Lifecell Corporation

Patent Trials and Appeals Board

Jan 1, 2021

2020003267 (P.T.A.B. Jan. 1, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/929,252 06/27/2013 Aaron Barere 128196-10301 1055
145655 7590 01/01/2021
McCarter & English, LLP/LifeCell
265 Franklin Street
Boston, MA 02110
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
01/01/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@mccarter.com
mvaneman@mccarter.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AARON BARERE and JEROME CONNOR
Appeal 2020-003267
Application 13/929,252
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TAWEN
CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–5, 7–16, and 20. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as LifeCell
Corporation. Appeal Br. 1.
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Application 13/929,252

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STATEMENT OF THE CASE
Autologous fat transfer, in which “adipose tissue is harvested from
one portion of a patient’s body and . . . reimplanted in a different anatomic
site,” “is a process that can be used for cosmetic and reconstructive
procedures.” Spec. ¶ 2. The Specification states:
Generally, the harvested tissue is processed before
reimplantation to remove undesirable substances such as
pharmaceuticals introduced into the tissue during harvesting,
and/or to increase the concentration of viable cells by removing
excess fluids and non-viable materials such as extracellular
matrix proteins and blood.
In the past, physicians have used various processing
conditions in an attempt to improve the quality of adipose
tissues for reimplantation. For example, poloxamers have been
used in an attempt to stabilize or alter adipocyte cell
membranes. Such approaches, however, may be overly
complicated or expensive.
Current methods for processing adipose tissue for
autologous fat transfer are effective but may be improved to
provide higher-quality tissue for reimplantation. Accordingly,
the present disclosure provides improved methods for
processing tissue for autologous fat transfer.
Spec. ¶¶ 2–4.
CLAIMED SUBJECT MATTER
The claims are directed to a method for treating tissue. Claim 1 is
illustrative:
1. A method for treating tissue comprising:
selecting a tissue comprising adipocytes for implantation;
contacting the tissue with a detergent at a concentration
and time sufficient to remove nonviable materials comprising
blood, water, and particulate tissue matrix from the tissue to
produce an adipose tissue comprising adipocytes and adipose
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extracellular tissue matrix, wherein a poloxamer is not used in
the contacting step; and
rinsing the tissue to remove the detergent, such that the
contacting and rinsing increase the concentration of viable
adipocytes in the tissue as compared to the tissue prior to
treatment.
Appeal Br. 15 (Claims App.) (formatting added for clarity).

REJECTION(S)
A. Claims 1, 3–5, 7, 8, 10–16, and 20 are rejected under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Austen2 and Kurita.3 Ans.
3.
B. Claim 9 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Austen, Kurita, and Smith.4 Ans. 9.

OPINION
A. Issues
The Examiner has rejected claims 1, 3–5, 7, 8, 10–16, and 20 as
obvious over Austen and Kurita and claim 9 as obvious over Austen, Kurita,
and Smith. The same issues are dispositive for both rejections.
Accordingly, we discuss the rejections together.

2 Austen, Jr. US 2010/0104542 A1, published Apr. 29, 2010.
3 Masakazu Kurita, Influences of Centrifugation on Cells and Tissues in
Liposuction Aspirates: Optimized Centrifugation for Lipotransfer and Cell
Isolation, 121 PLASTIC & RECONSTRUCTIVE SURGERY 1033 (2008).
4 Paul Smith et al., Autologous Human Fat Grafting: Effect of Harvesting
and Preparation Techniques on Adipocyte Graft Survival, 117 PLASTIC &
RECONSTRUCTIVE SURGERY 1836 (2006).
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The Examiner finds that Austen teaches all of the steps of claim 1,
except that it does not specifically describe any step in its process as a
“rinsing” step. Ans. 3–5, 5–6. However, the Examiner finds that Austen
teaches that, following incubation and washing of the samples with
detergents, the fat tissue samples are centrifuged and the middle fat layer
separated prior to injection into patients, and further finds that “it is
reasonable to consider that a majority of the detergent wash is removed by
the centrifugation and physical separation of the adipose tissue layer from
the detergent wash solution.” Ans. 4–5. The Examiner also finds that
Austen teaches that, prior to implantation the sample can be “further
processed, including washed, and in certain embodiments excess polymer
[(i.e., detergent)], or polymer solution, is removed by centrifugation or the
polymer is washed from the graft prior to implantation.” Ans. 5. The
Examiner thus finds that Austen establishes that “it is well known in the art
that the isolated adipose tissue would be washed (i.e. rinsed) to remove
excess polymer [(i.e., detergent)] prior to implantation.” Id.
Accordingly, the Examiner finds that it would have been obvious to a
skilled artisan to modify Austen’s method “by including rinsing to remove
excess polymer prior to implantation with a reasonable expectation of
success” and that “the claimed invention as a whole was prima facie obvious
in the absence of evidence to the contrary.” Ans. 5.5

5 The Examiner finds that Austen inherently teaches the limitation of “the
contacting and rinsing increas[ing] the concentration of viable adipocytes in
the tissue as compared to the tissue prior to treatment.” Ans. 6. However,
the Examiner further cites Kurita as additional support that “it was well
known in the art to process the fat tissue in a manner that increases the
viable adipocyte cells” and concludes that a skilled artisan would have found
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Appellant contends that the prior art combination does not teach “the
step of ‘contacting the tissue with a detergent at a concentration and time
sufficient to remove non-viable materials comprising blood, water, and
particulate tissue matrix from the tissue to produce an adipose tissue
comprising adipocytes and adipose extracellular tissue matrix’ as recited in
claim 1.” Appeal Br. 7–10. Appellant further contends that “Austen teaches
away from use of non-poloxamer detergents.” Appeal Br. 7, 10–12.
The issues with respect to this rejection are whether the combination
of Austen and Kurita suggests (1) the use of a non-poloxamer detergent; and
(2) contacting the tissue with a detergent “in a concentration and time
sufficient to remove non-viable materials comprising blood, water, and
particulate tissue matrix from the tissue to produce an adipose tissue
comprising adipocytes and adipose extracellular tissue matrix.”
B. Analysis
1. “wherein a poloxamer is not used in the contacting step”
We agree with Appellant that, based on the disclosures of Austen and
Kurita, the Examiner has not established that it would have been obvious to
a skilled artisan to use a non-poloxamer detergent in the claimed method.
Citing paragraphs 7, 97, 100, 139, and 145 of Austen, the Examiner
asserts that “Austen discloses the method employing Tween® 80, PEG 600,
PEG 3350, and a mixture [(i.e., a mixture of PEG 600 and PEG 3350)] (FIG.

it obvious “to modify the method of Austen to include increasing the
concentration of viable adipocytes, as taught by Kurita, for the predictable
result of successfully enhancing the viability of the fat graft in the method of
Austen, thus meeting the limitation of claim 1.” Id.
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13).” Ans. 5.6 Citing paragraphs 69 and 91 and Figure 13 of Austen, the
Examiner also discounts Appellant’s argument that Austen teaches away
from the use of non-poloxamer detergents, asserting that “Austen discloses
the same method steps as recited in claim 1 for both the non-poloxamer (e.g.
Tween) and poloxamer detergents.” Ans. 13.
We are not persuaded. While Austen describes contacting fat layers
with non-poloxamer detergents such as Tween® 80 and polyethylene
glycols, it does so in the context of unfavorably comparing these detergents
to the poloxamer P188. Austen ¶¶ 82–142 (Example 2, “Comparison of
P188 with Other Agents for Fat Transplantation”).
In comparing use of P188 to Tween 80 for purposes fat
transplantation, for example, Austen teaches that Tween 80 had “among the
highest reabsorption levels by weight,” where reabsorption is described as
“result[ing] from removal of dead cellular debris following
revascularization” and as “lead[ing] to inconsistent and undesirable results
for soft tissue restoration.” Id. ¶¶ 3, 139. Austen further teaches that
“Tween 80 resulted in the highest levels of injury by histological score and
was clearly toxic to fat grafts.” Id. ¶ 139. Similarly, Austen teaches that, as
compared to PEG 600, PEG 3350, and PEG 600+3350, “P188 demonstrated
statistically significant improvements in weight” and “superior cell viability”
at six weeks. Austen ¶¶ 114, 118. In conclusion, Austen states:
When polymers are all hydrophilic and large (PEG 3350,
PEG 8000) they are toxic to fat grafts. Small PEGs

6 We note that Austen generally teaches the use of triblock copolymers, not
merely poloxamer P188, in its method. However, the Examiner has not
asserted that triblock copolymers as taught by Austen include non-
poloxamer detergents.
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(PEG 600) are no better than saline. Non-block non-ionic
surfactants (Tween 80) also are toxic to fat. High
hydrophilicity seen in PEGs likely causes lysis of the
membrane by a detergent effect. Tween 80 has a long
hydrophobic tail and a smaller hydrophilic head. This
molecule also probably acts as a classic detergent and
lyses the cell membrane.
Id. ¶ 145.
Given the above teachings, we find that the Examiner has not
persuasively explained why a skilled artisan would combine the disclosures
of Austen and Kurita in a manner that meets the remaining limitations of
claim 1 and then use non-poloxamer detergents such as Tween® 80 or PEGs
in that method.
The Examiner asserts that Austen’s remark that “Tween 80 ‘probably’
acts as a classic detergent and lyses the cell membrane” is “merely
conjecture that is not supported by additional data evidencing cell lysis and
thus not persuasive.” Ans. 13. The relevant question, however, is whether a
skilled artisan would have had reason to further use Tween 80 in Austen’s
methods based on Austen’s disclosure, and the Examiner has not
persuasively explained why a skilled artisan would do so in light of Austen’s
teaching that use of Tween 80 resulted in “among the highest reabsorption
levels by weight” and “the highest levels of injury by histological score.”
The Examiner asserts that “[a]ll of the disclosures of a prior art
reference, including non-preferred embodiments, must be considered.” Ans.
14. The Examiner also asserts that “[a] prior art reference . . . is not limited
to the particular invention it is describing and attempting to protect.” Id.
The Examiner further asserts that “it is not a teaching away of significance
unless one of ordinary skill in the art would have understood the teaching as
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conveying that the method or structural configuration at issue cannot
reasonably be expected to achieve what it is required to achieve according to
the claimed invention.” Id.
We agree with the Examiner that all disclosures of a prior art
reference, including non-preferred embodiments, are to be considered in an
obviousness analysis. Merck & Co. Inc. v. Biocraft Labs., Inc., 874 F.2d
804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750
(CCPA 1976)). We also agree that “[a] reference may be said to teach away
when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). In particular, “a reference will
teach away if it suggests that the line of development flowing from the
reference’s disclosure is unlikely to be productive of the result sought by the
applicant.” Id.
In this case, however, Austen does in fact suggest that non-poloxamer
detergents such as Tween® 80 or PEGs should not be used to contact a
tissue comprising adipocytes where the tissue is to be used for implantation,
as required in claim 1, because, for instance, Tween® 80 and large
hydrophilic polymers such as PEG 3350 are toxic to fat grafts, whereas
small PEGs such as PEG 600 do not provide beneficial effect as compared to
saline control. Austen ¶¶ 139, 145. Similarly, Austen teaches that these
non-poloxamer detergents have inferior reabsorption levels by weight.
Austen ¶¶ 114, 139.
Neither are we persuaded by the Examiner’s apparent argument that
Austen does not teach away from using non-poloxamer detergents because it
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“discloses the same method steps as recited in claim 1 for both the non-
poloxamer (e.g. Tween) and poloxamer detergents.” Ans. 13.
It is true that “the question whether a reference ‘teaches away’ from
the invention is inapplicable to an anticipation analysis.” Celeritas
Technologies, Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir.
1998). However, the Examiner does not assert, and we do not find, that
Austen anticipates the method of claim 1. In particular, as the Examiner
acknowledges, Austen does not disclose a rinsing step in the method
described in paragraph 91,7 i.e., the method used to compare P188 with
Tween 80 and PEGs on their effects on fat transplantation. Ans. 5. Instead,
the Examiner asserts that the claimed rinsing step is disclosed in paragraph
69 of Austen, which teaches that in the methods of its invention “[t]he
resulting polymer/cell composition may be further processed before
implantation into a subject” and that, “[f]or example, the cells may be
washed, purified, extracted, or otherwise treated before implantation.” Id.;
Austen ¶ 69.
Even if paragraphs 69 and 91 of Austen in combination teach all of
the steps of claim 1, there must still be a reason to combine the disclosures
of these paragraphs to arrive at the claimed invention. Given the disclosures

7 To the extent the Examiner is arguing that “centrifugation to isolate the
adipose tissue layer from the soluble wash agents” to be a rinsing step, Ans.
5, we are not persuaded. The Examiner has not explained how the broadest
reasonable construction of “rinsing,” in light of the Specification, can
encompass centrifugation when the plain and ordinary meaning of “rinse” is
“to cleanse by flushing with liquid (such as water),” “to cleanse (as of soap)
by clear water,” and/or “to remove (dirt or impurities) by washing lightly or
in water only.” “rinse.” MERRIAM-WEBSTER, https://www.merriam-
webster.com/dictionary/rinse (last visited Dec. 22, 2020).
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in Austen discussed above regarding Tween 80 and the various PEGs, the
Examiner has not persuasively explained why a skilled artisan would have
modified the method disclosed in Austen’s paragraph 91 to add a washing or
rinsing step as described in Austen’s paragraph 69 and used Tween 80
and/or the PEG detergents in that modified method. In this regard, we note
that for purposes of an obviousness rejection it is not sufficient that the
Examiner finds that a skilled artisan could combine the disclosures of the
prior art to arrive at the claimed invention. InTouch Techs., Inc. v. VGO
Commc’ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014). Rather, the
Examiner must explain why a skilled artisan would have been motivated to
do so. Id.
Finally, the Examiner asserts that Appellant has not shown
unexpected results of improved cell viability commensurate with the scope
of detergents encompassed by claim 1. Id. We are not persuaded. Because
a preponderance of the evidence of record does not support the Examiner’s
conclusion that claim 1 is obvious over Austen and Kurita, evidence of
unexpected results is not necessary to reverse the rejection.
2. “contacting the tissue with a detergent at a concentration and
time sufficient to remove non-viable materials”
We further agree with Appellant that the Examiner has not established
a prima facie case that Austen and Kurita discloses a method of contacting
the tissue comprising adipocytes with a detergent “at a concentration and
time sufficient to remove non-viable materials comprising blood, water, and
particulate tissue matrix from the tissue.”
The Examiner asserts that paragraphs 91–92 of Austen teaches (1)
incubating the fat tissue layer from a lipoaspirate with various polymer
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agents (i.e., detergents) by washing for 30 minutes at 37ºC to allow for
sufficient mixing of tissue with the treatment agents and (2) centrifuging the
samples at 200 x G following incubation and washing and separating “the
middle fat layer . . . for injection into . . . mice.” Ans. 4. The Examiner
asserts:
Thus, the fat layer is removed from any remaining blood, water
and particulate tissue matrix and produces the fat layer, i.e.
adipose tissue, which comprises adipocytes and adipose tissue
extracellular matrix tissue that would be associated with the
adipocyte cell. Therefore the polymer incubation and washing,
followed by centrifugation and separation of the fat layer reads
on “contacting the tissue with a detergent at a concentration
and time sufficient to remove non-viable materials comprising
blood, water and particulate tissue matrix from the tissue to
produce an adipocyte tissue comprising adipocytes and adipose
extracellular tissue matrix”, as recited in claim 1.
Ans. 4; see also id. at 11 (further citing to paragraph 69 of Austen, which
teaches that “polymer/cell composition may be further processed before
implantation,” including by washing, purifying, extracting, or otherwise
treating the cells and also teaches that, in certain embodiments, excess
polymer may be removed by centrifugation or washing).
As Appellant points out, however, the Examiner appears to suggest
above that the removal of non-viable materials is accomplished by washing
and centrifugation in Austen, rather than by “contacting the tissue with a
detergent at a concentration and time sufficient to remove” such materials,
as required by claim 1. Reply Br. 4. Moreover, Austen teaches that “[a]ny
cells or tissue may be transplanted using the inventive technology” and that
in certain embodiments, “the cells are part of a fat graft (i.e., adipose tissue)
that contains different types of cells including, but not limited to, adipocytes,
stromal cells, epithelial cells, endothelial cells, fibroblasts, and blood cells.”
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Austen ¶ 8 (emphasis added). This would appear contra to the requirement
in claim 1 that the tissue selected for implantation be contacted with
detergent “at a concentration and time sufficient to remove non-viable
materials comprising blood, water, and particulate tissue matrix from the
tissue.” Appeal Br. 15 (Claims App.) (emphasis added).8
Thus, although we generally agree that where the claimed and prior
art method are substantially identical, the PTO may properly shift the burden
to Appellant to show that the prior art method does not necessarily or
inherently achieve the claimed result, see Ans. 11, in this case we are not
persuaded that the Examiner has shown that the prior art method is
substantially identical to the claimed method. Cf. In re Best, 562 F.2d 1252,
1254–1255 (CCPA 1977); In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).

8 The Examiner interprets Austen’s teaching with regard to blood cells to be
“directed to cells that can be added to the processed fat,” because “Austen’s
specific teaching of Fat Processing (paragraphs [0091]-[0092] notes washing
and centrifugation after polymer (detergent) treatment, which necessarily
separates the less dense fat layer from other cellular and tissue elements.”
Ans. 12. As an initial matter, the Examiner does not cite to any evidence to
support the assertions above. Furthermore, the Examiner does not cite to
persuasive evidence that washing and centrifugation are required in Austen’s
process, rather than merely embodiments. Thus, even assuming that
centrifugation necessarily removes some blood cells from fat layers, we are
not persuaded that Austen’s teaching regarding blood cells are only directed
to cells that can be added to the processed fat, as the Examiner asserts.
Finally, assuming the Examiner’s interpretation of Austen’s teaching to be
correct, the Examiner still has not persuasively explained why the method
described in Austen’s paragraph 91 necessarily contacted the tissue to be
transplanted with a detergent “at a concentration and time sufficient to
remove non-viable materials” from the tissue, given that the Examiner
appears to assert that it is the washing and/or centrifugation alone that results
in the removal of such materials.
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Accordingly, for the reasons explained above, we reverse the
Examiner’s rejection of claim 1 as obvious over Austen and Kurita. We
reverse the rejections of claims 3–5, 7–16, and 20, which depend directly or
indirectly from claim 1, for the same reasons. In re Fritch, 972 F.2d 1260,
1266 (Fed. Cir. 1992) (“[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious.”).

CONCLUSION
In summary:

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–5, 7, 8,
10–16, 20
103 Austen, Kurita 1, 3–5, 7, 8,
10–16, 20
9 103 Austen, Kurita,
Smith
9
Overall
Outcome
1, 3–5, 7–16,
20

REVERSED