Ex Parte Theil

Patent Trial and Appeal Board

Nov 1, 2017

14219472 (P.T.A.B. Nov. 1, 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.
14/219,472 03/19/2014 Elizabeth C. Theil CHOR-049CON 1067
24353 7590 11/03/2017
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
KOSAR, AARON J
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
11/03/2017 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELIZABETH C. THEIL1
Appeal 2017-003070
Application 14/219,472
Technology Center 1600
Before FRANCISCO C. PRATS, DEBORAH KATZ,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to dietary
supplements which have been rejected as indefinite and as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
“Iron deficiency is the most common nutritional deficiency worldwide
affecting 30 million people in both developed and developing countries.”
1 Appellant identifies the Real Party in Interest as Children’s Hospital &
Research Center at Oakland, Inc. Br. 3.
Appeal 2017-003070
Application 14/219,472
Spec. 13. Ferritin is a natural, non-toxic, slow-release form of biologically
available iron. Spec. 14. The Specification describes “a dietary supplement
that includes plant ferritin; and methods of use of such a supplement.” Spec.
16.
Claims 1—17 are on appeal. Claims 1 is the sole independent claim
and reads as follow:
1. A dietary supplement,
wherein the supplement comprises plant ferritin in an
amount of from about 10% to about 50% by weight of
the total protein,
and wherein the supplement is prepared from at least
the seeds and hull of a legume.
The claims stand rejected as follows:
Claims 1—17 have been rejected under 35U.S.C. § 112, second
paragraph, as indefinite.
Claims 1—17 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Lonnerdal2 in view of Kovacs3 and Garleb.4
Claims 1—5, 10, and 12—17 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Connor5 in view of Theil.6
2 Lonnerdal et al., Iron absorption from soybean ferritin in nonanemic
women, 83 Am. J. Clin. Nutr. 103 (2006) (“Lonnerdal”).
3 Kovacs et al., US 3,992,556, issued Nov. 16, 1976 (“Kovacs”).
4 Garleb at al., US 5,085,883, issued Feb. 4, 1992 (“Garleb”).
5 Connor et al., US 2009/0142360 Al, published June 4, 2009 (“Connor”).
6 Theil et al., A sustainable solution for dietary iron deficiency through plant
biotechnology and breeding to increase seed ferritin control, 52 Eur. J.
Clin. Nutr. S28 (1997) (“Theil”).
2
Appeal 2017-003070
Application 14/219,472
INDEFINITENESS
Appellant has not argued this rejection. Therefore, we summarily
affirm this rejection.
OBVIOUSNESS
LONNERDAL COMBINED WITH KOVACS AND GARLEB
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1—17 would
have been obvious over Lonnerdal combined with Kovacs and Garleb.
The Examiner finds that Lonnerdal teaches that ferritin derived from
soybeans is a suitable source of bioavailable iron. Final Act. 5. The
Examiner finds that Kovacs discloses food compositions and supplements
which contain iron as well as other minerals and vitamins. Final Act. 6. The
Examiner finds that Kovacs also teaches coating the iron compounds with
fat. Id. The Examiner finds that the addition of fiber to food stuffs is known
in the art as evidenced by Garleb. Final Act. 7. The Examiner concludes
that
[i]t would have been obvious and predictable for those of
ordinary skill to fortify known foods with soybean ferritin in
order to provide higher amounts of iron to subjects in need
thereof. The ingredients claimed by Applicant to be admixed
with a legume ferritin are ubiquitously used in foodstuffs and/or
are endogenous to food products as is evidenced by the prior art
discussed above and thus would be present in basic food
compositions which were already known in the art; i.e.,
vitamins, minerals, emulsifying agents, fibers and protein are
old and known, and are either intrinsically present in naturally-
occurring foods or known as conventional food additives for
making conventional foods/nutritional food supplements.
3
Appeal 2017-003070
Application 14/219,472
Final Act. 7—8.
Appellant contends that because of differences between supplemental
iron and ferritin, one skilled in the art would not substitute ferritin for the
iron compounds disclosed in Kovacs. Br. 4—6. Appellant argues that the
Examiner has not shown why one skilled in the art would select ferritin as
the iron containing compound used in Kovacs. Br. 6—8. Appellant argues
that neither Lonnerdal nor Kovacs teaches or suggests the use of ferritin in a
dietary supplement. Br. 8. Appellant also argues that Garleb does not teach
the use of ferritin in a supplement. Br. 9.
Findings of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF1. Lonnerdal teaches that “[i]ron from soybean ferritin is well
absorbed and may provide a model for novel, utilizable, plant-based forms
of iron for populations with a low iron status.” Lonnerdal 103.
FF2. Lonnerdal teaches that “[t]he absorption of iron from soybean
ferritin was high [approx.] 30%, and equally high as from FeSCL, as
determined by either whole-body counting or RBC incorporation.”
Lonnerdal 106.
FF3. Kovacs discloses a food product supplemented with vitamins
and minerals. Kovacs col. 1,11. 9—25.
FF4. Kovacs teaches that while the invention disclosed in Kovacs is
not limited to any particular containing compound, ferrous sulfate [FeSCL] is
preferred because of “its proven usefulness as an oral iron medicament, its
4
Appeal 2017-003070
Application 14/219,472
economy, and because of its biological availability.” Kovacs col. 3,11. 10—
15.
FF5. Garleb discloses a dietary fiber system which can be added to a
nutritional product. Garleb col. 18,11. 12—20.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant. After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality
of the record, by a preponderance of evidence with due
consideration to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]henthe
question is whether a patent claiming the combination of elements of prior
art is obvious,” the answer depends on “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
5
Appeal 2017-003070
Application 14/219,472
Analysis
We find the Examiner has established that the claims would have been
obvious over Lonnerdal combined with Kovacs and Garleb. Appellant has
not produced evidence showing, or persuasively argued, that the Examiner’s
determinations on obviousness are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim 1. We address Appellant’s arguments below.
Appellant argues that the Examiner has not shown why one skilled in
the art would select Lonnerdal and modify the reference to achieve the
claimed product. Br. 4. Appellant argues that the differences between the
ferritin disclosed in Lonnerdal and the iron compound disclosed in Kovacs
would not lead one skilled in the art to use ferritin as a substitute for the iron
compounds. Id. In support of this argument Appellant relies on the
declaration of Dr. Theil which list the differences between ferritin and other
iron compounds. Br. 4—6, Theil Deck7 Tflf 11—15. Dr. Theil opines that
ferritin and iron are not interchangeable. Theil Decl. 10.
Appellant also argues that given the list of iron complexes recited in
Kovacs, there is no reason why one skilled in the art would select ferritin as
the iron source. Br. 7—8. Appellant relies on our reviewing court’s decision
in In re Omeprazole Litigation, 483 F.3d 1364 (Fed. Cir. 2007) to support
their contention that where there is no apparent reason to select a specific
7 Declaration of Elizabeth C. Theil, submitted Nov. 5, 2013.
6
Appeal 2017-003070
Application 14/219,472
solution to solve the problem at hand, a prima facie case of obviousness
cannot be established. Br. 8.
We have considered Appellant’s arguments as well as the Declaration
of Dr. Theil and find them unpersuasive. Kovacs specifically teaches that
the invention is not limited to any specific iron containing compound and
that ferrous sulfate is preferred. FF4. Lonnerdal teaches that ferritin is a
source of dietary iron and that the iron absorbed from ferritin is equal to the
amount absorbed from ferrous sulfate. FF1 & 2. We agree with the
Examiner that it would have been prima facie obvious to substitute the soy
ferritin of Lonnerdal for ferrous sulfate in Kovacs to produce the claimed
invention. Ans. 21.
Appellant argues that neither Lonnerdal nor Garleb teach the use of
ferritin in a dietary supplement and that Kovacs does not teach the
substitution of ferritin for iron in a supplement. Br. 8—9. While these facts
may be true, Appellant’s argument is not persuasive. The rejection is based
in the teachings of the combined references. As discussed above, when the
teachings of Lonnerdal with respect to the absorption equivalence of ferritin
to ferrous sulfate are read in conjunction with Kovacs’ preference for ferrous
sulfate, the substitution of ferritin for ferrous sulfate would have been
obvious to one skilled ion the art. Although Dr. Theil states that there are
differences between iron and ferritin, including their structure, synthesis,
transport and storage, and toxicity, she does not contradict the teaching in
Lonnerdal that ferritin and ferrous sulfate demonstrate equivalent absorption
rates. See Lonnerdal 106. Accordingly, we are not persuaded that the
Examiner’s finding that ferritin was known to be a bioavailable source of
iron is erroneous. We are not persuaded that those of skill in the art would
7
Appeal 2017-003070
Application 14/219,472
not have considered it obvious to substitute ferritin for ferrous sulfate in the
food products of Kovacs.
Appellant argues that one skilled in the art would not select ferritin as
it can cause off-flavors when combined with fats. Br. 9. In support of this
argument, Appellant cites for the first time Drecker.8 Id.
Appellant’s argument is unpersuasive. As the Examiner points out,
Kovacs specifically addresses the issue of off-flavors by teaching that
dispersing the iron or iron compounds in a solid fat carrier one can avoid
“discoloration, off-flavors and off-odors.” Kovacs col. 2,11. 30-34; see Ans.
29. Moreover, Appellant has not shown good and sufficient reasons why the
Drucker reference was not presented earlier. 37 C.F.R. § 41.33(d)(1).
Therefore, the Examiner properly declined to consider the Decker reference.
Ans. 30—31.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over
Lonnerdal combined with Kovacs and Garleb.
Claims 2—17 have not been argued separately and therefore, fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
8 Drecker et al., Role of Ferritin as a Lipid Oxidation Catalyst in Muscle
Food, 39 J. Agric. Food Chem. 674 (1990) (“Drecker”).
8
Appeal 2017-003070
Application 14/219,472
CONNOR COMBINED WITH THEIL
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1—5, 10, and
12—17 would have been obvious over Connor combined with Theil.
The Examiner finds that Connor teaches that ferritin can be used to
treat individuals with iron deficiency disorders. Final Act. 10. The
Examiner finds that while Connor prefers the use of the human H-ferritin
subunit, Connor teaches that a wide array of ferritins can be used. Final Act.
10—11. The Examiner also finds that Connor teaches that the ferritin can be
administered orally in combination with sugars, olive oil, coloring agents
and flavoring agents. Final Act. 11—12. The Examiner finds that Theil
teaches that soy ferritin is a suitable, bioavailable form of iron which may be
administered to individuals with an iron deficiency. Final Act. 12. Thiel
also teaches that ferritin exhibits high conservation of ferritin amino acid
sequence and structure between plants, animals, and microorganisms. Thiel
S29; Final Act. 12-13. The Examiner concludes that
[o]ne of ordinary skill would be motivated to use plant
ferritin such as soybean ferritin as the ferritin in the Invention
by Conner et al. because soybean ferritin is known as a suitable,
bioavailable form of ferritin for supplementing iron poor diets
and because the description of the ferritin which can be used in
the Invention of Conner et al. indicates the use of homologues.
Since Theil et al. indicate that plant, animal and microbial
ferritin is highly conserved, one of ordinary skill would have a
reasonable expectation that legume ferritin such as soy ferritin
could suitably be used in the ferritin containing compositions of
Conner et al. to deliver ferritin and thus iron to the blood and
consequently to the [blood brain barrier].
Final Act. 13.
9
Appeal 2017-003070
Application 14/219,472
Analysis
Appellant contends that one skilled in the art would not have
substituted the soy ferritin of Theil9 for the human H-ferritin of Connor
because Connor teaches that the H-ferritin homologues useful in the
disclosed invention should be at least 80% identical with human H-ferritin,
but that soy ferritin is not 80% identical to human H-ferritin. Br. 10. In
support of this contention Appellant cites to Lescure10 which purports to
show that soy ferritin is less than 80% identical to H-ferritin. Id.
We are unpersauded by Appellant’s arguments. Like the Drecker
reference discussed above, Lescure was newly cited with Appellant’s
Appeal Brief. Appellant has offered no explanation as to why Lescure was
not presented earlier. See, Br. 10. Therefore, we decline to consider the
Lescure reference. 37 C.F.R. § 41.33(d)(1).
Left with only attorney argument regarding the identity of soybean
derived ferritin, we a find Appellant’s argument unpersuasive. Johnston v.
IVACCorp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
In addition, as the Examiner has pointed out, Connor only indicates a
preference for homologues having 80% identity with human H-ferritin.
Final Act. 10—11, Connor 130. Connor specifically teaches that the ferritin
“can also be a naturally occurring or synthetic homologues or variant of
human H-ferritin.” Connor 130. Connor goes on to teach that the ferritin
9 Appellant argues that there is no reason to use the ferritin of Lonnerdal as a
substitute for the human H-ferritin of Conner. Br. 10. Since the rejection
was based on Connor and Theil, we assume Appellant meant to refer to
Theil and not Lonnerdal.
10 Lescure et al., Ferritin gene transcription is regulated by iron in soybean
cell cultures, 88 Proc. Natl. Acad. Sci. 8222 (1991) (“Lescure”).
10
Appeal 2017-003070
Application 14/219,472
can be a combination of H and L ferritin units. Id. Thus, the teachings of
Connor are not as narrow as Appellant contends and permits the use of
ferritin having less than 80% identity with human H-ferritin.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Connor
combined with Theil.
Claims 2—5, 10, and 12—17 have not been argued separately and
therefore, fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 112, second paragraph.
We affirm the rejections under 35 U.S.C. § 103(a).
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. § 1.136(a).
AFFIRMED
11