Ex Parte Hsiao

Patent Trials and Appeals Board

Mar 26, 2019

13752403 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/752,403 01/29/2013
11336 7590 03/28/2019
Litron Patent and Trademark Office
l IF.-2, No.248, Sec. 3, Nanjing E. Rd.
Songshan District
Taipei City, 10595
TAIWAN
FIRST NAMED INVENTOR
Lily Hsiao
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.
61 l 7.032US_Lilyl3-001 1013
EXAMINER
MUI, CHRISTINE T
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
03/28/2019 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):
miketeng@litron-intl.com
j aniceshih@litron-intl.com
laurachu@litron-intl.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LILY HSIAO
Appeal2017-006247
Application 13/752,403
Technology Center 1700
Before MICHAEL P. COLAIANNI, JEFFREY W. ABRAHAM, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1, 4, 5, 21, 22, 27-32, 37-39, 42, and 45--47 in the
above-identified application. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 The appeal record includes the following: Specification, Jan 29, 2013
("Spec."); Final Office Action, Mar. 22, 2016 ("Final Action"); Appeal Brief,
Oct. 5, 2016 ("Appeal Br."); Examiner's Answer, Jan. 18, 2017 ("Answer");
Reply Brief, Mar. 8, 2017 ("Reply Br.").
2 According to the Appeal Brief, Appellant is also the real party in interest.
Appeal Br. 1.
Appeal2017-006247
Application 13/752,403
BACKGROUND
Appellant's invention relates to "the diagnosis and treatment of the
HSV (herpes simplex virus) infection of the dermal nerve fibers (DNFs) and
free nerve endings (FNEs) in the skin." Spec. ,r 1. According to the
Specification, "HSV establishes and maintains a latent infection in the nerve
ganglion proximal to the site of primary infection," which may include the
face or the genital area. Id. ,r 2.
Independent claim 1, which we reproduce below, is representative:
1. A method for treating a symptom of red sore which breaks, leaks
pus or fluid, and forms multiple clusters of yellowish crusts
surrounded by multiple vesicopapules on a skin area of the face of
a human, the method comprising: testing whether said human is
infected with Herpes simplex virus (HSV) that causes said
symptom; if said human is infected with said HSV that causes said
symptom, orally administering to said human an agent comprising
2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]ethyl-2-
amino-3-methylbutanoate or a pharmaceutically acceptable salt
thereof.
Appeal Br. 11 ( emphasis of key phrase added). The Specification identifies
the therapeutic agent as valacyclovir. Spec. ,r 162. Claim 28, also
independent, is substantially the same, except with a slightly different
therapeutic agent. See Appeal Br. 12; Spec. ,r 162 (identifying the agent as
acyclovir); see also Spec. ,r 163 (showing the chemical structures of
acyclovir and valacyclovir). According to the Specification, acyclovir "is an
antiviral drug ... used to treat infections caused by herpes viruses," while
"[ v ]alacyclovir is a prodrug that is nearly completely converted to
[a]cyclovir and L-valine," with 99% efficiency, in the digestive system.
Spec. ,r,r 165---69.
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Appeal2017-006247
Application 13/752,403
Claims 4, 5, 21, 22, 27, 38, 42, and 46 depend from claim 1, and
claims 29-32, 37, 39, 45, and 47 depend from claim 28. Appeal Br. 11-13.
The Examiner rejects claims 1, 2 8, 3 8, 3 9, 4 2, and 4 5--4 7 under 3 5
U.S.C. § 103(a) as being unpatentable over Kaminester3 in view ofEmmert. 4
Final Action 3-5. The Examiner rejects claims 4, 5, 21, 22, and 29-32 under
35 U.S.C. § 103(a) as being unpatentable over Kaminester in view of
Emmert and Beauchamp. 5 Id. at 5---6. The Examiner rejects claims 27 and 37
under 35 U.S.C. § 103(a) as being unpatentable over Kaminester in view of
Emmert and Pointe Scientific. 6 Id. at 6-7. 7
Appellant presents separate arguments only with respect to
independent claims 1 and 28, and these arguments are substantially the
same. See Appeal Br. 6-9. Therefore, under 37 C.F.R. § 4I.37(c)(l)(iv), we
limit our discussion to the rejection of independent claim 1 over Kaminester
and Emmert. Claims 4, 5, 21, 22, 27-32, 37-39, 42, and 45--47 fall with
claim 1.
DISCUSSION
The Examiner finds that Kaminester teaches all the limitations of
claim 1, except it does not teach that the recited symptoms appear on a skin
area of the face. Final Action 3--4. In particular, the Examiner finds that
3 Lewis H. Kaminester, Sexually Transmitted Diseases: An Illustrated Guide
to Differential Diagnosis (rev. ed. 1991) ("Kaminester").
4 David H. Emmert, Treatment of Common Cutaneous Herpes Simplex Virus
Infections, 61 Am. Fam. Physician 1697 (2000) ("Emmert").
5 Beauchamp, US 4,957,924 (issued Sept. 18, 1990).
6 Package Insert from Pointe Scientific, Inc., HSV IgG, Catalog No. T8007-
96, Rev. 8-12 (2012).
7 The Examiner has withdrawn a rejection under the written description
requirement of 35 U.S.C. § 112. Answer 7.
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Appeal2017-006247
Application 13/752,403
Kaminester discloses that the RSV-induced symptoms include a "red sore"
that (1) "breaks, leaks pus or fluid," and (2) "form[ s] multiple clusters of
yellowish crusts surrounded by multiple vesicopapules." Answer 7-8 (citing
Kaminester 8). Although Kaminester relates specifically to genital herpes,
the Examiner cites Emmert "as an evidentiary reference that the herpes
simplex virus and its symptoms are also found on the face." Id. at 8. Based
on Emmert, the Examiner finds that "[t ]he symptoms of the herpes simplex
virus on the genital area and the face are considered to be the same." Id.
The Examiner further finds that "both the Kaminester and Emmert
reference[ s] teach the use of acyclovir and valacyclovir as normal and
regular treatments of the herpes simplex virus." Id. In light of the above, the
Examiner determines that a person of ordinary skill in the art would have
had reason "to modify the method of Kaminester to detect and treat the form
of HSY on an individual's face with an agent treatment such as acyclovir
since this is a common cutaneous version of herpes and can effectively treat
the infection and duration of the oral lesions." Final Action 4.
Appellant argues that Kaminester does not show or describe "multiple
clusters of yellowish crusts surrounded by multiple vesicopapules" in any of
its pictures or text. Appeal Br. 6. Appellant acknowledges that Kaminester
teaches that symptoms include "a cluster of grouped vesicles." Appeal Br. 3;
see Kaminester 8 ("A primary genital herpes infection usually begins with an
erythematous rash that develops into a cluster of grouped vesicles on a red
base."). However, Appellant argues that this passage in Emmert "can mean
ONLY ONE cluster of vesicles instead of MULTIPLE clusters of vesicles."
Reply Br. 3. Appellant also argues that it is improper to combine Kaminester
and Emmert, because they discuss symptoms in separate patients, and they
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Appeal2017-006247
Application 13/752,403
discuss symptoms located in different areas of the body. Appeal Br. 6-7;
Reply Br. 3--4. 8
We do not find these arguments persuasive of reversible error.
Kaminester notes that HSV may cause symptoms at "multiple genital and
extragenital sites." Kaminester 8. Therefore, a person of ordinary skill in the
art would have expected that acyclovir and valacyclovir----drugs known for
suppressing RSV-would treat the HSV symptom of "multiple clusters of
yellowish crusts surrounded by multiple vesicopapules," on the face as well
as in the genital area. Emmert supports this conclusion, because in addition
to depicting multiple vesicopapules on the face, see Emmert Fig. 2, it
teaches that treating orolabial herpes with acyclovir "accelerates loss of
crusts"-referring to "crusts" in the plural, id. at 5.
Furthermore, the number of "clusters of yellowish crusts" does not
appear to be material to the Examiner's rationale for rejecting the claims.
"The combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results." KSR Int'!
Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). The Examiner has shown by a
8 In the Reply Brief, Appellant introduces new evidence to show that genital
herpes does not cause symptoms on the mouth or face, because in genital
herpes, HSV lies dormant in a bundle of nerves at the base of the spine, and
when it reactivates, it travels to the genital area, rather than the face. Reply
Br. 4 (citing Am. Sexual Health Ass'n, Herpes Signs and Symptoms,
http://www.ashasexualhealth.org/ stdsstis/herpes/ signs-symptoms/). We do
not consider this evidence because it is not responsive to an argument raised
in the Answer. See 37 C.F.R. § 4I.41(b)(2). Moreover, the evidence is not
material to the Examiner's rationale for rejecting the claims, given the
Examiner's finding, based on Emmert, that a skilled artisan would have
understood HSV can manifest the same symptoms on the face as in the
genital area. See Answer 8.
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Appeal2017-006247
Application 13/752,403
preponderance of the evidence that claim 1 recites the treatment of an HSV
infection, showing generally familiar symptoms, with known antiviral
agents, with a predictable outcome. Whether the symptoms include one
cluster or multiple clusters, or whether the symptoms appear in the genital
region or on the face, the Examiner has shown that a skilled artisan would
have had reason to treat an HSV infection with antivirals acyclovir or
valacyclovir, with a reasonable expectation of success.
For the above reasons, the preponderance of the evidence supports the
Examiner's conclusion of obviousness, and Appellant has not shown
reversible error. We therefore affirm the rejection of claims 1, 4, 5, 21, 22,
27-32, 37-39, 42, and 45--47.
DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended. See 37 C.F.R. §§ 1.136(a)(l )(iv), 41.50([)
(2018).
AFFIRMED
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