Ex Parte Bar-Shalom et al

Patent Trial and Appeal Board

Feb 25, 2019

11915655 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/915,655 06/17/2008 Daniel Bar-Shalom
22428 7590 02/27/2019
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
108221-0114 7710
EXAMINER
MATTISON, LORI K
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL BAR-SHALOM and LILLIAN SLOT 1
Appeal2017-007121
Application 11/915,655
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to a coated solid pharmaceutical composition in the form of a single dosage
unit for oral use. Claims 1, 5-11, 13, 17-31, 35, and 37--44 are on appeal as
rejected under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as "Egalet Ltd." Appeal Br.
3.
Appeal2017-007121
Application 11/915,655
STATEMENT OF THE CASE
Independent claim 1 is representative and is reproduced below:
1. A coated solid pharmaceutical composition in the
form of a single dosage unit for oral use, the dosage unit
consisting of one first fraction and one or two second fractions
and being provided with a coating, wherein:
i) the first fraction comprises a therapeutically and/or
prophylactically active substance dispersed in a dispersion
medium that is sufficiently fluid to flow at 3 8 °C, wherein the
active substance comprises from 0.1 to 80% by weight of the first
fraction, and the first fraction has a melting point cut off of at
most 3 8 °C, such that upon exposure by erosion of the second
fraction, the first fraction flows out of the dosage unit,
ii) each second fraction comprises an erodable matrix
comprising a polyethylene oxide having a molecular weight
(MW) of from 20,000 daltons to about 700,000, or a mixture of
a polyethylene oxide having a molecular weight (MW) of from
20,000 daltons to about 700,000 and a block copolymer of
ethylene oxide and propylene oxide having a MW of from about
3,000 to about 30,000 daltons, in an amount from 5-99.9% by
weight of the matrix, wherein the second fraction comprises from
20 to 95% by weight of the dosage unit, not including the weight
of the coating,
wherein, when the dosage unit has two second fractions,
the first fraction is disposed between the two second fractions
and the coating, and, when the dosage unit has one second
fraction, the first fraction is disposed between the coating and the
one second fraction, such that release of the active substance
from the first fraction is delayed for a delay period until the
second fraction erodes, and
wherein the coating has one or two openings exposing one
surface of the matrix of the second fraction, wherein the coating
is insoluble in and impermeable to gastrointestinal fluids.
Appeal Br. 28 (Claims Appendix).
2
Appeal2017-007121
Application 11/915,655
The following rejections are appealed: 2
Claims 1, 5-11, 13, 17-20, 23, 25, 27-31, 35, 37, and 39--44 stand
rejected under 35 U.S.C. § 103(a) over Babcock. 3 Final Action 5.
Claims 1-3, 5-11, 13, 17-20, 23, 25-31, 35, 37, and 39--44 stand
rejected under 35 U.S.C. § I03(a) over Babcock and Tracy. 4 Id. at 12.
Claims 1-3, 5-11, 13, 16-20, 23, 25, 27-31, 35, and 37--44 stand
rejected under 35 U.S.C. § 103(a) over Babcock and Iwata. 5 Id. at 13.
Claims 1-3, 5-11, 13, 17-25, 27-31, 35, 37, and39--44 stand rejected
under 35 U.S.C. § I03(a) over Babcock, Conte, 6 and Okamoto. 7 Id. at 14--
15; see also Answer 14 (clarifying that Okamoto is a part of the prior art
combination).
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief and properly presented
in the Reply Brief have been considered in this Decision; arguments not so-
presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015);
see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
2 A rejection under 35 U.S.C. § 112, first paragraph, was withdrawn.
Advisory Action dated Mar. 10, 2016.
3 US 2001/0053791 Al (published Dec. 20, 2001) ("Babcock").
4 US 2004/0028733 Al (published Feb. 12, 2004) ("Tracy").
5 US 6,458,824 B 1 (issued Oct. 1, 2002) ("Iwata").
6 US 6,183, 778 Bl (issued Feb. 6, 2001) ("Conte").
7 US 6,267,981 B 1 (issued July 31, 2001) ("Okamoto").
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Appeal2017-007121
Application 11/915,655
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
As applicable to the rejections on appeal and Appellants' arguments
there-over, "[t]he combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under§ 103." Id. at 419. "[T]he question is
whether there is something in the prior art as a whole to suggest the
desirability, and thus the obviousness, of making the combination, not
whether there is something in the prior art as a whole to suggest that the
combination is the most desirable combination available." In re Fulton,
391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted). "Patents [and
published applications] are part of the literature of the art and are relevant
for all they contain." In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991).
Where . . . the claimed and prior art products are identical or
substantially identical ... the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on 'inherency' under 35 U.S.C. § 102, on
'prima facie obviousness' under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO' s inability to manufacture products or to
obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted). Moreover, and congruent with the reasoning of In re Best,
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Appeal2017-007121
Application 11/915,655
A patent applicant is free to recite features of an apparatus either
structurally or functionally. See In re Swinehart, 439 F .2d 210,
212 ( CCP A 1971) ("There is nothing intrinsically wrong with
[ defining something by what it does rather than what it is] in
drafting patent claims."). Yet choosing to define an element
functionally, i.e., by what it does, carries with it a risk. As our
predecessor court stated in Swinehart, 439 F.2d at 213:
where the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject
matter shown to be in the prior art does not possess the
characteristic relied on.
In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (internal cites to
CCP A and USPQ reporters omitted).
"Obviousness does not require absolute predictability of success ....
For obviousness under§ 103, all that is required is a reasonable expectation
of success." In re O'Farrell, 853 F.2d 894, 903---04 (Fed. Cir. 1988).
The Examiner determined that the pharmaceutical composition of
claims 1, 5-11, 13, 17-20, 23, 25, 27-31, 35, 37 and 39--44 would have been
obvious over Babcock, as evidenced by Soylnfo 8 and Hydrogenated Palm
Kernel Oil. 9 Final Action 5-12 and Answer 3-11, 16-30 (collectively citing
8 Soy Info Center, History of Soy Oil Hydrogenation and of Research on the
Safety of Hydrogenated Vegetable Oils (2007),
http://www.soyinfocenter.com/HSS/hydrogenation2.php, accessed Aug. 12,
2013 ("Soy Info") ( disclosing that hydrogenated cottonseed oil has a melting
point of 36°C)
9 Kais Group, Hydrogenated Palm Kernel Oil I Welcome to Kais Group,
PBD Palm Oil (2011), http://kaisgroup.us/our-products/palm-oil-
products/hydrogenated-palm-kernel-oil, accessed July 9, 2013
5
Appeal2017-007121
Application 11/915,655
Babcock ,r,r 1, 9, 11-15, 60, 72, 105, 109, 133, 137, 150, 158, 160, 176,
181-185, 197-202, 208,240, 244--246, claim 16; also citing Soyinfo and
Hydrogenated Palm Kernel Oil, generally); see also Babcock, generally, but
specificallyi-fi-f 17, 21-25, 43--47, 50, 56, 106-108, 119,121,135,138,140,
149, 159, 164, 166-174, 177, 186-196, 210,220 (table 1), 234 (further
disclosing relevant subject matter regarding pharmaceutical composition
materials, structural configurations, coatings, manufacture, and
performance). Regarding these same claims, but also claim 26, in particular,
the Examiner determined that the claimed pharmaceutical composition
would have been obvious over Babcock and Tracy. Final Action 12-13 and
Answer 11-13 ( collectively citing Babcock ,r,r 1 72, 173, 187, 245-246;
Tracy abstract, ,r,r 71, 145). Regarding the same claims as the first rejection,
but also claim 3 8, in particular, the Examiner determined the claimed
pharmaceutical composition would have been obvious over Babcock and
Iwata. Final Action 13-14 and Answer 13-14 (collectively citing Babcock
,r 194; Iwata 12:40-55, 12:50-60). Regarding the same claims as the first
rejection, but also claims 21, 22, and 24, in particular, the Examiner
determined that the claimed pharmaceutical composition would have been
obvious over Babcock, Conte, and Okamoto. Final Action 14--16 and
Answer 14--15 ( collectively citing Babcock ,r 1; Conte title, 3: 10-25;
Okamoto title, 13:1---6, 9:10-15, 15:5-25, 16:20--40).
Except as otherwise indicated herein, we discern no error in the
Examiner's determinations on obviousness. Accordingly, except as
("Hydrogenated Palm Kernel Oil") ( disclosing that hydrogenated palm
kernel oil has a "slip melting point" of 36-38°C).
6
Appeal2017-007121
Application 11/915,655
otherwise indicated herein, we adopt the Examiner's findings of fact and
rationale on obviousness. In particular, we agree with the Examiner's
determinations regarding the teachings and suggestions of Babcock and,
based at least on the portions thereof cited by the Examiner, conclude claim
1 would have been obvious there-over.
Moreover, as further findings of fact, upon review of the Examiner-
cited reference, we conclude the disclosure of Babcock teaches and suggests,
inter alia, a pharmaceutical composition, structure, and formulation as
illustrated below:
erodabk: matrix materla.! as a watcr !
solubk plug, e.g., PEO of 50K-6tJOOK !
da!t<)ns \1W' (Babcock~~\ 158, 164, 197) !
,-......._.,......._., ':..:: ........ I
_.~.... ...
r·~~.r~;·;;;;~;·i:·;~~i~·j;;·i~~;~~·,1 .. iw I es:'t;;;~·;~··1
I in coating created using PEO I
i as a pl)re-formcr in Cl)ating i
I ~olntion (Babcllck ~1 187) ~ I
' '·' . '
I hokipnr·!····i·r·i··c···,·l··"··t·i·i·i··~·,·····li, ! (Habcod: 1! 197)
"····_: ....... -········
I ··Drug A" { U).(.,(l wt %,i cn1rapped in excipicn.s, e.g.,
I vtgdabk oils, t.g .. st,ybean oil and !)aim oil (F.laht,ock
!~t [05, l'.B, 135. !37-138. !67-l.74);drugi~
I as.'iociai~xi ·with a comxmtrntion-enham:ing rotymcr. .
.... J e.g., HPMC;:\S, I·ll')vlC. HPC {Babcock ii 47); a$ the
_..- core of a contrnlle