throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
`
`AKER BIOMARINE AS
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`Petitioner
`
`v.
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`NEPTUNE TECHNOLOGIES AND BIORESSOURCES, INC.
`Patent Owner
`
`________________
`
`Case IPR2014-00003
`Patent 8,278,351 B1
`________________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE1
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Petitioner Enzymotec Ltd. (“Enzymotec”), whose IPR2014-00556 has been joined
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`with this proceeding, joins in this Reply.
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`
`
`

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`
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`TABLE OF CONTENTS
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`Page
`CONSTRUCTION OF CLAIM TERMS .................................................... 1
`I.
`II. THE CLAIMS ARE ANTICIPATED BY BEAUDOIN ........................... 4
`PO Identifies Nothing Distinguishing The ’351 Patent Process .............. 4
`A.
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`B.
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`C.
`
`D.
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`E.
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`PO’s Reliance on Fraction II Rests on Legal and Factual Error .............. 6
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`PO’s Criticisms Of The Repeats Do Not Rebut Anticipation ................. 7
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`The Beaudoin Extracts Are Suitable For Human Consumption ............. 9
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`PO’s Arguments Regarding Claims 2, 3, 25, And 26 Are
`Erroneous .............................................................................................10
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`F.
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`Claims 5 And 28 Are Anticipated .........................................................11
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`III. THE CLAIMS ARE OBVIOUS .................................................................12
`Fricke Discloses The Claimed Phospholipid .........................................12
`A.
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`B.
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`C.
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`D.
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`E.
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`The Krill Extracts Are Suitable For Human Consumption ...................13
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`Fricke Discloses The Claimed Phospholipid Concentrations ................14
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`Fricke Discloses The Claimed Amounts of Omega-3 Fatty Acids ........14
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`The Claimed Metals Are Present ..........................................................15
`
`i
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`

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`
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`PO’s central argument regarding Beaudoin I (“Beaudoin”) is that applying
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`125° C heat “may cause degradation” of the Claimed Phospholipids. R at 4.2 This
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`theory cannot outweigh the unrebutted evidence (including its own expert’s admission)
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`that Beaudoin extracts have Claimed Phospholipids regardless of whether 125° C heat
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`is applied. PO’s remaining attempts to distinguish Beaudoin and the Fricke
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`combination—such as its assertions that Petitioner must show all Beaudoin’s extracts
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`anticipate, that Fricke does not disclose certain claim elements, and that neither
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`extract is suitable for human consumption—rest on clear error or a baseless claim
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`construction. The Board was correct to institute this trial, and the claims are invalid.
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`I.
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`CONSTRUCTION OF CLAIM TERMS
`After taking no issue with Petitioner’s proposed constructions in its Preliminary
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`Response, PO now attempts to avoid anticipation by improperly importing limitations
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`into its claims. PO interprets “suitable for human consumption” to “refer[] to krill
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`extracts that are safe and appropriate for humans to consume, including by oral
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`ingestion,” and proposes adding a host of limitations to its definition to exclude
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`extracts which are 1) not “suitab[le] for oral ingestion,” 2)“mere[ly] suitab[le] for
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`topical application,” 3) “suitable for only a single instance of consumption,” 4)
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`“untested on humans,” or 5) “contain[] an unknown quantity of residual solvent or
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`2 Emphasis is added unless otherwise noted. “R” and “R2” are PO’s Responses to
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`Petitioner’s Petition (Paper 66) and to Enzymotec’s Petition (Paper 77), respectively.
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`

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`
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`volatile matter.” R at 10–11. But “[c]laim terms are generally given their plain and
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`ordinary meanings,” with “only two exceptions…1) when a patentee sets out a
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`definition…or 2)…disavows
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`the full scope…in
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`the specification or during
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`prosecution.” Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014).
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`The plain meaning of “consumption” is broader than oral ingestion. Indeed, PO’s
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`proposed definition appears to concede this point: “to consume, including by oral
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`ingestion.” PO identifies no definition or disavowal that can support departure from
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`this meaning. PO cites oral uses described in the specification (R at 10), but
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`misleadingly omits the surrounding words:
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`When the phospholipid extract of the inventions is used as a
`nutraceutical, it can be in the form of foods, beverages, energy bars, sports
`drinks, supplements or other forms all as are known in the art. As noted above,
`the phospholipid extract of the invention is also useful in cosmetic
`preparations, e.g., moisturizing creams, sun-block products and other
`topical cosmetic products as known in the art.”
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`Ex. 1001 at 20:34–41. PO cites the Examples, but they too disclose “topical” use. R at
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`10 n.15; Ex. 1001 at Example 2. The specification contains no indication that the
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`extract must be taken for a minimum time, no discussion of volatile matter in the
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`extract, and no safety tests. Further, adopting PO’s construction would mean that
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`claim 70—“[a] cosmetic preparation comprising a krill extract…suitable for human
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`consumption”—requires a cosmetic preparation that is safe and appropriate for
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`humans to eat over an extended period, a proposition unsupported by evidence,
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`expert opinion or logic. Ex. 1097 at 222:8–19.
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`2
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`

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`
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`PO makes another attempt to shoehorn “oral” into the claims by arguing that
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`“capsule, tablet, solution, syrup, or suspension” (claim 24) is limited to “an oral
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`preparation.” R at 14. As noted, the specification clearly discloses both oral and non-
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`oral applications. Further, PO’s own expert admits that the “general definition” of
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`“solution” and “suspension” is broad and not limited to oral application: “solution”
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`means “a composition composed of different fractions,” and the claimed “solution”
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`and “suspension” “could be used for topical application.” Ex. 1097 at 197:24–199:1.
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`The only statement PO cites uses the word “may” (R at 14 n.27 (“Liquid preparations
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`for oral administration may take the form of, for example, solutions, syrups or
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`suspensions”)), and is by no means a clear definition or disavowal.
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`In another effort to avoid anticipation, PO argues that the Board was wrong to
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`conclude that the broadest reasonable construction of “about 5%” in claims 5 and 28
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`means 5% ± 50% and would encompass, for example, 23.7% fatty acids. The Board
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`was correct. The specification expressly defines “about” to mean “the numerical value
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`may vary by at least ± 50%.” Ex. 1001 at 21:61–64; see also id. at Table 5 (“Free Fatty
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`Acids…≥ 5.00”). PO argues a “high free fatty acid level…would indicate that
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`significant hydrolysis has occurred” and would be inconsistent with “a core teaching
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`of the ‘351 patent.” R at 12. But the ’351 patent nowhere mentions hydrolysis or a
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`need to avoid high free fatty acids. Rather, it emphasizes that the claimed extract has
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`“at least” the stated free fatty acid amounts, and even states that more free fatty acids
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`are “preferab[le].” Ex. 1001 at 16:46–47. PO is incorrect that the Board’s construction
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`3
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`

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`
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`is “nonsensical” because it would mean “claim 5 would cover…a negative amount of
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`free fatty acids.” R at 12. Claims 5 and 28 and the Board’s construction clearly require
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`free fatty acids, and thus do not encompass a negative amount. Indeed, under PO’s
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`view all claims that require “less than” a stated percentage of a component (e.g., “less
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`than 5%”) would presumably also be nonsensical because they too would encompass
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`negative values. But innumerable sensible patent claims use this phrase, and there is
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`no meaningful difference between this phrase and the Board’s sensible construction.
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`Even if the broadest reasonable construction were “nonsensical,” the claims cannot
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`be redrafted to avoid this. See Chef Am., Inc. v. Lamb-Weston Inc., 358 F.3d 1371, 1374
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`(Fed. Cir. 2004). PO’s argument is even weaker than that rejected in Chef America
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`because here the patent explicitly defines the term.
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` For the same reasons, the Board correctly construed “about 40% w/w,
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`wherein about represents ± 10%” and “about 45% w/w, wherein about represents ±
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`20%” as encompassing the ranges of 30% to 50% and 35% to 65%, respectively. As
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`PO admits, “about” should be construed consistently across the claims. R at 13.
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`II. THE CLAIMS ARE ANTICIPATED BY BEAUDOIN
`PO asserts its claims are not anticipated because Beaudoin extracts (1) do not
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`have any Claimed Phospholipids and (2) are not suitable for human consumption.
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`These assertions lack merit.
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`A.
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`PO Identifies Nothing Distinguishing The ’351 Patent Process
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`4
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`

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`
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`PO does not deny that if the ’351 patent and Beaudoin processes for making
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`the extracts are identical or virtually identical, their extracts’ compositions must also
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`be the same, including with respect to all of the claimed elements. In re Best, 562 F.2d
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`1252, 1255 (CCPA 1977); King Pharms, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1276 (Fed.
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`Cir. 2010). Petitioner’s experts did not “cherry pick”; they showed the processes were
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`identical for Fraction I and virtually identical for Fraction II, consecutive line-by-
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`consecutive line. Ex. 1046 at ¶7; Ex. 1042 at ¶63; Ex. 1002 at 5:22–6:20; Ex. 1001 at
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`18:32–19:9. PO has not rebutted this comparison (indeed it told the FDA it used
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`Beaudoin to make its claimed invention (Ex. 1107)), much less shown that any alleged
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`difference between the processes would affect the claimed elements.
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`PO’s sole theory is that Beaudoin allegedly includes a 125° C heating step at
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`the end of the process “[t]o get rid of traces of solvent” (R at 17), and that heating oil
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`to this temperature “may” destroy Claimed Phospholipids. Id. at 22–24. This fails to
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`explain why the ’351 patent extract would not be identical to Beaudoin’s extract
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`immediately before the heating step, which unquestionably is sufficient to anticipate
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`under the law. See Abbott Labs. v. Baxter Pharm. Prods, Inc., 471 F.3d 1363, 1369 (Fed.
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`Cir. 2006) (“We also do not find it material that…the anticipating method in the
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`[prior art] patent [is] ‘an intermediate step.’”). Regardless, PO’s expert admits that
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`the Claimed Phospholipids are present in Beaudoin’s extract prior to, and
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`would not all be destroyed by, the alleged heating step. Ex. 1093 at 57:23–25,
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`179:25–180:13. Indeed, Petitioner’s tests of Fraction I prepared with a heating step
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`5
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`

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`
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`confirm this. Ex. 1040 at ¶¶73–78, 93–98; Exs. 1049, 1050. So do PO’s tests. In 2011,
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`during prosecution of the ’351 patent’s parent, PO told the PTO that extracts it
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`prepared in 2011 according to Beaudoin did not contain the Claimed Phospholipids.
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`Exs. 1051, 1052; Ex. 1061 at 32–34; Ex. 1100 at 2–3. PO does not cite this evidence,
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`however, because Petitioner has since established that PO did detect Claimed
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`Phospholipids in its 2011 Beaudoin oil samples. Ex. 1040 at ¶87; Ex. 1054 at ¶36; Ex.
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`1056 at ¶22; Ex. 1051 at 0000018–20; Ex. 1103 at 117:8–119:25, 121:1–11, 122:4–
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`125:8. PO also never disclosed to the PTO (including the Board) that it repeated
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`Beaudoin in 2009 and detected Claimed Phospholipids in those samples, too. Id. 1103
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`at 38:17–42:2, 44:24–45:6, 55:18–58:14; Ex. 1098 at NEP877ITC-00267599–03.
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`Petitioners also obtained the various samples of Beaudoin oil PO analyzed (and that
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`PO used to obtain its patents) and independently confirmed Claimed Phospholipids
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`are in them. Ex. 1102 at 38:16–41:11; Ex. 1109.
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`B.
`PO’s Reliance on Fraction II Rests on Legal and Factual Error
`PO argues Beaudoin is distinguishable because “Beaduoin I’s Fraction II has a
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`lower total phospholipid concentration” reported in Table 14 than that described in
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`the ’351 patent, and because the Claimed Phospholipids were not detected in certain
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`Fraction II samples prepared by Dr. Haugsgjerd. R at 24. These arguments invite clear
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`error. Both Beaudoin and the ’351 patent state that two separate fractions are prepared:
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`Fraction I (acetone fraction) is made first by extracting krill with acetone, then after
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`isolating the acetone fraction, the solid residue is washed with a second solvent (ethyl
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`6
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`

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`
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`acetate or alcohol) to make Fraction II. Ex. 1002 at 6:15–18; Ex. 1001 at 19:3–5.
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`Fraction II is distinct from Fraction I and can be expected to have different
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`properties. Fraction I can (and does) anticipate regardless of Fraction II. Abbott Labs.,
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`471 F.3d at 1369; Ex. 1097 at 281:11–21.
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`C.
`PO’s Criticisms Of The Repeats Do Not Rebut Anticipation
`PO’s criticisms of Petitioner’s Beaudoin repeats are irrelevant. First, PO has
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`provided no evidence that any of the alleged deviations would materially affect the
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`results. In the case PO cites, the patentee conducted experiments showing that the
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`deviations from the prior art changed the outcome. See Pfizer Inc. v. Teva Pharm. U.S.A.
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`Inc., 882 F. Supp. 2d. 643, 680–81 (D. Del. 2012). PO has presented no such evidence.
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`Second, PO’s only theory is that Petitioner’s alleged deviations would tend to result in
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`more Claimed Phospholipids. But PO’s own expert admits PO’s own repeats show
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`Claimed Phospholipids are in Beaudoin’s extracts. See Section III.A, supra.
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`PO’s criticisms also are incorrect. PO asserts Mr. Haugsgjerd and Dr. Budge
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`improperly used “tools” (separatory funnel and centrifuge) to perform Beaudoin’s oil-
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`water separation step, which PO alleges must be done “passively.” R at 27. But PO’s
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`own expert testified that any “passive” (“sit and wait”) oil-water separation does
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`require a tool (Ex. 1097 at 99:24–101:10, 107:12–108:2), that Beaudoin expressly
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`teaches centrifugation (id. at 158:15–159:19; Ex. 1002 at 6:4–6), and that the term
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`“allowed” in Beaudoin (which he says prohibits centrifugation) is the same word he
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`used in his own peer-reviewed article to describe separation using a centrifuge. Id. at
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`7
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`

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`
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`144:2–147:5; Ex. 1091 at 1816. Additionally, the only difference between a separatory
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`funnel and the tool Dr. Jaczynski says Beaudoin permits is the funnel’s tapered shape.
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`Ex. 1097 at 109:13–24, 116:22–124:19; Exs. 1088, 1089. There is no evidence or
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`theory showing this difference would affect the extract’s composition. Further, PO’s
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`Beaudoin repeats it relied on to obtain its patents used “decantation” (Ex. 1104), and
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`the Beaudoin lab notebooks PO relies upon to argue how one would carry out the
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`process show that the inventors used a separatory funnel to separate oil from water.
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`Ex. 2059 at ¶59 & n.37; Ex. 2031 at 1–2; Ex. 1097 at 148:9–154:17, 156:18–157:4.
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`PO also claims Mr. Haugsgjerd “did not monitor the temperature of the oil
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`samples during heating to determine if and when they reached 125° C.” R at 27–28.
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`Not only is this incorrect3, but it also conflicts with PO’s claim that Dr. Budge should
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`not have monitored the oil samples’ temperature and heated them until they were at
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`125° C for 15 minutes. Ex. 2059 at ¶51. Further, PO’s claim that “exposing the oil to
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`temperatures over 100° C for over 30 minutes” (the time it took Dr. Budge’s samples
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`to reach 125° C) would make it “even less susceptible to hydrolysis” (id.) is nonsense:
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`PO’s own theory is that heating causes hydrolysis; thus, if anything, this alleged
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`3 Mr. Haugsgjerd’s oil bath was at precisely 125° C for 15 minutes (Ex. 1048 at 3; Ex.
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`2052 at AKBM_IPR0000055, 58, 66–68; Ex. 2049 at AKBM_IPR0000020), and it is
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`undisputed the samples would have heated to that temperature nearly immediately.
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`8
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`

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`
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`deviation should have resulted in fewer Claimed Phospholipids. Ex. 1097 at 251:20–
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`252:20.
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`PO further complains Petitioners did not test “whether the recreation samples
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`had similar concentrations of water or free fatty acid to the krill extracts described in
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`Beaudoin Tables 13 and 14.” R at 30. The relevant inquiries are whether Petitioners
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`repeated Beaudoin’s processes as interpreted by a POSITA (they did), and whether
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`the resulting extracts had the claimed elements (they did), not whether the extracts
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`match every single aspect of the Tables. Notably, PO did not assess these
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`characteristics in its own Beaudoin repeats used to gain allowance of the ’351 patent
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`(see Exs. 1051, 1052, 1100), and there is no reason such testing would be required.
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`D. The Beaudoin Extracts Are Suitable For Human Consumption
`The Board correctly recognized in the ID that the Beaudoin extracts are
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`suitable for human consumption as evidenced by their intended uses, including as
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`nutraceuticals, and actual consumption by Dr. Beaudoin. All of PO’s arguments to the
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`contrary hinge on its impermissibly limited claim construction and should be rejected
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`for this reason alone. PO’s arguments also fail even assuming its construction is
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`correct. PO argues that “Beaudoin’s extracts contain far too much water and volatiles
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`to be suitable for human consumption.” R at 31–32. Setting aside the obvious
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`problem with PO’s reasoning that a substance may have “too much water…to be
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`suitable for human consumption,” this theory ignores Beaudoin’s explicit instruction
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`“to get rid of traces of solvent.” R at 17. Also, the ’351 patentsays nothing about
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`9
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`

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`
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`how much “water and volatiles” is “too much,” and does not disclose any means for
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`removing solvent that is not disclosed in Beaudoin. See Ex. 1097 at 289:15–290:16;
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`King Pharms,, 616 F.3d at 1276 (“[T]o inherently anticipate, the prior art need only give
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`the same results as the patent, not better.”). Moreover, Beaudoin reports that prior to
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`the 125° C heating step, Fraction I contained a maximum of 10.0% combined water
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`and volatiles. R at 17. Even in the unlikely event all 10% were acetone, that amount
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`still would meet FDA guidelines for oral pharmaceuticals. Ex. 1095 at 7 (safe to
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`consume up to 50 mg acetone per day); Ex. 1106 (krill oil package for 300 mg capsule,
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`one capsule per day); Ex. 1097 at 218:12–22, 219:6–11.
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`E.
`PO’s Arguments Regarding Claims 2, 3, 25, And 26 Are Erroneous
`The parties agree Beaudoin expressly discloses its process can be applied to
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`either E. pacifica or E. superba. R2 at 8. The parties disagree as to whether Beaudoin
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`requires a 125° C heating step. Petitioner thus ran experiments applying Beaudoin to
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`each species, with and without 125° C heating, and showed multiple of these
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`combinations anticipate claims 2, 3, 25 and 26. Ex. 1044 at 0000018; Ex. 1041. PO
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`cannot escape the data, so it attempts to confuse the Board, arguing no anticipation
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`because (1) the data “reveal highly variant phospholipid concentrations among the
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`samples” and (2) anticipation requires “that all of the Budge samples necessarily
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`contained the claimed concentrations of phospholipids” (original emphasis). R2 at 4–
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`5. The Board should steer clear of PO’s trap. First, some of the samples (“60° C”) PO
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`compares were repeats of Beaudoin II. Second, the samples having <0.5%
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`10
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`
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`phospholipids are clearly not representative of Beaudoin. PO offers no explanation
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`for how one could repeat Beaudoin (which uses the same steps as the ’351 patent) and
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`obtain less than 0.5% phospholipids, both before and after heating. All experts agree
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`they would expect Beaudoin to result in similar phospholipid concentrations even
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`across species (R at 10), and the results for the samples with <0.5% phospholipids are
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`far different than any others. See Ex. 1097 at 278:24–279:14. Third, the remaining
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`samples were produced by multiple different processes (employing the different krill
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`species and heat treatments). Ex. 1041. Samples produced using the same heat
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`treatments had highly uniform results within the range of the claims, even as between
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`krill species (within 1–3 percentage points). Id.; Ex. 1044 at 0000018. It is basic law
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`that because Petitioner has shown at least one of the disclosed processes anticipates,
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`that suffices. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991). In any
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`event, differences in concentration ranges do not support patentability where, as here,
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`there is no evidence of criticality. See MPEP 2144.05.
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`F.
`Claims 5 And 28 Are Anticipated
`PO’s argument that Beaudoin does not anticipate claims 5 and 28 rests entirely
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`on its erroneously narrow construction of “about 5%” fatty acids. Even if PO’s
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`construction were adopted, Beaudoin’s Fraction I still would anticipate. Under PO’s
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`own theory, “low levels of free fatty acids, i.e., 2.5–7.5%” are “consistent
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`with…recovery of intact phospholipids,” which Beaudoin recovers. R at 12.
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`Neptune’s expert testified that a phospholipid concentration of 40% or 45% would
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`11
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`

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`
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`correspond to free fatty acid levels of 2.5–7.5% w/w. Ex. 1097 at 322:8–16, 285:20–
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`286:7. The uncontradicted experimental evidence shows that Beaudoin’s process,
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`including the heating step PO says is “required,” results in 44.4% and 43.7% percent
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`phospholipids for E. pacifica and E. superba, respectively (Ex. 1044 at 0000018; Ex.
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`1041), and thus would be consistent with free fatty acids of 2.5–7.5% w/w, according
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`to PO’s expert. Also, there is no evidence of criticality (MPEP 2144.05), and because
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`they disclose the same process, if a ’351 patent extract contains free fatty acids of 2.5–
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`7.5% w/w, so does an extract made according to Beaudoin.
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`III. THE CLAIMS ARE OBVIOUS
`A.
`Fricke Discloses The Claimed Phospholipid
`PO’s claim that Fricke does not disclose the Claimed Phospholipids lacks
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`merit. First, PO’s expert admits the Claimed Phospholipids naturally occur in krill and
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`are extracted with “any polar solvent” (Ex. 1093 at 59:23–60:5), which would include
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`Fricke’s chloroform and methanol. Second, PO identifies no reason Fricke’s Folch
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`method (the “classic and most reliable means for qualitatively extracting lipids” (Ex.
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`1105 at 1283)) would not extract the Claimed Phospholipids. Third, Fricke’s Table 6
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`discloses EPA and DHA at the extracted phospholipid’s sn-1 and sn-2 positions, and
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`a POSITA would recognize this means Claimed Phospholipids are present since the
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`presence of these fatty acids on phospholipids is combinatorial. Ex. 2037 at 172:2–
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`174:7. Fourth, PO’s argument contradicts its claim that the provisional application
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`discloses the Claimed Phospholipids. PO argues the provisional discloses Claimed
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`12
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`
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`Phospholipids by stating there is a krill extract with PC, PE, and PI esterified with
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`unspecified fatty acids, of which DHA and EPA are the “most prevalent.” R at 16.
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`Fricke discloses a krill extract with PC, PE, and PI, but goes beyond the disclosure of
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`the provisional, explicitly disclosing that DHA and EPA are esterified at both the sn-1
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`and sn-2 positions. Ex. 1006 at Table 6. PO’s own expert admits Fricke’s Table 6
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`discloses the Claimed Phospholipids with at least as much detail as PO’s provisional.
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`Ex. 1093 at 154:2–12, 155:25–158:20.
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`B. The Krill Extracts Are Suitable For Human Consumption
`All of PO’s arguments regarding suitability for human consumption hinge on
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`its improper interpretation of this term. PO has presented no evidence or argument
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`that the Fricke extracts are not suitable for at least topical use, and the references on
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`which Petitioners rely demonstrate that they are. Even assuming PO’s construction is
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`correct, PO’s arguments are without merit. FDA guidelines clearly contemplate oral
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`ingestion of chloroform and methanol. Ex. 1095 at 6. Further, PO offers no rebuttal
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`to Dr. Brenna’s opinion that these solvents necessarily would have been removed in
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`Fricke in order to perform the reported lipid analyses. Ex. 1042 at ¶281. PO’s
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`arguments that neither Fricke nor Bergelson “teach or suggest any way to remove
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`enough toxic solvent” (R at 42) are similarly without merit. PO does not dispute
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`Bergelson teaches (or that a POSITA would have known) solvents could be removed
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`by evaporation ( Ex. 2059 at ¶89; Ex. 1097 at 304:6–22), or the ample motivation to
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`13
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`do so. See, e.g., Ex. 1009 at 3, 4, 7, 8, 15. Everything PO identifies as teaching solvents
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`are “toxic” is in the prior art and would have motivated POSITA to remove them.
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`C.
`Fricke Discloses The Claimed Phospholipid Concentrations
`PO argues that Fricke discloses the weight percentage (wt%) of total lipids, and
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`not wt% of total extracts. Because Fricke used the Folch extraction method, however,
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`there is no difference between these units—except perhaps for trace amounts, Folch’s
`
`extract contains only lipids. Ex. 1078 at 502 (“One washing was sufficient for
`
`removing all the non-lipide contaminants from the crude extract.”). PO relies on a
`
`different extraction method (Bligh & Dyer) to make its point, but this method has
`
`been found to be less efficient than Folch. Ex. 1105 at 1286. Even assuming PO is
`
`correct, i.e., that there are about 8% non-lipid materials in the Fricke extracts, this
`
`would mean both extracts in Fricke’s Table 1 would fall within the claimed ranges,
`
`even under PO’s construction of those ranges.4 PO also ignores that a POSITA could
`
`adjust the claimed concentrations merely by adding something else. Ex. 2037 at
`
`267:22–269:21; see also MPEP 2144.05 (ranges not critical).
`
`D.
`Fricke Discloses The Claimed Amounts of Omega-3 Fatty Acids
`PO argues that Table 2 of Fricke shows fatty acids as a wt% of total fatty acids,
`
`not as wt% of total lipids in the extract. Ex. 2059 at ¶117. Notably, PO does not
`
`
`4 Even assuming only 90% are lipids, the phospholipid concentrations would be
`
`41.13% and 39.6% for the 1977 and 1981 samples, respectively. Ex. 1006 at Table 1.
`
`14
`
`

`
`
`
`assert that Fricke does not disclose at least 15% polyunsaturated fatty acids as claimed
`
`in claims 6 and 29. Even assuming PO’s interpretation is correct, Fricke still teaches at
`
`least 15% omega-3 fatty acids. Ex. 2037 at 196:16–198:14, 267:22–269:215; MPEP
`
`2144.05.
`
`E. The Claimed Metals Are Present
`Claim 13 places no limit on the amount of the metal which must be present.
`
`The WHO Bulletin demonstrates that krill contains the claimed metals zinc and
`
`selenium, and thus, a krill extract would contain (and a POSITA would expect them
`
`to contain) those metals. The Lee Declaration confirms their presence in krill
`
`extracts, Ex. 1045 at 000009, and PO identifies no extracts without zinc or selenium.
`
`
`
`
`
`September 18, 2014
`
`
`
`Respectfully submitted,
`
`By: /s/ Amanda J. Hollis
`
`
`5 The lowest weight fatty acid detected above trace levels was C12:0 (mw 200) (Table
`
`2). A PC with two C12:0 (mw 622) is 64.3% fatty acids; a TG with three C12:0 (mw
`
`638) is 94% fatty acids. 100% of the mw of free fatty acids is fatty acid. Applying
`
`these minimums to the weight percentages of each of these classes as reported for
`
`the 1977 sample in Table 1, 70% of the total lipids must be fatty acids (i.e., (64.3% x
`
`35.6%) + (94% x 33.3%) +16.1% = 70.3%). Multiplying 70.3% by total weight of
`
`fatty acids that are omega-3s (21.42%), omega-3s must be at least 15.1%.
`
`Analogously, PUFAs (24.03%) must be at least 16.9%.
`
`15
`
`

`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(b) that a complete
`
`copy of this PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE is
`
`being served electronically via e-mail (as consented to by the Patent Owner), on
`
`September 18, 2014, the same day as the filing of the above-identified document in
`
`the United States Patent and Trademark Office (USPTO), upon:
`
`
`J. Dean Farmer, Ph.D.
`dfarmer@cooley.com
`zpatdcdocketing@cooley.com
`Cooley LLP
`Attn: Patent Group
`1299 Pennsylvania Ave., NW, Ste.
`700
`Washington, D.C.
`Tel: (617) 937-2371
`Fax: (202) 842-7899
`Lead Counsel for Patent Owner
`
`
`Elizabeth J. Holland
`eholland@goodwinprocter.com
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 813-8800
`Facsimile: (212) 355-3333
`Reg. No. 47,657
`
`
`
`
`Jonathan G. Graves
`jgraves@cooley.com
`zpatdcdocketing@cooley.com
`Cooley LLP
`Attn: Patent Group
`
`1299 Pennsylvania Ave., NW, Ste. 700
`Washington, D.C.
`Tel: (617) 937-2370
`Fax: (202) 842-7899
`Back-up Counsel for Patent Owner
`
`
`
`Cynthia Lambert Hardman
`chardman@goodwinprocter.com
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 813-8800
`Facsimile: (212) 355-3333
`Reg. No. 53,179
`
`/John Mitchell Jones/
`J. Mitchell Jones, Ph.D.
`
`
`
`16

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