Ex Parte Schmid-Schonbein et al

Board of Patent Appeals and Interferences

Apr 9, 2010

11850169 (B.P.A.I. Apr. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GEERT W. SCHMID-SCHONBEIN and FRANK A. DELANO
__________

Appeal 2009-009546
Application 11/850,169
Technology Center 1600
__________

Decided: April 9, 2010
__________

Before ERIC GRIMES, HUBERT C. LORIN, and FRANCISCO C. PRATS,
Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
placing a quantity of doxycycline into a stream of commerce. The Examiner
rejected the claims as anticipated and obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse the Examiner’s art rejections but enter a new ground of
rejection for lack of patentable subject matter under 35 U.S.C. § 101.
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STATEMENT OF THE CASE
The Specification discloses that the compound doxycycline “has
found several therapeutic uses that received FDA approval . . . [including]
the treatment of certain bacterial infections, as prophylactic agent for
malaria, and also as an adjunct to dental scaling and root planning” (Spec.
10).
The Specification further discloses that doxycycline’s ability to inhibit
matrix metalloproteinases (MMPs) also renders it useful for treating
disorders for which FDA approval has not yet been granted, including “the
symptoms of diseases rooted in inflammation: Syndrome X, hypertension,
diabetes, etc.” (id. at 9). In view of that discovery, the Specification
describes methods of marketing doxycycline based on its use in the
previously unapproved treatments (id. at 6).
Claims 1-16 are pending and on appeal (App. Br. 4). Claim 1, the
only independent claim, is representative and reads as follows:
1. A method of placing a pharmaceutical compound into a
stream of commerce, comprising:
providing a quantity of a preparation of doxycycline for
use by a patient population, wherein the quantity is
based on a revised sales projection;
forecasting that at least some of the preparation will be
used to treat a non-gingival disease associated with
an matrix metalloproteinase (MMP) activity to
thereby arrive at the revised sales projection;
placing the quantity of the preparation in the stream of
commerce; and
wherein the disease has an etiology associated with at
least one of insulin resistance, hypertension, and
metabolic syndrome.

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The Examiner cites the following documents as evidence of
unpatentability:
Golub US 6,277,061 B1 Aug. 21, 2001
Morrison US 2003/0009367 A1 Jan. 9, 2003
Stanton US 2007/0072232 A1 Mar. 29, 2007

L.M. Golub et al., Tetracyclines Inhibit Connective Tissue Breakdown
by Multiple Non-Antimicrobial Mechanisms, 12 ADV. DENT. RES. 12-26
(Nov. 1998) (hereinafter “Sorsa”).1

Julie P. Sutherland et al., The Metabolic Syndrome and Inflammation,
2 METABOLIC SYNDROME AND RELATED DISORDERS 82-104 (2004) (abstract
only).

Céline Bouvet et al., Different Involvement of Extracellular Matrix
Components in Small and Large Arteries During Chronic NO Synthase
Inhibition, 45 HYPERTENSION 432-437 (2005).

Po-Yin Cheung et al., Matrix Metalloproteinase-2 Contributes to
Ischemia-Reperfusion Injury in the Heart, 101 CIRCULATION 1833-39
(2000).

Gary Gibbons et al., The Emerging Concept of Vascular Remodeling,
330 THE NEW ENGLAND JOURNAL OF MEDICINE 1431-38 (1994).

The following rejections are before us for review:
(1) Claims 1-7, 9-13, and 16, rejected under 35 U.S.C. § 102(b) as
anticipated by Sorsa (Ans. 3-5);
(2) Claims 1-12 and 16, rejected under 35 U.S.C. § 102(b) as
anticipated by Golub ‘061 (Ans. 5-7);

1 While the first named author of this publication is actually L.M. Golub, the
Examiner and Appellants have almost exclusively referred to this
publication as “Sorsa” and we will do the same for consistency.
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(3) Claim 15, under 35 U.S.C. § 103(a) as obvious over Sorsa or
Golub ‘061 in view of Sutherland (Ans. 7-9); and
(4) Claims 14 and 15, under 35 U.S.C. § 103(a) as obvious over Sorsa
or Golub ‘061 in view of Bouvet, Cheung, Gibbons, Morrison, and Stanton
(Ans. 10-14).
ANTICIPATION
ISSUE
Appellants contend, among other things, that claim 1 and its
dependents “expressly require ‘...forecasting that at least some of the
preparation will be used to treat a non-gingival disease associated with an
matrix metalloproteinase (MMP) activity to thereby arrive at [a] revised
sales projection...’ which is neither directly nor indirectly taught by Sorsa”
(App. Br. 10). Appellants repeat this contention with respect to Golub ‘061
(id. at 11).
The Examiner responds that “forecasting is a mental process and not
an active step” (Ans. 16).
Appellants reply that it is improper for the Examiner to ignore claim
1’s forecasting step, and urge that, when viewed in light of the Specification,
“the step of forecasting, among other things, includes preparation of a
revised sales projection” (Reply Br. 5).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to the anticipation rejections is whether the Examiner
provided an adequate basis for finding that Sorsa and/or Golub describe a
process having the claimed forecasting step.

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FINDINGS OF FACT (“FF”)
1. Sorsa discloses that the “ability of TCs [tetracyclines] to inhibit matrix
metalloproteinases (MMPs) such as collagenase was found to reflect
multiple direct and indirect mechanisms of action, and to be therapeutically
useful in a variety of dental (e.g., adult periodontitis) and medical (e.g.,
arthritis, osteoporosis, cancer) diseases” (Sorsa 12).
2. Sorsa discloses that a “partial listing of such TC-responsive diseases
includes: . . . several types of osteoporosis, including those associated with
diabetes mellitus and . . . additional complications of diabetes, including
impaired wound healing and nephropathy” (id. at 20).
3. Sorsa describes a separate investigation in which MMPs in humans
were inhibited by LDD (low dose doxycycline) formulations that contained
20 mg doxycycline per capsule, “rather than the commercially available 50
mg or 100 mg/cap” (id. (emphasis added)).
4. Golub ‘061 discloses “a method for inhibiting the activity of
membrane-type matrix metalloproteinase [MT-MMP] in a biological system
by providing a chemically modified tetracycline to the system” (Golub ‘061,
col. 4, ll. 43-45).
5. Golub ‘061 discloses that, while chemically modified tetracyclines are
preferred, “sub-antimicrobial doses of typically antibacterial tetracyclines
(e.g., doxycycline) can also be given according to the invention” (id. at col.
7, ll. 18-20).
6. Golub ‘061 discloses that diseases treatable by its methods include
disorders involving increased “levels of osteoclast cell activity, e.g.,
different types of arthritis, osteoporosis and other conditions characterized
by bone resorption. Various inflammatory conditions are also characterized
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by excessive MT-MMP activity, and the method can be used to inhibit MT-
MMP activity in those . . . mammals subject to or susceptible to such
conditions” (id. at col. 9, ll. 21-27).
7. The Examiner does not point to any disclosure in either Sorsa or
Golub ‘061 of providing a revised sales projection based on a forecast that at
least some sales of a doxycycline preparation would be used to treat a non-
gingival disease having an etiology associated with at least one of insulin
resistance, hypertension, and metabolic syndrome.
PRINCIPLES OF LAW
“[T]he examiner bears the initial burden . . . of presenting a prima
facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992).
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
The “Patent and Trademark Office (PTO) must consider all claim
limitations when determining patentability of an invention over the prior
art.” In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994).
ANALYSIS
Claim 1 recites a method of placing a doxycycline preparation into a
stream of commerce. To perform the claimed method, the practitioner must
provide a revised sales projection based on a forecast that at least some sales
of the doxycycline preparation will be used to treat a non-gingival
MMP-associated disease having an etiology associated with at least one of
insulin resistance, hypertension, and metabolic syndrome.
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We note Sorsa’s disclosure of using tetracyclines to treat diabetes-
related disorders (FF 2), as well as a doxycycline preparation that has been
placed into a stream of commerce (FF 3). We also note Golub ‘061’s
disclosure of treating inflammatory conditions with doxycycline (FF 5-6).
However, the Examiner points to no disclosure in either Sorsa or
Golub ‘061 of providing the revised sales projection required by claim 1,
based on the forecasting step recited in claim 1 (FF 7). We are therefore not
persuaded that the Examiner has made a proper prima facie case of
anticipation.
The Examiner’s position appears to be that, because they encompass
activities with no outwardly detectable action, mental steps can be ignored in
process claims. We do not agree.
We acknowledge that, under 35 U.S.C § 101, “mental processes–or
processes of human thinking–standing alone are not patentable even if they
have practical application. The Supreme Court has stated that ‘[p]henomena
of nature, though just discovered, mental processes, and abstract intellectual
concepts are not patentable, as they are the basic tools of scientific and
technological work.’” In re Comiskey, 554 F.3d 967, 979 (Fed. Cir. 2009)
(quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)).
As noted above, however, the Examiner “must consider all claim
limitations when determining patentability of an invention over the prior
art.” In re Lowry, 32 F.3d at 1582 (emphasis added).
Thus, the fact that claim 1 might contain mental steps which could
raise an issue under § 101 does not, in our view, absolve the Examiner from
the obligation of considering those steps when comparing the claim to the
prior art in a rejection under § 102 or 103. Accordingly, because the
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Examiner has not explained why Sorsa and Golub ‘061 meet all of the
limitations of claim 1, we reverse the Examiner’s anticipation rejections of
that claim, and its dependents, over those references.
OBVIOUSNESS --
SORSA OR GOLUB ‘061 IN VIEW OF SUTHERLAND
Claim 15 stands rejected under 35 U.S.C. § 103(a) as obvious over
Sorsa or Golub ‘061 in view of Sutherland (Ans. 7-9).
Claim 15 recites “[t]he method of claim 1, wherein the disease has an
etiology associated with hypertension.” The Examiner concedes that neither
Sorsa nor Golub ‘061 describe using doxycycline to treat a disease with an
etiology associated with hypertension (id. at 9).
To meet that deficiency the Examiner cites Sutherland as disclosing
that metabolic syndrome (MS), one of the disorders recited in claim 1,
includes hypertension as one of its characteristic symptoms (id.). Based on
the references’ teachings, the Examiner concludes that an ordinary artisan
would have considered it obvious to treat a patient with metabolic syndrome,
and its attendant hypertension, with doxycycline (id.).
The Examiner does not, however, point to any disclosure in
Sutherland that remedies the deficiencies of Sorsa and Golub ‘061, discussed
above, with respect to claim 1’s requirement of arriving at a revised sales
projection based on a forecast that at least some of the doxycycline
preparation will be used to treat the recited disorders. We therefore reverse
this rejection as well.

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OBVIOUSNESS --
SORSA OR GOLUB ‘061 IN VIEW OF
BOUVET, CHEUNG, GIBBONS, MORRISON, AND STANTON
Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as obvious
over Sorsa or Golub ‘061 in view of Bouvet, Cheung, Gibbons, Morrison,
and Stanton (Ans. 10-14).
Claim 14 recites “[t]he method of claim 1, wherein the disease further
has an etiology associated with free radical production.”
The Examiner concedes that neither Sorsa nor Golub ‘061 describe
using doxycycline to treat a disease having the etiology of claim 14 or claim
15, and cites Bouvet (administration of doxycycline to inhibit hypertrophic
vascular remodeling), Gibbons (vascular remodeling promotes
hypertension), and Cheung (effect of tetracyclines on free radicals) as
evidence that an ordinary artisan would have been motivated to treat such
disorders with doxycycline (id. at 11-12).
The Examiner cites Morrison as teaching that “manufacturers are
motivated to provide comprehensive information to health care professionals
and professionals are trained to assess such information” and that the “FDA
is a regulatory agency that functions to approve marketing of products
according to a complex regulatory scheme” (id. at 12). The Examiner cites
Stanton as disclosing that “the descriptions of approved drug usage,
including the suggested diagnostics studies or monitoring studies, and the
allowable parameters of such studies, are commonly described in the label or
insert which is distributed with the drug” (id. at 13).
Based on the references’ teachings, the Examiner concludes that an
ordinary artisan would have considered it obvious to “market doxycycline
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by providing it in a stream of commerce and expecting that at least some of
the preparation will be used to treat a non-gingival disease associated with
an MMP activity, such as a disease with an etiology associated with free
radical production or hypertension” (id. at 14).
We are not persuaded that the Examiner has made a prima facie case
of obviousness. The Examiner does not point to any teaching in any of the
cited prior art that remedies the above-discussed deficiencies in Sorsa and
Golub ‘061 with respect to claim 1, nor has the Examiner explained why an
ordinary artisan would have considered the forecasting step in claim 1
obvious.
It is well settled that “obviousness requires a suggestion of all
limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Because the Examiner’s obviousness rejection does not address all of
the limitations present in claims 14 and 15 through their dependency on
claim 1, we reverse the Examiner’s rejection of claims 14 and 15 over Sorsa
or Golub ‘061 in view of Bouvet, Cheung, Gibbons, Morrison, and Stanton.
NEW GROUND OF REJECTION -- 35 U.S.C. § 101
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection:
Claims 1-16 are rejected under 35 U.S.C. § 101 for failing to recite
patentable subject matter. The Federal Circuit has set forth the criteria for
determining whether process claims recite patentable subject matter under
§ 101:
[T]he proper inquiry under § 101 is not whether the process
claim recites sufficient “physical steps,” but rather whether the
claim meets the machine-or-transformation test. As a result,
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even a claim that recites “physical steps” but neither recites a
particular machine or apparatus, nor transforms any article into
a different state or thing, is not drawn to patent-eligible subject
matter. Conversely, a claim that purportedly lacks any “physical
steps” but is still tied to a machine or achieves an eligible
transformation passes muster under § 101.

In re Bilski, 545 F.3d 943, 961 (Fed. Cir. 2008) (citations omitted).
Claim 1 recites a process of placing a doxycycline preparation into a
stream of commerce. The process has three steps: (1) providing a quantity
of a preparation of doxycycline for use by a patient population, the quantity
being based on a revised sales projection, (2) forecasting that at least some
of the preparation will be used to treat a non-gingival disease associated with
a matrix metalloproteinase (MMP) activity to thereby arrive at the revised
sales projection, and (3) placing the quantity of the preparation in the stream
of commerce.
As is evident, neither providing a doxycycline preparation, nor
forecasting the quantity to be provided, nor placing that quantity into a
stream of commerce, physically transforms the doxycycline into a different
state or thing. See Bilski, 545 F.3d at (“Purported transformations or
manipulations simply of public or private legal obligations or relationships,
business risks, or other such abstractions cannot meet the test because they
are not physical objects or substances, and they are not representative of
physical objects or substances.”).
Nor do we see any step in any of the dependent claims that
accomplishes such a transformation. Accordingly, we conclude that the
claims do not meet the transformation prong of the machine-or-
transformation test.
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With respect to the machine prong of the test, we note that placing
doxycycline into a stream of commerce could involve a machine. However,
in In re Ferguson, 558 F.3d 1359, 1364 (Fed. Cir. 2009), the court
concluded that claims directed to processes of marketing products did not
meet the machine prong because they were “not tied to any concrete parts,
devices, or combination of devices.”
The court reasoned that “a machine is a ‘concrete thing, consisting of
parts, or of certain devices and combination of devices.’ This ‘includes
every mechanical device or combination of mechanical powers and devices
to perform some function and produce a certain effect or result.’” Id. (citing
In re Nuijten, 500 F.3d 1346, 1355 (Fed. Cir. 2007) (internal citations
omitted).
As claim 1 and its dependents do not recite, and are not tied to, any
specific concrete devices, we conclude that those claims do not meet the
machine prong of the machine-or-transformation test set out in Bilski.
Therefore, because claims 1-16 do not meet the machine-or-transformation
test, we conclude that they do not recite subject matter patentable under 35
U.S.C. § 101.
SUMMARY
We reverse the Examiner’s anticipation rejection of claims 1-7, 9-13,
and 16 over Sorsa, and also reverse the Examiner’s anticipation rejection of
claims 1-12 and 16 over Golub ‘061.
We also reverse the Examiner’s obviousness rejection of claim 14
over Sorsa or Golub ‘061 in view of Sutherland, as well as the Examiner’s
obviousness rejection of claims 14 and 15 over Sorsa or Golub ‘061 in view
of Bouvet, Cheung, Gibbons, Morrison, and Stanton.
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We enter a new ground of rejection of claims 1-16 under 35 U.S.C.
§ 101 as being drawn to nonpatentable subject matter. See 37 C.F.R.
§ 41.50(b).

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:

(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .

REVERSED, 37 C.F.R. § 41.50(b)

dm

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