Ex Parte 7449289 et alDownload PDFPatent Trials and Appeals BoardAug 27, 201495001599 - (R) (P.T.A.B. Aug. 27, 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. 95/001,599 04/08/2011 7449289 GENOM.051X(P-7330 RX) 7698 95896 7590 05/26/2015 David W. Highet, VP and Chief IP Counsel Becton, Dickinson and Company (Knobbe Martens) 1 Becton Drive, MC-110 Franklin Lakes, NJ 07417 EXAMINER TURNER, SHARON L ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 05/26/2015 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 ____________ BECKMAN COULTER, INC. Requester and Respondent v. GENEOHM SCIENCES CANADA, INC. Patent Owner and Appellant ____________ Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and JEFFREY B. ROBERTSON, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON REQUEST FOR HEARING This is decision on Requests for Rehearing under 37 C.F.R. § 41.79 by Patent Owner (“PO Req. Reh’g” dated Sept. 26, 2014) and Third Party Requester (“TPR Req. Reh’g” dated Sept. 29, 2014) of the Patent Trial and Appeal Board Decision on Appeal of Aug. 28, 2014 (“Dec. App.”). Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 2 I. PATENT OWNER’S REQUEST FOR REHEARING 1. Anticipation of claim 1 by Oliveira 2000 Patent Owner contends that the Board’s decision to affirm the rejection of claim 1 as anticipated by Oliveira 2000 is not supported by substantial evidence. PO Req. Reh’g 2. It was stated in the Board’s decision that, as “shown in Figure 1 [of Oliveira 2000], IS P4 in combination with a reverse MDV primer would amplify a region comprising IS431 which contains SEQ ID NO: 42.” Dec. App. 24. This statement about IS431 containing SEQ ID NO: 42 was based on disclosure in the ’289 patent. According to the ’289 patent, SEQ ID NO: 42 “exhibited nearly 100% identity with IS431.” ’289 patent, col. 17, ll. 45-46. The patent discloses that the inventors’ “sequence data revealed for the first time the location of this IS431 sequence at the right extremity of SCCmec adjacent to the integration site.” Id. at col. 17, ll. 47-49. IS431 encodes a transposase and had been described previously “within the right segment of SCCmec.[”] Id. at col. 13, ll. 64-67. Id. at 9, However, as pointed out by Patent Owner, Attachment 1 shows that only 61 nucleotides of SEQ ID NO: 42 are within the actual IS431 element. PO Req. Reh’g 3. Thus, the statement in the Decision that “IS431 . . . contains SEQ ID NO: 42” was an error. We have not been pointed to evidence that any other part of SEQ ID NO: 42 is present in Oliveira 2000. As discussed in the Decision, strain 85/2082 said to contain SEQ ID NO: 42 at the MREJ (MRSA polymorphic right extremity junction) region, is not disclosed in Oliveira 2000. Dec. App. 23. The issue is therefore whether amplification of a part of IS431 in the MREJ region is sufficient to meet the claim limitation. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 3 We have interpreted the claim to cover amplifying only a part of SEQ ID NO: 42, as long as that part is indicative of a MREJ type iv MRSA strain. Dec. App. 8. As discussed on page 24 of the Decision on Appeal, the IS431 element is a part of the right extremity MREJ region. Patent Owner’s statement that it is not the rightmost region is not persuasive since the claim does not specify that the amplified region must be the rightmost. PO Req. Reh’g 3-4. In addition, because the claim does not require the complete SEQ ID NO: 42 to be amplified as acknowledged by Patent Owner (see PO Req Reh’g 4 “It is not necessary to decide whether all or only some of the sequence of SEQ ID NO: 42 constitutes ‘the MREJ region sequence’”), we conclude that amplification of a part of IS431 which is present in the right extremity region (see Oliveira 2000, Fig. 1) is sufficient to anticipate the claim 1. Consequently, while we agree the Decision on Appeal contained an error, this error does not change the determination that the claim 1 is anticipated by Oliveira 2000. 2. Obviousness of claim 5 in view of Oliveira 2000 In the Decision, the Board entered a new ground of rejection of claim 5 in view of Oliveira 2000 combined with the ’507 patent or Hiramatsu 1996. Dec. App. 40. Claim 5 depends from claim 1 and specifies which sequence identifiers are indicative of which MREJ type. Patent Owner contends we erred in affirming the rejection of this claim for the same reasons as for claim 1. PO Req. Reh’g 8. Since we have found that the portion of IS431 present in the right extremity of Fig. 1 of Oliveira 2000 would be indicative of a MREJ type iv (’289 patent, col. 13, ll. 64–67), we decline to modify our Decision with respect to this claim. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 4 Summary Patent Owner’s Request for Rehearing is DENIED. II. REQUESTER’S REQUEST FOR REHEARING 1. Claim Interpretation Requester contends that the Board’s interpretation of claim 1 improperly imports a limitation from the specification of the ’289 patent into the claim. TPR Req. Reh’g 3. Specifically, Requester argues that the Board’s “definition of MREJ imported a limitation from the specification that the MREJ region sequences are only sequences ‘adjacent’ to the junction site and therefore excludes some but not all DNA sequences that are found farther upstream from integration site but are still downstream of mecA.” Id. at 3–4. In support of this position, Requester contends that “MREJ region” as used in the claim and the ’289 patent uses the term “includes” which is open-ended. Id. at 5. This argument is insufficient to show error in the Board’s interpretation. The claim recites that the MREJ region “includes sequence from both the SCCmec insert right extremity and chromosomal DNA adjoining that right extremity.” First, while it is true that “includes” is open-ended and could include additional sequence, the term “MREJ” itself would limit it to sequences of the right extremity. Second, the claim requires amplification of a MREJ region selected from a specific group of recited sequences, including SEQ ID NO: 42. The recited sequences correspond to a “MREJ region, which term is used in the ’289 patent and the prior art to mean sequences bracketing the right SCCmec-chromosome junction point. Dec. App. 6–8. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 5 Claims must be interpreted in the context of the specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). It is clear from reading the ’289 patent that the invention is based on the discovery of MREJ sequences which are located in the right extremity region of the MRSA chromosome (Dec. App. 3–4), and not sequences in the entire right downstream region as argued by Requester. 2. Anticipation by the ’507 patent The Decision on Appeal reversed the anticipation rejection of claims 1, 2, and 5 for two reasons. First, the Decision concluded that the Examiner had not provided sufficient evidence that SEQ ID NO: 42, present in bacterial strain 85/2082, is situated in the mecA “right extremity” junction. Dec. App. 12-13. Rather, it was found that the sequence is “located 31 kb from the integration junction” in a “downstream region, but not in the right extremity as required by the claim. Id. at 13. Second, it was concluded in the Decision that the Examiner did not establish by a preponderance of the evidence that primers were described in the ’507 patent that would amplify SEQ ID NO: 42. Id. Requester contends that “the PTAB’s requirement for the prior art to disclose a specific primer pair is improper as the PTAB itself recognizes that claim 1 does not require a specific primer pair.” TPR Req. Reh’g 8. This argument is not persuasive. The Decision did not require disclosure of a “specific primer pair,” but rather only a primer pair enabling for the amplification of an MREJ region. Dec. App. 13. The Decision found that the Examiner did not establish that primers were present in the ’507 patent that would amplify SEQ ID NO: 42. Id. Requester argues that there are examples in the ’507 patent that combine a mec side primer Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 6 with a junction side primer which “would allow one of skill in the art to envisage using the primers to amplify IS431.” Id. at 9 (emphasis added). It is unclear to what “the primers” Requester is referring. Requester mentions Nmec5 and Gmec 1045 in the Requester for Rehearing (id.), but it does not appear that these primers were said to be anticipatory in the Request for Reexamination. At the very least, Requester has not identified how this primer pair meets the claimed step of “contacting the sample with at least two primers” to amplify a sequence of SEQ ID NO: 42. With respect to the idea of envisaging choosing mecA and junction side primers (id.) to amplify an MREJ region, this alleged disclosure in the ’507 patent is not specific enough to anticipate the claimed subject matter because it requires a choice of primers from numerous sequences disclosed in the ’507 patent. Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999 (Fed. Cir. 2006). Consequently, we find Requester’s arguments unavailing. 3. Anticipation by Ito The anticipation rejection by Ito was reversed because there was insufficient evidence that a primer pair was disclosed in Ito that amplifies a MREJ region sequence which includes sequence from SEQ ID NO: 42. Dec. Appeal 20-21. The Decision identified tetK4 and merA1 primers as amplifying a part of a sequence of SEQ ID NO: 42, but determined that such sequence was not in the right extremity as required by the claim. Id. at 21. Requester urges in the Request for Rehearing that that “[o]ne of skill in the art would understand that primers can be designed” to unique regions that meet the claimed step of amplifying the MREJ region, but fails to explain how such “understanding” teaches with sufficient specificity the Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 7 amplification of an MREJ region corresponding to one of the recited sequence identifiers as required by an anticipation rejection. TPR Req. Reh’g 9. Atofina, 441 F.3d at 999. Consequently, Requester’s arguments do not convince us of error. 4. Anticipation by Oliveira 2001 Oliveira 2001 is cited as anticipatory under 35 U.S.C. § 102(a) (pre-AIA). To rebut the rejection, Patent Owner provided a declaration under 37 C.F.R. § 1.131 to establish that the inventors reduced to practice as much of the embodiment of claims 1, 2, and 5 said to be shown in Oliveira 2001. PO Appeal Br. 24; Declaration of Ann Huletsky, dated July 30, 2011 (“Huletsky Decl.”). The Decision found the declaration to be effective for the purpose of antedating Oliveira 2001. To antedate Oliveira 2001, it must be shown that the declaration shows as much as the invention which is taught by the publication. In re Stempel, 241 F.2d 755, 760 (CCPA 1957). First, it must be determined what Oliveira 2001 describes. Oliveira 2001 is said to be anticipatory because it is said to disclose primers which would yield amplicons within SEQ ID NO: 42-46, and 51. Request 46. Although SEQ ID NO:42 may not be 100% identical to the sequences in Oliveira 2001, such identity is not necessary as long as there are amplicons within SEQ ID NO: 42 which share 100% identity within amplicons disclosed in Oliveira 2001. To show that the inventors reduced to practice as much as shown in Oliveira 2001, i.e., an amplicon within SEQ ID NO: 42, Ms. Huletsky referred to Canadian Patent Application No. CA 02348042 (“the ’042 Application”) as describing SEQ ID NO: 42 and primers SEQ ID NOS: 64 and 79, which produced an amplicon from SEQ ID NO: 42 which is within the scope of claim 1. Huletsky Decl. ¶ 7. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 8 Neither the Examiner nor Requester provided evidence that such amplicon is not present in Oliveira 2001. Requester contends that the Board erred because: The Huletsky Declaration fails to establish possession of the invention or something falling within the scope of the claims. The legal standard requires that the signed Declaration itself must establish possession of the claimed subject matter and this Declaration fails to do so. This Declaration does not incorporate the Canadian priority document but rather selects out certain portions of the priority document, and then improperly uses those selected portions to conclude that the evidence is sufficient to support amplification of the MREJ region of at least one of NOs: 42, 43, 44, 45, 46, and 51. The Huletsky Declaration cannot establish possession of primers that amplify the MREJ region sequence of SEQ ID NO: 43-46 and 50 because those sequences in the Canadian priority document differ from those filed in the PCT application. TPR Req. Reh’g 10. This argument is not persuasive. The Canadian ’042 application contains the data which Ms. Huletsky relied upon to establish reduction to practice of an embodiment within the scope of the claim, i.e., SEQ ID NO: 42 and primers 64 and 79. It is common sense that a declaration establishing reduction to practice would necessarily need to refer to outside documents for such evidence, as is the case here, to show that what was asserted to have been done by a specific date was actually done. Requester did not provide sufficient legal basis to exclude the Huletsky declaration because the declarant required the ’042 application to prove the existence of an embodiment of the invention prior to the publication of Oliveira 2001. The rule, itself, permits “exhibits of drawings or records” to “accompany and form part of the affidavit and declaration.” 37 C.F.R. § 1.131(b). Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 9 Requester, as well as the Examiner, further found fault with the declaration because only one embodiment was shown. TPR Req. Reh’g 10-11. Requester has ignored In re Spiller, 500 F.2d 1170, 1177 (CCPA 1974) and In re Schreiber, 587 F. 2d 59, 62 (CCPA 1978) which establish that an applicant only has to show as much as what the reference discloses, or so much to render it obvious. Dec. App. 25 (fn. 12). In this case, the disclosure of SEQ ID NO: 42 as indicative of type iv MRSA strain, and primers 64 and 79, would render any sequence amplicon within SEQ ID NO: 42 obvious because the selection of other amplicons and oligonucleotides from the larger genus was routine and conventional at the time of the invention and because such amplicons and oligonucleotides could readily be envisaged. In re Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009) (“a person of ordinary skill in the art equipped with an IGFBP sequence is admittedly capable of envisioning how to make any antisense sequence”). Requester also contends: . . . alignment of primer SEQ ID NO:79 with SEQ ID NO:42 shows that this primer will not amplify the entire sequence of SEQ ID NO:42. The Declaration provides no explanation as to why amplifying a portion of the sequence of SEQ ID NO:42 is sufficient to establish possession of the entire sequence or why a single species of primer was sufficient to antedate a genus of amplicons as disclosed in Oliveira 2001. TPR Req. Reh’g 11. As explained in the claim interpretation section, the claim does not require that the primers amplify the complete sequence of SEQ ID NO: 42. According to the ’289 patent, primers 68 and 70 were initially utilized to discover SEQ ID NO: 42 as residing in the MREJ of certain MRSA strains, leading to the identification of a marker for the type iv MRSA. ’289 patent, col. 14, ll. 3–9, 38– Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 10 43, 53–59. Subsequently, primers 64 and 79 were used to amplify MRSA DNA and determine whether the strain is a type IV MRSA. Id. at col. 5, l. 55; col. 7, ll. 21–22. The amplicon produced by these primers appears to be 215 bps (id. at col. 34, l. 12), which is less than the 1045 bp size of SEQ ID NO: 42 (id. at col. 85– 86). 1 The Canadian ’042 application identifies the SEQ ID NO: 42 and primers 64 and 79 within it, which are used to detect the type IV MRSA. Thus, such disclosure shows possession of embodiment of the claim. This embodiment is sufficient to antedate Oliveira 2001 because it shows an amplicon indicative of an MREJ type iv, and renders obvious other amplicons within SEQ ID NO: 42 obvious. Requester further contends that the Huletsky declaration is defective because the “sequence of SEQ ID NO: 42 is not the same as HDG2 [of Oliveira 2001] (it has 99% sequence identity)” and the primer used to amplify the HDG2 sequence was different in sequence than SEQ ID NO:79. TPR Reh’g Req. 11. The rejection was based on the following finding: “Oliveira [2001] reference discloses several species of the claimed invention via disclosure of a number of different primer sets, and different sample DNAs corresponding to different sequences from the same (MRSA mecA-ofrX) MREJ regions which produce an amplicon.” RAN 18. The claim does not require specific primer sets as long as they amplify an MREJ region of a MREJ type iv. It is not necessary to find 100% identity to the complete SEQ ID NO: 42 sequence or to the specific primers disclosed in the ’289 patent because the claims are not limited to SEQ ID 1 This disclosure of primers 64 and 79 to produce an amplicon less than full-length SEQ ID NO: 42 is further evidence of the correctness of the construction of claim 1 to read on amplification of portions of SEQ ID NO: 42 to determine whether a strain is a type iv MRSA. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 11 NO: 42 in its entirety nor to a specific primer set. Ms. Huletsky provided adequate evidence that a sample was contacted with two primers which were capable of amplifying a sequence of SEQ ID NO: 42 as required by the claim. This embodiment is the same as the teaching in Oliveira 2001. Requester’s further requirement that amplicon be the same and the primers be the same is unwarranted since the claims are not limited to a specific amplicon or primer set, and the specific showing of primer set 64 and 79, and SEQ ID NO: 42, renders the full scope of the claim obvious under the Spiller doctrine. 5. Obviousness over Oliveira 2000 in view of the ’507 patent or Hiramatsu 1996 The Board reversed the Examiner’s determination not to reject 5 as obvious over Oliveira 2000 in view of the ’507 patent or Hiramatsu 1996, but not with respect to the proposed rejections of claims 2-4. Dec. App. 38-40 Claim 2 Claim 2 depends from claim 1, and further recites “wherein said at least two primers further include at least two primers that amplify the MREJ region sequence of anyone of SEQ ID NOs: 1, 20, 21, 22, 23, 24, 25, 41, 199, 2, 17, 18, 19, 26, 40, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 185, 186, 197, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 104, 184, and 198 under conditions of 50 mM KCl, 10 mM Tris-HC1 (pH 9.0), 0.1% Triton X-100, 2.5 mM MgCl2, at 55°C.” Requester contends that we overlooked the teaching in the ’507 patent of primers that would amplify one of the recited MREJ sequences recited in claim 2. TPR Req. Reh’g 13. Requester cited previous arguments during the reexamination Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 12 proceeding that the primers utilized to identify the recited sequences are the same as those in the ’507 patent. Id. We have not been pointed to evidence to the contrary. Thus, we agree with Requester that it would have been obvious to combine the primers for a type i MREP sequence of Hiramatsu ’507 with primers to detect a type iv MREP sequence using the primers of Oliveira 2000. Id. Consequently, we REVERSE the Examiner’s decision not to adopt the obviousness rejection of claim 2. Claim 3 Claim 3 depends from claim 1, and further recites “wherein said at least two primers include SEQ ID NO: 64 and at least one of the following primers: SEQ ID NO: 79 for the detection of MREJ type iv; SEQ ID NO: 80 for the detection of MREJ type v; SEQ ID NO: 204 for the detection of MREJ type vi; SEQ ID NO: 112 for the detection of MREJ type vii; SEQ ID NO: 113 for the detection of MREJ type vii; SEQ ID NO: 115 for the detection of MREJ type viii; SEQ ID NO: 116 for the detection of MREJ type viii; and SEQ ID NO: 109 for the detection of MREJ type ix.” Requester contends that the Board erred in not reversing the Examiner’s determination not to adopt the obviousness rejection. However, Requester has not provided evidence that the claimed sequences are present in either Oliveira 2000 or the ’507 patent. TRP Req. Reh’g 13-14. Consequently, absent such evidence, we maintain our decision to affirm the Examiner’s decision not to adopt the rejection. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 13 Claim 4 Claim 4 depends from claim 1, and further recites “comprising detecting the presence of SEQ ID NO: 172 as indicative of the presence of MREJ type x.” Requester contends that one of ordinary skill in the art “using the same strategy and methods as explicitly disclosed in any of the cited references would detect a sequence of SEQ ID NO: 172 if it was present in a strain using primers in accord with the disclosure of the '507 patent, or Oliveira 2000.” TPR Req. Reh’g 14. Requester has not presented evidence that SEQ ID NO 172 is present in any of the MRSA strains in the cited publications. Consequently, there is insufficient evidence that the Board misapprehended or overlooked any points in affirming the Examiner’s decision not to adopt the rejection of claim 4. 6. Obviousness over the ’507 patent or Ito in view of Hiramatsu 1996, Cheng (Grounds 11 and 12) The Board concluded that the Examiner correctly did not adopt the rejections of independent claim 1, and dependent claims 2-5, as obvious in view of the ’507 patent, Hiramatsu 1996, and Cheng (Rejection 11); and Ito, Hiramatsu 1996, and Cheng (Rejection 12). The Board found that Requester did not show the presence of SEQ ID NO: 42 in the right extremity in the only two strains for which public availably had been established. Dec. App. 33. Citing In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), Requester contends that the Board applied the wrong standard. TPR Req. Reh’g 15. Requester states: Many of the bacterial strains recited in the ’289 specification and used to identify the listed sequences of claim 1 were in the public domain and were known naturally occurring MRSA strains. One of ordinary skill in the art would have become aware that the Hiramatsu primers Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 14 were not working, but aware of the genetic variations, would have easily used Hiramatsu’s sequencing strategy, or at the least would have used a commercially available sequencer to sequence the DNA genes downstream of mecA as taught by the prior art and then do a simple comparison to determine the differences between sequences of all of the known MRSA strains. Id. at 15-16. Requester has not provided evidence that “the listed sequences of claim 1 were in the public domain and were known naturally occurring MRSA strains.” Id. In Kubin, claims to the DNA sequence encoding a NAIL protein were found to be obvious because the evidence showed the NAIL protein was known and a cDNA library from which to clone the cDNA encoding NAIL was also known. Kubin at 1354. Thus, the source from which to obtain a NAIL cDNA had been established in Kubin. In this case, Requester contends strains from which to obtain SEQ ID NO: 42 were publically available, but did not provide evidence of it. Accordingly, this case is readily distinguishable from Kubin. Summary We decline to modify the Decision on Appeal with respect to 1) claim interpretation, 2) anticipation by the ’507 patent, 3) anticipation by Ito, 4) Huletsky declaration antedating Oliveira 2001, and 5) obviousness of claims 3 and 4 over Oliveira 2000 in view of the 507 patent or Hiramatsu 1996; and 6) obviousness over the ’507 patent or Ito in view of Hiramatsu 1996, and Cheng. We modify the Decision on Appeal with respect the proposed obviousness rejection over Oliveira 2000 in view of the ’507 patent or Hiramatsu 1996 by reversing the Examiner’s determination not to adopt the rejection of claim 2. Requester’s Request for Rehearing is GRANTED-IN-PART. Appeal 2014-002900 Reexamination Control 95/001,599 Patent 7,449,289 B2 15 Patent Owner: Ned A. Israelsen KNOBBE, MARTENS, OLSON & BEAR LLP 12790 El Camino Real San Diego, CA 92130 Third Party Requester: Katherine M. Kowalchyk MERCHANT & GOULD, P.C. Representative for Beckman Coulter, Inc. P.O. Box 2903 Minneapolis, MN 55402-0903 Copy with citationCopy as parenthetical citation