Ex Parte Tabuteau

Patent Trial and Appeal Board

Jul 19, 2016

13468215 (P.T.A.B. Jul. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/468,215 05/10/2012 Herriot Tabuteau
45200 7590 07/21/2016
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1958603.00002 8920
EXAMINER
TCHERKASSKAYA, OLGA V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
07/21/2016 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HERRIOT T ABUTEAU
Appeal2015-001700
Application 13/468,215
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
RICHARD J. SMITH, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1 and 14--29
(Final Rej. 2). 2' 3 Examiner entered rejection under 35 U.S.C. § 103(a).
1 Appellant identifies the Real Party in Interest as "Antecip Bioventures II
LLC" (App. Br. 3).
2 In response to a Restriction Requirement Examiner withdrew then pending
claims 1-13 from consideration (see May 16, 2013 Office Action 2; cf see
December 21, 2012 Office Action). Nevertheless, Examiner subsequently
withdrew the restriction requirement as to claim 1 and included claim 1 in
the statement of the obviousness rejection (see May 16, Office Action 3).
Examiner subsequently made it clear that "[ c ]laims 1 and 14--29 [were]
currently under consideration" (see September 27, 2013 Office Action).
Therefore, notwithstanding Appellant's notation that claim 1 stands
withdrawn (see App. Br. 14); claim 1 is before this panel for review.
3 Pending claims 3, 7, and 12 stand withdrawn from consideration.
Appeal2015-001700
Application 13/468,215
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The claims are directed to: (a) an implantable device comprising a
solid biocompatible and non-biodegradable polymer matrix and sufentanil
encapsulated within the polymer matrix (see Appellant's Claim 1) and (b) a
method of (i) treating pain or opioid addiction for an extended duration after
a single administration of sufentanil or (ii) providing a constant serum
concentration of sufentanil for an extended duration, comprising, inter alia,
implanting one or more devices according to [Appellant's] claim 1 into the
body of a human (see Appellant's Claims 14 and 18). Claims 1, 14, and 18
are representative and reproduced in the Claims Appendix of Appellants'
Brief.
Claims 1 and 14--29 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Johnson; 4 Elklloury; 5 and Gibson. 6
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Gibson relates to "prolonged release devices for delivery of
pharmaceuticals where there is a critical need for uniform, zero-order release
kinetics" (Gibson i-f 3; see generally Ans. 4 ).
4 Johnson et al., US 2003/0171401 Al, published Sept. 11, 2003.
5 Elkhoury, US 5,919,473, issued July 6, 1999.
6 Gibson et al., US 2003/0007992 Al, published Jan. 9, 2003.
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Application 13/468,215
FF 2. Gibson discloses, in a preferred embodiment, the delivery of "a drug
such as a narcotic analgesic, which is very potent, and where the dosage
must be narrowly maintained within the safe and effective levels," such as
"sufentanil" (Gibson i-f 44; see Final Rej. 4; Ans. 4).
FF 3. Gibson discloses a device comprising a drug, such as sufentanil,
encapsulated within a rate-controlling polymer matrix, i.e., a membrane
polymer (Gibson i-fi-123-25; see generally Ans. 5---6).
FF 4. While Gibson prefers the polymer matrix to be biodegradable,
Gibson's disclosure is not limited to biodegradable polymer matrices, but
instead encompasses both biodegradable and non-biodegradable polymer
matrices (see Gibson i-f 35; id. at 7: Claims 34 and 36; see also id. at 7:
Claims 39, 42, and 51; Final Rej. 6; Ans. 5).
FF 5. Gibson discloses "[s]uitable materials that can be added to the
membrane[,i.e. matrix,] polymer to achieve the desired porosity" to, inter
alia, "alter release rates[ and] increase water uptake" (Gibson i-f 48; see
generally Ans. 5).
FF 6. Gibson's devices are for implantation into a human being such "that
the drug is released in the desired dosage over a defined period of time"
(Gibson i-fi-150 and 52; see id. 7: claims 42 and 51; see generally Ans. 5-6).
FF 7. Johnson discloses implantable "devices and methods for the
systemic delivery of ... [sufentanil] to treat pain" and, inter alia, treat
opioid dependence (Johnson Abstract; id. i-fi-19, 17, 63, and 81; see Final Rej.
3 and 6-7; Ans. 3).
FF 8. Johnson discloses that the
[ s ]pecific ranges of amount of drug delivered will vary
depending upon, for example, the potency and other properties
of the drug used and the therapeutic requirements of the subject.
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Application 13/468,215
In one specific embodiment, the formulation comprises
sufentanil and, in a specific embodiment, is delivered at a rate
of from about 0.01 µg/hr or 0.1µg/hr,0.25 µg/hr, 1 µg/hr,
generally up to about 200 µg/hr.
(Johnson i-f 13; id. i-f 15 ("delivery of the formulation is substantially
continuous, and can be for a pre-selected administration period ranging from
several hours to years, preferably from about 4 weeks to 12 months"); see
Final Rej. 3 and 7; Ans. 3.)
FF 9. Elkhoury "relates to a method, compositions, and apparatus for relief
of pain (Elkhoury 1: 7-8; see generally Final Rej. 3--4; Ans. 6).
FF 10. Elkhoury discloses an "opioid analgesic compris[ing] an opioid
agonist," such as "sufentanil" (Elkhoury 7: 42--46; see Final Rej. 3; Ans. 8).
FF 11. Elkhoury' s apparatus, or device, may be in the form of implantable
pellets, wherein several pellets may be implanted into a human (see
generally Elkhoury 13: 26-27; see Final Rej. 3 and 7; Ans. 8).
FF 12. Elkhoury discloses "that the amount of opioid analgesic agent
necessary to produce an effect at the peripheral receptor is based on, or
related to, the size of the area and the condition which is to be treated"
(Elkhoury 11: 49-52; see generally id. at 11: 49- 12: 4; see generally Final
Rej. 4 and 7-8; Ans. 8).
ANALYSIS
Based on the combination of Johnson, Elkhoury, and Gibson,
Examiner concludes that, at the time Appellant's invention was made, it
would have been prima facie obvious to: (1) produce an implantable device
comprising a biocompatible and non-biodegradable polymer matrix and
sufentanil encapsulated within the polymer matrix, as suggested by Gibson,
wherein the polymer matrix comprises a plurality of pores configured to
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Appeal2015-001700
Application 13/468,215
allow contact between the sufontanil and a physiological fluid of a mammal
into which the device is implanted to thereby release sufentanil in vivo from
the device into the mammal, wherein the implantable device is configured to
achieve contact between a physiological fluid and sufentanil inside the
polymer matrix by entry of the physiological fluid through the pores of the
device, as is required by Appellant's Claim 1; and (2) use the device
suggested by the combination of Johnson, Elkhoury, and Gibson in a method
of (i) treating pain or opioid addiction for an extended duration after a single
administration of sufentanil as required by Appellant's Claim 14, or (ii)
providing a constant serum concentration of sufentanil for an extended
duration, comprising, inter alia, implanting one or more devices into a
human being, as required by Appellant's Claim 18. See FF 1-12.
We find that the combination of Johnson, Elkhoury, and Gibson
makes clear that the amount of sufentanil released by the device is a results-
effective variable, which would be determined by a practitioner of ordinary
skill in this art (see, e.g., FF 3, 5, 6, 8, and 12). "[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation." In re
Aller, 220 F.2d 454, 456 (CCPA 1955).
We recognize, but are not persuaded by, Appellant's contention that
Gibson fails to suggest a polymer matrix comprising pores that falls within
the scope of Appellant's claimed invention (see App. Br. 7-8; Reply Br. 3-
4; cf FF 4; see generally FF 1---6). In this regard, we are not persuaded by
Appellant's contention that "Gibson teaches away from a non-biodegradable
implant" (App. Br. 8; cf FF 4). We are also not persuaded by Appellant's
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contention that "Gibson's membrane is not configured to encapsulate
sufentanil" (Reply Br. 4; cf FF 3; see generally FF 1---6).
We recognize, but are not persuaded by, Appellant's contention that
Johnson teaches away from Appellant's claimed invention simply because it
teaches a delivery device that differs from Gibson's (App. Br. 7; cf FF 1-8;
see Reply Br. 6 ("each reference[, relied upon by Examiner,] appears to be
directed to methods of solving the same technical problem: the long term
delivery of pain medication at very slow dissolution rates. However, each
reference approaches the problem in a different way")). Given that Gibson
teaches a device within the scope of Appellant's claimed invention, we are
not persuaded that the combination of Gibson with Johnson would render
Johnson's device inoperable for its intended purpose (see App. Br. 8-12; see
Reply Br. 3-7). To the contrary, Johnson suggests dosage amounts of
sufentanil for methods of treating conditions falling within the scope of
Appellant's claims 14 and 18 (FF 7-8). Thus, as discussed above, a person
of ordinary skill in this art would have reasonably constructed Gibson's
device to provide for the sufentanil dosages operable for the foregoing
methods, which fall within the scope of Appellant's Claims 14 and 18 (see
id.).
For the foregoing reasons, we find no evidence or persuasive
argument on this record to support a conclusion that the combination of
Johnson, Elkhoury, and Gibson, does not, or could not have been optimized
to release sufentanil at the rate required by Appellant's Claims 14 and 18 (cf
App. Br. 12-13). Similarly, we recognize, but are not persuaded by
Appellant's contention that "[t]he Office has mischaracterized the teachings
of the cited references" (Reply Br. 2 (emphasis removed)).
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Having found no deficiency in the combination of Johnson and
Gibson, we are not persuaded by Appellant's contention that Elkhoury fails
to make up for an alleged deficiency in the combination of Johnson and
Gibson (Reply Br. 5---6).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claims 1, 14, and 18 under 35
U.S.C. § 103(a) as unpatentable over the combination of Johnson, Elkhoury,
and Gibson is affirmed. Claims 15-17 and 19-29 are not separately argued
and fall with claim 14.
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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