Ex Parte Perez et al

Patent Trial and Appeal Board

Aug 2, 2016

12364548 (P.T.A.B. Aug. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/364,548 0210312009
32692 7590 08/04/2016
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
FIRST NAMED INVENTOR
Mario A. Perez
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
62005US008 4242
EXAMINER
MACAULEY, SHERIDAN R
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
08/04/2016 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIO A. PEREZ, TERRY R. HOBBS, and
STEPHANIE J. MOELLER1
Appeal2015-000427
Application 12/364,548
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of culturing cells using a matrix of a thermoplastic film having a flaky
surface, which have been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
"Tissue engineering and wound healing are approaches to
reconstruction and/or regeneration of lost or damaged tissue" that rely on
1 Appellants identify the Real Party in Interest as 3M Co. and 3M Innovative
Properties Co. (Appeal Br. 2.)
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Application 12/364,548
extracellular matrices for cell growth. (Spec. 1: 16-18.) "[F]or successful
tissue regeneration, sufficient cell propagation and appropriate
differentiation must be achieved in a three-dimensional cellular composite."
(Spec. 1:25-27.) In culture, "[c]ells often lose their morphology as well as
their biochemical and functional properties. As a result, dedifferentiated
cells may behave differently compared to their original tissue environment."
(Spec. 3:7-12.) According to Appellants' Specification "[i]n order for
cellular proliferation and differentiation [] to occur, attachment must occur
to the [extracellular matrix] with sufficient surface area," and to maintain
cell viability "[t]he free exchange of nutrients, gases and waste to and from
the cells proliferating throughout the [extracellular matrix] is necessary."
(Spec. 3: 12-18.) Appellants' invention is directed to a method of culturing
cells with an extracellular matrix. (Spec. 32: 6-13.)
Claims 1-12 and 17 are on appeal. 2 Claim 1 is representative and
reads as follows:
1. A method of culturing cells comprising:
providing a matrix of biaxially oriented, thermoplastic
film substrate having a schistose surface, the matrix dispersed
in a cell culture medium; and
inoculating the matrix with cells, allowing for cell growth
and attachment within the thickness of the matrix.
(Appeal Br. 14.)
2 Claims 13-16 are also pending, but stand withdrawn from consideration.
(Appeal Br. 2.)
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Application 12/364,548
The following grounds of rejection by the Examiner are before us on
review:
Claims 1-11 and 17 under 35 U.S.C. § 103 as unpatentable over Ma3
and Perez.4
Claims 1-12 and 17 under 35 U.S.C. § 103 as unpatentable over Ma,
Perez, and Ratner5 or Kim. 6
Claims 1-11 and 17 under the judicially-created doctrine of
obviousness-type double patenting over claims 1-18 of Perez and Ma.
Claims 1-12 and 17 under the judicially-created doctrine of
obviousness-type double patenting over Ma, Perez, and Ratner or Kim.
DISCUSSION
The Examiner finds that Ma teaches a method of culturing cells using
a porous structured polymer matrix dispersed in cell culture medium, where
the structure comprises platelets. (Final Action 3--4.) According to the
Examiner, the platelet structure is a flaky structure. (See, e.g., Final Action
5; Ans. 4--5.) The Examiner notes that Ma teaches the matrices disclosed
"are useful in a number of applications, such as tissue engineering scaffolds,
cell culture matrices, wound dressings, separation membranes, column fillers
for chromatography, filters, packaging material, and insulation material."
(Final Action 3.) The Examiner also finds that Ma teaches that "surface area
3 Ma, US 2002/0005600 Al, published Jan. 17, 2002.
4 Perez et al., US 6,331,343 Bl, issued Dec. 18, 2001.
5 Ratner et al., Biomaterials: Where We Have Been and Where We Are
Going, 6 Annu. Rev. Biomed. Eng. 41-75, (2004).
6 Kim et al., Development of biocompatible synthetic extracellular matrices
for tissue engineering, 16 Tibtech 224--230, (1998).
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Application 12/364,548
is an important factor in designing a matrix for cell culture and tissue
engineering." (Final Action 5.) The Examiner acknowledges that Ma does
not teach the underlying platelet formations has the claimed "biaxially
oriented, thermoplastic film substrate having a schistose surface" (Claim 1 ).
(Final Action 4.)
The Examiner finds that Perez teaches the biaxially oriented,
thermoplastic matrix claimed and that the surface "may comprise flakes that
are at the micrometer scale" (Final Action 4) and that the surface of the
matrices taught "advantageously provide a greater surface area" (Final
Action 5). The Examiner further finds that Perez teaches "the matrices are
useful in a number of applications, such as tape backings, filters, and
insulation materials." (Final Action 5.)
According to the Examiner, it would have been obvious to one of
ordinary skill in the art to use the Perez matrix in the cell culturing method
taught by Ma with a reasonable expectation of success (a) because one of
ordinary skill in the art "would ... recognize that the matrix of Perez would
... be useful in a method of culturing cells" in light of the fact that "both
[Ma and Perez] teach the use of [their] matrices [comprising similar
polymers and a flaky structure] for various purposes ranging from industrial
to biomedical" and there are "similar applications" taught in both, "such as
in filters and insulation materials and Ma further teaches that the matrices
are useful in methods of culturing cells" and (b) the Perez matrix has a
"greater surface area," which Ma teaches "is an important factor in
designing a matrix for cell culture and tissue engineering" and Ma teaches a
number of different configurations have been used for tissue culture. (Final
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Application 12/364,548
Action 5-7; Ans. 3--4.) The Examiner's rationale is the same for both the
obviousness of claim 1under35 U.S.C. § 103 and the judicially created
doctrine of obviousness-type double patenting. (Compare Final Action 5-7
to Final Action 9-10.)
We do not agree with the Examiner's conclusion of obviousness under
§ 103 or under the judicially created doctrine of obviousness-type double
patenting. Instead, we find ourselves in agreement with Appellants that the
Examiner has not advanced a sufficient motivation in the applied prior art or
a convincing line of reasoning that would have suggested the claimed
invention is obvious over Perez and Ma, even with Appellants' concession
that Perez teaches the claimed matrix material. (Appeal Br. 4--7).
First, we note that contrary to the Examiner's finding (Final Action 6),
Perez does not teach its matrix is useful in biomedical applications. Perez
discloses that the polymer matrix films of the invention
find use as tape backings, paper-like substrates for printing or
graphics, filters, fibrous mats and thermal and acoustical
insulation
(Perez 1: 11-14 ), or as "density reinforcements for thermo sets, impact
modifiers or crack propagation prevention in matrices such as
concrete ... and as fibrillar forms (dental floss or nonwovens, for example)"
(Perez 2:31-39).
Ma teaches that its inventive porous materials may be used
for many different applications such as tissue engineering
scaffolds, cell culture matrices, controlled release matrices,
wound dressings, separation membranes, column fillers of
chromatography, filters, packaging and insulating materials,
and so forth.
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Application 12/364,548
(Ma i-f 2.) We agree with Appellants (Appeal Br. 10) that the mere fact that
Perez and Ma both teach that their matrices are useful in filters and as
insulation material does not provide a basis for presuming Perez's matrices
would also be useful as a cell culture matrix, contrary to the Examiner's
view (Final Action 5, 9-10). The Examiner has not provided a rationale that
links the properties that make Ma's matrix material useful for filters and as
insulation material to making it also useful for cell culturing. Nor does the
Examiner demonstrate by a preponderance of the evidence that Perez's
material has the same properties described in Ma that make Ma useful for all
of the uses Ma discloses. As Appellants explain (Appeal Br. 9-10) the
matrices of Ma and Perez, in fact, have different porous structures, as
discussed below, and the macroporous structure is an attribute that Ma
indicates is an important parameter to control in tissue scaffolding. (Ma i-fi-1
6-9.)
We agree with Appellants (Appeal Br. 9-10) that, not only does Ma
not teach a biaxially oriented matrix (Appeal Br. 11 ), Ma does not teach the
use of matrices that have "flaky structures" (Appeal Br. 10), despite its
indication that the PLLA foamed skeleton "was composed of platelets" (Ma
i-f 96). Ma teaches the wall of the pores may have a platelet-like structure,
derived from the micropores in the wall (Ma Figs. 4C and 4D), not that the
macroporous structure is a flaky (or platelet-like) structure. (Ma i-f 96.)
We also agree with Appellants (Appeal Br. 9), that one cannot ignore,
as the Examiner has, Ma's teaching regarding the importance of a controlled
macroporous architecture and only focus on Ma's teaching that surface area
is important. There is no dispute that Ma teaches that increased surface area
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is a consideration that is important for a matrix material to be used in tissue
scaffolding. (Appeal Br. 5.) However, that is only one parameter
recognized as important. (Ma i-f 6.) Ma specifically teaches that the
invention described "advantageously has a designed and well-controlled
macroporous architecture" that "advantageously has substantially
completely interconnected pores" in contrast to prior art methods that
formed "random pore shapes and/or arrangements." (Ma i-f 9; Appeal Br. 9.)
The fact that Ma teaches "random geometrically shaped materials may
be desirable for incorporation into cell scaffolds" (Ans. 2 (citing Ma i-f 9))
does not mean the controlled macroporous architecture having
interconnected pores is omitted in the random geometrically shaped
materials. Indeed, Ma specifically indicates that the "well-designed and
controlled three dimensional configurations" of the macroporous
architecture is still a significant feature of the "random geometrically shaped
materials. (Ma i-f 9.) Thus, in stark contrast to the Examiner's assertion that
Ma teaches matrices with similar properties to that of Perez (Final Action 5;
Ans. 4), the fact that Perez's matrices "possess[] random interstitial spaces"
(Ans. 2-3) confirms that there is a significant difference in structural
properties between Ma's matrices and Perez's matrices. We agree with
Appellants that this difference in porosity, a factor that Ma indicates is
important to the matrix to be used for cell growth in tissue engineering (Ma
i-f 6), is at least one reason that one of ordinary skill in the art would not have
been motivated to use or have reasonably expected Perez's matrix to work in
the tissue scaffolding application described in Ma.
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Moreover, that Ma teaches "a number of additional configurations
have been used for tissue culture" (Ans. 3), does not provide a sufficiently
specific motivation to use or a suggestion that Perez's significantly different
matrix would reasonably be expected to work in Ma's tissue culturing
application. At best, such a generalization indicates that the proposed
modification may be "obvious to try." Obvious to try may lead to a
conclusion of obviousness "[ w ]hen there is a design need or market pressure
to solve a problem and there are a finite number of identified, predictable
solutions." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). The
statement in Ma cited by the Examiner, however, does not identify any
specific solution. Cf In re Kubin, 561F.3d1351, 1359 (Fed. Cir. 2009)
("[W]hat was [impermissibly] 'obvious to try' was to explore a new
technology or general approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance as to the
particular form of the claimed invention or how to achieve it.") (citing In re
O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). In addition, as Appellants
point out, Ma teaches cell culturing using matrices is challenging. (Appeal
Br. 7 (citing Ma i-f 5); see also Appeal Br. 10-11.)
For the foregoing reasons, we conclude that the Examiner has not
upheld the required burden of establishing a prima facie case of
obviousness. In re Sullivan, 498 F.3d 1345, 1351 (Fed. Cir. 2007) ("It is
well settled that the PTO bears the initial burden of presenting a prima facie
case ofunpatentability.") (internal quotation marks omitted). We, therefore,
reverse the rejection of claims 1-11 and 17 under 35 U.S.C. § 103 over Ma
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and Perez and under the judicially-created doctrine of obviousness-type
double patenting over Ma and claims 1-18 of Perez.
Claim 12 ultimately depends from claim 1. The Examiner does not
point to any teaching in Ratner or Kim that would remedy the deficiency of
the combination of Perez and Ma discussed above. Accordingly, we also
reverse the rejection of claims 1-12 and 17 under 35 U.S.C. § 103 over Ma,
Perez, Ratner, and Kim and under the judicially-created doctrine of
obviousness-type double patenting over Ma, claims 1-18 of Perez, Ratner,
and Kim.
SUMMARY
We reverse the rejection of claims 1-11 and 17 under 35 U.S.C. § 103
as unpatentable over Ma and Perez.
We reverse the rejection of claims 1-12 and 17 under 35 U.S.C. § 103
as unpatentable over Ma, Perez, and Ratner or Kim.
We reverse the rejection of claims 1-11 and 17 under the judicially-
created doctrine of obviousness-type double patenting over claims 1-18 of
Perez and Ma.
We reverse the rejection of claims 1-12 and 17 under the judicially-
created doctrine of obviousness-type double patenting over Ma, Perez, and
Ratner or Kim.
REVERSED
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