Henry E. Young et al.

Patent Trials and Appeals Board

Jan 28, 2020

12768471 - (D) (P.T.A.B. Jan. 28, 2020)

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.
12/768,471 04/27/2010 Henry E. Young 1304-1-019CON1 5674
26294 7590 01/28/2020
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
01/28/2020 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):
docketing@tarolli.com
rkline@tarolli.com
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. LUCAS
Appeal 2018-004405
Application 12/768,471
Technology Center 1600
BEFORE ERIC B. GRIMES, JOHN E. SCHNEIDER, and DAVID COTTA,
Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 47–49 and 51. We have jurisdiction
under 35 U.S.C. § 6(b).2

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as ABT Holding
Company. Appeal Br. 3.
2 Appellant notes that the pending appeal for SN 12/768,411 “may be related
to, directly affect, or be directly affected by or have a bearing on the Board’s
decision in the pending appeal.” We issued our decision in that case, Appeal
2017-002939, on Oct. 10, 2017, affirming the Examiner’s rejections.
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We AFFIRM.
CLAIMED SUBJECT MATTER
The claims are directed to pluripotent stem cells. Claim 47,
reproduced below, is illustrative of the claimed subject matter:
47. Isolated cells derived from postnatal human cells or tissues
and capable of self-renewal and capable of differentiation to cells
of endodermal, ectodermal and mesodermal lineages, wherein
the isolated cells express SSEA4 and do not express CD13, the
isolated cells having been produced by expanding, in culture, a
cultured cell clone from a postnatal human tissue.
The prior art relied upon by the Examiner comprises the following:

Name Reference Date
Young et al. (Young
’735”)
US 5,827,735 Oct. 27, 1998
Young et al., Pluripotent Mesenchymal Stem Cells Reside Within Avian
Connective Tissue, In Vitro Cell. Dev. Biol. 29A:723–736 (1993)
(“Young 1993”)
Young et al., Mesenchymal Stem Cells Reside Within the Connective
Tissue of Many Organs, Devel. Dynamics 202:137-144 (1995) (“Young
1995”)
Grande et al., Repair of Articular Cartilage Defects Using Mesenchymal
Stem Cells, Tissue Eng’g 1:345–353 (1995)

The Examiner has rejected the pending claims3 as follows:
Claims 47, 48, and 51 have been rejected under 35 U.S.C. § 101 as
being directed to non-statutory subject matter.

3 Claim 52 is pending in the application but has been withdrawn from
consideration. Final Act. 1.
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Claims 47–49 and 51 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Grande in view of Young 1993.
Claims 47–49 and 51 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Young 1995 in view of Young 1993.
Claims 47–49 and 51 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Young 1993.
Claims 47–49 and 51 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Young ’735.
NONSTATUTORY SUBJECT MATTER
Issue
The issue is whether a preponderance of evidence supports the
Examiner’s finding that claims 47, 48, and 51 are directed to non-statutory
subject matter.
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. 9–12.
Appellant contends that the Examiner has not established that the cells
recited in the claims exist in nature. Appeal Br. 10. Appellant argues 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. 10–
11, 14–18. Appellant contends that the Supreme Court’s decision in Ass’n
for Molecular Pathology v Myriad Genetics, Inc., 133 S. Ct. 2017 (2013) is
not relevant on this basis. Appeal Br. 11–14, 19. Similarly Appellant argues
that the Federal Circuit’s decision in In re Roslin Institute, 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. 19–21. Finally,
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Appellant argues that the claimed stem cells have a new utility. Appeal Br.
22–23.
Analysis
Appellant does not persuade us that a preponderance of the evidence
fails to support the Examiner’s conclusion that claims 47, 48, and 51 recite
subject matter ineligible for patenting under 35 U.S.C. § 101.
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208,
216 (2014).
To determine if a claim falls within an excluded category, we are
guided by the Supreme Court’s two-step framework, described in Mayo and
Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework, we
first determine what concept the claim is “directed to.” See Alice, 573 U.S.
at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
The Supreme Court has made it clear that naturally occurring
organisms are not patentable. Funk Bros. Seed Co. v. Kalo Innoculant Co.,
333 U.S. 127 (1948). In Funk Bros., the Supreme Court considered a patent
that claimed a mixture of naturally occurring strains of bacteria that helped
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leguminous plants extract nitrogen from the air and fix it in soil. 333 U.S. at
128–29. The Court concluded that this mixture of bacteria strains was not
patent eligible because the patentee did not alter the bacteria in any way. Id.
at 132.
In Chakrabarty v. Diamond, 447 U.S. 303, 305 (1980, the Court
clarified the scope of Funk. The patent at issue in Chakrabarty claimed a
genetically engineered bacterium that was capable of breaking down various
components of crude oil. Id at 305. The patent applicant created this non-
naturally occurring bacterium by adding four plasmids to a specific strain of
bacteria. Id. at 305 n. 1. Overturning the Board's rejections, the Court held
that the modified bacterium was patentable because it was “new” with
“markedly different characteristics from any found in nature and one having
the potential for significant utility.” Id. at 310 (emphasis added). As the
Court explained, the patentee's “discovery is not nature's handiwork, but his
own.” Id.
Accordingly, discoveries that possess “markedly different
characteristics from any found in nature,” id., are eligible for patent
protection. In contrast, any existing organism or newly discovered plant
found in the wild is not patentable. Id. at 309; see also In re Beineke, 690
F.3d 1344, 1352 (Fed.Cir.2012) (holding that a newly discovered type of
plant is not eligible for plant patent protection, in part, because such a plant
was not “in any way the result of [the patent applicant's] creative efforts or
indeed anyone's creative efforts.”).
In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.
576 (2013), the Court held that claims on two naturally occurring, isolated
genes (BRCA1 and BRCA2), which can be examined to determine whether
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a person may develop breast cancer, were invalid under § 101. Id. at 593.
The Supreme Court concluded that the BRCA genes themselves were
unpatentable products of nature. Id.
If the claim is “directed to” a natural phenomenon, we turn to the
second step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “A
claim that recites an abstract idea must include ‘additional features’ to
ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo,
566 U.S. at 77).
The PTO published revised guidance on the application of § 101.
USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent Subject
Matter Eligibility Guidance (“2019 Revised Guidance”). Under that
guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings
of abstract ideas (i.e., mathematical concepts, certain methods
of organizing human activity such as a fundamental economic
practice, or mental processes); and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP § 2106.05(a)–
(c), (e)–(h)).
See 2019 Revised Guidance, 84 Fed. Reg. at 54–55. The USPTO’s October
17, 2019 Memorandum, October 2019 Update: Subject Matter Eligibility
(“2019 October Update”), confirmed that the 2019 revised Guidance is
applicable to claims directed to products of nature, laws of nature or natural
phenomenon. 2019 October Update 1–2, available at
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https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df. Only if a claim (1) recites a judicial exception and (2) does not integrate
that exception into a practical application, do we then look to whether the
claim:
(3) adds a specific limitation beyond the judicial
exception that are not “well-understood, routine, conventional”
in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception.
See 2019 Revised guidance, 84 Fed. Reg. at 55.
As discussed more fully below, we have considered the positions of
the Examiner and Appellant and conclude that the claims as drafted are
directed to a natural phenomenon without anything significantly more. We
therefore agree with the Examiner that the claims are not patent eligible.
Step 2A – Prong 1
In the present case, claim 47 recites “[i]solated cells derived from
postnatal human cells or tissue, and capable of self-renewal and capable of
differentiation to cells of endodermal, ectodermal, and mesodermal lineages,
the cells expressing SSEA4, but not CD13, the isolated cells having been
produced by expanding, in culture, a cultured cell clone from a postnatal
human tissue.” Appeal Br. 31 (Claims App’x).
We, therefore, agree with the Examiner that, as to part 2A, prong 1 of
the test, Appellant’s claim 47 recites a natural phenomenon, namely a human
cell having certain characteristics.
Appellant’s arguments do not persuade us to the contrary.
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Appellant begins 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
The instantly claimed cells are naturally occurring
products. This is evidenced by the disclosure that teaches that
the pluripotent embryonic-like stem cells can be isolated from
human cells (p. 9, line 20), and specifically 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, 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 23+.
Therefore, the cells of the claimed invention are a natural
product that is not markedly different in structure from
naturally occurring products.

Ans. 5. We agree with the Examiner that the teachings of the Specification
support the Examiner’s conclusion that the cells exist in nature.
Appellant contends that the recited cells are different from those
which exist in nature in that the cells have adapted to exist in vitro. Appeal
Br. 12–13. We are unpersuaded. Appellant has not pointed to any specific
modifications that have occurred in the recited cells that did not exist in the
cells in vivo. Similarly, Appellant has not shown how the isolation and
culturing technique used to isolate and culture the recited stem cells induces
changes in the cells.
Appellant has submitted evidence that modifications can occur in
some cells during the process of culturing the cells, Appeal Br. 14–18,
however, Appellant has not established that such changes occur in the
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present case. Therefore, we are not persuaded by the articles cited by
Appellant.
Appellant’s efforts to distinguish the holdings in Myriad and Roslin
are similarly unpersuasive. As the Examiner points out, Appellant has
offered no evidence that the specific stem cells recited in the claims are
different from those which exist in nature. Ans. 11–12.
Step 2A – Prong 2
With respect to the question of whether there are additional elements
which incorporate the exception into a practical application, we find no such
elements in the claims as drafted. As noted above, claims 47, 48 and 51 are
directed to isolated cells. The claims do not recited any application of the
cells. See Appeal Br. 31 (Claims App’x).
Step 2B
As to part 2B of the test, we agree with the Examiner that the
additional limitations of expanding the cultured cell (claim 47), a culture
medium (claim 48), and proliferating the cells beyond 50 cell doublings
(claim 51) do not impart something substantially more than the natural
phenomenon. The additional limitations recited in claims 47 and 51 do not
materially distinguish the cells from those which exist in nature. Final Act.
11–12. The culture limitations of claim 48 do not add something
significantly more in that the use of “a medium capable of supporting the
proliferation of said cells,” claim 48, Appeal Br. 31, would be a matter of
routine, well understood, and conventional activities. Id.
Appellant argues that their invention embraces a new use for stem
cells. Appeal Br. 22–23. While this may be true, the claims at issue are not
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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.
We, therefore, agree with the Examiner that, under the Supreme
Court’s two-part test, claims 47, 48, and 51 recite subject matter ineligible
for patenting under § 101.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 47, 48, and 51 are directed to non-
statutory subject matter.
OBVIOUSNESS
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. 13. The
Examiner finds that Grande necessarily produces the same cells as recited in
claim 47. Id. at 14. The Examiner finds that Grande does not specifically
teach diluting the cultured cells its 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 provides such a teaching. 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 cells, as taught by Young, with a reasonable expectation of
success. One of ordinary skill in the art would have been
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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. 14–15.
Appellant contends 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. 23. Appellant argues that even if
there were a motivation to combine the references, one skilled in the art
would not have a reasonable expectation of success. Id. at 23–25. Appellant
also argues 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. Id. at 26–27.
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.
In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988) (citations
omitted).
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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 Office 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. Appellant has not produced evidence showing, or persuasively
argued, that the Examiner’s determinations on obviousness are incorrect.
Only those arguments made by Appellant 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)(1)(iv) (2015). We have identified claim 47 as
representative; therefore, all claims fall with claim 47. We address
Appellant’s arguments below.
Appellant contends 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. 24. We are unpersuaded. As Appellant’s
Declarant, Dr. Henry E. Young,4 admits, the cell mixtures produced by the
method of Grande and of Young 1993 contains the claimed cells. Young
Decl. 4 (“The Examiner states that Grande’s cell mixture (and Young’s cell
mixture) contains the instantly claimed PPELSCs. This is true.”). Appellant
has merely used the isolation and culturing techniques disclosed in Young
1993 to isolate the specific stem cells recited in the claims.
Appellant’s argument that one skilled in the art would not have a
reasonable expectation of success is also unpersuasive. Appeal Br. 24–25.
Appellant contends that because of the random nature of Young 1993’s

4 Declaration of Dr. Henry E. Young, signed June 11, 2013 (“Young Decl.”).
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cloning technique and the low number of the desired cells in the initial
culture, the likelihood of success is very small. Id. at 24. We agree with the
Examiner that one skilled in the art would have a reasonable expectation of
success. Ans. 27–28. 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.
Appellant argues that the invention calls for a specific selection step
not recited in the references. Appeal Br. 26–27. 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. 28.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 47 would have been obvious over Grande
combined with Young 1993.
Claims 48, 49, and 51 have not been argued separately and therefore
fall with claim 47. 37 C.F.R. § 41.37(c)(1)(iv).

THE REMAINING OBVIOUSNESS REJECTIONS
Appellant has presented essentially the same arguments against the
rejections based on Young 1995 combined with Young 1993, Young 1993
alone, and Young ’735. Appeal Br. 27–28. For the reasons stated above, we
affirm these rejections.
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CONCLUSION
The Examiner’s rejection under 35 U.S.C. § 101 is affirmed.
The Examiner’s rejections under 35 U.S.C. § 103(a) are affirmed
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
47, 48, 51 101 Eligibility 47, 48, 51
47–49, 51 103 Grande, Young
1993
47–49, 51
47–49, 51 103 Young 1995,
Young 1993
47–49, 51
47–49, 51 103 Young 1993 47–49, 51
47–48, 51 103 Young ’735 47–49, 51
Overall
Outcome
47–49, 51

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED