Ex Parte Nishtala et al

Patent Trial and Appeal Board

Nov 30, 2018

14328264 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/328,264 07/10/2014 Vasu Nishtala
34284 7590 12/04/2018
RUTAN & TUCKER, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
101674.0008Pl0 3485
EXAMINER
ZIMBOUSKI, ARIANA
ART UNIT PAPER NUMBER
3781
NOTIFICATION DATE DELIVERY MODE
12/04/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte V ASU NISHT ALA,
JEFFREY F. KLINE, and RONALD L. BRACKEN 1
Appeal2018-002925
Application 14/328,264
Technology Center 3700
Before JOHN C. KERINS, EDWARD A. BROWN, and
ANNETTE R. REIMERS, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Vasu Nishtala et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner's final decision rejecting claims 1-5. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 The Appeal Brief identifies C. R. Bard, Inc., as the real party in interest.
Appeal Br. 4.
Appeal2018-002935
Application 14/328,264
CLAIMED SUBJECT MATTER
Appellants' invention relates to waste management systems for
patients that are unable to care for themselves. Spec. para. 2.
Claim 1 is independent. Claim 1 is representative of the claimed
invention and reads as follows:
1. A waste management system, comprising:
a waste transport device, including a collection member
with a distal end opening having a first cross-sectional area and
a proximal end opening having a second cross-sectional area
less than the first cross-sectional area, a lumen fluidly
connecting the distal end opening to the proximal end opening,
a retention cuff disposed about an outer surface of the collection
member; and
a securement device, including a securement patch, a
securement tab, and means for attaching the securement device
to the waste transport device.
THE REJECTIONS
The Examiner has rejected:
(i) claims 3 and 4 under 35 U.S.C. § 112(b ), or pre-AIA § 112, second
paragraph, as being indefinite;
(ii) claims 1 and 2 under 35 U.S.C. § I03(a) as being unpatentable
over Kim (US 2004/0039348 Al, published Feb. 26, 2004) in view of von
Dyck (US 2006/0100595 Al, published May 11, 2006) and Kim '390 (EP
1900390 Bl, published Nov. 2, 2011);2
2 As the Examiner and Appellants have referenced US 2004/0039348 Al as
"Kim" and EP 1900390 Bl as "Kim '390," we shall do the same for
consistency.
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(iii) claims 3 and 4 under 35 U.S.C. § I03(a) as being unpatentable
over Kim in view ofvon Dyck, Kim '390, and Shultz (US 6,132,399, issued
Oct. 17, 2000); and
(iv) claim 5 under 35 U.S.C. § I03(a) as being unpatentable over Kim
in view ofvon Dyck, Kim '390, and Utterberg (US 2008/0097270 Al,
published Apr. 24, 2008).
ANALYSIS
Claims 3 and 4--Indefiniteness
The Examiner finds that the phrase "therapeutically effective amount"
in the limitation in claim 3 requiring "a therapeutically effective amount of
one or more active agents" renders claims 3 and 4 indefinite because the
Specification does not provide a standard for ascertaining the requisite
degree, and as a result, the scope of the claims is unclear. Final Act. 5---6.
Appellants contend that:
• "[t]he proper test is whether or not one skilled in the art could
determine specific values for the amount based on the disclosure"
(Appeal Br. 14; quoting In re Mattison, 509 F.2d 563 (CCPA 1975);
• the phrase "an effective amount ... for growth stimulation" was held
to be definite where the amount was not critical and those skilled in
the art would be able to determine from the written disclosure,
including the examples, what an effective amount would be (id.;
quoting In re Halleck, 422 F.2d 911 (CCPA 1970);
• the phrase "an effective amount" was held to be indefinite when the
claim failed to state the function which is to be achieved and more
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than one effect could be implied from the specification or the relevant
art (id.; quoting In re Fredericksen, 213 F .2d 54 7 ( CCP A 1954 ); and
• the Specification provides examples of active ingredients, types of
conditions or intended utilities, and examples of devices used to
address the conditions, such that an ordinary artisan would realize the
requisite degree of a therapeutic effective amount of the various
example ingredients or for any suitable active ingredient (id. at 14--15;
citing Spec. ,r 103).
Appellants further contend that because: (1) the exact amount is
irrelevant to the claims, (2) "a therapeutically effective amount" is
commonly understood as "a dose or amount of drug that produces a
therapeutic response or desired effect in some fraction of the subjects
taking it," and (3) the Specification discloses the desired effects or intended
outcomes for a therapeutic response," an ordinary artisan would understand
what the phrase "a therapeutically effective amount of one or more active
agents" means. Id. at 15-16; see also Reply Br. 11-13.
A claim is properly rejected as being indefinite under 35 U.S.C. § 112,
second paragraph if, after applying the broadest reasonable interpretation in
light of the specification, the metes and bounds of a claim are not clear
because the claim "contains words or phrases whose meaning is unclear." In
re Packard, 751 F.3d 1307, 1310 (Fed Cir. 2014).
We agree with the Examiner that the phrase "a therapeutically
effective amount of one or more active agents" is a term of degree that is
unclear because the Specification does not provide a standard for
ascertaining the requisite degree. As a result, the scope of claims 3 and 4
which employ that limitation is unclear.
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As Appellants point out, Mattison recognizes that whether or not one
skilled in the art can determine specific values for the amount based on the
disclosure is necessary to evaluate whether the phrase "therapeutically
effective amount" in claim 3 is indefinite. Here, nothing in the Specification
provides any guidance as to any specific values for "a therapeutically
effective amount" of a wide variety of active agents.
Appellants' citation to Halleck for the propositions that: (1) the
phrase "an effective amount ... for growth stimulation" was held to be
definite where the amount was not critical and (2) those skilled in the art
would be able to determine from the written disclosure, including the
examples, what an effective amount is, does not support their position that
the phrase at issue is clear. As noted above, the Specification does not
provide examples of what an effective amount is for any of the plethora of
active agents disclosed. Further, although "a therapeutically effective
amount" may not be critical with respect to the general operation of the
waste management system of claim 1, it is critical with respect to the
securement patch as claim 3 requires that the securement patch "compris[ es]
a substrate including a therapeutically effective amount of one or more
active agents."
Likewise, Appellants' citation to Fredericksen is unavailing. As
Appellants recognize, the phrase "an effective amount" was held to be
indefinite where the claim failed to state the function which is to be achieved
and more than one effect can be implied from the specification or the
relevant art. Here, claim 3 fails to state a "function which is to be achieved"
and paragraph 103 of the Specification, as Appellants noted, discloses
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Application 14/328,264
considerably more than one effect desired to be obtained from a large list of
potential active agents.
As such, even if "a therapeutically effective amount" is commonly
understood as "a dose or amount of drug that produces a therapeutic
response or desired effect in some fraction of the subjects taken," the
claimed phrase is unclear because the Specification does not provide a
standard for ascertaining the requisite degree for achieving a particular
desired effect. As such, the scope of claim 3 is unclear.
The rejection of claim 3, and of claim 43 which depends therefrom, as
being indefinite is sustained.
Claims 1 and 2--0bviousness--Kim/von Dyck/Kim '390
Appellants argue claims 1 and 2 as a group. Appeal Br. 9--13; Reply
Br. 4--10. We take claim 1 as representative of this group, and claim 2
stands or falls with claim 1.
The Examiner finds that the combination of Kim, von Dyck, and Kim
'390 discloses all limitations of claim 1. Final Act. 7-8. The Examiner
3 We note that claim 4 recites "is selected from the group consisting
essentially of' instead of "is selected from the group consisting of." Appeal
Br. 17; emphasis added (Claims App.). A Markush group such as this
should generally be "closed," and characterized with the transition phrase
"consisting of' rather than "comprising," "including," or "consisting
essentially of." See Abbott Labs. v. Baxter Pharmaceutical Products Inc.,
334 F.3d 1274, 1280 (Fed. Cir. 2003). As set forth in MPEP § 2173.0S(h),
[i]f a Markush grouping requires a material selected from an open list of
alternatives (e.g., selected from the group "comprising" ... the recited
alternatives), the claim should generally be rejected under 35 U.S.C.
§ 112(b) as indefinite because it is unclear what other alternatives are
intended to be encompassed by the claim. (Emphasis added).
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finds that Kim discloses a waste management system (bowel management
system 10) comprising a waste transport device including: (1) a collection
member (rectal catheter section 18) with a distal end opening having a first
cross-sectional area and a proximal end opening having a second cross-
sectional area and (2) a retention cuff (retention balloon 24) disposed about
an outer surface of the collection member. Id. at 7 ( citing Kim Figs. 1, 6, 7,
and 9). The Examiner relies on von Dyck as disclosing a waste management
system comprising a waste transport device including a collection member
(inflatable balloon 118) with a distal end opening having a first cross-
sectional area and a proximal end opening having a second cross-sectional
area less than the first cross-sectional area. Id. ( citing von Dyck Fig. 2).
The Examiner concludes that it would have been obvious to modify the
collection member of Kim to have the second cross-sectional area less than
the first cross-sectional area as taught by von Dyck to help funnel waste. Id.
Appellants contend that Figure 2 of von Dyck, relied on by the
Examiner, is an alternative embodiment to that of its Figure 1. Appeal Br.
9--10. Appellants further contend that the alternative embodiment in Figure
1 of von Dyck discloses a device having an annular balloon-like cuff 18
surrounding a collection member (patient proximal end 16 of catheter 12), as
an alternative to the device of Figure 2. Id. at 10. As such, according to
Appellants, Figure 2 of von Dyke teaches only a device having an inflatable
balloon, and not a collection member. Id. at 9--10; see also Reply Br. 4, 7.
Notwithstanding that the structure in Figure 2 is an inflatable balloon
118, the purpose and function of the inflatable balloon is to collect fecal
matter. See von Dyck Fig. 2. Thus, there is no reason why the Examiner
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cannot find that the inflatable balloon 118 corresponds to, or includes, a
collection member, as claimed. See Ans. 3.
Appellants argue that even if the inflatable balloon 118 were
considered to be a collection member, the construction in Figure 2 of von
Dyck would comprise an inflatable balloon that is integral with a collection
member, whereas claim 1 requires a collection member that is separate from
a retention cuff. Appeal Br. 10. Appellants also contend that there is no
evidence that the two embodiments of Figures 1 and 2 of von Dyke can be
combined. Id. at 11; see also Reply Br. 7-8.
These arguments are unpersuasive in that they do not address the
Examiner's rejection. Even if, as Appellants maintain, the inflatable balloon
in the Figure 2 embodiment of von Dyck functions as both a collection
member and a retention cuff, the Examiner relies on Kim as disclosing a
separate collection member and retention cuff. The Examiner relies on von
Dyck for the tapered interior shape or contour of the collection member, and
proposes to modify the Kim collection member to have that same shape or
contour. The latter argument fails to take into account the Examiner's stated
reason to modify Kim in view of von Dyke, and the reason is not otherwise
contested.
Appellants contend that von Dyke teaches away from using a separate
balloon with a funnel-like collection member because von Dyke at
paragraphs 10, 26, 27, and 43, states that Figure 2, which has only an
inflatable balloon, is an alternative embodiment. Appeal Br. 11; see also
Reply Br. 7-8. However, von Dyck does not discredit, criticize, or
disparage the use of either of its Figure 1 and Figure 2 embodiments, and the
inflatable balloon 118 with its tapered inner surface, relied on by the
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Application 14/328,264
Examiner, is used to collect fecal matter. DyStar Textilfarben GmbH & Co.
Deutsch/and KG v. CH Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006)
("[ w ]e will not read into a reference a teaching away from a process where
no such language exists.").
Appellants contend that the Examiner's proposed modification of the
waste management system of Kim, which Appellants couch in terms of
combining the two embodiments of von Dyck, is based on impermissible
hindsight reconstruction. Appeal Br. 11. As discussed above, the Examiner
provides a sound basis for modifying the waste management system of Kim
in the rejection of claim 1, including modify the collection member of Kim
to have the second cross-sectional area be less than the first cross-sectional
area, as taught by von Dyck, to help funnel waste. Final Act. 7. The
Examiner's rationale for combining the teachings of Kim and von Dyck in
the manner proposed is thus grounded in teachings present in the references
themselves (see id.; Ans. 3) and knowledge that was within the level of
ordinary skill at the time of the claimed invention was made, and not on
Appellants' disclosure alone. Thus, we do no not agree that the Examiner's
rejection is based on impermissible hindsight.
Appellants contend that, at paragraph 53, Kim teaches away from
other shapes for its balloon because it states that it is important that the
shape be substantially spherical. Appeal Br. 12-13; see also Reply Br. 4---6,
8-9. Specifically, Appellants argue that: (1) von Dyke fails to provide a
configuration that could be successfully applied to the rectal catheter section
18 of Kim, (2) Kim teaches away from modifying its rectal catheter section
18, and (3) there is no reason for the Examiner's proposed modification.
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These arguments are also unpersuasive as they do not address the
rejection. Paragraph 53 of Kim relates to retention balloon 24 and not the
rectal catheter section 18 which the Examiner finds as corresponding to the
claimed collection member. The Examiner's proposed modification is with
respect to the collection member 18 and not the retention balloon 24. See
Final Act. 7; see also Ans. 3, 5. Appellants appear to intimate that
modifying the rectal catheter section 18 of Kim to have a different shape
would also change the shape of the retention balloon 24. See Reply Br. 4---6,
8-9. However, modifying the cross-sectional areas of the openings at the
interior of the rectal catheter section 18 of Kim would not necessarily affect
the external surface of the rectal catheter section 18, and/ or the shape of the
retention balloon 24.
Appellants additionally argue, in this regard, that the modification to
Kim would result in the exterior surface of the inflatable cuff of Kim having
the same, non-spherical, exterior shape as the balloon in Figure 2 ofvon
Dyck. Appeal Br. 12-13. This argument suggests that the modification of
the device of Kim would require a bodily incorporation into Kim of the
entire configuration of Figure 2 of von Dyck, which is not what the
Examiner proposes. It is well-established that a determination of
obviousness based on the teachings from multiple references does not
require an actual, physical substitution of elements. In re Keller 642 F .2d
413,425 (CCPA 1981) ("The test for obviousness is not whether the features
of a secondary reference may be bodily incorporated into the structure of the
• C '') primary re1erence. . . . .
None of Appellants' arguments apprise us of Examiner error in
rejecting claim 1. Accordingly, we sustain the rejection of claim 1 as
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unpatentable over Kim, von Dyck, and Kim '390, with claim 2 falling with
claim 1.
Claims 3 and 4--0bviousness-- Kim/von Dyck/Kim '3 90/Shultz
Claim 5--0bviousness-- Kim/von Dyck/Kim '390/Utterberg
Appellants do not provide any substantive arguments for claims 3-5,
and rely on the arguments presented for claim 1. See Appeal Br. 13; Reply
Br. 10. For the reasons discussed above with respect to claim 1, we are not
apprised of error in these rejections.
Accordingly, the rejections of claims 3-5 are sustained.
DECISION
The rejection of claims 3 and 4 under 35 U.S.C. § 112, second
paragraph, as being indefinite, is affirmed.
The rejections claims 1-5 under 35 U.S.C. § 103(a), as being
unpatentable, are affirmed.
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
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