Ex Parte Burton et al

Patent Trial and Appeal Board

Dec 7, 2016

13128066 (P.T.A.B. Dec. 7, 2016)

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.
13/128,066 05/06/2011 Scott A. Burton 64422US005 6778
32692 7590 12/09/2016
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
EISENBERG, REBECCA E
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
12/09/2016 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT A. BURTON, FRANKLYN L. FREDERICKSON,
KRISTEN J. HANSEN, RYAN P. SIMMERS,
PERCY T. FENN, and CRAIG S. MOECKLY1
Appeal 2015-003407
Application 13/128,066
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of rapid, high-volume, intradermal infusion which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as 3M INNOVATIVE
PROPERTIES COMPANY. (App. Br. 2.)
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Application 13/128,066
STATEMENT OF THE CASE
Appellants’ “invention relates to hollow microneedle drug delivery
devices” that “replace hypodermic injections for rapid, painless delivery of
injectable drug formulations.” (Spec. 1:4,2:15-16)
Claims 1, 2, and 4-13 are on appeal. Claim 1 is illustrative:
1. A method of rapid, high-volume, intradermal infusion
with minimal pain, comprising:
applying an array of 10 to 30 hollow microneedles having
a length of greater than 100 pm to less than 1 mm into the skin
of a patient, with a microneedle spacing of no less than 1.5 mm
on average between adjacent microneedles;
pumping greater than 200 pL of fluid through the hollow
microneedles at a rate of greater than 20 pL/min.
(App. Br. 13 (Claims App’x).)
The claims stand rejected as follows:
I. Claims 1, 2, 4, 6-11, and 13 under 35 U.S.C. § 103(a) over
Yeshurun2 and Pettis.3
II. Claim 5 under 35 U.S.C. § 103(a) over Yeshurun, Pettis, and
Friden.4
III. Claim 12 under 35 U.S.C. § 103(a) over Yeshurun, Pettis, and
Rosenberg.5
2 Yeshurun, US 7,285,113 B2, issued Oct. 23, 2007.
3 Pettis et al., US 2005/0256499 Al, published Nov. 17, 2005.
4 Friden, US 2009/0082713 Al, published Mar. 26, 2009.
5 Rosenberg, US 6,623,457 Bl, issued Sept. 23, 2003.
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REJECTION I
Appellants argue the patentability of the claims together. We select
claim 1 as representative.
The Examiner finds that
Yeshuran discloses a method of rapid, high-volume, intradermal
infusion with minimal pain, comprising applying an array of 10
to 30 hollow microneedles (16) (lines 36^19 of column 10)
having a length of greater than 100 [p]m to less than 1 mm into
the skin of a patient (line 58 of column 2 to line 44 of column 3
and lines 36-49 of column 11), with a microneedle spacing of no
less than 1.5 mm on average between adjacent microneedles
(lines 36^49 of column 10 where it is disclosed that the spacing
between centers of adjacent microneedles is in the range of 2—4
times the maximum diameter of each needle which is disclosed
as a maximum width dimension (w) of no more than 400 pm and
shown in Figure 4) and pumping fluid through the hollow
microneedles. Yeshurun discloses the method substantially as
claimed.
(Ans. 2.) The Examiner finds that
[ejven though Yeshurun discloses pumping fluid through the
microneedles to allow for rapid, high-volume (due to the number
of microneedles used), intradermal infusion with minimum pain
(lines 28-41 of column 7 and lines 8-33 of column 8), Yeshurun
is silent on the specifics of pumping greater than 200 pL of fluid
through the hollow microneedles at a rate of greater than 20
pL/min.
{Id. at 2-3.)
The Examiner turns to Pettis as disclosing
a method of rapid, high-volume, intradermal infusion with
minimal pain, comprising applying an array of hollow
microneedles having a length of greater than 100 pm to less than
1 mm (paragraph [0018]) into the skin of a patient and pumping
greater than 200 pL of fluid through the hollow microneedles at
a rate of greater than 20 pL/min (paragraphs [0020], [0021], and
[0081]).
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{Id. at 3.) The Examiner concludes that it would have been obvious to
include in the step of pumping fluid through the microneedles of
Yeshurun the specifics of pumping greater than 200 pL of fluid
through the hollow microneedles at a rate of greater than 20
pL/min as taught by Pettis et al[.] as both Yeshurun and Pettis et
al[.] disclose a method of rapid, high-volume, intradermal
infusion with minimal pain, by pumping fluid through
microneedles and Pettis et al[.] teach that it is well known to
pump greater than 200 pL of fluid through the hollow
microneedles at a rate of greater than 20 pL/min in order to
achieve rapid, high-volume, intradermal infusion with minimal
pain.
{Id.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Yeshurun and Pettis would
have rendered claim 1 obvious?
Findings of Fact (FF)
1. Y eshurun teaches
a device for the delivery of fluids through a biological barrier,
the device comprising: (a) a substrate with a plurality of
microneedles projecting therefrom, each of the microneedles
having a maximum width dimension of no more than about 400
pm and a maximum height dimension of no more than about 2
mm ....
(Yeshurun 2:59-64; see also Ans. 2.)
2. Yeshurun teaches that “[i]n addition to avoiding plugging of the
needle and facilitating withdrawal and delivery of fluids across a biological
barrier, the shape illustrated also significantly increases the open area
presented by the hollow tube, thereby dramatically increasing rates of fluid
flow which can be achieved.” (Yeshurun 7:36^11; see also Ans. 2-3.)
3. Yeshurun teaches that
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the process described is clearly well suited to producing a one-
or two-dimensional arrays of microneedles projecting from the
surface of substrate . . . with any desired spacing, layout and
dimensions. In fact, it is a particularly preferred feature of the
microneedle structures of the present invention that a two-
dimensional array including at least 20 microneedles is provided.
. . . The spacing between centers of adjacent microneedles is
typically in the range of 2-4 times the maximum diameter of
each needle.
(Yeshurun 10:37^19; see also Ans. 2.)
4. Yeshurun teaches
The relatively painless nature of the procedure may
optionally be ensured by use of microneedles with a maximum
height h chosen to allow penetration only to the stratum comeum
(SC) and epidermis derma layers, thereby generally avoiding
contact with nerves. This is also helpful for applications in which
sampling of blood plasma rather than full blood is desired. For
such applications, maximum height dimension h is preferably
chosen to be no more than about 200 pm. For other applications
in which deeper delivery or sampling is desired, longer
microneedles are used to penetrate into the dermis. In this case,
all or most pain can be avoided by employing narrow
microneedles with a maximum width dimension of not more than
300 pm, and preferably not more than 200 pm.
(Yeshurun 8:17-30; see also Ans. 2-3.)
5. Pettis teaches an
improved delivery of the substance include but are not limited to
length of the needle, number of the needles, spacing between the
needles, and relative exposed height of the needle outlet for
targeting the specific compartment within the subject’s skin. The
invention encompasses altering such parameters so that the
devices penetrates the targeted space within the subject’s skin,
allowing the skin to seal around the needle and preventing
effusion of the substance onto the surface of the skin due to
backpressure. ... In some embodiments, the invention
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encompasses microneedles ranging in length from 0.5 mm to 2
mm, ....
(Pettis T| 18; see also Ans. 3.)
6. Pettis teaches “varying the volume of the substance delivered so
that at least 10 pL, at least 50 pL, at least 100 pL, at least 200 pL or at least
500 pL is deposited into the targeted compartment” (Pettis ^ 20; see also
Ans. 3.)
7. Pettis teaches that
[i]n some embodiments, fluid flow rate is kept constant while one
or more other parameters including but not limited to needle
length, number of needles, spacing between needles, infusion
rate, pressure of delivery and application site are altered. The
invention encompasses varying the fluid rate from about 50
pL/min to 200 pL/min, 100 pL/min to 500 pL/min, 5 pL/hr to
5000 pL/min.
(Pettis If 21; see also Ans. 3.)
8. Pettis teaches “an improved method of delivery of a substance
to a subject’s skin, in that it provides among other benefits, an efficient and
consistent deposition of the substance in to the targeted compartment,
enhanced subject compliance due to minimal to no pain perception.” (Pettis
^f 81; see also Ans. 3.)
9. Pettis teaches
In some embodiments, the device penetrates the skin at a
depth within the intradermal space at a depth of at least about 0.5
mm, preferably at least 1.0 mm up to a depth of no more than 3.0
mm. Preferably the needle has a length sufficient to penetrate
the intradermal space and an outlet at a depth within the
intradermal space so that the substance is delivered and deposited
therein. In general the needle is no longer than about 2 mm long,
preferably 300 pm to 2 mm; most preferably 500 pm to 1 mm.
(Pettis Tf 99; see also App. Br. 11.)
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DISCUSSION
We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 2-9; FF 1-9), and agree with the Examiner that claim 1
would have been obvious over Yeshurun and Pettis. We address below
Appellants’ arguments.
Appellants contend that the Examiner “errs in maintaining the
rejection because the combination of Yeshurun and Pettis fails to provide
teaching that allows a person of ordinary skill in the art to combine
Yeshurun and Pettis and achieve a predictable result.” (App. Br. 3.)
This argument is unpersuasive.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[A] person of
ordinary skill is also a person of ordinary creativity, not an automaton.” Id.
at 421. “If a person of ordinary skill can implement a predictable variation,
§103 likely bars its patentability.” Id. at 417.
It does not appear that Appellants dispute the Examiner findings that
“Yeshurun discloses the method substantially as claimed.” (Ans. 2; see also
Ans. 7, FF 1^1). As Examiner notes, “Yeshurun does not explicitly disclose
the specific pumping volume or rate as required by [Appellants’] claim,
though Yeshurun provides justification for a combination reference through
the disclosure of allowing for rapid, high volume, intradermal infusion with
minimum pain.” (Ans. 7; see also Ans. 2-3, FF 2, 4.)
Pettis teaches “varying the volume of the substance delivered so that
at least 10 pF, at least 50 pF, at least 100 pF, at least 200 pF or at least 500
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pL is deposited into the targeted compartment.” (FF 6; see also Ans. 7.)
Pettis also teaches that
[i]n some embodiments, fluid flow rate is kept constant while one
or more other parameters including but not limited to needle
length, number of needles, spacing between needles, infusion
rate, pressure of delivery and application site are altered. The
invention encompasses varying the fluid rate from about 50
pL/min to 200 pL/min, 100 pL/min to 500 pL/min, 5 pL/hr to
5000 pL/min.
(FF 7; see also Ans. 7.)
We thus agree with the Examiner that it would have been
obvious to pump greater than 200 pL of fluid through the hollow
microneedles at a rate of greater than 20 pL/min as taught by Pettis in the
system and method of Yeshurun in order to achieve rapid, high-volume
intradermal infusion with minimal pain. (See Ans. 3, 8.) The combined
teachings of Yeshurun and Pettis regarding pumping greater than 200 pL of
fluid at a rate of greater than 20 pL/min, would yield predictable results of
rapid, high-volume intradermal infusion with minimal pain.
Appellants contend that Yeshurun and Pettis teaches away from their
combination because they “teach minimizing pain by diametrically opposed
strategies that negate their combination to arrive at the method of claim 1.”
(See App. Br. 3—4.) More particularly, Appellants contend that “Yeshurun
teaches that pain is minimized by using short microneedles-microneedles
having a length no greater than 200 pm” while “Pettis teaches minimizing
pain by using longer microneedles-microneedles greater than 1 mm in
length.” (App. Br. 4 (citing Yeshurun 8:17-25 and Pettis ^ 163, Table 3);
see also Reply Br. 2^1.)
This argument is also unpersuasive.
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Yeshuran teaches “[t]he relatively painless nature of the procedure
may optionally be ensured by use of microneedles with a maximum height
h” in which the “maximum height dimension h is preferably chosen to be no
more than about 200 pm.” (FF 4 (emphasis added).)
Pettis teaches “an efficient and consistent deposition of the substance
in to the targeted compartment, enhanced subject compliance due to minimal
to no pain perception.” (FF 8.) Pettis teaches that parameters including the
“length of the needle, number of the needles, spacing between the needles,
and relative exposed height of the needle outlet” can be altered. (FF 5; see
also FF 7, 9 (“preferably at least 1.0 mm up to a depth of no more than 3.0
mm” (emphasis added).) As Appellants point out, Pettis also teaches that
“the needle is no longer than about 2 mm long, preferably 300 pm to 2 mm;
most preferably 500 pm to 1 mm.” (FF 9 (emphasis added); see also FF 5,
App. Br. 11.)
Based on the preponderance of the evidence, Yeshuran and Pettis
teach towards the claimed invention as opposed to away. Moreover,
Appellants’ contention appears to be based on certain of the references’
embodiments. “But in a section 103 inquiry, ‘the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) (quoting In reLamberti, 545 F.2d 747, 750, (CCPA
1976).)
Appellants argue that “[t]he Examiner fails to provide a clear
articulation of reasons why a person of ordinary skill in the art would have
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arrived at the method of claim 1 from combining Yeshurun and Pettis.”
(App. Br. 7; see also Reply Br. 5.)
This argument is unpersuasive. As the Examiner explains,
the motivation for the combination of the references is apparent
as both references disclose a method of rapid, high-volume,
intradermal infusion with minimal pain, by pumping fluid
through microneedles. Furthermore, Pettis teaches that it is well
known to pump greater than 200 pL of fluid through the hollow
microneedles at a rate of greater than 20 pL/min in order to
achieve rapid, high-volume, intradermal infusion with minimal
pain.
(Ans. 8.) See In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003)
(“Selecting a narrow range from within a somewhat broader range disclosed
in a prior art reference is no less obvious than identifying a range that simply
overlaps a disclosed range. . . . The normal desire of scientists or artisans to
improve upon what is already generally known provides the motivation to
determine where in a disclosed set of percentage ranges is the optimum
combination of percentages.”).
Appellants contend that “Pettis provides no evidence that the infusion
amounts and infusion rates listed in Pettis can be predictably achieved using
a microneedle array as recited in claim 1.” (App. Br. 7.)
This argument is also unpersuasive.
“[D]isco very of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.” In re Boesch, 617
F.2d 272, 216 (CCPA 1980). The preponderance of the evidence here shows
that features such as the number of needles and needle length and spacing
are results-effective. For example, Pettis teaches an
improved delivery of the substance include but are not limited to
length of the needle, number of the needles, spacing between the
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needles, and relative exposed height of the needle outlet for
targeting the specific compartment within the subject’s skin. The
invention encompasses altering such parameters so that the
devices penetrates the targeted space within the subject’s skin.
(FF 5 (emphasis added); see also FF 7.)
Given that Pettis teaches that the length of the needle, the number of
the needles, the spacing of the needles, and the exposed height of the needles
can be altered, the ordinary artisan would recognize that these parameters
are results optimizable variables, particularly in light of Pettis’ teaching that
“improved delivery of the substance include but are not limited to” those
parameters. (FF 5.)
We thus, agree with the Examiner that
Yeshurun and Pettis disclose similar factors such as needle
length which can influence the infusion rate. One skilled in the
art would recognize that other factors such as spacing between
needles and application site are dependent on the particular
application and can also be optimized to achieve the result of
rapid, high-volume, intradermal infusion with minimal pain.
Thus, the teachings of Pettis can be combined with the prior art
of Yeshurun to obtain the claimed subject matter and Pettis
clearly teach the claimed infusion amounts and infusion rates
using microneedles with similar lengths as the microneedles of
Yeshurun.
(Ans. 8-9.) We further note that Appellants appear to concede that the
infusion rate are dependent on these result effective variables. (See App. Br.
7 (“factors such as needle length, the number of needles, spacing between
needles, infusion rate, and application site can influence the infusion rate.”)
REJECTION II
Appellants do not argue the deficiencies of Friden and rely on the
arguments presented in regard to claim 1. (App. Br. 8-9.) Having affirmed
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the rejection of the parent claim for the reasons given above, we thus affirm
the rejection of claim 5.
REJECTION III
In regard to claim 12, the Examiner finds that “Yeshuran in view of
Pettis et al[.] disclose the method substantially as claimed.” (Ans. 6.)
The Examiner finds that “Yeshurun in view of Pettis et al[.] are silent
as to the specifics of the microneedles being spaced an average of at least 2
mm apart from each other.” (Id.)
The Examiner turns to Rosenberg as disclosing
a method of intradermal infusion with minimal pain, comprising
applying an array of hollow microneedles into the skin of a
patient where the microneedles are spaced an average of at least
2 mm apart from each other (line 28 of column 7 to line 25 of
column 8 and line 42 of column 10 to line 50 of column 11).
(Id.) The Examiner concludes that it would have been obvious to
provide the microneedles of Yeshurun spaced an average of at
least 2 mm apart from each other as taught by Rosenberg as both
Yeshurun and Rosenberg disclose a method of intradermal
infusion with minimal pain and Rosenberg teaches that it is well
known for the spacing of the microneedles to be varied such that
the microneedles can be spaced an average of at least 2 mm apart
from each other depending on the specific fluid being
administered and also teaches that this spacing of the
microneedles would allow for the avoidance of mixing and
interaction of different fluids in the instance that different fluids
are being injected through different microneedles.
(Id. at 6-7.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Yeshurun, Pettis, and
Rosenberg would have rendered claim 12 obvious?
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Findings of Fact (FF)
10. Rosenberg teaches that “[tjypically, the microneedles are
spaced a distance of about 0.05 mm to about 5 mm.” (Rosenberg 7:33-35;
see also Ans. 6.)
11. Rosenberg teaches
The device is particularly suitable for introducing a vaccine
intradermally, especially intraepidermally, for efficiently
delivering a small amount of the vaccine antigen for presentation
to the Langerhans cells. . . . The length, width and spacing of
the microneedles can varying depending on the pharmaceutical
agent being administered or required to penetrate or pierce the
stratum comeum to the optimum depth for the specific
pharmaceutical agent being administered.
(Rosenberg 10:46-57; see also Ans. 6.)
12. Rosenberg teaches that “[t]he microneedles are also less painful
to the patient and exhibit a lower incidence of skin necrosis common with
some DNA vaccines.” (Rosenberg 11:33-36; see also Ans. 6.)
DISCUSSION
Claim 12 requires “wherein the microneedles are spaced an average of
at least 2 mm apart from each other.” (App. Br. 14 (Claims App’x).)
We agree with the Examiner that claim 12 would have been obvious
over Yeshurun, Pettis, and Rosenberg. We address below Appellants’
arguments.
Appellants contend that
[t]he Examiner acknowledges that many factors influence
infusion rate: e.g., needle length, needle spacing, and application
site. {Id., page 9). The combination of Yeshurun, Pettis, and
Rosenberg fails, however, to disclose how these factors-and, in
particular, needle spacing-influence infusion rate. It is unclear
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from the combined disclosures of Yeshurun, Pettis, and
Rosenberg, therefore, whether adopting an array configuration
having microneedles spaced at least 2 mm apart will predictably
result in the recited infusion rate of 20 pL/min.
(App. Br. 10.)
This argument is unpersuasive for the reasons discussed above. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 421, In re Peterson, 315 F.3d at
1329-30 and In re Boesch, 617 F.2d at 276.
Appellants argue that “[bjecause Rosenberg discloses microneedle
arrays having a maximum length that is less than the minimum length of the
microneedles in the array disclosed by Pettis, Rosenberg and Pettis teach
away from their combination.” (App. Br. 11.)
This argument is also unpersuasive for the reasons discussed above.
Moreover, as the Examiner explains,
Rosenberg is being used only to disclose the spacing of the
microneedles. Any mention of the elements of Rosenberg aside
from the spacing have been used in a comparative manner to
further illustrate why this reference is combinable with the other
two references as it is also a microneedle device with similar
desired results of having rapid, high volume, intradermal
infusion with minimal pain.
(Ans. 9; see also FF 10-12.)
CONCLUSION OF LAW
We affirm the rejection of claims 1, 2, 4, 6-11, and 13 under
35 U.S.C. § 103(a) over Yeshurun and Pettis.
We affirm the rejection of claim 5 under 35 U.S.C. § 103(a) over
Yeshurun, Pettis, and Friden.
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We affirm the rejection of claim 12 under 35 U.S.C. § 103(a) over
Yeshurun, Pettis, and Rosenberg.
TIME PERIOD FOR RESPONSE
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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