Ex Parte Destaillats et al

Patent Trial and Appeal Board

Oct 21, 2016

12935829 (P.T.A.B. Oct. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/935,829 09/30/2010
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
10/25/2016
FIRST NAMED INVENTOR
Frederic Destaillats
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.
3712036-1181 7306
EXAMINER
THAKOR, DEV ANG K
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/25/2016 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FREDERIC DESTAILLATS, JEAN-BAPTISTE BEZELGUES,
FABIOLA DIONIS!, and CRISTINA CRUZ-HERNANDEZ1
Appeal2015-001427
Application 12/935,829
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1Appellants state the real party-in-interest is Nestec S.A. App. Br. 2.
Appeal2015-001427
Application 12/935,829
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 3, and 5-20.2 Specifically, claims 1,
3, 5-9, 16, and 19 stand rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Koss et al. (US 7,033,629 B2, April
25, 2006) ("Koss") and Ponroy (US 5,591,479, January 7, 1997) ("Ponroy").
Claim 17 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Koss and Ruxandra Bunea et al.,
Evaluation of the Effects of Neptune Krill Oil on the Clinical Course of
Hyperlipidemia, 9(4) ALT. MED. REV. 420-28 ("2004") ("Farrah"). 3
Claims 10-15, 18, and 20 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination Ponroy, Farrah,
Elswyk (US 2003/0060509 Al, March 27, 2003) ("Elswyk"), Pridmore-
Merten (WO 2005/074719 Al, August 18, 2005) ("Pridmore-Merten"), and
Viva Labs, Krill Oil Versus Fish Oil ("Viva Labs").
Claims 10-15, 18, and 20 also stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of Prosise (US
2005/0260302 Al, November 24, 2005) ("Prosise"), Ponroy, Farrah,
Elswyk, and Viva Labs.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
2 Claims 2 and 4 are canceled. See Final Act. 2.
3 Although Dr. Bunea is the first author of this reference, both Appellants
and the Examiner use another author's surname ("Farrah") to refer to this
reference. We herein follow their practice to avoid confusion in the record.
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Application 12/935,829
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to maternal food compositions
comprising long-chain polyunsaturated fatty acids ("LC-PUPA"). Abstract.
REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
Claim 1: A maternal food composition comprising a
source of lipids, wherein the source of lipids includes at least one
LC-PUPA that is docosahexaenoic acid (DHA) in a form
selected from the group consisting of phospholipids (PL) and
their lyso derivatives, and wherein the maternal food
composition is to be consumed during a pregnancy or a lactation
period, the composition comprising a source of carbohydrates
providing 40% to 80% of the total energy of the composition and
a source of fat providing 20% to 30% of the total energy of the
composition.
App. Br. 39.
FINDINGS OF FACT
F. 1: Farrah teaches:
Krill oil has a unique biomolecular profile of
phospholipids naturally rich in omega-3 fatty acids and diverse
antioxidants significantly different from the usual profile of fish
oils. The association between phospholipids and long-chain
omega-3 fatty acids highly facilitates the passage of fatty acid
molecules through the intestinal wall, increasing bioavailability
and ultimately improving the omega-3:omega-6 fatty acid ratio.
Farrah 421 (footnotes omitted).
F. 2: Example 1 of Appellants' Specification discloses that
supplementation of the maternal diet with DHA-PL or DHA-TG has an
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Application 12/935,829
influence on the level of DHA in the retina of newborn Sprague-Dawley
rats. Spec. 15.
F. 3: Example 1 of Appellants' Specification discloses that, at 14 days of
life, DHA-PL shows a moderately superior effect than DHA-TG. However,
at 21 days the opposite effect was observed. Spec. 15.
F. 4: Example 1 of Appellants' Specification discloses that, after the
weaning period, the animals received only a-linolenic acid as a source of n-3
fatty acids. Spec. 15.
F. 5: Example 1 of Appellants' Specification discloses that, after 3 months
under that diet, the analysis of the fatty acid composition of the retina
revealed that the level of DHA is statistically higher in animals fed with the
DHA-PL than those fed with DHA-TG or the control group. Spec. 15.
F. 6: Example 1 of Appellants' Specification discloses that Flicker ERG
experiments performed on newborns at day 21 show that DHA-PL treatment
improves rod sensitivity. Spec. 15 (citing Spec. Fig. 6).
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are prima facie obvious over the cited prior art
references. We address below the arguments raised by Appellants.
A. Claims 1, 3, 5, 8, 9, 16, and 19
Issue
Appellants argue that, despite the Examiner's finding that the
combined cited prior art teaches or suggests all of the limitations of the
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Application 12/935,829
claims, the Examiner erred by ignoring the surprising and unexpected results
disclosed in Appellants' Specification. App. Br. 8.
Analysis
Appellants do not dispute that the combined references teach or
suggest all of the limitations in the claims at issue, nor do they dispute any
motivation to combine the references. However, Appellants point to
Example 1 of their Specification, which they argue discloses unexpected and
surprising results. App. Br. 8. Appellants contend the data in Example 1
overcome the Examiner's prima facie case of obviousness for independent
Claim 1. Id.
Specifically, Appellants point to Example 1 of their Specification,
which describes a study employing three different diets used for feeding rats
during pregnancy and lactation. App. Br. 8 (see Spec. 12-14). Appellants
state that the basic macronutrient distributions were the same in all these
diets, however, the control diet did not contain docosahexaenoic acid
("DHA") or other long-chain polyunsaturated fatty acids ("LC-PUP As")
whereas the DHA-TG and DHA-PL groups contained the same level of
DHA added in these diets as triacylglycerols (TG) (fish oil) or phospholipids
(PL) (krill oil) (Appellants note that Koss does not teach a specific form of
DHA). App. Br. 8-9 (see F. 2--4).
Appellants argue that their Specification also discloses that all
neonates were euthanized after 14 or 21 days4 or three months thereafter. Id.
at 9 (see Spec. 14; Fig. 3). Appellants assert that the neonates of those rats
4 The weaning period of Sprague-Dawley rats ends at 21 days. See Spec. 14.
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Application 12/935,829
fed a DHA-containing diet exhibited enhanced incorporation ofn-3 PUPA,
and especially of DHA, compared to those fed the control diet. Id. (see F. 2-
3). Appellants also observe that a significant increase in DHA level of retina
and brain glial cells was observed in the DHA-PL group compared to other
diets. Id. Appellants argue this demonstrates that supplementation of the
maternal diet with DHA-PL is more efficient than DHA-TG in conferring
elevated levels of DHA to the offspring. Id.
Appellants argue that, at 21 days postpartum, opposite results were
observed, with higher levels ofDHA-TG observed. App. Br. 9 (see F. 3).
Finally, after weaning, the surviving rats of all test groups received only
alpha-linolenic acid as a source of n-3 fatty acids in their diets and, after 3
months, analysis of the fatty acid composition of the retina revealed that the
level of DHA was statistically higher in animals fed with DHA-PL than in
the other groups (DHA-TG and control). Id. (see F. 5). These results,
Appellants argue, demonstrate that the use of the DHA-PL as a supplement
during the pregnancy and lactation period has a long-term effect on the DHA
level in the retina. Id.
Furthermore, Appellants argue that the flicker electroretinogram
("ERG") experiments performed on newborns at day 21 postpartum
demonstrate that DHA-PL treatment improves rod sensitivity. App. Br. 9
(see F. 6).
Finally, Appellants argue, both DHA diets significantly increased
DHA levels in phosphatidylserine ("PS") purified from brain glial cells in
male pups both at day 14 and weaning (p<0.0001). Id.
Appellants summarize the results of the experiments disclosed in their
Specification thus: administration of the maternal food composition of the
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claimed invention, rather than a standard maternal diet supplemented with
D HA-PL from krill oil, ( 1) improves the level of D HA in the maternal milk,
(2) improves the accretion of DHA in the neonatal retina, (3) accelerates the
maturation of the neonatal retina, and ( 4) improves long term accretion of
DHA in the brain glial cell PS. App. Br. 10. Therefore, Appellants argue,
these results are new and unexpected in view of the prior art, and overcome
the Examiner's primafacie case of obviousness over Koss and Ponroy.
Appellants take issue with the Examiner's alleged reliance on the
teachings of Farrah, which was not cited by the Examiner in the rejection of
claim 1. App. Br. 10. According to Appellants, the Examiner stated, in the
Advisory Action of December 2, 2013, "[a] comparison of the claimed
invention with the disclosure of each cited reference to determine the
number of claim limitations in common with each reference, bearing in
mind the relative importance of particular limitations, will usually yield the
closest single prior art reference." Id. (emphasis added by Appellants)
(citing Adv. Act. 3 (quoting In re Merchant, 575 F.2d 865, 868 (CCPA
1978)); see also Manual of Patent Examining Procedure (MPEP) §
716.02(e) (9th ed., Rev. 07.2015, Nov. 2015)). However, Appellants argue,
Farrah discloses only a study in which administration of krill oil to patients
with hyperlipidemia reduced total cholesterol and LDL, and increased HDL.
Id. Appellants assert that Farrah does not teach that the krill oil was
consumed during a pregnancy or a lactation period, in a composition
comprising a source of carbohydrates providing 40% to 80% of the total
energy of the composition, or in a composition comprising a source of fat
providing 20% to 30% of the total energy of the composition. Id.
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Application 12/935,829
Therefore, Appellants contend, Farrah is not the closest prior art of record
for independent Claim 1. Id.
Appellants dispute the Examiner's finding that Farrah is the closest
prior art of record because use of krill oil is the source of their unexpected
results and, therefore, the claimed invention must be compared to a reference
using krill oil as the LC-PUPA. App. Br. 10. According to Appellants, that
finding is improper because it would require Appellants to "compare the
results of the invention with the results of the invention." Id. (citing MPEP
§ 716.02(e)(III)). Furthermore, Appellants argue, the experimental
comparison of the claimed invention to Farrah proposed by the Examiner
would not be a reasonable comparison because administration of the claimed
composition to infants via a pregnant or lactating mother would be compared
with administration of krill oil to patients with hyperlipidemia as taught by
Farrah. Id. at 10-11.
Appellants also take issue with the Examiner's finding that a skilled
artisan "would have reasonably expected that the use of the krill oil as the
LC-PUPA source would result in increased beneficial effects." App. Br. 11.
Appellants contend there is no basis for finding that unexpected results are
only applicable when no benefit whatsoever is expected, and assert that the
Examiner's finding that administration of DHA-PL would result in
"increased beneficial effects" is too general to suggest to the skilled artisan
the experimental results disclosed in the Specification. Id. Rather,
Appellants argue, the inquiry for unexpected results is whether a greater than
expected result, a superiority of a shared property, an unexpected property,
or the absence of an expected property is achieved by the claimed invention.
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Application 12/935,829
Id. (citing MPEP § 716.02(a)). Appellants assert that the experimental
evidence demonstrates unexpected properties.
The Examiner responds that it was never stated that Farrah was the
closest prior art for comparison, but rather that "a comparison with Koss
cannot constitute a comparison with the closest prior art for the purpose of
establishing unexpected results because of the extent to which the
comparison deviates from Koss." Ans. 4 (emphasis omitted). The Examiner
finds Appellants "[have] not explained this deviation in the presentation of
the alleged unexpected results." Id. (citing, inter alia, MPEP § 715.02)
(emphasis omitted).
Specifically, the Examiner finds the comparison made by Appellants
is not identical with the disclosure of the reference "chosen as closest prior
art" because the inventive composition used for the comparison includes
DHA derived from krill oil (DHA-PL), whereas the closest prior art of Koss
includes DHA derived from fish oil. Ans. 4. The Examiner finds DHA
from fish oil is structurally different from the DHA from krill oil, and would
therefore be expected to have a different effect. Id. at 4-5. The Examiner
finds this expectation is supported by Appellants' results indicating that the
observed increased benefit derived from the PL form of the DHA in krill oil,
as opposed to the TG form of the DHA in fish oil. Id. at 5.
The Examiner therefore finds that, even though the structure of DHA
in krill oil was known at the time of invention to be different from DHA in
fish oil (as taught by Farrah), Appellants fail to account for this difference
when comparing the instant composition with that of Koss, particularly
when making the comparison with Koss and Appellants' claimed
composition. Ans. 5. More particularly, the Examiner finds, Appellants do
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Application 12/935,829
not explain or account for the structural difference between the instant
composition and the composition of the prior art considered to give rise to
the allegedly unexpected results, as required by MPEP § 715.02. Under
these circumstances, the Examiner finds§ 715.02 of the MPEP establishes
that the burden is on Appellants to explain why, even with the defined
structural difference, the results are still unexpected. Ans. 5-6.
The Examiner also finds Farrah teaches that, at the time of invention,
it was known in the art that the use of krill oil as a DHA source generally
increases the bioavailability ofDHA. Ans. 6. This teaching is relevant to
the alleged expectedness of Appellants' results, the Examiner finds, because
it addresses the difference between the composition of the closest prior art
(Koss) identified by Appellants and Appellants' composition. Id. In
particular, finds the Examiner, krill oil would have been expected to provide
the observed benefits based on the state of the art at the time of invention
because it was known that DHA bioavailability is higher in krill oil than in
fish oil based on the complexing of DHA with PL, compared to TG. Id. at
6-7 (citing Farrah 421 ). The Examiner finds a person of ordinary skill in the
art would reasonably expect that the overall increase in the bioavailability of
krill oil-based DHA could produce the benefits observed by Appellants
when compared to fish oil. Id. at 7.
The Examiner finds further that the alleged unexpected results of
Appellants are not commensurate with the scope of the claims. Ans. 8. The
Examiner finds the data disclosed by Appellants' Specification to support
Appellants' claim of unexpected results were based on the benefits of
employing krill oil instead of fish oil or no DHA. Id. However, the
Examiner finds, the claims at issue do not limit the DHA source to krill oil.
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Application 12/935,829
Id. The Examiner finds krill oil is only introduced in dependent claim 17,
and that claims 1, 3, 5-9, 16, and 20 are drawn instead to DHA-PL. Id.
Appellants have not shown that other sources of DHA-PL are superior to the
fish oil described by Koss. Id. Therefore, the Examiner finds, there is no
nexus between the alleged unexpected results and the claimed invention,
which encompasses any DHA-PL. Id.
We are not persuaded by Appellants' argument. As an initial matter,
we agree with the Examiner that Appellants do not dispute the Examiner's
findings that the claims at issue would have been obvious based on the
combined cited prior art. See Ans. 3. The issue that confronts us, then, is
whether the results disclosed in Example 1 of Appellants' Specification are
sufficiently unexpected or surprising so as to overcome the Examiner's
prima facie conclusion of obviousness. We conclude that they are not.
We find Appellants' argument that the Examiner improperly relied
upon Farrah to be without merit. See App. Br. 10. The claims at issue are
directed to a composition, and Appellants do not dispute that the combined
cited prior art (Koss and Ponroy) teach or suggest all of the limitations of the
claimed compound. Rather, Appellants contend that the properties of the
composition produce surprising and unexpected results when employed in
the manner claimed in Appellants' method claims. However, we are not
persuaded by Appellants' argument that the Examiner is thereby constrained
to rely upon only those references cited as teaching the composition itself in
rebutting Appellants' argument that the properties of the composition
produce unexpected results. Indeed, the Examiner has explicitly relied upon
Farrah in rejecting all of Appellants' method claims. See Final Act. 6, 7, 11.
Furthermore, Appellants do not argue that Farrah is not art prior to their
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Application 12/935,829
claimed invention but only that, because Farrah was not cited in the
rejections of these composition claims, the Examiner may not use Farrah to
overcome Appellants' rebuttal arguments. We disagree: the Examiner need
not tum a blind eye to cited prior art, simply because that art was not cited as
teaching the claimed composition, but was cited instead as teaching a
portion of the method claims. We therefore reject Appellants' reasoning in
this respect.
Furthermore, we are not persuaded that Appellants have successfully
demonstrated that the results disclosed in their Specification are sufficiently
surprising or unexpected to overcome the Examiner's conclusion of
obviousness.
As an initial matter, we do not find it necessarily surprising or
unexpected, nor do Appellants provide any evidence why we should, that a
diet containing long-chain polyunsaturated DHA fatty acids (either PL- or
TG-based) would result in increased DHA levels in postpartum rats when
compared to those born to the control rats that were administered a diet
containing no DHA at all (i.e., the control animals). This is particularly so
when the differences in DHA in the control and experimental groups is of
relatively minor magnitude (approximately <5% total). See Spec. Figs. 5, 7.
The question, then, is whether it would have necessarily been surprising or
unexpected to a person of ordinary skill that the test subject rats born to rats
administered DHA-PL as part of their diet had statistically significantly
more DHA in their bodies at 14 days postpartum (but not at 21 days) and at
3 months age than those born to rats administered DHA-TG in their diet.
We find that it would not.
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Farrah teaches that krill oil has a unique biomolecular profile of
phospholipids, rich in omega-3 fatty acids (e.g., DHA) and diverse
antioxidants, that differs significantly from the usual profile of fish oils. See
F. 1. Specifically, Farrah teaches: "[t]he association between phospholipids
and long-chain omega-3 fatty acids highly facilitates the passage of fatty
acid molecules through the intestinal wall, increasing bioavailability and
ultimately improving the omega-3: omega-6 fatty acid ratio." Id. We agree
with the Examiner's conclusion that it would therefore have been obvious to
one of ordinary skill in the art to substitute DHA derived from krill oil, as
taught by Farrah, for DHA derived from fish oil to increase the
bioavailability of DHA in mammalian gestation and lactation.
Furthermore, although differences between DHA-PL and DHA-TG
disclosed by Appellants' Specification are, in some instances, statistically
significant, they are nonetheless slight of magnitude, differing only by
approximately two percent or less. See Spec. Figs. 5, 7. Given the
teachings of Farrah with respect to the greater bioavailability of krill oil-
derived DHA (see Farrah 421 ), we are not persuaded the data disclosed in
the Specification would have been entirely unexpected or sufficiently
different in kind as to overcome the Examiner's prima facie conclusion of
obviousness. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir.
2007) (Unexpected results are required to show a difference in kind to
overcome a primafacie conclusion of obviousness); see also Newell Cos. v.
Kenney Mfg. Co., 864 F.2d 757, 769 (Fed. Cir. 1988), cert. denied, 493 U.S.
814 (1989) (Although the record may establish evidence of secondary
considerations which are indicia of nonobviousness, the record may also
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establish such a strong case of obviousness that the objective evidence of
nonobviousness is not sufficient to outweigh the evidence of obviousness).
We therefore conclude that Appellants have not adduced evidence
sufficient to overcome the Examiner's prima facie conclusion of
obviousness and we affirm the Examiner's rejection of claims 1, 3, 5, 8, 9,
16, and 19. Furthermore, because Appellants explicitly rely upon the same
arguments with respect to claims 6, 7, and 18 (see App. Br. 11-12, 15), we
similarly affirm the Examiner's rejection of those claims.
B. Claims 17
Issue
Claim 17 recites: "The maternal food composition according to claim
1, wherein the at least one LC-PUP A is in the form of krill oil." App. Br.
42. Appellants argue the Examiner erred because Farrah fails to teach or
suggest the limitation of claim 1 requiring administering DHA to the infant
through the mother. App. Br. 12.
Analysis
Appellants argue neither Koss nor Farrah teaches or suggests that
administration of DHA-PL to the infant through the mother provides any
benefit over DHA-TG, much less the alleged unexpected results disclosed in
Appellants' Specification. App. Br. 12. Appellants dispute the Examiner's
finding that Farrah teaches krill oil provides increased bioavailability of
DHA and conclusion that the experimental results are not unexpected. Id.
According to Appellants, Farrah teaches a study in which administration of
krill oil to patients with hyperlipidemia reduced total cholesterol, LDL and
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Application 12/935,829
increased HDL. Id. Appellants assert that the Examiner has provided no
basis for extrapolating this teaching to infants indirectly receiving the DHA
through the mother. Id.
The Examiner responds that claim 17, like claim 1, is a composition
claim and not a method claim. Ans. 14. The Examiner finds Appellants'
argument, viz., the lack of teaching regarding administration to the mother, is
irrelevant, as it is not necessary for Farrah or Koss to teach a method of
administration of the compound to the mother. The Examiner finds
administration to the mother is an intended use of the composition and
therefore does not limit the structure of the composition. Id.
We agree with the Examiner. Appellants do not dispute that the
combined cited prior art would have made obvious the composition recited
in claim 17, or claim 1 from which it depends. Rather, they argue, the
combined references fail to teach the intended use of the composition, i.e.,
wherein the maternal food composition is to be consumed during a
pregnancy or a lactation period. That intended use is not limiting on the
composition of the claimed compound. In re Zierden, 411 F.2d 1325, 1328
(CCPA 1969) ("A mere statement of a new use for an otherwise old or
obvious composition cannot render a claim to the composition patentable").
Moreover, Farrah explicitly teaches that krill oil can be ingested as a
foodstuff by people, and we find that this genus includes ingestion by
pregnant and/or lactating females in the absence of any evidence to the
contrary. See Farrah 422. We consequently affirm the Examiner's rejection
of claim 1 7.
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C. Claims 10-15, 18, and 20
Analysis
Appellants argue these claims separately, but provide identical
arguments for each, so we address these arguments together. See App. Br.
13-37. Furthermore, Appellants rely upon the same arguments presented
with respect to claims 1, 3, 5, 8, 9, 16, and 19 supra. See App. Br. 10-11.
We have explained why we are not persuaded by Appellants' arguments
with respect to the latter claims, and we incorporate by reference that
explanation and apply it equally to these claims. We consequently affirm
the Examiner's rejection of claims 10-15, 18, and 2 0.
DECISION
The Examiner's rejection of claims 1, 3, and 5-20 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a)(l). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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