Ex Parte Busch

Patent Trial and Appeal Board

Feb 20, 2018

12598811 (P.T.A.B. Feb. 20, 2018)

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.
12/598,811 12/03/2009 Christer Busch C2432.0095 3883
32172 7590
BLANK ROME LLP
1825 Eye Street NW
Washington, DC 20006
EXAMINER
LEAVITT, MARIA GOMEZ
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
02/23/2018 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):
#IPDocketing-DC @BlankRome.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTER BUSCH1
Appeal 2016-008664
Application 12/598,811
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a culture
medium for culturing of mammalian mesenchymal stem cells or osteoblastic
cells.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellant, the real party in interest is Ascendia AB. (Appeal
Br. 2.)
Appeal 2016-008664
Application 12/598,811
STATEMENT OF THE CASE
Claims on Appeal
Claims 15—20, 42^44, and 48 are on appeal.2 (Appeal Br. 13—14
(APPENDIX A).) Claims 15 and 42, the only independent claims on appeal,
are illustrative and read as follows (emphases added):
15. A culture medium for culturing of mammalian
mesenchymal stem cells or osteoblastic cells consisting
essentially of (a) a water-soluble cellulose derivative selected
from the group consisting of hydroxyethyl cellulose,
hydroxypropyl cellulose, methyl cellulose, ethyl cellulose,
hydroxyethyl-methyl cellulose, hydroxyethyl-ethyl cellulose,
and hydroxypropyl-methyl cellulose, (b) at least one cell growth
promoting or sustaining agent, (c) water, (d) optionally a
pharmaceutical, (e) a source of calcium and a source of
phosphate, (f) optionally a water-insoluble particulate material,
and (g) optionally a proteinaceous enamel matrix derivative for
periodontal tissue regeneration.
42. A culture medium for culturing of mammalian
mesenchymal stem cells or osteoblastic cells consisting (a) a
water-soluble cellulose derivative selected from the group
consisting of hydroxyethyl cellulose, hydroxypropyl cellulose,
methyl cellulose, ethyl cellulose, hydroxyethyl-methyl cellulose,
hydroxyethyl-ethyl cellulose, and hydroxypropyl-methyl
cellulose, (b) at least one cell growth promoting or sustaining
agent, (c) optionally a pharmaceutical, and (d) a source of
calcium and a source of phosphate, (e) optionally a water-
2 Appellant elected the following species with traverse: (1) hydroxypropyl-
methyl cellulose (HPMC) as the water-soluble cellulose derivative, (2) salts
of essential elements as the growth promoting/sustaining agent, (3) calcium
hydrogen phosphate as the source of calcium recited in claims 17 and 44,
and (4) water-insoluble calcium phosphate as the water insoluble particulate
material recited in claim 18. (See Appellant’s Response to Restriction
Requirement dated Jan. 3, 2012 and Final Action dated Aug. 14, 2015, at 2.)
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Application 12/598,811
insoluble particulate material, and (f) optionally a proteinaceous
enamel matrix derivative for periodontal tissue regeneration.
Examiner’s Rejections
1. Claims 15, 16, and 18 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Weiss,3 as evidenced by Both4 and Coming.5 (Ans. 4—7.)
2. Claims 15, 16, 18, 19, 42, and 43 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Weiss, as evidenced by Both and Coming.
{Id. at 8—11.)
3. Claims 15 and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Weiss, as evidenced by Both and Coming, and Lin.6 {Id.
at 11-12.)
4. Claims 15 and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Weiss, as evidenced by Both and Coming, and
Gestrelius.7 {Id. at 12—13.)8
5. Claim 44 stands rejected under 35 U.S.C. § 103(a) as unpatentable
3 Weiss et al., Injectable Bone Substitute Using a Hydrophilic Polymer,
Bone 25, 67S-70S (1999) (“Weiss”).
4 Both et al., A Rapid and Efficient Method for Expansion of Human
Mesenchymal Stem Cells, Tissue Eng. 13, 3—9 (2007) (“Both”).
5 Minimum Essential Medium (MEM) Alpha Medium Product Description,
http://cellgro.com/products/classical-media/minimum-essential-medium-
mem-alpha-medium, last accessed Apr. 14, 2015 (“Coming”).
6 Lin et al., US 2005/0271740 Al, pub. Dec. 8, 2005 (“Lin”).
7 Gestrelius et al., In vitro studies on periodontal ligament cells and enamel
matrix derivative, J. Clin. Perodontology 24 (Abstract) (1997)
http://onlinelibrary.wiley.eom/doi/10.l 111/j. 1600-
051X.1997.tb00250.x/abstract, last accessed Feb. 6, 2012 (“Gestrelius”).
8 This ground of rejection does not appear in the Final Action dated Aug. 14,
2015. However, there is no indication in the Answer that this was a new
ground of rejection, and there is no evidence on this record that Appellant
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Application 12/598,811
over Weiss, as evidenced by Both and Coming, and Arweiler.9 (Id. at 13—
15.)
6. Claims 42 and 43 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Daculsi,10 as evidenced by Both and Coming. (Id. at 15—17.)
7. Claims 42-44 stand rejected 35 U.S.C. § 103(a) as unpatentable over
Daculsi, as evidenced by Both and Coming, and Lin. (Id. at 18—19.)
8. Claim 48 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Daculsi, as evidenced by Both and Coming, and Gestrelius. (Id. at 19—
20.)
DISCUSSION
The common issue with respect to all of the rejections is whether the
limitation “(b) at least one cell growth promoting or sustaining agent” in
claims 15 and 42 is met by water, based on the Examiner’s reference to a
cell growth medium (a-MEM) that includes water.
Weiss Rejections
Rejection Nos. 1—5 are based on Weiss, as evidenced by Both and
Coming. (Ans. 4—15.) The Examiner finds that Weiss
teaches a polymer/CaP filler composite comprising a
macromolecular gel suspension comprising: the cellulosic
nonionic hydrophilic derivative hydroxypropyl methyl cellulose
(HPMC), falling with the scope of (a) “a water-soluble cellulose
derivative”, said cellulosic polymer being dissolved in bidistilled
filed a Petition to challenge this rejection as a new ground. Appellant does
not address this rejection the Reply Brief.
9 Arweiler et al., Antibacterial effect of an enamel matrix protein derivative
on in vivo dental biofilm vitality, Clin. Oral Invest. 6, 205—09 (2002)
(“Arweiler”).
10 Daculsi et al., US 5,717,006, issued Feb. 10, 1998 (“Daculsi”).
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Application 12/598,811
water at a polymer concentration 2% w/w (e.g., polymer
solution), falling within the scope of (c) “water” [claim 15], the
polymer solution was mixed with a CaP power, falling with the
scope of [(e) claim 15; (d) claim 42],
(Ans. 4—5, 8.)
The Examiner further finds that the different aqueous solutions
comprising the composite mixture in Weiss
inherently and [necessarily][11] read on “at least one cell growth
promoting or sustaining agent” as evidenced by the teachings of
Both, wherein human mesenchymal stem cells (hMSCs) grow
and differentiate in a [] modified minimum Eagle’s medium (a-
MEM) which is an aqueous solution well suited for supporting
the growth of a broad spectrum of mammalian cell lines (see
product description by Coming).
(Ans. 5, 8.)
Daculsi Rejections
Rejection Nos. 6—8 are based on Daculsi, as evidenced by Both and
Coming. (Ans. 15—20.) Similar to the Weiss Rejections, the Examiner finds
that Daculsi teaches a composition comprising a mineral phase and an
aqueous phase (an aqueous solution of a polymer derived from cellulose
(HPMC)), that “inherently and [necessarily] reads on ‘at least one cell
growth promoting or sustaining agent,’” relying on Both and Coming as set
forth above in connection with the Weiss Rejections. (Ans. 15—16.)
Appellant’s Arguments
Appellant argues that “[a]ll rejections in this appeal are based on the
proposition that water alone is a growth promoting or sustaining agent.”
11 Rejection No. 2 under Section 103 uses the term “implicitly.” (Ans. 8.)
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(Appeal Br. 8.) Appellant further argues that “[b]oth of the main references,
Weiss and Daculsi, fail to teach or suggest a composition containing a cell
growth promoting or sustaining agent as required in the claims on appeal.”
(Id. at 11.)
As to the Weiss Rejections, Appellant argues that the Examiner erred
“by limiting focus[] to the presence of water in MEM, while ignoring what
MEM actually constitutes and the fact that Weiss never mentions MEM.”
(Id. at 7.) Appellant further argues that it is “extremely well known” to
those skilled in this art “that MEM must contain amino acids and other
ingredients in addition to water. . . . There is nothing that teaches or suggests
that water in the absence of those amino acids and other ingredients
constitutes a growth medium.” (Id. at 8.) Appellant advances similar
arguments regarding Daculsi and the Daculsi Rejections; namely, that
Daculsi does not disclose MEM, and that “[t]he rationale advanced for water
being a cell growth promoting or sustaining agent (b) is the same as in the
rejection[s] based on Weiss, and has been shown to be invalid above.” (Id.
at 10.)
Analysis
We find that Appellant has the better position. In particular, we find
that Weiss and Daculsi fail to disclose, or teach or suggest, the limitation
“(b) at least one cell growth promoting or sustaining agent,” even though the
Examiner finds that MEM includes water, as evidenced by Both and
Coming. The Examiner has thus failed to set forth a prima facie case of
anticipation, which requires that a prior art reference disclose every
limitation of the claimed invention. See In re Schreiber, 128 F.3d 1473,
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1477 (Fed. Cir. 1997). The Examiner has also failed to set forth a prima
facie case of obviousness, which requires a suggestion of all limitations in a
claim. See CFMT, Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed.
Cir. 2003).
We separately address claims 15 and 42.
Claim 15
We address claim 15 by considering its proper construction, as
pertinent to this appeal. Claim 15 includes the limitation “(b) at least one
cell growth promoting or sustaining agent,” and a separate limitation “(c)
water.” (Appeal Br. 13.) Limitation (b) is thus properly construed as
something other than water. That is, conflating limitations (b) and (c) to one
limitation—water—would improperly vitiate limitation (b). See Texas
Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171 (Fed.
Cir. 1993) (“[T]o construe the claims in the manner suggested by TI would
read an express limitation out of the claims. This, we will not do.”).
Moreover, this construction is consistent with the Specification’s description
of what Appellant considers to be a “cell growth promoting or sustaining
agent” used in a culture medium. In particular, the Specification indicates a
“cell growth promoting or sustaining agent [being] selected from salts
comprising essential elements, mono- and disaccharides, amino acids,
peptides, proteins, and hormones”12 and that members from this group of
12 The Examiner characterizes this list as “exemplary and non-limiting.”
(See Ans. 10.) However, while the choice of what cell growth promoting or
sustaining agent to include in the medium may be optional in the claims, we
find no support on this record for the Examiner’s position that the “selected
from” list of such agents is “exemplary and non-limiting.” (See Spec. 5,11.
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cell growth promoting or sustaining agent be included in the culture medium
for culturing mammalian mesenchymal stem cells or osteoblastic cells. (See
Spec. 5,11. 28—30 and 6,1. 27—p. 7,1. 3.)
We determine that the Examiner’s conclusion that water is a cell
growth promoting or sustaining agent meeting limitation (b) of clam 15 is in
error. (See Reply Br. 1—2.)
Claim 42
Unlike claim 15, claim 42 does not recite “water” as being included in
the culture medium that is required to include “at least one cell growth
promoting or sustaining agent.” (Appeal Br. 14.) In rejecting claim 42
based on Weiss or Daculsi, the Examiner concludes that an aqueous solution
recited in these references meets the limitation “(b) at least one cell growth
promoting or sustaining agent.” (See Ans. 8, 15—18.) According to the
Examiner, the aqueous solution of both references “inherently” or
“implicitly” reads on limitation (b) in light of Both teaching that “human
mesenchymal stem cells (hMSCs) grow and differentiate in a [] modified
minimum Eagle’s medium (a-MEM)” and Coming supports that MEM is
“well suited for supporting the growth of a broad spectmm of mammalian
cell lines.” (Id.)
28—30; 8,11. 7—10 and 23—26; see also claims 3 and 4 as filed, Spec. 18.) In
every instance in the Specification where reference is made to a cell growth
promoting or sustaining agent, what is included as such an agent is bounded
by the “selected from. . .” list. That is tme even where the cell growth
promoting or sustaining agent is an optional ingredient to be included in the
culture medium. (Spec. 8,11. 7—10 and 9,11. 4—7.)
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We find the Examiner’s position to be erroneous. While MEM may
be an aqueous solution as disclosed in Both (Both at 4—5), such does not
establish that water without the rest of the compositional elements of MEM
is a cell growth promoting or sustaining agent. We are persuaded by
Appellant that neither Weiss nor Daculsi mention MEM, and that MEM
includes ingredients other than water, thereby weighing against the
conclusion that water alone is a cell growth promoting or sustaining agent.
(See Appeal Br. 7—11.) Thus, whether MEM is an aqueous solution that is
well suited to support mammalian cell growth, as the Examiner asserts Both
and Coming establish, is not evidence that water without the other
ingredients of MEM is inherently a cell growth promoting or sustaining
agent.
Accordingly, for the reasons set forth above, we reverse Rejection
Nos. 1-8.
Conclusions
A preponderance of evidence of record fails to support the Examiner’s
rejections of:
(1) claims 15, 16, 18, 42, and 43 under 35 U.S.C. § 102(b)
(Rejection Nos. 1 and 6); and
(2) claims 15—20, 42^44, and 48 under 35 U.S.C. § 103(a)
(Rejection Nos. 2—5, 7, and 8).
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
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