Ex Parte Vreeke et alDownload PDFPatent Trial and Appeal BoardMar 10, 201410455012 (P.T.A.B. Mar. 10, 2014) 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. 10/455,012 06/06/2003 Mark S. Vreeke MSE #2653 5331 71331 7590 03/11/2014 NIXON PEABODY LLP 300 S. Riverside Plaza, 16th Floor CHICAGO, IL 60606-6613 EXAMINER FOREMAN, JONATHAN M ART UNIT PAPER NUMBER 3736 MAIL DATE DELIVERY MODE 03/11/2014 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 MARK S. VREEKE, STEVEN C. CHARLTON, ALAN R. McCLEARY, and BRUCE A. FLORA1 __________ Appeal 2012-001733 Application 10/455,012 Technology Center 3700 __________ Before MELANIE L. McCOLLUM, ERICA A. FRANKLIN, and ULRIKE W. JENKS, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a fluid collection apparatus. The Examiner has rejected the claims for obviousness and for lacking written description. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the real party in interest as Bayer Healthcare LLC (App. Br. 2). Appeal 2012-001733 Application 10/455,012 2 STATEMENT OF THE CASE Claims 1, 2, 4, 6-10, 12, 13, 51-60, 62-69, 71-80, and 82 are pending and on appeal (App. Br. 2). The claims subject to each rejection have not been argued separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative and reads as follows (emphasis added): 1. A fluid collection apparatus adapted to test a concentration of an analyte in a fluid, comprising: a lid having a lid surface; a base having a substantially planar base surface, said base surface and said lid surface facing each other; a spacer disposed between said lid surface and said base surface; a capillary channel defined between said lid surface and said base surface by said spacer, said capillary channel having an opening for receiving the fluid, said capillary channel being dimensioned to receive the fluid along the entire length of said capillary channel by capillary action; and a lance having a piercing end, said lance being disposed between said lid surface and said base surface and in said capillary channel, said lance being movable relative to said base and parallel to said plane of said base between a first position and a second position, said lance not moving completely out of said capillary channel, wherein in said second position, said piercing end of said lance extends beyond said lid and said base for puncturing and is positioned adjacent said opening of said capillary channel. Claims 1, 2, 4, 6-10, 12, 13, 51-60, 62-69, 71-80, and 82 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Ans. 4). Claims 1, 2, 4, 6, 8-10, 51-56, 58-60, 73-76, 78-80, and 82 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda (JP 2000-258382 A, Sept. 22, 2000) in view of Freeman et al. (US 5,938,679, Aug. 17, 1999) (Ans. 5). Appeal 2012-001733 Application 10/455,012 3 Claims 7, 57, and 77 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Freeman and Smart et al. (US 5,801,057, Sept. 1, 1998) (Ans. 7). Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Freeman, Smart, and Perez (US 7,264,627 B2, Sept. 4, 2007) (Ans. 8). Claims 62-69, 71, and 72 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Freeman and Perez (Ans. 9). Claims 1, 2, 4, 6, 8-10, 51-56, 58-60, 73-76, 78-80, and 82 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Ikeda et al. (US 6,051,392, Apr. 18, 2000) (Ans. 12). Claims 7, 57, and 77 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Ikeda and Yassinzadeh et al. (US 5,700,695, Dec. 23, 1997) (Ans. 14). Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Ikeda, Yassinzadeh, and Perez (Ans. 14). Claims 62-69, 71, and 72 stand rejected under 35 U.S.C. § 103(a) as obvious over Noda in view of Ikeda and Perez (Ans. 15). I In rejecting the claims for lacking written description, the Examiner finds: The claims require a capillary channel being dimensioned to receive fluid along the entire length of the capillary channel by capillary action and a lance that does not move (or is prevented from moving) completely out of the capillary channel. However, the specification fails to disclose an embodiment having a capillary channel dimensioned to receive fluid along Appeal 2012-001733 Application 10/455,012 4 the entire length of the capillary channel by capillary action and a lance that does not move completely out of the capillary channel. (Ans. 5.) Findings of Fact 1. The Specification discloses: In the illustrated embodiment, the capillary channel 18 . . . includes a reagent 19 that will react with the drawn blood in order to create a measurable reaction. According to one embodiment, the reagent 19 is disbursed throughout the entire capillary channel. A lance 24 is disposed in the capillary channel 18. The lance 24 is moveable through the capillary channel 18 in a direction parallel to the length of the capillary channel 18. (Spec. 5: 31 to 6: 6.) 2. The Specification also discloses: The operation of the device 10 illustrated in the embodiments of FIGS. 3-4b will now be described. A user will position the apparatus such that the second end 22 of the capillary channel 18 is pressed against the skin. The lance 24 is in a first position, shown in FIG. 4a, extending out from the first end 20 of the capillary channel 18. The user then pushes the lance 24 downward to a second position shown in FIG. 4b, such that the lance 24 extends past the second opening 22 of the capillary channel 18 and enters the skin. The lance 24 is pushed downward with enough force to create a puncture wound sufficient to draw blood. . . . Once the lance 24 has punctured the skin, the user pulls lance 24 out of the skin and up the capillary channel 18, at least past the reaction area 26. Blood is drawn into the capillary channel 18 via capillary action. The reagent 19 in the capillary channel 18 reacts with the blood to create a reaction that can be measured . . . . In some embodiments, the capillary channel 18 includes stops (not Appeal 2012-001733 Application 10/455,012 5 shown) that prevent the lance 24 from being completely pulled out of the capillary channel 18. (Id. at 7: 13-28.) Principles of Law “An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of [unpatentability].” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Analysis Representative claim 1 recites a “capillary channel being dimensioned to receive . . . fluid along the entire length of said capillary channel by capillary action.” We interpret this language to require a capillary channel that has the necessary length and width such that, under appropriate conditions, capillary action could be used to draw at least one fluid along its entire length. As noted by the Examiner (Ans. 5), the Specification discloses that “capillary channel 18 includes stops . . . that prevent the lance 24 from being completely pulled out of the capillary channel 18” (Finding of Fact (FF) 2). The question is whether the Specification discloses that capillary channel 18 is dimensioned to receive fluid along its entire length by capillary action. As noted by Appellants (App. Br. 11), the Specification discloses that “reagent 19 is disbursed throughout the entire capillary channel” (FF 1). However, we do not agree that Appellants have adequately shown that the presence of reagent along the entire capillary channel indicates that “the capillary channel 18 must be dimensioned to receive fluid along the entire Appeal 2012-001733 Application 10/455,012 6 length of the capillary channel 18 by capillary action” (App. Br. 11 (emphasis added)). As also noted by Appellants, “the capillary channel 18 generally has uniform dimensions along its entire length,” as shown in Specification Figure 4a (App. Br. 11). However, we conclude that Appellants have not provided sufficient evidence to support the position that, as a result, capillary channel 18 is dimensioned to receive fluid along its entire length by capillary action. Conclusion The evidence supports the Examiner’s position that the Specification fails to describe a capillary channel being dimensioned to receive fluid along the entire length of the capillary channel by capillary action. We therefore affirm the written description rejection. II In rejecting the claims over Noda and Freeman, alone or in view of additional references, the Examiner relies on Noda for disclosing many features of the claimed apparatus (Ans. 5-6). However, the Examiner acknowledges that “Noda fails to disclose the lance not moving completely out of the capillary channel” (id. at 6). The Examiner relies on Freeman for disclosing “a fluid collection apparatus having a lance (128) movable within a capillary channel (130 . . . ) from a first position (Figure 3A) to a second position (Figure 3C) for puncturing, wherein the lance does not move completely out of the capillary channel (Figures 3A - 3E),” and that the “capillary channel is dimensioned to receive the fluid along the entire length of the capillary channel by Appeal 2012-001733 Application 10/455,012 7 capillary action in that the capillary channel has a size which receives fluid by capillary action” (id.). The Examiner concludes that it would have been obvious “to modify the lance disclosed by Noda to not move completely out of the capillary channel as taught by Freeman et al. to create a disposable cartridge to aid in avoiding sanitary problems and danger of infection” (id. at 6-7). Findings of Fact 3. Freeman Figure 3 is reproduced below: Freeman Figure 3 depicts a blood sampling device 124 “with an actuator 126 for driving the cutting motion of a blade structure 128, i.e., for penetration into a tissue such as skin,” and a “housing 130 . . . enclos[ing] the blade structure 128, except at its distal end, which has an opening 132 for receiving blood from the patient’s skin” (Freeman, col. 5, ll. 53-61). 4. Freeman discloses that an “optional tube-like stabilizer 140 with a lumen 143 is connected to the housing 130 to confine the blade structure 128 and limit its lateral movement. The stabilizer 140 can be just Appeal 2012-001733 Application 10/455,012 8 slightly larger than the support 142 of the blade structure 128, to enable it to fit therein.” (Id. at col. 6, ll. 5-9.) 5. Freeman also discloses that “capillary action can provide the primary force to draw the blood up into the housing 130” (id. at col. 6, ll. 29- 30). 6. Freeman Figure 4 is reproduced below: [Freeman] FIGS. 4A, 4B, 4C, 4D, 4E show the actuation of the blade structure 128 in a manner similar to that shown in FIG. 3, including extension and retraction of the blade structure. After skin penetration (FIG. 4C), the retraction of the blade structure 128 and plunger 148 creates a suction to draw blood 150 into the chamber 144 (FIGS. 4D and 4E). (Id. at col. 6, ll. 35-40.) Analysis Appellants argue that “Noda and Freeman, alone or in combination, fail to teach or suggest a lance that does not move completely out of the capillary channel, where the capillary channel is dimensioned to receive the fluid along the entire length of the capillary channel by capillary action” Appeal 2012-001733 Application 10/455,012 9 (App. Br. 14). We agree that the Examiner has not set forth a prima facie case of obviousness. The Examiner relies on Freeman’s housing 130 for being a capillary channel (Ans. 6). Freeman discloses not moving lance 128 completely out of housing 130 (FF 3 & 6). However, we agree with Appellants that the Examiner has not adequately shown that housing 130 is dimensioned to receive fluid along its entire length by capillary action (App. Br. 15). Conclusion The Examiner has not set forth a prima facie case that Noda and Freeman suggest a lance that does not move completely out of the capillary channel, where the capillary channel is dimensioned to receive the fluid along the entire length of the capillary channel by capillary action. We therefore reverse the obviousness rejections over Noda and Freeman, alone and in view of additional references. III In rejecting the claims over Noda and Ikeda, alone or in view of additional references, the Examiner relies on Noda as discussed above (Ans. 12-13). In particular, the Examiner acknowledges that “Noda fails to disclose the lance not moving completely out of the capillary channel” (id. at 13). The Examiner relies on Ikeda for disclosing “a fluid collection apparatus having a lance (25) movable within a capillary channel (26) from a first position (Figure 3) to a second position (Figure 4a) for puncturing, wherein the lance does not move completely out of the capillary channel (Figures 3, 4a[,] 4b),” and that the “capillary channel is dimensioned to Appeal 2012-001733 Application 10/455,012 10 receive the fluid along the entire length of the capillary channel by capillary action in that the capillary channel has a size which receives fluid by capillary action” (id.). The Examiner concludes that it would have been obvious “to modify the lance disclosed by Noda to not move completely out of the capillary channel as taught by Ikeda et al. so as to use the lance as a working electrode and/or for aiding in the collection of the sample by sticking to the surface of the lance” (id.). Findings of Fact 7. Ikeda Figure 3 is reproduced below: Appeal 2012-001733 Application 10/455,012 11 Ikeda Figure 3 depicts a measurement device comprising a main body 20, wherein a “cylinder 21 of the main body 20 accommodates a cylindrical needle holder 24,” “has a cap 23 being screwed into one end thereof,” and “has a cylindrical member 26 detachably fitted at the other end thereof” (Ikeda, col. 6, ll. 14-23). 8. Ikeda discloses that a needle 25, which “doubles as a working electrode,” is mounted at a tip of the needle holder 24 and “should be detached after unscrewing the cap 23 from the main body 20 and taking out the needle holder 24” (id. at col. 6, ll. 30-34). 9. Ikeda Figures 4a and 4b are reproduced below: Ikeda “FIG. 4a illustrates a longitudinal cross-sectional view of the . . . measurement device [in Figure 3] at puncture of the skin, and FIG. 4b illustrates a longitudinal cross-sectional view of the same measurement device at measurement” (id. at col. 4, ll. 12-16). Appeal 2012-001733 Application 10/455,012 12 10. To use the device, Ikeda discloses: A user presses an opening of the cylindrical member 26 against the skin of a subject to be examined and pushes a switch 28. As a result, . . . the needle holder 24 moves toward a downward direction as shown FIG. 4a . . . . Then, the needle 25 mounted at the tip of the needle holder 24 is projected from the opening of the cylindrical member 26 and punctures the skin of the subject as shown in FIG. 4a. Upon puncture of the skin by the needle 25, body fluids leak out from the punctured skin. (Id. at col. 6, ll. 39-49.) 11. Ikeda also discloses that the “body fluids leaking from the skin penetrate throughout inside the cylindrical member 26 by sticking to the needle 25 or via the capillary phenomenon” (id. at col. 6, ll. 55-57). Analysis With regard to the obviousness rejection over Noda and Ikeda, Appellants argue that “Noda and Ikeda, alone or in combination, fail to teach or suggest a lance that does not move completely out of a capillary channel, where the capillary channel is dimensioned to receive the fluid along the entire length of said capillary channel by capillary action” (App. Br. 22). However, Appellants do not dispute the Examiner’s finding that Ikeda discloses a capillary channel “dimensioned to receive the fluid along the entire length of the capillary channel by capillary action” (Ans. 16). Instead, Appellants argue that, “contrary to the claimed invention, Ikeda teaches that the needle should be completely moved from the main body, and from the capillary channel in particular” (App. Br. 21-22). We are not persuaded. Representative claim 1 recites a “lance being movable . . . between a first position and a second position, said lance not moving completely out of said capillary channel.” We interpret this language to require that the lance Appeal 2012-001733 Application 10/455,012 13 be capable of moving from a first to a second position without moving completely out of the capillary channel. As noted by the Examiner, Ikeda discloses “a fluid collection apparatus having a lance (25) movable within a capillary channel (26) from a first position (Figure 3) to a second position (Figure 4a) for puncturing, wherein the lance does not move completely out of the capillary channel (Figures 3, 4a[,] 4b)” (Ans. 13; FF 7-10). While we understand that Ikeda discloses that the needle holder and needle can be taken out of the device (FF 8), we do not agree with Appellants that claim 1 requires that the lance be incapable of being removed from the capillary channel. We additionally note that Ikeda discloses that the “body fluids leaking from the skin penetrate throughout inside the cylindrical member 26 . . . via the capillary phenomenon” (FF 11). With regard to the obviousness rejections of claims 7, 12, 13, 57, 62- 69, 71, 72, and 77 over Noda and Ikeda in view of Yassinzadeh and/or Perez, Appellants argue that Noda and Ikeda in view of Yassinzadeh and/or Perez fail “to teach or suggest a lance that does not move completely out of the capillary channel, where the capillary channel is dimensioned to receive the fluid along the entire length of said capillary channel by capillary action” (App. Br. 23-25). However, for the same reasons we are not persuaded by Appellants’ argument that Noda and Ikeda fail to suggest this, we are also not persuaded that Noda and Ikeda in view of Yassinzadeh and/or Perez fail to suggest this. Conclusion The evidence supports the Examiner’s position that Noda and Ikeda suggest a lance that does not move completely out of a capillary channel, Appeal 2012-001733 Application 10/455,012 14 where the capillary channel is dimensioned to receive the fluid along the entire length of the capillary channel by capillary action. We therefore affirm the obviousness rejections over Noda and Ikeda, alone and in view of additional references. SUMMARY We affirm the written description rejection of claims 1, 2, 4, 6-10, 12, 13, 51-60, 62-69, 71-80, and 82. We also affirm the obviousness rejections of claims 1, 2, 4, 6, 8-10, 51-56, 58-60, 73-76, 78-80, and 82 over Noda in view of Ikeda, of claims 7, 57, and 77 over Noda in view of Ikeda and Yassinzadeh, of claims 12 and 13 over Noda in view of Ikeda, Yassinzadeh, and Perez, and of claims 62-69, 71, and 72 over Noda in view of Ikeda and Perez. However, we reverse the obviousness rejections of claims 1, 2, 4, 6, 8- 10, 51-56, 58-60, 73-76, 78-80, and 82 over Noda in view of Freeman, of claims 7, 57, and 77 over Noda in view of Freeman and Smart, of claims 12 and 13 over Noda in view of Freeman, Smart, and Perez, and of claims 62- 69, 71, and 72 over Noda in view of Freeman and Perez. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation