Monday, March 11, 2019

Judge Newman goes through inherency in QAPSULE

The case IN RE: QAPSULE TECHNOLOGIES, INC. gives an interesting walk-through of case law, including a citation to

Yale Lock Mfg. Co. v. Greenleaf, 117 U.S. 554, 559 (1886)
(“The scope of letters patent must be limited to the invention covered by the
claim, and while the claim may be illustrated it cannot be
enlarged by language used in other parts of the specification.”).

Of procedure,

Faced with the new ground of rejection, Qapsule had
the option of reopening prosecution before the examiner, or
requesting rehearing. See 37 C.F.R. § 41.50(B)(2). Qapsule
chose the rehearing route. Treating claim 1 as representative,
Qapsule argued that “Claim 1 includes a limitation
that the shell proteins are recombinant” whereas the shell
proteins identified by the Board in Perez “are not recombinant.”
’773 Application, Request for Rehearing, filed Jan.
22, 2018, at 3 (J.A.64). Qapsule stated in its request for
rehearing that Ye disclosed recombinant shell proteins, but
not in combination with recombinant proteins as claimed.
See id. But Qapsule acknowledged that the Board’s new
ground of rejection was for anticipation by Perez and not
Ye. See id. Accordingly, Qapsule argued that Perez did not
anticipate the rejected claims.

This led to invocation of

In re Dilnot, 300 F.2d 945, 950 (CCPA 1962), “addition of a
method step in a product claim, which product is not
patentably distinguishable from the prior art, cannot impart
patentability to the old product.”6 The Board concluded
that “whether the shell proteins were produced in a ‘recombinant’ eukaryotic
expression system in MDCK cells or produced as taught by Perez by virus infection in the MDCK
cells, the final constructs including the shell proteins would
be expected to be structurally identical because they would
share the same amino acid sequence, same glycosylation
patterns (if any), as they were produced by the same cell.”
Id. And the Board remarked that Qapsule had failed to
provide any evidence rebutting the inherency ruling. See

Of substantial evidence:

“[A]nticipation is a question of fact, including whether
an element is inherent in the prior art.” In re Gleave, 560
F.3d 1331, 1334–35 (Fed. Cir. 2009). Thus we review the
Board’s factual finding of inherent anticipation for support
by substantial evidence. 5 U.S.C. § 706(2)(E); Dickinson v.
Zurko, 527 U.S. 150, 152 (1999); In re Gartside, 203 F.3d
1305, 1316 (Fed. Cir. 2000). “Substantial evidence is something less
than the weight of the evidence but more than a
mere scintilla of evidence,” In re Kotzab, 217 F.3d 1365,
1369 (Fed. Cir. 2000), and “means such relevant evidence
as a reasonable mind might accept as adequate to support
a conclusion,” Consol. Edison Co. of New York v. NLRB, 305
U.S. 197, 229 (1938).

Yes, In re Best arises:

Qapsule further argues that the Board misapplied the
requirement of structural identity for inherent anticipation
under In re Best. 562 F.2d 1252, 1256 (CCPA 1977)
(“Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do
not necessarily or inherently possess the characteristics of
his claimed product.”). We find that the Board properly applied
the concept of inherency on an element-by-element
basis in order to establish that the M1 protein, viral RNA,
and PB1 protein would meet the claimed “shell protein,”
“bifunctional polynucleotide,” and “cargo protein” limitations, respectively.

If the anticipating reference has the elements following a "comprising" transition,
that is enough for a prima facie case:

On appeal, Qapsule points to the presence of additional
elements in Perez, such as a lipid envelope and other proteins, as evidencing
a structural difference between Perez’s
influenza A disclosure and the recited limitations of representative claim 1.
See Appellant Br. at 9–12. Qapsule contends that these structural differences negate anticipation.
That is incorrect, as applied herein, for as discussed supra,
Qapsule’s claims are not limited to the three recited components. The Board correctly found that the Examiner met
his burden of establishing structural identity of the
claimed synthetic capsule construct in view of the scope of
representative claim 1, and that this prima facie case has
not been rebutted by the Applicant. See In re Jung, 637
F.3d 1356, 1362 (Fed. Cir. 2011) (explaining the burdenshifting framework during prosecution); In re Mousa, 479
F. App’x 348, 352 (applying the same specifically to inherency).

There is also discussion of the distinction between comprising and having:

Similarly, the word “having,” in the clause “a bifunctional
polynucleotide having . . . a second aptameric activity for
retaining said bifunctional polynucleotide within said enclosure by assembly with the interior surface of said shell
protein” does not exclude additional, unrecited elements
from participating in capsule assembly. See id.:
The transition “having” can also make a claim
open. However, the term “having” does not convey
the open-ended meaning as strongly as “comprising.” “Having,”
for instance, does not create a presumption that the body of the claim is open.
Therefore, this court examines the claim in its full
context to determine whether [Applicant’s] use of
“having” limits claim 1 to its recited elements.
(internal citation omitted)


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