B at a specific position to maintain the structure of the three-dimensional tissue. The time for which the cells B are fixed may be temporary or permanent, but needs to be a time that at least ensures that the three-dimensional tissue will not collapse during cell culture and during use. A fixative that has biocompatibility and does not adversely affect the cells is preferable. The fixative may be mixed with the cells, or may be deposited separately from the cells. The fixative is not particularly limited and may be appropriately selected depending on the intended purpose. Examples of fixative include biopolymers (e.g., collagen, elastin, gelatin, and fibroin), coagulation factors (e.g., fibrinogen/thrombin), adhesion factors (e.g., fibronectin, laminin, and recombinant peptide), synthetic polymers” (see Lin at ¶ [0078]-[0079]). Thus, the use of a cell additive would have been readily apparent to one of ordinary skill in the art.
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 7-3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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