Ex Parte 7138275 et al

Board of Patent Appeals and Interferences

Mar 23, 2012

95001158 (B.P.A.I. Mar. 23, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/001,158 05/01/2009 7138275 674528-5002 8993
28381 7590 04/02/2012
ARNOLD & PORTER LLP
ATTN: IP DOCKETING DEPT.
555 TWELFTH STREET, N.W.
WASHINGTON, DC 20004-1206
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
04/02/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

GHAZI JASWINDER DHOOT
Requester & Appellant

v.

BLASTICON BIOTECHNOLOGISCHE FORSCHUNG GMBH
Patent Owner & Respondent
____________

Appeal 2011-010757
Application 95/001,158
Patent 7,138,275
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
DANIEL S. SONG, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2011-010757
Application 95/001,158
Patent 7,138,275

2
This is a decision1 on the appeal by the Third Party Requester of the
Examiner’s decision confirming the patentability of originally issued claims
1-14 and setting forth the patentability of newly added claims 15-23 of US
Patent No. 7,138,275 (“the ‘275 patent”). The Board’s jurisdiction for this
appeal is under 35 U.S.C. §§ 6(b), 134(c), and 306. We affirm-in-part and
reverse-in-part.

STATEMENT OF CASE
U.S. Patent No. 7,138,275 issued November 21, 2006. A “Request for
Inter Partes Reexamination” of issued claims 1-14 of the ‘275 patent was
filed by Thomas J. Kowalski of Frommer, Lawrence, & Haug LLP on May
1, 2009 pursuant to 35 U.S.C. §§ 311-318 and 37 C.F.R. § 1.913.
Reexamination was ordered. Claims 15-23 were added during the
proceeding. The reexamination proceeding culminated in the Examiner
confirming the patentability of claims 1-14 and determining that new claims
15-23 are patentable, all over prior art cited by the Third Party Requester
(Right of Appeal Notice (“RAN”) 34).
The Third Party Requester, Ghazi Jaswinder Dhoot, appeals the
Examiner’s decision favorable to the patentability of claims 1-23 (App. Br.
3). An oral hearing was held on December 21, 2011 in which oral
arguments were presented by the Requester’s counsel. The Patent Owner of
the ‘275 patent did not participate. A transcript of the hearing has been
entered into the record.

1 The decision mailed March 26, 2012 contained errors on page 1 and page
13 (claim numbers) which have now been corrected. The decision of March
26, 2012 is thus withdrawn and replaced by this new decision.
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Patent 7,138,275

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Claims 1, 5, and 15 are representative of the appeal claims and read as
follows:
1. A dedifferentiated, programmable cell of human monocytic origin,
wherein said dedifferentiated, programmable cell of human monocytic
origin expresses a CD14 antigen, a CD90 antigen, and a CD123 antigen.

5. A dedifferentiated, programmable cell of human monocytic origin,
wherein said dedifferentiated, programmable cell of human monocytic
origin expresses a CD14 antigen, a CD123 antigen, a CD90 antigen, and
a CD135 antigen.

15. The dedifferentiated, programmable cell of human monocytic origin
according to claim 1, wherein said dedifferentiated, programmable cell
of human monocytic origin does not express a CD34 antigen.

The Requester contends that the Examiner improperly withdrew prior
art rejections under 35 U.S.C §§ 102 and 103. The rejections are
summarized on pages 7-9 of the Requester’s Appeal Brief and will not be
repeated here. The primary prior art publications cited in all the rejections
are the ‘625 patent,2 the ‘826 published patent application,3 the ‘947
published patent application,4 and the ‘503 published patent application.5
All four publications are in the same family of patent publications and have
related and overlapping disclosures. The Requester referred to all four
patent publications as the “Primary References” and addressed their
teachings together. Thus, in reviewing the Examiner’s determination to

2 U.S. Patent 6,090,625 (filed Jan. 31, 1996) (issued July 18, 2000).
3 U.S. Patent Application Publication 2001/0024826 (filed Dec. 20, 2000)
(published Sept. 27, 2001).
4 U.S. Patent Application Publication 2003/0138947 (filed May 8, 2002)
(published July 24, 2003).
5 U.S. Patent Application Publication 2003/0064503 (filed May 9, 2001)
(published Apr. 3, 2003).
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Patent 7,138,275

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withdraw the anticipation and obviousness rejections, we shall consider the
cited four publications together, making reference to only the disclosure in
the ‘625 patent. We shall refer to the “Primary References” as
“Abuljadayel,” who is the sole named inventor of all four related patent
publications.
ISSUE
There are multiple independent claims in this appeal, all of which are
directed to a “dedifferentiated, programmable cell of human monocytic
origin.” The dedifferentiated cell is recited in the claims to express
different combinations of the CD14, CD90, CD123, and CD135 antigens
(compare, e.g., claims 1 and 5). According to the ‘275 patent, the term
“dedifferentiated” “. . . signifies the regression of an adult, already
specialized (differentiated) body cell to the status of a stem cell, i.e., of a
cell, which in turn can be transferred (programmed) into a number of cell
types.” (‘275 patent, col. 8, ll. 13-16.) Thus, the claimed cell is a “stem
cell” which has the ability to be reprogrammed into any body cell (‘275
patent, col. 8, ll. 33-41).
The ‘275 patent describes a process in which a human monocyte, a
cell isolated from human blood, is dedifferentiated which includes:
(a) providing human monocytes; (b) propagating the monocytes
in a culture medium, which contains cellular growth factor M-
CSF; (c) simultaneously cultivating the monocytes with or
subsequently to step (b) in a culture medium comprising IL-3;
and (d) obtaining human adult dedifferentiated programmable
stem cells by separating from culture medium.
(‘275 patent, col. 2, ll. 56-62.)
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The key issue in the rejections is whether the Abuljadayel patent
publications describe a “dedifferentiated, programmable cell of human
monocytic origin” as claimed. The controversy stems from the fact that the
claims require a specific set of antigens to be present on the
dedifferentiated cells (e.g., CD14, CD90, CD123, and CD135 antigens),
where Abuljadayel does not describe these antigens on its monocytic
dedifferentiated cells, but rather describes different antigens.
Abuljadayel’s method of dedifferentiating the monocytes is also different
from the method used in the ‘275 patent. Thus, the issue is whether there is
a reasonable basis to believe that Abuljadayel’s dedifferentiated cells are
the same as those which are claimed, despite these differences.

LEGAL PRINCIPLES
“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). When the limitations of a
claim are not expressly described in the prior art, the PTO must show “sound
basis for believing” that despite the failure of the prior art to describe them,
the limitations are inherently there and “the products of the applicant and the
prior art are the same.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
With these guiding principles, we turn to the Abuljadayel disclosure.

FINDINGS OF FACT (“FF”) FROM ABULJADAYEL
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[FF1] Abuljadayel describes “a method of preparing an
undifferentiated cell from a more committed cell” and the undifferentiated
cells produced as a result (‘625 patent, col. 1, ll. 8-10).
[FF2] In discussing the concept of retrodifferentiation, Abuljadayel
states: “‘While preserving the entire information encoded on its genome,
cells undergoing retrodifferentiation lose morphological and functional
complexity by virtue of a process of self-deletion of cytoplasmic structures
and the transition to a more juvenile pattern of gene expression.’” (‘625,
col. 2, ll. 41-46, quoting Jose Uriel (Cancer Research 36, 4269-4275, Nov.
1976.)
[FF3] The method for retrodifferentiation described in Abuljadayel
comprises “contacting a more committed cell with an agent that causes the
more committed cell to retrodifferentiate into an undifferentiated cell.”
(‘625 patent, col. 4, ll. 5-9.)
[FF4] “In another preferred embodiment, the more committed cell is a
differentiated cell, such as . . . a monocyte . . . .” (‘625 patent, col. 6, l. 66 to
col. 7, l. 4.)
[FF5] Abuljadayel describes an example in which blood cells obtained
from patients were treated with various agents to produce undifferentiated
cells (‘625 patent, col. 10, ll. 37-61).
[FF6] Treated blood cells were tested for the expression of antigens.
According to Abuljadayel, the treatments were found to change the antigen
expression on the cells, e.g., CD14 and CD34 (‘625 patent, cols. 11-21).
[FF7] “The CD34 antigen is present on immature haematopoietic
precursor cells and all haematopoietic colony-forming cells in bone marrow,
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including unipotent (CFU-GM, BFU-E) and pluripotent progenitors (CFU-
GEMM, CFU-Mix and CFU-blast).” (‘625 patent, col. 19, ll. 31-35.)
[FF8] “Normal peripheral blood lymphocytes, monocytes,
granulocytes and platelets do not express the CD34 antigen. CD34 antigen
density is highest on early haematopoietic progenitor cells and decreases as
the cells mature. The antigen is absent on fully differentiated haematopoietic
cells.” (‘625 patent, col. 19, ll. 43-48.)

ANALYSIS
We agree with the Requester that there is sufficient evidence to have
provided a reasonable basis to believe that the dedifferentiated monocytic
cells described in Abuljadayel are the same as those which are claimed.
Abuljadayel describes applying its treatment to monocytes in order to
retrodifferentiate the cells (FF4). In addition to this, Abuljadayel applied the
treatment to blood cells obtained from patients (FF5), which contain
monocytes. Thus, treating the blood sample with a treatment protocol said
to produce retrodifferentiation (FF3) would have inherently
retrodifferentiated monocytes in the sample to produce an undifferentiated
monocytic cell. In both cases, the same cell type as claimed is
retrodifferentiated to produce an undifferentiated cell.
The undifferentiated cell is taught by Abuljadayel as having a “more
juvenile pattern of gene expression.” (FF2.) The ‘275 patent similarly
characterizes its dedifferentiation process as causing “regression of an adult,
already specialized (differentiated) body cell to the status of a stem cell.”
(‘275 patent, col. 8, ll. 13-14). In other words, both Abuljadayel and the
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‘275 patent “take” an adult differentiated cell of the same cell type and
revert it back to an undifferentiated “juvenile” state. In simple terms, if the
same cell type is regressed, it stands to reason that the same “juvenile” stem
cell would result because the cell is tracing its steps backwards from an adult
cell.
The Examiner seemed to presume that there were different juvenile
states possible for the same adult monocyte, depending upon the treatment
protocol utilized to retrodifferentiate the adult cell. As a consequence, even
though both Abuljadayel and the ‘275 patent described dedifferentiated
monocytes, the Examiner concluded that the dedifferentiated cells were not
necessarily the same.
The only evidence for different dedifferentiated states is in the ’275
patent with respect to the CD34 antigen status of the cell. CD34 is an
antigen which is expressed on certain cells. According to the ‘275 patent:
“Less than 3%, preferably less than 1% of the stem cells according to the
invention express the CD34 antigen. Most preferably, none of the stem cells
of the invention express the CD34 antigen.” (‘275 patent, col. 8, ll. 35-38.)
The ’275 patent therefore teaches that its dedifferentiated monocytes can be
either CD34 positive or CD34 negative for the CD34 antigen. Claim 1 does
not limit the CD34 status of the cell and therefore covers dedifferentiated,
programmable cells of human monocytic origin which are CD34 positive
and CD34 negative. Dependent claims 15-23 are narrower and limit the
dedifferentiated cells to cells which lack CD34.
In contrast to the cells of claims 15-23, Abuljadayel teaches that
CD34 is present on dedifferentiated cells. Abuljadayel states that the “CD34
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antigen is present on immature haematopoietic precursor cells.” (‘625
patent, col. 19, ll. 31-32 (FF7).) “Normal . . . monocytes . . . do not express
the CD34 antigen. CD34 antigen density is highest on early haematopoietic
progenitor cells and decreases as the cells mature. The antigen is absent on
fully differentiated haematopoietic cells.” (‘625 patent, col. 19, ll. 43-48
(FF8).) Thus, based on Abuljadayel, the skilled worker would have
reasonably expected a dedifferentiated monocyte to be CD34 positive, a
juvenile stem cell type which, as discussed above, is covered by claim 1.
In sum, there is evidence of two different undifferentiated monocytes:
a CD34 positive and a CD34 negative cell type. Each arises from
dedifferentiating the same adult cell. While there may be differences in the
treatment protocols utilized to dedifferentiate the monocyte, because the
treatments have the same purpose and same result in regressing the adult cell
back to an earlier, more “juvenile” state (‘275 patent, col. 8, ll. 13-16; ‘625
patent, col. 2, ll. 41-46 (FF2)), it would have been reasonably expected that
the same dedifferentiated CD34 positive cell type would be arrived at,
regardless of the retrodifferentiation method used. To reiterate,
dedifferentiating an adult monocyte cell would be expected to result in the
same “juvenile” stem cell because the adult cell is tracing its steps
backwards to an earlier juvenile state.
As there was reasonable basis to believe that the CD34 positive cell in
Abuljadayel is the same CD34 positive cell described in the ‘275 patent, the
burden shifted to the Patent Owner to prove that it was not. Spada, 911 F.2d
at 708. Patent Owner did not file a brief in this appeal to present
countervailing evidence. Consequently, we conclude that this burden was
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not met and we reverse the Examiner’s determination that claims 1-14 are
not anticipated nor rendered obvious by the Abuljadayel patent publications
alone or combination with the additional prior art cited by the Requester
(App. Br. 7-9).
In reaching this determination, we recognize that the different sets of
antigens were utilized to characterize the cells in Abuljadayel and the ‘275
patent. However, it is well known that cells express many different antigens.
For example, a cell identified by two of the six antigens expressed by it is no
different from the same cell identified by a different two antigens of the
same six antigens. Thus, the fact that different antigens were used to
characterize the cells is not sufficient to distinguish the cells from each
other.
The Examiner also argued that the claimed cells were different than
those described in Abuljadayel because the cells in the Abuljadayel patent
publications “do not exhibit adherence to a culture vessel,” while those in
the ‘275 patent do. (RAN 6.) However, the Examiner did not provide
adequate support in the RAN for the conclusion that the adhesion properties
of the cells described in Abuljadayel were different. Nor did the Examiner
adequately address the Requester’s argument, which was backed by factual
evidence, that the adhesion properties represent the growth status of the cells
and do not reflect actual differences in the cell types (App. Br. 14-15.)
With respect to the Examiner’s arguments about differences in the
“starting” cells which were retrodifferentiated (RAN 10-11), as noted by the
Requester, Abuljadayel has express disclosure on retrodifferentiating adult
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11
monocytes (FF4), the same cell population recited in the claims and used in
the ‘275 patent.
Claims 15-23 are directed to a dedifferentiated, programmable cell of
human monocytic origin which “does not express a CD34 antigen.” We
interpret these claims to cover cells which lack CD34. As discussed above,
Abuljadayel teaches that CD34 is present on its dedifferentiated cells. Thus,
with respect to claims 15-24, we conclude that there was not a reasonable
basis to believe that Abuljadayel’s CD34 positive cells were the same as the
claimed cells which lack CD34.

SUMMARY
We reverse the Examiner’s conclusion confirming the patentability of
claims 1-14 over the cited prior art in the rejections on pages 7-9 of the
Requester’s Appeal Brief.
We affirm the Examiner’s determination that claims 15-23 are not
anticipated by, or obvious in view of, the cited prior art set forth in the
rejections listed on pages 7-9 of the Requester’s Appeal Brief.

SECTION 112 REJECTIONS
The Requester contends that the newly added claims 15-23, each of
which recites that the “dedifferentiated, programmable cell of human
monocytic origin does not express a CD34 antigen,” fail to meet the
enablement and written description requirements of 35 U.S.C. § 112, first
paragraph, and lack clarity as required by 35 U.S.C. § 112, second
paragraph.
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In the comments filed by Requester under 37 C.F.R. § 1.947 after
Patent Owner added claims 15-23 (“Comments”),6 Requester argued that the
newly added claims were not enabled (Comments 48), but Requester did not
argue that they lacked written description or were indefinite. Such
arguments appear not to have been made until the filing of the Appeal Brief.
To be appealable, such rejections need to have been listed in in the statement
of the non-adopted rejections in the Right of Appeal Notice (35 U.S.C. § 134
and 37 C.F.R. §§ 41.61(a)(2) and (d)). However, none of the § 112
rejections were listed in the RAN. Thus, the proposed written description
and indefinite rejections have not been properly presented for our review.
As to the enablement issue under § 112 because Requester timely raised this
issue in their Comments, we use our discretion to address the same.
The Requester contends:
the ‘275 patent fails to enable how to prepare a cell
product that has "none of the stem cells of the invention express
the CD34 antigen". Simply, no product in the '275 patent is
reported has [sic – “as”] having "none of the stem cells ...
express[ing] the CD34 antigen." And nowhere does the '275
patent teach how to obtain a product that has "none of the stem
cells ... express[ing] the CD34 antigen."
(App. Br. 28.)
This argument is not persuasive. The ‘275 patent expressly discloses
that cells can be eliminated on the basis of surface antigen markers (col. 12,
ll. 38-43.) The ‘275 discloses “[i]mmuno magnetic bead sorting” as an
example of a method to isolate one cell type from another (col. 12, ll. 43-
45). The CD34 antibody used to deplete the dedifferentiated cells of CD34

6 Comments by Third Party Requester to Patent Owner’s Response in Inter
Partes Reexamination under 37 C.F.R. § 1.947 (entered Oct. 30, 2009).
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cells was known in the art, as evidenced by Abuljadayel, which discloses
monoclonal antibodies to CD34 (‘625 patent, col. 11, l. 6). Requester has
not demonstrated that, armed with such tools, it would have required undue
experimentation to isolate cells which lack CD34 as claimed.

NEW GROUNDS OF REJECTION
37 C.F.R. § 41.77(a) states that “[t]he reversal of the examiner’s
determination not to make a rejection proposed by the third party requester
constitutes a decision adverse to the patentability of the claims which are
subject to that proposed rejection which will be set forth in the decision of
the Board of Patent Appeals and Interferences as a new ground of
rejection . . . .” As we have reversed the Examiner’s determination that
claims 1-14 are patentable over the prior art cited on pages 7-9 of the
Requester’s Appeal Brief, we are compelled to enter a new grounds of
rejection.
37 C.F.R. § 41.77(b) states:
(b) Should the Board reverse the examiner’s determination not
to make a rejection proposed by a requester, the Board shall set
forth in the opinion in support of its decision a new ground of
rejection; or should the Board have knowledge of any grounds
not raised in the appeal for rejecting any pending claim, it may
include in its opinion a statement to that effect with its reasons
for so holding, which statement shall constitute a new ground of
rejection of the claim. Any decision which includes a new
ground of rejection pursuant to this paragraph shall not be
considered final for judicial review. When the Board makes a
new ground of rejection, the owner, within one month from the
date of the decision, must exercise one of the following two
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options with respect to the new ground of rejection to avoid
termination of the appeal proceeding as to the rejected claim:

(1) Reopen prosecution. The owner may file a response
requesting reopening of prosecution before the examiner. Such
a response must be either an amendment of the claims so
rejected or new evidence relating to the claims so rejected, or
both.

(2) Request rehearing. The owner may request that the
proceeding be reheard under § 41.79 by the Board upon the
same record. The request for rehearing must address any new
ground of rejection and state with particularity the points
believed to have been misapprehended or overlooked in
entering the new ground of rejection and also state all other
grounds upon which rehearing is sought.

Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79.

AFFIRMED-IN-PART; REVERSED-IN-PART; 37 C.F.R. § 41.77(b)

KMF

Appeal 2011-010757
Application 95/001,158
Patent 7,138,275

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Patent Owner

ARNOLD & PORTER LLP
ATTN: IP Docketing Department
555 Twelfth Street, N.W.
Washington, DC 20004-1206

Third Party Requester

VEDDER PRICE PC
1633 Broadway, 47th Floor
New York, NY 10019