Ex Parte 7963906 et al

Patent Trial and Appeal Board

Nov 30, 2017

95001785 (P.T.A.B. Nov. 30, 2017)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/001,785 10/14/2011 7963906 STAN-694REX 5611
77974 7590 12/01/2017
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
12/01/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

UNISENSE FERTILITECH A/S
Respondent and Requester

v.

Patent of THE BOARD OF TRUSTEES
OF THE LELAND STANFORD JUNIOR UNIVERSITY
Patent Owner and Appellant
____________

Appeal 2017-007658
Reexamination Control 95/001,785
Patent 7,963,906 B2
Technology Center 3900
____________

Before, CHUNG K. PAK, RICHARD M. LEBOVITZ, and
RAE LYNN P. GUEST, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION UNDER 37 C.F.R. § 41.77(f)
This is a final decision under 37 C.F.R. § 41.77(f).
A decision in the appeal by Patent Owner from the Examiner’s Action
Closing Prosecution and Right of Notice of Appeal (“RAN”) in above-
identified inter partes reexamination was entered September 29, 2015 by the
Patent Trial and Appeal Board (“Decision on Appeal” or “DOA”). In the
Decision on Appeal, the Examiner’s rejections of all the pending claims
were affirmed but were designated new grounds of rejection under 37 C.F.R.
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§ 41.77(b) because the reasoning in the decision differed from the
Examiner’s. DOA 20.
Patent Owner requested reopening of prosecution pursuant to §
41.77(b)(1) and proposed amendments to the claims. Request to Reopen
Prosecution, filed October 29, 2015. The amendments were entered. Orders
Remanding to the Examiner (mailed August 1, 2016 and August 4, 2016).
Upon remand to the Examiner, the Examiner made a determination under §
41.77(d) (“41.77d Determination”) that the claims as amended remained
unpatentable under the rejections set forth in the DOA. 41.77d
Determination 10. Patent Owner filed a response to the determination under
§ 41.77(e) (PO 41.77e Comments). Subsequently, Requester also filed
comments under § 41.77(e) (Req. 41.77e Comments).
As explained in more detailed below, we agree with Examiner
determination and enter a final decision under § 41.77(f).

REJECTIONS
The claims remain rejected as follows (41.77d Determination 10):
1. Claims 1, 3-5, 9, 12, 16-19, 21-23, 27, 30, 34-36, 67, 69-71, 75, 78
and 82-84 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Lemmen.
2. Claim 1-5, 9, 12, 13, 15, 16, 19-23, 27, 30-31, 33, 34, 67-71, 75,
78, 79, 81 and 82 under pre-AIA 35 U.S.C. § 102(a) as anticipated by Mio
(2008).
3. Claims 10, 11, 28, 29, 43, 44, 58, 59 and 76-77 under pre-AIA 35
U.S.C. § 103(a) as obvious in view of Mio (2008) and Trounson.
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4. Claims 10, 11, 28, 29, 43, 44, 58, 59 and 76-77 under pre-AIA 35
U.S.C. § 103(a) as obvious in view of Lemmen, Ramsing (2007), Meng
(2009) and Trounson.
5. Claims 13, 31 and 79 under pre-AIA 35 U.S.C. § 103(a) as obvious
in view of Lemmen, Ramsing (2007), Meng (2009) and Mio (2008).
6. Claims 13, 31, 46, 61 and 79 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Lemmen and Robertson.

CLAIMS
Patent Owner did not argue the claims separately. As a consequence,
all the claims stand or fall together.
Claim 1, which is representative of the appealed subject matter, is
reproduced below (underling and brackets indicate amendments relative to
the original claim):
1. A method for [assessing the potential for] identifying good
or poor developmental competence of a human embryo
comprising:
1) measuring cellular parameters of a human embryo in
vitro, wherein said cellular parameters include:
(a) the duration of the first cytokinesis;
(b) the time interval between cytokinesis 1 and
cytokinesis 2; or
(c) the time interval between cytokinesis 2 and
cytokinesis 3, and
2) determining that the human embryo has [greater
potential for] said good developmental competence [when] if,
(a') the duration of the first cytokinesis is [about] 0 to
[about] 30 minutes;
(b') the time interval between the resolution of
cytokinesis 1 and the onset of cytokinesis 2 is [about] 8–15
hours; or
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(c') the time interval between the onset of cytokinesis 2
and the onset of cytokinesis 3 is [about] 0-5 hours;
thereby identifying said good or poor developmental
competence of the human embryo; and implanting the embryo
determined to have said good developmental competence in
step 2) into a female recipient.

CLAIM INTERPRETATION
Claim 1 has three steps: 1) measuring one of three specific cellular
parameters of a human embryo; 2) determining that the embryo has “good
developmental competence” when a specific parameter a’, b’, or c’ is met;
and 3) implanting the embryo determined to have said good developmental
competence.
As discussed in the Decision on Appeal, the 2) “determining” step
does not require anything more than mental recognition that an embryo
satisfies one of three recited parameters a’, b’, or c’. While step 3) requires
implantation of an embryo determined by the 2) “determining” step to have
good developmental potential, this requirement does not necessarily change
the way in which the method is carried out. If the prior art discloses an
embryo in which 1) a cellular parameter has been measured and then which
is 3) implanted into a female recipient, and such embryo can be shown to
meet one of the three recited parameters of step 2), then all the limitations of
the claim are met because the mere recognition that an implanted embryo
displayed one of the recited cellular parameters a’, b’, or c’ does not impart
patentability to an otherwise known method. It is well established that
merely recognizing something that was not known before, i.e., that the
parameters of step 2) are indicative of good developmental potential, is
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insufficient to render an old process again patentable. In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002). See also In re
Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); In re Omeprazole Patent Litig.,
483 F.3d 1364, 1373 (Fed. Cir. 2007).

ANTICIPATION BY LEMMEN
Findings of Fact
The following findings of fact disclosed in Lemmen are pertinent to
the anticipation determination:
L1.
In the present study, fertilized two-pronuclei (2PN) zygotes
were placed in the time-lapse system on the morning of day 1
and a picture was taken every fifth minute until 8.00 on day 2.
A number of events such as appearance and disappearance of
pronuclei or nuclei and time and synchronization of cell
cleavage were logged as time points after fertilization. The
average times for these events and the synchrony of them in
different blastomeres were calculated.
Lemmen 385.
L2.
After finishing recording, the following episodes/time points
were registered: disappearance of pronuclei, first cleavage,
appearance of nuclei in each of the two blastomeres,
disappearance of nuclei in each of the two blastomeres, second
cleavage of each of the two blastomeres and re-appearance of
nuclei in the blastomeres.
Id., 386.
L3.
In total, time-lapse recordings were made for 102 2PN oocytes,
of which 63 were fertilized with regular IVF and 39 were
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fertilized with ICSI. On day 2 after oocyte retrieval, 4% of the
2PN oocytes had not cleaved, 26% had developed into a 2-cell
embryo, 12% into a 3-cell embryo, 52% into a 4-cell embryo
and 6% into a ≥ 5-cell embryo.
Id.
L4.
Overall, 82% of the fertilized oocytes developed as embryos
with a quality sufficient for transfer or cryopreservation. . . . In
total, 29 embryos with time-lapse recording were transferred in
22 single-embryo transfer cycles resulting in six pregnancies
and seven double-embryo transfer cycles resulting in two
pregnancies. Of these, 19 single-embryo transfers were
performed with 4-cell embryos, allowing a more detailed
analysis. Also 2-, 3- and 5-cell embryos were transferred but
these groups were too small for individual analysis.
Id.
L5.
A subgroup of 19 single-embryo transfers using 4-cell embryos
after time-lapse recording resulted in six pregnancies.
Id., 387.
L6. Figure 1 shows the time in hours at which the first cleavage (“1.
Cleavage”) and second cleavage (“2. Cleavage”) occurred:
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` The time differences between the cleavages can be calculated as
follows: 1) 39.5-30.2= 9.3 hours; 2) 39.8-26.7= 13.1 hours; 3) 38.6-26.6=
12 hours.
L7. Figure 3 of Lemmen shows that “the duration of the 2- cell stage,
i.e., the time interval between the resolution of cytokinesis 1 and the
resolution of cytokinesis 2 was 13 h and 10.5 h for IVF and ICSI embryos,
respectively (see page 389, Figure 3).” RAN 37.
L8.
In addition, the four-cell embryos that implant may have a
shorter time difference between the second cleavages of the
blastomeres and thus have a higher degree of synchrony.
Lemmen 390.
Discussion
Lemmen describes both 1) measuring cellular parameters in a human
embryo (L1–L3) and 3) implanting the human embryo into a female
recipient (L4, L5) as required by claim 1.
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With regard to step 2), as found by the Examiner, Lemmen shows that
duration of the 2-cell stage is 13 hours and 10.5 hours, corresponding to the
recited “(b') the time interval between the resolution of cytokinesis 1 and the
onset of cytokinesis 2 is 8–15 hours” of step 2 of claim 1 (L7). Lemmen
also shows that the time between the first and second cleavages is 9.3 hours,
13.1 hours, and 12 hours (L6), which correspond approximately to “(b')” (8–
15 hours) of step 2 of claim 1 (L6; see DOA 5 (reproduced Fig. 5), 8–9).
Thus, Lemmen discloses that embryos measured by time-lapse recording
(L1, L2), met (b') of claim 1.
The four-cell embryos that implanted were also described by Lemmen
as “hav[ing] a shorter time difference between the second cleavages of the
blastomeres… and thus have a higher degree of synchrony” (L8), reasonably
meeting the time interval of 0–5 hours between cytokinesis 2 and cytokinesis
3 as in (c') of claim 1. RAN 37.
Lemmen teaches that four-cell embryos measured by time-recording
were implanted (L4, L5) as required by claim 1.
Based on these disclosures, the Examiner found Lemmen teaches
implanting embryos with good developmental competence as also required
by the claim. As discussed in the Decision on Appeal 20–24, while Lemmen
did not necessarily recognize that the implanted four-cell embryo’s had
“good developmental competence” as recited in the “determining” step,
recognition is unnecessary because it is tantamount to merely appreciating a
step that was carried out in Lemmen (namely, implanting embryos meeting
at least (b') of step 2 of claim 1 and thus which have good developmental
competence). It is well-established that merely recognizing a result of a step
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that had been carried out in the prior art is insufficient to distinguish the
claimed subject matter from that the prior art. DOA 21. Thus, Patent
Owner’s contention that the prior art “must disclose use of the claimed
parameters in the way that is claimed, as it is the appreciation of the
measured parameters that allows the determination” (PO 41.77e Comments
3) is inconsistent with the relevant case law as it pertains to 35 U.S.C. § 102.
See Decision 21-24.
Patent Owner contends that Lemmen found no differences in the
timing of early cleavage and timing of second cleavage between implanted
and non-implanted 4-cell embryos transferred and thus would have
“discourage[d] the person skilled in the art from pursuing the claimed
parameters in order to arrive at the claimed invention.” PO 41.77e
Comments 9. See also id. 10–11.
This argument does not persuade us that the Examiner erred in finding
Lemmen anticipatory. First, the parameter b in claim 1, said to be indicative
of “good developmental competence,” is “the time interval between the
resolution of cytokinesis 1 and the onset of cytokinesis 2,” not the time at
which each developmental event occurred individually. Patent Owner did
not address the fact that parameter b is expressly disclosed in Lemmen. See
L6, L7. In addition, Patent Owner also did not address Lemmen’s
suggestion of the possible significance of “the time interval between the
onset of cytokinesis 2 and the onset of cytokinesis 3” (L8) as in parameter c
of claim 1. Nonetheless, as already discussed, the issue is not whether
Lemmen had recognized parameters b or c as indicative of good
developmental competence, but whether Lemmen had implanted embryos
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with one of these characteristics. The evidence supports the finding that
embryo’s with such characteristics had been implanted by Lemmen.
Patent Owner contends that the Board erred in finding that the
implanted embryos inherently exhibited b’ or a’ of claim 1 because of the 29
embryo’s implanted only 8 resulted in successful pregnancy and that there is
“no way of knowing whether or not any of the embryos that were transferred
in Lemmen ‘inherently displayed’ even a single time parameter.” PO 41.77e
Comments 10. Patent Owner also contends that there is also no way of
knowing if any of the successful pregnancies resulted from a 4-cell embryo.
Patent Owner Request to Reopen Prosecution 16. Patent Owner considered
this significant because “the transfer of a 2- cell embryo could not be
cultured long enough to measure either parameters (b) or (c), since these
require cleavage from the 2-cell stage to the 3 cell stage and the 3-cell stage
to the 4-cell stage, respectively.” Id.
To begin, the claims do not require that a successful pregnancy
resulted from transfer of an embryo into a host. Patent Owner did not
explain why significance was placed on achievement of pregnancy;
however, for the sake of argument, we will assume that that because
pregnancy requires implantation and because implantation is a requirement
of the claim, Patent Owner means that a “successful pregnancy” is evidence
that an “implanting” step took place.
While Patent Owner argues that it is possible that only two-cell
embryos implanted (i.e., resulted in pregnancy) (Patent Owner Request to
Reopen Prosecution 16), we note that 19 of the 29 embryos transferred were
4-cell embryos (L4) and Lemmen teaches “[a] subgroup of 19 single-embryo
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transfers using 4-cell embryos after time-lapse recording resulted in six
pregnancies” (L5), indicating that at least six of the 4-cell embryos in fact
implanted and resulted in pregnancy. Thus, there is sufficient evidence to
support the finding that time-lapsed photographed 4-cell embryos were
implanted.
We also are not persuaded by the argument that there is “no way of
knowing” if any of the implanted embryo’s which resulted in pregnancy
displayed parameter b’ or c’ of step 2 of claim 1. PO 41.77e Comments 10.
As discussed above, the evidence is adequate to establish that
parameters b’ and c’ are described by Lemmen as characteristic of the
embryos it measured in the time-lapse photography. Because such
characteristics were discovered by the inventor to indicate good
developmental competency and likelihood of implantation, it is reasonable
that an embryo that resulted in implantation and pregnancy manifested good
developmental competency and the timing of parameters b’ and c’. The
discovery of such characteristic developmental timing, however, is
insufficient to distinguish the claimed method steps from Lemmen when the
method steps are otherwise identical. See case law discussion at DOA 21–
23.
The “determining” step and the “identifying” step of claim 1 is
necessarily met because the good developmental competency embryos (as
evidenced by the pregnancies) were in fact chosen for implantation. The
discovery as manifested in the “determining” step 2) is merely a statement of
the relationship between naturally occurring developmental events and good
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developmental competence, which is at most is a natural law itself, is not
sufficient to patentably distinguish the otherwise known method.
Based on the express teachings in Lemmen that embryos exhibit at
least b’ of claim 1 (L6, L7), the Examiner had a reasonable basis for finding
that the time-lapsed photographed and implanted embryos of Lemmen
would have experienced the same developmental timing. As held in In re
Best, 562 F.2d 1252, 1255 (CCPA 1977):
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . .
Whether the rejection is based on “inherency” under 35 U.S.C.
§ 102, on “prima facie obviousness” under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO’s inability to manufacture
products or to obtain and compare prior art products.
Thus, once “the PTO shows sound basis for believing that the
products of the applicant and the prior art are the same, the applicant has the
burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990). Having satisfied this burden by showing that b’ is a
characteristic of the embryos recorded by the time-lapse photography (L6
and L7), and thus logically characteristic of the photographed embryos that
were implanted, the burden shifted to Patent Owner to show that the
implanted embryos did not have the characteristics recited in the claim.
Patent Owner did not provide evidence to the contrary, but merely makes
attorney argument that they do not.
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Patent Owner’s argument that there is only a probability that the
implanted embryos met the claimed properties (PO 41.77e Comments 2–3),
is unpersuasive because Lemmen shows that the embryos met the recited
time parameter of b’ (see Figs 1 and 3 of Lemmon as summarized L6 and
L7) and that time-lapse photographed embryos were implanted (L4 and L5)
providing reasonable basis to believe that all the implanted embryos
exhibited the claimed developmental timing, shifting the burden to Patent
Owner to explain or provide evidence that despite this explicit disclosure,
the embryos did not.
In any event, the express teachings in Lemmen involving the study of
embryos exhibiting at least b’ and c’ of claim 1 for the implanting purposes
implies some determination or study of developmental competence of the
embryos. Otherwise, why would anyone would implant the embryos? See
In re Preda, 401 F.2d 825, 826 (CCPA 1968)

ANTICIPATION BY MIO (2008)
Findings of Fact
The following findings of fact disclosed in Mio (2008) are pertinent to
the anticipation determination:
M1. Mio (2008) utilized time-lapse cinematography (TLC) to study
the developmental changes of early human embryos. Mio (2008) 660.e1.
“Digital images of the culred embryos were acquired for 2-5 days.” Id.
M2.
Using this protocol, we obtained 286 images of oocytes and
embryos . . . Of the embryos that were subsequently thawed and
transferred into recipient uteri (n = 46), 4 healthy infants were
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born after TLC. In addition, there were 5 ongoing pregnancies
(21-35 weeks of gestation) and 1 miscarriage (at 8 weeks of
gestation) after TLC. The clinical pregnancy rate (per embryo
transfer cycle) after TLC was 21.8% (10/46) . . .
Id., 660.e2.
M3. The legend to Figure 4 states that “the first cleavage occurs over
a period of 30 minutes.” Id., 660.e5. Mio (2008) also teaches the “first
cleavage started at 22 hours and 1 minutes and was completed by 22 hours
and 23 minutes,” i.e., 22 minutes. Id., 660.e3.
M4. Mio (2008) reports that the first cleavage commences at 27.3 ±
1.0 and the second cleavage 37.2 ± 1.2 (Id.) or about 10 hours between
cleavages. Id. (Table).
M5.
Just after the completion of the first cleavage, the nuclei
observed in the blastomeres persisted for 12 hours and 44
minutes, with cytoplasmic ruffling. Thereafter, the second
cleavage started, and it was completed by 12 hours and 47
minutes.
Id.
Discussion
The Examiner found that Mio (2008) describes measuring cellular
parameters (M1) and implanting embryos (M2) as required by claim 1,
where the embryos experienced a first cytokinesis within 30 minutes (M3) as
in parameter a’ of claim 1 and an interval between cytokinesis 1 and 2
between 8–15 hours as in parameter b’ (M4, M5). RAN 31. Based on these
findings, the Examiner determined the claims are anticipated by Mio (2008).
Id.
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Patent Owner contends that the embryos captured in the time-lapse
movies by Mio (2008) were not implanted and thus do not meet the last step
of claim 1. PO 41.77e Comments 5. This argument is unpersuasive for the
same reasons discussed under the analysis for Lemmen, namely, that the
disclosure that time-lapsed photographed and implanted embryos exhibited
the recited parameters provides a reasonable basis for believing that all
implanted embryos did. See In re Best. Because the embryos implanted, it
is further reasonable that they have good developmental competence and
experienced the same developmental timing the inventors of the ’908 Patent
assert to have discovered.
Patent Owner also contends it is possible that embryos were
transferred at the 2-cell stage and thus would not have experienced
parameter b or c of claim 1. PO 41.77e Comments 6. This argument does
not persuade us that the Examiner erred in finding the claims anticipated.
Parameter a’ only requires one cell division to a two-cell stage. Thus, even
if only two-cell embryos were transferred and implanted, there is reasonable
basis that such embryos would have experienced developmental timing of
parameter a’ where first cytokinesis is 0-30 minutes (M3).

Conception and diligence to reduction to practice
The rejected claims of the ’906 Patent have a priority date of August
22, 2009. Mio (2008) was published online on September 29, 2008 (PO
Appeal Br. 42), which is less than a year before the ’906 Patent’s earliest
priority date. Thus, Mio (2008) is not a statutory bar to patentability under
pre-AIA 35 U.S.C § 102(b). A declaration under 37 C.F.R. § 1.131 can be
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used by an inventor to antedate a reference that qualifies as prior art under
35 U.S.C. § 102(a) by showing that the inventor made that portion of the
claimed invention that is disclosed in the prior art reference.1 In re Stempel,
241 F.2d 755 (CCPA 1957).
Under 37 C.F.R. § 1.131(a), a publication can be antedated and
eliminated as prior art by establishing “invention of the subject matter of the
rejected claim prior to the effective date of the reference or activity on which
the rejection is based.” Under 37 CFR § 1.131(b), Patent Owner bears the
burden to establish “facts . . . in character and weight, as to establish
reduction to practice prior to the effective date of the reference, or
conception of the invention prior to the effective date of the reference
coupled with due diligence from prior to said date to a subsequent reduction
to practice or to the filing of the application.”
Conception is “the formation, in the mind of the inventor, of a
definite and permanent idea of the complete and operative
invention, as it is thereafter to be applied in practice.”
Mergenthaler v. Scudder, 11 App.D.C. 264, 276 (D.C. Cir.
1897); see Coleman v. Dines, 754 F.2d 353, 359 (Fed. Cir.
1985).
In re Steed, 802 F.3d 1311, 1316 (Fed. Cir. 2015).
Conception is keyed to the claimed invention: “A conception
must encompass all limitations of the claimed invention.” Singh
v. Brake, 317 F.3d 1334, 1340 (Fed. Cir. 2003); see Taurus IP,
LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir.

1 “The applicant need show priority with respect to only so much of the
claimed invention as the references disclose, In re Stempel, 241 F.2d 755,
760, 44 CCPA 820, 826, 113 USPQ 77, 81 (1957), or only so much as to
render the claimed invention obvious. In re Spiller, 500 F.2d 1170, 1177,
182 USPQ 614, 619 (Cust. & Pat.App.1974).” In re Scheiber, 587 F. 2d 59,
62, 199 USPQ 782, CCPA 1978).
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2013); Slip Track Sys., Inc. v. Metal–Lite, Inc., 304 F.3d 1256,
1263 (Fed. Cir. 2002); Brown v. Barbacid, 276 F.3d 1327, 1336
(Fed. Cir. 2002). Conception requires more than “a general goal
or research plan”; it requires a “definite and permanent,”
“specific, settled idea,” namely, the idea defined by the claim at
issue. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d
1223, 1228 (Fed. Cir. 1994); see REG Synthetic Fuels, LLC v.
Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016).
Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, 846 F.3d
1213, 1218 (Fed. Cir. 2017).
Patent Owner provided several documents to establish conception and
diligence to reduction to practice of the claimed invention. PO 41.77e
Comments 6; Declaration of 1.131 (“1.131 Decl.”). Specifically, Patent
Owner provided Exhibit 4, a copy of a presentation prepared and presented
by co-inventor Connie Wong, Ph.D. to co-inventor Renee Reijo-Pera, Ph.D.
Patent Owner states that “Exhibit 4 documents the conception of the use of
these parameters for improvement of in vitro fertilization practice, (page 6),
in order to better select embryos for implantation.” Id., 7. The inventors
further explained:
By the time of this presentation, a number of preliminary
experiments were completed, and Dr. Wong presented the most
recent results regarding long term imaging of approximately 25
human embryos. See Exhibit 4, pages 15-18. Importantly, as
summarized in pages 17-18 of Exhibit 4, by the time of this
presentation, we had measured the timing, duration and quality
of the 1st and 2nd cell divisions and had a concrete idea that
these parameters could predict blastocyst formation, and
consequently, were likely useful in determining and/or
identifying human embryos having good or poor developmental
competence.
1.131 Decl. ¶ 17.
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We have reviewed Exhibit 4, including pages 15–18 cited by the
inventors in their declaration, and agree with the Examiner (41.77d
Determination 6) that there is not sufficient evidence to establish conception
of the claimed invention. To establish conception, the inventors have the
burden of establishing that that they had “a definite and permanent idea of
the complete and operative invention,” including all of its limitations. Steed,
802 F.3d at 1316; Cumberland, 846 F.3d at 1218.
Page 17 of Exhibit 4 discloses that 25 zygotes were imaged and
“Quantified the following parameters: cell size, major vs minor diameters,
zona thickness, timing, duration & quality of 1st & 2nd divisions, daughter
cell size, degree of fragmentation.” Page 18 of Exhibit 4 shows a “Tree
Analysis” with an entry “FirstDivDuration < 8.5.” However, the inventors
did not provide an explanation of how these disclosures established
conception of all the limitations of claim 1, particularly parameters b’ and c’
described in Mio (2008). See re Spiller, 500 F.2d at 1177 (fn. 1). In other
words, the inventors did not provide any adequate explanation why these
disclosures would have rendered the claimed invention obvious, Spiller, 500
F.2d at 1177 or show so much of the claimed invention as the reference
discloses, Stempel, 241 F.2d at 760.
Paragraph 17 of the Declaration asserts that the inventors had a “concrete
idea that these parameters . . . were likely useful in determining and/or
identifying human embryos having good or poor developmental
competence” but fails to provide evidence that the specific parameters a’, b’,
and/or c’ in claim 1 had been conceived. With respect to the value of “8.5,”
the inventors did not explain whether this value is meant to correspond to a’
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of claim and, even if it did, how this single value demonstrates conception of
a duration of 0 to 30 minutes as recited in claim 1.
Consequently, the Examiners conclusion, as follows, is supported by
a preponderance of the evidence:
Exhibit 4 is a general research plan and does not identify
the three claimed specific cellular parameters (the time
intervals) and does not state that these cellular parameters are
used in identifying good developmental competence of a human
embryo. Thus, Exhibit 4 fails to validate conception of the
invention prior to Mio (2008) because it does not identify the
specific parameters identified in the present claims.
41.77d Determination 6.
Patent Owner further provided evidence of experiments prior to Mio
(2008)’s publication and afterwards to establish diligence. The evidence is
presented in Exhibits 5–9. None the exhibits, as found by the Examiner,
establish conception of any of the ranges recited in the limitations of claim 1
prior to the publications of Mio (2008). 41.77d Determination 6.

OBVIOUSNESS REJECTIONS
There are four obviousness rejections (numbered 3–6) that reach the
subject matter of the dependent claims which the Examiner determined were
not described in either Lemmen or Mio (2008). Each rejection is based on
Lemmen or Mio (2008), or both, as the primary references for describing the
claimed method, and secondary publications to reach the specific limitations
in the dependent claims.
For Rejections 3 and 4 which cite Trounson, Patent Owner argued that
“Trounson teaches away from the claimed invention and discourages the
skilled person from arriving at the claimed invention by teaching pre-
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implantation genetic screening to remove embryos having disrupted
chromosome numbers.” 41.77e Comments 11.
This argument is not persuasive. Trounson was cited by the Examiner
for its teaching of using in vitro matured human oocytes as the source of
oocytes used to produce the embryos. RAN 33. While Trounson states that
preimplantation genetic diagnosis can be utilized to remove embryo
aneuploidies (Trounson 71), the publication does not discourage using
additional steps to determine which of the genetically healthy embryos have
the best chance of implantation (good developmental competence), and each
of Lemmen and Mio (2008) provide time-lapse photography “to identify
markers linked to good-quality embryos and implantation.” Lemmon,
Abstract. . Moreover, the claims do not exclude performing genetic
diagnosis, in addition to step 1) of measuring cellular parameters. Patent
Owner has not explained why one or ordinary skill in the art would have
been discouraged from measuring cellular parameters of embryos, which
each of Lemmen and Mio (2008) teach are useful ways of determining
developmental competence, simply because Trounson describes genetic
diagnosis to remove embryo aneuploidies.
Citing a declaration by Ann A. Kiessling, Ph.D. (Kiessling Decl.),
Patent Owner contends that there would have been no reasonable
expectation of success in achieving the claimed invention. 41.77e
Comments 11. Dr. Kiessling states that, based on the cited publications, one
of ordinary skill in the art would have utilized cellular parameters for
measuring developmental competence other than those recited in step 2) of
the claimed method. Kiessling Decl. ¶¶ 51, 57, 66, 68, 101, 102.
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Dr. Kiessling’s testimony is not persuasive because, as explained
above (see Claim Interpretation), the issue is not the obviousness of utilizing
parameters a, b, or c in step 2) in determining embryo developmental
competence because this step involves merely mental recognition which is
insufficient to distinguish the otherwise known steps of 1) and 3) of the
claimed method from Lemmen and Mio (2008).
The remaining obviousness arguments also address the obviousness of
step 2) which, as already discussed, does not patentably distinguish the claim
from the prior art.

SUMMARY
For the reasons discussed above, the Examiner’s Decision in the
Answer and Right of Appeal Notice not to adopt Rejections 2 and 3 is
affirmed.
This 37 C.F.R. § 41.77(f) Decision is final.

TIME PERIOD FOR RESPONSE
In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b).
Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph (d) of this
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section, and for submitting comments under paragraph (c) of this section
may not be extended.
An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141–44 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding “commenced” on or after November
2, 2002 may not be taken “until all parties’ rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See
also Manual of Patent Examining Procedure § 2682 (9th ed., Rev. 07.2015,
Nov. 2015).
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983.

AFFIRMED; 37 C.F.R. § 41.77(f )

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PATENT OWNER:

Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065

THIRD PARTY REQUESTER:

ELIZABETH J. HAANES, PH.D.
THOMPSON COBURN LLP
1909 K STREET, NW SUITE 600
WASHING TON, DC 20006