Ex Parte Reimer et al

Patent Trial and Appeal Board

Aug 29, 2017

13559888 (P.T.A.B. Aug. 29, 2017)

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.
13/559,888 07/27/2012 Karen REIMER 1861.2110001/JMC/DWH 3886
26111 7590 08/29/2017
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
1100 NEW YORK AVENUE, N.W.
WASHINGTON, DC 20005
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
08/29/2017 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 KAREN REIMER, WOLFGANG FLEISCHER, and
MICHAEL HOPP
Appeal 2015-005621
Application 13/559,888
Technology Center 1600
Before JOHN G. NEW, CHRISTOPHER G. PAULRAJ and
KRISTI L. R. SAWERT, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of treating a subject affected with acne. The Examiner rejected the claims
for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Background
According to the Specification, “[t]he present invention concerns the
use of PVP-iodine liposomes for treatment of acne.” Spec. 1 11. 4—5. The
1 Appellants identify the Real Party in Interest as Euro-Celtique S.A (See
Appeal Br. 3).
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Application 13/559,888
most common form of acne is Acne vulgaris, which can occur in forms of
different severity such as Acne comedonica, Acne papulopustulosa, and
Acne conglobata. Id. at 1,11. 13—29.
“In the prior art PVP-iodine has been used for the treatment of acne
always in the form of a soap solution, that is commercially available under
the designation Betadine (in the US) or Betaisadona (in Europe).” Id. at 4,
11. 20—22. Efficacy studies have shown that this “PVP-iodine complexes
containing soap solution.. .can be used for the topic treatment of mild forms
of Acne vulgaris,” but “do not provide for a high efficiency for the treatment
of acne as in almost all cases patients were treated also with antibiotics.” Id.
at 4,11. 22-30.
It has been surprisingly found that pharmaceutical preparations
according to the invention that comprise a antiseptic compound,
as e.g. PVP-iodine, in a pharmaceutically effective amount
combined with particles, as e.g. liposomes, can be ideally used
to treat efficiently both the different forms of Acne vulgaris and
other acne forms by topic application.
Id. at 8,11. 1—5.
The Claims
Claims 18—32 are on appeal. Independent claim 18 is representative
and reads as follows:
18. A method of treating a subject affected with acne, the
method comprising administering to a subject in need thereof a
preparation comprising PVP-iodine as a single antiseptic
compound in a pharmaceutically effective-amount combined
with pharmaceutically acceptable liposomes, wherein the
pharmaceutically effective-amount of the single antiseptic
compound is sufficient to reduce existing inflammatory
papules, pustules or abscesses in subjects with Acne
papulopustulosa and Acne conglobata.
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The Rejections
The Examiner rejected the claims as follows:
I. Claims 18—32 under 35 U.S.C. § 103(a) as being obvious over
Moore,2 Prussin,3 Halpem,4 Brown,5 EP ’3736/WO ’822,7 and
Krauser.8
II. Claims 18—32 under 35 U.S.C. § 103(a) as being obvious over
Buseman,9 EP ’373/WO ’822, and Krauser.
ANALYSIS
Findings of Fact
FF1. Moore is directed to a therapeutic method to reduce pain
and inflammation. Moore, Title. Moore teaches the treatment
of acne vulgaris (seven cases) wherein “[b]y the topical
application of a solution of 1000 PPM Iodine in propylene
carbonate or 2000 PPM Iodine in propylene carbonate, the
Acne conditions showed considerable to complete remission.”
Id. at 15:51—55.
FF2. Prussin teaches that iodine is a well-known substance
which has marked antiseptic properties. Prussin, 1:9-10.
Prussin further teaches that “[o]ne of the problems associated
2 Moore et al., US 4,497,823, issued Feb. 5, 1985.
3 Prussin et al., US 3,966,090, issued June 29, 1976.
4 Halpem, US 3,671,545, issued June 20, 1972.
5 E.J. Brown, A Povidone-Iodine Skin Cleanser Foam in the Management of
Acne Vulgaris, The British Journal of Clinical Practice, vol. 31, No. 4,
pg. 218 (1977)
6 Ruckert, EP 0 639 373 Al, published Feb. 22, 1995 (“EP ’373”).
7 Fleischer WO 00/72822 Al, published Dec. 7, 2000 (“WO ’822”).
8 Krauser, US 5,038,769, issued Aug. 13, 1991.
9 Buseman et al., US 6,495,158 Bl, issued Dec. 17, 2002.
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with the use of iodine as an antiseptic for human skin is the fact
that it tends to cause unsightly brown discoloration when
applied to the skin,” and, “[wjithout this effect, iodine would
have marked advantages in such uses as cleaning the hands of a
surgeon prior to operative procedures, in treatment of acne and
dandruff and in general antiseptic uses.” Id. at 1:11—18.
FF3. Halpem is directed to polyvinylpyrrolidone-iodine (PVP-
iodine) compounds. Halpem, Title. Halpem teaches iodine is
contraindicated for use in the presence of acne due to, inter
alia, concerns about staining. Id. at 1:34—42 (“[Sjince the acne
lesion is most commonly manifested on the face, the known
staining effects of preparations containing elemental iodine are
such as to discourage its use by the patient.”). Halpem teaches
that polyhydroxy compounds help prevent the staining of iodine
on skin. Id. at 1:74—2:12.
FF4. Brown discusses a povidone-iodine skin cleanser foam in
the management of Acne vulgaris. Brown, Title. In a study
evaluating the effect of the povidone-iodine (BETADINE) Skin
Cleanser Foam on patients with acne, Brown indicates that
“[o]f the 32 patients completing the course of therapy, 19 were
judged to have benefited considerably from the skin cleanser
foam, eight others derived some benefit and only five showed
no improvement attributable to the povidone-iodine skin
cleanser.” Id. at 218—219.
FF5. WO ’822 teaches PVP-iodine liposomal preparations,
which can be used to promote wound-healing. WO ’822, 12—
22 (Examples); see also id. at 8:14—16 (“In preferred
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embodiments, the invention’s preparations containing anti­
inflammatory agents may further comprise wound-healing
promoting agents known to promote epithelization.”)..
FF6. EP ’373 teaches PVP-iodine liposomal preparations,
which can be applied to wounds, skin, mucous membranes and
mucosa-like unkeratinized epithelial tissues of humans and
animals. EP ’373, 2:4-9, 3:50-52.
FF7. Krauser teaches an apparatus for treating ailments in
which “[a] supply of microbicidal agent or other medicant
within the apparatus housing is introduced into the flow stream
of the heated air by a spray device so that minute droplets of the
microbicidal agent or medicant are entrained within the flow
stream of the heated air.” Krauser, Abstract. Krauser teaches
that the preferred choice of microbicidal agents includes
povidone-iodine, which is a “highly effective, broad spectrum
topical microbicide for antiseptic use on skin, wounds and
mucosa.” Id. at 3:30-59. Krauser teaches that the apparatus
can provide regulated medicant delivery to treat acne. Id. at
6:23-30.
FF8. Buseman teaches an adhesive patch for treating acne, in
which the antiseptic agent can be povidone iodine. Buseman,
Abstract, 7:13—15. Buseman teaches that “Acne vulgaris is a
chronic disorder of the pilosebaceous follicles (apparatus)
characterized by comedones (blackheads), papules, pustules,
cysts, nodules, and often scars, that appear on the most visible
areas of the skin (e.g., the face, chest, back, neck, and upper
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arms).” Id. at 1:5—9. Buseman indicates that the type of acne
include, e.g., acne conglobate. Id. at 13:66—67.
Rejection I— Obviousness Based on Moore, Prussin, Halpern, Brown,
EP ’3 73/WO ’822, and Krauser
The Examiner finds that Moore and Prussin teach the use of iodine for
the treatment of acne, in particular Acne vulgaris. Ans. 2—3; FF1—2. The
Examiner further finds that Halpern and Brown teach the treatment of acne
using PVP-iodine (povidone-iodine). Ans. 2—3; FF3 4. The Examiner
acknowledges that Moore, Prussin, Halpern, and Brown do not teach the use
of liposomes or that the acne is caused by Acne papulopustulosa and Acne
conglobata. Ans. 3. The Examiner, therefore, relies upon EP ’373 and WO
’822 as teaching liposomal preparations of PVP-iodine that can be topically
applied to skin and mucous membranes, and that these compositions have
germicidal activity and wound healing properties. Ans. 3; FF5—6. The
Examiner further relies upon Krauser as teaching that “povidone-iodine is a
highly effective, broad spectrum topical microbicide which is not merely
bacteriostatic and kills both gram-positive and gram-negative bacterial
including antibiotic resistant strains and useful in the treatment of acne.”
Ans. 3^4; FF7.
The Examiner asserts that
[t]he use of the liposomes for the delivery of PVP-iodine
or the use of iodine in the form of PVP-iodine and the
treatment of acne would have been obvious to one of
ordinary skill in the art because of the equivalency
between iodine and PVP-iodine and the protracted
release and extended antimicrobial effect from the
liposomes taught by EP [‘373] and since WO [’822]
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teaches the administration of the compound in liposomes
for topical applications.
Ans. 4. The Examiner further asserts
[alternately the use of the liposomes of EP [‘373] or
WO [’822] for the treatment of acne would have been
obvious to one of ordinary skill in the art since the
references of Moore, Prussin, Halpem, and Brown show
that iodine compounds are known to be used for the
treatment of acne.
Id. The Examiner concludes that
[although the references do not teach the treatment of
acne caused by Acne populopustulosa and Acne
conglobata, it would have been obvious to one of
ordinary skill in the art that PVP-iodine would have been
effective against these bacteria since PVP-iodine is an
effective microbicide and kills both gram-positive and
gram-negative bacterial including antibiotic resistant
strains and useful in the treatment of acne as taught by
Krauser.
Id.
Appellants argue that a person of ordinary skill would not have been
led to treat more severe forms of acne with PVP-iodine as a single
pharmaceutically active compound in a liposome preparation. Appeal Br.
11—13. In particular, Appellants contend: “each of Moore, Prussin, Halpem,
and Brown rather requires at least one component in addition to iodine or
PVP-iodine for the treatment. For example, Moore requires propylene
carbonate; Pmssin requires hydrogen peroxide; Halpem requires a
polyhydroxy compound; and Brown requires a soap solution.” Id. at 11.
Additionally, Appellants argue that a person of ordinary skill in the art
would not have considered Krauser when developing a treatment for an
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already sensitive skin since it requires the application of heat in combination
with a microbicidal agent. Id. at 11. As such, Appellants contend that these
references teach way from an effective treatment using only PVP-iodine in
liposomes by requiring an additional component for the treatment. Id. at 13.
We are unpersuaded by these arguments. The prior art teachings cited
by the Examiner highlight the therapeutic utility of iodine, and in particular
PVP-iodine, in the topical treatment of acne. See FF1 4; FF7. Contrary to
Appellants’ arguments, the claims do not preclude any additional
“components” from being used in the treatment of acne, but rather only
require “a preparation comprising PVP-iodine as a single antiseptic
compound in a pharmaceutically effective amount combined with
pharmaceutically acceptable liposomes.” Cl. 18. Moreover, to the extent
additional “components” are used in the prior art treatment methods, we find
nothing in the cited references that would “criticize, discredit, or otherwise
discourage” the use of PVP-iodine as a “single antiseptic compound” for the
treatment of acne. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellants further argue a person of ordinary skill in the art would not
have had reason “to combine the teachings of EP ’373 or WO ’822 with that
of Moore, Prussin, Halpem or Brown . . . and reasonably expect that more
severe forms of acne, specifically Acne papulopustulosa and Acne
conglobate, can be effectively treated.” Appeal Br. 12. Appellants contend
“[tjhere are fundamental physiological differences between [the treatments
discussed in EP ’373 and WO ’822] and the treatment of more severe forms
of acne, i.e., Acne papulopustulosa and Acne conglobata.” Id. at 13.
Appellants also contend that “a person skilled in the art would have
understood that liposomes could have an unpredictable effect on the
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absorption of any free iodine and also the penetration of iodine through the
deeper dermal layers, thus modifying the effects of iodine.” Id.
We are also unpersuaded by these arguments. EP ’373 and WO ’822
both teach the beneficial use of PVP-iodine liposome preparations for
application on the skin to promote wound healing. FF5—6. Given the
known application of PVP-iodine in the treatment of acne, we find that the
skilled artisan would have found it obvious to also use liposomal
preparations of PVP-iodine in order to treat skin wounds (e.g., papules,
pustules, or abscesses) in subjects with more severe forms of acne, i.e., Acne
papulopustulosa and Acne conglobata. Moreover, Appellants cite no
support to suggest that a person of ordinary skill in the art would have
understood that liposomes could have an unpredictable effect on the
absorption and penetration of iodine through deeper dermal layers. Attorney
argument cannot take the place of evidence. In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997) (“An assertion of what seems to follow from common
experience is just attorney argument and not the kind of factual evidence that
is required to rebut a prima facie case of obviousness.”).
Appellants also argue that PVP-iodine with soap-disinfectant
(Betadine® Skin Cleanser) is not effective against more severe forms of
Acne vulgaris. Appeal Br. 14. In support, Appellants cite a study by
Millikan10 as disclosing that patients with more severe forms of acne, treated
with PVP-iodine soap solution and a supporting systemic tetracycline
therapy, failed to achieve the level of improvement observed in the group of
patients with a mild form of acne receiving the same treatment. Id. (citing
10 F.E. Millikan, A Double-Blind Study of Betadine Skin Cleanser in Acne
Vulgaris, Cutis, vol. 17, p. 394 (1976).
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Millikan, p. 395 11. 16—24, p. 398 col. 2 11. 22—31). We are not persuaded by
this argument as the Examiner’s obviousness rejection is not merely based
on applying the previously known Betadine skin cleanser to treat more
severe acne. Rather, as discussed above, the combination of prior art
references suggest that a person of ordinary skill in the art would have found
it obvious to apply a liposomal preparation of PVP-iodine in order to treat
wounds (e.g., papules, pustules, or abscesses) associated with Acne
papulopustulosa and Acne conglobata.
For the foregoing reasons, we determine that the Examiner has
demonstrated the obviousness of claim 18 over the combination of Moore,
Prussin, Halpem, Brown, EP ’373/WO ’822, and Krauser. Appellants have
not argued the rejected claims separately. Accordingly, Claims 19-32 fall
with claim 18. 37 C.F.R. § 41.37(c)(l)(iv).
Rejection II— Obviousness Based on Buseman, EP ’3 73/WO ’822,
and Krauser
The Examiner finds that “Buseman discloses compositions containing
povidone iodine for the treatment of acne caused by acne conglobata.” Ans.
5. The Examiner, however, also acknowledges that “[wjhat is lacking in
[Buseman] is the teaching of the use of liposomes for the delivery of
povidone iodine” and “the teaching that the acne is caused by Acne
populopustulosa and Acne conglobata.” Id. The Examiner relies upon the
teachings of EP ’373, WO ’822, and Krauser in the same manner as
discussed above. Based on these teachings, the Examiner asserts that it
would have been obvious to PVP-iodine liposome preparations “because of
the equivalency between iodine and PVP-iodine and the protracted release
and extended antimicrobial effect from the liposomes taught by EP [’373]
and since WO [’822] teaches the administration of the compound in
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liposomes for topical applications.” Id. at 6. With respect to the treatment
of the more severe forms of acne caused by Acne populopustulosa and Acne
conglobata, the Examiner asserts that “it would have been obvious to one of
ordinary skill in the art that PVP-iodine would have been effective against
these bacteria since PVP-iodine is an effective microbicide and kills both
gram-positive and gram-negative bacterial including antibiotic resistant
strains and useful in the treatment of acne as taught by Krauser.” Id.
Appellants argue that “the Examiner has misrepresented the teachings
of Buseman” insofar as “PVP-iodine is not listed as one of the topical acne
drugs,” and “Buseman does not even include PVP-iodine in any of the
exemplified therapeutic formulations for the treatment of acne.” Id. at 16—
17. We are not persuaded by this argument as Buseman plainly teaches that
the “[t]he therapeutic formulation can further include one or more antiseptic
agents,” wherein “[t]he antiseptic agent can be triclosan, phenoxy
isopropanol, chlorhexidine gluconate, povidone iodine, or any combination
thereof.” Buseman, 7:10-15 (emphasis added); FF8. Appellants other
arguments are similar to those discussed with respect to the rejection above.
See Appeal Br. 18—20. We find them unpersuasive for the same reasons as
set forth above.
We, therefore, determine that the Examiner has demonstrated the
obviousness of claim 18 over the combination of Buseman, EP ’373/WO
’822, and Krauser. Appellants have not argued the rejected claims
separately. Accordingly, Claims 19—32 fall with claim 18. 37 C.F.R. §
41.37(c)(l)(iv).
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SUMMARY
We affirm the rejections under 35 U.S.C. § 103(a).
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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