Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_04-cv-02123/USCOURTS-cand-3_04-cv-02123-50/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 28:1338 Patent Infringement

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United States District Court

For the Northern District of California

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United States District Court

For the Northern District of California

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

THERASENSE, INC.,

 Plaintiff,

 v.

 BECTON, DICKINSON AND COMPANY,

Defendant. /

No. C04-02123 MJJ

No. C04-03327 MJJ

No. C04-03732 MJJ

No. C05-03117 MJJ

ORDER RE: TOPICS FOR SUMMARY

JUDGMENT HEARING

The Court, having reviewed the parties’ summary judgment materials, instructs the parties to be

prepared to address the following questions at the February 22, 2008 hearing:

1. Is it undisputed that the potential of the counterelectrode in the accused Bayer and BD/Nova

products will differ depending on the glucose concentration of the sample being measured?

Abbott should identify any evidence in the record that creates a disputed fact as to this specific

point.

2. Abbott argues the Court should revise its construction of “reference counterelectrode.” Abbott

cites to relatively recent deposition testimony of Defendants’ witnesses, regarding the

nomenclature those individuals use, or have used, to describe the counterelectrode in the accused

products. What evidence in the record supports or contradicts the conclusion that these

individuals were using nomenclature consistent with one skilled in the art during the relevant

time period (the mid-1980s)?

3. Should the ‘745 patent’s express definition of measurement zone be given further construction

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United States District Court

For the Northern District of California

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by the Court to resolve the apparent disagreement between the parties’ experts as to how the

phrase “sized to contain only that portion of the sample that is to be interrogated” be interpreted?

4. If so, the Court’s preliminary view is that intrinsic evidence requires the measurement zone to

be a preexisting space whose dimensions are not dependent upon the measurement time or

variables unique to the specific sample being measured. Assuming this restriction, what

construction is most consistent with the intrinsic evidence, i.e., the 745 patent’s claims,

specification and prosecution history? 

5. The ‘745 patent requires a step of “contacting a sample with an electrochemical sensor . . .” By

what claim construction principles can this Court resolve whether this claim language is

referring solely to the initial action of bringing the sample and the sensor together for the first

time so they are touching? 

6. Assuming the Court’s construction of the non-flowing limitation precludes convection within

the sample chamber during measurement: What, if anything, about Dr. Bard’s expert testimony

create a triable issue of fact as to whether convection occurs in the accused BD/Nova strip? 

7. What evidence in the record establishes Abbott’s prima facie case that a 40mV variation in

potential during measurement in the BD/Nova strip is an “insignificant variation” in potential?

8. Are Dr. Johnson’s “hemitocrat effect” experiments, on their own, sufficient prima facie evidence

to establish that it is more likely than not that red blood cells reach the electrode in the BD/Nova

strip during measurement?

9. Is there a disputed issue of fact as to whether Figure 10 of the Nankai patent discloses the use

of two separate counterelectrodes? Figure 10 itself appears to show the pieces 5 and 5' as being

in electrical contact with each other, and collectively connected to only one lead. Can two

separate counterelectrodes be on the same lead? 

10. Is there any dispute of material fact on this record as to whether every element of the ‘890 patent

claims are disclosed in the Ikeda patent? In other words, if the Court concludes on this record

that it is undisputed that the Ikeda patent is prior art, does Abbott concede that the asserted ‘890

patent claims are anticipated and therefore invalid?

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11. For purposes of establishing “prior invention”, it appears to the Court that the law does not

require Abbott to prove that the original reduction to practice occurred in the United States.

Instead, if the invention was first reduced to practice outside the United States, Abbott can claim

a date of invention as of the date the invention was embodied in tangible form in the United

States. See Scott v. Koyama, 281 F.3d 1243, 1347 (Fed. Cir. 2002). Do Defendants contend

otherwise, and if so, based on what authority?

12. For purposes of establishing “prior invention”, what evidence put forth by Abbott in the present

record meets Abbott’s burden of production to show that the 1993-94 tests in the United States,

and/or the 1994 clinical trials in the United States, used electrode configurations that meet all

of the claim elements of the ‘890 claims?

13. With respect to the Gotoh patent, Defendants contend that the ‘745 patent, at column 43, lines

49-62, teaches there can be no background signal due to shuttling where the spacing of the

electrodes exceeds (Dm)t1/2. However, it appears to the Court that under the assumed values

(t=30 sec, Dm is between 10-5 and 10-6 cm2/sec) in that passage, the diffusion distance suggested

by the (Dm)t1/2. formula is between 54 and 173 μm. Is this calculation correct? If so, why would

the drafters of the ‘745 patent recommend “even more preferably” a spacing of 400 μm, if 200

μm would be sufficient to eliminate all shuttling?

14. Based on the Court’s inclusion of the words “back and forth” in its construction of the

background signal limitation construction, Defendants contend that for shuttling to occur, a

single mediator molecule must make a round trip during the measurement period, i.e., must

travel from the electrode to the counterelectrode, and back again, during the measurement

period. Is there a dispute between the parties as to whether this is an accurate scientific

description of shuttling? Can background signal be created if a mediator molecule simply makes

the one-way trip, but not the round trip, during the measurement period?

15. What specific evidence put forth by Abbott creates a triable issue as to whether the ‘225

reference discloses the use of a diffusable redox mediator, given the ‘225 reference’s express

mention of a diffusable redox mediator at column 9, lines 25-29? From the Court’s initial

review of Dr. Turner’s testimony, Dr. Turner appears to simply opine that the ‘225 teaches away

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from the use of a diffusable redox mediator. Does Dr. Turner’s testimony create a triable issue

of material fact?

16. Do Dr. Bard’s or Dr. Turner’s testimony create a triable issue of fact as to whether the ‘225

reference is enabling?

17. Assuming the Court finds that the ‘225 reference discloses the use of diffusible redox mediator,

discloses the non-flowing limitation fo the ‘745 patent, and is enabling: Is there any

disagreement between the parties as to which ‘745 claims should be declared anticipated by the

‘225 reference by this Court?

18. Assuming the Heller ‘225 reference anticipates claim 8 of the ‘745 patent: Why shouldn’t the

Court find that claim 11 is obvious in light of Dr. Weber’s uncontradicted testimony that it

would have been obvious to combine the ‘225 reference with other prior art references? Under

Federal Circuit precedent, must Defendants submit evidence regarding secondary considerations

to establish a prima facie case of obviousness? Do any of the secondary factors discussed by

Dr. Bard have any bearing on the additional claim limitation found in dependent claim 11?

IT IS SO ORDERED.

Dated: February 19, 2008 

MARTIN J. JENKINS

UNITED STATES DISTRICT JUDGE

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