Ex Parte Hodges et alDownload PDFPatent Trial and Appeal BoardNov 13, 201410105050 (P.T.A.B. Nov. 13, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ALASTAIR HODGES and RONALD CHATELIER __________ Appeal 2012-006951 Application 10/105,050 Technology Center 1600 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a disposable device for use in detecting a target antigen in a fluid sample. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Universal Biosensors Pty Ltd (see App. Br. 3). Appeal 2012-006951 Application 10/105,050 2 Statement of the Case Background The Specification teaches that it would “be advantageous to develop a device for performing an immunoassay that does not require any washing steps and is suitable for a single use as a disposable device” (Spec. 1 ¶ 3). The Claims Claims 1, 2, 4–13, 15–18, 20, 29–35, 38, and 40–42 are on appeal.2 Independent claim 1 is representative and reads as follows: 1. A disposable device for use in detecting a target antigen in a fluid sample, the device comprising a reaction chamber having a first height; an immobilized antibody positioned within the reaction chamber; a reporter complex comprising a probe and a reporter complex antigen, wherein the probe is linked to the reporter complex antigen, wherein the reporter complex antigen is bound to the immobilized antibody, and wherein the reporter complex antigen binds less strongly than the target antigen to the immobilized antibody; a detection chamber having a second height less than the first height of the reaction chamber wherein air trapped in the detection chamber prevents the detection chamber from being filled with sample, and having a vent which is initially closed; a sample ingress to the reaction chamber; and 2 Claims 3, 14, 19, 21–28, 37, 39, and 43–52 have been withdrawn from consideration (Office Action mailed Sept. 13, 2010, page 2). While the Examiner has included all of claims 1–35 and 37–52 in the provisional double patenting rejection (see Ans. 22–26), we consider that to be a typographical error in view of the earlier withdrawal of claims 3, 14, 19, 21–28, 37, 39, and 43–52 from consideration. Appeal 2012-006951 Application 10/105,050 3 a sample passageway between the reaction chamber and the detection chamber, wherein the device is adapted to move the sample from the reaction chamber to the detection chamber via capillary action upon opening the vent in the detection chamber to release trapped air. The issues A. The Examiner rejected claims 1, 2, 4, 6, 12, 15–18, 20, 29, 32, 34, 35, 40, and 41 under 35 U.S.C. § 103(a) as being obvious over Columbus,3 Freytag,4 and Gorin5 (Ans. 7–12). B. The Examiner rejected claims 5, 7, and 8 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Rubenstein6 (Ans. 13– 15). C. The Examiner rejected claims 9–11 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Jernigan7 (Ans. 15–16). D. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Vormbrock8 (Ans. 16–18). E. The Examiner rejected claims 30 and 31 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Say9 (Ans. 18–19). F. The Examiner rejected claim 33 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Uzan10 (Ans. 19–20). 3 Columbus, R.L., US 4,426,541, issued Jan. 17, 1984. 4 Freytag, J.W., US 4,434,236, issued Feb. 28, 1984. 5 Gorin et al., US 5,077,017, issued Dec. 31, 1991. 6 Rubenstein et al., US 4,376,825, issued Mar. 15, 1983. 7 Jernigan, W., US 5,434,055, issued July 18, 1995. 8 Vormbrock, R., US 5,258,315, issued Nov. 2, 1993. 9 Say et al., US 6,103,033, issued Aug. 15, 2000. Appeal 2012-006951 Application 10/105,050 4 G. The Examiner rejected claim 38 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Siegel11 (Ans. 20–21). H. The Examiner rejected claim 42 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Boles12 (Ans. 21–22). I. The Examiner provisionally rejected claims 1, 2, 4–13, 15–18, 20, 29– 35, 38, and 40–42 on the ground of nonstatutory obviousness–type double patenting as unpatentable over claims 64 and 66–93 of US Application 10/830,841 (now issued as US 8,685,714, Apr. 1, 2014) (Ans. 22–26). A. 35 U.S.C. § 103(a) over Columbus, Freytag, and Gorin The Examiner finds that Columbus teaches a test device (disposable device) for use in detecting a target antigen in a fluid sample, said device comprising . . . a first zone 22 (reaction chamber) having a first height h . . . a probe and a reporter complex antigen . . . a second zone 24 (detection chamber) having a second height h’ . . . and having an aperture 50 (vent) . . . a liquid inlet aperture 46 (sample ingress) to the first zone; and a sample passage way 60 between the first and second zone, wherein the device is adapted to move a sample from the first zone to the second zone via capillary action. (Ans. 8.) The Examiner acknowledges that “Columbus fails to teach that the labeled antigen analog is bound to the immobilized antibody and binds less strongly than the target antigen to the immobilized antibody. Columbus 10 Uzan et al., US 5,849,247, issued Dec. 15, 1998. 11 Siegel et al., US 5,272,258, issued Dec. 21, 1993. 12 Boles et al., US 5,932,711, issued Aug. 3, 1999. Appeal 2012-006951 Application 10/105,050 5 further fails to teach that the aperture (vent) in the second zone (detection chamber) is initially closed” (Ans. 8). The Examiner finds that “Freytag teaches an anti-analyte antibody that is displaceably bound to an analyte-analog, wherein the dissociation constant between said antibody and the analyte–analog is greater than the dissociation constant between said antibody and the analyte” (Ans. 9). The Examiner finds that “Gorin teaches an apparatus with multiple chambers and an external vent control to control the movement of fluid between the chambers. . . . Moreover, Gorin teaches that the vent system is an alternative to a meniscus flow stop” (Ans. 10). The Examiner finds it obvious to modify the Columbus antibody/antigen “by providing a labeled antigen analog (report complex antigen) bound to the immobilized antibody. . . . This arrangement, as taught by Freytag, provides for an efficient sensor that does not require a pre– incubation step” (Ans. 9). The Examiner further finds it obvious “that Columbus’s meniscus flow stop can be substituted by Gorin’s venting system” (Ans. 11). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the combination of Columbus, Freytag, and Gorin renders the claims obvious? Findings of Fact 1. Columbus teaches a [R]eaction vessel comprising first and second fluidly connected zones, inlet means permitting the introduction of liquid into the first zone, and a passageway connecting the zones. At least one of the zones contains a reagent capable Appeal 2012-006951 Application 10/105,050 6 of interacting with a material of the liquid, and the second zone is adapted to receive the liquid from the first zone (Columbus, col. 2, ll. 2–8). 2. Figure 2 of Columbus is reproduced below: In Figure 2, “a reaction vessel 20 is provided, comprising means defining a first zone 22 fluidly connected by passageway 60 to means defining an adjacent zone 24 adapted to receive liquid flow from zone 22” (Columbus, col. 4, ll. 55–59). 3. Columbus teaches that: Surfaces 26 and 28, FIG. 2, are spaced apart a distance h in zone 22, and distance h’ in zone 24, both of which are selected to provide capillary flow of liquid. . . . To complete the transfer of all the liquid into zone 24 following breach of passageway 60, and to retain liquid in zone 24, distance h’ is preferably less than distance h. . . . A quantity of liquid is to be deposited at aperture 46, preferably in drop form. (Columbus, col. 5, ll. 1–9.) 4. Columbus teaches that “[i]mmunoassays are possible using such a device, wherein a labeled amount, that is, the analyte analog, is included in the first zone, preferably to compete with the unlabeled analyte Appeal 2012-006951 Application 10/105,050 7 of the liquid for a bonding reaction with the reagent” (Columbus, col. 2, ll. 47–53). 5. Columbus teaches that to “permit air to be expelled from zones 22 and 24 ahead of an advancing liquid meniscus, apertures 50 are provided, preferably through member 42 in the vicinity of zone 24” (Columbus, col. 5, ll. 51–54). 6. Columbus teaches that in [A]ccord with well–known principles of capillarity, the smaller spacing of distance h’ insures that the liquid will preferentially flow into zone 24 . . . . Additional processing then takes place in zone 24, for example . . . measurement of analyte in the liquid by an appropriate scan . . . using electromagnetic radiation that passes through either member 44, as shown, or member 42 if exposed from above (Columbus, col. 8, ll. 16–27). 7. Freytag teaches that “[t]here is a need for a heterogeneous immunoassay which does not require a pre–incubation step and which is readily adaptable to automated or semi–automated instrumentation” (Freytag, col. 2, ll. 57–60). 8. Freytag teaches (1) contacting a liquid sample suspected of containing analyte with a solid phase having immobilized thereon an analyte-analogue to which there is displaceably bound a labeled, anti-analyte antibody in molar excess over the analyte, wherein the dissociation constant between said antibody and the analyte-analogue is greater than the dissociation constant between said antibody and the analyte, whereby said antibody is displaced from the immobilized analyte-analogue as said antibody forms a complex with the analyte from the liquid sample; (2) separating said complex Appeal 2012-006951 Application 10/105,050 8 from the solid phase; and (3) measuring the amount of said complex which is related to the amount of analyte initially present in the liquid sample. (Freytag, col. 2, l. 65 to col. 3, l. 11.) 9. Gorin teaches that a “sample is a liquid and may be derived from any source, such as a physiological fluid; e.g., blood, saliva, occular lens fluid, cerebral spinal fluid, pus, sweat, exudate, urine, milk, or the like. The liquid sample may be subjected to prior treatment” (Gorin, col. 4, ll. 23– 27). 10. Gorin teaches that “denatured blood/reagent mixture will then be mixed and assayed for hemoglobin A1c by measurement of the change in turbidity over about 30 seconds. Turbidity increases as a result of agglutination of antibody-coated latex particles, the antibody being specific for hemoglobin A1c” (Gorin, col. 18, ll. 33–37). 11. Figure 12B of Gorin is reproduced below: Appeal 2012-006951 Application 10/105,050 9 FIG. 12B discloses an embodiment comprising Sample application site 730 is provided in an upper face of block 790. Two channels lead away from the sample application site. One channel is measuring chamber 732 . . . a capillary pathway is provided for isolating a portion of the mixture initially formed in mixing chamber 740. Channel 761 along the front face of block 790 leads to a capillary space 762 to which a reagent can be applied before placing cover plate 795 over base 790. The capillary path proceeds to aperture 763, which traverses block 790. Capillary path 764 continues on the back face of block 790 and terminates at vent space 765 through back plate 795. Actual venting takes place through aperture 767 in back cover plate 797. A solenoid-controlled vent seal (not shown) forms part of the apparatus in which this embodiment is placed for controlling entry and exit of liquids into this capillary pathway. (Gorin, col. 17, ll. 1–36.) 12. Gorin teaches that “[c]apillary channels 761–764 provide the measurement (mixture isolation) capillary with vent control occurring at vent chamber 765” (Gorin, col. 18, ll. 45–47). 13. Gorin teaches “an apparatus and a method by which small samples can easily be measured and diluted. . . . Valves are provided to control the movement of fluid from chamber to chamber. . . . For some operations, valves can consist of externally controlled vent covers to control the flow of liquids in capillary spaces” (Gorin, col. 3, ll. 48–60). 14. Gorin teaches that “[v]alves consisting of external vent controls can be used in any situation where flow occurs through a capillary pathway (so that trapped air is effective to control flow of liquids) and where no liquid is stored in the cartridge prior to use” (Gorin, col. 11, ll. 54–58). Appeal 2012-006951 Application 10/105,050 10 15. Gorin teaches “U.S. Pat. No. 4,426,451 . . . describes a number of stop flow junctions that it refers to as ‘meniscus control means’ for use in a device in which there is capillary flow from one zone to another. The stop flow junctions described in that patent can be used in the apparatus of the present invention” (Gorin, col. 7, ll. 11–16). 16. Gorin teaches that “[i]t is also possible to use a valve to control flow of sample from the sample measuring chamber to the mixing chamber” (Gorin, col. 8, ll. 27–29). Principles of Law “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 7–26; FF 1–15) and agree that claim 1 is obvious over Columbus, Freytag, and Gorin. We address Appellants’ arguments below. Appellants contend that “Columbus is an improper reference for an obviousness rejection because the allegedly obvious modification to Columbus, to make it read upon the claims, would change the principle of operation of Columbus” (App. Br. 7–8). Appellants rely upon the Hodges Appeal 2012-006951 Application 10/105,050 11 Declaration,13 which states that “it is my expert opinion that a meniscus control and a vent control, when used to control a liquid flow in a system, rely on two mechanisms and principles of operation that are not only structurally different, but also structurally incompatible” (Hodges Decl. 5 ¶ 5C; see also App. Br. 11). The Examiner finds that “Gorin clearly indicates that the vent control is used interchangeably with the meniscus control” (Ans. 29). The Examiner further finds that the ordinary artisan “would have recognized that the two controls are species of the same genus -they are distinct, but not so different that altering one for the other would require a substantial reconstruction and redesign . . . [and] would find it obvious to remove the meniscus control and replace with a vent control” (id.). We find that the Examiner has the better position. Columbus and Gorin teach devices for analyzing biological samples using antibodies (FF 4, 9, 10). Both Columbus’ reaction chamber 20 (FF 2) and Gorin’s mixing/reaction chamber 740 (FF 11) are connected to sample ingress means, specifically aperture 46 in Columbus (FF 3) and sample application site 730 in Gorin (FF 11). Columbus and Gorin teach passage to detection chambers, specifically zone 24 in Columbus (FF 6) and capillaries 761–764 in Gorin (FF 12). We recognize that structural changes, as identified by Dr. Hodges, are necessary to modify the meniscus control of Columbus to the valve control of Gorin (see Hodges Decl. 7–8 ¶¶ 7A–7C). We also have considered his conclusion that “these two systems are not interchangeable or combinable” 13 Declaration of Dr. Alastair M. Hodges, filed Dec. 14, 2010. Appeal 2012-006951 Application 10/105,050 12 Hodges Decl. 8 ¶ 8B). Dr. Hodges relies upon a change in principle of operation (see Hodges Decl. 8 ¶ 7C), but does not demonstrate that undue experimentation, or indeed, any experimentation, would have been required to substitute a valve as taught in Gorin for the vent and meniscus control of Columbus (FF 1–16). We contrast the Hodges Declaration against Gorin’s teaching that the prior art was aware of a number of “‘meniscus control means’ for use in a device in which there is capillary flow from one zone to another” (Gorin, col. 7, ll. 10–15; FF 15). Gorin expressly suggests substituting valves for these meniscus control means, teaching that “[i]t is also possible to use a valve to control flow of sample from the sample measuring chamber to the mixing chamber” (Gorin, col. 8, ll. 27–29; FF 16). As we balance the teaching of Gorin that a valve may be substituted for a meniscus control means (FF 15–16) in very structurally similar devices with identical purposes as discussed above (FF 1–6, 9–14) against the negative teaching of the Hodges Declaration (Hodges Decl. 8 ¶ 8B), we find Gorin more persuasive. We also agree with the Examiner that In re Ratti, 270 F.2d 810 (CCPA 1959), does not mandate a different result (Ans. 27) and that the “skilled artisan would have recognized that the two controls are species of the same genus – they are distinct, but not so different that altering one for the other would require a substantial reconstruction and redesign” (Ans. 28). Our position finds substantial support in the underlying facts of the KSR decision itself, where the Supreme Court was not persuaded by the Federal Circuit’s reliance upon a statement from an “expert that claim 4 was Appeal 2012-006951 Application 10/105,050 13 nonobvious because, unlike in Rixon, the sensor was mounted on the support bracket rather than the pedal itself.” KSR, 550 U.S. at 415. That is, like the current case, some reconstruction of the prior art elements amounting to a change in the principle of operation of the pedal sensor would have been required to arrive at the claimed invention. The Court, however, found that “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. We conclude that substituting a valve for a vent and meniscus control is not beyond the skill of Gorin’s ordinary artisan (FF 15–16), and we agree with the Examiner that “Gorin teaches that using a valve in the form of a venting system is a functional alternative to a meniscus flow stop. Accordingly, the skilled artisan would have recognized that Columbus’s meniscus flow stop can be substituted by Gorin’s venting system” (Ans. 11). Appellants contend that “the Examiner has reconstructed the invention not from the knowledge and motivations of a person of ordinary skill in the art, but instead from the hindsight position of an Examiner with claims to reject no matter how many references must be assembled, combined, and modified to do so” (App. Br. 15). We are not persuaded. While we are fully aware that hindsight bias often plagues determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known Appeal 2012-006951 Application 10/105,050 14 methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. As discussed above, we conclude that the person of ordinary skill would have recognized the obviousness of modifying the meniscus flow immunoassay method of Columbus to use the heterogeneous immunoassay of Freytag “which does not require a pre–incubation step and which is readily adaptable to automated or semi–automated instrumentation” (Freytag, col. 2, ll. 57–60; FF 7) while also incorporating Gorin’s teaching that rather than use meniscus control, “[i]t is also possible to use a valve to control flow of sample from the sample measuring chamber to the mixing chamber” (Gorin, col. 8, ll. 27–29). We also note that it has been recognized that reliance on a “large number of references” does not, without more, weigh against the obviousness of the claimed invention. In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991) (“The criterion, however, is not the number of references, but what they would have meant to a person of ordinary skill in the field of the invention.”). Conclusion of Law The evidence of record supports the Examiner’s conclusion that the combination of Columbus, Freytag, and Gorin renders the claims obvious. B.–H. 35 U.S.C. § 103(a) rejections Appellants do not argue separately the claims in these obviousness rejections. Having affirmed the obviousness rejection of claim 1 over Columbus, Freytag, and Gorin for the reasons given above, we also find that Appeal 2012-006951 Application 10/105,050 15 the further obvious combinations render the remaining claims obvious for the reasons given by the Examiner (see Ans. 13–22). I. Double Patenting Rejection We summarily affirm the provisional obviousness–type double patenting rejection since no arguments were presented. See Manual of Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant's brief, appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it . . . .”). When the appellant fails to contest a ground of rejection to the Board, . . . the Board may treat any argument with respect to that ground of rejection as waived. In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008). SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, and Gorin. Pursuant to 37 C.F.R. § 41.37(c), we also affirm the rejection of claims 2, 4, 6, 12, 15– 18, 20, 29, 32, 34, 35, 40, and 41, as these claims were not argued separately. We affirm the rejection of claims 5, 7, and 8 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Rubenstein. We affirm the rejection of claims 9–11 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Jernigan. Appeal 2012-006951 Application 10/105,050 16 We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Vormbrock. We affirm the rejection of claims 30 and 31 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Say. We affirm the rejection of claim 33 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Uzan. We affirm the rejection of claim 38 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Siegel. We affirm the rejection of claim 42 under 35 U.S.C. § 103(a) as being obvious over Columbus, Freytag, Gorin, and Boles. We affirm the rejection of claims 1, 2, 4–13, 15–18, 20, 29–35, 38, and 40–42 on the ground of nonstatutory obviousness–type double patenting as unpatentable over claims 64 and 66–93 of US Application 10/830,841 (now issued as US 8,685,714, Apr. 1, 2014). 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