Ex Parte 6805837 et al

Board of Patent Appeals and Interferences

Feb 6, 2009

90007813 (B.P.A.I. Feb. 6, 2009)

This opinion is not binding precedent of the Board

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte BARRY M. TYDINGS
____________________

Appeal 2008-5799
Reexamination Proceeding 90/007,813
Technology Center 3991
____________________

Decided: February 6, 2009
____________________

Before: RICHARD E. SCHAFER, ROMULO H. DELMENDO and
SALLY G. LANE, Administrative Patent Judges.

SCHAFER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Patentee appeals the final rejection of Claims 1-8, 14, 16-21, 23, 25
and 26 in the reexamination of Patent 6,805,837 B2. 35 U.S.C. § 134(b).
The appeal was timely filed on September 24,2007. We have jurisdiction.
35 U.S.C. §§ 134(b) and 306.
A Primary Examiner rejected the claims on the basis of obviousness-
type double patenting of Claims 1-6 of Patent 6,379,620.
We affirm.
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Procedural Background
The patent under reexamination --Patent 6,805,837-- issued from
Application 10/264,605. That application is a continuation of Application
10/091,162 (the parent application). The parent application is a continuation
of Application 09/192,969 (the grandparent). The grandparent application
issued as Patent 6,379,620 whose claims are the basis of the double
patenting rejection under review.
The board previously addressed the subject matter of the invention in
Appeal 2007-0393. In a decision entered May 25, 2007, a board panel
affirmed the double patenting rejection of the claims of Patent 6,497,843
over claims 4 and 6 of the 620 patent. The former (843) patent issued from
the parent application. The record of this appeal includes declaration
testimony not present in the previous proceeding.
Technical Background
The subject matter of the invention relates to a urine testing system
used, for example, in drug screening. The system includes a cup for
collecting the urine and a lid for sealing the cup. The system also has an
assay assembly. The assay assembly includes an assay strip or strips for
identifying drug residue or other components of interest. It also includes
wicking material in contact with the assay strip and the urine. The wicking
transmits the urine to the assay strip.
FINDINGS OF FACT
The Claimed Subject Matter
F. 1. The rejected claims relate to a urine testing system. Brief, Claim 1, p.
A-1.
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F. 2. The system includes a transparent container and a sealable lid. Brief,
Claim 1, p. A-1; Claim 16, p. A-2-A-3.
F. 3. The system also includes an assay assembly located in the container.
Brief, Claim 1, p. A-1.
F. 4. The assay assembly includes two components: (1) a wicking material
and (2) an assay strip for chemically analyzing the urine sample. Brief,
Claim 1, p. A-1.
F. 5. The wicking contacts and transports the urine to the assay strip. Brief,
Claim 1, p. A-1.
F. 6. At the point of contact of the wicking and assay strip the urine
generally flows both up the wicking and up the assay strip. Brief, Claim 1,
p. A-1 (“the urine wicks up the wicking to the assay strip thereby to permit a
flow of urine in the container to the assay strip and wicks up the strip”).
The Subject Matter Claimed in the 620 Patent
F. 7. The claims of the 620 patent relate to a urine testing system. 620,
Claim 1, Col. 4, ll. 16-17.
F. 8. The 620 system includes a transparent container and a sealable lid.
620, Claim 1, Col. 4, ll. 19-21.
F. 9. The 620 system includes an assay assembly located in the container.
620, Claim 1, Col. 4, ll. 23-25.
F. 10. The 620 assay assembly also includes two components: (1) a wicking
material and (2) an assay strip for chemically analyzing the urine sample.
620, Claim 1, Col. 4, ll. 27-36.
F. 11. The wicking contacts and transports the urine to the assay strip. 620,
Col. 3, ll. 27-31.
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F. 12. At the point of contact of the wicking and the assay strip, the urine
generally flows both down the wicking and down the assay strip. 620,
Claim 1, Col. 4, ll. 31-36 (“wicking means provided on a rear surface of said
liquid impermeable backing separated from said assay strip by said liquid
impermeable backing with one portion of said wicking means extending
over a top edge of said liquid impermeable backing and overlapping a top
portion of said assay strip.”)
The Difference Between Patentee’s Claimed Subject Matter and
the Subject Matter Claimed in 620
F. 13. The difference between Patentee’s claimed subject matter and the
subject matter claimed in 620 is the location of the contact between the
wicking material and the assay strip and the general direction of urine flow
at the point of contact.
F. 14. In the rejected subject matter, the urine flows in a generally upward
direction at the point of contact, while in the 620 patent claims the urine
flows in a generally downward direction at that point. Brief, p. A-1, Claim
1; 620, Col. 4, ll. 31-36.
The Level of Skill in the Art
F. 15. The person having ordinary skill in the art would have understood the
principles of operation of the assay device and method of urinalysis claimed
in the 620 patent.
F. 16. The person having ordinary skill in the art would have understood that
urine must be brought into contact with the assay strips in order to detect the
presence or absence of the drugs.
F. 17. The person having ordinary skill in the art would have understood that
the urine moves through the wicking material by capillary action.
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F. 18. The person having ordinary skill in the art would have understood that
the urine also moves through the assay strip by capillary action.
F. 19. The person having ordinary skill in the art would have understood that
the urine was brought into contact with the assay strips by means of capillary
action in the wicking means.
Declaration Testimony
F. 20. Patentee relies upon the declaration testimony of the inventor, Barry
Tydings, and James G. Hipple.
F. 21. Tydings testifies that the claims of the 620 patent relate to an urine
test system where the urine flows upward and then flows down to contact the
assay strip. Tydings, p. 1, ¶ 2.
F. 22. That system is said to suffer from certain problems:
1. If there was too much urine in the cup, the urine would flood the
assay strip and wipe out the antigens or antibodies on the strip; and
2. If there was too little urine, the urine would not wick to the assay
strip. Tydings p. 1, ¶ 3.
F. 23. These problems are said to lead to inconsistent test results. Tydings, ¶
3, p. 2.
F. 24. Tydings further testifies that invention avoids inconsistent results by
avoiding urine flowing downward as required by the Claims 1-6 of the 620
patent. Tydings, ¶ 4, p. 2.
F. 25. He states that “cups of the present [claims] are far superior to those of
the ‘620 patent . . . .” Tydings, ¶ 5, p. 2.
F. 26. He also testifies that upward wicking functions differently than
downward wicking. Tydings, ¶¶ 13, p. 3.
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F. 27. He testifies that his main business since 1998 has been in the design,
manufacture and sales of urine test cups. Tydings, ¶ 5, p. 2.
F. 28. He says that that he has designed, had manufactured and sold over
four million different kinds of urine test cups, that “essentially most” of
these cups are covered by the claims and do not wick urine downward to
meet the assay strip. Tydings, ¶ 5, p. 2.
F. 29. He states that hundreds of thousands of infringing cups have been
sold. Tydings ¶ 7, p. 2.
F. 30. Tydings testifies that before he developed the wick-up construction
there were no competitors and many have since entered the field. Tydings ¶
7, p. 2.
F. 31. He testifies that there are many infringing urine test systems bearing
the same structure and functional characteristics of the claims. Tydings ¶ 7,
p. 2-3.
F. 32. He testifies that he tried to develop a commercial product using
downward wicking but was unsuccessful and had to abandon that
construction. Tydings ¶¶ 10 and 11, p. 3.
F. 33. He testifies that he is unaware of any commercial urine cups that use
downward wicking of the 620 patent. Tydings ¶ 7, p. 3.
F. 34. He testifies that there was substantial commercial demand and his
construction satisfied a previously unsolved need. Tydings ¶ 9, p. 3.
F. 35. Tydings testifies that he considers himself a person of ordinary skill in
the art of urine testing cups. Tydings, ¶ 5, p. 2.
F. 36. He testifies to the effect that it was not obvious to him that upward
wicking would either work or solve the problems associated with downward
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wicking and upward wicking at the point of contact would not have been
obvious over the prior art. Tydings ¶¶ 12 and 13, p. 3.
F. 37. He testifies that changing the construction from a downward flow to
an upward flow was not an obvious change. Tydings, ¶¶ 8 and 12, p.3.
F. 38. Hipple testifies that he is a person of ordinary skill in the art of urine
testing systems. Hipple, ¶ 6, p. 2.
F. 39. Hipple testifies that he has worked in the field of drug testing since
1997 and that his company distributes drug testing kits. Hipple, ¶ 2, p. 1
F. 40. He testifies that he is aware of kits in which the urine is wicked in a
downward direction. Hipple, ¶ 3, p. 1.
F. 41. He testified that his customers experienced problems with inconsistent
or invalid test results when there was too much urine in the cup causing
flooding or too little urine resulting in the urine not reaching the assay strip.
Hipple, ¶ 4, p. 2.
F. 42. Hipple testifies that it would not have occurred to him that having the
urine wick upward would cure the problems with downward wicking.
Hipple, ¶ 6, p. 2.
F. 43. He testifies that cups without downward wicking are superior in
construction. Hipple, ¶ 6, p. 2.
F. 44. He testifies that the change from a downward wicking construction
was not an obvious change and that it would not have been obvious to
anyone skilled in the art. Hipple, ¶ 7, p. 2.
F. 45. He testifies that in 1998 and 1999 he worked with the inventor to
develop solutions but no ready solution was apparent. Hipple, ¶ 8, pp. 2-3.
F. 46. He said that nothing led to the solution of the wick-up construction.
Hipple, ¶ 10, p. 3.
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F. 47. Hipple testifies that up the strip wicking functions differently than the
down the wick flow. Hipple, ¶ 11, p. 3.
F. 48. He testifies that it would not be appreciated that the up the wick flow
would function and be operable. Hipple, ¶ 11, p. 3.
F. 49. Hipple testifies that there are many competing cups which have
copied the construction and functional flow characteristics of the wick up the
strip construction and that those competitors did not exist before the
inventor’s solution. Hipple, ¶ 12, p. 3.
F. 50. The testimony fails to present sufficient facts to establish that a prima
facie case of double patenting was not made out.
F. 51. The testimony fails to establish the existence of any secondary indicia
of non-obviousness.
ISSUE
The overall issue here is the same as the overall issue in the earlier
appeal: Whether it would have been obvious to employ a wicking material
and assay strip configured to transport the urine in a generally upward
direction at the contact of the wicking and assay strip rather than a
configuration where the urine moved in a generally downward direction at
the point of contact.
ANALYSIS
The Prima Facie Case
The difference between the subject matter of the rejected claims in
this appeal and Claims 1-6 of the 620 patent is the same as in the previous
appeal. The difference resides in the contact point of the wicking and the
assay strip. In the claimed subject matter the urine flows in a generally
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upward direction at the point of contact, while in the 620 patent claims the
urine flows in a generally downward direction
One having ordinary skill in the art would have had a full
understanding of the principles governing the operation of the assay
assembly described in Claims 1-6 of the 620 patent. In particular that
hypothetical person would have understood that the assay assembly operates
by utilizing capillary action to bring the urine into contact with the assay
strip. The person of ordinary skill would have recognized and expected that
the assay assembly would work to identify the drugs of interest as long as
the urine wicked into contact with the assay strip. The person of ordinary
skill would have further expected that capillary action would bring the urine
into contact with the assay strip notwithstanding the location of the contact
point between the wicking and assay strip. Thus, changing the location of
the point of contact of the wicking and assay strip is a predictable variation.
“If a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability.”[1] KSR International Co. v. Teleflex Inc., 550
U.S. 398, 127 S. Ct. 1727, 1740 (2007). A urine testing system using an
assay assembly with a wicking material that “wicks up” at both the wicking
and the assay strip at their contact point would have been prima facie

1 While the rejection here is not under § 103, a rejection based upon double
patenting of the obviousness type is “analogous to [a failure to meet] the
non-obviousness requirement of 35 U.S.C. §103,” except that the patent
principally underlying the double patenting rejection is not considered prior
art. In re Longi, 759 F.2d 887, 892 n.4 (Fed. Cir. 1985). The analysis
concerning the correctness of the double patenting rejection parallels the
analysis for § 103. Id.
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obvious2 from the method and urine test system described by Claims 1-6 of
the 620 patent.
Patentee identifies a number of additional claim “features” said to be
“individually and collectively lacking in the claims of '620 . . . .” Appeal
Brief, p. 8-10. For example, Patentee lists the following allegedly
distinguishing features:
the urine wicks up the strip;
the urine wicks up the wicking to the assay strip;
the wicking is in communication with urine;
when there is urine in the container and the container is
in an upright position, the opening is above the
base; and
the wicking has a lower portion proximal to the base of
the container.
These features either do not add additional structural requirements not
already part of the difference we identified above or are expressly or
implicitly present in Claims 1-6 of the 620 patent. Thus, the feature that the
urine wicks up the strip was acknowledged as a difference between the
subject matter of the rejected and 620 claims and addressed above in our

2 A prima facie case of obviousness is established when the teachings from
the prior art itself would appear to have suggested the claimed subject matter
to a person of ordinary skill in the art. In re Bell, 991 F.2d 781, 783 (Fed.
Cir. 1993). The prima facie case is based upon the claimed subject matter
and the teachings of the prior art without considering any other evidence. In
re Schneider, 481 F.2d 1350, 1354 (CCPA 1973) ("By that we mean that
viewing only the references and the claimed subject matter, and not
considering any evidence of unexpected results, it would appear that the
references could be combined as proposed by the examiner and that the
conclusion that the claimed subject matter would have been obvious is
reasonable.") These principles apply equally to obviousness-type double
patenting except that the prior art is the claims of a patent. See n. 1.
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discussion of the prima facie case. The feature that the urine wicks up the
wicking to the assay strip and the wicking is in communication with urine
finds response in, e.g., Claim 6 (“allowing the urine to wick up the wicking
means and down the assay strip to react with the assay strip”). The feature
that the container is in an upright position with the opening above the base
when urine is in the container finds response in, e.g., Claim 4 (“introducing a
urine sample into a transparent container having an opening after removing a
cover from said opening, . . . placing the cover means back on the container
means to seal the opening. . . . “). The feature that the wicking has a lower
portion proximal to the base of the container finds response in at least Claim
6 (“a cover means provided on said assay strip and wicking means for
sealing said wicking means and assay strip from liquid contact with said
urine sample except at a bottom portion of said wicking means”). Thus,
none of these stated features identify structural differences which further
distinguish the subject matter of the rejected claims from the subject matter
of Claims 1-6 of the 620 patent.
Patentee also asserts additional language found in the dependent
claims and said not to be found in the 620 claims. Appeal Brief, p. 10. We
have considered these features and do not see that they present any structural
features not implicitly or explicitly part of the subject matter of the 620
claims.
The Declaration Evidence
Patentee relies on the declarations of the inventor, Barry Tydings, and
James G. Hipple. Patentee’s brief does not explain how the declarations
demonstrate non-obviousness. Rather, the brief merely points out that the
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declarations are submitted in support of patentability and quotes them at
length. Brief, pp. 11-14.
Notwithstanding the lack of guidance, we have attempted to carefully
review the declarations. We find them to be conclusory and devoid of
sufficient facts to demonstrate either that a prima facie case was not made
out or establish any secondary indicia of non-obviousness.
Both declarants testify that they are persons of ordinary skill in the art.
Tydings, ¶ 5, p. 2; Hipple, ¶ 6, p. 2. They also testify that construction of a
drug testing cup where the urine wicks up both the wicking and the assay
strip would not have been obvious from the subject matter of the 620 claims.
Tydings ¶¶ 8, 12 and 13, p. 3; Hipple, ¶ 7, p. 2.
We give little weight to those portions of the testimony.
“The decision of obviousness vel non is made not from the viewpoint
of the inventor, but from the viewpoint of a person of ordinary skill in the
field of the invention.” Arkie Lures Inc. v. Gene Larew Tackle Inc., 119
F.3d 953, 956 (Fed. Cir. 1997). “The person of ordinary skill is a
hypothetical person who is presumed to be aware of all the pertinent prior
art.” Custom Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955,
962 (Fed.Cir. 1986). The actual inventor's skill is irrelevant to the
obviousness inquiry. Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448,
454 (Fed. Cir. 1985). Neither Tydings nor Hipple are persons of ordinary
skill in the art as that phrase is used in evaluating obviousness.
With respect to the declarants’ opinions on the obviousness of the
subject matter of the rejected claims, that testimony goes to a legal question.
Double patenting, as well as obviousness, are legal conclusions. In re
Emert, 124 F.3d 1458, 1460 (Fed. Cir. 1997) (double patenting); KSR, 127
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S.Ct. at 1745 (obviousness). An opinion on the ultimate legal conclusion is
simply not “evidence.” Nutrition 21 v. United States, 930 F.2d 867, 871 n.2
(Fed. Cir. 1991); Avia Group Int'l, Inc. v. L.A. Gear Calif., Inc., 853 F.2d
1557, 1564 (Fed.Cir. 1988) (An opinion on the legal conclusion of
obviousness is neither necessary nor controlling). Thus, we give no weight
to the declarants’ opinions on obviousness.
The declarants testify that the claimed assay assembly and the
assembly claimed in the 620 patent function differently. Tydings, ¶¶ 13, p.
3; Hipple, ¶ 11, p. 3. Hipple also testifies that it would not have been
appreciated that the up the wick flow would function and be operable.
Hipple, ¶ 11, p. 3. The declarants, however, have not provided an
explanation of how the claimed and 620 assemblies in fact function
differently or why one skilled in the art would not have appreciated that
arranging the contact point so the urine generally flows in an upward
direction would not be operable. We do not give weight to the unsupported
opinions on these points. Opinions unsupported by facts are entitled to little
or no weight. In re Etter, 756 F.2d 852, 860 (Fed. Cir. 1985) (en banc). The
examiner’s final rejection made express findings on the level of skill in the
art and, in particular, he found that a person having ordinary skill in the art
would understand that the assay assemblies of both the 620 claims and
Patentee’s claims function by capillary action. Final Rejection, pp. 6-7. The
declarations fail to demonstrate any error in or even address this critical
finding.
The declarants also testify that the claimed urinalysis devices are
superior in solving two problems present in assay assemblies in which the
urine flows downward: (1) too much urine in the cup resulted in flooding of
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the assay strip wiping out the antibodies or antigens on the assay strip
(Tydings, ¶ 3, p. 1; Hipple, ¶ 4, p. 2) and (2) insufficient urine in the cup
would result in the urine failing to reach the assay strip (Tydings, ¶ 3, p. 1;
Hipple, ¶ 4, p. 2). These problems are said to have been solved by the
configuration where the urine moves in an upward direction at the point of
contact. Tydings, ¶ 4, p. 2; Hipple, ¶ 5, p. 2).
Patentee’s declarations do not demonstrate that the elimination of
flooding and low urine problems was unexpected. Unexpected superior
results must be established by factual evidence. CMFT, Inc. v. Yieldup Int’l
Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003); In re Soni, 54 F.3d 746, 751
(Fed. Cir. 1995) ("when an applicant demonstrates substantially improved
results . . . and states that the results were unexpected, this should suffice to
establish unexpected results in the absence of evidence to the contrary”).
The factual evidence must compare the closest “prior art,” in this case the
subject matter of Claims 1-6 of the 620 patent, with the claimed invention.
In re Baxter Travenol Labs, 952 F.2d 388, 392 (Fed. Cir. 1991). The
comparison must be under identical conditions except for the novel features
of the invention. See In re Brown, 459 F.2d 531, 536 (CCPA 1972).
Patentee has not presented any comparative test evidence comparing
Patentee’s urinalysis device with those claimed in the 620 patent under
identical conditions except for the contact point of the wicking and assay
strip. We find that unexpected superior results have not been established.
Under these circumstances, the patentee’s assertions of superiority are no
more than mere argument and conclusory statements. We give little
evidentiary value to the testimony on superior results.
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Patentee failed to prove that the claimed subject matter achieves
unexpected superior results compared to the subject matter of Claims 1-6 of
the 620 patent.
Tydings testifies to sales of over 4,000,000 urine test systems “most
of which are cups of the present claims where there is no wicking of urine
over the top of the backing.” Tydings, ¶ 5, p. 2. Assuming that the units
sold meet the limitations of the claims, information solely on numbers of
units sold is insufficient to establish commercial success. See Kansas Jack,
Inc. v. Kuhn, 719 F.2d 1144, 1151, 219 USPQ 857, 861 (Fed.Cir. 1983).
Patentees have provided no evidence, for example, of market share, growth
in market share, of replacing earlier units sold by others, or other facts which
would establish that purchasers bought the systems because of the benefit of
the invention.
Patentee failed to prove commercial success.
Tydings testifies that ‘[p]rior to my inventing the up the wick/up the
strip construction there were no competitors in the field. After the up the
wick/up the strip construction was developed many competitors entered the
field.” Tydings, ¶ 9, p. 3. Tydings also testifies that there are many
“infringers of cups bearing the structure and functional characteristics of the
claims . . . .” Tydings, ¶ 7, p. 2. Hipple testifies that he competes “with
many other cups having the structure and functional flow characteristic of
the up the wick/up the strip construction. These are copies of the up the
wick/up the strip system . . . .” Hipple, ¶ 12. p. 3.
This generalized testimony does not prove copying. The fact that
competitors are infringing does not, itself, prove copying. Proof of copying
requires that the alleged copier had knowledge of or access to the product
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and then replicated it. The testimony proves neither knowledge nor
replication. Tydings testimony that “prior to [his] invention” there were no
competitors and that competitors did not enter the field until his construction
was “developed” does not prove that the competitors entered the field as a
result of knowledge of Patentee’s urine test system. We are provided with
no evidence on how or when the purported copiers obtained knowledge of
the claimed subject matter. As to replication, the testimony does not
establish that the purported copied or infringing products meet the
limitations of the claims. The most we are told is that the products have “the
structure and the functional flow characteristics of the up the wick/up the
strip construction.”
Patentee failed to prove copying.
Tydings testifies that his urine test system satisfies an unsolved need.
For an unsolved need to be convincing of non-obviousness, that need must
be shown to be long felt. Thus, the evidence must establish that a
recognized problem has existed in the art for a long period of time prior to
solution by the inventor. The evidence does not prove the problem existed in
the art without solution for a long time.
Patentee failed to prove that the claimed invention satisfied a long felt
unresolved need in the art.
CONCLUSION OF LAW
The subject matter of Claims 1-8, 14, 16-21, 23, 25 and 26 would
have been obvious from the subject matter of Claims 1-6 of Patent
6,379,620. Patentee has failed to prove reversible error in the examiner’s
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final rejection of those claims on the grounds of obviousness-type double
patenting.3
DECISION
The Examiner's rejection of claims 1-8, 14, 16-21, 23, 25 and 26 is
affirmed.
AFFIRMED

ack
cc:

GREENBERG TRAURIG LLP (LA)
2450 COLORADO AVENUE, SUITE 400E
INTELLECTUAL PROPERTY DEPARTMENT
SANTA MONICA, CA 90404

Third Party Requester:

Peng Chen
MORRISON & FOERSTER LLP
1253 1 High Bluff Drive, Suite 100
San Diego, CA 92130

3 Patentee asserted that the examiner erred in construing the claims as means
plus function claims under 35 U.S.C. § 112, ¶ 6 (Brief pp. 14-17), and in not
accepting a terminal disclaimer to overcome the rejection (Brief pp.17-28).
The examiner withdrew any reliance on a § 112, ¶ 6, construction in the
Answer. Answer, p. 13. Patentee withdrew reliance on the terminal
disclaimer at oral argument.