Ex Parte Borgert et al

Patent Trial and Appeal Board

Jul 18, 2017

13883603 (P.T.A.B. Jul. 18, 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.
13/883,603 05/06/2013 Jorn Borgert 2010P01035WOUS 7903
24737 7590 07/20/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue SMITH, RUTH S
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
07/20/2017 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):
marianne. fox @ philips, com
debbie.henn @philips .com
patti. demichele @ Philips, com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JORN BORGERT, INGO SCHMALE, JURGEN ERWIN
RAHMER, BERNHARD GLEICH, and MICHAEL HARALD KUHN1
Appeal 2016-007351
Application 13/883,603
Technology Center 3700
Before JOHN E. SCHNEIDER, TIMOTHY G. MAJORS,
and DAVID COTTA, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for imaging the colon which have been rejected for failing to satisfy the
written description requirement, as indefinite, as anticipated, and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellant identifies the Real Party in Interest as Koninklijke Philips N.V.
Appeal Br. 4.
Appeal 2016-007351
Application 13/883,603
STATEMENT OF THE CASE
Colon screening typically involves an endoscopic colonoscopy where
a CCD or fiber optic camera on a flexible tube is passed through the anus.
Spec. 2. While this technique provides a visual diagnosis of the examined
area and permit’s biopsy or removal or lesions, the technique also brings
about a risk of bowel perforation. Spec. 2. The Specification describes a
non-invasive technique for imaging the colon using Magnetic Particle
Imaging. Spec. 1.
Claims 1—16 are on appeal. Claims 1 and 7 are the sole independent
claims and read as follow:
1. A method for collecting data by using Magnetic
Particle Imaging comprising the steps of:
(a) pre-delivering magnetic particles to a colon of a
subject;
(b) generating an imaging magnetic field with a spatial
distribution of the magnetic field strength such that an area of
examination in the colon consists of a first sub-area of the colon
with lower magnetic field strength, where the magnetization of
magnetic particles which were pre-delivered to the colon is not
saturated, and a second sub-area of the colon with a higher
magnetic field strength, where the magnetization of said
magnetic particles is saturated;
(c) changing the spatial location of both sub-areas in the
area of examination so that the magnetization of said particles
changes locally; and
(d) acquiring signals that depend on the magnetization in
the area of examination influenced by this change, wherein the
area of examination in the colon comprises a portion or
segment of the colon and wherein steps (b) to (d) are carried out
during an entire peristaltic cycle in said colon portion or
segment, followed by a reassignment of the area of examination
to a different portion or segment of the colon.
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Application 13/883,603
7. A food stuff configured for in vivo screening for
cancerous diseases of the colon, colon inflammation, polyps,
gastrointestinal patency or transit, or mucosa defects of the
colon by Magnetic Particle Imaging comprising a magnetic
particle suitable for Magnetic Particle Imaging, wherein said
magnetic particle is an iron oxide particle which includes a
coating, said iron oxide particle being resistant to
gastrointestinal breakdown, wherein said food stuff is free of
components which enhance the excretion of the magnetic
particle.
The claims stand rejected as follows:
Claim 16 has been rejected under 35 U.S.C. § 112, first paragraph, for
failing to satisfy the written description requirement.2
Claims 1—16 have been rejected under 35 U.S.C. § 112, second
paragraph, as indefinite.
Claim 7 has been rejected under 35 U.S.C. § 102(b) as anticipated by
Boeve.3
Claims 1—6, 8, 9, 12—14, and 16 have been rejected under 35 U.S.C.
§103 (a) as unpatentable over Boeve in view of Horn4, Geiger,5 or Loewke.6
2 In the Final Action mailed Aug. 31, 2015, the Examiner rejected claims 1—
16 under 35 U.S.C. § 112, first paragraph as (b) not being enabled. The
Examiner has withdrawn this rejection. Ans. 5.
3 Boeve, WO 2009/074952 A2, published June 18, 2007 (“Boeve”).
4 Horn, US 2007/0078335 Al, published Apr. 5, 2007 (“Horn”).
5 Geiger et al., US 2008/0175459 Al., published July, 24, 2008 (“Geiger”).
6 Loewke et al., US 2010/0149183 Al, published June 17, 2010 (“Loewke”).
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Claims 10, 11, and 15 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Boeve in view of Horn or Geiger or Loewke in further
view of Johnston7, Doyle,8 or Bikram.9
WRITTEN DESCRIPTION
Issue
The issue is whether the evidence of record supports the Examiner’s
finding that claim 16 fails to meet the written description requirement.
The Examiner finds the Specification fails to contain any example as
to how the peristaltic cycle of a patient can be determined. Final Act. 2.
Appellants contend that the Specification describes how to determine
a peristaltic cycle. Appeal Br. 9. In addition, Appellants contend that:
a peristaltic cycle is a clearly observable biological process and
a person with ordinary skill in the art would readily understand
that the approximate time of a patient’s peristaltic cycle can be
determined, for example, by observing the peristaltic
movements during imaging. Therefore, a person with ordinary
skill in the art would reasonably conclude that Applicants
possessed the features of “determining a time period of the
entire peristaltic cycle before performing steps (b)-(d)” on the
basis of the aforementioned at least implicit descriptions. Thus,
the original specification satisfies the written description
requirement.
Appeal Br. 10.
7 Johnston et al., US 2013/0023714 Al, published Jan. 24, 2013
(“Johnston”).
8 Doyle, US 2010/0297026 Al, published Nov. 25, 2010 (“Doyle”).
9 Bikram, US 2009/0148387 Al, published June 11, 2009 (“Bikram”).
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Principles of Law
“The ‘written description’ requirement. . . serves both to satisfy the
inventor’s obligation to disclose the technologic knowledge upon which the
patent is based, and to demonstrate that the patentee was in possession of the
invention that is claimed. . . . The descriptive text needed to meet these
requirements varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in existence.” Capon
v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).
“(1) [EJxamples are not necessary to support the adequacy of a written
description [;] (2) the written description standard may be met. . . even
when actual reduction to practice of an invention is absent; and (3) there is
no per se rule that an adequate written description of an invention that
involves a biological macromolecule must contain a recitation of known
structure.” Falknerv. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006).
Analysis
Appellants have the better position. The Specification describes the
invention, particularly the concept of a peristaltic cycle, in a manner that one
skilled in the art would understand that Applicants were in possession of the
invention as claimed. Spec. 17.
The Examiner’s reliance on the lack of examples is unwarranted.
Based on the record here, there is no requirement that the Specification must
contain examples to satisfy the written description requirement.
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Conclusion
We conclude that the evidence of record does not support the
Examiner’s finding that claim 16 fails to comply with the written description
requirement.
INDEFINITENESS
Issue
The issue with respect to this rejection is whether the evidence of
record supports the Examiner’s conclusion that claims 1—16 are indefinite.
The Examiner finds that claims 1—6 and 8—16 are indefinite in that the
term peristatic cycle is not defined. Final Act. 3. The Examiner also finds
that claim 6 is indefinite in that the term examining the colon does not
appear to be different from imaging the colon. Id. With respect to claim 7,
the Examiner finds that the term “free of components which enhance the
excretion of the magnetic particle” is indefinite in that the Specification
gives no examples of such components. Ans. 6.
Appellants contend the claims are not indefinite in that one skilled in
the art would understand how to determine the length of a patient’s
peristaltic cycle. Appeal Br. 15. With respect to Claim 6, Appellants argue
that the term examining is well understood in the art and encompasses more
than merely imaging the colon but includes such activities as reviewing such
images. Appeal Br. 16. Turning to claim 7, Appellants argue that one
skilled in the art would understand what food stuffs would enhance excretion
of the particles. Reply Br. 10.
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Principles of Law
“[I]t is well-established that the determination whether a claim is
invalid as indefinite ‘depends on whether those skilled in the art would
understand the scope of the claim when the claim is read in light of the
specification.’” Atmel Corp. v. Information Storage Devices Inc., 198 F.3d
1374, 1378 (Fed. Cir. 1999) (quoting North Am. Vaccine, Inc. v. American
Cyanamid Co., 7 F.3d 1571, 1579 (Fed. Cir. 1993)).
Analysis
Again, Appellants have the better position. The Specification clearly
defines what is meant by the peristaltic cycle. Spec. 17. In addition, the
Specification gives examples as to how the peristaltic cycle can be varied.
Spec. 18. We agree with Appellants that one skilled in the art, reading the
Specification, would understand the term peristaltic cycle and know how to
measure it and control it. Appeal Br. 14, Reply Br. 7.
The Examiner points to the lack of examples to support the
conclusion of indefmiteness. Ans. 6. We are unpersuaded. The presence or
absence of examples is not determinative of definiteness. The issue is
whether one skilled in the art would be able to understand and determine the
scope of the claims. For the reasons stated above, we agree with Appellants
that it does. Appeal Br. 14, Reply Br. 7.
Turning to claim 6, we agree with Appellants that one skilled in the
art would understand the term “examining” to include both imaging a
section of the colon and then reviewing the images. Reply Br. 8. This
interpretation is reasonable when read in light of the Specification. See,
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Spec. 8 (screening refers to analytical or visual examination of the colon),
Spec. 24 (screening, i.e., examination).
With respect to claim 7, we agree with Appellants that one skilled in
the art would understand what is meant by the term “free of components
which enhance the excretion of the magnetic particle.” Reply Br. 10.
Foodstuffs which enhance or promote bowel movements are well known in
the art and the Specification specifically teaches against using them. Spec.
23. The Examiner has not pointed to any evidence to support a conclusion
otherwise.
Conclusion of Law
We conclude that the evidence of record does not support the
Examiner’s conclusion that claims 1—16 are indefinite.
ANTICIPATION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s finding that claim 7 is anticipated by
Boeve.
The Examiner finds that Boeve discloses a magnetic particle which is
coated to be gastroresistant and comprises iron oxide. Final Act. 3. The
Examiner finds that since Boeve is silent as to components which enhance
excretion of the particles, such components must be absent. Final Act. 4.
Appellants argue that while Boeve discloses administering the
magnetic particles in food or drink, Boeve does not teach that the food must
be free of components which enhance the excretion of the particles. Appeal
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Br. 18—19. Appellants contend that the food of Boeve may or may not
contain components which enhance excretion of the particles. Appeal Br.
19.
Appellants also contend that Boeve does not teach the limitation
“configured ‘for in vivo screening for cancerous diseases of the colon.’” Id.
Principles of Law
“A reference may anticipate inherently if a claim limitation that is not
expressly disclosed ‘is necessarily present, or inherent, in the single
anticipating reference.’ The inherent result must inevitably result from the
disclosed steps; ‘[ijnherency . . . may not be established by probabilities or
possibilities.’” In re Montgomery, 677 F.3d 1375, 1379—80 (Fed. Cir. 2012)
(citations omitted, alterations in original).
“[T]he examiner must provide some evidence or scientific reasoning
to establish the reasonableness of the examiner’s belief that the functional
limitation is an inherent characteristic of the prior art” before the burden is
shifted to Applicants to disprove the inherency. Ex parte Skinner, 2
USPQ2d 1788, 1789 (BPAI 1986).
Analysis
Appellants have the better position. While Boeve teaches that the
magnetic particles can be administered with food, Boeve is silent as to the
composition of the food. Boeve 9,11. 8—14. As Appellants point out, it was
well known in the art that certain foodstuffs can enhance excretion. Reply
Br. 10. Thus the food referenced in Boeve may or may not contain
components which enhance excretion. Appeal Br. 19.
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The Examiner contends that since Boeve is silent as to the presence of
excretion-enhancing components, such components must be absent. Ans. 6.
We are unpersuaded. It is the Examiner’s burden to provide evidence or
sufficient reasoning that supports the proposition that excretion enhancing
components are necessarily absent. Ex parte Skinner, 2 USPQ2d at 1789.
Here that Examiner has not pointed to any sufficient evidence or scientific
reasoning to support the proposition that excretion enhancing components
are necessarily absent in the foods used in Boeve.
Conclusion
We conclude that a preponderance of the evidence does not support
the Examiner’s finding that claim 7 is anticipated by Boeve.
OBVIOUSNESS
Issue
Both rejections under 35 U.S.C. § 103(a) rely on the same primary
reference, Boeve, and the arguments presented by Appellants and the
Examiner are the same. Therefore, we treat the rejections together.
The issue with respect to these rejections is whether a preponderance
of the evidence supports the Examiner’s conclusion that the rejected claims
would have been obvious over Boeve combined with Horn, Geiger, or
Loewke; or Boeve combined with Horn, Geiger, or Loewke in further view
of Johnson, Doyle, or Bikram.
The Examiner finds that Boeve teaches:
a method for collecting data by using Magnetic Particle
Imaging comprising the steps of: (a) delivering magnetic
particles to a colon of a patient; (b) generating an imaging
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magnetic field with a spatial distribution of the magnetic field
strength such that an area of examination in the colon consists
of a first sub-area of the colon with lower magnetic field
strength, where the magnetization of a magnetic particle which
were pre-delivered to the colon is not saturated, and a second
sub-area of the colon with a higher magnetic field strength,
where the magnetization of said magnetic particle is saturated;
(c) changing the spatial location of both sub-areas in the area of
examination so that the magnetization of said particles changes
locally; and (d) acquiring signals that depend on the
magnetization in the area of examination influenced by this
change, wherein the area of examination in the colon comprises
a portion or segment of the colon.
Final Act. 4—5.
The Examiner acknowledges that Boeve is silent as to the duration of
the examination, but finds that determination of the optimum duration would
have been an obvious design choice. Final Act. 5.
Appellants contend that Boeve is silent as to performing the
examination during an entire peristaltic cycle or during any other biological
process. Appeal Br. 23. Appellants argue that Boeve is directed to an
entirely different process and would not lead one skilled in the art to
optimize the process for examination of the colon. Reply Br. 14.
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Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
“Even when obviousness is based on a single prior art reference, there
must be a showing of a suggestion or motivation to modify the teachings of
that reference.” In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313,
1316-17 (Fed. Cir. 2000) (citation omitted).
Analysis
Once again we find that Appellants have the better position. As the
Examiner acknowledges, Boeve is completely silent as to conducting the
claimed steps of (a)-(d) of the examination during an entire peristaltic cycle
of a patient. Final Act. 5. In addition, while Boeve discusses applying the
described method to the intestinal tract, Boeve does not tie the imaging
process to any biological function. Appeal Br. 23.
The Examiner argues that conducting the claimed steps during an
entire peristaltic cycle would have been obvious as matter of design choice.
Final Act. 5. We are unpersuaded. The burden is on the Examiner to
articulate a motivation to modify the method of Boeve to arrive at the
claimed method. Here the Examiner has not given a reason why one skilled
in the art would modify Boeve as suggested by the Examiner. This is
especially true as the method of Boeve is not directed to colon screening or
conducting an examination during any particular biological process, but to
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imaging an unspecified body region and to using the magnetic particles to
heat a region in the body. Boeve 1.
Conclusion of Law
We conclude that a preponderance of the evidence does not support
the Examiner’s conclusion that claims 1—6 and 8—16 would have been
obvious over Boeve combined with (i) Horn, Geiger, or Loewke, or (ii)
Boeve combined with Horn, Geiger, or Loewke, in further view of Johnson,
Doyle, or Bikram.
SUMMARY
We reverse the rejection under 35U.S.C. § 112, first paragraph.
We reverse the rejections under 35U.S.C. § 112, second paragraph.
We reverse the rejection under 35 U.S.C. § 102(b).
We reverse the rejections under 35 U.S.C. § 103(a).
REVERSED
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