CAFC decision in Novo Nordisk v. Caraco

From Novo Nordisk v. Caraco

As to reasons for allowance:



The examiner withdrew her rejection, explaining that
her decision was “[b]ased solely upon the Declaration
submitted by Dr. Sturis and reconsideration of the synergistic
effects demonstrated in Example 3.” Id. at 1001.
After additional proceedings not relevant here, the ’358
patent issued on January 13, 2004. Id. Claim 4 of the
patent, which is the sole claim at issue here, was not
amended at any point during prosecution. Id.


Note footnote 4:


For more details about the pharmaceutical applications
that inspired this case, or about the history,
language, and scope of the Hatch-Waxman Act, see Caraco,
132 S. Ct. at 1675-80.



At issue here



Following a bench trial, the district court held that
claim 4 of the ’358 patent was invalid because of obviousness
and that the patent was not enforceable because of
inequitable conduct. Novo appeals these rulings, and we
have jurisdiction under 28 U.S.C. §§ 1292(c)(2) and
1295(a).(...)

Novo attacks the district court’s obviousness ruling on
three grounds. First, it asserts that the district court
misallocated the burden of persuasion in this case by
forcing Novo to “overcome” Caraco’s “prima facie” case of
obviousness with evidence of unexpected results. Second,
Novo argues that even if the burdens were properly
allocated in this case, Caraco’s evidence insufficiently
supported the court’s ultimate obviousness findings.
Finally, Novo believes that the district court should have
deferred to the examiner’s original finding that the Sturis
and Moses studies demonstrated unexpected synergy.


The result


Novo attacks the district court’s obviousness ruling on
three grounds. First, it asserts that the district court
misallocated the burden of persuasion in this case by
forcing Novo to “overcome” Caraco’s “prima facie” case of
obviousness with evidence of unexpected results. Second,
Novo argues that even if the burdens were properly
allocated in this case, Caraco’s evidence insufficiently
supported the court’s ultimate obviousness findings.
Finally, Novo believes that the district court should have
deferred to the examiner’s original finding that the Sturis
and Moses studies demonstrated unexpected synergy.

Rose case discussed in Ex parte Shotwell

On design choice:



The Appellant’s contentions are not persuasive. The Examiner
articulates that the modification of size of Conaway’s bin is based on a design choice. “Design choice” is appropriate where the Appellant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function or give unexpected results. See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995).


About the Rose case
Ex parte Shotwell



The Appellant also contends that the holding of Rose does not apply in this case. See App. Br. 9-10. The Appellant points out that Rose states, “[w]e do not feel that this limitation is patentably significant since it at most relates to the size of the article under consideration which is not ordinarily a matter of invention.” App. Br. 9 (citing Rose at 463 (citing In re Yount, 171 F.2d 317 (CCPA 1948)). The Appellant points out that Yount cites to In re Ayres, 83 F.2d 297 (CCPA 1936) and In re Withington, 104 F.2d 192 (CCPA 1939). The Appellant asserts that the specifications in each of Yount, Ayres, and Withington included a statement of equivalency with respect to a different sizes and that the specifications in both Yount and Withington included a statement that “a change in size is of no difference.” App. Br. 9-10. The Appellant asserts that the instant Specification does not include such statements. See App. Br. 9-10. The Appellant also points out that “the Background section [of the instant Specification] recites difficulties associated with smaller-sized baskets and containers for use in a dishwasher machine.” App. Br. 10. See Spec. paras [001]-[003].

Ex parte Shen on "intended use or purpose"

from Ex parte Shen


It is well established that “[a]n intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” Boehringer Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345, (Fed. Cir. 2003). Thus, an apparatus capable of performing an intended use will anticipate an apparatus claim, even if the prior art does not disclose that the apparatus was actually put to the intended use recited in the claim. See In re Schreiber, 128 F.3d 1473, 1477(Fed. Cir. 1997). Accordingly, we agree with the Examiner that the structure disclosed by Moore is capable of conforming with a frontal surface of a ball cap as claimed.

CBS Sunday Morning on 16 June 2013 (Fathers Day)

Lee Cowan, not Charles Osgood, introduced the stories for Sunday Morning for June 16, 2013.

The Sunday Morning cover story was by Lee Cowan on the lives of the astronaut wives.

Second, story on comedian Jim Gaffigan. Fatherhood.

Third, Mo Rocca on Debbie Reynolds. The good girl you root for. Eddie Fisher and Elizabeth Taylor.

Fourth, "behind the music" on backup singers by Ben Tracy.

Serena Alschul. Bill Geist. Nancy Giles.

Headlines. North Korea has proposed high level talks with US. In Colorado, "black forest" fire. In Iran, Assan Rahani, moderate. Egypt's Islamic government cutting off relations with Syria. Kim Kardasian mother of baby girl. Phil Mikkelson holds one stroke lead. Game 2 of Stanley Cup. Forecast: warm weather across country. Last day of spring.

Story "Back on Earth…" Wife of Jim Lovell. April 1970. Apollo 13. Jim Lovell: This is the business I was in. author Lily Keppel. Sue Bean. Space suburbia. astro-wives. Jeannie Basset-Robinson. Also, wife of Gene Cernan, last man on the moon.
Never would argue. Charlie Basset died in a plane crash. In 1967, Apollo 1 tragedy. Most of the marriages fell apart. But Jim and Marilyn Lovell celebrated 61st anniversary. Wives of Apollo 12: being a part of the space race, proud, thrilled and happy.

Almanac. June 16, 1903. New Bern, North Carolina: Caleb Davis Bradham, got trademark on Pepsi. In 1959, Richard Nixon consumed Pepsi in Moscow. The Pepsi Generation. The Pepsi Challenge.
In 1985, New Coke. you've got the right one baby. Back to the Future-II.
Neither cola can afford complacency.

Close shave. Barber pole. Serena Alschul. Mike: dollarshaveclub.com. Michael Dubin. For a dollar a month, high quality razors sent to your home. March 6, 2012: launched a video. From 7 to 7:15am, site crashed. In 48 hours, 12,000 orders. Now, 200,000 members. New York Shaving Company. John Scala. Badger hair brushes. A throwback to a by-gone era. Straight razor. Nick Burns, shaving expert. In grown hairs with cartridge razors. Mach 3 shaving system. Skit on Mad TV: 20 blades. Shaving in ancient Egypt. In 1904: the invention of the safety razor by King Gilette. Look sharp; be sharp. Michael Dubin: lotions and potions used by your dad. Celebration around the culture of shaving.


Debbie Reynolds story recycled. Miss Burbank contest in 1948. Married Fisher in 1955 at Grossinger's.

One week after. Edward Snowden. Seth Doane files Sunday Journal from Hong Kong. Snowden chose China to hide. David Zweig is political science prof at Hong Kong University. US had put Chinese cyber-spying on agenda. On day of China/US meeting, Guardian broke story . Glen Greenwald got the scoop. Snowden would hold Rubik's cube. Simon Young is Hong Kong lawyer. Independent judiciary. Asylum law.

Anthony Mason on "Stand Up Dad." Jim Gaffigan. No sleep; the pay is horrible, but people like it. "I'm the Dumbo." Observational humor about everyday of life. Home birth. Home for Jim and Jeannie is a two bedroom walkup on Manhattan's east side. Book "Dad is fat." Solitary, introspective pursuit. Wrangler in a herd of runaway scooters. Chesterton, Indiana. Youngest of six kids. "I was funny." Graduated from Georgetown University in 1988. Raised to seek security. Studied finance. Worked as litigation consultant. Did an improv class because afraid of public speaking. Now 46 years old. Jokes about food, hot pockets. "I'm going to die." Dominos pasta bread bowl diet. Gotham Comedy Club. A clean comedian. Family friendly, clean. Bob Newhart was clean. Gaffghanistan.

Compared to 20 years ago, fathers are
--more involved in raising kids, 40%
--less involved in raising kids, 35%

The Big Texan Steak Ranch in Amarillo, Texas. 72 ounce steak. Danny Lee. Steak stare. Big Victor. In 50 years, 55,000 have taken the challenge; 8500 have won. Siberian tiger took 90 seconds to eat 72 ounce.

Ben Tracy with Mary Clayton. [Merry Clayton]. Professional background singer. Sideground singer. My job is to make them look incredible. Clayton was a Ray-lette. Joe Cocker, Neil Diamond. Lou Reed: doo, doo.... Spiritual vibe. We are the choir. In 1969, the Rolling Stones. Gimme Shelter. Female voice. "It's just a shot away." New documentary film: Twenty feet from stardom. Morgan Neville. Judith Hill on "The Voice." "This is it" comeback tour. Merry Clayton: we are grateful for getting our due, and it's about time too.

[Aside: both Jif and Nutella advertised hazelnut spread on June 16 on Sunday morning.]

24.4 married fathers with kids.

1.7 billion on electronic gadgets for Dad.

93 million fathers day cards sent. Just half sent to fathers. 30% of these cards are humorous. 75% of fathers would like more time off from work to be with new-borns.

Nancy Giles on bras. 85% of American women are wearing the wrong size. Playtex living bra. Maidenform. Bra-burning. Good bras cost money. Joke: this shade isn't exactly "nude" for a whole lot of us.

Paris air show. Tues. Obama to Berlin. Wed. end of slavery Thurs. Jen. Lopez gets star. Friday: first day of summer. Sat. 75th anniversary of Joe Louis and Max.

Steve Hartman. Driven. Luke Balowsky, law student. 16,000 strokes into coast to coast. Tee to shining tee. Another 30,000 strokes to finish.

Next week: the money issue.

Moment of nature. Spiriva HandiHaler. Gannets on New Zealand's North Island. Getting ready for Fathers Day.

I'm Lee Cowan. Thanks for joining us. Have a good rest of your weekend.

Mixed decision in Ex parte Liang

There is a mixed decision in Ex parte Liang.

The appellant wins on indefiniteness but loses on obviousness.

Of indefiniteness:



“The test for definiteness is whether one skilled in the art would understand the bounds of the claim when read in light of the specification.” Miles Laboratories, Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993).

Analysis
Appellant contends “that a plain reading of the claims leaves no doubt that the claimed compositions as a whole comprise less than 10% triglycerides.” (App. Br. 5.)

We find that Appellant has the better position. Here, the claim begins with “a composition” and then continues with “wherein said composition comprises less than 10% of triglycerides.” We agree with Appellant that the claim makes it clear that “said composition . . .” is referring to a composition comprising a reverse micelle system. Here the reverse micelle system contains a hydrophilic phase and hydrophobic continuous phase, thus, the triglycerides of the system being hydrophobic molecules would partition into the hydrophobic phase.

(...)
We agree with the Appellant‟s position. In a reverse micelle the hydrophobic phase is found on the outside of the micelle, and the hydrophilic phase is on the interior. Just because in most reverse micelle systems the active ingredient is packaged into the interior of the micelle does not make it unclear that Appellant desires to do just the opposite.
We reverse the rejection of claims 1, 4-8, 15, 16, 19, 20, 23-25, and 27-33 under 35 U.S.C. § 112, second paragraph.

Of obviousness




“In United States v. Adams, . . . [t]he Court recognized that when a
patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). (...)

Applying the KSR standard of obviousness to the findings of fact, we agree with the Examiner that the ordinary artisan would have reasonably selected cyclosporin as a hydrophobic drug as taught by Carlsson (FF 4) with the reverse micelle composition as disclosed by Constantinides (FF 1). Carlsson disclosed the production of reverse micelles including cyclosporin, a known hydrophobic drug (FF 4). Constantinides disclosed the production of reverse micelles including therapeutic compounds such as acyclovir, azithromycin, clarithromycin, and dirithromycin (FF 2), compounds that are known to be hydrophobic.



The chemical principle of "like dissolves like" arises:


Appellant fails to identify any evidentiary basis on this record that rebuts the Examiner‟s reasoning that like dissolves like. In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997) (Argument of counsel cannot take the place of evidence).

Kimberly-Clark loses diaper case at PTAB

Kimberly-Clark loses in Ex parte Elsberg

As to BRI:


During examination, the PTO gives claims “their broadest reasonable construction consistent with the specification.” In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010) (quoting In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007)).



Of analogous art


See In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (determination of analogous art based on same field of endeavor test).

Kenyon & Kenyon wins reversal in Ex parte Kuttenberger

In Ex parte Kuttenberger, Kenyon & Kenyon obtained reversal on rejection of claims directed to
-- A device for being situated in a vehicle and for determining a relative speed between the vehicle and a crash object, comprising (...) --


The Examiner asserts that Eisele’s disclosure in paragraph [0029] that the impact velocity may be measured by the precrash sensor and that features that change with impact velocity are based on the first integral of the acceleration signal, which is the velocity signal, “implies that the velocity is updated or corrected by the impact sensor after contact.” Ans. 9- 10. However, it is not apparent, and the Examiner does not adequately, explain, why this is the case.

For the above reasons, the Examiner fails to establish by a preponderance of the evidence that Eisele discloses a relative speed determining device comprising an arrangement for ascertaining the relative speed between the vehicle and a crash object based on a first signal of a pre- crash surround field sensor system and based on a second signal from a contact sensor system, “wherein the signal of the contact sensor system is used to correct the relative speed of the pre-crash surround field sensor system,” as called for in independent claim 15.

Re-hearing in Bonadio

Ex parte Bonadio

As to attorney argument:


Appellants‟ attorney argument does not persuade us otherwise. Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997) (stating that “arguments of counsel cannot take the place of evidence lacking in the record”) (quoting Knorr v. Pearson, 671 F.2d 1368, 1373 (CCPA 1982).



Best is cited in a concurring opinion:


“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See also In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”). For the foregoing reasons, I am not persuaded by Appellants‟ contention that the evidentiary burden was improperly shifted to Appellants on this record.

Affirmation-in-part in Ex parte Fung

Ex parte Fung

There is a citation to MEMS Tech. v. ITC, declining to LIMIT the term "electrically coupled" to direct coupling.

Query: is PTAB permitted to cite an unpublished decision of the CAFC to establish law in a PTAB case?

Elsewhere, the PTAB cites Chore-time, 713 F.2d 774, 779 (CAFC 1983).

Bosch case: CAFC may entertain appeals from patent infringement liability determinations when a trial on damages has not yet occurred.

Bosch v. Pylon


Given the nature of the arguments made by the parties and the amici, we take a moment to explain what this case is not about. This case does not involve the question of whether the district court has the authority to bifurcate the willfulness and infringement issues. As a general matter, it does. See Fed. R. Civ. P. 42(b). Likewise, we did not take this case en banc to determine whether the issues of infringement and willfulness are so interwoven that trying them separately violates the Seventh Amendment. Precedent of this court, nonetheless, indicates that it does not. See Voda v. Cordis Corp., 536 F.3d 1311, 1329 (Fed. Cir. 2008). Rather, we took this case en banc to determine whether we have jurisdiction when willfulness issues are outstanding and remain undecided. Bifurcation and Seventh Amendment issues are immaterial to this inquiry. Our jurisdiction is set by Congress and Congress has given us jurisdiction over patent cases that are final except for an accounting. Accordingly, the disposition of this issue turns on whether an “accounting” as described in § 1292(c)(2) includes the determination of willfulness.

As always, we begin with the statute. “[W]here words are employed in a statute which had at the time a well- known meaning at common law or in the law of this country, they are presumed to have been used in that sense.” Standard Oil Co. of N.J., 221 U.S. at 59. Our inquiry begins and ends with a determination of the historical meaning of an “accounting.” Specifically, we must determine whether at the time the statute was passed, an accounting included the determination of willfulness. (...)

Bosch is unable to point to anything in the text of the statute or in the legislative history that would indicate that when Congress first gave the courts of appeals inter- locutory jurisdiction over cases that are final except for an accounting, it intended to disturb the practice of deter- mining willfulness as part of an accounting. Indeed, after the enactment of §1292(c)(2)’s predecessor statute in 1927, courts continued to determine willfulness as part of an accounting, which occurred after the finding of liabil- ity. For example, in Pyle National Co. v. Lewin, the district court held the patents valid and infringed, and awarded treble damages prior to conducting an account- ing. 92 F.2d 628, 629, 631 (7th Cir. 1937). An appeal was then taken to the Seventh Circuit prior to the accounting.



The conclusion


For the reasons outlined above, this court answers each en banc question in the affirmative. We find that 28 U.S.C. § 1292(c)(2) does confer jurisdiction on this court to entertain appeals from patent infringement liability determinations when a trial on damages has not yet occurred. We also find that 28 U.S.C. § 1292(c)(2) confers
jurisdiction on this court to entertain appeals from patent infringement liability determinations when willfulness issues are outstanding and remain undecided. Accordingly, we return this case to the panel for disposition on the merits.

Mouttet cited in Ex parte Albert

Ex parte Albert


“If a person of ordinary skill, before the time of invention and without
knowledge of that invention, would have found the invention merely an easily
predictable and achievable variation or combination of the prior art, then the
invention likely would have been obvious.” Rolls-Royce, PLC v. United Techs.
Corp., 603 F.3d 1325, 1338 (Fed. Cir. 2010). Cf. In re Mouttet, 686 F.3d 1322,
1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness
based on teachings from multiple references does not require an actual, physical
substitution of elements.”) (citations omitted) .



Common sense is mentioned


See Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1329 (Fed. Cir. 2009) (“hold[ing] that while an analysis of obviousness always
depends on evidence that supports the required Graham factual findings, it also
may include recourse to logic, judgment, and common sense available to the
person of ordinary skill that do not necessarily require explication in any reference
or expert opinion.”)

Mouttet cited in Ex parte Hosoi

Ex parte Hosoi


Like our appellate reviewing court, “[w]e will not read into a
reference a teaching away from a process where no such language exists.”
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1364 (Fed. Cir. 2006). Moreover, “just because better
alternatives exist in the prior art does not mean that an inferior combination
is inapt for obviousness purposes.” In re Mouttet, 686 F.3d 1322, 1334
(Fed. Cir. 2012).


Note



In the request for an expanded panel, Appellants recognize that the
decision was not designated as “Informative” or “Precedential” (Req. Reh’g
19). Appellants assert, however, that an expanded panel is warranted, as the
decision is now “citable authority and will likely have a significant impact
upon the examiners in the Patent Corps that examine patent applications that
involve this issue” (id.). We do not agree. If we were to accept Appellants’
reasoning, every request for rehearing would be entitled to an expanded
panel.

KSR dooms appellant in Ex parte Weiner

The appellant lost in Ex parte Weiner

KSR is mentioned:


“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.

Analysis

Novak teaches that zalpha11 Ligand, now known as interleukin 21
(FF 1), “could be therapeutically used in B-cell leukemias and lymphomas”
(Novak, col. 115, ll. 31-35; FF 4; see FF 7). (...)

Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that the person of ordinary skill would have
reasonably combined Novak‟s B-cell lymphoma treating interleukin-21 with
other known chemotherapeutic agents for B-cell lymphoma such as Brown‟s
anti-idiotype antibodies (FF 1-10) since both Novak and Brown teach
administering chemotherapeutic agents in combination (FF 6, 8; see Ans. 5-
6). Such a combination is merely a “predictable use of prior art elements
according to their established functions.” KSR, 550 U.S. at 417.



The appellants lost on a "why not" argument:


Appellants contend that “if it was indeed obvious to combine 1L,-21
with anti-idiotype antibodies for the treatment of a B cell malignancy, why
would the „024 patent, which was initially filed 10 years after the
publication of Brown et al., fail to mention this possibility?” (App. Br. 4-5).

We are not persuaded. “The mere age of the references is not
persuasive of the unobviousness of the combination of their teachings,
absent evidence that, notwithstanding knowledge of the references, the art
tried and failed to solve the problem.” In re Wright, 569 F.2d 1124, 1127
(CCPA 1977). Appellants have provided no evidence addressing this point.


AND


While we are fully aware that hindsight bias often plagues
determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36
(1966), we are also mindful that the Supreme Court has clearly stated that “if
a technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we conclude
that the person of ordinary skill would have recognized that Novak‟s
teaching to treat B-cell lymphoma with IL-21 (FF 1-5) in combination
therapy with antibodies (FF 6-7) along with Brown‟s teaching to treat B-cell
lymphoma with anti-idiotype antibodies, alone or in combination (FF 8-10)
provides specific reasons to combine these two components for the treatment
of B-cell lymphoma.
Appellants contend that “surprisingly, the treatment of B cells with
IL-21 results in the production of Granzyme B, and further, that this
treatment can effect tumor cell killing” (App. Br. 5). Appellants contend
that “Inherency is a very limited doctrine almost exclusively applied to the
realm of anticipation” (id.). Appellants contend that “if it was permissible to
view the inherent outcome of any prima facie combination of references as
„spoiling‟ an unexpected result, then under no circumstance would an
unexpected result ever be sufficient” (id. at 6).

Of unexpected results:



In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995) (“It is well settled that unexpected results must be
established by factual evidence. Mere argument or conclusory statements…
[do] not suffice.”) Also see In re Pearson, 494 F.2d 1399, 1405 (CCPA
1974) (“Attorney‟s argument in a brief cannot take the place of evidence.”).


AND


Second, inherency may be relied upon in obviousness determinations.
See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Whether the rejection is
based on „inherency‟ under 35 U.S.C. § 102, on „prima facie obviousness'
under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the
same, and its fairness is evidenced by the PTO‟s inability to manufacture
products or to obtain and compare prior art products.”)
In Wiseman, the CCPA rejected the argument of Appellants
that a structure suggested by the prior art, and, hence,
potentially in the possession of the public, is
patentable to them because it also possesses an
Inherent, but hitherto unknown, function which they
claim to have discovered. This is not the law. A patent
on such a structure would remove from the public that
which is in the public domain by virtue of its
inclusion in, or obviousness from, the prior art.
In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979).

Product tolerant organisms

Note US 8,460,906 to Cobalt Technologies.

First claim


A system for making a solvent or organic acid, comprising a bioreactor that comprises: a) growth medium in contact with a solid or semi-solid support; and b) product tolerant microorganisms of the Clostridium genus on the solid or semi-solid support, wherein said microorganisms produce the solvent or organic acid and have previously been mutagenized and selected for tolerance to the solvent or organic acid on a solid or semi-solid support in the presence of the solvent or organic acid, wherein the tolerance of the selected microorganisms to the solvent or organic acid is greater on a solid or semi-solid support than the tolerance to the solvent or organic acid exhibited when the selected microorganisms are cultured in a liquid media, and wherein the microorganisms have been selected to exhibit at least 125% tolerance to the solvent or organic acid in comparison to the tolerance of corresponding non-mutagenized microorganisms.

Organic Seed Growers et al. v. Monsanto, 2012-1298

The outcome of the Monsanto case of 10 June 2013 was no justiciable controversy.


Because
Monsanto has made binding assurances that it will
not “take legal action against growers whose crops might
inadvertently contain traces of Monsanto biotech genes
(because, for example, some transgenic seed or pollen
blew onto the grower’s land),” Defs.’ Mem. of Law in Supp.
of Mot. to Dismiss at 5, Organic Seed Growers & Trade
Ass’n v. Monsanto Co., 851 F. Supp. 2d 544 (S.D.N.Y.
2012) (No. 11-CV-2163), ECF No. 20, and appellants have
not alleged any circumstances placing them beyond the
scope of those assurances, we agree that there is no
justiciable case or controversy. We affirm.



Link: http://www.cafc.uscourts.gov/images/stories/opinions-orders/12-1298.Opinion.6-6-2013.1.PDF