Ganey, Timothy et al.

Patent Trials and Appeals Board

Oct 9, 2019

14851964 - (D) (P.T.A.B. Oct. 9, 2019)

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.
14/851,964 09/11/2015 Timothy Ganey DN0276CIP 8177
119489 7590 10/09/2019
Vivex Biologics Group, Inc.
David L. King
5131 NE County Road 340
High Springs, FL 32643
EXAMINER
ISABELLA, DAVID J
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/09/2019 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):
davidlkingsr@windstream.net
uspto@dockettrak.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TIMOTHY GANEY and
TRACY SCOTT ANDERSON

Appeal 2019-002119
Application 14/851,964
Technology Center 3700
____________

Before MICHAEL L. HOELTER, WILLIAM A. CAPP, and
LEE L. STEPINA, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, 8–14, 18, 19, 24, and 25. Br. 5.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Vivex
Biomedical, Inc.” Br. 3.
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CLAIMED SUBJECT MATTER
The disclosed subject matter “relates to a transplant product derived
from human umbilical cord and shaped for use as a soft tissue barrier or
wound covering or other internal or external healing attachment and the
products method of manufacture.” Spec. ¶ 2. Apparatus claim 1 is the sole
independent claim, is illustrative of the claims on appeal, and is reproduced
below.
1. A shaped transplant product derived from human
umbilical cord comprising:
a collagenous tissue membrane derived from an umbilical
cord, configured as a soft tissue barrier or wound covering or
other internal or external wound healing attachment, wherein
the collagenous tissue membrane is shaped during manufacture
to have a defined memory retained shape wherein the defined
memory retained shape is a hollow cylindrically shaped wall of
the collagenous tissue membrane formed as a hollow elongated
split tube having ends defining a length of the split tube and
wherein the hollow elongated split tube has a longitudinal
extending slit forming a gap between two opposing edges
adjacent the longitudinal extending slit extending the length of
the split tube configured to open and pass blood or nerve
vessels inside the walls of the collagenous tissue membrane
wherein the collagenous tissue membrane has a plurality of
suture entry sites, the suture entry sites formed integrally in the
cylindrically shaped wall along the two opposing edges
adjacent the slit, each suture entry site has a structurally
enhanced peripheral wall adjacent a thin puncture center
surrounded by the peripheral wall thickened relative to the
cylindrically shaped wall of the hollow elongated split tube,
each suture entry site configured to act and perform like a
reinforced grommet configured to receive a suture through the
thin puncture center without any additional reinforcements,
wherein the hollow elongated split tube along the longitudinal
extending slit forming the gap is configured to close allowing
the two opposing edges to abut when sutured wherein each of
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the plurality of suture entry sites is formed by a heated tip that
forms the thin puncture center surrounded by the peripheral
wall thickened relative to the cylindrically shaped wall and an
exterior surface of said peripheral wall toughened creating the
structurally enhanced peripheral wall encircling each of the
suture entry sites while maintaining the thin puncture center.
EVIDENCE
Prudden US 2,115,122 Apr. 26, 1938
Gellman et al. US 6,042,534 Mar. 28, 2000
Snyder et al. US 6,632,239 B2 Oct. 14, 2003
Saadat et al. US 8,087,413 B2 Jan 3, 2012
Sun et al. US 2012/0010728 A1 Jan. 12, 2012
Tseng et al. US 2012/0141595 A1 June 7, 2012
Sudekum US 2014/0024885 A1 Jan. 23, 2014
Paulos et al. US 9,179,976 B2 Nov. 10, 2015
REJECTIONS
Claims 1, 2, 8, 12–14, 18, and 19 are rejected under 35 U.S.C. § 103
as unpatentable over Sun, Paulos, Snyder, Gellman, and Prudden.
Claims 9–12 are rejected under 35 U.S.C. § 103 as unpatentable over
Sun, Paulos, Snyder, Gellman, Prudden, and Tseng.
Claims 24 and 25 are rejected under 35 U.S.C. § 103 as unpatentable
over Sun, Paulos, Snyder, Gellman, Prudden, Tseng, Saadat, and Sudekum.
ANALYSIS
The rejection of claims 1, 2, 8, 12–14, 18, and 19
as unpatentable over Sun, Paulos, Snyder, Gellman, and Prudden
Appellant argues all these claims together. See Br. 12–14. We select
claim 1 for review, with the remaining claims standing or falling therewith.
See 37 C.F.R. § 41.37(c)(1)(iv).
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Appellant initially contends (after restating the Examiner’s rejection
of these claims) “that there is no instruction or suggestion why any of the
cited references would bother to maintain a thin membrane at the center.”
Br. 13. Appellant appears to disregard the express disclosure in Snyder and
Gellman, each of which discloses a fully open entry site and also a closed
entry site (i.e., “a thin puncture center”), and the reasons therefore. See, e.g.,
Snyder 6:65–67, 7:1–9, 7:31–39; Gellman Figs. 5G–5L; see also Gellman
11:30–35 (discussing these figures and stating that in the closed entry site
“embodiment of FIGS. 5I and 5J, the sling material at the suture receiving
site provides a puncture target into which the surgeon can insert the
suspending suture”), Final Act. 4–5, Ans. 3, 5. Accordingly, we are not
persuaded by Appellant’s contention.
Appellant further contends that “such a structure is extremely difficult
to achieve with a sharp tipped hot poker, as shown in the references” and
that “Appellants’ concept has advantages not taught or suggested.” Br. 13–
14. In effect, Appellant acknowledges the prior usage of “a sharp tipped hot
poker” to make these suture sites (consistent with the “formed by a heated
tip” recitation in claim 1), but, regardless, asserts that Appellant’s device
“has advantages not taught or suggested” therein.
First, such “advantages” are not recited in claim 1. Second, we have
been instructed that “even though applicant’s modification results in great
improvement and utility over the prior art, it may still not be patentable if the
modification was within the capabilities of one skilled in the art.” In re
Huang, 100 F.3d 135, 139 (Fed. Cir. 1996). Here, Appellant does not
explain how the “advantages” referenced above are not equally achievable
by, or not equally within the capability of, one skilled in the art, in view of
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the similar “formed by a heated tip” method disclosed in the combination of
Snyder and Gellman. Further, the Examiner states, “In addition, the hot
poker of Prudden appears to be structurally identical to that claimed. Thus, it
would appear that the use of the hot poker of Prudden would result in the
claimed suture entry site structure.” Ans. 4.
In view of such contentions by Appellant, “the Board is urged to
reverse this rejection.” Br. 14. However, based on the record presented, we
are not persuaded of Examiner error. Instead, we sustain the Examiner’s
rejection of claims 1, 2, 8, 12–14, 18, and 19 as unpatentable over Sun,
Paulos, Snyder, Gellman, and Prudden.
The rejection of claims 9–12
as unpatentable over Sun, Paulos, Snyder, Gellman, Prudden, and Tseng
Appellant argues claims 9–12 together. We select dependent claim 9
for review (dependent from claim 1), with the remaining claims standing of
falling with claim 9.
Claim 9 includes the limitation “wherein structural, chemical and
biochemical properties of the collagenous tissue membrane are retained.”
The Examiner relies on the additional teachings of Tseng as disclosing these
limitations. See Final Act. 7–8. Appellant does not address Tseng, but
instead focuses on Snyder’s “synthetic biocompatible polymer”
construction. Br. 14. In response, he Examiner states, “Appellant appears to
be arguing the references individually.” Ans. 4. We agree with the
Examiner that Appellant is not responding to the Examiner’s rejection.
Additionally, Appellant contends that “Snyder fails to teach any
details as to how the holes are formed.” Br. 14. The Examiner did not rely
on Snyder for the “how” limitation (i.e., “wherein each of the plurality of
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suture entry sites is formed by a heated tip that forms the thin puncture
center”). See Final Act. 4. Instead, the Examiner relied on Gellman and
Prudden for this “how” teaching (both disclosing the use of a hot poker).
See Final Act. 4–5 (citations omitted); see also Ans. 4. The Examiner
reiterates,
Examiner maintains that modifying the combination of Sun,
Paulos, and Snyder to employ heat treatments to produce either
the fully or not fully formed apertures of Snyder, as taught by
Gellman and Prudden, would have at least been obvious as such
a modification is a mere application of a known technique to
make and improve a device by simultaneously creating and
reinforcing its openings.
Ans. 4–5. Again, Appellant is not responding to the Examiner’s rejection.
Appellant further contends that “[w]hat is unique is how the suture
reinforcement is created in the umbilical tissue” and that “this invention
achieves this reinforced feature by changing not only the thickness
surrounding the holes, but actually toughens the peripheral wall by using a
heated tip to form the thickened wall.” Br. 15. However, this contention is
not persuasive for similar reasons expressed above when addressing Huang
and in view of the heated poker disclosed in both Gellman and Prudden. See
also Ans. 5.
Appellant’s subsequent argument regarding a remaining “thin
membrane” at the suture site (Br. 15) is again not persuasive in view of the
teachings of Snyder and Gellman discussed above. Appellant further seeks
to distinguish claim 1 by addressing the thickness of the umbilical cord
sleeve and asserting that, in Appellant’s device, “the sleeve wall[] is reduced
further when forming the thin membranes.” Br. 15. However, claim 1 is
silent as to any reduction of the sleeve wall when creating the recited “thin
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puncture center.” Instead, claim 1 recites that this “thin puncture center [is]
surrounded by [a] peripheral wall” and it is this peripheral wall that is
“thickened relative to the cylindrically shaped wall of the hollow elongated
split tube.” Appellant does not explain how such increased thickness or
strengthening surrounding the “puncture center” fails to likewise occur via
the teachings of Snyder, Gellman and/or Prudden. See e.g., Snyder Figs. 4,
6, 8; Gellman Figs. 5I, 5J; Prudden Figs. 2, 4–6. Hence, Appellant’s
contention that the “puncture center . . . is clearly thinner than the wall
thickness” is not a recited claim limitation and is not persuasive of Examiner
error.
In view of the above contentions, “appellants believe the examiner has
failed to establish a prima facie case of obviousness.” Br. 15–16. However,
based on the record presented, we are not persuaded of Examiner error.
Instead, we sustain the Examiner’s rejection of claims 9–12 as unpatentable
over Sun, Paulos, Snyder, Gellman, Prudden, and Tseng.
The rejection of claims 24 and 25 as unpatentable over
Sun, Paulos, Snyder, Gellman, Prudden, Tseng, Saadat, and Sudekum
Appellant argues claims 24 and 25 together. See Br. 16. We select
claim 24 (which depends from claim 1) for review, with claim 25 standing
or falling with claim 24. Claim 24 recites “wherein the number of the
plurality of suture entry sites adjacent one edge is one less, equal to or one
more than the number” on the opposite edge. The Examiner relies on any of
Paulos, Saadat, or Sudekum as meeting this limitation. See Final Act. 9. A
review of the joined edges illustrated in these references clearly disclose that
one edge has a number of suture entry sites that is “one less, equal to or one
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more than” its opposite edge. See e.g., Paulos Fig. 8B; Saadat Fig. 27A–B,
Sudekum Figs. 9–12.
Appellant also presents a statement that appears to address claim 25,
but which, instead, is a misrepresentation of the limitation recited therein.
Claim 25 specifically recites suture entry sites on opposing edges that are
arranged in an offset and interposed manner “when the collagenous tissue
membrane is rolled or folded such that the two opposing edges are aligned.”
Emphasis added. In contrast, however, Appellant contends, “[t]he present
invention has the edges capable of abutting in clam 1 without using a fold or
selvage for the suture placement.” Br. 16 (emphasis added). Regardless,
Figures 27A–B of Saadat disclose suture entry sites through “rolled or
folded” tissue. See also Final Act. 9; Ans. 6.
In view of the above contentions, “the Board is requested to overturn
this rejection and allow the claims.” Br. 16. However, based on the record
presented, we are not persuaded of Examiner error. Instead, we sustain the
Examiner’s rejection of claims 24 and 25 as unpatentable over Sun, Paulos,
Snyder, Gellman, Prudden, Tseng, Saadat, and Sudekum.
CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1, 2, 8, 12–14, 18,
and 19
35 U.S.C. § 103 over
Sun, Paulos, Snyder,
Gellman, and
Prudden
1, 2, 8, 12–14,
18, and 19

9–12 35 U.S.C. § 103 over
Sun, Paulos, Snyder,
9–12
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Claims
Rejected
Basis Affirmed Reversed
Gellman, Prudden,
and Tseng
24 and 25 35 U.S.C. § 103 over
Sun, Paulos, Snyder,
Gellman, Prudden,
Tseng, Saadat, and
Sudekum
24 and 25
Overall Outcome 1, 2, 8–14, 18,
19, 24, and 25

No period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED