Ex Parte Ganey

Patent Trial and Appeal Board

Jan 8, 2019

14865798 (P.T.A.B. Jan. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/865,798 09/25/2015
119489 7590
Vivex Biomedical Inc.
David L. King
5131 NE County Road 340
High Spring, FL 32643
01/08/2019
FIRST NAMED INVENTOR
Timothy Ganey
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.
DN0278 1767
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
01/08/2019 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 TIMOTHY GANEY 1
Appeal 2018-002728
Application 14/865,798
Technology Center 3700
Before DANIELS. SONG, WILLIAM A. CAPP, and JILL D. HILL,
Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
Final Office Action ("Final Act.") rejecting claims 1, 6-8, and 10 in the
present application, the remaining claims having been either withdrawn or
canceled (App. Br. 5). We have jurisdiction under 35 U.S.C. §§ 6(b) and
134(a).
We AFFIRM.
1 The Appellant is the Applicant, Vivex Biomedical, Inc., which is
identified as the real party in interest (Appeal Brief ("App. Br.") 3).
Appeal2018-002728
Application 14/865,798
The claimed invention is directed to a structurally enhanced tissue
graft (Abstract). Representative independent claim 1 reads as follows (App.
Br. 12, Claims App., formatting added):
1. A freeze-dried structurally enhanced placental tissue graft
made from placental tissue comprises:
at least one placental tissue membrane formed from a
single membrane having a corrugated portion of placental tissue
made of a series of pleated peaks and valleys and a lateral flat
portion of placental tissue adhered to the corrugated portion to
form the structurally enhanced placental tissue graft upon drying,
wherein the flat portion when placed in contact to an outer
surface along either peaks or valleys of the corrugated portion
adheres directly to the corrugated portion[,]
wherein the flat portion in combination with the
corrugated portion form open channels configured for infusion
of blood flow during implantation and the combination of the
folded over lateral flat portion and the corrugated portion have
the same exposed external surfaces and the channels created by
the folded flat portion and the corrugated portion have the same
internal surfaces;
wherein the exposed external surfaces are an epithelial
surface with an exposed jelly-like fibroblast cellular layer; and
wherein the structurally enhanced tissue graft has been
freeze dried.
REJECTION
The Examiner rejects claims 1, 6-8, and 10 under 35 U.S.C. § 103 as
obvious over Mathisen (US 2014/0222161 Al, pub. Aug. 7, 2014) in view
of Koob et al. (US 2014/0067058, pub. Mar. 6, 2014 (hereinafter "Koob"))
(Final Act. 2).
2
Appeal2018-002728
Application 14/865,798
ANALYSIS
Only those arguments actually made by the Appellant have been
considered in this decision. Arguments that the Appellant could have made
but chose not to make have not been considered and are deemed to be
waived. See 37 C.F.R. § 4I.37(c)(l)(iv); In re Jung, 637 F.3d 1356, 1365-
66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010
(precedential)).
The Examiner rejects independent claim 1, finding that Mathisen
discloses all of the limitations of the claims except for: "the device being
formed of a single membrane;" "the membrane being a placental tissue
membrane;" the two layers being "adhered prior to drying;" and the graft
being freeze dried. (Final Act. 3). The Examiner finds that Koob "discloses
a tissue graft comprising the use of placental tissue membrane to form a
graft and that placental membrane is well known in the field as disclosed in
[0002]." (Id.; Koob ,r 2 ("[h ]uman placental membrane ( e.g. amniotic
membrane) has been used for various types of reconstructive surgical
procedures since the early 1900s.")). The Examiner also finds that Koob
discloses drying the tissue membrane "on a mandrel or die to form the
pleated peaks and valleys," and freeze drying the tissue graft. (Final Act. 4
(citing Koob ,r,r 59-91, Fig. 2)).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to have made the device of Mathisen from a single
membrane because forming a two piece article as one piece involves only
routine skill. (Final Act. 3 (citing Howard v. Detroit Stove Works, 150 U.S.
164 (1893))). The Examiner also concludes that it would have been obvious
3
Appeal2018-002728
Application 14/865,798
to a person of ordinary skill in the art to have used placental membrane in
Mathisen because "select[ing] a known material on the basis of its suitability
for the intended use [i]s a matter of obvious design choice," and "the
selection of a known material based on its suitability for its intended use
supports a prima facie obviousness determination." (Final Act. 3--4).
The Examiner further concludes that it would also have been obvious
to freeze dry the graft in view of Koob "since the use of the freeze-dryer to
dehydrate the tissue grafts can be more efficient and thorough compared to
other techniques such as thermal dehydration as well as to minimize
formation of porous structures within the tissue graft." (Final Act. 4 ( citing
Koob ,r,r 59--91) ). The Examiner further states that claimed phrases
pertaining to adhering prior to drying, drying on a mandrel or die to form the
pleated peaks and valleys, and freeze drying are product by process
limitations. (Final Act. 4). We agree with the Examiner's findings and
conclusions of obviousness, and address the Appellant's arguments infra.
The Appellant argues that Mathisen discloses "a porous structure to
facilitate fluid flow through the porous material," and Koob discloses "a
mesh or woven structure to aid in fluid flow." (App. Br. 10). The Appellant
draws a distinction as to the claimed invention, stating "the nature of the
membrane is such that blood infusion is channeled through the troughs, but
the whole blood cells cannot pass across and through the membrane due to
the semi-permeable nature of placental tissue," and asserts that "[t ]his is
neither taught nor suggested in the cited prior art." (App. Br. 10-11). The
Appellant asserts that the Examiner's rejection "completely change[s] the
principle of operation of the prior art references, which operate by allowing
4
Appeal2018-002728
Application 14/865,798
whole blood to flow across and through the porous structure." (App. Br.
11).
These arguments are unpersuasive for a variety of reasons. First,
while Mathisen discloses a "thin porous component" (Mathisen, Abst.), and
Koob discloses a "biocompatible mesh" (Koob, Abst.), the Appellant does
not establish a basis for its assertion that the prior art devices "operate by
allowing whole blood to flow across and through the porous structure."
(App. Br. 11 ). The Appellant does not direct us to citations in the applied
prior art references in support of its assertion. Second, while the Appellant
asserts that placental tissue is "semi-permeable" while Mathisen is "porous,"
we understand semi-permeable to simply mean that its pores are very small
so as to restrict the type of material that can be passed therethrough.
Accordingly, a semi-permeable membrane is still porous, such that the
distinction being asserted is not substantiated. Finally, while Koob does
disclose a biocompatible mesh, it also discloses using placental tissue in
conjunction therewith (Koob ,r 59), which would also prevent allowing
whole blood to flow therethrough. Therefore, even if there is a distinction
between the "porous component" disclosed in Mathisen and the claimed
"placental tissue," we agree with the Examiner that the Appellant is arguing
that:
the qualities that make their device unique ... is due to the
natural properties of the placenta. If this is the case, the
placental membrane taught by Koob would have the same
properties; hence the device of Mathisen in view of Koob
would be able to block flow but allow flow through the open
channels created by the corrugations for blood infusion.
(Ans. 4; see also Ans. 2; Koob ,r 2).
5
Appeal2018-002728
Application 14/865,798
Hence, the Appellant's arguments are unpersuasive and we affirm the
Examiner's obviousness rejection of independent claim 1. The Appellant
does not submit any separate arguments directed to claims 6-8 and 10 that
depend from claim 1. Therefore, these dependent claims fall with claim 1.
CONCLUSION
The Examiner's rejection of claims 1, 6-8, and 10 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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
6