GE Healthcare Bio-Sciences Corp.

Patent Trials and Appeals Board

Oct 5, 2020

2019006788 (P.T.A.B. Oct. 5, 2020)

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.
14/743,960 06/18/2015 Parrish M. Galliher 266926 (1026-0021) 9817
123162 7590 10/05/2020
GE Healthcare - Grogan, Tuccillo & Vanderleeden LL
1350 Main Street, 5th Floor
Springfield, MA 01103
EXAMINER
HOBBS, MICHAEL L
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
10/05/2020 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):
docket@gtv-ip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PARRISH M. GALLIHER, GEOFFREY L. HODGE,
MICHAEL FISHER, PATRICK GUERTIN, and DAN MARDIROSIAN

Appeal 2019-006788
Application 14/743,960
Technology Center 1700

Before JEFFREY T. SMITH, GEORGE C. BEST, and BRIAN D. RANGE,
Administrative Patent Judges.

RANGE, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, 7, 10, 13, 17, 18, 20, 22, 23, 25,
26, 32–34, 39–41, 44–46, 49, and 58.2 We have jurisdiction under
35 U.S.C. § 6(b). We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as GE
Healthcare Bio-Sciences Corp. Appeal Br. 2.
2 The Office Action Summary refers to claim 9 rather than claim 10, but the
Examiner rejects claim 10. Final Act. 8. This error is harmless; Appellant is
aware that the Examiner rejected claim 10. Appeal Br. 4.
Appeal 2019-006788
Application 14/743,960

2
CLAIMED SUBJECT MATTER3
Appellant describes the invention as relating to systems for containing
and manipulating liquids relating to “cell culture, cell containment,
bioreactor, and/or pharmaceutical manufacturing systems.” Spec. 1:10–14.
Claim 1 is illustrative:
1. A system, comprising:
a first apparatus, comprising:
a first collapsible bag adapted for containing a
liquid, the first collapsible bag including at least one
inlet, at least one outlet, and a base plate that is attached
to the collapsible bag and configured to support an
impeller;
a first reusable support structure adapted for
surrounding and supporting the first collapsible bag; and
a second apparatus in fluid communication with the first
apparatus comprising:
a second collapsible bag, at least one inlet and at
least one outlet, and operative to separate solids from the
liquid;
wherein an outlet of the first collapsible bag is in fluid
communication with an inlet of the second apparatus, and
an outlet of the second apparatus is in fluid
communication with an inlet of the first collapsible bag to
facilitate recycling of the solids separated from the liquid back
to the first collapsible bag.
Appeal Br. 17 (Claims App.).

3 In this Decision, we refer to the Final Office Action dated October 29,
2018 (“Final Act.”), the Appeal Brief filed April 11, 2019 (“Appeal Br.”),
the Examiner’s Answer dated July 18, 2019 (“Ans.”), and the Reply Brief
filed September 18, 2019 (“Reply Br.”).
Appeal 2019-006788
Application 14/743,960

3
REFERENCES
The Examiner relies upon the prior art listed below in rejecting the
claims on appeal:
Name Reference Date
Chang et al.
(“Chang”) US 6,596,521 B1 July 22, 2003
Hodge et al.
(“the ’167 Patent”) US 7,629,167 B2 Dec. 8, 2009
Hodge et al.
(“Hodge”) US 2005/0272146 A1 Dec. 8, 2005
Selker et al.
(“Selker”) US 2008/0032389 A1 Feb. 7, 2008
REJECTIONS
The Examiner maintains (Ans. 3) the following rejections on appeal:
A. Claim 1 on the ground of nonstatutory obviousness-type double
patenting as being unpatentable over claims 1 and 2 of the ’167 Patent
in view of Chang and Selker. Final Act. 5.
B. Claims 1, 2, 7, 10, 13, 17, 18, 20, 22, 23, 25, 26, 32–34, 39–41, 46,
49, and 58 under 35 U.S.C. § 103 as obvious over Hodge in view of
Chang and Selker. Id. at 8.
C. Claims 44 and 45 under 35 U.S.C. § 103 as obvious over Hodge in
view of Chang. Id. at 16.
OPINION
We review the appealed rejections for error based upon the issues
identified by Appellant and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential),
cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t
Appeal 2019-006788
Application 14/743,960

4
has long been the Board’s practice to require an applicant to identify the
alleged error in the examiner’s rejections.”). After considering the evidence
presented in this Appeal and each of Appellant’s arguments, we are not
persuaded that Appellant identifies reversible error. Thus, we affirm the
Examiner’s rejections for the reasons expressed in the Final Office Action
and the Answer. We add the following primarily for emphasis.
Rejection 1, nonstatutory obviousness-type double patenting.
Appellant responds to this rejection by referring to the arguments
Appellant raises with respect to Rejection 2. Appeal Br. 8. Because those
arguments are unpersuasive for the reasons we explain below, we sustain
this rejection.
Rejection 2, obviousness over Hodge, Chang, and Selker.
The Examiner rejects claims 1, 2, 7, 10, 13, 17, 18, 20, 22, 23, 25, 26,
32–34, 39–41, 46, 49, and 58 under 35 U.S.C. § 103 as obvious over Hodge
in view of Chang and Selker. Final Act. 8. Appellant argues all claims as a
group. See Appeal Br. 9–15. Therefore, consistent with the provisions of 37
C.F.R. § 41.37(c)(1)(iv) (2017), we limit our discussion to claim 1, and all
other claims on appeal stand or fall together with claim 1.
The Examiner finds that Hodge teaches a disposable bioreactor
system teaching most recitations of claim 1. Final Act. 8–10 (citing Hodge).
The Examiner finds that Hodge differs with regards to explicit disclosure of
a second apparatus. Id. at 9. The Examiner finds that Chang discloses a
system for continuous fermentation that uses a fermenter in fluid
communication with a cell separator. Id. at 10 (citing Chang). The Examiner
finds that Chang teaches the second apparatus and recycling aspects of claim
Appeal 2019-006788
Application 14/743,960

5
1. Id. at 10–11. The Examiner determines that it would have been obvious to
modify Hodge to employ Chang’s separator “to separate the culture
cells/microorganisms from the culture medium” and states that the
suggestion for doing so would be “to separate and recycle the
microorganisms and separate out the ferment containing the product.” Id. at
11 (citing Chang). The Examiner further determines that modified Hodge
does not teach hollow fibers within a bag, and the Examiner relies on Selker
as teaching such fibers. Id. at 11 (citing Selker). The Examiner provides a
rationale why a person of skill in the art would have combined Selker’s
teachings with the teachings of Hodge and Chang. Id.
Appellant states that it “incorporates herein, its arguments made in the
prior responses.” Appeal Br. 10. The applicable rules do not permit such
incorporation. 37 C.F.R. § 41.37(c)(1)(iv) (“the brief shall contain . . . [t]he
arguments of appellant with respect to each ground of rejection, and the
basis therefor”). Below, we address arguments Appellant presents in the
Appeal Brief and Reply Brief.
Appellant argues that a person of skill in the art would not have
combined the teachings of Hodge and Chang because Hodge “require[s] a
high level of sterility that Chang is simply not capable of meeting.” Appeal
Br. 11. Appellant relies on the July 23, 2018, Declaration of Dr. Chor Sing
Tan (“Tan Decl.”) as providing evidence to support this argument. Id. This
argument is unpersuasive for two reasons. First, the Tan Declaration is
conclusory; it does not explain why a person of skill in the art would not
have been able to combine the teachings of Hodge and Chang while
maintaining sterility. Tan Decl. ¶ 5. Second and most importantly, the
Examiner finds that Hodge does not require sterility for every application.
Appeal 2019-006788
Application 14/743,960

6
Ans. 7. The Examiner’s finding is supported by a preponderance of the
evidence. See, e.g., Hodge ¶¶ 3 (“Such devices may also be used for sterile
mixing as well as non-sterile mixing applications.”), 9 (“embodiments of the
invention . . . also include advantages in non-sterile applications”).
Appellant argues that the Examiner does not state a specific non-
sterile use of Hodge. Reply Br. 7–8. Such a statement is unnecessary; as
explained above, Hodge teaches that its apparatus is useful for non-sterile
applications. A person of skill in the art would, therefore, understand that
sterility is not absolutely necessary to use Hodge’s apparatus. Appellant also
argues that non-sterile uses go against the Examiner’s stated rationale for
combining Hodge and Chang. Id. We disagree. The Examiner determines
that a person of skill in the art would have combined the teachings of Hodge
and Chang to separate and recycle microorganisms and ferment containing
the product. Final Act. 11. Appellant presents no evidence or persuasive
argument to show that sterility is required for all such processes. Meanwhile,
Hodge suggests just the opposite. Hodge ¶¶ 3, 9.
Appellant next argues that Chang teaches filtering microorganisms
“within the same vessel/fermenter in which the microoganisms are
cultivated” and thus teaches away from combining two apparatuses. Appeal
Br. 12. The Examiner, however, finds that Chang teaches a separate filter
and fermenter. The preponderance of the evidence supports the Examiner’s
position. See Chang Fig. 1 (indicating separate fermenters and cell
separators), 5:38–43 (“more than two stages of fermenters can be connected
with a cell-recycle multiple-stage continuous ferment[e]r in a serial manner,
each of which is equipped with cell separator to filtrate the ferment.”
(emphasis added)). Although Chang states that “microorganisms are
Appeal 2019-006788
Application 14/743,960

7
separated and recycled in the fermenter” (id. at 5:17–21), a person of skill in
the art would have understood this statement, in the context of Chang as a
whole, as using “the fermenter” to refer to a broader apparatus that includes
distinct fermenting and separation portions. Moreover, as the Examiner
finds, even if Chang taught that its separator and fermenter are combined,
Chang also teaches a second vessel for filtering. Ans. 7–8; Chang Fig. 1.
Appellant’s argument is also unpersuasive because Appellant does not
establish a teaching away. Appellant does not identify how either reference
criticizes, discredits, or otherwise discourages the solution of claim 1. See,
e.g., In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellant next argues that a person of skill in the art would not have
combined the teachings of Hodge and Chang because doing so would add
complexity and cost while gaining no benefit. Id. at 12–13; see also Tan
Decl. ¶ 6. This argument does not persuasively refute the Examiner’s stated
reason why a person of skill in the art would have combined the references’
teachings—“to separate and recycle the microoganisms and separate out the
ferment containing the product.” Final Act. 11. To the extent modified
Hodge would be more complex or costly, a person of skill in the art would
weigh this disadvantage against benefits for a given application. See
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a
given course of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine”).
Appellant also argues that claim 1 is patentable due to unexpected
commercial success. Appeal Br. 13–14; Reply Br. 8; Tan Decl. ¶¶ 8–9,
Ex. 1. Commercial success of a product embodying an invention tends to
show nonobviousness when “the commercial success . . . results from the
Appeal 2019-006788
Application 14/743,960

8
claimed invention” and is “due to the merits of the claimed invention beyond
what was readily available in the prior art.” J.T. Eaton & Co. v. Atl. Paste &
Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997). Commercial success can be
demonstrated by significant sales of the claimed product in a relevant
market. Id. However, information solely on numbers of units sold is
insufficient to establish commercial success. See In re Baxter Travenol
Labs., 952 F.2d 388, 391 (Fed. Cir. 1991). Moreover, evidence of
commercial success is only significant if there is a nexus between the
claimed invention and the commercial success. Ormco Corp. v. Align Tech.,
Inc., 463 F.3d 1299, 1311–12 (Fed. Cir. 2006); see also In re Mageli, 470
F.2d 1380, 1384 (CCPA 1973) (holding that conclusory statements or
opinions that increased sales were due to merits of invention are entitled to
little weight).
Here, the evidence presented by Dr. Tan is of limited persuasive value
because Dr. Tan provides no information regarding the relevant market. Tan
Decl. ¶¶ 8–9. Without accurate and persuasive evidence as to the relevant
market, evidence of unit sales carries little probative value. In re Baxter
Travenol Labs., 952 F.2d at 391 (“information solely on numbers of units
sold is insufficient to establish commercial success”). Although Dr. Tan
purports to present sales figures for bags before and after implementation of
claim 1, the difference in sales could have been, for example, due to
increased demand over time or change in marketing. The evidence presented
is not sufficient to establish that the XDR bags have commercial success
beyond sales of bags that are not within the scope of claim 1.
Dr. Tan’s declaration is also unpersuasive because it is conclusory.
Dr. Tan does not explain how the bags sold are unique to a system
Appeal 2019-006788
Application 14/743,960

9
implementing the recitations of claim 1 or why the features of claim 1
contributed to increased sales. Ans. 9–10. Dr. Tan’s declaration does not
provide information about the relevant market. See In re Huang, 100 F.3d
135, 140 (Fed. Cir. 1996) (holding that sales figures without information
about the size of market “provides a very weak showing of commercial
success, if any”) (emphasis original). Thus, Appellant’s argument regarding
evidence of commercial success does not, based on the totality of the
evidence before us, outweigh the evidence indicating obviousness or
otherwise identify error in the Examiner’s obviousness conclusion. See
Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1070 (Fed. Cir. 2016)
(holding that, based on totality of evidence, the evidence of secondary
considerations did not “tip the scales of patentability”) (quoting Graham v.
John Deere Co., 383 U.S. 1, 36 (1966)).
Appellant also argues that evidence of copying demonstrates non-
obviousness of claim 1. Appeal Br. 14–15; see also Tan Decl. ¶¶ 10–16 Exs.
2–6. Appellant’s evidence does not establish copying. Rather, the evidence,
at most, shows advertising of products with some similarity to claim 1.
Appellant does not attempt to establish that the products meet each recitation
of claim 1, and Appellant lacks evidence that the products were copied from
Appellant. Ans. 10–11.
Because Appellant’s arguments do not persuade us of Examiner error,
we sustain the Examiner’s rejection.
Rejection 3, obviousness over Hodge and Chang.
The Examiner rejects claims 44 and 45 under 35 U.S.C. § 103 as
obvious over Hodge in view of Chang. Final Act. 16. Appellant refers to the
Appeal 2019-006788
Application 14/743,960

10
arguments we address above. Appeal Br. 15. Because those arguments are
unpersuasive, we sustain this rejection.
CONCLUSION
In summary:
Claims
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1 Nonstatutory Double Patenting 1
1, 2, 7, 10,
13, 17, 18,
20, 22, 23,
25, 26, 32–
34, 39–41,
46, 49, 58
103 Hodge, Chang, Selker
1, 2, 7, 10,
13, 17, 18,
20, 22, 23,
25, 26, 32–
34, 39–41,
46, 49, 58

44, 45 103 Hodge, Chang 44, 45
Overall
Outcome
1, 2, 7, 10,
13, 17, 18,
20, 22, 23,
25, 26, 32–
34, 39–41,
44–46, 49,
58

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