Ex Parte Trevino et al

Patent Trial and Appeal Board

Apr 5, 2017

13253415 (P.T.A.B. Apr. 5, 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.
13/253,415 10/05/2011 Ramiro Trevino 51594-701.501 1356
21971 7590 04/07/2017
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
GITOMER, RALPH J
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
04/07/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAMIRO TREVINO and STEVEN R. ELLIS1
Appeal 2015-003421
Application 13/253,415
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
microorganism-containing composition, which have been rejected for lack of
written description, nonenablement, and obviousness. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Claims 1—4, 6—34, 36, and 59 are on appeal. Claim 1 is illustrative
and reads as follows:
1 Appellants identify the Real Party in Interest as Drylet, LLC. (Appeal
Br. 3.)
Appeal 2015-003421
Application 13/253,415
1. A composition for delivering microorganisms in a dry mode, the
composition comprising:
an inert carrier substrate having a porous structure, wherein the inert
carrier substrate is selected from the group consisting of diatomaceous earth,
walnut and pecan shells, rice hulls, cellulosic clay, montmorillonite clay,
bentonite clay, wool, cotton, cellulose, com cobs, cellulose shells,
precipitated silica, and combinations thereof;
microorganisms loaded throughout the pores of the inert carrier
substrate; and
a surface layer disposed on the outer surface of the inert carrier
substrate, wherein the surface layer includes an organic phase and is
permeable to molecules that aid in cell growth of the microorganisms such
that the composition is operable to allow for increased propagation of the
microorganisms within the pores of the inert carrier substrate as compared to
another composition having an absence of the surface layer.
Claim 59, the only other independent claim, is similar to claim 1 but
requires the inert carrier substrate to be precipitated silica.
The claims stand rejected as follows:
Claims 1—4, 6—34, 36, and 59 under 35 U.S.C. § 112, first paragraph,
for lack of written description (Ans. 2—3);
Claims 1—4, 6—34, 36, and 59 under 35 U.S.C. § 112, first paragraph,
for lack of enablement (Ans. 32); and
Claims 1—4, 6—34, 36, and 59 under 35 U.S.C. § 103(a) as obvious
based on Heitkamp3 and Palazzi4 (Ans. 5).
2 The Examiner did not clearly set out enablement as a basis of rejection
separate from written description, but did include a discussion of the Wands
factors, so we will treat it as a separate rejection.
3 Heitkamp, WO 97/12965, pub. April 10, 1997.
4 Palazzi, WO 2010/054439 Al, pub. May 20, 2010.
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Application 13/253,415
I
The Examiner has rejected all of the claims on appeal for lack of
adequate written description.5 The Examiner finds that
[a] key feature of the claimed composition is stability
(specification, pages 10-11, [0021 ]), and claim 7 is directed to a
shelf life of at least two years. . . . No evidence for this stability
is presented. Shelf life depends on temperature, pH, humidity,
concentration, and other parameters not recited or disclosed. Not
a single experiment was presented showing the long life asserted.
(Ans. 2-3.)
We agree with Appellants (Appeal Br. 10-11), however, that the
Specification describes each of the elements actually recited in claims 1 and
59, neither of which requires any particular degree of stability. We also
agree with Appellants {id. at 11—12) that claim 7 is adequately described by
the Specification. See AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336,
1352 (Fed. Cir. 2010) (“[T]he written description requirement does not
demand either examples or an actual reduction to practice; a constructive
reduction to practice that in a definite way identifies the claimed invention
can satisfy the written description requirement.”). The rejection for lack of
written description is reversed.
5 The Examiner actually stated that the written description and
nonenablement rejections applied to “[cjlaims 1-4, 6-36, 57.” (Ans. 2.)
Since claim 57 has been withdrawn from consideration (Office Action
mailed Apr. 4, 2014, page 1), however, we understand the rejection to apply
to claim 59 instead.
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Application 13/253,415
II
The Examiner has rejected all of the claims on appeal for lack of
enablement. The Examiner sets out findings under each of the factors of In
re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), and concludes that “an undue
level of experimentation would be required to determine under what
conditions the claimed composition would obtain the claimed degree of
stability.” (Ans. 3.)
We agree with Appellants, however, that the Examiner “does not
provide any evidence or technical reasons that demonstrate the quantity of
experimentation would be undue.” (Appeal Br. 13.) None of the
Examiner’s Wands findings, in fact, is supported by citation of any evidence
or sound technical reasoning. In the absence of evidence supporting the
conclusion of nonenablement, the Examiner has not made out a prima facie
case that undue experimentation would be required to practice the claimed
invention.
Ill
The Examiner has rejected all of the claims on appeal as obvious
based on Heitkamp and Palazzi. The Examiner finds that “Heitkamp . . .
teaches on page 1, last paragraph, biosupports made from porous inorganic
particles such as diatomaceous earth which have been well proven as
supports for chemical degrading bacteria.” (Ans. 5.)
The Examiner finds that Palazzi teaches probiotic compositions that
are storage stable and maintain viability. (Id.) The Examiner finds that
Palazzi teaches that “the microorganisms may be within a porous core bead
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Application 13/253,415
which may be covered by one or more layers,” where “[t]he preferred matrix
disposed on the core bead is a non-aqueous matrix comprising an oil.” (Id.)
The Examiner concludes that it would have been obvious to coat
Heitkamp’s porous supports “as taught by Palazzi because Palazzi teaches
the advantages of stabilizing microorganisms on a porous support by coating
them with the same materials as presently claimed.” (Id. at 5—6.)
We agree with the Examiner that the composition of claim 1 would
have been prima facie obvious based on the cited references. Heitkamp
discloses that “[t]he biosupports which are typically used in commercial
scale bioreactors are predominantly sand, granular activated carbon (GAC)
particles and porous inorganic particles such as diatomaceous earth.”
(Heitkamp 1:24—26.) Heitkamp teaches that “these biosupports, also known
as biocarriers, are commercially available and have been well-proven as
supports for chemical-degrading bacteria.” (Id. at 1:26—27.)
Palazzi discloses “probiotic compositions that may be stored at
ambient temperatures or lower while maintaining a suitable level of
probiotic viability.” (Palazzi 1:6—8.) “Probiotic microorganisms are well
known in the art and the term refers to live microbial preparations.” (Id. at
1:25-26.)
Palazzi discloses “a probiotic composition in pellet form comprising a
core bead and a probiotic microorganism embedded within a matrix, said
matrix substantially maintaining the viability of said microorganisms,
wherein the matrix is disposed on or in the core bead.” (Id. at 6:5—8.)
“Preferably the core bead is porous or semi-porous so that the matrix
containing the probiotic microorganism can be impregnated into the bead
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core to form a porous pellet or bead. Such a porous pellet may be covered
by one or more layers depending on requirements (eg. protection of the
pellet and/or microorganism. . .).” (Id. at 6:13—16.) Palazzi states that
“[t]he preferred matrix is a non-aqueous matrix comprising an oil.” (Id. at
6:23.) Suitable oils include olive oil and canola oil. (Id. at 8:27—28.)
We agree with the Examiner that, based on these teachings, it would
have been obvious to apply the matrix layer disclosed by Palazzi to
Heitkamp’s diatomaceous earth biosupports, which are carriers for chemical­
degrading bacteria. Palazzi provides a reason to do so, because it discloses
that its coated porous beads provide for storage of probiotic bacteria at
ambient temperatures while maintaining a suitable level of viability.
Appellants argue that “[a]s ‘increasing storage stability of similar
particles’ is not an element in any of the pending claims, the Examiner had
failed to properly construe the claims and has mischaracterized claim
elements.” (Appeal Br. 22.) Appellants argue that the surface layer of the
claimed particles is to allow for increased propagation of the
microorganisms in the inert carrier substrate, not for stability of the particles.
(Id.)
This argument is unpersuasive. “In determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. . . . [A]ny need or problem known
in the field of endeavor at the time of invention and addressed by the patent
can provide a reason for combining the elements in the manner claimed.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007). Here, Palazzi
teaches that its invention allows for storage of viable bacteria at ambient
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Application 13/253,415
temperatures, and therefore provides a reason to combine its teachings with
those of Heitkamp.
Appellants also argue that “the layers described in Palazzi are for the
purpose of aiding in the ‘protection of the pellet and/or microorganism,
addition of flavours and colour, addition of pre-biotics or different probiotic
microorganisms, addition of nutritional components and the like.’” (Appeal
Br. 24.) Appellants argue that “[njothing in Palazzi teaches that its layers
should be permeable to molecules that aid in cell growth of microorganisms,
or further that the layer would allow for increased propagation of
microorganisms as compared to equivalent inert carrier substrates without
surface layers.” (Id.)
We agree with the Examiner (Ans. 10), however, that the surface layer
taught by Palazzi meets the functional limitations of claim 1. As discussed
above, Palazzi teaches that its particles are coated with a matrix, preferably
one comprising an oil (Palazzi 5:23), and that suitable oils include olive oil
and canola oil (id. at 8:27—28).
Appellants’ Specification states that the organic phase of the surface
layer “can be lipids, polysaccharides, fatty acids, or combinations thereof.”
(Spec. 19.) The Specification provides working examples in which
precipitated silica granules are mixed with an emulsion comprising cetearyl
alcohol, cetyl ester, lecithin, olive oil, canola oil, B. subtilis bacteria, and
water. (Id. 170.) The Specification states that a “surface layer is formed.
In the present embodiment, the surface layer is comprised of fatty acid
alcohols, fatty acids, and lipids, while the water and B. Subtilis are located
within the precipitated silica granules.” (Id. 171.)
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Thus, the evidence supports a reasonable expectation that coating
particles with olive oil, canola oil, or a mixture of the two, as suggested by
Palazzi, will produce a surface layer having the functional characteristics
recited in claim 1.
Where ... the claimed and prior art products are identical or
substantially identical ... the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on “inherency” under 35 U.S.C. § 102, on
“prima facie obviousness” under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted)
Appellants have not pointed to persuasive evidence showing that the
product made obvious by Heitkamp and Palazzi would not have the
properties recited in claim 1.
Appellants also argue that the focus of Heitkamp is on porous
polymeric biosupports, while the particles of Palazzi are designed to dissolve
or disintegrate when exposed to liquids, and therefore “the references render
each other inoperable (e.g. using the dissolving delivery system of Palazzi
for waste water treatment would render a composition unsuitable for
Heitkamp’s invention and using the compositions of Heitkamp for probiotic
delivery would render the composition in Palazzi unsuitable for
consumption).” (Appeal Br. 26—27.)
This argument is unpersuasive, because the rejection is based on
modifying Heitkamp’s particles to include the surface layer taught by
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Application 13/253,415
Palazzi, not using Palazzi’s particles in place of Heitkamp’s, or vice versa.
“Claims may be obvious in view of a combination of references, even if the
features of one reference cannot be substituted physically into the structure
of the other reference.” Orthopedic Equip. Co. v. United States, 702 F.2d
1005, 1013 (Fed. Cir. 1983).
Finally, Appellants argue that the “Examiner has failed to address any
of the dependent claims and how the dependent claims are made obvious in
view of the cited references.” (Appeal Br. 27.) Appellants argue that “it is
unclear to Applicants why Examiner has rejected these dependent claims as
obvious in view of the cited art. . . . Because the Examiner has failed to
provide clear reasoning with rational underpinning to support [the]
obviousness rejection, the Examiner has not set forth a proper prima facie
case of obviousness for any of the dependent claims.” {Id. at 29-30.)
We agree with Appellants that the Examiner did not point to evidence
or provide a reasoned basis for rejecting any of the dependent claims, or
independent claim 59. The Examiner stated that the limitations of the
dependent claims are “tangential to the teachings of the references.” (Ans.
11.) However, the initial burden of establishing a prima facie case of
obviousness rests on the Examiner.
[T]he PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in
“notifying] the applicant . . . [by] stating the reasons for [its]
rejection, or objection or requirement, together with such
information and references as may be useful in judging of the
propriety of continuing the prosecution of [the] application.” 35
U.S.C. § 132. That section “is violated when a rejection is so
uninformative that it prevents the applicant from recognizing and
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Application 13/253,415
seeking to counter the grounds for rejection.” Chester v. Miller,
906 F.2d 1574, 1578 (Fed. Cir. 1990).
In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011). The Examiner’s rejection
of the dependent claims and claim 59 fails to meet the standard of 35 U.S.C.
§ 132, and is therefore reversed.
SUMMARY
We reverse both of the rejections under 35 U.S.C. § 112, first
paragraph.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a).
We reverse the rejection of claims 2-4, 6—34, 36, and 59 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-IN-PART
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