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 .
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.
Election/Restrictions
Applicant’s election without traverse of claims 1-4, 7, 39, and 40 in the reply filed on 11/10/2025 is acknowledged.
Claims 9,12-15,17-20,25,29 and 32-33 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
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 2-4 is 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.
In reference to claims 2 and 3:
Claim 2 recites the trademarks “Matrigel” and “Geltex”. As used in the claim, the presence of these trademarks does not comply with the requirements of 35 U.S.C. §112(b). See MPEP 2173.05(u).
In reference to claim 4:
Claim 4 recites “wherein the support bath further comprises materials selected from the group consisting of: agarose, agarose slurry, gelatin, gelatin slurry, PBS, water, water-soluble polymer, PEG of molecular weight 8000Da, PEG of molecular weight 20000Da, PEG of any molecular weight between 8000 and 20000Da, PEG of any molecular weight between 0-8000Da, PEG of any molecular weight, methylcellulose, dextran, and any viscosity modifying reagent” (emphasis added). However, claim 1, from which claim 4 depends, recites “a support bath solution comprising PEG (polyethylene glycol) and agarose”. It is unclear what materials the support bath should “further comprises” as “agarose” and “PEG of any molecular weight” are previously required of the support bath. In order to advance prosecution, claim 4 has been interpreted as requiring at least one listed material outside of the “agarose” and “PEG of any molecular weight”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 39, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jun (KR20180049745A – reference is made to the Machine Translation).
In reference to claim 1:
Jun discloses a bioprinting system (Fig. 1) comprising:
a 3D bioprinter with a nozzle (para 0041, Figs. 1 and 2);
at least one bioink (para 0024); and
a support bath solution comprising PEG (polyethylene glycol) and agarose (para 0034).
In reference to claim 2:
In addition to the discussion of claim 1, above, Jun further discloses wherein the at least one bioink comprises at least one material selected from the group consisting of:
collagen of any type from any species, fibrin, hyaluronic acid (para 0028).
In reference to claim 3:
In addition to the discussion of claim 2, above, Jun further discloses wherein the at least one bioink further comprises one or more cells selected from the group consisting of: any cell type (paras 0002, 0026, 0030, 0076).
In reference to claim 4:
In addition to the discussion of claim 1, above, Jun further discloses wherein the support bath further comprises materials selected from the group consisting of: gelatin (para 0034).
In reference to claim 39:
In addition to the discussion of claim 1, above, Jun further discloses wherein the resolution of the printed feature is altered by modifying translational speed of the nozzle during printing (para 0084).
In reference to claim 40:
Jun discloses a bioprinting system (Fig. 1) comprising:
a 3D bioprinter with a nozzle (para 0041, Figs. 1 and 2);
at least one bioink comprising PEG (polyethylene glycol) (para 0029) and agarose (para 0028); and
a support bath solution comprising a collagenous solution (para 0034, see para 0018 of Applicant’s specification, as published, disclosing that a collagenous solution is a solution containing collagen).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jun as applied to claim 1, above, and further in view of Ogle (US20220031848A1).
In addition to the discussion of claim 1, above, Jun further discloses wherein the bioink is a collagenous material (para 0028, see para 0018 of Applicant’s specification, as published, disclosing that a collagenous solution is a solution containing collagen) and a crosslinking agent PEG (para 0029).
Jun fails to disclose wherein the nozzle comprises: a first and second lumen; a first bioink reservoir containing a collagenous bioink fluidly connected to the first lumen; and a second bioink reservoir containing a bioink comprising PEG fluidly connected to the second lumen.
However, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). As applied to the instant application, this would have been obvious in view of Ogle. Ogle teaches a bioprinting system (Fig. 19). Ogle further teaches utilizing a coaxial nozzle in order to simultaneously dispense bioink fed from a first reservoir through a first orifice and the cross-linking agent fed from a second reservoir through a second orifice (para 0149). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the nozzle and feed system of Jun with the coaxial nozzle and reservoir system of Jun because all of the claimed elements are known in the art and the combination yields predictable results, e.g. the materials are extruded with techniques known in the art for extruding such materials.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW L SWANSON whose telephone number is (571)272-1724. The examiner can normally be reached M-Th 0800-1900 and every other Friday 0800-1600.
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/ANDREW L SWANSON/ Examiner, Art Unit 1745