Ex Parte Tong et al

Board of Patent Appeals and Interferences

Feb 6, 2009

10923444 (B.P.A.I. Feb. 6, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte SUN-WING TONG and YI-WEI TANG
__________

Appeal 2008-5634
Application 10/923,444
Technology Center 1600
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Decided: February 6, 2009
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving a claim to a method
of collecting nasopharyngeal specimens. We have jurisdiction under 35
U.S.C. § 6(b). We affirm-in-part.

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Statement of the Case
Background
The Specification teaches that in “viral upper respiratory infections,
the diagnostic material is often virally infected, exfoliated upper respiratory
ciliated columnar epithelial cells, or extracellular viral particles, capsid
protein or nucleic acid” (Spec. 5:7-9). “The current gold standard method of
harvesting virally infected upper respiratory epithelial cells . . . involves the
instillation of a sterile electrolyte solution via a plastic cannula into the
nasopharynx, and the recovery of the fluid by aspiration into a trap bottle
using negative pressure.” (Spec. 4:2-5). According to the Specification
“[w]ith the exception of collection of saliva, all of the existing [harvesting]
methods involve mild to significant patient discomfort, ranging from mild
irritation to pain.” (Spec. 6:16-17).
The Claims
Claims 1-3 and 5-7 are on appeal. We will focus on claims 1, 5, and
6, which are representative and read as follows:
1. A method of collecting and testing nasopharyngeal
specimens comprising the steps of: 1) positioning the patient
with his or her face pointing upwards, 2) dropping at least a
single drop of a sterile solution into each eye at a time and
then holding head erect and blinking several times, 3)
repeating step 2 until about 2-5mL of solution has been used
up, 4) having the patient spit out the collected fluid in the
back of the throat into a specimen container, and 5) testing
the collected fluid for a disease or disorder selected from the
group consisting of viral upper respiratory infections,
malignancies of the nasal, nasopharyngeal, and
oropharyngeal regions, gene alteration, certain chemicals,
biological abnormalities, and combinations thereof.

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5. The method of claim 1, wherein the viral upper
respiratory infection is SARS coronavirus infection,
influenza A virus infection, influenza B virus infection,
parainfluenza virus infection, coronavirus upper respiratory
infection, adenovirus upper respiratory infection, rhinovirus
upper respiratory infection, respiratory syncytial virus
infection, metapneumovirus infection, or other emerging
viral infections.

6. The method of claim 1, wherein the malignancy of the
nasopharyngeal region is nasopharyngeal cancer.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Blair US 2002/0142294 A1 Oct. 3, 2002
Liu US 2003/0134293 A1 Jul. 17, 2003

Scruggs et al., Route of Absorption of Drug and Ointment After
Application to the Eye, 10 ANNALS OF OPTHALMOLOGY 267-271 (1978).
Sahlin et al., Gravity, Blink Rate and Lacrimal Drainage Capacity,
124 AM. J. OF OPTHALMOLOGY 758-764 (1997).
David P. Austen, Lacrimal dilation and syringing, OPTOMETRY
TODAY 29-32 (1999).
Ukkonen et al., Preparation of nasopharyngeal secretions for
immunofluorescence by one-step centrifugation through Percoll, 15 J. OF
VIROLOGICAL METHODS 291-301 (1987).
McIntosh et al, Diagnosis of Human Coronavirus Infection by
Immunofluorescence: Method and Application to Respiratory Disease in
Hospitalized Children, 2 J. OF MED. VIROLOGY 341-346 (1978).
Greg Basky, Accurate test for nasopharyngeal cancer developed by
Canadian researchers, 161 CAN. MED. ASS’N J. 125 (1999)

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The issue
The Examiner rejected claims 1-3 and 5-7 under 35 U.S.C. § 103(a) as
obvious over Scruggs, Sahlin, Austen, Liu, Blair, Ukkonen, McIntosh, and
Basky (Ans. 4-7).
The Examiner finds that “Scruggs teaches that fluids, including larger
volumes of fluid, administered to the eye will travel through the
nasolacrimal route to the back of the throat” (Ans. 6). The Examiner finds
that “Sahlin et al. teaches that when the nasolacrimal duct is at a 45° or 0°
angle (i.e., the head is tilted back or horizontal) lacrimal drainage of a saline
solution increases” (Ans. 6). The Examiner also finds that “Liu and Blair et
al. teach testing nasal or nasopharyngeal samples for virus such as
respiratory syncytial virus, influenza, rhinovirus, parainfluenza II and I, and
adenovirus” (Ans. 6). The Examiner finds that “one would expect that the
samples . . . collected by Scruggs et al. would also contain specimens . . . .
These specimens can be tested for the presence of virus or cancerous cells as
demonstrated by Liu, Blair et al., Ukkonen et al., Mclntosh et al., and
Basky” (Ans. 7).
Appellants contend that “a person of ordinary skill in the art would
not reasonably expect that the method of Scruggs et al. would produce
adequate quality of nasopharygeal specimen for testing” (App. Br. 6).
Appellants contend that “compared to the closest prior art identified by the
Examiner, the present invention is more effective and/or safer, which would
not be expected from the cited art” (App. Br. 8). Appellants further contend
that “[i]t is this invention that resolves the long felt but unresolved problem”
(App. Br. 8).
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In view of these conflicting positions, we frame the obviousness
issues before us as follows:
(1) Did the Examiner err in finding claim 1 obvious over the
conjunctival instillation methods of Scruggs, Sahlin and Austen?
(2) Did the Examiner err in finding claims 5 and 6 obvious over the
conjunctival instillation methods of Scruggs, Sahlin and Austen with the
screening methods of Liu, Blair, Ukkonen, McIntosh, and Basky?
Findings of Fact (FF)
1. The Specification provides no definition for the claim term
“certain chemicals” (see Spec. 22, l. 20, where only mention of chemical
profile is found).
2. Scruggs teaches a method of collecting nasopharyngeal samples
where “[m]ineral oil, U.S. P., was instilled into 2 volunteers in three 10 µl
doses. Saliva and nasal secretions were collected over the following 30
minutes” (Scruggs 268, col. 2).
3. Scruggs teaches that fluorscein was “instilled into the
conjunctival sac” and that the “fluorescein also was quickly noted in nasal
secretions following instillation in both vehicles” (Scruggs 269, col. 1).
4. Scruggs teaches that “[n]asal secretions and saliva were
collected for an hour following conjunctival application . . . [d]roplets of an
oily material were readily seen in saliva and nasal secretions but were absent
in control secretions” (Scruggs 269, col. 2).
5. Scruggs teaches that “[f]ollowing instillation of three 10 µl
doses of mineral oil to each eye in 2 subjects, saliva was collected for 20
minutes. The secretions were then washed with chloroform, and the extract
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analyzed and compared to control secretions with gas-liquid
chromatography . . . Mineral oil was detected in both subjects” (Scruggs
269, col. 2).
6. Scruggs teaches that “[w]e were able to clear in 4 subjects an
average of 3 m[l] of saline drops in one hour using this method” (Scruggs
270, col. 1).
7. Scruggs teaches that “we have shown that ointment placed in
the conjunctival sac does reach the nose and throat” (Scruggs 271, col. 2).
8. Sahlin teaches that “[l]acrimal drainage capacity showed a high
correlation to blink rate when the nasolacrimal duct was in a horizontal
position, in which the effect of gravity was minimized” (Sahlin 762, col. 1).
9. Sahlin teaches that “[w]e found that the lacrimal drainage
increased significantly when the nasolacrimal duct was in a 45-degree
position compared with the horizontal position” (Sahlin 762, col. 2).
10. Austin teaches that “[o]n blinking, the attachment of the
preseptal orbicularis muscle helps create positive and negative pressure in
the lacrimal sac which sucks tears into it . . . . This is called the tear pump”
(Austin 29, col. 2).
11. Liu teaches that “a method is described that detects and
distinguishes a class of single stranded RNA viruses” (Liu 12 ¶ 0103),
12. Liu teaches that to “perform a clinic test, nucleic acid sample
extracted from nasopharyngeal aspirate of a patient will be used as the
template” (Liu 12 ¶ 0105).
13. Blair teaches “a viral load analysis of COPD [chronic
obstructive pulmonary disease] clinical trial samples” using “nasal swabs
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taken with additional samples taken on exacerbation (nasal swabs and
spontaneous sputum)” (Blair 4 ¶ 0090-0091).
14. Ukkonen teaches that a “simple method was developed for
separation of cells from nasopharyngeal secretion for the diagnosis of
respiratory virus infections by immunofluorescence microscopy” (Ukkonen
291, abstract).
15. Basky teaches a method where “[c]ells are gently removed from
the back of the nose, then subjected to DNA screening to confirm the
presence of cancer” (Basky 125, col. 1).
16. McIntosh teaches detection of coronavirus where “serologic
reagents were applied to nasopharyngeal secretion cells obtained from 106
infants and children” (McIntosh 341, abstract).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int'l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
However, KSR teaches that an invention “composed of several
elements is not proved obvious merely by demonstrating that each of its
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elements was, independently, known in the prior art.” Id. There must be “a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
Id.
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.”). Also see In re Morris, 127 F.3d 1048, 1054-56 (Fed. Cir.
1997). (“Absent an express definition in their specification, the fact that
appellants can point to definitions or usages that conform to their
interpretation does not make the PTO's definition unreasonable when the
PTO can point to other sources that support its interpretation.”)
Analysis
We separately analyze claim 1 and claims 5-6 since the claim 1
Markush group specifically comprises testing of “certain chemicals” in step
5 while claims 5-6 do not include testing “certain chemicals”.
Claim 1
In analyzing claim 1, we begin by interpreting the meaning of “certain
chemicals” (see Claim 1). The Specification provides no specific definition
for “certain chemicals” (FF 1). Claim 1 also does not provide any
limitations on “certain chemicals” (see Claim 1). Therefore, applying the
broadest reasonable interpretation of “certain chemicals”, the term includes
any chemicals, including mineral oil or fluorescein. See, e.g., In re Hyatt,
211 F.3d 1367, 1372 (Fed. Cir. 2000) (“During examination proceedings,
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claims are given their broadest reasonable interpretation consistent with the
specification.”).
Scruggs teaches a method of collecting and testing nasopharyngeal
specimens with the step of instilling a solution into the patient’s eyes (FF 2,
3, 5, 7). Scruggs teaches collecting saliva (FF 4). Scruggs expressly teaches
testing the collected fluid for “certain chemicals”, where “droplets of an oily
material were readily seen in saliva and nasal secretions but were absent in
control secretions” (Scruggs 269, col. 2; FF 3-5). Scruggs tests the material
for mineral oil by gas-liquid chromatography (FF 5). Scruggs also instills
and tests for fluorescein (FF 3). Scruggs teaches repeated instillations to
instill volumes up to 3 mls of solution (FF 6).
While Scruggs does not teach positioning the patient and blinking by
the patient, Sahlin teaches that the optimal angle for instillation is 45 degrees
and that blinking assists in instillation (FF 8-9). Austin also teaches that
blinking assists in instillation (FF 10).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that it would have been obvious to collect and test “certain
chemicals”, including mineral oil and fluorescein, as required by claim 1
since Scruggs teaches instillation of a solution into the eyes, including up to
3 mls of solution, followed by collection of the saliva and testing the saliva
for the presence of “certain chemicals” (FF 2-7). An ordinary practitioner
would have applied the known patient positioning and blinking means to
optimize the instillation as evidenced by Sahlin and Austin (FF 8-10). Such
a combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 127 S. Ct. at 1740.
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We are not persuaded by Appellants’ argument that “a person of
ordinary skill in the art would not reasonably expect that the method of
Scruggs . . . would produce adequate quality of nasopharygeal specimen for
testing” (App. Br. 6). Scruggs demonstrates specific detection of two
different chemicals in the specimens collected, mineral oil and fluorescein.
This detection provides evidence which directly demonstrates success (FF 3-
5). See In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (“For
obviousness under § 103, all that is required is a reasonable expectation of
success.”).
With regard to claim 1, we also do not find persuasive Appellants’
argument that “compared to the closest prior art identified by the Examiner,
the present invention is more effective and/or safer” (App. Br. 8).
Appellants’ argument relies upon the collection methods of Liu, Blair,
Ukkonen and McIntosh, but the proper comparison is with the collection
method of Scruggs, which is essentially identical to the method claimed,
except for disclosing the positioning of the patient and the rate of blinking
(FF 2-7). Appellants do not provide any evidence for an unexpected result
relative to the instillation and collection method of Scruggs, Sahlin, and
Austin (see App. Br. 8). See In re Baxter-Travenol Labs., 952 F.2d 388, 392
(Fed. Cir. 1991) (“When unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”)
Claims 5-6
In analyzing dependent claims 5 and 6, we begin by noting that these
claims do not comprise detection of “certain chemicals”. While Scruggs
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teaches instillation and detection of fluorescein and mineral oil (FF 2-5),
Scruggs provides no reason to instill a sterile solution into patients’ eyes in
order to test for diseases or disorders such as those found in claims 5 and 6.
Additionally, while Liu, Blair, Ukkonen, McIntosh, and Basky teach
sensitive detection methods of diseases or disorders based upon
nasopharyngeal samples (FF 11-16), none of these references provide any
reason to obtain the samples using a step of instilling sterile solution into
patients’ eyes.
In KSR, the court noted that an invention “composed of several
elements is not proved obvious merely by demonstrating that each of its
elements was, independently, known in the prior art.” KSR, 127 S. Ct. at
1741. There must be “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” Id.
The Examiner argues the combination of Scruggs with the detection
prior art of Liu, Blair, Ukkonen, McIntosh, and Basky since “one would
expect that the samples . . . collected by Scruggs et al. would also contain
specimens, such as cells or virus particles, from the nasolacrimal duct and
the nasal, nasopharyngeal and oropharyngeal passages” (Ans. 7).
While this is a close case, we do not agree with the Examiner that
Scruggs provides the ordinary artisan with a reason to obtain samples for
viral or cancer testing by instillation of liquid through the lacrimal duct.
The Examiner does not provide a reason to test samples derived from
liquid instilled into the lacrimal duct. Rather, the Examiner concludes that
“[t]hese specimens can be tested for the presence of virus or cancerous cells”
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(Ans. 7). The conclusion that something can be done is not a reason that
would have prompted a person of ordinary skill to combine prior art
elements.
Conclusions of Law
(1) The Examiner did not err in finding claim 1 obvious over the
conjunctival instillation methods of Scruggs, Sahlin and Austen.
(2) The Examiner erred in finding claims 5 and 6 obvious over the
conjunctival instillation methods of Scruggs, Sahlin and Austen with the
screening methods of Liu, Blair, Ukkonen, McIntosh, and Basky.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a). Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the
rejection of claims 2, 3 and 7 as these claims were not argued separately.
We reverse the rejection of claims 5 and 6 under 35 U.S.C. § 103(a).
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)(iv)(2006).
AFFIRMED-IN-PART
LP
KENT H. CHENG, ESQ.
COHEN, PONTANI, LIEBERMAN & PAVANE
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551 FIFTH AVENUE
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