Ex Parte Ellwanger et al

Patent Trial and Appeal Board

Jun 15, 2017

13719598 (P.T.A.B. Jun. 15, 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.
13/719,598 12/19/2012 Colleen Ellwanger CVT-001 5815
51414 7590 06/19/2017
GOODWIN PROOTFR T T P
EXAMINER
PATENT ADMINISTRATOR TSAI, MICHAEL JASPER
100 Northern Avenue
BOSTON, MA 02210 ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/19/2017 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):
PATENTBOS @GOODWINPROCTER.COM
PSOUSA-ATWOOD@GOODWINPROCTER.COM
GLENN.WILLIAMS@GOODWINPROCTER.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COLLEEN ELLWANGER, BRIAN NOBLE,
TIM COKER, and SEAN PLUNKETT
Appeal 2015-002005
Application 13/719,598
Technology Center 3700
Before LINDA E. HORNER, JASON W. MELVIN, and
BRENT M. DOUGAL, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Civitas Therapeutics, Inc. (Appellant)1 seeks our review under
35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Non-Final
Office Action dated February 14, 2014 (hereinafter “Non-Final Act.”),
rejecting claims 1, 6, 7, 9-13, 31, and 32.2 Appellant’s representative
1 Civitas Therapeutics, Inc. is the applicant as provided in 37 C.F.R. § 1.46
and the real party in interest. Appeal Brief 2 (June 16, 2014) (hereinafter
“Appeal Br.”).
2 Claims 2-5, 8, and 14-30 are canceled. Non-Final Act. 1.
Appeal 2015-002005
Application 13/719,598
presented arguments at an oral hearing on May 23, 2017. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm and designate our affirmance as a NEW GROUND OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Appellant’s claimed subject matter relates to “devices ... for
puncturing a capsule to release a powdered medicament therefrom.” Spec.,
para. 2. Claim 1 is the sole independent claim and is reproduced below.
1. A combination of a capsule and a device for
puncturing the capsule to release a powdered medicament
therefrom, the combination comprising:
(a) the capsule comprising:
opposing domes;
a cylindrical wall portion defined by a capsule wall
radius r measured from a central axis of the opposing
domes;
a volume of at least 0.50 cm3; and
a thickness between 0.08 mm and 0.12 mm; and
(b) the device comprising:
a chamber for receiving the capsule; and
a mechanism for puncturing at least one hole in only
a single dome of the capsule, a center of each hole located
within an annular puncture region bounded and defined in
the single dome by 0.4r and 0.8r, and wherein a total
surface area of all puncture holes is (i) between 0.5% and
2.2% of a total surface area of the capsule and (ii) between
3% and 15% of a total surface area of the single dome.
Appeal Br. 15 (Claims App.).
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EVIDENCE
The Examiner relied upon the following evidence in the Non-Final
Office Action:
Messora US 3,927,195 Dec. 16, 1975
Drizen et al. US 6,007,843 Dec. 28, 1999
(“Drizen”)
Edwards et al. US 2003/0150453 Al Aug. 14, 2003
(“Edwards”)
Appellant submitted a “Declaration of Dr. Sean Plunkett Under
37 CFR § 1.132” on August 5, 2013 (hereinafter “First Plunkett
Declaration”) in response to a Non-Final Office Action. The Examiner
entered and considered the First Plunkett Declaration, as set forth in the
Final Office Action dated September 13, 2013 (hereinafter “2013 Final
Action”). As such, the First Plunkett Declaration is part of the official
record and is properly before us in the appeal.
Appellant subsequently submitted a “Supplemental Declaration of Dr.
Sean Plunkett Under 37 CFR § 1.132” on October 29, 2013 (hereinafter
“Supplemental Plunkett Declaration”) in response to the 2013 Final Action.
As set forth in an Advisory Action dated November 21, 2013 (hereinafter
“Adv. Act.”), the Examiner refused to enter the Supplemental Plunkett
Declaration because it was filed after issuance of the 2013 Final Action and
Appellant failed to provide a showing of good and sufficient reasons why it
was necessary and was not earlier presented. Adv. Act. 1. Appellant
subsequently resubmitted the Supplemental Plunkett Declaration along with
a Request for Continued Examination on January 9, 2014 (hereinafter “RCE
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filing”). As such, the Supplemental Plunkett Declaration is part of the
official record and is properly before us in the appeal. Although the RCE
filing was entered, it is not clear from the record that the Examiner
considered the Supplemental Plunkett Declaration.
Appellant also submitted a “Declaration of Dr. Anthony Hickey
Under 37 CFR § 1.132” (hereinafter “Hickey Declaration”) with the RCE
filing. The Examiner entered and considered the Hickey Declaration, as set
forth in the Non-Final Office Action from which this appeal is taken. As
such, the Hickey Declaration is part of the official record and is properly
before us in the appeal.
REJECTIONS
The Non-Final Office Action includes the following rejections:
1. Claims 1, 7, 9-13, 31, and 32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Edwards and Messora.3 4Non-Final
Act. 2-7.
2. Claim 6 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Edwards, Messora, and Drizen. Id. at 7.
3 Although the statement of the first ground of rejection lists only claims 1,
7, and 9-13, the discussion of the rejection also includes an analysis of
claims 31 and 32. Non-Final Act. 2, 6-7. We understand claims 31 and 32
to be subject to the first ground of rejection.
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ANALYSIS
First Ground of Rejection
Appellant argues claims 1, 7, and 9-13 as a first subgroup, and argues
claims 31 and 32 as a second subgroup. Appeal Br. 5-13. We select claim 1
as representative of the first subgroup and claim 31 as representative of the
second subgroup. Claims 7 and 9-13 stand or fall with claim 1, and claim
32 stands or falls with claim 31. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 1, 7, and 9-13
Appellant contends the inventors discovered that the claimed
combination of puncture hole location and puncture hole surface area
“advantageously avoids the capsule collapsing upon itself when punctured”
and the “puncture hole surface areas reliably and repeatably allow for a full
dose of a low-density powder to be emitted from a large capsule at a
sufficient volumetric flow rate and an achievable magnitude of volumetric
flux so as to be consumed in a single breath by a typical adult patient.”
Appeal Br. 5. Appellant argues the Examiner improperly determined that
the claimed surface area limitations would have been obvious and
improperly disregarded the rebuttal evidence presented by Appellant,
including three sworn inventor and expert declarations. Id. at 6.
Appellant asserts that the evidence presented in the Supplemental
Plunkett Declaration rebuts the Examiner’s determination of obviousness of
the claimed size and location of the puncture holes. Appeal Br. 7 (arguing
that this declaration shows the combination of the surface area and the
location bound for the puncture holes optimizes release of the powdered
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medicament and that the particular location bound claimed for the puncture
holes was unexpected). Appellant’s argument further cites to certain
paragraphs of the Specification and the Figures in support thereof. Id. n.12
(citing Spec., paras. 50-53, 55-58, Figs. 6-9). We do not find the evidence
presented in the Declaration and the cited paragraphs and Figures from the
Specification to be persuasive of error in the Examiner’s rejection of
claim l.4
Paragraphs 4 through 6 of the Supplemental Plunkett Declaration and
paragraphs 50 through 53 of the Specification address the total surface area
of the puncture holes in claim 1. The Supplemental Plunkett Declaration
states that Dr. Plunkett, together with his co-inventors, discovered that for
large volume capsules having a particular thickness, the combined total
surface area of the puncture holes must be at least 0.5% of the total surface
area of the capsule to allow an acceptable percentage of powder to be
emitted in a single patient breath. Supplemental Plunkett Declaration, para.
4. Dr. Plunkett further states that, together he and his co-inventors
discovered that it is undesirable for the combined total surface area of the
puncture holes to be greater than 2.2% because the puncture force that
results from producing puncture holes greater than that size can approach or
exceed the loading limits for typical capsule materials. Id. at para. 5. Dr.
4 Because we find no indication in the record that the Examiner considered
the Supplemental Plunkett Declaration, and because we address this
Declaration herein in the first instance, we designate our affirmance as a new
ground of rejection to afford Appellant a full and fair opportunity to respond.
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Plunkett also states that “the percentage of powder emitted from the capsule
approaches 100% generally asymptotically and little to no appreciable
benefit (in terms of the percentage of powder emitted from the capsule)
exists for puncture hole areas beyond that size.” Id. Thus, Dr. Plunkett
characterizes the claimed upper and lower bounds in the total surface area of
all puncture holes as “critical.” Id. at para. 6 (citing Spec, paras. 50-53,
Figs. 6-7).
The cited portions of the Specification describe results from testing of
size 00 capsules punctured to create holes with a total combined surface area
ranging from 0.027 cm2 to 0.066 cm2 (i.e., 0.0042 in2 to 0.0102 in2). Spec.,
para. 50. “The percentage of the filled powder mass emitted during a
simulated breath was then measured for each hole area configuration.” Id.
The results of the study are shown in table 600 of Figure 6 and graph 700 of
Figure 7. Id. The results led to the conclusion that “the average fraction of
powder emitted in a single breath increases asymptotically towards 100%
with increasing puncture hole area. Id. at para. 51. Appellant’s
Specification describes that when a combined total surface area of all the
puncture holes is about 0.5% of the total surface area of the entire capsule,
48% of the capsule’s powder is emitted, on average, in a single breath of a
patient. Id. at para. 52. “This represents the lower bound on an acceptable
percentage of powder to be emitted in a single breath of a pediatric patient.”
Id. The Specification further describes:
It has been found that it is undesirable for the combined total
surface area of all the puncture holes to be greater than about
2.2% of the total surface area of the entire capsule, because the
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puncturing force that results from producing puncture holes
greater than that size can approach or exceed the loading limits
for typical capsule materials. . . . [T]he percentage of powder
emitted from the capsule approaches 100% generally
asymptotically and little to no appreciable benefit (in terms of the
percentage of powder emitted from the capsule) exists for
puncture hole areas beyond that size.
Id. at para. 53.
As seen in Figures 6 and 7, however, the chart shows the results of
emitted powder testing on capsules in which the combined surface area of all
puncture holes was 0.5% to 1.3% of the total capsule surface area. The
testing does not show any data points above 1.3% of the total capsule
surface area. Further, at 1.3%, the testing shows that 98% of the powder
was emitted from the capsule. As the percentage of powder emitted from
the capsule approaches 100% generally asymptotically, it is difficult to
discern from these test results an appreciable benefit in terms of the
percentage of powder emitted from the capsule for combined total surface
area puncture holes greater than 1.3% and up to the upper bound of 2.2%.
Further, we see no evidence that the testing described in the Specification
included any testing of a capsule with a combined total surface area of
puncture holes of 2.2%. We find very little evidence to support a criticality
to the upper end of the range of 2.2%. Further, the upper end of the range
appears to be the result of routine experimentation to discern an upper limit
of combined puncture hole surface area that would not cause collapse of the
capsule.
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Paragraphs 7 through 11 of the Supplemental Plunkett Declaration
and paragraphs 55 through 58 of the Specification address the location of the
puncture holes as recited in claim 1. The Supplemental Plunkett Declaration
states that Dr. Plunkett, together with his co-inventors, discovered that for
large volume capsules having a particular thickness, if the centers of the
puncture holes in a capsule’s dome are located below 0.4r, the rate of dome
collapse increases dramatically. Supplemental Plunkett Declaration, para. 7.
Dr. Plunkett further states that, together with his co-inventors, they
discovered if the centers of the puncture holes are located at greater than
0.8r, the puncturing mechanism can tear down the cylindrical wall of the
capsule or create a side load on the capsule that might deflect or crush the
capsule. Id. at para. 8. Thus, Dr. Plunkett characterizes the claimed upper
and lower bounds in the puncture hole location as “critical.” Id. at para. 9
(citing Spec, paras. 55-58, Figs. 8-9). Dr. Plunkett further states that
throughout the course of developing the claimed invention, the inventors
experimented with known prior puncturing approaches, e.g., puncturing the
sidewall, both domes, or the centralized tip of the capsule’s dome(s). Id. at
para. 10. Dr. Plunkett attested:
Only after extensive effort did we unexpectedly discover
that, in order to achieve our intended objective (i.e., to release
the correct amount of powder medicament from the capsule in a
single patient breath without collapsing the capsule itself), it is
critical to puncture only a single dome of the capsule such that
the center of each hole is located within an annular puncture
region bounded and defined in the single dome by 0.4r and 0.8r
and such that a total surface area of all puncture holes is between
0.5% and 2.2% of a total surface area of the capsule. The fact
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that the release of powdered medicament from a capsule is
optimized by a combination of all of that particular surface area
and that particular location bound and solely one dome was
unexpected. In fact, contrary to the suggestion of the many prior
approaches described above, it was only confirmed after the
extensive analysis and testing described above and in paragraphs
[0050]—[0053] and [0055]—[0058] of our originally-filed
specification (with reference to FIGS. 6-9 thereof).
Id. at para. 11.
The burden of showing unexpected results rests on the person who
asserts them by establishing that the difference between the claimed
invention and the closest prior art was an unexpected difference. See In re
Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Further, it is well established
that “any superior property must be unexpected to be considered as evidence
of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371
(2007). Dr. Plunkett’s declaration does not explain the factual basis for
concluding that a person having ordinary skill in the art would have
considered the results as set forth in the Tables in the Specification to be
unexpected. See In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973).
Further, the declaration fails to compare the results to the closest prior art,
i.e., Edwards, in which punctures holes are located on one of the capsule’s
domes and in a location that is distanced from the centralized tip. In re
Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”).
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Paragraphs 55 and 56 of Appellant’s Specification describe a
simulation of the capsule material’s response to a constant force loading at
different positions along the radius of the capsule’s dome using finite
element analysis and the mechanical properties of the capsule material.
Spec., para. 55. The results of that analysis are shown in table 800 of Figure
8 and in graph 900 of Figure 9. Id. According to the Specification, “[t]he
analysis predicts, as can be observed from FIGS. 8 and 9, that a change in
degree of deflection in response to a constant loading force similar to that
imparted to the capsule material during puncturing will occur between 40%
to 50% of the dome radius.” Id. at para. 56. Paragraph 57 describes a
separate laboratory study that was conducted to confirm the simulation
results. Id. at para. 57. “The study showed that once the centers of the
puncture holes reached values below 0.4r the rate of dome collapse
increased dramatically.” Id. As such, the preferred location for the center of
each puncture hole is in the annular region of the capsule dome that is no
less than 0.4r. Id. at para. 58. The outer boundary of the puncture region is
described to be about 0.8r because attempting to puncture the capsule dome
in a region greater than 0.8r might lead to the puncturing mechanism
slipping off the capsule’s dome and/or tearing down the cylindrical wall
portion of the capsule, and/or creating a side load on the capsule, causing it
to detrimentally deflect within the inhaler chamber. Id.
Dr. Plunkett’s characterization of the claimed invention as an
“unexpected” discovery is not sufficient to demonstrate unexpected results.
Further, the Specification does not demonstrate a connection between the
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location of the puncture holes and the ability to release a correct amount of
the powder medicament in a single breath. Rather, the location of the
puncture holes is described in the Specification as being relevant only to
preventing collapse of the capsule when the puncture holes are made. There
is no evidence that the claimed ranges for location of the punctures holes
was unexpected, but rather the evidence shows that it was simply unknown
until a finite element analysis was run.
The Specification does not tie together the claimed location of the
puncture holes and the claimed total surface area of the puncture holes to
evidence a combined effect of these two parameters. Rather, as detailed
above, the Specification describes the need for placement of the puncture
holes within a certain range of locations to avoid collapse of the capsule
during puncturing, and the Specification describes the total surface area of
the puncture holes being between a certain range to optimize delivery of the
medicament in a single breath. In conclusion, although the simulations and
studies described in the Specification may demonstrate the reasons for the
claimed ranges, it does not provide evidence that either the location of the
punctures hole or the total surface area of the puncture holes, or their
combination, provided unexpected results.
Appellant asserts the prior art fails to evince it was known in the art
that the location and surface area of the puncture holes are result effective
variables. Appeal Br. 7-10 (arguing the prior art teaches either puncturing a
sidewall, or both domes, or a centralized tip of one or both domes).
Appellant argues that none of the prior art references of record teach
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puncturing a single one of the capsule’s domes. Id. This argument,
however, fails to account for the fact that Edwards, the primary reference
relied on in the rejection of claim 1, teaches puncturing a single one of the
capsule’s domes at a position that is not at the centralized tip of the dome.
Edwards, Fig. 2; Non-Final Act. 4 (Examiner finding that Edwards “appears
to disclose the puncturing mechanism being configured such that the center
of each hole is located within an annular puncture region bounded and
defined in the at least one dome by 0.4r and 0.8r as shown in FIG. 8, but
does not specifically disclose such a region being between about 0.4r and
0.8r”).
The Examiner determined that situating the puncture region between
about 0.4r and 0.8r would have been obvious because it “would be
dependent upon the capsule size and dimensions.” Non-Final Act. 4. The
Examiner further explains:
Edwards clearly discloses a . . . pair of prongs for puncturing a
single capsule dome (as seen in FIG. 8 and 9b of Edwards) and
also provides that the device as disclosed is able to accommodate
capsules of differing sizes (capsule size 2, 1, 0, 00, or 000)
(Edwards, para. 0091). With such evidence that [the] chamber
of the device of Edwards is able to accommodate capsules of
differing sizes[,] one of ordinary skill in the art at the time the
invention was made would have found the optimization of the
location through routine experimentation.
Ans. 9.
In response, Appellant provides expert testimony from Dr. Anthony
Hickey opining that the claimed location bounds for the puncturing holes in
large capsules “would not have been obvious to me, nor to others having an
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ordinary level of skill in my professional field, at the time of the invention.”
Hickey Declaration, para. 13 (declarant attesting that he “would have
pursued the strategy employed in industry to pierce small capsules5
containing solid, dense particles, and would have assumed that methodology
would also work for large capsules that contain a large volume of a low
density powder”). The problem with this testimony is that it fails to address
the fact that Edwards teaches the claimed piercing strategy of piercing holes
in a single one of the capsule’s domes at a position that is not at the
centralized tip of the dome for use with large capsules. Edwards, Fig. 2
(showing U-shaped staple having two prongs 232 configured to puncture
one dome of the capsule at a distance removed from O.Or), para. 91
(describing that the apparatus can be used to puncture capsule sizes 0 and 00
(e.g., having volumes of 0.67 cm3 and 0.95 cm3, respectively). According to
Appellant’s Specification, these capsule sizes are “large” capsules. Spec.,
para. 8 (describing size 0 and size 00 capsules, having volumes of 0.68 cm3
and 0.95 cm3, respectively, as “larger capsules”).
Further, Appellant argues that Edwards “teaches away” from the
claimed puncture location range because Edwards teaches using the same
chamber size for different size capsules, which would result in a puncture
hole location falling outside of the claimed range for a size 2 capsule. Reply
5 Dr. Hickey attests that the piercing strategy employed in industry to pierce
small capsules “is to either: (a) pierce the centralized tip(s) of the capsule’s
dome(s) (i.e., pierce the capsule’s dome(s) at about O.Or ... or (b) pierce the
sidewall of the capsule . . . .” Hickey Declaration, para. 11.
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Br. 8-11. Appellant’s calculations, however, are based upon the convenient
starting assumption that the prongs of Edwards are sized to puncture a size 0
capsule at 0.6r. Id. at 9. Thus, the calculations are based on a starting
premise that conveniently proves Appellant’s point. For instance, Appellant
does not calculate the puncture hole location on a size 2 capsule in the event
the prongs are designed to puncture a size 0 capsule at the lower end of the
claimed range, i.e., 0.4r. Using Appellant’s rendering (Reply Br. 10) and
calculations provided in the Reply Brief, were one to design Edward’s
prongs to puncture a size 0 capsule at 0.4r, then the corresponding punctures
to a size 2 capsule within the same chamber and with the same prongs would
be at 0.59r and at 0.68r, which locations are within the claimed range. As
such, we do not agree that Edwards teaches away from the claimed range.
Appellant further argues that Edwards “does not recognize the
problem — i.e., that piercing a large hole through a large capsule requires a
relatively high force loading which will, if the capsule is punctured in an
incorrect region, collapse the capsule before the puncture is created.” Reply
Br. 7. Edwards, however, is well aware of the possibility of capsule collapse
due to the force applied while puncturing a capsule. See, e.g., Edwards,
para. 140 (describing testing of various staple designs (e.g., sharp edge
staples, circular section staples, and square section staples) to discern the
effort required to puncture the capsule with each design and the recognizing
the possibility of crushing the capsule during puncturing). Thus, we agree
with the Examiner that based on Edward’s disclosure of a two-pronged
staple that is used to puncture the dome of a capsule in an area of the capsule
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removed from the center point of the dome, it would have been a matter of
routine optimization for a person skilled in the art to determine the
optimized annular range for the location of the puncture holes to avoid
crushing the capsule during puncturing.
Further, the arguments in the Appeal Brief as to result effective
variable focus only on the location of the puncture holes. There is no
argument or evidence specifically challenging the Examiner’s position that
the total surface area of the puncture holes was known in the art to be a
result effective variable.6 Rather, Appellant argues only that the
combination of surface area and location was not appreciated in the art. Yet,
as we noted supra, the Specification does not support Appellant’s assertion
of a synergy in the combination of the claimed surface area (which relates to
the amount of medicament released) and puncture location (which relates to
the ability to puncture the capsule without damaging it).
Appellant further argues that the Examiner erred in reasoning that the
claimed location bounds of the puncture holes would have been obvious in
view of Edwards, as modified by Messora, because it is based on “a non-
6 The prior art recognizes the total surface area of the puncture holes as a
result effective variable. In particular, Edwards explicitly recognizes that
“larger longitudinal prongs of the present invention can create larger
openings in the receptacles than conventional piercing devices, which allows
for higher emitted doses at low peak inspiratory flow rates, low volumes,
and high dosage quantities” and that increasing the size of the holes in the
receptacle improves the powder flow from the receptacle. Edwards, paras.
44, 45.
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existent capsule sized to the Examiner’s whim and fancy.” Appeal Br. 11-
12. The Examiner specifically found that Edwards discloses a puncture
apparatus for use with large capsules (as discussed supra). We agree with
this finding. See Edwards, para. 91 (describing capsules of size 0 (volume
of 0.67 cm3) and size 00 (volume of 0.95 cm3)), id. at paras. 116-117
(describing experiments performed using size 00 capsules), Spec. Fig. 3
(chart of standard capsule sizes).
Appellant further argues that “Edwards teaches away from the surface
area claim limitations and, thus, Appellant’s claimed invention.” Reply Br.
5 (citing Edwards, paras. 116, 117). Specifically, Appellant asserts that
Edwards discloses a single fixed capsule hole surface area of 0.013 square
inches, which translates to approximately 1.325% of a total surface area of a
size 00 capsule. Id. Appellant argues that because Edwards teaches that the
disclosed hole surface area is the “maximum” and Appellant’s claimed range
exceeds that maximum, Edwards teaches away from the claimed range.
Edwards teaches:
Initially, it was discovered that it is always desirable to maximize
the capsule hole area. Accordingly, the capsule hole area was
fixed at 0.013 square inches. It should be understood that the
present invention encompasses other capsule hole areas,
especially when used with different sized capsules. It was also
determined that the total area of the holes in the mouthpiece was
an important factor but that the number of holes in the
mouthpiece did not effect the results.
Edwards, para. 117.
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We do not agree with Appellant that this disclosure in Edwards
constitutes a teaching away. Although Edwards teaches a total puncture
hole surface area of 1.3% in order to “maximize the capsule hole area,” this
disclosure would not have discredited or led one having ordinary skill in the
art away from experimenting to see if a larger surface area would be
possible. Instead, Edwards encourages such experimentation by indicating
the desirability to maximize this parameter. Notably, the upper limit of the
puncture hole area tested in Figures 6 and 7 of Appellant’s Specification is
1.3%, which matches the total surface area disclosed in Edwards. Further,
because the percentage of powder emitted from the capsule approaches
100% generally asymptotically, it is difficult to discern from the test results
provided in Appellant’s Specification an appreciable benefit in terms of the
percentage of powder emitted from the capsule for combined total surface
area puncture holes greater than 1.3% and up to the upper bound of 2.2%.
The upper end of the range appears to be the result of routine
experimentation to discern an upper limit of combined puncture hole surface
area that would not cause collapse of the capsule.
For these reasons, and considering all of the evidence presented in
support of both the obviousness and nonobviousness of the claimed
invention, we find that Appellant has not demonstrated error in the
Examiner’s rejection of claim 1. Accordingly, we sustain the rejection of
claim 1, and claims 7 and 9-13 which fall with claim 1, under 35 U.S.C.
§ 103(a) as unpatentable over Edwards and Messora. We designate our
affirmance as a new ground of rejection.
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Claims 31 and 32
Dependent claims 31 and 32 recite narrower limitations of the location
boundary of the puncture holes and the total surface area of all puncture
holes.7 Appeal Br. 16 (Claims App.). Appellant states that the “arguments
above regarding the patentability of independent claim 1 apply similarly
here to the narrower limitations of dependent claims 31 and 32.” Id. at 13.
For the same reasons discussed supra in our analysis of claim 1, and
considering all of the evidence presented in support of both the obviousness
and nonobviousness of the claimed invention, we find that Appellant has not
demonstrated error in the Examiner’s rejection of claim 31. Accordingly,
we sustain the rejection of claim 31, and claim 32 which falls with claim 31,
under 35 U.S.C. § 103(a) as unpatentable over Edwards and Messora. We
designate our affirmance as a new ground of rejection.
Second Ground of Rejection
Appellant does not present any additional arguments for dependent
claim 6 apart from the arguments presented in support of independent claim
1, from which claim 6 depends. Appeal Br. 13 (arguing Drizen does not
cure the deficiencies of Edwards and Messora with regard to claim 1).
Accordingly, for the same reasons discussed supra, we sustain the rejection
7 Claim 31 recites “the center of each hole is located with an annular
puncture region bounded and defined in the single dome by 0.5r and 0.8r.”
Appeal Br. 16 (Claims App.). Claim 32 recites “the total surface area of all
puncture holes is between 1.1% and 1.6% of the total surface area of the
capsule.” Id.
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Appeal 2015-002005
Application 13/719,598
of claim 6 under 35 U.S.C. § 103(a) as unpatentable over Edwards, Messora,
and Drizen. We designate our affirmance as a new ground of rejection
DECISION
The rejection of claims 1, 7, 9-13, 31, and 32 under 35 U.S.C.
§ 103(a) as unpatentable over Edwards and Messora is affirmed.
The rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable
over Edwards, Messora, and Drizen is affirmed.
As explained supra, because our affirmance of each ground of
rejection relies on consideration of the Supplemental Plunkett Declaration in
the first instance, and relies on a more thorough consideration of the Hickey
Declaration than that provided by the Examiner, we designate our
affirmance of each rejection as a NEW GROUND OF REJECTION
pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new
ground of rejection pursuant to this paragraph shall not be considered final
for judicial review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
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Appeal 2015-002005
Application 13/719,598
(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 prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be found in
the Manual of Patent Examining Procedure § 1214.01.
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)(l)(iv).
AFFIRMED; 37 C.F.R, $ 41.50(b)
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