Ex parte Melin

Board of Patent Appeals and Interferences

Dec 21, 1998

08121663 (B.P.A.I. Dec. 21, 1998)

Application for patent filed September 15, 1993. According to appellant, the application is a continuation of1
Application 07/562,413, filed August 2, 1990, now abandoned, which is a continuation of Application 07/222,810, filed July 22,
1988, now abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 44
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte CHRISTIAN MELIN
_____________
Appeal No. 95-2633
Application 08/121,6631
______________
ON BRIEF
_______________
Before McKELVEY, Senior Administrative Patent Judge, and SCHAFER and LEE, Administrative
Patent Judges.
SCHAFER, Administrative Patent Judge.
Decision on Appeal Under 35 U.S.C. § 134
Appeal No. 95-2633
Application 08/121,663
2
This appeal is from a decision of a primary examiner rejecting claims 1-5, 7-9, and 11-15. We
reverse the rejection of claims 1-4 and affirm the rejection of claims 5, 7-9 and 11-15.
The invention relates to a process for refining olive oil (claims 1-4), a refined olive oil made by the
process (claim 5) and parenteral and enteral formulations including the refined olive oil (claims 7-9 and 11-
15). See the Appendix to Appellant’s Appeal Brief (Appendix) found at
pp 13-16 of applicant’s brief.
In arguing the rejection, applicant does not argue the patentability of the dependent claims separate
from the independent claims from which they depend. Brief, p. 6. So we could decide this appeal on the
basis of independent claims 1, 14 and 15. However, claim 5 is a product-by-process and requires
treatment separate from the other claims dependent on claim 1. Accordingly we decide this appeal on the
basis of claims 1, 5, 14 and 15, which are reproduced below:
1 . A process for making a purified olive oil for use in enteral and parenteral
nutritional formulations, the method comprising:
providing an olive oil sample to be purified having a previously determined
oleic acid content;
neutralizing the oleic acid present in the oil by contacting the oil sample
with an amount of a saturated aqueous solution of alkaline carbonate equivalent to
two to ten times the weight of oleic acid present in the oil sample, allowing an
aqueous phase to separate and washing the oil with water until complete neutrality
to provide a neutralized oil sample; and
drying and decolouring the neutralized oil sample by contacting the
neutralized oil sample with bleaching earth under an inert atmosphere at a
temperature of between about 20°C to about 80°C to provide a purified oil
product having an acceptably low amount of peroxides, free acids and pigments
for enteral and parenteral nutritional administration.
5. A[n] olive oil, suitable for use as an enteral or parenteral foodstuff, wherein
the oil is obtained by the process defined in claim 1.
Appeal No. 95-2633
Application 08/121,663
3
14. A parenteral formulation including a purified olive oil product obtained by
a method comprising:
providing an olive oil sample to be purified having a previously determined
oleic acid content;
neutralizing the oleic acid present in the oil by contacting the oil sample
with an amount of a saturated aqueous solution of alkaline carbonate equivalent to
two to ten times the weight of oleic acid present in the oil sample, allowing an
aqueous phase to separate and washing the oil with water until complete neutrality
to provide a neutralized oil sample; and
drying and decolouring the neutralized oil sample by contacting the
neutralized oil sample with bleaching earth under an inert atmosphere at a
temperature of between about 20°C to about 80°C to provide a purified oil
product having an acceptably low amount of peroxides, free acids and pigments
for parenteral and nutritional administration.
15. An enteral formulation including a purified olive oil product obtained by a
method comprising:
providing an olive oil sample to be purified having a previously determined
oleic acid content;
neutralizing the oleic acid present in the oil by contacting the oil sample
with an amount of a saturated aqueous solution of alkaline carbonate equivalent to
two to ten times the weight of oleic acid present in the oil sample, allowing an
aqueous phase to separate and washing the oil with water until complete neutrality
to provide a neutralized oil sample; and
drying and decolouring the neutralized oil sample by contacting the
neutralized oil sample with bleaching earth under an inert atmosphere at a
temperature of between about 20°C to about 80°C to provide a purified oil
product having an acceptably low amount of peroxides, free acids and pigments
for enteral and nutritional administration.
Appendix, pp. 13-16. Claims 5, 14 and 15 are product-by-process claims which incorporate or
specifically recite the steps of claim 1.
Appeal No. 95-2633
Application 08/121,663
Issued March 28, 1989, based on an application filed August 7, 1986. 2
Issued February 5, 1985, based on an application filed July 6, 1982.3
4
The examiner rejects all claims under 35 U.S.C. § 103(a) over the combined teachings of U.S.
Patents 4,816,189 (Rothbart) and 4,497,800 (Larson). Examiner’s Answer, pp. 3-5. The examiner also2 3
separately rejected claims 7-9 and 11-15 over Larson alone. Examiner’s Answer, p. 6
The Rothbart patent is directed to a process for refining “edible frying oils,” particularly soybean
oils. Rothbart, col. 1, lines 6-9. Rothbart describes the process at col. 3, lines 12-21:
In general, the process involves the steps of: treating unrefined, unbleached
soybean oil with a caustic agent; heating and water washing the treated oil; . . .
dispersing into the oil a minor amount of finely divided, activated metallic salts and
oxides including bleaching earths, clays, etc., and heating the resulting dispersion
in a carbon dioxide atmosphere to a temperature between about 212 degrees F.
to about 260 degrees F. for a predetermined time.
About 212° to about 260°F is the same as about 100° C to about 125°C.
The examiner has identified three differences between the claimed process and the Rothbart patent:
(1) the express recitation of olive oil, (2) the express recitation of the amount of carbonate used to neutralize
the oleic acid, and (3) the temperature used to dry and decolor (bleach) the neutralized oil. Examiner’s
Answer, p. 4. The examiner concluded that none of these differences would have rendered the claimed
invention unobvious and presented argument supporting his conclusion. Examiner’s Answer, p. 4.
Applicant’s brief challenges the examiner’s conclusion only with respect to the temperature difference.
Brief, pp. 9-10.
In the examiner’s view “to modify the time and temperature at which the oil of Rothbart is treated
is seen to be an obvious matter of choice with regard to the particular oil treatment conditions which are
desired.” Examiner’s Answer, pp. 4-5. Missing from the examiner’s rationale is any explanation as to why
one having ordinary skill in the art would be motivated to modify the process by using a lower temperature.
Appeal No. 95-2633
Application 08/121,663
In this regard, we note that bleaching of vegetable oils, such as olive oil, subsequent to4
deacidification is typically carried out at a temperature of 90-110°C under a vacuum. 23 Kirk-Othmer Encyclopedia of
Chemical Technology, pp. 717, 724-26 (3rd Ed., 1983).
5
“The mere fact that the prior art may be modified in the manner suggested by the Examiner does not make
the modification obvious unless the prior art suggested the desirability of the modification.” In re Fritch, 972
F.2d 1260, 1266, 23 USPQ2d 1780, 1784-85 (Fed. Cir. 1992); In re Gordon, 733 F.2d 900, 902, 221
USPQ 1125, 1127 (Fed. Cir. 1984). Nothing in the prior art relied upon by the examiner in rejecting the
process claims suggests the desirability of using a temperature of “about 20°C to about 80°C. ” 4
The rejection of claims 1-4 is reversed.
As we indicated above, claims 5, 14 and 15 are product-by-process claims. While
product-by-process claims are limited by and defined by the process, determination of patentability is
based solely on the product itself. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir.
1985); In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972); In re Pilkington, 411 F.2d
1345, 1348, 162 USPQ 145, 147 (CCPA 1969). The patentability of a product does not depend on its
method of production. Thorpe 777 F.2d at 697, 227 USPQ at 966; Pilkington, 411 F.2d at 1348, 162
USPQ at 147. If the product in a product-by-process claim is the same as or obvious from a product of
the prior art, the claim is unpatentable even though the prior product was made by a different process.
Thorpe 777 F.2d at 697, 227 USPQ at 966; In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-93
(Fed. Cir. 1983). Thus, in evaluating the patentability of product-by-process claims we compare the
claimed product with the product described in the prior art. The comparison includes the expressly
claimed properties and characteristics as well as those implicitly resulting from the process.
Claim 5 is directed to an olive oil “suitable for use as an enteral or parenteral foodstuff.” Claims
14 and 15 are directed to parenteral and enteral formulations, respectively, “including a purified olive oil
product . . . having an acceptably low amount of peroxides, free acids and pigments” for enteral,
parenteral and nutritional administration. Thus the issue with respect to the product-by-process claims
Appeal No. 95-2633
Application 08/121,663
6
is whether the prior art teaches or suggests an olive oil having these characteristics. More specifically, does
the prior art teach or suggest an olive oil “suitable for use as an enteral or parenteral foodstuff” or an olive
oil containing formulation having an “acceptably low amount of peroxides, free acids and pigments” suitable
for enteral, parenteral, and nutritional administration.
The examiner relies on the Larson patent as evidence that the product-by-process claims are not
patentable. Larson relates to liquid diet formulations. Larson’s disclosed formulation includes “a lipid
[(fat)] component of safflower oil or a suitable equivalent.” Larson, col. 4, lines 33-34 (emphasis and
bracketed material added). Larson goes on to teach that the
fatty component in the diet may be provided in various forms. Natural fat
components such as, for example, safflower oil, soybean oil, corn oil, cotton seed
oil, coconut oil, olive oil, and the like, may be used.
Larson, col. 5, lines 29-32 (emphasis added). While the patent exemplifies the use of safflower oil, the
above-quoted language expressly teaches that olive oil is a “suitable equivalent” to safflower oil. In view
of this clear suggestion and direction, it would have been prima facie obvious for one having ordinary skill
in the art to use olive oil in the Larson formulations.
Larson also teaches that it
is intended that this composition be used for enteral feeding, either orally or by
intubation, for patients suffering from malnourishment and conditions associated
therewith as well as for maintenance of patients with compromised digestive and/or
absorptive function which can arise from a variety of causes.
Larson, col 4, lines 56-62. Thus, Larson expressly teaches a foodstuff suitable enteral feeding. The olive-
oil containing formulations suggested by Larson meet the limitation of claim 5 that the formulation be
“suitable for use as an enteral or parenteral foodstuff.”
The Larson formulations also appear to meet the limitations of claims 14 and 15, that the
formulations have “an acceptably low amount of peroxides, free acids and pigments” for both enteral and
parenteral and nutritional administration. Larson’s teaching that the diet formulation is suitable for
Appeal No. 95-2633
Application 08/121,663
7
“maintenance of patients with compromised digestive and/or absorptive function” suggests that the
formulations may also be used for parenteral administration. Since the Larson formulations are nutritionally
complete and are useful for enteral and parenteral administration, the formulations implicitly have an
“acceptably low amount of peroxides, free acids and pigments.”
Based on the record before us, a prima facie case of obviousness has been made out with respect
to the subject matter of claims 5, 14 and 15. The burden, thus shifted to applicant to demonstrate that the
olive oil-containing formulations suggested by Larson do not possess the characteristics set out in the
claims. Thorpe, 777 F.2d at 697, 227 USPQ at 966. The PTO does not have the ability to manufacture
products or to obtain and compare prior art products. In re Best, 562 F. 2d 1252, 1255, 195 USPQ 430,
433-34 (CCPA 1977). Applicant has not sustained this burden.
Applicant argues that Larson fails “to describe or suggest . . . that the olive oil used should be free
from harmful lipid peroxides . . . .” (Emphasis added.) Brief, p. 11. Applicant relies on inventor Melin’s
declaration as evidence that refining olive oil at a temperature of about 100°C would produce harmful lipid
peroxides. Melin testifies:
[I]f a neutralized and washed olive oil sample is contacted with the bleaching earth
and the sample is heated in an inert atmosphere at a temperature of about 100°C.
for a period of about 35 minutes and is filtered and analyzed, that thermal oxidation
of that oil sample will occur so that the resulting product will contain undesirable
amounts of peroxide contaminants and possibly other harmful lipid oxidation
products.
Melin Declaration, p. 2, ¶ 4.
The problem with applicant’s argument is that claims 5, 14 and 15 do not require that the olive oil
“be free from harmful lipid peroxides.” The claims only require that the olive oil be “suitable for use as an
enteral or parenteral foodstuff” or have “acceptably low amount of peroxides, free acids and pigments for”
enteral, parenteral and nutritional administration. In our view, Larson suggests olive oil-containing
formulations which meet the claim requirements. The Melin declaration does not demonstrate that the olive
Appeal No. 95-2633
Application 08/121,663
8
oil-containing formulations suggested by Larson do not have the characteristics required by claims 5, 14,
and 15.
The rejection of claims 5, 7-9 and 11-15 is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended
under 37 CFR § 1.136(a). 37 CFR § 1.196(f).
AFFIRMED-IN-PART
)
FRED E. McKELVEY, Senior )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
RICHARD E. SCHAFER )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
JAMESON LEE )
Administrative Patent Judge )
Appeal No. 95-2633
Application 08/121,663
9
Appeal No. 95-2633
Application 08/121,663
10
HILL, STEADMAN & SIMPSON
85th Floor Sears Tower
Chicago, Illinois 60606