Yong Dai et al.

Patent Trials and Appeals Board

Aug 29, 2019

11787381 - (D) (P.T.A.B. Aug. 29, 2019)

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.
11/787,381 04/16/2007 Yong Dai AM102516 2636
25291 7590 08/29/2019
Pfizer Inc.
Attn:Legal Patent Department, Chief IP Counsel
235 East 42nd Street
NEW YORK, NY 10017
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
08/29/2019 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):
~IPGSMadisonDocketing@pfizer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte YONG DAI, ALAN M. GOLDBERG, MICHAEL A. GOODE,
RAYMOND ALAN BARTOLUCCI, and JAMES O. FRAZIER1
__________

Appeal 2018-004817
Application 11/787,381
Technology Center 1600
__________

Before ERIC B. GRIMES, DEBORAH KATZ, and RYAN H. FLAX,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition for lubricating a solid dosage form, 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 “Wyeth, LLC (formerly
called ‘Wyeth’), which is a wholly owned entity of Pfizer Inc.” Appeal
Br. 3.
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STATEMENT OF THE CASE
The Specification states that compounds like magnesium stearate are
commonly used to facilitate tableting of pharmaceutical compositions. Spec.
¶ 2. However, “use of magnesium stearate as a lubricant does have several
disadvantages.” Id. ¶ 3. “The present invention provides a composition
comprising a matrix with embedded liquid lubricants. The embedded liquid
lubricants serve to provide lubrication for tableting of the composition.” Id.
¶ 14.
Claims 52–54 are on appeal and read as follows:
52. A composition for lubricating a solid dosage form
comprising an embedded lubrication matrix consisting
essentially of vitamin E dispersed in an admixture of starch and
maltodextrin and optionally a processing aide, wherein the
weight ratio of vitamin E to the admixture of starch and
maltodextrin is 1:1 and further the solid dosage form is free of
stearate.

53. The embedded lubrication matrix composition of
claim 52, wherein the embedded lubrication matrix contains a
processing aide.

54. The embedded lubrication matrix composition of
claim 53, wherein the processing aide is silicon dioxide.

DISCUSSION
The Examiner has rejected claims 52–54 under 35 U.S.C. § 103(a) as
obvious based on Chen2 and Schmidt.3 Final Action4 5. The Examiner finds

2 US 2002/0127303, pub. Sept. 12, 2002.
3 US 4,603,143, iss. July 29, 1986.
4 Office Action mailed March 22, 2017.
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that Chen discloses “a powder composition for vitamin tablets comprising a
matrix of vitamin E dispersed in an admixture of ‘starch’ (e.g. modified food
starch) and maltodextrin.” Id. at 6. The Examiner finds that, in Chen’s
composition, “the vitamin E (i.e. the fat-soluble substance) can be present in
an amount of up to about 40 wt%; the admixture of ‘starch’ and maltodextrin
is present in the amount of about 40%.” Id.
The Examiner finds that Chen does not “disclose that the weight ratio
of vitamin E to the admixture of ‘starch’ and maltodextrin is 1:1, and that the
composition further comprises silicon dioxide.” Id. However, the Examiner
finds that Schmidt discloses “a powder composition for vitamin tablets
comprising a matrix of 40–60 wt% vitamin E and a silicon material,
specifically silicon dioxide,” and discloses that “a more stable and free-
flowing vitamin E powder can be prepared by employing at least 40 wt%
vitamin E with silicon dioxide as a processing aide.” Id. at 6–7.
The Examiner concludes that it would have been obvious
to employ about 40 wt% vitamin E with silicon dioxide in the
Chen et al. composition, with the reasonable expectation of
success that the resulting vitamin E powder will be more stable
and free-flowing. The resulting vitamin E powder will thus
contain about 40 wt% vitamin E and about 40 wt% of the
admixture of “starch” and maltodextrin; thus, the weight ratio
of vitamin E to the admixture of “starch” and maltodextrin is
about 1:1.
Id. at 7.
We agree with the Examiner that the composition of claim 52 would
have been obvious based on the cited references. Chen discloses
compositions comprising a fat-soluble substance (1–40 wt %) and an
emulsifier (0.1–30 wt %), “encapsulated in a carbohydrate matrix composed
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of maltose or maltose syrup, or a mixture of low-molecular weight
carbohydrates, optionally in combination with 0.1 wt% to about 50 wt% of a
high-molecular weight carbohydrate.” Chen ¶ 6.
The fat-soluble substance can be a vitamin, such as vitamin E. Id. ¶ 7.
The high-molecular weight carbohydrate can be “maltodextrin, which, when
present, is used at a level of 0.1 wt % to about 50 wt %.” Id. ¶ 11. Suitable
emulsifiers include a “chemically modified starch obtainable . . . under the
tradename CAPSUL.” Id. ¶ 13.
The compositions disclosed by Chen thus include those that comprise
vitamin E as the fat-soluble substance (1–40 wt %) and CAPSUL (a
modified starch) as the emulsifier (0.1–30 wt %), encapsulated in a
carbohydrate matrix comprising maltodextrin as the high molecular weight
carbohydrate (0.1–50 wt %), as well as maltose.
The combined weight percent of modified starch, as emulsifier (0.1–
30 wt %), and maltodextrin (0.1–50 wt %) is 0.2–80 wt %, and therefore
includes the full range of 1–40 wt % vitamin E disclosed by Chen. Thus,
Chen’s ranges include, and would have made obvious, amounts that would
result in a 1:1 ratio of vitamin E and the admixture of starch and
maltodextrin. “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).
Although Chen states that “stearyl and oleyl esters” are suitable
emulsifiers (Chen ¶ 13), it does not disclose a requirement for stearate, and
thus makes obvious a composition free of stearate. Taken as a whole, Chen
therefore would have made obvious the composition of claim 52.
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Schmidt discloses “a free-flowing, fat-soluble vitamin-containing
powder which has improved stability comprising: (a) at least one fat-soluble
vitamin material, and (b) a silicon containing material predominately in the
form of substantially discrete agglomerates.” Schmidt 1:38–43. “[T]he
resulting powders contain from about 40 to 60 percent by weight activity.”
Id. at 3:11–12. Schmidt discloses that its “preferred embodiment . . . is a
free-flowing, substantially non-agglomerated . . . , high density vitamin E
powder.” Id. 2:50–53. Schmidt exemplifies compositions comprising
vitamin E and hydrated silicon dioxide. See, e.g., id. at 4:12–28.
Based on the teachings of Chen and Schmidt, it would have been
obvious to include silicon dioxide in Chen’s vitamin E composition to get a
free-flowing powder with improved stability, as disclosed by Schmidt. The
combined references therefore would have made obvious the compositions
of claims 53 and 54.
Appellants argue that “this application has been previously appealed”
and, “[t]he PTAB decision with regard to claims 52–54 was a complete
reversal of the examiner’s rejection of those claims.” Appeal Br. 9–10.
Appellants argue that “[b]ased on MPEP 1214.04, the PTAB reversal
brought those claims up for immediate action. . . . ; however, the Examiner
did not immediately allow those claims.” Id. at 10. Appellants thus argue
that “[t]he new 35 U.S.C. §103(a) rejection of claims 52–54 under the Chen
and Schmidt references is not consistent with the PTAB’s decision regarding
those claims.” Id. at 10–11.
This argument is unpersuasive. As Appellants acknowledge, the
“previous 35 U.S.C. §103(a) rejection [was] over the cited references of
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Cherukuri in view of Schmidt [] and Valentine.” Id. at 9. The rejection on
appeal now, based on Chen and Schmidt, is therefore not inconsistent with
the previous reversal of a rejection based on different evidence.
Appellants also argue that “Chen discloses a preferred composition in
which fat-soluble vitamin, an emulsifier and an antioxidant are encapsulated
in a carbohydrate matrix. Chen’s specification does not describe how the
ingredients are encapsulated. The dictionary definition of ‘encapsulate’ is ‘to
enclose in or as if in a capsule.’” Appeal Br. 12. Appellants argue that the
“embedded lubrication matrix” of the claims is described in the
Specification as an oily liquid finely dispersed in an oil insoluble material,
where the matrix appears to be dry, not oily, and is free-flowing. Id. at 12–
13. Appellants argue that the recited “embedded lubrication matrix would
not have been obvious to one of skill in the art based on Chen’s disclosure of
an oil-in-water emulsion which is encapsulated in a carbohydrate matrix.”
Id. at 13.
This argument is not persuasive. Chen describes a method of making
its compositions as follows:
Generally the low-molecular weight carbohydrates optionally in
combination with high-molecular weight carbohydrates [e.g.,
maltodextrin] are first dissolved in water. . . . Then the
antioxidant and the emulsifier [e.g., CAPSUL] are added. The
so called carbohydrate matrix is obtained in this manner. Then,
the fat soluble substance [e.g., vitamin E] . . . is mixed with an
antioxidant, if desired, and the resulting mixture is gradually
added to the aqueous phase while the mixture is homogenized
with a mixer to form an oil in water emulsion. . . .
The conversion of a thus-manufactured emulsion into a dry
powder can be effected by methods known in the art, e.g., by
spray drying.
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Chen ¶¶ 18–19.
Thus, Chen describes forming a carbohydrate matrix that includes a
high-molecular weight carbohydrate such as maltodextrin and an emulsifier
such as CAPSUL (a modified starch), then adding vitamin E while mixing to
form an oil-in-water emulsion, which is spray dried. Appellants have not
shown, by evidence or sound technical reasoning, that the claimed
embedded lubrication matrix differs structurally from Chen’s composition.
Appellants also argue that the “claimed composition is free of
stearate. . . . [T]he term ‘stearate’ is not mentioned in Chen’s disclosure. It
would not have been obvious to one of skill in the art to prepare Applicants’
composition which does not contain stearate based on Chen’s disclosure.”
Appeal Br. 13.
This argument is not persuasive. The fact that Chen does not mention
stearate in its disclosure is evidence that there would have been no reason to
include stearate in Chen’s composition. The lack of any expressed need for
stearate would have made obvious a composition free of stearate based on
Chen’s disclosure.
Appellants also argue that
Schmidt’s composition is a powder containing only the fat-
soluble vitamin and a silicon-containing absorbent material. . . .
The particulate material containing silicon used by Schmidt is
not used as a processing aide in combination with other
ingredients. It would not have been obvious to one of skill in
the art to combine Chen’s oil-in-water emulsion with Schmidt’s
fat-soluble vitamin and silicon absorbent material to prepare
Applicants’ embedded lubrication matrix.
Appeal Br. 13. Appellants conclude that “[t]he Examiner has erroneously
reached a conclusion of obviousness by viewing the prior art from the
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perspective of one who already knows the claimed invention, rather than as
one of ordinary skill in the art at the time of the invention.” Id. at 14.
This argument is not persuasive. Schmidt discloses that combining a
fat-soluble vitamin, such as vitamin E, with a silicon-containing material,
such as silicon dioxide, results in “a free-flowing, fat-soluble vitamin-
containing powder which has improved stability.” Schmidt 1:38–40.
Schmidt therefore supports a reasonable expectation that including silicon
dioxide in Chen’s composition (a vitamin E-containing powder) would also
result in a free-flowing powder with improved stability. Appellants have not
provided evidence or persuasive technical reasoning to show otherwise.
Finally, Appellants argue that they “have claimed silicon dioxide as
an optional processing aide.” Reply Br. 7. Appellants argue that the
Specification “states, ‘Typically, the processing silicon dioxide processing
aid would be included in an amount of about 0.2 to 2.5%.’” Id. (quoting
Spec. ¶ 52). In contrast, Appellants argue, “silicon dioxide is not a mere
processing aid in the Schmidt ’143 composition; it is a main ingredient of
the composition.” Id.
This argument is also unpersuasive. The claims do not recite any limit
on the amount of processing aid(e) or silicon dioxide that may be included in
the claimed composition. Nor have Appellants pointed to any definition in
the Specification that would justify interpreting the claim language to
impose a cap on the amount of silicon dioxide: the Specification’s statement
that silicon dioxide would “typically” be included in certain amounts does
not mean that amounts outside the recited range are not encompassed by the
claim language.
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SUMMARY
We affirm the rejection of claims 52–54 under 35 U.S.C. § 103(a)
based on Chen and Schmidt.
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