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 .
Response to Arguments
Applicant's arguments filed 2/02/2026 have been fully considered. Regarding claims 1-10 and 16, the claims are allowed due to amendments and arguments found persuasive.
Regarding claims 11, 14, 15, 17, 18, Applicant’s arguments regarding the combination of McAlpine and Beh are moot. The claims are rejected as a product or an article that is obvious in view of Beh and Veiseh.
Allowable Subject Matter
Claims 1-10 and 16 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record includes McAlpine et al. (US 2019/0122584 A1), Beh (US 2024/0217170 A1), Veiseh et al. (US 2022/0143270 A1).
McAlpine teaches printing a sacrificial support material to form a supporting cylinder around which the ink was printed, see [0141].
Beh teaches 3D printing with biomaterials such as gelatin [0057] as the flowable support 106, Fig. 1, see [0111].
Veiseh teaches the non-degradable core can include encapsulated therapeutic cells and/or biosensors, wherein the degradable shell serves as a scaffold for blood vessel growth [0015], Fig, 1, [0170], mesenchymal stem cells are encapsulated in a 3D-printed, degradable shell, [0037].
However, the prior art does not teach or suggest the claimed print head being configured to dispense a first biomaterial which is self supporting when printed and configured to dispense a second biomaterial which is a low viscosity, substantially non self-supporting but self-assembling polymer biomaterial when printed initially; b) moving the print head in a first plane relative to the article being printed according to the software, such that the at least one of the first and second biomaterials is dispensed from the printhead at said plane; and repeating said movement in further multiple planes substantially parallel to the first plane and dispensing at least one of the first and second materials at the further planes such that the article is printed in a layer by layer manner in multiple layers each layer having an article area; whereby, the first biomaterial provides an enclosure for the second biomaterial and thereby allowing the self-assembly of the second material in said enclosure.
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.
Claim 18 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.
Claim 18 recites “disposable cassette according to claim 14, wherein the self- supporting biomaterial from the printhead is located in a first layer of the multiple layers that define the vessels,” rendering the claim indefinite. Examiner notes that the instant specification discloses “cassette 130 includes two printable material vessels 132 and 134, each pressurisable by the pump 120” as depicted in Fig. 3. Thus the claimed “first layer of multiple layers” is unclear for a liquid material in a vessel that can pumped. Further, there does not appear to be support in the instant specification for layers in the vessel. For purposes of examination, the cassette will be understood to include only viscous materials that do not contain layers. Examiner suggest removing the language or clarifying the meaning.
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.
Claim(s) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beh (US 2024/0217170 A1) in view of Veiseh et al. (US 2022/0143270 A1).
Regarding claim 11, Beh teaches a 3D printed article formed from at least two biomaterials each printed by means of dispensing from a print head to form multiple layers, (Examiner notes the claim is interpreted as a product-by-process claim and the claims are not limited to the manipulations of the recited steps, only the structure implied by the steps, see MPEP 2113. Beh teaches inkjet or extrusion printing, and using a second and further third printing modalities that may be the same as or different from each other, [0045] the sacrificial material may be extruded from a dispensing outlet e.g., an extruder nozzle [0063]) the layers each defining an article area, the biomaterials including a first self-supporting biomaterial printed only to a first part of the article area (Beh teaches 3D printing with biomaterials such as gelatin [0057] as the flowable support 106, Fig. 1, see [0111]) and a second substantially non self-supporting [material] printed only to a second part of the article area different to the first area. (deposition of material, for example using an extruder to deposit Pluronic F127 fibers [0119]) wherein the first biomaterial is a biocompatible biomaterial selected from: gelatin, alginate, and thermos-responsive hydrogel. (Beh teaches gelatin [0057] as the flowable support 106, Fig. 1, see [0111]).
McAlpine does not teach each the first biomaterial forming a mould for the second biomaterial which is self-assembled in the mould, and the second biomaterial is as self-assembling polymer selected from: collagen types 1 to 28, jellyfish collagen, nascent protein polypeptides, deoxyribonucleic acids (DNA) and ribonucleic acids (RNA).
Veiseh teaches the first biomaterial forming a mould for the second biomaterial which is self-assembled in the mould (Veiseh teaches the non-degradable core can include encapsulated therapeutic cells and/or biosensors, wherein the degradable shell serves as a scaffold for blood vessel growth [0015], Fig, 1, [0170], mesenchymal stem cells are encapsulated in a 3D-printed, degradable shell, [0037]) and the second biomaterial is selected from: collagen types 1 to 28, jellyfish collagen, nascent protein polypeptides, deoxyribonucleic acids (DNA) and ribonucleic acids (RNA). (Veiseh teaches materials for encapsulation included biological material can such as tissue, cells, biological micromolecules, or biological macromolecules including nucleic acids, polypeptides, proteins, [0099]. Examiner notes the instant specification paragraph [0007] teaches nucleic acid and nascent protein polypeptides, to be “self-assembling polymers”.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to use the method of Beh to encapsulate the nucleic acids and polypeptides of Veiseh as the biomaterial of in order to create bulk encapsulation of bioactive cells in a complex gel architecture to target desired in vivo responses, see [0039].
Regarding claim 17, Beh as modified meets the claimed 3D printed article according to claim 11, wherein the first self- supporting biomaterial from the printhead is located in a first layer of the multiple layers at the first part of the article area, and the second substantially non self- supporting biomaterial is located in the first layer but at the second part of the article area different from the first part of the article area, such that the first self- supporting biomaterial and the second substantially non self- supporting biomaterial are located adjacent each other in an x- y coordinate system that defines the article area. (Beh depicts in Fig. 3D an article formed by encapsulating one material with another such that a single x-y plane contains the first biomaterial and the second biomaterial. Furthermore, Beh teaches inkjet or extrusion printing, and using a second and further third printing modalities that may be the same as or different from each other, [0045] the sacrificial material may be extruded from a dispensing outlet e.g., an extruder nozzle [0063]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beh (US 2024/0217170 A1) in view of Veiseh et al. (US 2022/0143270 A1) and McAlpine et al. (US 2019/0122584 A1).
Regarding claim 15, Beh as modified does not meets the claimed article according to claim 11 wherein the first and second parts of article area are in the form of concentric rings.
McAlpine teaches a printed prostate model (e.g., by printing a sacrificial support material to form a supporting cylinder around which the ink was printed, see [0141].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to vary the pattern taught by McAlpine to meet the claimed concentric rings in order to optimize the usefulness of the organ models described herein for the purpose of procedure rehearsal, see [0141].
Claim(s) 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Veiseh et al. (US 2022/0143270 A1) in view of Beh (US 2024/0217170 A1).
Regarding claim 14, Beh meets the claimed disposable cassette comprising: respective vessels containing the first and second biomaterials, (a syringe setup to automatically dispense more prepolymerization solution during the printing process, [0093]) and the second biomaterial is a substantially non self-supporting but self-assembling polymer selected from a group consisting of: collagen types 1 to 28, jellyfish collagen, nascent protein polypeptides, deoxyribonucleic acids (DNA) and ribonucleic acids (RNA), Veiseh teaches materials for encapsulation included biological material can such as tissue, cells, biological micromolecules, or biological macromolecules including nucleic acids, polypeptides, proteins, [0099]. Examiner notes the instant specification paragraph [0007] teaches nucleic acid and nascent protein polypeptides, to be “self-assembling polymers”.) each biomaterial being arranged for dispensing to a 3D printer. (for printing 3D hydrogels with multiple materials [0093]).
Veiseh does not teach wherein the first biomaterial is a self-supporting biocompatible biomaterial selected from a group consisting of: gelatin, alginate, and thermo-responsive hydrogel,
Beh teaches wherein the first biomaterial is a self-supporting biocompatible biomaterial selected from a group consisting of: gelatin, (Beh teaches 3D printing with biomaterials such as gelatin [0057] as the flowable support 106, Fig. 1, for a second material 102, see [0111]) alginate, and thermo-responsive hydrogel.
It would have been obvious to one of ordinary skill in the art before the effect filing date of the present invention to select the gelatin material of Beh as the generic 3D printed material of Veiseh because it allows for arbitrary designs to support cell viability, see Beh [0126].
Regarding claim 18, Veiseh as modified meets the claimed disposable cassette according to claim 14, wherein the self- supporting biomaterial from the printhead is located in a first layer of the multiple layers that define the vessels, (For purposes of examination, the cassette will be understood to include only viscous materials that do not contain layers) and the substantially non self-supporting but self- assembling polymer is also located in the first layer, such that the self- supporting biomaterial is adjacent to the substantially non self-supporting but self-assembling polymer in a direction orthogonal to a dispensing direction of the print head. , (Veseh teaches a syringe setup to automatically dispense more prepolymerization solution during the printing process, [0093]. Beh teaches the sacrificial material may be extruded from a dispensing outlet e.g., an extruder nozzle [0063]. Examiner notes the orientation of the syringe/cassette is the intended use of the claimed product, see MPEP 2114.)
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kitout et al. (US 20180265720 A1) teaches [0007] light curing molding ink set by which a light cured article having the good dimensional accuracy can be obtained, and a method for manufacturing a light cured article using the light curing molding ink set.
Kroll et al. (US 2020/0164109 A1) teaches [0009] method of producing a perfusable multi-layered tubular tissue construct comprising: depositing on a substrate one or more filaments, each filament comprising: a plurality of concentric and coaxial cell-laden ink layers, each cell-laden ink layer comprising one or more predetermined cell types and extending at least a portion of the length of the filament.
Conclusion
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 MICHAEL M. ROBINSON whose telephone number is (571)270-0467. The examiner can normally be reached Monday-Friday 9:30AM-6PM.
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/MICHAEL M. ROBINSON/Primary Examiner, Art Unit 1744