Ex Parte Khachik

Board of Patent Appeals and Interferences

Feb 20, 2009

11330423 (B.P.A.I. Feb. 20, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte FREDERICK KHACHIK
__________

Appeal 2008-63531
Application 11/330,423
Technology Center 1600
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Decided: February 20, 2009
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Before FRED E. McKELVEY, Senior Administrative Patent Judge, and
ERIC GRIMES and RICHARD M. LEBOVITZ, Administrative Patent
Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claim 22, the only
claim pending. The Examiner has rejected the claim on the basis that it's

1 This appeal and the appeal in related application 11/702,486 (Appeal 2009-
2557) involve the same issue. Consolidated oral argument was held for the
two cases on Feb. 11, 2009.
Appeal 2008-6353
Application 11/330,423

limitations lack adequate written description. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
This appeal arises out of an application for reissue of U.S. Patent
5,382,714, originally issued Jan. 17, 1995. The ‘714 patent discloses a
“method of isolating, purifying and recrystallizing substantially pure lutein”
(‘714 patent, abstract). “Lutein is a naturally occurring carotenoid that has
no vitamin A activity” (id. at col. 1, ll. 8-9).
Claim 22 is the only pending claim and reads as follows:
Claim 22. A method for providing lutein to humans which comprises:
(a) providing a lutein composition suitable for human consumption
having (1) at least about 90% lutein having been extracted and purified from
plant extracts which contain 10% or less of non-lutein carotenoids, (2) no
traces of toxic chemicals that would render the lutein composition unsuitable
for human consumption and (3) significantly less than about 10% of non-
lutein carotenoids obtained by purification of said plant extracts; and
(b) administering said lutein composition to a human.
NEW MATTER REJECTIONS
The Issue
The Examiner has rejected claim 22 under 35 U.S.C. §§ 251 and 112,
first paragraph, on the basis that the claim contains new matter in its
recitation of a “lutein composition suitable for human consumption having at
least about 90% lutein . . . [and] no traces of toxic chemicals” (Answer 3,
4).2

2 In stating the rejections, the Examiner also included as a basis of new
matter the phrases “10% or less of non-lutein carotenoids” and “significantly
2
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Application 11/330,423

The Examiner’s position is that the ‘714 patent would have been
understood by those skilled in the art to disclose that lutein suitable for
human consumption is at least 97% pure, not 90% pure as stated in the claim
(Answer 5), and that the ‘714 patent “also does not provide adequate support
for a lutein compos[i]tion, suitable for human consumption, which
comprises no traces of toxic chemicals that would render the said
composition [un]suitable for human consumption” (id. at 4).
Appellant contends that, when the ‘714 patent is considered as a
whole, it adequately describes lutein composition meeting both of the
limitations that the Examiner objects to (see, e.g., Appeal Br. 14-15).
The issue presented is: Did the Examiner err in finding that a person
of ordinary skill in the art would not have recognized in the disclosure of the
‘714 patent a description of a lutein composition, suitable for human
consumption, having “at least about 90% lutein” and “no traces of toxic
chemicals”?
Findings of Fact
1. The ‘714 patent discloses a “method of isolating, purifying and
recrystallizing substantially pure lutein” (‘714 patent, abstract).
2. The ‘714 patent discloses that “[t]here has been recent evidence to
suggest that lutein . . . possesses strong antioxidant capabilities and may be
useful in reduction of the incidence of cancer” (id. at col. 1, ll. 58-62).
less than 10% of non-lutein carotenoids” (Answer 3, 4). The Examiner,
however, made clear that these limitations were not considered to introduce
new matter into the claim. (Id. at 6-7: “[T]he Examiner does not take issue
with the language ‘which contain 10% or less of non-lutein carotenoids…’
or the language ‘significantly less than 10% of non-lutein carotenoids.’”)
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Application 11/330,423

3. The ‘714 patent discloses that “[p]ure lutein, free from chemical
contaminants and suitable for human consumption, is needed to design and
conduct proper human interventional studies” (id. at col. 2, ll. 7-10).
4. The ‘714 patent discloses that “substantially pure lutein, if
economically available, could be used in cancer prevention studies, as well
as an attractive, naturally occurring, non-harmful color additive in human
foods” (id. at col. 3, ll. 1-4).
5. The ‘714 patent discloses that the objectives of its invention
include “provid[ing] purified lutein in crystalline form such that it is
acceptable for human consumption and use in cancer prevention trials” and
“provid[ing] purified lutein in crystalline form such that it is acceptable as a
color additive in human food” (id. at col. 3, ll. 17-24).
6. The ‘714 patent discloses “an efficient method of isolating,
purifying, and recrystallizing substantially pure lutein preferably from a
saponified marigold oleoresin. . . . Lutein, in pure form may be used as an
analytical standard and in cancer prevention trials, and as a safe and
effective color additive in human foods.” (Id. at col. 3, ll. 31-39.)
7. The ‘714 patent discloses that the purification method involves
“series of filtrations and water/alcohol washes to obtain crude lutein
crystals,” followed by recrystallization of the crude lutein crystals to produce
lutein in high purity (id. at col. 3, ll. 39-47).
8. The ‘714 patent discloses that “the purified lutein is required not to
contain even traces of any toxic chemicals” (id. at col. 4, ll. 16-17).
9. The ‘714 patent discloses that the crude lutein crystals before
recrystallization are “normally about 70% pure” (id. at col. 4, l. 48).
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Appeal 2008-6353
Application 11/330,423

10. The ‘714 patent discloses that “[w]hile 70% pure lutein may be
acceptable for use in animal feed, further purification of this compound may
be employed to produce lutein with purity greater than 97% for human
consumption” (id. at col. 4, ll. 49-52).
11. The ‘714 patent discloses that, after recrystallization, the purity of
“the resulting lutein is usually greater than 90%, most often greater than
97%” (id. at col. 5, ll. 17-18).
12. The ‘714 patent provides two working examples, each of which is
said to result in lutein with a purity of greater than 97% (id. at col. 6, ll. 13-
14, 54-55).
Principles of Law
The Examiner
“bears the initial burden . . . of presenting a prima facie case of
unpatentability.” In re Oetiker, 977 F.2d 1443, 1445, 24
USPQ2d 1443, 1444 (Fed. Cir. 1992). Insofar as the written
description requirement is concerned, that burden is discharged
by “presenting evidence or reasons why persons skilled in the
art would not recognize in the disclosure a description of the
invention defined by the claims.” . . . If . . . the specification
contains a description of the claimed invention, albeit not in
ipsis verbis (in the identical words), then the examiner . . ., in
order to meet the burden of proof, must provide reasons why
one of ordinary skill in the art would not consider the
description sufficient.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
“In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). The written description requirement is
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satisfied if the disclosure conveys with reasonable clarity to those skilled in
the art that the inventor was in possession of the invention. See id.
Analysis
The Examiner has rejected claim 22 on the basis that two limitations
of the claim lack adequate descriptive support in the ‘714 patent: a lutein
composition “suitable for human consumption having . . . at least about 90%
lutein” and having “no traces of toxic chemicals” (Answer 3-4).
With respect to the latter limitation, we agree with Appellant (Reply
Br. 10) that the ‘714 patent’s disclosure that “the purified lutein is required
not to contain even traces of any toxic chemicals” provides adequate support
for a lutein composition that contains “no traces of toxic chemicals that
would render the lutein composition unsuitable for human consumption,” as
recited in claim 22.
With respect to the limitation that the lutein composition has at least
about 90% lutein and is suitable for human consumption, the Examiner
relies on the following statement in the ‘714 patent: “While 70% pure lutein
may be acceptable for use in animal feed, further purification of this
compound may be employed to produce lutein with purity greater than 97%
for human consumption” (FF 10). The Examiner finds that “[n]owhere, in
the original disclosure, can it be found that the newly added concept of
lutein with a purity greater than 90% and/or a lutein composition having at
least about 90% lutein is suitable for human consumption” (Answer 5-6).
On this issue as well, we conclude that the Examiner has not
adequately shown that those skilled in the art would not have recognized that
Appellant was in possession of the claimed composition based on the
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disclosure of the ’714 patent as a whole. The ‘714 patent discloses that its
objectives included providing lutein suitable for human consumption (FF 5).
The ‘714 patent characterizes such compositions as “substantially pure” (FF
4) and discloses a process for producing recrystallized, “substantially pure,”
lutein (FF 6). The ‘714 patent discloses that its process of purifying lutein
results, after recrystallization, in lutein with a purity that is “usually greater
than 90%, most often greater than 97%” (FF 11).
We agree with Appellant that, when the ‘714 patent is read as a
whole, it would have been understood by those skilled in the art to describe
substantially pure lutein compositions that are suitable for human
consumption and have a purity that is “usually greater than 90%,” or in the
words of claim 22, “at least about 90%.”
The passage that the Examiner focuses on is not to the contrary. The
‘714 patent states that “further purification . . . may be employed to produce
lutein with purity greater than 97% for human consumption” (FF 10,
emphasis added). That passage makes clear that the disclosed method
makes possible lutein compositions with greater than 97% purity, and that
such compositions would be suitable for human consumption, but it does not
say that only lutein compositions with 97% purity are suitable for human
consumption. For the reasons discussed above, we conclude that the ‘714
patent’s disclosure would have been recognized by those of skill in the art to
be broader than Examiner’s interpretation of it.
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OBJECTION TO AMENDMENT
The Issue
The Examiner has objected to a proposed amendment, filed Jan. 10,
2006, to the ‘714 patent’s Specification (Answer 3). The amendment
requests the following change: “While 70% pure lutein may be acceptable
for use in animal feed, further purification of this compound may be
employed to produce lutein with a purity greater than [97%] 90% for human
consumption” (Appeal Br. 13, quoting proposed amendment to ‘714 patent,
col. 4, ll. 49-52). The Examiner objects to the proposed amendment on the
basis that the disclosure of “lutein with a purity greater than 90% for human
consumption” introduces new matter into the disclosure (Answer 3).
Appellant contends that the proposed amendment does not introduce
new matter for the same reason that the limitation of claim 22 is adequately
supported by the disclosure of the ‘714 patent (Appeal Br. 26).
Principles of Law
Where the new matter is confined to amendments to the
specification, review of the examiner’s requirement for
cancelation is by way of petition. But where the alleged new
matter is introduced into or affects the claims, thus
necessitating their rejection on this ground, the question
becomes an appealable one, and should not be considered on
petition even though that new matter has been introduced into
the specification also.
(Manual of Patent Examining Procedure, § 608.04(c).)
Analysis
The Examiner’s objection to the amendment filed Jan. 10, 2006 is
based on the same new matter issue underlying the rejections of claim 22
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under 35 U.S.C. §§ 251 and 112, first paragraph. Therefore, the issue is
properly reviewed by way of appeal rather than petition. As discussed in
detail above, we conclude that the disclosure of the ‘714 patent, considered
as a whole, would have been recognized by those of skill in the art to show
possession of a lutein composition suitable for human consumption and
having at least about 90% purity. We therefore conclude that the proposed
amendment does not introduce new matter into the disclosure of the ‘714
patent.
CONCLUSIONS OF LAW
The Examiner erred in finding that a person of ordinary skill in the art
would not have recognized in the disclosure of the ‘714 patent a description
of a lutein composition, suitable for human consumption, having “at least
about 90% lutein” and “no traces of toxic chemicals.”
SUMMARY
We reverse the rejection of claim 22 under 35 U.S.C. §§ 251 and 112,
first paragraph, and the objection to the amendment filed Jan. 10, 2006.

REVERSED

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