Ex Parte Wulf et al

Patent Trials and Appeals Board

Jun 27, 2019

14873566 - (D) (P.T.A.B. Jun. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/873,566 10/02/2015
29880 7590 07/01/2019
FOX ROTHSCHILD LLP
PRINCETON PIKE CORPORATE CENTER
997 LENOX DRIVE
BLDG. #3
LAWRENCEVILLE, NJ 08648
FIRST NAMED INVENTOR
Hans Christian Wulf
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
162047.48104 8733
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
07/01/2019 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):
ipdocket@foxrothschild.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANS CHRISTIAN WULF, ASLAK GODAL, JO KLA VENESS,
and PER HARALD FUGLERUD1
Appeal 2018-000339
Application 14/873,566
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
DAVID COTTA, 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 obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 The real party in interest in this appeal is Photocure ASA. App. Br. 3.
Appeal 2018-000339
Application 14/873,566
STATEMENT OF CASE
The following claim is representative.
1. A method of photodynamic treatment of acne
compnsmg:
(a) administering to an area characterized by acne on a
patient in need of such treatment a composition comprising
methyl ALA ester at a concentration of 4% to 8% by weight of
the composition, or the equivalent concentration of a
pharmaceutically acceptable salt, for a period of 30 minutes to
90 minutes, and
(b) administering photoactivating light to the area.
Cited References
Godal et al.
("Godal '44 7")
Grounds of Rejection
US 8,546,447 B2 Oct. 1, 2013
Claims 1, 4-21, and 23-35 are rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1-21 of Godal '44 7.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at page 4.
With regard to the obviousness-type double patenting rejection, relevant
Godal '447 claims are reproduced below.
1. A method of treating acne comprising administering to
an area of skin affected by acne on a body an effective amount
of a photosensitizer which is methyl 5-aminolevulinic acid
(ALA) ester or a pharmaceutically acceptable salt thereof,
and exposing the area to an effective amount of photoactivating
light.
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Application 14/873,566
2. The method of claim 1, wherein the method comprises
administering a pharmaceutically acceptable salt of methyl
ALA ester.
3. The method of claim 2, wherein the method comprises
administering the hydrochloride salt of methyl ALA ester.
4. The method of claim 3, wherein the hydrochloride salt of
methyl ALA ester is applied in a composition at a concentration
in the range of 0.02 to 25% w/w.
5. The method of claim 4, wherein the hydrochloride salt of
methyl ALA ester is applied at a concentration in the range of
about 5% w/w.
6. The method of claim 1, further comprising a waiting
time period between administering the hydrochloride salt of
methyl ALA ester and exposing the area to photoactivating
light.
7. The method of claim 6, in which the waiting time period
is from 1 to 3 hours.
8. The method of claim 7, in which the photoactivating
light has a wavelength in the range of 300 to 800 nm.
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).
Obviousness-Type Double Patenting Rejection
The Examiner argues that
Both sets of claims refer to treating acne administering a
composition comprising methyl 5-ALA to the affected area
with overlapping concentrations. The current application claims
anticipate the copending application claims. · · · Both
applications recite using the same compositions and/or
derivatives thereof. See current application claim 1 and
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Application 14/873,566
copending application claim 1. The compositions recited in the
claims are obvious variations of each other.
Ans. 4.
Appellants contend that
[T]he combination of low concentrations of MAL
[ methylamino-levulinate hydrochloride] and short
administration times recited in the present claims make the
present claims nonobvious. The claims of U.S. Patent No
8,546,447 do not change this conclusion. Only claims 4 and 5
recite specific concentrations; only claim 7 and its dependent
claims recite a specific administration time. None of the '44 7
patent claims recite a combination of a specific MAL
concentration and specific administration time. Claim 4 recites
a concentration "in the range of 0.02 to 25% w/w."
As discussed ... [in the Brief with respect to the withdrawn
obviousness rejection], the prior art taught that concentrations
lower than 20% should be paired with administration times
longer than 3 hours. Therefore, when claim 4 is read in the
context of the prior art ( discussed in Sakamoto, Torezan, and
Anderson and the First Godal Declaration ... ), it would not be
obvious to choose a MAL concentration within the range of 4%
to 8% from the recited range of claim 4 of the '447 patent, and
to pair that MAL concentration with any administration time
shorter than 3 hours, much less to pair that MAL concentration
with an administration time of 30 minutes to 90 minutes.
Accordingly, none of the presently pending claims is obvious in
view of claim 4 of the '44 7 patent.
App. Br. 29.
Appellants cite General Foods Corp. v. Studiengesellschaft Kahle
mbH, 972 F.2d 1272, 1273 (Fed. Cir. 1992) for the proposition that
For the purposes of the obvious-type double patenting, each
claim from the reference patent is to be taken as a complete
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Application 14/873,566
invention, and it is that complete invention, not part of the
invention, that is used to assess the challenged claims. "[E]ach
claim is an entity which must be considered as a whole."
App. Br. 30. Appellants argue that, "[a]ccordingly, claim recitations from
separate claims ( that do not depend from one another) cannot be combined
as if they were prior art disclosures." Id.
ANALYSIS
We find that the preponderance of the evidence supports the position
of the Examiner, and affirm the obviousness-type double patenting rejection
of the Examiner.
Claims 1, 4, and 7 of Godal '447 are reproduced below.
1. A method of treating acne comprising administering to
an area of skin affected by acne on a body an effective amount
of a photosensitizer which is methyl 5-aminolevulinic acid
(ALA) ester or a pharmaceutically acceptable salt thereof,
and exposing the area to an effective amount of photoactivating
light.
4. The method of claim 3, wherein the hydrochloride salt of
methyl ALA ester is applied in a composition at a concentration
in the range of 0.02 to 25% w/w.
7. The method of claim 6, in which the waiting time period is from 1
to 3 hours.
Claim 7 of Godal '44 7 ultimately depends from claim 1 but does not
depend from claim 4.
Appellants argue that
"[E]ach claim is an entity which must be considered as a
whole." General Foods Corp. v. Studiengesellschaft Kahle,
972 F.2d 1272, 1273 (Fed. Cir 1992) (emphasis in original).
Because an analysis for double patenting is concerned only
with what is claimed, it is an error to look to what a reference
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Application 14/873,566
claim discloses (as if it were prior art), rather than what
invention the claim defines. Id. at 1280. Accordingly, claim
recitations from separate claims (that do not depend from one
another) cannot be combined as if they were prior art
disclosures.
App. Br. 30. Appellants contend that, nothing in the Godal '447 claims
suggests that concentrations of ALA at a concentration of from 4-8% can be
administered for a period of 30-90 minutes with effective results. App. Br.
29.
We are not persuaded by Appellants' arguments. Appellants'
attention is directed to In re Schneller, 397 F.2d 350, 354 (CCPA 1968).2 In
Schneller, the applicant said, "that in the patent he has claimed ABCX in
claims 2, 3, and 4 and that here [in the application] he is claiming ABCY
and, therefore, there is no double patenting." Schneller, at 354. The Court
agreed that the claims of the patent and of the application were directed to
separate inventions, but stated,
It is at this point that we have to disagree with appellant. True,
there is no double patenting in the sense of claiming the same
invention because ABCX and ABCY are, in the technical
patent law sense, different inventions. The rule against 'double
patenting,' however, is not so circumscribed. The fundamental
reason for the rule is to prevent unjustified timewise extension
2 We note that Schneller is binding precedent relative to General Foods. See
Deckers Corp. v. U.S., 752 F.3d 949, 965 (Fed. Cir. 2014) ("In our first
published opinion, sitting en bane, we adopted the case law of the CCP A as
our binding precedent. South Corp. v. United States, 690 F.2d 1368, 1369
(Fed.Cir.1982) (en bane) ... Thus, we as a panel are bound by prior CCPA
decisions unless and until those CCP A decisions are overturned en bane or
through Supreme Court intervention.)
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of the right to exclude granted by a patent no matter how the
extension is brought about.
Id., at 354. The CCP A further stated in Schneller that
The controlling fact is that patent protection for the ... [ subject
matter], fully disclosed in and covered by the claims of the
patent, would be extended by allowance of the appealed claims.
Under the circumstances of the instant case, wherein we find no
valid excuse or mitigating circumstance making it either
reasonable or equitable to make an exception, and wherein there
is no terminal disclaimer, the rule against 'double patenting'
must be applied.
Id., at 354.
In the present case, as in Schneller, the subject matter, fully disclosed
in and separately covered by the claims of the patent, would be extended by
allowance of the appealed claims. In particular, claims 1, 4, and 7 of Godal
'447 are directed to overlapping subject matter, but not the same subject
matter claimed in the present application. More particularly, the subject
matter of the combination invention of claims 1 and 4 is covered in Godal
'447 (via claim dependency); and the combination invention of claims 1 and
7 is covered in Godal '447 (via claim dependency). We acknowledge that
the claims of Godal '44 7 do not directly encompass the combination
invention of claims 1, 4, and 7. However, here, as in Schneller, the pending
claims are directed to a separate invention than that claimed in the reference
patent. Here, we are considering the entirety of what is claimed in claim 4 of
the reference patent, Godal '44 7, and the entirety of what was claimed in
claim 7 of the reference patent. In the language of General Foods, we are
considering what these claims define rather than what they disclose.
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Because, the present application combines the features of patented
claims 1, 4, and 7 of Godal '447 into a single combination claim, patent
protection would be extended by allowance of the appealed claims.
Similarly, in In re Metoprolol Succinate Patent Litigation, 494 F.3d
1011 (2007), the court
noted that "[n]on-statutory, or 'obviousness-type,' double
patenting is a judicially created doctrine adopted to prevent
claims in separate applications or patents that do not recite the
'same' invention, but nonetheless claim inventions so alike that
granting both exclusive rights would effectively extend the life
of patent protection." Perricone, 432 F.3d at 1373 (citation
omitted).
Metropolol, at 1016. We conclude in the present case, that the Godal '447
patent claims do not recite the 'same' invention, but nonetheless claim
inventions so alike that granting both exclusive rights would effectively
extend the life of patent protection."
We affirm the obviousness-type double patenting rejection.
CONCLUSION OF LAW
We affirm the obviousness-type double patenting rejection.
AFFIRMED
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