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 .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Claim 1 includes the limitation “wherein the cassette defines a sterilizable sealed enclosure forming a jacket of the printing module”. While the instant specification does not appear to contain drawings that differentiate the cassette from sealed enclosures of Fig. 1-12. Thus, the term “cassette” is given the broadest reasonable interpretation to include any sealed enclosure.
Claim Rejections - 35 USC § 102
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) 1-5, 7, 8, 10-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maggiore (US 2017/0335271 A1).
Regarding claim 1, Maggiore teaches a cassette for a bioprinting system for producing biological tissue, (supply both a structural material and a biological material for additive manufacturing [0023]) the cassette comprising: a printing module (a dispensing device 806, Fig. 10) containing at least one printhead for printing transferable objects of biological interest to a target for producing a biological tissue; a leaktight interaction zone (transfer hatch 810 may be utilized to remove objects aseptically from the sterilized chamber 802 and/or to connect to additional sterilized chambers, Fig. 10, [0154]) for interacting with an activation device for controlling the physical transfer of an object of biological interest present in the printhead to the target; (Maggiore teaches data cable 864 may provide data, power, and/or fluid communication to the internal dispensing device 856, Fig. 11, [0159], and hydraulic and/or pneumatic pistons arranged in a piston assembly 882 may be filled with fluid [0158]). wherein the cassette defines a sterilizable sealed enclosure forming a jacket of the printing module, (Examiner notes that chamber 802 of Maggiore meets the claimed cassette because the claim recites “forming a jacket of a the printing module”) the printing module is located within the sterilizable sealed enclosure, and the cassette does not contain an activation device for controlling the physical transfer of an object of biological interest present in the printhead to the target (automated control assembly 880 is outside the chamber 802, Fig. 11.
Regarding claim 2, Maggiore meets the claimed cassette of claim 1, wherein the cassette has at least one communicating identification device capable of transmitting information relating to the printhead and/or to the target to the activation device. (contain a wireless communication device 890 to import robotic arm assembly control protocol, Fig. 11, [0160]).
Regarding claim 3, Maggiore meets the claimed cassette of claim 1, further comprising a displacement device configured to cause relative displacement of the printhead with respect to the target. (corresponding pistons 812 on the robotic arm assembly 804, Fig. 10).
Regarding claim 4, Maggiore meets the claimed a bioprinting method for the manufacture of a structured biological material from materials comprised at least in part of biological particles, (Maggiore teaches dispensing biological materials may include materials comprising a biological system, such as cells, cell components, cell products, [0025]) the method including controlling a movement of at least one target via a robot in three dimensions, (automated control assembly 880 controls robotic arm assembly 854, Fig. 11, Fig. 11) the target (multi-well plates 808, Fig. 10) facing at least one printhead placed in a sealed and sterile enclosure, (transfer hatch 810 may be utilized to remove objects aseptically from the sterilized chamber 802 and/or to connect to additional sterilized chambers, Fig. 10, [0154]) the printhead being supplied with the material and controlled from outside the enclosure. (data cable 864 may provide data, power, and/or fluid communication to the internal dispensing device 856, Fig. 11, [0159])
Regarding claim 5, Maggiore meets the claimed bioprinting method of claim 4, further comprising maturing the printed biological material within a maturation area located inside the sterilizable sealed enclosure. (Maggiore teaches the dispensing device is configured for maintaining or promoting cell growth and optimizing the conditions for such growth [0038]. Thus, Maggiore indirectly teaches a step of “maturing” a printed target when provided with one. The conditions for “maturing” a printed target are not described in the claim and the broadest reasonable interpretation would include any sterile chamber, given that many biological species grow at standard room temperature and atmosphere.)
Regarding claim 7, Maggiore meets the claimed bioprinting method of claim 4, further comprising regulating one or more of pH, temperature, (An operator may control the temperature of the heating element 24 and the dispensing of the structural material 16 through a computer control board 26 that may contain a processing device 28, [0044]) dissolved O2, hygrometry, culture medium exchange, stirring, and infusion within the sterilizable sealed enclosure via a leaktight interaction zone.
Regarding claim 8, Maggiore meets the claimed method of claim 4, wherein the printhead is controlled from outside the enclosure via an activation device mechanically, electrically, (data cable 864 may provide data, power, and/or fluid communication to the internal dispensing device 856, Fig. 11, [0159]) acoustically, or optically coupled with the printhead.
Regarding claim 10, Maggiore meets the claimed cassette of claim 1, wherein the cassette further comprises a removable substrate module ( plurality of printing trays or containers such as multi-well plates 808, [0146], Fig. 10) within the sterilizable sealed enclosure.
Regarding claim 11, Maggiore meets the claimed cassette of claim 1, wherein the cassette further comprises a feed source located within the sterilizable sealed enclosure. (Maggiore teaches the dispensing device 808 to be inside the sterilized chamber 802, Fig. 10, where the dispensing device that can supply both a structural material and a biological material for additive manufacturing, [0023]).
Regarding claim 12, Maggiore meets the claimed cassette of claim 1, wherein the cassette further comprises a leaktight interaction zone configured to allow for interaction with a feed source located outside the sterilizable sealed enclosure. (transfer hatch 810 may be utilized to remove objects aseptically from the sterilized chamber 802 and/or to connect to additional sterilized chambers, Fig. 10, [0154]).
Regarding claim 13, Maggiore meets the claimed cassette of claim 1, wherein the cassette further comprises a leaktight interaction zone (transfer hatch 810 may be utilized to remove objects aseptically from the sterilized chamber 802 and/or to connect to additional sterilized chambers, Fig. 10, [0154]) for interacting with devices configured to control and regulate one or more of pH, temperature, dissolved 02, hygrometry, culture medium exchange, stirring, and infusion. (An operator may control the temperature of the heating element 24 and the dispensing of the structural material 16 through a computer control board 26 that may contain a processing device 28, [0044]).
Regarding claim 15, Maggiore meets the claimed cassette of claim 1, wherein the cassette is coupled to one or more tissue characterization devices. (Maggiore teaches the dispensing device is configured for maintaining or promoting cell growth and optimizing the conditions for such growth [0038]. Maggiore teaches the sensors utilized for positioning may also be utilized to scan the workspace, the printing tray, and/or the three dimensional object prior to, during, and/or after printing. These scans may be utilized to determine the structure or microstructures of the printed materials [0045]).
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maggiore (US 2017/0335271 A1) in view of Langenfield (US 2017/0369827 A1).
Regarding claim 14, Maggiore does not meet the claimed cassette of claim 1, wherein the cassette further comprises a network interface card.
Maggiore teaches internal data cable 816 may transmit sensor data and related information, [0151].
Langenfield teaches wherein the cassette further comprises a network interface card. Langenfield teaches a printing system for printing tissue into a tissue enclosure, a multi-dimensional printer, a delivery device operably coupled to the multi-dimensional printer, a motion controller commanding the delivery device to print the tissue, [0011]. Langenfield teaches the connection between printer 100 and processor 55 can be established using Ethernet or serial technology, see [0303]. Examiner notes that the instant specification discloses Ethernet port to be an example of a network interface, see [0122].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to combine the Ethernet port of Langenfield with the printer inside of a sterilized printing chamber of Maggiore because it improves control of the print progress and returning deposition device to a home position when the ending the process, see Langenfield, [0303].
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maggiore (US 2017/0335271 A1) in view of Maggiore ‘793 (US 2016/0068793 A1).
Regarding claim 16, Maggiore does not explicitly teach the claimed cassette of claim 1, wherein the jacket of the printing module comprises a rigid material.
Maggiore ‘793 teaches a printer assembly 3, is sterilizable and disposable, i.e. intended for single use. The printer housing 5 can be formed of rigid walls or flexible walls 7 held open by a rigid internal and/or external skeleton, [0128].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to combine the sterilizable and disposable printer assembly with rigid walls of Maggiore ‘793 with the printer assembly of Maggiore because it is capable to form, cut, print, or coat a material under sterile conditions in a reliable and easy manner, see Maggiore ‘793.
Regarding claim 17, Maggiore does not teach the claimed cassette of claim 1, wherein the jacket of the printing module comprises a flexible material.
Maggiore ‘793 teaches a printer assembly 3, is sterilizable and disposable, i.e. intended for single use. The printer housing 5 can be formed of rigid walls or flexible walls 7 held open by a rigid internal and/or external skeleton, [0128].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to combine the sterilizable and disposable printer assembly with flexible walls of Maggiore ‘793 with the printer assembly of Maggiore because it is capable to form, cut, print, or coat a material under sterile conditions in a reliable and easy manner, see Maggiore ‘793.
Allowable Subject Matter
Claims 6 and 9 are 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:
Regarding claim 6, although magnetic fasteners are known in the art ([0033] Maggiore) it is not taught or suggested wherein controlling the movement of at least one target via a robot in three dimensions comprises using a magnetic target support within the sterilizable sealed enclosure interacting with stator coils outside the sterilizable sealed enclosure.
Regarding claim 9, although magnetic fasteners are known in the art ([0033] Maggiore) it is not taught or suggested wherein the cassette further comprises a magnetic target support within the sterilizable sealed enclosure configured to interact with stator coils outside the sterilizable sealed enclosure.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thurner et al. (US 2010/0206224 A1). Thurner teaches device 12 to control [0042] temperature [0045] gaseous composition. The walls forming the central housing 12 sufficiently sealed to ensure its cleanliness, [0027], Fig. 1.
Maggiore ‘152 (US 2016/0297152 A1) teaches the printer assembly housing is sealed with respect to the container for accommodating at least one biologically active fluid [0046], controlled gases or other fluids from the sterilizable mixing container 450, [0100].
Conclusion
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.
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, Sam Zhao can be reached at (571)270-5343. 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.
/MICHAEL M. ROBINSON/Primary Examiner, Art Unit 1744