Ex Parte Hakala

Patent Trial and Appeal Board

Jan 29, 2018

13127057 (P.T.A.B. Jan. 29, 2018)

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.
13/127,057 05/02/2011 Olli Hakala BOY 992701 US 8925
35969 7590
Bayer HealthCare LLC (PH)
attn: Aseem V. Mehta
Vice-President, Chief Patent Counsel
100 Bayer Blvd, PO Box 915
Whippany, NJ 07981-0915
EXAMINER
KOO, BENJAMIN K
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
01/31/2018 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):
uspoccs @ bayer. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OLLI HAKALA
Appeal 2016-001620
Application 13/127,0571
Technology Center 3700
Before JAMES P. CALVE, ERIC C. JESCHKE, and
ARTHUR M. PESLAK, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Olli Hakala (“Appellant”) seeks review under 35 U.S.C. § 134(a) of
the Examiner’s decision, as set forth in the Final Office Action dated
November 5, 2014 (“Final Act.”), rejecting claims 1—4, 6-8, and 11-14. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies Bayer OY as the real party in interest. Br. 3.
Appeal 2016-001620
Application 13/127,057
BACKGROUND
The disclosed subject matter relates to an intravaginal delivery
system. Spec. 1,1. 4. Claims 1 and 13 are independent. Claim 1 is
reproduced below, reformatted from the version provided by Appellant, and
with emphasis added:
1. Intravaginal delivery system (1) comprising
at least one compartment (la, lb)
comprising a core (2) of a first cross sectional
diameter (d2) and a membrane (3) encasing
the core (2), wherein the core (2) and the
membrane (3) essentially consist of a same or
different polymer composition, forming a
core-membrane system (5) with a first end
and a first cross sectional surface and a
second end and a second cross sectional
surface and
a rod-shaped, permeable coupler (6)
with a second cross sectional diameter (de)
and of a length (L) for connecting the first
end and the second end of the core-membrane
system (5)
characterized in that there is an
opening (4) essentially in the middle of the
first or second end of the core-membrane
system (5), within which opening (4) the rod­
shaped, permeable coupler (6) is positioned,
and characterized in that the second cross
sectional diameter (de) is smaller than the
first cross sectional diameter (d2), and
characterized in that the first cross sectional
diameter (d2) is 2-10 mm and the second
cross sectional diameter (de) is 0.5^1.0 mm.
2
Appeal 2016-001620
Application 13/127,057
REJECTIONS
1. Claim 4 stands rejected under 35 U.S.C. § 112, fourth
paragraph, as being of improper dependent form for failing to further limit
the subject matter of the claim upon which it depends, or for failing to
include all the limitations of the claim upon which it depends.
2. Claims 1—4, 6-8, and 11-14 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Wong (US 4,402,695, issued Sept. 6, 1983)
and Tailing (WO 2009/066006 Al, published May 28, 2009)2.
DISCUSSION
Rejection 1 — The rejection of claim 4 under
35 U.S.C. § 112, fourth paragraph
The Examiner rejected claim 4 under 35 U.S.C. § 112, fourth
paragraph, stating that Appellant “claims ‘an opening (4)’ again in claim 4
which has already been claimed in claim 1.” Final Act. 2.
Appellant does not present any arguments addressing this Rejection,
stating that this Rejection “is not at issue” as “Appellant is willing to amend
the claim to overcome th[is] [Rjejection if the rejection^ under 35 U.S.C.
§ 103(a) [is] overruled.” Br. 7. We summarily affirm.
2 The Examiner states that US 2010/0285097 Al (published Nov. 11,
2010) is a “US equivalent” to Tailing. Final Act. 3. Appellant does not
contest this statement, and refers to the United States Publication in the
briefing. See Br. 10-11 (referring to paragraph numbering present only in
the United States Publication). We will refer to the United States
Publication as “Talling-US.”
3
Appeal 2016-001620
Application 13/127,057
Rejection 2 — The rejection of claims 1—4, 6—8,
and 11—14 under 35 U.S.C. § 103(a)
Appellant states that “independent claims 1 and 13 and those claims
which depend thereon stand or fall together.” Br. 7. We select independent
claim 1 as representative, with the remaining claims standing or falling with
claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (2014).
For claim 1, the Examiner relied on Wong for various limitations, but
stated that Wong:
does not explicitly show the opening being essentially in the
middle of the first or second end of the core-membrane system,
although the opening as defined by 14 could be considered an
opening in the middle of at least membrane and applicant has not
clearly excluded the opening from being within the middle of
core itself.
Final Act. 3; see also Br. 13 (Claims App.) (claim 1 reciting “an opening (4)
essentially in the middle of the first or second end of the core-membrane
system (5)” (shown with emphasis supra)). The Examiner stated that
Tailing “has been cited to explicitly show a membrane (3) encasing a core
(8) and an opening (as defined within 8) essentially in the middle of a core­
membrane system (3 & 8) within which opening a rod-shaped coupler (9) is
positioned.” Final Act. 3 (discussing reference numerals shown only in
Figure 7 of Tailing (and Talling-US)). According to the Examiner, it would
have been obvious for one of ordinary skill in the art at the time of the
invention to have incorporated the “opening/coupler configuration of Tailing
into the Wong device because such a configuration is simply an art-
recognized alternative compartment design wherein continuous element (9)
can be used as a supplemental support element for better resilience during
insertion and/or to aid in placement.” Id.; see also Ans. 2-3 (stating that
4
Appeal 2016-001620
Application 13/127,057
“the motivation to use the coupler design of Tailing [in] the Wong device
lies in the fact that it is a simple substitution, simply allowing the coupler to
exist within both the core and the membrane instead of just the membrane,
which does not incur any unexpected results or render Wong inoperable and
would be an obvious art-recognized alternative coupler”).
Appellant contends that “there is no suggestion or motivation to make
the proposed modification of Wong because combining Wong with Tailing
would change the principle of operation of Wong and renders Wong
inoperable for its intended purpose.” Br. 9. Appellant states that, in the
Figure 3 embodiment in Wong, (1) “[cjoupling member \la is used as a
joint for joining two ends to form a single annular shaped system” and
(2) “[a] passageway 19 in coupling member \la permits the passage of the
liquid mass transfer conductor 15 to flow in reservoir 13.” Id. at 10.
Appellant states that Figure 2 “illustrates a similar system, in which the
coupling member 17 is a solid material, with no passageway.” Id.
According to Appellant, “[i]n each case, the coupling member is ‘in mated
relation with the inside of module 12 to form an essentially liquid-tight-
union.’” Id. (quoting Wong, col. 3, lines 23-26). Appellant states that
Tailing discloses that “[tjubular compartments can be joined into a closed
system using a ‘plug or [a] stopper made of any inert, biocompatible
material which does not permit the transport of active material.’” Id. at 10-
11 (quoting Talling-US ^ 80); see also Tailing 22,11. 5-7 (same disclosure).
Appellant states, “[i]n the Wong device, the drug is in a liquid or semi-liquid
reservoir with two ends joined together via a liquid-tight-union between a
connector and two ends of the device.” Id. at 11. Appellant argues that:
5
Appeal 2016-001620
Application 13/127,057
[o]ne could theoretically modify the device of Wong to
incorporate the connector of Tailing, which is positioned in the
middle of either end of a core-membrane system to make a
device of the present invention would be to add a membrane and
stuff the device of Wong with an inert supporting member, such
as the elastomeric matrix and membrane of Tailing. However,
to do so would render Wong inoperable for its intended purpose.
Id. For the reasons discussed below, we are not apprised of error by
Appellant’s arguments.
We first address the argument that the proposed modification “renders
Wong inoperable for its intended purpose.” Br. 9. Where a proposed
modification would render the prior art invention being modified
unsatisfactory for its intended purpose, the proposed modification would not
have been obvious. See In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984).
Having considered Appellant’s brief, we agree with the Examiner that “it is
unclear as to how or why Wong would be rendered inoperable” by the
proposed modification. Ans. 2 (also stating that “the reasoning for Wong’s
supposed inoperability is . . . unclear”).
As noted by the Examiner, Appellant appears to argue that the
proposed modification would prevent the transfer of fluid through
passageway 19 in coupling \la, shown in Figure 3 of Wong. See Ans. 3
(discussing Appellant’s quotation from Talling-US ^ 80); see also Wong,
col. 3,11. 20-23 (“Coupling 17a, in this embodiment, has a passageway 19
therethrough that permits the passage of a liquid mass transfer conductor 15
to flow in reservoir 13.”). As an initial matter, the record does not support
Appellant’s position that paragraph 80 of Talling-US describes aspects of
the Figure 7 embodiment relied upon. See Ans. 3 (“[TJhere is no indication
in paragraph [0080] of Tailing [-US] that this plug or stopper is the same as
6
Appeal 2016-001620
Application 13/127,057
element 9 in Fig. 7, which is currently being relied upon, and which has been
labeled as an ‘inert support member[,]’ not a plug or stopper.”).
Moreover, even assuming that the proposed modification would
preclude the “passage” described in Wong (col. 3,11. 20-23), the description
of the Figure 2 embodiment in Wong conflicts with Appellant’s position that
the disclosed “passage” represents the “intended purpose” of the Figure 3
embodiment. As noted by the Examiner (Ans. 3), the Figure 2 embodiment
includes coupling member 17 that is “a solid material placed inside the
module to form an end-to-end fluid-tight connection, for successful use of
system 10 during release of drug 11.” Wong, col. 3,11. 10-13 (emphasis
added); see also Br. 10 (acknowledging that the Figure 2 embodiment has
“no passageway”). Wong then describes the embodiment in Figure 3 as
“similar to the system illustrated in FIG. 2” except for coupling 17a, as well
as elements 18 and 19. Id., col. 3,11. 14-26. Based on these disclosures, we
agree with the Examiner that the Figure 2 embodiment would not provide
the “passage” like the Figure 3 embodiment, but would still “operate.” Ans.
3 (stating that “the passage of fluid through the coupler of Wong is NOT a
necessary requirement to allow Wong to operate”). That is, both the Figure
2 and Figure 3 embodiments would perform the disclosed function of the
systems: “releasing a drug to the vagina for the management of health and
disease.” Wong, col. 2,11. 49-51. In other words, whether or not material
can move via coupling member 17 (Figure 2) or coupling \la (Figure 3),
drug 11 can exit from reservoir 13 via rate controller 14 to the vagina, as
intended in all cases. Id. at col. 2,1. 59 to col. 3,1. 26. For these reasons, we
are not apprised of error by Appellant’s first argument.
7
Appeal 2016-001620
Application 13/127,057
We turn now to the argument that the proposed modification “would
change the principle of operation of Wong.” Br. 9. A proposed
modification that changes the “basic principles under which the [prior art]
was designed to operate” may not support a conclusion of obviousness. In
re Ratti, 270 F.2d 810, 813 (CCPA 1959). Here, Appellant does not identify
the principle of operation of Wong that would purportedly be changed by the
proposed modification. To the extent Appellant argues that the “passage”
discussed above (see Wong, col. 3,11. 20-23) is the “basic principle^ under
which the [prior art] was designed to operate” {Ratti, 270 F.2d at 813), we
disagree. For the same reasons discussed above, the description of the
Figure 2 embodiment in Wong conflicts with the position that the disclosed
“passage” represents the “basic principle^” of operation of the Figure 3
embodiment. Cf. Ratti, 270 F.2d at 813 (stating that the proposed
modification would “require a substantial reconstruction and redesign of the
elements shown in [the prior art] as well as a change in the basic principles
under which the [prior art] was designed to operate”). Thus, we are not
apprised of error by Appellant’s second argument.
For these reasons, we sustain the rejection of claim 1 as unpatentable
over Wong and Tailing. Claims 2-4, 6-8, and 11-14 fall with claim 1.
8
Appeal 2016-001620
Application 13/127,057
DECISION
We affirm the decision to reject claim 4 under 35 U.S.C. § 112, fourth
paragraph, and we affirm the decision to reject claims 1 4, 6-8, and 11-14
under 35 U.S.C. § 103(a).
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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
9