Ex Parte MacDonald et al

Board of Patent Appeals and Interferences

May 27, 2010

10731256 (B.P.A.I. May. 27, 2010)

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.
10/731,256 12/09/2003 John Gavin MacDonald KCX-859 (19100) 4720
22827 7590 05/27/2010
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
SCHLIENTZ, NATHAN W
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
05/27/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN GAVIN MACDONALD and JASON LYE
__________

Appeal 2010-000817
Application 10/731,256
Technology Center 1600
__________

Decided: May 27, 2010
__________

Before ERIC GRIMES, TONI R. SCHEINER, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of administering a compound via nanoparticles. The Patent
Examiner rejected the claims on the ground of obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
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Application 10/731,256

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STATEMENT OF THE CASE
Claims 28, 30, 31, 33-35, 37, 38, 40, 42-44, 64 and 65 are on appeal.
Claim 28 is representative and reads as follows:
28. A method of using a triggerably releasable delivery system, the
method comprising administering to a mucosal membrane of a patient
a plurality of nanoparticles containing silica coated with alumina and
having a size of about 500 nanometers or less, wherein the alumina
provides a site on a surface of the nanoparticles to which is bonded a
functional compound, wherein the nanoparticles possess a zeta
potential of about 20 millivolts or more, wherein the nanoparticles are
contained within a vehicle that further comprises a pH altering
material, and wherein the functional compound is released from the
surface of the nanoparticles upon exposure to a change in pH.
(Emphasis added.)

The Examiner rejected the claims as follows:
• claims 28, 30, 31, 33-35, 37, 38, 40, 42-44, 64 and 65 under
35 U.S.C. § 103(a) over Bosch,1 Breitbarth,2 Ma3 and Daraio4; and
• claims 28, 30, 31, 33-35, 37, 38, 40, 42-44, 64 and 65 under
35 U.S.C. § 103(a) over Tan,5 Bosch, Breitbarth, Ma and Daraio.

1 William H. Bosch et al., Nanoparticulate Compositions Comprising
Inorganic Cores, WO 03/032959, Apr. 24, 2003. The record contains two
versions of the Bosch publication: the first, published Apr. 24, 2003; and a
“Corrected Version” published May 13, 2004. We rely on and cite to the
first, published Apr. 24, 2003.
2 Richard Breitbarth, Composition For Stimulating And Inducing Hair
Growth, U.S. Patent No. 5,597,575, issued Jan. 28, 1997.
3 Yi Hua Ma et al., Adsorption of Proteins and Antibiotics on Porous
Alumina Membranes, 80 FUNDAMENTALS OF ADSORPTION (MOTOYUKI
SUZUKI ED. ELSEVIER pp. 389-396 (1993).
4 Marta E. Daraio et al., Aggregation and Photophysics of Rose Bengal in
Alumina-Coated Colloidal Suspensions, 84 HELVETICA CHIMICA ACTA
2601-2614 (2001).
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Application 10/731,256

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Claims 30, 31, 33-35, 37, 38, 40, 42-44 and 64 have not been argued
separately and therefore stand or fall with claim 28. 37 C.F.R.
§ 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that “it would have been prima facie
obvious for one skilled in the art at the time of the invention to apply the
alumina coated silica nanoparticles with active agents adsorbed thereon to
mucosal membranes, as taught by Bosch et al., with the expectation that a
small change in pH will readily and controllably release the active agent
from the surface of the nanoparticles, as reasonably taught by Breitbarth and
Ma et al.” (Ans. 7.)
Appellants contend that (1) the references “fail to teach or suggest
nanoparticles contained within a vehicle that further comprises a pH altering
material” (App. Br. 7); (2) “[t]he Examiner improperly combines the
teachings of Bosch with Breitbarth” and Breitbarth teaches away from the
claimed invention (id. at 8-9); and (3) claim 65 is patentable because
although Ma teaches that the amount of tetracycline adsorbed is a function
of pH, “it cannot be said that Ma obviates releasing tetracycline from the
surface upon exposure to a change in pH” (id. at 10)
The issues with respect to this appeal are:
whether the references teach or suggest nanoparticles contained within
a vehicle that further comprises a pH altering material;

5 Weihong Tan et al., Coated Nanoparticles, U.S. Patent No. 6,548,264 B1,
issued Apr. 15, 2003.
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Application 10/731,256

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whether Breitbarth taught away from the claimed invention; and
whether Ma taught or suggested that tetracycline would be released
from alumina by a pH change.

Findings of Fact
1. Bosch taught pharmaceutical compositions comprising “at least one
nanoparticulate inorganic core, at least one active agent [i.e.,
functional compound] adsorbed or bound to the surface of the core,
and a pharmaceutically acceptable carrier [i.e., vehicle], as well as any
desired excipients.” (Id. at 5:15-19.)
2. Bosch taught that “[t]he active agent can be a drug,” and listed a
variety of drugs including antibiotics. (Id. at 11-13.)
3. We find that Appellants’ “functional compound” corresponds to the
“active agent” that Bosch taught.
4. Bosch taught that “liquid application forms include emulsions,
suspensions, syrups, and elixirs.” (Id. at 23:15.)
5. Appellants’ Specification states: “[t]he particles can be used as is, for
instance, or can be combined with a liquid, gel or other vehicle which
may facilitate delivery of the particles depending on the particular
application. Such liquid and gel vehicles are known to those skilled in
the art.” (Spec. 5, ll. 24-26.)
6. We find that Appellants’ “vehicle” corresponds to the “carrier” that
Bosch taught.
7. Bosch taught that useful nanoparticles were preferably within the size
range that Appellants claim (id. at 10:15-26), and described a working
example using Ludox CL®, a 12 nanometer alumina coated silica, as
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Application 10/731,256

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the inorganic core, coated with the functional compound naproxen (id.
at 29:4-10).
8. In a section titled “Active Agents Useful in Mucous Applications,”
Bosch taught applying the nanoparticles with active agent to mucosal
membranes including orally, to the lungs, throat and gastrointestinal
tract. (Id. at 14:11-20.)
9. According to Bosch, “[o]ther pharmaceutical therapeutic
methodologies include colonic, oral, rectal, intravaginal, . . . ,
pulmonary, nasal, buccal, topical, local, . . . , buccal spray, or nasal
spray administration.” (Id. at 14:21-24.)
10. Bosch taught that “[p]harmaceutical compositions according to the
invention may also comprise one or more . . . buffers . . . . Such
excipients are known in the art.” (Id. at 20:8-11.)
11. The Specification states: “triggering of the delivery system may be
accomplished through . . . introducing chemistries such as pH altering
materials to the delivery systems to trigger the release of functional
compounds. Chemistries that may be introduced to a delivery system
include bicarbonates, carbonates and buffering salts . . . .” (Spec. 16,
ll. 4-10.)
12. We find that Appellants’ “pH altering material” includes “buffering
salts” and corresponds to the “buffer” that Bosch taught.
13. The Examiner found that Bosch’s nanoparticles had the claimed zeta
potential (Ans. 6), and Appellants state they “have not challenged this
disclosure of Bosch” (Reply Br. 5).
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14. According to Breitbarth, “[t]opical application for administering drugs
and even for controlled release of drugs is now used extensively.”
(Breitbarth, col. 3, ll. 32-34.)
15. Ma stated: “[t]he equilibrium adsorption of . . . the antibiotic
tetracycline on alumina membranes was measured as a function of
pH.” (Id. at 389, Introduction.)
16. Ma disclosed that tetracycline’s equilibrium adsorption on alumina
was a function of pH. (Ma 389 (Abstract, Introduction); 391 (Results
and Discussion, Fig. 1); 392 (Fig. 2 and Table 1).)

Principles of Law
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention – including all its
limitations – with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995). A prior art reference is said to teach away from an
Applicant’s invention “when a person of ordinary skill, upon reading the
reference, would be discouraged from following the path set out in the
reference, or would be led in a direction divergent from the path that was
taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
“Obviousness does not require absolute predictability of success. . . . [A]ll
that is required is a reasonable expectation of success.” In re O'Farrell,
853 F.2d 894, 903-04 (Fed. Cir. 1988).

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Application 10/731,256

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Analysis
Claim 28
We agree with the Examiner’s findings concerning the scope and
content of Bosch, Breitbarth and Ma. While we agree with the Examiner
that Bosch did not disclose that the active molecule would be released from
the nanoparticle as a result of change in pH, we agree that a person of
ordinary skill in the art, informed by Breitbarth and Ma, would have
expected a change in pH to readily release the active agent from Bosch’s
nanoparticles. We find the Bosch, Breitbarth and Ma disclosures sufficient
evidence to conclude that the subject matter claimed would have been
obvious. The Examiner has not shown how the Tan and Daraio disclosures
add substantially to the prima facie case of obviousness, nor have Appellants
persuaded us that either reference weakens it. Under these circumstances,
we find it unnecessary to discuss Tan or Daraio further.
Contrary to Appellants’ first argument (see App. Br. 7), we find that
Bosch taught nanoparticles contained within a vehicle that further comprises
a pH altering material. We also find that Breitbarth’s disclosure, that topical
application of controlled release drugs was common, did not teach away
from the claimed invention. Appellants offer no evidence that a person of
ordinary skill in the art would have doubted Breitbarth’s statement merely
because it was made in the context of an invention for hair treatment. Nor
do we find that Breitbarth would have discouraged a person of ordinary skill
in the art from applying Bosch’s method. Thus, we find Appellants’
“teaching away” argument unpersuasive. (See App. Br. 8-9.)
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Application 10/731,256

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Claim 65
Claim 65 is directed to the method of claim 28, through claim 64,
“wherein the functional compound includes tetracycline.” Appellants
contend that Ma concerned only the conditions under which tetracycline
could be adsorbed to alumina, and did not teach or suggest that tetracycline
would be released from alumina by a pH change. (App. Br. 10.) Thus, Ma
could not have supported an expectation of success for using tetracycline as
Bosch’s antibiotic. We disagree. Ma described the adsorption of
tetracycline to alumina as a pH dependent “equilibrium adsorption.” Ma
showed that at some pH values, equilibrium favored adsorption, and at other
pH values equilibrium did not favor adsorption, i.e., adsorbed tetracycline
would desorb. We find this evidence supports the Examiner’s findings that
(1) tetracycline would be released from alumina by a pH change, and
(2) there would have been a reasonable expectation of success in using
tetracycline as the antibiotic in Bosch’s method.

CONCLUSIONS
Bosch taught nanoparticles contained within a vehicle that further
comprised a pH altering material.
Breitbarth did not teach away from the claimed invention.
Ma taught or suggested that tetracycline would be released from
alumina by a pH change.

Appeal 2010-000817
Application 10/731,256

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SUMMARY
We affirm the rejection of claims 28, 30, 31, 33-35, 37, 38, 40, 42-44,
64 and 65 under 35 U.S.C. § 103(a) over Bosch, Breitbarth, Ma and Daraio;
and
We affirm the rejection of claims 28, 30, 31, 33-35, 37, 38, 40, 42-44,
64 and 65 under 35 U.S.C. § 103(a) over Tan, Bosch, Breitbarth, Ma and
Daraio.

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

lp

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