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.
Invitation for an Examiner Interview
If Applicant believes anything contained herein is unclear or incorrect the Examiner encourages Applicant to request an interview with the Examiner.
Response to Argument
Applicant’s arguments, see page 7 paragraphs 2-3, filed 04/06/2026, with respect to claims 2-4 have been fully considered and are persuasive. The rejections under 35 U.S.C. §112(b) of 12/04/2025 have been withdrawn.
Applicant’s arguments, see page 8 second full paragraph, filed 04/06/2026, with respect to the rejection(s) of claim(s) 1 and 40 (it appears there is a typographical error and “Independent claims 7 and 40” should read “Independent claims 1 and 40”) under 35 U.S.C. §102(a)(1) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ogle (US20220031848A1 – previously of record).
Applicant's remaining arguments filed 04/06/2026 have been fully considered but they are not persuasive. Applicant argues, in relation to dependent claim 7, that the prior art does not teach or suggest “enabling macromolecular crowding and interlayer connectivity” as required of currently amended claim 7 (pg 9 ln 13-21), that the current claims are directed to intentional regulation of the rate of macromolecular crowding induced collagen assembly and that the rate of collagen assembly be modulated relative to a layer-to-layer deposition interval (pg 9 last paragraph continuing on page 10), that Jun does not disclose or suggest regulating a rate of collagen assembly relative to deposition timing or recognize collagen assembly kinetics as a design variable during printing (page 10 ln 7-13). While the Examiner agrees the prior art does not teach or suggest “enabling macromolecular crowding and interlayer connectivity”, the prior art appears to teach each of the structural limitations of the claimed bioprinting system and thus the manner of operating the bioprinting system does not differentiate it from the prior art. See MPEP 2114.
Applicant next argues that Ogle discloses photo-crosslinkable bioinks in which layer adhesion and mechanical integrity are controlled through externally triggered covalent crosslinking following deposition while the present claims “expressly” exclude chemical modification and instead rely on non-covalent, macromolecular crowding-induced collagen assembly”. The Examiner respectfully disagrees. Claim 7, as currently amended, recites “enabling macromolecular crowding and interlayer connectivity”. This limitation does not exclude chemical modification and only requires the structure enable macromolecular crowding and interlayer connectivity. As the prior art appears to teach each of the structural limitations of the claimed bioprinting system and thus the manner of operating the bioprinting system does not differentiate it from the prior art. See MPEP 2114.
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) 1-4, 7, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jun (KR20180049745A – previously of record, reference is made to the Machine Translation) in view of Ogle (US20220031848A1 – previously of record).
In reference to claims 1 and 7:
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) which is collagenous (para 0028, applies to claim 7); and
a support bath solution comprising PEG (polyethylene glycol) and agarose (para 0034).
Jun fails to disclose wherein the nozzle comprises: a first and second lumen (claim 1) or 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 (claim 7).
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, PEG, which is taught by Jun, is a known cross-linking agent). 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.
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).
Jun fails to disclose wherein the nozzle comprises: a first and 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, PEG, which is taught by Jun, is a known cross-linking agent). 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ozbolat (US20160288414A1)
Cui (US20190008998A1)
Rodriguez (US20200247053A1)
Moretto (US20230264417A1)
Tamayol (US20240165879A1)
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phillip Tucker can be reached at (571)272-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW L SWANSON/Primary Examiner, Art Unit 1745
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