Ex Parte Hansen

Patent Trial and Appeal Board

Nov 29, 2017

13995335 (P.T.A.B. Nov. 29, 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.
13/995,335 11/13/2013 Soeren Kjellerup Hansen 8221.204-US 7251
23650 7590
NOVO NORDISK INC.
INTELLECTUAL PROPERTY DEPARTMENT
800 Scudders Mill Road
Plainsboro, NJ 08536
EXAMINER
SHAH, NILAY J
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
12/01/2017 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):
nnipatent @ novonordisk. com
KISW @novonordisk.com
lklw @ novonordisk. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SOEREN KJELLERUP HANSEN
Appeal 2016-008116
Application 13/995,335
Technology Center 3700
Before BRETT C. MARTIN, MICHELLE R. OSINSKI, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Soeren Kjellerup Hansen (“Appellant”)1 seeks review under 35 U.S.C.
§ 134(a) of the Examiner’s decision, as set forth in the Final Office Action
dated September 30, 2015 (“Final Act.”), and as further explained in the
Advisory Action dated February 8, 2016 (“Adv. Act.”), rejecting claim 1
under 35 U.S.C. § 103(a) as unpatentable over Moller (US 2008/0208142
Al, published Aug. 28, 2008), Glejbol (US 2009/0043264 Al, published
Feb. 12, 2009), and Levander (US 5,728,075, issued Mar. 17, 1998). Claims
2—12 have been canceled. Appeal Br. 4, 14 (Claims App.). We have
1 Appellant identifies Novo Nordisk Healthcare AG, Switzerland as
the real party in interest. Appeal Br. 4.
Appeal 2016-008116
Application 13/995,335
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
BACKGROUND
The disclosed subject matter “relates to a drive system for a piston
rod.” Spec. 1,1. 3. Claim 1, the sole claim on appeal, is reproduced below:
1. A piston rod drive system (10) for a drug
mixing and delivery device, the piston rod drive
system (10) comprising:
- a main body (1) adapted for coupling with
a reservoir having at least two chambers,
- a user operable activation element (2)
operatively coupled with the main body (1) and
configured to move axially and rotationally
relative to the main body (1) between a first
position and a second position, and
- a piston rod element (3) operatively
coupled with the activation element (2) and the
main body (1) and configured to move axially and
non-rotationally relative to the main body (1) in
response to the activation element (2) being moved
between the first position and the second position.
DISCUSSION
The Examiner relied on Moller for certain limitations in claim 1, but
stated that “Moller is silent regarding the axial movement of the piston rod
being non-rotational.” Final Act. 3. The Examiner found, however, that
“Glejbol teaches a piston rod element 4 ([Fjigure 1) configured to move
axially and non-rotationally.” Id. (citing Glejbol 1 51,11. 1—9; 160,11. 10-
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13; 1 80,11. 1—7). 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 modified the piston rod of Moller to incorporate a
rectilinear track parallel to the longitudinal axis of the piston
thereby configuring the piston rod element move axially and
non-rotationally relative to the main body in response to the
activation element being moved between the first position and
the second position as taught by Glejbol for the purpose of
amplifying the translational effect of the activation element on
the axial movement of the piston with respect to the cartridge
thereby regulating the dose being delivered.
Final Act. 3^4 (citing Glejbol 1 60,11. 10—13).
The Examiner also stated that “Moller is further silent regarding a
reservoir having at least two chambers.” Id. at 4. The Examiner found,
however, that “Levander teaches a design of a drug mixing and delivery
device 1 ([Fjigure 5) wherein the reservoir 24 contains at least two chambers
25 and 26.” Id. 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 modified the reservoir of Moller to incorporate the
reservoir having at least two chambers as taught by Levander
since both Moller and Levander are teaching a design of a drug
mixing and delivery device and Levander further teaches that it
is well known in art to have the reservoir having at least two
chamber[s] for the purpose of containing the drug and its carrier
in different compartments.
Id. (citing Levander, col. 4,11. 62—67).
First, Appellant argues that Moller “is directed to a dose setting
mechanism for an injection device” and “addresses problems when injecting
certain types of medications (medications that precipitate) when the
medication level in the reservoir drops below a predetermined threshold.”
Appeal Br. 7—8 (discussing Moller 12). Appellant contends that “Moller
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does not teach or suggest a drug ‘mixing device’ as is claimed,” but
“[ijnstead, Moller simply references ‘mix insulin’, which is a pre-fabricated
pharmaceutical mixture of at least two types of insulin in the same vial, for
example a short-acting insulin along with a longer acting insulin.” Id. at 8;
see also Moller 12 (discussing “mix insulin”). According to Appellant, “[i]t
is improper to use the term ‘mix insulin’ to infer that Moller discloses a
mixing device.” Id.
We are not apprised of error by this argument. As an initial matter,
we agree with the Examiner that claim 1 does not positively recite a “mixing
device,” as asserted by Appellant. See Ans. 4 (“Claim 1 is not positively
reciting a drug mixing and delivery device.”). Instead, in the preamble,
claim 1 recites: “A piston rod drive system (10) for a drug mixing and
delivery device, the piston rod drive system (10) comprising.” Appeal Br. 14
(Claims App.) (emphasis added). We view the language “for a drug mixing
and delivery device” as setting forth an intended use of the claimed “piston
rod drive system,” rather than as limiting the scope of claim 1. See Bicon,
Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) (“Preamble
language that merely states the purpose or intended use of an invention is
generally not treated as limiting the scope of the claim.”). Appellant does
not explain why the preamble language at issue limits claim 1.
Moreover, to the extent the preamble language at issue is limiting,
Appellant does not address or show error in the Examiner’s finding that:
if the reservoir of Moller is modified with the reservoir of
Fevander[,] which contains at least two chambers[,] then the
piston rod drive system of Moller is capable for [use as] a drug
mixing and delivery device and comprises a main body adapted
for coupling with a reservoir having at least two chambers.
Ans. 5.
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We turn now to the argument “that since both the primary document
Moller, and the secondary document Glejbol, are not mixing devices, a
prima facie case of obviousness does not exist to combine both Moller and
Glejbol with the third document (Levander) which is a mixing device.”
Appeal Br. 8—9. We are not apprised of error based on this argument
because Appellant has not shown that the alleged differences between the
references undermine the factual findings or reasoning relied on to support
the conclusion of obviousness. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 420 (2007) (“[FJamiliar items may have obvious uses beyond their
primary purposes, and in many cases a person of ordinary skill will be able
to fit the teachings of multiple patents together like pieces of a puzzle.”).
Second, Appellant argues that “neither Moller nor Glejbol disclose[s]
or suggests]: [1] a piston rod drive system suitable for a drug mixing and
delivery device (as noted above [regarding the first argument]); or [2]
coupling the piston rod drive system to a reservoir having at least two
chambers.” Appeal Br. 9.
We are not apprised of error based on the first of these two assertions
for the reasons discussed above regarding Appellant’s first argument. We
are also not apprised of error based on the second assertion. The Examiner
does not rely on either Moller or Glejbol alone to address the first clause in
claim 1, which recites “a main body (1) adapted for coupling with a reservoir
having at least two chambers.” By arguing that neither Moller nor Glejbol,
alone, teaches all aspects of the first clause, Appellant does not address the
rejection as articulated, in which the Examiner relies on certain combined
teachings of the prior art. See Ans. 5 (“Piston rod drive system of Moller
and Glejbol are both capable of attaching to a reservoir and if the reservoir
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of Moller and Glejbol contains two chambers as taught by Levander, then
the piston rod drive system is capable for a drug mixing and delivery device
and attachable to a reservoir having at least two chambers.”); see also In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.”).
Third, Appellant argues that Levander “teaches away from [the]
claim[] because Levander discloses a rotating piston rod,” which, according
to Appellant, “is something that [Appellant] is expressly trying to avoid.”
Appeal Br. 9 (discussing Spec. 2,11. 14—17).
We are not apprised of error by this argument. As noted by the
Examiner, “Levander was used for only modifying the reservoir of Moller,”
not regarding the recited “piston rod element.” Ans. 6; see Merck, 800 F.2d
at 1097. Moreover, teaching away requires a reference to actually criticize,
discredit, or otherwise discourage the claimed solution, not merely disclose
an alternative. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellant has not identified such statements in Levander. That Levander
teaches a rotating piston rod, rather than one “configured to move axially
and non-rotationally relative to the main body” in certain instances (as
recited), does not, on the record here, amount to a teaching away.
Fourth, Appellant argues that “Moller does not teach a mixing device,
neither does the secondary document of G[l]ejbol, only the tertiary
document Levander teaches a mixing device” and that “[a] mixing device
often has different requirements than a (non-mixing) syringe.” Appeal Br.
10. Appellant argues that “a mixing device often requires driving of
multiple pistons, which require the user to overcome considerable ‘stiction’
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force” and that “[f]or at least this reason [Appellant] claims a gearing (via
‘coupled’ and ‘configured to move’ language) between the activation
element, main body, and piston rod element, which provides mechanical
advantage and aids the user in mixing.” Id. at 10—11. Appellant also argues
that “Levander[,] while a mixing device, has a rotational piston rod” and that
“mixing and matching features as in Moller, Glejbol, and Levander is
impermissible hindsight reconstruction and would not have provided a
reasonable expectation of success in achieving” claim 1. Id. at 11; see also
id. at 10 (“[Appellant] claims a mixing device (not in Moller or Glejbol), and
a non-rotating piston rod (not in Levander), and respectfully submit that
combining all three documents still does not achieve the claims with a
reasonable expectation of success.”).
We are not apprised of error by this argument. As an initial matter,
we agree with the Examiner that Appellant does not “positively claim[] a
gearing between the activation element, main body, and piston rod element.”
Ans. 6. Further, for the same reasons discussed with respect to the third
argument above, we are not apprised of error in the Rejection merely
because Levander teaches a rotating piston head. See id. (stating that
Levander “was used only for modifying the reservoir of primary reference
Moller”). Although Appellant contends that the Examiner has engaged in
hindsight reconstruction, Appellant does not address the reasoning provided
to modify the relied-upon prior art (Final Act. 2-4). We determine that the
Examiner’s reasoning supports a prima facie case of obviousness of claim 1.
See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). By not addressing
the reasoning provided, Appellant has not shown error in the relevant
findings or the conclusion as to obviousness. See id. (discussing how, if an
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examiner presents a prima facie case, “the burden of coming forward with
evidence or argument shifts to the applicant”); see also In re Cree, Inc., 818
F.3d 694, 702 n.3 (Fed. Cir. 2016) (viewing an “impermissible hindsight”
argument as “essentially a repackaging of the argument that there was
insufficient evidence of a motivation to combine the references”).
As to the “reasonable expectation of success,” Appellant has not
provided any evidence or technical reasoning to support the position that the
proposed modification would have been beyond the level of ordinary skill in
the art. See KSR, 550 U.S. at 418 (stating that the obviousness analysis “can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ”); see also id. at 421 (“A person of ordinary
skill is also a person of ordinary creativity, not an automaton.”).
Fifth, Appellant argues that “the combination falls short of [the] claim
because an express purpose of [the] claim is a non-rotating piston rod.”
Appeal Br. 12. Appellant also argues that “that the mixing in Levander is
quite sub-standard because it does not provide any mechanical advantage for
mixing the components of cartridge(s), and provides all the disadvantages as
noted” at page 2, lines 14 to 17 of the Specification. Id.
We are not apprised of error by Appellant’s fifth argument. As
discussed in the summary of the Rejection above, the Examiner relies on
certain teachings in Glejbol to modify Moller to provide a “piston rod
element” as recited, which includes being “configured to move axially and
non-rotationally relative to the main body” in certain instances (as recited).
Here, Appellant contends that the combination of prior art would not provide
this feature but does not explain why. See 37 C.F.R. § 41.37(c)(l)(iv) (“The
arguments shall explain why the examiner erred as to each ground of
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rejection contested by appellant.”). As to the arguments regarding Levander,
claim 1 does not require (1) any specific level of “mixing” or (2) any
“mechanical advantage.” See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(rejecting arguments “not based on limitations appearing in the claims”).
As to Appellant’s assertion that certain statements from the Advisory
Action are “hindsight [re]construction” (Appeal Br. 12), we disagree.
Contrary to Appellant’s position {id.), we view the Examiner’s statement
that “Levander reference is used only for modifying the device of Moller to
have at least two chamber [sic]” (Adv. Act. 2) as clarifying the proposed
modification, not as indicating the presence of hindsight reconstruction.
Sixth, Appellant argues that “[i]n making the combination^] the
[E]xaminer has simply dissected the piston 4 from the Glejbol structure.”
Reply Br. 6. According to Appellant, “[i]t would be reasonable to assume a
person having skill in the art might remove the gearbox/piston assembly
from Glejbol and incorporate that into the Moller structure,” but “[w]hat
cannot be explained is how a person of skill in the art would simply dissect
the Glejbol piston only and graft that into the Moller structure.” Id.
For procedural reasons, we need not address this argument. See
37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief which was
not raised in the appeal brief, or is not responsive to an argument raised in
the examiner’s answer, including any designated new ground of rejection,
will not be considered by the Board for purposes of the present appeal,
unless good cause is shown.”). This new argument addresses the rejection
as originally set forth in the Final Office Action, rather than positions raised
in the Answer. And Appellant has not shown good cause for failing to
provide this new argument in the Appeal Brief.
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If considered timely, with this argument, Appellant has not provided
sufficient evidence or technical reasoning to support the position that the
proposed modification would have been beyond the level of ordinary skill in
the art. See KSR, 550 U.S. at 418 (stating that the obviousness analysis “can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ”).
For these reasons, we sustain the rejection of claim 1.
DECISION
We affirm the decision to reject claim 1.
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
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