Ex Parte Campbell et al

Patent Trials and Appeals Board

May 6, 2019

13463127 - (D) (P.T.A.B. May. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/463, 127 05/03/2012
21839 7590 05/08/2019
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
FIRST NAMED INVENTOR
Joy Campbell
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.
0086030-000007 3389
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
05/08/2019 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):
ADIPDOC 1@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOY CAMPBELL, RONALD E. STROHBEHN,
ERIC M. WEA VER, BARTON S. BORG, LOUISE. RUSSELL,
FRANCISCO JAVIER POLO POZO, JOHN D. ARTHINGTON,
and JAMES D. QUIGLEY III 1
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Application 13/463, 127
Technology Center 1600
Before JOHN G. NEW, RYAN H. FLAX, and RACHEL H. TOWNSEND,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of treating gastrointestinal diseases related to
chronic immune stimulation. Claims 1, 2, and 5 are on appeal as rejected
under 35 U.S.C. § 112, first paragraph, and§ 103(a). We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as "Lauridsen Group Inc."
Appeal Br. 2. Herein we refer to the Substitute Specification of Dec. 28,
2012 ("Spec."); the Final Rejection of Feb. 17, 2017 ("Final Action"); the
Appeal Brief of Aug. 11, 2017 ("Br."); and the Examiner's Answer of Nov.
27, 2017 ("Answer"). No Reply Brief was submitted by Appellants.
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STATEMENT OF THE CASE
The Specification states:
The primary source of nutrients for the body is blood,
which is composed of highly functional proteins including
immunoglobulin, albumin, fibrinogen and hemoglobin.
Immunoglobulins are products of mature B cells (plasma cells)
and there are five distinct immunoglobulins ["lg"] referred to as
classes: M, D, E, A, and G. IgG is the main immunoglobulin
class in blood. Intravenous administration of immunoglobulin
products has long been used to attempt to regulate or enhance the
immune system.
Spec. 1:25-31. The Specification further states, "[a]ccording to the
invention, a plasma composition comprising immunoglobulin, when
administered orally, regulates and lowers nonspecific immunity responses
and induces a lowering and regulation of serum IgG levels and TNF-a levels
relative to animals not orally fed immunoglobulin or plasma fractions." Id.
at 3:16-20.
Claim 1 is representative and is reproduced below:
1. A method of treating gastrointestinal diseases related to
chronic immune stimulation, comprising orally administering to
a human subject afflicted with Crohn's disease, ulcerative colitis,
inflammatory bowel disease (IBD), irritable bowel syndrome
(IBS), or HIV, a non-specific immunoglobulin concentrate that
is a fraction derived from pig, bovine, ovine, poultry, equine, or
goat blood, serum, or plasma, wherein the immunoglobulin
concentrate is orally administered in combination with a
pharmaceutically acceptable carrier, and wherein the
immunoglobulin concentrate is administered in an amount that
comprises 0.5-2.5% by weight of the subject's total dietary
intake.
Br. 17 (Claims Appendix).
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The following rejections are appealed:
Claims 1, 2, and 5 stand rejected under 35 U.S.C. § 112, first
paragraph, for lacking an enabling disclosure. Answer 2.
Claims 1, 2, and 5 stand rejected under 35 U.S.C. § 112, first
paragraph, for lacking a written description (new matter added). Answer 5.
Claims 1, 2, and 5 stand rejected under 35 U.S.C. § 102(b), or
alternatively, 35 U.S.C. § 103(a), over Polo Pozo. 2 Answer 5.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief have been considered;
arguments not so presented in the Brief are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474
(BP AI 2010) (informative) ("Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived.").
Except as otherwise indicated below, we adopt the Examiner's
findings of fact and rationale as set forth in the Final Action and Answer.
Final Action 2-7; Answer 2-12. Findings of fact set forth below highlight
certain evidence.
2 EP 1 044 690Al (published Oct. 18, 2000) ("Polo Pozo").
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I. ENABLEMENT
Relevant Law
over,
Relevant to the Examiner's rejection and Appellants' arguments there-
Section 112 requires that the patent specification enable "those
skilled in the art to make and use the full scope of the claimed
invention without undue experimentation". . . . [S]ee also In re
Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) ("[T]he spec-
ification must teach those of skill in the art how to make and how
to use the invention as broadly as it is claimed.").
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070-71 (Fed. Cir.
2005). As to the scope of the claimed invention, "the claims define the
invention ... [ and] limitations from the specification are not to be read into
the claims." Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988). The
Patent Office applies the broadest reasonable construction standard in
prosecution proceedings. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131,
2145 (2016). Furthermore, "an invention may be enabled even though it has
not been described." University of Rochester v. G.D. Searle & Co., Inc., 358
F.3d 916, 921 (Fed. Cir. 2004).
Findings of Fact (FF)
FF 1. The claims require: (1) treating by "orally administering
to a human subject afflicted with [e.g.,] Crohn's disease ... "; (2) "a
non-specific immunoglobulin concentrate that is a fraction derived
from [ e.g.,] pig ... serum, or plasma"; (3) "the immunoglobulin
concentrate is orally administered in combination with a
pharmaceutically acceptable carrier"; and ( 4) "the immunoglobulin
concentrate is administered in an amount that comprises 0.5-2.5% by
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weight of the subject's total dietary intake." See Br. (Claims
Appendix).
FF2. Further to the preceding finding of fact, the claims do not
require any specific result to be achieved by the recited method of
treatment. All the claims require is the administration of the claimed
non-specific immunoglobulin concentrate formulation, at the claimed
dose, to a member of the claimed population ( which effects some
treatment).
Analysis
The Examiner determined, regarding the invention defined by claims
1, 2, and 5, that "[t]he specification disclosure is insufficient to enable one
skilled in the art to practice the invention as claimed without an undue
amount of experimentation." Answer 2. The Examiner premised this
determination on the rationale that "biological methods which rely on
previously undescribed and generally unpredictable mechanisms" require
"'more detail as to how to make and use the invention in order to be
enabling'." Id. ( citing MPEP § 2164.03). Furthermore, the Examiner's
determination is based on an interpretation of the claims as requiring an
"effective treatment" for one of the recited disease states. Id. at 3.
We conclude the Examiner's determination here is based on an
incorrect claim interpretation. Under the broadest reasonable interpretation
of the claims, no claim requires an "effective treatment." See FFl, FF2. All
that is required by the claims is to administer the claimed non-specific
immunoglobulin concentrate formulation, at the claimed dose, to a member
of the claimed population, which effects some treatment of gastrointestinal
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disease in that population. Id. There is nothing unpredictable or that would
have been difficult for the skilled artisan to comprehend in such a method,
which essentially consists of well-known steps (identifying a diseased
population, formulating a non-specific immunoglobulin concentrate dose
based on patient weight, and orally administering the dose). " [A]
specification need not disclose what is well known in the art." Genentech
Inc. v. Novo NordiskA/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997) (citation
omitted). Therefore, we conclude the Examiner has not established that the
claims lack an enabling disclosure.
II. WRITTEN DESCRIPTION/NEW MATTER
Relevant Law
Relevant to the Examiner's rejection and Appellants' arguments there-
over, "[t]he 'written description' requirement serves a teaching function, ...
in which the public is given 'meaningful disclosure in exchange for being
excluded from practicing the invention for a limited period of time."'
University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916,922 (Fed.
Cir. 2004) (citation omitted). Another "purpose of the 'written description'
requirement is ... [to] convey with reasonable clarity to those skilled in the
art that, as of the filing date[], [the applicant] was in possession of the
invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563---64 (Fed. Cir.
1991 ); see also Enzo Biochem Inc. v. GenProbe Inc., 296 F .3d 131 6, 1329
(Fed. Cir. 2002). The requirement is satisfied when the specification "set[s]
forth enough detail to allow a person of ordinary skill in the art to
understand what is claimed and to recognize that the inventor invented what
is claimed." University of Rochester, 358 F.3d at 928.
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"[ A ]pplicants have some flexibility in the 'mode selected for
compliance' with the written description requirement" ( University of
Rochester, 358 F.3d at 928), and it is well-settled that actual reduction to
practice is not necessary to satisfy the requirement (id. at 926). Whether or
not a specification satisfies the requirement is a question of fact, which must
be resolved on a case-by-case basis (Vas-Cath, 935 F.2d at 1562-63), and it
is the Examiner's "initial burden [to] present[ ] evidence or reasons why
persons skilled in the art would not recognize in the disclosure a description
of the invention defined by the claims" (In re Wertheim, 541 F .2d 257, 263
(CCP A 197 6) ). "The written description requirement is not met if the
specification merely describes a 'desired result."' Vasudevan Software, Inc.
v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015) (citing Ariad
Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010)).
Findings of Fact (FF)
FF3. Further to the preceding findings of fact, the claims
require treating by "orally administering to a human subject afflicted
with [e.g.,] Crohn's disease ... ,"anon-specific immunoglobulin
concentrate that is "administered in an amount that comprises 0.5-
2.5% by weight of the subject's total dietary intake." See Br. (Claims
Appendix). Therefore, the scope of the claims spans administered
doses of 0.5-2.5% by weight of total dietary intake that would be
expected to result in some treatment.
FF4. The Specification's disclosure regarding oral
administration of a non-specific immunoglobulin concentrate at a
dosage based on a percentage of the subject's total dietary intake can
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potentially be found at Example 5, which describes feeding an array
of formulations to mice. Spec. 26-34. Of eight dietary treatments,
one was lg concentrate at 2.5% and one was lg concentrate at 0.5%
( for the sake of argument, we presume these percentages are based on
the subjects' total dietary intake; however, this is not specified).
FF5. Further to the preceding finding of fact, the Specification
states, regarding TNF-a suppression, "[t]he immunoglobulin rich
fraction suppressed TNF-a production at [0].5% but not at 2.5%." Id.
at 31 :28-29 ( the Specification describes that TNF-a concentrations,
and hints that IL-IO concentrations, are identifiers of effective
treatment). No similar conclusion is stated with respect to IL- I 0
levels and any immunoglobulin concentrate dose. Id. at 26-34.
FF6. Further to the preceding findings of fact, the
Specification (Example 5) discloses TNF-a and IL- IO production
results based on administration of the aforementioned eight dietary
treatments, including lg concentrates of 2.5% and 0.5%, and indicates
that, when fed these two lg concentrate doses, the respective
productions of TNF-a and IL- IO each increased upon stimulation to a
greater extent than a control treatment. Spec. 33 (tables 13 and 14);
cf FF5.
Analysis
The Examiner determined "[t]he specification and the claims as
originally filed do not provide support for: B) Regarding Claims 1 and 2, a
method employing ' ... immunoglobulin concentrate ... in an amount that
comprises 0.5-2.5% by weight of the subject's total dietary intake'."
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Answer 5. Because this subject matter was added to the claims by
amendment during prosecution, the Examiner identified that the written
description rejection was for the introduction of new matter into the claims.
Id. We agree with the Examiner's determination: the Specification does not
support the "method of treating gastrointestinal diseases related to chronic
immune stimulation, comprising ... immunoglobulin concentrate is
administered in an amount that comprises 0.5-2.5% by weight of the
subject's total dietary intake," as claimed. The Specification does not
support that treatment could be expected over the claimed 0.5-2.5% by
weight of the subject's total dietary intake range, as claimed. See FF3-FF6.
And, the Specification is ambiguous, at best, weather the disclosed 0.5% and
2.5% samples tested reflect percentages based on total dietary intake.
Appellants argue that the disclosed list of dietary treatments (1-8) of
Experiment II (Example 5) in the Specification supports the claimed subject
matter because "the cited Examples provided test subjects with dietary
immunoglobulin concentrations that ranged from 0.5% to 2.5% of the diet."
This is not persuasive. Even if the "lg concentrate, 2.5%" and the "lg
concentrate, [0].5%" were intended to indicate percentages of daily intake
by weight, which we can only assume arguendo because it is not specified,
these represent only two specific points in the claimed 0.5-2.5% range and
the Specification indicates specifically that only the 0.5% point was effective
at reducing TNF-a production, while the 2.5% point was not (also, Spec.
does not indicate that either point was effective at reducing IL- I 0
production). FF5. Disclosure of a single point, or even end points, in a
claimed range does not disclose the range. See, e.g., In re Lukach, 442 F .2d
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967, 969 (CCP A 1971) ( disclosure of points in a range is not disclosure of
the range under the written description requirement).
Appellants also argue that the data in the Specification shows "IL- I 0
production increased more significantly in subjects fed either 0.5% or 2.5%
immunoglobulin concentrate (IL-IO production increase of 329 pg/ml and
274 pg/ml, respectively) as compared to subjects fed the control diet, which
lacked immunoglobulin concentrate (IL-IO production increase of 156
pg/ml)" and that this supports the claimed subject matter. It is unclear
exactly how this is so or how such data supports the claims because
Appellants neither explain as much in their brief nor submit other evidence,
e.g., a declaration of an expert, to explain it. Why the changes disclosed in
the data of the tables in the Specification matter, or how they relate to the
claimed treatment and dosage ranges, remain ambiguous.
We find nothing in the record that persuades us that the Examiner's
determinations regarding the claims' failings under the written description
requirement are in error.
III. ANTICIP A TION/0BVI0USNESS
Relevant Law
Relevant to the Examiner's rejection and Appellants' arguments there-
over, "[a]nticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
Furthermore, regarding obviousness, "[ t ]he combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550
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U.S. 398,416 (2007). "[W]hen a patent claims a structure [or method]
already known in the prior art that is altered by the mere substitution of one
element [ or step] for another known in the field, the combination must do
more than yield a predictable result." Id. (citing United States v. Adams, 383
U.S. 39, 50-51 (1966)). "[T]he analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." Id. at 418.
Moreover, "the discovery of an optimum value of a variable in a
known process is normally obvious." In re Antonie, 559 F.2d 618, 620
(CCP A 1977). Exceptions to this rule include cases where (1) the results of
optimizing a variable were unexpectedly good and (2) the parameter
optimized was not recognized in the prior art as one that would affect the
results. Id.
Findings of Fact (FF)
FF7. Polo Pozo discloses:
applications of mixtures of gamma globulin-rich plasma proteins
of animal origin for the preparation of medicinal compositions,
food and dietary preparations: [a] suitable for the prevention and
treatment of gastrointestinal disorders in human beings . . . ; [b]
suitable for improving the immunological state of human beings
... ; [ c] suitable for the treatment of malabsorption processes in
human beings ... , and [ d] suitable for the treatment of clinical
conditions accompanied by malnutrition in human beings ...
and that "[i]t is of particular interest that the immuno-globulins should
be non-specific." Polo Pozo Abstract, ,r 21.
FF8. Further to the preceding finding of fact, Polo Pozo
discloses that the aforementioned gamma-globulin-rich plasma
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proteins for treating humans are derived from bovine, ovine, goat,
rabbit, and porcine plasma sources. Polo Pozo ,r,r 14, 31.
FF9. Further to the preceding findings of fact, Polo Pozo
discloses treating, inter alia, ulcerative colitis, Crohn's disease, and
AIDS. Polo Pozo ,I 17.
FFlO. Further to the preceding findings of fact, Polo Pozo
discloses, "[ o ]ne advantageous form of application is obtained when
the medicinal compositions, food and dietary preparations are usable
dissolved in water, milk, juices, yoghurts and other foodstuffs. These
other foodstuffs are preferably humanised milk, paps and other baby
foods," i.e., orally administered formulations and pharmaceutically
acceptable carriers. Polo Pozo ,r 19.
FF 11. Further to the preceding findings of fact, Polo Pozo
discloses that "[i]t is also an object of the invention to prepare a
concentrate of the gamma globulin fraction of over 90 wt%," i.e.,
nearly pure or essentially so. Polo Pozo ,r,r 21, 31.
FF12. While Polo Pozo teaches orally administering non-
specific, non-human derived immunoglobulin concentrate to humans
to treat, e.g., Crohn's disease, it does not expressly disclose a dose of
such concentrate at 0.5-2.5% by weight of the subject's total dietary
intake.
Analysis
The Examiner determined:
[Polo Pozo] teaches the treatment of Crohn' s disease and
ulcerative colitis comprising the oral administration of porcine,
bovine, equine, ovine, or goat lg concentrate (see particularly,
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the Summary of the Invention). It is unclear whether o[r] not the
immunoglobulin concentrates of the reference meet the newly
added weight limitation of the claims given the fact that the
specification fails to disclose the specific composition of the lg
concentrates taught therein. However, the optimization of the lg
content of the lg concentrates of the claimed method comprises
only routine optimization of the claimed method and is, thus,
considered to be prima facie obvious to one of ordinary skill in
the art at the time the invention. Said routine optimization does
not render the claimed method patentably distinct.
Answer 5; see also id. at 11-12. We discern no error in the Examiner's
determination of obviousness. The claims would have been obvious over
Polo Pozo. FF7-FF12. However, as the Examiner notes, Polo Pozo does
not disclose each claim limitation, i.e., it does not disclose the claimed
dosage range; therefore, even if such was a mere optimizable result-effective
variable, Polo Pozo does not anticipate. We address Appellants' arguments
below.
Appellants argue:
Claims 1 and 2 include a limitation requiring that "the non-
specific immunoglobulin concentrate is administered in an
amount that comprises 0.5-2.5% by weight of the subject's total
dietary intake." In rejecting these claims as anticipated and/or
obvious, the Examiner has not identified any disclosure in [Polo
Pozo] that teaches or suggests the weight percent limitation of
the present claims, and in fact [Polo Pozo] does not contain any
disclosure that teaches or suggests the administration of such an
amount of immunoglobulin concentrate.
Br. 14--15. Appellants argue this distinguishes the claims as not anticipated
and not obvious over Polo Pozo.
Appellants' argument is not persuasive regarding obviousness. The
Examiner determined that the dosage range of the active component, non-
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specific lg concentrate, was obvious as a routinely optimizable variable. We
agree. As noted above, "the discovery of an optimum value of a variable in
a known process is normally obvious." In re Antonie, 559 F.2d at 620.
Here, there is no persuasive argument or evidence presented by Appellants
that the claimed dosage range produced unexpected results. Nor is there
persuasive evidence that the claimed active component, i.e., non-specific
immunoglobulin concentrate, was not a known, result-effective variable.
Tailoring the dosage of an active component in a pharmaceutical
formulation is accomplished by mere routine and obvious optimization. See,
e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007).
For the reasons above, we are not persuaded the Examiner erred in
making a prima facie case for obviousness. Nor are we persuaded that there
is evidence rebutting such a case for obviousness.
SUMMARY
The enablement rejection under 35 U.S.C. § 112, first paragraph, is
reversed.
The written description rejection under 35 U.S.C. § 112, first
paragraph, is affirmed.
The alternative anticipation rejection under 35 U.S.C. § 102 is
reversed.
The alternative obviousness rejection under 35 U.S.C. § 103 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 )(iv).
AFFIRMED
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