Ex Parte Chang et al

Patent Trial and Appeal Board

Jul 23, 2014

12072578 (P.T.A.B. Jul. 23, 2014)

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.
12/072,578 02/27/2008 Yunik Chang 767.0131 5237
29085 7590 07/24/2014
HOWARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035
EXAMINER
MAIER, LEIGH C
ART UNIT PAPER NUMBER
1673
MAIL DATE DELIVERY MODE
07/24/2014 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte YUNIK CHANG and GORDON J. DOW
__________

Appeal 2012-003874
Application 12/072,578
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC B. GRIMES, and ULRIKE W. JENKS,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written descriptive support and anticipation. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
The following claims are representative.
1. A method for increasing the dissolved concentration of
betacyclodextrin in an aqueous fluid composition comprising combining in
the aqueous fluid composition betacyclodextrin and niacin or niacinamide in
amounts that are sufficient to provide a dissolved concentration of
betacyclodextrin in the aqueous fluid between 0.5% and 1.5% w/w at 5° C.

7. An aqueous solution composition comprising betacyclodextrin and
niacin or niacinamide, wherein the concentration of betacyclodextrin that is
dissolved in the aqueous fluid is between 0.5% and 1.5% w/w and, wherein,
when the temperature of the aqueous solution composition is brought to 5°
C. the betacyclodextrin does not precipitate.

13. A method for increasing the solubility capacity of betacyclodextrin
in an aqueous solution at 5° C comprising combining in the aqueous solution
optionally a gelling agent, the betacyclodextrin in an amount sufficient to
provide a dissolved concentration in the aqueous gel between 0.5% and 1.5%
w/w, and an amount of niacin or niacinamide that is sufficient to maintain the
dissolved concentration of betacyclodextrin in the aqueous solution at a
concentration of between 0.5% and 1.5% w/w for one week at a temperature
of 5° C .

24. A method for increasing the dissolved concentration of
betacyclodextrin in an aqueous fluid composition comprising combining in
the aqueous fluid composition betacyclodextrin and niacin or niacinamide in
an amount that is sufficient to provide a dissolved concentration of
betacyclodextrin in the aqueous fluid that is higher than the saturated
dissolved concentration of betacyclodextrin in the aqueous fluid in the
absence of the niacin or niacinamide.

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Cited References

Chang et al., US 6,881,726 B2, patented Apr. 19, 2005.

Pedersen, Effect of hydrotropic substances on the complexation of
clotrimazole with β-cyclodextrin, 19 DRUG DEV. INDUS. PHARM. 439-448
(1993).

Grounds of Rejection
1. Claims 1, 3, 7, 9, 13, and 21-23 are rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written
description requirement.
2. Claims 1, 3, 7, 9, 13, and 18-25 are rejected under 35 U.S.C.
§ 102(b) as being anticipated by Chang.
3. Claims 1, 3, 7, 9, 13, 18-20, 24, and 25 are rejected under
35 U.S.C. § 102(b) as being anticipated by Pedersen.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
6. The following facts are highlighted.
1. On page 9, lines 3-8, the Specification discloses the following:
In accordance with the invention, the concentration of
cyclodextrin in aqueous solution may be between 0.1% and
20%, or higher. Preferably, the concentration of cyclodextrin in
the solution is no more than about 5% w/w. In the case of beta-
cyclodextrin [BCD] the concentration in aqueous solution is
limited by its solubility in water. An aqueous solution, such as
a gel, of beta-cyclodextrin is saturated at a concentration of
about 0.5% at 5°C (refrigerator temperature).

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2. On page 9, lines 9-12, the Specification discloses the following:
The solutions, especially in gel formulation, are non-
tacky, fast-drying, and cosmetically elegant. The solutions,
including the gel formulations, are physically stable at 5°C
(refrigerator temperature) or room temperature conditions for at
least 7 days. No crystal formation or precipitation is observed
after one week at 5°C.

3. On page 10, lines 1-9, the Specification discloses the following:
For example, if a stable 1% MTZ [metronidazole] aqueous
solution is desired, 0.1% to 1.0% BCD may be used and an
amount of niacinamide or niacin may be combined in the
solution to bring the solubility of MTZ to 1%. The amount of
niacinamide to be combined in the solution is less than that
which, without the presence of BCD in the solution, can
enhance the solubility of MTZ sufficiently to obtain a 1%
solution of MTZ, or whatever level of MTZ is desired. In
accordance with this embodiment of the invention for a 1%
aqueous solution of MTZ, the concentration of BCD % w/w in
the solution is preferably at a level of 1.0% or less and the
concentration of niacinamide or niacin equal to or more than
that of BCD.

4. Table 1 of the Specification is reproduced below.

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Table 1 shows a generic formula gel used in subsequent formulary
examples in the Specification. Amounts of BCD and niacin or
niacinamide in the generic gel are imported into the table from
subsequent Tables in the Specification. (Spec. 12, ll. 7-15.)
5. Table 2 of the Specification is reproduced below.

Table 2 shows the stability of various BCD concentrations at 5°C.
Some of these concentrations were tested in the gels of Table 1 in
subsequent Examples in the Specification. Table 2 does not show the
presence of niacin, and thus no niacin is present in the gel of Table 1
when Table 2 is imported into Table 1. Table 2 show that at a
concentration of BCD at 1.5% w/w formed crystals at one week.
(Spec. 13, ll. 1-9.)

Written Description Rejection
Discussion
ISSUE
The Examiner contends that
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The concentration range of beta-cyclodextrin (BCD) in
solution has been broadened from 0.5% to 1.0% w/w to 0.5% to
1.5% w/w [in the pending claims]. Although the original
claims for this continuing application support the compositions
and methods, this is the only support for the new method, and
this concentration was not recited in the original claims. In
support of this amendment, Applicant cites Table 2, which
discloses concentration of BCD as high as 1.5% w/w. Table 2
is a demonstration of the solubility of BCD at various
concentrations.

(Ans. 4-5.)

Appellants argue that

The application expressly discloses that the solutions
described were observed at a temperature of 5° C (refrigerator
temperature) and that they were stable when observed after one
week. The application expressly discloses that the concentration
of cyclodextrin is between 0.1 and 20% and that, in the case of
beta-cyclodextrin (BCD), it is saturated at a concentration of
0.5% at 5° C. The application further states that 0.1 % to 1.0%
BCD concentration may be used (which is above the saturated
concentration of BCD in aqueous fluid) and that an amount of
niacinamide or niacin is combined with the BCD to bring the
solubility of metronidazole (MTZ) to 1%. Further, the
specification states that the solution of BCD and niacinamide or
niacin is prepared, and then the metronidazole is added.

(App. Br. 14-15.)

The issue is: Does the Specification as originally filed support the
pending claim scope.

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PRINCIPLES OF LAW
The purpose of the written description requirement is to “ensure that
the scope of the right to exclude, as set forth in the claims does not
overreach the scope of the inventor’s contribution to the field of art as
described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d
1342, 1345 (Fed. Cir. 2000). To that end, to satisfy the written description
requirement, the inventor “must also convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or she was in possession
of the invention.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64
(Fed. Cir. 1991). “One shows that one is ‘in possession’ of the invention by
describing the invention, with all its claimed limitations” (emphasis in
original). Lockwood v. American Airlines, 107 F.3d 1565, 1572 (Fed. Cir.
1997). It is not necessary for the specification to describe the claimed
invention ipsissimis verbis; all that is required is that it reasonably convey to
those skilled in the art that, as of the filing date sought, the inventor was in
possession of the claimed invention. Union Oil Co. of California v. Atlantic
Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000); Vas-Cath Inc. v.
Mahurkar, 935 F.2d at 1563-64; In re Gosteli, 872 F.2d 1008, 1012 (Fed.
Cir. 1989); In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978).
When an Applicant claims a class, the Applicant “must describe that
class in order to meet the description requirement of the statute.” In re
Lukach, 442 F.2d 967, 968 (CCPA 1971). “[W]hile the description
requirement does not demand any particular form of disclosure …, or that
the specification recite the claimed invention in haec verba, a description
that merely renders the invention obvious does not satisfy the requirement.”
Ariad Pharms, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir.
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2010) (citations omitted). “[T]he specification must demonstrate that the
applicant has made a generic invention that achieves the claimed result and
do so by showing that the applicant has invented species sufficient to
support a claim to the functionally-defined genus.” Id. at 1349. “[A]n
adequate written description of a claimed genus requires more than a generic
statement of an invention's boundaries.” Id.

ANALYSIS
We are persuaded by the Examiner’s argument that there is no
descriptive support in the application as originally filed for the claimed BCD
concentration range of between 0.5% and 1.5% w/w at 5° C.
Appellants submit that “the disclosure at page 9, lines 4-8 [FF1],
support a concentration of BCD greater than 1.0%, including the 0.5% to
1.5% as called for in claim 1.” (App. Br. 13.) Appellants argue that
As called for in present independent claim 7, an aqueous
solution composition comprises betacyclodextrin and niacin or
niacinamide (page 5, lines 4-6), wherein the betacyclodextrin
that is dissolved in the aqueous fluid is between 0.5% and 1.5%
w/w (support is found in the specification on page 13, Table 2,
which discloses a BCD concentration of 1.5% and on page 12,
Table 1, which discloses that BCD concentration and
niacinamide or niacin concentration are as shown in Table 2 to
6, and on page 9, lines 4-5), wherein, when the temperature of
the aqueous composition is brought to 5° C, the BCD does not
precipitate (page 9, lines 9-12). Claim 9 depends from claim 7
and calls for physically stable for one week at 5° C (page 9, line
11).
(App. Br. 8-9, emphasis added.)
In our view, one of ordinary skill in the art would find that the
Specification does not reasonably convey to those skilled in the art that, as
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of the filing date sought, the inventor was in possession of the claimed BCD
concentration range of between 0.5% and 1.5% w/w at 5° C.
The generic disclosure of cyclodextrin in aqueous solution of between
0.1% and 20%, or higher at page 9, lines 4-8 (FF1), alone, is not sufficient to
support the specific pending claim scope. Put another way, when an
Applicant claims a class, such as the broad genus of BCD in aqueous
solution of between 0.1% and 1.5%, the Applicant “must describe that class
in order to meet the description requirement of the statute.” In re Lukach,
442 F.2d at 968. Merely drawing a fence around the outer limits of a
purported genus of up to 20% concentration cyclodextrin is not an adequate
substitute for a description showing that one has invented—that is, has
possession of—a genus including a 1.5% concentration of BCD and not just
the species of Table 4 of the Specification. See Lockwood, 107 F.3d at 1572.
The Specification, page 9, lines 7-8, states that, “[a]n aqueous
solution, such as a gel, of betacyclodextrin is saturated at a concentration of
about 0.5% at 5°C (refrigerator temperature).” The Specification Table 4
(page 14) exemplifies BCD concentrations in an aqueous solution consistent
with claim 1 of no higher than 1% w/w. As such, the Specification does not
support aqueous solutions as claimed with BCD concentrations of up to
1.5%. Appellants point to no specific example in the Specification of
solubilized concentrations of BCD in the aqueous solutions within the claim
scope. It remains unclear from Table 2 of the Specification, what amount of
niacin or niacinamide is required to obtain a stable concentration of 1.5%
BCD in an aqueous fluid.
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Thus, the amended claimed range including a dissolved concentration
of beta-cyclodextrin in the aqueous fluid between 0.5% and 1.5% w/w at
5° C is not supported by the original application as filed.
The written description rejection is affirmed.

Anticipation rejections
Anticipation by Chang
ISSUE
The Examiner finds that

The instant application is filed as a continuation of
11/037,430, filed 1/18/05, which is a continuation of
10/033,835, filed 12/24/01. However, the parent, ‘430, does
not support the methods recited in instant claims 1, 3 and 13 or
the product recited in instant claims 7 and 9.
…
The examiner does not find that the specification, as
originally filed in the grandparent application, S. N.
10/033,835, provides written description for the instant claims.
It is noted that the title and abstract filed in the instant
application are not present in ‘835. The specification describes
both β-cyclodextrin and niacin (amide) as being solubilizing
agents. However, the specification concentrates on how they
both are used in combination with metronidazole to solubilize
that agent.
Claim 1 has been amended so that the composition is a
“fluid” rather than a “gel.” The concentration range has been
broadened from 0.5% to l.0% w/w to 0.5% to l.5% w/w. The
specification describes combining the niacin or niacinamide
with BCD before the addition of the MTZ suggesting a
transitory mixture of BCD and niacin or niacinamide. See page
10, lines 15-17. However, the specification further describes
the preparation of the solution including MTZ at elevated
temperature before cooling, so clearly this does not support a
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solution with niacin or niacinamide with BCD but without MTZ
at 5° C, much less one that is physically stable for a week at
that temperature. There is no discussion regarding the stability
of any solution not containing MTZ at this temperature.

(Final Rej. 2-3.)

The Examiner finds that
The [Chang] reference discloses an aqueous gel
composition comprising niacin or niacinamide and BCD that is
stable for a week at 5° C. See Tables 4 and 6. The preparation
of this composition anticipates [ ] the instant composition. In
preparing the compositions, the reference also accomplishes the
step of each method, thereby anticipating the method claims.
This finding of anticipation is not inconsistent with the
finding that applications 11/037,430 and 10/033,835 do not
fully support the instant claims. A narrow disclosure that
anticipates a broader claim does not necessarily provide full
written description for said broader claim. Neither does a
disclosure of a mixture of components necessarily describe a
particular action of one component upon another component.

(Ans. 5.)
Appellants contend that the Chang patent is not prior art to the present
application. In particular, Appellants argue that
The present application was filed on February 27, 2008
as a continuation of application 11/037,430, which was a
continuation of application 10/033,885, which eventually issued
as the cited Chang patent. The present application contains the
identical disclosure as that of the Chang patent.
As discussed above … dealing with the rejection of the
present claims, under 35 U.S.C. §112, first paragraph, for lack
of compliance with the written description requirement, each of
the pending claims is fully supported in the present
specification. Accordingly, because the present specification is
identical to that of the Chang patent and is a direct continuation
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of the Chang patent, the present claims are entitled to claim
priority from the Chang patent.

(App. Br. 20.)

The issue is: Is Chang prior art to the present claims?

ANALYSIS
Appellants argue that the anticipation rejection is improper because
Chang is not prior art to the present application and that the present
application a “continuation of application 11/037,430, which was a
continuation of application 10/033,885, which eventually issued as the cited
Chang patent. The present application contains the identical disclosure as
that of the Chang patent.” (App. Br. 20.)
We find that Chang is prior art to the pending claims of the present
application. We have found above, that the pending claims do not find
support in the original Specification, as filed. Therefore, the added pending
claims including the 1.5% BCD concentration are not entitled to the priority
date of the 10/033,835 application filed Dec. 24, 2001, and therefore U.S.
Patent 6,881,726 to Chang issuing April 19, 2005 from the ’835 application
is prior art to the present application which was filed February 27, 2008.
In view of the fact that the written description rejection has been
affirmed, we agree with the Examiner that Chang is prior art to the present
application and the anticipation rejection is affirmed.

Anticipation by Pedersen
The Examiner argues that
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Pedersen discloses aqueous solutions comprising
nicotinamide (niacinamide) in combination with BCD at
concentrations within the recited range. See page 442, 1st full
paragraph. The reference is silent regarding stability at 5° C.
However, the Office does not have the facilities for preparing
the claimed materials and comparing them with prior art
inventions, the burden is on Applicant to show a novel or
unobvious difference between the claimed product and the
product of the prior art. See In re Best, 562 F.2d 1252, 195
USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205
USPQ 594 (CCPA 1980).

(Ans. 5-6.)
Appellants contend that
Pedersen discloses on page 442, first paragraph following
the heading “β-CD solubility in nicotinamide solution," that up
to 180 mg of BCD were added to 10 ml samples of ammonium
phosphate buffer containing 0.5 M nicotinamide and that these
samples were stored at a temperature of 23 +/- 2°C. This
corresponds to a concentration of BCD of 1.8%.
Funk, J. Incl. Phenom. Molec. Recog. Chem. 16:299-314
(1993), a reference previously cited by the Examiner and
presented to the Examiner in the Amendment filed on July 11,
2011 in response to this basis of rejection, discloses that the
solubility of BCD in water at room temperature is 1.8%. Thus,
the concentration of BCD dissolved in the aqueous formulation
of Pedersen in the presence of nicotinamide, is no higher than
the saturated concentration of BCD in the absence of
nicotinamide. Pedersen did not disclose any studies regarding
the solubilization of higher concentrations of BCD. Further,
there is no suggestion in Petersen [sic] that the solubility of
BCD in an aqueous composition, in the presence of
nicotinamide can be increased above its saturated solubility in
an aqueous composition that lacks nicotinamide.

(App. Br. 21.)
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The issue is: Does the Examiner’s cited prior art, Pedersen, support a
prima facie case of anticipation of the pending claims.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
“[T]he examiner must provide some evidence or scientific reasoning to
establish the reasonableness of the examiner’s belief that the functional
limitation is an inherent characteristic of the prior art” before the burden is
shifted to Applicants to disprove the inherency. Ex parte Skinner, 2
USPQ2d 1788, 1789 (BPAI 1986). “Inherency, however, 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.”
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).

ANALYSIS
We do not find that the Examiner has set forth a prima facie case of
anticipation of the pending claims over Pedersen.
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The Examiner argues that, “Pedersen discloses aqueous solutions
comprising nicotinamide (niacinamide) in combination with BCD at
concentrations within the recited range. See page 442, 1st full paragraph.
The reference is silent regarding stability at 5° C.” (Ans. 5.) Thus, the
Examiner argues that the reference disclosure is sufficient to shift the burden
of proof to Appellants to show that the claimed method and that of Pedersen
are not the same. (Ans. 5-6.) We are not persuaded by the Examiner’s
argument and do not find that the Examiner has provided sufficient evidence
to shift the burden of proof to Appellants.
The portion of Pedersen, page 442, that the Examiner relies upon
reads:
Various amounts of β-CD (0, 20, 40, 60, 80, 100, 120,
140, 160 and 180 mg) were added to 10 ml samples of ammonium
phosphate buffer containing 0.5 M nicotinamide. The samples
were heated gently to dissolve the β-CD, afterwards they
were stored for 72 hours at 23±2°C. The samples were
examined for precipitate.

Appellants calculate that the BCD in Pedersen’s 180 mg sample
corresponds to a concentration of 1.8% BCD (App. Br. 21). Since that is the
highest-concentration sample disclosed by Pedersen, it is reasonable to
conclude that some of the lower-concentration samples are within the 0.5%
to 1.5% range recited in the claim.
However, the claims on appeal also require that amounts of BCD and
niacin (or niacinamide) be sufficient to provide a dissolved BCD
concentration in the range of 0.5 to 1.5% at 5° C (see claim 1, emphasis
added). Although Pedersen discloses that its samples were stored at room
temperature (23 ± 2° C), not at refrigerator temperature (5° C), the Examiner
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has not pointed to evidence supporting a finding that Pedersen’s samples
would inherently have maintained solubility of BCD at a concentration
within the claimed range at 5° C, as required by the claims on appeal, and
therefore has not made a showing sufficient to shift the burden of proof to
Appellants.
We do not find that the Examiner has met the burden of proof in the
first instance to support a prima facie case of anticipation and the
anticipation rejection in view of Pedersen is reversed.

CONCLUSION OF LAW
The written description rejection is affirmed. The anticipation
rejection in view of Chang is affirmed. The anticipation rejection in view of
Pedersen is reversed.
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

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