Ex Parte Moser et al

Patent Trial and Appeal Board

Mar 13, 2017

13403681 (P.T.A.B. Mar. 13, 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.
13/403,681 02/23/2012 Christian Moser 046549-5030US2(00006) 1348
78905 7590 03/15/2017
Saul Ewing LLP (Philadelphia)
Attn: Patent Docket Clerk
Centre Square West
1500 Market Street, 38th Floor
Philadelphia, PA 19102-2186
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
03/15/2017 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):
patents@saul.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTIAN MOSER, ANDREAS KAMMER, and
RINALDO ZURBRIGGEN1
Appeal 2016-000966
Application 13/403,681
Technology Center 1600
Before DONALD E. ADAMS, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
treating or preventing a disease involving administration of a lipid vesicle.
The Examiner entered final rejections for anticipation and obviousness. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Helvetic Airways AG.
App. Br. 3.
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Application 13/403,681
STATEMENT OF THE CASE
Background
The Specification discloses:
use of a lipid vesicle for the preparation of a medicament for non-
specifically stimulating the immune response of an animal to a
disease or disorder. The invention further relates to a method of
non-specifically stimulating the immune response of an animal,
i.e. treating, eliminating and/or preventing a disease or disorder,
involving administering a lipid vesicle to an animal in need
thereof. The lipid vesicle comprises, in its lipid membrane, at
least one viral envelope protein.
Spec. 1:3-9.
The Claims
Claims 37-40, 43, and 47—54 are on appeal. Sole independent claim
37 illustrates the appealed subject matter and reads as follows:
37. A method of non-specifically stimulating the
immune response of an animal to effect therapy of a disease or
disorder in the animal, comprising administering to the animal
an empty lipid vesicle comprising, in its lipid membrane, at least
one viral envelope protein,
wherein the disease or disorder is not associated with or
caused by the virus from which the at least one viral envelope
protein is derived, and
wherein the disease or disorder is infectious or neoplastic,
whereby the immune response of the animal is non-
specifically stimulated to effect therapy of the disease or disorder
in the animal.
App. Br. 44 (Claims Appendix).
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The Issues
The following rejections are on appeal:
Claims 37-40, 43, 47-49, and 51—53 are rejected under 35
U.S.C. § 102(b) as anticipated by Marchisio2 as evidenced by Eich.3 Ans. 3.
Claims 37-40, 43, 47-48, and 51—53 are rejected under 35
U.S.C. § 102(b) as anticipated by Pluschke.4 Ans. 3.
Claims 37-40, 43, and 47—54 are rejected under 35 U.S.C. § 103(a) as
obvious over Pluschke and Mischler.5 Ans. 5.
2 Paola Marchisio et al., Efficacy of Intranasal Virosomal Influenza Vaccine
in the Prevention of Recurrent Acute Otitis Media in Children, 35: Clin.
Infect. Dis. 168—174, © 2002 Infectious Diseases Society of America
(“Marchisio”).
3 G. Eich, et al., Nasalflu Berna: intranasaler, inaktiviterter Grippeimpfstoff
10: Schweiz Med. Forum 260-262 (2001) (“Eich”).
4 US 2004/0175392, published Sep. 9, 2004 (“Pluschke”).
5 Robert Mischler and Ian C. Metcalfe, Inflexal®Va trivalent virosome
subunit influence vaccine: production, 20: Vaccine B17—23, © 2002
Elsevier Science Ltd. (“Mischler”).
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Claims 37-40, 43, and 47—53 are rejected under 35 U.S.C. § 103(a) as
obvious over Matsumoto,6 Masihi,7 and Schumacher.8 Ans. 5.
Claims 37-40, 43, and 47—54 are rejected under 35 U.S.C. § 103(a) as
obvious over Matsumoto, Masihi, Schumacher, and Amacker.9 Ans. 7.
Claims 37-40, 43, and 47—54 are rejected under 35 U.S.C. § 103(a) as
obvious over Marchisio in view of Mischler. Ans. 8.
FINDINGS OF FACT (FF)
FF1. The Specification discloses that “the terms ‘non-specific’,
‘unspecific’ and the like refer to a general immunostimulatory activity of the
lipid vesicle against at least one disease or disorder which is not associated
with or caused by a virus from which the at least one viral envelope protein
is derived” and that “‘specific’ immuno stimulatory activity refers to the
stimulation of the immune system to prevent, combat and/or eliminate a
6 Kensuke Matsumoto, et al., Stimulation of Nonspecific Resistance to
Infection Induced by Muramyl Dipeptide Analogs Substituted in the y-
Carobxyl Group and Evaluation of Na-Muramyl Dipeptide- Na-
Stearoyllysine, 39: Infect. &Immun. 3, 1029-1040, © 1983, American
Society for Microbiology (“Matsumoto”).
7 K.N. Masihi, Immunomodulatory agent for prophylaxis and therapy of
infections, 14: Int’l. J. Antimicrob. Agents 181-191 © 2000 Elsevier
Science B.V. and International Society of Chemotherapy (“Masihi”).
8 Reto Schumacher, et al., Influenza virosomes enhance class I restricted
CTL induction through CD4+ T cell activation, 22: Vaccine 714—723,
© 2003 Elsevier Ltd. (“Schumacher”).
9 Mario Amacker, et al., Peptide-loaded chimeric influenza virosomes for
efficient in vivo induction of cytotoxic T cells. 17: Intl. Immun. 695—704
(2005) (“Amacker”).
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particular disease or disorder associated with or caused by the parental
virus.” Spec. 11:1—18.
FF2. Marchisio teaches “[t]he evidence that viral infections are
associated with many, if not most, episodes of AOM [8] has caused
immunoprophylaxis against respiratory viruses to receive growing
attention.” Marchisio 168.
FF3. Marchisio teaches:
To evaluate the efficacy of an intranasal, inactivated, virosomal
subunit influenza vaccine for prevention of new episodes of
acute otitis media (AOM) in children with recurrent AOM, 133
children aged 1-5 years were randomized to receive the vaccine
(n = 67) or no vaccination (n = 66). During a 6-month period, 24
(35.8%) vaccine recipients had 32 episodes of AOM; 42 (63.6%)
control subjects had 64 episodes. The overall efficacy of
vaccination in preventing AOM was 43.7% (95% confidence
interval, 18.6-61.1; P = .002). Children vaccinated before
influenza season had a significantly better outcome than did
those vaccinated after the onset of influenza season.
Marchisio Abstract.
FF4. The Examiner cites Pluschke for teaching a method for treating
malaria in a mammal comprising two steps:
(i) pre-immunization with empty immunopotentiating
reconstituted influenza virosomes or IRIVs (i.e., empty lipid
vesicles comprising in their membrane HA and NA); and (ii)
immunization with IRIVs loaded with malarial antigenic
epitopes which occurs at least three weeks after the pre­
immunization step.
Ans. 3.
The Examiner finds the “step of pre-immunization with empty IRIVs
necessarily stimulates non-specific immune responses to effect therapy for
malaria (i.e., a disease not associated with or caused by influenza virus from
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which the envelope proteins are derived; claim 37) because all that is
required to achieve such is to administer empty IRIVs.” Id. at 3^4 (citing
Pluschke Abstract and H 25, 28, 32, 36, 41, and 59).
FF5. Pluschke teaches an example showing
the immunogenicity studies of the peptide-loaded virosomes in
mice . . . BALB/c mice were pre-immunized intramuscularly
with 0.1 ml of the commercial whole virus influenza vaccine
Inflexal Bema™ (Bema Biotech, Bern, Switzerland). At least
three weeks later they were immunized with peptide-loaded
IRIVs in intervals of at least two weeks. Blood was collected
before each immunization and two weeks after the final
injection.
Pluschke 1 59. Monoclonal antibodies were generated from spleen cells of
the mice. Id. at 1 64.
FF6. Pluschke teaches an example showing “the parasite growth-
inhibitory effect of the antibodies elicited by use of the peptides of the
invention.” Pluschke 173. Pluschke teaches that when the “two major fine
specificities were tested . . . both exhibited substantial inhibitory activity
[with] [a] 95.3% reduction of parasite growth was observed” over the
control. Id.
FF7. Pluschke teaches preimmunization of mice with Inflexal®, a
vaccine against influenza, prior to treatment with loaded IRIVs. Pluschke
167.
FF8. Mischler teaches that Inflexal comprises three different
virosomes, wherein each virosome comprises an HA derived from a
different influenza strain. Mischler Table 1, providing composition of
virosomal pool production for the three monovalent virosomes.
FF9. The Examiner finds that Matsumoto teaches “a method of
stimulating non-specific immune responses to generate protection against
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bacterial infections in mice, the method comprising the intravenous
administration of the adjuvant MDP-Lys(L18), wherein administering MDP-
Lys(L18) confers protection against different subsequent bacterial
infections.” Final Act. 6 (citing Matsumoto Abstract, pp. 1032, 1034).
FF10. Because Matsumoto teaches stimulating non-specific immune
responses using MDP-Lys(L18) and not IRIVs, the Examiner looks to
Masihi for the teaching that “MDP-Lys(L18) is a potent inducer of CSFs,
TNF, and IFN-y [] wherein IFN- y , TNF, and GM-CSF are
immunomodulatory agents suitable to elicit non-specific immune responses
suitable to treat infections in general.” (citing Matsumoto Abstract, pp. 181,
185-189).
FF11. The Examiner finds Schumacher teaches that “empty IRIVs
are adjuvants capable of inducing the Thi cytokines IFN-y, TNF, and GM-
CSF and also a CTL response, which are necessary to treat infectious
diseases in general and cancer,” meaning that “IRIVs stimulate non-specific
immune responses.” (citing Schumacher pp. 714, 718, 722).
FF12. The Examiner finds Amacker teaches that “IRIVs comprising
influenza HA and NA derived from different influenza strains (i.e.,
chimeric) were known and used in the prior art as adjuvants.” (citing
Amacker Abstract, p. 697).
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ANTICIPATION
Rejection over Marchisio as evidenced by Eich
The Examiner has rejected claims 37—40, 43, 47 49, and 51—53 under
35 U.S.C. § 102(b) as anticipated by Marchisio as evidenced by Eich. Ans.
3. The Examiner finds that Marchisio, as evidenced by Eich,
teach[es] a method of non-specifically stimulating the immune
response in children to effect therapy of acute otitis media
[AOM] caused by viral or bacterial infections, the method
comprising administering to the children Nasaflu Bema spray,
i.e., empty virosomes comprising influenza hemagglutinin and
neuraminidase.
Ans. 3.
The Examiner concludes that the limitation “whereby the immune
response of the animal is non-specifically stimulated to effect therapy of the
disease or disorder in the animal” that is “recited in the instant claim [3]7 is
inherent to the method of Marchisio et al. because all that is required to
stimulate non-specific immune response to different diseases is to administer
empty virosomes.” Id. Based on this finding of inherency, the Examiner
concludes Marchisio anticipates the claimed invention. Id.
Appellants argue:
Marchisio does not teach the administration of IRIVs [empty
influenza virosomes] to treat AOM. Rather, Marchisio teaches
the administration of influenza virosomes to prevent influenza
virus infection. Prevention of influenza can in turn prevent the
subsequent development of other secondary diseases, such as
AOM. Thus, the immunological properties of the virosome itself
as taught in Marchisio are restricted to prevention of influenza
virus infection. The use of the influenza virosomes in Marchisio
is not “non-specific” as required by the present claims, because
in Marchisio the influenza virosomes are used to treat and/or
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prevent a disease (influenza) associated with the vims from
which the at least one viral envelope protein is derived (IRIVs).
App. Br. 16.
Appellants cite several passages in Marchisio that acknowledge ear
infection recurrence is mitigated by vaccination against influenza (e.g.,
“vaccine-induced prevention of influenza also leads to the prevention of
AOM and other respiratory infections”). Id. Appellants also argue the
recommended timing of the use of IRIVs in Marchisio, ‘“carefully planned
to complete the administration of the vaccine doses before the estimated
onset of the influenza season,’” demonstrates that the use of influenza
virosomes is to induce adaptive immunity (e.g., “specific” immunity)
because they treat the disease caused by the same vims from which the
virosomal envelope proteins are derived, not non-specific immunity as
claimed. Id. at 16—17.
The Examiner responds that
[although not specifically taught as a mechanism of eliciting
non-specific immune responses, stimulating the innate immunity
is inherent to the methods of Marchisio et al... . because all that
is required to achieve such is to administer empty virosomes.
The instant claims do not recite more than this. The instant
specification does not teach more than this.
Ans. 9—10.
Appellants have the better position. Claim 37 requires that the animal
have a “disease or disorder” to be treated, meaning that the animal must
have previously had the disease, or be suspected of contracting the disease in
the future, to receive the treatment. Further, the disease to be treated must
be “not associated with or caused by the virus from which the at least one
viral envelope protein is derived” in order to cause a non-specific immune
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response. See FF1, defining “non-specific” as “general immunostimulatory
activity of the lipid vesicle against at least one disease or disorder which is
not associated with or caused by a vims from which the at least one viral
envelope protein is derived.”
Marchisio teaches “viral infections are associated with many, if not
most, episodes of AOM.” FF2. With this understanding, Marchisio
evaluated the effect of IRIVs in preventing new episodes of AOM in
children with recurrent AOM, and found increased success when the
treatment was given prior to influenza season. FF3. We agree with
Appellants that the increased resistance to new episodes of AOM observed
by Marchisio suggests a correlation with causation of AOM by the influenza
vims, rather than the viral independence required for the claimed non­
specific immunity.
The Examiner has not identified any teaching in Marchisio from
which we may confirm that the therapy of AOM was solely for those
episodes caused by bacterial infections, and not by the viral infections
established by Marchisio to cause “many, if not most, episodes of AOM.”
FF2. Accordingly, the Examiner has not established that the episodes of
AOM that are treated by delivery of the IRIVs in Marchisio were not caused
by influenza such that the observed treatment can be attributed to non­
specific immunity as required by claim 37. “The keystone of the inherency
doctrine is inevitability. For anticipation by inherency, a later-claimed
invention must have necessarily resulted from the practice of a prior art
reference. Our precedent has been steadfast in this strict requirement of
inevitability.” In re Montgomery, 677 F.3d 1375, 1384 (Fed. Cir. 2012).
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Because the Examiner has not provided evidence sufficient to support a
prima facie case of anticipation, we reverse the rejection of claims 37—40,
43, 47-49, and 51—53. See In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir.
1993) (“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.”).
Rejection over Pluschke
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions with regard to anticipation of the
invention by Pluschke, as set out in the Final Action and Answer. Final Act.
3-A; Ans. 3^4.
The Examiner has set forth a prima facie case that claims 37-40, 43,
47-48, and 51—53 are anticipated by Pluschke. FF4. We address
Appellants’ arguments below.
Appellants argue “[t]he pre-immunization taught in Pluschke is
performed not to provide the desired immunization against malaria, but to
allow for the generation of anti-influenza antibodies in naive animals, so that
these mice better model influenza infection in human patients.” App. Br. 11.
Appellants argue this pre-immunization is “directed to the elicitation of anti­
influenza antibodies in naive animals as part of the animal’s adaptive
immunity and is specific in nature [and therefore] bear[s] no relation to the
non-specific stimulation of the present invention, which relates to the
animal’s innate immunity.” Id. at 12.
We are not persuaded.
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In some cases, [an] inherent property corresponds to a claimed
new benefit or characteristic of an invention otherwise in the
prior art. In those cases, the new realization alone does not
render the old invention patentable. Thus, when considering a
prior art method, the anticipation doctrine examines the natural
and inherent results in that method without regard to the full
recognition of those benefits or characteristics within the art field
at the time of the prior art disclosure.
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377—1378 (Fed. Cir.
2005).
Although Pluschke may have pre-immunized the mice for the sole
purpose of generating anti-influenza antibodies, Pluschke nonetheless
treated an animal with an empty IRIV and ultimately looked for and
observed an immune response generated against malaria. FF5, FF6. While
it is true that after treating with the empty IRIV, Pluschke subsequently
immunized mice with a peptide-loaded virosome before measuring the
immune response generated against malaria (FF5), Appellants have not
persuasively shown that the immune response identified by Pluschke is
exclusively specific and that the claimed non-specific immune response did
not also occur. We agree with the Examiner that the steps taken by Pluschke
would inherently have generated the claimed non-specific immune response.
Although Appellants attempt to distinguish in time between the “transient,
short-lived effect” of the non-specific response generated by the invention as
compared to the “long-lasting immune response” of Pluschke as a means to
distinguish any observed effect, the cited support in the Specification (9:1—
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32) does not clarity the time frame or meaningfully distinguish it from
Pluschke’s observed immune response.10 App. Br. 12—13.
We do not address Appellants’ second argument directed to the
second step of Pluschke, as we agree with the Examiner that step one is the
anticipating disclosure, not step two. Ans. 3^4.
Appellants rely on their arguments regarding the rejection of claim 37
for all dependent claims. App. Br. 13—15. Where “claims are not separately
argued, they all stand or fall together.” In re Kaslow, 707 F.2d 1366, 1376
(Fed. Cir. 1983); 37 C.F.R. § 41.37(c)(l)(iv). Separately arguing a claim
requires “more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art.” In re Lovin, 652 F.3d 1349, 1357
(Fed. Cir. 2011). Accordingly, claims 38-40, 43, 47-48, and 51—53 fall with
claim 37.
10 The Specification states the effect is “transient” and the “onset of this
effect is quite rapid, and is certainly more rapid than any immunostimulatory
effect arising from a specific, i.e. adaptive immune response would be
expected to be.” Spec. 9:24—26. However, this does not foreclose that the
response could indeed be adaptive, nor does it demonstrate that any non­
specific immune effects would not have continued through the time period in
which the effects were measured in Pluschke. In addition, Appellants cite
paragraph 38 of Pluschke as evidence that the alleged “specific” immune
response is “long-lasting” (App. Br. 12), but paragraph 38 does not address
the time frame of the immune response.
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OBVIOUSNESS
Rejection over Pluschke and Mischler
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions with regard to obviousness of the
invention over Pluschke and Mischler, as set out in the Final Action and
Answer. Final Act. 5—6; Ans. 5.
For the reasons discussed above (FF4—6), we find Pluschke anticipates
and also renders claims 37—40, 43, 47-48, and 51—53 obvious because
Pluschke teaches every limitation of claim 37. “[A] determination of
anticipation, as well as obviousness, involves two steps. First is construing
the claim,. . . followed by, in the case of anticipation or obviousness, a
comparison of the construed claim to the prior art.” Key Pharms. v. Hereon
Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998). See also In re McDaniel,
293 F.3d 1379, 1385 (Fed. Cir. 2002) (citations omitted) (“It is well settled
that ‘anticipation is the epitome of obviousness’”). Accordingly we
determine only whether claims 49, 50, and 54 are obvious over Pluschke and
Mischler. The Examiner has set forth a prima facie case that claims 49, 50,
and 54 are obvious over Pluschke and Mischler. Ans. 5; FF4—8. We address
Appellants’ arguments below.
In making the rejection, the Examiner finds that although “Pluschke et
al. teach a mammal, they do not specifically teach a human or a ruminant” as
recited in claims 49 and 50. Ans. 5. The Examiner concludes “one of skill
in the art would have found it obvious to use the method of Pluschke et al. to
treat malaria in any mammal, including humans and ruminants such as
cows.” Id. We agree, as both humans and ruminants are mammals regularly
targeted for treatment with pharmaceutical compositions.
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With regard to claim 54, which recites a chimeric IRIV, the Examiner
finds that Pluschke teaches preimmunization of mice prior to treatment with
an IRIV with Inflexal®. FF7. The Examiner finds Mischler discloses that
Inflexal is composed of three monovalent virosomes, each comprising “an
HA derived from a different influenza strain.” Ans. 5; FF8. The Examiner
concludes a skilled artisan “would have found it obvious to modify the
composition of Pluschke et al. by incorporating all three HAs into the same
virosome to achieve the predictable result of obtaining an IRIV adjuvant.”
Ans. 5.
Appellants argue “Mischler does not cure the deficiencies in Pluschke
[because it] teaches the use of an influenza virus-related virosome (IRIV) to
treat an influenza infection, and thus the therapy taught in Mischler is
“specific.” App. Br. 22. For this reason, Appellants argue the skilled artisan
“would not have identified Pluschke and/or Mischler as a way to solve the
scientific problem addressed by the present invention: a method of non-
specifically stimulating the immune response of an animal to effect therapy
of an infectious or neoplastic disease or disorder.” Id. at 23. Instead,
Appellants argue the Examiner used “impermissible hindsight” in
constructing the rejection. Id. Appellants also argue the skilled artisan
“would not have modified the teachings of Pluschke and Mischler as to
arrive at the present invention with reasonable expectation of success”
because Mischler “teaches ‘specific’ methods of treating an influenza
infection with an IRV” while Pluschke is targeted at eliciting innate
immunity in an animal. Id. at 24.
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
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U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly
stated that the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). In this
case, Pluschke alone teaches the use of a chimeric IRIV because it teaches
administration of Inflexal®. FF7. The Examiner looks to Mischler merely
to confirm that the vaccine is chimeric. Ans. 5. As discussed above,
Pluschke anticipates the central invention, and claim 54 recites a natural
enhancement of that invention, a chimeric vaccine, which one of skill in the
art would recognize would stimulate and/or broaden the immune response,
precisely as it is used by Pluschke. Ans. 5; FF7. Without evidence, which
Appellants do not provide, these attorney arguments are unpersuasive. See
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in
a brief cannot take the place of evidence.”). We affirm the rejection.
Rejection over Matsumoto, Masihi, and Schumacher
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions with regard to obviousness of the
invention over Matsumoto, Masihi, and Schumacher, as set out in the Final
Action and Answer. Final Act. 6—7; Ans. 5—7.
The Examiner has set forth a prima facie case that claims 37-40, 43,
and 47—53 are obvious over Matsumoto, Masihi, and Schumacher. FF9-11.
We address Appellants’ arguments below.
Appellants argue the Matsumoto teaches “the use of a bacterial cell
wall fragment analog to stimulate non-specific resistance to bacterial
infection” and that a bacterial cell wall fragment analog is “wholly unrelated
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and distinct” from a lipid vesicle or IRIV. App. Br. 27. Applicants argue
the Examiner applied “impermissible hindsight” to reconstruct the invention.
Appellants further argue Masihi and Schumacher do not cure the
deficiencies in Matsumoto because both are “wholly unrelated to the present
invention” and use distinct methods. Id. at 27—28.
We are not persuaded.
In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed
purpose of the patentee controls. . . . [A]ny need or problem
known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the
elements in the manner claimed.
KSR, 550 U.S. at 419-20.
We agree with the Examiner that “[t]he problem addressed by the
instant invention is [achieving] non-specific stimulation of immune
responses to stimulate resistance to infections. Matsumoto et al. teach
eliciting non-specific immune responses to stimulate resistance to infections
and thus their teachings are material to the problem addressed by the
appellants]” and, further, that Matsumoto “teach[es] all method steps
required by the claims.” Ans. 15—16; FF9—11.
Appellants next argue a skilled artisan would not have had a
reasonable expectation of success combining the teachings of the cited
references because the methods taught are different and cannot be combined.
App. Br. 28. According to Appellants, “Matsumoto teaches a method of
stimulating non-specific resistance to bacterial infection. Contrary to
Matsumoto, Schumacher teaches a method of stimulating specific resistance
to bacterial infection.” Id. at 29. Appellants argue “the Office has failed to
present any actual argument or evidence that Matsumoto and Schumacher
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are indeed combinable in an obviousness rejection” and that the Examiner
has used impermissible hindsight to recreate the invention. Id. at 30.
This argument is unpersuasive. “Obviousness does not require
absolute predictability of success. . . . For obviousness under § 103, all that
is required is a reasonable expectation of success.” In re O’Farrell, 853
F.2d 894, 903—04 (Fed. Cir. 1988). Both Matsumoto and Schumacher
induced immune responses in mammalian cells. FF9, FI 1. The Examiner
presented a prima facie case of obviousness, shifting the burden to
Appellants. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (“the
examiner bears the initial burden, on review of the prior art or on any other
ground, of presenting a prima facie case of unpatentability. If that burden is
met, the burden of coming forward with evidence or argument shifts to the
applicant.”)
Absent evidence, which Appellants do not provide, we are not
persuaded by Appellants that the skilled artisan would not have replaced
MDP-Fys(F18) as used by Matsumoto with IRIVs to stimulate non-specific
immune responses, given that Masihi and Schumacher teach the substitution
would accomplish the same type(s) of immune stimulation. FF9—11. See
KSR, 550, U.S. at 420 (“. . . in many cases a person of ordinary skill will be
able to fit the teachings of multiple patents together like pieces of a
puzzle.”). We affirm the rejection of claim 37. Because Appellants rely on
their arguments regarding the rejection of claim 37 for all dependent claims
(App. Br. 31—32), we similarly affirm the rejection of claims 38—40, 43, and
47-53.
Rejection over Matsumoto, Masihi, Schumacher, and Amacker
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We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions with regard to obviousness of the
invention over Matsumoto, Masihi, Schumacher, and Amacker, as set out in
the Final Action and Answer. Final Act. 7—8; Ans. 7—8.
In responding to this rejection, Appellants rely on their arguments
regarding the alleged the alleged deficiencies of Matsumoto, Masihi, and
Schumacher. App. Br. 33. We have addressed those arguments above.
Appellants argue Amacker does not cure the deficiencies of the other
cited references as “Amacker teaches only the use of chimeric IRIVs.” Id.
This argument is not persuasive because the Examiner’s reference is based
on the combined teachings of Matsumoto, Masihi, Schumacher, and
Amacker. Ans. 7—8. Nonobviousness cannot be established by attacking the
references individually when the rejection is predicated upon a combination
of prior art disclosures. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed.
Cir. 1986); see also In re Keller, 642 F.2d 413, 426 (CCPA 1981) (finding
“one cannot show non-obviousness by attacking references individually
where, as here, the rejections are based on combinations of references”
(citations omitted)). Thus, whether Amacker fails to individually teach
induction of a non-specific immune response is not dispositive. The
Examiner cites Amacker as teaching use of chimeric IRIVs. Ans. 7; FF12.
The Examiner sufficiently establishes that an ordinary artisan reading
Matsumoto, Masihi, Schumacher, and Amacker would have reasonably
expected that the chimeric IRIVs of Amacker could be substituted for the
IRIV of Schumacher. Ans. 7—8.
Appellants next argue that Amacker teaches away from the claimed
invention because “the IRIVs taught by Amacker are not empty because they
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are loaded with bioactive peptides” rather than the empty virosomes
claimed, which would not motivate the skilled artisan to use empty
virosomes. App. Br. 33—34.
The Examiner responds:
Amacker et al. was cited as evidence that chimeric IRIVs were
known and used in the prior art, thus rendering obvious using
chimeric IRIVs in the method of Matsumoto et al., Masihi, and
Schumacher et al. There is no teaching or suggestion in the entire
reference or the entire art pointing against using empty chimeric
IRIVs instead of empty IRIVs in the method of Matsumoto et al.,
Masihi, and Schumacher et al.
Ans. 19.
The Examiner has the better position.
Under the proper legal standard, a reference will teach away
when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the
applicant’s invention. A statement that a particular combination
is not a preferred embodiment does not teach away absent clear
discouragement of that combination.
Syntex (U.S.A.) LLCv. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted).
We agree with the Examiner that, absent evidence to the contrary,
Amacker informs a person of ordinary skill that chimeric IRIVs may be used
to induce an immune response, rather than teaching away from the instant
claims. The rejection is affirmed.
Rejection over Marchisio and Mischler
The Examiner has rejected claims 37—40, 43, and 47—54 under 35
U.S.C. § 103(a) as obvious over Marchisio and Mischler. Ans. 8. As
discussed above, we find that the Examiner has not established that the
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episodes of AOM that are treated by delivery of the IRIVs in Marchisio were
not caused by influenza such that the observed treatment can be attributed to
non-specific immunity as required by claim 37. Because the Examiner relies
on the anticipation rejection in making the obviousness rejection, and does
not cite any additional bases for the rejection relevant to establishing the
required non-specific immunity, we also reverse this rejection.
SUMMARY
We reverse the rejection of claims 37-40, 43, 47 49, and 51—53 under
35 U.S.C. § 102(b) as anticipated by Marchisio as evidenced by Eich.
We affirm the rejection of claims 37-40, 43, 47-48, and 51—53 under
35 U.S.C. § 102(b) as anticipated by Pluschke.
We affirm the rejection of claims 37-40, 43, and 47—54 under 35
U.S.C. § 103(a) as obvious over Pluschke and Mischler.
We affirm the rejection of claims 37-40, 43, and 47—53 under 35
U.S.C. § 103(a) as obvious over Matsumoto, Masihi, and Schumacher.
We affirm the rejection of claims 37-40, 43, and 47—54 under 35
U.S.C. § 103(a) as obvious over Matsumoto, Masihi, Schumacher, and
Amacker.
We reverse the rejection of claims 37-40, 43, and 47—54 under 35
U.S.C. § 103(a) as obvious over Marchisio in view of Mischler.
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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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