Kenneth Evans et al.

Patent Trials and Appeals Board

May 11, 2021

2020005039 (P.T.A.B. May. 11, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/546,757 07/11/2012 Kenneth M. Evans XY-17 (US-03) 1022
114661 7590 05/11/2021
XY, LLC
22575 State Highway 6 South
Navasota, TX 77868
EXAMINER
GOUGH, TIFFANY MAUREEN
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
05/11/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents@stgen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENNETH M. EVANS and THOMAS B. GILLIGAN1
Appeal 2020-005039
Application 13/546,757
Technology Center 1600
Before JOHN G. NEW, JOHN E. SCHNEIDER, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of enriching sperm cells for a desired sex. The Examiner rejected
the claims as obvious over the prior art. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as XY, LLC.
Appeal Br. 3.
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CLAIMED SUBJECT MATTER
Claims 232–244, 263, and 267 are on appeal. Final Act. 2. Claim
232, the only independent claim, reads as follows:
232. A method of enriching sperm cells for a desired sex
comprising:
producing a stream including stained sperm cells and sheath
fluid, the sperm cells being stained with a DNA binding dye;
exciting individual stained sperm cells within the stream with
multiple pulses of a pulsed laser that produces a laser beam
having a wavelength between about 350 nm and 360 nm and an
average power greater than l00mW;
detecting an amount of emitted fluorescence from each of said
individual stained sperm cells;
identifying X chromosome bearing sperm and/or Y
chromosome bearing sperm based on the emitted fluorescence
in response to the pulsed laser; and
collecting a viable population of X chromosome bearing sperm
and/or Y chromosome bearing sperm.
Appeal Br. 38 (Claims Appendix).
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REFERENCES
The Examiner relied upon the following prior art references:
Name Reference Date
Lakowicz US 5,504,337 April 2, 1996
Durack US 2005/0112541 A1 March 28, 2003
Ortyn US 2002/0030812 A1 March 14, 2002
Piper WO 92/08120 A1 May 14, 1992
Andrew Held & Arnd Krueger, Quasi-CW Solid-State Lasers Expand
Their Reach, Photonics Spectra, Dec. 2002, available at
https://www.photonics.com/Articles/Quasi-CW_Solid_State_Lasers_
Expand_Their_Reach/p5/vo16/i88/a14378 (“Held”)
Spectra-Physics, Inc. brochure and specification sheet for Vanguard 350-
HMD 355 laser (2003) (“Spectra-Physics”)
REJECTION
Claims Rejected 35 U.S.C. § Reference(s)/Basis
232–244, 263, 267 103(a) Durack, Ortyn,
Lakowicz, Piper, Held,
Spectra-Physics
OPINION
Appellant focuses its arguments on independent claim 232 and
dependent claims 239, 240, 242, and 243. See generally Appeal Br. We
select independent claim 232 as representative of claims 232–238, 241, 244,
263, and 267, and, like Appellant, separately address dependent claims 239,
240, 242, and 243. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 232
In brief, the Examiner finds that Durack teaches a method for sorting
and collecting viable sperm cells using a flow cytometry system that
comprises the steps recited in claim 232. Final Act. 3–4. The Examiner also
finds that at the time of the claimed invention, the use of pulsed lasers in
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flow cytometry and to differentiate sex chromosomes was known (as
demonstrated by, e.g., Ortyn, Piper, Lakowicz, and Held), and that in view
of their known advantages over continuous wave (“CW”) lasers, a person of
ordinary skill in the art would have been motivated to use a pulsed laser
meeting the claimed parameters in Durack’s flow cytometry method. Id. at
5–7; Ans. 3–7. We adopt the Examiner’s findings, and agree that the
appealed claims would have been obvious over the cited prior art for the
reasons explained by the Examiner. See Final Act. 3–7; Ans. 3–7. We
address Appellant’s arguments below.
Appellant argues that Durack fails to disclose use of a pulsed laser
before the priority date of the appealed claims.2 Appeal Br. 9. Appellant
also argues that the “cited secondary references . . . each fail[] to teach or
suggest any application for producing viable [sperm] populations.” Id. at 12.
These arguments are not persuasive, because they ignore the combination of
teachings cited by the Examiner. “[O]ne cannot show non-obviousness by
attacking references individually where, as here, the rejections are based on
combinations of references.” In re Keller, 642 F.2d 413, 426 (CCPA 1981).
It is not necessary for Durack to disclose use of a pulsed laser, because the

2 Although Durack discloses use of a pulsed laser (see Durack ¶¶ 350–357),
Appellant argues that “Durack neither discloses nor implies the use of a
pulsed laser prior to the critical date,” because this subject matter is not
disclosed in Durack’s provisional applications (filed March 28, 2003).
Appeal Br. 9–10. The Examiner, however, does not rely on Durack for
disclosure of a pulsed laser, but rather relies on Ortyn, Piper, Lakowicz,
Held, and Spectra-Physics for this teaching. See Final Act. 5–6. We note
that on this record, Appellant does not dispute that Durack qualifies as prior
art as of the date of its provisional applications for the subject matter on
which the Examiner relies in Durack.
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Examiner cites Ortyn, Lakowicz, Piper, Held, and Spectra-Physics for this
disclosure. See Final Act. 5–7. Indeed, Appellant concedes that the “cited
secondary references disclose the existence of pulsed lasers.” Appeal Br.
12. Similarly, it is not necessary for Ortyn, Lakowicz, Piper, Held, or
Spectra-Physics to disclose a method of sorting viable sperm, because the
Examiner cites Durack for this disclosure. See Final Act. 3.
Appellant also argues that Durack fails to disclose “exciting
individual stained sperm cells . . . with multiple pulses of a pulsed laser.”
Appeal Br. 11. We are not persuaded by this argument. Rather, we agree
with the Examiner that “exciting individual cells is inherent to flow
cytometry.” Final Act. 8. Although Appellant cites Piper to dispute that
exciting individual cells is “inherent to the use of a pulsed laser” (Appeal
Br. 28, emphasis added), Appellant does not dispute the Examiner’s finding
that “exciting individual cells is inherent to flow cytometry” (Final Act. 8,
second emphasis added).3 Appellant also argues that the Examiner
misapplies inherency by “stating something is inherent in a combination of
references, not in a primary reference or any particular reference for that
matter.” Id. at 28. The Federal Circuit, however, has rejected such an
argument. See, e.g., Persion Pharms. LLC v. Alvogen Malta Operations
Ltd., 945 F.3d 1184, 1191 (Fed. Cir. 2019) (“To the extent Persion contends
that inherency can only satisfy a claim limitation when all other limitations
are taught in a single reference, that position is contrary to our prior

3 Indeed, Mr. Evans acknowledges that “[g]enerally in flow cytometry,
particles or cells are fluidically manipulated into a single file line, more or
less, for passing through an interrogation location at which a source of
electromagnetic radiation is focused.” Declaration of Mike Evans Under 37
C.F.R. § 1.132 (“Evans Decl.”) ¶ 4 (emphasis added).
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recognition that ‘inherency may supply a missing claim limitation in an
obviousness analysis’ where the limitation at issue is ‘the natural result of
the combination of prior art elements.’”) (quoting PAR Pharm., Inc. v. TWI
Pharms., Inc., 773 F.3d 1186, 1194–95 (Fed. Cir. 2014)).
Appellant also argues that the Examiner’s reliance on pulsed lasers
disclosed in the “secondary references” is “divorc[ed] . . . from the context
of the applications for which [the lasers] are actually disclosed.” Appeal Br.
12; see also id. at, e.g., 14 (arguing that “the specific application described
in Ortyn relates to a FISH process, which is not suitable for generating a
population of sorted viable sperm”), 14 (“Lakowicz deploys a laser for a
different purpose and that laser performs a different function as compared to
claim 232.”), 16 (“[T]he stated purpose of the laser in Piper (i.e. time pulses
to illuminate particles one time) is mutually exclusive to the claimed
invention (i.e. multiply irradiating sperm cells).”); 17 (arguing that in Held
and Spectra-Physics, “there is no teaching or suggestion provided anywhere
for applying the disclosed lasers into a sperm sorting application”).
We are not persuaded by Appellant’s arguments, because “[t]he test
for obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference . . . . Rather,
the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d at 425.
Here, the Examiner does not propose to bodily incorporate the specific lasers
and/or systems disclosed in Ortyn, Lakowicz, Piper, Held, or Spectra-
Physics into Durack’s flow cytometry system. Rather, the Examiner relies
on these references to demonstrate that “at the time of the claimed invention,
the use of [a] pulsed laser in flow cytometry systems was known,” and that
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“pulsed lasers offer several advantages over CW lasers.” Final Act. 5, 6.
We agree with the Examiner that the known advantages of pulsed lasers over
CW lasers would have suggested to a person of ordinary skill in the art to
use a pulsed laser in Durack’s method.
Appellant also argues a lack of motivation to combine a pulsed laser
with Durack’s method, and a lack of reasonable expectation of success in
obtaining viable sperm, because “sperm are generally more delicate than
other cells.” Appeal Br. 19, 20 (citing, e.g., Evans Decl. ¶¶ 7, 8, 11, 13–15).
Appellant also argues that the knowledge of dye-laser interaction as a source
of sperm injury would have compounded these concerns. Id. at 21–22
(citing Johnson4; Johnson and Welch5).
Even assuming that sperm heath is affected by external conditions to a
greater extent than other cells (see Evans Decl. ¶¶ 7, 8), and that sperm
injury can be compounded by dye-laser interaction (see id. ¶ 16), Durack (as
well as Johnson and Johnson and Welch) demonstrate that laser illumination
of stained sperm can result in viable sperm cells. On this record, Appellant
has not pointed us to specific factual support for the premise that a person of
ordinary skill in the art would have believed that pulsed lasers would have
negatively affected sperm viability. We acknowledge Johnson’s teaching
that when irradiating sperm, “it is useful to reduce laser power to the

4 L.A. Johnson, Advances in Gender Preselection in Swine, 52 Journal of
Reproduction and Fertility Ltd., 255–266 (1997) (“Johnson”).
5 L.A. Johnson & G.R. Welch, Sex Preselection: High-speed Flow
Cytometric Sorting of X and Y Sperm for Maximum Efficiency, 52
Thereogenology, 1323–1341 (1999) (“Johnson and Welch”). Although
Appellant cites only Johnson as teaching a dye-laser interaction, the quote
that spans pages 21–22 of the Appeal Brief is from Johnson and Welch. See
Johnson and Welch, 1335.
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minimum necessary to obtain resolution between the X and Y peaks.”
Johnson, 260. But in the later-published Johnson and Welch article, the
authors state that despite their assumption that “the lower the laser output
power the less effect upon the fertilization and embryo development,” in an
experiment with swine embryos, they found that lower laser power (25 mW)
was more detrimental to embryo development than higher laser power (125
mW). Johnson and Welch, 1335. Thus, on this record, we are not persuaded
that Johnson and Welch “reflects the understanding of those in the art that
higher laser power is detrimental to sperm health and to subsequent embryo
development” (Appeal Br. 22) sufficient to undercut the Examiner’s findings
on motivation to combine or reasonable expectation of success.
Appellant’s arguments also fail to account for the Examiner’s
finding—undisputed on this record—that “when using a pulsed laser, the
laser is off more than it is on.” Ans. 22. Thus, in view of the reduced time
of exposure, Appellant has not persuasively established that a skilled artisan
would have understood that a higher peak power delivered by a pulsed laser
would necessarily cause more damage to sperm than a laser of lower peak
power but longer exposure time. Indeed, we agree with the Examiner that
“[t]here is nothing of record which would indicate that the technology by
which a pulsed laser power operates, i.e. high peak power for picoseconds at
a time, would be detrimental to sperm.” Id. We further note that “Held
discusses the concern of whether the high peak power would kill or damage
sorted cells and [found] that below 260 mW, the laser has no effect on cell
viability.” Ans. 18; see also Held 4. Although Held does not identify the
type of cell tested, Appellant’s generalized arguments regarding the relative
fragility of sperm cells are not sufficient, on this record, to undercut the
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Examiner’s findings on motivation to combine or reasonable expectation of
success.6
Appellant argues that “literature specific to sorting sperm . . . taught
away from using higher power lasers.” Appeal Br. 21 (citing Evans Decl.
¶ 18). Although Mr. Evans states that “[t]he Johnson Article and the
Johnsons and Welch Article each teach away from the use of high laser
powers in the flow sorting of sperm” (Evans Decl. ¶ 16), we find this
testimony entitled to little weight, because the declarant does not explain
what disclosure in these articles provides the alleged teaching away. See In
re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he
Board is entitled to weigh the declarations and conclude that the lack of
factual corroboration warrants discounting the opinions expressed in the
declarations.”); Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003)
(“It is within the discretion of the trier of fact to give each item of evidence
such weight as it feels appropriate.”). We also agree with the Examiner that
“Johnson teaches using an average power of between 75-125 mW which
does not teach away from [Appellant’s] claimed average power greater than
100mW.” Ans. 21. And as noted above, Johnson and Welch teach that
higher laser power (125 mW) was less detrimental to the fertility of swine
embryos than lower laser power (25 mW). Accordingly, on this record, we
are not persuaded by Appellant’s teaching away argument.

6 We also note that while claim 232 requires a “viable population” of sperm,
it does not require 100% viability. Appeal Br. 38 (Claims Appendix). In
other words, the claimed method permits some loss of sperm viability.
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Unexpected Results
Appellant argues that the “claimed method provides the following
unexpected results i) pulsed lasers may be used at high peak powers to
produce viable populations of sperm and . . . ii) pulsed lasers allow for a
reduction in the amount of dye required for sex sorting sperm.” Appeal Br.
18. In support of (i), Appellant cites the Specification, which states:
“Surprisingly, even though sperm sorted on a high speed flow cytometer
may be damaged by UV light between about 300-500 mW, it is now shown
in this invention that powers between about 100-500 mW may not be
damaging to sperm if they are delivered in pulses.” Id. (citing Spec. 7:31–
8:1, 41:9–32 (Example 2), 44:26–45:14 (Example 7); Evans Decl. ¶¶ 8, 16–
18); see also id. at 19–20 (arguing that the claimed method yields more than
predictable results).
We are not persuaded that Appellant has established that it was
surprising that pulsed lasers may be used to produce viable sperm. Although
the Specification mentions potential damage to sperm caused by UV light
between 300–500 mW (Spec. 7:31–34), Appellant has not pointed us to any
evidence of record demonstrating that laser powers of 300–500 mW result in
non-viable sperm. We acknowledge Johnson’s teaching that “[t]he
percentage of unfertilized eggs decreased from 60% at 200 mW to 25% at
125 mW.” Johnson, 260. While this indicates that a CW laser at 125 mW
resulted in fewer unfertilized eggs compared to a CW laser at 200 mW, we
reiterate that while claim 232 requires a “viable population” of sperm, it
does not require 100% viability. Appeal Br. 38 (Claims Appendix).
Appellant’s evidence and argument does not persuade us that persons of
ordinary skill in the art would have expected a lack of a viable population of
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sperm under the claimed conditions. As such, Appellant has not
persuasively established that obtaining viable sperm based on the claimed
method would have been surprising. See Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1371 (Fed. Cir. 2007) (“[B]y definition, any superior property
must be unexpected to be considered as evidence of non-obviousness.”).
Indeed, inventor Evans states that “those of skill in the art did not know
whether the average power alone would affect sperm viability, or if a pulsed
laser having a low average power, but a high peak power would also be
detrimental to sperm.” Evans Decl. ¶ 17 (emphasis added). The uncertainty
reflected in this statement undercuts a purported expectation of lack of a
viable population of sperm from use of a pulsed laser as claimed.
Additionally, unexpected results “must be shown to be unexpected
compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991). Here, Example 2 of the Specification reports
results only for a pulsed laser; there is no comparison to a prior art CW laser.
See Spec. 41. Example 7 does compare pulsed lasers to a CW laser, but
finds that all lasers “yield[ed] similar numbers of intact viable sperm.” Id. at
45. Thus, Example 7 at best demonstrates the claimed subject matter
achieves comparable performance to the closest prior art, but does not
demonstrate a “superior property or advantage that a person of ordinary skill
in the relevant art would have found surprising or unexpected.” In re Soni,
54 F.3d 746, 750 (Fed. Cir. 1995) (emphasis added).
In support of (ii) (i.e., Appellant’s contention that pulsed lasers
unexpectedly allow for a reduction in the amount of dye required for sex
sorting sperm), Appellant has not identified any evidence of record that
characterizes the purported reduction in stain as unexpected. Only
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Appellant’s brief describes these results as unexpected. However, attorney
argument in a brief cannot take the place of evidence. In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974). Moreover, an appellant must prove a nexus
between the alleged unexpected results and the merits of the claimed
invention. See In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). Here,
claims 232–238, 241–244, 263, and 267 recite “stained sperm cells,” but
lack limitations directed to the amount of stain (whether a “reduced” amount
or otherwise). Claims 239 and 240 recite a “reduced amount of fluorescent
dye,” but neither claim requires that the “reduced amount” be measured with
respect to the amount used with prior art flow cytometry systems (i.e.,
systems using non-pulsed lasers). That is, the Specification indicates at least
two measures for total amount of stain, i.e., (1) the amount to “complete[ly]
attach stain molecules to each binding site of a sperm cell;” and (2) the
“amount[] used with conventional CW laser cell sorting technology.” Spec.
25. Because the claimed “reduced amount” is not necessarily less than the
amount used in prior art methods using a non-pulsed laser, on this record,
Appellant has not established a nexus between the purported unexpected
results and the claimed subject matter.
Claims 239 and 240
Claim 239 depends from claim 232, and further requires the step of
“staining the sperm cells with a DNA binding dye comprising a reduced
amount of fluorescent dye.” Appeal Br. 39. Claim 240 depends from claim
239, and further requires “proving a percentage of stain selected from a
group consisting of between about 90% and about 80%, between about 80%
and about 70%, and between about 70% and about 60% of a maximum
stain.” Id. Appellant argues that these claims “should be found non-obvious
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over the art of record because the asserted combination fails to disclose
staining with a reduced amount of stain and because claimed method
provides unexpected results.” Id. at 24.
We are not persuaded by these arguments. We addressed the alleged
unexpected results above. And contrary to Appellant’s assertion, Durack
does disclose using a reduced amount of stain. See Ans. 5; Durack ¶¶ 380,
184. Although Durack does not teach the specific percentages recited in
claim 240, we agree with the Examiner that “it would have been obvious to
one of ordinary skill in the art at the time of the instant invention to use a
lower percentage of dye to stain the sperm cells in the method and apparatus
taught by Durack,” because Durack teaches that the amount of dye should be
optimized with a view to maintaining sperm viability, and teaches factors
that impact the optimal amount of stain. Ans. 6; Durack ¶ 380 (“[I]t is
desirable to use lower stain concentrations and shorter staining periods to
minimize any harmful impact of the staining process on the sperm.”), ¶ 184
(“The preferred concentration of the DNA selective dye in the staining
mixture is a function of a range of variables which include the permeability
of the cells to the selected dye, the temperature of the staining mixture, the
amount of time allowed for staining to occur, and the degree of enrichment
desired in the subsequent sorting step.”). Thus the Examiner has adequately
established that a person of ordinary skill in the art would have been
motivated to use a reduced amount of stain, with a reasonable expectation of
success of arriving at the claimed reduced amounts.
Appellant argues that “there is no[] teaching or suggestion within
Durack prior to the critical date that the use of a pulsed [laser] permits dye
levels to be dropped in such significant quantities,” and thus Durack teaches
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only “a desired result without a proposed solution.” Appeal Br. 25. We
disagree. As indicated above, Durack teaches reducing dye levels to
maintain sperm viability. Even though Durack does not specifically teach
that use of a pulsed laser permits a reduction in dye, as noted above, it does
teach other factors that permit a reduction in dye. See Durack ¶ 380. To
render an invention obvious, the prior art does not have to address the same
problem addressed by a patent applicant. See KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 419 (2007) (“In determining whether the subject matter of a
patent claim is obvious, neither the particular motivation nor the avowed
purpose of the patentee controls. What matters is the objective reach of the
claim. If the claim extends to what is obvious, it is invalid under § 103.”).
Durack provides motivation to reduce dye and teaches a range of factors that
impact the amount of dye used. This is sufficient to render Appellant’s
claims to a “reduced amount of dye” obvious.
Claims 242 and 243
Claims 242 and 243 depend directly or indirectly from claim 232, and
further require the step of “utilizing at least one shared resource to sort the
sperm.” Appeal Br. 40. Appellant argues that “[u]nexpectedly, the high
peak power provided by the pulsed laser demonstrates an excellent synergy
in a shared resource system.” Id. at 24. We are not persuaded by this
argument because the purported unexpected results are supported by
attorney argument only, without citation to any evidence of record. In re
Pearson, 494 F.2d at 1405.
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CONCLUSION
We affirm the rejection of claims 232–244, 263, and 267 under 35
U.S.C. § 103 as unpatentable over Durack, Ortyn, Lakowicz, Piper, Held,
and Spectra-Physics.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
232–244,
263, 267
103(a) Durack, Ortyn,
Lakowicz, Piper,
Held, Spectra-
Physics
232–244,
263, 267

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED