AMRYT RESEARCH LIMITED

Patent Trials and Appeals Board

Dec 8, 2020

2020003176 (P.T.A.B. Dec. 8, 2020)

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.
16/010,995 06/18/2018 Armin SCHEFFLER AMRT-003/03US 1099
58249 7590 12/08/2020
COOLEY LLP
ATTN: IP Docketing Department
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
12/08/2020 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):
zIPPatentDocketingMailboxUS@cooley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ARMIN SCHEFFLER
__________

Appeal 2020-003176
Application 16/010,995
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, DAVID COTTA, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for enhancing the rate of reepithelialization of a wound using betulin. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Parties in Interest as Amryt
Research Limited and Birken AG (see Appeal Br. 3). We have considered
the Specification of June 18, 2018 (“Spec.”); Final Office Action of Feb. 4,
2019 (“Final Action”); Appeal Brief of Nov. 1, 2019 (“Appeal Br.”);
Examiner’s Answer of Jan. 23, 2020 (“Ans.”); and Reply Brief of Mar. 23,
2020 (“Reply Br.”). An oral hearing was held on Dec. 1, 2020.

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Statement of the Case
Background
“Oleogels are based on a nonpolar liquid, for example, an oil, a wax,
or a paraffin, to which a gel-forming agent is added to achieve the desired
physical properties” (Spec. ¶ 3). In “the pharmaceutical field, oleogels are
used for topical applications. . . . Oleogels have pronounced thixotropy, i.e.,
they liquefy in the event of mechanical action and subsequently resolidify”
(id. ¶ 4). “The use of a highly dispersed triterpene as an oleogel-forming
agent and an oleogel having a highly dispersed triterpene as an oleogel-
forming agent are described” in the prior art (id. ¶ 5).
Triterpenes, such as betulin, lupeol, betulinic acid, oleanolic
acid, and similar compounds, are renewable raw materials
which occur in comparatively high concentrations in birch bark,
but which also occur in other plants or plant components, e.g.,
in rosemary leaves, mistletoes, or apple peels. Betulin,
betulinic acid, lupeol, and oleanolic acid are pentacyclic
triterpenes, of which the three first mentioned have a lupane
framework.
(id. ¶ 11). “The object of the invention is to provide an effective
preparation, which is simple to produce, for healing wounds of the skin, in
particular for healing chronic wounds” (id. ¶ 7).
The Claims
Claims 1–15 are on appeal. Claim 1 is the sole independent claim, is
representative and reads as follows:
1. A method for enhancing the rate of reepithelialization of a
wound, comprising administering to the wound an oleogel
comprising a triterpene fraction, wherein the triterpene fraction
comprises betulin.

Appeal Br. (Claims App.).

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The Rejections
A. The Examiner rejected claims 1–13 and 15 under 35 U.S.C. § 103(a)
as obvious over Scheffler ’285,2 Tolstikov,3 and Broughton II4 (Final Act.
3–7).
B. The Examiner rejected claim 14 under 35 U.S.C. § 103(a) as obvious
over Scheffler ’285, Tolstikov, Broughton II, and Scheffler ’7895 (Final Act.
7–10).
C. The Examiner rejected claims 1–15 under 35 U.S.C. § 103(a) as
obvious over Scheffler ’285, Scheffler ’789, Harish,6 Kuno,7 and Broughton
II (Final Act. 10–13).
D. The Examiner rejected claims 1–15 on the ground of nonstatutory
double patenting as being unpatentable over claims 3–18 of U.S. Patent No.
8,828,444,8 Tolstikov, and Scheffler ’285 (Final Act. 15–16).

Appellant addresses the obviousness and obviousness-type double-
patenting rejections together. Because we agree that the same issues relate
to each of these rejections, we will also address the rejections together.

2 Scheffler, US 2007/0299285 A1, published Dec. 27, 2007.
3 G. A. Tolstikov et al., Betulin and Its Derivatives. Chemistry and
Biological Activity, 13 Chemistry for Sustainable Development 1–29 (2005).
4 Broughton II et al., Wound Healing: An Overview, 117 Plast. Reconstr.
Surg. 1e-S–4e-S (2006).
5 Scheffler, US 2003/0087789 A1, published May 8, 2003.
6 B. G. Harish et al., Wound healing activity and docking of glycogen-
synthase-kinase-3-β-protein with isolated triterpenoid lupeol in rats, 15
Phytomedicine 763–7 (2008).
7 Kuno et al., US 2003/0133958 A1, published July 17, 2003.
8 Scheffler, US 8,828,444 B2, issued Sept. 9, 2014.
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The Examiner finds that Scheffler ’285 teaches “an oleogel forming
agent which comprises at least one highly dispersed triterpene” that is “in an
amount ranging from 1% by weight to 20% by weight” (Final Act. 3–4).
The Examiner finds Scheffler ’285 teaches the “betulin content is
advantageously more than 80% by weight, based on the triterpene content”
and that “betulin is well known in the art to have antiseptic properties, anti-
inflammatory effects and antiviral action” (id. at 4).
The Examiner acknowledges that Scheffler ’285 “lack a specific
disclosure on wound healing or reepithelization rate” (Final Act. 5). The
Examiner finds Tolstikov teaches “antiseptic properties of betulin, due to
which this compound began to be used as a plaster for sterilization of
wounds and cuts” (id.). The Examiner finds Broughton II teaches
“Epithelialization, angiogenesis, granulation tissue formation, and collagen
deposition are the principal steps in this building portion of wound healing.
Epithelialization occurs early in wound repair” (id. at 6).
The Examiner finds it obvious to apply the Scheffler ’285 betulin
containing oleogel to wounds because the prior art teaches “triterpines such
as betulin [are] known for wound healing” (Final Act 6–7).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner’s conclusion that the cited prior art
combinations render the claims obvious?
Findings of Fact
1. Scheffler ’285 teaches: “Oleogels are used for topical
application, in particular in the pharmaceutical field” (Scheffler ’285 ¶ 4).
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2. Scheffler ’285 teaches the “oleogel-forming agent according to
the present invention has at least one highly dispersed triterpene . . . such as
betulin, lupeol” (Scheffler ’285 ¶¶ 8–9).
3. Scheffler ’285 teaches the “antiseptic properties of betulin were
demonstrated as early as 1899, so it was used for sterilizing wound dressings
and bandages (Scheffler ’285 ¶ 12).
4. Scheffler ’285 teaches the “oleogel produced in this way is
suitable for treatment of a wide variety of skin diseases in humans and
animals. Examples include actinic keratoses and basalioma in humans and
mastitis in mammals” (Scheffler ’285 ¶ 40).
5. Tolstikov teaches the “antiseptic properties of betulin, due to
which this compound began to be used as a plaster for sterilization of
wounds, cuts” (Tolstikov 21, col. 2).
6. Tolstikov teaches betulin compositions “exhibit wound healing
activity” (Tolstikov 22, col. 1).
7. Broughton II teaches: “Epithelization begins shortly after
wounding and is first stimulated by inflammatory cytokines, IL-1 and TNF-
α, upregulate keratinocyte growth factor (KGF) gene expression in
fibroblasts” (Broughton 3e-S, col. 1).
8. Scheffler ’789 also teaches an emulsion comprising betulin that
can be topically applied to human skin (Scheffler ’789 ¶¶ 39–40, 97–101).
9. Harrish teaches “[l]upeol has been proved to be one of the
potent wound healing agent which has been shown to elicit the cutaneous
wound healing” (Harrish 766, col. 2).
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10. Kuno teaches “an external agent for the skin comprising at least
. . . betulin and physiologically acceptable salts thereof or derivatives
thereof” (Kuno ¶ 11).
11. Kuno teaches “betulinic acid and betulin belong to the lupane-
type triterpenes and it is known that they are substances existing in a variety
of plants . . . Betulinic acid is a kind of lupane-type triterpenes . . . and it is
known that the compound shows . . . a wound-healing promoting function”
(Kuno ¶¶ 61–62).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). It is important to provide “a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
“[I]nherency may supply a missing claim limitation in an obviousness
analysis.” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1194–95
(Fed. Cir. 2014); see also Endo Pharm. Sols., Inc. v. Custopharm Inc., 894
F.3d 1374, 1381 (Fed. Cir. 2018) (“An inherent characteristic of a
formulation can be part of the prior art in an obviousness analysis even if the
inherent characteristic was unrecognized or unappreciated by a skilled
artisan.”). “The inherent teaching of a prior art reference” is a “question of
fact.” In re Napier, 55 F.3d 610, 613 (Fed.Cir.1995).
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Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–7, FF 1–11). We agree that the prior art renders the claims
obvious. We address Appellant’s arguments below.
1. Rational underpinning
Appellant contends:
The cited references do not teach applying an oleogel to a
wound. Rather, they are limited to other specific uses of an
oleogel (as described in more detail below in Section VII.B.5)
or to betulin and its use in wound healing generally as an
antiseptic, or as an anti-inflammatory agent. Contrary to the
Examiner’s conjecture, the skilled person would recognize that
an agent that has a positive effect on wound healing overall
would not necessarily have any particular effect on
reepithelialization. In the particular case of betulin, the skilled
person would in fact expect it to have a negative effect on
reepithelialization.
(Appeal Br. 10).
We find these arguments unpersuasive. While Scheffler ’285 only
teaches an oleogel comprising betulin (FF 2) that can be topically applied
(FF 1) for treatment of a variety of conditions (FF 4), Tolstikov expressly
teaches betulin compositions “exhibit wound healing activity” (FF 6). In the
Sumeray Declaration,9 Dr. Sumeray states: “In my expert opinion, the
references cited by the Examiner teach that betulin is an anti-infective, anti-
inflammatory agent and can be useful in wound healing overall, and that the
process of wound healing involves re-epithelialization” (Sumeray Decl.
¶ 12). Dr. Sumeray further states “the references presented by the Examiner
discuss the use of betulin for application to wound dressings or generally as

9 Declaration of Dr. Mark Sumeray, dated May 29, 2019.
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a ‘wound healing agent’” (Sumeray Decl. ¶ 13). We are not persuaded that
appellant has overcome the plain teaching of Scheffler and Tolstikov,
supported by Dr. Sumeray, that betulin may usefully be applied to wounds
for wound healing. See In re Zelinski, 329 F.2d 977, 981 (CCPA 1964)
(“Appellant has submitted no proof to the contrary . . . We do not feel that
appellant has overcome the plain teaching of the references.”).
We, therefore, agree with the Examiner that Scheffler and Tolstikov
plainly suggest administering an oleogel comprising a betulin fraction to
wounds for the purpose of wound healing because betulin was a known
wound-healing agent (see Ans. 5; FF 1–6).
We recognize, but are not persuaded by, Appellant’s argument that
“nothing in the references that would have suggested to the skilled person
that betulin or betulin-containing formulations may be applied to a wound
and would have a positive effect on the rate of reepithelialization of the
wound” (Appeal Br. 11). Appellant also contends “the skilled person would
know not to apply the general teaching of the cited references (sterilization
and anti-inflammatory activity of betulin) to the particular situation where
re-epithelialization is needed” (Reply Br. 3).
Because the Examiner has established that it would have been obvious
to apply an oleogel comprising betulin to a wound, and because
administration of the same oleogel as disclosed by the Specification to the
same wounds as disclosed by the Specification would necessarily obtain the
same result as that obtained by the Specification, we find that the process
rendered obvious by the cited references inherently discloses enhancing the
rate of reepithelization. (see, e.g., Spec. ¶ 31; Millennium Pharm., Inc. v.
Sandoz, Inc., 862 F.3d 1356, 1365 (Fed. Cir. 2017) (citing Par Pharm., 773
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F.3d at 1195.) (“A result is obvious when it is ‘the natural result flowing
from the operation as taught,’ or a ‘property that is necessarily present’ when
applying a process disclosed in the prior art.”)).
Here, the evidence of record supports the Examiner’s position that
administration of the oleogel containing betulin to wounds would necessarily
result in reepithelialization as the Specification teaches in “wound healing,
the oleogel promotes the reepithelialization” (Spec. ¶ 31). Thus, while the
prior art may have been unaware that the obvious application of betulin to
wounds would necessarily and inherently result in reepithelialization,
“[i]nherency is not necessarily coterminous with the knowledge of those of
ordinary skill in the art. Artisans of ordinary skill may not recognize the
inherent characteristics or functioning of the prior art.” MEHL/Biophile Int’l
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999). Appellant
provides no evidence that some wounds require reepithelialization and
others do not, while Broughton II teaches that reepithelialization occurs in
all wounds generally (FF 7).
The preamble statement in claim 1 that application of an oleogel
containing betulin to wounds is “[a] method for enhancing the rate of
reepithelialization of a wound” at best represents recognition of a new
benefit of a method suggested by the prior art. However, “[i]t is a general
rule that merely discovering and claiming a new benefit of an old process
cannot render the process again patentable.” In re Woodruff, 919 F.2d at
1578; see also Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d
1368, 1376–77 (Fed. Cir. 2001) (“However, the claimed process . . . consists
of the same steps as described by [the cited art]. Newly discovered results of
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known processes directed to the same purpose are not patentable because
such results are inherent.”).
2. Expectation of success
Appellant contends
the skilled person would have expected any use of betulin to
have a positive effect with respect to inhibition or clearance of
infection, but would have understood that that would be
coupled with a reduced inflammatory response. The skilled
person would further know that reducing the inflammatory
response would have a dampening effect on the mechanisms of
reepithelialization. . . .
The skilled person would have had no reasonable expectation of
success in a method of enhancing the rate of reepithelialization
of a wound via application of betulin or a betulin-containing
formulation to that wound. Instead, the skilled person would
have expected, if one were to apply a betulin-containing
formulation to a wound, that infection may be cleared but that
reepithelialization would be inhibited. Thus, no reasonable
expectation of arriving at the claimed subject matter can be
found in the cited references.
(Appeal Br. 13).
We find this argument unpersuasive because the skilled artisan would
have had a very strong expectation of success in applying an oleogel
containing betulin to a wound, whether directly or indirectly by application
to a bandage or plaster that was itself applied to a wound (FF 3, 5, 6).
“Obviousness does not require absolute predictability of success . . . all that
is required is a reasonable expectation of success.” In re Kubin, 561 F.3d
1351, 1360 (Fed. Cir. 2009).
Insofar as this argument is directed to the inherent result of applying
the oleogel containing betulin to a wound, the evidence in the Specification
supports the inherency of reepithelization upon administration of the oleogel
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containing betulin to a wound (Spec. ¶ 31). Appellant provides no evidence
that the result would not be inherent, rather simply arguing that the artisan
would be unaware that this inherent result would be an additional benefit
resulting from treatment of wounds with oleogels containing betulin.
However, “[i]t matters not that those of ordinary skill heretofore may not
have recognized these inherent characteristics.” In re Cruciferous Sprout
Litigation, 301 F.3d 1343, 1350 (Fed. Cir. 2002).
3. Inherency
Appellant contends
the Office is using inherency principles that relate to
anticipation, and not to obviousness. Appellant submits that the
subject matter was, in fact, not present in the prior art reference,
since, for example, there is no reference or combination of
references that actually teach applying the claimed oleogel to a
wound and, importantly, the prior art does not recognize the
reepithelialization property of the claimed oleogel. Not only
does the prior art fail to recognize the reepithelialization
property, but in fact the skilled person would have specifically
expected the claimed formulation not to have this property
because of its known anti-inflammatory properties, as described
in detail above.
(Appeal Br. 15).
We find this argument unpersuasive for several reasons. First,
“inherency may supply a missing claim limitation in an obviousness
analysis.” Par, 773 F.3d at 1194–95. There is a further requirement that the
evidence shows the inherent result is a necessary and natural result of the
obvious method. Id. at 1195. In the current case, the Specification and other
evidence of record reasonably supports the finding that reepithelialization is
a necessary and natural result of treating a wound with an oleogel containing
betulin (see, e.g., Spec. ¶ 31). Second, Appellant provides no rebuttal
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evidence that this would not be the necessary and natural result. See In re
Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and
prior art products are identical or substantially identical . . . the PTO can
require an applicant to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product . . . Whether the
rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie
obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art products.”). Third,
as discussed above, ignorance of the inherent, necessary, and natural result
does not render the claim unobvious because “[i]t matters not that those of
ordinary skill heretofore may not have recognized these inherent
characteristics.” Cruciferous Sprout, 301 F.3d at 1350.
4. Teaching away
Appellant contends the “cited references teach away from the claimed
method for enhancing the rate of reepithelialization of a wound for similar
reasons as those set forth in the preceding sections, that is, that the skilled
person would have expected an inhibition rather than enhancement of the
rate of reepithelialization” (Appeal Br. 16).
We do not find this argument persuasive. “The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from . . . because such disclosure does not criticize, discredit, or otherwise
discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004). Here, none of the cited prior art teaches away from applying
oleogel compositions containing betulin to wounds. Indeed, Tolstikov
specifically teaches applying betulin to wounds as it has wound healing
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activities (FF 6) and Harrish and Kuno both teach similar triterpene
compounds that also have wound healing properties (FF 9, 11).
We recognize that Dr. Sumeray asserts that anti-inflammatory
properties of betulin might have led the artisan to expect “betulin to impede
the rate of re-epithelialization” (Sumeray Decl. ¶ 12). However, Dr.
Sumeray also acknowledges that “the references cited by the Examiner teach
that betulin . . . can be useful in wound healing overall” (id.). Thus, overall,
Dr. Sumeray supports the obviousness of applying betulin to wounds, but
simply argues the ordinary artisan would have been unaware of the natural
and necessary further benefit of betulin of enhancing reepithelialization.
This does not constitute a teaching away from performing the method, but
rather ignorance of the inherent result of the method. As we have already
noted, “[i]t matters not that those of ordinary skill heretofore may not have
recognized these inherent characteristics.” Cruciferous Sprout, 301 F.3d at
1350.
5. Teaching claim limitations
Appellant contends Tolstikov’s teachings are
either limited to applying betulin to objects to sterilize those
objects, or it is coupled with disclosure relating to other wide-
ranging activities of betulin that do not involve application to a
wound but rather are more likely to involve oral or systemic
administration. There is nothing to indicate to the skilled
person that one should apply the betulin to a wound.
(Appeal Br. 18).
We remain unpersuaded by this argument. Tolstikov’s teachings
reasonably suggest the application of betulin to wounds. Tolstikov’s
teaching that betulin was used as a plaster for sterilization of wounds
reasonably supports either direct application of betulin to the wound or
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indirect application via betulin soaked into the plaster or bandage (FF 5).
Tolstikov’s teaching that betulin has wound healing activity (FF 6) provides
a reason to apply betulin topically to a wound. To the extent that Appellant
argues Tolstikov does not anticipate claim 1, we find this argument
unpersuasive because the rejection is for obviousness, not anticipation. “[A]
person of ordinary skill has good reason to pursue the known options within
his or her technical grasp. If this leads to the anticipated success, it is likely
the product not of innovation but of ordinary skill and common sense.”
KSR, 550 U.S. at 421. In this case, applying a known wound healing agent
such as betulin (FF 6) in a oleogel composition containing betulin that was
known to be topically applied to human skin (FF 1, 4) would have
reasonably been an obvious, common sense treatment of wounds.
6. Hindsight
Appellant contends
the Office alleges that “an oleogel comprising betulin and
taught to be applied to a wound, would necessarily affect the
reepithelialization step in the same manner as claimed.”
(emphasis added; Advisory Action). This is impermissible
hindsight reconstruction. The art does not teach applying an
oleogel comprising betulin to a wound, for the reasons
discussed above. To make the jump from sterilization of wound
dressings (as in Scheffler ‘285 and ‘789) or general “wound
healing” disclosure (as in Tolstikov and Kuno) to application of
an oleogel comprising betulin to a wound of a patient, one of
ordinary skill in the art would have had to find motivation in the
art to do so.
(Appeal Br. 19).
We are aware that hindsight bias may plague determinations of
obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966). We note
that KSR rejected the rigid application of the teaching, suggestion and
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motivation test argued by Appellant, but rather stated that the “combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results.” KSR, 550 U.S. at 416.
As already discussed extensively above, the combination of Scheffler ’285
and Tolstikov reasonably suggests treating wounds with an oleogel
containing betulin. We also remain persuaded that performing the obvious
method would necessarily and naturally result in reepithelialization
consistent with the Specification (Spec. ¶ 31). Appellant provides no
evidence to the contrary. Best, 562 F.2d at 1255.
Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that the cited prior art renders the claims obvious.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–13, 15 103 Scheffler ’285,
Tolstikov,
Broughton II
1–13, 15
14 103 Scheffler ’285,
Tolstikov,
Broughton II,
Scheffler ’789
14
1–15 103 Scheffler ’285,
Scheffler ’789,
Harish, Kuno,
Broughton II
1–15
1–15 Obviousness-
type Double-
Patenting
U.S. Patent No.
8,828,444,
Tolstikov, Scheffler
1–15
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
’285
Overall
Outcome
1–15

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