Ex Parte Goudsmit et al

Patent Trial and Appeal Board

Nov 27, 2012

11372585 (P.T.A.B. Nov. 27, 2012)

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.
11/372,585 03/10/2006 Jaap Goudsmit 9310-22CT3 5714
20792 7590 11/27/2012
MYERS BIGEL SIBLEY & SAJOVEC
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
11/27/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAAP GOUDSMIT,
PIETER OUDSHOORN, SUZANNE JURRIAANS, and
VLADIMIR VLADIMIROVICH LUKASHOV
__________

Appeal 2010-012304
Application 11/372,585
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 14, 15, 18, 19, and 26-33.1 We have
jurisdiction under 35 U.S.C. § 6(b).

1 Claims 21 and 23 are also pending, but stand withdrawn from
consideration (App. Br. 2; see also Ans. 2).
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STATEMENT OF THE CASE
Claim 14 is representative of the claims on appeal, and reads as
follows:
14. A pair of hybridizing primers, for the amplification of a target
sequence located within the LTR region of the genome of HIV-1, said
hybridizing primer pair consisting of a first primer and a second primer,
wherein the first primer consists of a first hybridizing oligonucleotide, which
hybridizes to the target sequence or its complement along the entire length
of the first hybridizing oligonucleotide, being 10-50 nucleotides in length
and wherein said first hybridizing oligonucleotide comprises at least 10
sequential nucleotides of the hybridizing nucleotide sequence of:
SEQ ID NO: 1: G GGC GCC ACT GCT AGA GA, and
wherein said second primer consists of a second hybridizing
oligonucleotide, which hybridizes to the target sequence or its complement
along the entire length of the second hybridizing oligonucleotide, being 10-
50 nucleotides in length and wherein said second hybridizing
oligonucleotide comprises at least 10 sequential nucleotides of the
hybridizing nucleotide sequence of:
SEQ ID NO:4: CTG CTT AAA GCC TCA ATA AA,
wherein said first and second oligonucleotides amplify a target
sequence located within the LTR region of the HIV-l genome.

The following ground of rejection is before us for review:
Claims 14, 15, 18, 19, and 26-33 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Montagnier,2
Eberle,3 McDonough,4 STN Registry No. 181793-79-3,5 and Stefano.6
We affirm.

2 Montagnier et al., US 5,221,610, Jun. 22, 1993.
3 Eberle et al, US 5,413,906, May, 9, 1995.
4 McDonough, EP 0 617 132 A2, Mar. 28, 1994.
5 STN Registry No. 181793-79-3, (entered STN Oct. 10, 1996)
6 Stefano, US 5,472,840, Dec. 5, 1995.
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ANALYSIS
The Specification teaches that the “invention is related to nucleic acid
sequences that can be used in the field of virus diagnostics, more specifically
the diagnosis of infections with the AIDS causing Human
Immunodeficiency Virus (HIV)” (Spec. 1). The sequences are located in the
long terminal repeat (LTR) portion of the HIV genome (id. at 4). According
to the Specification, “by using a pair of oligonucleotides according to the
invention in an amplification reaction, accurate and reliable amplification of
nucleic acid derived from all presently know [sic] sub-types of HIV can be
achieved” (id. at 10).
Example 4 of the Specification analyzed 40 HIV-1 positive samples
from various geographical regions for HIV-1 RNA using the primer pair
SEQ ID 9/SEQ ID 5, and SEQ ID NOs 7 or 8 as probes (id. at 17).
Comparison was made with gag primer pairs (id.). The Specification
teaches that probes/primers derived from the HIV-1 LTR region were able to
detect HIV-1 in all tested samples, whereas the primer/probe combination
from the gag region only detected the presence of HIV-1 in 72.5% of the
samples tested (id. at 18; see also id. Table 3).
In Example 5, “33 samples harbouring HIV-l RNA of known
envelope-based subtypes were tested” (id. at 18). The Specification reports
that using the LTR primer pair of SEQ ID 9/SEQ ID 5 with a probe of SEQ
ID 7, “HIV-1 RNA was detected from all 33 HIV-1 samples” (id. at 19).
When a gag primer/probe combination was used, the assay failed to detect
subtypes A and E each from one of the samples, and failed to detect HIV-1
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RNA from all of the samples containing group O members (id. at 19; see
also id. at 18, Table 4).
The Examiner rejected claims 14, 15, 18, 19, and 26-33 as being
rendered obvious by the combination of Montagnier, Eberle, McDonough,
STN Registry No. 181793-79-3 and Stefano (Ans. 6). As Appellants do not
argue the claims separately, we focus our analysis on claim 14, and claims
15, 18, 19, and 26-33 stand or fall with that claim. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that Montagnier teaches that early detection of
infection by HIV-1 is essential (Ans. 8). The Examiner also finds that the
“structure/organization of the nucleotide sequence of HIV-1 as well as the
nucleotide sequence of same are know [sic] in the art at the time of filing”
(id.). Specifically, the Examiner finds:
Montagnier et al., column 19, bridging to column 20,
teach of the potential that any given individual may have been
exposed to HIV-1 with genetic variations, and that detection of
the particular variant(s) of HIV-I that an individual has been
exposed to “is preferably carried out” using primers and probes
“derived from highly conserved regions of the viral genome,
such as the LTR ...”

(Id. at 9.)
Montagnier “relates to polypeptides that correspond to peptides
encoded by the nef gene of strains of Human Immunodeficiency Virus
(HIV)” (Montagnier, col. 1, ll. 9-11). Montagnier teaches that serologic
assays may identify individuals with prior exposure to HIV-1, but they do
not specifically determine current infection (id. at col. 18, ll. 61-63).
Montagnier also teaches that isolation of HIV-1 particles from an HIV-1
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seropositive person can take up to three to four weeks and lacks sensitivity
(id. at col. 18, l. 66, col. 19, l. 7). Montagnier teaches that “PCR is
advantageous because this technique takes less than three days to complete”
(id. at col. 19, ll. 12-13).
According to Montagnier, “DNA primer pairs of known sequence
positioned 10-300 base pairs apart that are complementary to the plus and
minus strands of the DNA to be amplified can be prepared by well-known
techniques for the synthesis of oligonucleotides” (id. at col. 19, ll. 24-28).
Specifically, Montagnier teaches:
Since a patient may have been infected with HIV-1
containing genetic variations or deletions in the regions targeted
for amplification, the PCR technique using a single primer pair
may not produce reliable results. Specifically, such variation
could result in inefficient primer or probe binding, or
elimination of specific restriction endonuclease sites, or both of
these problems. For this reason, the PCR technique is
preferably carried out with several primer pairs and probes
derived from highly conserved regions of the viral genome,
such as the LTR, qao [sic, gag], and env regions of HIV-1.

(Id. at col. 19, l. 60-col. 20, l. 2.)
The Examiner finds that “STN Registry No. 11793-79-3 discloses the
nucleotide sequence of the LTR of HIV-1” (Ans. 10). The Examiner also
finds that the SEQ ID NO: 4 of claim 14 is embedded in the STN sequence
(id. at 14).
The Examiner finds that McDonough discloses SEQ ID NO: 50,
which contains the complete nucleotide sequence of SEQ ID NO: 1 of claim
14 (Ans. 12).
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McDonough relates “to the design and construction of amplification
oligonucleotides and probes to Human Immunodeficiency Virus Type 1
(HIV), which allow [for] detection of the organism in a test sample”
(McDonough, p. 2). McDounough also teaches that SEQ ID NO: 50 may be
used as an amplification oligonucleotide (id. at 4).
We find Eberle to be cumulative to McDonough, and thus do not
discuss it further (see, e.g., Ans. 12). Moreover, Stefano was cited to meet a
limitation of dependent claims 18, 19, 27, 28, 30, 31, and 33 (Ans. 13), and
we thus also do not address that reference further.
The Examiner finds that the prior art, such as Montagnier “clearly
establishes that there were design pressures and market needs for primers
that would allow for the detection of HIV-1 genome via PCR” (Ans. 11).
The Examiner also found that the art also focused on conserved regions of
the HIV-1 genome, such as those from the LTR region, and thus “‘there are
a finite number of identified, predictable solutions’” (id.).
The Examiner thus concludes that it would have been obvious to the
ordinary artisan in view of the teachings of Montagnier to use primers
directed at the LTR region of HIV-1 as it would allow for the amplification
of HIV-1 LTR sequences (id. at 14). The Examiner notes that the “state of
the art provides for computer-based sequence comparison and selection of
primers,” and thus “one of skill in the art would have had been amply
motivated and would have also had a most reasonable expectation of success
in selection of useful and functional primer pairs, which includes the
claimed primers, as they are an inherent property of the conserved regions of
the LT[R] region of HIV-1” (id. at 18-19).
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Appellants argue that Montagnier is drawn to “‘a purified protein that
corresponds to a peptide encoded by the nef gene of HIV’” (App. Br. 6
(citing Montagnier, Abstract and col. 2, ll. 64-66)). Appellants assert that
“to the extent that Montagnier [ ] makes any mention of the LTR region of
the HIV-1 genome, it is in a single sentence in which it is mentioned that
primers derived from any conserved region of the HIV-1 genome including
the gag and env regions, in addition to the LTR, could be used in a PCR
assay employing several primer pairs and probes” (id. at 7). Appellants
assert that the three regions mentioned by Montagnier “constitute over 50%
of the virus genome (over 4800 nucleotides),” arguing that Montagnier
“provides no guidance to direct the selection of any primer from any
particular conserved region over any other conserved region” (id.).
Appellants assert further that Montagnier “fails to teach or suggest any LTR
primers and further fails to provide any incentive or suggestion to motivate
one of ordinary skill in the art to specifically chose [sic] any primer pairs
from the LTR region over any primer pairs from either the gag or env
regions of the HIV genome” (id.).
As to McDonough, Appellants assert that the reference “only
describes the use of oligonucleotides for distinguishing HIV-1 from non-
HIV viruses found in human blood tissues” (id. at 10). Appellants argue that
McDonough discloses 140 different oligonucleotides, including SEQ ID
NO: 50, which encompasses SEQ ID NO: 1 (id.). Appellants assert that
McDonough provides no motivation to choose SEQ ID NO: 50 from the 140
disclosed oligonucleotides, or to combine it with the other references to
arrive at the claimed primer pair (id. at 10-11).
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While acknowledging that the sequence in the STN listing
encompasses SEQ ID NO: 4, Appellants assert that the STN listing only
discloses 688 nucleotides of the HIV genome, and nothing more (id. at 11).
Appellants argue that the selection of SEQ ID NO: 4 from the listing is more
than routine optimization, and there is nothing in that reference or the other
references cited by the Examiner pointing to SEQ ID NO: 4 or the claimed
primer pair (id. at 12).
Appellants also argue that the Research Genetics Advertisement7 cited
by the Examiner “is insufficient for finding HIV primers,” as the ordinary
artisan would still have to choose from the large number of primers
produced by the program (App. Br. 8). Appellants assert that the program
cannot predict which of the primers will be useful (id. at 8-9).
Appellants’ arguments have been carefully considered, but are not
found to be convincing.
The Supreme Court has 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., 550 U.S. 398, 418 (2007). “If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its patentability.”
Id. Under the correct obviousness analysis, “any need or problem known in
the field of endeavor at the time of invention and addressed by the patent can

7 Research Genetics, Designer PCR, 313 NUCLEIC ACIDS RESEARCH 22(15)
(1994) (Advertisement).
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provide a reason for combining the elements in the manner claimed.” Id. at
420.
In determining whether obviousness is established by combining the
teachings of the prior art, “the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981). In addition, a reference disclosure
is not limited only to its preferred embodiments, but is available for all that it
discloses and suggests to one of ordinary skill in the art. In re Lamberti, 545
F.2d 747, 750 (CCPA 1976).
While Montagnier is arguably directed to the nef gene of HIV, that
does not obviate Montagnier’s teaching of the need for rapid tests for HIV,
that the use of PCR is advantageous because it takes less than three days to
complete, and the use of primer pairs from the conserved regions of the viral
genome, such as the LTR region. The STN registry confirms that the
nucleotide sequence of the LTR region was known, and McDonough teaches
an amplification primer that distinguishes HIV from other viruses that
encompasses SEQ ID NO: 4 of instant claim 14. Given the state of the art
that the selection of appropriate primer pairs was known (see, e.g.,
Montagnier, col. 19, ll. 24-28), we agree with the Examiner that the selection
of the primer pair recited in claim 14 would have been prima facie obvious
to the ordinary artisan at the time of invention.
Appellants’ arguments that the three regions mentioned by
Montagnier constitute over 50% of the virus genome do not convince us
otherwise. The choice of any primer pair from the conserved regions of the
HIV genome would have been prima facie obvious over the teachings of
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Montagnier. Again, we note that the sequence of the HIV genome was
known, and the ordinary artisan would have been able to select appropriate
primer pairs from the conserved regions of the HIV genome, as PCR was a
known technique, as were the requirements for the selection of primer pairs
to amplify a desired nucleic acid.
As to the Research Genetics Advertisement, we note that we did not
rely on the advertisement in determining whether the Examiner had set forth
a prima facie case of obviousness as it was not used or discussed in the
statement of the rejection. At best, we find it only to be additional evidence
of the level of skill of the ordinary artisan, as well as the state of the art.
That is, the advertisement demonstrates that computer programs were known
to allow for the identification of appropriate primers. While there may have
been some additional selection from there, the Advertisement demonstrates
that computer based methods of sequence comparison and selection of
primers was known.
Appellants argue further that the “Examiner has failed to make the
factual findings required to make a rejection based on the ‘obvious to try’
rationale” (App. Br. 14-21). Thus, for example, Appellants argue that there
was no recognition of the problem solved by Appellants, that is, “the ability
to identify all subtypes of HIV-1 with a single primer pair” (id. at 15).
Appellants also argue that the Examiner has not established that there is a
finite number of identified, predictable solutions to the art recognized
problem (id. at 18-19), nor that there was a reasonable expectation of
success (id. at 20). Specifically, Appellants assert:
[C]ontrary to what Montagnier et al. teaches, which is the
use of multiple primer pairs from any conserved region of the
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HIV-1 genome for detection of HIV, the present inventors
surprisingly discovered that particular primer pairs from the
LTR region provide superior results in terms of being able to
identify all subtypes of HIV-1 tested. In the present
specification, the inventors show that the primer pairs of the
claimed invention derived from the LTR region were able to
detect all HIV-1 subtypes tested. In contrast, primers derived
from the conserved gag region of the HIV-1 genome were not
able to detect all HIV-1 subtypes tested (see, Tables 3 and 4 of
Examples 4 and 5, respectively). Accordingly, one of ordinary
skill in the art trying to solve the problem of detecting all
subtypes of HIV-1 with a single amplification reaction using a
single primer pair rather than multiple primer pairs would . . .
not be led to, and would actually be guided away from, the
solution provided by the present invention, by relying on the
teachings of Montagnier et al.

(Id. at 17.)
Appellants’ arguments are again not found to be convincing. That is,
we conclude that the Examiner has made the requisite fact findings to
support an “obvious to try” rationale.
First, the Examiner has identified a problem in the art—that is, the
need for rapid testing for HIV-1. There is no need for the problem identified
to be the same as that identified by Appellants. In that regard, we note that
claim 14 is drawn to two primers, and as noted by the Examiner (Ans. 3-4),
the claim encompasses a large genus of primers. There is nothing
preventing the use of the claimed primer pair in methods that may also
utilize other primer pairs, as suggested by Montagnier. And the argument
that the primer pair may be used to identify all subtypes of HIV-1 with a
single primer pair is more an argument as to the method of using the primer
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pair, as opposed to an argument directed to the composition, that is the
primer pair, itself.
Second, as to a recognized number of identified, finite solutions, the
Examiner relies on Montagnier for teaching that primer pairs may be chosen
from conserved regions of the HIV genome, such as the LTR region of the
virus. Given that Montagnier directs the ordinary artisan to “conserved
regions” of the genome, specifically suggests the LTR region, and given the
level of skill in the art in PCR and primer pair selection, we conclude that
the Examiner has established that there were a finite number of predictable
solutions available to the ordinary artisan. Based on the above, we further
conclude that there was a reasonable expectation of success of obtaining the
primer pair of claim 14. See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir.
1988) (noting that all that is required is a reasonable expectation of success,
not absolute predictability of success).
To the extent that Appellants are arguing unexpected results, we note
that the burden of demonstrating unexpected results rests on the party
asserting them, and “it is not enough to show that results are obtained which
differ from those obtained in the prior art; that difference must be shown to
be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). “Mere improvement in properties does not always suffice to show
unexpected results.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995).
Moreover, it is well settled that results must be established by factual
evidence. “Mere argument or conclusory statements in the specification
does not suffice.” In re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
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Here, while Appellants point to Examples 4 and 5 of the
Specification, it is unclear how those results demonstrate that the claimed
primer pair has unexpected properties. First, the primer pair used in
Examples 4 and 5 (SEQ ID 9/SEQ ID 5) is not the same as the claimed
primer pair, and Appellants have provided no evidence on the record
demonstrating that one would expect the same results for the claimed primer
pair as obtained for the primer pair used in the Examples. Moreover, while
Appellants assert that the gag primer pair is also highly conserved, the
Specification only references a journal article for the gag primer pair (see
Spec. pp. 17-18, Example 3). Appellants have provided no evidence to
compare the conservation of the sequence of the claimed primer pair to the
conservation of the gag primer pair used in Examples 4 and 5 to determine if
the results were actually unexpected. As noted by the Federal Circuit,
attorney argument cannot take the place of evidence lacking in the record.
Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
Appellants assert further that the instant appeal is not analogous to In
re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (App. Br. 21). Appellants argue
that “[w]hile methods for preparation of primers in general were known at
the time the present application was filed, no guidance was provided to one
of ordinary skill in the art with respect to parameters or direction that would
lead to success in choosing among the choices provided by the prior art for
the specific primers or primer pairs themselves” (id.). According to
Appellants, that makes the instant appeal different from Kubin, where the
prior art “not only pointed directly to the specific target protein but also
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provided the means for obtaining that specific protein and its coding
sequence” (id. at 21-22).
The claims at issue in Kubin were drawn to a genus of isolated
polynucleotides that encoded a protein that bound to CD48 and were at least
80% identical to the CD48 binding region of the NAIL (Natural Killer
Activation Inducing Ligand) protein. Kubin, 561 F.3d at 1353. The Federal
Circuit determined that using conventional techniques to isolate the gene
sequence rendered the claims obvious. Id. at 1361.
In Kubin, the Federal Circuit looked at In re O’Farrell, 853 F.2d 894,
903 (Fed. Cir. 1988), where the Federal Circuit “outlined two classes of
situations where ‘obvious to try’ is erroneously equated with obviousness
under § 103.” Id. at 1359. The first is to “‘vary all parameters or try each of
numerous possible choices until one possibly arrived at a successful result,
where the prior art gave either no indication of which parameters were
critical or no direction as to which of many possible choices is likely to be
successful.’” Id. (quoting O’Farrell, 853 F.2d at 903). The Federal Circuit
in Kubin equated that to “throw[ing] metaphorical darts at a board filled with
combinatorial prior art possibilities,” cautioning that “courts should not
succumb to hindsight claims of obviousness.” Id. According to the Federal
Circuit, “[t]he inverse of this proposition is succinctly encapsulated by the
Supreme Court’s statement in KSR that where a skilled artisan merely
pursues ‘known options’ from a ‘finite number of identified, predictable
solutions,’ obviousness under § 103 arises.” Id. (quoting KSR, 550 U.S. at
421); see also Ortho–McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d
1358, 1364 (Fed. Cir. 2008) (“KSR posits a situation with a finite, and in the
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context of the art, small or easily traversed, number of options that would
convince an ordinarily skilled artisan of obviousness.”).
The second situation occurs where “what was ‘obvious to try’ [is] to
explore a new technology or general approach that seemed to be a promising
field of experimentation, where the prior art gave only general guidance as
to the particular form of the claimed invention or how to achieve it.” Kubin,
561 F.3d at 1359 (quoting In re O’Farrell, 853 F.2d at 903). According to
the Federal Circuit, the inverse was affirmed in KSR, when the Supreme
Court stated that “§ 103 bars patentability unless ‘the improvement is more
than the predictable use of prior art elements according to their established
functions.’” Id. at 1359-60 (quoting KSR, 550 U.S. at 417).
The Federal Circuit went on to note in Kubin that the Board’s
rejection of the claims in O’Farrell did not fall afoul of either of the above
two situations, further noting that “an obviousness finding was appropriate
where the prior art ‘contained detailed enabling methodology for practicing
the claimed invention, a suggestion to modify the prior art to practice the
claimed invention, and evidence suggesting that it would be successful.’”
Id. at 1360 (quoting O’Farrell, 853 F.2d at 902). Specifically, the Federal
Circuit stated in O’Farrell and reiterated in Kubin, “‘[o]bviousness does not
require absolute predictability of success ... all that is required is a
reasonable expectation of success.’” Id. at 1360 (quoting O’Farrell, 853
F.2d at 903-904).
Given the above discussion, we disagree with Appellants that Kubin is
not relevant to the present appeal. The Federal Circuit in Kubin looked at
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the two situations presented in O’Farrell where an “obvious to try” rationale
is not appropriate.
The first is to “‘vary all parameters or try each of numerous possible
choices until one possibly arrived at a successful result, where the prior art
gave either no indication of which parameters were critical or no direction as
to which of many possible choices is likely to be successful.’” Kubin, 561
F.3d at 1359 (quoting O’Farrell, 853 F.2d at 903). That situation is not
presented by the instant appeal. As is demonstrated by Montagnier, PCR
was known in the art, as were the criteria for the selection of primer pairs to
amplify a desired nucleotide sequence. As is demonstrated by Montagnier
and McDonough, the use of PCR for detection of HIV-1 was known in the
art. As is demonstrated by STN Registry No. 11793-79-3, the sequence of
the HIV-1 genome was known in the art. As is demonstrated by
Montagnier, the use of a primer pair from the conserved regions of the HIV-
1 genome, such as the LTR region, was known in the art. As is
demonstrated by McDonough, the use of a primer encompassing the
sequence of the SEQ ID NO: 4 in claim 14 was known in the art. The only
piece not taught by the prior art is the selection of the particular primer pair
required by claim 14. But given the guidance in the art, the rejection of the
Examiner is not equivalent to “throw[ing] metaphorical darts at a board
filled with combinatorial prior art possibilities,” Kubin, 561 F.3d at 1359,
but is the pursuit of known options from a finite number of possibilities.
The second situation in which “an obvious to try” rationale is not
appropriate is to “explore a new technology or general approach that seemed
to be a promising field of experimentation, where the prior art gave only
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general guidance as to the particular form of the claimed invention or how to
achieve it.” Kubin, 561 F.3d at 1359 (quoting In re O’Farrell, 853 F.2d at
903). As explained above, this is not a new technology, and the art provided
guidance to the ordinary artisan how to achieve the primer pair of claim 14.
That is, the primer pair of claim 14 is the predictable use of prior art
elements according to their established functions.
Thus, this case is analogous to Kubin, in that the prior art contained
enabling methodology to arrive at the claimed invention, that is, the claimed
primer pair for amplifying a target sequence located within the LTR region
of the HIV-1 genome.

SUMMARY
The rejection of claim 14 under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Montagnier, Eberle, McDonough, STN
Registry No. 181793-79-3 and Stefano is affirmed. Claims 15, 18, 19, and
26-33 fall with that claim.

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

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