Stephanie Kladakis et al.

Patent Trials and Appeals Board

Aug 18, 2020

2020000884 (P.T.A.B. Aug. 18, 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.
10/775,034 02/09/2004 Stephanie M. Kladakis 47062-019F01US
(MIT5032US
6915
30623 7590 08/18/2020
Mintz Levin/Boston Office
One Financial Center
Boston, MA 02111
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3799
NOTIFICATION DATE DELIVERY MODE
08/18/2020 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):
IPDocketingBOS@mintz.com
IPFileroombos@mintz.com
mintzdocketing@cpaglobal.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEPHANIE M. KLADAKIS,
SRIDEVI DHANARAJ, and ROBERT BOOCK
____________

Appeal 2020-000884
Application 10/775,034
Technology Center 3700
____________

Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s
decision to reject the claims. 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 Depuy
Synthes Products, Inc., a Johnson & Johnson company. Appeal Br. 1.
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STATEMENT OF THE CASE
The Examiner rejected the claims in the Final Office Action (“Final
Act”) as follows:
Claims 1, 3, 9, 10, 13–15, 17, 18, 20, 21, 24, 25, 30, 31, 34–36, 38,
39, 42–47, and 50–55 under pre-AIA 35 U.S.C. § 103(a) as obvious in view
of Harle (US 5,769,897, issued June 23, 1998) (“Harle”), Mueller et al. (US
5,837,235, issued Nov. 17, 1998) (“Mueller”), and Peterson et al. (US,
6,200,606 B1, issued Mar. 13, 2001) (“Peterson”). Final Act 3.
Claims 4, 16, 26, 37, 48, and 49 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Harle, Mueller, Peterson, and Binnette et al. (US
8,637,066 B2, issued Jan. 28, 2014) (Binnette”). Final Act. 6.
Claim 1 is representative and reproduced below:
1. A composite implant for repairing a tissue defect in a
patient, comprising:
a wedge-shaped porous tissue scaffold formed from a
bioresorbable, synthetic polymeric material and including at
least one pocket containing finely minced fragments of viable
tissue that are not suspended in a carrier,
wherein the tissue scaffold has opposed side walls,
opposed top and bottom walls, and an end wall, the pocket has
an opening formed in one of the opposed side walls, the opposed
top and bottom walls, and the end wall, and the pocket is closed
along a remainder of the opposed side walls, the opposed top and
bottom walls, and the end wall; and
wherein the viable tissue comprises naturally occurring
cells and their extracellular matrix, and the naturally occurring
cells and their extracellular matrix being native to the viable
tissue.

REJECTIONS BASED ON HARLE, MUELLER, AND PETERSON
The Examiner finds that Harle describes a wedge-shaped porous
tissue scaffold with a pocket filled with viable tissue fragments, meeting the
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corresponding first limitation of claim 1. Final Act. 3. The Examiner
acknowledges that Harle does not describe the fragments as being “finely
minced fragments of viable tissue” as recited in the claim. However, the
Examiner finds that Mueller describes minced tissue fragments. Id. at 3–4.
The Examiner determined it would have been obvious to one of ordinary
skill in the art to use minced fragments in Harle’s scaffold “such that the
particles enhance or are easily exposed to cells for promoting tissue
regeneration.” Id. at 4.
The Examiner also finds that Harle does not describe using cells “not
suspended in a carrier” as recited in the claim. Final Act. 4. The Examiner
determines it would have been obvious to one of ordinary skill in the art to
omit the carrier from the cells in view of the teaching in Peterson that cells
can be administered without a carrier. Id. The Examiner also determines it
would have been obvious to omit the carrier from the cells introduced into
the tissue scaffold pocket described by Harle “in order to provide immediate
cellular response by not providing a carrier to shield or encase the viable
cells, thus leaving them exposed.” Id.
Appellant argues that that the modification proposed by the Examiner
is contrary to the teachings in Mueller and Peterson. Appeal Br. 5.
With respect to Mueller, Appellant contends that Muller teaches a
seven step method, of which two steps are necessary and not optional. Id.
The two necessary steps, according to Appellant are:
(a) “preparation of a suspension of tissue particles of endogenic
omentum or other fatty tissue,” and (b) “application of the tissue
particles to the carrier by filtering the suspension through the
carrier (porous or pulverulent carrier), by filtering with the
carrier (pulverulent carrier), filtering off and subsequent
counterfiltration with a gelling liquid (gel-like carrier) or mixing
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with a not completely solidified gel (gel-like carrier).” [Mueller]
at col. 5, lines 1-25 (emphasis added).
Appeal Br. 6.
Appellant argues that one of ordinary skill in the art would not have
disregarded Mueller “by not suspending the tissue particles after acquiring
the tissue particles and by not using a carrier” because it is a necessary step
and omitting it would “change[] the principle of operation under which
Mueller is designed to operate. Appeal Br. 6.
This argument does not persuade us that the Examiner erred. The
Examiner cites Mueller for its teaching of using minced tissue fragments and
provides a clear explanation of why one of ordinary skill in the art would
have used them in Harle’s tissue scaffold. Final Act. 3–4. Thus, the teaching
in Mueller that a carrier is necessary is not pertinent because the Examiner
relied on the publication only for its description of minced tissue. Appellant
did not identify a flaw in the Examiner’s reasoning.
The rejection does not change the “principle of operation” of Mueller
as asserted by Appellant. Mueller applies its tissue suspension to the carrier
by filtering the suspension through it. Mueller, col. 5, ll. 8–15 (“application
of the tissue particles to the carrier by filtering the suspension through the
carrier (porous or pulverulent carrier)”). Thus, the suspension is necessary
for its application to the carrier material. Harle’s scaffold has a void for
depositing the tissue, and therefore does not require the tissue to be in a
suspension for its application to the scaffold. Thus, in the Examiner’s
rejection, Mueller’s carrier is replaced by the pocket for tissue described by
Harle which (like Mueller’s carrier) retains the tissue. Therefore, the
principle of operation of Mueller has not been changed.
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Appellant argues that the rejection is also contrary to the teachings in
Peterson. Appellant states that Peterson teaches the necessity of a carrier
(Appeal Br. 7) because the “carrier insures that the cells are retained on the
porous surface of the implant device-for a useful time period” (Peterson, col.
12, ll. 28–30). This argument does not persuade us that the Examiner erred.
There is no evidence on this record that the problem described in Peterson
would be encountered when Harle is used as the tissue support in the manner
proposed by the Examiner. As explained by the Examiner, and discussed
above, Harle’s scaffold has a pocket in which the tissue is placed, providing
a space to retain the tissue. See, e.g., Ans. 7–8.
For the foregoing reasons, the rejection of claim 1 as obvious is
affirmed.

Claims 42, 46, and 52
Claim 42, depends from claim 1, and further recites “wherein cells
from the viable tissue in the pocket of the scaffold populate at least a portion
of the scaffold.” Claims 46 and 52 depend on different independent claims,
but recite the same feature. Appellant states that the rejection is improper
because “by the Examiner’s own admission, Harle, Mueller, and Peterson
fail to teach or suggest features identical to the language of claim 42.”
Appeal Br. 9.
The Examiner does not make such an admission. The Examiner states
that it can be “deduced” from the teachings in the cited publications that the
cells populate the scaffold or carrier. Final Act. 6. In other words, the
Examiner finds with respect to this claim that cited publications reasonably
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suggest the claim limitation. Appellant does not identify a deficiency in the
Examiner’s findings, which were made explicit in the Final Action.

Claims 43, 47, and 53
Claim 47, depends from claim 1, and further recites “wherein at least
a portion of the scaffold is capable of being populated with cells from the
native tissue following implantation.” Claims 47 and 53 depend on different
independent claims, but recite the same feature. Appellant states that the
rejection is improper for the reasons as for claim 42. Appeal Br. 9. However,
the Examiner did not admit the limitations in claims 43, 47, and 53 are not
described in the cited publications. Rather, the Examiner cited specific
disclosure in Harle at column 8, lines 50–53 (“The communication
established by these micropores and capillary ducts in the second component
2 greatly facilitates the biointegration”) as teaching that “the cells of the
native tissue are capable of integrating in the scaffold once implanted.” Final
Act. 6.

Claim 54
Claim 54, depends from claim 1, and further recites “wherein the
pocket has the opening in the end wall, and the opening is centrally located
in the end wall.” Appellant states that this limitation has advantages, as
described in the Specification, in simplifying loading of the implant and
facilitating migration of the tissue through the entire scaffold in all
directions. Appeal Br. 10. In contrast, Appellant contends the void in Harle’s
scaffold “is in a slanted top wall extending between the first component's
large end 1B and small end 1C” and is not described as being centrally
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located and is silent as to the void’s location and size. Id. at 10–11.
Appellant further argues that the recited limitation solves the stated problem
and serves a different function and purpose than described in Harle. Id. at
11.
Fig. 2 of Harle is copied below:

Figure 2 shows the wedge-shaped body with a void 1D on one side of
the body for incorporating biomaterial 2. Harle, col. 7, ll. 45–58. Claim 54
does not require the end wall to be smaller than any other side wall.
Therefore, the depiction of void 1D in one end of the wedge and centrally
located, meets the limitations of the claim. While it may be true that Harle
does not disclose in words that void is centrally located, Figure 2 shows it
located centrally and a picture is no less a description of something than the
written words that could be used to describe it. Contrary to Appellant’s
argument (Appeal Br. 11), the Examiner does not rely on the measurements
or scale of the drawing, but rather relies on the explicit depiction of a void in
the center of the scaffold. Hockerson-Halberstadt, Inc. v. Avia Group
Intern., Inc., 222 F.3d 951, 956 (Fed. Cir. 2000), cited by Appellant, had to
do with the proportions of a groove in a drawing and whether it was
inconsistent with statements made during prosecution. The statement in
Hockerson-Halberstadt that “patent drawings do not define the precise
proportions of the elements and may not be relied on to show particular sizes
if the specification is completely silent on the issue” related to the issue of
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the proportions of grooves and fins in footwear. Id. Here, the precise
proportions of the void is not at issue, just whether it is centrally located, and
the figure expressly shows this. “Drawings and pictures can anticipate
claims if they clearly show the structure which is claimed.” MPEP 2125.I.
(Ninth Ed., Rev. 10.2019, Last Revised June 2020). The centrally located
void in Harle would possess the same advantages described in the
Specification. Appeal Br. 10.
To the extent, it would be implied that the claimed “end wall” is
placed at the end, this meaning, as discussed by the Examiner, is an
“intended use” of the scaffold because it depends on its orientation when
placed in the patient. Ans. 9–10.

Conclusion
For the foregoing reasons, the rejection of claim 1, 42, 43, 46, 47, 52,
53, and 54 is affirmed. Separate arguments were not provided for claims 3,
4, 9, 10, 13–15, 16, 17, 18, 20, 21, 24, 25, 26, 30, 31, 34–36, 37, 38, 39, 44,
45, 48, 49, 50, 51, and 55. The rejections of these claims are therefore
affirmed, as well. 37 C.F.R. 41.37(c)(1)(iv).

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 9, 10,
13–15, 17,
18, 20, 21,
24, 25, 30,
31, 34–36,
38, 39, 42–
47, 50–55
103 Harle, Mueller,
Peterson
1, 3, 9, 10,
13–15, 17,
18, 20, 21,
24, 25, 30,
31, 34–36,
38, 39, 42–
47, 50–55

4, 16, 26,
37, 48, 49
103 Harle, Mueller,
Peterson, Binnette
4, 16, 26,
37, 48, 49

Overall
Outcome
1, 3, 4, 9,
10, 13–18,
20, 21, 24–
26, 30, 31,
34–39, 42–
55

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

AFFIRMED