Ex Parte MichaelDownload PDFBoard of Patent Appeals and InterferencesOct 31, 201111436718 (B.P.A.I. Oct. 31, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/436,718 05/17/2006 Seul Michael LEAPS-C11-C1 8815 26158 7590 10/31/2011 WOMBLE CARLYLE SANDRIDGE & RICE, LLP ATTN: IP DOCKETING P.O. BOX 7037 ATLANTA, GA 30357-0037 EXAMINER FORMAN, BETTY J ART UNIT PAPER NUMBER 1634 MAIL DATE DELIVERY MODE 10/31/2011 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte MICHAEL SEUL ____________ Appeal 2010-004008 Application 11/436,718 Technology Center 1600 ______________ Before ERIC B. GRIMES, LORA M. GREEN, and RICHARD M. LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal under 35 U.S.C. § 134 by the Patent Applicant from the Patent Examiner’s rejections in the above-identified U.S. Patent Application. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b) and 134. We affirm-in-part. Appeal 2010-004008 Application 11/436,718 2 BACKGROUND The claims in this application (“the ‘718 application”) are directed to a “bead array comprising a planar, random assembly of encoded, oligonucleotide-bearing beads in a designated area on a substrate.” According to the ‘718 application, the arrays have “applications in pharmaceutical and agricultural drug discovery and in in-vitro or genomic diagnostics.” (P. 1, ll. 9-10.) Claims 114, 116, 117, 143, and 144 are pending and stand rejected by the Examiner as follows: 1. Claim 114 under 35 U.S.C. § 102(b) as anticipated by Drmanac;1 and 2. Claims 116, 117, 143, and 144 under 35 U.S.C. § 103(a) as obvious in view of Drmanac combined with Coffer2 or Seul.3 Claim 114 is representative and reads as follows: 114. A bead array comprising a planar, random assembly of encoded, oligonucleotide-bearing beads in a designated area on a substrate, wherein different oligonucleotide-bearing beads are randomly distributed throughout the array, wherein different oligonucleotides are attached to different beads and said beads are encoded with a fluorescent signature which permits identification of the oligonucleotides attached thereto, and permits distinguishing of individual beads including 1 EP 0 392 546, published October 17, 1990, inventor Radoje T. Drmanac, hereinafter referred to as “Drmanac.” 2 Coffer, Jeffery, L., et al. (1992), Characterization of quantum-confined CdS nanocrystallites stabilized by deoxyribonucleic acid (DNA), Nanotechnology, 3, 69-75. Hereinafter referred to as “Coffer.” 3 Seul, Michael & Andelman, D. (1995), Domain Shapes and Patterns: The Phenomenology of Modulated Phases, Science,267(5197), 476-483. Hereinafter referred to as “Seul.” Appeal 2010-004008 Application 11/436,718 3 distinguishing different beads from each other, wherein the beads have a diameter of from 2 microns to 20 microns, and said beads are affixed to the substrate in an ordered array configuration wherein the beads are in designated positions, in accordance with a given outline. (App Br. 7, Claims Appendix) CLAIM INTERPRETATION We begin with claim interpretation because a claim must be properly interpreted before it can be compared to the prior art. During patent examination, claim terms are given “the broadest reasonable meaning . . . 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). The claimed bead array is recited to be a “random assembly of encoded, oligonucleotide-bearing beads in a designated area on a substrate, wherein different oligonucleotide-bearing beads are randomly distributed throughout the array.” The beads are “in an ordered array configuration wherein the beads are in designated positions, in accordance with a given outline.” The beads are thus in a “random assembly” and “randomly distributed” in “designated positions.” The Specification uses such terms but does not define them (e.g., p. 19, ll. 1-2; p. 19, ll. 32-33; p. 20, ll. 6-7; p. 20, ll. 16-19). Thus, we adopt the ordinary meaning of these terms as they would be understood by a person of skill in the art. The terms “random assembly” and “randomly distributed” indicate that each bead has an equal probability of occurring at any position in the Appeal 2010-004008 Application 11/436,718 4 bead array.4 The beads are also “in a designated area” on the substrate and “in designated positions, in accordance with a given outline.” The latter phrases would be interpreted in the context of the claim to mean that the beads are placed in areas (the “designated area” or “positions . . . in accordance with a given outline”) of the substrate which were chosen beforehand (the “designated” area or “given” outline). The beads “are in designated positions, in accordance with a given outline.” We interpret the term “outline” to mean that the area in which the beads are placed has a defined boundary or outer limit, consistent with the ordinary meaning of such term.5 The Specification refers to “a designated area of arbitrary outline” (p. 12, l. 10) and forming arrays “with a given overall outline” (p. 20, ll. 18-19), descriptions which also indicate that “outline” is a reference to the boundary of the designated area in which the beads are placed. 1. ANTICIPATION BY DRMANAC Findings of Fact (“FF”) Drmanac [FF1] Drmanac describes sequencing by hybridization (“SBH”) comprising attaching genomic clones to discrete particles (“DP”) (col. 7, ll. 22-27 & 41- 42). 4 Merriam-Webster, http://www.merriam- webster.com/dictionary/random?show=1&t=1319301942, accessed October 22, 2011. 5 Merriam-Webster, http://www.merriam-webster.com/dictionary/outline, accessed October 22, 2011. Appeal 2010-004008 Application 11/436,718 5 [FF2] “Aliquotes [sic] of DPs from each well are mixed together and spread in the monolayer of required density. This is followed by the necessary number of fixations. In this way one can obtain hybridization areas (HA) similar to filters in a dot blot procedure.” (Col. 7, ll. 27-31.) [FF3] “One can imagine a simple case in which each HA contains enough randomly displayed DPs that each clone from the library is represented at least once. The other HAs are replicas but DPs are present in different places.” (Col. 7, ll. 33-37.) [FF4] Drmanac explains that the DPs can be recognized in three principal ways “which can be combined.” 1) Labeling with physical attributes of DP like size, shape and color which can be differentiated in a phase of reading, for instance, during image analysis. 2) Labeling with different combinations of ONs which can be recognized as such by hybridization with appropriate ONPs . . . . 3) Labeling (better recognition) by the use of certain fraction of ONPs on all HA. (Col. 7, l. 45 to col. 8, l. 3.) [FF5] Drmanac describes a method of determining genomic sequences using oligonucleotide probes (“ONP”) bound to discrete particles (“DP”) (col. 8, ll. 32-37). The method is called “Inverse DP-SBH” (“ISBH”) (id.). [FF6] The DPs “are used for forming monolayer HA (OHA oligohybridization area).” (Col. 9, ll. 13-14.) [FF7] Drmanac describes methods of making DPs, each carrying a different ON (oligonucleotide) (col. 15, ll. 14-32). Appeal 2010-004008 Application 11/436,718 6 [FF8] The hybridization areas into which the DPs are placed are characterized by Drmanac as a “random monolayer,” where the area has a defined shape, e.g., 10 cm x 10 cm (col. 17, ll. 28-34). [FF9] Drmanac teaches that “more or less square submatrices are possible” in the hybridization areas (HA) comprising DPs (col. 19, ll. 45-46). [FF10] Drmanac teaches: Therefore, parallel formation of many submatrices of the type 104 to 105 targets x 10-100 ONPs seems to us as most rational way to proceed. The parallelism can be of the two kinds: a formation of all 100-1000 submatrices with the same group of ONPs on a single HA, and simultaneous hybridization in separate vessels on HA “replicas” with many different ONP groups. (Col. 19, l. 54 to col. 20, l. 3.) [FF11] Drmanac teaches that “different fluorescent molecules” can be used as labels for the DPs to discriminate between different DPs (col. 20, ll. 47- 52; col. 21, ll. 9-31). [FF12] This functional cassette preparations are independent (and usable for any) of the individual object of a species given, i.e. individual genome. The consequence is preparation of ONPs containing integrated information of type - basic element x position, usable for any DNA. This also results in DP preparation integrating the addressing information, so that it needs not be determined by robotic positioning operations. (Col. 23, ll. 10-18.) [FF13] Drmanac describes DPs with a 4 µm diameter (col. 17, l. 26). [FF14] Drmanac does not describe the material which comprised the DPs. Legal Principles Appeal 2010-004008 Application 11/436,718 7 “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently. Anticipation is an issue of fact, and the question whether a claim limitation is inherent in a prior art reference is a factual issue. . . .” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted). Analysis The following findings of fact establish that Drmanac describes every limitation of the claimed “bead array”: •“A bead array comprising a planar, random assembly of encoded, oligonucleotide-bearing beads” and “different oligonucleotide-bearing beads are randomly distributed throughout the array” (App Br. 7, Claims Appendix). [FF15] Drmanac describes a “random monolayer” of oligonucleotide- bearing beads (FF2, FF3, FF6, & FF8) which meets the limitation of “a planar, random assembly of encoded, oligonucleotide-bearing beads” and of beads “randomly distributed throughout the array.” [FF16] Drmanac explicitly teaches that the DPs (“beads”) do not have to be placed at predetermined positions in the array, but can be randomly displayed, because Drmanac’s method allows the DPs to be recognized by imaging once the DPs have been arrayed randomly in the hybridization area substrate (FF4 & FF6). •Beads “in a designated area on a substrate” and “wherein the beads are in designated positions, in accordance with a given outline” (App Br. 7, Claims Appendix). Appeal 2010-004008 Application 11/436,718 8 [FF17] Drmanac teaches that the DPs (“beads”) are placed in defined hybridization areas of the substrate (FF2, FF8, & FF9) and thus are placed in positions that were designated beforehand to hold the DPs – meeting the limitation of a “designated area” in “designated positions . . . in accordance with a given outline” as those phrases would be understood by a person of skill in the art. •“wherein different oligonucleotides are attached to different beads” (App Br. 7, Claims Appendix). [FF18] Drmanac teaches making DPs (“beads”), each carrying a different ON (oligonucleotide) (FF7). •“said beads are encoded with a fluorescent signature which permits identification of the oligonucleotides attached thereto, and permits distinguishing of individual beads including distinguishing different beads from each other” (App Br. 7, Claims Appendix). [FF19] Drmanac describes labeling the DPs with fluorescent molecules to discriminate between the different DPs having different oligonucleotides (FF4, FF7, & FF11), meeting the “fluorescent signature” limitation of the claim. •“wherein the beads have a diameter of from 2 microns to 20 microns” (App Br. 7, Claims Appendix). [FF20] Drmanac describes using DPs (“beads”) of a 4 µm diameter (FF13), which falls within the claimed range. Appeal 2010-004008 Application 11/436,718 9 •“wherein the beads are in designated positions, in accordance with a given outline.” (App Br. 7, Claims Appendix). [FF21] Drmanac describes making hybridization areas and submatrices of square sizes (FF8 (10 cm x 10 cm) & FF9) and thus describes beads in a “given outline” or outer square boundary – meeting the corresponding limitation of the claim. Appellant’s Arguments Appellant contends that the particles are not “randomly distributed throughout the array” as recited in the claims (App. Br. 3-4). We do not agree. Drmanac expressly refers to “randomly displayed DPs” and a “random monolayer” (FF3 & FF8; FF15 & FF16) – providing explicit support for the claimed limitation. Appellant also contends that Drmanac does not describe “beads . . . in designated positions, in accordance with a given outline.” Appellant states: [t]he fact that HA regions are replicated across the surface does not create beads “in accordance with a given outline.” There is no description in Drmanac that the replicas are placed in a particular position with respect to every other replica, as would be necessary to place the beads in particular positions. (App. Br. 4.) As summarized above, Drmanac describes placing DPs in an area of a substrate that was determined beforehand to be for DPs (FF17), and thus meets the limitation of “designated positions . . . in accordance with a given outline” as we have interpreted that phrase. The hybridization areas comprising the DPs can be square and thus have a “given outline” as recited in the claim (FF21). Appeal 2010-004008 Application 11/436,718 10 Appellant’s argument about Drmanac not describing beads in “a particular position with respect to every other replica” is unpersuasive because the claim does not require this feature. Rather, the beads are expressly recited to be “randomly distributed” in the arrays. The claim also does not require there to be more than one replica in the claimed bead array. The term “designated” as used in the claim means that the area in which the beads are placed was determined beforehand to be a place for the beads – not that the beads must be arrayed in specific predetermined positions within this area. Interpreting claim 114 to require the beads to be in particular positions chosen before arraying would be contrary to the recited limitation that the “beads are randomly distributed throughout the array.” Appellant did not explain how randomly arrayed beads could be “random” and, at the same time, be “placed in a particular position with respect to every other replica” (App. Br. 4). The rejection of claim 114 as anticipated by Drmanac is affirmed. 2. OBVIOUSNESS REJECTION Legal principles Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to Appeal 2010-004008 Application 11/436,718 11 manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted). Once “the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). (citation omitted.) Analysis Claim 143 is drawn to a “bead array” having substantially the same limitations as recited in claim 114, but further reciting that the “beads are affixed to the substrate in an ordered crystalline array configuration.” The Examiner found that Drmanac did not teach a bead array in a crystalline array configuration (Answer 5). However, the Examiner found that “nanoparticles in crystalline arrangement were well known in the art at the time the claimed invention was made as taught by Coffer and Seul.” (Id.) Based on Coffer and Seul, the Examiner concluded: it was well known that aliquots of DNA-containing particles form DNA stabilized crystalline monolayers and the formation was ubiquitous. Therefore, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made that at least some of the particles in the HA of Drmanac would be in crystalline formation. (Id. at 6.) The Examiner’s position is that inherently at least some of the particles in the HA of Drmanac would be in the claimed crystalline array configuration formation. Thus, the issue is whether the Examiner had a factual basis upon which to believe that Drmanac’s beads would be arrayed in a “crystalline array configuration” as recited in claim 143. Appeal 2010-004008 Application 11/436,718 12 The Examiner based the belief on the teachings in Coffer and Seul. We thus turn to these publications. Coffer describes cadmium sulfide crystallites stabilized by DNA (Coffer, p. 69). Cadmium sulfide (CdS) is a semiconductor (id.). The Examiner did not provide sufficient evidence that the discrete particles (DP) disclosed in Drmanac would form lattice planes of crystalline particles as described by Coffer (id. at 71, col. 2). In particular, Drmanac did not describe the material which comprised the DPs (FF14). Thus, there is insufficient information to determine whether Drmanac’s DPs would behave similarly to the CdS crystallites described in Coffer. Consequently, we conclude that the Examiner did not have reasonable basis upon which to believe that Drmanac’s DPs would form a crystalline array. Seul was cited by the Examiner for its “teaching that crystalline configurations are ubiquitous in particle formations and as such, suggests that at least some of the particles of Drmanac would have been in crystalline formation.” This finding is insufficient evidence that the DPs (particles bearing oligonucleotides) described in Drmanac would form crystalline arrays. The Examiner did not show a basis for believing that the DPs of unknown composition (FF14) of Drmanac would form a crystalline array as did the specific particles in Seul. The Examiner also did not provide a reason why a person of ordinary skill in the art would have utilized the particles in either Coffer or Seul as the DPs of Drmanac. In view of the foregoing we reverse the rejection of claim 143, and claims 116, 117, and 144 which depend on claim 143 and incorporate all the limitations of claim 143. Appeal 2010-004008 Application 11/436,718 13 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-IN-PART rvb Copy with citationCopy as parenthetical citation