Ex Parte Diegelmann et al

Patent Trial and Appeal Board

Jul 19, 2017

11884363 (P.T.A.B. Jul. 19, 2017)

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 07/19/2017
WHITHAM, CURTIS & COOK, P.C.
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
07/19/2017 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 2015-002795
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 promoting hemostasis, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
“Hemorrhage typically results from rupture of one or more blood
vessels.” (Spec. 7.) “The active control of hemorrhage is referred to as
‘hemostasis’.” (Id.) Promoting hemostasis “involves, for example: slowing

1 Appellants identify the Real Party in Interest as Virginia Commonwealth
University of Richmond, VA. (Appeal Br. 3.)
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or stanching the flow of blood; and enhancing, facilitating or causing the
blood to clot, particularly at the site of a wound.” (Id.) Appellants’
invention is directed to compositions comprising clay minerals and their use
“for effectively treating and controlling hemorrhage.” (Id. at 4.)
Claims 1, 3, 4, 6, 7, 19, 20, and 23–30 are on appeal. Claims 1, 28,
and 29 are representative and reads as follows:
1. A method of promoting hemostasis in a hemorrhaging wound
having a high-pressure blood flow, comprising
without causing an exothermic reaction, applying a
composition comprising one or more clay minerals selected from
the group consisting of kaolin and bentonite to said
hemorrhaging wound having high-pressure bleeding in a
quantity sufficient to promote hemostasis and said one or more
clay minerals promoting blood clotting and stanching the blood
flow from the wound.
28. A method of promoting hemostasis in a hemorrhaging
wound having a high-pressure blood flow, comprising
applying to said wound a composition comprising kaolin
and/or bentonite, in a quantity sufficient to promote hemostasis,
and said kaolin and/or bentonite promoting blood clotting and
stanching the blood flow from the wound.
29. A method of stanching a high-pressure blood flow,
comprising:
applying kaolin and/or bentonite to the high-pressure
blood flow, until the applied kaolin and/or bentonite stanches the
high-pressure blood flow.
(Appeal Br. 27–28.)
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The following ground of rejection by the Examiner is before us on
review2:
Claims 1, 3, 4, 6, 7, 19, 20, and 23–30 under 35 U.S.C. § 103(a) as
unpatentable over Wnek3 in combination with Connor4 or Hubbard5 and
Hursey6 or JP’228.7
DISCUSSION
I. Claims 1 and 28
The Examiner finds that Wnek teaches a method for treating a high
pressure bleeding wound involving applying a dressing that includes a
hemostatic substance that is an absorbent material and a clot promoting
agent. (Final Action 6–7; Ans. 3–4.) The Examiner notes that Wnek does
not teach kaolin or bentonite as the clot promoting agent. (See Final Action
7; Ans. 4.)
The Examiner finds that Connor, Hubbard, and Hursey teach that
kaolin and bentonite are known blood coagulants, and that JP’228 teach

2 The provisional rejection of claims 1, 3, 4, 6, 7, 19, 20, and 23–20 on the
ground of nonstatutory double patenting made in the Final Office Action
(Final Action 3–4) is moot in view of the filing of the Terminal Disclaimer
on September 22, 2014 and approval of that Terminal Disclaimer on
September 23, 2014.
3 Wnek et al., US 2004/0013715 A1, published Jan. 22, 2004.
4 William E. Connor, THE ACCELERATION OF THROMBUS FORMATION BY
CERTAIN FATTY ACIDS, 41(6) J. Clin. Invest. 1199–1205 (1962).
5 Donald Hubbard & George Lucas, Ionic charges of glass surfaces and
other materials, and their possible role in the coagulation of blood, 15(2) J.
Appl. Physiol. 265–270 (1960).
6 Hursey et al., US 2003/0133990 A1, published July 17, 2003.
7 JP 11-071228, published Mar. 16, 1999. The Examiner relied on a
computer translation of this reference, as do we.
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kaolin “ha[s] excellent hemostatic effect.” (Final Action 7; Ans. 4.)
According to the Examiner, Connor teaches that bentonite and kaolin
“provide very short thrombus formation time compared to other coagulation
elements.” (Id.) The Examiner notes that Hubbard teaches that these
materials “are the most active procoagulant powdered glass.” (Id.) The
Examiner further notes that Hursey teaches that kaolin is a blood coagulation
accelerator. (Id.)
The Examiner contends that it would have been obvious to one of
ordinary skill in the art to treat a high pressure bleeding wound by applying
pressure using gauze and absorbent materials as taught by Wnek and include
kaolin as a clotting agent in the dressing of Wnek in light of the prior art
teachings that kaolin is known to accelerate blood coagulation and has
hemostatic properties. (Final Action 8; Ans. 4–5.) The Examiner further
concludes that one of ordinary skill in the art would have expected the kaolin
or bentonite addition to result in a dressing where hemostasis would be
“greatly and quickly accelerated.” (Id.)
The Examiner also notes, with regard to the limitation in claim 1 that
the step of applying the kaolin is accomplished “without causing an
exothermic reaction,” that the prior art does not indicate that kaolin is
expected to provide an exothermic reaction, and, thus, the limitation would
be met by the modified Wnek method. (Final Action 8; Ans. 5.)
Appellants argue the Examiner’s rejection is in error because none of
the prior art references relied upon suggest that high pressure bleeding can
be effectively addressed in vivo using kaolin and bentonite (Appeal Br. 14,
Reply Br. 1) and without the application of pressure (Reply Br. 2).
Appellants also argue that the prior art teaches away from the use of kaolin
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and bentonite in vivo to stanch high pressure arterial bleeding (Appeal Br.
14–15, Reply Br. 2), and that the Examiner “has not properly weighted the
evidence directed to secondary indicia of non-obviousness” that relates to
Appellants’ “finding that high pressure bleeding can be staunched with
kaolin and/or bentonite” (Appeal Br. 15–17, Reply Br. 2).
We do not find Appellants’ arguments persuasive as to claims 1 and
28, in particular, because they rely on an interpretation of the claim that is
narrower than the broadest reasonable interpretation. “[D]uring examination
proceedings, claims are given their broadest reasonable interpretation
consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed.
Cir. 2000).
a. Claim Construction
1. The claim steps
Claim 1 is a method “comprising” a single enumerated step, i.e.,
“without causing an exothermic reaction, applying a composition comprising
one or more clay minerals selected from the group consisting of kaolin and
bentonite. . . .” Similarly, claim 28 is a method “comprising” a single
enumerated step, i.e., “applying to said wound a composition comprising
kaolin and/or bentonite. . . .”
“The transition ‘comprising’ in a method claim indicates that the
claim is open-ended and allows for additional steps.” Invitrogen Corp. v.
Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003). Consequently, in
claim 1, although there is a required step of applying kaolin and/or bentonite
without causing an exothermic reaction, the claim does not preclude
additional steps, such as applying pressure with a swellable material, or even
causing an exothermic reaction by the application of some other material
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besides kaolin or bentonite. Similarly, claim 28 requires that kaolin and/or
bentonite is applied to the wound, but does not preclude additional steps,
such as applying pressure with a swellable material, or even causing an
exothermic reaction during the application of kaolin or bentonite, or causing
an exothermic reaction by the application of some other material besides
kaolin or bentonite.
2. “Promote hemostasis and . . . promoting blood clotting and
stanching the blood flow”
In addition to the foregoing, claims 1 and 28 require that kaolin and/or
bentonite are present in a quantity sufficient “to promote hemostasis” as well
as “promoting blood clotting and stanching the blood flow from the wound.”
The ordinary meaning of stanching is to stop or restrict the flow of
blood from a wound. This is consistent with Appellants’ Specification
which defines hemostasis as “[t]he active control of hemorrhage” and
“hemorrhage” as “the loss of blood from one or more anatomical sites of a
patient that, if left untreated, would jeopardize the health of the patient.”
(Spec. 7.) Appellants’ Specification further indicates that “[t]he promotion
of hemostasis involves, for example: slowing or stanching the flow of blood;
and enhancing, facilitating or causing the blood to clot, particularly at the
site of a wound.” (Id.) Thus, in describing hemostasis, Appellants’
Specification differentiates slowing from stanching. Furthermore, Example
3 of Appellants’ Specification entitled “Use of Bentonite Composition to
Stanch Bleeding in vivo” describes a method in which “swine . . . were used
to test the ability of bentonite clay granules to stop arterial bleeding.” (Spec.
21–22.) Thus, we construe the term “stanching” as used in claims 1 and 28
to mean stopping or restricting the flow of blood from a wound.
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As used in the phrase “promoting blood clotting and stanching the
blood flow,” we find that the clay minerals, kaolin or bentonite, need to be
supplied in a quantity sufficient to “promote” stopping of blood flow, as well
as promote blood clotting. In short, neither claim 1, nor claim 28 require
that the quantity of kaolin or bentonite stop blood flow.
With this understanding of claims 1 and 28, we now turn to
Appellants’ arguments.
b. Claims 1 and 28 do not exclude Wnek’s method that employs both a
swellable material and a clot promoting agent
Appellants, in the Reply Brief, recognize that Wnek teaches clotting
agents may be used in combination with the device containing a swellable
material. (Reply Br. 2.) Appellants contend, however, that Wnek does not
teach or suggest the use of clotting agents without the swellable materials
causing a back pressure in the wound to stop high pressure bleeds. (Id.) As
discussed above, however, claims 1 and 28 are open-ended in using the
transitional phrase “comprising.” As a consequence, we agree with the
Examiner that “[e]xpansion of swellable material to provide pressure on the
wound is . . . not excluded[] by the present invention. . . .” (Ans. 11.)
Appellants argue that the swellable material of Wnek causes an
exothermic reaction “which is not present in the claimed invention.” (Reply
Br. 2). However, claim 1 does not preclude a process where an exothermic
reaction results somewhere along the line. Rather, claim 1 requires that
applying kaolin and bentonite does not cause an exothermic reaction. Claim
28 similarly does not preclude a process where an exothermic reaction
results at all. The Examiner asserted, and Appellants do not contest, that
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“the references that teach kaolin are not expected to provide an[] exothermic
reaction.” (Final Action 8.)
As the Examiner pointed out, Wnek teaches “that the clot[] promoting
agents are provided in a form to maximize their passage through the bag to
the exterior of the dressing” thus the clot promoting agent “contacts the
wound.” (Ans. 11 (emphasis omitted).) We agree with the Examiner’s
finding. (See Wnek ¶ 74.) In light of that teaching, we agree with the
Examiner that Wnek teaches a method in which the clot promoting factor
would be applied to the wound apart from the swellable material, and, thus,
would not create an exothermic reaction when applied. (See Ans. 5.)
Consequently, we agree with the Examiner that Wnek’s use of a
swellable material and clot promoting materials to stop high pressure
bleeding, in which the clot promoting materials would pass through the bag
to the exterior of the dressing, is not excluded by the claimed process. (Ans.
11–12.) Moreover, as will be discussed below, we agree with the Examiner
that it would have been obvious to one of ordinary skill in the art from the
additional prior art cited by the Examiner to use kaolin and/or bentonite as
the clotting promoting material in the Wnek method. (Ans. 14–16.) We
also agree that such material would have been understood by one of ordinary
skill in the art to promote stopping of blood flow. (Id.)
c. The Examiner’s prima facie case that kaolin or bentonite would
promote stanching of blood flow has not been rebutted by sufficient
evidence
As discussed above, under the broadest reasonable construction,
claims 1 and 28 do not require that the kaolin or bentonite actually stop
blood flow. Rather, it is sufficient that the kaolin or bentonite promote
stopping of blood flow.
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It is undisputed that kaolin and bentonite are known to promote blood
coagulation. Indeed, these materials are known to accelerate blood
coagulation, providing very short thrombus formation time. (See, e.g.,
Connor 1201–1202 and Table 1 and Figure 3 (noting that glass, kaolin, and
bentonite “highly accelerated thrombus formation . . . similarly to the most
potent of the saturated fatty acids”); Hubbard 265 (noting that kaolin and
bentonite “quickly impart blood curdling capacity to plasma”), Hubbard 268
(noting glass surfaces and kaolins “are known to accelerate the normal
coagulation rate of blood”); Hursey ¶ 18 (including kaolin in a list of known
“blood coagulation accelerator materials”).) Moreover, JP’228 teaches
kaolin has “outstanding” hemostatic properties. (JP’228 ¶¶ 32–34.) We find
such coagulation and hemostatic properties would promote stopping of
blood flow because the liquid blood would be changed to coagulated form
which would necessarily promote stopping of blood flow. Indeed, Acheson8
supports such a conclusion, in noting that “hypotension, allowing
spontaneous clotting, and vasospasm . . . limit arterial hemorrhage.”
(Acheson 871.) Thus, the claim limitation requiring that the kaolin promote
stanching of blood flow would inherently be met by the coagulation that
would take place between the blood and the clay. Indeed, JP’228 considers
including kaolin in the compositions to promote stopping bleeding when
applied to a bleeding wound because of its clotting acceleration ability.

8 Eric M. Acheson et al., Comparison of Hemorrhage Control Agents
Applied to Lethal Extremity Arterial Hemorrhages in Swine, 59 (4) J.
Trauma Injury, Infection, and Critical Care, 865–873, (2005). This is an
article relied on by Appellants, among other reasons, in an effort to establish
the claimed invention meets a long-felt but unmet need. (See Appeal Br. 16,
17.)
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(See, e.g., JP ’228 ¶¶ 2, 32–34, 70.) Hursey further supports such a
conclusion as it teaches using materials to facilitate stopping low pressure
bleeding because they are known to be blood coagulation accelerator
materials. (See, e.g., Hursey ¶¶ 17–18, 89–90.)
Appellants contend that because the evidence of record establishes
that bandages that were found to be effective for low pressure bleeds turned
out to be ineffective for high pressure bleeds, and because the prior art does
not demonstrate kaolin or bentonite to be hemostatic agents in relation to
high pressure bleeds, one of ordinary skill in the art would not have found it
obvious to use these known clot promoting materials to stanch high pressure
bleeds. (Appeal Br. 20–21; Reply Br. 2.) In other words, argue Appellants,
“[t]here is no evidence, teaching, or suggestion within the Hubbard or other
cited references that would allow one of ordinary skill in the art to
extrapolate the coagulation effect to hemostasis and the stanching of high
pressure bleeding.” (Appeal Br. 21.)
We understand Appellants’ evidence and argument that the blood
coagulation promoting property of kaolin and bentonite would not be
understood to meet the claim requirement of stanching to rest on interpreting
claims 1 and 28 to require that the kaolin or bentonite, by itself, is
responsible for stopping blood flow in a high pressure bleed. (See, e.g.,
Appeal Br. 15 (citing Ward Decl.9); Appeal Br. 20 (citing Acheson).) For
example, the Ward Declaration the Appellants rely on refers to evidence that
“glass based bandages were unable to stop high pressure bleeding.” (Ward
Decl. ¶ 4.) Furthermore, the Acheson article Appellants rely on indicates

9 Declaration of Dr. Kevin Ward submitted July 20, 2012.
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that chitosan dressing and quick clot were not able to “stop this arterial
bleeding.” (Acheson 873.)
As discussed above, claim 1 and 28 requires the kaolin and/or
bentonite “promote” stopping of blood flow in a high pressure bleed, not that
it stops the blood flow. Thus, we do not find Appellants’ argument and
evidence persuasive.
Moreover, we note that Acheson indicates that chitosan dressing,
which was known to have a blood coagulating effect, was effective in
reducing the bleeding rate, though not in stopping a high pressure bleed. (Id.
at 872.) In other words, Acheson supports the position of the Examiner that
materials known to have a blood coagulating effect would “promote”
stopping of blood flow, even if it would not be able to stop the blood flow.
In light of the foregoing, we find there to be insufficient evidence pointed to
by Appellants that one of ordinary skill in the art would doubt that kaolin
and bentonite would reasonably be expected to promote stopping blood flow
in a high pressure bleed despite their known blood coagulation properties.
That is so even where the coagulation ability was not “demonstrated” in vivo
in a bleed situation. (Appeal Br. 14–15.) The preponderance of the
evidence supports that one of ordinary skill in the art would have a
reasonable expectation that coagulation properties would be likely to
promote stopping of blood flow in a bleed situation even absent in vivo
evidence.
Appellants rely on the testimony of Dr. Ward that
At the interview, we discussed the Connor reference. It
was noted that Connor only demonstrates the relative ability of
various substances (e.g., glass, kaolin, bentonite, and fatty acids)
to activate the clotting system in vitro. As discussed at the
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interview, the activation of the clotting system does not imply
that these substances are capable of staunching high pressure
bleeding, and in my opinion, the fact that activation does not
correspond to high pressure bleeding performance would be
recognized and understood by those of skill in the art.
Furthermore, we also discussed during the interview the
references supplied with the previous response which clearly
demonstrate that glass based bandages were unable to stop high
pressure bleeding (glass being one of the substances identified
by Connor as activating the clotting system).
(Ward Decl. ¶ 4 (emphasis added).) It is not clear that Dr. Ward’s
discussion concerning one of ordinary skill in the art not correlating
activation of the clotting system to stanching high pressure bleeding
considers that the claims only require promoting stopping and not stopping.
Indeed, in light of the remainder of the paragraph and Dr. Ward’s
Declaration as a whole, it would appear that Dr. Ward’s testimony is
referring to whether or not someone of ordinary skill in the art would
correlate the activation of the clotting system to stopping high pressure
bleeding, and not to promoting stopping of blood flow. (See, e.g., Ward
Decl. ¶ 4 (“Furthermore, we also discussed during the interview the
references supplied with the previous response which clearly demonstrate
that glass based bandages were unable to stop high pressure bleeding”);
Ward Decl. ¶ 2 (referring to a demonstration showing “an embodiment of
the . . . invention” that “stanched the high pressure bleeding very quickly” in
a bleed that “would not stop by itself”), ¶ 5a (“it is my opinion that it would
not be obvious to one of ordinary skill in the art having full knowledge
Connor and Mershon, that one could produce a technology from Connor and
Mershon capable of stopping high pressure bleeding . . .”).)
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In light of the discussion above, and contrary to Appellants’ position,
we do not find evidence that the prior art, when considered “in its entirety,”
“teach[es] away from the claimed invention” (Appeal Br. 14 (emphasis
omitted)), under the broadest reasonable construction of the claim.
d. The asserted secondary considerations were properly considered
by the Examiner
Appellants cite to Baker10 as evidence of the invention satisfying “a
long-felt, unmet need” because “the performance results with kaolin were
recognized by others as being important and unexpected.” (Appeal Br. 15
(emphasis omitted); Reply Br. 2–3.) However, we note that Baker reports
on in vitro whole blood coagulation studies, not on applying kaolin to a site
of internal bleeding. Thus, Baker does not reflect unexpected results of the
claimed invention, nor does it evidence satisfaction of a long-felt but unmet
need by the claimed invention.
Baker notes that there was “motivation [in the art] to use clays as an
alternative to QC[, i.e., Quick Clot, which is a zeolite 5A composite
material,] to reduce the risk of thermal injury” and, thus, studied the heat
release by QC and kaolin upon application to water and found that kaolin
“which has similar [blood clotting] efficacy in vitro, does not release
measureable heat upon addition to water.” (Baker 4391.) However, Baker
does not indicate that kaolin’s activity of having an “exceptionally fast
clotting response” on blood is unexpected. (Id.) Baker does state that it was
“surprising that a layered clay such as kaolin could share comparable blood-
clotting activity with QC, despite the observation that dehydration and

10 Sarah E. Baker et al., Controlling Bioprocesses with Inorganic Surfaces:
Layered Clay Hemostatic Agents, 19 Chem. Mater. 4390–4392 (2007).
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release of heat do not appear to play a role in the clotting activity of the
clays.” (Id.) That “surprising” observation by Baker, however, is not
evidence of an unexpected ability of kaolin to promote coagulation of blood,
but rather refers to an unexpected comparability to another known blood
clotting agent despite differing observed but inherent properties of the
materials. We do not find such an observation relevant to establishing the
claimed invention satisfies “a long-felt, unmet need.”
Appellants further argue that the Examiner’s combination of prior art
and medical literature
does not comport with the fact that military medicine for over
200 hundred years (those skilled in the art of hemostasis of high
pressure bleeding wounds) or civilian medical science (civilian
trauma surgeons, emergency medicine and related specialties) or
the medical supply industry and related pharmaceutical industry
would not have used the information that the Examiner believes
is obvious to develop kaolin or bentonite related products to save
hundreds of thousands of lives.
(Appeal Br. 16; Reply Br. 3.) The methods of claim 1 and 28, however, are
not directed to “saving lives” or even to “stopping high pressure blood flow”
which may lead to saving lives.
Appellants contend that “safely and effectively addressing high
pressure bleeding remains a concern for NATO and the US Army (see
Declaration of Dr. Kevin Ward filed July 20, 2012 and the Pusateri[11] article
discussed above).” (Appeal Br. 17; Reply Br. 3 (citing in addition

11 Anthony E. Pusateri et al., Effect of a Chitosan-Based Hemostatic
Dressing on Blood Loss and Survival in a Model of Severe Venous
Hemorrhage and Hepatic Injury in Swine, 54(1) J. Trauma Injury, Infection,
and Critical Care, 177–182 (2003).

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Acheson).) Dr. Ward’s opinion is that the U.S. Army and U.S. military
research programs in hemostatic technology to treat high pressure bleeding
“would have knowledge of the fact that bentonite, kaolin, and glass activate
the clotting system as demonstrated by Connor” but that it would not have
been obvious to one of ordinary skill in the art to “produce a technology
from Connor and Mershon[, a reference that like Wnek teaches utilizing
superabsorbent polymers in stopping blood flow,] capable of stopping high
pressure bleeding since the U.S. Military has not done so.” (Ward Del.
¶ 5a.) However, as noted, under the broadest reasonable construction,
claims 1 and 28 are not limited to stopping high pressure bleeding with
kaolin or bentonite alone. Instead, they encompass promoting stopping of
blood flow using kaolin and/or bentonite, and do not exclude providing
additional materials that would assist in stopping blood flow, such as the
swellable materials taught by Wnek. Thus, we do not find Dr. Ward’s
Declaration to evidence the claimed invention satisfying a long-felt but
unmet need.
Pusateri describes the hemostatic effect of chitosan observed in a
grade V liver injury model, which is a low-pressure hemorrhage. A chitosan
dressing was determined to reduce hemorrhage and improve survival after
severe liver injury. (See Pusateri at 180.) Acheson describes testing of
chitosan bandages, among other bandages, in a high pressure bleed model
and the bandage was found ineffective for stopping high pressure bleeds.
(Acheson 866 (Table 1: noting CD was effective for venous/parenchymal
bleeding but not against high-pressure arterial hemorrhage).) We do not
disagree with Appellants that the Pusateri and Acheson articles appear to
support that NATO and the U.S. Army were looking to “safely and
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effectively address” wound dressings that will stop high pressure bleeding.
However, the claimed invention is a method where kaolin and/or bentonite
promotes stopping blood flow in a high pressure bleed, not that they, by
themselves, stop high pressure blood flow. Thus, these articles are not
deemed to establish the claimed invention has satisfied a long-felt, but
unmet need.
In light of the foregoing, we find the Examiner has properly
considered the evidence of record.
For all of the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claims 1 and 28 for obviousness over Wnek in
combination with Connor or Hubbard and Hursey or JP’228.
Appellants do not separately argue claims 3, 6, 7, 19, and 25–27, and,
therefore, those claims fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
e. Dependent claims 4, 20, 23, and 24
Appellants purportedly separate argument with respect to claim 4 rests
on the same arguments against Wnek, Connor, Hursey, Hubbard, and JP’228
addressed above. (Appeal Br. 23.) Consequently, we find that Appellants
have not separately argued claim 4. Accordingly, it falls with claim 1.
Appellants’ separate argument concerning claim 24 is that the prior art
does not teach a gauze contacting clay mineral directly on the hemorrhaging
wound. (Appeal Br. 22.) However, as discussed above, Wnek does teach
that the clot promoting agents are sized to be released from the bag and then
external to the device. Moreover, the bag is made of gauze and applied to
the wound. Thus, we do not find this additional argument by Appellants
persuasive of Examiner error in rejecting claim 24 for obviousness over
Wnek in combination with and Connor or Hubbard and Hursey or JP’228.
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Appellants’ argument concerning claim 20 that the prior art does not
teach placement of a substrate which carries clay mineral on or in the
hemorrhaging wound (Appeal Br. 23) is unavailing. As the Examiner
explained (Ans. 20–21), Wnek teaches applying a dressing or bag containing
the clot promoting materials to the wound site, which materials are sized to
be able to pass through the bag, and, thus, the bag with clot promoting
agents reads on the claim limitation.
Claim 23 requires “formation of a cast.” Appellants contend that none
of the references discuss “application of clay minerals to a hemorrhaging
wound to promote the formation of a cast (e.g., a hardened plug).” (Appeal
Br. 21.) The Examiner responds, and Appellants do not dispute, that
“forming a cast is expected from combination of clay with the blood on the
wound” as would occur when the kaolin or bentonite passes outside of the
dressing and contacts the blood from the wound. (Ans. 19.) In light of the
fact that the Appellants do not contest that the formation of the cast would
be an inherent function as the Examiner described, we find no error in the
Examiner’s rejection of this claim as being obvious over the cited prior art.
II. Claim 29
In contrast to claims 1 and 28, claim 29 requires the applied kaolin
and/or bentonite “stanches” the high pressure blood flow, not just that it
promote stanching. The Examiner finds that “claim 29 is obvious over the
cited references for the reason claim 1 is obvious as set forth [above].”
(Ans. 21.)
We disagree with the Examiner’s conclusion that the invention recited
in claim 29 would have been obvious over the cited references.
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a. Claim Construction
As discussed above, we construe the term staunch to require stopping
or restricting the flow of blood from a wound.
b. The prior art does not provide a reasonable expectation of success
According to the Examiner, in light of the fact that bentonite and
kaolin were known hemostatic agents, one of ordinary skill in the art would
have found it obvious to adjust the amount of these clay minerals so as to
achieve the claimed result. (Ans. 15.) As noted above, the claimed result
requires the kaolin and/or bentonite to stop high-pressure blood flow. We
find that a preponderance of evidence of record establishes that one of
ordinary skill in the art would not have had a reasonable expectation that
clay minerals would stop high-pressure blood flow.
As Appellants explain, “Connor details in vitro experiments for
thrombus formation.” (Appeal Br. 20; see also Ward Decl. ¶ 4.) Dr. Ward,
pointed out in his Declaration that the Connor reference identifies glass, in
addition to clay minerals, as a substance that activates the clotting system,
but glass based bandages have been demonstrated not to be able to stop high
pressure bleeding. (Ward Decl. ¶ 4.) An article submitted during
prosecution by Appellants confirms Dr. Ward’s sworn testimony. (See
Dubick12 at 21-3 (noting that a “dual-fiber dressing made of type E

12 Michael A. Dubick & Bijan Kheirabadi, New Technologies for Treating
Severe Bleeding in Far-Forward Combat Areas, North Atlantic Treaty
Organization Science and Technology Organization, published April 7,
2010, available at
https://www.sto.nato.int/publications/STO%20Meeting%20Proceedings/For
ms/All%20MPs.aspx?RootFolder=%2Fpublications%2FSTO%20Meeting%
20Proceedings%2FRTO-MP-HFM-
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19
continuous filament glass and a specialty rayon material woven together as a
special textile material . . . [was not] successful in stopping an arterial
hemorrhage”).)
Like Connor, neither Hubbard nor JP’228 provide one of ordinary
skill in the art with a reasonable expectation that in light of the known blood
coagulation properties of bentonite and kaolin, one could extrapolate that
when used in sufficient amount, those compounds could stop high pressure
bleeds. That is because, neither of those reference demonstrates that the
acceleration of blood coagulation by a clay mineral is capable of stopping
flowing blood, whether high pressure flow or low pressure flow. As Dr.
Ward notes in his sworn testimony, “the fact that activation [of blood
clotting] does not correspond to high pressure bleeding performance would
be recognized and understood by those of skill in the art.” (Ward Decl. ¶ 4.)
Although Hursey does demonstrate certain materials considered to be
useful in promoting blood coagulation did stop bleeding from a toenail
injury (i.e., a low pressure bleed), Appellants point to evidence of record
demonstrating that just because a material can stop bleeding in low pressure
bleeds, such is insufficient to conclude that the material can likewise stop
high pressure bleeds. (Appeal Br. 18–19.) For example, Acheson describes
testing of chitosan bandages (CD), considered to be effective for stopping
blood flow for low pressure bleeds, but were found ineffective for stopping
high pressure bleeds. (Acheson 866 (Table 1: noting CD was effective for
venous/parenchymal bleeding but not against high-pressure arterial

182&FolderCTID=0x0120D5200078F9E87043356C409A0D30823AFA16F
602008CF184CAB7588E468F5E9FA364E05BA5&View=%7B72ED425F-
C31F-451C-A545-41122BBA61A7%7D.
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20
hemorrhage), 868 (noting “CD provided hemostasis in one subject, but
subsequently failed (14 minutes later)”), 872 (noting that CD was unable to
provide significant hemostasis during severe arterial bleeding).)13
In sum, Appellants provided evidence of the unpredictability of
stopping high pressure blood flow even when a material is known to
promote coagulation. The Examiner appears to have dismissed this evidence
out of hand with the following reasoning:
it is argued that agents such as kaolin and bentonite have their
latent hemostatic properties that would be exhibited upon
contacting blood, from venous or arterial origin. What makes the
difference would be the amount of the administered hemostatic
agent and the method used for applying the hemostatic agent
including application of pressure.
(Ans. 10.) The Examiner points to no evidentiary support that one of skill in
the art would have reasonably expected that increasing the amount of clay
minerals that are known to be able to promote blood coagulation in vitro or
in low pressure bleeds would also be able to stop a high pressure bleed by
increasing the amount of that material despite evidence that known materials
that promote coagulation have failed to stop high pressure bleeding.
For the foregoing reasons, we conclude that the Examiner has failed to
establish by a preponderance of the evidence that the subject matter of claim
29 would have been obvious at the time of Appellants’ invention.
Consequently, we reverse the Examiner’s rejection of independent claim 29
and dependent claim 30 under 35 U.S.C. § 103(a) as unpatentable over
Wnek in combination with Connor or Hubbard and Hursey or JP’228.

13 Pusateri describes the hemostatic effect of chitosan observed in a grade V
liver injury model, which is a low-pressure hemorrhage.
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21
SUMMARY
We affirm the rejection of claims 1, 3, 4, 6, 7, 19, 20, and 23–28 under
35 U.S.C. § 103(a) as unpatentable over Wnek in combination with Connor
or Hubbard and Hursey or JP’228.
We reverse the rejection of claims 29 and 30 under 35 U.S.C. § 103(a)
as unpatentable over Wnek in combination with Connor or Hubbard and
Hursey or JP’228.
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