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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-4, 7-10, 12-16, and 18) in the reply filed on 10/09/2025 is acknowledged.
Claim Rejections - 35 USC § 102
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.
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, 7, 9-10, 12-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tudor et al. (US 6,364,218 B1).
Regarding claim 1, Tudor et al. teach a system (Figs. 1-8, item 10 – material valve, 12 – nozzle assembly; additionally see col 3 lines 9-65) comprising:
a mixer having a longitudinal axis (see Fig. 1-8 item 14-mixing tube with mixer shroud 18, said mixer having a longitudinal axis, col 3 lines 24-45 recites that the nozzle assembly 12 includes mix tube 14, an insert 16, and a mixer should 18), the mixer defining a flow channel that extends along the longitudinal axis (Figs 1, 2, 4, 8, 9 specifically showing the mixer defining a flow channel that extends along the longitudinal axis),
the mixer comprising: at least one inlet configured to receive a first printable biomaterial and a second printable biomaterial (Figs. 1, 2, 4, 8, 9 showing upper inlet 24a of the mixer 12/18 configured to receive a first printable material via hose 10c, and a second printable material via hose 10d, and capable of supplying biomaterials; col 3 lines 10-33); an outlet spaced from the inlet along the longitudinal axis (Figs. 1, 2, 4, 8, item 24b, and col 3 lines 26-28 regarding having a conical nozzle tip portion 24b);
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Tudor. Fig. 8 showing helical elements 26 and 28 for mixing
and at least one mixing element positioned within the flow channel between the at least one inlet and the outlet of the mixer (Figs. 1, 2, 4, 8, and 9 item 26, and 28 which are mixing element, see also col 3 lines 26-38 which discloses a plurality of helical elements positioned in the flow channels), wherein the at least one mixing element is configured to control a spatial distribution of the first and second printable biomaterials across and along the longitudinal axis (see Figs. 1-9, the mixing element 26/28 are configured to control the spatial distribution of the first and second printable materials across and along the longitudinal axis, as intended use).
Tudor et al. further teach having a sleeve that defines a sheath channel that surrounds the outlet of the mixer, wherein the sleeve comprises an inlet that is configured to receive a crosslinker (Fig. 1, 2, 4, 8, and 9 – see sleeve 20 defining a sheath channel that surrounds the outlet of the mixer; col 3 lines 24-25, discloses nozzle assembly 12 includes a mix tube 14, an insert 16, a mixer should 18, and an air should 20; Figs. 1-9, item 20d, see how the sleeve 20 comprises an inlet 20d that is configured to receive a fluid, and the fluid is capable of being a crosslinker; see col 4 lines 1-8, discloses tubular air should 20 nozzle surface 20c. A pair of diametrically opposed air inlet apertures 20d are provided proximate the upper end 20e of the main body portion of the shroud, see annotated Fig. 8 below).
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Fig. 8 – Tudor et al. showing channel 20d -inlet is capable of receiving fluid as claimed.
As for claim 2, Tudor et al. further teach wherein each mixing element of the at least one mixing element is a helical mixing element that is configured to divide the flow channel into opposed flow channel segments (Figs 1, 2, 4, 8, and 9 specifically showing plurality of helical mixing element 26 and 28 arranged along the longitudinal axis of the mixer; see additionally col 3 lines 26-38 that also discloses a plurality of mix elements 26 and 28 comprising alternating left and right hand helical elements positioned in stacked fashion within tube member 24).
As for claim 3, Tudor et al. further teach wherein the at least one helical mixing element comprises a plurality of helical mixing elements that are arranged along the longitudinal axis of the mixer (Figs. 1-9 see plurality of helical mixing elements 26/28 arranged along the longitudinal axis of the mixer; col 3 lines 26-28, discloses a plurality of mix element 26 and 28 comprising alternating left and right-hand helical elements positioned in stacked fashion within the tube member 24).
As for claim 4, Tudor et al. further teach wherein each mixing element of the plurality of mixing element is rotationally offset from each adjacent mixing element of the plurality of mixing elements (Figs. 1, 2, 4, 8, 9 shows each mixing element 26/28 is rotationally offset from each adjacent mixing element 26/28; additionally see col 3 lines 26-28 which discloses a mix elements 26 and 28 comprising alternating left and right hand helical elements positioned in stacked fashion within tube member 24).
As for claim 7, Tudor et al. further shows wherein the at least one inlet comprises a first inlet that is configured to receive the first printable biomaterial and a second inlet that is configured to receive the second printable biomaterial (see Fig. 4, item 10c and 10d is able capable handling different material including biomaterials as claimed).
As for claim 9, Tudor et al. further teach at least one first actuator that is configured to effect flow of the first printable biomaterial and the second printable biomaterial (Figs. 1, 2, 4, 8, 9 shows first actuator comprising material vale 10 configured to effect flow of the first and second printable materials A and B, see how the materials are capable of being printable biomaterials; see col 3 lines 10-23); and a second actuator that is configured to effect flow of the crosslinker (Figs. 1, 2, 4, 8, and 9 showing how the second actuator is provided for varying the flow of fluid through the sleeve, and see how the second actuator is capable of effecting the flow of crosslinker; col 5, lines 7-40, discloses “It will be understood that air is delivered to air inlets 20d through suitable hoses connected with suitable sources of pressurized air. The air supply pressure may be varied during the course of the dispense cycle to compensate for changes in robot tool tip speed and/or changing height between the discharge orifice and the surface to which the swirled adhesive pattern is applied”).
As for claim 10, Tudor et al. further teach wherein the sleeve comprises an outlet that is spaced from the outlet of the mixer along the longitudinal axis of the mixer in a direction away from the at least one inlet of the mixer (Figs 1-9 see how the sleeve 20 comprises an outlet 20g that is spaced from the outlet 24b of the mixer along the longitudinal axis of the mixer in a direction away from the inlet 24a of the mixer; col 4, lines 43-63, “the discharge opening 20g of the air shroud”).
Claims 12 - 16, recites wherein the bioprinter is configured to print a fiber comprising a plurality of linear, angled or radial compartments…wherein the bioprinter is configured to print droplets comprising a plurality of spherical, spherical wedges, linear, angled or radial comparts…as claimed. However, claim 1 appears to recites system and including all the structures, and claim 12-16 pertains to process of using the system to produce specific product which is an intended use of the apparatus, unless otherwise applicant specifically claim the structures.
As for claim 18, Tudor et al. further teaches wherein the mixer and a nozzle are unitarily formed as a monolithic component (see Figs 1-9 item 14 and 24; see how the mixer 14 and outlet nozzle 24b are unitarily formed as a monolithic component; see col 3. Lines 26-38, which discloses “a conical nozzle tip portion 24b”).
Response to Arguments
Applicant's arguments filed 4/16/2026 have been fully considered but they are not persuasive.
Regarding 102(a)(1) rejection made for claim(s) 1-4, 7, 9-10, 12-16, and 18 as being anticipated by Tudor et al. (US 6,364,218 B1), the Applicant mainly argued that Tudor teaches nozzle assembly 12 includes a mix tube 14, an insert 16, a mixer shroud 18, a dispense tip 22 (as shown on Figs. 2, 4, 8, and 9). It is mainly argued that “The air shroud 20 interacts with the mixer shroud 18 to provide a plurality of circumferentially spaced axially extending flutes or grooves, as defined by the flutes 18 e. The flutes do not surround the mix tube 14 or the outlet of the mix tube but are circumferentially separated from each other. The claimed coaxial sleeve in contrast surrounds the outlet of the mixer. Since the flutes are discrete axially extending structures that are circumferentially separated from each other as seen in FIGS. 7 and 8, one of ordinary skill would not use them to produce a crosslinked sheath as alleged by the Examiner, especially a sheath that is required to surround the extrudate that emanates from the flow channel.”
Examiner’s response: Applicant’s response is considered, however, is not found persuasive. The Examiner now provided an annotated Fig. 8 (Tudor et al.) showing having a sleeve that defines a sheath channel that surrounds the outlet of the mixer, wherein the sleeve comprises an inlet that is capable of receiving a crosslinker. Applicant’s reference to element 18 and 18e which are flutes, is not found persuasive as examiner identified element 20 as part of the sleeve or exterior surface that includes inlet for introducing materials. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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NAHIDA SULTANA
Primary Examiner
Art Unit 1743
/NAHIDA SULTANA/Primary Examiner, Art Unit 1743
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