Quake et al.v.Lo et al.

Patent Trial and Appeal BoardApr 7, 2014

13070275 (P.T.A.B. Apr. 7, 2014)

BoxInterference@uspto.gov 571.272.4683 Filed: February 27, 2018 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD STEPHEN QUAKE and HEI-MUN CHRISTINA FAN Junior Party (Patent 8,008,018), v. YUK-MING DENNIS LO, ROSSA WAI KWUN CHIU, and KWAN CHEE CHAN Senior Party (Application 13/070,275). Patent Interference No. 105,920 (DK) (Technology Center 1600) Judgment 37 C.F.R. § 41.127 Before, SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges. KATZ, Administrative Patent Judge. Interference 105,920 -2- Following the Decision on Remand (“Decision,” Paper 273), Quake was ordered to show why the interference should continue to a priority or derivation phase. (See “Order,” Paper 274.) The Order was issued because Quake asserted dates of conception and derivation in its Priority Statement earlier than the dates accorded to and asserted by Lo. (Compare Quake Priority Statement, Paper 57, with Redeclaration, Paper 43, and Lo Priority Statement, Paper 52.) Quake failed, though, to “[p]rovide a copy of the earliest document upon which [Quake] will rely to show conception” with its Priority Statement as required under 37 C.F.R. § 41.204(2)(iv). Instead, Quake asserted that “the earliest document proving conception is a communication between Dr. Stephen Quake and his attorney dated January 2, 2006, that is subject to attorney client privilege.” (Quake Priority Statement, Paper 57, at 2:25-3:1.) The Order to Show Cause provided Quake an opportunity to submit this document. In its Response to the Order to Show Cause, Quake did not submit a copy of the communication between Dr. Quake and his attorney. Instead, Quake submitted a copy of Quake’s application 11/701,686 (“the ’686 application”), filed on February 2, 2007 (Exh. 20041) as the earliest document on which it intends to rely. (Response to Order to Show Cause (“Response”), Paper 275, at 3:8–9.) In the Decision on Remand, the Board determined that the ’686 application is not a constructive reduction to practice of the Count in this Interference. (See Decision, Paper 273, at 17:11–21:5.) We denied Quake’s request for rehearing of 1 We note that Quake cites Exhibit 2002, while Quake Exhibit List (Paper 265) identifies the ’686 application as Exhibit 2004. Interference 105,920 -3- that Decision. (Decision on Request for Rehearing, Paper 277.) The arguments Quake puts forth in its response to the Order to Show Cause are similar to those it raised in its Request for Rehearing. For example, Quake argues that there is testimony in the record showing that methods were well-known at the time the ’686 application was filed to utilize sequence/statistical analyses on individually sequenced samples, and that those methods would have been equally applicable to the sequence data obtained in Quake’s sequenced mixed sample. (See Response, Paper 275, at 4:20–25.) Quake argues that methods were well known in the prior art that could be applied to carry out the method of the Count, along with the disclosures of the ’686 application. (See Response, Paper 275, at 5:11-13.) As discussed in the Decision on Request for Rehearing, Quake’s arguments do not persuade us that the decision to deny Quake benefit of its ’686 application should be modified. (See Decision on Request for Rehearing, Paper 277.) Because we determine that the ’686 application is not a reduction to practice of the Count, Quake has failed to show why it will prevail over Lo in a priority or derivation phase. Quake does not submit any other evidence of an earlier conception, reduction to practice, or derivation. Quake also argues that the interference should proceed to a priority phase because of the determination in Interference 105,922 that Quake had an actual reduction to practice of the sequencing embodiment of the Count prior to the filing date accorded to Lo in that proceeding. (Response, Paper 275, at 5:16–19.) The count of Interference 105,922 was different from the current count and the specifications of Quake’s currently involved patent and applications are different from the Quake specifications involved in that interference. Accordingly, the Interference 105,920 -4- determination of priority in that interference is not dispositive of the issues of this interference. Because Quake has failed to submit a document on which it can rely to show priority earlier than Lo’s accorded priority date and has failed to provide a persuasive reason why this interference should continue to a priority or derivation phase, we enter judgment against Quake as to Count 1, the sole count in the interference. It is ORDERED that claims 1-4 of Quake's involved patent 8,008,018 be CANCELED 35 U.S.C. § 135(a); FURTHER ORDERED that a copy of this judgment be entered in the administrative records of the involved 8,008,018 patent and 13/070,275 application. FURTHER ORDERED that a party seeking judicial review timely serve notice on the Director of the United States Patent and Trademark Office. 37 C.F.R. §§ 90.1 and 104. FURTHER ORDERED that the parties are directed to 35 U.S.C. § 135(c) and to 37 C.F.R. § 41.205 regarding the filing of settlement agreements. Interference 105,920 -5- cc (via electronic delivery): Attorney for Quake: R. Danny Huntington Sharon E. Crane Rothwell, Figg, Ernst & Manbeck, PC dhuntington@rfem.com scrane@rfem.com Attorney for Lo: Michele C. Bosch Steven P. O’Connor Finnegan, Henderson, Farabow, Garrett & Dunner, LLP michele.bosch@finnegan.com steven.oconnor@finnegan.com Michael J. Wise Perkins Coie, LLP mwise@perkinscoie.com BoxInterference@uspto.gov 571.272.4683 Filed: February 27, 2018 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD STEPHEN QUAKE and HEI-MUN CHRISTINA FAN Junior Party (Patent 8,008,018), v. YUK-MING DENNIS LO, ROSSA WAI KWUN CHIU, and KWAN CHEE CHAN Senior Party (Application 13/070,275). Patent Interference No. 105,920 (DK) (Technology Center 1600) Decision on Request for Rehearing 37 C.F.R. § 41.125(c) Before, SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges.1 KATZ, Administrative Patent Judge. 1 Judge Richard E. Schafer is not available for this decision. Interference 105,920 -2- Quake requests rehearing of the Decision on Remand (Paper 273 (“Decision”)) in this proceeding. (See Quake Request for Rehearing (“Request”), Paper 276.) To prevail, Quake must identify, with specificity, both the matters believed to have been misapprehended or overlooked and the place where the matters were previously addressed in a motion, opposition, or reply. (See 37 C.F.R. § 41.125(c)(3).) The Decision held that the claims of Quake’s involved patent 8,008,018 (“the ’018 patent”) lack sufficient written description support under 35 U.S.C. § 112, first paragraph and, thus, granted Lo Motion 1. (See Decision, Paper 273, at 3:13– 17:10.) In addition, the Decision held that neither of Quake’s earlier applications 11/701,686 (“the ’686 application”) and 60/764,420 provides a sufficient written description of the Count and, thus, denied Quake Motion 1. (See Decision, Paper 273, at 17:11–21:5.) Quake argues that the Decision overlooked testimony by Lo’s witness, Dr. Stacy Bolk Gabriel, Ph.D., regarding the knowledge in the art at the time of Quake’s filing, including alleged admissions showing that the Quake specification adequately describes the invention of the Count. (Request, Paper 276, at 1:2–8.) According to Quake, there is testimony in the record that methods were well-known at the time the ’686 application was filed that utilized sequence/statistical analyses on individually sequenced samples, and that those methods would have been equally applicable to the sequence data obtained in Quake’s sequenced mixed sample. Interference 105,920 -3- (See Request, Paper 276, at 6:3–8.) We are not persuaded that such testimony indicates anything was overlooked or misapprehended or that the Decision should be modified. The Decision was based on the finding that even if it would have been known how to use statistical methods to normalize the frequency of random sequence reads by the size of the chromosome, the ’018 patent does not describe doing so and, thus, does not describe methods requiring such normalization. (See Decision, Paper 273, at 16:15–18.) As explained in the Decision, the failure to describe normalization to chromosome size would have indicated to one of ordinary skill in the art that the inventors had not contemplated the methods of determining aneuploidy from massively parallel sequencing of randomly selected DNA fragments recited in Quake’s claims and the Count. (See Decision, Paper 273, at 16:18–17:6.) Quake fails to direct us to evidence or argument we overlooked or misapprehended indicating that either normalization to chromosome size was described in the Quake specifications or that such analysis was not necessary to the methods recited in Quake’s claims or the Count. Quake argues that we overlooked portions of Dr. Gabriel’s cross-examination testimony in Exhibit 2078. (See Request, Paper 276, at 8:18–9:7, citing Exh. 2078 at 73:22–74:18.) The cited portion was relied upon in Quake Reply 1 for an argument about the “t-test,” which is a test used to determine statistical significance. (See Quake Reply 1, Paper 81, at 5:1–4.) Quake argues that Dr. Gabriel’s testimony indicates one of skill in the art would have known how to use a t-test (or a “z-test”) to determine the normal ratio and determine if the observed ratio was too Interference 105,920 -4- high or too low relative to the norm. (See Request, Paper 276, at 8:18–9:7, citing Exh. 2078, at 73:22–74:18.) The Decision addressed this portion of Dr. Gabriel’s testimony and found it to be unpersuasive. (See Decision, Paper 258, at 14:4–16.) As explained, Dr. Gabriel’s testimony does not indicate that the Quake specification discloses using the t- or z-test for normalization to chromosome size as required when using sequences from randomly selected DNA fragments.2 “[W]ritten description is about whether the skilled reader of the patent disclosure can recognize that what was claimed corresponds to what was described; it is not about whether the patentee has proven to the skilled reader that the invention works, or how to make it work, which is an enablement issue.” Alcon Research Ltd. v Barr Laboratories, Inc., 745 F.3d 1180, 1191 (Fed. Cir. 2014). Accordingly, this argument does not persuade us that the Decision overlooked anything indicating it should be modified. Quake also argues that the Board improperly concluded that a specific portion of Dr. Gabriel’s statements on cross-examination was limited in scope to what was disclosed in the Lo Priority Statement. (See Request, Paper 276, at 8:12– 17, citing Exh. 2078 at 34:13–35:9.) As explained in the Decision, Dr. Gabriel was 2 We note that the portion of Dr. Gabriel’s testimony cited by Quake was in response to questions about “predetermined target sequencing” not random sequencing. (See Exh. 2078 at 73:7–21 (“Q. Okay. The question was, the sentence that reads, ‘PCR reactants are added to each well to amplify at least predetermined target sequencing.’ And my question was: Why did you say, ‘at least two’? A. Because there's a test in the reference. Q. Okay. In multiplex PCR, are there more than two predetermined target sequences? A. There can be. Q. And multiplex PCR is disclosed in the '018 patent, isn't it? A. Where? Q. Look at column 12, lines 32 to 35. (Witness reviewing) A. Yes.”).) Interference 105,920 -5- directed to Example 3 of Exhibit 2074 prior to the specific testimony highlighted by Quake. (See Exh. 2078, 30:17–31:8 (“So now going back to Exhibit 2074 . . . .”); see Quake Exhibit List, Paper 265, at 4 (identifying Example 2074 as “Lo Priority Statement, as filed in Interference No. 105,924, on July 31, 2013”).) (See Decision, Paper 273, at 15:17–16:14.) She testified that Example 3 of Exhibit 2074 “actually says you've got to take into account the chromosome size of things you're comparing.” (See Exh. 2078, at 34:17–19.) Because Dr. Gabriel testified to what Exhibit 2074 “actually says,” we are not persuaded that it was an error in the Decision to determine that the testimony was limited to that document. Quake does not explain what was overlooked or misapprehended in the record of the interference by this determination. Nor does Quake point to similar testimony by Dr. Gabriel regarding that language of Quake’s specifications. Because the determination of whether there is sufficient written description support is made on the basis of what is described in the specification in question, we are not persuaded by Quake’s argument that the Decision should be modified. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (“the hallmark of written description is disclosure. . . . the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.). Quake also argues that paragraph 80 of Exhibit 2099, a declaration by Dr. Gabriel in the inter partes review of patent 8,195,415, was not considered in the Decision. (See Request, Paper 276, at 8:12–17.) In paragraph 80, Dr. Gabriel testifies that “a t-statistic is a statistical method known in the art.” (Exh. 2099, ¶ 80.) Dr. Gabriel also testifies that Interference 105,920 -6- a person of ordinary skill in the art at the time of the invention of the '415 patent would have applied conventional statistical analyses, such as a t- test statistic, to the methods disclosed in Lo II with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to use the confidence intervals derived from t statistics when evaluating sequence tag density data to determine the disomy of chromosomes in a mixed sample. (Exh. 2099, ¶ 80.) It is not clear how this statement is relevant to the issue of written description in the involved Quake specifications because patent 8,195,415 has a different specification and no prior applications in common with the involved ’018 Quake patent. Furthermore, Quake fails to explain how this testimony indicates that the currently involved Quake specifications describe using statistical tests for normalization to chromosome size in order to determine aneuploidy from massively parallel sequencing of randomly selected fragments. The testimony appears to relate to the obviousness of claims from patent 8,195,415 over the prior art, but Quake has not explained how those claims or the prior art are relevant to the issue of written description or benefit in the current interference. Quake argues further that we overlooked Dr. Gabriel’s testimony in Exhibit 1076. (See Request, Paper 276, at 9:25–10:21.) Quake does not indicate where Exhibit 1076 was cited in its original briefs and we do not find any citation. If the testimony was not cited, we could not have overlooked it. Accordingly, we are not persuaded that the Decision should be modified in light of this testimony. Quake also argues that [i]n the related Quake patent that was the subject of Interference 105,922, normalization is done by counting sequence tags per 50kb bins. However, normalization could just as easily be performed by dividing sequence tag reads by chromosome length (number of bases) and using the t-test disclosed Interference 105,920 -7- in the Quake specification to determine with statistical significance whether there were more sequence tags aligning to a chromosome suspected of being aneuploid than one believed to be euploid, as discussed by Dr. Gabriel above [in Exhibit 1076]. (Request, Paper 276, at 10:22–11:2 (footnote omitted).) This argument is unpersuasive because Interference 105,922 involved Quake patent 8,195,415, which, as explained above, is not related to the currently involved ’018 Quake patent involved in this interference. Whether or not “normalization could just as easily be performed by” a method does not indicate that the method is described sufficiently in the Quake specifications. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (“The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.”). Quake’s argument fails to persuade us that the Decision should be modified. Quake also refers to the testimony of its own witness, Dr. Detter, in its Request. (See Request, Paper 276, at 6:9–23, citing Exh. 2049, at ¶ 151, and 7:22– 26, citing Exh. 2082 at ¶¶ 28–37.) Quake does not argue that we overlooked or misapprehended this testimony, though we note that the specific portions of Dr. Detter’s testimony cited by Quake (Exh. 2049 ¶ 151 and Exh. 2082 ¶¶ 28–37) were not cited in the Decision. The Decision did cite paragraph 100 of Dr. Detter’s declaration (Exh. 2049), which is similar to paragraph 151. In both paragraphs 100 and 151, Dr. Detter states that certain portions of the ’686 application, including paragraphs 104 and 141–149, support step (d) of the Count, which recites using the Interference 105,920 -8- data obtained in the other steps to compare the amounts of identified chromosomes and determine the presence or absence of fetal aneuploidy. In neither paragraph 100 nor 159, though, does Dr. Detter explain how normalization is described in the specification, beyond a conclusory statement. Dr. Detter testifies that “[t]hese paragraphs describe the concept of counting chromosomes, normalization and using statistical significance to determine the presence or absence of a fetal aneuploidy” (Exh. 2049, ¶ 151), but does not discuss normalization any further. As explained in the Decision, “Quake cites to the testimony of Dr. Detter in support of its argument [that paragraphs 27, 59, 95, 99, 104, and 141-149 of the ’686 application support step d of the Count], but neither Quake nor Dr. Detter explain how these paragraphs support the element of the Count.” (Decision, Paper 273, at 19:9–17.) In regard to Dr. Detter’s second declaration, Exhibit 2082, paragraphs 28–37, cited in Quake’s Request (see Paper 276 at 7:22–26), as explained above, discussion of the t-test does not persuade us that the method of Quake’s claims or the Count was sufficiently described in Quake’s specifications. Because Quake has failed to persuade us that the Decision should be modified, Quake’s request for rehearing is DENIED. Quake’s request for a contingent motion In an e-mail sent on 19 January 2018 to the Board, Quake requested a conference call to discuss authorization to file a contingent motion for reopening the record in this interference. (See Appendix.) Specifically, Quake requests that Dr. Gabriel’s testimony during the prior civil action under 35 U.S.C. § 146 be added to the record of this proceeding. (See id.) Quake previously requested Interference 105,920 -9- additional briefing in light of information and evidence developed during discovery in the intervening 35 U.S.C. § 146 action that was asserted to be relevant to the issues on remand. (See Order – New Briefing and Evidence, Paper 271, at 2–3.) A conference call was not considered to be necessary. Information obtained during the § 146 action was not considered by the Federal Circuit, which held that the district court did not have subject matter jurisdiction to review the Board's interference decisions in the § 146 proceeding because the America Invents Act abolished the rights of parties to bring such actions. See Bd. of Trustees of Leland Stanford Junior Univ. v. Chinese Univ. of Hong Kong, 860 F.3d 1367, 1374 (Fed. Cir. 2017). The Federal Circuit also determined that “the activities in the district court are a nullity when the district court lacks subject matter jurisdiction to consider a matter.” Id. Quake’s request to present additional briefing and evidence on the remand of this interference to the Board was denied in light of the court’s decision and because Quake did not show that it lacked an opportunity to present evidence during the interference before the Board or that the arguments and evidence originally presented were incomplete. (See Order – New Briefing and Evidence, Paper 271.) Quake did not request rehearing of that decision. In the current request, Quake asserts that the Board’s interpretation of Dr. Gabriel’s testimony regarding Lo’s Priority Statement (Exh. 2074) was incorrectly limited to the context of that document and that Dr. Gabriel’s testimony during the § 146 action would “remove any doubt that her statements regarding the skill in the art were general and not limited in that manner.” (See Appendix.) As explained above, Quake has not persuaded us that there was any error in the Interference 105,920 -10- determinations made about Dr. Gabriel’s testimony regarding Lo’s Priority Statement. We are not persuaded that testimony about the skill in the art, beyond the evidence Quake has already presented on that issue, will shed sufficient further light on whether the disclosures in Quake’s involved specifications provide sufficient written description as to warrant re-opening these proceedings when each party has had its chance to place evidence in the record. Quake asserted that it would be a denial of due process to not reopen the record to add Dr. Gabriel’s testimony. (See Appendix.) Because Quake has failed to show why it did not have a full and fair opportunity to present evidence and argument with its original briefs, including from the cross-examination of Dr. Gabriel conducted during the interference, it is not clear what due process was denied. Accordingly, Quake’s request for authorization to file a contigent motion is DENIED. cc (via electronic delivery): Attorney for Quake: R. Danny Huntington Sharon E. Crane Rothwell, Figg, Ernst & Manbeck, PC dhuntington@rfem.com scrane@rfem.com Attorney for Lo: Michele C. Bosch Steven P. O’Connor Interference 105,920 -11- Finnegan, Henderson, Farabow, Garrett & Dunner, LLP michele.bosch@finnegan.com steven.oconnor@finnegan.com Michael J. Wise Perkins Coie, LLP mwise@perkinscoie.com Interference 105,920 -12- Appendix From: Danny Huntington [mailto:dhuntington@rothwellfigg.com] Sent: Friday, January 19, 2018 1:08 PM To: Interference Trial Section ; Kattula, Amy Cc: Bosch, Michele (michele.bosch@finnegan.com) ; Steven P. O'Connor - Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (steven.oconnor@finnegan.com) ; Sharon Crane ; Edward Reines (edward.reines@weil.com) ; Erik van Leeuwen Subject: Interference Nos. 105,920 (DK); 105,923 (DK); and 105,924 (DK) - Quake request for a telephone conference to request permission to file a contingent motion to reopen the record In connection with preparing a Request for Rehearing in the above-identified interferences, party Quake has concluded that the Board’s interpretation of admissions made by Lo’s expert, Dr. Gabriel, concerning the knowledge of those skilled in the art, was incorrectly limited to the context of Lo’s Priority Statement. Specifically, party Quake submits that Dr. Gabriel’s testimony in the 146 action removes any doubt that her statements regarding the skill in the art were general and not limited in that manner. Counsel for party Quake would like permission to immediately file a contingent motion to reopen the record if party Quake’s Requests for Rehearing are denied. That motion would explain why it would be a denial of due process if the record is not reopened to add the testimony of Dr. Gabriel on this issue developed during discovery in the intervening 35 USC 146 so that it may be considered by the Board. Counsel for party Lo has been contacted and indicated that they will oppose party Quake’s request to file this contingent motion. Party Lo will oppose the motion if authorized at least because the Board has already considered a request to reopen the record in these interferences and exercised the discretion it was afforded by the Federal Circuit, and denied that request noting that neither party argued to the Board or the Federal Circuit that it lacked an opportunity to present evidence to the Board during the interferences, and because Quake failed to timely file a request for rehearing of the Board’s December 12, 2017, decision to not reopen the record. Counsel for the Parties have conferred and are available for a telephone conference at the convenience of the Board on any day other than Monday through Wednesday, January 22-24, 2018. Respectfully submitted, R. Danny Huntington Lead counsel for Party Quake R. Danny Huntington, Esq. ROTHWELL, FIGG, ERNST & MANBECK, P.C. 607 14th Street, N.W. Suite 800 Washington, D.C. 20005 Interference 105,920 -13- Main No: (202) 783-6040 Fax No: (202) 783-6031 dhuntington@rfem.com STATEMENT OF CONFIDENTIALITY The information contained in this electronic message and any attachments to this message are intended for the exclusive use of the addressee(s) and may contain confidential and/or privileged information. If you are not the addressee, note that any disclosure, copy, distribution or use of the contents of this message is prohibited. If you are not the intended recipient, please notify Rothwell, Figg, Ernst & Manbeck, P.C. immediately at (202) 783-6040 or email us at dhuntington@rfem.com, and destroy all copies of this message and any attachments.

Quake et al. V. Lo et al.