R. Lane. Smith et al.

Patent Trials and Appeals Board

Jan 2, 2020

14553869 - (D) (P.T.A.B. Jan. 2, 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.
14/553,869 11/25/2014 R. Lane Smith 3815.02-1D 9817
77974 7590 01/02/2020
STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING
BOZICEVIC, FIELD & FRANCIS LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
FOX, ALLISON M
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
01/02/2020 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@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte R. LANE SMITH, DENNIS R. CARTER, and
DAVID J. SCHURMAN
Appeal 2018-006463
Application 14/553,869
Technology Center 1600
Before TAWEN CHANG, RYAN H. FLAX, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 11, 18–20, and 23–28. See Final
Act. 2. 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 “The Board of
Trustees of the Leland Stanford Junior University.” Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to a hydrostatic pressure vessel comprising
human chondrocytes. Claim 11, reproduced below, is illustrative of the
claimed subject matter:
11. A hydrostatic pressure vessel comprising human
chondrocytes isolated from a human having osteoarthritis,
wherein the chondrocytes are present within a scaffold.
Appeal Br. 9 (Claims Appendix).
REFERENCE
The Examiner relied on the following prior art reference: Lafeber et
al., Intermittent Hydrostatic Compressive Force Stimulates Exclusively the
Proteoglycan Synthesis of Osteoarthritic Human Cartilage, Vol. 31, No. 7,
British Journal of Rheumatology, 437–442 (1992) (“Lafeber”).
REJECTION
Claims 11, 18–20, and 23–28 stand rejected under pre-AIA 35 U.S.C.
§ 102(b) as being anticipated by Lafeber. Final Act. 6.
OPINION
Claim 11 is the only independent claim on appeal. Appellant did not
provide separate arguments for any of the dependent claims. Accordingly,
we focus our analysis on independent claim 11, and the dependent claims
stand or fall with this claim. 37 C.F.R. § 41.37(c)(1)(iv); cf. 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.”).
Claim 11 is directed to “[a] hydrostatic pressure vessel comprising
human chondrocytes isolated from a human having osteoarthritis, wherein
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the chondrocytes are present within a scaffold.” Appeal Br. 9 (Claims
Appendix). The Examiner asserted that “natural articular cartilage contains
chondrocytes in an extracellular matrix” (citing Lafeber 437), and thus
concluded that the claim term “human chondrocytes . . . present within a
scaffold” reads on human articular cartilage. Final Act. 5.
The Examiner found that Lafeber placed samples of human articular
cartilage in microtitre plates with a culture medium, placed those plates in a
pressure chamber, and subjected the samples to intermittent hydrostatic
compressive forces. Final Act. 6–7 (citing Lafeber 438). The Examiner
found that “[t]he samples of normal cartilage, present in the microtitre plates
in the culture medium, provided in the pressure chamber before application
of any pressure . . . read[] on the [claimed] composition.” Final Act. 7.
More specifically, the Examiner stated: “The pressure vessel reads on a
hydrostatic pressure vessel. Healthy human articular cartilage inherently
contains human chondrocytes present within a scaffold (the extracellular
matrix of cartilage reads on a scaffold).” Id.
Appellant argues that it is unreasonable to interpret the claim term
“scaffold” to include the extracellular matrix (“ECM”) of cartilage, and that
“one of skill in the art would readily recognize that the ‘scaffold’ recited in
Claim 11 is a non-ECM support structure.” Appeal Br. 8. Appellant asserts
that “[b]ecause Lafeber does not disclose chondrocytes present within a
scaffold as required by Claim 11, Lafeber cannot anticipate.” Id.
To determine whether Lafeber anticipates, we must determine
whether the claim term “human chondrocytes . . . present within a scaffold”
reads on human articular cartilage, as asserted by the Examiner. Final
Act. 5. We determine that it does not.
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During patent examination, claim terms are given “the broadest
reasonable meaning . . . 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 the applicant’s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Here, Appellant’s Specification does not provide an express definition
for the term “scaffold.” The Specification uses the term “scaffold” in only
two instances. The first instance occurs in paragraph 52, which states:
“De novo formation” means production of cartilage connective
tissue, fibrocartilage, tendon and bone as a result of adherence
by chondrocytes, fibroblasts, fibrochondrocytes, tenocytes and
osteoblasts within a support structure (scaffold or collagen
matrix) following exposure to loading interval.
Spec. ¶ 52 (emphasis added). The second instance occurs in paragraph 83,
which states:
For in vitro treatment, damaged cartilage tissue is removed
from a patient by surgical means. The interval loading regimen
can be applied to the intact tissue such as osteochondro
cartilage graft for ex vivo treatment. For in vitro treatment, the
normal or diseased cartilage matrix is degraded and the
interval loading regimen is applied to the resulting cartilage
cells cultured in suspension within scaffold/support or as
monolayers. After the application of the loading regimen, the
resulting de novo formed tissue or collection of cells is re-
implanted into a patient. Preferably, but not necessarily, the
transplant is autologous.
Spec. ¶ 83 (emphasis added).
We find little support in these paragraphs for equating a native
cartilage sample with “human chondrocytes . . . present within a scaffold” as
recited in claim 11. Final Act. 5. Paragraphs 52 and 83 in the Specification
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both use the term “scaffold” in connection with discussing the de novo
production of cartilage. Paragraph 52 discusses the “de novo formation” of
cartilage as a result of adherence by cells “within a support structure
(scaffold or collagen matrix) following exposure to a loading interval.”2
Spec. ¶ 52. Use of the disjunctive “or” in paragraph 52 signifies a difference
between a scaffold and a collagen matrix, but does little to elucidate whether
the claim reads on a native cartilage sample. A “collagen matrix”
conceivably could be found within or outside of a native cartilage sample,
and thus we find that this passage does not clearly distinguish a scaffold
from a native cartilage sample.
Paragraph 83, however, is more instructive. This paragraph first
describes application of the loading regimen to “intact tissue” for ex vivo
treatment. Spec. ¶ 83; see also id. ¶ 86 (teaching that in the ex vivo method,
torn or shredded cartilage is surgically removed as a cartilage graft and
subjected to the loading regimen). The paragraph then describes an in vivo
treatment, wherein de novo tissue can be formed. In this method, a sample
of normal or diseased cartilage matrix is degraded, the resulting cartilage
cells are cultured in suspension with a scaffold/support or as monolayers, the
interval loading regimen is applied, and the resulting de novo-formed tissue
is re-implanted into the patient. Spec. ¶ 83. Thus, paragraph 83 of the
Specification distinguishes between treatment of a sample of native, intact
tissue and of tissue generated de novo from cells cultured in suspension with
a scaffold/support.

2 The Specification describes a “loading interval” as stimulation of treated
tissue or isolated cells with repeated periods of applied hydrostatic pressure
followed by periods of recovery. Spec. ¶ 68.
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Thus, on this record, we determine that the Specification distinguishes
between intact tissue (such as the sample of excised, native cartilage in
Lafeber) and tissue generated de novo from cells cultured in suspension with
a scaffold/support. We conclude that the sample of excised, native cartilage
in Lafeber therefore does not read on the claim term “human
chondrocytes . . . present within a scaffold.”
This understanding of claim 11 is consistent with the excerpts of the
O’Brien and Chan articles cited in the record.3 Appellant reproduced
Figure 1 from O’Brien in its Appeal Brief. See Appeal Br. 6. This figure
indicates that the scaffold and cells are distinct materials that are added
together to form engineered tissue, with the scaffold “act[ing] as a template
for tissue formation.” Appeal Br. 6 (quoting O’Brien Fig. 1). Thus, like the
guidance in the Specification, O’Brien discusses the use of a scaffold in the
context of tissue formation/engineering. We see nothing in the O’Brien
excerpts that indicates a person of ordinary skill in the art would have
considered a sample of excised, native cartilage like that in Lafeber to read
on the claim term “human chondrocytes . . . present within a scaffold.”
The quoted excerpts from Chan indicate that “scaffolds in engineered
tissues” are designed to perform functions analogous to the functions of the
“extracellular matrix (ECM) in native tissues.” Appeal Br. 7 (quoting Chan

3 In its Appeal Brief, Appellant quoted two articles, O’Brien, F.J. 14(3)
Materials Today 88–95 (2011) (“O’Brien”) and Chan & Leong, Scaffolding
in tissue engineering: general approaches and tissue-specific
considerations, Eur. Spine J. Suppl. 4:S467–S479 (2008) (“Chan”).
Appellant did not make copies of these articles of record, although it appears
that the Examiner located a copy of the Chan article. Ans. 7. Because the
record lacks copies of the referenced O’Brien and Chan articles, we limit our
analysis to the portions of the articles that are quoted in the record.
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Table 1). Again, like the Specification and O’Brien, Chan discusses the use
of a scaffold in the context of tissue formation/engineering. Nothing in the
cited excerpts from Chan uses the term “scaffold” in connection with a
sample of native tissue.
The Examiner quoted the Chan reference as stating: “Intuitively, the
best scaffold for an engineered tissue should be the ECM of the target tissue
in its native state.” Ans. 7 (quoting Chan S468) (emphasis omitted). While
this quote suggests that ECM in its native state could be an ideal scaffold on
which to build an engineered tissue, it does not support the notion that a
person of ordinary skill in the art would have considered a sample of human
articular cartilage as removed from a human to read on the claim term at
issue. Instead, Chan distinguishes “scaffolds in engineered tissue” from
“ECM in native tissues.” See Appeal Br. 7 (quoting Chan S468).
Although this does not impact our ultimate disposition of the case, we
note that we are also not persuaded by Appellant’s argument that “scaffold”
should be construed to mean “a non-ECM support structure.” Appeal Br. 8.
We see no support for such a construction in the Specification, because
paragraphs 52 and 83—the only paragraphs in the Specification that
expressly mention scaffolds—do not speak to the materials with which
scaffolds can or cannot be made. Moreover, we agree with the Examiner
that “[t]he reproduced sections of O’Brien et al and Chan et al are
considered to show that an artificial or exogenous material may serve as a
scaffold material in tissue engineering, but [are] not considered to
appropriately define ‘scaffold’ as being limited to artificial or exogenous
materials.” Ans. 7. More importantly, the issue at hand is not what
materials the scaffold can be made of, but whether natural articular cartilage
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containing chondrocytes in ECM reads on “human chondrocytes . . . present
within a scaffold” as recited in claim 11, as addressed above.
For the reasons discussed above, we determine that the claim term
“human chondrocytes . . . present within a scaffold” does not read on a
sample of human articular cartilage as removed from a human, as taught in
Lafeber. “Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). Because we determine that Lafeber does
not disclose each and every limitation of claim 11, we reverse the
anticipation rejection. We also reverse the rejection of claims 18–20 and
23–28, which depend from claim 11, for the same reason. In re Fritch, 972
F.2d at 1266.

CONCLUSION
We reverse the Examiner’s rejection of claims 11, 18–20 and 23–28
under pre-AIA 35 U.S.C. § 102(b) as being anticipated by Lafeber.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
11, 18–20
23–28
102(b) Lafeber 11, 18–20
23–28

REVERSED