Ex Parte 7963906 et al

Patent Trial and Appeal Board

Sep 28, 2015

95001785 (P.T.A.B. Sep. 28, 2015)

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-151/05US
197110-2173
5611
58249 7590 09/29/2015
COOLEY LLP
ATTN: Patent Group
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
09/29/2015 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 2015-004831
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 ON APPEAL
This is a decision on the appeal by Patent Owner from the Patent Examiner’s
final rejection of claims 1–91 in the above-identified inter partes reexamination of
United States Patent 7,963,906 B2. The Board’s jurisdiction for this appeal is
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under 35 U.S.C. §§ 6(b), 134, and 315 (pre-AIA). We affirm, but designate the
affirmance as new grounds of rejection.
BACKGROUND
The patent in dispute in this appeal is United States Patent 7,963,906 B2
(“the ’906 patent”) which issued June 21, 2011. The Patent Owner and real party
in interest is The Board of Trustees of the Leland Stanford Junior University.
Appeal Br. 1.
Unisense Fertilitech A/S (“Requester”) requested inter partes reexamination
of the ’906 patent under 35 U.S.C. §§ 311–318 and 37 C.F.R. §§ 1.902–1.997.
Request for Inter Partes Reexamination dated October 14, 2011 (“Request”).
Requester is the Respondent in this proceeding. Oral arguments were heard on
August 7, 2015, a transcript of which will be entered into the record in due course.
The Appeal Brief lists a related district court litigation which is said to be on
Appeal to the Federal Circuit. Appeal Br. 1.
Patent Owner appeals the Examiner’s final rejection of claims 1–91. Claims
1, 19, and 67 are the independent claims, and the remaining claims depend from
them. Claim 1 is representative and reads as follows:
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,
(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.

The ’906 patent teaches that one of the “major challenges” in in vitro
fertilization (“IVF”) “has been to identify the embryos that are most suitable for
transfer and most likely to result in term pregnancy.” ’906 patent, col. 1, ll. 35–38.
The patent describes the use of time-lapse imaging to observe early embryo
development to identify parameters predictive of human embryo viability. Id. at
col. 2, ll. 31–59. For example, Lemmen 2008,
1
cited as prior art in this
reexamination, is said by the ’906 patent to have reported that “synchrony of nuclei
after the first division was found to correlate with pregnancy outcomes.” Id. at col.
2, l. 60 to col. 3, l. 2. The ’906 patent describes three events which the inventors
determined to identify embryos with good developmental potential or competence.
These are: 1) the duration of a cytokinesis event (e.g., cytokinesis 1), 2) the time
interval between cytokinesis 1 and cytokinesis 2; and 3) the time interval between
cytokinesis 2 and cytokinesis 3. Id. at col. 3–4.
Fig. 5 of the ’906 patent illustrates these events and is reproduced below:

1
Josephine Lemmen, Kinetic Markers of Human Embryo Quality Using Time-
Lapse Recordings of IVF/ICSI-Fertilized Oocytes, 17(3) Reproductive
BioMedicine Online 385 (30 July 2008).
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Figure 5, reproduced above, is a diagram showing time lapses between the
stages of mitosis. As shown in Figure 5, during development, the fertilized oocyte
(egg) replicates its DNA and then undergoes a first cell division into two cells (3rd
drawing from left). The entire process is called “mitosis,” which involves the
replication of the DNA and then the splitting of the cell into two in the process
called “cytokinesis” (shown in Fig. 5 as beginning with a furrow in the single cell
(2nd drawing from left) and ending with two cells (3
rd
drawing from left)). Next,
each of the two cells undergoes mitosis – 2nd mitosis (cell division of one of the
two cells of the 1st mitosis) and 3rd mitosis (cell division of the second of the two
cells of the 1st mitosis) – to produce a four cell embryo (rightmost drawing).
Figure 5 shows the duration of the first cytokinesis, from the beginning of
the process where a furrow is observed to the end of the process where cytokinesis
is finished (2nd and 3rd drawing from the left). The time between the 1st

and 2nd
mitosis is also shown, where the 3rd drawing from the left shows the end of the 1st

mitosis (cytokinesis completed ending in two formed cells) and the 4th drawing
from the left shows the beginning of the cytokinesis in the 2nd mitosis in the
formation of a furrow in one of the two cells formed during the 1st mitosis.

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REJECTIONS
Twenty-five grounds of rejection are listed in Patent Owner’s Appeal Brief
as being appealed. Appeal Br. 2–5. Because several of the rejections involved the
same claims and thus were unnecessarily duplicative, we have only given
consideration to the following rejections:
1. Claims 1–91 as unpatentable under 35 U.S.C. § 112 (pre-AIA), first
paragraph, as failing to comply with the written description requirement.
2. Claims 18, 84, 85 and 91 as unpatentable under 35 U.S.C. § 112 (pre-
AIA), second paragraph, as indefinite for failing to particularly point out and
distinctly claim the subject matter which the inventor or joint inventor regards as
the invention.
3. Claims 1–9, 12, 15–27, 30, 33–42, 45, 48–57, 60, 63–75, 78, 81–87, and
89–91 under 35 U.S.C. § 102(b) as anticipated by Mio (2006).
2

5. Claims 10, 11, 28, 29, 43, 44, 58, 59, 76, and 77 under 35 U.S.C. § 103 as
obvious in view of Mio (2006) and Trounson.
3

6. Claims 13, 31, 46, 61, and 79 under 35 U.S.C. § 103 as obvious in view of
Mio (2006) in view of Mio (2008).
4

8. Claims 1–5, 9, 12, 16–23, 27, 30, 34–41, 42, 45, 49–57, 60, 64–71, 75, 78,
82–87, and 89–91 under 35 U.S.C. § 102(b) as anticipated by Meng (2009).
5

2
Yasuyuki Mio, Morphological Analysis of Human Embryonic Development
Using Time-Lapse Cinematography, 23 J. Mamm. Ova Res. 27 (2006).
3
Alan Trounson et al., Maturation of Human Oocytes In Vitro and Their
Development Competence, 121 Reproduction 51 (2001).
4
Yasuyuki Mio et al., Time-Lapse Cinematography of Dynamic Changes
Occurring During In Vitro Development of Human Embryos, 199 Am J. Obstet.
Gynecol. 660 (2008).
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12. Claims 10, 11, 28, 29, 43, 44, 58, 59, 76, and 77 under 35 U.S.C. § 103
as obvious in view of Meng (2009) and Trounson.
13. Claims 13, 31, 46, 61, and 79 under 35 U.S.C. § 103 as obvious in view
of Meng (2009) and Mio (2008).
15. Claims 1–5, 9, 12–14, 15, 16, 19–23, 27, 30–34, 37–42, 45–49, 52–57,
60–64, 67–71, 75, and 78–82 under 35 U.S.C. § 102(b) as anticipated by Mio
(2008).
17. Claims 10, 11, 28, 29, 43, 44, 58, 59, 76, and 77 under 35 U.S.C. § 103
as obvious in view of Mio (2008) and Trounson.
18. Claims 1, 3–9, 12, 15, 19, 21–27, 30, 33, 37, 39–42, 45, 48, 52, 54–57,
60, 63, 67, 69–75, 78, and 81 under 35 U.S.C. § 102(b) as anticipated by Adachi
(2005).
6

19. Claims 10, 11, 28, 29, 43, 44, 58, 59, 76, and 77 under 35 U.S.C. § 103
as obvious in view of Adachi (2005) and Trounson.
20. Claims 13, 31, 46, 61, and 79 under 35 U.S.C. § 103 as obvious in view
of Adachi (2005) and Mio (2008).
22. Claims 1, 3–9, 12, 14, 16–19, 21–27, 30, 32, 34–37, 39–42, 45, 47, 49–
52, 54–57, 60, 62, 64–67, 69–75, 78, 80, 82–85, 87, and 88–91
7
under 35 U.S.C. §
102(b) as anticipated by Lemmen (2008).

5
Li Meng et al., “Remote Monitoring and Evaluation of Early Human Embryo
Development by a Robotic-Operated Culture-Imaging System, PCRS 2009 Annual
Meeting, Oral Presentation (2009).
6
Yumi Adachi et al., Analysis of Physiological Process in Early Stage of Human
Embryos After ICSI Using Time-Lapse Cinematography, 22 J. Mamm Ova. Res.
70 (2005).
7
Claim 88 was not identified in the statement of the rejection on page 36 of the
RAN, but the claim was included in the discussion on page 38 of rejected claims.
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24. Claims 10, 11, 28, 29, 43, 44, 58, 59, 76, and 77 under 35 U.S.C. § 103
as obvious in view of Lemmen (2008), Ramsing,
8
Meng (2009), and Trounson.
25. Claims 13, 31,
9
46, 61 and 79 under 35 U.S.C. § 103 as obvious in view
of Lemmen (2008), Ramsing, Meng (2009), and Mio (2008).
In addition to these rejections, we set forth the following new ground of
rejection under 37 C.F.R. § 41.79(b).
Claims 13, 31, and 79 are rejected under 35 U.S.C. § 103 as obvious in view
of Adachi (2005), Mio (2006), or Lemmen (2008), and Robertson.
10

PRIORITY
The ’906 patent claims benefit to U.S. Provisional Patent Application No.
61/332,651, filed May 7, 2010 and U.S. Provisional Patent Application No.
61/236,085 (“the ’085 provisional”), filed Aug. 22, 2009. The Examiner denied
the present claims benefit of the ’085 provisional, concluding that limitations b, b’,
c, and c’ were not described in the ’085 provisional application. RAN 4. As
explained below, we reverse this decision.

Limitations b and b’
(b) the time interval between cytokinesis 1 and cytokinesis 2;
(b’) the time interval between the resolution of cytokinesis 1 and the
onset of cytokinesis 2 is 8–15 hours.

8
Niels Ramsing et al., WO 2007/144001 A2 (Dec. 21, 2007).
9
Claim 31 was not included in the statement of the rejection on page 42 of the
RAN, but it recites the same limitation as other rejected claims, so we have
included it here for consistency.
10
Sarah Robertson et al., US 6,605,468 B1 (Aug. 12, 2003).
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The first issue is whether the ’085 provisional describes “the time interval
between the resolution of cytokinesis 1 and the onset of cytokinesis 2 is 8–15
hours.”
First, the ’085 provisional contains the same Figure 5 which appears in the
’906 patent and with the same bar labeled “Time between 1st & 2nd mitosis.” This
bar depicts the resolution of cytokinesis 1 at the left end of the bar (two cells) and
the onset of cytokinesis 2 at the right end of the bar (beginning of furrow). Thus,
the skilled worker would have recognized that the ’085 provisional application
describes the time interval between the resolution of cytokinesis 1 and the onset of
cytokinesis 2. A drawing alone may provide adequate description for a claim.
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 1114 (Fed. Cir. 1991).
Secondly, the ’906 patent discloses that “the time interval between the
resolution of cytokinesis 1 and the onset of cytokinesis 2” corresponds to the “time
between the first and second division.” Specifically, the legend to Figure 5 of the
’906 patent states that Figure 5 “is a diagram showing time lapses between stages
used for the present evaluations, including the . . . time between the first and
second division (measured as the time interval between the resolution of
cytokinesis 1 and the onset of cytokinesis 2). ’906 patent, col. 4, ll. 54-58
(emphasis added). The ’085 provisional describes “(2) the time interval between
the first and second cell divisions (also referred to as the time interval between the
first and second mitosis).” ’085 provisional ¶ 19 (emphasis added). Thus, the
synonym (“time between the first and second division”) for “the time interval
between the resolution of cytokinesis 1 and the onset of cytokinesis 2” provided in
the ’906 patent appears in the ’085 provisional. Consequently, the ’085
provisional provides written description support for “the time interval between the
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resolution of cytokinesis 1 and the onset of cytokinesis 2” because such time
interval is defined in the ’906 patent as “time between the first and second
division” and this phrase appears in the ’085 provisional. Consistently, the ’085
provisional discloses that this time interval is 8–15 hours, the same time as
claimed. Id.
The ’906 patent has further defined the time between the first and second
division in terms of cytokinesis events, but the fact that the ’085 provisional does
not characterize the cytokinesis events in words is immaterial because the
provisional contains the alternative synonym disclosed in the ’906 patent.
With respect to the limitation of (b) “the time interval between cytokinesis 1
and cytokinesis 2,” the ’085 provisional describes measuring the duration of
cytokinesis and time between cell divisions (¶ 23) and generally describes
measuring cytokinesis and time between mitotic events. ’085 provisional, ¶¶ 59,
82, 169, 170, 174. The Examiner has not provided sufficient explanation as to why
such disclosure would fail to serve as written description support for the recited
measuring step.
In sum, we conclude that limitations b and b’ are described in the ’085
provisional application.

Limitations c and c’
(c) the time interval between cytokinesis 2 and cytokinesis 3,
(c’) the time interval between the onset of cytokinesis 2 and the onset
of cytokinesis 3 is 0-5 hours

In the ’906 patent, the legend to Fig. 5 describes “time between the 2nd and
3rd mitosis” as the same as the “time interval between the initiation of cytokinesis
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2 and the initiation of cytokinesis 3,” i.e., the “onset” of each event. ’906 patent,
col. 4, ll. 58–61 (emphasis added). While the ’085 provisional does not disclose
the cytokinesis language of claim 1, it describes “(3) the time interval between the
second cell and third cell divisions (also referred to as the time interval between
the second and third mitosis).” ’085 provisional ¶ 19 (emphasis added). Because
the ’085 provisional equates first and second cell division with “mitosis” and the
’906 patent equates 2nd and 3rd mitosis with “cytokinesis,” express written
description for the limitation (c’) of claim 1 is provided by the synonymous
language. Consistently, the time interval for (3) is disclosed as being between 0
and 5 hours, same time period for c’. Id.
The claim also recites that “the time interval between cytokinesis 2 and
cytokinesis 3.” As discussed above, the ’085 provisional generally describes
measuring cytokinesis, the duration of cytokinesis and time between cell divisions
(¶ 23) and generally describes measuring cytokinesis and time between mitotic
events. ’085 provision ¶¶ 59, 82, 169, 170, 174. The Examiner has not provided
sufficient explanation as to why this disclosure would fail to provide written
description support for the recited measuring step.
In sum, we conclude that limitations c and c’ are described in the ’085
provisional application.

CLAIM INTERPRETATION
Claim 1 is directed to a method for identifying good or poor developmental
competence of a human embryo. The claim has two steps. The first step involves
“measuring cellular parameters of a human embryo in vitro.” The second step
involves “determining that the human embryo has said good developmental
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competence.” The proper interpretation of the second step of the claimed method is
in dispute.
The second step is reproduced below:

2) determining that the human embryo has said good developmental
competence when,
(a’) the duration of the first cytokinesis is 0 to 30 minutes;
(b’) the time interval between the resolution of cytokinesis 1
and the onset of cytokinesis 2 is 8–15 hours; or
(c’) the time interval between the onset of cytokinesis 2 and the
onset of cytokinesis 3 is 0–5 hours,

The Examiner interpreted the claim to mean that “good developmental
competence” is determined in conjunction with one of the three events (a’), (b’),
and (c’). RAN 11, 13–14. That is, the Examiner interpreted “when” to mean “in
conjunction with” and to indicate the timing of when “good developmental
competence” is determined. Id. See also Resp’t Br. 3–4. Based on this
interpretation, the Examiner found that “other cellular parameters or markers [can
be] used to determine whether the embryo has good developmental competence” as
long as one of three events is also present. RAN 11.
Patent Owner contends that the Examiner’s interpretation is unreasonably
broad and is inconsistent with the patent specification’s description. Appeal Br. 5–
7.

Discussion
During reexamination of an unexpired patent, claims are given their broadest
reasonable interpretation consistent with the patent specification. In re Suitco
Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010); In re Abbott Diabetes Care
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Inc., 696 F.3d 1142, 1148 (Fed. Cir. 2012). The “PTO applies to the verbiage of
the proposed claims the broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in applicant’s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
In the “Summary of the Invention” of the ’906 patent, the inventors describe
their invention as providing methods for “identifying embryos and oocytes in vitro
that have a good developmental potential, i.e. the ability or capacity to develop into
a blastocyst, which are thus useful in methods of treating infertility in humans.”
’906 patent, col. 3, ll. 18–22. The patent states that a “cell parameter is . . .
employed to provide a determination of the developmental potential of the
embryo.” Id. at col. 3, ll. 27–29. Three specific cell parameters are mentioned:
cytokinesis 1; the time interval between cytokinesis 1 and cytokinesis 2; and the
time interval between cytokinesis 2 and cytokinesis 3. Id. at col. 3, ll. 33–37; col.
3, ll. 65 to col. 4, l. 3. These are the same parameters which are claimed. The
patent carried out specific experiments which showed that these three cellular
parameters, i.e., a’, b’, and c’ of claim 1, predicted good developmental potential.
Id. at col. 4, l. 54 to col. 5, l. 9 (legends to Figs. 5–7) (“FIG. 7 is a graph showing a
receiver operating characteristic (ROC) curve for predicting blastocyst formation
using the 3 dynamic morphological parameters.”) Specifically, the patent discloses:
As demonstrated in the examples sections below and in FIG. 7, the
use of three parameters provides sensitivity of 94% and specificity of
93% with a cutoff point of 3 times the standard deviations of the
blastocyst distribution. In other words, methods of the invention are
able to correctly identify the number of embryos that are going to
develop into blastocysts 94% of the time (sensitivity), and the number
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of embryos that are going to arrest before the blastocyst stage 93% of
the time (specificity).
Id. at col. 21, ll. 34–42.
Similarly, the patent teaches
Detailed analysis of . . . our imaging results indicated that
normal embryos followed strict timing in cytokinesis and mitosis
during early divisions . . . In particular, we noted three temporal
intervals, or parameters, in the cell cycles of early-stage embryo that
were strictly regulated: (1) duration of the first cytokinesis, (2) time
interval between the first and second mitosis, and (3) synchronicity of
the second and third mitosis [between the initiation of cytokinesis 2
and the initiation of cytokinesis 3 (id. at col. 19, ll. 11–13)]. The
relationship between these three time intervals and morphological
changes is shown in FIG. 5.
Id. at col. 33, ll. 37–51.
It is apparent from the disclosure in the ’906 patent, as indicated by the
sections reproduced above, that while other cellular parameters indicative of good
developmental potential may have been contemplated, good developmental
competence is specifically determined in this invention using the morphological
parameters a’, b’, and c’ recited in claim 1. These three event are mentioned in the
“Summary of the Invention,” in the figures (see Figs. 5 and 6), and in the examples
(Example 1 beginning at column 31, l. 55). The ’906 patent states that “[m]ethods
of human embryo evaluation are thus lacking in several respects and can be
improved by the present methods.” Id. at col. 3, l. 6–7. The skilled worker, upon
reading the ’906 patent would therefore have recognized that morphological
parameters a’, b’, and c’ are one such improvement described by the inventors.
The Examiner’s interpretation of the claim to require only that parameters
a’, b’ and c’ are measured, and not necessarily used to determine good
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developmental competence, is contrary to the patent’s written description because
the only use of these parameters is to predict embryo competence. The Examiner’s
reading of the claim is therefore explicitly inconsistent with the ’906 patent’s
written description. The only support the Examiner can find for this interpretation
appears to be defining “when” to mean “in conjunction with.” RAN 13–14.
However, in adopting this definition, the Examiner failed to read the claims in
view of the specification or to provide persuasive evidence to back this definition.
Requester attempts to support the Examiner’s interpretation by providing
evidence that “when” means “after,” and, therefore, the claim does not require that
“determining that the human embryo has said good developmental competence” is
a result of measuring a’, b’, or c’. Resp’t Br. 4. However, Requester’s definition
of the term ignores the plain teachings in the ’906 patent in which good
developmental consequence is determined by observing a’, b’, and c’. While
“when” might be used to be mean “after,” it also indicates “at the time or in the
event that,”
11
a meaning that is entirely consistent with Patent Owner’s position
and the ’906 patent description that a’, b’, and c’ are the events which indicate the
good developmental competence.
Moreover, both the Examiner and Requester have ignored the recitation of
“determining” in step 2 which means “to conclude or ascertain, as after reasoning,
observation, etc.” In other words, the most logical reading of the claim is that
good developmental competence is ascertained after observing the occurrence of
one of the listed events, an interpretation which is not inconsistent with “when”
meaning “at the time or in the event that” a’, b’, or c’ occur.

11
http://dictionary.reference.com/browse/when. Accessed Aug. 12, 2015.
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WRITTEN DESCRIPTION REJECTION
The Examiner rejected claims 1–91 as lacking written description to support
“good developmental competence” as recited in all the claims. RAN 15. The
Examiner cites the broad description of developmental competence in the ’906
patent,
12
contrasting with the “experimental evidence related to development of
blastocyst only.” Id. Requester further argues that the blastocyst example is only
one species and insufficient to “provide adequate written description support for
the broad genus of ‘good or poor developmental competence’ encompassed by the
claims.” Resp’t Br. 7–8.
As explained below, the rejection is reversed.
Under 35 U.S.C. § 112, first paragraph (pre-AIA), the “specification shall
contain a written description of the invention.” A specification adequately
describes an invention when it “reasonably conveys to those skilled in the art that
the inventor had possession of the claimed subject matter as of the filing date.”
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc).
In this case, the ’906 patent describes good developmental competence as
having a 55% chance or more of developing a desired. ’906 patent, col. 18, ll. 42–
45. The patent also states that “the developmental potential of an . . . embryo is the
ability or capacity of that . . . embryo to develop into a healthy blastocyst; to
successfully implant into a uterus; to go through gestation; and/or to be born live.”
Id. at col. 18, ll. 33–36. The terms “competence” and “potential” are used

12
“By ‘good developmental potential’, it is meant that the embryo/pluripotent cell
is statistically likely to develop as desired, i.e. it has a 55%, 60%, 70%, 80%, 90%,
95% or more chance, e.g. a 100% chance, of developing as desired.” ’906 patent,
col. 18, ll. 42–45.
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interchangeably. While the description may be broad, neither the Examiner nor the
Requester has adequately explained why such broad description in the patent
results in a failure to comply with the written description requirement. It has not
been shown that the inventors did not describe all the characteristics and feature of
the claimed genus and therefore lacked possession of it. University of California v.
Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
Requester argues:
Not every embryo that reaches the blastocyst stage will implant, not
every embryo that implants will go through gestation, and not every
embryo that goes through gestation will be born live. All of these later
milestones are included under the definition of “good developmental
potential” as defined in the specification. And the specification still
provides no guidance as to how the POSA could identify those
embryos that, after reaching the blastocyst stage, would reach any of
these later milestones. Thus, the specification still fails to demonstrate
possession of the claimed methods over their full scope.
Resp’t Br. 8.
Neither the claim nor the definition of good developmental competence
requires describing how to identify embryos that would reach one of the stated
“milestones,” as argued by Requester. “Good developmental competence” only
requires a 55% chance of developing as desired. Selecting an embryo that meets
one of the three recited criteria leads to the selection of an embryo with a 55%
chance or more of developing as desired. This constitutes an adequate description
of the invention because it shows that the inventors have invented what is claimed,
namely selecting embryo’s which satisfy at least one of the three recited
morphological criteria. Arguably, the recitation of “good developmental
competence” narrows the claimed subject matter because it adds the requirement
that the embryo “is statistically likely to develop as desired, i.e. it has a 55%, 60%,
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70%, 80%, 90%, 95% or more chance, e.g. a 100% chance, of developing as
desired.” ’906 patent, col. 18, ll. 33–36. However, we do not agree that
narrowing the claim in such a way eviscerates its written description. It is not
necessary that inventor was able to predict with certainty the outcome of each
developmental pathway embarked upon by the embryo for “possession” of the
claimed subject matter because the definition itself calls for the embryo to be
“statistically likely to develop as desired,” and thus only a higher probability it will
attain such development. Id.
Furthermore, while there is a preferred embodiment in which “[e]mbryos
that reached the blastocyst stage could be predicted, with sensitivity and specificity
of 94% and 93% respectively” by relying on all three a’, b’, and c’ events (’906
patent, col. 34, ll. 14–38), each parameter was described as “autonomously
predictive of the developmental potential of the embryo,” but at less sensitivity (id.
at col. 34, ll. 34–38. Thus, there is a description in the ’906 patent of using each
parameter individually to determine developmental potential.
In sum, the rejection of claims 1–91 as failing to comply with the written
description requirement is reversed

INDEFINITENESS
The Examiner rejected claims 18, 84, 85, and 91 as indefinite. RAN 15.
The Examiner states:
These claims recite a combination of two intervals to be used to
determine the good developmental competence of the embryo,
whereas the independent claims recite only one time interval. By
requiring a combination of time intervals for two cellular parameters
in claims 18, 84, and 91, the use of “or” in claims 1, 67 and 85
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explicitly moves this combination outside the scope of the claims,
thereby rendering the claims indefinite.
RAN 15.
Good developmental competence according to independent claim 1 is
determined when a developing embryo satisfies developmental parameter a’, b’, or
c’. An embryo that satisfies a’ and b’ still meets claim 1 because the claim does
not exclude embryos as having good developmental competence when two of the
three recited parameters are met. When an embryo satisfies event a’, it is
determined to have good developmental competence. The further determination
that it also meets events b’, or c’, or b’ and c’, would still mean that the embryo has
good developmental competence as a result of first having satisfied a’. The “or”
indicates a’, b’, or c’ can be used to determine developmental competence, but
does not exclude a determination involving two or more of the parameters.
Accordingly, we reverse the rejection based on § 112, second paragraph.

ANTICIPATION
There are five anticipation rejections: Rejection 3 over Mio (2006),
Rejection 8 over Meng (2009), Rejection 15 over Mio (2008), Rejection 18 over
Adachi (2005), and Rejection 22 over Lemmen (2008).
Patent Owner submitted a declaration pursuant to 37 C.F.R. § 1.131 to
antedate Meng (2009) and Mio (2008). Appeal Br. 15. The Examiner did not
consider the declaration because the Examiner improperly denied the ’906 patent
benefit to the filing date of the ’085 provisional application, and had therefore
concluded that Patent Owner could not invoke § 1.131 because the publications
were published more than a year before the patent filing date and were a statutory
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bar under 35 U.S.C. § 102(b). Id.; RAN 47. This conclusion is incorrect as Meng
(2009) and Mio (2008) were not published more than a year before the filing date
of the ’085 provisional application. We have not addressed the sufficiency of the
§ 1.131 declaration, but the Examiner may do so if Patent Owner choses to re-open
prosecution (see below, section titled “NEW GROUNDS OF REJECTION”).
There are three groups of claim which we shall address separately. The
groups are as follows:
1) Group 1 claims involve “determining” the developmental competence
based on the observation of the measured a’, b’, or c’;
2) Group 2 claims involves method in which, after the “determining” step is
completed, further comprises “selecting the human embryo having said good
developmental competence”; and
3) Group 3 claims involve “implanting” an embryo which has good
developmental competence.

Group 1 claims
This group involves independent claims 1 and 19, and claims that depend
from them. The Examiner found that each of the cited publications describe one of
the measuring steps a, b, or c recited in claim 1. These finding are summarized in
the RAN on pages 33–34 for Adachi (2005), pages 16–17 for Mio (2006), pages
36–37 for Lemmen (2008), page 31 for Mio (2008), and page 24 for Meng (2009).
Patent Owner did not identify a defect in the Examiner’s findings regarding
the teaching in the cited prior art publications of the recited measuring cellular
parameters a, b, and c. Appeal Br. 20–21. Instead, Patent Owner argued that the
Examiner’s interpretation of the claim is unreasonably broad by construing “the
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‘determining’ or ‘identifying’ step of the claims as a ‘mental step in which the
relative assessment of the quality of a given developing embryo is made in
conjunction with’ whether the claimed parameters fall inside or outside of the
specified time ranges.” Id. at 20.
While we agree with Patent Owner that the Examiner did not interpret the
claim properly, nonetheless the Examiner’s decision that the recited “determining”
step does not distinguish over the publications is consistent with the principles of
inherent anticipation. Since the Examiner did not base the rejection on this
reasoning, we shall designate the rejections as “new grounds” under 37 C.F.R. §
41.79.
First, we begin with the claims. No special meaning is attributed in the ’906
patent to the term “determining” as it is recited in claim 1. We construe it
according to its ordinary dictionary definition to mean “to conclude or ascertain, as
after reasoning, observation, etc.”
13
The Examiner found the “determining” step to
be a “mental step,” i.e., a step that does not require a physical manipulation of the
human embryo, but rather would include a determination made entirely in the mind
of the observer after making the recited physical measurements. RAN 11, 13. In
other words, the “determining” step in claim 1 reads simply on a mental
ascertainment or recognition that an embryo has good developmental competence,
but does not require an additional manipulative physical steps. The Examiner’s
reasoning is logical, and we adopt it.
Claim 19 uses the phrase “identifying that the human embryo has said good
developmental potential.” Again, no special meaning is afforded to “identifying”
in the ’906 patent so we construe “identify” to have its ordinary meaning as “to

13
http://dictionary.reference.com/browse/determine. Accessed Aug. 12, 2015.
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recognize or establish as being a particular person or thing.”
14
For the same reasons
discussed for claim 1, we concur with the Examiner’s determination that the
“identifying” step is a mental step which only requires recognition that an embryo
with the cellular parameter of a’, b’, and c’ has good developmental competence.
It is well-established by case precedent that merely recognizing something
that was inherent, but not known before, is 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); MEHL/Biophile
Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999); In re Omeprazole
Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007). A prior art publication can
therefore anticipate the claimed subject matter when all the steps carried out in the
publication are identical to those claimed and the only difference is recognition
that the steps produce a result that heretofore had not been appreciated.
In MEHL/Biophile, the patentee claimed a “method of hair depilation”
utilizing steps which had been described in a prior art publication. The prior art
method did not perform the steps for the purpose of hair depilation, but it was
determined that hair depilation would have been a necessary, albeit unrecognized
and inherent, consequence of carrying out the method. MEHL/Biophile, 192 F.3d
at 1366. Although the claim preamble expressly required the method to be
performed for the purpose of hair depilation, the court did not find it necessary that
the article’s authors “appreciate the results” of their process to constitute an
anticipation of the claimed process because the process carried out in the prior art
publication was identical to the process which was claimed. Id.

14
http://dictionary.reference.com/browse/identify. Accessed Aug. 12, 2015.
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In Cruciferous Sprout, the patents-in-suit described methods of preparing
food products that contain high levels of substances called glucosinolates that
induce Phase 2 enzymes, the latter which were known to be involved in the human
body’s mechanism for detoxifying carcinogens. Cruciferous Sprout, 301 F.3d at
1344. “The inventors of the patents-in-suit recognized that the Phase 2 enzyme-
inducing agents [glucosinolates] . . . are far more concentrated in certain
[cruciferous] sprouts (such as broccoli and cauliflower . . .) that are harvested
before the two-leaf stage than in corresponding adult plants.” Id. Glucosinolate
levels were known to be variable. Id. The inventors found it “desirable to select
the seeds of those cruciferous plants which, when germinated and harvested before
the two-leaf stage, produce sprouts that contain high levels of the desired enzyme-
inducing potential.” Id. Among the claims contained in the patents-in-suit was a
claim reciting “identifying seeds which produce cruciferous sprouts . . . containing
high Phase 2 enzyme inducing potential.” Id. at 1349. The validity of the
“identifying” claim was challenged because seeds having high Phase 2 enzyme-
inducing potential had been grown and eaten prior to the patent’s filing date. Id. at
1350. The patent owner argued that its claims were not anticipated because the
prior art did not “specify which cultivars should be sprouted.” Id. at 1351. In
other words, the prior art had not carried out the “identifying” step. The court did
not find this argument persuasive:
Thus, according to Brassica, the prior art fails to meet the
“identifying” steps of the claims because it does not specify which
cultivars should be sprouted. However, all of the appropriate cultivars
that are identified in Brassica's patent are in the public domain. ’895
patent, col. 10, ll. 43–65. Brassica cannot credibly maintain that no
one has heretofore grown and eaten one of the many suitable cultivars
identified by its patents. It is unnecessary for purposes of anticipation
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for the persons sprouting these particular cultivars to have realized
that they were sprouting something rich in glucosinolates and high in
Phase 2 enzyme-inducing potential.
Id.
The recitation in the claim of a step that required identification of the
sprout’s properties did not persuade the court that the inventors had done anything
more than “recognize[] something about sprouts that was not known before.” Id.
Because the cited prior art references had described the sprouts as suitable for
eating and had grown them, the court found that the “references therefore meet the
claim limitation of identifying seeds to use in order to have sprouts with the
inherent properties of glucosinolates and high Phase 2 enzyme-inducing activity.”
Id.
The claims at issue in this reexamination comprise “determining” and
“identifying” the competence of a human embryo when one of three recited
cellular parameters is met. The Examiner found that the physical step in the claim
of measuring the cellular parameters had been performed in the cited prior art
publications, which are findings that are not challenged by Patent Owner. Under
Cruciferous Sprout, as long as the method steps are identical, it unnecessary for the
purpose of inherent anticipation to have realized that some of the embryos
measured in the prior art publications had good developmental potential. The step
of “identifying” particular seeds in Cruciferous Sprout did not change how the
process was carried out. The reasoning in Cruciferous Sprout is applicable to the
’906 patent claim because the cited references teach the same measuring steps, and
the only distinguishing feature over the prior art is the recognition that embryo’s
measured by that criteria have “good developmental potential” as recited in the
claim, when at least some embryos inherently had characteristics a’, b’, or c’
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falling within the recited ranges and, thus, had “good developmental potential”
even if unrecognized in the prior art.
Accordingly, we affirm the anticipation rejections of the group 1 claims.

Group 2 claims
Group 2 includes dependent claims that have the same “determining” or
“identifying” step recited in claims 1 and 19, but which also recite an additional
step of “selecting the human embryo having said good developmental
competence.” These claims are claims 37–42, 45–57, 60–75, and 78–84.
The ’906 patent does not define the term “selecting,” but uses the term
broadly. For example, the patent discloses that “[w]hen transferring the petri
dishes between different stations, the embryos can sometimes move around,
thereby making it difficult to keep track of embryo identity.” ’906 patent, col. 26,
ll. 63–65. “This poses a challenge when time-lapse imaging is performed on one
station, and the embryos are subsequently moved to a second station for embryo
selection and transfer.” Id. at col. 26, l. 65 to col. 27, l. 1 (emphasis added). In this
context, the term “select” indicates that a choice is made between embryos having
good and poor developmental competence, but there is no requirement that an
embryo be physically manipulated, isolated or “transferred” in any way. In other
words, the term “select” is used broadly enough to include recognition or
appreciation that an embryo with good developmental competence is “suitable for
transfer and most likely to result in term pregnancy” (id. at col. 1, ll. 36–37). See
also col. 35, ll. 55–57 (“The dynamic morphological parameters can be used to
select the optimal embryos for transfer or cryo-preservation during an IVF
procedure.”)
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Consequently, the recitation of a “selecting” step does not necessarily
change how the claimed processed is carried out, but rather is broad enough to
constitute a recognition that the measurement of cellular parameters a’, b’, and c’
makes an embryo suitable for subsequence transfer and implantation. For this
reason, the same analysis for the “determining” and “identifying” steps of claims 1
and 19 are applicable to the Group 2 claims. The claims reciting the “selecting”
step are anticipated by Adachi (205), Mio (2006), Lemmen (2008), Mio (2008),
and Meng (2009) for the reasons already discussed.
Accordingly, we affirm the anticipation rejections of the group 2 claims,
claims 37–42, 45–57, 60–75, and 78–84.

Group 3
Claims 14 and 88 are dependent claims “further comprising implanting the
human embryo determined to have said good developmental potential into a female
human subject.” Claim 47 depends on claim 14.
The Examiner found these claims anticipated by Lemmen (2008), who, in
addition to disclosing measuring parameters a, b and c, as discussed above, also
discloses implantation of human embryos that resulted in pregnancy. Lemmen
(2008) 387; RAN 38. Since some of the embryos resulted in pregnancy, there is a
sound basis to believe
15
that they inherently had “good developmental
competence” and inherently displayed at least one cellular parameter a’, b’, or c’

15
When the limitations of a claim are not expressly described in the prior art, the
PTO must show “sound basis for believing” that despite the failure of the prior art
to describe them, the limitations are inherently there and “the products of the
applicant and the prior art are the same.” In re Spada, 911 F.2d 705, 708 (Fed. Cir.
1990).

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recited in claim 1. Thus, a preponderance of the evidence supports the finding that
Lemmen (2008) implanted the very same embryos that the ’906 patent had
recognized as having good developmental competence as a result of having
experienced a’, b’, or c’ of claim 1. “Inherency is not necessarily coterminous with
the knowledge of those of ordinary skill in the art. Artisans of ordinary skill may
not recognize the inherent characteristics or functioning of the prior art.”
MEHL/Biophile, 192 F.3d at 1365. The anticipation rejection of these claims in
view of Lemmen is affirmed, as well.

Summary
The anticipation Rejections 3, 8, 15, 18, and 22 are affirmed but are
designated new grounds of rejection under 37 C.F.R. § 41.79(b) because our
rationale differs from the Examiner’s.

OBVIOUSNESS
We consider the obviousness rejections only as they pertain to claims 10, 11,
13, 28, 29, 31, 43, 44, 46, 58, 59, 61, 76, 77, and 79 since these claims either have
not been rejected as anticipated or have been rejected over Mio (2008) which is not
a statutory bar under 35 U.S.C. § 102(b).

Matured in vitro
Claims 10, 28, and 76 recite that the oocyte used to produce the embryo is
“matured in vitro.” Claims 11, 29, 43, 44, 58, 59, and 77 depend from claims 10,
28, and 76. The claims are rejected as obvious under Rejections 5, 12, 17, 19, and
24.
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The Examiner fund that Trounson “discloses the maturation, fertilization,
embryo cleavage and pregnancy rates from in vitro matured human oocytes in
presence or absence of exogenous human chorionic gonadotropin (hCG).” RAN
22. The Examiner stated that it would have been obvious to one of ordinary skill
in the art at the time of the invention “to combine the teachings of Mio (2006) and
Trounson, since both the references were directed to evaluating the potential for
successful embryonic development.” Id. The Examiner further found a reasonable
expectation of success of using matured human embryos “in view of the
microscopic images presented in Trounson and the numerous reported successful
outcomes reported therein of the use of in vitro matured oocytes in in vitro
fertilization procedures and in selecting embryos having good developmental
competence.” Id.
The same rationale was used for Trounson combined with Adachi (2005)
(id. at 35), Mio (2008) (id. at 33), and Meng (2009) (id. at 29).
The Examiner’s rationale is supported by a preponderance of the evidence.
Patent Owner did not provide rebuttal arguments or evidence in its briefs.
Consequently, we affirm Rejections 5, 12, 17, 19, and 24 for the reasons set for the
by the Examiner.

Embryos frozen prior to “measuring”
Claims 13, 31, and 79 recite “wherein the embryos have been frozen prior to
measuring the parameters.” Claims 46 and 61 depend from these claims.
In Rejections 6, 13, 20, and 25, the Examiner found that neither of Adachi
(2005), Mio (2006), Lemmen (2008), and Meng (2009) describes utilizing frozen
embryos. RAN 23. However, the Examiner found that Mio (2008) reports
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“measurement of cellular events in a previously frozen embryo using time-lapse
cinematography (see page 660).” Id. The Examiner concluded that “since
cryopreserved embryos were routinely used successfully to produce pregnancies,
the previously frozen embryos could have been likewise used for time-lapse
microscopy with a reasonable expectation of success.” Id. See also id. at 30
(discussion of Meng (2009)), 35–36 (discussion of Adachi (2005)), 42 (discussion
of Lemmon (2008)).
The Examiner’s rationale is supported by a preponderance of the evidence.
Patent Owner did not provide rebuttal arguments or evidence in their briefs.
Consequently, we affirm Rejections 6, 13, 20, and 25 for the reasons set for the by
the Examiner.

Robertson
The Robertson patent is newly cited. Robertson describes classifying and
grading embryos using morphological cellular parameters to identify viable ones.
Robertson, col. 7, ll. 33–49. The embryos had been frozen and thawed prior to
making the measurements. Id. Robertson describes the frozen embryos as donated
for their studies. Id. at col. 6, ll. 53–59. It would have been obvious to one of
ordinary skill in the art to have utilized frozen embryos in the methods of Adachi,
Mio (2006), and Lemmen (2008), since they were known to be viable after
freezing and therefore provided a convenient source of embryos for implantation.
Accordingly, claims 13, 31, 46, 61, and 79 are rejected under 35 U.S.C. § 103 as
obvious in view of Adachi (2005), Mio (2006), or Lemmen (2008), and Robertson.
We designate this as a new ground of rejection under 37 C.F.R. § 41.79(b).

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SECONDARY CONSIDERATIONS
Patent Owner provided evidence of secondary considerations. Secondary
considerations cannot be used to overcome an anticipation rejection under 35
U.S.C. 102. In re Wiggins, 488 F.2d 538, 543 (CCPA 1973). Consequently, the
evidence is only pertinent to the obviousness rejections, specifically of claims 10,
11, 13, 28, 29, 31, 43, 44, 58, 59, 76, 77, and 79, which are not rejected under any
anticipation grounds.
In order for evidence of secondary considerations to be persuasive, the
Patent Owner has the burden to show a “nexus” or link between what is claimed
and the secondary consideration. See In re GPAC Inc., 57 F.3d 1573, 1580 (Fed.
Cir. 1995). Secondary considerations are generally not persuasive when the prior
art possesses the same characteristics relied upon by the patent owner in the
evidence of the secondary consideration. In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991); J.T. Eaton & Co., Inc. v. Atlantic Paste & Glue Co., 106
F.3d 1563, 1571 (Fed. Cir. 1997). For a secondary consideration to be persuasive
evidence of nonobviousness, it must be connected to the features of the claimed
invention beyond what was readily available in the prior art. Id.
In this case, claims 10, 11, 13, 28, 29, 31, 43, 44, 46, 58, 59, 61, 76, 77, and
79 further recite limitations about the maturation of the oocyte and the embryo as
having been frozen prior to the measuring step. The additional limitations are not
described by Patent Owner as having giving rise to the praise and long-felt need.
The steps in independent claims 1, 19, and 67 cannot establish the nexus between
the claim and the evidence of secondary considerations because such steps were
found to be anticipated by five different publications and thus were readily
available in the prior art. For this reason, we concluded that Patent Owner did not
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provide adequate evidence of non-obviousness of the subject matter of claims 10,
11, 13, 28, 29, 31, 43, 44, 46, 58, 59, 61, 76, 77, and 79.

NEW GROUNDS OF REJECTION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Correspondingly, no portion of the decision is final for purposes of
judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if
appropriate, however, the Board may elect to defer issuing any decision on such
request for rehearing until such time that a final decision on appeal has been issued
by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R. § 41.77(b)-
(g). The decision may become final after it has returned to the Board. 37 C.F.R.
§ 41.77(f).
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE
MONTH FROM THE DATE OF THE DECISION, must exercise one of the
following two options with respect to the new grounds of rejection to avoid
termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be either an
amendment of the claims so rejected or new evidence relating to the claims so
rejected, or both.
(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record. . . .

Any request to reopen prosecution before the Examiner under
37 C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.”
Accordingly, a request to reopen prosecution is limited to issues raised by the new
ground(s) of rejection entered by the Board. A request to reopen prosecution that
includes issues other than those raised by the new ground(s) is unlikely to be
granted. Furthermore, should the patent owner seek to substitute claims, there is a
presumption that only one substitute claim would be needed to replace a cancelled
claim.
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A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c). Requester comments under 37 C.F.R. § 41.77(c) shall be
limited in scope to the issues raised by the Board’s opinion reflecting its decision
to reject the claims and the patent owner’s response under paragraph 37 C.F.R.
§ 41.77(b)(1). A newly proposed rejection is not permitted as a matter of right. A
newly proposed rejection may be appropriate if it is presented to address an
amendment and/or new evidence properly submitted by the patent owner, and is
presented with a brief explanation as to why the newly proposed rejection is now
necessary and why it could not have been presented earlier.
Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for all
patent owner responses and requester comments, is required.
The Examiner, after the Board’s entry of a patent owner response and
requester comments, will issue a determination under 37 C.F.R. § 41.77(d) as to
whether the Board’s rejection is maintained or has been overcome. The
proceeding will then be returned to the Board together with any comments and
reply submitted by the owner and/or requester under 37 C.F.R. § 41.77(e) for
reconsideration and issuance of a new decision by the Board as provided by
37 C.F.R. § 41.77(f).

AFFIRMED; § 41.77(b)
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Patent Owner:

COOLEY LLP
ATTN: PATENT GROUP
1299 PENNSYLVANIA AVENUE, NW
SUITE 700
WASHINGTON, DC 2004

Third Party Requester:

ELIZABETH J. HAANES, PH.D.
THOMPSON COBURN LLP
1909 K STREET, NW SUITE 600
WASHINGTON, DC 2006