Enrico Bastianelli et al.

Patent Trials and Appeals Board

Aug 6, 2019

12808336 - (D) (P.T.A.B. Aug. 6, 2019)

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.
12/808,336 06/15/2010 Enrico Bastianelli 10-755-WO-US 2639
20306 7590 08/06/2019
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
300 S. WACKER DRIVE
32ND FLOOR
CHICAGO, IL 60606
EXAMINER
FAN, LYNN Y
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
08/06/2019 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 ENRICO BASTIANELLI, CINDY BADOER,
CHRISTELLE BIZIMUNGU, and XAVIER PESESSE
____________

Appeal 2019-001654
Application 12/808,3361
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JENNIFER MEYER CHAGNON, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 11–14, 17, 18,
and 20 (Final Act.2 2).3 Examiner entered rejections under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellants identify “Bone Therapeutics S.A.” as the real party in interest
(Appellants’ July 23, 2018 Appeal Brief (App. Br.) 2).
2 Examiner’s November 24, 2017 Final Office Action.
3 Claims 16 and 19 stand withdrawn from consideration (Final Act. 2).
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STATEMENT OF THE CASE
Appellants’ disclosure “relates to therapeutic applications of bone-
forming cells in the treatment of inflammatory rheumatic diseases (IRD),
and in particular in the treatment of inflammation in (inflammatory
component of) IRD” (Spec. 1: 5–7). Appellants’ claim 11 is representative
and reproduced below:
11. A method for treating inflammation of inflammatory
rheumatic diseases (IRD) in a subject, comprising
administering by injection of isolated bone-forming cells to a
subject suffering from inflammation, wherein the bone-forming
cells:
i. display anti-inflammatory properties;
ii. comprise expression of alkaline phosphatase (ALP), or
ALP of the bone-liver-kidney type and/or osteocalcin
(OCN);
iii. exhibit capability to mineralize the external surroundings,
or synthesize calcium-containing extracellular matrix;
and
iv. are not differentiated towards cells of adipocytic lineage
or chondrocytic lineage;
v. are not genetically modified;
vi. and wherein the IRD is selected from osteoarthritis (OA),
psoriatic arthropathy, gout, pseudogout and arthritis of
various origins comprising rheumatoid arthritis (RA),
enteropathic arthritis, reactive arthritis and Reiter
syndrome, pauciarticular juvenile rheumatoid arthritis,
Still disease, Behcet disease, systemic lupus
erythematosus, septic arthritis and spondyloarthropathies
comprising ankylosing spondylitis, enteropathic
spondylitis and undifferentiated spondyloarthropathy,
wherein said osteoarthritis (OA), psoriatic arthropathy,
gout, pseudogout and arthritis of various origins
comprising rheumatoid arthritis (RA), enteropathic
arthritis, reactive arthritis and Reiter syndrome,
pauciarticular juvenile rheumatoid arthritis, Still disease,
Behcet disease, systemic lupus erythematosus, septic
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arthritis and spondyloarthropathies comprising
ankylosing spondylitis, enteropathic spondylitis and
undifferentiated spondyloarthropathy, comprises
inflammation.
(App. Br. 10.)
Grounds of rejection before this Panel for review:
Claims 11–14, 17, and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Egrise4 and RA.5
Claim 20 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Egrise, RA, and NIAMS.6

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans.7 3–8) and provide the following findings for emphasis.
FF 1. Egrise discloses that the administration of osteoblasts or osteoblast
phenotype cells obtained from bone marrow stem cells (BMSC) of a human
subject who is at risk for or has a bone-related disorder can be useful for

4 Egrise et al., WO 2007/093431 A1, published Aug. 23, 2007.
5 Description of Rheumatic Diseases and Terms, available at
https://web.archive.org/web/20070830044719/http:/www.rheumatic.org/
primer.htm, last accessed Aug. 1, 2016.
6 Osteoporosis and Arthritis: Two Common but Different Conditions,
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) (2006), available at https://web.archive.org/web/20071030075018
/http://www.niams.nih.gov/Health Info/Bone/Osteoporosis/
Conditions Behaviors/osteoporosis arthritis.asp, last accessed Aug. 1, 2016.
7 Examiner’s October 29, 2018, Second or Subsequent Examiner’s Answer.
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treating the bone-related disorder in the subject (Egrise 16: 10–13; see Ans.
4).
FF 2. Egrise discloses that “bone-related disorders which can benefit from
administration of osteoblasts or osteoblast phenotype cells . . . include . . .
rheumatoid arthritis” (Egrise 16: 22–31; see Ans. 5).
FF 3. Egrise discloses that
an osteprogenitor, osteoblast or osteoblast phenotype cells may
encompass any cell of the osteogenic cell lineage which will
have at least one characteristic, and may display at least two, at
least three, at least four or at least five characteristics, from the
following list: (a) positive for CD90, CD73 and CD105 (b)
positive for alkaline phosphatase (ALP) (more specifically,
ALP of the bone-liver-kidney type); (c) positive for osteocalcin
(specific for mature osteoblasts); (d) density between 1.050 and
1.090 g/cm3; (e) positive for osteonectin (positive in osteoblasts
and precursors); (f) a cell diameter between 6 to 70μm and
substantially cuboidal shape; (g) positive for type I collagen
(procollagen) and/or for vimentin and/or bone sialoprotein; (h)
positive for other osteoblast-specific markers, such as BMP
receptors, PTH receptors; (i) evidence of ability to mineralize
the external surroundings, or synthesize calcium-containing
extracellular matrix, when exposed to osteogenic medium.
(Egrise 17: 19–29; see also id. at 33: 26–29 (Egrise discloses
“ostoeprogenitors, osteoblasts or osteoblast phenotype cells, as well as cell
populations comprising such, which show superior characteristics, such as,
e.g., fast proliferation, rapid mineralization, and substantially absent
potential to differentiate towards adipocytes or chondrocytes”); see Ans. 4–
5.)
FF 4. Egrise discloses:
[A] method for preventing and/or treating bone disease,
comprising:
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(a) obtaining a biological sample comprising BMSC from a
subject in need of such treatment;
(b) obtaining osteoprogenitors, osteoblasts or osteoblast
phenotype cells, or obtaining an isolated cell population
comprising osteoblast or osteoblast phenotype cells, from the
BMSC in vitro or ex vivo according to methods of the
invention; and
(c) administering the so-obtained osteoprogenitors, osteoblasts
or osteoblast phenotype cells or the said cell population
comprising such to the subject.
(Egrise 36: 5–12; see also id. at ll. 18–23; id. at 48: 4–5 (“the composition
can be administered by injection”); see Ans. 4–5.)
FF 5. Examiner finds that “Egrise does not teach treating inflammation of
the IRD wherein the subject suffers from inflammation . . ., and the IRD
comprises both an inflammation and bone lesion(s) or the IRD comprises an
inflammation and does not comprise bone lesion(s)” (Ans. 5).
FF 6. RA discloses that “[a]rthritis means joint inflammation” and that
“[r]heumatoid arthritis is a disease which causes chronic inflammation of the
joints, the tissue around the joints, as well as other organs in the body” (RA
1–2; id. at 2 (“The joint inflammation of rheumatoid arthritis causes
swelling, pain, stiffness, and redness in the joints” and “[w]hen body tissues
are inflamed, the disease is active”); see Ans. 5).
FF 7. RA discloses that “[c]hronic inflammation can cause damage to body
tissues, cartilage and bone” (RA 2; see Ans. 5).
FF 8. Examiner finds that the combination of Egrise and RA “do not teach
[a] method wherein the bone-forming cells are administered simultaneously,
sequentially or separately with glucocorticoids or non-steroidal anti-
inflammatory drugs (NSAID)” and relies on NIAMS to disclose that
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“glucocorticoids and NSAID are commonly used to treat rheumatoid
arthritis” (Ans. 7 (citing NIAMS 2: Table); see Ans. 7).
ANALYSIS
The rejection over the combination of Egrise and RA:
Appellants “do not dispute that Egrise teaches a method for treating
bone disease comprising administering isolated bone-forming cells (BFCs)
from a subject who has a bone-related disorder, and that one of the bone-
related disorders mentioned by Egrise is rheumatoid arthritis” (App. Br. 4–5;
see generally FF 1–4). Appellants also do not dispute Examiner’s finding
that Egrise discloses “bone-forming cells, which appear to be the same as [in
Appellants’] claim[s]” (see App. Br. 8). Appellants further “recognize that
the RA reference teaches that rheumatoid arthritis is a chronic inflammatory
disorder and that rheumatoid arthritis patients suffer from inflammation” and
that “[t]his was known in the art at the time of the invention” (App. Br. 6;
see generally FF 6–7). Thus, we find no error in Examiner’s conclusion
that, at the time Appellants’ invention was made, it would have been prima
facie obvious to treat rheumatoid arthritis, which is a chronic inflammatory
disorder, with Egrise’s isolated bone-forming cells (see Ans. 5; see also FF
1–7).
It is a general rule that merely discovering and claiming a
new benefit of an old process cannot render the process again
patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif.,
814 F.2d 628, 632–33 (Fed. Cir.), cert. denied, 484 U.S. 827
. . . (1987); Bird Provision Co. v. Owens Country Sausage, Inc.,
568 F.2d 369, 375 . . . (5th Cir. 1978).
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Therefore, we
are not persuaded by Appellants’ contention that Examiner’s rejection
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is based on inapplicable legal principles (see App. Br. 7–9; see Reply
Br. 5–6).
For the foregoing reasons, we are not persuaded by Appellants’
contention that “there is nothing within Egrise, the RA reference, or
the state of the art at the time of the invention to support” “the
Office’s reasoning . . . that the BFCs of Egrise exerted a positive
effect upon an inflammatory component of rheumatoid arthritis, in
particular a positive effect that can be extended to inflammatory
processes more generally,” because “Egrise is completely silent on the
impact of the disclosed BFCs on inflammation or an inflammatory
component of rheumatoid arthritis” (App. Br. 6 (emphasis omitted);
see Reply Br.8 2–4). To the contrary, we find that Appellants
discovered a new benefit of Egrise’s old process, which cannot render
the old process patentable. See In re Huai-Hung Kao, 639 F.3d 1057,
1071 (Fed. Cir. 2011); In re Woodruff, 919 F.2d at 1578.
For the same reasons, we are not persuaded by Appellants’
contention that Examiner relied “on impermissible hindsight in view
of the discovery as disclosed in the instant application” (App. Br. 7
(emphasis added); see id. (“it is the Applicants who demonstrated for
the first time the anti-inflammatory properties of bone-forming cells,
and by extension, their utility in addressing an inflammatory
component of a disease process” (emphasis omitted)); see also Reply
Br. 4–5).

8 Appellants’ December 20, 2018 Reply Brief.
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The rejection over the combination of Egrise, RA, and NIAMS:
Appellants’ claim 20 depends from and further limits Appellants’
claim 11 to require that “the bone-forming cells are administered
simultaneously, sequentially or separately with an agent selected from the
group consisting of disease-modifying antirheumatic drugs (DMARD),
glucocorticoids, no-steroidal anti-inflammatory drugs (NSAID) and
analgesics” (App. Br. 11).
Based on the combination of Egrise, RA, and NIAMS, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to administer isolated bone-forming cells
simultaneously, sequentially or separately with glucocorticoids or NSAID to
treat rheumatoid arthritis since each of the instant components was well-
known in the art for treating rheumatoid arthritis” (Ans. 7–8; see FF 1–8).
Appellants do not address the rejection of Appellants’ claim 20 (see
e.g., App. Br. 2–3; see id. at 9). Therefore, the rejection is summarily
affirmed. See MANUAL OF PATENT EXAMINING PROCEDURE
§ 1205.02 (“If a ground of rejection stated by the examiner is not addressed
in the appellant’s brief, that ground of rejection will be summarily sustained
by the Board.”).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Egrise and RA is affirmed. Claims 12–14, 17, and
18 are not separately argued and fall with claim 11.
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The rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Egrise, RA, and NIAMS is affirmed.

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)(1)(iv).

AFFIRMED