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.
10/855,798 05/27/2004 Reinhard Vehring 53306-US-CNT 8325
1095 7590 08/12/2010
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
SASAN, ARADHANA
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
08/12/2010 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 REINHARD VEHRING, DANFORTH P. MILLER,
and DAVID LECHUGA-BALLESTEROS
__________
Appeal 2010-006253
Application 10/855,798
Technology Center 1600
__________
Before DONALD E. ADAMS, DEMETRA J. MILLS, and STEPHEN
WALSH, Administrative Patent Judges.
WALSH, Administrative Patent Judge.
DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical formulation. The Patent Examiner rejected the claims on the
grounds of anticipation and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-006253
Application 10/855,798
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STATEMENT OF THE CASE
Claims 27-40, which are all the pending claims, are on appeal. Claim
27 is representative and reads as follows:
27. A spray-dried pharmaceutical formulation comprising:
particles comprising an active agent and an excipient encapsulating
the active agent, wherein the excipient is more soluble in water than
the active agent.
The Examiner rejected the claims as follows:
• claims 27-40 under 35 U.S.C. § 102(b) as anticipated by Staniforth
(WO 97/03649)2 and the Physicians’ Desk Reference (PDR)3;
• claims 27-40 under 35 U.S.C. § 102(e) as anticipated by
Staniforth(US 6,475,523)4 and the Physicians’ Desk Reference (PDR);
• claims 27-39 under 35 U.S.C. § 102(b) as anticipated by Basu5;
• claims 27, 30 and 33 on the ground of nonstatutory obviousness-
type double patenting over claims 1, 8, 9, 13 and 15 of US Patent No.
6,518,2396; and
• claims 27, 33 and 38 on the ground of nonstatutory obviousness-
type double patenting over claims 1, 17, 18, 21-23, 25 and 26 of US Patent
No. 6,835,3727.
2 John Nicholas Staniforth, WO 97/03649, published Feb. 6, 1997.
3 PHYSICIANS’ DESK REFERENCE, 49th Ed., p. 572 (1995).
4 John Nicholas Staniforth, Patent No. US 6,475,523 B1, filed June 16,
1998, issued Nov. 5, 2002.
5 Sujit K. Basu et al., Pub. No. US 2001/0036481 A1, published Nov. 1,
2001.
6 Mei-Chang Kuo and David Lechuga-Ballesteros, US 6,518,239 B1, issued
Feb. 11, 2003.
7 Mei-Chang Kuo and David Lechuga-Ballesteros, US 6,835,372 B1, issued
Dec. 28, 2004.
Appeal 2010-006253
Application 10/855,798
3
ANTICIPATION
The Issues
The Examiner found that the Staniforth WO publication, the
Staniforth patent, and the Basu patent each disclosed the spray-dried
formulation that Appellants now claim.
Appellants contend that none of the references anticipate the invention
because none disclosed each and every limitation of Appellants’
formulation. Appellants argue that Staniforth did not disclose a spray dried
particle with an excipient “encapsulating” an active agent. (App. Br. 4.)
Appellants argue that Basu did not disclose “an encapsulated particle.” (Id.
at 6.)
The Examiner responds that “Staniforth teaches that the additive
material may be present in the powder in the form of a coating on the
surfaces of active material.” (Ans. 10.) Addressing Appellants’ argument
concerning Basu’s disclosure, the Examiner responded:
the encapsulation or coating of the active agent with the
excipients . . . is an inherent feature of the spray dried particles
comprising active agents and excipients that are disclosed by
Basu. Moreover, Basu teaches that the envelope mass density
of the particles is defined as the mass of the particles divide by
the minimum sphere envelope volume within which it can be
enclosed (Page 6, [0082]). A skilled artisan will take this
teaching of envelope and the particles enclosed in the envelope
as a coating of particles.
(Id. at 14.)
The issues with respect to these rejections are:
did either Staniforth reference describe a particle comprising an
excipient encapsulating the active agent; and
Appeal 2010-006253
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did Basu inherently describe a particle comprising an excipient
encapsulating the active agent?
Findings of Fact
1. The Examiner’s statements of rejection identified disclosures in the
references by citing to certain pages or columns and lines. We find
the evidence supports the particular page or column and line findings
the Examiner did make.
2. The statements of rejection cited Staniforth’s disclosure of “a coating
on the surfaces of the particles of active material.” (Ans. 4 and 6.)
3. The statements of rejection did not cite to evidence that Staniforth
explicitly disclosed particles comprising an excipient “encapsulating”
the active agent (claim 27), or particles comprising the active agent
“encapsulated” by the excipient (claim 38).
4. Staniforth described its particles as having a discontinuous covering:
[T]here is no “coating” of the active particles in the sense in
which that word would normally be used in the art, namely to
refer to a continuous envelope around the active particle.
Instead, a discontinuous covering is formed on the active
particle. It is believed that the presence of such a discontinuous
covering, as opposed to a “coating” is an important and
advantageous feature of the present invention.
Staniforth WO, p. 12, ll. 25-33; Staniforth ‘523, col. 7, ll. 12-19.
7. The statement of rejection did not cite to evidence that Basu explicitly
disclosed particles comprising an excipient “encapsulating” the active
agent (claim 27), or particles comprising the active agent
“encapsulated” by the excipient (claim 38).
8. Basu taught:
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The envelope mass density of an isotropic particle is defined as
the mass of the particle divided by the minimum sphere
envelope volume within which it can be enclosed. In one
embodiment of the invention, the particles have an envelope
mass density of less than about 0.4 g/cm3.
(Basu, p. 6 ¶ 82.)
9. An ordinary definition8 of “encapsulate” is:
1 : to enclose in or as if in a capsule
.
Principles of Law
“[U]nless a reference discloses within the four corners of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the claim, it
cannot be said to prove prior invention of the thing claimed and, thus, cannot
anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. Verisign, Inc.,
545 F.3d 1359, 1371 (Fed. Cir. 2008). The requirement that the prior art
elements themselves be “arranged as in the claim” means that claims cannot
be “treated ... as mere catalogs of separate parts, in disregard of the part-to-
part relationships set forth in the claims and that give the claims their
meaning.” Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
730 F.2d 1452, 1458-1459 (Fed. Cir. 1984).
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question
8 encapsulate. (2010). In Merriam-Webster Online Dictionary. Retrieved
August 3, 2010, from http://www.merriam-
webster.com/dictionary/encapsulate
Appeal 2010-006253
Application 10/855,798
6
whether a claim limitation is inherent in a prior art reference is
a factual issue.
In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
To support a finding of inherency, the evidence “must make clear that the
missing descriptive matter is necessarily present in the thing described in the
reference . . . . Inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (citations omitted).
Analysis
A. The Rejections over Staniforth
We find that the Staniforth references did not describe particles in
which an excipient encapsulates the active agent. Staniforth explicitly stated
that it forms a discontinuous covering around the active agent, not a
continuous envelope. (FF 4). Staniforth explained that its use of the term
“coating” was different from the ordinary usage in the pharmaceutical arts,
and did not refer to a continuous envelope around the active ingredient. (Id.)
In the ordinary sense, encapsulate means to enclose in or as if in a capsule.
(FF 8). Thus, Staniforth’s discontinuous covering coating did not enclose
the active ingredient as if in a capsule because its coating did not envelope
the active ingredient. As Appellants put it by analogy: “[a] reference that
discloses chocolate and peanut butter does not anticipate a claim to a
Reese’s® Peanut Butter Cup.” (Reply Br. 4.) The evidence does not support
finding that Staniforth disclosed “the part-to-part relationships set forth in
Appeal 2010-006253
Application 10/855,798
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the claims and that give the claims their meaning.” See Lindemann,
730 F.2d at 1459.
B. The Rejection over Basu
Appellants dispute the Examiner’s finding that encapsulation was an
inherent feature of Basu’s spray-dried particles. (App. Br. 7). Appellants
also dispute the Examiner’s finding a person of ordinary skill in the art
would have taken Basu’s description of envelope mass density to mean that
the particles were encapsulated. (Id.) According to Appellants, measuring
envelope mass density is done for both coated and uncoated particles, and
does not mean the measured particles necessarily comprised an excipient
encapsulating the active agent. (Id.)
In the Response to Argument section of the Answer, the Examiner
ignores the disputed envelope mass density issue that is the rejection’s basis
for inherent anticipation. Instead, the Examiner proposes a new explanation
for inherent anticipation. Referring to Basu’s disclosures that the bioactive
agent can be hydrophobic and that the particles are prepared by spray drying,
the Examiner writes:
[w]hen the phospholipid and bioactive agent (which can be
hydrophobic) are combined in the spray dryer, the hydrophobic
portion of the phospholipid will align with the inner,
hydrophobic portion of the resultant spray dried particle which
contains the hydrophobic bioactive drug. Consequently, the
hydrophobic portion of the phospholipid will be on the outer
portion of the particle, i.e., the encapsulating or coating layer.
(Ans. 15-16.) Appellants reply that they do not understand the Examiner’s
application of Basu. (Reply Br. 5.)
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Application 10/855,798
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We find that the Examiner’s Response to Argument presents a new
ground of rejection. The explanation concerning the kind of particle that
would be inherently produced by spray drying a hydrophobic drug and a
phospholipid was not presented in the statement of rejection. We therefore
do not consider it as a part of the rejection.
Appellants have explained that determining mass density does not
mean that an excipient encapsulates an active ingredient. The Examiner
does not dispute Appellants’ point that mass density is determined for both
coated and uncoated particles. We find the evidence insufficient to establish
that Basu’s particles necessarily had an excipient encapsulating an active
agent. See Robertson, 169 F.3d at 745.
OBVIOUSNESS-TYPE DOUBLE PATENTING
The Issue
The Examiner concluded that claims 27, 30 and 33 are not patentably
distinct from certain claims in Kuo ‘239 and Kuo ‘372. (Ans. 8.)
Appellants contend “the Examiner has provided no reasoning why one
of ordinary skill in the art would have found it obvious to modify the
claimed invention of ‘239 in a manner that would arrive at Appellant’s claim
27.” (App. Br. 9.) Appellants make the same argument for the rejection
over Kuo ‘372. (Id. at 11.)
The issue with respect to these rejections is whether modification of
the invention claimed in Kuo ‘239 or ‘372 would be required to arrive at the
invention defined by claim 27 and, if so, did the rejections articulate a
rationale sufficient to support the conclusions of obviousness.
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Application 10/855,798
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Findings of Fact
The Examiner finds that the claims in Kuo ‘239 “are drawn to a composition
comprising an active agent and a di- or tri-peptide (which includes
trileucine)” and particles thereof having a mass median diameter less
than about 10 microns. (Ans. 8.)
Principles of Law
Obviousness-type double patenting entails a two-step analysis. First,
the allegedly conflicting claims are construed and, second, the difference(s)
between the claims are considered to determine whether the claims are
patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955,
968 (Fed. Cir. 2001). “A later patent claim is not patentably distinct from an
earlier patent claim if the later claim is obvious over, or anticipated by, the
earlier claim.” (Id.)
“Rejections 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.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007).
Appeal 2010-006253
Application 10/855,798
10
Analysis
The rejected claims recite the limitation “particles comprising . . . an
excipient encapsulating the active agent.” The patented claims on which the
rejections are based do not recite that feature of Appellants’ invention. The
rejections do not account for that difference. We therefore must reverse the
rejections.
CONCLUSIONS
Staniforth did not describe a particle comprising an excipient
encapsulating the active agent.
The evidence is insufficient to support finding that Basu’s particles
necessarily comprised an excipient encapsulating the active agent.
The explanation for obviousness-type double patenting did not
consider all the differences between the pending and patented claims, and
did not support the conclusion of obviousness-type double patenting.
SUMMARY
We reverse the rejection of claims 27-40 under 35 U.S.C. § 102(b) as
anticipated by Staniforth (WO 97/03649) and PDR.
We reverse the rejection of claims 27-40 under 35 U.S.C. § 102(e) as
anticipated by Staniforth(US 6,475,523) and PDR.
We reverse the rejection of claims 27-39 under 35 U.S.C. § 102(b) as
anticipated by Basu.
We reverse the rejection of claims 27, 30 and 33 on the ground of
nonstatutory obviousness-type double patenting over claims 1, 8, 9, 13 and
15 of US Patent No. 6,518,239.
Appeal 2010-006253
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We reverse the rejection of claims 27, 33 and 38 on the ground of
nonstatutory obviousness-type double patenting over claims 1, 17, 18, 21-23,
25 and 26 of US Patent No. 6,835,372.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
REVERSED
lp
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER NJ 07936-1080
