Ex Parte 7838221 et alDownload PDFPatent Trial and Appeal BoardFeb 25, 201695002216 (P.T.A.B. Feb. 25, 2016) 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. 95/002,216 09/13/2012 7838221 GENOM.057X1(P-7322RE) 1078 95896 7590 02/25/2016 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 02/25/2016 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 Appellant v. GENEOHM SCIENCES CANADA, INC. Patent Owner and Respondent ____________ Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and JEFFREY B. ROBERTSON, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal by the Requester from the Patent Examiner’s final decision to not adopt rejections of claims 1–14 in the above-identified inter partes reexamination of US 7,449,289 B2. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We affirm the Examiner’s decision. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 2 I. BACKGROUND The patent in dispute in this appeal is US 7,838,221 B2 (“the ’221 patent”) which issued November 23, 2010. A request for inter partes reexamination of the ’221 patent under 35 U.S.C. §§ 311-318 and 37 C.F.R. §§ 1.902-1.997 was filed September 13, 2012. The Requester is Beckman Coulter, Inc. (“Requester”). Appeal Br. 3. The real party in interest for the ’221 patent is GeneOhm Sciences Canada, Inc. (“Patent Owner”). Patent Owner Respondent Brief (“Resp’t Br.”) 3. The claimed subject matter of the ’221 patent relates to a method to detect the presence of a methicillin-resistant type xiii Staphylococcus aureus (MRSA) strain in a specimen. S. aureus is a human opportunistic pathogen which is major cause of morbidity and mortality. ’221 patent, col. 1, ll. 23–25. “Some of the most common infections caused by S. aureus involve the skin.” Id. at col. 1, ll. 25–26. “Some of the more serious infections produced by S. aureus are bacteremia, pneumonia, osteomyelitis, acute endocarditis, myocarditis, pericarditis, cerebritis, meningitis, scalded skin syndrome, and various abscesses.” Id. at col. 1, ll. 28–31. “Methicillin-resistant S. aureus (MRSA) emerged in the 1980s as a major clinical and epidemiologic problem in hospitals.” ’221 patent, col. 1, ll. 36–38. MRSA are resistant to all β-lactams, including penicillins and cephalosporins, which are some of the most commonly used antibiotics to treat S. aureus infections. Id. at col. 1, ll. 39–41. Methicillin-resistance is conferred by the acquisition of the mecA gene. ’221 patent, col. 1, ll. 51–64. It was discovered previously that the mecA gene is carried by a genetic element, designated as the staphylococcal cassette chromosome mec (SCCmec), which is inserted into the chromosomal DNA. Id. at Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 3 col. 1, l. 5 to col. 2, l. 3. The patent teaches that there are various “types” of MRSA strains which differ in the sequence of the region where the SCCmec integrates into the chromosomal DNA. Id. at col. 3, ll. 10–13. The ’221 patent describes published methods of characterizing different MRSA strains by using primers that “hybridize to the right extremities of the 3 types of SCCmec DNAs in combination with a primer specific to the S. aureus chromosome, which corresponds to the nucleotide sequence on the right side of the SCCmec integration site.” Id. at col. 2, ll. 63–66. These methods are called “MREP typing” (mec right extremity polymorphism) because of the presence of polymorphisms around the integration site. Id. at col. 3, ll. 6 –7. The ’221 patent claims are specifically directed to the detection of a type xiii MRSA strain. Type xiii MRSA differs in sequence from previously known MRSA types. The ’221 patent teaches that the nucleotide sequences from the right extremity of SSCmec obtained from type xiii bacterial strains were different from previously known MRSA types by lacking a 102 bp insertion found in several other types, and that this difference could be identified by amplicon size. Id. at col. 20, ll. 59–64; col. 21, ll. 5–8; Fig. 2; Appeal Br. 14. II. RELATED APPEALS This appeal is related to Reexamination Control No. 95/001,599 of U.S. Patent No. 7,449,289. A decision by the Patent Trial and Appeal Board was issued August 28, 2014. An Inter Partes Reexamination Certificate issued on Dec. 7, 2015 confirming the patentability of claims 3 and 4, and canceling claims 1, 2, and 5. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 4 III. REJECTIONS In view of claim amendments made by Patent Owner, the Examiner withdrew the following rejections: 1. Claims 1–14 under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by WO 02/099034 (Huletsky et al., published December 12, 2001) (“the ’034 WO Application”); 2. Claim 1–2, 5, 6, 9 and 11–14 under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by EP 1529847 (Cuny et al., published November 5, 2015) (“the ’847 EP application”); 3. Claims 1–14 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Ito et al. (2001), Antimicrobial Agents and Chemotherapy, 45: 1323-1336 (“Ito”) and the ’034 WO Application. Requester appeals from the Examiner’s withdrawal of the rejections. Appeal Br. 4. 4. Requester also contends that the claim amendments made by Patent Owner on March 19, 2014 do not meet the requirements of 35 U.S.C. § 112. Id. at 10–12. Although Requester specifically mentions § 112, second paragraph (pre- AIA), the arguments also implicate § 112, first paragraph for lack of written description (pre-AIA). Id. We therefore have addressed both statutory requirements. IV. CLAIM Claim 1 is the only independent claim on appeal. Claims 2–14 depend from claim 14. Claim 1 reads as follows [brackets indicate deleted material and underling indicates added material relative to the original claims]: Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 5 1. A method to detect the presence of an MREJ type xiii methicillin resistant Staphylococcus aureus (MRSA) strain comprising: contacting a first primer and a second primer with a sample to be analyzed for the presence of said MREJ type xiii MRSA strain, said MREJ type xiii MRSA strain including a Staphylococcal cassette chromosome mec (SCCmec) element containing a mecA gene inserted into chromosomal DNA, thereby generating a polymorphic right extremity junction (MREJ) type xiii sequence that comprises sequences from both the SCCmec element right extremity and chromosomal DNA adjoining said right extremity, wherein said first and second primers are at least 10 nucleotides in length, and wherein said first primer is specific for and hybridizes with said SCCmec element right extremity of an MREJ type xiii sequence selected from the group consisting of SEQ ID NOs: 15, 25 and 26 and complements thereof, and wherein said second primer hybridizes with a chromosomal sequence of S. aureus, wherein said first primer and said second primer together generate a first amplicon of MREJ type xiii specific sequences that spans the mec right extremity junction of MREJ type xiii sequences under amplification conditions only if said MREJ type xiii MRSA strain is present in the sample; and wherein said contacting of said first primer and said second primer takes place under annealing conditions; and [[wherein generating and ]]detecting the presence of said first amplicon of MREJ type xiii specific sequences as indicative of the presence of said MREJ type xiii MRSA strain in the sample. V. ENTRY OF CLAIM AMENDMENTS Requester contends the claim amendments made March 19, 2014 by Patent Owner are improper and should not have been entered. Appeal Br. 8. The proprietary of the Examiner’s action in entering a claim amendment is not appealable to the Patent Trial and Appeal Board (“PTAB”). Under 35 U.S.C. 134, only rejections of a claim are appealable to the PTAB. Consequently, we shall not consider this issue. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 6 VI. ANTICIPATION REJECTIONS Claim 1 requires “contacting a first primer and a second primer with a sample to be analyzed for the presence of said MREJ type xiii MRSA strain.” The first primer “is specific for and hybridizes with said SCCmec element right extremity of an MREJ type xiii sequence selected from the group consisting of SEQ ID NOs: 15, 25 and 26 and complements thereof.” The second primer “hybridizes with a chromosomal sequence of S. aureus.” The claim further requires that “said first primer and said second primer together generate a first amplicon of MREJ type xiii specific sequences that spans the mec right extremity junction of MREJ type xiii sequences under amplification conditions only if said MREJ type xiii MRSA strain is present in the sample.” (Underlining indicates amendment to original claim.) Requester contends that each of the ’034 WO Application and the ’847 EP Application describe the first and second primers recited in the claim. Appeal Br. 12–13; 22–23. While Requester does not identify MREJ type xiii specific sequences in the’034 WO and the ’847 EP Applications, Requester contends that the claim does not require detection of type xiii sequences. Id. at 14. Rather, Requester contends that the claim covers detecting the presence or absence of MREJ type xiii sequences. Id. at 7. When the type xiii sequences are absent from the sample, Requester argues that the claim is anticipated by the ’034 WO Application and the ’847 EP Application which utilize the same primers as claimed, albeit to detect other MRSA types. The Examiner construed the claim to require generating a first amplicon of MREJ type xiii specific sequences and detecting the presence of the type xiii specific amplicon as indicative of the strains presence in the sample. RAN 6–7. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 7 Since neither of the ’034 WO Application and the ’847 EP Application detected type xiii sequences, the Examiner did not adopt the rejections. The principal issue in both anticipation rejections is the proper interpretation of claim 1. We thus must begin with claim interpretation. Claim interpretation Claim 1 is drawn to a “method to detect the presence of an MREJ type xiii methicillin resistant Staphylococcus aureus (MRSA).” The method comprises a “contacting” step and “detecting” step. The “detecting” step was added by amendment on March 19, 2014 in which Patent Owner deleted “wherein generating” from the claim and amended the claim to explicitly require “detecting the presence of said first amplicon of MREJ type xiii specific sequences.” Despite the recitation of an explicit step in which of MREJ type xiii sequences are detected, Requester contends that the claim reads on carrying out the “contacting” step but not “detecting” the type xiii sequences because the claim also recites (emphasis added: wherein said first primer and said second primer together generate a first amplicon of MREJ type xiii specific sequences that spans the mec right extremity junction of MREJ type xiii sequences under amplification conditions only if said MREJ type xiii MRSA strain is present in the sample. Requester argues that the “plain meaning” of the claim in view of the “only if” clause “is that the claims encompass assays in which the amplicon is produced only under certain circumstances, i.e., when the MREJ type xiii strain is present in the sample.” Rebuttal Br. 4. Requester also contends that the “detecting” step “encompasses a physical detection step suitable for detecting the presence of any Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 8 MREJ amplicon, regardless of the particular MREJ type that is actually detected.” Appeal Br. 8. The question is whether the “wherein” clause stating that an amplicon is generated “only if” the “MREJ type xiii MRSA strain is present in the sample” has the effect of enlarging the scope of the claim to embodiments in which the strain is absent from the sample. In our opinion, this is not the broadest reasonable interpretation of the claim. (During reexamination of an unexpired patent, claims are given their broadest reasonable interpretation consistent with the patent specification. In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010); In re Abbott Diabetes Care Inc., 696 F.3d 1142, 1148 (Fed. Cir. 2012).) To begin with, the claim preamble recites a “method to detect the presence of an MREJ type xiii methicillin resistant Staphylococcus aureus (MRSA) strain.” The claim preamble thus positively recites to “detect the presence of” the type xiii strain, not the presence or absence of it. Presence or absence is an embodiment contemplated by the ’221 patent. (See ’221 patent, col. 8, ll. 13–15: “Also disclosed herein are methods providing for the detection of the presence or absence of an MRSA strain in a sample that includes nucleic acids.”) However, presence or absence is not recited in the claim preamble. The “terms appearing in a preamble may be deemed limitations of a claim when they ‘give meaning to the claim and properly define the invention.’” In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir. 1994). “Language in a preamble limits a claim where it breathes life and meaning into the claim . . . but not where it merely recites a purpose or intended use of the invention.” (Internal citations omitted.) Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1118 (Fed. Cir. 2004). Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 9 The claim also positively recites a step in which the type xiii MRSA strain is detected: “detecting the presence of said first amplicon of MREJ type xiii specific sequences as indicative of the presence of said MREJ type xiii MRSA strain in the sample.” When this step is read in the context of the claim preamble, it would be understood by one of skill in the art that the step requires the presence of an MREJ type xiii amplicon to be physically detected. If the physical step of detecting the amplicon of MREJ type xiii specific sequences is not accomplished, the claim is not performed. The “wherein” clause is not inconsistent with this interpretation. The “wherein” clause states that an “amplicon of MREJ type xiii specific sequences” is “generate[d] . . . only if” the type xiii MRSA strain “is present in the sample.” This language is a statement that, when (“only if”) the type xiii strain is present in the sample, an amplicon “specific” for it is generated. In other words, it is an assertion that a “specific” amplicon for type xiii strains is generated by the first and second primers. Because both the claim preamble and the detecting step require detecting the presence of the type xiii MRSA strain, it would be unreasonable to read the “wherein clause” as broadening the claim to cover identifying the absence of the type xiii strain when no MREJ type xiii specific amplicon sequences is generated. In reaching this determination, we do not find the “wherein” clause to be non-limiting, but rather construe it to be statement of the properties of the two primers when they contact a MREJ type xiii MRSA strain under annealing condition as required by the claim. See Griffin v. Bertina, 285 F.3d 1029, 1033–34 (Fed. Cir. 2002) stating that whether a “wherein” clause is limiting is “fact- specific” and depends on the context in which it is recited in the claim. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 10 Requester’s contention that the claim covers conducting the “contacting” step in the absence of detecting a type xiii MRSA specific amplicon and without detecting it ignore the claim preamble, the positive recitation of a “detecting” step, and construes the “wherein” clause broader than reasonably justified by the full context of the claim. Anticipation The anticipation rejections are based on Requester’s contention that each of the ’034 WO Application and the ’847 EP Application describe the same typing MRSA assay and primers as claimed. Appeal Br. 12–24. Requester does not assert, nor provide evidence, that the cited published patent applications describe a type xiii MRSA strain. Instead, Requester asserts that the claims do not require the presence of a type xiii strain. Id. at 14, 24. As explained above, Requester’s interpretation of the claim is not reasonable. The claims require detecting the presence of a type xiii MRSA strain. Requester also argues: Since the primers described in the ’034 application hybridize to MREJ type xiii, the methods described there would necessarily result in the generation of an MREJ type xiii specific amplicon, if the MREJ type xiii strain were present in the sample. Id. at 15. However, no evidence has been presented that the ’034 WO Application, nor the ’847 EP Application, describe a sample with a type xiii MRSA strain. VII. OBVIOUSNESS REJECTION Requester contends that the Examiner erred in failing to reject claim 1–14 under 35 U.S.C. § 103 as obvious in view of Ito and the ’034 WO Application. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 11 Requester states that Ito describes PCR-based, MREP typing on different MRSA strains. Appeal Br. 24. Requester further states that “the ‘034 application follows on Ito et al. and provides sequence information for the MREJ region of an additional seven MRSA strains (MREJ types iv to x) that were available from public depositories.” Id. at 25. Requester contends that the type xiii strains “identified as ‘new’ in the ’221 patent were previously known clinical isolates and references strains that had been deposited in publicly available depositories.” Id. Requester argues that it would have been obvious to one of ordinary skill in the art to have obtained these strains and design primers to them based on the new sequence information obtained from them. Id. at 26–27. The Examiner did not adopt the rejection. The Examiner explained: The prior art fails to demonstrate the existence of such [type xiii] strains, such sequence differences, their location and size, or the ability to identify such differences as type xiii, based upon any prior art procedure. There was no foreknowledge that such type xiii strains existed, nor could the artisan be assured that the standard procedures would have found them. RAN 16. Requester has not provided persuasive evidence to establish the obviousness of the claimed subject matter. The ‘221 patent lists strains CCR1-11976, -12382, and -12383 as the sources of the type xiii sequences. ’221 patent, Table 3 and 8. However, Requester has not provided persuasive evidence that CCRI strains - 11976, -12382, and -12383 were publically available and characterized as MRSA strains. Absent such information, the skilled worker would not have had the starting materials readily available, and/or known they were MRSA strains, which could have provided the basis to select them and characterize by the methods Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 12 described in Ito and the ’034 WO Application. Consequently, we affirm the Examiner’s decision not to adopt the rejection. SECTION 112 Requester contends that claim amendments do not comply with 35 U.S.C. ¶ 112. Requester contends that the ’221 patent “fails to disclose a single detection method or primer that is specific to the detection of only an MREJ type xiii- specific amplicon.” Appeal Br. 10. Requester also contends the term “MREJ type xiii specific sequences” lacks support in the Specification and is ambiguous because “it is not clear whether the amendments to claim 1 require generation of an amplicon comprising sequences that are truly unique to MREJ type xiii, or whether such sequences may also be present in other MREJ types.” Id. at 11. To satisfy the written description requirement under 35 U.S.C § 112, the inventor “must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). Requester’s arguments are not supported by persuasive evidence. The claims do not require the first and second primer to be specific for a type xiii sequence. Rather, the claims recite “first primer . . . specific for and hybridizes with said SCCmec element right extremity of an MREJ type xiii sequence selected from the group consisting of SEQ ID NOs: 15, 25 and 26 and complements thereof” and a second primer to a chromosomal sequence of S. aureus. The primer does not have to be “specific” for the type xiii sequence; rather, it must be specific for the SSCmec element of the type xiii sequence. This does not impose the requirement that the primers be specific for the type xiii sequence, itself. Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 13 The ’221 patent describes the use of the claims first and second primers to obtain an MREJ type sequence. ’221 patent, col. 17, ll. 10-20; col. 20, ll. 59–65; col. 4, ll. 41–44. The ’221 patent characterizes the PCR product from three bacterial strains as “new,” “novel” and indicative of MREJ type xiii. Id. at Table 8 (SEQ ID NOS. 15, 25, and 26); col. 7, l. 29; col. 20, ll. 59–64. While the phrase “MREJ type xiii specific sequences” is not recited in the ’221 patent, based on the mentioned disclosure in the patent and the disclosure of “specific amplification products (id. at col. 14, l. 8), the ordinary skilled would have understood that the new and novel sequences 15, 25, and 26 are “specific” for the type xiii strain. In describing the claimed invention, there is no requirement that the wording be identical to that used in the specification as long as there is sufficient disclosure to show one of skill in the art that the inventor “invented what is claimed.” Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000). Thus, as long as a person “of ordinary skill in the art would have understood the inventor to have been in possession of the claimed invention at the time of filing, even if every nuance of the claims is not explicitly described in the specification, then the adequate written description requirement is met.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). In regard to Requester’s statement that it is not clear whether the claimed amplicon comprises sequence “truly unique to MREJ type xiii” or “whether such sequences may also be present in other MREJ types,” the ’221 patent expressly refers to using primers and probes “specific” for different MREJ types so that the type of the MREJ can be determined (at col. 11, ll. 4–7) and describes “MRSA- specific multiplex PCR” assays (at col. 15, ll. 63–64), specific detection of MRSA strains (Example 1), and detection of novel sequences present in type xiii strains, Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 14 but no other strains (at col. 20, ll. 59–64). As pointed out by the Examiner, “Type xiii strains and amplicons are characterized by SEQ ID NO's 15, 25 and 26 and differ by the absence of one or two 102 base pair insertions, see particularly ‘221 20:59-64, 21:4-9, Figure 2 and SEQ ID NO's 15, 25 and 26.” RAN 7. Accordingly, it would be understood that recited specific amplicons are unique to the MREJ type xiii. TIME PERIOD FOR RESPONSE In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the appeal may file a request for rehearing of the decision within one month of the date of: . . . [t]he original decision of the Board under § 41.77(a).” A request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). Comments in opposition to the request and additional requests for rehearing must be in accordance with 37 C.F.R. § 41.79(c)-(d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) of this section, for requesting further rehearing under paragraph (d) of this section, and for submitting comments under paragraph (c) of this section may not be extended. An appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an inter partes reexamination proceeding “commenced” on or after November 2, 2002 may not be taken “until all parties’ rights to request rehearing have been exhausted, at which time the decision of the Board is final and appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See also MPEP § 2682 (8th ed., Rev. 7, July 2008). Appeal 2015-006967 Reexamination Control 95/002,216 Patent 7,838,221 B2 15 In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. AFFIRMED Patent Owner: Brenden Gingrich KNOBBE, MARTENS, OLSON & BEAR LLP 12790 El Camino Real San Diego, CA 92130 Third Party Requester: Kevin Bastian KILPATRICK TOWNSEND & STOCKTON LLP Two Embarcadero Center 8th Floor San Francisco, CA 94111-3834 Copy with citationCopy as parenthetical citation