ABS Global, Inc.v.XY, Inc.

Patent Trial and Appeal Board

Apr 15, 2016

11608079 (P.T.A.B. Apr. 15, 2016)

Trials@uspto.gov Paper: 25
571-272-7822 Entered: April 15, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
ABS GLOBAL, INC. and GENUS PLC,
Petitioner,
v.
XY, LLC,
Patent Owner.
_______________
Case IPR2014-01550
Patent 7,820,425 B2
____________________

Before JACQUELINE WRIGHT BONILLA,1
GRACE KARAFFA OBERMANN, and MICHELLE R. OSINSKI,
Administrative Patent Judges.

OBERMANN, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318 and 37 C.F.R. § 42.73

1 Judge Bonilla replaces Judge Mitchell on the panel.
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I. INTRODUCTION
This is a Final Written Decision in an inter partes review of claims 1–
4, 6–9, 11–13, 15, 21–28, and 31–34 (“the challenged claims”) of U.S.
Patent No. 7,820,425 B2 (Ex. 1001, “the ’425 patent”). We instituted
review on the following grounds stated in the Petition (Paper 1, “Pet.”):

Claims Basis References
1–4, 6–9, 11–13, 15,
21–28, and 31–34 § 103(a) Seidel
2 and Salisbury3
1–4, 6, 25, 26, 31, and
32 § 103(a) Fugger
4
7–9, 11–13, 15, 21–24,
27, 28, 33, and 34 § 103(a) Fugger and Salisbury

Patent Owner filed a Response (Paper 15, “Resp.”) and Petitioner
filed a Reply (Paper 17, “Reply”). The record includes a transcript of the
final oral hearing conducted on January 11, 2016. Paper 24 (“Tr.”). We
have jurisdiction under 35 U.S.C. § 6(c). For the reasons that follow, we
determine that Petitioner shows by a preponderance of the evidence that the
challenged claims are unpatentable.

2 Seidel et al., US 7,195,920 B2, issued March 27, 2007 (Ex. 1005).

3 G. W. SALISBURY, N. L. VANDEMARK, AND J. R. LODGE, PHYSIOLOGY OF
REPRODUCTION AND ARTIFICIAL INSEMINATION OF CATTLE 442–554 (W.H.
Freeman & Co. 2d ed. 1978) (Chapters 16 and 17) (Ex. 1006) (“Salisbury”).

4 E. F. Fugger et al., Births of Normal Daughters after MicroSort Sperm
Separation and Intrauterine Insemination, In-Vitro Fertilization, or
Intracytoplasmic Sperm Injection, 13 HUMAN REPRODUCTION 2367–70
(Sept. 1998) (Ex. 1007) (“Fugger”).
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A. Related Proceedings
Petitioner indicates that the ’425 patent was asserted in XY, LLC v.
Trans Ova Genetics, L.C., No. 13-CV-00876-WJM-BNB (D. Colo.). Pet. 2.
B. The ’425 Patent and the Field of Invention
The ’425 patent is titled “Method of Cryopreserving Selected Sperm
Cells.” Ex. 1001, Title. The challenged claims are directed to a method of
selecting (that is, sorting) non-human sperm for a specific characteristic,
such as sex-selection, then freezing the sorted sperm for later use to fertilize
an egg. Ex. 1001, Abstract, 1:17–21, 31:64–32:11.
Claim 1, the only independent challenged claim, is reproduced below:
1. A method of freezing separated sperm cells, comprising the
steps of:
a) obtaining sperm cells from a male of a species of non-human
mammal;
b) differentiating said sperm cells based upon at least one
property which allows a portion of said sperm cells to be
identified as bearing either an X-chromosome or a
Y-chromosome;
c) separating said sperm cells into a discrete population based
upon said at least one property;
d) establishing from said discrete population a selected sperm
sample having a sufficient number of sperm cells to fertilize an
egg of a female of said species of non-human mammal;
e) freezing said selected sperm sample.
Id. at 31:64–32:11.
The remaining challenged claims depend directly or indirectly
from claim 1 and further limit the method of freezing, except that
claim 31 specifies a frozen separated cell sample in accordance with
the method of claim 1. Id. at 32:12–34:50.
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According to the ’425 patent, “[a] wide variety” of sorting
techniques were available in the prior art. Id. at 4:16–40; Ex. 1003
¶ 46. The ’425 patent discloses that the preferred sorting method for
use in the invention is conventional flow cytometry, which uses
“differential staining with fluorescent dyes or binding to fluorescently
labeled molecules, such as antibodies or nucleic acids.” Id. at 4:41–
44. Because an X chromosome contains slightly more DNA than a
Y chromosome, an X-chromosome bearing sperm absorbs more dye
than a Y-chromosome bearing sperm, allowing for separation based
on sex-selection. Id. at 4:47–52.
The ’425 patent also states that “techniques for freezing
unselected sperm” were “well known.” Id. at 2:10–11; Ex. 1003
¶¶ 52–59 (and citations therein to Ex. 1009, Ex. 1010). The ’425
patent identifies conventional methods of freezing sperm as suitable
for use in the invention, explaining in an example that sorted sperm is
“frozen conventionally.” Id. at 17:2.
C. The Asserted Prior Art
The asserted prior art includes Seidel and Salisbury. Seidel
discloses a technique for sorting non-human sperm for sex-selection.
Ex. 1005, 1:62–2:4, 6:12–30. Salisbury discloses a technique for
successfully freezing non-human sperm for later use in fertilizing an
egg. Ex. 1006, 443–5385; see Ex. 1003 ¶¶ 199–212 (summarizing
Salisbury’s disclosure). Patent Owner’s own witness could articulate

5 We follow the parties’ convention of referring to the original page numbers
of documents, not those added by the parties to the exhibits.
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no difference between the method of claim 1 and the method of
Seidel, as modified to include the freezing step of Salisbury.
Ex. 1035, 171:17–174:5, 179:8–24, 182:11–16.
The asserted prior art also includes Fugger. Fugger shows that,
at the time of the invention, human sperm had been successfully
frozen for later use to fertilize an egg. Specifically, Fugger disclose a
method of sorting and freezing human sperm to produce “normal and
healthy” human babies. Ex. 1007, 2368. That sets up the central
dispute; whether a person of ordinary skill in the art would have had
the desire and technical acumen to sort and freeze non-human sperm
with a reasonable expectation of success.

II. DISCUSSION
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
assigned their broadest reasonable interpretation in light of the specification
of the patent in which they appear. 37 C.F.R. § 42.100(b). Claim terms are
given their ordinary and customary meaning as understood by one of
ordinary skill in the art in the context of the entire disclosure. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). If an inventor
acts as his or her own lexicographer, the definition must be set forth with
reasonable clarity, deliberateness, and precision. Renishaw PLC v. Marposs
Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
To the extent that any term requires express construction for the
purposes of this decision, we discuss that construction in our analysis of the
grounds of unpatentability. See Wellman, Inc. v. Eastman Chem. Co., 642
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F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to
the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc.
v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
B. Principles of Law
Petitioner bears the burden of proving unpatentability of the
challenged claims, and that burden never shifts to Patent Owner. Dynamic
Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir.
2015). To prevail, Petitioner must establish facts supporting its challenge by
a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
differences between the subject matter sought to be patented and the prior art
are such that the subject matter as a whole would have been obvious at the
time the invention was made to a person of ordinary skill in the art. KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Obviousness is resolved
based on underlying factual determinations, including: (1) the scope and
content of the prior art; (2) any differences between the claimed subject
matter and the prior art; (3) the level of skill in the art; and (4) objective
evidence of nonobviousness, i.e., secondary considerations. See Graham v.
John Deere Co., 383 U.S. 1, 17–18 (1966).
C. Level of Ordinary Skill in the Art
The prior art in this case is representative of the level of ordinary skill
in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
Patent Owner contends that Petitioner’s witness, Dr. Marvin M. Pace,6

6 Dr. Pace began researching the cryopreservation of sperm in the 1960’s and
has been actively involved in the field for his entire adult life. He has
performed research and published in the field of sperm freezing. For
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opines from the viewpoint of a hypothetical person of ordinary skill in the
art who “may have no background in sperm cell sorting at all.” Resp. 12
(citing Ex. 1003 ¶ 41). Patent Owner contends that this is an erroneous
viewpoint, because an ordinary artisan must have “at least . . . 3 years of
experience working in the field of sperm cell sorting” in addition to
experience freezing sperm. Id. (citing Ex. 2015 ¶ 91).
We find that Dr. Pace’s testimony is keyed to the knowledge and
understanding of a person of ordinary skill in the art. A full and fair reading
of Dr. Pace’s testimony reveals that, in fact, he opines from the perspective
of a hypothetically ordinary artisan who has “at least 3 years experience with
methods of freezing sperm” (Ex. 1003 ¶ 41) and, additionally, is familiar
with conventional sperm sorting techniques, as described in the prior art,
including Seidel and Fugger. See, e.g., id. ¶¶ 41, 46–51, 230, 233–34, 248,
305–308. A hypothetical person of ordinary skill in this art need not acquire
their understanding of sperm sorting through hands-on experience, as
proposed by Patent Owner. Resp. 12; Ex. 2015 ¶ 91. Knowledge acquired
through familiarity with the prior art is sufficient. “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 Indus., Inc.,
807 F.2d 955, 962 (Fed. Cir. 1986).

example, he developed “a straw freezing system” for cryopreserving sperm.
He conducted over 300 laboratory experiments on semen physiology and
cryopreservation of sperm. Ex. 1003 ¶¶ 2–9. We find that Dr. Pace is
qualified to opine from the perspective of an ordinary artisan in the field of
the invention.
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D. Analysis
Three obviousness grounds are at issue in this review, based on the
following prior art references: (1) the combined disclosures of Seidel and
Salisbury; (2) Fugger alone; and (3) the combined disclosures of Fugger and
Salisbury. We address each ground in turn below.
1. The Ground Based on Seidel and Salisbury
Petitioner asserts that the subject matter of claims 1–4, 6–9, 11–13,
15, 21–28, and 31–34 would have been obvious over the combined
disclosures of Seidel and Salisbury. Pet. 15–36. The thrust of Patent
Owner’s opposition is that Seidel teaches away from freezing sperm cells
that have already been compromised by the damaging effects of sorting.
Resp. 14–23. We first address the ground as applied against claim 1, then
turn to the challenged claims that depend directly or indirectly from claim 1.
a. Analysis of Claim 1
(1) Seidel Discloses Steps (a) Through (d) of Claim 1
Seidel relates to a method of sorting non-human sperm cells—for
example, by separating cells bearing an X chromosome from those bearing a
Y chromosome—to facilitate sex-selection in non-human mammalian
offspring produced by artificial insemination. Ex. 1005, 1:12–29; 5:41–42.
Seidel expressly discloses the step of obtaining sperm from a non-human
mammal by collecting bull semen through the use of an artificial vagina.
Pet. 17–18 (citing Ex. 1005, 13:17–21; Ex. 1003 ¶¶ 182, 226). In other
words, Seidel discloses “obtaining sperm cells from a male of a species of
non-human mammal” as specified in step (a) of claim 1.
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Step (b) of claim 1 requires “differentiating said sperm cells based
upon at least one property which allows a portion of said sperm cells to be
identified as bearing either an X-chromosome or a Y-chromosome.”
Ex. 1001, 32:1–4. Seidel is directed to separating non-human sperm via
conventional flow cytometry, which the ’425 patent identifies as “a preferred
method for separating cells.” Id. at 4:41; Ex. 1005, 5:53–7:33; Ex. 1003
¶¶ 186–89, 227. We find that Seidel discloses step (b) of claim 1.
Step (c) of claim 1 requires “separating said sperm cells into a discrete
population based upon said at least one property.” Ex. 1001, 32:5–6. Both
the ’425 patent and Seidel discuss the method pioneered by Larry Johnson,
in which a sample stream of X- and Y-chromosome bearing cell streams are
distinguished and separated by a flow cytometer. Compare Ex. 1005, 1:62–
2:4, 6:12–30 (Seidel, applauding Larry Johnson’s “seminal” work in
developing the flow cytometry technique for sorting sperm cells), with
Ex. 1001, 4:41–60 (the ’425 patent, identifying Johnson’s flow cytometry
technique as “preferred” for separating cells in the method of the invention).
Seidel discloses that “the only quantitative technique used to achieve
the separation of X- and Y-chromosome bearing sperm has been that
involving individual discrimination and separation of the sperm through the
techniques of flow cytometry.” Ex. 1005, 1:62–66. Seidel informs that “by
sensing the degree of dye present in the sperm cells it is possible to
discriminate between X-bearing sperm and Y-bearing sperm by their
differing emission levels.” Id. at 6:24–30; Pet. 18 (citing Ex. 1003 ¶¶ 188,
228); see Ex. 1005, 7:1–25 (Seidel, reporting that “rates of sorting in the
thousand and twelve hundred ranges have already been achieved” for non-
human sperm by using a MoFlo® high speed flow cytometer). Seidel also
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explains that flow cytometry allows one to “discriminate between cells
based on a particular characteristic and place them in the appropriate
collector.” Ex. 1005, 6:40–45; see Pet. 18 (citing Ex. 1003 ¶¶ 189, 228).
We are persuaded that Seidel discloses step (c) of claim 1.
We next address whether Seidel discloses “establishing from said
discrete population a selected sperm sample having a sufficient number of
sperm cells to fertilize an egg of a female of said species of non-human
mammal” as required by step (d) of claim 1. Ex. 1001, 32:7–10. Seidel
discloses establishing a population of X-bearing sperm, diluting the sperm to
the desired concentration, and placing the sperm into a straw. Ex. 1005,
14:26–28; Ex. 1003 ¶¶ 190–91, 194, 196–97. Seidel describes using that
selected sperm sample to successfully artificially inseminate a female
bovine. Ex. 1005, 15:16–16:9; Ex. 1003 ¶¶ 198, 229. On this record, we are
persuaded that Seidel discloses step (d) of claim 1.
Petitioner acknowledges that Seidel does not teach expressly freezing
the sorted non-human sperm sample as required by step (e) of claim 1.
Pet. 19. As explained in the next section, however, Petitioner persuasively
shows that an ordinary artisan would have had the desire and skill to freeze
Seidel’s sorted sperm, by applying Salisbury’s conventional freezing
technique to cryopreserve the sample for later use in fertilizing an egg.
(2) Salisbury Discloses Freezing Step (e) of Claim 1
The ’425 patent states that “techniques for freezing unselected sperm
are well known” and, further, that advances in cryopreservation and sperm
storage “have facilitated widespread distribution and commercialization of
sperm intended for artificial insemination or in vitro fertilization.” Ex. 1001,
2:10–11, 1:29–32. In describing the equilibration and freezing of sperm,
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the ’425 patent states that, “[f]ollowing equilibration, any standard freezing
method can be employed, provided the freezing rate is not too rapid (i.e., not
in excess of about 0.5°C./minute).” Id. at 10:54–57. Salisbury describes
principles and techniques of freezing non-human spermatozoa (Ex. 1006,
494–539), and recognizes the problems that may occur when the freezing
rate is too rapid, id. at 508–12, Fig. 17-6. Salisbury does not expressly
describe freezing sperm that have been subjected to a cell sorting process.
(3) Reasons to Combine the
Disclosures of Seidel and Salisbury
Petitioner argues that one of ordinary skill in the art would have been
led to combine the teachings of Seidel and Salisbury in view of the known
commercial benefits of separated, frozen non-human sperm:
A person of ordinary skill in the art would have been motivated
to freeze separated sperm in light of the commercial benefits to
separated, frozen sperm. For example separated sperm allows
farmers to vary the male to female offspring ratio. Female
dairy cows are normally more valuable than males because only
females can produce milk and because female calves have a
lower incidence of difficult births (female calves tend to be
smaller than male calves). And, because fresh sperm quickly
loses viability, frozen sperm allows breeders to store sperm
over long periods of time and to use it to artificially inseminate
cows at the optimal time. Frozen sperm can be shipped long
distances, permitting producers to take advantage of the genetic
attributes of bulls located far away from the heifers to be
impregnated.
Pet. 16 (citing Ex. 1003 ¶¶ 43, 92, 230 (Pace Declaration)).
Patent Owner confirms that “[t]he benefits of freezing were well-
known in the industry and easily appreciated by those of skill in the art well
before” the time of the invention. Resp. 22 (citation omitted). In Patent
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Owner’s view, however, Seidel teaches away from freezing sorted sperm, in
disclosures which acknowledge that sorting imposes stresses on the already-
delicate sperm cells. Id. at 14–15 (citing Ex. 1005, 2:24–25, 45–49, 56–67;
7:48–51, 62–64; 9:52–57; Ex. 2015 ¶¶ 20, 114). Patent Owner submits that
a person of ordinary skill in the art would not have been led to apply a
damaging method of freezing to a cell population that is already
compromised by the deleterious effects of a sorting process. Id. at 16.
A reference teaches away if it “criticize[s], discredit[s], or otherwise
discourage[s]” modifying the reference to arrive at the claimed invention. In
re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Patent Owner directs us to
no disclosure in Seidel that mentions freezing, much less a teaching that
“criticize[s], discredit[s], or otherwise discourage[s]” the application of a
freezing step to sorted sperm. Id.; see Resp. 14–16 (teaching away
argument). We will not “read into a reference a teaching away from a
process where no such language exists.” DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
Patent Owner’s evidence that freezing “would exacerbate the deleterious
effects of sorting” does not persuade us that Seidel teaches away from the
proposed combination with Salisbury. Resp. 20 (quoting Ex. 2015 ¶ 126).
We are persuaded that “nothing inherent in the process of separating
sperm cells” would have discouraged an ordinary artisan from combining
Seidel’s sorting technique with Salisbury’s freezing technique. See, e.g.,
Ex. 1003 ¶ 90. Petitioner persuasively argues that “the prior art is full of
examples where sperm was subjected to the stresses of a sorting process,
frozen, and then used to produce pregnancies.” Reply 2. Specifically,
Petitioner directs us to evidence that artisans in the field had been applying
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sorting and freezing, in combination, for decades to obtain non-human
sperm populations suitable for fertilization. Id. at 3–5; see Ex. 1003 ¶¶ 81–
90 (Dr. Pace, discussing prior art methods in which non-human sperm was
sorted, frozen, and then used for insemination (citing Exs. 1018–1026)). For
example, one prior art process achieved a “very high conception rate” using
non-human sperm that was first subjected to a stressful series of sorting
steps, then frozen according to conventional cryopreservation methods.
Reply 3–4 (quoting Ex. 1019, 14:39–43) (citing Ex. 1019, 12:50–60; 15:37–
46; Ex. 1035 72:7–18; 73:15–81:6; 82:16–83:15; 899–90:15).
Even if those prior art sorting techniques were less reliable at sorting
sperm than flow cytometry, Petitioner shows persuasively that, at the time of
the invention, it was routine in the field of the invention to apply sorting and
freezing techniques in tandem to non-human sperm cell populations with
success. See Reply 3–4 (discussing the disclosures of Exs. 1019 and 1025);
Ex. 1003 ¶¶ 81–90 (and citations to prior art therein). Patent Owner’s own
witness confirms that the references advanced by Petitioner, in fact, disclose
examples in which non-human sperm was subjected to the stresses of both
sorting and freezing, then used to fertilize an egg. Reply 4–6 (citing
Ex. 1035, 73:15–81:6, 82:16–83:15, 88:4–89:2, 89:9–90:15).
Research conducted by Dr. Chris Polge would have further
encouraged an ordinary artisan to combine Seidel’s method of sorting for
sex-selection with Salisbury’s method of freezing in order to achieve the
benefits of cryopreserving sorted non-human sperm for later use in
fertilization. Ex. 1003 ¶ 93 (citing Ex. 1027, 10 (discussing “preliminary
experiments . . . carried out on freezing sperm after sorting” for non-human
animal breeding)); Resp. 22 (contesting import of Ex. 1027); Reply 8–9
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(reasserting import of Ex. 1027). The evidence shows that an ordinary
artisan, seeking to extend Dr. Polge’s work, would have combined Seidel’s
sorting and Salisbury’s freezing techniques. As explained in KSR:
When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a
person of ordinary skill has good reason to pursue the known options
within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a combination was
obvious to try might show that it was obvious under § 103.
Reply 2 (quoting KSR, 550 U.S. at 421); see id. at 8–9 (further discussing
Dr. Polge’s work).
In light of the known commercial benefits of freezing sorted non-
human sperm, the evidence of a decades-long practice of freezing sorted
non-human sperm, the encouraging work of Dr. Polge, and Dr. Pace’s
persuasive testimony on the issue, we find that an ordinary artisan, reading
Seidel and Salisbury, would not have been “led in a direction divergent from
the path” taken by the inventor of the ’425 patent. In re Mouttet, 686 F.3d
1322, 1333–34 (Fed. Cir. 2012) (quotations omitted); Ricoh Co. v. Quanta
Computer Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008) (quotations omitted).
On the contrary, a person of ordinary skill in the art would have been
led to combine Seidel’s method of sorting non-human sperm, based on sex-
selection, with Salisbury’s method of freezing to cryopreserve the sorted
sample for later use in fertilizing an egg. The knowledge of the art suggests
the utility of freezing non-human sperm, after sorting for sex-selection, to
facilitate distribution and commercialization of sperm for non-human animal
breeding. Even if we accept Patent Owner’s counterview—that the sorting
process would have been understood to make sperm more vulnerable to the
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damaging effects of freezing—we are not persuaded that the mere possibility
of failure makes unobvious the successful sorting and freezing of non-
human sperm. See In re Moreton, 129 USPQ 288 (CCPA 1961) (“An
argument that if one slavishly following the prior art . . . will sometimes
succeed and sometimes fail, then he is always entitled to a patent in case of
success [is] not the intention behind 35 U.S.C. 103. Obviousness does not
require absolute predictability. Where . . . the knowledge of the art clearly
suggests” something “as useful . . ., the mere possibility of failure does not
render the [] successful use ‘unobvious.’”).
Seidel uses a sorted sperm sample to successfully inseminate a female
bovine; in other words, Seidel discloses a sorted sperm sample that includes
“a sufficient number of sperm cells to fertilize an egg.” Ex. 1001, 32:7–11;
Pet. 19 (citing Ex. 1005, 15:16–16:9; Ex. 1003 ¶¶ 198, 229). Here, it is
useful to highlight that, in claim 1, it is the sorted sperm sample of
step (d)—not the sorted and frozen sperm sample of step (e)—that must
have “a sufficient number of sperm cells to fertilize an egg.” Ex. 1001,
32:7–11. No express terms in claim 1 require the sorted sperm sample to
retain any utility for use in fertilization, after it is frozen in step (e).7 Id.
Nevertheless, we cannot ignore that the entire thrust of the ’425 patent
disclosure is directed toward freezing a sperm sample that “can be thawed
and used for fertilization.” Ex. 1001, Abstract, 2:35–67; see also, e.g., id. at
10:29–11:45, 17:11–27. That persuades us that a person of ordinary skill in

7 Patent Owner asserts an argument based on a misconception that the term
“having a sufficient number of cells to fertilize an egg” modifies the
“selected sperm sample” after freezing step (e) of claim 1. Ex. 1001, 32:8–
9, 11; Resp. 20–21 (bridging paragraph).
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the art, reading the claim language in light of the specification, would have
understood that the “selected sperm sample” of claim 1 must have some
utility for fertilization, at the conclusion of the freezing step of claim 1(e).
Id. at 32:11. Not even Petitioner, who would benefit from the broader
construction, advocates reading claim 1 so broadly as to yield “nothing, no
viable sperm at the end of the process.” Tr. 10:1–9.
Therein lies a conundrum. There is no particular number of viable
sperm cells that will ensure fertilization; accordingly, neither party proposes
a number, or even a numerical range, of viable sperm cells that will
successfully fertilize an egg. Reply 12. It is possible to achieve fertilization
using low numbers of viable sperm, and it is also possible to achieve
complete failure (no fertilization) using high numbers of viable sperm. Id.
at 12–15. But this much is clear: A sample having no viable sperm cells
cannot fertilize an egg. Id. For the reasons that follow, we find that a sperm
sample is useful for fertilization if it contains at least one viable sperm cell.
At the time of the invention, an ordinary artisan would have
understood that conventional procedures for fertilizing an egg included not
only artificial insemination (in which sperm are introduced into the uterus or
cervix), but also in vitro fertilization (“IVF”), in which the egg is combined
with sperm in a laboratory dish outside the body. Ex. 2015 ¶¶ 52–54;
Resp. 5 (Patent Owner’s overview of fertilization methods).
Intracytoplasmic sperm injection (“ICSI”) was a known method of
IVF that required just one viable sperm cell, which is injected directly into
the egg. Ex. 2015 ¶ 55; Reply 5–6 (citing Ex. 1035, 121:3–4; Ex. 1003
¶ 51). Although the ’425 patent does not refer expressly to ICSI, claim 1
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contains no terms that limit the fertilization technique for which the sorted
and frozen sperm must be useful. Ex. 1001, 32:11 (step 1(e)).
Patent Owner’s own witness confirms that, in “ICSI, a single cell can
be sufficient to fertilize an egg.” Ex. 1035, 121:5–7; see Resp. 5 (Patent
Owner’s overview of fertilization procedures, including ICSI). Not even
Patent Owner goes “so far as to suggest that one of ordinary skill in the art
would have expected the combination of Seidel and Salisbury to kill all of
the cells.” Reply 6; see Resp. 19–20 (arguing that sperm sorting imposes
“severe deleterious effects” on sperm, but stopping short of arguing that
Seidel’s improved sorting method would kill all of the sperm in a sample).
On this record, at the time of the invention, a sperm sample containing
at least one viable sperm cell would have been understood to be useful in a
fertilization procedure, namely, ICSI. Even if we exclude ICSI from the
universe of known fertilization procedures, however, the result remains the
same. Seidel discloses that the pregnancy rate of heifers inseminated with
sorted sperm cells was not significantly different from the rate achieved with
unsorted sperm cells. Pet. 31 (citing Ex. 1005, 15:16–16:9; Ex. 1003 ¶¶ 198,
281). Patent Owner’s own witness agrees that, “if you use Seidel’s
disclosure and then freeze the cells, they will survive the process and
produce a sufficient number to fertilize eggs.” Reply 10 (quoting Ex. 1035,
182:11–16). In other words, one led to combine Seidel and Salisbury, to
achieve the well-known benefits of freezing, would have attained a sorted,
frozen sperm sample having the same level of utility for artificial
insemination that is reported in the ’425 patent.
For the foregoing reasons, we find that Petitioner has set forth
reasoning with a rational underpinning as to why a person of ordinary skill
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in the art would have combined the teachings of Seidel and Salisbury to
arrive at the invention of claim 1.
b. Analysis of Dependent Challenged Claims
Petitioner presents detailed arguments and evidence that dependent
claims 6–9, 11–13, 15, 21–24, 28, 31, 33, and 34 are unpatentable as
obvious over the combined disclosures of Seidel and Salisbury. See Pet. 20–
36 (and citations to record therein). Patent Owner does not address the
patentability of those claims separately from claim 1. Resp. 14 (“The
dependent claims, therefore, are also not obvious because they depend from
claim 1.”). The information presented in the Petition satisfies Petitioner’s
burden with respect to those dependent claims.
Petitioner also presents detailed arguments and evidence that
dependent claims 2–4, 25–27, and 32 are unpatentable as obvious over the
combined disclosures of Seidel and Salisbury. See Pet. 20–22, 31–35 (and
citations to record therein). Patent Owner raises additional arguments, as to
those claims, that are separate from the arguments presented as to claim 1.
Resp. 24–30. We first address claims 25–27, then turn to claims 2–4 and 32.
Claims 25–27 require establishing, by the freezing method of claim 1,
“an insemination sample having a sufficient number of sperm cells to
inseminate a female.” Ex. 1001, 34:14–16. That limitation of claim 25
modifies the sorted, frozen sperm sample. Id. We agree with Patent Owner
that the term “insemination” excludes an IVF procedure, such as ICSI, in
which fertilization occurs outside the female body. Resp. 27–29 (and
citations to record therein). For the reasons stated above, however, even if
ICSI and other IVF techniques are excluded from the universe of known
fertilization procedures, the result does not change. A person of ordinary
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skill in the art would have had the desire and skill to combine Seidel and
Salisbury and, thereby, would have attained a frozen sample having the same
level of utility for artificial insemination that is reported in the ’425 patent.
Claim 27 additionally requires an “insemination sample” that
“contains between about one million and about three million sex-selected
sperm cells.” Ex. 1001, 34:22–25. Nothing in the terms of claim 27
specifies that the same number of cells must be viable; accordingly, this
limitation refers to the absolute number of cells (whether viable or not)
contained in the sample. See Reply 11–12 (citing Ex. 1035, 151:22–153:10).
Petitioner directs us to persuasive evidence that Seidel’s sorting technique
produces samples having between about one million and three million sex-
selected sperm cells. Pet. 32 (citing Ex. 1005, 14:11–12; Ex. 1003 ¶¶ 194,
287). We agree with Petitioner that Patent Owner does not genuinely
“dispute that Seidel discloses sorting at rates that will produce doses of more
than 1 million cells.” Reply 12; see Resp. 27–30. Seidel discloses that
sorted and unsorted sperm samples produce similar pregnancy rates in
heifers and, further, uses a sorted sperm sample to successfully fertilize a
female bovine via artificial insemination. Ex. 1005, 15:16–16:9; Ex. 1003
¶¶ 198, 229, 281.
Patent Owner argues that additional reasons support the patentability
of claims 2–4 and 32 over Seidel and Salisbury. Resp. 24–27. First, Patent
Owner points out that Seidel is directed to the same flow cytometry sorting
method, involving fluorescence-activated cell sorting (“FACS”), that is
useful to sort cells according to the method of claims 2–4 and 32. Id. at 24–
26. Second, Patent Owner argues that “Seidel’s disclosure regarding the
stresses that sperm cells must endure during sorting by flow cytometry and
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FACS” show that “a person of ordinary skill in the art would not have had a
reasonable expectation of success in combining the freezing method of
Salisbury with the sorting method of Seidel.” Id. at 26. We agree with
Petitioner that this argument is essentially the same as the teaching away
argument presented in the context of claim 1. Reply 11. For reasons stated
above in connection with claim 1, Patent Owner’s alleged additional
arguments pertaining to claims 2–4 and 32 are not persuasive.
Petitioner satisfies its burden with respect to the obviousness of the
subject matter of claims 2–4, 25–27, and 32 over the disclosures of Seidel
and Salisbury. We next turn to Petitioner’s assertion that the challenged
claims are invalid based on Fugger alone or in combination with Salisbury.
2. The Ground Based on Fugger Alone
Petitioner asserts that claims 1–4, 6, 25, 26, 31, and 32 are
unpatentable as obvious over Fugger. Pet. 36–44. The Petition includes
detailed explanations of how each claim limitation is met by that reference,
as well as rational reasons for modifying the reference, and directs us to the
declaration of Dr. Pace (Ex. 1003). Id. Patent Owner responds that Fugger
does not demonstrate the obviousness of a method for freezing sorted non-
human sperm, because Fugger freezes sorted human sperm. Resp. 31–32.
Fugger uses the conventional flow cytometry method to separate
human sperm cells for preconception sex-selection, which results in a
desired female sex-selection in 92.9% of births. Ex. 1007, 2367 (Abstract).
The introduction section in Fugger, however, also discusses the use of flow
cytometric separation (“FCS”) to sort non-human X- and Y-bearing sperm:
In 1987, Johnson et al. reported flow cytometric separation
(FCS) of animal X- and Y-bearing spermatozoa into two
enriched populations based on total DNA difference (United
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States Patent #5,135,759). Subsequently, pregnancies and
births have been reported in the rabbit (Johnson et al., 1989),
swine (Johnson, 1991), ovine (Morrell and Dresser, 1989), and
bovine (Cran et al., 1993) species using such flow sorted
spermatozoa. Over 400 offspring, all normal, have been born
using flow sorting technology, including three successive
generations in swine (L.A. Johnson, personal communication)
and five successive generations in rabbits (Morrell and Dresser,
1989).
Id. at 2367.
Fugger’s examples relate to sorted human sperm. In that regard,
Fugger discloses that sorted human sperm samples are placed into cryotubes
or straws “and subsequently frozen in a programmable rate freezer.”
Pet. 37–38 (quoting Ex. 1007, 2368) (citing Ex. 1003 ¶¶ 223, 309). Frozen
human sperm samples “were thawed at room temperature, centrifuged, and
resuspended” prior to use. Ex. 1007, 2368. “Pregnancies [were] attained
with the use of frozen sorted sperm cells.” Id. at 2369.
Fugger compares human sperm to bovine sperm in the FCS separation
process. Fugger states that “[s]everal characteristics specific to human
sperm cells present unique challenges for FCS compared with domestic
animal spermatozoa.” Id. at 2369. Those characteristics include the
percentage total DNA difference between X- and Y-bearing spermatozoa,
physical shape and morphology, variation in the size of the Y chromosome,
heterogeneity of the sperm cells, and the range of individual variability. Id.
Fugger notes that pregnancies using intrauterine insemination with less than
1X106 motile sperm cells have been achieved in bovine and human species.
Id. (citations omitted).
We find that Fugger discloses each method step of claim 1, except
that claim 1 requires non-human sperm, and Fugger’s method is applied to
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human sperm. See Pet. 36–39 (and citations to record therein). The crux of
Patent Owner’s counter argument is that a person of ordinary skill in the art
would not have been prompted to apply Fugger’s combined sorting and
freezing method to non-human sperm cells, because “human sperm exhibit
differences from sperm cells of other species.” Resp. 33.
Petitioner asserts that it would have been obvious to apply Fugger’s
method to the sperm of non-human mammals with a reasonable expectation
of success. Pet. 38–39. Specifically, Petitioner asserts that a person of
ordinary skill in the art would have been led to apply the teachings of Fugger
to sperm cells of non-human species, such as bovine, because of the known
commercial benefits of doing so, which included increasing the percentage
of milk-producing offspring, reducing the number of difficult births, and
taking advantage of optimal times for insemination of the female with
genetic attributes of high quality bulls that may be located away from the
female to be inseminated. Id. (citing Ex. 1003 ¶¶ 43, 92, 305).
Patent Owner responds that Fugger teaches away from combining
sorting and freezing processes on non-human sperm samples, by discussing
differences between human and non-human sperm cells. Resp. 31–33.
Patent Owner directs us to this disclosure in Fugger: “Concerns regarding
embryo development in bovine and rabbit species were not observed in our
experience with humans.” Id. at 32 (quoting Ex. 1007, 2369) (citations
omitted). That language does not rise to the level of a teaching away. A
reference does not teach away if it merely expresses a general preference for
an alternative invention from amongst options available to the ordinarily
skilled artisan, and the reference does not discredit or discourage
investigation into the invention claimed. Fulton, 391 F.3d at 1201.
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Patent Owner’s teaching away argument also is unpersuasive for other
reasons. Fugger describes a method of employing flow cytometry to sort
non-human sperm for sex-selection, resulting in the birth of over 400
offspring, all normal, “including three successive generations in swine.”
Ex. 1007, 2367. Fugger points out the problems in using flow cytometry for
human sperm, which were not issues for non-human sperm, such as bovine.
Id. at 2369. From Fugger’s description, using flow cytometry for non-
human sperm, such as bovine, did not present the “unique challenges” of
using that method for human sperm cells. Id. (“Several characteristics
specific to human sperm cells present unique challenges for” flow
cytometric separation “compared with domestic animal spermatozoa.”).
Based on the full trial record, we are persuaded that Fugger does not teach
away from using flow cytometry to sort non-human sperm samples.
Nor does Fugger teach away from freezing sorted non-human sperm
cells. We agree with Patent Owner that the occurrence of “cold shock,”
caused by a sudden change in temperature, was not a concern with human
sperm, but was known to lead to non-viability and cell death in non-human
sperm. Resp. 4, 34–35. We find, however, that it was well within the level
of ordinary skill in the art to protect non-human sperm from the effects of
“cold shock” by controlling the change in temperature during freezing.
Reply 17–18 (citing Ex. 1003 ¶ 74; Ex. 1035, 224:12–20). That finding is
consistent with the disclosure of the ’425 patent, which states that “[s]perm
from any species can be selected and frozen according to the method of the
invention,” including “[h]uman sperm, bovine, equine, porcine, ovine, elk
and bison sperm.” Ex. 1001, 4:1–8. Fugger reports seven pregnancies out
of 27 patients in 33 cycles using frozen human sperm sorted for sex-
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selection. Ex. 1007, 2368. That data establishes that Fugger obtained a
sorted sperm sample having a sufficient number of sperm to fertilize an egg.
Patent Owner’s counterview that “the data set in Fugger was too small to
lead to any conclusions” is unpersuasive. Resp. 35; Reply 19.
Patent Owner raises one other contention—that the evidence cited in
the Petition fails to establish that Fugger’s method establishes an
“insemination sample” within the meaning of claims 25 and 26. Resp. 38–
42. As explained in our analysis of the ground based on Seidel and
Salisbury, see supra, we agree with Patent Owner that the term
“insemination” excludes IVF procedures, including ICSI, in which
fertilization occurs outside the female body. We, therefore, find
unpersuasive Petitioner’s argument that Fugger discloses an “insemination
sample” used for IVF. Pet. 42. On that point, Fugger discloses “[f]rozen
specimens used for IVF or ICSI,” without any mention of frozen samples
used for intrauterine insemination. Ex. 1007, 2368. Petitioner fails to
identify persuasive evidence that Fugger froze the sorted samples that were
used for intrauterine insemination. Reply 19–20. Patent Owner, by contrast,
directs us to evidence that Fugger’s frozen samples were not used for
intrauterine insemination. Resp. 38–39 (and evidence cited therein).
Petitioner fails to carry its burden of proving that Fugger discloses or
suggests a frozen, sorted “insemination sample” as required by claims 25
and 26. Ex. 1001, 34:14–15. Petitioner fails to carry its burden as to claims
25 and 26, but carries its burden of proof as to claims 1–4, 6, 31, and 32.
3. The Ground Based on Fugger and Salisbury
Petitioner challenges claims 7–9, 11–13, 15, 21–24, 27, 28, 33, and 34
as unpatentable under 35 U.S.C. § 103(a) over the combined disclosures of
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Fugger and Salisbury. Pet. 44–59. Petitioner provides detailed explanations
of how each claim limitation is met by the references. Petitioner shows
persuasively that a person of ordinary skill in the art would have recognized
that the method taught in Fugger could be improved when applied to other
animals, using the teachings of Salisbury. And Petitioner provides rational
reasons why the combined disclosures of Fugger and Salisbury would have
led an ordinarily skilled artisan to the subject matter of claims 7–9, 11–13,
15, 21–24, 28, 33, and 34. Pet. 44–59 (and citations to record therein). The
Petition is supported by the declaration of Dr. Pace. Ex. 1003).
Dr. Pace states that
A person of ordinary skill in the art also would have been
motivated to combine Fugger 1998 (which pertains to freezing
human sperm) with Salisbury 1978. There would have been a
strong motivation to freeze separated animal sperm due to the
benefits of both separated and frozen sperm. A person of skill
looking to apply the teachings of Fugger 1998 to other animals
would have recognized that the method taught in Fugger 1998
could be improved when applied to other animals by modifying
that method in modest respects. Such a person would have
turned to references such as Salisbury 1978, one of the most
respected texts in the field of artificial insemination.
Furthermore, in light of the long history of freezing animal
sperm and the numerous reports of successful freezing of
animal sperm, such a person would have expected to be
successful in freezing animal sperm separated by the methods
disclosed in Fugger 1998.
Ex. 1003 ¶ 336 (citation omitted).
We credit Dr. Pace’s testimony, as it is consistent with the teachings
disclosed in the cited references. Although Fugger describes using flow
cytometry for human sperm cells, Fugger also discusses using the process
for non-human sperm cells, and the success in doing so. Ex. 1007, 2367–69.
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We are persuaded that one of ordinary skill in the art would have been led to
look to the teachings of Salisbury, which focus on cattle. Ex. 1006, Title.
Patent Owner disagrees based on arguments made in connection with
the ground based on Fugger alone. Resp. 42–43. Specifically, Patent Owner
argues that “the addition of Salisbury in combination with Fugger does not
alter . . . that Fugger teaches away from extending the Fugger method to
non-human species or attempting to use separated, frozen sperm for artificial
insemination.” Id. at 43. For the reasons stated above in connection with
the ground based on Fugger alone, those arguments are unpersuasive, with
one exception: Petitioner has not carried its burden of showing that
claim 27—which, like claim 25, requires a freezing method that establishes
an “insemination sample”—is unpatentable over Fugger and Salisbury.
Ex. 1001, 34:23. Petitioner carries its burden, however, with respect to
claims 7–9, 11–13, 15, 21–24, 28, 33, and 34
4. Secondary Considerations
Factual inquiries for an obviousness determination include secondary
considerations based on objective evidence of nonobviousness. See
Graham, 383 U.S. at 17–18. The totality of the evidence submitted may
show that the challenged claims would not have been obvious to one of
ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir.
1984). Secondary considerations may include long-felt but unsolved need,
failure of others, unexpected results, commercial success, copying, licensing,
and praise. Graham, 383 U.S. at 17; Transocean Offshore Deepwater
Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349, 1355 (Fed.
Cir. 2012). “[E]vidence rising out of the so-called ‘secondary
considerations’ must always when presented be considered en route to a
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determination of obviousness.” Stratoflex v. Aeroquip Corp., 713 F.2d
1530, 1538 (Fed. Cir. 1983).
Patent Owner presents evidence of secondary considerations, which
we weigh en route to ruling on Petitioner’s obviousness challenges.
Resp. 43–49. Specifically, Patent Owner presents evidence that “leading
scientists” employed by Petitioner’s own parent company “expressed initial
skepticism that a separated sperm sample could be frozen.” Resp. 44 (citing
Ex. 2012); see Ex. 2015 ¶¶ 202–05 (opinion testimony relating to Patent
Owner’s asserted evidence of industry skepticism). Petitioner responds that
the statements advanced by Patent Owner are not shown to relate to the
technique disclosed in the ’425 patent. Reply 21–23. We are persuaded,
however, that Patent Owner’s evidence is not entirely without merit, and we
weigh it against the strength of the evidence supporting a conclusion of
obviousness.
Patent Owner also asserts that an article, which appeared in Beef
Magazine, demonstrates the commercial success of the invention claimed in
the ’425 patent. Resp. 47–49 (citing Ex. 2022). Sales information, in the
absence of evidence as to market share or what sales would normally be
expected in the market, does not support an inference that the sales represent
a substantial share of any definable market, and thus, is insufficient to show
commercial success. Cable Elec. Prod., Inc. v. Genmark, Inc., 770 F.2d
1014, 1027 (Fed. Cir. 1985) (reversed on other grounds). Patent Owner does
not point us to any actual sales data, or evidence that any commercial
success was driven by the claimed invention—as opposed, for example, to
the inventions of other patents controlled by Patent Owner, such as the
break-through flow cytometry method developed by Larry Johnson, and
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intellectual property relating to the revolutionary high speed sorter known as
the MoFlo®, which both are discussed in Seidel. Reply 24–25; Ex. 1005,
2:1–8. Seidel lauds Johnson’s work as “so significant an advancement that it
has for the first time made the commercial separation of” sex-selected sperm
cells “feasible.” Ex. 1005, 2:1–8. Seidel also reveals MoFlo® cell sorters
“have increased sorting speeds extraordinarily and have thus made flow
cytometry a technique which is likely to make feasible the commercial
application of sperm sorting.” Id. at 7:6–9. Patent Owner fails to show that
its asserted evidence of commercial success reflects the merits of the
invention of the ’425 patent, instead of other intellectual property readily
available in the prior art. See, e.g., J.T. Eaton & Co. v. Atl. Paste & Glue
Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997) (“asserted commercial success of
the product must be due to the merits of the claimed invention beyond what
was readily available in the prior art” (emphasis added)).
Patent Owner also alleges that there was a long-felt but unsolved need
for the invention of the ’425 patent. Resp. 45–47. That evidence is
unpersuasive for the same reasons stated above. Petitioner persuasively
argues that any long felt but unsolved need “was solved in the prior art, not
in the ’425 patent, which admittedly relies on prior art techniques to produce
a ‘sufficient number of cells.’” Reply 23–24. We are persuaded that the
actual force behind any evidence of long-felt need relates to Patent Owner’s
control over Larry Johnson’s break-through flow cytometry method for sex-
selecting sperm, and the MoFlo® high speed flow cytometer that
revolutionized the commercialization of such sorting. Id. at 24–25. On this
record, it appears that any long-felt need was solved in the prior art, not the
invention of the challenged claims of the ’425 patent.
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Even affording it some weight, Patent Owner’s evidence of secondary
considerations is insufficient to overcome the strong showing of obviousness
made out by Petitioner in this review. See Süd-Chemie, Inc. v. Multisorb
Techs., Inc., 554 F.3d 1001, 1009 (Fed. Cir. 2009) (“evidence of unexpected
results and other secondary considerations will not necessarily overcome a
strong prima facie showing of obviousness”).

III. CONCLUSION
Taking account of the arguments and evidence presented during trial,
including all evidence of secondary considerations , we determine that
Petitioner establishes by a preponderance of the evidence that claims 1–4, 6–
9, 11–13, 15, 21–28, and 31–34 of the ’425 patent are unpatentable based on
the following grounds of obviousness under 35 U.S.C. § 103(a):
A. Claims 1–4, 6–9, 11–13, 15, 21–28, and 31–34 are unpatentable as
obvious over the combination of Seidel and Salisbury;
B. Claims 1–4, 6, 31, and 32 are unpatentable as obvious over
Fugger; and
C. Claims 7–9, 11–13, 15, 21–24, 28, 33, and 34 are unpatentable as
obvious over the combination of Fugger and Salisbury.

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IV. ORDER
For the foregoing reasons, it is
ORDERED that claims 1–4, 6–9, 11–13, 15, 21–28, and 31–34 of
the ’425 patent are unpatentable; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
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PETITIONER:

Jeffrey P. Kushan
jkushan@sidley.com

Peter S. Choi
Peter.choi@sidley.com

Matthew S. Jorgenson
mjorgenson@sidley.com

PATENT OWNER:

Kirt O’Neill
koneill@akingump.com

Daniel L. Moffett
dmoffett@akingump.com

Andy Rosbrook
arosbrook@akingump.com

Rehan M. Safiullah
rsafiullah@akingump.com

Ruben H. Munoz
rmunoz@akingump.com

Matthew G. Hartman
mhartman@akingump.com