Ex Parte Eckerbom et alDownload PDFPatent Trial and Appeal BoardSep 14, 201713063648 (P.T.A.B. Sep. 14, 2017) 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. 13/063,648 06/06/2011 Anders Eckerbom MAPHA.008NP 4403 64735 7590 09/18/2017 KNOBBE, MARTENS, OLSON & BEAR, LLP MASIMO CORPORATION (MASIMO) 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 EXAMINER AGAHI, PUYA ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 09/18/2017 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): jayna.cartee@knobbe.com efiling @ knobbe. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANDERS ECKERBOM and ROBERT ZYZANSKI1 Appeal 2016-006238 Application 13/063,648 Technology Center 3700 Before ULRIKE W. JENKS, JOHN G. NEW, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a gas sampling line for conducting respiratory gases from a patient respiratory interface to a gas monitor. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Background “In respiratory care, it is often desirable to analyse and monitor the gas composition of a patient’s exhaled and/or inhaled breathing gases. For 1 According to Appellants, the real party in interest is Masimo Corporation. (Appeal Br. 3.) Appeal 2016-006238 Application 13/063,648 instance, measurement of respiratory CO2, O2, N2O and anesthetic agents, such as halothane, isoflurane, enflurane, sevoflurane or desflurane, is useful in the care of critically ill patients undergoing anesthesia or mechanical ventilation. Typically, the gas concentrations of the patient’s breathing gases are monitored by transferring a portion of the breathing gases through a sampling line to a suitable gas sensor or gas monitor. The patient’s exhaled breathing gases are usually saturated with moisture at body temperature. Thus, water naturally condenses when the gas sample is cooled to room temperature when passed through the sampling line. Collected condensate, together with secretion, bacteria or other contaminants possibly present in the breathing gases, may result in inaccurate readings at the sensor or even adversely affect a delicate gas monitor.” (Spec. 1,11. 9-23.) Claims on Appeal Claims 1, 2, 4—8, and 12—19 are on appeal. (Claims Appendix, Appeal Br. 11—13.) Claim 1 is illustrative and reads as follows: 1. A gas sampling line having a channel for conducting respiratory gases from a patient respiratory interface to a gas monitor, the gas sampling line comprising a patient respiratory interface connector adapted to couple the gas sampling line to a patient respiratory interface; a gas sampling tube adapted to conduct respiratory gases; and a gas monitor connector adapted to couple the gas sampling line to a gas monitor, wherein the gas sampling tube is comprised of a first polyether block amide material, wherein the first polyether block amide material comprises polyether segments and polyamide segments in a ratio of polyether to polyamide from about 60:40 to about 40:60, and the polyether segments comprise polyethyleneoxide; and 2 Appeal 2016-006238 Application 13/063,648 wherein a CO2 component of the respiratory gases passes the gas sampling tube without being absorbed in or adsorbed to the tube material to allow for an accurate reading at the gas monitor. (Appeal Br. 11.) Independent claim 12 recites a method for sampling of respiratory gases comprising conducting respiratory gases through a tube, and further recites essentially the same limitations as recited in the two wherein clauses of claim 1. (Id. at 12.) Examiner’s Rejections 1. Claims 1, 2, 4—7, and 12—19 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Norlien,2 Sridhar,3 and Arkema.4 (Final Act. 3—6.)5 2. Claim 8 stands rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Norlien, Sridhar, Arkema, and Fudge.6 (Id. at 6—7.) DISCUSSION Issue Whether a preponderance of evidence of record supports the Examiner’s rejections under 35 U.S.C. § 103(a). 2 Norlien et al., US 5,042,500, issued Aug. 27, 1991 (“Norlien”). 3 S. Sridhar et al., Development of crosslinkedpoly(ether-block-amide) membrane for CO2/CH4 separation, Colloids and Surfaces A: Physiochem. Eng. Aspects 297, 267—74 (2007) (“Sridhar”). 4 Pebax® Product Brochures, consisting of MEDICAL APPLICATIONS (June 2007), BREATHABLE FILM (June 2007), and APPLICATION AREAS (June 2000), as cited by the Examiner on Aug. 5, 2013 (Notice of References Cited) (collectively “Arkema”). 5 Office Action dated May 1, 2015. 6 Fudge et al., US 2005/0161042 Al, pub. July 28, 2005. 3 Appeal 2016-006238 Application 13/063,648 Analysis The Examiner’s rejections rely on Norlien’s teaching of a gas sampling line that includes a gas sampling tube to conduct respiratory gases from a patient to a monitor. (Final Act. 3, citing Norlien Fig. 1.) The Norlien sampling tube is fabricated from a polymer called Nafion® that “exhibits high permeability to moisture (water vapor) but does not readily pass other respiratory gases, such as oxygen and carbon dioxide.” (Norlien, col. 1,11. 55—58; Final Act. 4.) The Examiner finds, however, that “Norlien does not teach the gas sampling tube is comprised of a first polyether block amide material, wherein the first polyether block amide material comprises polyether segments and polyamide segments in a ratio of polyether to polyamide from about 60:40 to about 40:60, and the polyether segments comprise polyethyleneoxide.” (Final Act. 4.) The Examiner relies on Sridhar, particularly Table 1 thereof, for teaching PEBAX-1657 polymer with a polyamide content at 40%, thereby teaching “polyether segments and polyamide segments in a ratio of polyether to polyamide from about 60:40 to about 40:60.” (Id.) Table 1 is illustrated below: Table 1 Permeation profGerties of two grades of PEBAX polymers at. 20 kg/cnr Membrane Polyamide Permeante (K) (GPU®) Selectivity, type content (%) CO' < :H, XVxv./ '&ch4 PEBAX-1657 PEBAX-2533 40 3,7 C 20 5,5 f 1.17 1.34 21.2 16,2 ;i :i GPU “10" [cm3 (STPycnr s cmHgJ and Feed pressuire “20kg/emC (Sridhar 272, left col.) Table 1 above lists PEBAX permeation properties. 4 Appeal 2016-006238 Application 13/063,648 The Examiner also points to Table 1 above to find that Sridhar teaches lowering permanence to CO2 depending on the PEBAX grade used, and further finds that ‘“increasing the crosslinking duration [of PEBAX-1657] resulted in a fall in the [CO2] permanence’[], which reads on ‘[without] being absorbed in or adsorbed to the tube material,’” as recited in the claims. (Final Act. 4, citing Sridhar Table 1 and 272, right col.) The Examiner relies on Arkema as showing breathable films and tubing using PEBA (polyether block amides) in medical applications, finding that it “can be less expensive than Nafion® tubes”7 and that “PEBA is used in a variety of medical applications due [to] its biocompatibility, sterilizability, outstanding mechanical properties, and breathability.” (Final Act. 4—5.)8 Based on those findings, the Examiner concludes that it would have been prima facie obvious to one of ordinary skill in the art to substitute the tubing of Norlien with tubing made of PEBAX-1657 or PEBAX-2533 (Sridhar) as this would be a simple substitution and further because such a product has been widely established in a variety of medical applications (tubing, catheters, medical films, etc.) due to cost-reductive advantages in addition to PEBA’s biocompatibility, sterilizability, outstanding mechanical properties, and breathability (Arkema). (Id. at 5.) 7 We agree with Appellants that the Examiner did not establish that the cross-linked PEBAX material would have been less expensive than Nafion® polymer tubes, particularly after taking into account the additional cost of cross-linking. (Reply Br. 3.) 8 Only some of the pages of the PEBAX® APPLICATION AREAS brochure are numbered. The Examiner does not provide a citation, but appears to be citing to page 1 of the 2 page MEDICAL APPLICATIONS brochure. 5 Appeal 2016-006238 Application 13/063,648 Appellants contest the rejection, stating that “a person of ordinary skill in the art would not have been motivated to substitute the tubing of Norlien with tubing made of PEBA for conducting respiratory gases in view of Sridhar and Arkema.” (Appeal Br. 8.) Furthermore, Appellants contend that “if there is no teaching that PEB AX [has] the same or similar properties that are advantageous for use as gas sampling line like what Nafion has, PEB AX would not have been considered as a potential Nafion replacement.” (Reply Br. 2.) The Examiner bears the initial burden of establishing a prima facie case of obviousness and has not done so. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In particular, the Examiner fails to provide a persuasive “reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Examiner’s rejection is premised on the position that PEB AX- 1657 polymer and Nafion® polymer are functional equivalents. (Ans. 4—5.) In particular, the Examiner states that both Nafion and the currently claimed particular grade of PEB A materials function in an equivalent manner with respect to the flow of carbon dioxide and water vapor in the tubing (i.e. the particular grade of PEBA materials allow for carbon dioxide to pass through tube, while permeating water vapor out of the tube), as evidence by Arkema and Sridhar. (Id.) We are not persuaded. While Arkema teaches the use of PEB AX for tubing, such as catheters, it references grades such as “Pebax® 2533SA” for such applications. (Arkema MEDICAL APPLICATIONS 1.) But, as noted in Sridhar Table 1 above, grade 2533 does not satisfy the claimed ratios of 6 Appeal 2016-006238 Application 13/063,648 polyether to polyamide. Furthermore, neither Sridhar nor Arkema teach the use of any grade of PEBAX polymers for gas sampling tubes. On the other hand, Arkema references grades such as “Pebax® MV1657” for films, such as surgery gowns and bandages, not tubing. (Id.) PEBAX grade 1657 is thus taught for a different purpose than Nafion® polymer tubing. Moreover, the Examiner relies on the cross-linking of grade 1657 (not commercially available grade 1657 as provided by Arkema) to satisfy the claim limitation of “wherein a CO2 component of the respiratory gases passes the gas sampling tube without being absorbed in or adsorbed to the tube material.” (Final Act. 4.) But, as Appellants point out, the Examiner has not established that cross-linked PEBAX polymer would maintain the water vapor permeance of unmodified PEBAX polymer.9 Accordingly, on this record we are simply not persuaded that Nafion® polymer and PEBA-1657 polymer are functional equivalents, or that “substituting the Nafion Tubing of Norlien with the particular grade of PEBA materials would be prima facie obvious to one of ordinary skill in the art at the time of invention since doing so would be a simple substitution resulting in cost-reductive advantages.’ '’ (Ans. 5 (emphasis added).) We find that the Examiner has not established that the art teaches or suggests that Nafion® polymer and PEBAX-1657 polymer are functional equivalents for use in gas sampling tubes to conduct respiratory gases. Moreover, in our view, the Examiner provides no persuasive reason to 9 The Examiner states that PEBAX-1657 polymer showed considerable affinity to water, citing Sridhar 270, bottom of left column. (Ans. 4.) But the remainder of that paragraph indicates that water sorption was reduced as a result of cross-linking. (See Sridhar 270, bottom of left col.) 7 Appeal 2016-006238 Application 13/063,648 combine a material indicated for film applications (PEBAX-1657 polymer) in place of the Nafion® polymer of the Norlien gas sampling device, particularly where other grades of PEBAX polymer are referenced for tubing, such as catheters, and the art does not teach any grade of PEB AX polymer that may be used for gas sampling tubes. Accordingly, the rejection of claims 1,2, 4—7, and 12—19 is reversed. The rejection claim 8 is reversed because it depends from claim 1. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988). Conclusions of Law A preponderance of evidence of record fails to support the Examiner’s rejections of claims 1, 2, 4—8, and 12—19 for obviousness. SUMMARY We reverse the rejections of all claims on appeal. REVERSED 8 Copy with citationCopy as parenthetical citation