Ex Parte Young et al

Patent Trial and Appeal Board

Oct 5, 2017

12768411 (P.T.A.B. Oct. 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.
12/768,411 04/27/2010 Henry E. Young 1304-1-019CIPCON 5554
26294 7590 10/10/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
TON, THAIAN N
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
10/10/2017 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):
rkline @ tarolli. com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HENRY E. YOUNG and PAUL A. LUCAS1
Appeal 2017-002939
Application 12/768,411
Technology Center 1600
Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and DAVID COTTA,
Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
pluripotent human stem cells and methods for producing them which have
been rejected as being directed to non-statutory subject matter and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Cells which do not progress through the normal sequence of
development and differentiation are known as reserve stem cells. Spec. 2.
31 Appellants identify the Real Party in Interest as ABT Holding Company.
Appeal Br. 3.
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Application 12/768,411
Reserve stem cells are used for the continued maintenance and repair of an
organism. Id. One type of stem cell is known as pluripotent stem cells.
Spec. 3. Pluripotent stem cells are stem cells which are not committed to a
specific type of tissue lineage. Id. This allows the cells to proliferate as
long as they remain uncommitted to a specific tissue lineage. Id. The
Specification describes pluripotent stem cells derived from non-embryonic
cells or tissue as well as method for isolating the stem cells. Spec. 9-10.
Claims 33, 35, 36, and 38 are on appeal.2 Claims 33 and 36 are
representative of the rejected claims and read as follow:
33. Isolated postnatal human cells capable of self­
renewal and capable of differentiation to cells of endodermal,
ectodermal, and mesodermal lineages, the cells expressing
SSEA4, but not CD13, said isolated cells having been produced
by expanding, in culture, a cultured cell clone from a postnatal
human tissue.
36. A method of obtaining the cells of claim 33, the
method comprising the steps of;
(a) obtaining cells from a postnatal animal source;
(b) slow freezing the cells in a medium containing 7.5%
(v/v) dimethyl sulfoxide until a final temperature of -80° C is
reached;
(c) thawing the frozen cells;
(d) culturing the thawed cells;
(e) cloning the cultured cells of step (d); and
(f) expanding the cloned cells to produce the isolated
cell of claim 33.
2 Appellants list clam 39 as being subject to this appeal. Appeal Br. 7.
Claim 39 was withdrawn from consideration as being directed to a non-
elected species. Final Act. 2.
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Application 12/768,411
The claims stand rejected as follows:
Claims 33, 35, and 38 have been rejected under 5 U.S.C. § 101 as
directed to non-statutory subject matter.3
Claims 33, 35, 36, and 38 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Grande4 in view of Young 19935.
Claims 33, 35, 36, and 38 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Young 19956 in view of Young 1993.
Claims 33, 35, 36, and 38 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Young 1993.
Claims 33, 35, and 38 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Young ‘735.7
NON-STATUTORY SUBJECT MATTER
Issue
Then issue is whether a preponderance of evidence supports the
Examiner’s finding that claims 33,35, and 38 are directed to non-statutory
subject matter.
3 The examiner initially rejected claim 36 as being directed to non-statutory
subject matter. Final Act. 7. This rejection was withdrawn by the Examiner.
Advisory Action mailed Nov. 25, 2015.
4 Daniel A. Grande, et al., Repair of Articular Cartilage Defects Using
Mesenchymal Stem Cells, 1 Tissue Eng. 345 (1995) (“Grande”).
5 H. E. Young et al., Pluripotent Mesenchymal Stem Cells Reside within
Avian Connective Tissue Matrices, 29 A In Vivo Cell. Dev. Biol. 723 (1993)
(“Young 1993”).
6 H.E. Young et al., Mesenchymal Stem Cells Reside Within the Connective
Tissue of Many Organs, 202 Dev. Dynamics 137 (1995) (“Young 1995”).
7 Young et al., US 5,827,735, issued Oct. 27, 1998 (“Young ‘735”).
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Application 12/768,411
The Examiner finds that the claims are directed to a natural
phenomenon and do not recite additional elements which amount to
something significantly more than a natural phenomenon. Final Act. 7—10.
Appellants contend that the Examiner has not established that the cells
recited in the claims exist in nature. Appeal Br. 16. Appellants argue that
the recited cells do not exist in nature in that they have adapted to survive in
the environment they are placed in after they are extracted. Appeal Br. 18—
28. Appellants contend that the Supreme Court’s decision in Ass ’n for
Molecular Pathology v Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) is not
relevant on this basis. Appeal Br. 26. Similarly Appellants argue that the
Federal Circuit’s decision in In re Roslin Institute (Edinburgh), 750 F.3d
1333 (Fed. Cir. 2014), is not relevant in that in Roslin the cells were not
changed by environmental factors as in the present case. Appeal Br. 27.
Finally, Appellants argue that the claimed stem cells have a new utility.
Appeal Br. 29.
Analysis
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s conclusion that claims 33, 35, and 38 are
directed to subject matter ineligible for patenting under 35 U.S.C. § 101.
“Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.” 35 U.S.C. § 101.
The Supreme Court has “long held that this provision contains an
important implicit exception: Taws of nature, natural phenomena, and
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abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS Bank Intern.,
134 S.Ct. 2347, 2354 (2014).
Our reviewing court has summarized the Supreme Court’s two-part
test for distinguishing between claims to patent-ineligible exceptions, and
claims to patent-eligible applications of those exceptions, as follows:
Step one asks whether the claim is “directed to one of [the]
patent-ineligible concepts.” [Alice, 134 S.Ct. at 2354], If the
answer is no, the inquiry is over: the claim falls within the ambit
of § 101. If the answer is yes, the inquiry moves to step two,
which asks whether, considered both individually and as an
ordered combination, “the additional elements ‘transform the
nature of the claim’ into a patent-eligible application.” Id.
(quoting Mayo [Collaborative Services v. Prometheus Labs, Inc.,
132 S.Ct. 1289, 1297 (2012)]).
Step two is described “as a search for an ‘inventive
concept.’” Id. (quoting Mayo, 132 S.Ct. at 1294). At step two,
more is required than “well-understood, routine, conventional
activity already engaged in by the scientific community,” which
fails to transform the claim into “significantly more than a patent
upon the” ineligible concept itself. Mayo, 132 S.Ct. at 1298,
1294.
Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
In the present case, claim 33 recites “[isolated postnatal human cells
capable of self-renewal and capable of differentiation to cells of endodermal,
ectodermal, and mesodermal lineages, the cells expressing SSEA4, but not
CD 13, said isolated cells having been produced by expanding, in culture, a
cultured cell clone from a postnatal human tissue.” Appeal Br. 33 (Claims
App’x).
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We agree with the Examiner that, as to part one of the Supreme
Court’s test, Appellants’ claim 33 is expressly directed to a natural
phenomenon, namely postnatal human cells having certain characteristics.
As to part two of the Supreme Court’s test, we agree with the
Examiner that the additional limitations of expanding the cultured cell
(claim 33), a culture medium (claim 35), and proliferating the cells beyond
50 cell doublings (claim 38) do not impart something substantially more
than the natural phenomenon. The additional limitations recited in claims 33
and 38 do not materially distinguish the cells from those which exist in
nature. Final Act. 8—9. The culture limitations of claim 35 do not add
something significantly more in that the use of “a medium capable of
supporting the proliferation of said cells”, claim 35, Appeal Br. 33, would be
a matter of using routine, well understood and conventional activities. Final
Act. 9.
We, therefore, agree with the Examiner that, under the Supreme
Court’s two-part test, claims 33, 35, and 38 recite subject matter ineligible
for patenting under §101.
Appellants’ arguments do not persuade us to the contrary.
Appellants begin by arguing that the Examiner has not shown that the
recited cells exist in nature. Appeal Br. 16. We are unpersuaded. As the
Examiner points out
Appellants have identified a cell type that is found in the human
body; the disclosure teaches that the instantly claimed cells can
be isolated from various non-embryonic tissues including
muscle, dermis, fat, tendon, ligament, perichondrium,
periosteum, heart, aorta, endocardium, myocardium, epicardium,
large arteries and veins, granulation tissue, peripheral nerves,
peripheral ganglia, spinal cord, dura, leptomeninges, trachea,
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esophagus, stomach, small intestine, large intestine, liver, spleen,
pancreas, parietal peritoneum, visceral peritoneum, parietal
pleura, visceral pleura, urinary bladder, gall bladder, kidney;
associated connective tissues or bone marrow. See p. 9, lines
16+.
Ans. 3.
We agree with the Examiner that the teaching of the Specification
supports the Examiner’s conclusion that the cells exist in nature.
Appellants contend that the recited cells are different from those
which exist in nature in that the cells have adapted to exist in vitro. Appeal
Br. 18—28. We are unpersuaded. Appellants have not pointed to any
specific modifications that have occurred in the recited cells that did not
exist in the cells in vivo. Similar, Appellants have not shown how the
isolation and culturing technique used to isolate and culture the recited stem
cells changes induces changes in the cells.
Appellants have submitted evidence that modifications can occur in
some cells during the process of culturing the cells, Appeal Br. 21—25,
however, Appellants have not established that such changes occur in all
cases or, specifically, in the present case. Therefore, we are not persuaded
by the articles cited by Appellants.
Appellants’ efforts to distinguish the holdings in Myriad and Roslin
are similarly unpersuasive. As the Examiner points out, Appellants have
offered no evidence that the specific stem cells recited in the claims are
different from those which exist in nature. Ans. 7—8.
Finally, Appellants argue that their invention embraces a new use for
stem cells. Appeal Br. 29. While this may be true, the claims are not
directed to a new use of the cells but to the stem cells themselves and as
such, they are directed to patent ineligible subject matter.
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Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 33,35, and 38 are directed to non-
statutory subject matter.
OBVIOUNSESS
GRANDE IN VIEW OF YOUNG 1993
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the rejected claims
would have been obvious over Grande in view of Young 1993.
The Examiner finds that Grande teaches using the same starting
materials and same method as the present invention. Final Act. 10. The
Examiner finds that Grande necessarily produces the same cells as recited in
claim 33. Id. The Examiner finds that, although Grande does not teach
human cells, it suggests doing so because “one of ordinary skill in the art
would readily understand that Grande provides methods for producing
specific cell types, and that these cells types could be produced using human
tissues, with a reasonable expectation of success, in order to produce
autologous cells for methods of therapy.” Id. at 11.
The Examiner finds that Grande does not specifically teach diluting
the cultured cells to clonal density, culturing the diluted cells and
propagating a single cell to obtain the stem cells recited in the claims. Id.
The Examiner finds that Young 1993 provides such teachings. Id. The
Examiner concludes that
it would have been obvious to one of ordinary skill in the art to
modify the teachings of Grande, to include clonal analysis of the
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cells, as taught by Young, with a reasonable expectation of
success. One of ordinary skill in the art would have been
motivated to utilize clonal analysis of the cells in order to
produce individual cell clones, which would be used to determine
pluripotency, or to establish a cell line.
Final Act. 12.
Appellants contend that there is no motivation to combine the
references as the specific stem cells claimed were not known to exist at the
time the invention was made. Appeal Br. 9. Appellants argue that even if
there were a motivation to combine the references, one skilled in the art
would not have a reasonable expectation of success. Appeal Br. 9-11.
Appellants also argue that the present claims are distinguishable over the
teachings of the references in that they call for a specific selection step not
found in the references. Appeal Br. 11—12.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie case
of unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
The consistent criterion for determination of obviousness
is whether the prior art would have suggested to one of ordinary
skill in the art that this process should be carried out and would
have a reasonable likelihood of success, viewed in the light of
the prior art. Both the suggestion and the expectation of success
must be founded in the prior art, not in the applicant’s disclosure.
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In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988) (citations
omitted).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the claims would have been obvious over Grande combined with Young
1993. Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations on obviousness are incorrect.
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim
33 as representative; therefore, all claims fall with claim 33. We address
Appellants’ arguments below.
Appellants contend that there is no motivation to combine the
references as the claimed cells were not known to exist at the time the
invention was made. Appeal Br. 9. We are unpersuaded. As Appellants’
Declarant admits, the cell mixtures produced by the method of Grande and
by Young 1993 contain the claimed cells. Young 2013 Deck8 4 (“The
Examiner states that Grande’s cell mixture (and Young’s cell mixture)
contain the instantly claimed PPELSCs [pluripotent embryonic-like stem
cells; Spec. 35:25—28]. This is true.”). Appellants have merely used the
isolation and culturing techniques disclosed in Young 1993 to isolate the
specific human stem cells recited in the claims.
8 Declaration Under 37 C.F.R. § 1.132, filed June 17, 2013. (“Young 2013
Deck”).
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Appellants’ argument that one skilled in the art would not have a
reasonable expectation of success is also unpersuasive. Appeal Br. 9-11.
Appellants contend that because of the random nature of Young 1993’s
cloning technique and the low number of the desired cells in the initial
culture, the likelihood of success is very small. Appeal Br. 10. We agree
with the Examiner that one skilled in the art would have a reasonable
expectation of success. Ans. 12—13. The screening of a significant number
of samples or clones appears to have been well within the skill of one skilled
in the art and would not suggest that isolation of the claimed cells would not
be successful. For example, Young 1993 discusses the cloning and analysis
of over 1000 clones. Young 1993 Abstract, 728.
Appellants argue that the invention calls for a specific selection step
not recited in the references. Appeal Br. 11—12. We remain unpersuaded.
As the Examiner points out, the claims do not recite a specific selection
technique but merely recite the same technique as taught by the references.
Ans. 13-14.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that calm 33 would have been obvious over Grande
combined with Young 1993.
Claims 35, 36, and 38 have not been argued separately and therefore
fall with claim 33. 37 C.F.R. § 41.37(c)(l)(iv).
THE REMAINING OBVIOUSNESS REJECTIONS
Appellants have presented essentially the same arguments against the
rejections based on Young 1995 combined with Young 2993, Young 1993
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alone, and Young ‘735. Appeal Br. 12—14. For the reasons stated above, we
affirm these rejections.
SUMMARY
We affirm the rejection under 35 U.S.C. § 101.
We affirm the rejections 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
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