throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`
`
`
`
` Paper 45
`Entered: May 16, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`_______________
`
`Case IPR2014-00003
`Patent 8,278,351 B2
`_______________
`
`
`
`Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`BONILLA, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`I.
`
`INTRODUCTION
`
`Aker Biomarine AS (“Aker”) filed a Petition to institute an inter partes review
`
`of claims 1-94 of U.S. Patent No. 8,278,351 B2 (Ex. 1001; “the ’351 patent”).
`
`Paper 6 (“Pet.”). Neptune Technologies and Bioressources, Inc. (“Neptune”) filed a
`
`Patent Owner Preliminary Response. Paper 16. Thereafter, the Parties filed a Joint
`
`Motion to Limit Petition, requesting that the Board limit the Petition to claims 1-6,
`
`9, 12-13, 19-29, 32, 35-36, and 42-46 of the ’351 patent. Paper 18. We granted
`
`the Joint Motion, thereby limiting this proceeding to the aforementioned claims.
`
`Paper 21.
`
`On March 23, 2014, we instituted a trial based on Petitioner’s challenges to:
`
`(1) claims 1, 3-6, 9, 12, 13, 19-24, 26-29, 32, 35, 36, and 42-46, but not claims 2
`
`and 25, as anticipated by WO 00/23546 (Ex. 1002, “Beaudoin I”), and (2) all
`
`challenged claims as obvious over the combination of Fricke (Ex. 1006), Bergelson
`
`(Ex. 1017), Yasawa (Ex. 1015), Itano (Ex. 1009), and the WHO Bulletin
`
`(Ex. 1018). Paper 22 (“Decision”). We denied all remaining grounds of
`
`unpatentability as redundant to the above grounds, except that we denied all
`
`anticipation grounds asserted in the Petition regarding claims 2 and 25. Id. at 27-
`
`28, 16-20. In its Request for Rehearing, Aker asks that the Board reconsider its
`
`denial to institute a review of claims 2 and 25 as anticipated by Beaudoin I.
`
`Paper 26 (“Rehearing Req.”) 1-3.
`
`II. ANALYSIS
`
`When rehearing a decision on petition, the Board reviews the decision for an
`
`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be
`
`determined if a decision is based on an erroneous interpretation of law, if a factual
`
`finding is not supported by substantial evidence, or if the decision represents an
`
` 2
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United
`
`States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d
`
`1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir.
`
`2000). The party requesting rehearing has the burden of showing the decision
`
`should be modified, and “[t]he request must specifically identify all matters the
`
`party believes the Board misapprehended or overlooked, and the place where each
`
`matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R.
`
`§ 42.71(d).
`
`Claims 2 and 25
`
`Dependent claims 2 and 25 each recite the krill extract of claim 1 or 24,
`
`respectively, having “a total phospholipid concentration in an amount of about
`
`40% w/w, wherein about represents ±10%.” Ex. 1001, 28:65-67, 31:36-38. We
`
`denied Aker’s ground that Beaudoin I anticipates claims 2 and 25. Decision 17.
`
`In its Request for Rehearing, Aker contends two points. Rehearing Req. 2.
`
`First, Aker asserts that the Board incorrectly applied the standard of inherent
`
`anticipation, and overlooked that “Beaudoin I explicitly discloses a phospholipid
`
`concentration within the claimed range.” Id. at 2, 5-6. We note that we addressed
`
`both express and inherent anticipation in our Decision when stating that “Aker fails
`
`to explain adequately how the range disclosed by Beaudoin I fell within a range
`
`defined as about 40% w/w, wherein about represents ±10%, i.e., from 30% to
`
`50%.” Decision 17. That said, we grant the Request for Rehearing to explain
`
`more fully why we denied Aker’s ground of anticipation of claims 2 and 25 by
`
`Beaudoin I, whether it be express or inherent anticipation.
`
`As Aker correctly notes in its Petition, “Beaudoin I discloses 54.1+/-6.1%
`
`phospholipids and polar material w/w in Fraction I extracts.” Pet. 20 (citing
`
`Ex. 1002, 23, Table 14) (emphasis added). Thus, Beaudoin I’s description of
`
` 3
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`concentration percentages of “[p]hospholipids or other polar material” in Table 14
`
`does not disclose explicitly a total phospholipid concentration as recited in
`
`challenged claims 2 and 25. Ex. 1002, Table 14. Rather, Table 14 in Beaudoin I
`
`describes percentages, in krill oil Fractions I and II, of material having
`
`phospholipids (at some undisclosed concentration) plus “other polar material” (at
`
`some undisclosed concentration). Thus, Aker does not explain sufficiently in its
`
`Petition, or in its Request for Rehearing, how one can ascertain the total
`
`phospholipid concentration of Fraction I by looking at Table 14 or elsewhere in
`
`Beaudoin I.
`
`It is possible that Fraction I contains the recited total phospholipid
`
`concentration (see Decision 17), but Table I does not describe expressly that it
`
`does. Table 14 of Beaudoin I indicates that the total phospholipid concentration in
`
`Fraction I depends on the amount of “other polar material,” as well as the final
`
`concentration of “[p]hospholipids or other polar material,” existing in that fraction.
`
`Ex. 1002, Table 14. Aker fails to establish adequately, with argument or evidence,
`
`that “Beaudoin I expressly discloses phospholipid concentrations within the ranges
`
`claimed by claims 2 and 25.” Rehearing Req. 6-7. Thus, Aker does not establish a
`
`reasonable likelihood that it would prevail on the ground that Beaudoin I expressly
`
`anticipates challenged claims 2 and 25.1
`
`
`1 In its Request for Rehearing, Aker also contends that Beaudoin I alone renders
`claims 2 and 25 prima facie obvious. See, e.g., Rehearing Req. 9-10, 14. A
`rehearing request “must specifically identify all matters the party believes the
`Board misapprehended or overlooked, and the place where each matter was
`previously addressed in a motion . . . .” 37 C.F.R. § 42.71(d). Aker fails to show
`where it asserted this obviousness ground in its Petition. See, e.g., Pet. i-ii, Table
`of Contents. Consistently, the “error” asserted by Aker in its Request for
`Rehearing relates to the ground of anticipation by Beaudoin I.
`
` 4
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`In its second point, Aker further contends that the “Board adopted Aker’s
`
`argument that because ‘the processes described in the ’351 patent and . . . the prior
`
`art [Beaudoin I] are virtually indistinguishable,’ as a result so, too, ‘would be the
`
`resulting extracts.’” Rehearing Req. 2-3, 11 (citing Pet. 12;2 Decision 13). Thus,
`
`according to Aker, it established a prima facie case of anticipation, and under In re
`
`Best and “its progeny,” the burden shifted to Neptune to produce evidence as to
`
`why the resulting compositions would be different, which Aker contends Neptune
`
`failed to do. Id. at 3, 10-13 (citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977);
`
`In re Spada, 911 F.3d 705, 708 (Fed. Cir. 1990)).
`
`Contrary to Aker’s assertion, we did not “adopt” Aker’s contention that the
`
`processes of the ’351 patent and Beaudoin I are virtually indistinguishable.
`
`Rehearing Req. 2-3, 11. Aker cites our Decision at page 13, which discusses the
`
`asserted ground of anticipation of claims 1 and 24 by Beaudoin I. While we
`
`discuss some of Aker’s contentions, the Decision concludes that “evidence
`
`presented by Aker tends to demonstrate that the E. pacifica krill extract disclosed
`
`in Beaudoin I comprised at least one phospholipid” recited in claim 1 “under the
`
`principles of inherency as explained by Aker,” citing page 12 of Aker’s Petition.
`
`Decision 13 (citing Pet. 12). On page 12 of its Petition, Aker asserts that Neptune
`
`“identif[ies] phospholipid molecules that naturally occur in krill and all prior krill
`
`extracts,” i.e., an inherency position. Pet. 12.
`
`In support of its inherency position regarding claims 1 and 24, Aker cited
`
`declaration evidence, including the van Breeman Declaration (Ex. 1040). Pet. 14.
`
`Specifically, as noted in our Decision, the “van Breemen Declaration, in particular,
`
`2 The Request for Rehearing cites Paper 4 at 12. See Rehearing Req. 2-3. Paper 4
`is a Certificate of Service. We assume that Aker intends to refer to its Petition
`(Paper 6) at 12.
`
` 5
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`provides mass spectrometry evidence that the E. pacifica acetone extracts
`
`contained PC-EPA/EPA, PC-DHA/DHA, and PC-EPA-DHA.” Decision 11 (citing
`
`Ex. 1040, ¶¶ 73-85, 93-98). That declaration evidence, not Aker’s contention that
`
`the processes of Beaudoin I and the ’351 patent are virtually indistinguishable,
`
`persuaded us that Aker established a reasonable likelihood that it would prevail on
`
`the ground that Beaudoin I anticipates claims 1 and 24.
`
`Moreover, in relation to claims 2 and 25, Aker argued in its Petition that
`
`“Beaudoin I discloses 54.1+/-6.1% phospholipids and polar material w/w in
`
`Fraction I extracts (Ex. 1002, Table 14, p. 23[])[,] which falls within or touches the
`
`claimed ranges.” Pet. 20. Thus, Aker did not assert the “virtually
`
`indistinguishable” process argument in relation to claims 2 and 25 in its Petition,
`
`nor did it explain how In re Best applies in the context of the additional limitations
`
`added by these two dependent claims. Rather, Aker only made that argument in
`
`relation to independent claims 1 and 24. Id.; see also id. at 12-19.
`
`Even if we assume that Aker’s contentions regarding claims 1 and 24 apply
`
`equally to claims 2 and 25, however, Aker still fails to establish a reasonable
`
`likelihood of prevailing. In its Request for Rehearing, Aker contends that it
`
`explained previously that the extraction processes in Beaudoin I and the
`
`’351 patent are “virtually indistinguishable.” Rehearing Req. 10-11 (citing
`
`Pet. 12). In its Petition, Aker relies on declarations by Drs. Storrø and Brenna,
`
`“which present a line-by-line comparison of the ’351 and the Beaudoin I and II
`
`methods,” and points to certain processes described in Beaudoin I and the
`
`’351 patent. Pet. 12, 17 (citing Ex. 1046, ¶ 7; Ex. 1042, ¶ 63; Ex. 1002, 5:21-6:20;
`
`Ex. 1001, 18:53-19:9).
`
`Notably, the “line-by-line” comparisons presented in the declarations by
`
`Drs. Storrø and Brenna, as well as cited disclosures in Beaudoin I and the
`
` 6
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`’351 patent themselves, describe that multiple steps in the referenced processes
`
`include different options. See, e.g., Ex. 1046, ¶ 7 (using terms such as
`
`“preferable,” “preferred,” “preferably,” and “optionally”); Ex. 1042, ¶ 63 (using
`
`terms such as “best,” “preferred,” “preferably,” and “optionally”). Aker does not
`
`establish sufficiently what specific processes (i.e., which exact options) Beaudoin I
`
`used when making extracts, such as the fractions described in Table 14.
`
`Moreover, evidence cited by Aker in relation to its “virtually
`
`indistinguishable” contention, including the “line-by-line comparison,” all indicate
`
`that the relevant processes in Beaudoin I and the ’351 patent include two separate
`
`extraction steps, e.g., “a 2 hour extraction with 6:1 volume ratio of acetone,” and
`
`extraction “with alcohol, such as ethanol, isopropanol, t-butanol or alternatively
`
`with ethyl acetate, preferably two volumes (original volume of material).”
`
`Ex. 1002, 5:30-6:17; Ex. 1001, 18:32-45 (stating that the “most preferred
`
`extraction solvent system is 100% acetone in the first extraction followed with a
`
`95%/5% ethyl acetate/ethanol mixture” extraction). Table 14 of Beaudoin I,
`
`however, describes “[p]hospholipids or other polar material” in Fractions I and II.
`
`Ex. 1002, 23, Table 14. Beaudoin I describes that Fraction I (subjected to the first
`
`extraction step only) contains 54.1 ±6.1 percent of “[p]hospholipids or other polar
`
`material,” while Fraction II (subjected to both extraction steps) contains only
`
`8.5 ±1.6 % of the same material. Id. at Table 14, notes a) and b).
`
`Thus, Beaudoin I describes that its processes involving two extraction steps,
`
`which Aker contends are “virtually indistinguishable” to processes described in the
`
`’351 patent, produce an extract (Fraction II) that does not have the total
`
`phospholipid concentration recited in claims 2 and 25. Instead, Beaudoin I’s
`
`Fraction II has a lower total phospholipid concentration (i.e., a portion of 8.5
`
`±1.6 % of “[p]hospholipids or other polar material,” as compared to 30-50%
`
` 7
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`phospholipids), indicating that processes of Beaudoin I and the ’351 patent are not,
`
`in fact, “virtually indistinguishable.” Aker has not established sufficiently,
`
`therefore, that Beaudoin I, when preparing extracts, such as those analyzed in
`
`Table 14, used a process that was “virtually indistinguishable” from that used by
`
`the ’351 patentee when preparing the extracts recited in claims 2 and 25 (see, e.g.,
`
`Ex. 1001, 17:49-18:6, Table 5).
`
`Thus, on the record before us, Aker does not establish that the Board abused
`
`its discretion when concluding that Aker failed to establish a reasonable likelihood
`
`that it would prevail on the ground that Beaudoin I anticipates challenged claims 2
`
`and 25, expressly or inherently.
`
`Claims 3 and 26
`
`Having granted Aker’s Request for Rehearing with regard to claims 2 and
`
`25, we also address a matter misapprehended in our Decision regarding dependent
`
`claims 3 and 26. Claims 3 and 26 are similar to claims 2 and 25, except that each
`
`of claims 3 and 26 recite the krill extract of claim 1 or 24, respectively, having “a
`
`total phospholipid concentration in an amount of about 45% w/w, wherein about
`
`represents ±20%,” i.e., a total phospholipid concentration in the range of 25-65%
`
`w/w. Ex. 1001, 29:1-3, 31:39-41. We previously concluded that “there is a
`
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`
`claims 3 and 26 as anticipated by Beaudoin I.” Decision 14.
`
`Upon reconsideration of our Decision regarding these claims, we conclude
`
`that Aker has not established a reasonable likelihood that it would prevail on the
`
`ground that Beaudoin I anticipates challenged claims 3 and 26, expressly or
`
`inherently, for all of the same reasons discussed above, and in our previous
`
`Decision (Decision 17), in relation to claims 2 and 25. For example, Beaudoin I’s
`
`Fraction II has a lower total phospholipid concentration (i.e., a portion of
`
` 8
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`8.5 ±1.6 % of “[p]hospholipids or other polar material,” as compared to 25-65%
`
`phospholipids as required by claims 3 and 26), indicating that processes of
`
`Beaudoin I and the ’351 patent are not, in fact, “virtually indistinguishable.”
`
`Similarly, we conclude that Aker has not established a reasonable likelihood that it
`
`would prevail on the ground that Beaudoin II (Ex. 1003), Maruyama (Ex. 1004),
`
`Fujita (Ex. 1005), or Fricke (Ex. 1006) anticipates challenged claims 3 and 26, for
`
`the same reasons discussed above and previously (Decision 18-20), in relation to
`
`claims 2 and 25.
`
`Thus, we modify our previous Decision to deny Aker’s grounds that
`
`Beaudoin I, Beaudoin II, Maruyama, Fujita, or Fricke anticipates claims 3 and 26.
`
`III. CONCLUSION
`
`We grant Aker’s Request for Rehearing to explain in more detail our
`
`reasoning for denying institution of a trial based on the ground of anticipation of
`
`claims 2 and 25 by Beaudoin I. For the reasons discussed above, Aker has not
`
`carried its burden of demonstrating an abuse of discretion in our Decision in
`
`relation to anticipation of claims 2 and 25. 37 C.F.R. § 42.71(c). We modify our
`
`previous Decision, however, to deny Aker’s ground that Beaudoin I anticipates
`
`claims 3 and 26, and to clarify that we deny Aker’s grounds that Beaudoin II,
`
`Maruyama, Fujita, and Fricke each anticipate claims 3 and 26, for the same reasons
`
`discussed above in relation to claims 2 and 25.
`
` 9
`
`
`
`
`
`

`

`Case IPR2014-00003
`Patent 8,278,351 B2
`
`
`For the reasons given, it is
`
`IV. ORDER
`
`
`
`ORDERED that our previous Order in our Decision instituting inter partes
`
`review (Paper 22, 28-29) is modified to the extent that we deny the Petition with
`
`respect to the grounds that claims 3 and 26 of the ’351 patent, under 35 U.S.C.
`
`§ 102, are anticipated by each of Beaudoin I, Beaudoin II, Maruyama, Fujita, and
`
`Fricke.
`
`
`
`
`
`
`
`PETITIONER:
`
`J. Mitchell Jones
`Casimir Jones SC
`jmjones@casimirjones.com
`
`Amanda Hollis
`Kirkland & Ellis
`amanda.hollis@kirkland.com
`
`
`
`
`PATENT OWNER:
`
`Stephen L. Altieri
`Cooley LLP
`saltieri@cooley.com
`
`J. Dean Farmer
`Cooley LLP
`dfarmer@cooley.com
`
`
`
`10
`
`
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket