Ex Parte Lynch et al

Patent Trials and Appeals Board

Jun 21, 2019

12676819 - (D) (P.T.A.B. Jun. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/676,819 11/22/2010
61275 7590 06/25/2019
The Marbury Law Group, PLLC
11800 Sunrise Valley Drive
15THFLOOR
Reston, VA 20191
FIRST NAMED INVENTOR
Roland M. Lynch
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.
9058-104 5377
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
06/25/2019 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):
ptonotices@marburylaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROLAND M. LYNCH and LW ANDIKO E. MASINDE 1
Appeal2018-003929
Application 12/676,819
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER,
and RACHEL H. TOWNSEND, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134(a) involving claims to
anesthetic compositions 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 Capsulated Systems, Inc.
Appeal Br. 2.
2 We have considered and herein refer to the Specification of Mar. 5, 2010
("Spec."); Final Office Action of Aug. 1, 2016 ("Final Act."); Appeal Brief
of Aug. 30, 2017 ("Appeal Br."); Examiner's Answer of Dec. 28, 2017
("Ans."); and Reply Brief Feb. 28, 2018 ("Reply Br.").
Appeal2018-003929
Application 12/676,819
STATEMENT OF THE CASE
Pain management may involve the use of local anesthetics as well as
opiates and over-the-counter pain relievers. Spec. 1-2. The Specification
describes compositions and methods for using local anesthetics for extended
pain relief. Spec. 2.
Claims 70-89 are on appeal. Claim 70 is representative of the
rejected claims and reads as follows:
70. A composition for prolonged release of local anesthetic and
reduced side effects in long-term local pain relief consisting
essentially of:
a plurality of microparticles having a microparticle size
of from about 20 microns to about 150 microns,
wherein substantially each of the microparticles comprise
one or more local anesthetic compounds,
wherein the plurality of microparticles comprises at least
two groups of microparticles which are different from each
other,
wherein at least one of the groups of microparticles
comprise at least one polymer for controlling the release of the
local anesthetic compound which has a molecular weight of at
least 57,600 Daltons and further comprise the one or more local
anesthetic in an amount of at least about 70% by weight,
wherein the composition further comprises at least one
other group of microparticles of pure local anesthetic compound
with a drug loading of 100%, and
wherein the composition is substantially free of an
augmentation agent adapted to extend the pain relief of the local
anesthetic compound, and
wherein the average amount of local anesthetic
compound in the composition is at least about 50% by weight.
2
Appeal2018-003929
Application 12/676,819
Claims 70-89 have been rejected under 35 U.S.C. § I03(a) as
unpatentable over Chasin, 3 Sackler, 4 and Smith. 5
DISCUSSION
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the claims would have been obvious over Chasin combined with Sackler and
Smith.
The Examiner finds that Chasin discloses a composition comprising a
plurality of microparticles wherein the microparticles comprise at least 70%
by weight of one or more local anesthetics. Final Act. 4. The Examiner
finds that Chasin teaches that the composition can be substantially free of an
augmentation agent. Id. The Examiner finds that Chasin teaches that the
microparticles can comprise 60% to about 85% local anesthetic and a
biocompatible biodegradable polymer where the polymer has a molecular
weight of from 40 kDa to 120 kDa. Id. The Examiner finds that Chasin
teaches that the composition can comprise two different groups of
microparticles and that the composition can comprise both an immediate
release form and a prolonged release form. Id. at 5.
The Examiner finds that Sackler teaches a controlled release local
anesthetic composition comprising micro spheres. Id. at 7. The Examiner
finds that Sackler teaches that the composition can comprise both an
immediate release form as well as a prolonged release form. Id.
3 Chasin et al., US2003/0I52637 Al, published Aug. 14, 2003 ("Chasin").
4 Sackler et al., US 6,699,908 B2, issued Mar. 2, 2004 ("Sackler").
5 Smith et al., US 6,194,000 Bl, issued Feb. 27, 2001 ("Smith").
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Application 12/676,819
The Examiner finds that Smith discloses a therapeutic pain relief
composition. Id. at 8. The Examiner finds that Smith teaches that a suitable
immediate release composition may comprise only the active agent. Id.
The Examiner concludes
It would have been prima facie obvious to a person of
ordinary skill in the art at the time the present invention was
made to include [ a pure local anesthetic compound with] the
drug loading of 100% because Sackler et al. teach controlled
release local anesthetic formulations prepared, e.g., in the form
of injectable microspheres, provide both immediate local
anesthesia after administration, and provide greatly enhanced
safety. Thus, the controlled release formulations according to
the invention release enough local anesthetic, in vivo, to
provide a normal onset of local anesthesia. However, in an
unexpected benefit, the same controlled release local anesthetic
formulations fail to cause the expected toxic results when
injected into test animals in what would otherwise be toxic
amounts. (column 2, lines 56-67). Therefore, the present
invention provides for safe regional local anesthesia at a site in
a patient, by administering at the site a local anesthetic
incorporated in a biocompatible, biodegradable, controlled
release formulation where the site of administration is located at
or adjacent to a nerve or nerves innervating a region of the
patient to be so anesthetized.
One of ordinary skill in the art would have been
motivated to include the pure local anesthetic in immediate
release form in order to achieve an immediate relief of pain as
described by Sackler et al. and one of ordinary skill in the art
would have been motivated to include the immediate release of
the pure drug just by adding the pure drug particles because as
an alternative Smith et al. teach . . . A suitable immediate
release (IR) form of the NMDA receptor antagonist which is a
drug used to treat pain may simply be particles of the antagonist
or particles of the antagonist admixed with soluble components.
Id. at 9-10.
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Appeal2018-003929
Application 12/676,819
Findings of Fact
We adopt the Examiner's findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF 1. Chasin teaches the preparation of pharmaceutical preparations
which provide localized analgesic effect comprising a "pharmaceutically
acceptable biocompatible biodegradable carrier containing a local anesthetic
and the parenteral administration of such carrier in a manner such that a
localized analgesic effect is attained for a prolonged period of time." Chasin
Abstract.
FF2. Chasin teaches that the biocompatible polymer can have a
molecular weight of from 40 kDa to 120 kDa. Chasin ,r 11.
FF3. Chasin teaches that the microparticles may comprise from 60%
to 85% by weight local anesthetic. Id.
FF4. Chasin teaches that the composition may also comprise a dose
of local anesthetic in immediate release form. Id. ,r ,r 13 and 22.
FF5. Chasin teaches
In certain preferred embodiments, the duration of local
analgesia is at least about 2 days, optionally the duration can be
from about 2 to about 7 days after administration. In certain
other preferred embodiments, the duration of local analgesia is
from about 2 to about 4 days, or from about 3 to about 5 days,
or from about 4 to about 7 days after administration.
Id. ,I 12.
FF6. Chasin teaches
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Appeal2018-003929
Application 12/676,819
In other preferred embodiments, the formulations do not
include an effective amount of an augmenting agent and
provide a measurable change in sensory responses at the site of
administration in a human patient for a time period from about
1 day to about 3 days after administration. Opionally [sic] the
formulations contain no augmenting agent.
Id. ,T 21.
FF7. Chasin teaches "[t]he mean diameter of injectable microcapsules
or microspheres is in a size range, for example, from about 5 microns to
about 200 microns in diameter. In a more preferred embodiment, the
microcapsules or microspheres range in mean diameter from about 20 to
about 130 microns." Id. iT 116.
FF8. Sackler discloses a composition comprising a local anesthetic
and a biocompatible biodegradable controlled release material. Sackler
Abstract.
FF9. Sackler teaches that the composition can be in the form of
microspheres having a size range of from 5 to 200 microns. Id. col. 6, 11.
27--44.
FFlO. Sackler teaches
A desired release profile can be achieved by using a
mixture of polymers having different release rates and/or
different percent loading of local anesthetic and/or augmenting
agent, for example, polymers releasing in one day, three days,
and one week, so that linear release is achieved even when each
polymer per se does not release linearly over the same time
period. In addition, a mixture of microspheres having one or
more different local anesthetic agents, having the same or
different controlled release profile, can be utilized to provide
the benefits of different potencies and spectrum of activity
during the course of treatment.
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Application 12/676,819
Id. col. 8, 11. 15-26.
FF 11. Sackler teaches that the composition may comprise a portion
that is an immediate release form of local anesthetic to release enough local
anesthetic to provide a normal onset of local anesthesia. Id. col. 20, 11. 58-
59 ( claim 2); id. col. 9, 11. 24--26, id. col. 2, 11. 55---64.
FF12. Smith discloses a method for treating pain comprising
administering an analgesic composition comprising both an immediate
release form and a sustained release form of an NMDA receptor antagonist.
Smith Abstract.
FF 13. Smith teaches that the immediate release form of the
composition may simply be particles of the active agent. Id. col. 3, 11. 29-
32.
FF14. Smith teaches
The particle size of the IR [immediate release] and SR
[ sustained release] dosage form depends on the technology
used. The particle sizes component range from the submicron
to 500 µm for powder technologies (mixtures, spray drying,
dispersions etc), 5-1700 µm for coating technologies (wurster,
top spray, bottom spray, spray drying, extrusion, layering etc),
to 1-40 mm for tabletting technologies.
Id. col. 4, 1. 66-col. 5, 1. 5.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
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Application 12/676,819
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
We find the Examiner has established that the subject matter of the
claims would have been obvious to one of ordinary skill in the art at the time
the invention was made over Chasin combined with Sackler and Smith.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner's determinations on obviousness are incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015). We have identified claim 70 as representative;
therefore, all claims fall with claim 70. We address Appellants' arguments
below.
Appellants contend that the references do not teach or suggest the
claim elements "wherein the composition further comprises at least one
other group of microparticles of pure anesthetic with a drug loading of
100%" and "a microparticle size of from about 20 microns to about 150
microns." Appeal Br. 5. Appellants contend that the Examiner concedes
that Chasin does not teach the 100% loading in combination with the
microparticle size. Id. Appellants argue that the remaining references,
Sackler and Smith, do not teach this claim requirement as well. Specifically,
Appellants contend that Sackler teaches compositions comprising at most
95% anesthetic and that Smith is directed to NMDA receptor antagonists and
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Application 12/676,819
not local anesthetics. Id. at 5---6. Appellants also contend that Smith does
not each or suggest the limitation calling for a microparticle size of from 20
microns to 150 microns. Id. at 6.
We have considered Appellants' arguments and are not persuaded.
"In determining whether obviousness is established by combining the
teachings of the prior art, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations
omitted). "A prima facie case of obviousness typically exists when the
ranges of a claimed composition overlap the ranges disclosed in the prior
art." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Each of the references teach compositions for treating pain
comprising an immediate release component and a sustained release
component. FF 1, 4, 10, 11, and 12. Smith teaches that the immediate
release form can comprise solely the active agent and that the particle sizes
for both the immediate release form and the sustained release form can range
from submicron to 500 microns. FF13 and 14. Chasin and Sackler both
teach microparticles can range in size from 5 to 200 microns. FF7 and 9.
Thus, while the pain medication may be different in Smith than what is
described in Chasin and Sackler, the references, nevertheless, teach that
various pain medications can be prepared in overlapping microparticle size
ranges for immediate release. Appellants' have not provided evidence or
otherwise established that the processes described in Smith cannot be used to
achieve the microparticle range for an NMDA receptor agonist cannot also
be used to achieve those particle sizes for the local anesthetics described in
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Application 12/676,819
Chasin and Sackler. Thus, given the specific teachings of Smith that the
immediate release form can comprise only the active agent and the
overlapping particle sizes taught by all three references, we agree with the
Examiner that the references do render obvious the 100% loading of local
anesthetic in combination with the claimed particle size .
Appellants contend that the references do not provide a motivation to
combine the reference and do not provide a reasonable expectation of
success. Appeal Br. 6. Appellants contend that the references do not give
sufficient guidance as to the specific parameters to use to reach the claims
invention. Appellants argue that Chasin's preferred molecular weight for the
polymer component is from 20,000 to 50,000 which is below the claimed
range. Id. at 7. Appellants also argue that while Chasin provides examples
using 40,000, 80,000 and 120,000 molecular weight polymers, Chasin does
not point to any advantage in using the higher molecular weight polymers.
Id.
We are not persuaded by Appellants' arguments. While Chasin may
refer to polymers having a molecular weight of from 20,000 to 50,000,
Chasin also teaches that the molecular weight range can be from 5 kDA to
about 200 kDA (Chasin ,r 118) as well as teaching specifically that polymers
with a molecular weight of from 40kDa to 120kDa can be used in the
disclosed composition (FF2), and provides specific examples of such
particles (Chasin Examples 1--4) and their release of local anesthetic (see
e.g., id. i-fi-f503-509). When determining obviousness, "the prior art as a
whole must be considered. The teachings are to be viewed as they would
have been viewed by one of ordinary skill." In re Hedges, 783 F.2d 1038,
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Application 12/676,819
1041 (Fed. Cir. 1986). Expressed preference for certain embodiments within
a disclosed genus does not teach away from rest of embodiments within
genus. In re Susi, 440 F .2d 442, 446 n.3 (CCP A 1971 ).
As with the particle size limitation, the overlapping molecular weight
ranges establish a prima facie case of obviousness. While Appellants have
offered an argument regarding the alleged deficiency of polymers with
molecular weights of 7,400 and 28,500, Appellants have not established that
those deficiencies are applicable to the higher molecular weight polymers
taught by Chasin. Appeal Br. 7.
Appellants also argue that the Examiner's reasoning for combining
the references is based on hindsight. Appeal Br. 8. Appellants contend that
Smith is related to a different drug system and only provides an effect for 24
hours. Id. Appellants contend that only through the impermissible use of
hindsight would one skilled in the art combine the references. Id.
While we agree with Appellants that Smith is not directed to the use
of a local anesthetic, we do not agree that one skilled in the art would not
look to Smith to develop the claimed invention. Like Chasin and Sackler,
Smith is directed to relieving pain using both an immediate release form of a
drug and a prolonged release form of a drug. FFl, 4, 10, 11, and 12. Smith
teaches that the immediate release form can comprise solely the active agent.
FF13. We agree with the Examiner that it would have been obvious to apply
the teachings of Smith to the compositions of Chasin to develop a
composition meeting the limitation of the present claims. "[I]f a technique
has been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
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Application 12/676,819
using the technique is obvious unless its actual application is beyond his or
her skill." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,417 (2007).
With respect to the application of hindsight, as demonstrated above,
the elements of the invention can be found in the references as well as a
motivation to combine the references. Appellants have not pointed to any
specific teaching in the present Specification that is not found in the cited
references. See Appeal Br. 8. "Any judgment on obviousness is in a sense
necessarily a reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of ordinary
skill at the time the claimed invention was made and does not include
knowledge gleaned only from applicant's disclosure, such a reconstruction is
proper." In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Appellants next argue that Chasin teaches away from the claimed
invention. Appeal Br. 8. Appellants contend that the present invention is
directed to a composition for long-term pain relief without the need for
augmentation agents. Id. Appellants contend that Chasin teaches that
compositions without augmentation agents can prolong pain relief for only
three days and that augmentation agents are needed to extend relief beyond
three days. Id. at 9. Appellants contend that through this teaching Chasin
"criticizes, discredits, and discourages attempts to achieve long-term pain
relief without use of augmentation agents." Id. Appellants contend that
neither Sackler nor Smith teach compositions which provide long-term pain
relief. Id. at 10.
We are not persuaded that the references teach away from the claimed
invention.
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Application 12/676,819
The term long-term local pain relief appears in the preamble and is
directed to an intended use of the recited composition, as such it does not
constitute a limitation. "Where ... a patentee defines a structurally
complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention, the preamble is not a claim
limitation." Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 70 would have been
obvious over Chasin combined with Sackler and Smith.
Claims 71-89 have not been argued separately and therefore fall with
claim 70. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
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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