Ex Parte Clayton et al

Patent Trial and Appeal Board

Feb 7, 2013

11526156 (P.T.A.B. Feb. 7, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte JESSICA CLAYTON, DONALD S. NELSON,
DAVID SWEDLOW, JOEL COLBURN,
and ROGER MECCA
____________________

Appeal 2010-006755
Application 11/526,156
Technology Center 3700
____________________

Before: JOHN C. KERINS, JAMES P. CALVE, and
BEVERLY M. BUNTING, Administrative Patent Judges

BUNTING, Administrative Patent Judge

DECISION ON APPEAL

Appeal 2010-006755
Application 11/526,156
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STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
35 and 47-57. App. Br. 3. Claims 36-46 are canceled. Id. We have
jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART and enter a
NEW GROUND OF REJECTION of claims 18-35 and 51-57 pursuant to
our authority under 37 C.F.R. § 41.50(b).

CLAIMED SUBJECT MATTER
The claimed subject matter is directed to a package for protecting a
medical device which has an inflatable region. Claims 1, 18, 47 and 51 are
the independent claims. Claim 1, reproduced below, is illustrative of the
claims on appeal:
1. A package for a medical device with an inflatable
region, comprising a substantially non-stretchable region that
substantially conforms to the shape of the inflatable region of
the medical device when the inflatable region is inflated.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Bley
Ogushi
US 5,765,682
US 6,732,734 B2
Jun. 16, 1998
May 11, 2004
Sheetz
Opie
US 2004/0195132 A1
US 2005/0040061 A1
Oct. 7, 2004
Feb. 24, 2005

REJECTIONS
Appellants appeal the following grounds of rejection set forth in the
Final Rejection that was mailed May 28, 2009 (“Final Rej.”):
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Application 11/526,156
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Claims 1-17 and 47-50 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite. App. Br. 5.
Claims 1, 4, 5, 7-16, 18, 21, 22, 24-35 and 47-57 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Bley. App. Br. 5.
Claims 2, 3, 19 and 20 stand rejected under 35 U.S.C. §103(a) as
being unpatentable over Bley in view of Sheetz. App. Br. 5.
Claims 6 and 23 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Bley in view of Opie. App. Br. 6.
Claim 17 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Bley as applied to claim 1 and further in view of Ogushi.
App. Br. 6.

ANALYSIS
Rejection of claims 1-17 and 47-50 under 35 U.S.C § 112, second
paragraph, as being indefinite
The Examiner found that claim 1 is indefinite since it recites the
limitation “the medical device” and there is insufficient antecedent basis for
this limitation in the claim, as a medical device has not been positively
recited. Ans. 3. The Examiner further found that claim 47 recites the
limitations “the medical device” and “the cuff” and that there is insufficient
antecedent basis for these limitations in the claim, as a medical device has
not been positively recited. Id. According to the Examiner, Appellants have
not made clear whether the “medical device” and the “cuff” are being
positively recited as part of the structure of the package or if the recitation of
the “medical device” and “cuff” are directed to an intended use of the
package. Ans. 8. The Examiner noted that the claims are not definite since
the claims reference an object (i.e., a medical device) that is variable. Id.
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Appellants argue claims 1 and 47 do not lack clarity or particularity as
to the scope of the claims in the context of the art or the disclosure, or render
the claims “insolubly ambiguous.”1 App. Br. 9. According to Appellants,
claims 1 and 47 are not ambiguous when read in the context of the
Specification, which clearly indicates that both claims are directed to
packages. Reply Br. 3. Appellants submit that claims 1 and 47 directed to a
package are distinguishable from claims 18 and 52, which are directed to a
shipping assembly comprising both a medical device and a package. Id. at
3-4. Appellants contend that the rejection is unclear as the Examiner has
provided no explanation as to how the recited “medical device” is variable.
Reply Br. 5.
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). Merely that a
claim is broad does not mean that it is indefinite. See In re Johnson, 558
F.2d 1008, 1016 n.17 (CCPA 1977); In re Miller, 441 F.2d 689, 693 (CCPA
1971); In re Gardner, 427 F.2d 786, 788 (CCPA 1970). However, if a claim
is amenable to two or more plausible claim constructions, the USPTO is
justified in requiring an applicant to more precisely define the metes and
bounds of the invention by holding the claim unpatentable under 35 U.S.C.
§ 112, second paragraph, as indefinite. Ex parte Miyazaki, 89 USPQ2d
1207, 1211-12 (BPAI 2008) (precedential). Moreover, “[t]he scope of claim

1 We do not address whether the 35 U.S.C. § 112 was improperly made
final as Appellants assert (App. Br. 9) because it is a petitionable matter, not
an appealable matter, and Appellants had the opportunity to raise this issue
in a timely Petition to the Director under 37 C.F.R. § 1.181 but have not
done so.
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language cannot depend solely on the unrestrained, subjective opinion of a
particular individual purportedly practicing the invention.” Datamize, LLC
v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005).
We agree with Appellants that claims 1 and 47 are directed to a
package. However, claim 1 recites that the package comprises “a
substantially non-stretchable region that substantially conforms to the shape
of the inflatable region of the medical device when the inflatable region is
inflated.” It is unclear as to what structural configuration is claimed for the
substantially non-stretchable region of the package because the limitation
“the shape of the inflatable region of the medical device when the inflatable
region is inflated” (emphasis added) is amenable to two or more plausible
claim constructions, the meaning of which depends on the unrestrained,
subjective opinion of a person practicing the invention.
The Specification provides minimal guidance as to the shape and
structure of the inflatable region of the medical device, and broadly teaches
that the protective enclosure may take a variety of forms and shapes to
provide the desired protective function. Spec., p. 9, para. [0033]. With
regards to the protective function of the package, the Specification discusses
how the endotracheal tube may be sterilized after it is packaged, and how the
inflated cuff may deform in shape and/or expand in diameter during the
sterilization process if not constrained by the shape of the non-stretchable
region of the package. Spec., p. 10, para. [0034]. The Specification also
discloses that the substantially non-stretchable region prevents the inflatable
region of the medical device, i.e the cuff from expanding when exposed to
increased temperatures and decreased pressures, and so the non-stretchable
region may not conform to the deflated shape of the inflatable region of the
medical device, but rather conforms to the desired inflated shape of the
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inflatable region of the medical device. Spec., p. 11, para. [0036]. Further,
the Specification acknowledges that the shape of the non-stretchable region
of the package “may vary to accommodate the shape of the inflated cuff”.
Id. We interpret the teachings found in the Specification to disclose that the
shape of the inflatable region of the medical device varies depending on
whether the inflatable region is slightly inflated so as not to be installed in a
trachea, partially inflated, fully inflated with respect to retention within a
trachea of a patient, or intentionally overinflated to remove wrinkles from
the wall of the inflatable region of the medical device and can vary due to
external factors such as temperature or pressure. It is unclear which
inflatable shape of the medical device the substantially non-stretchable
region substantially conforms to, or whether the substantially non-
stretchable region substantially conforms to the shape of the inflatable
region of the medical device by constraining the inflation of the medical
device inflatable region to maintain the inflatable region of the medical
device at some undefined shape dictated by the shape of the substantially
non-stretchable region of the package.
Claim 47 recites “a package region that accommodates a cuff of the
medical device when the cuff is in a configuration that is not suitable for
insertion into a patient.” The Specification teaches that the cuff is part of an
endotracheal tube and is deflated prior to insertion into a trachea of a patient
and inflated to a recommended pressure. Spec., para. [0032]. Therefore, we
interpret claim 47 as reciting a cuff that is in some configuration other than a
deflated state and Appellants’ Specification teaches that the amount of
inflation of the inflatable region of the medical device is variable, and
likewise the shape of the package region is variable based on how the
inflation of the cuff is to be constrained. Spec. paras. [0034] – [0036].
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Therefore, for the reasons discussed supra for claim 1, claim 47 is subject to
two or more plausible constructions as to the extent to which the cuff is
inflated and the scope depends on the unrestrained, subjective opinion of a
person practicing the invention.
Accordingly, we sustain the Examiner’s rejection of claims 1-17 and
47-50 under 35 U.S.C § 112, second paragraph, as being indefinite, but
designated our affirmance as a NEW GROUND OF REJECTION under 37
C.F.R. § 41.50(b), to afford Appellants a fair opportunity to respond.

NEW GROUNDS OF REJECTION
For the following reasons, we also reject claims 18-35 and 51-57
under 35 U.S.C. § 112, second paragraph, as being indefinite.

Independent Claim 18
Independent claim 18 and its dependent claims 19-35 are directed to a
shipping assembly that includes a medical device having an inflated region
and a package having a substantially non-stretchable region that
substantially conforms to the shape of the inflated region of the medical
device. As discussed above with respect to independent claims 1 and 47, the
relative degree of inflation (i.e., minimal, partially inflated, inflated to retain
in a patient, overinflated to eliminate wrinkles or inflated/deflated due to
external factors) of the inflated region defines the shape of the inflated
region, and the shape of the substantially non-stretchable region also can
potentially determine the shape of the inflated region of the medical device.
As a result of this variability, the inflated region of the medical device can
have unlimited shapes, and a person of ordinary skill in the art would not be
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able to ascertain the metes and bounds of the claim limitations directed to
the substantially non-stretchable region of the package of claim 18.
With regard to the 35 U.S.C. § 112, second paragraph, requirement for
“particularly pointing out and distinctly claiming the subject matter which
the applicant regards as his invention,” it has been stated that the “essence of
that requirement is that the language of the claims must make it clear what
subject matter they encompass.” In re Hammack, 427 F.2d 1378, 1382
(CCPA 1970). This has been frequently stated in a shortened form as a
requirement that the claims set forth the “metes and bounds” of their
coverage. See, e.g., In re Venezia, 530 F.2d 956, 958 (CCPA 1976); In re
Goffe, 526 F.2d 1393, 1397 (CCPA 1975); In re Watson, 517 F.2d 465, 477
(CCPA 1975); In re Knowlton, 481 F.2d 1357, 1366 (CCPA 1973).
Accordingly, we enter a NEW GROUND OF REJECTION of claims 18-35
under 35 U.S.C. § 112, second paragraph, as being indefinite, pursuant to
our authority under 37 C.F.R. § 41.50(b).

Independent Claim 51
Claim 51 is directed to a shipping assembly that includes a medical
device having a cuff that is at least partially inflated so that the medical
device is not suitable for insertion in a patient, and “a package comprising a
region that encloses the cuff of the medical device whether the balloon is
inflated or deflated.” (emphasis added) It is unclear from the plain language
of the claim and the Specification as to whether the cuff and the balloon are
intended to be the same structure or different structures, as some medical
devices include both a cuff and a balloon. A review of the Specification
does not indicate a particular description of a “balloon” device, although it is
indicated that the cuff 12 is described in the context of an endotracheal tube,
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and one of ordinary skill in the art would appreciate that the cuff can be used
with an endotracheal tube or other medical devices where it is desirable to
form a seal between the device and a surrounding passage or pathway. Spec.
para. [0033]. As acknowledged by the Examiner, it is known in the prior art
for a medical device, such as an endotracheal tube, to use the terms “cuff”
and “balloon” as synonyms as shown in Ogushi. Reply Br. 8-9. A further
review of Ogushi indicates that the medical device may have both a primary
balloon or cuff and a secondary smaller pilot balloon. Obushi, Abstract and
fig. 1. The Ogushi reference clearly demonstrates that the term “balloon”
may have more than one meaning (i.e., also as a cuff), and a medical device
may have more than one balloon (primary and secondary). Thus, one skilled
in the art would not be able to determine the metes and bound of the claimed
invention since independent claim 51 does not clearly establish whether the
cuff and balloon are the same structure. We enter a NEW GROUND OF
REJECTION of claims 51-57 under 35 U.S.C § 112, second paragraph, as
being indefinite, pursuant to our authority under 37 C.F.R. § 41.50(b).

Prior Art Rejections of claims 1-35and 47-57
Because we sustain the rejection of claims 1-17 and 47-50 as being
indefinite, and have entered new grounds of rejection of claims 18-35 and
51-57 as being indefinite, we pro forma reverse the prior art rejections of
claims 1-35 and 47-57 because such determinations are based on a
speculative assumption as to the meaning of those claims. See In re Wilson,
424 F.2d 1382, 1385 (CCPA 1970); In re Steele, 305 F.2d 859, 862-63
(CCPA 1962) (determinations as to obviousness cannot be made for
indefinite claims).

Appeal 2010-006755
Application 11/526,156
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DECISION
The rejection of claims 1-17 and 47-50 under 35 U.S.C. § 112,
second paragraph is affirmed. Insofar as our reasoning differs from that of
the Examiner, we denominate our affirmance a NEW GROUND OF
REJECTION.
The rejection of claims 1, 4, 5, 7-16, 18, 21, 22, 24-35 and 47-57
under 35 U.S.C. § 102(b) as anticipated by Bley is reversed.
The rejection of claims 2, 3, 19 and 20 under 35 U.S.C. § 103(a) as
unpatentable over Bley and Sheetz is reversed.
The rejection of claims 6 and 23 under 35 U.S.C. § 103(a) as
unpatentable over Bley and Opie is reversed.
The rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable
over Bley and Ogushi is reversed.
As provided supra, we enter a NEW GROUND OF REJECTION of
claims 18-35 and 51-57 under 35 U.S.C. § 112, second paragraph, as being
indefinite.
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
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will be remanded to the Examiner….
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record….

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)

mls