17366 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Notices

8. Implement, monitor and update the

water conservation plan

The CVP contractors listed below

have developed water conservation

plans which Reclamation has evaluated

and preliminarily determined meet the

requirements of the Criteria.

• Arvin Edison Water Shortage

District.

• Bella Vista Water District.

• Colusa County Water District.

• Corning Water District.

• Dunnigan Water District.

• Gravelly-Food Water District.

• Monterey County Water Resources

Agency.

• Proberta Water District.

• San Juan Water District.

• Santa Barbara, City of.

• Santa Barbara, County of.

• Tea Pot Dome Water District.

• The West Side Irrigation District.

• Thomes Creek Water District.

• Westside Water District.

Public comment on Reclamation’s

preliminary (i.e., draft) determinations

at this time is invited. Copies of the

plans listed above will be available for

review at Reclamation’s Mid Pacific

(MP) Region Office and MP’s area

offices. If you wish to review a copy of

the plans, please contact Ms. Reifsnider

to find the office nearest you.

Dated: March 28, 1995.

Franklin E. Dimick,

Assistant Regional Director.

[FR Doc. 95–8320 Filed 4–4–95; 8:45 am]

BILLING CODE 4310–94–M

INTERNATIONAL TRADE

COMMISSION

[Investigation No. 337–TA–349]

Certain Diltiazem Hydrochloride and

Diltiazem Preparations; Notice of

Commission Decision to Review

Portions of an Initial Determination

AGENCY: U.S. International Trade

Commission.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the U.S. International Trade

Commission has determined to review

certain portions of the initial

determination (ID) and Order No. 52

issued by the presiding administrative

law judge (ALJ) on February 2, 1995, in

the above-captioned investigation.

FOR FURTHER INFORMATION CONTACT:

Cynthia P. Johnson, Esq., Office of the

General Counsel, U.S. International

Trade Commission, telephone 202–205–

3098.

SUPPLEMENTARY INFORMATION: On

February 1, 1995, the presiding ALJ

issued his final ID finding that there was

no violation of section 337. He found

that claim 1 of U.S. Letters Patent

4,438,035 (′035 patent) was not

infringed by any of respondents’

processes, that claim 1 was invalid as

obvious under 35 U.S.C. 103, and that

the ′035 patent was unenforceable

because of complainants’ inequitable

conduct during reexamination

proceedings before the U.S. Patent and

Trademark Office. In a separate order

(Order No. 52), issued on the same date,

the ALJ granted respondents’ motion for

evidentiary sanctions. In that order, he

stated that because there is a

Commission preference for decisions on

the merits based on all the evidence

adduced, and because he believes that

the same conclusions of law regarding

infringement would be appropriate

whether or not the sanctions of Order

No. 52 are applied, he was imposing

sanctions on complainants only as

alternate relief, i.e., only if the

Commission determines based on all the

evidence of record that respondents

have infringed claim 1 of the ′035

patent.

On February 21, 1995, complainants

filed a petition for review of the ALJ’s

final ID. They also filed a separate

petition for review of Order No. 52. On

the same day, the Commission

investigative attorneys (IAs) filed a

petition for review of the ALJ’s finding

that a domestic industry exists.

On March 6, 1995, the IAs, the

Fermion respondents, and the

Profarmaco respondents filed

oppositions to complainants’ petition

for review. Respondent Gyma

Laboratories also filed an opposition to

petition for review indicating that it

principally relies on and concurs in the

response filed by the Profarmaco

respondents.

Having examined the record in this

investigation, including the ID and

Order No. 52, the Commission has

determined to review the issues of (1)

claim interpretation, (2) whether claim

1 of the ′035 patent is infringed by

respondents’ processes; (3) whether

claim 1 of the ′035 patent is invalid as

obvious under 35 U.S.C. § 103; (4)

whether the ′035 patent is

unenforceable; and (5) Order No. 52.

The Commission has determined not to

review the remainder of the ID. The

Commission regards the ID as including

Order No. 52. The Commission has also

denied complainants’ motion for leave

to file the affidavit of James Gambrell,

and denied complainants’ request for an

oral hearing. With regard to the

Gambrell affidavit, the Commission

believes that reopening the record to

accept the affidavit at this late stage of

the investigation would not be

appropriate.

On review, the Commission is

particularly interested in answers to the

following questions:

(1) Is claim 1 of the ′035 patent

entitled to any range of equivalents? If

not, why not? If so, does the range of

equivalents cover (1) use of methyl ethyl

ketone, the next higher homolog of

acetone, as a solvent when used with

potassium hydroxide as a base, or (2)

use of potassium carbonate and toluene

as the base-solvent combination? Why?

(2) What is the status of the Abic

group of respondents? Have they settled

their differences with complainants? If

so, will a motion to terminate the Abic

group of respondents from the

investigation be forthcoming?

(3) Is there any suggestion or

motivation in the prior art references as

a whole applied in the ID to combine

those references so as to render obvious

under 35 U.S.C. 103 the invention

claimed in claim 1 of the ’035 patent?

(4) Was there a sale in the United

States of the product produced by the

Tanabe trade secret KOH/DMSO process

within the meaning of 35 U.S.C. 102(b)?

Is there applicable case law relevant to

complainants’ contention that sales of a

product for the sole purpose of FDA

approval do not constitute an ‘‘on sale’’

bar within the meaning of 35 U.S.C.

102(b)? The Commission is interested in

an analysis, based on the evidence of

record, of whether sales made solely for

purposes of FDA approval constitute an

‘‘on sale’’ bar, taking into account the

analysis set forth by the Federal Circuit

in considering whether a prior use or

sale is a statutory bar in, e.g., Pennwalt

Corp. v. Akzona Inc. (and cases cited

therein) 740 F.2d 1573 (Fed. Cir. 1984).

The Commission is also interested in

any evidence of record relevant to

complainants’ contention that the only

sales in the United States of Tanabe’s

trade secret KOH/DMSO process were

for purposes of FDA approval. If the

Tanabe KOH/DMSO process is found to

be prior art, what suggestion or

motivation, if any, is there in the prior

art that the use of DMSO as a solvent

would have rendered the solvents of

claim 1 of the ’035 patent obvious under

35 U.S.C. 103? Finally, assuming that

the Tanabe KOH/DMSO process is prior

art, was it more pertinent than the

references before the examiner during

the reexamination proceedings?

In connection with final disposition

of this investigation, the Commission

may issue (1) an order that could result

in the exclusion of the subject articles

from entry into the United States, and/

or (2) cease and desist orders that could

result in respondents being required to
Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Notices 17367

1A stay will be issued routinely by the

Commission in those proceedings where an

informed decision on environmental issues

(whether raised by a party or by the Commission’s

Section of Environmental Analysis in its

independent investigation) cannot be made prior to

the effective date of the notice of exemption. See

Exemption of Out-of-Service Rail Lines, 5 I.C.C.2d

377 (1989). Any entity seeking a stay on

environmental concerns is encouraged to file its

request as soon as possible in order to permit the

Continued

cease and desist from engaging in unfair

acts in the importation and sale of such

articles. Accordingly, the Commission is

interested in receiving written

submissions that address the form of

remedy, if any, that should be ordered.

If a party seeks exclusion of an article

from entry into the United States for

purposes other than entry for

consumption, the party should so

indicate and provide information

establishing that activities involving

other types of entry either are adversely

affecting it or are likely to do so. For

background, see the Commission

Opinion, In the Matter of Certain

Devices for Connecting Computers via

Telephone Lines, Inv. No. 337–TA–360.

If the Commission contemplates some

form of remedy, it must consider the

effects of that remedy upon the public

interest. The factors the Commission

will consider include the effect that an

exclusion order and/or cease and desist

orders would have on (1) the public

health and welfare, (2) competitive

conditions in the U.S. economy, (3) U.S.

production of articles that are like or

directly competitive with those that are

subject to investigation, and (4) U.S.

consumers. The Commission is

therefore interested in receiving written

submissions that address the

aforementioned public interest factors

in the context of this investigation.

If the Commission orders some form

of remedy, the President has 60 days to

approve or disapprove the

Commission’s action. During this

period, the subject articles would be

entitled to enter the United States under

a bond, in an amount determined by the

Commission and prescribed by the

Secretary of the Treasury. The

Commission is therefore interested in

receiving submissions concerning the

amount of the bond that should be

imposed.

Written Submissions

The parties to the investigation are

requested to file written submissions on

the issues under review. The

submissions should be concise and

thoroughly referenced to the record in

this investigation, including references

to specific exhibits and testimony.

Additionally, the parties to the

investigation, interested government

agencies, and any other interested

persons are encouraged to file written

submissions on the issues of remedy,

the public interest, and bonding.

Complainants and the Commission

investigative attorneys are also

requested to submit proposed remedial

orders for the Commission’s

consideration. The written submissions

and proposed remedial orders must be

filed no later than the close of business

on April 13, 1995. Reply submissions

must be filed no later than the close of

business on April 20, 1995. No further

submissions will be permitted unless

otherwise ordered by the Commission.

Persons filing written submissions

must file with the Office of the Secretary

the original document and 14 true

copies thereof on or before the deadlines

stated above. Any person desiring to

submit a document (or portion thereof)

to the Commission in confidence must

request confidential treatment unless

the information has already been

granted such treatment during the

proceedings. All such requests should

be directed to the Secretary of the

Commission and must include a full

statement of the reasons why the

Commission should grant such

treatment. See 19 C.F.R. 201.6.

Documents for which confidential

treatment is granted by the Commission

will be treated accordingly. All

nonconfidential written submissions

will be available for public inspection at

the Office of the Secretary.

This action is taken under the

authority of section 337 of the Tariff Act

of 1930 (19 U.S.C. 1337) and sections

210.54-.55 of the Commission’s Interim

Rules of Practice and Procedure (19 CFR

210.54-.55).

Copies of the public version of the ID

and all other nonconfidential

documents filed in connection with this

investigation are or will be available for

inspection during official business

hours (8:45 a.m. to 5:15 p.m.) in the

Office of the Secretary, U.S.

International Trade Commission, 500 E

Street S.W., Washington, D.C. 20436,

telephone 202–205–2000. Hearingimpaired persons are advised that

information on the matter can be

obtained by contacting the

Commission’s TDD terminal on 202–

205–1810.

Issued: March 30, 1995.

By order of the Commission.

Donna R. Koehnke,

Secretary.

[FR Doc. 95–8356 Filed 4–4–95; 8:45 am]

BILLING CODE 7020–02–P

INTERSTATE COMMERCE

COMMISSION

[Docket No. AB–290 (Sub-No. 169X)]

Norfolk and Western Railway

Company—Abandonment Exemption—

Between Ferguson Junction and Glen

Echo, MO

Norfolk and Western Railway

Company (NW) has filed a notice of

exemption under 49 CFR Part 1152

subpart F—Exempt Abandonments to

abandon its 2.56-mile line of railroad

between milepost UD–9.94 at Glen Echo

and milepost UD–12.50 at Ferguson

Junction in St. Louis County, MO.

NW has certified that: (1) No local

traffic has moved over the line for at

least 2 years; (2) there is no overhead

traffic on the line; (3) no formal

complaint filed by a user of rail service

on the line (or by a state or local

government entity acting on behalf of

such user) regarding cessation of service

over the line either is pending with the

Commission or with any U.S. District

Court or has been decided in favor of

the complainant within the 2-year

period; and (4) the requirements at 49

CFR 1105.7 (service of environmental

report on agencies), 49 CFR 1105.8

(service of historic report on State

Historic Preservation Officer), 49 CFR

1105.11 (transmittal letter), 49 CFR

1105.12 (newspaper publication), and

49 CFR 1152.50(d)(1) (service of verified

notice on governmental agencies) have

been met.

As a condition to use of this

exemption, any employee adversely

affected by the abandonment shall be

protected under Oregon Short Line R.

Co.—Abandonment—Goshen, 360 I.C.C.

91 (1979). To address whether this

condition adequately protects affected

employees, a petition for partial

revocation under 49 U.S.C. 10505(d)

must be filed.

Provided no formal expression of

intent to file an offer of financial

assistance (OFA) has been received, this

exemption will be effective on May 5,

1995, unless stayed pending

reconsideration. Petitions to stay that do

not involve environmental issues,1