Taghizadeh, Rouzbeh R.

Patent Trials and Appeals Board

Oct 17, 2019

15241585 - (D) (P.T.A.B. Oct. 17, 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.
15/241,585 08/19/2016 Rouzbeh R. Taghizadeh AUX-003C2D1 2841
51414 7590 10/17/2019
GOODWIN PROCTER LLP
PATENT ADMINISTRATOR
100 NORTHERN AVENUE
BOSTON, MA 02210
EXAMINER
XU, QING
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
10/17/2019 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):
GLENN.WILLIAMS@GOODWINPROCTER.COM
PSOUSA-ATWOOD@GOODWINPROCTER.COM
US-PatentBos@goodwinlaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROUZBEH R. TAGHIZADEH1
____________

Appeal 2019-003681
Application 15/241,585
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Auxocell
Laboratories, Inc. App. Br. 2.

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claim 31 as unpatentable under 35 U.S.C.
§ 101 as being directed to nonstatutory subject matter.
Claim 31 also stands rejected as unpatentable under 35 U.S.C.
§§ 102(b) and 103(a) over Fong, C.Y. et al., Comparative Growth Behaviour
and Characterization of Stem Cells from Human Wharton’s Jelly, 15 REPR.
BIOMED. ONLINE 708–718 (2007) (“Fong”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM and enter a new ground of rejection.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to cell-depleted Wharton’s Jelly that
can be used as a medium for maintaining cells in culture. Spec. ¶¶ 21–23.

REPRESENTATIVE CLAIM
Claim 31 is the only claim on appeal and recites:
31. A cell culture medium comprising a cell-depleted
Wharton’s Jelly filtrate containing a buffer, wherein the cell-
depleted Wharton’s Jelly filtrate is prepared by a method
comprising mincing umbilical cord tissue comprising Wharton’s
Jelly, subsequently diluting the umbilical cord tissue with the
buffer, subsequently filtering the umbilical cord tissue to
generate a filtrate, and sedimenting Wharton’s Jelly stem cells
from the filtrate to generate the cell-depleted Wharton's Jelly
filtrate.

App. Br. 9.
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ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are directed to nonstatutory subject
matter under 35 U.S.C. § 101. We further agree with, and expressly adopt,
the Examiner’s findings, reasoning, and conclusion that the claims would
have been anticipated by, and obvious over, the prior art. We also enter a
new ground of rejection. We address below the arguments raised by
Appellant.

A. Rejection of claim 31 under 35 U.S.C. § 101
Issue
Appellant argues that the Examiner erred in concluding that the claim
is directed to a product of nature, and therefore to a judicial exception under
Section 101. App. Br. 2–5.

Analysis
The Examiner concludes that claim 31 is directed to a judicial
exception without adding significantly more. Final Act. 3. The Examiner
finds that claim 31 is directed to a product of nature because the chemical
components comprised in the claimed culture medium are similar to those in
naturally occurring Wharton’s Jelly. Id. The Examiner finds that the
additional element of “a buffer” does not weigh in favor of eligibility
because the buffer is well understood, routine, and conventional, and is
recited at a high level of generality. Id. at 4.
Appellant’s claim 31 recites: “a cell culture medium comprising a
cell-depleted Wharton’s jelly filtrate containing a buffer ….” App. Br. 9.
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The claim further includes product-by-process limitations, i.e., the steps of
mincing, diluting, filtering, and sedimenting. Id. However, “even though
product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself.” In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985). Accordingly, we evaluate the
patentability of the claim, including under Section 101, based on the product
itself.
Appellant argues that the claimed product is not a cell-depleted jelly,
but rather “a cell culture medium (filtrate).” Reply Br. 2. Claim 31 recites
“a cell culture medium” in the preamble. However, “where a patentee
defines a structurally complete invention in the claim body and uses the
preamble only to state a purpose or intended use for the invention, the
preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed.
Cir. 1997). The body of claim 31 recites: “a cell-depleted Wharton’s Jelly
filtrate” and “a buffer.” These elements constitute a structurally complete
invention, and the preamble recites merely the intended use for the
invention, i.e., a cell culture medium. Accordingly, we conclude that the
preamble does not limit the claim.
In performing an analysis of patentability under Section 101, we
follow the framework set forth by the Supreme Court in Mayo Collaborative
Servc’s v. Prometheus Labs., Inc., 566 U.S. 66 (2012). We are also mindful
of, and guided by, the United States Patent and Trademark Office’s 2019
Revised Patent Subject Matter Eligibility Guidance, 84(4) Fed. Reg. 50–57
(January 7, 2019) (the “Guidance”).
Following the first step of the Mayo framework, we find that claim 31
recites a composition of matter and therefore falls into one of the broad
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statutory categories of patent-eligible subject matter under 35 U.S.C. § 101.
In the next step of the Mayo analysis, we determine whether the claim at
issue is directed to a nonstatutory, patent-ineligible concept, i.e., a law of
nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S. at 70–
71; Guidance 54 (step 2A, Prong 1). If we determine that the claim is
directed to a judicial exception, we then determine whether the limitations of
the claim reciting the judicial exception are integrated into a practical
application. Id. (Step 2A, Prong 2). Finally, if we determine that the claim
is directed to a judicially-created exception to Section 101, we evaluate the
claims under the next step of the Mayo analysis, considering the elements of
each claim both individually and “as an ordered combination” to determine
whether additional elements “transform the nature of the claim” into a
patent-eligible application. Mayo, 566 U.S. at 78–79; 2019 Guidance at 56
(Step 2B).
Claim 31 recites, in relevant part: “A cell culture medium comprising
a cell-depleted Wharton’s Jelly filtrate containing a buffer, wherein the cell-
depleted Wharton’s Jelly filtrate is prepared by a method comprising
mincing umbilical cord tissue comprising Wharton’s Jelly.2” Appellant’s
Specification discloses that the claimed composition comprises Wharton’s
Jelly that is extracted from umbilical cord tissue. See Spec. ¶ 21. “[W]hen
the cells are separated from the digested tissue, the remaining, cell-depleted

2 Wharton’s Jelly is the connective tissue of the umbilical cord. See J.E.
Davies et al., Concise Review: Wharton’s Jelly: The Rich, but Enigmatic,
Source of Mesenchymal Stromal Cells, 6 STEM CELLS TRANSL. MED. 1620–
30 (2017).
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digested tissue is a rich, sterile solution that can be used for maintaining
cells … some cells may be present, although in substantially reduced
numbers, within this rich, sterile, cell-depleted solution derived from the
digested tissue.” Id. Therefore, the claim recites an isolated natural product,
i.e., Wharton’s Jelly that is substantially depleted of its cellular constituents.
Isolating a natural product and thereby creating a non-naturally
occurring material does not necessarily result in patent-eligible subject
matter. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569
U.S. 576, 593 (2013). In Myriad, the Supreme Court held claims directed to
isolated DNA were not “saved by the fact that isolating DNA from the
human genome severs chemical bonds and thereby creates a nonnaturally
occurring molecule.” 569 U.S. at 593. Rather, to be patent eligible, a
“nonnaturally occurring manufacture or composition of matter” must
possess “markedly different characteristics from any found in nature.” Id. at
590–591 (citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)).
Appellant argues that: “the cell-depleted Wharton’s Jelly filtrate
recited in claim 31 possesses markedly different characteristics from
Wharton’s Jelly in its natural state.” App. Br. 3. Appellant argues that:
[C]ompared to its naturally-occurring counterpart, Wharton’s
Jelly, the mixture of cell-depleted Wharton’s Jelly filtrate and a
buffer has markedly different characteristics (e.g., reduced
viscosity, changed extracellular matrix structure, and lack of
cells and unbroken tissues) which are relevant to the nature of
the invention as a component of a cell culture medium and which
are a result of the Appellant’s efforts.

Id. at 4.
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We are not persuaded by Appelant’s argument. The Specification
explains that cell-depleted Wharton’s Jelly filtrate can be used as a medium
for maintaining cells, e.g., culturing mesenchymal stem cells. See Spec. ¶¶
21–23. However, naturally-occurring Wharton’s Jelly in situ also provides
an environment for maintaining stem cells. See Fong 708 (“Stem cells have
been found in umbilical cord blood, the Wharton’s jelly, and in the other
perivascular mesenchymal areas within the cord”). Furthermore, the
Wharton’s Jelly recited in the claims is obtained by “mincing umbilical cord
tissue comprising Wharton’s Jelly, subsequently diluting the umbilical cord
tissue with the buffer, subsequently filtering the umbilical cord tissue to
generate a filtrate, and sedimenting Wharton’s Jelly stem cells.” Claim 31.
In other words, Wharton’s Jelly is extracted from the umbilical cord tissue,
and then filtered to remove the cells present within the jelly, much as blood
serum can be prepared by removing the cellular elements of blood.
However, other than removal of the cells, the Wharton’s Jelly remains
structurally the same as it was prior to removal from the umbilical cord
tissue, save for dilution with the buffer, which we address infra.
Appellant has not shown that the cell-depleted Wharton’s Jelly filtrate
is a transformation of the natural product, or that the claimed filtrate has
properties not possessed by the naturally-occurring Wharton’s Jelly in situ.
Rather, the discovery that cell-depleted Wharton’s Jelly filtrate functions as
a culture medium is no more than the discovery of a property of the product
of nature and is therefore not patent eligible. Consequently, we are not
persuaded that the claimed cell-depleted Wharton’s Jelly filtrate is markedly
different from the natural product and we find that the claims recite a
judicial exception, i.e., a product of nature.
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We next determine whether the judicial exception is integrated into a
practical application. See 2019 Guidance at 55 (Step 2A, Prong 2). For
example, integration may include using the natural product in a particular
treatment or prophylaxis for a medical condition or a particular manufacture
that is integral to the claims. Id.
Appellant argues that the additional element, i.e., the buffer, allows
the mixture to be used in a cell culture medium. App. Br. 5. Appellant
argues that the buffer “provides resistance to pH changes that occur during
the course of culturing cells, and the removal of cells that occur naturally
within Wharton’s Jelly allows the Wharton’s Jelly cell-depleted filtrate to be
used for culturing other cell types, avoiding contamination from cells
normally present in Wharton’s Jelly.” Id. at 5.
We do not find this argument persuasive. Claim 31 recites an isolated
natural product and its combination with a buffer. As we have explained
supra, the preamble’s recitation of “a cell culture medium” is not limiting
upon the claim. Claim 31 thus recites a composition, viz., Wharton’s Jelly
and a buffer, which has the natural property of being able to act as a cell
culture medium, but the claims proper do not recite limitations requiring that
the claimed composition be so used. As such, the limitations of the claim
recite only the composition, a product of nature and a buffer, and do not
recite the integration of that composition into any practical application.
Finally, we evaluate whether additional elements in the claims recite
“an inventive concept —i.e., an element or combination of elements that is
sufficient to ensure that the patent in practice amounts to significantly more
than a patent upon the [ineligible concept] itself.” Ariosa Diagnostics, Inc.
v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Particularly, we
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evaluate whether the claims include specific limitations that are not “well-
understood, routine, conventional activity previously engaged in by
scientists who work in the field.” Mayo, 566 U.S. at 79. Claim 31 combines
an isolated natural product (cell-depleted Wharton’s Jelly filtrate) with a
buffer. It is universally acknowledged that buffering solutions are
commonly combined with isolated natural products in the biological arts,
and are known for washing, diluting, protecting, and storing biological
tissue. See Spec. ¶¶ 18, 27; see also Berkheimer v. HP Inc., 881 F.3d 1360,
1368 (Fed. Cir. 2018). There is no evidence of record that the claim
includes other, unconventional elements, either alone or in combination. See
In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161 (Fed. Cir. 2018).
Accordingly, we find that the addition of a buffer to the Wharton’s Jelly
appends no more than routine and conventional material to the natural
product.
We therefore conclude that the claims recite no additional elements
that amount to significantly more than a patent on the ineligible concept
itself. See Ariosa, 788 F.3d at 1378. Because the claim is directed to a
judicial exception and the additional recited elements do not transform the
judicial exception into a patent-eligible invention, we sustain the Examiner’s
rejection upon this ground.

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B. Rejection of claim 31 under 35 U.S.C. §§ 102 and 103
Issue
Appellant argues that the Examiner erred in concluding that the claims
are anticipated and obvious over the prior art. App. Br. 5–9.

Analysis
The Examiner finds Fong teaches a method of preparing a
composition comprising cell-depleted Wharton’s Jelly solution in a DMEM
(“Dulbecco’s modified Eagle’s medium”). Final Act. 4 (citing Fong 709).
The Examiner finds cell-depleted Wharton’s Jelly solution is a supernatant
produced by the steps of: 1) enzymatically digesting umbilical cord pieces in
DMEM, 2) detaching Wharton’s Jelly from the surrounding cord blood
vessels into DMEM, 3) breaking up the gelatinous Wharton’s Jelly mass by
re-suspending with a pipette, and 4) centrifuging the suspension to remove
cells. Ans. 9–10 (citing Fong 709). With respect to the buffer, the Examiner
finds DMEM contains a sodium bicarbonate buffer system. Id. at 11. The
Examiner finds the “supernatant of [] Fong et al., obtained through the steps
similar to those recited in lines 3-6, is consequently [the] same as or
equivalent to the ‘cell-depleted Wharton’s Jelly filtrate containing a buffer’
recited in the instant claim.” Id. at 10.
Appellant argues that Fong does not teach a cell culture medium
comprising cell-depleted Wharton’s Jelly. App. Br. 6. Appellant
particularly argues that Fong discards “the supernatant comprising cell-
depleted Wharton’s Jelly and DMEM.” Id. Appellant further argues that
Fong does not teach the process steps of the claim, including mincing and
filtering. Reply Br. 6–7.
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With respect to the buffer, Appellant argues that DMEM does not
include a buffer, citing a product description for modified DMEM that
states: “DMEM uses a sodium bicarbonate buffer system (3.7 g/L) and
therefore requires a 5–10% CO2 environment to maintain a physiological
pH.” App. Br. 7. Appellant argues that “[m]ammalian cells are commonly
cultured in DMEM or similar media at 5–10% CO2, which form the
bicarbonate buffer system for growing cells.” Id. at 8.
We are not persuaded. As discussed supra, “cell culture medium”
recited in the preamble is not a limitation of the claim if the body of the
claim defines a structurally complete invention. Supra at 4. Moreover,
although Fong does not disclose a filtrate, the Specification explains that
both centrifugation and filtering provide cell-depleted Wharton’s Jelly, and
the patentability of the claim is determined by the product itself, and not by
the product-by-process steps. Spec. ¶ 5. Accordingly, we address whether
the prior art discloses a combination of cell-depleted Wharton’s Jelly filtrate
containing a buffer.
We begin with Appellant’s argument with respect to the buffer. The
product description of DMEM unambiguously states that DMEM uses a
sodium bicarbonate buffer system in a concentration of 3.7 g/L. The
reference to a 5–10% CO2 environment merely instructs those of ordinary
skill in the art on the correct incubator settings for culturing cells in DMEM.
Accordingly, we do not agree with Appellant’s argument with respect to the
buffer.
We agree with Appellant that Fong teaches discarding the supernatant
containing the cell-depleted Wharton’s Jelly and DMEM. Nevertheless,
patent law “establishes that a prior art reference which expressly or
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inherently contains each and every limitation of the claimed subject matter
anticipates.” Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1379 (Fed.
Cir. 2003). “The extent of the inherent disclosure does not limit its
anticipatory effect. In general, a limitation or the entire invention is inherent
and in the public domain if it is the ‘natural result flowing from’ the explicit
disclosure of the prior art.” Id.
In Schering, our reviewing court found claims directed to a metabolite
of loratadine (“DCL”) were inherently anticipated by administering
loratadine to patients, even if the existence of the DCL metabolite was
fleeting and was not recognized in the art. Id. at 1377–1378. The court
found that the prior art “need not describe how to make DCL in its isolated
form. The [prior art] need only describe how to make DCL in any form
encompassed by a compound claim covering DCL.” Id. at 1381.
We agree with the Examiner that a composition of a cell-depleted
Wharton’s Jelly filtrate containing a buffer is the natural result flowing from
the explicit disclosure of Fong. Although the cell-depleted Wharton’s Jelly
in Fong is not retained, it is nevertheless disclosed as existing for some
period of time, and that is sufficient to establish inherent anticipation.
Schering, 339 F.3d at 1379. Because Fong discloses the same composition
as claim 31, we sustain the Examiner’s rejection of the claim as anticipated
and obvious. In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (“It is
well settled that ‘anticipation is the epitome of obviousness.’”)

NEW GROUND OF REJECTION
We here enter a new ground of rejection. Independent claim 31 is
unpatentable under 35 U.S.C. § 102(b) as being anticipated by Sobolewski,
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K. et al., Wharton’s Jelly as a Reservoir of Peptide Growth Factors, 26
PLACENTA 747–752 (2005) (“Sobolewski”).3
Sobolewski discloses “that Wharton’s jelly … contains several growth
factors in amounts comparable to or higher than those in the umbilical cord
arterial wall.” Sobolewski 749. The growth factors include acidic FGF,
basic FGF, EGF, IGF-I, PDGF and TGF-b. Id. at 747.
Sobolewski discloses the following method for isolating Wharton’s
Jelly:
20 cm sections of [ ] umbilical cords … were excised and
submitted to isolation of Wharton’s jelly and umbilical cord
arteries using microsurgical technique. The tissue samples were
washed with 0.9% NaCl and stored at -70°C until assay. Tissue
homogenates (10% w/v) were prepared in 0.15 M Tris-HCl
buffer, pH 7.6 or in 0.15 M acetic acid with the use of a knife
homogeniser (20,000 rpm, 30 s, 0°C). The homogenates were
submitted to ultrasonification (20 kHz, 3 × 15s, 0°C) and
centrifugation at 10,000 × g for 30 min at 4°C. The supernatants
(tissue extracts) were collected and subsequently assayed for
growth factors using ELISA and Western blot analysis.

Id. at 748. Sobolewski’s isolation method includes the steps of mincing
umbilical tissue, diluting the tissue with a buffer, centrifuging the tissue, and
collecting supernatant. As discussed supra, the natural result of this method
is the same product of claim 31. Moreover, Sobolewski collects the cell-
depleted Wharton’s jelly containing a buffer and identifies numerous growth

3 Appellant cited Sobolewski in an Information Disclosure Statement dated
November 1, 2016.
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factors that would be useful components in a cell culture medium.
Accordingly, we find Sobolewski anticipates claim 31.

CONCLUSION
The rejection of claim 31 as unpatentable under 35 U.S.C. § 101, is
affirmed.
The rejection of claim 31 as unpatentable under 35 U.S.C. §§ 102 and
103 is affirmed.
We have entered a new ground of rejection for independent claim 31
pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a]
new ground of rejection . . . shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that 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.

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
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AFFIRMED
37 C.F.R. § 41.50(b)

Claim
Rejected
35 U.S.C. § Basis Affirmed Reversed New
Grounds
31 101 Eligibility 31
31 102/103 Fong 31
31 102 Sobolewski 31
Overall
Outcome
31 31