Ex Parte Garcia-Rodenas et al

Patent Trials and Appeals Board

May 14, 2019

14352231 - (D) (P.T.A.B. May. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/352,231 04/16/2014
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
05/16/2019
FIRST NAMED INVENTOR
Clara Garcia-Rodenas
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.
3712036-02120 9249
EXAMINER
PAPCIAK, SHARON M
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
05/16/2019 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLARA GARCIA-RODENAS and NORBERT SPRENGER1
Appeal2018-007086
Application 14/352,231
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for the promotion of intestinal angiogenesis, nutrient absorption, and enteral
feeding tolerance comprising administering a composition that includes,
among other things, a certain oligosaccharide mixture. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as "Nestec S.A." Appeal Br.
2. Herein we reference the Specification filed Apr. 16, 2014 ("Spec."); Final
Office Action dated Dec. 6, 2017 ("Final Act."); Appeal Brief filed Mar. 23,
2018 ("Appeal Br."); Examiner's Answer dated May 14, 2018 ("Ans."); and
Reply Brief filed Jun. 28, 2018 ("Reply Br.").
Appeal2018-007086
Application 14/352,231
STATEMENT OF THE CASE
The Specification states that in infants, "[i]mpaired blood flow can
delay intestinal development, impair nutrient absorption and tolerance to
enteral feeds, alter intestinal motility and it is believed to be a causative
factor in the pathogenesis of necrotizing enterocolitis." Spec. 1 :26-28.
Appellants' invention thus relates to "the administration of a mixture of
specific oligosaccharides in combination with at least one long chain
polyunsaturated fatty acid (LC-PUPA) and at least one probiotic," which the
Specification states is "particularly effective in the promotion of intestinal
angiogenesis and of nutrient absorption and of enteral feeding tolerance
and/or in the prevention and/or treatment of intestinal inflammation, such as
necrotizing enterocolitis, and/or in the recovery after intestinal injury and/or
surgery." Id. at 3:25-30.
Claims 1-3, 5-11, and 14-1 7 are on appeal. Final Act. 2. Claim 1 is
illustrative and reads as follows:
1. A method for the promotion of intestinal
angiogenesis and of nutrient absorption and of enteral feeding
tolerance, the method comprising:
administering to an infant having a characteristic selected
from the group consisting of recovering from intestinal injury,
recovering from intestinal surgery, suffering from necrotizing
enterocolitis, and combinations thereof a composition
comprising at least one long chain polyunsaturated fatty acid
(LC-PUPA), at least one probiotic, and an oligosaccharide
mixture containing 0.25-20 wt% of at least one N-acetylated
oligosaccharide with respect to the total weight of the
oligosaccharide mixture, 0.5-30 wt% of at least one sialylated
oligosaccharide with respect to the total weight of the
oligosaccharide mixture, and 50-99 .3 wt% of at least one
neutral oligosaccharide with respect to the total weight of the
oligosaccharide mixture, thereby increasing at least one
2
Appeal2018-007086
Application 14/352,231
angiogenic growth factor selected from the group consisting of
CD34 and VEGF (vascular endothelial growth factor).
Appeal Br. 31 (Claims Appendix).
The claims stand rejected as follows:
1. Claims 1-3, 5-11, and 14-17 are rejected under 35 U.S.C.
§ 103(a) as obvious over the combination of Chow,2 Fichot,3
Eicher,4 and McCluer. 5
2. Claims 1-3, 5-11, and 14-17 are rejected under 35 U.S.C.
§ 103 (a) as obvious over the combination of Georgi, 6
Sprenger,7 Eicher, and McCluer.
ANALYSIS
Rejection Over Chow, Fichot, Eicher, and McCluer
The Examiner rejected the claims as obvious over the combination of
Chow, Fichot, Eicher, and McCluer. Final Act. 4. The Examiner found that
Chow teaches pediatric formulas for use in treating or preventing
gastrointestinal-related conditions and diseases. Id. at 5. The formulas
comprise an oligosaccharide blend, LC-PUP As, and can include a pro biotic.
Id. at 5-6. In relevant part, the Examiner found that Chow does not teach
the claimed amounts of oligosaccharides. 8 Id. at 6. The Examiner found
2 Chow et al., US 2012/0172319 Al, published Jul. 5, 2012 ("Chow").
3 Fichot et al., CA Patent App. Pub. 2 725 039 Al, published Jan. 14, 2010
("Fichot").
4 Eicher et al., WO 99/49882, published Oct. 7, 1999 ("Eicher").
5 Mccluer et al., US 4,895,838, issued Jan. 23, 1990 ("Mccluer").
6 Georgi et al., US 2010/0234286 Al, published Sept. 16, 2010 ("Georgi").
7 Sprenger et al., WO 2007/101675 Al, published Sept. 13, 2007
("Sprenger").
8 Although not cited by the Examiner, we note that the compositions in
Examples 31-34 of Chow appear to include a mixture of sialylated, N-
3
Appeal2018-007086
Application 14/352,231
that Fichot teaches amounts of oligosaccharides that overlap with the claims.
Id. at 7; Ans. 21. According to the Examiner, a person of ordinary skill in
the art at the time the invention was made would have been motivated to
combine Chow's formulas with the specific oligosaccharide amounts taught
by Fichot because Fichot shows "an infant nutritional composition that
enhances nutrient absorption in the intestines," and shows that certain
oligosaccharides "reduce lipogenesis and promote fatty acid beta-oxidation."
Final Act. 9, 10.
Appellants argue, among other things, that a person of ordinary skill
in the art would not have looked to Fichot for possible modifications to
Chow, given the different purposes for their respectively disclosed
compositions (i.e, reducing the risk of obesity, reducing lipogenesis, and
promoting beta-oxidation of fatty acids in Fichot, and treating or preventing
formula intolerance or other gastrointestinal diseases in Chow). Appeal Br.
7; Reply Br. 3. Appellants also argue that the Examiner relies on certain
health-promoting benefits discussed in Fichot's background section, but
Fichot "does not teach that its mixture improves digestion or absorption of
essential nutrients." Appeal Br. 7; 9 see also Reply Br. 3. Appellants also
argue that Eicher and McCluer "do not provide any reason or motivation for
the skilled artisan to look to Fichot (related to obesity) for possible
acetylated, and neutral oligosaccharides (i.e., 6'SL, LNnT, and GOS,
respectively), in amounts that fall with the claimed wt% ranges. Chow
,-J 159.
9 Unless otherwise noted, all emphases in quotes appear in Appellants'
briefs.
4
Appeal2018-007086
Application 14/352,231
modifications to the method of Chow (improving growth and maturation of
the gut barrier)." Appeal Br. 9.
After considering the evidence and arguments, we agree with
Appellants that the Examiner has not adequately explained why a skilled
artisan would have looked to Fichot to optimize the amounts of
oligosaccharides in Chow's formulas. Both references teach infant
formulas, and thus are analogous art. See, e.g., In re Clay, 966 F.2d 656,
658-59 (Fed. Cir. 1992). However, the formulas were developed with
different purposes. Fichot' s formulas are directed to reducing the risk of
obesity by reducing lipogenesis and promoting beta-oxidation of fatty acids
(see, e.g., Fichot 4:15-26), whereas Chow's formulas are directed to treating
or preventing formula intolerance or other gastrointestinal issues by
improving growth and maturation of the gut barrier. See, e.g., Chow ,i 6.
The Examiner reasoned that the "nexus" between Chow and Fichot is
that both references disclose infant formulas supplemented with
oligosaccharide mixtures. Final Act. 7, 19. The Examiner pointed to
Fichot' s disclosure stating that certain oligosaccharides are prebiotics, or
non-digestible food ingredients that stimulate intestinal bacteria
growth/activity, which can result in a number of health-promoting effects.
Ans. 20 (citing Fichot 1:16-24, 2:4-12). Further, relying on passages from
Fichot's background discussion, the Examiner found that Fichot "shows an
infant nutritional composition that enhances nutrient absorption in the
intestines." Final Act. 9; see also Ans. 7 (citing Fichot 1:19-22), 20 (citing
Fichot 1: 16-24). The Examiner asserted that this is also "accomplished by
the composition[] shown by Chow." Final Act. 9.
5
Appeal2018-007086
Application 14/352,231
We do not agree with the Examiner that Fichot's background
discussion demonstrates an infant formula that enhances nutrient absorption.
Rather, at best, these portions of Fichot merely provide a background
discussion of the potential health-promoting effects of increasing helpful
intestinal bacteria, such as by providing prebiotics, rather than a specific
teaching about the ability of Fichot's formulas to improve absorption of
essential nutrients. We agree with Appellants that Fichot' s teachings
regarding the functions of its formulations are their ability to reduce the risk
of obesity later in life, reduce lipogenesis, and promote beta-oxidation of
fatty acids. Appeal Br. 7; Fichot at, e.g., 4:15-26; 5:6-7; 12:4-15:8. As
such, we find that the Examiner has not identified a persuasive reason why a
person of ordinary skill in the art would have modified Chow's formula to
incorporate the amounts of oligosaccharides taught in Fichot.
Because the Examiner has not identified an adequate motivation to
combine the teachings of Chow and Fichot, we reverse the rejection of
claims 1-3, 5-11, and 14-17 as obvious over the combination of Chow,
Fichot, Eicher, and McCluer.
Rejection Over Georgi, Sprenger, Eicher, and McCluer
The Examiner rejected the claims as obvious over the combination of
Georgi, Sprenger, Eicher, and McCluer. Final Act. 12. We adopt the
Examiner's findings of fact and reasoning made in connection with this
rejection (see id. at 12-21; Ans. 33-46), and agree that the claims would
have been obvious over this combination of prior art for the reasons the
Examiner articulated. We begin by addressing Appellants' arguments
regarding claim 1, then address the remaining claims below.
6
Appeal2018-007086
Application 14/352,231
Appellants assert that the Examiner failed to provide a motivation to
combine Sprenger and Georgi (Appeal Br. 21 ), particularly in view of the
different purposes of the compositions disclosed in these references
(prevention/treatment of infections, and improving oral tolerance,
respectively). Reply Br. 6. We are not persuaded by these arguments. The
Examiner provided numerous reasons why a person of ordinary skill in the
art would have been motivated to combine these references. See, e.g., Final
Act. 17 ( citing, e.g., Sprenger' s teaching that prebiotics synergistically
enhance the anti-pathogenic and immunomodulatory properties of pro biotic
compositions); Ans. 17-18, 35-36. Further, in arguing that Georgi is
"entirely directed to a composition for improving oral tolerance in low
birthweight infants" (Reply Br. 6), Appellants mischaracterize Georgi.
Georgi not only teaches improving oral tolerance, but also that its formulas
are useful in the treatment and/or prevention of an infection, including
intestinal tract infections and respiratory tract infections-the same types of
infections addressed in Sprenger. Cf Georgi ,-J 31 ( disclosing compositions
for treatment and/or prevention of an infection selected from the group
consisting of necrotizing enterocolitis, intestinal tract infection, respiratory
tract infections and urinary tract infections in a fragile infant) with Sprenger
5:8-6:9 (disclosing compositions for treatment and/or prevention of
pathogenic infections of the gastrointestinal tract, immune conditions, and
upper respiratory tract infections); see also Final Act. 12, 18.
Appellants next argue that the Examiner erred in finding that the
skilled artisan would have used routine optimization to optimize the amounts
of oligosaccharides. Appeal Br. 21-22; Reply Br. 6-7. Specifically,
Appellants argue that "the Examiner has not identified any features or
7
Appeal2018-007086
Application 14/352,231
characteristics as being result-effective variables to which the amounts of
claimed specific oligosaccharides each should be optimized." Appeal Br.
21. As to the Examiner's assertion (in the Jan. 23, 2018 Advisory Action)
that McCluer shows that angiogenesis can be increased by administering an
angiogenically-effective amount of oligosaccharide, Appellants state that
McCluer merely tested the angiogenic effect of a mixture of human milk
oligosaccharides, rather than the effect of each individual oligosaccharide
contained in the mixture. Appeal Br. 21-22. Thus, according to Appellants,
"upon reading McCluer, the skilled artisan would not recognize the amount
of each individual oligosaccharide as a variable to be optimized." Id.
We are not persuaded by Appellants' arguments. First, Sprenger
discloses ranges ofN-acetylated, sialylated, and neutral oligosaccharides
that overlap with or encompass the claimed ranges. See, e.g., Ans. 46;
Sprenger at Abstract, claims 1, 2, and 4. Such overlap between the prior art
ranges and the claimed range is evidence of obviousness and sufficient
motivation to optimize the ranges. In re Applied Materials, Inc., 692 F.3d
1289, 1295 (Fed. Cir. 2012) (obviousness affirmed where prior art taught
groove dimensions that overlapped with claimed dimensions). Indeed, "[a]
prima facie case of obviousness typically exists when the ranges of a
claimed composition overlap the ranges disclosed in the prior art." In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Although evidence that
claimed ranges are "critical" may constitute evidence of nonobviousness, In
re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997), Appellants have not
directed us to persuasive evidence showing that the claimed ranges achieve
unexpected results, as will be further discussed below.
8
Appeal2018-007086
Application 14/352,231
Furthermore, Appellants have not addressed the Examiner's findings
that a person of ordinary skill in the art would have been motivated to
optimize the amount of oligosaccharides based on Georgi's teachings about
the effects of certain individual oligosaccharides. See, e.g., Final Act. 16;
Ans. 16-17, 34-36; see also Georgi ,i,i 41-48 (discussing effects of different
types of oligosaccharides on, e.g., intestinal pH and stimulation of intestinal
flora). Moreover, contrary to Appellants' assertions, McCluer does not
merely disclose the angiogenic effect of a mixture of oligosaccharides; it
also discloses the angiogenic effects of individual oligosaccharides. See,
e.g., McCluer 13:55-14:50, 15:20-63. Accordingly, we find that the prior
art did recognize that varying the amounts of individual oligosaccharides
( and not just the overall mixture of oligosaccharides) could impact bodily
functions. "A recognition in the prior art that a property is affected by the
variable is sufficient to find the variable result-effective." In re Applied
Materials, Inc., 692 F.3d at 1297. Appellants have not persuaded us that the
Examiner erred with respect to finding that a skilled artisan would have used
routine optimization to arrive at the claimed amounts of oligosaccharides.
Finally, Appellants argue that McCluer discloses that its composition
is administered by injection, and "[ n Jothing in McCluer discloses the effects
of digestion and efficacy regarding stomach acid and enzymes." Appeal Br.
22. We are not persuaded by this argument, because McCluer specifically
teaches that injection is not the exclusive mode of administration. McCluer
23:45-51; see also id. at 23:52-55 and 23:57-59 (allowing for other modes
of administration); id. at claim 1 (broadly directed to "administering").
Further, although Appellants do not elaborate on the significance of "the
effects of digestion and efficacy regarding stomach acid and enzymes," we
9
Appeal2018-007086
Application 14/352,231
note that the prior art teaches that oligosaccharides are effective when
administered enterally, which suggests no impediment to the enteral
administration of oligosaccharides. See, e.g., Georgi ,i,i 59, 63-64; Sprenger
18: 5-19: 19.
We conclude that Appellants have not established reversible error
with respect to the Examiner's prima facie case of obviousness for claim 1.
Appellants rely on the same arguments for claim 1 7 as made for claim 1.
Appeal Br. 22-23; Reply Br. 7. We have addressed those arguments above,
and that analysis also applies here.
With respect to the rejection of dependent claims 2-10 and 14-16
over the combination of Georgi, Sprenger, Eicher, and McCluer, Appellants
assert that the cited prior art fails to render obvious the additional limitations
recited in each dependent claim. Appeal Br. 23-29. We observe that
Appellants' arguments with respect to these dependent claims do not address
the Examiner's detailed findings on where these particular limitations are
recited in the prior art (see Final Act. 12-18; Ans. 39-45), but instead
merely recite the claim language and assert that the cited prior art references
do not render obvious the claimed subject matter. Such arguments are not
substantive arguments for patentability and are insufficient to establish error
in the rejection. 37 C.F.R. § 41.37(c)(l)(iv) ("A statement which merely
points out what a claim recites will not be considered an argument for
separate patentability of the claim."); see also, e.g., In re Lovin, 652 F.3d
1349, 1357 (Fed. Cir. 2011) ("[T]he Board reasonably interpreted Rule
41.37 to require more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art.").
10
Appeal2018-007086
Application 14/352,231
With respect to dependent claim 11, Appellants assert that McCluer
discloses that the oligosaccharides described therein are administered via
injection, whereas claim 11 requires that the composition is in a form
selected from the group consisting of a preterm infant formula, a human
milk fortifier, a starter infant formula, a follow-on formula, a baby food
formula, an infant cereal formula, a growing-up milk, a medical food
product for clinical nutrition, and a supplement. Appeal Br. 28. Appellants
assert that "even if combinable, this proposed combination of Georgi,
Sprenger, Eicher, and McCluer would not have arrived at the elements of
dependent Claim 11 in combination with the novel and non-obvious
elements of independent Claim 1 from which Claim 11 depends." Id. We
are not persuaded by this argument, because as discussed above, McCluer is
not limited to administration by injection. Further, other references in the
combination teach infant formulas, foods, and the like (see, e.g., Georgi
,-J 59; Sprenger 11 :30-12:2; Eicher 4:22-26), and "one cannot show non-
obviousness by attacking references individually where, as here, the
rejections are based on combinations of references." In re Keller, 642 F.2d
413,426 (CCPA 1981).
Unexpected Results
Appellants assert that "evidence of unexpected results rebuts any
primafacie case of obviousness." Appeal Br. 22. Appellants argue that the
experiment disclosed in the Specification shows that addition of certain
oligosaccharides to a control diet resulted in "better expression of
angiogenic growth factors and marker of angiogenesis than the two control
compositions." Appeal Br. 10. Appellants assert that better expression of
11
Appeal2018-007086
Application 14/352,231
these growth factors and marker indicates better vascularization. Id. at 10-
11.
We are not persuaded that Appellants have demonstrated unexpected
results that overcome the prima facie case of obviousness. Appellants must
prove a nexus between the alleged unexpected results and the merits of the
claimed invention. See In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir.
1995). However, on this record, the oligosaccharide content of the
composition used in Appellants' experiment is unclear. The Specification
states, in pertinent part, that the composition included an oligosaccharide
mixture ("DDWP"), which "usually contains a mixture of about 30 wt 0/o"
of the N-acetylated oligosaccharides GalNAcal,3GalBl,4Glc and
GalBl,6GalNAcal,3GalBl,4Glc. Spec. 20:2-6 (emphasis added). While
this may be the "usual" mixture, 10 the Specification does not indicate
whether the composition used in the reported experiment included this
"usual" mixture. But, even assuming that it did, the amount ofN-acetylated
oligosaccharides in this mixture is "about 30 wt%," which is outside of the
claimed "0.25-20 wt%" range recited in independent claims 1 and 17.
Appeal Br. 31, 33 (Claims Appendix). Accordingly, Appellants have not
demonstrated a nexus between the alleged unexpected results and the
claimed invention.
Even assuming that the tested composition falls within the scope of
the claims, we agree with the Examiner that Appellants have not established
unexpected results, given that the inventive composition was not compared
10 In fact, this appears to be the same oligosaccharide mixture disclosed in
Sprenger. See Sprenger 15:6-12.
12
Appeal2018-007086
Application 14/352,231
to the closest prior art. Appellants argue that they need not compare the
claimed invention with a composition suggested by the combination of cited
references. Appeal Br. 11. We agree. See, e.g., In re Geiger, 815 F.2d 686,
690 (Fed. Cir. 1987) (Newman, J., concurring) ("It is not required that the
claimed invention be compared with subject matter that does not exist in the
prior art."). Nevertheless, purported unexpected results "must be shown to
be unexpected compared with the closest prior art." In re Baxter Travenol
Labs., 952 F.2d 388,392 (Fed. Cir. 1991). Here, Appellants' experiment
compared a composition that purportedly fell within the scope of the claims
to a control composition that lacked oligosaccharides and probiotics. Spec.
19:25-22:17. But the prior art cited by the Examiner taught compositions
containing oligosaccharides and probiotics. See, e.g., Sprenger 16 (Ex. 3).
Accordingly, Appellants have not demonstrated unexpected results, at least
because they did not compare their invention to the closest prior art.
Moreover, Appellants must demonstrate that the results were
unexpected. Appellants assert that the oligosaccharide-containing diet
demonstrated better "normalized mRNA expressions of CD34 and VEGF"
and thus "a better vascularization" than the control diet. 11 Appeal Br. 10-11.
Even accepting Appellants' assertions as true, Appellants have not explained
how these results are unexpected. The prior art taught that oligosaccharides
were known to promote angiogenesis. See, e.g., McCluer 2:45-46; McCluer
claim 1. Accordingly, better vascularization following administration of
oligosaccharide compositions would have been expected. Appellants have
11 We agree with the Examiner that Appellants have not substantiated a link
between elevated levels of VEGF and CD34 mRNA and better
vascularization. Ans. 26, 45.
13
Appeal2018-007086
Application 14/352,231
not persuaded us that the results reported in the Specification were
unexpected. See In re Gershon, 372 F.2d 535, 538 (CCPA 1967)
("Expected beneficial results are evidence of obviousness of a claimed
invention, just as unexpected results are evidence ofunobviousness
thereof.").
Finally, Appellants argue that "there is no requirement that the claims
recite the unexpected results." Appeal Br. 11. Although we agree with this
proposition, we do not find it to be a basis for reversal, because we do not
read the Examiner's rejection as requiring that the alleged unexpected results
be recited in the claims.
In view of the foregoing analysis, we determine that Appellants have
not shown reversible error in the Examiner's rejection of claims 1-3, 5-11,
and 14-17 as obvious over the combination of Georgi, Sprenger, Eicher, and
McCluer.
SUMMARY
We reverse the Examiner's rejection of claims 1-3, 5-11, and 14-17
under 35 U.S.C. § 103(a) as obvious over the combination of Chow, Fichot,
Eicher, and McCluer.
We affirm the Examiner's rejection of claims 1-3, 5-11, and 14-1 7
under 35 U.S.C. § 103(a) as obvious over the combination of Georgi,
Sprenger, Eicher, and McCluer.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a).
AFFIRMED
14