Ex Parte Barrett-Reis et al

Patent Trial and Appeal Board

Jul 28, 2017

11370610 (P.T.A.B. Jul. 28, 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.
11/370,610 03/08/2006 Bridget Barrett-Reis 7831USO! (35226/06110) 1847
106587 7590 08/01/2017
Ahhntt T ahnratnries;
EXAMINER
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIDGET BARRETT-REIS, CYNTHIA BLACK,
and TERRENCE B. MAZER1
Appeal 2016-007766
Application 11/370,610
Technology Center 1700
Before JEFFREY T. SMITH, KAREN M. HASTINGS, and
AVELYN M. ROSS, Administrative Patent Judges.
ROSS, Administrative Patent Judge.
DECISION ON APPEAL2
Appellants appeal under 35 U.S.C. § 134(a) from a final rejection of
claims 43, 45^47, 51, 53—55, 59, and 60. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as Abbott Laboratories.
Appeal Br. 3.
2 In our Decision we refer to the Specification (“Spec.”) filed March 8, 2006,
the Final Office Action (“Final Act.”) dated June 27, 2015, the Appeal Brief
(“Appeal Br.”) filed January 27, 2016, the Examiner’s Answer (“Ans.”)
dated June 17, 2016, and the Reply Brief (“Reply Br.”) filed August 12,
2016.
Appeal 2016-007766
Application 11/370,610
STATEMENT OF THE CASE
The subject matter on appeal relates “to concentrated human milk
fortifier liquids for use in combination with human milk or other infant
feeding compositions.” Spec. 1. Claim 43, reproduced below, is illustrative
of the claimed subject matter:
43. A composition comprising water, at least one fat, at least
one protein, and at least one carbohydrate, that has been heat
sterilized to produce a commercially sterile concentrated liquid
human milk fortifier composition,
wherein the commercially sterile concentrated liquid
human milk fortifier composition comprises
fat in a total amount of about 10 to about 40 weight% (on
a dry weight basis);
protein in a total amount of about 28 to about 45 weight%
(on a dry weight basis) comprising at least one of intact or
hydrolyzed milk protein, intact or hydrolyzed casein protein,
intact or hydrolyzed whey protein;
carbohydrate in a total amount of about 20 to about 50
weight % (on a dry weight basis);
calcium in an amount of about 7 mg calcium per mL of
commercially sterile concentrated liquid human milk fortifier
composition; and
phosphorous in an amount of about 4 mg phosphorous per
mL of commercially sterile concentrated liquid human milk
fortifier composition; and
wherein the commercially sterile concentrated liquid
human milk fortifier composition has a caloric density of about
1.4 to about 6 kcal/mL and is suitable for mixing with human
milk or other infant feeding compositions in a ratio of about 1:3
to 1:9 followed by administration of the mixture to an infant.
Appeal Br. 20 (Claims App’x).
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Application 11/370,610
REJECTIONS
The Examiner maintains the following rejections:
A. Claims 43, 45, 46, 51, 53, 54, 59, and 60 stand rejected
under 35 U.S.C. § 103(a) as being unpatentable over
Barrett-Reis3 in view of Klor,4 Auestad,5 and Kamarei.6
Final Act. 2.
B. Claims 47 and 55 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Barrett-Reis in view of Klor,
Auestad, and Kamarei, and further in view of Baxter.7 Id.
at 12.
Appellants request reversal of Rejections A—B. Appellants argue
independent claims 43 and 51 together and do not present separate argument
for the remaining claims. See Appeal Br. 11 and 18. Therefore, we focus
our discussion on claim 43 to resolve the issues on appeal.
OPINION
The Examiner rejects claims 43 and 45 as obvious over Barrett-Reis
in view of Klor, Auestad, and Kamarei. Final Act. 2. The Examiner finds
that Barrett-Reiss discloses a human milk fortifier having 1 to 30 percent fat
by weight, 24 to 55 percent protein by weight protein (which may be intact
or hydrolyzed milk, casein, and whey proteins), 15 to 75 percent
carbohydrates by weight, 118mg/3.8g calcium and 67 mg/3.8g phosphorus.
3 Barrett-Reis et al., US 6,472,003 B2, issued October 29, 2002
(“Barrett-Reis”).
4 Klor et al., US 5,886,037, issued March 23, 1999 (“Klor”).
5 Auestad et al., US 6,495,599 B2, issued December 17, 2002 (“Auestad”).
6 A. Reza Kamarei, US 6,039,985, issued March 21, 2000 (“Kamarei”).
7 Jeffrey H. Baxter, US 2004/0081708 Al, April 29, 2004 (“Baxter”).
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Id. at 2—3. The Examiner further finds that Barrett-Reis discloses a caloric
density of 1.0 kcal/gm to 8.5 kcal/gm. Id. at 3. The Examiner acknowledges
that Barrett-Reis does not teach “that the human milk fortifier is provided in
commercially sterile concentrated liquid form,” “calcium is present at about
7 mg/ml,” “phosphorous is present at about 4 mg/ml,” and “a caloric density
of 1.4 kcal/ml to 6.00 kcal/ml.” Id. The Examiner finds that Klor discloses
a liquid nutritional supplement having similar fat, protein, and carbohydrate
amounts and has a caloric density of 1.0 kcal/ml to 2.0 kcal/ml. Id. at 3^4.
The Examiner further finds that Auestad discloses a liquid and dry
formulations of infant formula to promote growth for preterm infants having
a calcium content of 1200 mg/L (1.2 mg/ml) and a phosphorus content of
650 mg/L (.65 mg/ml). Id. at 4. The Examiner also finds Kamarei teaches a
stabilized, commercially stable infant formula having a minimum calcium
content of 60 mg/kcal, a minimum phosphorus content of 30 mg/kcal, but no
maximum amount for either calcium or phosphorus. Id. The Examiner
reasons that it would have been obvious to modify the powdered fortifier of
Barrett-Reis to be in liquid form, as taught by Klor, Auestad, and Kamarei,
because Barrett-Reis discloses that a liquid is an intermediate form to make
a powdered formulation, Auestad teaches administering liquid supplements
to infants, and it is known in the art to provide supplements to breast milk
with liquid concentrates. Id. at 4—5. The Examiner further reasons that one
skilled in the art would have reason to provide a commercially stable, shelf
stable form for the fortifier so “that [it] is free of microorganisms capable of
reproducing in the food under normal non-reffigerated conditions and viable
microorganisms.” Id. at 5. The Examiner also reasons that it would have
been obvious to modify the fortifier of Barrett-Reis to include the claimed
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amounts of calcium and phosphorus because Barrett-Reis teaches these
supplements contribute to bone mineralization and typical human milk lacks
appropriate concentrations. In this regard, Auestad teaches 1.2 mg/mL
calcium and 0.65 mg/ml phosphorus where Kamarei teaches “that there is no
maximum amounts for calcium and phosphorus.” Id. The Examiner reasons
that while the particular claimed amount is not disclosed, one skilled in the
art would have found it obvious to adjust the calcium and phosphorus levels
to optimize the amount necessary for proper bone mineralization. Id. With
respect to the caloric density, the Examiner reasons first that the caloric
density disclosed in Barrett-Reis could have been adjusted by one skilled in
the art to account for a liquid formulation and to achieve a concentration
having “an adequate amount of calories for a nutritional supplement
intended to be diluted in human breast milk, since it has been held that
discovering an optimum value of a result effective variable involves only
routine skill in the art.” Id. at 6. Alternatively, the Examiner reasons that
because Barrett-Reis and Klor contain overlapping amounts of fat, protein
and carbohydrates, and Klor teaches a caloric density of 1.0 kcal/ml to 2.0
kcal/ml, the claimed caloric density would have been obvious “because the
compositional proportions taught by Klor overlap the instantly claimed
proportions and therefore are considered to establish a prima facie case of
obviousness.” Id.
Appellants present several arguments to oppose the Examiner’s
rejections. First, Appellants contend that the liquid formulations of Klor,
Auestad, and Kamarei, each relating to conventional infant formulas,
provide no reason to modify a powdered human milk fortifier of Barrett-Reis
to be presented in liquid form. Appeal Br. 12. Appellants contend that the
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term “human milk fortifier” expressly excludes conventional infant formulas
like those of Klor, Auestad, and Kamarei, which are not added to human
milk but rather a substitute for human milk. Id.
Appellants’ arguments are not persuasive of reversible error. The test
for obviousness is not whether the claimed invention is expressly suggested
in any one or all of the references, but whether the claimed subject matter
would have been obvious to those of ordinary skill in the art in light of the
combined teachings of those references. See In re Keller, 642 F.2d 413, 425
(CCPA 1981). Here, the Examiner finds that the secondary references, and
Auestad in particular, do in fact teach a liquid to be used in combination
with human milk and not simply as a substitute for milk as alleged by
Appellants. Ans. 13 (citing Auestad, col. 9,11. 53—56 (“Infant formula refers
to nutritional formulations that... are intended to replace or supplement
human breast milk.”)). Auestad further teaches that “feeding regimens
[involving nutrient-enriched formulas] may be the exclusive source of
caloric intake for the infant, or they may be complemented with human mi Hi'
and that feeding “may consist of exclusively formula [or] formula plus
human milk." Auestad, col. 5,1. 67—col. 6,1. 2 (emphasis added) and col. 6,
11. 28—31 (emphasis added). Thus, it is clear from the teachings of Auestad
that its nutritional supplement may be added to human milk.
Moreover, Barrett-Reis recognizes that both powder and liquid
fortifiers are known. See Barrett-Reis col. 2,11. 1—10 and 58—64. By way of
example, Barrett-Reis discusses one such known fortifier, Similac Natural
Care® Liquid, and explains that “if mom’s milk supply is limited, a liquid
fortifier may be used to stretch her supply of human milk. Similac Natural
Care® is designed to be added to preterm milk in a one-to-one ratio.” Id. at
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col. 2,11. 63—67 (emphasis added). Therefore, the teachings of Barrett-Reis
and Auestad each suggest providing a human milk fortifier in liquid form.
Next, Appellants argue that “modifying the powdered human milk
fortifier of Barrett-Reis to provide a liquid human milk fortifier would
destroy the purpose of providing the human milk fortifier as a powder to
achieve minimal dilution of human milk.” Appeal Br. 12. According to
Appellants, providing “a liquid human milk fortifier would clearly dilute
human milk more than a powdered human milk fortifier,” which is in
conflict with the stated advantages of Barrett-Reis. Id.
Appellants do not persuade us of reversible error in the Examiner’s
rejection. If a proposed modification would render the prior art being
modified unsatisfactory for its intended purpose, then there is no suggestion
or motivation to make the proposed modification. In re Gordon, 733 F.2d
900, 902 (Fed. Cir. 1984). A reference, however, is not limited to the
teaching in its preferred embodiment, but also for what one of ordinary skill
might reasonably infer from the teachings. See In re Lamberti, 545 F.2d
747, 750 (CCPA 1976) (“all disclosures of the prior art, including
unpreferred embodiments, must be considered”). As discussed above,
Barrett-Reis discloses a liquid human milk fortifier. See Barrett-Reis col. 2,
11. 1—10 and 58—67. Thus, while Barret-Reis prefers a powdered fortifier
because “there is minimal dilution of human milk” {id. at col. 4,11. 19—20),
such teaching does not supplant the broader disclosure of Barrett-Reis
regarding non-inventive liquid embodiments.
Third, Appellants argue that Auestad teaches away from a
combination with Barrett-Reis because the modification would render
Barrett-Reis unsatisfactory for its intended purpose. Appeal Br. 13.
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Appellants explain that Barrett-Reis teaches the presence of an emulsifier in
the fortified powder to improve emulsion stability but, Auestad excludes
emulsifiers from liquid formulations when spray drying. Id. Thus,
Appellants rationalize that “Auestad teaches away from Barrett-Reis by
teaching the removal of emulsifiers from the liquid formulation.” Id.
Appellants fail to identify a reversible error in the Examiner’s
rejection. To teach away, a reference must discourage one of ordinary skill
in the art from following the path set out in the reference, or lead that person
in a direction divergent from the path taken by the applicant. In re Gurley,
27 F.3d 551, 553 (Fed. Cir. 1994). “A reference does not teach away ... if
it merely expresses a general preference for an alternative invention but does
not ‘criticize, discredit, or otherwise discourage’ investigation into the
invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004)). As the Examiner explains, Auestad does not teach
away because “Auestad does not require that when powders are formulated
that they must not contain emulsifiers, instead Auestad discloses that
emulsifiers are typically not added.” Ans. 14 (citing Auestad, col. 19,11. 30—
21). We agree; a disclosure of more than one alternative does not constitute
a teaching away absent criticism or discrediting of the solution claimed.
Fourth, Appellants contend that the Examiner’s reason for modifying
the human milk fortifier to be in a commercially sterile, shelf stable form
employs circular reasoning. Appeal Br. 13. Appellants also assert that the
Examiner’s reliance on Kamarei to suggest a commercially sterile infant
formula is misplaced. Id. According to Appellants, “commercially sterile”
requires that the food be free of microorganisms under non-reffigerated
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conditions; however, Kamarei requires refrigeration for its compositions.8
Id.
Appellants’ arguments are not persuasive of reversible error.
According to Kamarei, “commercial sterility” is achieved through a heat
treatment which renders the food product free of “[microorganisms capable
of reproducing in the food under normal non-reffigerated conditions of
storage and distribution.” Kamarei, col. 3,11. 5—15. Appellants do not
disagree with the definition of “commercial sterility” found in Kamarei and
adopted by the Examiner. See Appeal Br. 13—14; Reply Br. 4. As the
Examiner aptly finds (Ans. 15), the definition of commercial sterility found
in Kamarei is not limited to heat-treated products stored under non-
reffigerated environments, but rather, to heat-treated products that are free of
microorganisms that reproduce under non-refrigerated conditions. Thus,
whether the inventive formulations of Kamarei are refrigerated is irrelevant
to the complete teachings that commercial sterility and removal of
microorganisms is advantageous.
Moreover, Kamarei discloses infant formula products, containing
essential macronutrients and micronutrients, where microorganisms and
bacterial enzyme are removed through sterilization techniques. Kamarei,
col. 1,11. 36-48. In particular, Kamarei describes prior art sterilization
methods, involving “such powerful heat treatment, that all microorganisms
8 Appellants, for the first time in their Reply Brief, additionally argue that
“Kamarei also teaches away from using a sterilization process.” Reply Br.
4. Appellants have not explained, nor is it apparent, that these arguments
were necessitated by the Examiner’s Answer or could not have been
presented in the principal brief. Therefore, these arguments are untimely
and we will not reach arguments presented for the first time in a reply brief
in the absence of good cause. 37 C.F.R. § 41.41(b)(2).
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are killed” to achieve a commercially sterile and shelf-stable product that
may be stored at room temperature. Id. at col. 2,11. 57—67; see also id. at
col. 3,1. 20-col. 4,1. 15. Thus, Kamarei provides reason to modify the
human milk fortifier to be in a commercially sterile, shelf stable form in
order to ensure that microorganisms and bacterial enzymes are removed.
Fifth, Appellants argue that the subject references fail to teach or
suggest the claimed calcium and phosphorus content. Appeal Br. 14.
Appellants contend that the Examiner ignores the fact that Auestad—
teaching a calcium concentration of 1300 to 1800mg/l and a phosphorus
concentration of 700 to 1000mg/l—falls short of the claimed amounts. Id.
Further, Appellants dispute the Examiner’s position that Kamarei teaches no
maximum concentration for calcium and phosphorus. Id. Rather,
Appellants point to the text of Kamarei’s disclosure that teaches “a range for
the calcium and phosphorous concentrations of ‘from about 60 to about 234
mg of Calcium; from about 30 to about 159 mg of Phosphorus . . . per five
fluid ounces’” and equating to a maximum of 1.58 mg/ml calcium and 1.08
mg/ml phosphorus. Id. (quoting Kamarei col. 11,1. 67—col. 12,1. 10).
Therefore, the calcium and phosphorus concentrations of the references are
well below the claimed amounts of 7mg/ml and 4 mg/ml for calcium and
phosphorus respectively.
Appellants’ arguments do not persuade us of reversible error by the
Examiner. We agree with the Examiner “that it would have been obvious to
modify the concentration of the fortifier by diluting and optimizing the
amounts based on the desired end product especially when supplementing
the nutrition of premature infants.” Final Act. 15; Ans. 16. “A recognition
in the prior art that a property is affected by the variable is sufficient to find
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the variable result-effective.” In re Applied Materials, Inc., 692 F.3d 1289,
1297 (Fed. Cir. 2012). It is well settled that it would have been obvious for
the ordinarily skilled artisan to develop workable or even optimum ranges
for result-effective parameters. In re Boesch, 617 F.2d 272, 276 (CCPA
1980); In reAller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.”).
Here, Barrett-Reis teaches that calcium and phosphorus are important
nutrients and “when [human milk] is fortified with calcium and phosphorus,
there is increase accretion of these minerals and improvement of bone
density.” Barrett-Reis, col. 2,11. 1—3 and col. 4,11. 60—62; see also id. at
col. 10,11. 19-20 (“Calcium, phosphorus, and magnesium are needed for
proper bone mineralization.”). Barrett-Reis also discloses that phosphorus
“is needed for the growth and function of soft tissue.” Id. at col. 10,11. 24—
26. Barrett-Reis recognizes that “[rjelative to estimates of the low birth
weight (LBW) infants’ requirements, human preterm human milk is lacking
in calcium, phosphorus, energy and protein.” Id. at col. 4,11. 56—57; see also
id. at col. 1,11. 64—66 (same). Thus, the general conditions of the claim are
known in the prior art—i.e., it is known to supplement human milk with
calcium and phosphorus to promote bone mineralization and density because
human milk alone is insufficient to meet the needs of preterm infants—and
adjusting the concentration to satisfy the needs of a preterm infant would
require no more than routine skill.
Lastly, Appellants urge that the Examiner has failed to show there was
a reasonable expectation of success because “one of skill in the art would not
seek to achieve such relatively high levels of calcium and phosphorous in a
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liquid product (especially one that must be commercially sterile). . . due to
the unpredictable nature of the art.” Appeal Br. 16. According to
Appellants, “there are known stability problems caused by raising the levels
of minerals such as calcium and phosphorous in liquids containing milk-
based proteins.” Id. Appellants rely upon Exhibits 3—6 for the proposition
that high concentrations of calcium lead to poor heat stability in milk
products. Id.
We are not persuaded of reversible error by the Examiner. It is well
established that obviousness does not require absolute predictability of
success; rather, all that is required is a reasonable expectation of success. In
re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). The predictable use of
prior art elements according to their established function is ordinarily
obvious; further, the “inferences and creative steps that a person of ordinary
skill in the art would employ” can be taken into account. KSR Int 7 v.
Teleflex Inc., 550 U.S. 398, 417—18 (2007). “A person of ordinary skill is
also a person of ordinary creativity, not an automaton.” Id. at 421. In this
instance, Barrett-Reis recognizes the stability problems identified by
Appellants. Barrett-Reis explains that
it is known that soluble divalent minerals, particularly calcium,
are capable of interacting with proteins. The destabilization of
proteins results in denatured protein that precipitates out of
solution or clings to the sides of the reconstitution/delivery
container. Consequently, the protein is not actually delivered to
the infant which contribute to the slower growth rates ....
Barrett-Reis, col. 12,11. 6—13. And, as the Examiner also finds (Ans. 17),
Barrett-Reis teaches that when calcium is provided in a micronized insoluble
form and added to human milk denaturation of the protein was prevented
and absorption by the preterm infant was adequate. Barrett-Reis, col. 12,11.
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47—50. Thus, Barrett-Reis recognizes the desirability of using micronized
insoluble calcium to prevent protein destabilization while maintaining
bioavailability of calcium for preterm infants and provides a reasonable
expectation of success.
Appellants do not adequately explain or support their position “that a
powdered formula having components with a very small particle size does
not create a reasonable expectation of success in formulating a concentrated
liquid formula that includes protein and relatively high amounts of calcium
and phosphorus, particularly given the stability issues associated with such
liquid formulas.” Reply Br. 7.
Therefore, on this record, we sustain the Examiner’s rejections.
CONCLUSION
The Examiner did not reversibly err in rejecting claims 43, 45, 46, 51,
53, 54, 59, and 60 under 35 U.S.C. § 103(a) as being unpatentable over
Barrett-Reis in view of Klor, Auestad, and Kamarei.
The Examiner did not reversibly err in rejecting claims 47 and 55
under 35 U.S.C. § 103(a) as being unpatentable over Barrett-Reis in view of
Klor, Auestad, and Kamarei, and further in view of Baxter.
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DECISION
For the above reasons and those presented by the Examiner, the
Examiner’s rejections of claims 43, 45^47, 51, 53—55, 59, and 60 are
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
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