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March 9, 2010

Less Than Best Mode

The American arm of Japan's Ajinomoto complained to the ITC to stop foreign imports of dietary supplement lysine, under the aegis of 5,827,698 and 6,040,160. The snag was that their patent applications didn't actually disclose their production techniques. That cost them the patents for failing to meet best mode, and inequitable conduct for knowingly doing so.

Ajinomoto v. International Trade Commission (ITC) and a bunch of foreign bio-chem manufacturers (CAFC 2009-1081) precedential

Commercial lysine is produced by mutant bacteria that add up to big bucks: a billion-dollar industry. Bug tinkering bought patent protection to Ajinomoto. But the actual tinkering wasn't fully disclosed.

In contrast to the disclosure in the specification [for '698], it is undisputed that the actual strain used by the inventors had two additional genetic alterations made to it before the addition of mutant ldc.

Ajinomoto scientists identified two bacteria strains into which they introduced mutation.

Yet before filing the Japanese application from which the '160 patent claims priority, the inventors characterized a different strain, AE-70, as their best lysine producer.

After construing the claims, the ITC ALJ (administrative law judge) found the patents buggy.

Specifically, the ALJ found that the asserted claims were invalid for multiple violations of the best mode requirement of 35 U.S.C. § 112, first paragraph, and that both patents were unenforceable for inequitable conduct because of those best mode violations.

The ALJ next held both patents unenforceable for inequitable conduct. For both patents, the ALJ found that materiality was established by the best mode violations and that intent to deceive was established by the inventors' intentional inclusion of fictitious data coupled with their failure to disclose their preferred strains and, with respect to the '698 patent, carbon source at a time when Ajinomoto was facing increased business competition from another lysine supplier. The ALJ then, in weighing materiality and intent, concluded that equity demanded a finding of inequitable conduct because both prongs were established to a high degree.

The Commission backed its ALJ. Hence the appeal.

The road of best mode has two forks in it -

Section 112 of the Patent Act provides that the patent specification "shall set forth the best mode contemplated by the inventor of carrying out his invention." 35 U.S.C. § 112, ¶ 1. Known as the best mode requirement, it comprises part of the quid pro quo of the patent grant, prohibiting inventors from receiving the benefit of the right to exclude while at the same time concealing from the public preferred embodiments of their inventions. See Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1330 (Fed. Cir. 2002). Compliance with the best mode requirement is a question of fact, but the scope of the invention to which the best mode applies is a question of law, which we review de novo. See Bayer AG v. Schein Pharms., Inc., 301 F.3d 1306, 1312, 1320 (Fed. Cir. 2002).

To satisfy the best mode requirement, an inventor must disclose the preferred embodiment of his invention as well as preferences that materially affect the properties of the invention. See id. at 1319. The disclosure requirement, however, is limited to "the invention defined by the claims." Id. at 1315; see also Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1567 (Fed. Cir. 1996). Subject matter outside the scope of the claims falls outside of the best mode requirement. AllVoice Computing PLC v. Nuance Commc'ns, Inc., 504 F.3d 1236, 1246-48 (Fed. Cir. 2007). Accordingly, we have held that a threshold step in a best mode inquiry is to define the invention by construing the claims. Bayer, 301 F.3d at 1320 (citing N. Telecom Ltd. v. Samsung Elec. Co., 215 F.3d 1281, 1286-87 (Fed. Cir. 2000)).

Once the invention is defined, determining compliance with the best mode requirement is a two-prong inquiry. First, the court must determine whether, at the time the patent application was filed, the inventor possessed a best mode of practicing the claimed invention. United States Gypsum Co. v. Nat'l Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996). This prong is highly subjective; it focuses on the inventor's own personal preferences as of the application's filing date. N. Telecom, 215 F.3d at 1286. Second, if the inventor has a subjective preference for one mode over all others, the court must then determine whether the inventor "concealed" the preferred mode from the public. Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 928 (Fed. Cir. 1990)). In other words, the second prong asks whether the inventor's disclosure is adequate to enable one of ordinary skill in the art to practice the best mode of the invention. Id. This second inquiry is objective; it depends upon the scope of the claimed invention and the level of skill in the relevant art. Id.

Ajinomoto didn't challenge the facts, only "that the Commission made multiple legal errors in defining the scope of its claimed inventions and the scope of the best mode requirement."

[F]ocusing on the inventions recited in the asserted claims, the Commission correctly included within the scope of the best mode requirement an obligation to disclose the inventors' preferred host strains.

Infringement requires all claim limitations to be present, not just those that distinguish the claim from the prior art. So too with the best mode requirement, which applies to the invention claimed, with all its limitations, not just the novel ones. Ajinomoto claimed the right to exclude competitors from practicing a method of producing lysine by cultivating a bacterium with an ldc or dapA mutation. Thus, the "two-way street" of the best mode requirement obligated Ajinomoto to disclose its best bacterium for carrying out those inventions.

The inventors could not, consistent with the best mode requirement, claim the cultivation of a bacterium containing an ldc mutation while simultaneously keeping from the public the identity of the one and only bacterium they used to practice that cultivation. See Chemcast, 913 F.2d at 930 ("[W]here the inventor has failed to disclose the only mode he ever contemplated of carrying out his invention, the best mode requirement is violated.").

Ajinomoto tried to wriggle by claiming a different priority date.

A patentee may seek to rely on an earlier priority date to overcome intervening prior art, as did the patentee in Go Medical Industries Pty, Ltd. v. Inmed Corp., 471 F.3d 1264, 1270 (Fed. Cir. 2006), cited by Ajinomoto. A patentee may also argue in the alternative for different priority dates at trial. But a patentee cannot, as Ajinomoto attempts here, reverse a finding of invalidity by unveiling after trial an alternative priority date on which it would now like to rely.

Ajinomoto did not preserve an argument to appeal inequitable conduct because it failed to challenge the ITC's finding intent to deceive.

Affirmed.

Posted by Patent Hawk at March 9, 2010 4:18 PM | § 112

Comments

CAFC: "First, the court must determine whether, at the time the patent application was filed, the inventor possessed a best mode of practicing the claimed invention. United States Gypsum Co. v. Nat’l Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996)."

More judicial babel-talk. "Possessed a best mode"??? The 112 phrase is possess the invention and contemplate the best mode.

It is not possible to possess (or contemplate) a "best" mode unless you have at least two. "Best" is a comparative adjective. Always has been; always will be. 5th grade grammar. I cannot have a "best" when I have only 1 because no other exists for comparison.

So the babel-talk is really saying the inventor must have more than one mode and disclose the best one in order to satisfy 112. Bosh.

Also, being in possession of an invention is not the same thing as being in possession of a "best mode." There is no statutory requirement to be in possession of a best mode.

If you have only one mode that is within the scope of the claims, then you are in possession of the invention without being in possession of a "best mode."

Nevertheless, it's a purty gud decision, eh? And not an easy one either, what with the Colt case to distinguish. The priority date section near the end raises this question most of you can probably answer without my having to look it up:

1. You file in Japan in 2000 and disclose your best mode, so you are cool. Then you file a PCT in 2001. Then file your US national in 2002, but just before your file in the US your best mode changes. Are you still cool? Dou have to disclose the new best mode when you file in US? Seems to me it would be verbotten new matter.

2. Same as above, but if you knew the 2002 best mode in 2000 but did not "contemplate" it as a best mode until just before you file in the US (i.e. realize how good it is), which best mode do you have to disclose? I don't believe you'd want to file the US appl with a disclosure that was not made in the original -- it would be new matter. The EPO would dock your clock for sure. Even if you filed the original appl and a preliminary amendment contemporaneously, it would still be new matter.

There's probably an easy answer to this, but I gott'a get to work.

Posted by: Babel Boy at March 11, 2010 11:09 AM

"If you have only one mode that is within the scope of the claims, then you are in possession of the invention without being in possession of a "best mode.""

ur dmb.

Posted by: 6000 at March 11, 2010 11:16 AM

In the namesake of Babel, there are a number of definitions of “best”:

1) in a most excellent way or manner; "he played best after a couple of martinis"

2) the supreme effort one can make; "they did their best"

3) it would be sensible; "you'd best stay at home"

4) the person who is most outstanding or excellent; someone who tops all others; "he could beat the best of them"

5) (superlative of `good') having the most positive qualities; "the best film of the year"; "the best solution"; "the best time for planting"; "wore ...

6) outdo: get the better of; "the goal was to best the competition"

7) better: from a position of superiority or authority; "father knows best"; "I know better."

8) better(p): (comparative and superlative of `well') wiser or more advantageous and hence advisable; "it would be better to speak to him"; "the White House thought it best not to respond"

from wordnetweb.princeton.edu/perl/webwn


Clearly, the first two can exist with a singular item.


Note also, that the requirement in 112 paragraph 1 has two shall’s:

Shall contain…

And

Shall set forth the best mode contemplated (rather than “contemplate the best mode.” )

There is no “possess” in 112 paragraph 1.

Posted by: Pedantic Pete at March 11, 2010 3:21 PM

I knew these points were going to be a lot more subtle than what a lot of the local readers are capable of handling.

6000: "ur dmb"

Thanks. Can't take issue with that, but I am at least smart enough to see that I'm not as dmb as you.

Pete:
Each of the examples you give requires a comparison, at least implicitly. Your "playing best" or "doing their best" only make sense in comparison to at least one other, lesser effort. Any comparison requires 2, minimum.

This is 5th grade grammar. Unless you did ESL.

Sure, people misuse the word in instances where there is only one thing or event, but they do so in order to deceitfully imply there were more than one thing or event, as in "My best time is 10 seconds flat." when, fact it is his only time.

Pete:
"There is no “possess” in 112 paragraph 1."

Can't argue that. But your fight is not with me; it's with Lourie. He's the one that places "possess" in 112.1, not me. Read the opinion. Or just read Hawk's summary:

"Section 112 of the Patent Act provides that the patent specification "shall set forth the best mode contemplated by the inventor of carrying out his invention." 35 U.S.C. § 112, ¶ 1 . . . Once the invention is defined, determining compliance with the best mode requirement is a two-prong inquiry. First, the court must determine whether, at the time the patent application was filed, the inventor possessed a best mode of practicing the claimed invention."

So what's your point?

Posted by: Babel Boy at March 12, 2010 9:49 AM

"Can't argue that" - so why do you?

My point was in direct contradiction to your statement "The 112 phrase is possess the invention and contemplate the best mode." that was in your post.

Sorry that I did not see Lourie write that, I just saw you write that (I did say that I was pedantic, didn't I?).


"Your "playing best" or "doing their best" only make sense in comparison to at least one other, lesser effort."

Not quite right Babel - as the "other" effort can be a hypothetical one, and any such "other" effort would also qualify in the patent sense.

For example, "You have one shot at this - do your best" does not mean that there was an actual second effort.


Since I only need one example to show that your position is wrong, well, your position is wrong. Nothing subtle about it. I guess that's my point.

Posted by: Pedantic Pete at March 12, 2010 11:20 AM

"Sure, people misuse the word in instances where there is only one thing or event, but they do so in order to deceitfully imply there were more than one thing or event,"

Kind of like Congress misused it. LOL

Posted by: 6000 at March 12, 2010 11:58 AM

Pendatic
It's great that you hang out on adult blogs, but don't neglect to do your homework or clean up your room.

6000
You think it's laughable that Congress would misuse a word? You must be in high school, too.

Posted by: Babel Boy at March 13, 2010 3:19 PM

Babel,

What's your point?

So you were shown to be wrong - so what? Cherry that you want to use the "adult blog" line, but when you are the one that uses that lame line when some "kid" shows you up, you are the one that looks like you are trading name-calling in the grade school parking lot. If you want to battle, show some thinking, show that you weren't wrong, or at least come up with something better than acting like an adult while you are sulking.

Just think before you type the next time you want to rant and look like a fool.

Hope that wasn't too subtle for you.

Posted by: Pedantic Pete at March 13, 2010 5:09 PM