11218896 (P.T.A.B. Dec. 5, 2013)

Ex Parte Landy et al

Patent Trial and Appeal BoardDec 5, 2013

11218896 (P.T.A.B. Dec. 5, 2013)

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. 11/218,896 09/02/2005 John Landy III B-001 2217 7590 12/05/2013 MORRIS I. POLLACK 19 Eberhardt Road East Hanover, NJ 07936 EXAMINER MCCALISTER, WILLIAM M ART UNIT PAPER NUMBER 3753 MAIL DATE DELIVERY MODE 12/05/2013 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN LANDY III and MICHAEL GILDERSLEEVE ____________ Appeal 2012-000220 Application 11/218,896 Technology Center 3700 ____________ Before JOSEPH A. FISCHETTI, MICHAEL C. ASTORINO, and GEORGE R. HOSKINS, Administrative Patent Judges. HOSKINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE John Landy III and Michael Gildersleeve (“Appellants”) appeal under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 42-53. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2012-000220 Application 11/218,896 2 CLAIMED SUBJECT MATTER Claim 42 is illustrative of the subject matter on appeal: 42. An IV infusate fluid pressure responsive valve, for insertion into an IV fluid-flow path to be responsive to the pressure of infusate fluid flowing through the IV fluid flow path; comprising: (a) IV fluid pressure sensing means insertable into the IV fluid-flow path to be responsive to fluid pressure of IV fluid when flowing through the IV fluid flow path; (b) IV fluid entry means for the fluid pressure responsive valve to receive IV fluid flow from the IV fluid flow path and direct the IV fluid to said IV fluid pressure sensing means; (c) IV fluid exit means for the IV fluid pressure responsive valve to direct IV fluid from said fluid pressure sensing means back into the fluid flow path; (d) said IV fluid pressure sensing means being constructed to react to fluid pressure in excess of an unchangeable, predetermined, critical limit to restrict and/or close-off IV fluid flow to said IV fluid pressure sensing means while permitting IV fluid flow from the fluid pressure responsive valve; and (e) said IV fluid pressure sensing means being fabricated from materials that are steralizable and nonpyrogenic. See App. Br. Clms. Appx. REJECTIONS Appellants request our review of the following rejections (App. Br. 6): Claims 42-53 are rejected under 35 U.S.C. § 103(a) as unpatentable over Massengale (US 2002/0104569 A1, pub. Aug. 8, 2002). Claims 50-53 are rejected under 35 U.S.C. § 103(a) as unpatentable over Massengale in view of Cassidy (US 6,480,257 B2, iss. Nov. 12, 2002). Appeal 2012-000220 Application 11/218,896 3 ANALYSIS Rejection of Claims 42-49 as Unpatentable over Massengale Appellants argue independent claims 42 and 47 together as a group, and we select claim 42 to decide the appeal with respect to those claims. See App. Br. 6-8; 37 C.F.R. § 41.37(c). Appellants argue this rejection is improper because the Examiner erred in finding the pressure regulator 10 of Massengale is constructed “to react to fluid pressure in excess of an unchangeable, predetermined, critical limit” as required by claim 42. See App. Br. 6-8 (emphasis added). The Examiner argues Massengale discloses two alternative embodiments, one which is changeable and one which is pre- set and thereafter unchangeable. See Ans. 4-5 (citing Massengale, para. [0023] and claims 35-371). We agree with the Examiner. We appreciate that the Massengale disclosure indicates a preference for a variable, rather than a pre-set, pressure regulator. See, e.g., Massengale, para. [0002]. Nonetheless, Massengale additionally provides as follows: After a pressure source is attached to the inlet 35, the cap 30 is advanced against the diaphragm [20] causing the annular tip of the cap flange 115 to deflect the diaphragm 20, thereby unseating the valve element 80 from the valve seat 50. . . . The cap is adjusted until the desired outlet pressure is attained. For a preset pressure device, a suitable adhesive or the like is applied to the threads at 115 to prevent changes in the output pressure setting. Massengale, para. [0023] (emphasis added). As the Examiner found, once the “suitable adhesive” is applied “to prevent changes in the output pressure 1 We note Massengale does not include claims 35-37, nor does the patent (US 6,619,308) which issued from the published Massengale application. Appeal 2012-000220 Application 11/218,896 4 setting”, the Massengale pressure regulator 10 is then unchangeable as required by claim 42. See Ans. 7. We disagree with Appellants’ suggestion that, even when adhesive is applied, the Massengale pressure regulator 10 “remains infinitely variable.” App. Br. 6. Appellants’ questioning of the timing of adhesive application and the specific materials used (see Rep. Br. 4) are also unavailing; the disclosure in Massengale is complete enough to teach the claim limitation at issue here. We therefore sustain the Examiner’s rejection in this respect. Appellants next argue this rejection is improper because Massengale fails to disclose or suggest use of its pressure regulator 10 in an IV infusate fluid delivery system. See App. Br. 6-8; Reply Br. 4-6. The Examiner asserts IV infusate fluid delivery is merely an intended use of claim 42, and not an affirmative limitation. See, e.g., Ans. 4 and 8. Even assuming arguendo that IV infusate delivery is a limitation of these claims, we still sustain the Examiner’s rejection, firstly because “inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 939 (CCPA 1963). And secondly, the Examiner concluded that even if Massengale does not expressly disclose an IV infusate fluid delivery system,2 it would have been obvious from the Massengale disclosure to use the pre-set Massengale pressure regulator 10 in an IV flow path. See Ans. 5. We agree with that conclusion. Massengale indicates its pressure regulator 10 may be employed “in connection with small pumps used in the medical field wherein fluids are 2 The Examiner found Massengale paragraph [0005] expressly discloses IV infusate fluid delivery. See Ans. 5. We do not sustain that finding, because that paragraph fails to state the patient “dispensing” is intravenous. Appeal 2012-000220 Application 11/218,896 5 being dispensed to a patient.” Massengale, para. [0005]. As the Examiner concluded, that disclosure is a “strong suggestion” (Ans. 5) that the Massengale pressure regulator 10 can be employed in an IV infusate fluid delivery system. IV infusate fluid delivery systems are small pumps, used in the medical field, to dispense fluid to a patient. Appellants assert paragraphs [0005] and [0008] of Massengale teach away from using the single, specific fluid outlet pressure embodiment in the medical field / IV delivery context, in favor of the variable pressure embodiment. See App. Br. 7. We find, however, that Massengale merely exhibits a preference for the variable pressure embodiment in that context, and does not render the single, pre-set pressure embodiment patentable in that context. See In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994) (“A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.”); see also In re Mouttet, 686 F.3d 1322, 1333-34 (Fed. Cir. 2012). Appellants further rely on the Declaration of inventor John Landy in urging for the patentability of claim 42 over Massengale. See App. Br. 8. Mr. Landy states the Massengale valve is “normally in the closed (off) state until adjusted” while the claimed invention “is normally in the open state until activated by excess input pressure at which point it limits flow to a single maximum pressure.” Landy Decl., paras. 4-5. However, as pointed out by the Examiner (see Ans. 8-9), Mr. Landy’s description of the Massengale valve describes the valve in a pre-assembled and pre-use state. In order for the Massengale valve to operate as intended, one must adjust the cap 30 to open the valve 80, which then during use will stay open until activated by an excess input pressure, just like the claimed invention. Appeal 2012-000220 Application 11/218,896 6 For the foregoing reasons, we sustain the Examiner’s conclusion that it would have been obvious to one of ordinary skill in the art to employ the pre-set embodiment of the Massengale valve in an infusate IV delivery set. We further sustain the Examiner’s conclusion that one of ordinary skill designing such an infusate IV delivery set would use “steralizable and nonpyrogenic”3 materials as required by the claims. See Ans. 5. Appellants separately argue for the patentability of dependent claims 43-46, 48, and 49, on the basis that Massengale does not disclose a “piston.” See App. Br. 8-9; Reply Br. 5. We are not persuaded. The Specification discloses a first piston 220 (Fig. 8, para. [0035]), a second piston 274 (Fig. 9, para. [0038]), a first piston-like valve cap 316 (Fig. 10, para. [0039]), and a second piston-like valve cap 414 (Fig. 11, para. [0041]). We agree with the Examiner that, in light of that disclosure, the valve element 80 in Massengale is a “piston” as recited in the claims. See Ans. 4. The Examiner’s later analysis refers to the diaphragm 20 in Massengale as the “piston.” See Ans. 9-10. Appellants argue that analysis is in error, because the Massengale diaphragm 20 does not slide up and down like the diaphragm 310 in Figure 10 of the Specification. See Reply Br. 5. Appellants’ argument is unpersuasive, because Figure 11 of the Specification is substantially the same as the Massengale structure 20/80 in this regard. In any event, the diaphragm 20 and the valve element 80 in Massengale are both part of one integral component, so we find no error in the Examiner’s referring to the diaphragm 20 in light of the Examiner’s initial statement that the valve element 80 is the piston. 3 “Pyrogenic” is defined as “producing or produced by heat or fever.” See www.merriam-webster.com (last visited Nov. 26, 2013). Appeal 2012-000220 Application 11/218,896 7 For the foregoing reasons, we sustain the Examiner’s rejection of claims 42-49 as unpatentable over Massengale. Rejection of Claims 50-53 as Unpatentable over Massengale Claim 50 recites, in part, a “heating device” for the IV fluid. See App. Br. Clms. App’x. The Examiner found the Massengale pressure regulator 10 lacks a heater, but concluded “it would have been obvious to heat fluid going into a patient (which inherently requires some sort of ‘heater’) to avoid hypothermia” and “to combine the regulator and heater into a single device for compactness.” Ans. 5. We, however, agree with Appellants that the Examiner’s analysis in this regard is not supported by the evidence of record. See App. Br. 9. In particular, the Examiner failed to cite any evidence — whether in Massengale itself, some other prior art reference, or the knowledge of one of ordinary skill in the art — to support the determination that it would have been obvious to heat fluid going into a patient. For this reason, we do not sustain the Examiner’s rejection of claims 50-53 as unpatentable over Massengale. Rejection of Claims 50-53 as Unpatentable over Massengale and Cassidy In the alternative to rejecting claims 50-53 as unpatentable over Massengale alone, the Examiner cited Cassidy as disclosing the “heating device” of claim 50 (see Ans. 5-6 and 10-11), and concluded: “[i]t would have been obvious in view of Cassidy to use a heater to heat the infusate controlled by Massengale for injection into a human body while avoiding hypothermia or other complications and to put both devices in a common housing for compactness, as is well known in the medical art.” Ans. 6. Appeal 2012-000220 Application 11/218,896 8 As pertinent to this rejection4, Appellants generally assert “there is no description, showing, teaching or suggestion of combining” the Cassidy heater with the Massengale valve in an IV infusate delivery set. See App. Br. 10-11; Reply Br. 6. That argument is too general to adequately address the Examiner’s rationale for combining Massengale and Cassidy, provided in the Answer at pages 5-6 and 10-11. We therefore sustain the rejection of claims 50-53 as unpatentable over Massengale in view of Cassidy. DECISION We AFFIRM the rejection of claims 42-49 as unpatentable over Massengale, and the rejection of claims 50-53 as unpatentable over Massengale and Cassidy. We REVERSE the rejection of claims 50-53 as unpatentable over Massengale. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Vsh 4 Much of Appellants’ argument is directed to the rejection of claims 50-53 as obvious over Cassidy in view of Massengale. See App. Br. 10-11; Reply Br. 6. However, the Examiner has withdrawn that rejection. See Ans. 10-11.