Ex Parte Hartmann et al

Patent Trial and Appeal Board

Feb 18, 2016

11662348 (P.T.A.B. Feb. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/662,348 01125/2008
7590 02/18/2016
Michael H, Baniak
Mcdonnel Boehnen Hulbert&Berghoff LLP
300 South Wacker Drive
Suite 3100
Chicago, IL 60606
FIRST NAMED INVENTOR
Peter Edwin Hartmann
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.
07-160 2258
EXAMINER
YOO, HONG THI
ART UNIT PAPER NUMBER
1793
MAILDATE DELIVERY MODE
02/18/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER EDWIN HARTMANN, CHING TAT LAI,
JILLIAN LOIS SHERRIFF, KAREN NORRIE SIMMER,
MICHELLE ANNE LEWIS, LEON ROBERT MITOULAS, and
BRONWYN ISABELLE DA VIS
Appeal2014-002049
Application 11/662,348
Technology Center 1700
Before ROMULO H. DELMENDO, JEFFREY T. SMITH, and
MICHELLE N. ANKENBRAND Administrative Patent Judges.
DELMENDO, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants 1 seek our review under 35 U.S.C. § 134(a) of a
decision of the Primary Examiner to reject claims 2, 4, 6, 7, 10-12, 18, 21,
22, 24--26, and 28-38. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 The Appellants state that "Medela Holding AG" is the real party in interest
(Appeal Brief filed August 16, 2013, hereinafter "App. Br.," 4).
Appeal2014-002049
Application 11/662,348
BACKGROl.J1'-JD
The subject matter on appeal relates to a method for providing
supplemental nutrients to an infant by isolating a human milk fortifier from
the mammary secretion of the mother of the infant, fortifying the same
mother's liquid milk by adding the fortifier thereto, and thereafter providing
the infant with the fortified liquid milk (Specification, hereinafter "Spec.,"
Abstract; 1, 11. 10-12; 3, 11. 24--29, 4, 11. 13-16).
Claim 18 is reproduced from page 28 of the Appeal Brief (Claims
App.) as follows:
18. A method of providing supplemental nutrients to
infants comprising the steps of:
a) isolating a mammary secretion of a specific mother
when lactating;
b) producing an isolated human milk fortifier
comprising at least one human milk component which is
selected from the mammary secretion and separated therefrom
for use in the fortifier, wherein the concentration of the at least
one human component in the fortifier is in an amount greater
than the amount of the human milk component as originally and
naturally derived from the mammary secretion, and wherein the
human milk component is at least one of an aqueous and/or
nonaqueous natural constituent of the mammary secretion;
c) adding a [sic] the fortifier to liquid human milk
from the same specific mother from which the mammary
secretion was isolated in a manner adapted for optimal
immunological supply, hormonal supply, or growth of the
infant; and
d) administering such fortified milk to an infant of the
specific mother.
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Application 11/662,348
THE REJECTIONS
The Examiner rejected the claims as follows:
I. Claims 6, 7, 18, 21, 24--26, 28-30, 33, and 34 under 35 U.S.C.
§103(a) as unpatentable over Medo2 in view of Gaull et al.
("Gaull"). 3
II. Claims 2, 4, 10-12, 22, 31, and 32 under 35 U.S.C. § 103(a) as
unpatentable over Medo, Gaull, and Barrett-Reis et al.
("Barrett-Reis")4 as evidenced by Kirschmann. 5
III. Claims 35-38 under 35 U.S.C. § 103(a) as unpatentable over
Medo, Gaull, and Griffin et al. ("Griffin"). 6
(Examiner's Answer entered October 10, 2013, hereinafter "Ans.," at 4--12;
Final Office Action entered December 17, 2012, hereinafter "Final Act.," at
2-10.)
DISCUSSION
I
In arguing for the reversal of Rejection I, the Appellants argue claims
6, 7, 18, 21, 24--26, 28-30, 33, and 34 together, focusing on independent
claim 18 (App. Br. 8-23). Therefore, consistent with 37 C.F.R.
§ 41.37(c)(l)(iv), we confine our discussion to representative claim 18.
The Examiner found Medo discloses isolating a human milk
component from a mammary secretion to produce a nutritional formulation,
2 U.S. 2002/0182243 Al published December 5, 2002.
3 U.S. Patent 6,270,827 Bl issued August 7, 2001.
4 U.S. Patent 6,294,206 Bl issued September 25, 2001.
5 Nutrition Almanac, published 1975.
6 U.S. Patent 6,162,472 issued December 19, 2000.
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Application 11/662,348
or isolated human milk fortifier as specified in claim 18, to be administered
to an infant (Ans. 4). The Examiner also found that "Medo discloses the
nutritional formulation (isolated human milk fortifier) obtained from human
milk ... i.e. human milk protein ... is reformulated with components of
human milk" (id.).
The Examiner found that Medo does not disclose "fortifying the
nutritional formulation (isolated human milk fortifier) to the same mother's
milk as the human milk base" (id.), as required by claim 18. However, the
Examiner found Medo discloses mothers wish to provide their own milk to
their babies (i.e., "species-specific" milk) and that such "species-specific"
milk is known to have a significant role in disease prevention and infant
development (id. at 5). The Examiner also found that Medo discloses a
collection of pooled donor milk and isolating the human milk proteins from
the pooled donor milk to be administered to an infant (id.). From these
findings, the Examiner concluded that it would have been obvious to one of
ordinary skill in the art at the time of the invention to use the mother's own
milk as the fortifier and the human base milk (id.).
Additionally, the Examiner found Gaull discloses an isolated human
milk fortifier containing human milk protein including host resistance
factors of human milk "to improve the nutritional value of an infant's diet"
(id.). The Examiner also found that Gaull discloses a "concentrated
composition (isolated human [milk] fortifier) can be incorporated to
mother's own milk" (id. at 6). Based on these findings, the Examiner
concluded "it would have been obvious to use ... mother's own milk as the
liquid human milk (human milk base) in Medo' s method because Gaull
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teaches combining mother's own milk ... with a human milk fortifier was a
well-known practice" (id.).
With respect to the remaining limitations of claim 18, the Examiner
found Medo discloses providing the fortifier in a concentrated and isolated
format, which the Examiner concluded results in a fortifier with a
concentration in an amount greater than that naturally derived from the
mammary secretion (id. at 6). Additionally, the Examiner found Medo
discloses colostrum, which the Examiner determined is a natural constituent
in an aqueous medium (id. at 7). The Examiner also found that Gaull
recognizes that human milk proteins in the fortifier added to milk supplied to
infants provide for "growth in Very-Low-Birth Weight Infants" (id.).
The Appellants contend that the claims are "directed to the 'closed
loop' arrangement between mother and child"-i.e., Medo fails to disclose
fortified milk using components of the same mother for use with the same
mother's infant (App. Br. 10-11). The Appellants argue, inter alia, Medo
discloses several separate concepts, none of which suggests that "isolated
components of human milk are added back into the same mother's milk" (id.
at 15). Initially, the Appellants contend that Medo discloses a nutritional
formulation containing human milk proteins or host resistance factors of
human milk, wherein these proteins or factors are directly administered to an
infant (id.). The Appellants further argue that Medo alternatively discloses a
method of isolating human milk, "wherein a sample of human milk from a
donor is provided, which is then fortified with heat-resistant and heat
sensitive nutrients" (id.). The Appellants argue these differing embodiments
neither suggest the requirement of "human milk fortifier" nor that "the
components are derived from mammary secretion" (id.).
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With respect to Gaull, the Appellants argue Gaull also does not
disclose "fortifying a mother's own milk using a component derived and
separated from that mother's own milk" (id. at 14). The Appellants further
contend that "Gaull actually discourages using extracted human milk
proteins, in favor of the synthetic alternative" (id.).
We have fully reviewed the Appellants' in-depth analysis of the Medo
and Gaull disclosures; however, we find that the Appellants arguments do
not reveal any reversible error in the Examiner's factual findings, analysis,
and conclusion of obviousness. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir.
2011).
It is well-settled that one cannot show nonobviousness by attacking
references individually when the rejection is based on a combination of
reference. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Additionally, a
reference may be relied upon for all that it would have reasonably suggested
to one having ordinary skill the art. Merck & Co., Inc. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("the mere absence from the prior
art of a teaching or a limitation recited in the patent at issue is insufficient
for a conclusion of nonobviousness"), cert. denied, 493 U.S. 975 (1989).
Specifically, as found by the Examiner (Ans. 4), Medo discloses
obtaining mammary secretion from a mother and isolating milk components,
such as human milk proteins or host resistant factors (HRF), from the human
milk for administration directly to an infant (i-fi-f 10-11). As found by the
Examiner (Ans. 5, 13), Medo discloses the general desire of mothers to
provide their own milk for use specifically with their own baby (i-f 32). In so
disclosing, Medo discloses screening the mother's own milk according to
"standard donor screening" and discloses pooling the mother's own milk
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"intended for her own baby" (id.). Additionally, as found by the Examiner
(Ans. 4), Medo discloses the human milk proteins, including the so-called
host resistance factors of human milk, are prepared from pooled human milk
(iT 34).
Gaull discloses "human milk proteins, including the so-called host
resistance factors (HRF) of human milk, are useful and are employed to
enhance and improve the nutritional value of an infant's diet" (col 2, 11. 57-
60). Additionally, Gaull discloses an isolated human fortifier can be
incorporated to a mother's own milk, pooled or banked milk, or can be
supplied directly to the infant (col 2, 11. 61---65; col. 6, 11. 30-36).
Given the collective teachings of Medo and Gaull and upon
considering what they would have suggested to one of ordinary skill, we
conclude that a person ordinary skill in the art would have been prompted to
include isolated human milk proteins, including host resistant factors,
derived from fresh human milk as suggested by Medo, into a mother's own
milk, as suggested by Gaull, with a reasonable expectation of predictable
results because Medo discloses such human milk proteins are directly
administered to the infant and Gaull suggests concentrated human milk
proteins alternatively can be included directly in the mother's own milk.
KSR Int'!. Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) ("[W]hen a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result.").
Additionally, as found by the Examiner (Ans. 5), Medo discloses
collecting and storing mother's own milk for "mother's wishing to provide
their own milk for use specifically with their own baby" and delivery of such
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to mother's own baby (i1i132-33). Also, as found by Examiner (Ans. 15)
and admitted by the Appellants (App. Br. 10), Medo explicitly discloses "the
best food or nutrition supplied to an infant is its own mother's milk" (i-f 5).
Therefore, in view of this teaching and upon considering what it would have
suggested to one of ordinary skill in the art, we share the Examiner's
conclusion of the obviousness of using the mother's own milk as both the
milk source for the fortifier and human milk base. The Appellants have not
directed us to persuasive evidence to the contrary. In this regard, the test for
obviousness is not the express disclosure or suggestion of the claimed
invention in any or all of the references but, rather, what the references taken
collectively would have suggested to those of ordinary skill in the art
presumed to be familiar with them. In re Rosselet, 347 F.2d 847, 851
(CCPA 1965); In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986).
The Examiner further found that Medo discloses a collection of
pooled donor milk includes mother's milk (Ans. 5). The Appellants disagree
with this factual finding, noting "there is absolutely no disclosure in Medo
that a collection of pooled donor milk includes mother's own milk" (Reply
Brief filed December 10, 2013, hereinafter "Rep. Br.," 2). We agree with
the Appellants that Medo does not disclose the pooled donor milk includes
the infant's mother's milk; however, we find this incorrect factual finding
insufficient to reveal reversible error in the Examiner's conclusion of
obviousness for the reasons already set forth above. As previously set forth,
Medo discloses collecting and pooling mother's own milk for "mother's
wishing to provide their own milk for use specifically with their own baby"
and delivery of such to mother's own baby (i-fi-f 32-33). Additionally, as
admitted by the Appellants (Br. 10), Medo explicitly discloses "the best food
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or nutrition supplied to an infant is its own mother's milk" (ii 5). Thus, we
hold that the use of mother's own milk would have been obvious not based
on its inclusion in the donor pool, but on the known and articulated benefits
and desires of feeding mother's own milk to their own infant. KSR, 550
U.S. at 421 ("A person of ordinary skill is also a person of ordinary
creativity, not an automaton.").
The Appellants also contend that there "was a surprising result
observed when the mother's own milk formed the source of the component
which was being fortified (e.g., enriched)" (App. Br. 11 ). To the extent that
this argument is made in support of unexpected results, we find the record
deficient of sufficient factual evidence to support unexpected results of the
broadly drafted claims. Additionally, as we found above, the idea that
mother's own milk provides beneficial results is not new, as Medo explicitly
discloses "the best food or nutrition supplied to an infant is its own mother's
milk" (iT 5).
The Appellants argue benefits of the claimed subject matter,
specifically stating the claims provide for "an individualized 'cocktail' of
nutrients" and that "the nutrition can be optimally adapted by tailor-made
enrichment/derichment of constituents for consequential growth,
immunological or hormonal regulation" (App. Br. at 13-15). Additionally,
the Appellants assert the aim of the invention is "to supply nutrients which
are not present or insufficiently present in its mother's own milk when
needed" (id. at 22). The Appellants also state that "it is not at all obvious to
pump the milk in order to analyze it, and to discard and therefore waste most
of the components of it in order to filter out one specific desired component,
let alone to later on supplement a later expressed sample from the same
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mother with the extracted component of the first sample" (id.). To the extent
that these assertions are made to support patentability, we find these
arguments unpersuasive because these features do not appear in the claims
as drafted. See In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998) (The
"name of the game is the claim" and unclaimed features cannot impart
patentability to claims). See also In re Self, 671 F.2d 1344, 1348 (CCPA
1982) ("[A]ppellant's arguments fail from the outset because ... they are
not based on limitations appearing in the claims.").
Additionally, the Appellants argue that "a person skilled in the art
starting from Medo, in view of Gaull, would at the most want to enhance
cow milk-based or soy-milk based formulas" (App. Br. 21 ). Thus, the
Appellants argue one skilled in the art "would be discouraged from
extracting human milk from mother's milk" because "Gaull leads away from
extracting the proteins from fresh milk ... as Gaull lists the disadvantages of
recovering or producing proteins from fresh milk" (id. at 22). We find these
arguments unconvincing because they fail to consider the totality of the
facts; where, as discussed above, Medo discloses benefits of using the
mother's own milk for their infant and also discloses the benefits associated
with using human milk (i-f 5). See Medichem, S.A. v. Rolabo, S.L., 437 F.3d
1157, 1165 (Fed. Cir. 2006) ("[O]bviousness must be determined in light of
all the facts, and there is no rule that a single reference that teaches away
will mandate a finding of nonobviousness. Likewise, a given course of
action often has simultaneous advantages and disadvantages, and this does
not necessarily obviate motivation to combine.").
Therefore, given the collective teachings of Medo and Gaull and their
suggestion to one of ordinary skill in the art, a person ordinary skill in the art
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would have found it obvious to have used the mother's own milk to isolate
the concentrated milk protein, combining this isolated milk protein (e.g.
HRF) with the mother's own milk, as suggested by Gaull, to provide the
infant with its mother's own milk fortified with nutritional formulation from
the mother's milk. The skilled artisan would have been so motivated
because, as established by Medo, "the best food or nutrition supplied to an
infant is its own mother's milk" (i-f 5).
II
In arguing for the reversal of Rejection II, the Appellants present no
additional arguments and, therefore, we maintain this rejection for
substantially the same reasons as set forth above.
III
In arguing for the reversal of Rejection III, the Appellants present no
additional arguments and, therefore, we maintain this rejection for
substantially the same reasons as set forth above.
SUMMARY
For these reasons and those reasons as set forth in the Answer,
rejections I, II, and III are affirmed. Therefore, the Examiner's final
decision to reject claims 2, 4, 6, 7, 10-12, 18, 21, 22, 24--26, and 28-38 is
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)(l).
AFFIRMED
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