Ex Parte Lee et al

Board of Patent Appeals and Interferences

Jan 17, 2012

11111240 (B.P.A.I. Jan. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte BRIAN CRAIG LEE, STEVEN W. STEINFIELD,
WINTHROP D. CHILDERS, MARK A. VAN VEEN,
and MOHAMMAD M. SAMII
____________

Appeal 2011-005540
Application 11/111,240
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 55, 57-61, 64, 67,
and 89 (App. Br. 5; Reply Br. 2). We have jurisdiction under 35 U.S.C.
§ 6(b).

Appeal 2011-005540
Application 11/111,240

2
STATEMENT OF THE CASE
The claims are directed to an ingestible sheet usable in an apparatus
for manufacturing a pharmaceutical dose. Claim 55
1
is representative and is
reproduced in the “CLAIMS APPENDIX” of Appellants‟ Brief (App. Br.
21).
Claims 55, 61, and 64 stand rejected under 35 U.S.C. § 102(a) as
being anticipated by Jolliffe.
2

Claims 55, 61, and 64 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Jolliffe and Percin.
3

Claims 57-60 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Jolliffe and Sullivan
4
with or without Percin.
Claims 67 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Jolliffe and Hoffman
5
with or without Percin.
Claims 89 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Jolliffe and Childers
6
with or without Percin.
We reverse the rejection under 35 U.S.C. § 102(a).
We reverse the rejection of claim 61 under 35 U.S.C. § 103(a).
We affirm all other grounds of rejection. However, because our
rationale differs from that of the Examiner, we designate our affirmance as a
new ground of rejection.

1
Claims 57-61, 64, 67, and 89 depend directly or indirectly from claim 55.
2
Jolliffe, GB 2 338 896 A, published January 12, 2000.
3
Percin et al., US 6,474,786 B2, issued November 5, 2002.
4
Sullivan et al., US 5,992,742, issued November 30, 1999.
5
F. Hoffmann-La Roche & Co., GB 1 561 100, published February 13,
1980.
6
Childers, US 2002/0187248 A1, published December 12, 2002.
Appeal 2011-005540
Application 11/111,240

3
Anticipation:
ISSUE
Does the preponderance of evidence on this record support the
Examiner‟s finding that Jolliffe teaches the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. For clarity, we reproduce Appellants‟ figures 8a-8c below to
illustrate a sheet having a two-dimensional array of deposits dispensed
thereon as disclosed in Appellants‟ Specification (Spec. 23:12 - 24: 30):

Figures 8a-8c are perspective views of dosage forms according to an
embodiment of Appellants‟ invention (Spec. 4: 31 - 5: 6).
FF 2. Jolliffe teaches a chewable oral dosage unit with multiple reservoirs,
as illustrated in Jolliffe‟s figures 1 and 2, reproduced below:

Appeal 2011-005540
Application 11/111,240

4
“Figure 1 is [a] plan view of an oral unit dosage according to . . . [Jolliffe‟s]
invention; Figure 2 is a[ ] side view cross section (A-A) of an oral unit
dosage according to . . . [Jolliffe‟s] invention” (Jolliffe 9: 3-6; see also
Jolliffe Title).
FF 3. Jolliffe teaches “an oral dosage form . . . comprising multiple
reservoirs that are spatially separated and contain[] liquid medication in each
reservoir” (Ans. 4).
FF 4. Jolliffe teaches that “[t]he dosage form has the advantage that the
reservoirs are filled with at least two different liquid fills” (id.).
FF 5. The Examiner finds that “[t]he reservoirs are inherently two
dimension[al] structures because they have width and height” (id.).
FF 6. The Examiner finds that Jolliffe‟s figures illustrate “two rows of the
active materials” and, since each reservoir has width and height, the figures
illustrate “two adjacent two-dimensional rows” (Ans. 12-13 (emphasis
removed); see also FF 5).
ANALYSIS
We agree with Appellants‟ contention that the Examiner‟s
characterization of the dimensions of Jolliffe‟s individual reservoirs, as
having a height and width, is not relevant to invention of claim 55, which
requires an ingestible sheet comprising a first and second two dimensional
array of deposits (id.; see also App. Br. 12; Cf. FF 1). We also agree with
Appellants‟ contention that “even if the arrangement of [Jolliffe‟s] Figure 1
were divided as the Examiner has suggested, such a division would only
provide two separate rows of reservoirs. As a row is a linear arrangement,
i.e. having only the dimension of length, it does not constitute a two-
dimensional array” (App. Br. 11; Cf. FF 1 and 2). In sum, we agree with
Appeal 2011-005540
Application 11/111,240

5
Appellants‟ contention that Jolliffe‟s teaching that “different reservoirs may
contain different liquid fills” is not a teaching “of separate two-dimensional
arrays as required by Appellants‟ claims” (App. Br. 11; Cf. FF 2-3).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support the
Examiner‟s finding that Jolliffe teaches the claimed invention. The rejection
of claims 55, 61, and 64 under 35 U.S.C. § 102(a) as being anticipated by
Jolliffe is reversed.

Obviousness:
The combination of Jolliffe and Percin:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 7. Percin suggests “a micromachined two-dimensional array droplet
ejector” (Percin, Abstract; Ans. 5 and 17).
FF 8. Percin suggests that “[t]he droplet ejector can be used for inkjet
printing, biomedicine, drug delivery, drug screening, fabrication of biochips,
fuel injection and semiconductor manufacturing” (Percin, col. 4, ll. 43-47;
Ans. 5 and 17).
FF 9. Percin fails to suggest “two dosage forms,” an “ingestible substrate”
or a “backing [o]n the ingestible sheet” (Ans. 6).
FF 10. Jolliffe suggests a dosage form comprising an ingestible substrate,
such as “starch, cellulose derivatives or preferably gelatin” (id.).
Appeal 2011-005540
Application 11/111,240

6
FF 11. Jolliffe‟s dosage form comprises reservoirs that are spatially
separated, wherein the reservoirs may be “filled with at least two different
liquid fills that are incompatible if combined in the same reservoir, for
example two incompatible medicines, or medicine and incompatible
excipient” (Ans. 6 and 17; see also FF2 at Fig. 2).
FF 12. Jolliffe suggests coating the substrate with a cellulose derivative,
such as hydroxyethyl cellulose (Ans. 6).
ANALYSIS
Claim 55:
Based on the combination of Percin and Jolliffe, the Examiner
concludes that it would have been obvious to one of ordinary skill in the art
at the time of the invention to utilize Percin‟s device to produce a dosage
form comprising an ingestible sheet with a bioactive fluid deposited on the
sheet in the form of a two-dimensional array (see Ans. 19; FF 7-10).
We agree with Appellants‟ contention that the Examiner‟s reference
to “[t]he „wells‟ and „substrate‟ of Percin are components of the ejector
itself, not a structure onto which droplets are deposited” (App. Br. 15; Cf.
Ans. 5). Nevertheless, Percin suggests that the device can be used for a
number of purposes including biomedical applications (FF 8). Accordingly,
since Percin‟s device releases droplets from a two-dimensional array, the
droplets released from Percin‟s device and deposited on a substrate will,
absent evidence to the contrary, be arranged in a two-dimensional array (see
FF 7). Thus, the combination of Percin and Jolliffe suggests an ingestible
sheet comprising a first dosage form having a first two-dimensional array of
deposits of a bioactive fluid dispensed thereon.
Appeal 2011-005540
Application 11/111,240

7
Therefore, the issue distills down to whether the combination of
Percin and Jolliffe reasonably suggests a second dosage form having a
second two dimensional array of deposits of a bioactive fluid dispensed
thereon as is required by Appellants‟ claim 55. Jolliffe suggests a dosage
form comprising different medicaments that are spatially separated on a
substrate (FF 11; see also FF 2 at Fig. 2). Applying Jolliffe‟s suggestion to
spatially separate different medicaments in the context of Percin, a person of
ordinary skill in this art would reasonably understand the combination to
suggest utilizing Percin‟s device to dispense a second dosage form on the
substrate in a second two-dimensional array of deposits. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (It is proper to “take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ”).
Because claim 55 is not concerned with the administration scheme of
the dosage form, we are not persuaded by Appellants‟ contention that
Jolliffe contemplates administering separate medicaments “simultaneously
as a single dose” (App. Br. 16; see also Reply Br. 7-8).

Claim 61:
Appellants provide separate arguments for claim 61, which requires
the ingestible sheet of claim 55 to further comprise a releasable backing.
The Examiner reasons that Jolliffe‟s suggestion to coat the substrate with a
cellulose derivative “reads on the [releasable] backing of [Appellants‟] claim
61” (Ans. 6; FF 12). We are not persuaded. The Examiner failed to
establish an evidentiary basis to support a conclusion that coating a substrate
with a cellulose derivative is equivalent to a substrate comprising a
Appeal 2011-005540
Application 11/111,240

8
releasable backing as required by Appellants‟ claim 61. In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness.”).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness with regard to claim 55. The rejection of claim 55 under 35
U.S.C. § 103(a) as unpatentable over the combination of Jolliffe and Percin
is affirmed. Because it is not separately argued claim 64 falls together with
claim 55. 37 C.F.R. § 41.37(c)(1)(vii). However, because our rationale
differs from the Examiner‟s we designate our affirmance as a new ground of
rejection.
The preponderance of evidence on this record fails to support a
conclusion of obviousness with regard to claim 61. The rejection of claim
61 under 35 U.S.C. § 103(a) as unpatentable over the combination of Jolliffe
and Percin is reversed.

The combination of Jolliffe and Sullivan with or without Percin:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 13. Jolliffe and Percin are relied upon as discussed above (FF 2-4 and 7-
12).
Appeal 2011-005540
Application 11/111,240

9
FF 14. Jolliffe and Percin fail to suggest a “dosage form compris[ing]
manufacturing information or patient information” (Ans. 8).
FF 15. Sullivan suggests imprinting machine readable code on a dosage
form (id.).
ANALYSIS
Appellants contend that while “Sullivan discloses pills having a
machine readable code printed thereon . . . Sullivan does not remedy the
shortcomings of the combination of Jolliffe and Percin” (App. Br. 17; Reply
Br. 8). We are not persuaded. For the reasons set forth above, we find no
deficiency in the combination of Jolliffe and Percin.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 57 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Jolliffe, Percin and Sullivan is
affirmed. Because they are not separately argued claims 58-60 falls together
with claim 57. 37 C.F.R. § 41.37(c)(1)(vii). However, for the reasons set
forth above, we designate our affirmance as a new ground of rejection.

The combination of Jolliffe and Hoffman with or without Percin:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 16. Jolliffe and Percin are relied upon as discussed above (FF 2-4 and 7-
12).
Appeal 2011-005540
Application 11/111,240

10
FF 17. Jolliffe and Percin fail to suggest the film thickness set forth in
Appellants‟ claim 67 (Ans. 9).
FF 18. Hoffman suggests a dosage form comprising an edible sheet having a
thickness of 25-250 microns (id.).
ANALYSIS
Appellants contend that “Hoffman fails to remedy the failure of
Jolliffe and Percin to teach two separate dosage forms each having a two-
dimensional array of deposits deposited thereon” (App. Br. 18; Reply Br. 9).
We are not persuaded. For the reasons set forth above, we find no
deficiency in the combination of Jolliffe and Percin.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 67 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Jolliffe, Percin and Hoffman is
affirmed. However, for the reasons set forth above, we designate our
affirmance as a new ground of rejection.

The combination of Jolliffe and Childers with or without Percin:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 19. Jolliffe and Percin are relied upon as discussed above (FF 2-4 and 7-
12).
FF 20. Jolliffe and Percin fail to suggest two active agents overlapping as
required by Appellants‟ claim 89 (Ans. 10).
Appeal 2011-005540
Application 11/111,240

11
FF 21. Childers suggests a dosage form comprising multiple
pharmaceuticals, wherein each are “separated by a barrier or sealing layer to
isolate the different pharmaceuticals from each other” (id.).
ANALYSIS
Appellants contend that Childers fails to remedy “the failure of the
combination of Jolliffe and Percin to teach the claimed dosage forms”
(Reply Br. 9; App. Br. 18-19). We are not persuaded. For the reasons set
forth above, we find no deficiency in the combination of Jolliffe and Percin.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 89 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Jolliffe, Percin and Childers is
affirmed. However, for the reasons set forth above, we designate our
affirmance as a new ground of rejection.

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
Appeal 2011-005540
Application 11/111,240

12
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

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-IN-PART

cdc