Ex Parte D Angelo

Board of Patent Appeals and Interferences

Feb 10, 2003

08500535 (B.P.A.I. Feb. 10, 2003)

The opinion in support of the decision being
entered today was not written for publication
and is not binding precedent of the Board.
Paper No. 89
tFED
UNITED STATES PATENT AND TRADEMARK OFFICE
& BEFORE THE BOARD OF PATENT APPEALS 6V
AND INTERFERENCES
HENRY B. SCHUR and NICHOLAS G. LEVANDOSKI
Junior Party'
v .
JOSEPH P. D'ANGELO
Senior Party'
Interference No. 104,178
FINAL DECISION
Before URYNOWICZ, PATE and MARTIN, Administrative Patent Judaes.
URYNOWICZ, Administrative Patent Judae.
The invention at issue in this interference
relates to a method and apparatus for collecting saliva. The
particular subject matter in issue is illustrated by counts 1
1 Application 08/501,417, filed August 8, 1995. Assigned to Analyte
Diagnostics, Inc.
2 Application 08/500,535, filed July 11, 1995, which is a
continuation-in-part of Serial No. 08/432,778 filed May 2, 1995, which is a
continuation-in-part of Serial No. 08/239,726 filed May 9, 1994, both
abandoned.
Interference No. 104,178
and 2 as follows:
Count 1
A method of collecting saliva samples for body fluid
analysis, which comprises:
placing absorptive means into a patient's oral
cavity; absorbing saliva into the absorptive means;
removing the absorptive means from the patient's
oral cavity and placing the absorptive means into a collection
container having elastically resilient walls; and
driving the saliva from the absorptive means and
collecting the saliva in the collection container by squeezing
the collection container to drive the saliva out of the
absorptive means and into the collection container.
Count 2
An assembly for collecting saliva for body fluid
analysis, comprising:
absorptive means for placing into a patient's oral
cavity and for absorbing saliva therein;
a collection container defining a cavity adapted to
receive said absorptive means, said collection container
having elastically resilient walls adapted to collapse toward
one another upon being squeezed to drive the saliva from said
absorptive means when said absorptive means is disposed in
said collection container.
The claims of the parties which correspond to the
counts are:
Count 1:
Schur et al. (Schur) Claims 1 and 5
D'Angelo Claims 1 and 2
Count 2:
Schur et al. (Schur) Claims 6-10, 17 and 20
D'Angelo Claims 3-12
2
Interference No. 104,178
This proceeding was declared on April 13, 1998 and
party D'Angelo was accorded senior party status based on its
earlier filing date of July 11, 1995.
On September 8, 1999, D'Anqelo was accorded benefit
of the May 9, 1995 filing date of PCT/US95/05889 for counts 1
and 2 (Paper No. 39).
Both parties took testimony, filed briefs and
appeared for oral argument at final hearing.
The Issues Set Forth by Schur
At page I of its brief, Schur presents the following
issues for decision by the Board,
(a) Whether Schur, not D'Angelo, is entitled to benefit of
the filing date of PCT/US95/05889 filed May 9, 1995,
(b) Whether D'Angelo is entitled to amend his preliminary
statement, and if not, whether D'Angelo is entitled to
any date earlier than his July 11, 1995 filing date,
(c) Whether D'Angelo is held to his filing date based on
his failure to file and serve his record in this
interference,
(d) Whether D'Angelo derived the invention of his
application S.N. 08/500,535 from Schur and Levandoski,
(e) Whether Levandoski's testing was a reduction to
practice of count 1,
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Interference No. 104,178
(f) Whether the work of William Sullivan was a reduction
to practice of count 2 and attributable to Schur and
Levandoski, and
(g) Whether evidence presented by D'Angelo is admissible.
D'Angelo has not provided a separate listing of the
issues for decision by the Board.
Benefit of the May 9, 1995 Filinq Date
of PCT/US95/05889
The party Schur argues to the effect that it is
entitled to benefit of the filing date of the PCT application
because the junior party co-inventors, Henry Schur and
Nicholas Levandoski, are listed inventors in the application,
and the showing made in its original preliminary motion for
benefit of the application established support for counts 1
and 2 therein. According to Schur, the Administrative Patent
Judge (APJ) inadvertently confused the sole applicant, Joseph
D'Angelo, in the PCT application with the inventors Henry
Schur and Nicholas Levandoski in said application, and should
not have granted D'Angelo benefit of the filing date of the
PCT application simply because it was amended to name D'Angelo
as the sole applicant.
Schur further argues to the effect that D'Angelo is
not entitled to benefit of the PCT application because
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Interference No. 104,178
D'Angelo never filed a timely motion for benefit of the
application.
D'Angelo states that the PCT application was filed
in the United States Patent and Trademark Office (PTO) as the
receiving office of the PCT, and not in a foreign country.
The senior party submits that priority cannot be claimed under
35 U.S.C. § 119 because benefit of priority under this section
can only be based on a foreign application.
D'Angelo takes the position that 3S U.S.C. § 120 is
also not available as a basis on which to claim benefit of the
PCT application. The contention is made that benefit of
priority under this section can only be based on an
application filed in the United States or on an international
application under 35 U.S.C. § 363. It is submitted that in
the latter case, priority applies only if the international
application designated the United States and that the PCT
application in question did not designate the United States.
Rule 1.655(a) has been amended to make it clear that
a Board panel at final hearing will resolve the merits of an
interference (e.g., patentability or an attempt to obtain
benefit of an earlier application) without giving deference to
any interlocutory order which is substantive and not
procedural. See Consideration of Tntgrlocutory Rulings at
Final Hearina in Tnterference Proceedings, 64 Fed. Reg.
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Interference No. 104,178
12,900, 12,901 (March 16, 1999). Accordingly, we consider the
substantive issues dealt with by the APJ in his interlocutory
capacity and raised by the parties in their briefs giving them
de novo consideration in this decision.
Under 35 U.S.C. § 365(a), which specifically relates
to 35 U.S.C. § 119, a national application is entitled to the
right of priority based on a prior filed international
application which designated at least one country other than
the United States. Whereas the PCT application in question
designated at least one country other than the United States,
sections 119 and 365(a) are controlling here.
We are of the opinion that the junior party Schur is
not entitled to benefit of the May 9, 1995 filing date of the
application PCT/US95/05889. Schur and Levandosky, the
inventors named in the involved Schur application, are both
named along with Dr. D'Angelo, the senior party, as inventors
in the PCT application. Thus, there is a disagreement as to
inventorship between the national and PCT applications. In
such a situation, the priority date should be refused until
the inconsistency is resolved. See MPEP § 201.15, Reitz v.
Inoue, 39 USPQ2d 1838, 1840 (Bd. Pat. App. & Int. 1995).
Here, the party Schur never resolved the inconsistency when it
filed its motion (Paper No. 11) for benefit of the PCT
application.
6
Interference No. 104,178
Whereas the senior party D'Angelo failed to resolve
the inconsistency in inventorship between its involved
application and the PCT application as of the time D'Anqelo
was accorded benefit of the PCT application, it is our finding
that the senior party should not have been granted benefit of
the PCT application, and benefit thereof is hereby denied to
it.
In view of the above findings with respect to the
PCT application, the party D'Angelo is senior party by virtue
of the earlier filing date, July 11, 1995, of its involved
application. Whereas this proceeding involves co-pending
applications of the parties, the junior party Schur has the
burden of establishing priority by a preponderance of the
evidence. 37 CFR § 1.657(a).
D'Anaelo's Motion to Suppress Evidence
(Paiper No. 77)
The senior party moves to suppress ýSchur et al.'s
Affidavit" because it is not notarized, and Shur Exhibits 1, 4
and 5 because they are not authenticated 3.
The motion is dismissed. The senior party was
obliged to file objections to admissibility by December 12,
'Hereinafter, Schur and D'Angelo exhibits will be referred to as SX and
DX, respectively, and the Schur and D'Angelo records will be referred to
as SR and DR, respectively.
7
Interference No. 104,178
1999 and notify the APJ via a conference call with the
participation of opposing party of the filing of objections
but failed to do so. See page 2 of the ORDER of the APJ dated
September 8, 1999 (Paper No. 40). As such, party D'Angelo
waived objections to Schur's evidence.
Schur's Motion to Strike (Paiper No. 54)
On March 6, 2000, Schur moved for an order to strike
D'Anqelo's affidavit testimony and DX - B through M, and 0.
With respect to affidavits, Schur submits that these were to
be served by February 18, 2000 and that they were served
belatedly on February 29, 2000. it is argued that DX - B
through F are irrelevant, DX - G is not admissible to show a
first conception because it was not attached to D'Angelo's
preliminary statement (37 CFR § 1.629(d)), Schur has had no
opportunity to cross-examine with respect to DX - H, and DX
I through M, and 0 are not admissible as unauthenticated
hearsay.
Schur's motion is dismissed. At page 2 of the ORDER
of the APJ dated February 3, 2000 (Paper No. 45), the APJ
stated that,
Any objections to the admissibility of any
evidence contained in or submitted with an
affidavit under §1.672(b) must be filed by
March 3, 2000 and the party objecting must
notify the Administrative Patent Judge (APJ),
via a conference call with the participation of
opposing party, of the filing of objections.
8
Interference No. 104,178
Failure to so notify the APJ will constitute a
waiver of any objection raised.
Schur did not comply with this order in that it did
not notify the APJ via a conference call, with the
participation of the opposing party, D'Angelo, of the filing
of objections. Thus, Dr. D'Angeio, who was prosecuting his
case pro se, was denied an opportunity during a conference
call with party Schur to come to an agreement with Schur
overcoming its objections. In accord with the notice in the
order, failure by Schur to notify the APJ constitutes a waiver
of any objection raised in its motion to strike'.
The Party Schur's Recor
The testimony of the co-inventor, Henry Schur, is to
the following effect.
On or about January 10, 1994, he, in conjunction
with co-inventor, Nicholas Levandoski, conceived a saliva
sample collection apparatus and a method of collecting saliva
samples for body fluid analysis. The apparatus contained a
polyurethane sponge for placing in a patient's oral cavity for
absorbing saliva therein and a container having elastically
resilient walls adapted to collapse toward one another upon
'Even if Schur's motion were not dismissed on the above ground, it would
not have been granted on the basis the evidence was belatedly served
because the service was only several days late and there was no
prejudice resulting therefrom.
9
Interference No. 104,17B
being squeezed to drive the saliva out of the polyurethane
sponge when the sponge is disposed in the collection
container.
In mid-February 1994, he prepared a prototype of the
sponge and resilient container with the assistance of a
colleague, Daniel Glenn, and showed the prototype to Dr.
Joseph D'Angelo, the senior party. He made a drawing of the
sponge and resilient container containing the sponge on or
about March 27, 1994 (SX - 1). on or about April 1994, he
prepared a general description of the saliva collection sponge
system (SX - 2).
Schur actively pursued the development of a saliva
sponge and resilient container for collecting saliva from the
sponge from conception with Nicholas Levandoski on or about
January 10, 1994, up through making a prototype product in
mid-February 1994, and thereafter continued to refine the
sponge and resilient container up through August 199S, with
the desire to manufacture a commercial saliva tester as
described in involved application S.N. 08/501,417.
The co-inventor, Nicholas Levandoski, testified to
the following effect.
On or about January 10, 1994, he, in conjunction
with Henry Schur, conceived a saliva sample collection
apparatus and a method of collecting saliva samples for body
10
Interference No. 104,178
fluid analysis, the apparatus containing a polyurethane sponge
for placing in a patient's oral cavity for absorbinq saliva
therein and a container having elastically resilient walls
adapted to collapse toward one another upon being squeezed to
drive the saliva out of the polyurethane sponge when the
sponge is disposed in the collection container.
In mid-February 1994, Henry Schur arranged to have a
prototype of the sponge and a resilient container therefore
built by Donald (sic:Daniel) Glenn and showed the prototype to
Dr. Joseph D'Angelo. On or about March 27, 1994, Levandoski
reviewed a drawing prepared by Henry Schur of the sponge and
resilient container containing the sponge (SX - 1), and he
subsequently reviewed a general description titled 'SALIVA
COLLECTION SPONGE SYSTEM" prepared by Schur on or about April
1994 (SX - 2).
In paragraph 5 of his testimony, Levandoski asserts
that he took several of the saliva collection sponges and
container apparatus to Jackson Memorial Hospital' on or about
March, 1994 and placed the polyurethane sponges from each
apparatus in a control serum containing drugs of abuse and
Phenobarbital, among other drugs. A sponge was placed with
the control serum in the collection container having
elastically resilient walls. The serum was squeezed out of
5 Jackson Memorial Hospital is in Miami, Florida.
11
Interference No. 104,178
the sponge by squeezing the collection container. The
collected serum was tested to confirm the presence of drugs of
abuse, Phenobarbital and other drugs in the recovered fluid.
Levandoski asserted that the test was analogous to testing for
these drugs in saliva.
In paragraph 6 of his testimony, Levandoski states
that he conducted another test in his home in March 1994. He
drank a cup of coffee and drew a blood sample to test for the
presence of caffeine in his blood. He placed a sponge in his
oral cavity to absorb saliva and then squeezed the saliva out
of the sponge in a resilient tube. A test of the saliva
confirmed that the presence of caffeine in the saliva was
approximately at the same concentration found in his blood
sample.
Schur's involved application substantially discloses
the same apparatus which was used to test for caffeine in
Levandoski's saliva.
The co-inventors actively pursued the development of
the saliva sponge and resilient container for collecting
saliva from the sponge from their conception on or about
January 10, 1994, through the making of a prototype in mid
February, 1994. The prototype was used successfully in
testing the apparatus in Jackson Memorial Hospital.
Thereafter, Levandoski continued to refine the refine the
12
Interference No. 104,178
sponge and resilient container apparatus with Henry Schur up
through August 1995.
Joel Marcus testified that in the Spring of 1994, he
was Henry Schur's accountant. He averred that he remembers
discussions and personal observations pertaining to a saliva
collector and a squeeze tube, and that Schur and Levandoski
'-were the inventors of the Saliva Collection and Dr. D'Angelo
was the person in overall charge of fundraising and other
administrative functions."
William Sullivan testified to the effect that he is
an employee and part owner of Double B Tool and Dye Company
for the last nineteen years. Double B Tool and Dye builds
custom molds for the plastic industry.
Henry Schur contacted him in the summer of 1994
about preparing a mold for a saliva collector. Schur
explained to him the need for plastic parts with a foam sponge
at one end and a squeezable tube for retaining the foam sponge
and allowing saliva to be squeezed from the sponge. There
also would need to be a cap at the bottom of the flexible
tube. The tube was to be made from a soft vinyl or a soft
polyethylene so it could be squeezed. Sullivan indicated that
his recollection of the meeting with Schur is based on records
of job numbers forward and backward of the job number for the
squeezable tube and noted the date of completion. He made the
13
Interference No. 104,178
mold for the flexible tube requested by Schur and delivered it
to Schur in September or October 1994 at his office in
Americare Transtech Inc.'
In a supplemental declaration, Sullivan testified
that the resilient flexible tube shown in the picture
identified as SX - 5 is one of the resilient flexible tubes
made by him for Henry Schur from the mold delivered to Schur
in September or October 1994, and that the tube is one of
about 100 which he prepared in the equipment of East Coast
Plastics in about October 1994, at Schur's request'. These
tubes were delivered to Schur in October, 1994.
The testimony of Daniel Glenn is to the following
effect. He was employed by Americare Transtech, Inc. between
May, 1992 and June, 1994, and that after he left he did some
consulting work for the company. It was in January, 1994 when
he began working on a saliva collection device. At that time,
a tube was to be utilized as part of the device. Glenn worked
with the inventors in an attempt to produce a sponge for the
collection device. Henry Schur provided him with pacifiers
and Glenn used the nipples of the pacifiers as molds to
produce sponges from commercially available material, which
6Americare Transtech, Inc. was Schur's employer and Dr. D'Angelo was
president of the company.
'Sullivan was a partner in East Coast Plastics.
14
Interference No. 104,178
Schur also provided him. it was at a staff meeting that Dr.
D'Angelo assigned Schur the task of finding an inert material
for making the sponges.
After leaving the company, Glenn was called back by
Dr. D'Angelo to solve a problem with the sponge device. The
problem was that the glue holding the sponge to a cap
separated. The solution was to put a hole in the cap and to
pour the material for making the sponge through the hole such
that the sponge is molded into the cap. Glenn indicated that
he did not know when the idea of making the tube of the
collection device flexible was conceived.
01pinion as to Schur's Case
We are of the opinion that the junior party Schur
has failed to establish conception of the subject matter of
either count prior to its filing date.
There is simply no independent corroboration of the
activity of Henry Schur and Nicholas Levandoski in the period
January through March of 1994. The testimony of Joel Marcus,
a certified public accountant, is deficient as to dates when
he had discussions with Schur and when he made observations
pertaining to a saliva collector and a squeezable tube.
Marcus testified that to his knowledge Henry Schur and
Nicholas Levandoski were the inventors "...of the Saliva
Collection", but this does not establish that he is testifying
15
Interference No. 104,178
Collection", but this does not establish that he is testifying
about either the method or apparatus defined in counts I
and 2. Furthermore, the testimony of Marcus to the effect
that Schur and Levandoski are the inventors is a mere
conclusion. There appears to be no reason why Marcus did not
testify as to facts and dates upon which his belief is based.
Daniel Glenn was unable to state with any degree of certainty
when discussions occurred with Henry Schur concerning a saliva
collection device with a flexible collector or tube, and the
testimony of William Sullivan is not concerned with the
January through March, 1994 time period. Lastly, the
documents identified as SX - 1 and 2', of which page 2 of SX
I has a date of March 27, 1994, were made by Schur. No
corroborating witness testified about those exhibits, and they
are but self-serving documents.
The testimony of William Sullivan concerning later
inventive acts by the junior party is unpersuasive. That
testimony concerns alleged activity involving Henry Schur and
Sullivan in the summer of 1994, and as late as October of that
year. The co-inventor and witness, Henry Schur, did not
testify about any such activity with Sullivan in the above
time period and this casts doubt on whether the activity
occurred as related by Sullivan. Sullivan testified in
paragraph 3. of his declaration that he was certain of the
16
Interference No. 104,178
time of year of these inventive acts because he looked at his
job numbers forward and backward of the job number for
constructing the mold for the making of a squeezable tube and
noted the date of completion. However, no files carrying
these job numbers are of record, and cross-examination
testimony of Sullivan from a prior proceeding of record in the
senior party D'Angelo's case, indicates that Sullivan had no
file having a job number for making a mold for a squeezable
tube with respect to which he could have checked job numbers
forward and backward of the job number of the mold so as to
identify a date of completion of the mold (DX - N, pages 2-6).
Sullivan's testimony in this regard is inconsistent.
Furthermore, in his supplemental affidavit, William
Sullivan testified that he prepared about 100 flexible tubes
at the request of Henry Schur in about October, 1994 and
delivered them to Schur that same month. However, in
contrast, in the aforementioned cross-examination of Sullivan
from the prior proceeding (DX - N, page 8, lines 17-22), he
testified that,
I built the molds, the steel molds that make
the plastic parts. East Coast Plastics runs
the molds, they put them in a molding press and
they squeeze the plastic into the mold, open
the mold up and have the parts come out. I
build the molds.
Sullivan testified at page 10 of this testimony that he went
down to a lab in Miami to Henry Schur and Dr. D'Anqelo to
17
Interference No. 104,178
prove out his tool or mold. This testimony is to the effect
that Sullivan did not prepare any flexible tubes himself which
he delivered to Henry Schur but that he brought a mold to the
laboratory where it was used to make flexible tubes.
Sullivan's accounts are difficult to harmonize, and it is not
clear from them what, if anything, he actually did for the
junior party in about October, 1994.
Still further, there is no document in the record of
the junior party which is a bill or charge from Double B Tool
and Dye Company to Americare Transtech, Inc. for work
performed at the request of Henry Schur in constructing a mold
to be utilized in making a squeezable tube. The existence of
such a document would normally be expected if Sullivan
constructed a mold in response to a request from Henry Schur
at the time alleged.
In its brief at page 9, the junior party argues that
Dr. D'Angelo derived the invention of counts 1 and 2 from
Schur and Levandoski. The basis for this charge is that
D'Angelo admits at paragraph 8 of his preliminary statement
(SR-64) that 'Schur communicated the concept that 'the
prototype tube with the pipette tip needs to be very flexible
on the sides...' on January 27, 1995" and further admits at
paragraph 20A. of his preliminary statement (SR-66) that
"Schur contacted the company's patent attorney, Mr. Werner
18
Interference No. 104,178
Stemer (reg. No. 34,956) with a description of the invention
of Count I and Count 2".
This argument is unpersuasive. A preliminary
statement is not regarded as evidence but as merely setting
dates earlier than which evidence is not effective. Halbert
v. Schuurs, 220 USPQ 558, 565 (Bd.Pat.Int. 1983); Dewey v.
Lawton, 347 Fd. 629, 630-31, 146 USPQ 187, 188 (CCPA 1965).
Consequently, the particular statements in D'Angelo's
preliminary statement are not regarded as effective admissions
except for the setting of limiting dates.
Actual Reduction to Practice an
Diliaence by Schur
Even if the junior party had established a date of
conception prior to D'Angelo, the senior party would have been
entitled to prevail herein because (1) the party Schur has no
corroborating evidence establishing that the aforementioned
testing of Levandoski constituted an actual reduction to
practice of count 1 (Schur issue (e) at page I of its brief),
(2) William Sullivan's testimony as to his activity in 1994 is
not credible and cannot establish actual reduction to practice
of count 2 (Schur issue (f) at page 1 of its brief), and (3)
party Schur has no specific facts establishing that it was
reasonably diligent from just prior to D'Angelo's entry into
19
Interference No. 104,178
the field on July 11, 1995 to its constructive reduction to
practice on August 8, 19958.
In view of our findings above, the senior party
D'Angelo is entitled to prevail herein on the basis of its
earlier filing date.
Whereas party D'Angelo is entitled to prevail on the
basis of its earlier filing date, D'Angelo's motion to file a
corrected preliminary statement (Paper No. 60), Schur's motion
for sanctions to strike the testimony of Larry Shanley (Paper
No. 67) and D'Angeio's motion for extension of time to take
testimony and to compel Schur to cooperate with the scheduling
of the deposition of Mr. Shanley (Paper No. 66) are dismissed
as moot.
Judament
Judgment as to the subject matter of counts I and 2,
the only counts, is hereby awarded to Dr. Joseph P. D'Angelo,
the senior party. On the present record, the party DfAngelo
is entitled to a patent with claims 1 and 2 corresponding to
REven if Suilivan's testimony were convincing, at best it would have
established that a flexible tube intended for use in the collection of
saliva was made. There was no test establishing that apparatus
satisfying the subject matter of count 2 was used successfully for
collecting and storing samples of saliva which could be used to provide
accurate body fluid constituent analysis. This was the intended use as
per Schur's specification at page 1, lines 9 and 10. The nature of the
alleged testing by co-inventor Levandoski set forth at paragraphs 5 and
6 of his testimony, referred to above, reflects the extensive degree of
testing he considered necessary to establish successful testing in this
field of endeavor.
20
Interference No. 104,178
count 1, and claims 3-12 corresponding to count 2; the party
Schur is not entitled to a patent with its claims I and 5
corresponding to count 1, and claims 6-10, 17 and 20
corresponding to count 2.
ASTA L M. 0 1
Admýin trative Pa e Judge
WILLIAM F. PATE, III. )BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
)INTERFERENCES
//POHN C. MARTIN
ý/Administrative Patent Judge
SMU/gjh
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Interference No. 104,178
Attorney(s) for Schur et al.:
Herbert W. Larson
Larson and Larson
7381 114th Avenue N. #406
Largo, Florida 33-773
Attorney(s) for D'Angelo:
Dr. Joseph P. D'Angelo
Americare Building, Third Floor
20 N.W. 181st Street
Miami, Florida 33169
22