Theodore Malinin

Patent Trials and Appeals Board

Sep 30, 2021

2021000082 (P.T.A.B. Sep. 30, 2021)

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.
15/803,967 11/06/2017 Theodore I. Malinin DN0316 5865
51108 7590 09/30/2021
DAVID L. KING, SR.
5131 N.E. COUNTY ROAD 340
HIGH SPRINGS, FL 32643
EXAMINER
MARTIN, PAUL C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
09/30/2021 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
valerie365@yahoo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THEODORE I. MALININ
Appeal 2021-000082
Application 15/803,967
Technology Center 1600
Before JOHN E. SCHNEIDER, DEBRA L. DENNETT, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims directed to a method of making a
biological membrane for indefiniteness and/or obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s Specification states that “[s]mooth membranous tissue
allografts are widely used clinically in promoting healing and tissue

1 Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as himself. (Appeal Br. 3.)
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reconstruction.” (Spec. ¶ 2.) “Some of those membranes are used fresh or
frozen, but a large number are preserved by drying, often freeze-drying.”
(Id.)
Appellant’s Specification explains that there are some problems with
use of these grafts. For example, “incorporation of the graft is delayed
because blood vessels, during angiogenesis, must overcome the solid barrier
of decellularized dermis or cellular and intact tissues.” (Id. ¶ 3.) A second
problem “is slippage [of the smooth membranous tissue allografts] when
positioned onto a wound site or a defect being repaired.” (Id.) Appellant’s
invention is directed to solving these problems. (Id. ¶¶ 7–8.)
Claims 1–3, 5–9, 18, and 19 are on appeal. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A method of making smooth two-sided biological membranes
into three-dimensional membrane structures with regularly or
irregularly spaced surface concave depressions on an at least first
side and projections on at least the opposite second side, the
method comprising the steps of:
acquiring a smooth wetted or fresh two-sided membrane
for drying;
placing the smooth wetted or fresh two-sided membrane
on a support surface of a perforated plate, the perforated plate
having a plurality of closely and uniformly spaced holes or
depressions on the entire support surf ace of the plate for forming
depressions on a first side of the membrane and projections on
an opposite second side adjacent the support surface;
drying the smooth wetted or fresh two-sided membrane on
the perforated plate wherein the membrane locally sags or sinks
into each of the perforations forming depressions on the first side
and corresponding projections on the opposite second side of the
membrane converting the membrane into a three-dimensional
structure when dried;
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forming either prior to drying, during drying or post drying
the three-dimensional structure has projections formed on the
first side with the depressions so the membrane has the first side
with a configuration of projections and depressions and the
second side similarly has a combination of depressions and
projections, wherein the irregular surface is on both the first side
and second side providing a slippage resistance of the membrane
on either side; and
wherein the projections or depressions are artificial
regularly and closely and uniformly spaced bumps forming an
irregular surface across the entire membrane when implanted
preventing slippage of the membrane and facilitating vascular
ingrowth.
(Appeal Br. 20.)
The prior art relied upon by the Examiner is:
Name Reference Date
Daniel et al. (Daniel
’003)
US 9,272,003 B2 Mar. 1, 2016
Daniel et al. (Daniel
’588)
US 9,687,588 B2 June 27, 2017
Scholz et al. EP 0399782 A2 Nov. 28, 1990
Enrico G. Bartolucci A Clinical Evaluation
of Freeze-Dried
Homologous Dura
Mater as a Periodontal
Free Graft Material,
52(7) J. Periodontol.,
354–61
1981

The following grounds of rejection by the Examiner are before us on
review:
Claims 1 and 18 under 35 U.S.C. § 112(b) as being indefinite.
Claims 1, 6, 8, and 9 under 35 U.S.C. § 103 as unpatentable over
Daniel ’588 and Scholz.
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Claims 1–3, 6–9, 18, and 19 under 35 U.S.C. § 103 as unpatentable
over Daniel ’003 and Scholz.
Claims 1–3, 5–9, 18, and 19 under 35 U.S.C. § 103 as unpatentable
over Daniel ’003, Scholz, and Bartolucci.

DISCUSSION
Indefiniteness
The Examiner finds that the limitation “the irregular surface” in
claims 1 and 18 lacks sufficient antecedent basis. (Final Action 3.)
Although Appellant does not specifically respond to this rejection, we
disagree that there is insufficient antecedent bases for this phrase in the
claims as amended by Appellant. In particular, both claims 1 and 18
indicate that the projections or depressions are “bumps forming an irregular
surface across the entire membrane when implanted.”
Thus, we do not affirm the rejection of claims 1 and 18 for lacking
sufficient antecedent basis.

Obviousness: Daniel ’588 and Scholz
The Examiner found Daniel ’588 teaches making three-dimensional
amnion membrane structures by placing a membrane on a support surface
called a drying fixture, where the fixture can be a screen or frame and can
have grooves laid out in a grid arrangement. (Final Action 4 (citing Daniel
’588 8:59–64, 9:15–22).) The Examiner further found that Daniel ’588
teaches the drying fixture is used to facilitate freeze-drying and that during
the freeze-drying the membrane molds around the groove projections and
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depressions thereby creating a three dimensional structure as claimed. (Id. at
4 (citing Daniel ’588 9:37–38, 47–48), 7.)
The Examiner found that Scholz teaches preparing a membrane for a
surgical graft where the membrane is placed on a plate having holes through
which spikes project upward to create open perforations in the membrane.
(Final Action 5 (citing Scholz 4:45–52).) The Examiner also found that
Scholz teaches that the perforations serve both to permit natural tissue
growth there through to anchor the membrane to surrounding tissue, and to
mechanically anchor the membrane to the natural tissue with the material
projecting from the surface thereof. (Id. (citing Scholz 1:31–40).)
The Examiner found that it would have been obvious to one having
ordinary skill in the art to have modified the process of Daniel to include “a
perforated plate having a plurality of uniformly closely spaced perforations
over the entire surface as taught by Scholz because this is no more than the
use of known technique . . . to a known method.” (Id. at 6.) The Examiner
found that the motivation to make the modification would have been for the
benefits that Scholz teaches are achieved with the perforations in the
membrane and the projection of material from the perforations. (Id.)
We agree with the Examiner’s conclusion of obviousness.
Both Daniel ’588 and Scholz are concerned with membranes used for
grafts. Scholz teaches the importance of texturizing a replacement
membrane for use in tissue repair where many materials used have low
adhesion making accurate placement difficult. (Scholz 1:6–22.) Scholz
explains that having membrane material projecting from the surface, i.e.
“texturizing” it, “serves to mechanically anchor the membrane in place on
the natural tissue.” (Id. at 1:32, 1:37–40.) Scholz achieves the texturizing
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by creating perforations in the membrane. (Id.) In light of the foregoing, we
do not find Appellant’s argument that “Scholz is unlikely to provide an anti-
slip feature” (Appeal Br. 15) persuasive. “Attorney argument is not
evidence.” Icon Health & Fitness v. Strava, 849 F.3d 1034, 1043 (Fed. Cir.
2017) (citing See, e.g., Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d
1371, 1380 (Fed. Cir. 2009) (“[U]nsworn attorney argument . . . is not
evidence and cannot rebut . . . other admitted evidence . . . .”).
Scholz also explains that having perforations in the membrane
“permit[s] natural tissue growth inside the perforation, thereby anchoring the
membrane to the surrounding natural tissue.” (Id. at 1:35–36.) Scholz
further teaches that the arrangement of the perforations can vary based on a
number of considerations including the desirability of angular edges for
adhering the membrane to the tissue surface, but preferably can be arranged
in a square grid. (Id. at 5:3–7, 23–36.).
Daniel ’588 teaches that laying a tissue over a drying plate that has
raised texture will, on drying, result in the tissue molding itself around the
raised texture and into the indented texture. (Daniel ’588 9:30–38.)
Although Daniel ’588 primarily teaches the texture can provide a company
logo, it also notes that the texture can provide “desired attributes requested
by the end user (e.g., surgeon.)” (Id.) Scholz teaches that surgeons would
desire texturing over the membrane so that such texturing can help prevent
slippage of the membrane when placed during surgery. Moreover, Daniel
’588 teaches that “any size and shape arrangement can be used for the drying
fixture, as will be appreciated by those skilled in the art.” (Daniel ’588
9:25–27.)
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Given the teachings of Daniel ’588 and Scholz, we agree with the
Examiner that it would have been obvious to use a perforated plate as taught
by Scholz to create a membrane, on drying, that has angular projections of
membrane material formed on one side, which would be perceived as
depressions from the opposite side,2 in the process of Daniel ’588, which
teaches that any size and shape arrangement can be used for the drying
fixture. “The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). That is the case
here, and Scholz provides a reason that one would have desired to use the
perforated plate in the process of Daniel ’588.
Appellant argues that claims 1 and 18 require both the first side and
the second side to have a combination of projections and depressions “and
the membrane has no differentiation as to the sides.” (Appeal Br. 15.)
Appellant urges that Daniel ’588 has, as “a critical feature,” a texture that
identifies a side of the membrane. (Id.) We do not find this argument
persuasive of non-obviousness. First, the claims do not require there be no
differentiation as to the sides. Instead, the claim requires that there be
bumps on both sides of the membrane to create an irregular surface on both
sides. Such is the natural result of drying the membrane over a perforated

2 We note that “depressions” are not defined in Appellant’s Specification
and claim 2 teaches that one or more of the projections or depressions are
perforated, i.e. forms an opening at one end of the projection or depression.
(See Spec. ¶ 10) Thus, the fact that a depression has a perforation therein
does not prevent it from being deemed a depression. Consequently, we
determine that having sides that protrude upward from a plane is sufficient
to conclude a projection exists, and that sides that protrude downward from a
plane is sufficient to conclude a depression exists.
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plate because, as Daniel ’588 teaches, the membrane, on drying, “mold[s]
itself around the raised texture or into the indented texture.” (Daniel ’588
9:36–37.) Thus, with a perforated plate, the membrane would sink into the
perforations and leave a raised portion at every area of the grid that has a
solid portion. As such, bumps would be formed on both sides of the
membrane, i.e., raised portions above a mid-plane of the membrane and
depressions below that same mid-plane, which, if the membrane were
flipped, would be depressions and raised portions, respectively. For this
reason, we do not find Appellant’s argument that “Scholz has no teaching as
to creating depressions or projections on each side” (Appeal Br. 15)
persuasive of non-obviousness.
Second, as the Examiner noted (Ans. 15), the combination of Daniel
’588 and Scholz does not preclude also including a pattern that can be used
to form an identifying logo and/or for determining the orientation of the
membrane.
Appellant argues that the claims require projections and depressions
on a first side as well as similar projections and depressions on a second
side. (Appeal Br. 14.) The Specification teaches that the two-sided
biological membranes have depressions created on a first side of the
membrane and corresponding projections on an opposite second side. (Spec.
¶¶ 9, 14, 21, 27.) And, the Specification indicates that this is what is formed
by placing the membrane on a support surface of a perforated plate that has a
plurality of closely and uniformly spaced holes of depressions on the entire
surface, as is claimed. (Id. ¶¶ 9, 24.) Given that the process of Daniel ’588
as modified by Scholz would be made in the same way as described in
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Appellant’s Specification, we conclude that the method would produce the
structure as claimed.
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 1, 6, 8, and 9 under 35 U.S.C. § 103 as unpatentable over Daniel ’588
and Scholz.

Obviousness: Daniel ’003 and Scholz
The disclosure of Daniel ’003 is substantially similar to Daniel ’588.
Appellant presents substantially the same arguments of non-obviousness as
noted above, which we do not find persuasive. (Compare Appeal Br. 15
with id. at 17–18.) Appellant does seem to provide one additional argument
as follows:
the [E]xaminer [has not] demonstrated any plausible reason
why a non-slip surface on both sides could be made when the
primary reference has no expectation or concept that such a
feature is needed. Scholz would also not do this for any logical
reason as that was not a goal or feature contemplated as clearly
why would he use sutures to hold the membrane in place.
(Appeal Br. 17–18.) We do not find this argument persuasive. “In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under § 103.” KSR, 550 U.S. at 419. As
explained above with respect to Daniel ’588 and Scholz, the natural result of
using the Scholz perforated plate in the method taught by Daniel to provide
the texturing that Scholz teaches provides for mechanical anchoring on the
natural tissue of the otherwise slippery graft material would result in bumps
on both sides of the mid-plane of the membrane. Thus, the method rendered
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obvious by the combination of Daniel ’003 with Scholz would result in the
structure whether or not Scholz contemplated such a result.
Thus, we affirm the Examiner’s rejection of claims 1–3, 6–9, 18, and
19 under 35 U.S.C. § 103 as unpatentable over Daniel ’003 and Scholz.
Appellant does not provide additional arguments against the rejection
adding Bertolucci. Thus, we affirm the Examiner’s rejection of claims 1–3,
5–9, 18, and 19 under 35 U.S.C. § 103 as unpatentable over Daniel ’003,
Scholz, and Bartolucci for the reasons just discussed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 18 112(b) Indefiniteness 1, 18
1, 6, 8, 9 103 Daniel ’588,
Scholz
1, 6, 8, 9
1–3, 6–9,
18, 19
103 Daniel ’003,
Scholz
1–3, 6–9,
18, 19

1–3, 5–9,
18, 19
103 Daniel ’003,
Scholz, Bartolucci
1–3, 5–9,
18, 19

Overall
Outcome
1–3, 5–9,
18, 19

TIME PERIOD FOR RESPONSE
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)(1)(iv).

AFFIRMED