Ex Parte 8900639 et al

Patent Trial and Appeal Board

Dec 13, 2017

90013599 (P.T.A.B. Dec. 13, 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.
90/013,599 10/01/2015 8900639 4280.092838REX 6534
24978 7590 12/14/2017
GREER, BURNS & CRAIN, LTD
300 S. WACKER DR.
SUITE 2500
CHICAGO, IL 60606
EXAMINER
CAMPELL, BRUCE R
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
12/14/2017 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 VANWORLD PHARMACEUTICAL (RUGAO) COMPANY
LIMITED,
Patent Owner and Appellant
Appeal 2017-008831
Reexamination Control 90/013,599
Patent 8,900,639 B2
Technology Center 3900
Before JAMES T. MOORE, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal by the Patent Owner from the
Examiner’s final rejection of claims 1—4 in the above-identified ex parte
reexamination of U.S. Pat. No. 8,900,639 B2. The Board’s jurisdiction for
this appeal is under 35 U.S.C. §§ 6(b), 134(b), and 306.
We reverse the decision of the Examiner rejecting claims 1-4.
Appeal 2017-008831
Reexamination Control 90/013,599
Patent 8,900,639 B2
BACKGROUND
This appeal involves U.S. Pat. No. 8,900,639 B2 (“the ’639 patent”)
which issued December 2, 2014. A Request for Reexamination was filed by
a Third-Party Requester on October 1, 2015 pursuant to 35 U.S.C. §§ 302—
307 and 37 C.F.R. § 1.510.
The real party-in-interest is identified in the Appeal Brief (“App. Br.”)
as Vanworld Pharmaceutical (Rugao) Company Limited. App. Br. 1. A
hearing was held Oct. 25, 2017. A transcript of the hearing will be entered
into the record in due course.
Claims 1—4 are pending and stand rejected by the Examiner under pre-
AIA 35 U.S.C. § 103(a) as obvious in view of Shen (Chinese Invention
Patent Publication CN 1205233A, published Jan. 20, 1999) and Seki
(Chinese Invention Patent Publication CN 1237632A, published Dec. 8,
1999). Final Action (“Final Act.”) 4.
Claim 1, the only independent claim on appeal, reads as follows:
A process for obtaining a rabbit skin extract, said process
comprising:
i) inoculating a rabbit subcutaneously with a vaccinia
virus, wherein said subcutaneous injection is 0.1-0.4 ml of a
vaccinia virus solution containing 106-109 viral particles per one
milliliter per each injection site, wherein the total number of
injections is from 100 to 250 per rabbit, wherein the rabbit
weighs 1.5-3 kg;
ii) feeding and monitoring the rabbit for at least 72 hours
to monitor development of skin inflammation;
iii) sacrificing the rabbit between 72 and 96 hours after
inoculation;
iv) harvesting the inflamed rabbit skin within 15 minutes
of step iii) and preserving the inflamed rabbit skin at -18 degree
C.;
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Reexamination Control 90/013,599
Patent 8,900,639 B2
v) obtaining a rabbit skin extract by treating the inflamed
rabbit skin obtained in step iv) with a 3% phenol solution at 4
degree C. for at least 72 hours, wherein the ratio between said
rabbit skin and said phenol solution is at least 1 :4 by weight;
vi) processing said rabbit skin extract from step v) to
obtain a rabbit skin extract with a pH of 4.5;
vii) incubating said processed rabbit skin extract from
step vi) with activated charcoal;
viii) eluting said processed rabbit skin extract from the
activated charcoal from step vii) under a basic pH, thereby
obtaining the rabbit skin extract.
REJECTION
The claims comprises eight steps, numbered i) to viii), for preparing
an extract of rabbit skin. The rabbit skin extract is prepared by “inoculating
a rabbit subcutaneously with a vaccinia virus,” harvesting the inflamed skin,
and extracting it with a phenol solution. The ’639 patent teaches that the
extract can be used as an analgesic. ’639 patent, col. 2,11. 40-47.
The Examiner found that Shen teaches intracutaneous injection of
vaccinia virus into a rabbit for producing an analgesic drug. Ans. 2; Shen,
Abstract. The Examiner further found:
Shen discloses a method [of extracting inflamed rabbit skin]
almost exactly as claimed. The differences between Shen and
the claimed method are the storage temperature for harvested
skin in step iv) (-80° vs -18°) and the phenol concentration in
step v) (3.5X by weight of 2% solution vs. 4X by weight 3%
solution).
Ans. 3.
The Examiner states that “Generally, differences in concentration or
temperature will not support the patentability of subject matter encompassed
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Patent 8,900,639 B2
by the prior art unless there is evidence indicating such concentration or
temperature is critical.” Id.
The Examiner also cited Seki for the following teaching:
Seki discloses a method of obtaining a rabbit skin extract for
the purpose of producing an analgesic drug therefrom. Rabbits
were injected intracutaneously at 50, 150 or 200 sites, with each
site receiving 0.2 ml of antigen containing 106or 107 vaccinia
virus particles per ml.
Id. at 2—3.
Patent Owner argues that neither Shen not Seki teach subcutaneous
injection as claimed, but instead only disclose intracutaneous injection.
App. Br. 10-11. Subcutaneous injection is injection of the vaccinia virus
underneath the cutaneous layer of the skin; intracutaneous injection is
injection of the virus into the cutaneous layer of the skin.
In the Final Action, the Examiner found that both Shen and Seki teach
intracutaneous injection, but the Examiner did not provide a reason as to
why one of ordinary skill in the art would have injected the virus
subcutaneously as claimed. The Examiner stated that the ’639 patent
specification states that the preferred vaccination route is subcutaneous
(Ans. 5), but did not address the fact that no other route is disclosed in the
patent.
The Examiner stated there is no “explanation of how such a large
volume of solution could be injected into the skin of a rabbit without the
viral antigen also reaching subcutaneous tissues (Seki discloses injecting 0.4
ml at 200 sites for a total of 80 ml; see Abstract),” but provided no evidence
that the solution was injected subcutaneously as claimed. The Examiner
also cited disclosure in Shen that the vaccinated rabbits experienced
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Patent 8,900,639 B2
subcutaneous edema, but did not explain why this means the solution was
injected subcutaneously, when Shen explicitly disclosed intracutaneous
injection. Shen 8 (Example 3). The “subcutaneous edema” referenced by
the Examiner occurred after the intracutaneous injection when the
inflammation “grew well” and the skin had “thickened.” Id. Thus, the
appearance of the subcutaneous edema was well after injection had been
made and is not evidence that the injection site was subcutaneous.
In making an obviousness determination, “it can be important to
identify 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 Inti Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). Here, the
Examiner has not provided an adequate reason for injecting vaccinia virus
subcutaneously, rather than intracutaneously as in Shen and Seki. For
example, the Examiner’s statements about the locations of intracutaneous
and subcutaneously being anatomically adjacent (Ans. 5) is not a sufficient
reason to choose subcutaneous when neither Shen nor Seki disclose this
route.
In the Request for Reexamination, the Requester stated:
However, the reference [Shen] discloses that as a result of the
injection, “the inflammation grew well, with the color of skin
turning from red to mauve, accompanied by thickened skin and
subcutaneous edema.” See CN 1205233A Example 2 at page 7
lines 15-21, Example 3 at page 8, lines 26-32, and Example 4,
page 9, lines 36-42. The specification of the ’639 patent (col. 2,
lines 4-9) discloses that the rabbit’s “skin tissues are
sufficiently inflamed is effected when the rabbit skin
inflammatory tissue shows visible blains accompanying with
changing colour from redness to mauveness and becomes thick,
and its subcuticle and hip become swollen.” Accordingly, the
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result on the skin inflammation from intracutaneous injection is
the same as the result from subcutaneous injection, and it would
be a routine matter and obvious to one ordinarily skilled in the
art to use either intracutaneous injection or subcutaneous
injection to obtain the same or substantially the same result.
Request 55.
This argument is not persuasive.
First, as discussed by Patent Owner, routes of administration differ
depending upon the specific virus which is administered. App. Br. 11. As
an example, Patent Owner states “IPV and Hib inoculates must be
administered intramuscular, while the measles inoculate is administered
subcutaneously.” Id., 12. Seki also teaches that “inflammatory tissues
having higher inhibiting activity of kallidinogenase production could be
obtained in greater yields by intracutaneous vaccination” (Seki 3), indicating
the preference for intracutaneous administration. Thus, the teaching in Shen
and Seki of intracutaneous injection is not a teaching of subcutaneous.
Second, while Requester contends that the skin inflammation is the
same with both subcutaneous and intracutaneous injection, the cited
description, indeed, shows differences, such as the appearance of visible
blains in the method of the patent. Request 55. Furthermore, the fact that
both routes show inflammation of the skin when vaccinia virus is injected is
not evidence that the administration routes are interchangeable and obtain
the same results on the pertinent physiological levels. Requester did not
provide evidence that the pertinent inflammatory responses are the same and
produce the same physiological substances and cells. For example, reaching
this conclusion in the absence of persuasive evidence would be like
concluding that a bacterial infection is the same as a viral infection simply
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because they both produce a fever, a sequelae of almost any infection.
Furthermore, Seki teaches that methods were known for producing an
inflammatory response in rabbit tissues, but a “detailed method for obtaining
inflammatory tissues containing physiological active substances with high
yield and high quality is still unknown.” Seki 3. Moreover, as stated by the
attorney of record at the Oral Hearing held on October 25, 2017, the
subcutaneous immune response is “different type of response” from an
intracutaneous immune response. See Record of Oral Hearing 15:25—16:6.
In sum, because the evidence is not adequate to establish the
obviousness of claim 1 over Shen and Seki, the rejection of claim 1, and
dependent claims 2-4, are reversed.
REVERSED
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