B. Braun Medical Inc.

Patent Trials and Appeals Board

Jan 7, 2022

2020004372 (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. 14/693,867 04/23/2015 Benjamin R. Lane 5031-0016CMPDR 1092 39083 7590 01/07/2022 KENEALY VAIDYA LLP 3050 K Street, N.W. Suite 302 Washington, DC 20007 EXAMINER STCLAIR, ANDREW D ART UNIT PAPER NUMBER 3799 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): avaidya@kviplaw.com uspto@kviplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BENJAMIN R. LANE, MARIANO MUMPOWER, JAKE A. COWPERTHWAITE, JAMIE KENDALL, JEREMY C. SAVAGE, CHET B. LARROW, ALEX K. FLAMM, DAVE E. HERSHEY, AARON S. PEARL, MICHAEL Y. BROWN, KARL KONRAD JR., JOEL BARTHOLOMEW, MIKE JANDERS, and EDWIN BURNARD ____________ Appeal 2020-004372 Application 14/693,867 Technology Center 3700 ____________ Before BENJAMIN D. M. WOOD, BRANDON J. WARNER, and LEE L. STEPINA, Administrative Patent Judges. WARNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-23 and 25-29. Claim 24 is canceled, claims 30-34 are withdrawn, and claim 35 is indicated as allowable but for its dependency from a rejected base claim. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). An oral hearing was held January 14, 2021. We REVERSE. 1 We use the word “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as B. Braun Medical Inc. Appeal Br. 4. Appeal 2020-004372 Application 14/693,867 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention relates to a device for preparing mixtures of fluids, such as a plurality of medical, nutritional, and/or pharmaceutical ingredients to be mixed or compounded together for delivery to a patient. See, e.g., Spec. ¶¶ 1-2. Claims 1, 8, and 16 are independent. Claim 1, reproduced below with emphasis added, is illustrative of the subject matter on appeal. 1. A compounding device for transferring materials from at least two distinct material sources to a final container, comprising: a housing, the housing defining a valve surface and a pump surface; at least one rotatable micro valve actuation device adjacent the valve surface; at least one rotatable macro valve actuation device adjacent the valve surface; a micro pump located adjacent the pump surface on the housing; and a macro pump located adjacent the pump surface on the housing, wherein the rotatable micro valve actuation device operates to rotate in one of a clockwise direction, a counterclockwise direction, and a combination of clockwise direction and counterclockwise direction, and in coordination with the micro pump to convey material from at least one of the material sources to the final container, and the rotatable macro valve actuation device operates to rotate in one of a clockwise direction, a counterclockwise direction, and a combination of clockwise direction and counterclockwise direction, and in coordination with the macro pump to convey materials from at least another one of the material sources to the final container. Appeal 2020-004372 Application 14/693,867 3 EVIDENCE The Examiner relies on the following evidence in rejecting the claims on appeal: Isreeli US 3,582,234 June 1, 1971 Young US 4,553,963 Nov. 19, 1985 Iwatschenko US 4,625,494 Dec. 2, 1986 Bernstein ’755 US 4,682,755 July 28, 1987 Campau US 5,197,708 Mar. 30, 1993 Bryant US 5,634,896 June 3, 1997 Vilks US 6,077,055 June 20, 2000 Martucci US 6,202,711 B1 Mar. 20, 2001 Bernstein ’556 US 7,322,556 B2 Jan. 29, 2008 Beiriger US 2011/0004143 A1 Jan. 6, 2011 REJECTIONS The following rejections are before us for review: I. Claim 1 stands rejected under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Young. Final Act. 8-9. II. Claims 1 and 8 stand rejected under 35 U.S.C. § 103 as being unpatentable over Beiriger in view of Campau or Bernstein ’556 or Bernstein ’755. Id. at 9-11. III. Claims 1-4 and 6-15 stand rejected under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and further in view of Campau. Id. at 11-16. IV. Claim 5 stands rejected under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and Campau and further in view of Vilks. Id. at 17. Appeal 2020-004372 Application 14/693,867 4 V. Claims 16-19, 21-23, and 25-29 stand rejected under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and further in view of Bryant and Isreeli. Id. at 17-23. VI. Claim 20 stands rejected under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko in view of Bryant and Isreeli and further in view of Vilks. Id. at 23. ANALYSIS In all the obviousness rejections on appeal, the Examiner starts with the device of either Martucci or Beiriger, but acknowledges that neither reference includes the valve actuation devices in the configuration recited, specifically where each valve actuation device operates “in coordination with” its respective pump, as emphasized above. To account for this shortcoming, the Examiner turns to various references for disclosing known rotary clamping valves, stating that it would have been obvious to modify the base device with such valves “for the purpose of providing a secondary control for optimizing the flow rate through the tube,” and noting that combining such known elements would simply provide for the valves to operate together in the same way as they would separately. Final Act. 9; see id. at 9-10, 12-13. But this reasoning disregards the fact that both Martucci and Beiriger already control the flow of source material and would not seem to do so any differently with the addition of rotary clamping valves. In short, therefore, we agree with Appellant that the rejections do not sufficiently explain why a person of ordinary skill in the art would have combined these disparate teachings. See Appeal Br. 14-16, 22-24, 28-31. Appeal 2020-004372 Application 14/693,867 5 In other words, we agree with Appellant that the Examiner has not sufficiently articulated reasoning based on rational underpinnings as to why one skilled in the art would have been prompted to combine the teachings of Martucci with Young or Iwatschenko (along with the other cited references), or Beiriger with Campau, Bernstein ’556, or Bernstein ’755 in the manner proposed. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (stating that “[r]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness” (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006))). Here, in response to Appellant’s arguments, the Examiner reiterates the individual findings relied upon, noting that a skilled artisan would understand the operation of conventional clamping valves, but does not further explain an objective reason why the combinations of teachings relied upon would have been made. See Ans. 3-12. Rejections based on obviousness must rest on a factual basis; in making such a rejection, the Examiner has the initial burden of supplying the requisite factual basis and may not, because of doubts that the invention is patentable, resort to speculation, unfounded assumptions, or hindsight reconstruction to supply deficiencies in the factual basis. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). In this case, absent improper hindsight reconstruction, we do not see a sufficient reasoned explanation based on a rational underpinning as to why one of ordinary skill in the art would have been led to modify either Martucci or Beiriger with additional valves, let alone valves that would work “in coordination with” metering pumps, and a reason for such modification is not otherwise evident from the record. Appeal 2020-004372 Application 14/693,867 6 Although we appreciate that the individual findings relied upon from the cited art appear to be supported by a preponderance of the evidence, we note that a claim “composed of several [features] is not proved obvious merely by demonstrating that each [feature] was, independently, known in the prior art.” KSR Int’l Co., 550 U.S. at 418. Rather, a sustainable obviousness rejection further needs to explain the reasoning by which those findings support the Examiner’s conclusion of obviousness. Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-30 (Fed. Cir. 2009). In this case, the rejections fail to meet this required standard. Accordingly, based on the record before us, the Examiner has not met the burden of establishing a proper case of obviousness. On this basis, we do not sustain the obviousness rejections. DECISION We REVERSE the Examiner’s decision rejecting claim 1 under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Young. We REVERSE the Examiner’s decision rejecting claims 1 and 8 under 35 U.S.C. § 103 as being unpatentable over Beiriger in view of Campau or Bernstein ’556 or Bernstein ’755. We REVERSE the Examiner’s decision rejecting claims 1-4 and 6-15 under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and further in view of Campau. We REVERSE the Examiner’s decision rejecting claim 5 under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and Campau and further in view of Vilks. Appeal 2020-004372 Application 14/693,867 7 We REVERSE the Examiner’s decision rejecting claims 16-19, 21-23, and 25-29 under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko and further in view of Bryant and Isreeli. We REVERSE the Examiner’s decision rejecting claim 20 under 35 U.S.C. § 103 as being unpatentable over Martucci in view of Iwatschenko in view of Bryant and Isreeli and further in view of Vilks. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1 103 Martucci, Young 1 1, 8 103 Beiriger, Campau, Bernstein ’556, Bernstein ’755 1, 8 1-4, 6-15 103 Martucci, Iwatschenko, Campau 1-4, 6-15 5 103 Martucci, Iwatschenko, Campau, Vilks 5 16-19, 21-23, 25-29 103 Martucci, Iwatschenko, Bryant, Isreeli 16-19, 21-23, 25-29 20 103 Martucci, Iwatschenko, Bryant, Isreeli, Vilks 20 Overall Outcome 1-23, 25-29 REVERSED