Ex Parte Brown et al

Patent Trial and Appeal Board

Jun 28, 2018

13815873 (P.T.A.B. Jun. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/815,873 03/15/2013
143139 7590 07/02/2018
MiMedx Group, Inc./ Alston & Bird LLP
Bank of America Plaza
101 S. Tryon Street, Suite 4000
Charlotte, NC 28280-4000
FIRST NAMED INVENTOR
Rebeccah J.C. Brown
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.
061435/483419 9319
EXAMINER
VISONE, THOMAS J
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
07/02/2018 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):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REBECCAH J.C. BROWN and THOMAS J. KOOB 1
Appeal2017-007877
Application 13/815,873
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1Appellants state that the real party-in-interest is MIMEDX GROUP, INC.
App. Br. 3.
Appeal2017-007877
Application 13/815,873
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-8 which stand rejected as
unpatentable under 35 U.S.C. § I02(e) as being anticipated by, or,
alternatively, under 35 U.S.C. § I03(a) as being obvious over, Morse et al.
(US 2013/0344162 Al, December 26, 2013) ("Morse").
Claims 1-8 which stand rejected as unpatentable under 35 U.S.C.
§ I02(e) as being anticipated by, or, alternatively, under 35 U.S.C. § I03(a)
as being obvious over, Liu et al. (US 2007/0021762 Al, January 25, 2007)
("Liu").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to compositions using modified
placental tissue grafts composed of at least one membrane, capable of
recruiting stem cells in vivo and in vitro. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A composition comprising an effective amount of
dehydrated micronized modified placental tissue, said
composition sufficient to elicit stem cell recruitment when placed
proximate to a body part, said micronized modified placental
tissue comprising particles having a particle size of less than
about 350 µm and comprising an effective amount of stem cell
recruiting factors so as to promote stem cell recruitment in vivo,
wherein at least a portion of said micronized placental tissue has
epithelial and fibroblast cells retained thereon, and further
2
Appeal2017-007877
Application 13/815,873
wherein the effective amount of micronized modified placental
tissue is at least 0.03 grams per kilogram of body weight of a
patient.
App. Br. 13.
A. Rejection of claims 1-8 under 35 U.S.C. § 102(e) over Morse
Issue
Appellants argue that the Examiner erred because Morse fails to teach
or suggest the limitation of claim 1 reciting: "wherein the effective amount
of micronized modified placental tissue is at least 0.03 grams per kilogram
of body weight of a patient." App. Br. 9.
Analysis
The Examiner finds that the composition disclosed by Morse is
structurally indistinguishable from Appellants' claimed composition. Final
Act. 3.
With respect to the disputed limitation, the Examiner finds that the
limitation simply encompasses the amount of prior art product present, e.g.,
in a container, package, or vial. Id. The Examiner finds that the limitation
does not confer any meaningful structural differences to distinguish the
claimed composition from the prior art. Id. The Examiner points out that,
although the discovery of a new use for an old structure based on unknown
properties of the structure might be patentable as a process of using the
composition, when the claim recites using an old composition or structure
and the "use" is directed to a result or property of that composition or
3
Appeal2017-007877
Application 13/815,873
structure, then the claim is anticipated. Id. (citing In re Hack, 245 F.2d 246,
248 (C.C.P.A. 1957); In re May, 574 F.2d 1082, 1090 (C.C.P.A. 1978).
Appellants argue that Morse does not disclose the effective amount
with sufficient specificity to render the claims anticipated. App. Br. 9.
According to Appellants, Morse does not teach or suggest the lower end of
the range of the claimed effective amount or any exemplary amounts that
would have fallen within the range claimed by Appellants. Id. Appellants
assert that Morse teaches that a 50 ml vial is used to store the micronized
materials, however, Appellants argue, Morse provides no information about
the amount of placental tissue that was stored in the vial. Id. ( citing Morse ,r
99).
Appellants argue further that Morse also fails to teach how to use "a
container, package, or vial" to determine the effective amount of micronized
modified placental tissue. Id. at 10. In fact, Appellants contend, Morse fails
to teach stocking the micronized placental tissue with "a container" or a
"package," let alone gauging an effective amount. Id.
We are not persuaded by Appellants' arguments. The limitation in
question reciting: "wherein the effective amount of micronized modified
placental tissue is at least 0.03 grams per kilogram of body weight [sic] of a
patient" is reciting an effective dosage or, more specifically, a quantitative
measure of the claimed composition to be applied per unit of body mass, that
will be effective in the recruitment of stem cells. However, the amount of
the claimed composition to be applied is not a structural property of the
composition itself; the structural properties of the composition are the same
regardless of whether 0.03 g/kg body mass or 3 g/kg body mass were to be
applied. Because Appellants' claims are directed to a composition of matter,
4
Appeal2017-007877
Application 13/815,873
and not to its use in, for example, a claimed method of recruiting stem cells,
and because Morse teaches all of the structural properties the claimed
composition, we affirm the Examiner's rejection on this ground.
B. Rejection of claims 1-8 under 35 U.S.C. § 103(a) over Morse
Issue
Appellants argue that the Examiner erred because Morse is not
eligible prior art for an obviousness rejection of Appellants' claims. App.
Br. 10.
Analysis
Appellants argue that both Morse and the Appellants' application
were co-owned by Appellant at the time of filing of the instant application,
and thus Morse is not available as prior art for the alleged obviousness
rejection under 35 U.S.C. § 103(c)(l). App. Br. 10.
The Examiner responds that applications and references (whether
patents, patent applications, patent application publications, etc.) will be
considered to be owned by, or subject to an obligation of assignment to the
same person, at the time the invention was made, if Appellants or the patent
owner(s) make(s) a statement to the effect that the application and the
reference were, at the time the invention was made, owned by, or subject to
an obligation of assignment to, the same person and signed in accordance
with 37 C.F.R § 1.33(b). Ans. 13 (citing Guidelines Setting Forth a
Modified Policy Concerning the Evidence of Common Ownership, or an
Obligation of Assignment to the Same Person, as Required by 35 U.S.C.
103(c), 1241 Official Gazette 96 (December 26, 2000) (the "Guidance").
5
Appeal2017-007877
Application 13/815,873
In reply, Appellants state that: "Morse and the subject application
were co-owned by Appellant, or subject to an obligation of assignment to
Appellant, at the time the invention was made." Reply Br. 2. The Reply
Brief is signed by counsel for Appellants, in accord with the Guidance. Id.
at 3. See Guidance ("Applications and references ... will be considered by
the examiner to be owned by ... the same person, at the time the invention
was made, if the applicant( s) or an attorney or agent of record makes a
statement to the effect that the application and the reference were, at the time
the invention was made, owned by, or subject to an obligation of assignment
to, the same person").
We consequently agree with Appellants that Morse is not eligible
prior art for a rejection on the ground obviousness under 35 U.S.C. §
10 3 ( c) ( 1), and we reverse the Examiner's rejection.
C. Rejection of claims 1-8 under 35 U.S.C. § 102(e) over Liu
Issue
Appellants argue the Examiner erred because Liu fails to disclose the
claimed micronized placental tissue that retains both epithelial and fibroblast
cells, as recited in claim 1. App. Br. 11.
Analysis
Appellants repeat their arguments supra that Liu, like Morse, fails to
disclose the claimed effective dosage. App. Br. 11.
Appellants argue further that Liu fails to disclose the claimed
micronized placental tissue that retains both epithelial and fibroblast cells.
App. Br. 11. According to Appellants, Liu discloses that the amniotic
6
Appeal2017-007877
Application 13/815,873
membrane is decellularized to the extent that "substantially all cellular
material and cellular debris ( e.g., all visible cellular material and cellular
debris) is removed," followed by washing "to assure removal of cellular
debris ... as well as any extracellular debris." Id. (citing Liu ,r,r 211-215).
Appellants assert that Liu discloses that the "decellularization steps may be
repeated as necessary ... until no visible cellular material and cellular debris
remain." Id. (citing Liu ,r 215). Appellants contend that, because both
epithelial and fibroblast cells are well-known cellular components, Liu
therefore discloses an amniotic membrane deprived of all epithelial and
fibroblast cells. Id.
The Examiner responds that Liu discloses that the "amniotic
membrane [tissue] is substantially decellularized." Ans. 15 (quoting Liu
,r 211) ( emphasis added). The Examiner finds that Liu defines "substantially
decellularized" thus: "Substantial decellularization" of the amniotic
membrane preferably removes at least 90% of the cells, more preferably
removes at least 95% of the cells, and most preferably removes at least 99%
of the cells ( e.g., fibroblasts, amniocytes and chorionocytes ). Id. ( citing Liu
,r 211 ). The Examiner therefore finds that Liu expressly discloses an
amniotic membrane retaining up to 10% of the epithelial and fibroblast cells
present in the amniotic membrane. Id.
We agree with the Examiner. Appellants' claims recite: "wherein at
least a portion of said micronized placental tissue has epithelial and
fibroblast cells retained thereon." Paragraph [0211] of Liu expressly
discloses that up to ten percent of epithelial and fibroblast cells may be
retained in the composition. We consequently affirm the Examiner's
rejection on this ground.
7
Appeal2017-007877
Application 13/815,873
D. Rejection of claims 1-8 under 35 U.S.C. § 103(a) over Liu
Because we conclude that claims 1-8 are anticipated by Liu, we also
conclude, for the same reasons explained supra, that claims 1-8 are obvious
over Liu and we affirm the Examiner's rejection on this ground. See In re
Kalm, 378 F.2d 959, 962 (C.C.P.A. 1967) (Anticipation is the epitome of
obviousness).
DECISION
The Examiner's rejection of claims claims 1-8 as unpatentable under
35 U.S.C. § 102(e) and 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
8