EMD Millipore Corporation

Patent Trials and Appeals Board

Jul 30, 2021

2020006167 (P.T.A.B. Jul. 30, 2021)

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.
15/677,526 08/15/2017 David Yavorsky MCA-1262/2 7943
42754 7590 07/30/2021
Nields, Lemack & Frame, LLC
176 E. Main Street
Suite #5
Westborough, MA 01581
EXAMINER
RUSSEL, JEFFREY E
ART UNIT PAPER NUMBER
1654
MAIL DATE DELIVERY MODE
07/30/2021 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 DAVID YAVORSKY, JOHN AMARA,
JOAQUIN UMANA, WILLIAM CATALDO,
MIKHAIL KOZLOV, and MATTHEW STONE1
Appeal 2020-006167
Application 15/677,526
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
process for purifying a virus, which have been rejected as indefinite, lacking
adequate written description, and anticipated. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies the real party in interest as EMD Millipore
Corporation. Appeal Br. 3. “Appellant” refers to “applicant” as defined in 37
C.F.R. § 1.42.
Appeal 2020-006167
Application 15/677,526

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STATEMENT OF THE CASE
Claims 1 and 2 are on appeal. Claim 1, reproduced below, is
illustrative (emphasis added to disputed limitation):
1. A process for purifying a negatively-charged virus for which
bacteriophage phi6 is a model, comprising contacting a sample
containing said negatively-charged virus with an axially
compressed bed of cut nylon staple fiber media, wherein said
fibers have a cross-section comprising a body region defining
a substantially longitudinal axis, and have a plurality of projections
extending outwardly from said body region, and wherein said
fibers have imparted thereon a polymeric functionality, wherein
the surfaces of said polymeric functionality are modified with
pendant trimethylammonium groups; washing said fibers to
remove unbound species; and eluting said negatively-charged
virus, thereby to purify the negatively-charged virus.

The claims stand rejected as follows:
Claims 1 and 2 under 35 U.S.C. § 112(b) as indefinite (Ans. 3–4);
Claims 1 and 2 under 35 U.S.C. § 112(a) as failing to comply with the
written description requirement (Ans. 3); and
Claims 1 and 2 under 35 U.S.C. § 102(a)(1) as anticipated by
Yavorsky2 (Ans. 4).
OPINION
35 U.S.C. § 112(b)
Claims 1 and 2 stand rejected as being indefinite. The Examiner
concludes that the definition of “model” is unclear because there are
multiple possible ways in which phi6 may be said to “model” other viruses,

2 Yavorsky et al., US 2012/0029176, published Feb. 2, 2012.
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such as charge, size, sequence, structure, target, and/or ability to be purified
by trimethylammonium-modified chromatographic separation media. Ans. 4.
Appellant argues that those skilled in the art often use models or
surrogates that are closely enough related so as to provide useful data, and
points to references of record3 disclosing phi6 as such a model. Appeal Br.
19 (citing Lev,4 Iyer,5 and Aranha-Creado6). Appellant argues that the
meaning of the recitation that phi6 is a model for negatively-charged viruses
is clear. Id.
While we agree that phi6 has been used as a model for other viruses in
the references of record, this prior use does not provide an adequate
definition for the subgenus of negatively charged viruses for which phi6
serves as a model in the context of Appellant’s claimed purification method.
In particular, Appellant has expressly stated that “the claims do not
encompass purification or removal of all . . . negatively charged viruses. . . .
Instead, and importantly, the claims recite purification or removal of only
those negatively charged viruses for which bacteriophage phi6 is a model.”
Reply Br. 3. For this reason, it is clear that Appellant interprets the claims to

3 We understand Appellant’s citation of “the references of record” (Appeal
Br. 19) to mean the references discussed in the Appeal Brief in regard to the
rejection for inadequate written description.
4 Lev et al., US 2009/0220940, published Sept. 3, 2009.
5 Iyer et al., US 2011/0142863, published June 16, 2011.
6 Aranha-Creado et al. “Application of bacteriophages as surrogates for
mammalian viruses: a case for use in filter validation based on precedents
and current practices in medical and environmental virology,” PDA Journal
of Pharmaceutical Science and Technology, 53:75–82 (1999).
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be limited to purification of only some, not all, negatively charged viruses;
specifically, those for which phi6 is, in some sense, a model.
However, the metes and bounds of the subgenus of negatively charged
viruses that are encompassed by the claimed process is unclear because the
record does not make clear what property or properties of phi6 are compared
to those of other negatively charged viruses to determine which viruses phi6
is a model for. As the Examiner has pointed out (Ans. 3), the word “model”
is not used, let alone defined, in Appellant’s Specification.
We have reviewed the passages of Lev, Iyer, and Aranha-Creado cited
by Appellant, but do not find that the term has an art-accepted definition.
Appellant points to Lev’s Table 1, but only as evidence that phi6 has a
negative charge at the pH used in the Specification’s Example 33. Appeal
Br. 14–15. Appellant cites Iyer as evidence that “phi6 has a negative charge
at a pH of above 7.” Id. at 15. Appellant argues that these disclosures show
that those skilled in the art would appreciate that phi6 has a negative charge
at pH 8, as used in Example 33, “and is a model for negatively charged
viruses.” Id. However, these disclosures do not help to define the subgenus
“of only those negatively charged viruses for which bacteriophage phi6 is a
model.” Reply Br. 3.
Appellant also cites Tables II and IV of Aranha-Creado as evidence
that phi6 has been “used as a sized-based model for Murine Leukemia
Virus, as a sized-based model for HIV, and as model for enveloped
viruses.” Appeal Br. 16–17. However, the fact that phi6 can be used as a
model for some viruses based on its size and for other viruses based on its
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enveloped characteristic, does not help to define the property or properties of
negatively-charged viruses that define phi6 as a model for other viruses.
Thus, the record does not make clear the scope of the negatively
charged viruses for which bacteriophage phi6 is a model, to which the
claims are limited. We affirm the rejection under 35 U.S.C. § 112(b).

35 U.S.C. § 112(a)
Claims 1 and 2 stand rejected for failing to comply with the written
description requirement. The Examiner finds that “[t]here is no original
disclosure supporting the claim limitation of a negatively-charged virus ‘for
which bacteriophage phi6 is a model’ as is recited in instant claims 1 and 2”.
Ans. 3. The Examiner notes that “the word ‘model’ is not used in the
original disclosure of this application.” Id.
Appellant argues that those skilled in the art often use bacteriophages
as virus models. Appeal Br. 7. Appellant argues that clearly virus
purification is disclosed in the Specification and Example 33 exemplifies
such purification. Id. at 8. Appellant asserts that although “the term ‘model’
is not used in Example 33, it is certainly implied, as Example 33 expressly
states that the performance achieved is [‘]comparable to membrane-based
anion-exchange media employed in commercial viral chromatography
applications.’” Id. at 11. Appellant asserts that the pH used in Example 33
means that phi6 is negatively charged under the conditions used, meaning it
is a model for negatively charged viruses. Id. Appellant cites Lev and Iyer as
evidence that those skilled in the art would appreciate that phi6 is negatively
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charged at the pH used in Example 33, and therefore “is a model for
negatively charged viruses.” Id. at 14–15.
Appellant also points to Aranha-Creado as an example of
bacteriophages used as surrogates for mammalian viruses; in particular as a
size-based model for Murine Leukemia Virus and HIV, and a model for
enveloped viruses. Id. at 16–17.
The Examiner responds that Iyer “discloses only that Phi6 is used as a
model for influenza virus, not the entire genus of negatively-charged
viruses.” Ans. 5. The Examiner also notes that Aranha-Creado discloses the
use of phi6 for size studies, not for charged-based separation studies. Id. at 6.
Thus, the Examiner concludes that neither reference supports the assertion
that Example 33 was intended as a model for anion exchange
chromatography of the entire genus of negatively charged viruses. Id.
We agree with the Examiner that the originally filed application does
not provide written description support for the subset of negatively charged
viruses for which bacteriophage phi6 is a model. The claims are directed to
a process of purifying a negatively-charged virus for which phi6 is a model,
and Appellant expressly states that “the claims do not encompass
purification or removal of all (or ‘the entire genus of’) negatively-charged
viruses,” but instead “only those negatively charged viruses for which
bacteriophage phi6 is a model.” Reply Br. 3. For this reason, it is clear that
Appellant intends phi6 to serve as a model only for some negatively charged
viruses, but not others.
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As the Examiner pointed out, however, the word “model” does not
appear in Appellant’s Specification7 (including the original claims). Rather,
the Specification states that the invention relates to “purification of
biomolecules” generally. Spec. 1. The Specification also states that the
disclosed method provides “[t]he ability to capture or remove large
biological species such as viruses,” generically. Id. at 7. The Specification’s
Example 33 describes “[t]he results of static binding capacity and elution
recovery measurements for bacteriophage φ6,” but the heading of that
example is “fiber media capability for the bind/elute purification of viruses,”
generically. Id. at 81. The disclosures of Lev, Iyer, and Aranha-Creado are
discussed above, and do not show that those skilled in the art would have
recognized in Appellant’s Specification a disclosure of a method of
purifying a subset of negatively-charged viruses for which phi6 is a model.
In short, Appellant has not persuasively shown that the Specification
describes a method of purifying a subset of negatively-charged viruses for
which phi6 is a model, even assuming (as Appellant argues in the Appeal
Brief) that those skilled in the art would have recognized from Example 33
that phi6 was used as a model of negatively-charged viruses in general. The
Specification does not describe what other property or properties of a
negatively-charged virus determine whether phi6 is a model for that virus
such that the claimed process of purification would be applicable, and
therefore does not show possession of the claimed method.
We affirm the rejection under 35 U.S.C. § 112(a).

7 We have considered the originally filed Specification, as well as the
amendments filed Dec. 14, 2017; Dec. 6, 2018; and Oct. 10, 2019.
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35 U.S.C. § 102(a)(1)
Claims 1 and 2 stand rejected as anticipated by Yavorsky. (The instant
application states that it “is a continuation of . . . a continuation of U.S.
Patent Application Serial No. 13/191,992” (Spec. 1), which was published as
the Yavorsky reference.)
The Examiner finds that in Example 33, Yavorsky teaches a method
in which a sample comprising bacteriophage phi6 is contacted with the same
media recited in the instant claims and is eluted from the media using the
same method steps recited in the instant claims. Ans. 4. The Examiner finds
that Yavorsky can be applied as prior art because the instant claims are not
supported by the disclosure of the parent applications, for the same reason
that the instant claims lack adequate descriptive support in the instant
Specification. Id. at 8–10.
Appellant does not contest the Examiner’s findings regarding
Yavorsky’s Example 33, but argues that Yavorsky is not prior art because
the instant claims are supported by the parent and grandparent cases to
which priority is claimed. Appeal Br. 20.
Because we agree with the Examiner that the instant claims are not
supported by the parent and grandparent cases (for the same reason the
instant Specification does not provide an adequate written description), the
instant claims are not entitled to the benefit of an earlier filing date, and thus
Yavorsky is eligible as a prior art reference. We affirm the rejection under
35 U.S.C. § 102(a)(1). See In re Slayter, 276 F.2d 408, 411 (CCPA 1960)
(“It is well settled that a generic claim cannot be allowed to an applicant if
the prior art discloses a species falling within the claimed genus.”).
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2 112(b) Indefiniteness 1, 2
1, 2 112(a) Written Description 1, 2
1, 2 102(a)(1) Yavorsky 1, 2
Overall
Outcome
1, 2

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