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, 2, 3, 9, 16, 17, 20, 21, 28, and 34 in the reply filed on 04/27/2026 is acknowledged.
Claims 39, 40, 41, 43, 45, 46, 54, 55, 60, and 63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/27/2026.
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 3, 21, and 34 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 claim 3:
Claim 3 recites the limitations:
“the at least one of the one or more transparent channels” in line 2
“the at least one of the one or more transparent channels” in line 3
“the at least one of the one or more transparent channels” in lines 12-13.
There is insufficient antecedent basis in the claim for these limitations.
Claim 3 further recites:
“a plurality of transparent channels” in line 6.
It is unclear whether the “a plurality of transparent channels” is intended to be separate from “the at least one of the one or more transparent channels” recited elsewhere in the claim.
Claim 34 is rejected as depending from an indefinite claim.
In reference to claim 21:
Claim 21 recites the limitation “selected from the group comprising or consisting of” in line 2. It is unclear whether the claim is limited to the group listed or if the group is an open group. See MPEP 2173.05(h).
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) 1,9,16-17,20-21 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyer (WO2020056517A1 – previously of record) in view of Howell (US20200101670A1 – previously of record).
In reference to claims 1, 9, and 28:
Beyer discloses a microfluidic crosslinking printhead material flow sensing system (paras 0043, 0045, 0047, 00110) comprising:
a microfluidic crosslinking printhead (paras 0043, 0045, 0047, Figs. 2-6);
a camera system to monitor material flow through the microfluidic crosslinking printhead and to provide streaming images of the material flow (para 00110), the material flow comprising at least one cross-linkable material (para 0014),
a computer system to determine physical properties of a printed fiber, resulting from crosslinking created by the material flow, by analyzing the material flow as represented in the streaming images (para 00110, claim 25 discussing a control processor for controlling flow rates); and
wherein the computer system compares the images to user-established material flow parameters corresponding to the physical properties of a printed fiber within a predetermined tolerance and records the material flow parameters for the material flow, and results the comparison (para 00110, 0118-00119).
Beyer does not disclose wherein the computer system comprises a machine-learning based system for performing the comparison (claim 1), (i) the machine-learning based system identifies one or more deviations in the material flow from the user-established material flow parameters (claim 9), (v) the machine-learning based system is selected from the group consisting of a convolutional neural network (CNN) (claim 28), or (vi) the machine-learning based system comprises a graphics processing unit (GPU) (claim 28). However, this would have been obvious in view of Howell. Howell teaches machine learning using a CNN and a GPU (paras 0018, 0025) for extrusion printing processes (abstract). Howell further teaches wherein the machine-learning based system identifies one or more deviations in the material flow from the user-established material flow parameters (para 0027) and comprises a camera for capturing images of extruded material which are fed to a computer system comprising a machine-learning based system to determine physical properties and adjust the control parameters to regulate filament quality and printing time to allow for real-time monitoring and control that are necessary for long production runs without human intervention (paras 0013-0015). It would have been obvious to a person having ordinary skill in the art to combine the printhead of Beyer with the computer system comprising a machine-learning based system of Howell in order to obtain a microfluidic crosslinking printhead material flow sensing system which regulates filament quality and printing time to allow for real-time monitoring and control that are necessary for long production runs without human intervention.
The phrase “preferably wherein said at least one cross-linkable material comprises a hydrogel is not given patentable weight” has been given its broadest reasonable interpretation as a preferred embodiment and, as such, “wherein said at least one cross-linkable material comprises a hydrogel” is not given patentable weight.
The claims have been given their broadest reasonable interpretation. As such, the use of and/or at the end of clause “(v)” is interpreted as requiring only one of clauses i-vii be met in order to meet the claim. While the above clauses have been specifically identified by the Examiner, only of the clauses is required to meet the claim.
In reference to claim 16:
In addition to the discussion of claim 1, above, Beyer further teaches wherein the microfluidic crosslinking printhead comprises a three-dimensional (3D) bioprinting printhead, and the system comprises a 3D bioprinting system to produce bioprinted fibers (Abstract, para 0012).
In reference to claim 17:
In addition to the discussion of claim 16, above, Beyer further discloses wherein:
(i) the 3D bioprinting printhead comprises a plurality of channels to selectively provide a respective plurality of materials for the material flow (Fig. 4);
(iv) the bioprinted fibers are coaxially layered hydrogel fibers (paras 00139-00142);
The claims have been given their broadest reasonable interpretation. As such, the use of and/or at the end of clause “(v)” is interpreted as requiring only one of clauses i-vi be met in order to meet the claim. While the above clauses have been specifically identified by the Examiner, only of the clauses is required to meet the claim.
In reference to claim 20:
In addition to the discussion of claim 1, above, Beyer further discloses wherein the material flow further comprises at least one biological material (para 0012).
In reference to claim 21:
In addition to the discussion of claim 20, above, Beyer further discloses wherein:
(i) the cell population is selected from the group comprising or consisting of a single-cell suspension and cell aggregates (para 00120);
(iii) the material flow further comprises dyes (para 00128);
(iv) the cell-laden biomaterials flow through the respective channels to produce the bioprinted fibers (abstract);
(v) the bioprinted fibers are coaxially layered hydrogel fibers;
(vi) the bioprinted fibers comprise a core hydrogel material, and a shell hydrogel material around the core hydrogel material, wherein the core hydrogel material is disposed concentrically within the shell hydrogel material within the predetermined tolerance (para 0021-0022)
The claims have been given their broadest reasonable interpretation. As such, the use of and/or at the end of clause “(vi)” is interpreted as requiring only one of clauses i-vii be met in order to meet the claim. While the above clauses have been specifically identified by the Examiner, only of the clauses is required to meet the claim. Clauses ii and vii are interpreted as optional alternative/additional limitations which are not required in the claim.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
After search the prior art regarded as nearest the claimed invention is Beyer (WO2020056517A1 – previously of record). Beyer discloses a microfluidic crosslinking printhead material flow sensing system (paras 0043, 0045, 0047, 00110) comprising: a microfluidic crosslinking printhead (paras 0043, 0045, 0047, Figs. 2-6); a camera system to monitor material flow through the microfluidic crosslinking printhead and to provide streaming images of the material flow (para 00110), the material flow comprising at least one cross-linkable material (para 0014), a computer system to determine physical properties of a printed fiber, resulting from crosslinking created by the material flow, by analyzing the material flow as represented in the streaming images (para 00110, claim 25 discussing a control processor for controlling flow rates); and wherein the computer system compares the images to user-established material flow parameters corresponding to the physical properties of a printed fiber within a predetermined tolerance and records the material flow parameters for the material flow, and results the comparison (para 00110, 0118-00119). While Howell (US20200101670A1 – previously of record) renders obvious the remaining limitations of claim 1, Beyer, Howell, and the remaining prior art available fail to teach or otherwise render obvious wherein the microfluidic crosslinking printhead comprises one or more transparent channels, and the camera system monitors material flow through at least one of the one or more transparent channels as required of claim 2. The Office is unable to discern a reasonable rationale from the prior art that such features are taught, suggested, or otherwise rendered obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bauer (US20190022725A1)
Sachs (US20190118258A1)
Thayer (US20210031456A1)
D’Apuzzo (US20210239958A1).
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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