ASPECT BIOSYSTEMS LTD.Download PDFPatent Trials and Appeals BoardDec 10, 20202020005140 (P.T.A.B. Dec. 10, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/898,036 12/11/2015 Simon Travis BEYER ASPT-006/PCT/US 3501 160212 7590 12/10/2020 SQUIRE PB (SFR-IP) 275 BATTERY STREET, SUITE 2600 SAN FRANCISCO, CA 94111-3356 EXAMINER KIM, YUNJU ART UNIT PAPER NUMBER 1742 NOTIFICATION DATE DELIVERY MODE 12/10/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): IP-Squire@SquirePB.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte SIMON TRAVIS BEYER, KONRAD WALUS, TAMER MOHAMED, and ANAS AMJAD MOHAMMAD BSOUL Appeal 2020-005140 Application 14/898,036 Technology Center 1700 ____________ Before LINDA M. GAUDETTE, DONNA M. PRAISS, and JOHN A. EVANS, Administrative Patent Judges. PRAISS, Administrative Patent Judge. DECISION ON APPEAL1 Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 1–29, 31, and 37. An oral hearing was held on November 19, 2020. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 In this Decision, we refer to the Specification filed Dec. 11, 2015 (“Spec.”), the Final Office Action dated Aug. 1, 2019 (“Final Act.”), the Appeal Brief filed Jan. 31, 2020 (“Appeal Br.”), the Examiner’s Answer dated Apr. 30, 2020 (“Ans.”), the Reply Brief filed June 30, 2020 (“Reply Br.”), and the Declaration of Simon Beyer filed July 3, 2019 (“Beyer Decl.”). 2 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Aspect Biosystems Ltd. as the real party in interest. Appeal Br. 1. Appeal 2020-005140 Application 14/898,036 2 STATEMENT OF THE CASE The invention relates to a three-dimensional (3D) printing system for fabricating 3D cell-laden hydrogel structures as an alternative to two- dimensional (2D) surfaces, such as micro-well plates and Petri dishes, for performing cell culture studies. Spec. ¶¶ 2, 4. The Specification describes existing systems for fabricating cellular constructs using fused fiber deposition techniques as being difficult to control cell placement because cells are added to the scaffold after printing. Id. ¶ 5. The Specification also describes existing systems for direct printing of cellular materials using ink jet printing technology as slow processes and the shear force involved with propelling droplets of fluid onto a substrate as potentially damaging to cells dispersed in the fluid. Id. ¶ 6. According to the Specification, other prior art methods require multiple nozzles and/or cartridge orifices to print multiple different materials, which increases movement of the printing system and decreases printing speed and efficiency. Id. ¶ 8. Claim 1, reproduced below, is illustrative of the subject matter on appeal (disputed limitations italicized). 1. A system for additive manufacturing of three- dimensional structures, the system comprising: -at least one print head for receiving and dispensing materials, the materials comprising at least one first material and at least one second material, the print head comprising: -a single orifice for dispensing the materials; -microfluidic channels arranged within the print head comprising at least two first channels for receiving and directing the first material and one or more second channels for receiving and directing the second material, the second channel and each of the first channels joining together at a common Appeal 2020-005140 Application 14/898,036 3 first intersection point to form a dispensing channel which extends to the orifice, and -fluidic switches, each fluidic switch corresponding to one of the microfluidic channels in the print head and configured to allow or disallow fluid flow in the microfluidic channels of the print head when actuated; -a receiving surface for receiving a first layer of the materials dispensed from the orifice; -a positioning unit for positioning the orifice of the print head in three dimensional space, the positioning unit operably coupled to the print head; and -a dispensing means for dispensing the materials from the orifice of the print head. Appeal Br. 20 (Claims App.). ANALYSIS We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential), cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”). After considering the argued claims in light of the case law presented in this Appeal and each of Appellant’s arguments, we are persuaded of reversible error in the appealed rejections. The Examiner rejects claims 1–29, 31, and 37 as follows. Final Act. 4–22. Appeal 2020-005140 Application 14/898,036 4 Claim(s) Rejected 35 U.S.C. § References/Basis 1–7, 14–17, 19 103 Kang,3 Lee4 8–11, 20, 21, 27, 28, 31, 37 103 Kang, Lee, Hull 5 12, 22–25 103 Kang, Lee, Hull, Lechmann6 13, 26 103 Kang, Lee, Hull, Lechmann, Mark7 18 103 Kang, Lee, Bheda8 29 103 Kang, Lee, Hull, Lechmann, Bheda Each of the rejections is based on the same modification of Kang with Lee. Final Act. 4–22. Thus, the dispositive issue in this appeal is whether the Examiner’s modification (id. at 5–6) of Kang’s system with Lee’s microfluidic chip comprising a single orifice and a number of individually controllable inlets for Kang’s four separate syringes is supported by reasoning having rational underpinnings. Conclusory statements are insufficient to merit an obviousness rejection; “instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). 3 US 2012/0089238 A1, Apr. 12, 2012. 4 Edward Kang, Gi Seok Jeong, Yoon Young Choi, Kwang Ho Lee, Ali Khademhosseini, Sang-Hoon Lee, Digitally tunable physicochemical coding of material composition and topography in continuous microfibers, 10 Nature Materials 877 (Nov. 2011). 5 US 2008/0206383 A1, Aug. 28, 2008. 6 US 2011/0190904 A1, Aug. 4, 2011. 7 US 2014/0328963 A1, Nov. 6, 2014. 8 US 2014/0232035 A1, Aug. 21, 2014. Appeal 2020-005140 Application 14/898,036 5 Appellant argues modification of Kang would render Kang unsatisfactory for its intended purpose and change Kang’s principle of operation. Appeal Br. 10; Reply Br. 1. Appellant points out Kang individually prints structural support polymers separate from cellular materials so that the cellular composition can be cooled and the structural support polymer can be heated. Appeal Br. 10 (citing Kang ¶¶ 10, 27, 28, 30, 32–34, 38, 50, 99, 100); Reply Br. 2. Modification with Lee’s system, which simultaneously prints a crosslinker, a hydrogel, and optionally a biomaterial, Appellant contends, would require significant reengineering of the entire system and is not simply a substitution of Lee’s microfluidic chip for Kang’s multi-syringe system. Appeal Br. 10–11 (citing Beyer Decl. ¶¶ 6–7). Appellant additionally contends no practical way of combining Kang with Lee is provided in the record for switching between the “hot” and “cold” material without clogging the device or killing the cells in the cold material where it makes contact with the hot material. Id. at 11–12; Reply Br. 2. The Examiner’s response does not adequately address Appellant’s arguments regarding the modification of Kang’s system for separately delivering cellular and polymer support materials with Lee’s delivery system. The Examiner does not dispute that Kang’s technique iteratively prints different materials with separate dispensers due to the toxic nature and temperature requirements of the extruded support polymers. Ans. 3. Instead, the Examiner finds Lee controls valve operations for serial, parallel, or mixed materials. Id. In the case of serial operation, the Examiner finds Lee teaches independently controlling each inlet channel and serial coding the material extruded from the microfluidic chip so that it is not mixed with another material. Id. (citing Lee 1:22–27, Figs. 2a, 2b). The Examiner’s Appeal 2020-005140 Application 14/898,036 6 response does not adequately explain why a skilled artisan would modify Kang’s process with Lee’s teachings regarding serial operation and a single orifice in view of Kang’s teaching to separately control the temperature of materials in the cartridges or syringes. Kang ¶¶ 99, 100. In rejecting claims under 35 U.S.C. § 103, it is incumbent upon the Examiner to establish a factual basis to support the legal conclusion of obviousness. See In re Fine, 837 F.2d 1071, 1073 (Fed. Cir. 1988). In so doing, the Examiner must make the factual determinations set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966) (noting that 35 U.S.C. § 103 leads to three basic factual inquiries: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; and (3) the level of ordinary skill in the art). Furthermore, the Examiner’s obviousness rejection must be based on “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness” . . . . [H]owever, the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ. KSR Int’l. Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). If the Examiner’s burden is met, the burden then shifts to the Appellant to overcome the prima facie case with argument and/or evidence. Obviousness is then determined on the basis of the evidence as a whole and the relative persuasiveness of the arguments. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). It is not sufficient for the Examiner to point to where the various claim limitations may be disclosed in the prior art references. An invention “composed of several elements is not proved Appeal 2020-005140 Application 14/898,036 7 obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Therefore, in view of the absence of a rationale for modifying Kang’s system to accommodate a single orifice, we are persuaded by Appellant’s argument that modification of Kang with Lee’s teachings is not adequately supported with reasoning and would render Kang unsuitable for its intended purpose. Accordingly, we reverse the Examiner’s rejections of claims 1–29, 31, and 37 under 35 U.S.C. § 103 over the combination of Kang and Lee alone and together with the cited secondary references. CONCLUSION For these reasons and those the Appellant provides, we reverse the Examiner’s rejections of claims 1–29, 31, and 37 under 35 U.S.C. § 103. Appeal 2020-005140 Application 14/898,036 8 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1–7, 14–17, 19 103 Kang, Lee 1–7, 14–17, 19 8–11, 20, 21, 27, 28, 31, 37 103 Kang, Lee, Hull 8–11, 20, 21, 27, 28, 31, 37 12, 22–25 103 Kang, Lee, Hull, Lechmann 12, 22–25 13, 26 103 Kang, Lee, Hull, Lechmann, Mark 13, 26 18 103 Kang, Lee, Bheda 18 29 103 Kang, Lee, Hull, Lechmann, Bheda 29 Overall Outcome 1–29, 31, 37 REVERSED Copy with citationCopy as parenthetical citation