Ex Parte Smith et al

Patent Trial and Appeal Board

Jan 16, 2019

14020794 (P.T.A.B. Jan. 16, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/020,794 09/07/2013
77974 7590 01/18/2019
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
Bryan R. Smith
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
3815.133 6132
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
01/18/2019 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRYAN R. SMITH and ELIVER GHOSN
Appeal 2018-001863
Application 14/020, 794 1
Technology Center 1600
Before ERICA A. FRANKLIN, ELIZABETH A. LA VIER,
and DAVID COTTA, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claims 10, 12, 13, 24, 25, 27-29, 31-34, and 46-
57. We have jurisdiction under 35 U.S.C. § 6(b ). For the reasons set forth
below, we AFFIRM.
BACKGROUND
The Specification relates to using carbon nanotubes to visualize
tissues and deliver therapeutic treatment. Spec. ,r 3. Claim 10 is illustrative,
and recites:
1 Appellants identify the real party in interest as the Board of Trustees of the
Leland Stanford Junior University. Br. 3.
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Application 14/020,794
10. A method for locating a tumor in a mammalian subject,
wherein the mammalian subject comprises a subset of
monocytes selected from Ly-6Chi monocytes or CD14+
monocytes, and wherein the method comprises:
a) delivering single walled carbon nanotubes (SWNTs), which
are conjugated to a detectable label to form conjugated carbon
nanotubes, to the mammalian subject;
b) allowing the subset of monocytes to selectively internalize
said conjugated carbon nanotubes, thereby producing
conjugated carbon nanotubes-carrying monocytes;
c) allowing the tumor to take up the conjugated carbon
nanotubes-carrying monocytes; and
d) imaging the conjugated carbon nanotubes-carrying
monocytes expressing Ly-6Chi or CD14+ and taken up by the
tumor, wherein the detectable label enables imaging of the
SWNTs by a method selected from the group consisting of:
fluorescent intravital microscopy, Raman imaging,
photoacoustic imaging, ultrasound imaging, near-infrared
imaging, magnetic resonance imaging, radiolabel-based
imaging, computed tomography, and X-ray imaging.
Br. 13 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 10, 12, 13, 24, 51, and 53 stand rejected under 35
U.S.C. § 112(a) as failing to comply with the written description
requirement. Ans. 4.
2. Claims 10, 12, 13, 24, 51, and 53 stand rejected under 35
U.S.C. § 112(a) as failing to comply with the enablement requirement.
Ans. 7.
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Application 14/020,794
3. Claims 10, 12, 13, 27-29, 31-34, 46, 48-50, 55, and 57 stand
rejected under 35 U.S.C. § I03(a) (pre-AIA) as unpatentable over
Bangera. 2 Ans. 13.
4. Claims 24, 25, 47, 51-54, and 56 stand rejected under 35
U.S.C. § I03(a) (pre-AIA) as unpatentable over Bangera, Kutryk, 3
and Swirski. 4 Ans. 22.
DISCUSSION
A. Rejections 1 & 2
The gist of the written description and enablement rejections is the
same: that the Specification's disclosure is inadequate "as it relates to which
peptides other than" (Ans. 4) those containing RGD and RAD can be used
with the invention. See id. at 6 (written description), 7 (enablement). 5 As
the Examiner acknowledges, the rejected independent claims do not require
a peptide. E.g., id. at 6. Instead, "when it is set forth that a peptide is
present (see claims 12, 13, 51, and 53, for example), written description is
lacking for peptides other than RGD/RAD and RGD/RAD containing
peptides." Id.; see also id. at 11 (discussing enablement).
2 Bangera et al., US 2010/0068808 Al, published Mar. 18, 2010.
3 Kutryk et al., US 2005/0025752 Al, published Feb. 3, 2005.
4 Swirski et al., Ly-6Chi Monocytes Dominate Hypercholesterolemia-
Associated Monocytosis and Give Rise to Macrophages in Atheromata, 117 J.
CLIN. INVEST. 195 (2007).
5 The Specification explains that conjugating RGD peptides to SWNTs causes
a marked increase in tumor targeting, in comparison to RAD-SWNTs. Spec.
,r 29. "RAD peptides serve as a control for RGD peptides." Id. ,r 47.
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Application 14/020,794
Nanotube/peptide conjugation is not required for the invention to
function. See Spec. ,r 50; Smith Deel. ,r,r 10-12. 6 Therefore, the rejected
claims that do not recite peptides cannot be said to be inadequately described
or enabled based on this non-essential element. Moreover, we agree with
Appellants that the Specification provides adequate support for peptides
other than RGD. See Br. 8. The written description and enablement
requirements are both considered from the perspective of the ordinarily
skilled artisan. From this viewpoint, the Specification's exemplary
teachings regarding RGD-conjugated SWNTs (see Spec. Examples 1 & 2)
are sufficient, as swapping out one peptide for another would have been a
matter of routine experimentation. Indeed, as the Examiner acknowledges
with respect to the§ 103 rejections (Rejections 3 and 4), it was known in the
prior art that "[ v ]arious peptides may be used with the nanostructures for
targeting" (Non-Final Action 12 (discussing Bangera ,r,r 74, 84)7).
Accordingly, we do not sustain Rejections 1 and 2.
B. Re} ections 3 & 4
In Appellants' view, "the 'tubular nanostructures' of Bangera are not
capable of being selectively internalized. This is due to the structure of the
tubular nanostructures described in Bangera, which are targeted to a lipid
bilayer membrane and form a pore in the lipid bilayer membrane." Br. 9.
Accordingly, Appellants argue that Bangera not only fails to teach or
suggest the claimed methods, but indeed teaches away from them;
6 Declaration of Bryan R. Smith, Ph.D., under 37 C.F.R. § 1.132, dated Nov.
10,2016.
7 Non-Final Action dated Jan. 19, 2017.
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Application 14/020,794
furthermore, any attempt to modify Bangera to achieve the claimed
invention would render Bangera inoperable and change Bangera's principle
of operation. Id. at 8; see also id. at 10-11.
These arguments are not persuasive, because they disregard Bangera's
embodiments in which the nanostructures are modified with ligands,
especially CD 14, which allows for selective targeting of
monocytes/macrophages. See Ans. 19--20 ( citing Bangera ,r 83 8).
Appellants argue that "the Office Action conflates the concept of selective
internalization of the nanotubes by monocytes ( which are type of white
blood cell) as recited in the independent claims and the targeting of tumor
cells as purportedly disclosed in Bangera." Br. 10. But where the
monocytes are the tumor cells, Bangera's CDI4-bearing nanostructures are
selectively targeted to CDI4+ monocytes. See Bangera ,r,r 83, 167.
Furthermore, while Appellants focus on Bangera's embodiments in
which the nanostructure is inserted into the lipid bilayer of the cell
membrane (see Br. 9 (discussing Bangera Fig. IC)), Bangera also teaches
embodiments in which the tubular nanostructures are selectively directed
toward organelles within the cell ( such as mitochondria) (see Bangera ,r 151;
see also Ans. 20-21) or in which the nano structures are "actively taken up
by the cell through the process of endocytosis" (id. ,r 155). Thus, even if we
agreed with Appellants that insertion of the nanostructure into the lipid
bilayer of the cell membrane does not amount to "intemaliz[ ation ]" for
8 The Examiner's Answer cites "pages 11-12, bridging paragraph" of
Bangera. Ans. 20. For consistency with citations to Bangera elsewhere in
this Decision, we cite to the corresponding paragraph number of Bangera.
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Application 14/020,794
purposes of claim 10 (see Br. 10),9 the mitochondrial insertion and
endocytosis embodiments of Bangera assuredly do. In sum, we agree with
the Examiner's assessment:
Both Bangera et al and Appellant disclose overlapping
nanostructure which is conjugated to a detectable label that are
used for the same purpose and targets the same population ( e.g.,
CD 14 monocytes) .... [I]f the compositions are the same, they
cannot have mutually exclusive properties. In other words, if
the conjugate composition comprises the same components in
both Appellant's and Bangera et al's invention both inventions
would be capable of being internalized. This logic appears to
be consistent with Bangera et al' s teaching that the
nanostructures are able to cross the cell's membrane to reach the
membrane of targeted internal organelle.
Ans. 21-22.
Having considered Appellants' arguments, we are not persuaded of
any reversible error by the Examiner in rejecting claim 10. Appellants do
not separately argue claims 12, 13, 27-29, 31-34, 46, 48-50, 55, and 57;
these fall with claim 1. See 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv). Accordingly, we
sustain Rejection 3 in its entirety. Appellants' arguments in support of the
claims subject to Rejection 4 are not distinct from those made regarding
Rejection 3 (see Br. 8, 11 ). We thus sustain Rejection 4 in its entirety for the
same reasons.
9 For the reasons discussed by the Examiner at page 16 of the Non-Final
Action and page 21 of the Answer we agree with the Examiner that insertion
of the nanostructure into the lipid bilayer of the cell membrane does amount
to "internaliz[ ation]."
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CONCLUSION
Rejections 1 and 2 are not sustained. Rejections 3 and 4 are
sustained. 10 No time period for taking any subsequent action in connection
with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
10 Because a § 103 rejection stands as to each of the appealed claims, our
disposition of this appeal is an affirmance, not an affirmance-in-part.
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