Ex Parte JUST et al

Patent Trial and Appeal Board

Oct 19, 2018

12705682 (P.T.A.B. Oct. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/705,682 02/15/2010
27572 7590 10/23/2018
HARNESS, DICKEY & PIERCE, P.L.C.
P.O. BOX 828
BLOOMFIELD HILLS, MI 48303
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
LOTHARJUST
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.
4965-000408/CO 9085
EXAMINER
UNDERDAHL, THANE E
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
10/23/2018 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte LOTHARJUST, TIMO SCHMIDT,
and FRANZ MASER 1
Appeal2017-009937
Application 12/705,682
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Eberhard-Karls-Universifat
Tiibingen Universifatsklinikmn. App. Br. 3.
Appeal2017-009937
Application 12/705,682
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1--4 and 6-15. Specifically, claims 1-
4, 6-10, and 15 stand rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Erik (US 6,436,456 Bl, August 20,
2002) ("Erik"), Chancellor et al. (US 2006/0121006 Al, June 8, 2006)
("Chancellor"), and H. Herrmann et al., In Vitro Culture of Muscle Tissue
from Normal, Heterozygous, and Dystrophic Chicks, 22(2) J. CELL BIOLOGY
391--401 (1964) ("Herrmann").
Claims 11-13 stand rejected as unpatentable under 35 U.S.C. § I03(a)
as being obvious over the combination of Erik, Chancellor, Herrmann, and
Myles et al. (US 2002/0197718 Al, December 26, 2002) ("Myles").
Claim 14 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Erik, Chancellor, Herrmann, and
Gabriels, Jr. (US 4,996,154, February 26, 1991) ("Gabriels").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to the use of a collagen-containing
composition for the cultivation of biological cells, a method for the
cultivation of biological cells, a method for the implantation of biological
material into an organism and a method for the improvement of a
composition in its suitability for the cultivation of biological cells. Abstr.
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Application 12/705,682
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method for the cultivation of biological material,
comprising the following steps:
(1) Providing a composition suitable for use as a carrier
for biological material,
(2) Contacting said biological material with said
composition, and
(3) Incubating said composition with said biological
material under cultivation conditions,
wherein said composition comprises the following
parameters:
Collagen [wt.-%]:
Amide nitrogen [wt.-%]:
Polyol [ wt.-%]:
Fat [ wt.-%]:
Ash [wt.-%] :
Water [wt.-%]:
pH Value:
Weight per unit area [g/m2]:
Tensile strength [N/mm2]:
App. Br. 11.
approx .. 30 to 80,
approx .. 0.06 to 0.6,
approx .. 0 to 50,
approx .. 0 to 20,
approx .. 0 to 10,
approx .. 5 to 40,
approx .. 6.8 to 8.0,
approx .. 10 to 100,
approx .. 0.5 to 100.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings,
reasoning, and conclusion that Appellants' claims are primafacie obvious
over the combined cited prior art. We address the arguments raised by
Appellants below.
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Application 12/705,682
Issue 1
Appellants argue the Examiner erred in finding that Chancellor
discloses or suggests cultivating biological material on a commercial
sausage casmg. App. Br. 7.
Analysis
The Examiner finds that Erik teaches a film that is an edible collagen
casing, treated with ammonia, that is less than 3 5 microns in thickness
(0.035 mm). Final Act. 3 (citing Erik, col 1, 11. 50-55). The Examiner finds
that these collagen casings may be shaped into tubes and used in ham
production for producing sausages. Id. ( citing Erik, col. 2, 11. 60-68; col. 1,
11. 10-15). The Examiner finds that, given that Erik describes a collagen
casing produced commercially by Naturin GmbH, which is also the casing
disclosed in Appellants' Specification, the collagen film of the cited prior art
is either identical to, or sufficiently similar to, the claimed film that whatever
differences exist are not patentably significant. Id.
The Examiner finds that, although Erik does not disclose using its
casings as a carrier to cultivate cells, Chancellor teaches animal cells,
including muscle-derived cells ("MDCs"), seeded on a film or matrix such
as commercially available natural sausage casings comprising submucosa,
stem cells, and other precursor cells. Final Act. 4--5 ( citing Chancellor ,r,r
17, 10). The Examiner finds that such seeded casings can then be cultured
under appropriate conditions to proliferate the cells, and that the films can be
flat to form a monolayer, or rolled into a tube. Id. at 5 (citing Chancellor ,r,r
11, 15).
Appellants acknowledge that that compositions meeting the
limitations of the composition recited in claim 1 are "either inherently or
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Application 12/705,682
obviously met by Erik." App. Br. 6 (quoting Final Act. 4). However,
Appellants further agree with the Examiner's finding that Erik does not
teach casings used as a carrier to cultivate cells, and argue that the
Examiner's conclusion of primafacie obviousness therefore stands or falls
on whether the teachings of Chancellor, combined with the other cited prior
art references, teaches this limitation. Id. According to Appellants, the
Examiner's primafacie conclusion of obviousness is based on Chancellor's
teaching the use of commercial sausage casings as a scaffold for growing
biological material. Id. at 7. Appellants disagree, and argue that the
Examiner has impermissibly relied upon hindsight in this obviousness
analysis. Id.
Appellants contend that the Examiner has taken the position that
Chancellor teaches that cells, such as MDCs, can be seeded on commercially
available sausage casings. App. Br. 7. Appellants assert, however, that
Chancellor does not teach or suggest that commercially available sausage
casings have ever been used as a carrier for the growth of animal cells. Id.
Appellants assert that such use is the subject of Appellants' claims on
appeal, and is described for the first time in Appellants' Specification. Id.
Appellants argue that Chancellor states that MDCs are seeded onto a matrix,
and not onto a commercial sausage casing. Id. ( citing Chancellor ,r 17).
Appellants next point to the Declaration of Prof. Dr. Lothar Just2,
filed May 4, 2016 (the "Just Declaration"). Dr. Just states that:
2 Prof. Dr. Just is one of the named inventors of the instant application and
is Professor in the Institute of Clinical Anatomy and Cell Analysis at the
University of Tiibingen. Just Deel. ,r 1. Dr. Just received his Ph.D. degree
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In [0017] [ of Chancellor] the authors propose to cultivate cells
(MDCs) onto a matrix and to use the resulting cell/matrix
construct as a casing for sausages. There is further an implication
- although it does not say it directly- that a suitable matrix might
be made of collagen. I believe the U.S. Examiner has used this
implication as the basis to use Chancellor to reject my claims as
obvious or lacking inventive step.
App. Br. 8 (quoting Just Deel. ,r 5 (italics in original)). Dr. Just concludes
that: "the disclosure of Chancellor is drawn to solid scaffolds or to collagen
gels, which do not have the tensile strength recited in the claims."3 Id. at 8
( quoting Just Deel. ,r 11 ). Appellants therefore assert that Chancellor
teaches cultivating MDCs on a matrix and using the resulting construct as a
casing for sausage. Id. Appellants assert that, in this context, only the
resulting construct, i.e., the product made by seeding MDCs onto a matrix, is
subsequently used as a sausage casing. Id.
Appellants argue further that the matrix taught by Chancellor is not a
commercial sausage casing like that taught by Erik. App. Br. 8. Rather,
Appellants point to paragraph [0015] of Chancellor, which teaches that
MDCs are grown on "scaffolds and matrixes known in the art," and that "the
from the Albert-Ludwigs-University of Freiburg and has over 20 years of
experience. Id. We find Dr. Just qualified to render an expert opinion in
the instant appeal.
3 Because Appellants admit that Erik teaches essentially the same
composition as claimed, we reject Dr. Just's conclusion in this respect. See
In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of
patent law, a compound and all of its properties are inseparable; they are
one and the same thing").
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matrix ... may be composed ofbiosorbant components (e.g., polylactic acid
or polyglycolic acid) .... " Id. Appellants next note that paragraph [0016] of
Chancellor teaches that MDCs are cultured on microcarrier beads, so that the
matrix is made of collagen beads. Id. Appellants also note that Chancellor's
paragraph [0011] provides a suggestion to use a mixture of collagen,
polystyrene, or other elements to which cells adhere. Id. Finally, Appellants
point to claim 6 of Chancellor, which states that the "carrier is selected from
the group consisting of a collagen-containing substance, a chitin-containing
substance, a polylactic acid polymer and a polyglycolic acid polymer." Id.
Therefore, Appellants argue, the matrix of Chancellor is not a sausage
casing. Id.
Appellants acknowledge that paragraph [0017] of Chancellor teaches
that commercially available sausage casings include collagen casings, but
argue that, taken in context, paragraph [0017] teaches only that collagen is a
scaffold for growth and proliferation of animal cells. App. Br. 8.
Specifically, Appellants argue paragraph [0017] teaches only that a specific
compound in commercially available sausage casings, i.e., collagen, can be
used as a scaffold for growing animal cells. Id. Appellants note that their
Specification discloses the same fact. Id. ( citing Spec. 5).
Finally, Appellants argue that the Examiner also erred in concluding
that: "It would be obvious for one of ordinary skill in the art to use the
sausage casings of Erik [ ] in the method of Chancellor [ ] since Chancellor
[] expressly states sausage casings are suitable for their method." App. Br.
9 ( quoting Final Act. 5-6). Appellants assert that Chancellor does not teach
that sausage casings are suitable for the method of growing MDCs but,
rather, Chancellor applies MDCs onto a matrix, and the seeded matrix in
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tum can be used as a sausage casing. Id. Appellants contend that using
commercial casings as carriers on which to cultivate biological material is
taught only in Appellants' Specification. Id.
We are not persuaded by Appellants' arguments. Appellants
acknowledge that Erik teaches collagen-based synthetic sausage casings that
are essentially identical to the compositions recited in Appellants' claims
See Erik col. 1, 11. 13-19; Spec. ,r 17. Chancellor is directed to the use of
cultured animal cells as ingredients in nutritional and therapeutic products
by incorporating them into any of a number of edible, topical, oral, or other
products. Chancellor Abstr. Chancellor teaches: "the use of MDC-seeded
casings for sausages, vegetarian sausages, and/or other processed food
products." Id. at ,r 17. Specifically, Chancellor teaches that:
MDCs are seeded onto a matrix and the resulting construct is
used as a casing for sausage or a related product. Commercially
available sausage casings include collagen casings, regenerated
cellulose casings, and natural casings comprised of intestinal
submucosa. Two of these materials, collagen and intestinal
submucosa (which itself contains collagen as a principal
component), have already been shown to function as excellent
scaffolds for the growth and proliferation of animal cells in tissue
engineering applications. MDC-seeded casings can be further
built up from multiple layers of seeded matrices in order to add
thickness and integrity to the casing. The MDC-containing
casings can be filled with a variety of edible products including,
but not limited to, conventional meat or poultry-based sausage
material, vegetarian sausage material, and sausage material
containing animal cells grown in vitro and processed in
accordance with any of the aforementioned methods and
descriptions.
Id. ( emphasis added).
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Appellants' arguments notwithstanding, none of the language in the
claims expressly or implicitly requires the use of commercial sausage
casings. Appellants' Specification discloses that collagen-based sausage
casings meeting the requirements recited in the claims are commercially
available (see Spec. ,r 17), but such a disclosure is not limiting on the claims:
We remind Appellants that they may not attempt to import limitations from
the Specification into the language of the claims. See In re Van Geuns, 988
F.2d 1181, 1184 (Fed. Cir. 1993).
Summarizing, Erik teaches a collagen-based synthetic sausage casing
that is essentially indistinguishable from Appellants' claimed composition
used for cultivating, i.e., culturing, cells. Chancellor teaches the
incorporation of MDCs into food products and, further, teaches that
commercially available, collagen-based sausage skins comprising collagen
and intestinal submucosa are well known in the art to: "function as excellent
scaffolds for the growth and proliferation of animal cells in tissue
engineering applications." We agree with the Examiner that a person of
ordinary skill in the art would find it obvious to combine the teachings of
Erik (which teaches Appellants' claimed collagen-based composition) with
the teachings of Chancellor ( which teaches that the compositions of Erik are
known to be excellent matrices for cell culture). See In re Keller, 642 F .2d
413,425 (C.C.P.A. 1981) (holding that the test for obviousness is not ... that
the claimed invention must be expressly suggested in any one or all of the
references," but rather, "what the combined teachings of the references
would have suggested to those of ordinary skill in the art").
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Nor are we persuaded by Appellants' contention that the Examiner
impermissibly relied upon hindsight in concluding that the claims are prima
facie obvious:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Appellants have
not persuasively pointed to any limitation of the claims that could have been
gleaned only from Appellants' Specification and not from the prior art.
Appellants do not raise any arguments based on the disclosures of
Myles or Gabriels. We consequently affirm all of the Examiner's rejections.
DECISION
The Examiner's rejection of claims 1--4 and 6-15 under 35 U.S.C.
§ 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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