Ex Parte Wang et al

Patent Trial and Appeal Board

Feb 28, 2017

14032556 (P.T.A.B. Feb. 28, 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.
14/032,556 09/20/2013 Yi-Lan Wang ETH5614USDIV1 6153
27777 7590 03/02/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
DAVIS, DEBORAH A
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
03/02/2017 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):
j nju spatent @ coru s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YI-LAN WANG and XINTIAN MING1
Appeal 2015-007953
Application 14/032,556
Technology Center 1600
Before ERIC B. GRIMES, ROBERT A. POLLOCK, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of hemostatic treatment, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that “Golden Moss is considered a plant-
based Traditional Chinese Medicine (TCM) that has been used for the
treatment of rheumatism, lumbago, sciatica and dysuria. Cibotium barometz
1 Appellants identify the Real Party in Interest as Ethicon, Inc. (Br. 3.)
Appeal 2015-007953
Application 14/032,556
(also called Golden Moss, Fern Lamb of Tartary, or Gou-Ji) has been
traditionally used as anti-inflammatory and analgesic.” (Spec. 19.)
Claims 11 and 18—22 are on appeal. Claim 11 is representative and
reads as follows:
11. A method of providing a hemostatic treatment to a bleeding site,
comprising the steps of applying topical hemostatic preparation comprising:
an extract of the rhizomes of Golden Moss, a gelatin, and a saline solution to
the bleeding site, wherein the gelatin is a powder as an absorbable
hemostatic powder matrix.
The claims stand rejected as follows:
Claims 11 and 18—22 under 35 U.S.C. § 103(a) based on Wu2 and
Wolff3 (Ans. 2) and
Claims 11 and 18—22 under 35 U.S.C. § 103(a) based on Epstein4 and
CN ’9165 (Ans. 4).
I
The Examiner has rejected all of the claims on appeal as obvious
based on Wu and Wolff. The Examiner finds that Wu teaches that the
“rhizome hairs of Cibotium barometz is an anti-inflammatory and can be
used as a poultice on wounds to stop bleeding.” (Ans. 3.) The Examiner
2 Wu et al., The constituents of Cibotium barometz and their permeability in
the human Caco-2 monolayer cell model, 125 J. Ethnopharmacology
417-422 (2009).
3 Wolff, US 7,923,431 B2, issued April 12, 2011.
4 Epstein, US 6,045,570, issued April 4, 2000.
5 CN 101317916 (A), published Dec. 10, 2008. Our citations are to the
English translation of record (abstract only).
2
Appeal 2015-007953
Application 14/032,556
also finds that Wu teaches “active compounds . . . isolated from an aqueous
ethanol extract from the rhizomes of Cibotium barometz(Id.)
The Examiner finds that Wolff teaches “a hemostatic bleeding control
composition . . . [that] preferably comprises an absorbable gelatin and a
saline solution.” (Id.) The Examiner concludes that “both Wu et al. and
Wolff teach[] hemostat agents to stop bleeding wounds and thus [it] would
be obvious to further add or combine compositions that are useful for the
same purpose.” (Id. at 4.)
Appellants argue that Wu “notes that the yellow hairs on the rhizomes
[of Golden Moss] have been used in poultices to stop bleeding” (Br. 5) but
“to the extent Wu contemplates using the Golden Moss as a hemostatic
agent; the material is not an extracted material, but the ‘hairs’ in a poultice”
(id. at 6). Appellants argue that there is no evidence showing that the
compounds extracted by Wu have hemostatic activity and “[therefore, the
record lacks any basis for one to reasonably expect that an extract from the
Golden Moss, as opposed to the hairs of Golden Moss, could be combined
with gelatin and saline to produce a topical hemostatic preparation.” (Id.)
We agree with Appellants that the cited references do not support a
prima facie case of obviousness. The rejection cites Wu as disclosing an
extract from rhizomes of Golden Moss containing compounds with
hemostatic activity. This finding is not supported by the evidence.
Wu discloses that “[t]he rhizome of Cibotium barometz is anti­
inflammatory” and “[t]he yellow hairs on the rhizomes are used in poultices
on wounds to stop bleeding.” (Wu 417, right col.) Wu discloses that “[t]he
dried rhizomes removed [sic] the smaller roots and yellow hairs of Cibotium
3
Appeal 2015-007953
Application 14/032,556
barometz (7 kg) were powdered and extracted with 70% aqueous ethanol.”
{Id. at 418, left col.) Wu states that column chromatography (CC)
“separations from 70% aqueous ethanol extract of dried rhizomes of
Cibotium barometz have led to the isolation of: three sesquiterpenes . . . and
an unusual orthoester spiropyranosyl derivative of proto-catechuic acid.”
{Id. at 419, right col.) Wu states that the intestinal permeability of three of
the compounds was tested in an in vitro model system; one was found to be
well-absorbed and two were found to be poorly absorbed. {Id. at 422, left
col.)
Wu does not disclose that any of the compounds isolated from its
ethanol extract, or the ethanol extract itself, has any hemostatic activity. It
states that the yellow hairs on the rhizomes of Golden Moss have been used
to stop bleeding, but it also states that its extract was derived from “dried
rhizomes removed [sic] the smaller roots and yellow hairs.” {Id. at 418, left
col.) Wu also states that “[t]he rhizomes are harvested at the end of the
growing season, the smaller roots and yellow hairs are removed then the
rhizomes are chipped into slices and dried for later use.” {Id. at 417, right
col.)
Thus, we understand Wu to say that its extract was derived from
rhizomes from which the yellow hairs had been removed. Only the yellow
hairs are disclosed for hemostatic use. In view of these disclosures, we
agree with Appellants that Wu would not have made obvious the use of an
extract of the rhizomes of Golden Moss in a hemostatic composition. We
therefore reverse the rejection of claims 11 and 18—22 based on Wu and
Wolff.
4
Appeal 2015-007953
Application 14/032,556
II
The Examiner has rejected all of the claims on appeal as obvious
based on Epstein and CN ’916. The Examiner finds that Epstein teaches a
biological sealant comprising gelatin, saline or water, and thrombin that is
introduced to a site of bleeding. (Ans. 5.) The Examiner finds that CN ’916
“teaches a medicine for treating uterine bleeding comprising Cibotium
barometz as an active ingredient.” (Id.) The Examiner concludes that it
would have been obvious to substitute Cibotium barometz for the thrombin
in Epstein’s composition “because both Cibotium barometz and thrombin
powder are used to control bleeding and thus possess hemostatic properties.”
(Id.)
Appellants argue, among other things, that “[ajbnormal uterine
bleeding is medically indicated when there is an irregularity of timing,
volume, frequency or duration and occurs in the absence of pregnancy.”
(Br. 7, citing Committee Opinion.6) Appellants argue that “the standard of
care treatments for abnormal uterine bleeding is preferably medical therapy
and then surgical management. Examples of medical therapy are hormone
treatment and alternatively administration of antifibrinolytic drugs.” (Id.)
“Therefore, the current standard of care for abnormal uterine bleeding does
not suggest the use of topical delivery of hemostatic gelatin materials.” (Id.
at 8.)
6 Committee Opinion, Management of Acute Abnormal Uterine Bleeding in
Nonpregnant Reproductive-Aged Women, The American College of
Obstetricians and Gynecologists, Committee on Gynocologic Practice, April
2013 (of record).
5
Appeal 2015-007953
Application 14/032,556
We agree with Appellants that the evidence does not support the
Examiner’s position that topical application of a composition comprising
gelatin, saline, and an extract of Golden Moss, as required by the claims on
appeal, would have been obvious based on the cited references.
Epstein discloses a “biological sealant comprising a gelatin slurry . . .
[that] contains gelatin, saline or water and thrombin” and is used for
“occlusion of vascular access sites, other puncture sites and natural tracts in
the human body.” (Epstein, abstract and 1:41—42.)
CN ’916 discloses “a medicine for curing uterine bleeding” that
contains Cibotium barometz, among other things. (CN ’916, abstract.) CN
’916 states that “[t]he preparation method includes decocting the raw
materials and then manufacturing into granules or filling into medicinal
bags.” (Id.) CN ’916 states that “the medicine of the present invention is a
safe and effective prescription and fills the gap in clinical treatment of
uterine bleeding.” (Id.) CN ’916 does not describe how its medicine is
administered.
Committee Opinion states that acute abnormal intrauterine bleeding
(AUB) refers to an episode of heavy bleeding that requires immediate
intervention to prevent further blood loss. (Committee Opinion 1, left col.)
Committee Opinion states that “[mjedical therapy is considered the preferred
initial treatment (Table 2). However, certain situations may call for prompt
surgical management.” (Id. at 3, right col.) Table 2 shows that “medical
therapy” refers to intravenous or oral administration of hormones or
tranexamic acid. (Id. at 4.) Tranexamic acid is an antifibrinolytic drug that
prevents fibrin degradation. (Id. at 5, left col.)
6
Appeal 2015-007953
Application 14/032,556
Committee Opinion also states that “[o]nce the acute episode of
bleeding has been controlled, multiple treatment options are available for
long-term treatment.” (Id.) The treatments “include the levonorgestrel
intrauterine system, OCs [oral contraceptives] . . . , progestin therapy (oral or
intramuscular), tranexamic acid, and nonsteroidal anti-inflammatory drugs.”
(Id.) Finally, Committee Opinion states that “[djesmopressin may help treat
acute AUB in patients with von Willebrand disease.” (Id.)
Thus, none of the treatments for intrauterine bleeding described by
Committee Opinion involves topical application of a therapeutic
composition. On balance, we conclude that a preponderance of the evidence
of record does not support the Examiner’s position that “[although the
uterus is inside the body cavity, one skilled in the art would reasonably
understand that a hemostat that form clots on the inside of the body would
be capable of forming blood clots on the outside of the body (i.e. topical)”
and therefore a skilled artisan would have considered it obvious to topically
apply a composition comprising the medicine of CN ’916 in order to treat
bleeding. (Ans. 11.)
In summary, a preponderance of the evidence does not support a
conclusion that topical application of a composition comprising an extract of
Golden Moss, gelatin, and saline would have been obvious based on Epstein
and CN ’916. We therefore reverse the rejection based on those references.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
7