Ex Parte Morris et al

Patent Trial and Appeal Board

Sep 27, 2012

10879797 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL D. MORRIS, STEVEN A. GOLDSTEIN,
BARBARA R. McCREADIE, and TSO-CHING CHEN
__________

Appeal 2011-010144
Application 10/879,797
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for assessing bone tissue. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses a method and an apparatus “for
diagnosing or helping to diagnose a bone tissue condition of a patient. For
example, a susceptibility to fracture of the bone tissue may be estimated.”
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(Spec. 2, ¶ 6.) In the disclosed method, “spectral content information for
light scattered, reflected, or transmitted by the bone tissue is determined.
The spectral content information is used, at least in part, to determine
whether the patient has a bone tissue condition.” (Id.)
Claims 1, 3, 4, 6, 16-26, 28, and 34-62 are on appeal. Claims 1 and
48 are representative and read as follows:
1. A method for determining whether a patient has a condition related
to bone tissue of the patient, the method comprising:
irradiating a portion of bone tissue of the patient through skin of the
patient using a substantially monochromatic light source;
receiving light scattered from the portion of the bone tissue;
determining Raman spectral content information associated with the
received light; and
determining, based at least on the Raman spectral content information,
whether the patient has a bone tissue condition.

48. A method for determining bone tissue susceptibility to fracture,
the method comprising:
irradiating a portion of bone tissue of a patient using a light source;
receiving light scattered from the portion of the bone tissue;
determining Raman spectra information from the received scattered
light;
determining a level of bone fracture risk of the patient based at least in
part on the Raman spectra information, wherein the level of bone fracture
risk is from a plurality of risk levels including a plurality of above-normal
risk levels.

The claims stand rejected as follows:
• Claims 1, 3, 4, 6, 16-18, 20-26, 28, 38-40, and 42-49 under 35
U.S.C. § 102(b) in view of Marchitto;1

1 Marchitto et al., Patent Application Publication, US 2002/0002336 A1, Jan.
3, 2002.
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• Claims 19 and 41 under 35 U.S.C. § 103(a) in view of Marchitto
and Motz;2
• Claims 34-37 under 35 U.S.C. § 103(a) in view of Marchitto and
Abbink;3
• Claims 1, 3, 4, 6, 16-18, 20-26, 28, 38-40, 42-49, and 50-62 under
35 U.S.C. § 103(a) in view of Marchitto and Timlin;4
• Claims 19 and 41 under 35 U.S.C. § 103(a) in view of Marchitto,
Timlin and Motz; and
• Claims 34-37 under 35 U.S.C. § 103(a) in view of Marchitto,
Timlin and Abbink.
I.
Issue
The Examiner has rejected claims 1, 3, 4, 6, 16-18, 20-26, 28, 38-40
and 42-49 as anticipated by Marchitto. The Examiner finds that Marchitto
discloses “a method for evaluating a connective tissue condition of a patient”
(Answer 4), including a bone tissue condition (id. at 5). The Examiner finds
that Marchitto’s method comprises irradiating a portion of connective tissue,
receiving light from the tissue, and “determining spectral content
information associated with the received light” (id. at 4). The Examiner
finds that Marchitto also discloses “processing the spectral content
information to separate Raman … spectral information associated with

2 Motz et al., Patent Application Publication, US 2003/0191398, Oct. 9,
2003.
3 Abbink et al., US 6,574,490 B2, June 2, 2003.
4 Jerilyn A. Timlin et al., Chemical Microstructure of Cortical Bone Probed
by Raman Transects, 53 APPLIED SPECTROSCOPY (NO. 11) 1429-1435 (1999).
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connective tissue of interest from spectral content information associated
with other tissues …; and generating an indicator of the connective tissue
condition” (id. at 5). With regard to claim 48, the Examiner finds that
Marchitto discloses determining fracture susceptibility “by detecting . . .
osteoporosis and other related bone diseases, or by acquiring bone mineral
density data … [since] the susceptibility to fracture depends on the content
of the bone structure” (id.).
With regard to claim 1, Appellants contend that Marchitto does not
disclose an apparatus, or a method, “that is capable of determining whether a
patient has a bone tissue condition based on Raman measurements made
through skin of the patient. Accordingly, Marchitto does not enable one of
ordinary skill in the art to carry out the claimed invention, and as such does
not anticipate.” (Appeal Br. 10.)
With regard to claim 48, Appellants contend that the Examiner has not
shown that Marchitto discloses or suggests determining “bone fracture risk
based at least in part on Raman spectra information from scattered light
received from … bone tissue …, wherein the level of bone fracture risk is
from a plurality of risk levels including a plurality of above-normal risk
levels” (Appeal Br. 6-7).
The issues presented are: Does the evidence of record support the
Examiner’s findings that Marchitto discloses and enables the inventions of
independent claims 1 and 48?
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Findings of Fact
1. Marchitto discloses that “the bone mineral density (BMD)
measurement is the only way to make a definitive diagnosis of osteoporosis”
(Marchitto 1, ¶ 7).
2. Marchitto discloses that “[b]one densitometry can detect
osteoporosis before a fracture occurs, predict the patient’s chances of
fracturing in the future and determine the rate of bone loss, and/or monitor
the effects of treatment” (id. at 1, ¶ 8).
3. Marchitto discloses that “biochemical changes in bone, as a
consequence of disease processes such as osteomalacia and osteoporosis,
can be non-invasively assessed using an optical fiber based Raman
spectrometer” (id. at 3, ¶ 21).
4. Marchitto discloses “a method for detecting a bone disease in a test
subject, comprising the steps of transmitting radiant energy to surface of
skin overlaying a bone …; [and] detecting radiant energy reflected from the
skin surface to obtain Raman spectra, … which reflects biochemical
compositions of the bone” (id. at 3, ¶ 22).
5. Marchitto discloses that the method also comprises “comparing the
biochemical compositions of the test bone with those of a normal bone” to
identify diseased bone (id.).
6. Marchitto discloses “a device for detecting a bone disease,
comprising a source for producing radiant energy; an applicator for
transmitting radiant energy; a means for detecting reflected radiant energy;
and a Raman spectrometer” (id. at 3, ¶ 23).
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7. Marchitto discloses that the source of radiant energy can be a laser
(id. at 4, ¶ 35).
8. Marchitto discloses that the “most efficient collection geometry [of
the probe] is to use a beam-splitter geometry where the reflected radiant
energy is captured by the same optical system as is used to apply the
incident energy” (id. at 4, ¶ 33).
9. Marchitto discloses that “a (typical) 1xn fiber applicator (i.e. a
single, central fiber carrying the incident beam and an annular array of n-
fibers arranged around the one) is not the most efficient” design for the
probe (id.).
10. Appellants have provided a declaration under 37 C.F.R. § 1.132
of Michael D. Morris (filed Nov. 2, 2009, Supplemental Appeal Br.,
Evidence Appendix).
11. Dr. Morris declares that Marchitto teaches that the “Raman probe
that must be used is a ‘beam-splitter geometry where the reflected radiant
energy is captured by the same optical system as is used to apply the
incident energy.’ Marchitto describes this type of probe as having ‘coaxial
source and collection optics.’” (Morris Declaration, ¶ 10.)
12. Dr. Morris declares that “Marchitto describes a ‘1xn fiber
applicator (i.e., a single, central fiber carrying the incident beam and an
annular array of n-fibers arranged around the one)’ type of probe, and I
understand that Marchitto teaches that this type of probe cannot be used” (id.
at ¶ 11.)
13. Dr. Morris declares that “Marchitto’s teaching regarding the type
of probe to use for Raman analysis of bone tissue is wrong and Marchitto's
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probe cannot enable determining whether someone has a bone tissue
condition via Raman measurements made through the skin” (id. at ¶ 12).
14. Dr. Morris declares that, “[a]ccording to [his] research, a probe
with coaxial collection and illumination cannot be utilized when measuring
through skin because not enough photons from the bone tissue and too many
photo[n]s from overlying tissue would be collected to make a useful
measurement” (id. at ¶ 17).
15. Dr. Morris declares that “in order to collect a sufficient amount of
the photons scattered by the bone tissue and to reject a sufficient amount of
photons scattered by skin … to thus make a useful measurement of the bone
tissue, collection fibers that are spaced apart from the illumination fiber must
be utilized” (id. at ¶ 16).
16. The Specification discloses that “[f]or Raman spectrometry,
optical probes designed for Raman spectrometry may be used. For example,
any of a variety of commercially available fiber optic probes can be used.”
(Spec. 13, ¶ 60.)
17. The Specification discloses that “[e]xisting commercially
available fiber optic probes may be modified, or new probes developed, to
maximize collection efficiency of light originating at depths of 1 millimeter
or more below the surface of a highly scattering medium, such as tissue.
Such modified, or newly developed probes, may offer better signal-to-noise
ratios and/or faster data collection.” (Id. at 13, ¶ 61.)
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Analysis
Claim 1
Claim 1 is directed to a method for determining whether a patient has
a bone tissue condition by irradiating bone tissue through skin using a
substantially monochromatic light source, receiving light scattered from the
bone tissue, determining Raman spectral content information associated with
the received light, and determining, based on the Raman spectral content
information, whether the patient has a bone tissue condition.
Marchitto discloses that biochemical changes in bone that are related
to diseases such as osteoporosis can be non-invasively assessed using an
optical fiber-based Raman spectrometer. Marchitto discloses that the
method comprises transmitting radiant energy through the skin to a bone,
and detecting reflected radiant energy to obtain Raman spectra that indicate
the biochemical composition of the bone. Marchitto discloses that the
biochemical composition information of the tested bone is compared with
that of normal bone to detect disease. Thus, Marchitto discloses the method
of claim 1.
Appellants argue that Marchitto does not enable one of ordinary skill
in the art to practice the method of claim 1 and therefore does not anticipate.
Specifically, Appellants argue that “Marchitto teaches that a Raman probe
with a beam splitter geometry must be used; i.e., a 1xn fiber applicator must
not be used…. Marchitto goes on to disclose that ‘[a] probe will then be
designed with coaxial source and collection optics” (Appeal Br. 11).
Appellants argue that the Morris Declaration provides evidence that
“Marchitto’s teaching regarding the probe is wrong” (id.) because a coaxial
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system will not collect sufficient photons to make a useful measurement of
bone tissue; instead, the source and collection fibers must be spaced apart
(id. at 12). Appellants also cite two research papers5 as further support for
their position (see id. at 17).
“[A] prior art publication cited by an Examiner is presumptively
enabling barring any showing to the contrary by a patent applicant.” In re
Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). See also id. at
1289:
[D]uring patent prosecution, an examiner is entitled to reject
claims as anticipated by a prior art publication or patent without
conducting an inquiry into whether or not that prior art
reference is enabling. As long as an examiner makes a proper
prima facie case of anticipation by giving adequate notice under
§ 132, the burden shifts to the applicant to submit rebuttal
evidence of nonenablement.
Here, Marchitto discloses that its method can be practiced using a
probe having a co-axial design that allows for simultaneous illumination and
detection (Marchitto 5, ¶ 48). That disclosure is presumed to be enabling,
and it is Appellants’ burden to show, by a preponderance of the evidence,
that it is not. Cf. In re Sasse, 629 F.2d 675, 681 (CCPA 1980) (“[W]hen the
PTO cited a disclosure which expressly anticipated the present invention … ,
the burden was shifted to the applicant. He had to rebut the presumption of
operability … by a preponderance of the evidence.”).

5 P. Matousek et al., Subsurface Probing in Diffusely Scattering Media
Using Spatially Offset Raman Spectroscopy, 59 APPLIED SPECTROSCOPY (NO.
4) 393-400 (2005).
P. Matousek et al., Numerical Simulations of Subsurface Probing in
Diffusely Scattering Media Using Spatially Offset Raman Spectroscopy, 59
APPLIED SPECTROSCOPY (NO. 4) 1485-1492 (2005).
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Appellants have provided a declaration under 37 C.F.R. § 1.132 of
Michael D. Morris, and argue that “Dr. Morris’s statements … are evidence
in support of a finding that Marchitto is not an enabling reference under 35
U.S.C. § 102” (Appeal Br. 15-16). While Appellants are correct that a
declaration is evidence, the weight to which that evidence is entitled depends
on the factual support provided for the statements made in it:
The Board has broad discretion as to the weight to give to
declarations offered in the course of prosecution. See Velander
v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003)
(“[A]ccord[ing] little weight to broad conclusory statements [in
expert testimony before the Board] that it determined were
unsupported by corroborating references [was] within the
discretion of the trier of fact to give each item of evidence such
weight as it feels appropriate.”).
In re American Acad. of Science Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir.
2004) (alterations in original).
In this case, Dr. Morris cites no specific evidence of record to support
the statements made in his Declaration. Since Dr. Morris has not cited any
specific evidence that provides a factual basis for his conclusions, his
testimony is entitled to little weight as evidence that Marchitto is not
enabling. Our conclusion in this regard is reinforced by the apparent conflict
between the statements in the Morris Declaration and the statements in the
Specification describing the invention of Dr. Morris and his co-inventors.
Dr. Morris states that only certain types of probes can be used to carry
out the method of claim 1 (FF 15) and that a probe with coaxial collection
and illumination cannot be used (FFs 13-14). The Specification, however,
does not tell those skilled in the art that the disclosed method can only be
practiced with certain types of probes. The Specification says only that
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“optical probes designed for Raman spectrometry may be used. For
example, any of a variety of commercially available fiber optic probes can
be used.” (FF 16.) While the Specification also discloses that existing
probes may be modified to maximize light collection efficiency, it states
only that such modified probes would improve the signal-to-noise ratio or
the speed of data collection (FF 17), not that they would be necessary to
practice the disclosed invention.
Appellants also cite two research papers as support for their position
that Marchitto is not enabling (Appeal Br. 17-19). However, while the
Matousek papers show that separating the illumination and collection of
light improves analysis of bone tissue, Appellants have pointed to no clear
disclosure in either paper that demonstrates that the probe disclosed by
Marchitto does not work in Marchitto’s method.
In summary, Marchitto’s disclosure is presumed to be enabling, and
Appellants have not provided a showing sufficient to rebut that presumption.
Thus, we affirm the rejection of claim 1 as anticipated by Marchitto. Claims
3, 4, 6, 16-18, 20-26, 28, 38-40 and 42-47 were argued as a group with claim
1 and therefore fall with it. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 48
With regard to claim 48, Appellants argue that the “Examiner has
failed to establish that Marchitto discloses or suggests determining a level of
bone fracture risk of a patient from a plurality of risk levels including a
plurality of above-normal risk levels, based at least in part on Raman spectra
information” (Appeal Br. 8).
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This argument is not persuasive. Marchitto discloses that “bone
densitometry … can predict the patient’s chances of bone fracturing in the
future” (FF 2). Marchitto describes its system for detecting bone
composition via Raman spectral analysis as a method for providing data like
those derived from densitometry measurements, but without the X-ray
exposure (see Marchitto, ¶¶ 8, 11, 12, 25, 29). Thus, a skilled worker would
recognize that Marchitto’s method would also be useful for predicting future
risk of bone fracture. A skilled worker would also recognize that risk of
bone fracture is not a binary determination of either “normal” or “above-
normal,” but would also include a plurality of above-normal risk levels
because risk of fracture increases along with measured parameters that
indicate increasingly advanced bone pathology. Thus, determining fracture
risk in osteoporotic patients would inherently involve “determining a level
of bone fracture risk of a patient from a plurality of risk levels including a
plurality of above-normal risk levels.”
We therefore affirm the rejection of claim 48 as anticipated by
Marchitto. Claim 49 falls with claim 48. 37 C.F.R. § 41.37(c)(1)(vii).
Conclusion of Law
The evidence of record supports the Examiner’s findings that
Marchitto discloses and enables the inventions of independent claims 1 and
48.
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II.
Issue
The Examiner has rejected claims 1, 3, 4, 6, 16-18, 20-26, 28, 38-40,
42-49 and 50-62 under 35 U.S.C. § 103(a) in view of Marchitto and Timlin.
We affirm the rejection of claim 1 based on Marchitto and Timlin for
the same reasons discussed above with regard to Marchitto. Claims 3, 4, 6,
16-18, 20-26, 28, 38-40, 42-48, and 53-60 fall with claim 1 because they
were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
Thus, the remaining issue with respect to this rejection is whether the
evidence supports the Examiner’s rejection of claims 50-52, 61 and 62 as
obvious in view of Marchitto and Timlin. Claims 50 and 61 are
representative. Claim 50 depends on claim 1, and adds the limitation that
“determining Raman spectral content information associated with the
received light comprises measuring a ratio of a first spectral portion
corresponding to amide to a second spectral portion corresponding to amide”
(Appeal Br. 41 (Claims Appendix)). Claim 61 also depends (indirectly) on
claim 1, and adds the limitations that “determining Raman spectral content
information associated with the received light comprises measuring a first
ratio of a first spectral portion corresponding to carbonate to a second
spectral portion corresponding to phosphate” as well as “measuring a second
ratio of a third spectral portion corresponding to phosphate to a fourth
spectral portion corresponding to amide” (Appeal Br. 43 (Claims Appendix,
claim 56) “wherein the fourth spectral portion corresponds to amide III” (id.
at 43 (claim 61)).
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In the rejection of claims 50-52, 61, and 62, the Examiner relies on
Marchitto as discussed above. The Examiner finds that Marchitto also
discloses “measuring carbonate, phosphate, and amide I” (Answer 10-11).
The Examiner finds that Timlin discloses “Raman analysis of bone. Timlin
et al. teach that spectral components corresponding to amide are typical
markers for the protein or organic matrix of bone, and that phosphate and
carbonate are markers for changes in mineral composition.” (Id. at 10.) The
Examiner finds that Timlin discloses a phosphate vibration as “the strongest
marker for bone mineral … and amide I …, typically used as a marker for
bone matrix” (id.).
The Examiner concludes that it would have been obvious “to analyze
and obtain data from any bands which relate to cartilage and/or bone, as
these will yield further data to aid in the diagnosis” (id. at 11). The
Examiner reasons that the “selection of a specific band or ratio for
diagnostic purposes would be an obvious choice without undue
experimentation. As taught by Timlin et al., analyzing phosphate, carbonate,
and amide I is important for analyzing bone composition, and their spectral
bands have been previously studied and determined.” (Id.)
Claim 50
With regard to claim 50, Appellants argue that Marchitto “proposes
making several measurements of Raman spectra of bone tissue, none of
which is … an amide-to-amide ratio” (Appeal Br. 25) and that “while Timlin
describes several spectral components that are markers for Raman analysis
of bone …, none of the described measurements is an amide-to-amide ratio”
(id.). Appellants argue that the “Examiner has not provided a reason that
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one of ordinary skill in the art would … determine whether a patient has a
bone tissue condition based on the amide-to-amide ratio” (id.).
We agree with Appellants that the Examiner has not adequately
explained why the cited references would have made it obvious to measure
an amide-to-amide ratio in bone. Neither of the references discloses that
such a measurement would be useful in determining whether a patient has a
bone tissue condition and the Examiner has not set forth any persuasive
reasoning as to why such a measurement would be useful in determining
whether a patient has bone tissue condition.
Thus, we reverse the rejection of claims 50-52 as being obvious in
view of Marchitto and Timlin.
Claim 61
With regard to claim 61, Appellants argue that neither Marchitto nor
Timlin describe measuring the phosphate-to-amide III ratio of bone (Appeal
Br. 25-26). Appellants argue that “the Examiner has not provided a reason
that one of ordinary skill in the art would … determine whether a patient has
a bone tissue condition based on the phosphate-to-amide III ratio” (id.).
The Examiner responds that Timlin measures “a mineral-to-matrix
ratio … While Timlin et al. do not explicitly state phosphate to amide ratio,
it is stated in Timlin … that phosphate refers to mineral, and amide refers to
matrix” (Answer 15).
We agree with the Examiner that the combination of Marchitto and
Timlin would have made obvious the method of claim 61. Marchitto
discloses that the phosphate-to-Amide I ratio is a measure of the mineral-to-
matrix ratio (Marchitto 3, ¶ 19). Marchitto also discloses that, in a dog
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model, changes in the phosphate-to-Amide I ratio were consistent with
measurements of bone density (id. at 3, ¶ 18).
Timlin discloses that “Raman spectroscopy is well suited for studying
bone … chemistry” (Timlin, 1429, right col.). Timlin also discloses that the
“phosphate v1 band … is a prominent marker for mineral content in bone.
Amide I, amide III, and C-H wag are typical markers for the protein or
organic matrix of bone.” (Id.) In view of these disclosures, we agree with
the Examiner that it would have been obvious to one of ordinary skill in the
art to substitute Amide III for the Amide I in Marchitto’s method for
measuring mineral-to-matrix ratios, and thus measure a phosphate-to-Amide
III ratio, because Timlin discloses that both Amide I and Amide III are
markers for matrix components.
Thus we affirm the rejection of claim 61 as obvious in view of
Marchitto and Timlin. Claim 62 falls with claim 61. 37 C.F.R.
§ 41.37(c)(1)(vii).
III.
The Examiner has also rejected claims 19 and 41 as obvious in view
of either Marchitto and Motz or in view of Marchitto, Motz and Timlin, and
has rejected claims 34-37 as obvious in view of Marchitto and Abbink or in
view of Marchitto, Abbink and Timlin. Appellants have waived any
arguments based on Motz and Abbink (Appeal Br. 20-21, 29-31).
Therefore, as discussed above with regard to Marchitto, we also affirm the
rejections of claims 19, 34-37, and 41.
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SUMMARY
We affirm the rejection of claims 1, 3, 4, 6, 16-18, 20-26, 28, 38-40,
and 42-49 under 35 U.S.C. § 102(b) and the rejection of claims 1, 3, 4, 6,
16-26, 28, 34-49, and 53-62 under 35 U.S.C. § 103(a). However, we reverse
the rejection of claims 50-52 under 35 U.S.C. § 103(a).
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).

AFFIRMED-IN-PART

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