Automedx, Inc.v.Artivent Corporation

Trademark Trial and Appeal Board

Aug 17, 2010

No. 91182429 (T.T.A.B. Aug. 17, 2010)

Mailed:
August 17, 2010

UNITED STATES PATENT AND TRADEMARK OFFICE
_____

Trademark Trial and Appeal Board
_____

Automedx, Inc.
v.
Artivent Corporation
_____

Opposition No. 91182429
to Application Serial No. 77017595
filed on October 10, 2006
_____

Stephen P. Hollman of Hogan & Hartson, L.L.P. for
Automedx, Inc.

Omid A. Mantashi, Esq. for Artivent Corporation.
_____

Before Walters, Cataldo and Bergsman,
Administrative Trademark Judges.

Opinion by Bergsman, Administrative Trademark Judge:

Artivent Corporation (“applicant”) filed an intent-to-
use application for the mark SAVE, in standard character
form, for the goods set forth below:
Medical devices, namely, resuscitation
apparatus, manual ventilators, manual
emergency ventilators, transport
ventilators, powered ventilators,
powered emergency ventilators, positive
end expiratory valves, oxygen masks,
oxygen tubing, oxygen filters,
endotracheal tubes, nasopharyngeal
airway tubing, laryngeal masks, airway
nanometers, all for use during
artificial ventilation or resuscitation,
for regulating or controlling
ventilation, and for regulating or
THIS OPINION IS CITABLE AS A
PRECEDENT OF THE T.T.A.B.
Opposition No. 91182429
2
controlling resuscitation; accessories
for the aforementioned ventilators and
resuscitators, in Class 10.

We will refer to these goods collectively as “ventilators”.

Automedx, Inc. (“opposer”) opposed the registration of
applicant’s mark on the ground of priority of use and
likelihood of confusion. Specifically, opposer alleged that
it has used the mark SAVe to identify portable ventilators
since prior to the filing date of the application at issue
and that applicant’s mark SAVE for ventilators so resembles
opposer’s previously used mark SAVe for portable ventilators
as to be likely to cause confusion. Despite applicant’s
denial of opposer’s allegations that the marks SAVE and SAVe
are nearly identical and that the goods at issue,
ventilators and portable ventilators, are similar, the only
issue that was tried and argued by the parties was priority.
Preliminary Issue
Applicant objected to the rebuttal testimony deposition
of Christopher Murphy, the Chief Operating Officer for the
Armed Forces Institute for Regenerative Medicine, on the
ground that Mr. Murphy’s deposition constitutes improper
rebuttal. Mr. Murphy testified regarding, inter alia,
testing opposer’s products in 2006, the purchase of
opposer’s products in 2006, and the military’s practice of
testing medical devices to develop battlefield-ready
products.
Opposition No. 91182429
3
We agree with applicant that Mr. Murphy’s testimony
constitutes improper rebuttal. Evidence which should
constitute part of an opposer’s case in chief, but which is
made of record during the rebuttal period, is not considered
when the applicant objects.
Applicant is entitled to an opportunity
to rebut, during its testimony period,
any testimony and evidence proffered in
support of the allegations in the notice
of opposition. This opportunity is
foreclosed if opposer withholds the
evidence until its rebuttal testimony
period, which is intended to be limited
to denials, refutations or explanations
of applicant’s testimony and evidence.
(Emphasis added).

General Electric Company v. Graham Magnetics Incorporated,
197 USPQ 690, 692 n.5 (TTAB 1977). Notwithstanding
opposer’s argument that Mr. Murphy’s testimony “serves to
deny, explain and discredit the evidence submitted by
Applicant during its trial period,” we find that opposer’s
rebuttal testimony, specifically the aforementioned
testimony regarding testing opposer’s products in 2006, the
purchase of opposer’s products in 2006, and the military’s
practice of testing medical devices to develop battlefield-
ready products, does not refute or explain applicant’s
evidence, but rather adds to opposer’s proofs made as part
of its case in chief,. Accordingly, applicant’s objection
is sustained and Mr. Murphy’s testimony submitted by opposer
Opposition No. 91182429
4
during its rebuttal testimony period has not been
considered.
The Record
By operation of Trademark Rule 2.122, 37 CFR §2.122,
the record includes the pleadings and the application file
for applicant’s mark. The record also includes the
following testimony and evidence:
A. Opposer’s Evidence.

1. Opposer’s notice of reliance on documents obtained
from the Internet1 and applicant’s responses to opposer’s
requests for admission;
2. Testimony deposition of Ian Halpern, applicant’s
President and CEO, with attached exhibits;
3. Testimony deposition of James Evans, opposer’s
President and CEO, with attached exhibits; and
4. Rebuttal testimony deposition of William P.
Wiesman, opposer’s Chairman, with attached exhibits.
B. Applicant’s Evidence.
Applicant filed three notices of reliance on various
documents.

1 The parties stipulated to the admissibility of documents
printed from the Internet through a notice of reliance. See also
Safer Inc. v. OMS Investments Inc., 94 USPQ2d 1031 (TTAB 2010)
(documents obtained from the Internet may be admitted into
evidence through a notice of reliance in the same manner as a
printed publication in general circulation provided the documents
Opposition No. 91182429
5
Standing

Opposer was formed to commercialize the automated,
portable ventilator invented by Sekos, Inc. and since its
formation in November, 2004, opposer has been manufacturing
and selling SAVe portable ventilators.2 This is sufficient
to demonstrate that opposer has a real interest in this
proceeding and, therefore, its standing. Lipton Industries,
Inc. v. Ralston Purina Co., 670 F.2d 1024, 213 USPQ 185, 189
(CCPA 1982).
Priority
In order for opposer to prevail on its Section 2(d)
claim, it must prove that it has a proprietary interest in
its SAVe mark and that it obtained that interest prior to
the actual or constructive first use by applicant. Herbko
International Inc. v. Kappa Books Inc., 308 F.3d 1156,
64 USPQ2d 1375, 1378 (Fed. Cir. 2002); Otto Roth & Co., Inc.
v. Universal Corp., 640 F.2d 1317, 209 USPQ 40, 43
(CCPA 1981); Miller Brewing Co. v. Anheuser-Busch Inc.,
27 USPQ2d 1711, 1714 (TTAB 1993). For purposes of
determining priority of use, applicant’s date of first use

identify the date of publication or date accessed and printed, as
well as their source).
2 Wiesman Dep., pp. 14, 19, 20; Evans Dep., pp. 29, 31, 46, 50-
55, 61, 209, 227-228, 246.
Opposition No. 91182429
6
is October 10, 2006, the filing date of its intent-to-use
application.3
Establishing opposer’s first use date for its SAVe mark
is more complex because opposer is relying on sales of its
ventilators prior to October 10, 2006. Those sales were
made for purposes of testing and were completed prior to the
FDA approval of opposer’s ventilators for human use.
Applicant contends that such use is neither bona fide use
nor lawful use.
A. Testimony and evidence regarding opposer’s use of its
SAVe mark prior to October 10, 2006.

William Wiesman is a medical doctor, a retired colonel
in the United States Army, former Director of Combat
Casualty Care Research for the U.S. Military, and an
entrepreneur. BioStar Group is the trade name for the
conglomerate under which Mr. Wiesman operates his many
companies, including Sekos, Inc. and opposer.4 Sekos, Inc.
is a research and development company. Sekos, Inc. “was
founded simply to develop products or ideas or take ideas
into products that could be then commercialized.”5 “Sekos
does not make, manufacture, or sell anything. We only do

3 Applicant did not submit any evidence of earlier use of its
mark.
4 Wiesman Dep., pp. 10-11.
5 Wiesman Dep., pp. 11-12; see also Evans Dep., p. 22.
Opposition No. 91182429
7
research and development.”6 Mr. Wiesman is the CEO of
Sekos, Inc.7
Opposer was formed to commercialize the portable
ventilator developed by Sekos, Inc.8
[Opposer] is a company that was built
around a technology that was developed
in Sekos, so the idea was to spin mature
technologies developed in Sekos into
other companies that could then
manufacture and sell those devices or
technologies, so [opposer] was
specifically designed to manufacture and
sell technology that was developed in
Sekos.”9

Dr. Wiesman is the Chairman of opposer. With the exception
of Mr. Evans, all the shareholders of opposer are
shareholders of Sekos, Inc.10
Sekos, Inc. created the ventilator that opposer sells.
The SAVe ventilator “is a mechanical respiratory system that
runs off a battery that runs a compressor with integrated
sensors that control the delivery of air to an individual
that cannot breathe. It is very small and compact. It’s
designed for the battlefield and military use. It’s
designed to be rugged and usable by nonmedical personnel.”11

6 Wiesman Dep., p. 33.
7 Wiesman Dep., p. 12.
8 Wiesman Dep., pp. 14, 20; see also Evans Dep., p. 29 (opposer
was formed to commercialize the automated ventilator developed by
Sekos, Inc.).
9 Wiesman Dep., p. 14.
10 Evans Dep., pp. 174-175, 283. There is a discrepancy in Mr.
Evans’ testimony as to whether all the shareholders of Sekos,
Inc. were also shareholders of opposer. (Evans Dep., pp. 23 and
174-175).
11 Wiesman Dep., 20.
Opposition No. 91182429
8
The SAVe ventilator also has civilian functionality in
connection with emergency transportation of patients, mass
casualty situations, and in police cruisers.12
After opposer was incorporated in November 2004,
opposer licensed patent rights, trade secrets and technical
know-how for the portable ventilator from Sekos, Inc.13
Q. This license, sir, did it include
the entire business of Sekos that
was pertinent to the micro-
ventilator?

A. Yes.

* * *

Everything related to that
ventilator was transferred out of
Sekos to the new entity. Sekos
does not currently do any
ventilator work anymore.14

In fact, Mr. Adrian Urias, the chief designer, became an
employee of opposer.15
Opposer’s “approach to rolling out the SAVe ventilator
was to initially target the Special Forces community within
the military and to use that as a platform to get into the
larger military space and use the funds and revenues
generated from those activities to launch into the pre-
hospital market which would include ambulances, police

12 Evans Dep., pp. 8 and 12 and Exhibit 2; see also Halpern Dep.,
p. 65 and Exhibits 6 and 11.
13 Evans Dep., pp. 23, 28-29; Wiesman Dep., pp. 50-52.
14 Wiesman Dep., p. 52.
15 Wiesman Dep., pp. 40-41, 51; Evans Dep., pp. 294-295.
Opposition No. 91182429
9
cruisers, fire trucks, emergency preparedness and pan flu
readiness and potentially even hospitals.”16
Sekos, Inc. proposed the idea of a simplified automated
ventilator to the Air Force. The Air Force liked the idea
and committed $200,000 to the effort.17
Q. Did [opposer] assume any role in
connection with the performance of
that contract with the Air Force?

A. Yes. [Opposer] was incorporated in
November 2004. The five prototypes
which were the final deliverable
(sic) of the contract were not
delivered to the Air Force
Protection Battle Lab until I
believe April 2005.

Between November and April the work
that was done was being done from
our perspective under [opposer] but
to keep things congruent for the
Air Force we oftentimes interfaced
with them under the name of Sekos.
The contract was with Sekos and the
Air Force.18

On cross-examination, Mr. Evans expounded on the
relationship between Sekos, Inc., opposer and the Air Force.
A. Actually, the contract was with,
was formulated with Sekos.

[Opposer] assumed the
responsibility of executing that
contract once the company was
incorporated.

* * *

16 Evans Dep., pp. 46-47.
17 Evans Dep., pp. 22, 30.
18 Evans Dep., p. 31.
Opposition No. 91182429
10
Q. When you say [opposer] assumed that
contract, I’m having a hard time
understanding that so I want to ask
you some questions about that.

Did Sekos assign that contract to
[opposer]?

* * *

A. There were no legal documents
between [opposer] and Sekos
assigning the contract.

However, all the resources working
the contract, namely the people,
the engineers became employees of
[opposer].

* * *

Sekos continued to pay for some of
the resources in [opposer] in
exchange for equity in [opposer].

So Dr. Wiesman continued to pay
salaries because [opposer] didn’t
have any money of its own and in
exchange for that Dr. Wiesman
received additional shares in
[opposer].19

Opposer delivered its first prototypes to the Air Force
Protection Battle Lab in April 2005.20 Subsequently, in
August 2006, opposer filled a second order for the
ventilators, sending five units to a military contracting
organization in Lexington, Kentucky for ultimate delivery to

19 Evans Dep., pp. 293-296; see also Wiesman Dep., p. 61 (the
contract was not assigned to opposer).
20 Evans Dep., pp. 31, 46, 50-51, 61, 67, 77, 302.
Opposition No. 91182429
11
the Special Forces Unit stationed at Fort Bragg, North
Carolina.21
All ventilators noted above were labeled as SAVe
ventilators.22 They also displayed opposer’s name.23
However, the operator’s manual accompanying the ventilators
delivered to the Air Force displayed the Sekos, Inc. name on
the cover. Internally within the operator’s manual,
opposer’s name, not Sekos, Inc., appeared on photographs of
the unit.24 According to Mr. Evans, the Sekos, Inc. name
appeared on the cover of the operator’s manual for clarity
because “this contract was originally formulated with Sekos
and for consistency purposes for the Air Force we included
that.”25 The operator’s manuals that accompanied the units
delivered to the Special Forces Unit displayed opposer’s
name, not Sekos, Inc.26 On cross-examination, Mr. Evans
reiterated that prior to FDA approval, opposer was the only
company that had distributed any of the SAVe units.27 Dr.

21 Evans Dep., pp. 51, 105-108, 111 and Exhibits 28 and 29.
22 Evans Dep., pp. 46, 67-70, 117-118 and Exhibits 14-17.
23 Evans Dep., Exhibits 14 and 15.
24 Evans Dep., Exhibits 20 and 21.
25 Evans Dep., p. 76; see also Evans Dep., p. 353 (“So there was a
transition period as far as the Air Force was concerned where we
would start off with Sekos and we became known as [opposer]”).
On the other hand, Dr. Wiesman testified that since the Air Force
had contracted with Sekos, Inc., it was appropriate for Sekos,
Inc. to provide the Air Force with the contract deliverables
(i.e., the ventilators and operator’s manuals). (Wiesman Dep.,
pp. 65-66)
26 Evans Dep., Exhibit 39.
27 Evans Dep., pp. 209-210.
Opposition No. 91182429
12
Wiesman confirmed that Sekos never used the SAVe
trademark.28
Because the ventilators initially shipped were not FDA
approved for human use, they were designated as prototype or
demonstration units, not for human use.29 On September 6,
2007, the FDA granted opposer approval to use its SAVe
ventilators for human use.30 The initial sales noted above
were test models to perfect the SAVe ventilator for human
use.
There were a number of things that had
to be done before we felt comfortable
that the device was fit to be used in
humans.

The device was tested multiple times in
a swine model, it was tested multiple
times in what we refer to as a bench
test, it was used multiple times by the
military in field exercises.

All this had to come together to make us
feel comfortable that we had a product
that was not only safe but was ready for
the market.

In addition, there are a number of FDA
standards that the device has to meet
before you can submit to the FDA.

So it took us two and a half years or so
to get to that point.31

28 Wiesman Dep., p. 33.
29 Evans Dep., pp. 70-71, 78, 118-119, 128 and Exhibits 18-19,
31-36, 41.
30 Evans Dep., p. 130.
31 Evans Dep., pp. 131-132.
Opposition No. 91182429
13
“The devices were used on animals to test the efficacy and
safety of the device and to establish that they could be
used safely in human subjects.”32 Applicant’s President,
Ian Halpern confirmed that animal research is useful for
testing the efficacy of a device on living organisms and for
safety.33 In fact, the military tested prototypes of
applicant’s SAVE ventilator.34
Dr. Wiesman testified that the sale of a demonstration
unit of a medical device not approved for human use
constitutes a sale made in the ordinary course of
business.35
Q. And on the document sir, do you see
where it says demonstration unit?

A. Yes.

Q. What does that refer to?

A. The demonstration unit implies that
it would not be used on humans.

Q. Based on your experience in the
medical device industry, sir, can
you tell me whether a demonstration
unit is suitable for sale in the
ordinary course of business?

* * *

A. [W]e would sell this unit with the
label on it, absolutely.36

32 Evans Dep., p. 134. Swine are often selected for studies
because the anatomy of their respiratory system is similar to the
human respiratory system. (Evans Dep., pp. 139-140).
33 Halpern Dep., pp. 31-32.
34 Halpern Dep., p. 70.
35 Wiesman Dep., pp. 56-57.
36 Id.
Opposition No. 91182429
14
B. Whether opposer’s sales of demonstration units
constitute bona fide use of a mark in the ordinary
course of trade, and not merely to reserve a right in a
mark?

Section 45 of the Trademark Act, 15 U.S.C. §1127,
defines “use in commerce” as the “bona fide use of a mark in
the ordinary course of trade, and not merely to reserve a
right in a mark.”
A key factor is that the sale or sales
made cannot be “token” in the sense that
they are artificially made solely to
reserve a right in a mark and not made
as part of a usual product or service
launch. Thus, even sales made in a test
marketing program will probably suffice
as a bona fide use of the mark in the
ordinary course of trade because test
market sales are a common harbinger of a
proposed new product launch.

McCarthy On Trademarks And Unfair Competition §19:109
(4th ed. 2010).
Use in commerce should be interpreted with flexibility
to account for different industry practices.
The legislative history of the Trademark
Law Revision Act reveals that the
purpose of the amendment was to
eliminate “token use” as a basis for
registration, and that the new, stricter
standard contemplates instead commercial
use of the type common to the particular
industry in question.

Paramount Pictures Corp. v. White, 31 USPQ2d 1768, 1774
(TTAB 1994), aff’d, White v. Paramount Pictures Corp.,
108 F.3d 1392 (Fed. Cir. 1997) (non-precedential).
Opposition No. 91182429
15
In this regard and apropos to the facts in this case, the
legislative history of the 1988 Revision Act references a
“company’s shipment to clinical investigators during the
Federal approval process” as being in the ordinary course of
trade.37 The Senate Judiciary Committee Report made the
following comment:
The committee intends that the revised
definition of “use in commerce” be
interpreted to mean commercial use which
is typical in a particular industry.
Additionally, the definition should be
interpreted with flexibility so as to
encompass various genuine, but less
traditional, trademark uses, such as
those made in test markets, infrequent
sales of large or expensive items, or
ongoing shipments of a new drug to
clinical investigators by a company
awaiting FDA approval, and to preserve
ownership rights in a mark if, absent an
intent to abandon, use of a mark is
interrupted due to special
circumstances.

S. Rep. No. 100-515, p. 44-45 (September 15, 1988).
We also note that test marketing has been recognized as
sufficient to establish use of a mark. See Game Power
Headquarters Inc. v. Owens, 37 USPQ2d 1427, 1431 (E.D. Pa.
1995) (“Test marketing of the service mark, “Game Power
Headquarters”, constitutes a bona fide use in commerce . . .
Sales of goods under a brand name in test marketing area are
actual sales from which rights in a mark can accrue”); see

37 House Judiciary Committee Report on H.R. 5372, J.R. No. 100-
1028, p. 15 (October 3, 1988).
Opposition No. 91182429
16
also E.I. du Pont de Nemours and Co. v. G.C. Murphy Co.,
199 USPQ 807, 812 (TTAB 1987) (“[s]ales of goods under a
brand name in a test marketing area are actual sales from
which rights in a mark can accrue”); cf. Paramount Pictures
Corp. v. White, 31 USPQ2d at 1769 n. 9 (the use at issue was
not genuine trademark use, it was de minimis and
noncommercial in nature and not made in the ordinary course
of trade in games). The Board has held that bona fide test
marketing and experimental sales in small volumes are
sufficient to show use of a mark. E.I. du Pont de Nemours
and Co. v. Big Bear Stores, Inc., 161 USPQ 50, 51 (TTAB
1969) (test marketing of the mark SUPER SHIELD for a premium
exterior clear finish proved unsatisfactory and plaintiff
assigned the mark to another product considered near in
quality but lower in price). The issue in all the above-
referenced cases was whether there was genuine use of the
mark in commerce.
Thus, the issue we must decide is whether opposer’s
April 2005 and August 2006 sales were test sales for
legitimate commercial purposes in the ordinary course of
trade or token sales to reserve the mark for registration.
If the sales at issue were made for legitimate marketing or
other commercially reasonable reasons in the ordinary course
of trade (i.e., genuine use of the mark), then we must find
Opposition No. 91182429
17
that the sales constitute bona fide use of the mark in
commerce.
Based on the testimony and evidence of record, we find
that opposer’s April 2005 and August 2006 sales of the
ventilators to the military were for legitimate business
reasons (i.e., to test and refine the portable ventilators)
and not merely to reserve the right to register the marks.
We are not persuaded by applicant arguments, as set
forth below, that opposer’s use of its mark is not bona fide
commercial use:
1. Opposer failed to show use of its mark on medical
devices. According to applicant, because opposer did not
receive FDA approval to sell its portable ventilators for
human use until September 6, 2007, any prior use was not in
connection with medical devices.38
[Opposer’s] claimed activities in
selling and shipping prototypes not
intended for use as medical devices
intended for humans can only be
considered pre-marketing activities:
[opposer] was not testing the market
through the sale of medical devices in a
limited market, it was in fact engaging
in product research and development, and
market research and development. There
is no evidence indicating that [opposer]
advertised the availability of products
for sale to the public. It transported
or sold only a handful of devices to
selected recipients who, by [opposer’s]
own admission, were cooperatively
engaged in product testing, research,
and development with [opposer].

38 Applicant’s Brief, pp. 9-10 and 21-26.
Opposition No. 91182429
18
* * *

[Opposer] is claiming the exclusive
right to use the SAVE (sic) trademark on
medical devices intended for humans, yet
it did not place such goods in trade on
the open market in a limited area so
that it could be said to be testing the
market for such products. Rather, by
its own admission, [opposer] was
cooperatively testing its own devices
with certain key potential customers, in
a private manner, in order to ultimately
manufacture a product that could be sold
on the open market to those customers.39

We disagree with applicant’s premise that the products
sold by opposer to the military were required to be FDA
approved before the sales of those product may constitute
bona fide use of the mark in commerce. Opposer sold
prototype or demonstration units to the military for a
legitimate commercial purpose: that is, to “test and
evaluate the technology to decide whether or not they were
interested in buying a more significant number of human use
units in the future,” even though the units the military
purchased were not approved for human use.40 The military
was testing the efficacy, ease of use and portability of the
ventilators.41 The fact that these initial sales to the
military were mutually beneficial in that they allowed the
military to test the initial units before committing to a

39 Applicant’s Brief, p. 26.
40 Evans Dep., pp. 335-336.
41 Evans Dep. p. 336.
Opposition No. 91182429
19
larger purchase, and they permitted opposer to refine the
product to make it commercially attractive so the military
would purchase a significant number of units, supports the
legitimate commercial basis for the sales.
2. Opposer’s use of the mark in units sold for
product testing is not a bona fide commercial use sufficient
to support priority.42 We disagree with applicant’s
argument. We find that opposer’s sales of its products to
the military were an arm’s length transaction in which
properly labeled SAVe ventilators, albeit for testing and
not human use, were sold and transported in commerce. Based
on the nature of the products at issue and the evidence of
record in this case, the fact that the products were sold
and transported to the customer for testing does not make
the sale and transportation of those products any less
legitimate.
3. Opposer has not proven that private product
testing is typical commercial use in connection with medical
devices.43 This argument misses the point. As indicated
above, the issue is whether opposer’s sales for “private
product testing” were for a legitimate, commercial reason in
the ordinary course of trade and not merely to reserve the
right to register the mark. Whether private product testing

42 Applicant’s Brief, pp. 26-27.
43 Applicant’s Brief, pp. 27-30.
Opposition No. 91182429
20
constitutes typical commercial use in connection with
medical devices is a fact that we may consider in
determining whether opposer’s sales were for a legitimate,
commercial reason in the ordinary course of trade, but it is
not the test in and of itself. In this regard, we have
determined that the sales of opposer’s portable ventilators
to the military so the military could test the units for
efficacy, ease of use and portability constitutes a
legitimate, commercial use regardless of whether sales of
medical devices for testing purposes is typical.
4. Opposer’s product testing does not establish bona
fide use in commerce because opposer was not selling its
intended goods in trade.44 In other words, according to
applicant, “opposer is attempting to rely on the putative
sale or shipment of a few investigational use prototypes not
intended for human use to establish technical priority with
respect to medical devices intended for human use.”45
Simply put: prior to Applicant’s
constructive priority date, Opposer had
no medical devices intended for or
suitable for sale in the medical device
market. It had no products that were
approved or cleared for use under the
relevant regulatory regimes for use as
medical devices on humans. It should
not be allowed to rely on a limited
distribution of prototypes in
collaborative product testing and
development to claim prior technical

44 Applicant’s Brief, pp. 30-33.
45 Applicant’s Brief, p. 31.
Opposition No. 91182429
21
trade mark use with respect to medical
devices intended for use on humans.46

This argument is essentially the same as applicant’s
first argument. As indicated above, we do not agree with
applicant’s premise that the products sold by opposer to the
military were required to be FDA approved before the sales
of those products may constitute bona fide use of the mark
in commerce. See the discussion supra.
5. Opposer’s testimony regarding its April 2005 sale
is not corroborated by any documentary evidence.47 However,
“oral testimony, if sufficiently probative, is normally
satisfactory to establish priority of use in a trademark
proceeding.” Powermatics, Inc. v. Globe Roofing Products
Co., Inc., 341 F.2d 127, 144 USPQ 430, 432 (CCPA 1965).
While oral testimony is strengthened by corroborative
documentary evidence, oral testimony alone that is
consistent, definite and without contradictions may be
sufficiently probative. B.R. Baker Co. v. Lebow Bros.,
150 F.2d 580, 66 USPQ 232, 236 (CCPA 1945). The testimony
of Mr. Evans was consistent, definite and without
contradictions. Moreover, it remained consistent, definite
and without contradictions throughout applicant’s rigorous

46 Applicant’s Brief, p. 33.
47 Applicant’s Brief, pp. 11-12.
Opposition No. 91182429
22
and lengthy cross-examination. Furthermore, Mr. Evans’
testimony was corroborated by Dr. Wiesman, who was also
cross-examined by applicant.
6. The April 2005 sale was made on behalf of Sekos,
Inc., not opposer.48 We disagree. After Sekos, Inc.
contracted with the Air Force to deliver 5 prototypes of the
portable ventilator, Dr. Wiesman incorporated opposer and
transferred the assets of the ventilator program to opposer.
Opposer fulfilled the obligations under the contract even
though the operator’s manual identified Sekos, Inc. and
Sekos, Inc. never formally notified the Air Force that
opposer was the owner of the portable ventilator being
provided to the Air Force. The record clearly establishes
that opposer is the successor-in-interest to Sekos, Inc. for
the technology regarding SAVe portable generators and that
the SAVe trademark was used only by opposer. It is further
clear from the record that Dr. Wiesman has been the central
figure of what can be characterized as a number of research
and development projects that are ultimately marketed by
separate entities. Even if the SAVe mark was used by Sekos,
Inc. and then subsequently used by opposer, the mark points
to a single source: that is, the use of the SAVe mark was
for the benefit of and inured to the benefit of Dr. Wiesman
through his conglomerate, including Sekos, Inc. and opposer.

48 Applicant’s Brief, pp. 12-17.
Opposition No. 91182429
23
See Airport Canteen Services, Inv. v. Farmer’s Daughter,
Inc., 184 USPQ 622, 627 (TTAB 1974).
B. Whether opposer’s sale of SAVe portable ventilators
prior to the FDA’s approval constitutes lawful use of
the mark in commerce?

Determining whether the use of a mark is lawful under
one or more of the myriad of regulatory acts involves two
questions: (1) whether a court or government agency having
competent jurisdiction under the statute involved has
previously determined that party is not in compliance with
the relevant statute; or (2) whether there is a per se
violation of a statute regulating the sale of a party’s
goods. General Mills Inc. v. Healthy Valley Foods,
24 USPQ2d 1270, 1273 (TTAB 1992). In this case, there has
been no final determination of noncompliance by a court or
agency regarding opposer’s initial shipments of its SAVe
portable ventilators. Rather, applicant has attempted to
show that opposer’s April 2005 and August 2006 shipments of
SAVe portable ventilators were per se violations of FDA
regulations.49
[I]t is incumbent upon the party
charging that the use was unlawful to
demonstrate by clear and convincing
evidence more than that the use in
question was not in compliance with
applicable law. Such party must prove
also that the non-compliance was
material, that is, was of such gravity
and significance that the usage must be
considered unlawful – so tainted that,

49 Applicant’s Brief, pp. 30-33.
Opposition No. 91182429
24
as a matter of law, it could create no
trademark rights -- warranting
cancellation of the registration of the
mark involved.

General Mills Inc. v. Healthy Valley Foods, 24 USPQ2d at
1274. Furthermore, “there must be some nexus between the
use of the mark and the alleged violation before the
unlawfulness of a shipment can be said to result in the
invalidity of a registration.” Id. citing Satinine Societa
v. P.A.B. Produits, 209 USPQ 958, 967 (TTAB 1981).
Applicant argues that opposer’s April 2005 and August
2006 transactions violate FDA regulations because they are
sales of medical devices that have not been approved for
human use.
[t]he FDCA establishes an extensive
regulatory regimen pertaining to medical
devices. Central to that regimen is the
requirement that any establishment
involved in the manufacturing of medical
devices should register with the FDA
unless its activities are exempt, for
example as a manufacturer of devices
intended for veterinary use, or a
manufacturer of devices used solely for
testing or research purposes and not for
sale. 21 U.S.C. § 360(b)(2),
21 U.S.C. § 360 (g)(3); see also
21 C.F.R. § 807.65(b) (veterinary
exception), 21 C.F.R. § 807.65(f) (non-
commercial testing exemption).
Furthermore, before a medical device
such as [opposer’s] may be marketed for
human use it must receive 510(k)
clearance from the FDA.

* * *

Opposer’s (sic) neglect the significant
fact that FDA only exempts manufacturers
Opposition No. 91182429
25
from establishment registration when the
manufacturer is engaged in non-
commercial product testing and
development. 21 U.S.C. § 360 (g)(3).
Indeed, Opposer itself has admitted that
it is not subject to this non-commercial
exemption afforded under the FDCA. … In
fact, a violation of the establishment
registration requirement is a prima
facie case of misbranding.
21 U.S.C. § 360(o).50

Furthermore, applicant contends that opposer may not
argue that its initial prototype or demonstration units were
not subject to FDA approval because they were only test
products and at the same time assert that they were goods in
trade. According to applicant, if the portable ventilators
are goods in trade, which they must be in order for opposer
to claim priority, then the sale of the portable ventilators
must be approved for human use by the FDA to constitute
lawful use in commerce.51
Despite applicant’s vigorous argument, we find that
applicant failed to show that there was a per se violation
of any law or FDA regulations. As previously indicated, we
disagree with applicant’s premise that the products sold by
opposer to the military were required to be FDA approved
before the sales of those products may constitute bona fide
use of the mark in commerce. Opposer sold its portable

50 Applicant’s Brief, pp. 31-32.
51 Applicant’s Brief, p. 32.
Opposition No. 91182429
26
ventilators to the military in an arm’s length transaction
so the military could test the efficacy, ease of use, and
portability of the units with the aim of refining the
ventilator for future purchases. While they were not sold
for human use, they were bona fide sales and there is no
perceptible violation of any laws or regulations.
In view of the foregoing, we find that opposer’s April
2005 and August 2006 sales of its SAVe portable ventilators
were bona fide sales in the ordinary course of trade in
lawful commerce and not merely to reserve a right in the
mark.
Because we have found that opposer has made bona fide
sales in the ordinary course of trade, we do not have to
determine whether opposer’s use constitutes use analogous to
trademark use.
As indicated above, although applicant denied that
there is a likelihood of confusion, it did not proffer any
evidence or argument on the issue and, therefore,
essentially conceded that there is a likelihood of
confusion. Suffice it to say, the evidence shows that there
is a likelihood of confusion between the opposer’s mark SAVe
and applicant’s mark SAVE both for use in connection with
ventilators.52

52 Because the drawing of applicant’s mark is depicted in standard
character form, applicant is not claiming the right to depict is
Opposition No. 91182429
27
Decision: The opposition is sustained and registration
to applicant is refused.

mark in any special form and, in fact, may depict its mark in any
reasonable manner, including SAVe.