Ex Parte Awad et al

Patent Trial and Appeal Board

Dec 29, 2016

10874402 (P.T.A.B. Dec. 29, 2016)

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.
1903-0001 7745
EXAMINER
FOX, ALLISON M
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE
10/874,402 06/23/2004
28078 7590 12/29/2016
MAGINOT, MOORE & BECK, LLP
One Indiana Square, Suite 2200
INDIANAPOLIS, IN 46204
Hani Awad
12/29/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANI AWAD, BRADLEY T. ESTES, and
FARSHID GUILAK1
Appeal 2015-007177
Application 10/874,402
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real parties-in-interest are the named inventors and
licensee Cytex Therapeutics, Inc. App. Br. 2.
Appeal 2015-007177
Application 10/874,402
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 2, 5, 7, 8, 28, 39-42, and 48—52.
Specifically, the claims stand rejected as unpatentable under U.S.C. § 112,
first paragraph, as lacking written descriptive support.2
Claims 1, 2, 5, 7, 8, 28, 39-42, and 48—52 also stand rejected as
unpatentable under U.S.C. § 112, first paragraph, as lacking enablement.
Claims 5 and 50-52 stand further rejected as unpatentable under
U.S.C. § 112, second paragraph, as being indefinite.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a product for implantation within
a soft tissue site of the human or animal body that comprises a pulverized or
morselized matrix of a substantially nonmineralized native soft tissue
(NSTM) of the human or animal body, provided in a therapeutic amount to
induce growth of native tissue or organs and healing at the tissue site. Abstr.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A product for introduction within a soft tissue site of the
human or animal body comprising a matrix consisting of a
morselized or pulverized substantially non-mineralized native
soft tissue (NSTM) of the human or animal body, wherein the
2 Appellants do not argue claim 28 on this ground, even though it was
rejected by the Examiner. See App. Br. 5; Final Act. 4. We consequently
consider claim 28 as being argued with the other claims.
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NSTM is composed of a soft tissue of the same type of tissue as
at the soft tissue site, and wherein the matrix is a three-
dimensional matrix operable to promote cellular growth within
and through said three-dimensional matrix.
App. Br. 20.
ISSUES AND ANALYSES
With the exception of the rejections under 35 U.S.C. § 112, second
paragraph, we agree with, and adopt, the Examiner’s findings and
conclusion that the appealed claims lack written descriptive support and
enablement under 35 U.S.C. § 112, first paragraph. We do not agree with the
Examiner’s conclusion that claims 5 and 50-52 are indefinite. We address
the arguments raised on appeal by Appellants below.
A. Rejection of claims E 2, 5, 7, 8, 28, 39-42, and 48—52 for lack of written
description support
Issue
Appellants argue the Examiner erred in finding Appellants’
Specification does not describe a three-dimensional matrix consisting of a
morselized or pulverized non-mineralized soft tissue matrix (NSTM)
operable to promote cellular growth within and through said three-
dimensional matrix. App. Br. 6.
Analysis
Appellants point out that the Examiner has admitted that Appellants’
Specification does describe a three-dimensional matrix consisting of
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morselized NSTM. App. Br. 5 (citing Final Act 5). However, Appellants
dispute the Examiner’s finding that there is no disclosure in the Specification
that this three-dimensional matrix has the ability to promote cellular growth
through the matrix on its own. Id. at 6. According to Appellants, the
Examiner finds that the disclosure in Example 1 of the Specification
requires the surgeon at the point of care to reconstitute the dry formulation
of the devitalized native soft tissue matrix derived from cartilage (“NSTM-
CH”) with saline to form an injectable slurry. Id. (citing Spec. 13).
Appellants argue that Example 1 discloses only one delivery
mechanism for introducing the claimed product into the site of a defect.
App. Br. 6. Appellants assert that, in other examples, different fluids are
combined with the claimed product, such as synovial fluid, blood serum or
plasma, saline, growth factors, serum, plasma or synovial fluid, reconstituted
cell suspension, ADAS cell suspension, hydrogel, and cell suspension. Id.
(citing Exs. 2—8). Appellants argue that none of these example fluids or
suspensions are described as essential to promote cellular growth in the
claimed three-dimensional matrix, because none of these example fluids are
required for this function. Id. Rather, Appellants contend, these exemplary
fluids can help with the introduction of the claimed product into a defect site
(e.g., saline), or can improve the function of the claimed matrix (e.g.,
chondro-inductive factors). Id.
Appellants argue further that the Specification discloses that the
NSTM “may be implanted or injected at the needed site(s) in the body,” and
that the NSTM composite can be “reconstituted as a tissue scaffold to
promote the ex vivo regeneration of various tissues which can then be
implanted in the body....” App. Br. 7 (citing Spec. 3). According to
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Appellants, the described NSTM scaffold is capable of ex vivo regeneration
of tissues, which necessarily involves cellular growth within and through the
NSTM scaffold. Id. Appellants point out that Example 1 of the
Specification discloses that the particle size of the native cells used to form
the inventive product is “a size effective to provide differentiation cues for
the native cells of the soft tissue site in which the product of the present
invention is implanted” and that differentiation cues are associated with cell
or tissue growth. Id. (quoting Spec 12). Appellants contend that, if tissue
ingrowth is not a function of the claimed NSTM product, then there would
be no need for providing differentiation cues to the native cells. Id.
Appellants argue the Specification describes this differentiation cue feature
because cellular growth through the NSTM product is characteristic of the
product. Id.
Appellants characterize the written description rejection as a new
matter rejection based on the assertion that newly added limitations
(promoting cellular growth in a three-dimensional matrix consisting of the
NSTM) are not supported in Appellants’ Specification. App. Br. 8.
Appellants assert that no determination was made in the Final Office Action
as to what a person of ordinary skill in the art would understand from
Appellants’Specification. Id. In particular, Appellants argue, no
determination was made as to whether a skilled artisan would understand the
specification to disclose that the matrix consisting of the NSTM is operable
to promote cellular growth; rather, Appellants argue, the rejection was
premised on details from the specific examples in which the claimed NSTM
product is combined with other compositions, such as saline, to form a
slurry. Id.
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The Examiner responds that the Specification does disclose
lyophilized, three-dimensional NSTM as a matrix, and that the lyophilized
three-dimensional NSTM matrix can be provided in its dry form, or mixed
with a liquid carrier or with other bioactive agents. Ans. 10. The Examiner
states that the rejection is not based upon the Specification’s failure to
disclose a lyophilized, three-dimensional NSTM matrix, per se, but rather
that Specification fails to disclose a lyophilized, three-dimensional NSTM
matrix which is operable to promote cellular growth within and through the
matrix. Id.
In response to Appellants’ argument that their Specification supports
the matrix consisting of NSTM is operable to promote cell growth on and
within the matrix due to the recitation that the tissue is pulverized to a size
“effective to provide differentiation cues for the native cells,” The Examiner
finds this passage only serves to state the individual milled particles are
capable of providing differentiation cues for native cells, which is a distinct
biological consideration from a three-dimensional matrix that is operable to
promote cell growth on and within the matrix. Id.
We are not persuaded by Appellants’ arguments. Claim 1 requires
that the matrix be “operable to promote cellular growth within and through
said three-dimensional matrix.” Claim 1 also requires that the matrix
“consists] of morselized or pulverized substantially non-mineralized native
soft tissue.” Because the claims use the transitional phrase “consisting of’ in
connection with the matrix, the matrix must contain only “pulverized
substantially non-mineralized native soft tissue.” In re Gray, 53 F.2d 520,
11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App.
1948) (“consisting of’ defined as “closing the claim to the inclusion of
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materials other than those recited except for impurities ordinarily associated
therewith”).
We find the Specification does not provide written description support
for the claims because the Specification does not teach a matrix consisting
only of pulverized substantially non-mineralized native soft tissue that is
operable to promote cellular growth within and through the three-
dimensional matrix. Indeed, the Specification suggests that a matrix
containing only pulverized non-mineralized native soft tissue would not
support growth. For example, in describing such pulverized tissue in
connection with Example 1, the Specification states:
In a preferred embodiment of the invention, the tissue is
pulverized to a particle size that is insufficient as a scaffold to be
populated by native cells. Instead, the particle size is limited to
a size effective to provide differentiation cues for the native cells
of the soft tissue site in which the product of the present invention
is implanted. In the preferred embodiment, the particle size is less
than about 800 pm. In a more specific embodiment, the particle
size is limited to a range of 1—100 pm.
Spec. 12 (emphasis added). This suggests that pulverized native soft tissue
alone is incapable of supporting growth. The Specification further suggests
that the pulverized tissue of Example 1 requires additional components to
support growth in its description of how the pulverized tissue is used. It
teaches that after being pulverized, the tissue in Example 1 is homogenized
and subsequently “freeze dried or lyophilized to produce a dry form of the
devitalized native cartilage matrix.” Id. This lyophilized form is
subsequently reconstituted: “in an appropriate volume of saline or a
pharmaceutical solution of chondro-inductive growth factors such that the
concentration of the reconstituted slurry is, for example, -20% (w/v). The
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surgeon then implants the hydrated slurry into the defect in a surgical repair
procedure.” Id. at 13. Notably the matrix implanted by the surgeon includes
saline and growth factors. Accordingly, it does not support claims that
require that the matrix consist only of the lyophilized particles and not the
additional fluid materials that constitute the reconstituted slurry.
Claim 1 requires that “the matrix is a three-dimensional matrix
operable to promote cellular growth within and through said three-
dimensional matrix.” This is in direct tension with the particles of the
lyophilized matrix, that are of a size “that is insufficient as a scaffold to be
populated by native cells.” The Specification does not resolve this tension;
it is silent with respect to how the lyophilized particles form a three-
dimensional matrix within and through which cellular growth is promoted.
We acknowledge Appellants’ argument that the Specification
discloses that the particles of the matrix are of a size that is “effective to
provide differentiation cues for the native cells of the soft tissue site in
which the product of the present invention is implanted.” See Spec. 12.
Nevertheless, we interpret this disclosure as meaning that the particles are
capable of providing various factors promoting differentiation. We do not
interpret it to mean that the lyophilized small particle matrix constitutes a
three-dimensional matrix within and through which cellular growth is
promoted, particularly given that only example provided in the Specification
of pulverized substantially non-mineralized native soft tissue expressly
describes lyophilized particles are of insufficient size to act as a scaffold to
be populated (that is, the cells are within and through) the native cells.
Moreover, a written description “that merely renders the invention obvious”
does not satisfy the written description requirement of the first paragraph of
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Section 112. AriadPharms, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352
(Fed. Cir. 2010).
The first paragraph of Section 112 requires that the written description
must:
clearly allow persons of ordinary skill in the art to recognize that
[the inventor] invented what is claimed. In other words, the test
for sufficiency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the
filing date.
Ariad, 598 F.3d at 1351 (internal citations omitted). In this instance we find
that a person of ordinary skill would not recognize that a slurry consisting of
particles too small in size to act as a scaffold for the cells comprises a matrix
capable of promoting cellular growth within and through said three-
dimensional matrix. We consequently affirm the Examiner’s rejection of the
claims.
B. Rejection of claims E 2, 5, 7, 8, 28, 39-42, and 48—52 for lack of
enablement
Issue
Appellants argue the Examiner erred in finding that Appellants’
Specification does not enable a method for making the claimed product that
the result of cellular growth within and through the matrix. App. Br. 10.
Analysis
Appellants argue the Examiner’s rejection is premised on the assertion
that there is no description of a method of producing an NSTM matrix that is
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operable to promote cellular growth within and through the matrix. App. Br.
11. Appellants contend the Examiner again relies on the same findings used
in support of the written description rejection; namely that cellular growth is
only shown in the reconstituted matrix embodiments. Id. Appellants repeat
their arguments presented supra in opposition to the Examiner’s conclusion.
Id.
Further, Appellants point to two prior art references Hiles et al. (US
2002/0099448, July 25, 2002) (“Hiles”) and Dupont et al. (US 5,618,925,
April 8, 1997) (“Dupont”) upon which the Examiner relied in prior art-based
rejections. App. Br. 10. According to Appellants, the Examiner finds the
methods taught by Hiles and Dupont “produce products which, on the face,
seem to be exceedingly similar to that which Applicant claims,” but these
“exceedingly similar” products do not have the property recited in
Appellants’ claims, and therefore one of ordinary skill would conclude that
there is unpredictability in the art. Id. Appellants contend this alleged
unpredictability was used in the Office Action to raise Appellants’ burden of
showing enablement and to assert that a person of ordinary skill would be
left with the burden of undue experimentation to produce a product that
meets the limitations of Applicant's claims. Id.
Appellants argue Hiles teaches a lyophilized SIS sponge prepared
using comminuted small intestine submucosa (SIS) with a mean particle size
of about 150 pm. App. Br. 11. However, Appellants argue the sponge of
Hiles is not a three-dimensional matrix as claimed. Id. For this, and other
reasons argued by Appellants, the products taught by Hiles are not
“exceedingly similar” to Applicant's claimed composition. Id.
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Similarly, Appellants argue Dupont teaches a composition that is a
tightly packed pellet, and not a matrix, that is capable of cellular growth
within the pellet, as recognized by a person of ordinary skill in the art. App.
Br. 12 (citing Declaration of Dr. Bradley Estes (the “Estes Deck) 113).
Appellants contend that Dr. Estes explained that the inventive product used
for comparison was “the product defined by the claims of the current
application,” which at least implicitly relies on the method steps described in
this application. Id. (citing Estes Deck 111). Appellants contend this
assertion is irrelevant to Dr. Estes’ conclusions regarding a product produced
using the protocol set forth in Dupont and relied on by the Examiner to
support the enablement rejection. Id.
Appellants point to Section 112’s requirement that “the claimed
invention be enabled so that any person skilled in the art can make and use
the invention without undue experimentation.” App. Br. 15 (citing M.P.E.P.
§2164.01). Appellants contend the Examiner’s rejection for lack of
enablement is not supported by any findings regarding the level of skill in
the art of the level of experimentation typical in this art. Id.
Specifically, Appellants contend the level of skill is very high: all of
the co-inventors have doctoral degrees. App. Br. 16. Appellants argue that,
even in the commercialization of tissue repair products, such as that claimed
by Appellant, companies justify their product with scientific support. Id.
(citing App’x to Applicant Initiated Interview Summary 17—21 March 11,
2013 (excerpts from product brochure of Arthrex, Inc.; App’x to Response
to Office Action, May 16, 2014).
Appellants argue further that, with respect to tissue engineering and
repair products, the unpredictability is not in whether certain procedures will
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produce a specific product with specific characteristics; rather the primary
unpredictability is whether the product will work in situ to repair the tissue
site. Id. Appellants argue a person of skill in this art would have engaged in
significant experimentation to prove efficacy. Id. However, Appellants
argue, based on their expert declarations, determining whether a particular
procedure will result in a three-dimensional matrix, or whether a resulting
three-dimensional structure is capable of cellular ingrowth is well within the
level of skill, essentially requiring no experimentation. Id. at 16—17.
The Examiner repeats the admission that Appellants’ Specification
discloses how to make a three-dimensional matrix consisting of NSTM
particles, but finds that there is no evidence that the matrix, per se (i.e.
without being reconstituted with water or fluid) is capable of supporting cell
growth on or within the matrix. Ans. 11.
With respect to Appellants’ argument that Hiles and Dupont are not
similar to the instantly claimed product, the Examiner finds the methods of
Hiles and Dupont are the same as the process steps reported in Example 1 of
the Specification, with the exception that Hiles and Dupont disclose specific
particle sizes (Hiles teaches milling particles to a size of 150 pm and Dupont
to a size of less than 500 pm), whereas the instant specification only reports
a particle size of less than 800 pm or preferably 1-100 pm. Ans. 11.
The Examiner disagrees with Appellants’ argument that the products
of Hiles and Dupont must contain a liquid element. The Examiner finds both
Hiles and Dupont teach lyophilizing the products, which is the same
technique reported in the instant Specification. Ans. 11.
With respect to the Estes Declaration, the Examiner states the
Declaration was relied upon to remove the anticipation rejection over
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Dupont. Ans. at 11—12. The Examiner finds, however, that although the
Estes Declaration compared the product of Dupont with Appellants’ claimed
composition, no specifics were provided on how the product representing
Applicants’ own work was made. Id. at 12.
The Examiner notes that an enablement rejection hinges on the idea
that products of identical composition, and made by the same method,
cannot have mutually exclusive properties. Ans. 12. The Examiner finds
that Appellants are arguing that the claimed product has properties distinct
from products which are made by the same methods disclosed by
Appellants’ Specification. Id. However, the Examiner finds that exact
correlation cannot be made because Appellants do not provide enough detail
in their Specification (i.e., regarding the exact size of the particles used to
create the NSTM matrix). Id.
We are not persuaded by Appellants’ arguments. As an initial matter
we agree with the Examiner that both Hiles and Dupont teach compositions
that read substantially on the claims on appeal. Hiles teaches a processed
collagenous submucosa of a soft tissue. Hiles 15. The submucosa is
delaminated from its source, lyophilized, and ground. Id. at || 40, 46.
Dupont also teaches using a homogenized ground cartilage solution, which
is centrifuged, the pellet lyophilized and then reconstituted in fluid prior to
administration. Dupont Abstr.; col. 8,11. 7—10. Both Dupont and Hiles,
therefore, teach “a matrix consisting of a morselized or pulverized
substantially non-mineralized native soft tissue (NSTM) of the human or
animal body, wherein the NSTM is composed of a soft tissue,” as recited in
claim 1.
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However, we do not entirely agree with the Examiner that Hiles does
not teach “wherein the matrix is a three-dimensional matrix operable to
promote cellular growth within and through said three-dimensional matrix,”
as recited in claim 1. Hiles explicitly teaches that its submucosal tissue
sponge “provides a three dimensional structure for cell culture or in vivo
growth.” Hiles 172. However, this only occurs after reconstitution of the
lyophilized tissue.
Nevertheless, for the reasons we have explained supra, we find no
support, either in the prior art or Appellants’ Specification, to persuade us
that a person or ordinary skill in this highly specialized art would have been
able, upon reading Appellants’ claims and Specification, to make and use “a
three-dimensional matrix operable to promote cellular growth within and
through said three-dimensional matrix” without undue experimentation. We
consequently affirm the Examiner’s rejection of the claims on this ground.
C. Rejection of claims 5 and 50-52 as indefinite
Issue 1: claim 5
Claim 5 depends from claim 39 and recites: “The product of claim 39,
wherein said NSTM further consists of a soft tissue of a different type of
tissue than the tissue at the tissue site.” App. Br. 20. The claim was
amended to read as such on February 11, 2009. Nevertheless, both
Appellants and the Examiner argue the claim as though it were still
dependent on claim 1, as in the original claim. Because neither Appellant
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nor the Examiner argue claim 5 with respect to the proper independent
claim, viz., claim 39, we do not consider the presented arguments, and we
reverse.
Issue 2: claims 50—52
Appellants argue the Examiner erred in finding that claims 50—52 are
indefinite due to uncertainty as to whether the matrix of claim 1 is “floating
in a composition of saline or if the matrix is reconstituted in the saline,
making the product a slurry or putty.” App. Br. 18 (quoting Final Act. 8).
Analysis
Claim 50 is representative and recites: “The product of claim 39,
wherein the matrix is combined with saline such that the matrix comprises
approximately 10%-20% weight per unit volume.” Appellants dispute the
Examiner’s finding that if the product is a slurry or putty it no longer
comprises a self-supporting matrix. App. Br. 18.
According to Appellants, claims 50-52 recite that the product of
independent claims 1, 39, and 49 includes the matrix combined with saline
in a specific weight ratio. Id. Whether the matrix is combined with another
composition, including saline, argue Appellants, does not render the
underlying matrix no longer self-supporting, because reconstituting the
NSTM matrix does not eliminate the self-supporting nature of the matrix.
Id. (citing Spec. 136). Appellants contend that there is consequently no
uncertainty in the limitations of claims 50—52.
Appellants also dispute the Examiner’s finding that claims 50—52
impermissibly broaden the scope of the respective independent claims
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because claims 1, 39 and 49 recite that the matrix “consists of’ the NSTM,
whereas claims 50—52 state that “the matrix now comprises a certain amount
of saline.” App. Br. 18.
Appellants maintain that claims 50—52 do not recite that the matrix
comprises any additional material. Id. Rather, Appellants argue, the claims
recite the matrix “is combined with saline” to form the claimed composition.
Appellants contend that the language “such that the matrix comprises
approximately 10%-20% weight per unit volume” has been interpreted by
the Examiner as a property of the matrix. Id. Appellants assert, however,
that the percent ratio pertains to the volume of the product and, in particular,
to the contribution of the matrix to the product when combined with the
saline. Id. Appellants therefore argue that a person of ordinary skill in the
art would not construe the claim as requiring the saline to be part of the
matrix, but instead would interpret the claim as intended to mean that the
product comprises the saline combined with the matrix in which the matrix
occupies a specific weight per volume ratio of the product. Id. at 18—19.
The Examiner responds that Appellants have previously traversed
rejections by the Examiner, based on references which taught matrices
combined with saline or fibrin, arguing that the use of the term “consisting
of’ in defining the matrix specifically excludes any additional material
(including water, saline, or fibrin gel) from being present in the matrix
material. Ans. 12—13 (citing Appellants’ Resp., June 21, 2010) The
Examiner states that prior art rejections over Badylak (US 5,695,998) and
Gomes et al. (US 2004/0129182) were removed specifically because of the
limiting to “consisting of’ with respect to the matrix. Id. at 13. The
Examiner therefore finds the presence of additional agents is specifically
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excluded in the matrix due to the transitional language “consisting of’ and
thus it cannot be claimed in the dependent claims that the matrix further
comprises saline, because, the Examiner finds, claims 50-52 improperly
broaden the scope of their respective independent claims. Id.
We disagree with the Examiner’s findings and conclusion. First,
claim 1 recites: “A product for introduction within a soft tissue site of the
human or animal body comprising a matrix....” Use of the transition
“comprising” in the language of a claim creates a presumption ... that the
claim does not exclude additional, unrecited elements.” Crystal
Semiconductor Corp. v. TriTech Microelectronics Inti, Inc., 246 F.3d 1336,
1348 (Fed. Cir. 2001). Consequently, we find the addition of saline does not
impermissibly expand the scope of the claim, because the claim language is
not exclusive of the addition of other matter (e.g., saline) to the claimed
product.
Second, we also agree with Appellants that the addition of saline in
amounts such that the matrix constitutes a given percent weight by volume
refers to the complete composition comprising the matrix and the added
saline. We consequently find claims 50—52 do not impermissibly expand the
scope of the respective independent claims, and we reverse the Examiner’s
rejection.
DECISION
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The Examiner’s rejection of claims 1, 2, 5, 7, 8, 28, 39-42, and 48—52
as unpatentable under 35 U.S.C. §112, first paragraph, is affirmed.
The Examiner’s rejection of claim 5 and 50—52 as unpatentable under
35 U.S.C. §112, second paragraph, is reversed.
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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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