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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 8-10, 14, and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US 2012/0089238 A1, hereinafter Kang) in view of Xie et al. (US 2008/0111282 A1, hereinafter Xie), Williams (US 2015/0343673 A1, hereinafter Williams), and Edwards et al. (US 2004/0231594 A1, hereinafter Edwards).
Regarding Claims 8-10 and 20-25, Kang teaches in Figure 2 a bioprinter with pressure controller 25 controlling hollow body non-contact dispensing syringes 11 dispensing fluid from the bodies to exit orifices (where the bodies narrow) to nozzle inlets that are located below the exit orifices and fluidly communicate with the respective exit orifices (nozzles that, although not explicitly identified as being integral or separate, would be obvious to choose from the finite and limited predictable choices of either integral or separate from the syringe, the nozzles having the claimed inner diameter of 100 microns to 3 millimeters as claimed per [0022]), the nozzles having a wall defining a fluid path extending from the respective inlets of the nozzle to an outlet of the nozzle, and bioink being supplied by a controllable valve (per [0082], and with no valve indicated between the exit orifice of the syringe and the rest of the syringe body.
However, while Kang teaches in [0021] that the syringes are activated by things such as pneumatic, hydraulic, or mechanical pressure via pressure controller 25, Kang does not explicitly teach that the syringes include an actuator in contact with a proximal end of a plunger dimensioned to translate in the hollow body of the syringe.
In analogous art pertaining to 3D printing, Xie teaches in Figure 4 and [0045] that such an actuator-based system is known in the syringe art with actuators 75-77 contacting respective proximal ends of plungers contained in syringes 72-74 and with no valve between the exit orifice of the respective bodies of the syringes and distal ends of the plungers, and thus it would have been obvious to substitute Xie’s dispensing mechanism for Kang as necessary to achieve the predictable result of dispensed material, in a bioprinter wherein respective syringes do not include a valve between the respective exit orifices of the bodies of the syringes and respective distal ends of plungers, with pressure controller 25 executing a program stored in the controller to drive the actuators toward the proximal ends of the plungers to dispense bioink from the bodies of the syringes.
However, the previous combination does not explicitly teach a fluid passageway as claimed supplying pulsed fluid to separate droplets and force the droplets of dispensed material to exit the nozzle outlets by blowing the droplets away from the nozzle using pulsed fluid from the source of fluid.
In analogous art pertaining to 3D printing, Williams teaches in [0039] that a known method of droplet delivery includes an air impingement step within the nozzle to separate droplets between desired and undesired droplets by delivering pulses of air to divert the undesired droplets, and wherein the residual force of air thus forces the desired droplets to exit the outlet of the nozzle so that the desired droplets can be said to be blown away from the nozzle using pulsed fluid from the source of fluid (thus defining a nozzle including a fluid passageway in fluid communication with a source of fluid and the fluid path).
Therefore, it would have been obvious to use controlled pulsed droplet delivery per Williams as a simple substitute for droplet delivery of the previous combination to yield the predictable result of delivering droplets through the nozzle.
However, while it is strongly implied in the previous combination that the process operates by moving the dispensing unit from one selected location on a plate to the next to deposit droplets via plunger actuation, the previous combination does not explicitly teach such a step.
In analogous art pertaining to 3D printing, Edwards teaches in Clam 38 that is known that when printing microstructures via droplet deposition, the microstructure can be achieved by moving the deposition head relative to the substrate to deposit droplets at different predetermined selected locations on the substrate, and thus it would have been obvious to a person having ordinary skill in the art prior to the invention’s filing to carry out the previous combination’s plunger actuations with blown droplets by moving the dispensing unit from one selected location to another to achieve the predictable result of printing a microstructure.
Specifically regarding Claims 10 and 25, Kang’s bioprinter also includes a temperature controller 27 surrounding the bodies of the syringes, all mounted on a 3-axis XYZ motion system controlled by controller 34.
Regarding Claim 14, while Kang and Xie are silent on droplet volume and Williams teaches picoliter volumes for its application, a person having ordinary skill in the art prior to the invention’s filing would know to adjust to appropriate volumes for bioprinting applications such as Kang and Xie, and in deciding how to apply the pulses from Williams to the previous combination, would have found it obvious to use volumes between 10 nanoliters and 15 microliters by adjusting the pulse interval (since interval is understood to be a property of pulses) to find a workable range of droplet volumes (there is a clear direct relationship between the pulse interval that breaks bioink into droplets and the volume of the droplets), since finding workable ranges has been held to be within ordinary skill in the art.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kang, Xie, Williams, and Edwards as applied to Claim 8 above, and in view of Forgacs et al. (US 2012/0288938 A1, hereinafter Forgacs).
Regarding Claims 11-12, while the above combination is silent on a temperature-controlled plate having humidity control adjacent, Forgacs teaches uses a temperature-controlled plate in [0078] and Kang generally suggests humidity control in [0080], at least motivating adding Forgacs for enchanced temperature control while locating the humidity control adjacent the plate to further achieve that purpose.
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kang, Xie, Williams, and Edwards as applied to Claim 8 above, and in view of Gaylo et al. (US 2004/0005182 A1, hereinafter Gaylo).
Regarding Claims 15-19, while the above combination is silent on adding a control mechanism to control a valve for supplying the fluid, in analogous art pertaining to 3D printing Gaylo in [0159]-[0165] teaches that via a controller that implicitly delivers a peak-and-hold signal and pulse signal, a separately-valved pulsed delivery system is known to achieve pulse control down to microsecond range, and thus it would have been obvious to introduce such a valve and controller to the combination above to achieve the predictable result of the source of fluid comprising a controllable valve for supplying millisecond pulsed fluid/air, since such a substitution would be a simple substitution of a generic pulsed fluid/air mechanism for a more precise version.
Terminal Disclaimer
The terminal disclaimer filed on April 23, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,400,183 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to the pending claim have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN M OCHYLSKI whose telephone number is (571)270-7009. The examiner can normally be reached Monday-Friday 9-6.
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/RYAN M OCHYLSKI/Primary Examiner, Art Unit 1743