Robert F. Diegelmann et al.

Patent Trials and Appeals Board

Jul 18, 2019

11884363 - (D) (P.T.A.B. Jul. 18, 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.
11/884,363 09/12/2008 Robert F. Diegelmann 02940633AA 3371
30743 7590 07/18/2019
W&C IP
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
07/18/2019 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 ROBERT F. DIEGELMANN, KEVIN R. WARD,
MARCUS E. CARR, and GARY LEE BOWLIN
__________

Appeal 2018-008761
Application 11/884,3631
Technology Center 1600
__________

Before DONALD E. ADAMS, RACHEL H. TOWNSEND, and
DAVID COTTA, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of stanching high-pressure blood flow, which have been rejected as
indefinite and/or not enabled. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
This Application returns to us after Appellants elected continued
examination following our Decision affirming-in-part the Examiner’s

1 Appellants identify the real party in interest as Virginia Commonwealth
University and Z-Medica, LLC. (Appeal Br. 3.)
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obviousness rejection in the Final Action dated July 8, 2014. Appellants
amended the claims to reflect our determination in the prior decision that the
prior art relied upon by the Examiner did not provide a reasonable
expectation of success that kaolin or bentonite would stop high-pressure
blood flow. Ex Parte Diegelmann, Appeal 2015-002795, 2017 WL
3105861, at *10–11 (PTAB July 19, 2017).
Claims 1, 4, 6, 7, 20, and 23–68 are on appeal. Claim 64 is
representative and reads as follows:
64. A method of stanching blood flow in a hemorrhaging
wound having a high-pressure blood flow, comprising
applying to said wound a composition comprising one or
more clay minerals, in a quantity sufficient to stanch the blood
flow, and said one or more clay minerals stanches the blood
flow from the wound.
(Appeal Br. 21.)

The following grounds of rejection by the Examiner are before us on
review:2
Claims 64–68 under 35 U.S.C. § 112, first paragraph for lack of
enablement.

2 The rejection of claims 1, 4, 6, 7, 20, 23–28, and 55–68 under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over Wnek (US 2004/0013715 A1;
Jan. 22, 2004) in view of Connor (William E. Conner, The Acceleration of
Thrombus Formation by Certain Fatty Acid, 41(6) J. Clin. Invest. 1199–05
(1962) (“Conner”)), Hubbard (Donald Hubbard & George L. Lucas, Ionic
charges of glass surfaces and other materials, and their possible role in the
coagulation of blood, 15(2) J. Applied Physiology 265–70 (1959)
(“Hubbard”)), and further in view of Hursey (US 2003/0133990 A1; July 17,
2003) and Kenji (JP 11-071228; Mar. 16, 1999) has been withdrawn by the
Examiner. (Ans. 3–4.)

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Claims 4, 29–54, 57, and 59–62 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim that which the applicant regards as the invention.
DISCUSSION
Enablement
The Examiner contends that the Specification, “while being enabling
for bentonite for stanching high pressure blood flow, does not reasonably
provide enablement for all clays for stanching high pressure blood flow.”
(Non-Final Action3 3.) According to the Examiner the claimed invention is
in the physiological arts which “are generally viewed as unpredictable.” (Id.
at 5; see also id. at 7.) The Examiner also asserts that “the state of the art
with regard to stanching high pressure blood flow using clays was at an early
stage of development and obtaining high pressure blood flow stanching
using clay was highly unpredictable” even though it was predictable to use
clay to stanch non-high pressure flow blood. (Id. at 7.) The Examiner also
contends that “achieving a useful therapeutic outcome in stanching high
pressure blood flow is unpredictable” as evidenced by statements made by
Appellants in their Appeal Brief filed in the prior Appeal. (Id. at 5–6.) The
Examiner explains that Appellants stated, in reliance on a prior art reference
Baker,4 that not all clay materials are created equal in terms of clotting
capability, “‘(i.e., hydrotalcite did not perform anywhere near as
successfully as kaolin, see Baker reference).’” (Id. at 6.)

3 The Non-Final Action has a mail date of October 4, 2017.
4 Sarah E. Baker et al., Controlling Bioprocesses with Inorganic Surfaces:
Layered Clay Hemostatic Agents, 19 Chem. Mater. 4390–92 (2007).
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The Examiner notes that the relative level of skill in the art is high but
that undue experimentation would have been required “to develop stanching
high pressure arterial blood flow using any clay material encompassed by
the claims.” (Id. at 8.) According to the Examiner, “[t]he guidance provided
in the [S]pecification regarding any other clays that stanch high pressure
blood flow amounts to no more than generic statements that the clays other
than bentonite may work” and is “no more tha[n] theoretical speculation in a
highly unpredictable art.” (Id.)
We disagree with the Examiner’s conclusion that claims 64–68 are not
enabled for their full scope. The issue is whether “the specification teach[es]
those in the art to make and use the invention without undue
experimentation.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
We first address the Examiner’s finding that this art is unpredictable,
which is the linchpin of the enablement rejection. The Examiner, citing the
MPEP § 2164.03, has stated that the physiological art is recognized as
unpredictable. (Non-Final Action 7.) However, MPEP § 2164.03 does not
so state. Rather, this section states that most physiological activity involves
unpredictable factors. The Examiner has not pointed to any evidence,
however, demonstrating that there are unpredictable physiological factors in
the activity of stanching the flow of blood in a high pressure bleed. All that
the Examiner has provided is evidence that the clotting ability of clays is not
equal. (Id. at 6 (citing Baker).) That the clotting abilities of clay are not
equal is not evidence that clotting is unpredictable in stanching blood flow.
Appellants agree that not all clays can stanch high-pressure bleeding.
(Appeal Br. 15.) However, Appellants explain that the Specification “sets
forth an example of a particular test for determining whether a given
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hemostatic agent is effective against high-pressure bleeding.” (Id. at 11
(citing Spec. 21–22).) Appellants further note that “[t]he Specification
demonstrates that this level of experimentation is routine in the field of
hemostasis.” (Id. at 12.) The Examiner does not contest the foregoing,
arguing instead that Appellants have not shown the listed claims are able to
stanch high-pressure blood flow. (See, e.g., Ans. 9–10.)
While stanching high-pressure blood flow with clay (the inventive
method) may have been nascent at the relevant time, stanching high-pressure
blood flow with clotting materials was not. (See, e.g., Spec. 1–3 (describing
a chitosan bandage, fibrin sealant dressing, rapid deployable hemostat
bandage and Quick-Clot).) Furthermore, while it may be unknown a priori
whether a clay will stanch a high-pressure bleed, such knowledge is not
required to establish enablement. The issue is whether one of ordinary skill
in the art would be able to practice the invention without undue
experimentation. The test of enablement is not whether any experimentation
is necessary, but whether, if experimentation is necessary, it is undue. In re
Angstadt, 537 F.2d 498, 504 (CCPA 1976); see also MPEP § 2164.08(b)
(“The presence of inoperative embodiments within the scope of a claim does
not necessarily render a claim nonenabled. The standard is whether a skilled
person could determine which embodiments that were conceived, but not yet
made, would be inoperative or operative with expenditure of no more effort
than is normally required in the art.”). In light of the fact that there was a
known test identified in the Specification to assess whether a clay would or
would not work and that this level of testing is routine in the field of
hemostasis, there is no undue burden for one of ordinary skill in the art to
make and use the full scope of the claimed invention. That is particularly
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true in light of the Examiner’s agreement that the level of skill in the art was
high (Non-Final Action 8) and the Specification broadly discloses that the
invention is directed to compositions comprising clay minerals to control
hemorrhaging (see Appeal Br. 10).
Consequently, we do not sustain the Examiner’s rejection that claims
64–68 lack enablement.
II
112, second paragraph
Claims 4 and 35
Both claim 4 and 35 require that the kaolin used in the method be
“electrospun into a bandage.” The Examiner concludes these claims are
indefinite because the Specification discloses mixing clay with the polymer
carrier then electrospinning the mixture into fibers and not electrospinning
clay itself and it is not clear how one can electrospin clay alone. (Non-Final
Action 10.) We disagree with the Examiner’s conclusion of indefiniteness.
The question is whether one of ordinary skill in the art would find the
language the Examiner focused on to be unclear or vague such that they
would not understand the scope of the invention with reasonable certainty.
See In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014); Ex Parte
McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25,
2017) (precedential) (quoting Packard, 751 F.3d at 1314 (“‘A claim is
indefinite when it contains words or phrases whose meaning is unclear.”’)).
The Examiner and Appellants appear to agree that, as taught in the
Specification, the claim encompasses kaolin combined with a carrier and
electrospun together, thus providing the kaolin in combination with other
materials as fibers that form the bandage. (Spec. 5–6.) The Examiner
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contends that the claim also encompasses kaolin which itself is electrospun
such that it forms into a bandage. Appellants contend that “[t]here is no
language that could be interpreted as limiting the claims” to “require that the
kaolin must be capable, all by itself, of forming the electrospun fibers.”
(Appeal Br. 7.) However, we “determine[] the scope of claims . . . upon
giving claims their broadest reasonable construction ‘in light of the
specification as it would be interpreted by one of ordinary skill in the art.”’
Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc)
(quoting In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir.
2004)). While the claims do not require that the kaolin alone be electrospun
into fibers, the broadest reasonable interpretation of the claim admits of such
interpretation. While this interpretation may not be exemplified, the
description in the Specification supports it. (See, e.g., Spec. 5 (“The
invention further provides an electrospun fiber comprising one or more clay
minerals. . . . The electrospun fiber may further comprising one or more
substances such as, for example, gelatin.”).)
With respect to the Examiner’s question as to how one can electrospin
clay alone, we note that whether or not it is clear how one can electrospin
clay alone has no bearing on whether one of ordinary skill in the art would
not understand the scope of the invention with reasonable certainty.
“[B]readth is not to be equated with indefiniteness.” In re Miller, 441 F.2d
689, 693 (CCPA 1971).
We, therefore, do not sustain the Examiner’s rejection that claims 4
and 35 are indefinite.
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Claims 31 and 57
The Examiner contends that the scope of these claims is
unascertainable because “fiber-like” is not an element that is “actually
disclosed” in the Specification. (Non-Final Action 10–11.) The Examiner
recognizes the term is present in the Specification, but contends that rather
than define what “fiber-like” materials are, the Specification describes a
method of making such a material by electrospinning. (Ans. 5.)
We do not find the claim language to be unclear or vague such that
one of ordinary skill in the art would not understand the scope of the
invention with reasonable certainty in light of the Specification’s description
of how to make “a fiber-like material . . . using the technique of
electrospinning.” (Spec. 11.) In that description, it is explained that “[i]n
yet another embodiment of the invention, the mineral clay is incorporated
into a fiber-like material for use in bandages using the technique of
electrospinning.” (Id.) The Specification then describes the fiber-like
material so produced as “forming a solid fiber that collects on the target as a
non-woven ‘fabric’ or mat/scaffolding.” (Id.) Moreover, a product obtained
by such a method is depicted in figures 2–6. (Spec. 6.) Consequently, we
understand the Specification to define the term “fiber-like material” as used
in the claims with respect to kaolin being incorporated therein to be a solid
fiber material that is “a non-woven ‘fabric’ or a mat/scaffolding.” We,
therefore, do not determine that the claim language fiber-like used in claims
31 and 57, in view of the Specification, is indefinite.
Claims 42 and 62
The Examiner contends that these claims are “indefinite because it is
not clear how the materials other than cellulose had to resemble cellulose to
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satisfy the limitations of the claim” (Non-Final Action 11) and the
Specification does not disclose “cellulose-type as varieties of cellulose
species that can be applied to high-pressure blood flow wound” (Ans. 6).
We again disagree with the Examiner that this claim language is so unclear
or vague such that one of ordinary skill in the art would not understand the
scope of the invention with reasonable certainty.
The Specification identifies that there are “cellulose of many types”
that are appropriate hemostatic or absorptive agents that may be used in
conjunction with a clay mineral composition in the practice of the invention.
(Spec. 9–10.) Thus, we agree with Appellants, that “cellulose types” would
be understood by one of ordinary skill in the art to embrace all species of
cellulose. (Appeal Br. 7.)
We, therefore, do not sustain the Examiner’s rejection that claims 42
and 62 are indefinite.
Claim 29
The Examiner contends that this claim is indefinite because the claim
is confusing as to whether the method requires repeating the application of
amounts kaolin until the kaolin stanches the blood flow or whether a specific
amount of kaolin is required all at once and maintained in the blood flow
until blood flow stanches. We agree with the Examiner that under the
broadest reasonable construction the claim can plausibly be read as being a
method that either requires continuous application of amounts of kaolin until
the kaolin stanches the blood flow or a specific amount of kaolin is applied
all at once and maintained in the blood flow until blood flow stanches.
While Appellants argue that the Specification does not require an amount
and repetition of application of kaolin to stanch the blood flow (see, e.g.,
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Appeal Br. 8–9; Reply Br. 4), we disagree that the broadest reasonable
construction of the claim in light of the Specification precludes such an
interpretation. In particular, the Specification states “[t]he clay minerals are
applied in a quantity sufficient to promote one or both of the following: i)
hemostasis and ii) formation of a cast.” (Spec. 5.) In addition the
Specification states that “[t]he formulations of the present invention may be
administered to a site of bleeding . . . . Examples include . . . directly to a
wound, (e.g. by shaking powdered or granulated forms of the material
directly into or onto a site of hemorrhage).” (Id. at 10.)
However, we disagree with the Examiner that the claim is indefinite
because it can encompass both possibilities. The fact that the clay can be
applied all at once to stanch the blood flow or can be added continuously
until it stanches the blood flow does not render the claim vague, just broad.
Again, breadth is not equated to indefiniteness. Miller, 441 F.2d at 693.
Claims 59–62
The Examiner notes that the limitation “said internal wound” in these
claims does not have sufficient antecedent basis. (Non-Final Action 11.)
Appellants’ Brief does not address this rejection. We, therefore, summarily
affirm the Examiner’s rejection upon this ground. See 37 CFR
§ 41.37(c)(iv) (“[A]ny arguments or authorities not included in the appeal
brief will be refused consideration by the Board for purposes of the present
appeal.”).
SUMMARY
We reverse the rejection of claims 64–68 under 35 U.S.C. § 112, first
paragraph for lack of enablement.
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We reverse the rejection of claims 4, 29–54, and 57 under 35 U.S.C.
§ 112, second paragraph, as being indefinite for failing to particularly point
out and distinctly claim that which the applicant regards as the invention.
We affirm the rejection of claims 59–62 under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim that which the applicant regards as the invention.
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).

AFFIRMED-IN-PART