Michael Nuttal

Patent Trials and Appeals Board

Oct 22, 2019

12854329 - (D) (P.T.A.B. Oct. 22, 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.
12/854,329 08/11/2010 Michael Nuttal 6298-712 7576
757 7590 10/22/2019
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
HONG, THOMAS J
ART UNIT PAPER NUMBER
3715
MAIL DATE DELIVERY MODE
10/22/2019 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 MICHAEL NUTTAL

Appeal 2019-000813
Application 12/854,329
Technology Center 3700
____________

Before LINDA E. HORNER, NATHAN A. ENGELS, and
FREDERICK C. LANEY, Administrative Patent Judges.

HORNER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1‒5 and 7‒20.2 We have jurisdiction
under 35 U.S.C. § 6(b).
The Examiner rejected the claims as failing to comply with the written
description requirement and as being unpatentable over various
combinations of the prior art. Appellant argues that the Specification

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 Trudell
Medical International. Appeal Brief 2 (June 12, 2018) (“Appeal Br.”).
2 Claim 6 is canceled. Appeal Br. 2.
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provides adequate written description support for the scope of the claims.
Appellant further argues that the prior art does not render obvious the
subject matter of the claims. For the reasons explained below, we agree with
Appellant that the Examiner erred in rejecting the claims for lack of
adequate written description. Appellant has not identified error, however, in
the Examiner’s obviousness determination. Thus, we affirm.
CLAIMED SUBJECT MATTER
The claimed subject matter on appeal relates to systems and methods
for evaluating medication delivery from a delivery apparatus using a model
face and airway. Spec. ¶ 15. The model face and airway simulates a bone
structure, a trachea, soft tissue, and an epidermal skin layer of a person. Id.
The model face and airway may be mounted on a test cradle that applies a
medication delivery apparatus for use in evaluating medication delivery
from the delivery apparatus. Id.
Claims 1, 12, 17, and 18 are independent, and claim 1 is illustrative of
the subject matter on appeal and is reproduced below. The limitation
relevant to the outcome of this appeal is shown in italics.
1. A model face and airway for use in evaluation of
medication delivery by a delivery apparatus, the model face and
airway comprising:
a simulated bone structure defining a nasal cavity;
a simulated trachea defining an air passageway in
communication with the nasal cavity of the simulated bone
structure;
simulated soft tissue positioned over at least a portion of
the simulated bone structure; and
a simulated epidermal skin layer surrounding at least one
side of the simulated soft tissue;
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wherein the simulated soft tissue and the simulated
epidermal skin layer are configured to allow air to enter into the
air passageway at the nasal cavity of the simulated bone
structure; and
wherein the simulated bone structure, simulated soft
tissue, and simulated epidermal skin layer are configured to, in
response to a facemask of a medication delivery apparatus
applied to the model face at a force, emulate a seal between a
human face and the facemask of the medication delivery
apparatus when the facemask of the medication delivery
apparatus is applied to the human face at the force.
Appeal Br. 12 (Claims Appendix).
EVIDENCE
Meythaler et al. US 2005/0100873 A1 May 12, 2005
Owens et al. US 6,957,961 B1 Oct. 25, 2005
Sakezles US 7,272,766 B2 Sept. 18, 2007
Cohen et al. US 7,549,866 B2 June 23, 2009
Limbrick et al. US 2009/0173173 A1 July 9, 2009
REJECTIONS
The following rejections are on appeal:
1. Claims 1‒5 and 7‒20 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description
requirement.
2. Claims 1, 2, 5, 7‒9, 11‒17, 19, and 20 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Owens and Cohen.
3. Claims 3 and 4 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Owens, Cohen, and Sakezles.
4. Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Owens, Cohen, and Meythaler.
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5. Claim 183 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Limbrick, Owens, and Cohen.
PRIOR APPEAL
This application was the subject of prior Appeal 2014-004251,
decided June 13, 2016 (“the prior appeal”). In the prior appeal, the Board
entered a new ground of rejection of then-pending claims 1‒5 and 7‒20
under 35 U.S.C. § 112, second paragraph, as being indefinite. The Board
determined that the claims, which recited applying a facemask of a
medication delivery apparatus to a model face at “a clinically appropriate
force,” were indefinite because the Specification and the record before us on
appeal failed to provide “objective boundaries” to determine the scope of
this term. The Board did not reach the obviousness rejections in the prior
appeal because, to do so, would have required speculative assumptions as to
the meaning of the claims.
After the prior appeal, Appellant amended each of the independent
claims to replace “a clinically appropriate force” with “a force.” The
Examiner thereafter entered the written description and obviousness
rejections that are now before us on appeal.
ANALYSIS
Written Description Rejection
The Examiner rejected the claims because Appellant amended each
claim to recite “force” in place of “a clinically appropriate force” which

3 According to the Examiner, the recitation in claim 18 of an evaluation
method using a testing cradle is not supported by U.S. Provisional Appl. No.
61/233,014, to which the present application claims priority. The rejection
of claim 18 is based on an earliest effective filing date of August 11, 2010.
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“suggest[s] that now the scope of the amended ‘force’ encompasses
clinically inappropriate force such as a force powerful enough to deform or
demolish the model face.” Final Act. 3. The Examiner found that the
original disclosure “fails to reasonably convey . . . whether [Appellant]
possessed durable model face and airway sufficient to sustain under such
unlimited force as claimed.” Id.
Appellant argues that the Specification “describes and illustrates a
structure of a model face as claimed” and “describes and illustrates a testing
cradle that may be utilized to apply a facemask to the model face with a
force so that a simulated bone structure, a simulated soft tissue, and a
simulated epidermal skin layer of the model face may emulate a seal
between a human face and the facemask.” Appeal Br. 6; Reply Brief 5
(Nov. 7, 2018) (“Reply Br.”) (citing Spec. ¶ 17).
The Examiner responds that “achieving an optimal seal is relevant to
how much force is applied to the facemask during the tests” and that the
Specification “disclose[s] embodiments achieving the seal configured only
in response to ‘clinically appropriate force.’” Examiner’s Answer 5 (Sept.
13, 2018) (“Ans.”). The Examiner finds that “[t]he ordinary person in the
art would not know how to emulate the seal as claimed without knowing
what is the metes and bounds of the clinically appropriate force.” Id. at 6.
To satisfy the written description requirement, “the [original]
specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
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inventor had possession of the claimed subject matter as of the filing date.”
Id. “[T]he level of detail required to satisfy the written description
requirement varies depending on the nature and scope of the claims and on
the complexity and predictability of the relevant technology.” Id. at 1351
(citing Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005).
The “wherein” clause that is the subject of this rejection imposes
limitations on the structures of the simulated bone structure, soft tissue, and
epidermal skin layer of the model face. These structural limitations require
that the components of the model face are configured to be able to emulate a
seal that would normally occur between a human face and a facemask of a
medication delivery apparatus when the facemask is applied to the human
face at a force. Thus, the “force” is not the critical aspect of this limitation.
Rather, the construction of the recited components of the model face that
render it capable of emulating a seal are critical to the claimed seal.
As pointed out by Appellants, the Specification describes a specific
implementation in which the simulated bone structure comprises nylon, the
simulated soft tissue comprises foam such as TC-265 A/B produced by BJB
Enterprises, Inc. to simulate subcutaneous fat and muscle, and the simulated
epidermal skin layer comprises a chemically-resistant material such as
Skinflex III produced by BJB Enterprises Inc. to simulate an epidermal skin
layer on the face. Spec. ¶ 17. The Specification further describes that the
durometer of the simulated soft tissue and simulated epidermal skin layer is
between approximately 21 and 31 for durometer type OOO. Id.
Appellant’s Specification also describes that the accurate
representation of a face and airway of an infant allows for greater accuracy
in testing a seal. Spec. ¶ 18. The Specification describes that these
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simulated structures can be formed by mapping to a CT scan of an average
person or specific patient:
In some implementations, the model face and airway 102
is created based on a computed tomography scan (“CT scan”)
of a sinus cavity and tracheal area, including a mouth cavity, of
an average person or of a specific patient. Generally, a sintered
nylon, which is a beaded nylon material, is placed in an array
and scanned with a laser pursuant to the CT scan contours. The
scanning of the nylon with the laser welds the beads of the
nylon together such that after the scanning is complete, any
loose beads of nylon may be blown out of the mold.
The remaining fused structure of nylon substantially
maps to the CT scan of the sinus cavity and the tracheal area.
The remaining fused structure of nylon additionally includes
bone structures captured in the CT scan such as the cheekbone
and the jawbone behind and around the nasal cavity and the
mouth cavity. It will be appreciated that the remaining fused
structure of nylon corresponds to the simulated bone structure
104 and simulated trachea 106 described above. One example
of a simulated mouth cavity 116 and simulated trachea created
in this manner is shown in Fig. 5b.
In some implementations, the simulated bone mouth
cavity 116 and simulated trachea 106 may be used to evaluate
medication delivery from a delivery apparatus without the
simulated soft tissue 108 and simulated epidermal skin layer
110. However, in implementations where the simulated soft
tissue 108 and simulated epidermal skin layer 110 are used, the
simulated soft tissue 108 and simulated epidermal skin layer
110 may be prepared according to the CT scan so that when
assembled with the simulated bone structure 104 and the
simulated trachea 106, the model face 102 accurately represents
the CT scan.
Spec. ¶¶ 22‒24.
We find that the description provided in Appellant’s Specification
provides adequate disclosure of the structure of the model face configured to
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emulate the seal recited in each of independent claims 1, 12, 17, and 18. The
Specification describes specifically how the components of the model face
are formed to resemble an actual human face and the specific materials used
to construct each component of the model face.
We disagree with the Examiner’s interpretation of this claim
limitation to require a model face and airway capable of emulating a seal at a
force powerful enough to deform or demolish the model face. Final Act. 3.
Such a reading of the “force” limitation to encompass an unlimited amount
of force is unreasonably broad when the claim is read in light of the
Specification. Rather, the claim recites that when a facemask of a medical
delivery apparatus is applied to the model face at a force, the model face is
configured to emulate a seal that would occur between a human face and the
facemask when the facemask is applied the human face at the same force.
This limitation is means that the construction of the model face closely
resembles a human face so that the same seal that occurs with an actual
human face can be achieved with the model face.
As discussed above, the Specification adequately describes the
construction of a model face to achieve this result. For this reason, we do
not sustain the rejection of claims 1‒5 and 7‒20 under 35 U.S.C. § 112, first
paragraph.
Obviousness Rejection of Claims 1, 2, 5, 7‒9, 11‒17, 19, and 20 over Owens
and Cohen
The Examiner found that Owens discloses a model face and airway of
claim 1 comprising a simulated bone structure, a simulated trachea, and
simulated soft tissue, wherein the simulated soft tissue and skin are
configured to allow air to enter via a nasal cavity into a passageway defined
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by the simulated trachea. Final Act. 4. The Examiner also found that
because Owens discloses that the simulated head portion is made based on a
CT scan of an actual person’s head, the simulated head portion is a
“practically realistic replica of [a] human head” and, therefore, would
emulate a seal as claimed. Id. at 4‒5 (citing Owens, 8:50‒51).
Appellant contests the Examiner’s finding that the model face and
airway of Owens is configured to emulate a seal as claimed. Appeal Br. 7.4
Appellant argues that “[t]here is no teaching or suggestion in col[umn] 8,
lines 50‒51 of the Owens [mannequin] being configured to . . . emulate a
seal” as claimed. Id. Appellant argues that the mannequins of Owens are
used to monitor the results of trauma or injury to a human body and not for
testing a medication delivery apparatus. Id. at 7‒8.
The Examiner proposed to modify Owens to add the simulated skin
layer disclosed in Cohen “in order to design a body portion that closely
simulates the physical characteristics and properties of the respective body
portion.” Final Act. 5. Appellant does not contest the Examiner’s proposed
modification of Owens with the teaching of Cohen. Rather, Appellant
argues that even when combined, Owens in view of Cohen does not disclose
a model face configured to emulate a seal as claimed. Appeal Br. 8.5

4 Appellant argues the claims subject to this ground of rejection as a group.
Appeal Br. 7‒9. We select claim 1 as representative, and claims 2, 5, 7‒9,
11‒17, 19, and 20 stand or fall with claim 1. See 37 C.F.R.
§ 41.37(c)(1)(iv).
5 Appellant asserts that in previous Office Actions (dated November 23,
2012 and March 3, 2013), the Examiner acknowledged that Owens in view
of Cohen does not teach a model face configured to emulate a seal. Appeal
Br. 8. In these prior Office Actions, the Examiner had found, however, that
Owens in view of Cohen implicitly discloses the claimed model face
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The Examiner explains that the claims require the model face to be
configured to emulate the seal, and that the Specification describes scanning
a human face and airway using a computed tomography scan (“CT scan”) so
that the simulated replication will reproduce realistic contours of the human
model face. Ans. 9‒10 (citing Spec. ¶¶ 22‒23). The Examiner notes that
Owens teaches the substantially identical process of making a simulated
head based on a CT scan of an actual person’s head. Ans. 10. Thus, the
Examiner determines that Owens’s simulated head is configured to emulate
a seal as claimed. Id. The Examiner finds no structural difference between
the claimed model face and airway and the product resulting from the prior
art having substantially identical structural limitations and manufactured via
the substantially identical process. Id. Based on the structural similarity, the
Examiner finds that the simulated model face of the prior art “will show
substantially identical seal emulation capacity as claimed.” Id.
Appellant responds that there is no teaching or suggestion in the cited
portion of Owens that its mannequin is configured to emulate a seal.
Appellant further argues that the Examiner’s inherency finding is flawed
because:
While CT scans may be utilized in the design of both the
manikin in Owens and the model face of the present
application, it does not necessarily follow that the model head
of the smoothened expoxy [sic] resin used to monitor trauma or
injury to the human body as taught in Owens would be suitable

configured to emulate a seal. The Examiner then cited Liland (US
2007/0089747 A1, published April 26, 2007), in combination with Owens
and Cohen, for Liland’s explicit disclosure of a facemask testing apparatus
applied at a clinically acceptable force. Thus, we disagree with Appellant’s
assertion that the Examiner conceded that Owens in view of Cohen does not
teach a model face configured as claimed.
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for testing a medication delivery apparatus or emulating a seal
between a human face and a medication delivery apparatus.
Reply Brief 6‒7 (November 7, 2018) (“Reply Br.”).
A patent applicant is free to recite features of an apparatus either
structurally or functionally. See In re Swinehart, 439 F.2d 210, 212 (CCPA
1971) (“[T]here is nothing intrinsically wrong with [defining something by
what it does rather than what it is] in drafting patent claims.”). “Yet,
choosing to define an element functionally, i.e., by what it does, carries with
it a risk.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). As stated
in Swinehart, 439 F.2d at 213:
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.
Nevertheless, before an applicant can be put to this burdensome task, the
examiner must provide sufficient evidence or scientific reasoning to
establish there is a sound basis for the examiner’s belief that the functional
limitation is an inherent characteristic of the prior art. See In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990).
As discussed above, Appellant’s Specification describes achieving an
accurate representation of a face and airway of an infant by forming the
simulated bone, soft tissue, and epidermal skin structures by mapping to a
CT scan of an average person or a specific patient. Spec. ¶¶ 22‒24. Thus,
the Specification describes that the configuration of the model face and
airway that allows the model to emulate a seal between a human face and
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medication delivery apparatus can be achieved by configuring the model to
replicate an actual human face using a CT scan of an actual human face.
The portion of Owens relied on by the Examiner in the rejection
describes that “[a] CT scan of a child head was taken to determine the
skeletal structure and tissue of the head.” Owens, 8:50‒51. Thus, the
simulated model face and airway of Owens, which includes a simulated
bone structure and simulated human flesh, is based on a CT scan of an actual
human head in order to replicate an actual human face.
Based on the description provided in Appellant’s Specification of the
method of making the claimed model face and airway and the similar
method disclosed in Owens, we find that the Examiner provided sufficient
evidence and reasoning to establish a sound basis for the Examiner’s belief
that the model face and airway of Owens, as modified by the teaching of
Cohen, is configured so as to be capable of emulating a seal between a
human face and a medication delivery apparatus as claimed.
The burden then shifted to Appellant to prove that the subject matter
shown to be in the prior art does not possess this characteristic. In re Best,
562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior
art products are identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.”). Appellant has not met
this burden to show error in the Examiner’s rejection.
First, Appellant’s argument that Owens does not explicitly teach or
suggest that its mannequin is configured to emulate a seal with a human face
does not address the Examiner’s finding that this capability is an inherent
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characteristic of the prior art. Second, Appellant’s argument that Owens’s
mannequin is designed for a different use, i.e., to monitor the results of
trauma or injury to a human body, is not availing because, again, it does not
address the finding that this capability is an inherent characteristic of the
structure of the prior art. Third, Appellant’s argument that “it does not
necessarily follow that the model head of the smoothened expoxy [sic] resin
. . . would be suitable for testing a medication delivery apparatus or
emulating a seal between a human face and a medication delivery apparatus”
(Reply Br. 6‒7) does not provide an adequate explanation as to why the
Examiner’s inherency finding is unsound.
For instance, Appellant’s conclusory statement that the claimed
characteristic of the model face does not “necessarily follow” from the fact
that Owens’s mannequin is made based on a CT scan, fails to affirmative
distinguish Owen’s mannequin from the claimed model face and airway.
Further, Appellant’s argument that the model head of the smoothened epoxy
resin would not be capable of emulating a seal appears to be based on a
misunderstanding of Owens’s disclosure. Owens does not describe that the
model made of epoxy resin is the mannequin head. Rather, Owens describes
using the epoxy resin model to create a mold, which is then used to cast the
mannequin head.
Specifically, Owens describes that the CT scan is “converted into a
stereolithography file to provide a three-dimensional image of a child head,”
and based on the image, “a three-dimensional model of a child head is made
of an epoxy resin” and “smoothened to provide a consistent test surface.”
Owens, 8:51‒57. Owens then describes that using this model 56, a mold 58
for a child head is manufactured, and then the mold 58 is separated into two
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halves for casting. Id. at 8:59‒62. Owens teaches that “[a] mold for a skull
is also made in a similar manner” and that “a skull 60 is then cast with a
suitable bio-simulated material based on the mold 62 for the skull.” Id. at
8:63‒65. This skull 60 is then mounted in mold 58 for casting additional
components to simulate the actual child head using “bio-simulating material
prepared for the human flesh” for casting these additional components. Id.
at 9:10‒11, 44‒48.
Appellant does not explain persuasively why the model child head
made according to Owens’s method so that it replicates an actual child’s
head would not necessarily be capable of emulating a seal between a human
face and a medication delivery apparatus. Thus, we sustain the rejection of
claim 1 as unpatentable over Owens and Cohen. Claims 2, 5, 7‒9, 11‒17,
19, and 20 fall with claim 1.
Remaining Obviousness Rejections of claims 3, 4, 10, and 10
Appellant relies on the same arguments presented in support of claim
1 to assert error in the remaining rejections on appeal, each of which
similarly rely on Owens, as modified by Cohen, in the same manner as
discussed above. Appeal Br. 7‒10. For the same reasons discussed above,
Appellant has not identified error in these additional rejections. Thus, we
sustain the rejections under 35 U.S.C. § 103(a) of claims 3, 4, 10, and 18.
DECISION
We do not sustain the rejection of the claims under 35 U.S.C. § 112,
first paragraph. We sustain, however, the rejections of the claims under
35 U.S.C. § 103(a). Thus, the decision of the Examiner of unpatentability of
claims 1‒5 and 7‒20 is affirmed.
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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).
CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1‒5, 7‒20 § 112, first
paragraph
1‒5, 7‒20
1, 2, 5, 7‒9, 11‒
17, 19, 20
§ 103(a)
Owens, Cohen
1, 2, 5, 7‒9,
11‒17, 19, 20

3, 4 § 103(a)
Owens, Cohen,
Sakezles
3, 4
10 § 103(a)
Owens, Cohen,
Meythaler
10
18 § 103(a)
Limbrick, Owens,
Cohen
18
Overall Outcome 1‒5, 7‒20

AFFIRMED