Ex Parte FredrickDownload PDFBoard of Patent Appeals and InterferencesDec 3, 200910868330 (B.P.A.I. Dec. 3, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte JOSEPH P. FREDRICK __________ Appeal 2009-004048 Application 10/868,330 Technology Center 1600 __________ Decided: December 3, 2009 __________ Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and JEFFREY N. FREDMAN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 from the rejection of claims 16-27 and 31-33, directed to methods of contacting a defined region of a chemical array with a fluid. The claims have been rejected on the grounds of anticipation and indefiniteness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2009-004048 Application 10/868,330 STATEMENT OF THE CASE Chemical arrays such as biopolymer arrays . . . include regions of usually different sequence polynucleotides arranged in a predetermined configuration on a substrate. . . . The arrays, when exposed to a sample, will exhibit an observed binding pattern . . . indicative of the presence and/or concentration of one or more polynucleotide components of the sample (Spec. ¶ 1). The invention is directed to a method of delivering sample and reagent fluids to defined regions of the array (Spec. ¶¶ 4, 5). Claims 16 and 31 are representative of the subject matter on appeal: 16. A method of contacting a first fluid with a defined region of a surface of an array assembly comprising at least one chemical array, said method comprising: (a) positioning a reservoir plate comprising a support comprising a plurality of holes through said plate relative to said surface of said array assembly such that a capillary space is provided between said reservoir plate and said surface of said array assembly; and (b) introducing said first fluid through at least one hole of said reservoir plate such that said first fluid contacts a defined region of said array assembly surface. 31. A method of contacting a fluid with a defined region of a surface of an array assembly, said method comprising: (a) operatively positioning a reservoir plate, comprising a support comprising a plurality of holes through said plate, relative to said surface of said array assembly; (b) introducing said fluid through at least one hole of said reservoir plate such that said fluid contacts a defined region of said array assembly surface; (c) removing said reservoir plate a distance from said array assembly to flood a surface of said array assembly with a liquid; and (d) flooding a surface of said array assembly with a liquid. 2 Appeal 2009-004048 Application 10/868,330 The Examiner rejected claims 16-27 and 31-33 under 35 U.S.C. § 102(b) as anticipated by Pfost et al. (US Patent 6,485,690 B1, issued November 26, 2002). The Examiner also rejected claims 22 and 23 under 35 U.S.C. § 112, second paragraph, as indefinite. We affirm-in-part. ANTICIPATION The Examiner finds that Pfost discloses all of the steps of the claimed methods. Appellant contends that Pfost doesn’t disclose positioning the reservoir plate and array assembly such that “a capillary space [is] located between the reservoir plate and the surface of the array assembly” (App. Br. 8). In addition, Appellant contends that Pfost doesn’t disclose “flushing the surface of the array assembly, wherein said flushing step does not comprise a reservoir plate” (id. at 18), or “removing the reservoir plate a distance from the array assembly, and flooding the surface of the array assembly with a liquid” (id. at 22). The principal issues raised by this rejection are as follows: Has Appellant shown that the Examiner erred in finding that Pfost discloses the step of positioning a reservoir plate relative to the surface of an array assembly such that a capillary space is provided between them? Has Appellant shown that the Examiner erred in finding that Pfost discloses flushing the surface of the array assembly, where the flushing step does not comprise a reservoir plate? 3 Appeal 2009-004048 Application 10/868,330 Has Appellant shown that the Examiner erred in finding that Pfost discloses the step of removing the reservoir plate a distance from the array assembly to flood a surface of the array assembly with a liquid? FINDINGS OF FACT The Invention FF1 The claimed invention is directed to methods for contacting a fluid with (i.e., depositing a fluid on) a defined region of a surface of a chemical array comprising “positioning a reservoir plate comprising a support comprising a plurality of holes through said plate relative to said surface of said array assembly” and introducing a fluid through the reservoir plate such that the fluid “contacts a defined region of said array assembly surface” (claims 16 and 31). FF2 In one embodiment, the method includes positioning the reservoir plate relative to the surface of an array assembly “such that a capillary space is provided between said reservoir plate and said surface of said array assembly” (claim 16). FF3 The Specification doesn’t define “capillary space,” but defines “capillary distance” as follows: By capillary distance is meant a gap small enough to hold capillary. In this manner, the capillary distance enables fluid to be maintained between the reservoir plate and a surface of the array assembly at a defined region by capillary forces, where the capillary distance is any suitable distance that provides a capillary. . . . In this manner, fluid may be retained at defined regions of the array assembly . . . due at least in part to the capillary forces provided by the capillary distance of the spaced-part [sic] reservoir plate. (Spec. ¶ 111.) 4 Appeal 2009-004048 Application 10/868,330 FF4 “In use, a reservoir plate is positioned in opposition and relative to an array assembly as shown in FIG. 11” of the Specification (Spec ¶ 103), reproduced immediately below: Figure 11 of the Specification shows an embodiment of the invention in which “a reservoir plate is positioned in opposition and relative to an array assembly . . . spaced-apart from the array substrate a distance [D] such as a capillary distance” (id.). FF5 Another embodiment of the invention includes positioning the reservoir plate “relative to a surface of an array assembly such that the reservoir plate or a portion thereon is directly contacted with a surface of the array assembly” (e.g., claim 33) (id. at ¶ 107). FF6 In certain embodiments, after positioning the reservoir plate relative to the array assembly, and introducing a fluid through the reservoir plate to contact a defined region of the array assembly, the method includes removing the reservoir plate a distance from the array assembly and flooding a surface of the array assembly with a liquid (e.g., claims 31-33). 5 Appeal 2009-004048 Application 10/868,330 Pfost FF7 Pfost discloses a method of synthesizing a chemical array using a “multiple fluid sample processor” 10, also called a fluid array layered device, or a fluidic array (Pfost, col. 5, ll. 50-56), shown in Figures 2, 6, 7, and 8 reproduced immediately below: Figure 2 illustrates Pfost’s layered processor 10, which includes top reagent reservoir layer 12, middle fluidic delivery or distribution layer 14, and bottom layer or well plate layer 16 (id. at col. 5, ll. 57-61). Figures 6, 7, and 8 show cross sections of layers 12, 14, and 16, respectively. 6 Appeal 2009-004048 Application 10/868,330 FF8 Layer 12 of Pfost’s processor contains a number of apertures 20 which are selectively positioned immediately above channels 22 in the middle or fluidic layer 14 and in communication with fluidic inlets in layer 14. . . . A series of micro-sized channels . . . [in] plate 12 convey the materials (e.g. liquids) from the apertures 20 to positions above selected openings 22 and/or 24 in the middle layer. The openings 22 and 24 are connected in the middle layer 14 by an elongated microchannel 26 which in turn has a plurality of small passage channels 28. . . . (Pfost, col. 5, l. 64 to col. 6, l. 8.) Layer 16 has a plurality of reaction wells 30 and “[e]ach of the reaction wells 30 has one or more entrance channels 32 and one or more exhaust or drain channels 34” (id. at col. 6, ll. 16-17). FF9 Pfost teaches that a liquid reagent is inserted into openings 20' (or 20) and “[t]hen, by capillary forces . . . the reagent fills the row or column channel 26', as shown in FIG. 12” (Pfost, col. 7, l. 67 to col. 8, l. 2). Pfost’s Figure 12 is reproduced immediately below: Figure 12 is a cross section of Pfost’s processor. In addition to channel 26', (also called an elongated microchannel), which runs through middle layer 14, Figure 12 shows a “capillary forming structure (also called a microvalve) 37 . . . in channel 32' at the entrance to the reaction well 30'” (id. at col. 8, ll. 5-7). “A second smaller capillary valve 39 is formed at the outlet . . . to the well 30'” (id. at col. 8, ll. 40-41). 7 Appeal 2009-004048 Application 10/868,330 FF10 “The microvalves can be capillary forming structures which form capillary barriers and prevent further movement of liquid materials” (Pfost, col. 7, ll. 3-5). FF11 Pfost teaches that “layer 16 . . . is preferably detachably coupled to layer 14 or a combination of layers 12 and 14, although layer 16 could also be permanently bonded to them” (Pfost, col. 6, ll. 29-31). FF12 The Examiner finds that Pfost discloses “forming capillary spaces between the upper and bottom plates (e.g., Figures 7-10; col.6, lines 5+; cols. 7-8, bridging para), which reads on the providing capillary space of clms 16, 32 and 33” (Ans. 3). Specifically, the Examiner finds that “the feature 26 or 26' are formed between two layers of substrates and form microchannels (i.e., capillary space) that have dimensions in various ranges such as 5-300 microns (e.g. col.6, lines 5+; col.7, lines 40+) and the spaces indicated as 26 or 26' can be filled by capillary forces (e.g. col.8, lines 1+)” (id. at 8). FF13 During the chemical synthesis process, the processor is contacted with various reaction reagents, and “washing fluid is then delivered to openings 20' and pressure is applied to the chip member 10' through the microchannels. This results in waste materials being exhausted from the chip” (Pfost, col. 8, ll. 45-48). Once the “chemical synthesis process is completed[,] [t]he final products in each of the wells are then removed from the member 10' by being independently ejected into arrays of wells in a product layer (a/k/a “mother”) plate 41 where they are available for analysis or biological assays” (id. at col. 8, ll. 61-65). 8 Appeal 2009-004048 Application 10/868,330 PRINCIPLES OF LAW “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). During examination, the PTO must interpret terms in a claim using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Nevertheless, “courts must not ‘import[ ] limitations from the specification into the claim.’ . . . [I]t is improper to ‘confin[e] the claims to th[e] embodiments’ found in the specification . . . .” In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (citations omitted, bracketed text in internal quotes in original). ANALYSIS Claims 16, 18-20, and 24-27 Appellant does not provide separate arguments for claims 18-20 and 24-27, therefore, we select claim 16 as representative of this group of claims. 37 C.F.R. § 41.37(c)(1)(vii) (2006). Appellant contends that the Examiner erred in “equating . . . ‘forming capillary spaces between the upper and bottom plates’ in Pfost with the ‘capillary space’ between the reservoir plate and the surface of the array 9 Appeal 2009-004048 Application 10/868,330 assembly as in Claim 16” (App. Br. 7).1 Appellant contends “in contrast to the ‘capillary space’ between the reservoir plate and the surface of the array assembly . . . as shown by ‘D’ in the . . . embodiment of the invention depicted in Fig. 11” (id. at 8), microchannel [26] disclosed in Pfost does not provide a capillary space between the reservoir plate and the surface of the array assembly as in the current claims, because the microchannel “space” is located between two walls of microchannel 26 in the middle of layer 14 . . . [and] do[es] not provide a gap small enough to retain fluid between the reservoir plate and the surface of the array assembly (id. at 11). If we understand Appellant’s argument, it is that the claimed method requires positioning the reservoir plate (analogous to Pfost’s layer 12) over the array assembly (analogous to Pfost’s layer 16) so that a capillary space “small enough to retain fluid between the reservoir plate and the surface of the array assembly” is maintained between them, with no intervening structures. (Id.) Pfost, on the other hand, positions layer 14 in between and in contact with layers 12 and 16, with microchannels running through layer 14 to connect openings in layer 12 with corresponding reaction wells in layer 16. Appellant’s argument is not persuasive. Claim 16 may encompass the embodiment depicted in Figure 11 of the Specification (FF4), but it is not 1 Appellant also contends that the Examiner erred in equating Pfost’s “capillary forming structures” (element 37) with the “capillary space” between the reservoir plate and the surface of the array assembly required by claim 16 (App. Br. 7). We agree with Appellant that capillary forming structure 37 is a “microsized valve” (FF10, FF11) rather than a “space.” 10 Appeal 2009-004048 Application 10/868,330 limited to that embodiment. Claim 16 merely requires positioning a reservoir plate relative to the surface of an array assembly “such that a capillary space is provided between said reservoir plate and said surface of said array assembly” and “introducing said first fluid through . . . said reservoir plate such that said first fluid contacts a defined region of said array assembly surface.” Pfost teaches that microchannel 26 is filled by “capillary forces” (FF9). Moreover, microchannel 26 “in turn has a plurality of small passage channels 28” each of which connects to an entrance channel 32 on the array and feeds directly into a reaction well 30 of the array - a defined region of the array assembly surface (FF8). It’s true that the capillary space formed by Pfost’s microchannel 26 is provided in a layer interposed between layers 12 and 16, but nothing in claim 16 precludes a layer between the reservoir plate and the array assembly. Appellant has not shown that the Examiner erred in finding that Pfost discloses the step of positioning a reservoir plate relative to the surface of an array assembly such that a capillary space is provided between them. Claim 17 Claim 17 depends from claim 16 and further requires “maintaining said fluid at said defined region by . . . capillary forces.” Appellant contends that “Pfost does not disclose the element of maintaining fluid at a defined region of a surface of an array assembly by at least one of capillary forces, because there is no surface of the array assembly that is a capillary space from the reservoir plate in Pfost” (App. Br. 15). This argument is not persuasive. Pfost teaches that microvalves or capillary forming structures (i.e., elements 37 and 39) “form capillary barriers and prevent further movement of liquid materials” (FF9, FF10). 11 Appeal 2009-004048 Application 10/868,330 Claim 21 Claim 21 depends indirectly from claim 16 and requires “flushing said surface of said array assembly” with a fluid. Appellant contends that “the washing step of Pfost comprises fluid that flows through microchannels 26 in middle layer 14, before reaching well 30” and “the surface of [Pfost’s] layer 16 is not even exposed, but rather abuts the bottom of layer 14” (App. Br. 18). If we understand Appellant’s argument, it is that claim 21 requires flushing every surface of the array, not just the surface of a well. This argument is not persuasive. While the present Specification does disclose several illustrative embodiments where every surface of a planar array is exposed and flushed with a washing fluid, claim 21 is not limited to those embodiments and does not recite language that would reasonably be interpreted to require washing or flushing every surface of the array. Pfost’s washing step flushes reagents from the wells of the array (FF13), and Pfost’s wells are defined regions of the surface of an array - the regions on which the synthesis reaction occurs. Claim 23 Claim 23 requires flushing the surface of the array assembly, “wherein said flushing step does not comprise a reservoir plate.” Appellant contends that Pfost “does not disclose the element of removing the reservoir plate” to flush the surface of the array (App. Br. 21). We agree with Appellant on this point. While Pfost teaches that layer 16 (the array) can be removed from layers 12 and 14 once synthesis is complete (FF11), the Examiner has not shown that Pfost discloses introducing fluids to the array without introducing them through the reservoir plate and microchannels (FF13). 12 Appeal 2009-004048 Application 10/868,330 Claims 31-33 Claims 31-33 require “positioning a reservoir plate . . . relative to said surface of said array assembly;” introducing a fluid to the array through the reservoir plate; and “removing said reservoir plate a distance from said array assembly to flood a surface of said array assembly with a liquid;” and “flooding a surface of said array assembly with a liquid.” Appellant contends that “Pfost fails to teach . . . removing the reservoir plate a distance from the array assembly, and flooding the surface of the array assembly with a liquid” (App. Br. 22). Appellant’s argument is persuasive. “Removing” is an active step which requires moving the reservoir plate from its initial position relative to the array assembly to a new position before flooding the array with a liquid. As discussed above, Pfost teaches that layer 16 (the array) can be removed from layers 12 and 14 once synthesis is complete (FF11), but the Examiner has not shown that Pfost discloses introducing fluids to the array without introducing them through the reservoir plate and microchannels (FF13). CONCLUSIONS OF LAW Appellant has not shown that the Examiner erred in finding that Pfost discloses the step of positioning a reservoir plate relative to the surface of an array assembly such that a capillary space is provided between them. The Examiner erred in finding that Pfost discloses flushing the surface of the array assembly, where the flushing step does not comprise a reservoir plate. The Examiner erred in finding that Pfost discloses the step of removing the reservoir plate a distance from the array assembly to flood a surface of the array assembly with a liquid. 13 Appeal 2009-004048 Application 10/868,330 The rejection of claims 16-27 and 31-33 as anticipated by Pfost is affirmed with respect to claims 16-22 and 24-27 and reversed with respect to claims 23 and 31-33. INDEFINITENESS The Examiner rejected claims 22 and 23 as indefinite in reciting “wherein said second fluid comprising said flushing step comprises a reservoir plate,” and “said flushing does not comprise a reservoir plate,” respectively, because “[i]t is not clear how the reaction reagent can comprise a method step, or how a method step can comprise an apparatus part.” (Ans. 12.) We will reverse this rejection. We agree with Appellant that one of skill in the art would understand that the flushing step in claim 22 involves introducing a fluid through the reservoir plate, while the flushing step in claim 23 does not (App. Br. 30). SUMMARY The rejection of claims 16-27 and 31-33 under 35 U.S.C. § 102(b) as anticipated by Pfost is affirmed with respect to claims 16-22 and 24-27 and reversed with respect to claims 23 and 31-33. The rejection of claims 22 and 23 under 35 U.S.C. § 112, second paragraph, is reversed. 14 Appeal 2009-004048 Application 10/868,330 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)(1)(iv)(2006). AFFIRMED-IN-PART cdc AGILENT TECHNOLOGIES INC. INTELLECTUAL PROPERTY ADMINISTRATION,LEGAL DEPT. MS BLDG. E P.O. BOX 7599 LOVELAND, CO 80537 15 Copy with citationCopy as parenthetical citation