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 § 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 12-16 and 18 are 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 12 recites “the bioprinter” in line 1. There is insufficient antecedent basis for this claim limitation. Furthermore, claim as written is vague and indefinite as it is unclear whether for each instance of “the bioprinter” whether the applicant is referring to “the system” or anything other than the system. For the purpose of examination, the Examiner considers that applicant is referring to the “the system”. Similarly claims 13-16 recites the term “the bioprinter” and also requires similar correction as mentioned above.
Claim 18 recites “the mixer and nozzle” in line 1. There is insufficient antecedent basis for the claim term “the nozzle” and it is unclear whether mixer as recited above also includes a nozzle. Applicant is urged to clarify this in the next action.
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, 7-10, 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);
PNG
media_image1.png
987
737
media_image1.png
Greyscale
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).
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 8, 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).
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”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2023/0302724 A1 pertains to additive manufacturing and mixing downstream materials, US 2021/0213676 A1 – additive manufacturing system with mixing ingredient – and additionally see US 7,484,881 B2; US 6,840,281 B1; US 5,609,271; US 5,498,078; US 5,092,492; US 2022/0410094 A1; US 2017/0120513 A1; US 2014/0196807 A1; US 2005/0062185 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAHIDA SULTANA whose telephone number is (571)270-1925. The examiner can normally be reached Mon-Friday (8:30 AM -5:00 PM).
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, Galen Hauth can be reached at 571-270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
NAHIDA SULTANA
Primary Examiner
Art Unit 1743
/NAHIDA SULTANA/Primary Examiner, Art Unit 1743