Ension, Inc. et al.

Patent Trials and Appeals Board

Jan 7, 2022

2021001078 (P.T.A.B. Jan. 7, 2022)

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. 16/220,566 12/14/2018 Mark Gartner Ension-1601/MIT 20910J 6522 36787 7590 01/07/2022 BLYNN L. SHIDELER THE BLK LAW GROUP 3000 Village Run Road Suite 103-251 WEXFORD, PA 15090 EXAMINER PEO, JONATHAN M ART UNIT PAPER NUMBER 1779 NOTIFICATION DATE DELIVERY MODE 01/07/2022 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): blynn@BLKLawGroup.com cbelleci@BLKLawGroup.com patents@BLKLawGroup.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARK GARTNER, MINKYUN NOH, and DAVID L. TRUMPER Appeal 2021-001078 Application 16/220,566 Technology Center 1700 Before MICHAEL P. COLAIANNI, DEBRA L. DENNETT, and SHELDON M. MCGEE, Administrative Patent Judges. MCGEE, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-20. We have jurisdiction. 35 U.S.C. § 6(b). We reverse. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real parties in interest as Massachusetts Institute of Technology and Ension Inc. Appeal Br. 2. Appeal 2021-001078 Application 16/220,566 2 CLAIMED SUBJECT MATTER The claims are directed to extracorporeal life support systems and integrated blood pump oxygenator systems. Claims 1, 11, 17; Spec. ¶ 3. The systems includes a heparin treated oxygenator surface and a magnetic levitation motor. Spec. ¶ 18. Claim 1 is illustrative of the claimed subject matter and is reproduced below with the key limitations on appeal italicized: 1. An extracorporeal life support system comprising: a central housing member defining a blood inlet and a central blood flow path extending along a general longitudinal axis of the system; a center pump housing member coupled to the central housing member and defining a pump inlet in fluid communication with the central blood flow path; an impeller rotationally received within the area of the pump inlet formed by the central pump housing member, wherein the impeller is magnetically supported and magnetically driven; an array of hollow fiber membranes configured for gas transfer within the system for oxygenation of blood flowing radially outwardly across the array of the hollow fiber membranes, wherein each of the hollow fiber membranes of the array of the hollow fiber membranes includes a covalently-bonded heparin-based bioactive surface, and wherein the central blood flow path extends from the impeller to a position to flow perpendicular radially outwardly over the array of the hollow fiber membranes; and a blood outlet configured to receive the blood flowing radially outwardly past the array of the hollow fiber membranes. Appeal 2021-001078 Application 16/220,566 3 REJECTIONS I. Claims 1-10 under 35 U.S.C. § 112(b) as indefinite; II. Claims 1 and 11 under 35 U.S.C. § 103 as unpatentable over Gartner2 in view of Garimella3; III. Claims 7, 8, 13, and 14 under 35 U.S.C. § 103 as unpatentable over Gartner in view of Garimella, and further in view of Gellman4; IV. Claims 2 and 12 under 35 U.S.C. § 103 as unpatentable over Gartner in view of Garimella, and further in view of Isaacson5; V. Claims 3, 4, and 17 under 35 U.S.C. § 103 as unpatentable over Gartner in view of Garimella, Isaacson, and further in view of Gellman; VI. Claims 9, 10, 15, and 16 under 35 U.S.C. § 103 as unpatentable over Gartner in view of Garimella, and further in view of Tanaka6; and VII. Claims 5, 6, and 18-20 under 35 U.S.C. § 103 as unpatentable over Gartner in view of Garimella, Isaacson, Gellman, and further in view of Tanaka. Final Act. 6-25. 2 US 2013/0343954 A1, published Dec. 26, 2013. 3 US 2015/0352265 A1, published Dec. 10, 2015. 4 US 2008/0199357 A1, published Aug. 21, 2008. 5 US 5,205,721, issued Apr. 27, 1993. 6 JPH 04235724 A, published Aug. 24, 1992. We rely on the uncontested English-language machine translation. Appeal 2021-001078 Application 16/220,566 4 OPINION Rejection I The Examiner rejects claims 1-10 as indefinite for reciting “extracorporeal life support system” in the preamble. Final Act. 7. According to the Examiner, this recitation is indefinite because it omits essential structural cooperative relationships between elements of claim 1, namely the “support” of “extracorporeal life” by the claimed system’s “oxygenation of blood.” Id.; see also Ans. 23 (maintaining the rejection because “an object that has or receives life is missing.”). We reverse this rejection. “Generally, the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). “[T]he definiteness of the language employed must be analyzed-not in a vacuum, but always in light of the teachings of the prior art and of the particular application disclosure as it would be interpreted by one possessing the ordinary level of skill in the pertinent art.” In re Moore, 439 F.2d 1232, 1235 (CCPA 1971). Here, as explained by the Specification (Spec. ¶¶ 3-16) and Appellant (Appeal Br. 11-12; Reply Br. 3), the preamble uses terms well understood in this art. Based on this disclosure and because a preamble is not generally construed as a limitation, we find that the skilled artisan would be reasonably apprised of the scope of claims 1-10. Rejections II-VII under § 103 In support of each rejection under 35 U.S.C. § 103 before us (Final Act. 8-25; Ans. 23-30), the Examiner finds that Gartner discloses that “the impeller is magnetically supported and magnetically driven.” Final Act. 9. Appeal 2021-001078 Application 16/220,566 5 Appellant contends that Gartner fails to describe the claimed “magnetically supported structure” because Gartner’s impeller is supported mechanically without the use of magnets. Appeal Br. 14. Appellant argues that Gartner explicitly discloses that the known “impeller 24 is rotationally mounted to a stationary shaft 44 coupled to [impeller] housing 28 . . . . The mounting structure includes conventional bearings 46 between the shaft 44 and the impeller 24 [and] . . . further includes an annular hydrogel impeller packing material 48 adjacent the bearings 46 and around the shaft 44.” Id. (citing Gartner ¶ 29; Fig. 3) (emphases omitted.). Appellant contrasts Gartner’s non-magnetically supported impeller with the presently claimed impeller. Appeal Br. 13. Appellant argues that the Specification describes “magnetic levitation for the impeller 14 . . . of the Extracorporeal Life Support (ECLS),” which “enables contact-free impeller 14 rotation against the pump housing.” Id. (citing Figs. 1, 3) (emphasis omitted). In response, the Examiner argues that claim 1 fails to recite “that the ‘impeller’ must be ‘magnetically levitated’ or that it has ‘contact-free’ rotation.” Ans. 23. The Examiner determines that the meaning of the limitation “magnetically supported and magnetically driven” is broader than Appellant’s allegedly narrow construction. Id. The Examiner finds Gartner’s Figures 6 and 7 show that impeller 28 is magnetically supported because impeller “housing 28 of the impeller 24 is placed directly on top of magnetic drive 52,” which “explicitly drives this impeller 24.” Id. at 24 (citing Gartner Figs. 6, 7; ¶ 32) (emphasis added). Appellant’s argument is persuasive of reversible error. “[D]uring examination proceedings, claims are given their broadest reasonable Appeal 2021-001078 Application 16/220,566 6 interpretation consistent with the specification.” In re Translogic Tech., Inc., 504 F.3d 1249, 1256 (Fed. Cir. 2007) (quoting In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)); see also In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (The scope of the claims in patent applications is not determined solely on the basis of the claim language, but is based on giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art.). In this case, while the Examiner is correct that Gartner’s impeller 24 is placed directly on top of magnetic drive 52 to drive additional “magnets 52 [] placed at the bottom of impeller 24” (Ans. 24 (citing Gartner Fig. 2)), the Specification is instructive as to the broadest reasonable scope of the claim term “magnetically supported.” For example, the Specification indicates and illustrates that “the impeller is magnetically supported and magnetically driven by a hysteresis motor.” Spec. ¶ 30; Figs. 1, 3, 4. The Specification further indicates that the ECLS “utilizes a magnetic levitation/drive system for . . . blood pump applications based on a hysteresis motor concept.” Id. ¶ 49; Title (“Extracorporeal Life Support System with . . . Magnetic Levitation Motor.”). The Examiner does not point us to any disclosure within the Specification that reasonably supports a broader interpretation so as to include a mechanically supported impeller, which is placed on top of a magnetic drive, such as Gartner’s. Gartner ¶ 32; Figs. 2, 3, 6, 7 (see also id. at ¶¶ 12, 13; claims 1, 15 (disclosing that the non-magnetic “impeller housing [is] supporting the impeller.”) Appeal 2021-001078 Application 16/220,566 7 Thus, we determine that the broadest reasonable construction for the claimed “magnetically supported and magnetically driven” impeller in light of the Specification does not encompass Gartner’s impeller 24 placed on magnetic drive 52 as set forth by the Examiner. Final Act. 9. In sum, because the Examiner has failed to show that Gartner’s mechanically supported impeller 24 satisfies the claimed “magnetically supported and magnetically driven” impeller and because each of the rejections under § 103 are based on this erroneous finding, we do not sustain the Examiner’s rejections of claims 1-20 under 35 U.S.C. § 103. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s) / Basis Affirmed Reversed 1-10 112(b) Indefiniteness 1-10 1, 11 103 Gartner, Garimella 1, 11 7, 8, 13, 14 103 Gartner, Garimella, Gellman 7, 8, 13, 14 2, 12 103 Gartner, Garimella, Isaacson 2, 12 3, 4, 17 103 Gartner, Garimella, Isaacson, Gellman 3, 4, 17 9, 10, 15, 16 103 Gartner, Garimella, Tanaka 9, 10, 15, 16 5, 6, 18-20 103 Gartner, Garimella, Isaacson, Gellman, Tanaka 5, 6, 18-20 Overall Outcome 1-20 REVERSED