William Maxwell et al.

Patent Trials and Appeals Board

Jul 13, 2021

2021002474 (P.T.A.B. Jul. 13, 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.
11/668,148 01/29/2007 William Maxwell Chisholm Maxwell XY-20 (US-02) 3341
88484 7590 07/13/2021
CR MILES P.C.
405 Mason Court, Suite 119
Fort Collins, CO 80524
EXAMINER
MCNEIL, STEPHANIE A N
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
07/13/2021 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):
crmiles@crmiles.com
patents@stgen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte WILLIAM MAXWELL CHISHOLM MAXWELL,
FIONA KATE HOLLINSHEAD, JUSTINE KELLIE O’BRIEN, and
GARETH EVANS
__________

Appeal 2021-002474
Application 11/668,148
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of processing sperm cells. The Examiner rejected the claims as failing to
comply with the enablement requirement and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

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
(see Appeal Br. 4). We have considered the Specification of January 29,
2007 (“Spec.”); Final Office Action of May 8, 2020 (“Final Act.”); Appeal
Brief of Nov. 3, 2020 (“Appeal Br.”); and Examiner’s Answer of Dec. 18,
2020 (“Ans.”).
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Statement of the Case
Background
Although the various devices and methods of sperm cell
processing, generally, and the collection, handling, separation,
storage, transportation, usage, fertilization, and insemination of
sperm cells have been improved over the past several years,
significant problems remain with respect to maintaining sperm
quality, such as viability, motility, functionality, and
preservation and stimulation relative to such techniques,
especially with regard to artificial insemination (in vivo) and in
vitro fertilization (IVF) procedures.
(Spec. 1:26–31). It has “been traditionally understood that processing steps
such as preservation, specifically cryopreservation, and sorting might be too
damaging to the sperm cells” (id. at 3:12–14). The Specification states that
results from traditional sperm cell processing procedures may teach “away
from subsequent processing steps such as sorting and cryopreservation, or
processing steps incorporating multiple cryopreservation steps” (id. at 3:21–
23).
The Claims
Claims 1, 4, 10–15, 30, 31, 34, 35, 38–40, 42, 44, and 46–56 are on
appeal. Claim 1 is an independent claim, is representative and reads as
follows:
1. A method of processing sperm cells, comprising:
obtaining once-cryopreserved sperm cells of a nonhuman
mammal;
thawing said once-cryopreserved sperm cells;
sorting said once-cryopreserved sperm cells subsequent
to thawing to yield an X-chromosome bearing sperm cell
population or a Y-chromosome chromosome bearing sperm cell
population; and

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cryopreserving said X-chromosome bearing sperm cell
population or said Y-chromosome bearing sperm cell
population to yield twice-cryopreserved sorted sperm cell
populations effective upon thawing of fertilizing an egg which
develops into a blastocyst of said nonhuman mammal.

The Rejections
A. The Examiner rejected claims 1, 4, 10–15, 30, 31, 34, 35, 38–40, 42,
44, and 46–55 under 35 U.S.C. § 112, first paragraph, scope of enablement
(Final Act. 2–6).
B. The Examiner rejected claims 1, 4, 10–15, 30, 31, 34, 35, 38–40, 42,
47, and 50–53 under 35 U.S.C. § 103(a) as obvious over Schenk2 and Colas3
(Final Act. 10–12).
C. The Examiner rejected claims 44 and 46 under 35 U.S.C. § 103(a) as
obvious over Schenk, Colas, and Prieto4 (Final Act. 12–13).
D. The Examiner rejected claims 48, 49, 54, and 55 under 35 U.S.C.
§ 103(a) as obvious over Schenk, Colas, and Dalimata5 (Final Act. 13–14).
E. The Examiner rejected claim 56 under 35 U.S.C. § 103(a) as obvious
over Schenk, Colas, Dalimata, and Valcárcel6 (Final Act. 14–15).

2 Schenk et al., Cryopreservation of Flow-Sorted Bovine Spermatozoa, 52
Theriogenology 1375–91 (1999).
3 Colas, G., US 3,973,003, issued Aug. 3, 1976.
4 Prieto et al., US 6,204,431 B1, issued Mar. 20, 2001.
5 Dalimata et al., Cryopreservation of Rabbit Spermatozoa Using Acetamide
in Combination with Trehalose and Methyl Cellulose, 48 Theriogenology
831–41 (1997).
6 Valcárcel et al., Comparison between Sephadex G-10 and Percoll for
Preparation of Normospermic, Asthenospermic and Frozen/Thawed Ram
Semen, 41 Anim. Reprod. Sci. 215–24 (1996).
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A. 35 U.S.C. § 112, first paragraph, scope of enablement
The Examiner finds that the full scope of claim 1 is not enabled by the
Specification, which only enables a “method of processing sperm cells that
results in sperm capable of yielding blastocysts wherein the method employs
a particular set of cryopreservatives and a particular freezing and thawing
process, i.e. one that uses a particular density gradient with other specific
conditions as is the case with claim 56” (Final Act. 2–3). The Examiner
finds the Specification “does not reasonably provide enablement for any
method in which sperm are frozen and thawed twice using any other
freezing and thawing protocol, thereby yielding sperm capable of yielding
any number of blastocysts” (id. at 3).
Appellant contends
the term “cryopreserved” does not imply that sperm can be
frozen by any means. Rather, the specification and the common
definition of cryopreserved is “to maintain the viability of cells
by storing them at very low temperatures.” The known art
recognized that . . . standard modes of “cryopreservation”
preserve[] the viability of sperm cells.
(Appeal Br. 38). Appellant contends the “specification coupled with what
was well known in the art at the time of the invention describes alternatives
to the method of Hollinshead and alternative freezing conditions known in
the art” (id. at 41). Appellant concludes “a person of ordinary skill in the art
(which Examiner concedes is high) could practice the full breadth of the
invention of Claim 1 without undue experimentation” (id. at 47).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that the
Specification does not enable the full scope of the claimed invention?
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Findings of Fact
Breadth of Claims
1. The Examiner finds:
Claim 1 is broadly drawn to a method comprising
obtaining sperm that have been cryopreserved by any means;
thawing them in any way; sorting them according to their
containing an X- or Y-chromosome; and re-cryopreserving
them by any means. Claim 1 requires that once the sperm cells
are thawed in some unspecified manner, they are effective of
developing a blastocyst[] after they fertilize an egg.
(Final Act. 3).
Presence of Working Examples
2. The Specification teaches, in one example, that “[f]rozen semen
from 2 rams . . . was used throughout. Post-thaw sperm treatments
comprised (i) unsorted (Control); (ii) sorted (Frozen-Sort) and (iii) sorted
then re-frozen (Frozen-Sort-Frozen). X and Y sperm were separated using a
high-speed sorter” (Spec. 16:14–17). The Specification teaches that
“[b]lastocyst development rate was higher for oocytes fertilized with Froz-
Sort-Froz than with Control sperm. These results demonstrate that frozen-
thawed ram sperm can be sex-sorted for either immediate or future use in an
IVF system after re-cryopreservation” (Spec. 17:7–10).
3. The Specification does not provide the specific conditions for
cryopreservation used for either the first or second freezing or thawing event
in the example (see Spec. 16:4 to 17:21).
4. The Specification’s remaining examples do not use twice-
cryopreserved sperm as required by claim 1 (see Spec. 14:1 to 15:10 and
17:22 to 19:15).
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Amount of Direction or Guidance Presented
5. The Specification teaches , as to sorting sperm, a
processing technique, 200μl of thawed spermatozoa was placed
onto a 2ml separation gradient (90%:45%) of Puresperm™, a
human preparation, and a Tris based diluent. The gradient
preparations were then centrifuged at 1000g for 15 minutes.
The post-Puresperm™ pellet was removed, slowly diluted 1:4
with warm Tris based diluent and centrifuged at 650g for 3
minutes. The supernatant was removed and the sperm stained,
incubated and sorted.
(Spec. 14:4–9).
6. The Specification generally teaches “[s]perm samples are
cryopreserved, such as by freezing, using various preservation techniques,
such as freezing in a Hepes-buffered crydiluent. Sperm cells may be
provided as pellets or straws and may be thawed using various thawing
techniques” (Spec. 11:16–18).
Relative skill in the art
7. The Examiner and Appellant appear to agree that the skill in the
art is high (see Final Act. 9).
State of the Prior Art and Unpredictability of the Art
8. Seidel7 teaches: “Spermatozoa that have been cryopreserved
and thawed do not tolerate the sexing process well, particularly if they are to
be re-frozen. Since sperm sorting is a slow process relative to the needs for
most applications, keeping spermatozoa healthy between semen collection
and sorting is important” (Seidel 736, col. 1).

7 Seidel et al., Current Status of Sexing Mammalian Spermatozoa, 124
Reprod. 733–43 (2002).
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9. Seidel teaches “stallion spermatozoa are sexed routinely after
storage in appropriate diluents at 5–15ºC for 18 h, resulting in excellent
fertility if spermatozoa are not cryopreserved after sorting” (Seidel 736, col.
1).
10. Underwood8 teaches:
It has long been believed impossible to double-freeze sperm
while maintaining fertilizing ability, particularly with the added
stresses of sex-sorting. This was disproved by the birth of
lambs following embryo transfer (ET) of in vitro produced
embryos derived from sex-sorted, double frozen ram sperm
(Hollinshead et al. 2004a) .[9] Following this was the birth of
lambs after low dose artificial insemination (AI) of sex-sorted,
double frozen ram sperm.
(Underwood 460, col. 2.)
11. Hollinshead teaches “Semen was diluted 1:4
(semen:diluent, v/v) using a zwitterion-buffered diluent containing 13.5%
egg yolk and 6% glycerol (ZWIT) . . . and frozen and thawed using the
pellet method described by Evans & Maxwell (1987)” (Hollinshead 558, col.
1).
12. Hollinshead teaches after sorting, “[s]orted spermatozoa (FS)
were centrifuged at 700 g for 6 min at room temperature (21ºC). Each 50 µl
pellet was slowly re-suspended 1:4 (sperm pellet:diluent, v/v) with either
ZWIT diluent and re-frozen (FSF treatment)” (Hollinshead 559, col. 1).

8 Underwood et al., Development of Procedures for Sex-Sorting Frozen-
Thawed Bovine Spermatozoa, 44 Reprod. Dom. Anim. 460–66 (2009).
9 Hollinshead et al., Birth of Lambs of a Pre-Determined Sex after In Vitro
Production of Embryos Using Frozen–thawed Sex-Sorted and Re-Frozen-
Thawed Ram Spermatozoa, 127 Reprod. 557–68 (2004).
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13. Hollinshead teaches
this study has demonstrated that frozen-thawed samples can be
sex-sorted at high purities and then re-cryopreserved and
successfully used in an IVF system to produce viable embryos.
Assisted reproductive techniques (sperm and embryo
preservation, IVF, ET [embryo transfer]) were successfully
combined with sperm-sexing technology, resulting in the
production of offspring. This significant development will help
overcome limitations imposed by distance of the sperm sorter
from the site of semen collection and ET in both livestock and
wildlife species.
(Hollinshead 567, col. 1.)
14. The Schenk Declaration10 states
it is my opinion that Underwood correctly characterizes the
general wisdom of those of ordinary skill in the art of assisted
reproduction using sex selected sperm at the time of the invention
of Claim 1 and that at the time of the invention it was “believed
impossible to double-freeze sperm while maintaining fertilizing
ability, particularly with the added stresses of sex-sorting”.
(Schenk Decl. ¶ 14.)
15. The Schenk Declaration states
a person of ordinary skill in the art at the time of the invention
would be led away from cryopreserving sorted once
cryopreserved sperm cells to produce sorted twice
cryopreserved sperm cells because it was well understood at the
time of the invention that cryopreservation and sorting each
substantially reduced the fertility of sperm cells and because the
general wisdom was that it would be impossible to double-
freeze sperm while maintaining fertilizing ability, particularly
with the added stresses of sex-sorting.
(Schenk Decl. ¶ 15.)

10 Declaration of John L. Schenk, dated Feb. 2, 2015.
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Principles of Law
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the specification of
the application.
In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993).

Factors to be considered in determining whether a disclosure
would require undue experimentation . . . include (1) the
quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Analysis
In addressing the Wands factors, we find that the balance of factors
does not support the Examiner’s position. The scope of enablement issue
centers on the question of whether different methods of freezing and thawing
cells would operate in the method of first cryopreserving sperm, then
thawing and sorting the sperm, then cryopreserving again, followed by
functional fertilization using the sorted and twice cryopreserved sperm.
There are working examples (FF 2–4) as well as guidance in the
Specification (FF 5–6) in a highly skilled art (FF 7). As to the freezing and
thawing in particular, the Specification teaches that “[s]perm samples are
cryopreserved, such as by freezing, using various preservation techniques,
such as freezing in a Hepes-buffered crydiluent. Sperm cells may be
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provided as pellets or straws and may be thawed using various thawing
techniques” (FF 6). Thus, the Specification contemplates the efficacy of
other prior art known cryopreservation and thawing techniques (FF 6).
While the Examiner did provide post-filing date evidence in
Underwood that the invention was unpredictable prior to the inventive
disclosure of Hollinshead (which paper was co-authored by the current
inventors) (FF 10) as well as some discussion in Seidel that re-frozen sperm
would not “tolerate the sexing process” (FF 8, 9), Hollinshead itself showed
working examples using frozen, sorted and re-frozen sperm (FF 11–13).
Hollinshead also shows prior art freezing and thawing methods were known
such as that of Evans & Maxwell (FF 11).
“Where an applicant asserts that a specification contains enablement
commensurate in scope with the protection sought by the claims, but the
examiner is of the opinion that the disclosure is nonenabling, he has the
burden of substantiating his doubts concerning enablement with reasons or
evidence.” In re Budnick, 537 F.2d 535, 537 (CCPA 1976). In this case, the
weight of the evidence does not show that the claimed method will only, or
even best, operate using the cryopreservation, thawing, or sorting method
recited in the Specification and detailed in Hollinshead. In the absence of
evidence that other cryopreservation, thawing, or sorting methods would
either be non-functional or would be unpredictable in the process of claim 1
or similar processes, we are not persuaded that the rejection meets the
burden necessary to show the claims are not commensurate in scope with
Specification. “It is not necessary that every permutation within a generally
operable invention be effective in order for an inventor to obtain a generic
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claim, provided that the effect is sufficiently demonstrated to characterize a
generic invention.” Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that the Specification does not enable the full scope
of the claimed invention.

B. 35 U.S.C. § 103(a) over Schenk and Colas
The Examiner finds Schenk teaches “a method for sorting and
cryopreserving bull sperm” but does not “specifically teach sorting sperm
that have previously been cryopreserved and thawed” (Final Act. 10–11).
The Examiner finds Colas teaches “a method for preserving ram semen in
liquid nitrogen vapor (Example 1) and further teaches that sperm samples so
preserved can be thawed and used for insemination” (id. at 11). The
Examiner finds an “artisan would have been motivated to sort the unfrozen
sperm of Colas using the method of Schenk for the expected benefit of
increasing the probability that the offspring due to a particular insemination
procedure will have a specific gender” (id.).
Appellant contends “Schenk does not teach or suggest sorting sperm
that have previously been cryopreserved and thawed, nor does any other
prior art reference applied by Examiner individually or in combination with
Schenk teach sorting sperm that have previously been cryopreserved and
thawed” (Appeal Br. 26; emphasis omitted). Appellant contends “it is
unambiguously clear that Examiner is drawing on hindsight knowledge of
the claimed invention where the prior art does not contain or suggest that
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knowledge, and is using the Applicant’s disclosure as a template for its own
reconstruction” (id. at 25).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Schenk and
Colas render obvious a second cryopreservation step after a first
cryopreserved and thawed sperm cell sample was sorted?
Findings of Fact
16. Schenk teaches, as to the obtaining step, that “semen was
collected from bulls on a routine collection schedule” (Schenk 1376).
17. Schenk teaches, as to the sorting step, that:
Stained sperm were maintained at 22 ± 1 °C during sorting. A
two-line argon laser operating at 351 and 364 nm and 150 mW
was used to excite the Hoechst 33342 dye. The flow
cytometer/cell sorter used was an SX MoFlo® operating at 50
psi. A TRIS-based sheath fluid was used, consisting of TRIS
(hydroxymethyl) aminomethane (tris; 197.0 mM), citric acid
monohydrate (55.4 mM) and fructose (47.5 mM).
(Schenk 1376, footnotes omitted).
18. Schenk teaches “spermatozoa pass through the flow cytometer
under standard operating conditions with the exception that all droplets
containing viable sperm are collected into a single tube instead of two tubes
containing X- and Y-bearing populations” (Schenk 1377).
19. Schenk teaches, as to a cryopreservation step, that:
Following incubation at 22°C for 1 to 3 h to simulate actual
sorting batches, sperm were cooled to 5°C over 70 min, then the
contents of the 2 tubes were pooled and transferred to a
refrigerated, swinging-bucket centrifuge at 5°C and centrifuged
at 850 x g for 20 min. . . . Sperm within individual bulls were
pooled and diluted immediately with an equal volume of TRIS-
B fraction (20% egg yolk-TRIS containing 12% [v/v] glycerol),
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which was added as 2 equal volumes at 15-min intervals. Final
concentration was 20 x 106 sperm/ml, and 6% glycerol (v/v).
Extended sperm then were packaged into .25-ml
polyvinylchloride straws to be frozen by routine procedures on
racks in static liquid nitrogen vapor.
(Schenk 1377).
20. Schenk teaches, as to effective fertilization, “[p]rocedures
developed to date result in reasonable pregnancy rates for sorted, frozen
sperm artificially inseminated into heifers” (Schenk 1389).
21. Colas teaches, as to the obtaining step, that “1.5 ml of ram
semen from a ram of the ‘Ile de France’ breed was collected” (Colas 5:16–
17).
22. Colas teaches, as to the cryopreservation step, that “the diluted
semen was conditioned in straws of 0.45 ml useful volume and freezing was
performed under the usual conditions in liquid nitrogen vapor” (Colas 5:29–
32).
23. Colas teaches, as to effective fertilization, that: “Ewes of the
‘Ile de France’ breed were artificially inseminated . . . with semen preserved
by freezing . . . . A lambing rate of 60% was obtained” (Colas 5:50–58).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
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Analysis
We agree with Appellant that neither Schenk nor Colas provide any
reason for using two separate cryopreservation steps separated by an
intermediate sorting of thawed semen for either an X-chromosome bearing
sperm cell population or a Y-chromosome chromosome bearing sperm cell
population as required by claim 1. In particular, the issue here is not
whether, if the two cryopreservation steps and intermediate sorting step were
performed, they would succeed, but rather whether the ordinary artisan
would have performed these steps in the first place.
We note that the evidence cited in the scope of enablement rejection
would reasonably discourage the artisan from freezing before sorting and
then refreezing because at the time of filing the art stated “[i]t has long been
believed impossible to double-freeze sperm while maintaining fertilizing
ability, particularly with the added stresses of sex-sorting” (FF 10). Indeed,
Seidel suggests that even cryopreserving after sorting will not function (FF
9).
We are therefore not persuaded by the Examiner’s scientific reasoning
that the advantages identified by the Specification such as time flexibility
would have necessarily been in the mind of the ordinary artisan when
considering the combination of Schenk and Colas. And while it would have
been obvious, despite Seidel’s teaching, to sort unfrozen sperm such as that
of Colas prior to a first freezing step because Schenk actually performs that
method (see Final Act. 12; FF 16–20), that does not provide a reason to sort
sperm that have previously been frozen and then freeze again as required by
claim 1. This rejection relies on hindsight. “We must still be careful not to
allow hindsight reconstruction of references to reach the claimed invention
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without any explanation as to how or why the references would be combined
to produce the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512
F.3d 1363, 1374 n.3 (Fed. Cir. 2008).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that Schenk and Colas render obvious a second
cryopreservation step after a first cryopreserved and thawed sperm cell
sample was sorted.

C.–E. 35 U.S.C. § 103(a)
Having reversed the obviousness rejection of claim 1 over Schenk and
Colas for the reasons given above, we also find that the further combinations
do not provide reasons or motivation for a second cryopreservation step. We
therefore reverse these rejections for the same reasons as given above.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 4, 10–
15, 30, 31,
34, 35,
38–40, 42,
44, 46–55
112 Enablement 1, 4, 10–
15, 30, 31,
34, 35, 38–
40, 42, 44,
46–55
1, 4, 10–
15, 30, 31,
34, 35,
103(a) Schenk, Colas 1, 4, 10–
15, 30, 31,
34, 35, 38–
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Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
38–40, 42,
47, 50–53
40, 42, 47,
50–53
44, 46 103(a) Schenk, Colas, Prieto 44, 46
48, 49, 54,
55
103(a) Schenk, Colas, Dalimata 48, 49, 54,
55
56 103(a) Schenk, Colas, Dalimata,
Valcárcel
56
Overall
Outcome
1, 4, 10–
15, 30, 31,
34, 35, 38–
40, 42, 44,
46–56

REVERSED