Ex Parte Tien

Patent Trial and Appeal Board

Jun 26, 2017

12888245 (P.T.A.B. Jun. 26, 2017)

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.
12/888,245 09/22/2010 Robert Tien 3054CIP-2 4070
29141 7590 06/28/2017
Brundidge & Stanger, P.C./SLG
1925 BAT .TENDER AVENUE, STE. 560
Alexandria, VA 22314
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
06/28/2017 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):
mail@brundidge-stanger.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT TIEN1
Appeal 2016-007640
Application 12/888,245
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellant states the real party-in-interest is the named inventor, Robert
Tien. App. Br. 3.
Appeal 2016-007640
Application 12/888,245
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 5, 7, and 8. Specifically, claims 1,
5, and 7 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being
obvious over the combination of E.C. Unger et al., Gene Delivery using
Ultrasound Contrast Agents, 18(4) Echocardiography, 355—61 (2001)
(“Unger”), Urquhart et al. (US 2005/0049486 Al, March 3, 2005)
(“Urquhart”), Liang et al. (US. 2003/0208116 Al, November 6, 2003)
(“Liang”), Cath Lab Digest, GE Medical Systems Receives FDA Clearance
for Software that Fuses 3D X-ray and MR images of the Brain, Clinical
and Industry News, March 30, 2015, http://www.cathlabdigest.com/
articles/Clinical-and-lndustry-News-26 (“Cath Lab”), GE Medical Systems:
GE Medical Systems Introduces Revolutionary X-ray Technology: GE
Advantx LCA + System Helps Treat Blood Vessel Diseases Linked to Heart
Attacks and Strokes, Press Release, (“GE Press Release), Wood et al., US
2007/0167806 Al, July 19, 2007) (“Wood”), Nolte et al. (US 2002/0120192
Al, August 29, 2002) (“Nolte”), Takayama (US 5,123,404, June 23, 1992)
(“Takayama”), and Zhu (US 6,264,610 Bl, July 24, 2001) (“Zhu”).2
2 The Examiner also rejected claims 1 5, 7, and 8 as unpatentable under 35
U.S.C. § 112, second paragraph, as being indefinite for failing to particularly
point out and distinctly claim the subject matter. Final Act. 2. The
Examiner has withdrawn the rejection of independent claim 1 and dependent
claims 5 and 8 on this ground. Ans. 2. However, the Examiner maintains
the rejection of dependent claim 7 because the claim was dependent on
canceled claim 6 and has not been amended by Appellant to be dependent on
independent claim 1 and because the claim term “the liquid” of claim 7 lacks
proper antecedent basis. See Ans. 2; Final Act. 3. Because Appellant does
not address these issues, we summarily affirm the rejection of claim 7 upon
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Application 12/888,245
Claim 8 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Unger, Urquhart, Liang, Cath Lab,
GE Press Release, Wood, Takayama, Zhu, and Unger et al. (US
2001/0031740 Al, October 18, 2001) (“Unger 2”)
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellant’s invention is directed to a method and system for leading
macromolecule substances into target cells, which includes an image picking
unit, an image merging unit, an injection unit, and an energy conversion
module. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A system for leading macromolecule substances into
target cells, comprising:
an imaging device configured to pick up three-
dimensional (3D) structure images of tissue that includes the
target cells, wherein the imaging device is any of a computed
tomography (CT) device and a magnetic resonance imaging
(MRI) device;
a blood vessel photographic device configured to pick up
3D blood vessel photographic images of the tissue, wherein the
blood vessel photographic device injects a developer into at least
one blood vessel surrounding the tissue and simultaneously
captures consecutive snapshots of the at least one blood vessel to
this ground. See 37 C.F.R. § 41.37(c)(iv) (Claims not argued are considered
waived).
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Application 12/888,245
provide the 3D blood vessel photographic images of the tissue,
wherein the 3D structure images are merged into the 3D blood
vessel photographic images, wherein the merged images are used
to choose a blood vessel passage that fully covers the target cells;
an injection unit configured to inject artificial blood along
the chosen blood vessel and to inject the macromolecule
substances into the tissue;
an ultrasonic wave conversion module configured to exert
energy on the artificial blood thereby activating tiny bubbles to
perform biological effects which form non-permanent holes in
cell membranes of the target cells for leading the macromolecule
substances into the target cells, wherein the ultrasonic wave
conversion module comprises a base portion, an ultrasound
dispersion unit, and an imaging guided robotic arm, wherein the
ultrasound dispersion unit comprises a circular disk with eight
symmetrically positioned low energy transducers located on a
peripheral of the circular disk and a B-Mode diagnostic
transducer located in a center of the circular disk, wherein the B-
Mode diagnostic transducer has a diameter between 3 to 5
centimeters (cm) and a maximal depth of penetration between 20
to 30 cm.
App. Br. 14.
ISSUES AND ANALYSIS
We herein agree with, and adopt, the Examiner’s findings and
conclusion that the appealed claims are obvious over the cited prior art
references. We address the arguments raised by Appellant on appeal below.
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Application 12/888,245
Issue 1
Appellant argues the Examiner erred in finding that Unger teaches the
limitation of claim 1 reciting “inject[ing] artificial blood along the chosen
blood vessel.” App. Br. 8.
Analysis
The Examiner finds, in relevant part, that Figure 5 of Unger teaches a
liquid perfluorocarbon gene carrier, which the Examiner, using the broadest
reasonable interpretation of the claim term, interprets as corresponding to the
claimed “artificial blood.” Final Act. 4. The Examiner reasons the liquid
perfluorocarbon gene carrier may be broadly and reasonably interpreted as
artificial blood because (1) it performs a therapeutic/immune function (i.e., a
function that human blood performs); and (2) because Appellant’s
Specification expressly discloses that: “An example of artificial blood is
perfluorocarbon (PFC) nanoemulsions.” Id. (citing Spec. 1 53).
Appellant argues that the “liquid perfluorocarbon gene carrier” taught
by Unger is not equivalent to the “perfluorocarbon nanoemulsions” recited
by Appellant’s Specification as an example of artificial blood. App. Br. 8.
According to Appellant, although both devices comprise perfluorocarbon, a
nanoemulsion is defined as “oil-in-water (o/w) emulsions with mean droplet
diameters ranging from 50 to 1000 nm.” Id. (citing AZO Nano website,
http://www.azonano.com/article.aspx?Articlel0= 1244). By comparison,
Appellant argues, a gene carrier is not limited in size and also does not
include an emulsion layer, such as a nanoemulsion. Id.
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The Examiner responds that, even assuming, arguendo, that a liquid
perfluorocarbon gene carrier is not equivalent to a perfluorocarbon
nanoemulsion, the claim recites only “inject[ing] artificial blood,” and does
not require injecting a perfluorocarbon nanoemulsion. Ans. 3. The
Examiner again points to Appellant’s Specification’s disclosure that: “What
is meant by artificial blood is that it fulfills some functions of biological
blood, especially in humans.” Id. (citing Spec. 1 53). The Examiner finds
Unger's liquid perfluorocarbon gene carrier reads on the claimed limitation
of injecting artificial blood, in its broadest reasonable interpretation, because
it performs a therapeutic or immune function (i.e., a function that human
blood performs), as defined in Appellant’s Specification.
We agree with the Examiner. Appellant’s Specification provides no
explicit definition of the claim term “artificial blood,” other than its
disclosure that: “What is meant by artificial blood is that it fulfills some
functions of biological blood, especially in humans.” Spec. 1 53. The
Specification provides an exemplary definition of such blood as: “An
example of artificial blood is perfluorocarbon (PFC) nanoemulsion. The
artificial blood has a pretty small volume about 150 nanometer, so that
capillary vessel would not be jammed, and the artificial blood would not
enter into the apertures between the blood vessels.” Id.
Appellant’s Specification thus provides a single example of artificial
blood, but one that does not further limit the Specification’s disclosure that
artificial blood must “fulfill[ ] some functions of biological blood, especially
in humans.” Unger teaches a:
Liquid perfluorocarbon gene carrier. The outer surface is
stabilized by amphipathic lipid. Targeting ligands have been
incorporated onto the head groups of the lipids. The genetic
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Application 12/888,245
material is stabilized by cationic lipids. Electron microscopy
studies have shown that the DNA is condensed as an electron-
dense granule within the center of the nanoparticle. The diameter
of these particles is about 100-200 nanometers.
Unger Fig. 5 (caption); see also Fig 3 (depicting “The effects of cavitation
on microvascular permeability. Nanospheres and drugs can be delivered into
the interstitium as the microbubbles cavitate. This process can be used to
improve local drug delivery”).
We agree with the Examiner’s finding that Unger thus teaches
“artificial blood,” as defined by Appellant’s Specification. Unger teaches
artificially-constructed gene delivery vehicles that can be delivered via the
microvasculature of the cardiovascular system to deliver drugs at target sites.
We find that this corresponds, broadly and reasonably, with “fulfill[ing]
some functions of biological blood,” as required by Appellant’s
Specification, viz., the delivery of compounds and messengers via the
circulatory system. We are therefore not persuaded by Appellant’s
arguments upon this issue.
Issue 2
Appellant argues the Examiner erred in finding the combined cited
prior art references teach or suggest the limitation of claim 1 reciting:
“wherein the ultrasound dispersion unit comprises a circular disk with eight
symmetrically positioned low energy transducers located on a peripheral of
the circular disk.” App. Br. 9.
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Analysis
The Examiner finds, inter alia, the arrangement/size of transducer
arrays used to facilitate gene transfection/ultrasound imaging is an obvious
design choice in the absence of showing any criticality of unexpected result.
Final Act. 9 (citing e.g., Wood ]Hf 20-21).
The Examiner also finds Takayama teaches therapeutic ultrasound
transducers in which the transducer array includes at least eight
symmetrically positioned transducers. Final Act. 10 (citing Takayama Fig.
7). The Examiner also finds Zhu teaches a multi-measurement probe having
a transducer array located in the center wherein transducer elements appear
to have about a 3 cm diameter. Id. (citing Zhu Fig. 3).
Appellant disagrees with the Examiner’s finding that Takayama
teaches that “the ultrasound dispersion unit comprises a circular disk with
eight symmetrically positioned low energy transducers located on a
peripheral of the circular disk” at Fig. 7. Ans. 9. Appellant argues that,
although Takayama teaches a plurality of transducers that are fitted within
holes of the supporting member 10, the piezoelectric elements (i.e.,
transducers) are arranged across the entire supporting member, and not just
on the peripheral of the circular disk as required by the claim 1. Id. (citing
Takayama Fig. 7). Furthermore, argues Appellant, there is no teaching of
the piezoelectric elements being low energy, or a specific number (eight) of
such elements being utilized; indeed, Appellant notes Figure 7 of Takayama
appears to depict more than eight transducers. Id.
The Examiner responds that the arrangement/size of transducer arrays
used to facilitate gene transfection/ultrasound imaging may be considered to
be an obvious design choice, in the absence of Appellant’s showing any
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criticality of unexpected result. Ans. 5. The Examiner points especially to
Wood, which teaches that the same end result of the claimed invention (i.e.,
gene transfection or sonoporation) can be achieved by other transducer
arrays. Id. The Examiner further finds, by way of example, that Nolte
teaches a conventional relationship between transducer diameter, operating
frequency and target depth. Id. (citing Nolte Tflf 21—22).
Nevertheless, the Examiner further finds, Takayama teaches, with
respect to therapeutic ultrasound transducers, a transducer array includes at
least eight symmetrically-positioned transducers. Ans. 5 (citing Takayama
Fig. 7, col. 5,11. 6-26).
The Examiner also finds that Zhu depicts a multi-measurement probe
having a transducer array located in the center, in which the transducer
elements have approximately a 3 cm diameter. Ans. 6 (citing Zhu Fig. 3).
The Examiner finds that Zhu teaches that the operating frequency for
transducer array 12 is 6 MHz which is considered to result in a 20-30 cm
maximal depth of penetration, as disclosed by Appellant’s Specification. Id.
(citing Zhu col. 4, LL. 1—20; Spec. 142).
The Examiner therefore concludes that a person of ordinary skill in
the art would have been motivated to have modified the transducer
arrangement described by Wood with any well-established/conventional,
predictable transducer arrangement (i.e., size/position) and configuration
settings (i.e., frequency) in order to selectively image and treat target areas
within the body. Ans. 6.
We are not persuaded by Appellant’s arguments. Figure 7 of
Takayama is reproduced below:
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Application 12/888,245
Figure 7 of Takavama depicts a top plan view of a plate for
supporting ultrasonic transducers used in one embodiment of
the disclosed invention
Figure 7 depicts holes Ci-Cn for supporting ultrasound transducers
arrayed concentrically on the circular disk, “with eight symmetrically
positioned low energy transducers located on a peripheral of the circular
disk,” as required by claim 1. It is true, as Appellant asserts, that Takayama
also discloses additional transducers, both apparently arranged on the
periphery and in the inner concentric rings, but the language of claim 1 does
not preclude additional transducers located in the periphery, or in inner
concentric rings. Moreover, we also agree with the Examiner that the
precise number and location of ultrasound transducers would be a design
choice well within the competence of a person of ordinary skill in this art.
With respect to Appellant’s argument that Takayama fails to teach or
suggest that the piezoelectric elements as being low energy, the Examiner
relies upon Zhu as teaching that the operating frequency for transducer array
12 is 6 MHz which is considered to result in a 20—30 cm maximal depth of
penetration, as disclosed by Appellant’s Specification. Id. (citing Zhu col. 4,
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11. 1—20; Spec. 142). We consequently agree with the Examiner upon this
issue.
Issue 3
Appellant argues the Examiner erred by failing to support the
combination of the nine cited references by providing some teaching,
suggestion or motivation, in the prior art that would have led one of ordinary
skill to modify the prior art references or to the combine prior art reference
teachings to arrive at Appellant’s claimed invention. App. Br. 9—10.
Analysis
Appellant argues that, instead of identifying a teaching, suggestion or
motivation to combine the references, the Examiner has identified only a
“shared advantage” (i.e., an advantage that the recited claimed invention
shares with the invention “as combined” from the nine prior art references.
App. Br. 10.
By way of Example, Appellant points to the Examiner’s finding that,
when combining Unger, Urquhart, Liang, Cath Lab, and GE Press Release,
the Examiner finds that the shared advantage of how the combination of
references would “efficiently plan and target cells in need of therapy.” Id.
(citing Final Act. 8). Therefore, argues Appellant, the Examiner has failed
to provide any evidence that the “shared advantage” actually might have
motivated one skilled in the art to combine the nine prior art references to
arrive at the recited claimed invention. Id.
Appellant argues further that the Examiner’s “shared advantage” test
cannot qualify as a “reason to make the combination” under KSR Int 7 Co. v.
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Teleflex Inc., 550 U.S. 398 (2007), because any combination that would
arrive at an invention would always and necessarily share the same
advantages as the Appellant’s claimed invention. Id. According to
Appellant, if all combinations that reach the recited claimed invention
always and necessarily share advantages with the recited claimed invention
(because the combination is the recited claimed invention), then whenever
an invention is a combination of prior art elements, all such inventions must
be deemed unpatentable, which is an incorrect application of the
obviousness test promulgated under KSR. Id. at 10-11.
Appellant argues further that, under KSR, a rejection on obviousness
grounds must be explicit in that it “cannot be sustained by mere conclusory
statements; instead, there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.” App.
Br. 11 (quoting KSR, 550 U.S. at 418 (citing In re Kahn, 441 F. 3d 977, 988
(Fed. Cir. 2006)). Appellant contends that, whereas the Examiner’s shared
advantage test may loosely quality as “articulated reasoning,” it does not
have the requisite rational underpinning since it cannot differentiate between
obvious and nonobvious combinations. Id.
Appellant accordingly asserts that it is irrational to employ an
obviousness analysis that cannot possibly succeed in distinguishing obvious
from nonobvious combinations because it is not only legally insufficient to
support obviousness rejections by simply identifying a benefit or advantage
that the suggested combination would share with the claimed invention, but
it is also logically flawed because it fails to meet KSR’s “rational
underpinning” requirement. App. Br. 11.
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The Examiner responds that the number of references in a rejection
does not, without more, weigh against the obviousness of the claimed
invention. Ans. 8 (citing In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991)).
As for the motivation to combine well-established, conventional pre­
operative imaging and planning steps to Unger’s targeted gene delivery, the
Examiner concludes that:
[A]t the time of the invention, it would have been obvious
to a person of ordinary skill in the art to have modified the system
and method for delivering (e.g., leading) macromolecule
substances into target cells in vivo as described by Unger with
well-known surgical planning steps of acquiring and merging
diagnostic imaging data from multiple modalities or techniques
(e.g. CT/MRI and X-Ray), as described by Urquhart, Fiang,
[Cath Fab], and [t]he GE Press Release in order to efficiently
plan and target cells in need of therapy.
Ans. 7 (quoting Final Act. 8).
The Examiner points out that the limitation reciting “to choose a
blood vessel passage that fully covers the target cells” is not tied to a
particular component of the system (i.e., a processor or algorithm) and is
therefore considered to be a mental step taken by the surgeon to plan the
catheterization procedure. App. Br. 7. Therefore, Examiner finds that the
“appropriate” procedure planned by the surgeon using the imaging data as
described above would include a step of choosing the blood vessel passage
that fully covers the target cells, in its broadest reasonable interpretation. Id.
The Examiner finds the motivation for enhancing the pre-operative planning
and targeting (i.e., “efficiently planning”) cells in need of therapy with
known, predictable techniques relates to examples (C) and (D), as set forth
in MPEP § 2143. Id.
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We are not persuaded by Appellant’s arguments. The Examiner finds
that Unger teaches most of the limitations of claim 1, as well as the
limitations that are most critical to Appellant’s claimed invention, viz.:
[I]nject[ing] a developer into at least one blood vessel
surrounding the tissue and simultaneously captur[ing]
consecutive snapshots of the at least one blood vessel to provide
the 3D blood vessel photographic images of the tissue [and]
an ultrasonic wave conversion module configured to exert energy
on the artificial blood thereby activating tiny bubbles to perform
biological effects which form non-permanent holes in cell
membranes of the target cells for leading the macromolecule
substances into the target cells.
See Final Act. 4—5 (citing Unger 355—360). As the Examiner states, the
remainder of the references are cited to support the imaging and delivery of
the sonoporation-inducing ultrasound, all of which are suggested by Unger
and which are all well known in the art. See Final Act. 8, Ans. 7.
Specifically, the Examiner concludes with respect to these latter
references:
[I]t would have been obvious to a person of ordinary skill in the
art to have modified the system and method for delivering ([i.e.,]
leading) macromolecule substances into target cells in vivo as
described by Unger with well-known surgical planning steps of
acquiring and merging diagnostic imaging data from multiple
modalities or techniques (e.g. [,] CT/MRI and X-Ray) as
described by Urquhart, Liang, [Cath Lab], and [t]he GE Press
Release in order to efficiently plan and target cells in need of
therapy.
Final Act. 8. Similarly, with respect to the Wood, Takayama, Nolte, and
Zhu references, the Examiner concludes: “[0]ne skilled in the art would
have been motivated to use any known or conventional transducer
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arrangement (e.g. [,] size/position) and configuration settings (e.g. [,]
frequency) in order to selectively image and treat target areas within the
body.” Final Act. 11.
In summary, we agree with the Examiner that Unger teaches or
suggests the principal inventive limitations of Appellant’s invention and that
the rest of the references, relating to the limitations concerned with imaging,
injection and delivery of ultrasound energy, are cited to include processes
that are well known in the art. Moreover, we find that the Examiner has
articulated a rational and reasonable underpinning to a motivation to
combine the references, i.e., to clinically implement the teachings of Unger
in such a fashion so as “to efficiently plan and target cells in need of
therapy” and “to selectively image and treat target areas within the body.”
Final Act. 8, 11. We therefore affirm the Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 1, 5, 7, and 8 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
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)(l)(iv).
AFFIRMED
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