Ex Parte Piemonti et al

Patent Trial and Appeal Board

Sep 12, 2018

13500544 (P.T.A.B. Sep. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/500,544 04/05/2012
26201 7590 09/14/2018
FISH & RICHARDSON P.C. (AU)
P.O BOX 1022
Minneapolis, MN 55440-1022
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Lorenzo Piemonti
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
3638 l-0003US 1 8864
EXAMINER
CRUZ, KATHRIEN ANN
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
09/14/2018 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):
P ATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LORENZO PIEMONTI, LUISA DAFFONCHIO, and
MARCELLO ALLEGRETTI 1
Appeal2017-000095
Application 13/500,544
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge DEMETRA J.
MILLS.
Opinion Dissenting filed by Administrative Patent Judge ERIC B. GRIMES.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify DOMPE PARMACEUTICI S.P.A. as the real party in
interest. App. Br. 1.
Appeal2017-000095
Application 13/500,544
STATEMENT OF CASE
The following claim is representative.
23. A method of treating an individual receiving a pancreatic
islet cell transplant, the method comprising:
identifying an individual diagnosed with Type 1 diabetes;
and
administering to the individual, before and after the
individual undergoes pancreatic islet cell transplantation, a
medicament comprising a compound effective to inhibit
CXCL8 biological activity derived from CXCRl and/or CXCR2
activation.
Cited References
Hezi-Yamit US 2005/0261762 Al Nov. 24, 2005
M. James Shapiro, Islet Transplantation in Seven Patients with Type 1
Diabetes Mellitus Using a Glucocorticoid-Free Immunosupresive Regimen,
343 THE NEW ENGLAND J. OF MEDICINE NO 4, 230-23 8 (July 27, 2000)
(hereinafter "Shapiro").
Bertini, Noncompetitive allosteric inhibitors of the Inflammatory Chemokine
Receptors CXCRJ and CXCR2: Prevention of Reperfusion Injury, IOI
PNAS NO 32, 11791-11796 (2004) (hereinafter "Bertini").
Grounds of Rejection
Claims 23-31 are rejected under pre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Shapiro, Bertini, and Hezi-Yamit.
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Application 13/500,544
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 2-13. The following facts are highlighted.
1. There is an election of species in this case. Appellants elected
Group II (claims 23-28) is elected for examination (May 6, 2013).
The elected species is [(4-isobutylphenyl)propionyl] methane-
sulfonamide, listed in paragraph [0042] of the published
application (US 2012/0202884). 2
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"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'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
When the examiner has required the applicant to elect single chemical
species for examination, the issue on appeal is the patentability of the single
elected species. It is appropriate to limit discussion to that single issue and
take no position respecting the patentability of the broader generic claims,
including the remaining, non-elected species. See Ex parte Ohsaka, 2
USPQ2d 1461 (Bd. Pat. App. Int. 1987).
2 Response to Election Requirement, dated May 6, 2013.
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Application 13/500,544
To differentiate between proper and improper
applications of "obvious to try," this court outlined two classes
of situations where "obvious to try" is erroneously equated with
obviousness under § 103. In the first class of cases, what would
have been "obvious to try" would have been 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.
In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (citing In re O'Farrell,
853 F.2d 894, 903 (Fed. Cir. 1988)).
Obviousness Rejection
The Examiner finds that, "Shapiro teaches that seven consecutive
patients ... who had had type 1 diabetes mellitus ... underwent islet
transplantation." Final Act. 6. In all seven patients, exogenous insulin
therapy quickly became unnecessary once sufficient numbers of islets were
transplanted. Id. Shapiro discloses the administration of a glucocorticoid
free immunosuppressive regime. Id. "Shapiro disclose that islet
transplantation has been investigated as a treatment for type 1 diabetes
mellitus in selected patients with inadequate glucose control despite insulin
therapy (page 230, right column, first paragraph)." Id. Shapiro discloses that
immunosuppression was initiated immediately before transplantation. Id. at
7.
The Examiner admits that, "Shapiro does not disclose the addition of
the elected species, R)-ibuprofen methanesulfonamide (repertaxin), to the
immunosuppressive regimen." The Examiner relies on Bertini and Hezi-
Yamit to make up for this deficiency. Final Act. 7.
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Application 13/500,544
Bertini discloses that chemokine CXC ligand 8 (CXCL8)/IL-8 and
related agonists recruit and activate polymorphonuclear cells by binding the
CXC chemokine receptor 1 (CXCRl) and CXCR2. Ans. 6. Bertini
discloses the unique mode of action of a small-molecule inhibitor
(Repertaxin which is R-ibuprofen methanesulfonamide) against organ
reperfusion injury. Id. Hezi-Yamit discloses that DF-1681 is also known as
repertaxin and is being developed for treatment of transplant rejection. Id.
Hezi-Yamit discloses that DF-1681 is believed to be an anti-inflammatory/
immunosuppressant, specifically an IL-8 antagonist. Id. DF-1681 has the
chemical name 2(R)-( 4-isobutylphenyl)-N-( methylsulfonyl)propionamide
(paragraph 0049). Id. The Examiner concludes that
It would have been obvious to one of ordinary skills in
the art at the time of the invention to administer glucocorticoid-
free immunosuppressive and R)-ibuprofen methanesulfonamide
jointly to an individual with diabetes type 1 and having islet cell
transplant. One would have been motivated to administer a
glucocorticoid free immunosuppressive agent and R)-ibuprofen
methanesulfonamide for the treatment of an individual with
diabetes type 1 and having islet cell transplant because it was
known in the art at the time of the invention was made to
administer a glucocorticoid free immune-suppressive agents
for patients with type 1 diabetes and islet transplantation and is
also known that R)-ibuprofen methanesulfonamide is effective
in the protection of organs against reperfusion injury as well as
a anti-inflammatory/immunosuppressant, specifically an IL-8
antagonist.
Final Act. 9.
Appellants argue that
1. Repertaxin is not immunosuppressive. App. Br. 6.
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Application 13/500,544
2. The immunosuppressants of Shapiro, Bertini, and Hezi-Yamit are
not used for the same purpose as repertaxin. App. Br. 4.
3. There is no expectation of success that repertaxin would work for
islet cell transplantation. App. Br. 7.
4. Solid organ transplants and islet cell transplants are different. App.
Br. 5.
ANALYSIS
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellants' arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner's argument set forth in the Final Rejection and Answer.
Appellants argue that repertaxin is not immunosuppressive, and that
the immunosuppressants of Shapiro, Bertini, and Hezi-Yamit are not for the
same purpose as repertaxin. App. Br. 4, 6.
We are not persuaded by Appellants' arguments. Shapiro states that
sirolimus 3 and tacrolimus are effective glucocorticoid-free immune-
suppressants useful in pancreatic islet transplantation in patients with type- I
diabetes. Abstract. Hezi-Yamit discloses that repertaxin (DF-1681, R(-)-2-
[( 4-isobutylphenyl)propionyl]-methanesulfonamide) is also a known anti-
inflammatory agent/immune-suppressant for the treatment of transplant
rejection. Hezi Yamit ,, 10, 49. The Examiner has therefore provided
3 Sirolimus is also known as rapamycin. See,
https://en. wikipedia.org/wiki/Sirolimus.
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Application 13/500,544
evidence on this record, that sirolimus, tacrolimus, and repertaxin are
immunosuppressive agents known to be useful in organ transplantation.
We recognize that Appellants (and the Dissent) challenge the direct
statement by Hezi-Yamit that "DF-1681 is also known as repertaxin and is
being developed by Dompe Farmaceutici for treatment of transplant
rejection. It is believed to be an anti-inflammatory/immunosuppressant,
specifically an IL-8 antagonist." Hezi-Yamit ,r 49. However, "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). In this case, neither Appellants nor the
Dissent point to persuasive evidence that rebuts the teaching of Hezi-Yamit
that repertaxin was expected to function as both an anti-inflammatory agent
and as an immunosuppressant useful to prevent transplant rejection.
Appellants point to two references regarding transplantation that omit IL-8
inhibitors (App. Br. 6) and one reference that uses repertaxin for another
purpose of reperfusion injury4 (App.Br. 6-7), but none of these references
specifically address, much less rebut, the express teaching of Hezi-Yamit
that repertaxin has anti-inflammatory activity and is useful for transplant
rejection. Hezi-Yamit ,r 49. The Dissent also presents arguments
concerning Shapiro, which were not previously argued by Appellants.
4 We note that the reference cited by Appellants, Cavalieri, 18 Int. J. Immun.
Path. 475 (2005), also suggests the use of repertaxin in transplantation,
stating "Liver transplantation has become an accepted therapy for end-stage
liver diseases, but graft injury after reperfusion has been one of "the critical
problems to overcome ... we have demonstrated repertaxin efficacy in
preventing post-ischemic injury 24 hours after reperfusion." (Cavalier 484).
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In the present case, the Examiner combines multiple known
immuno-suppressants useful in organ transplantation, including, in the case
of Shapiro, islet cell transplantation, citing In re Kerkhoven, 626 F.2d 846
(CCPA 1980).
During oral hearing on August 21, 2018, Appellants argued that the
facts of the present case are similar to those of In re Geiger, 815 F .2d 686
(Fed. Cir. 1987). We however, find that the facts of the present case can be
distinguished from those of Geiger. In Geiger, the claims were directed to a
method of inhibiting scale formation on and corrosion of metallic parts in
cooling water systems by use of compositions containing (1) a sulfonated
styrene/maleic anhydride (SSMA) copolymer, (2) a water soluble zinc
compound, and (3) an organo-phosphorus acid compound or water soluble
salt thereof. The claims were rejected over Ii, Snyder and Hwa patents. Ii
disclosed the
use in cooling water systems of scale and corrosion prevention
compositions comprised of a polymeric component in
combination with one or more compounds selected from the
group consisting of inorganic phosphoric acids and water
soluble salts thereof, phosphonic acids and water soluble salts
thereof, organic phosphoric acid esters and water soluble salts
thereof, and polyvalent metal salts. Although the Ii polymeric
component may contain maleic acid and styrene monomers,
there is no disclosure of the specific copolymer, SSMA,
required in applicant's claims.
Id. at 687.
The Snyder patent disclosed a method for treating cooling water
systems prone to scale formation by the addition of a composition comprised
of an acrylic acid/lower alkyl/hydroxy acrylate copolymer and another
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Application 13/500,544
polymeric component, which may be SSMA or a styrene/maleic anhydride
(SMA) copolymer. Id. at 687. The Hwa patent was directed to a method for
treating boiler water systems that are prone to scale formation by addition of
a composition comprised of SSMA and an organo-phosphorus acid
compound. In re Geiger at 687.
In Geiger, The Federal Circuit concluded that:
Hwa does disclose the specifically-recited organo-phosphorus
acid compound. It provides, however, no suggestion to add a
zinc compound to its disclosed combination of SSMA and
organ-ophosphorus acid compounds, or to use SSMA in
combination with an organo-phosphorus acid compound in the
treatment of a cooling water system, where the characteristics
may significantly differ from those in Hwa's boiler water
system. Hwa also provides no suggestion that SSMA could
prevent precipitation of the zinc (II) ion in alkaline cooling
water in the manner ascribed to the polymeric component of Ii.
In re Geiger at 688.
The Federal Circuit concluded in Geiger that there was no prima face
case obviousness because, "[a]t best, in view of these disclosures, one
skilled in the art might find it obvious to try various combinations of these
known scale and corrosion prevention agents. However, this is not the
standard of 35 U.S.C. § 103." In re Geiger, at 688.
On the other hand, the KSR also addressed the "obvious to try" issue:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
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Application 13/500,544
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007).
In KSR, the Supreme Court held that an "obvious to try" fact situation
may be enough to support a prima facie case of obviousness. Under a KSR
"obvious to try" analysis, Shapiro and Hezi-Yamit disclose a finite number
of predictable immunosuppressants for use in organ transplantation known
to those of ordinary skill in the art. Because the selection or combination of
known organ transplant immunosuppressants leads to the anticipated
immunosuppressive success, the result is likely not a product of innovation
but of ordinary skill and common sense. It is prima facie obvious to
combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition which is to
be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079--80,
440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279
F.2d 274, 276-77 (1960). As explained in Crockett, the idea of combining
them flows logically from their having been individually taught in the prior
art. In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
While the Federal Circuit did not reach the unexpected results or
secondary considerations in Geiger, Appellants, in that case, provided data
in that case showing that the Hwa system was relatively ineffective in a
coo ling system.
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Application 13/500,544
In the present case, Appellants further argue that it was known in the
art from Gao, 5 that not all immunosuppressive agents were useful in islet
cell transplants. Appellants argue that, in Gao, "many of the
[immunosuppressant] drugs commonly used, including sirolimus and
tacrolimus ... have negative effects on beta-cell function and viability in
vitro." (footnote omitted). Therefore, Appellants argue that, "there would
have been no reasonable expectation that the modification of Shapiro's
protocol with another immunosuppressant would have improved or
maintained the outcome described by Shapiro." App. Br. 7.
We are not persuaded by Appellants' argument. Gao concluded that
"sirolimus and daclizumab are amenable for use in clinical islet
transplantation." Gao, 1025. Shapiro also supports this fact. Abstract. In
Gao, "Sirolimus and tacrolimus showed a small positive effect on effect on
islet cell proliferation. Gao, 1022. "Tacrolimus and sirolimus did not affect
the DNA content of islet cells." Gao, 1023. While Gao discloses that
reductions in insulin content of islet cells was seen in tacrolimus and
mycophenolate mofetil (MMF) islet studies, "[t]he differences in absolute
amounts of insulin were not statistically significant due to considerable
variation in cell compositions among different batches of starting tissue."
Gao, 1023, col. 1. Gao further indicated that some issues with sirolimus
could be overcome with use of a higher proportion of beta cells. Gao, 1025,
col. 2.
5 Gao, et al., "Effects of Immunosuppressive Drugs on In Vitro Neogenesis
of Human Islets," 7 AMERICAN JOURNAL OF TRANSPLANTATION, 021-26
(2007).
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Application 13/500,544
While Gao discloses that various immunosuppressive agents have
costs that must be weighed against their benefits ( tacrolimus and sirolimus
may have some negative effects on beta cell function and viability (Gao, p.
1021, col.2.)), the fact that the motivating benefit (immunosuppression)
comes at the expense of another benefit (islet cell proliferation, Gao, Fig.
2A), should not nullify its use as a basis to modify the disclosure of one
reference with the teachings of another. Instead, the benefits, both lost and
gained, should be weighed against one another." Medi chem S.A. v. Rolabo
S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
Nor is this a case of improper application of the "obvious to try"
principle where "obvious to try" is erroneously equated with obviousness
under § 103 as described in In re Kahn. The present case is one of cost
benefit determination analyzing the use of known immunosuppressive
agents for organ transplantation, and is not a case 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. The use of known
immunesuppressive agents and the general conditions for their known use in
organ transplantation in this case, reasonably suggests that the ordinary
artisan would optimize these result effective variables to maximize desirable
immunosuppression while minimizing other side effects. Indeed, Bertini
teaches treatment "with an optimal dose of Repertaxin" (Bertini 11792, col.
1) while Hezi-Yamit teaches "[p ]referably, the optimum dosages will be the
highest non-toxic" dose (Hezi-Yamit ,r 82).
"[W]here the general conditions of a claim are disclosed
in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation." Aller, 220 F.2d at
456. This rule is limited to cases in which the optimized
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Application 13/500,544
variable is a "result-effective variable." In re Antonie, 559
F.2d 618, 620 (CCPA 1977); see Boesch, 617 F.2d at
276 ("[D]iscovery of an optimum value of
a result effective variable ... is ordinarily within the skill of the
art.").
In re Applied Materials, 692 F.3d 1289, 1295 (Fed. Cir. 2012) [emphasis
original].
Appellants have not come forward with evidence of unexpected
results in this case. Appellants have not come forward with evidence that
one of ordinary skill in the art would have been dissuaded from selecting
repertaxin for use as in immunosuppressant in islet cell transplantation,
based upon its known, effective use in organ transplantation, generally.
Repertaxin is acting in its expected manner, as an immunosuppressive agent
for use in organ transplant, as suggested by Hezi-Yamit, and is combined
with other immunosuppressants specifically known to be useful in islet cell
transplantation (Shapiro) to achieve the expected benefit of
immunosuppression. Appellants have not established that issues associated
with organ transplantation generally are not similar in the case of pancreas
and/or islet cell transplantation. In both instances, organ viability is a
concern addressed by those of ordinary skill in the art, and immune
suppressant ability is a known parameter which those of ordinary skill in the
art optimize to achieve organ viability.
We limit this decision to the elected species and take no position with
respect to the patentability of the broader generic claims, including the
remaining, non-elected species. See Ex parte Ohsaka, 2 USPQ2d 1461 (Bd.
Pat. App. Int. 1987).
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Application 13/500,544
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejection,
which is affirmed for the reasons of record. All pending, rejected claims
fall.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 41.50(±).
AFFIRMED
14
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LORENZO PIEMONTI, LUISA DAFFONCHIO, and
MARCELLO ALLEGRETTI
Appeal2017-000095
Application 13/500,544
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge, dissenting.
I respectfully dissent. In my view, the Examiner's conclusion that a
person of ordinary skill in the art would have considered it obvious to add
repertaxin6 to the immunosuppressive agents used by Shapiro is not
supported by a preponderance of the evidence or by the rationale of In re
Kerkhoven, 626 F .2d 846 (1980). Rather, I agree with Appellants that "the
glucocorticoid-free immunosuppressive agents of Shapiro and the Repertaxin
of Bertini and Hezi-Yamit were not understood by one of ordinary skill in the
art at the time of the invention to be useful for the same purpose, and there
was no reasonable expectation that the modification of Shapiro would have
yielded a protocol useful for islet cell transplantation." Appeal Br. 4.
6 Repertaxin is also referred to as DF-1681 or 2(R)-(4-isobutylphenyl)-N-
(methylsulfonyl)propionamide (Hezi-Yamit, 49) or, by the Examiner, as
R)-ibuprofen methanesulfonamide (Ans. 8).
Appeal2017-000095
Application 13/500,544
The Examiner concludes that "it would have been prima facie obvious
to combine glucocorticoid-free immunosuppressive agents and rapertaxin
[sic] composition cojointly in a formulation as a immune suppressive agents
to treat rejection of pancreatic islet transplant." Final Action7 10. The
Examiner cites In re Kerkhoven for the proposition that "[i]t is prima facie
obvious to combine two compositions each of which is taught by the prior art
to be useful for the same purpose, in order to form a third composition which
is to be used for the very same purpose." Id. at 9-10.
The only evidence in the cited references, however, that repertaxin isw
an immunosuppressant is provided by Hezi-Yamit, which states that
"repertaxin ... is being developed by Dompe Farmaceutici for treatment of
transplant rejection. It is believed to be an anti-inflammatory/
immunosuppressant, specifically an IL-8 antagonist." Hezi-Yamit ,r 49.
Hezi-Yamit does not disclose that repertaxin is actually effective in the
treatment of transplant rejection, or that it is in fact an immunosuppressant,
much less that it is effective as an immunosuppressant in pancreatic islet cell
transplantation. In addition, the evidence of record shows that, even if
repertaxin was known to be an immunosuppressant, not all
immunosuppressants are effective in preventing rejection of islet cells.
Shapiro states that islet cell transplantations carried out using a
"regimen of immunosuppression consist[ing] of antibody induction with an
antilymphocyte globulin combined with cyclosporine, azathioprine, and
glucocorticoids" resulted in only 12.4% of patients reaching insulin
independence for periods of more than one week and only 8.2% having done
7 Office Action mailed Aug. 24, 2015.
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so for more than one year. Shapiro 230, right col. Shapiro also discloses
that, although the "combination of sirolimus, low-dose tacrolimus, and
glucocorticoids in liver, kidney, and pancreas transplantation has been
associated with extremely low rates of rejection," glucocorticoids have a
diabetogenic effect; for islet cell transplantion, Shapiro replaced the
glucocorticoids with a monoclonal antibody against the interleukin-2
receptor. Id. at 237, left col.
Shapiro therefore provides evidence that simply because a compound
was known to be an effective immunosuppressant-and the cited evidence
does not show that repertaxin was-that alone would not suggest that it
would be effective in the specific context of islet cell transplantation. The
evidence of record therefore does not support the Examiner's conclusion that
Shapiro's combination of immunosuppressants, on the one hand, and
repertaxin, on the other, were "taught by the prior art to be useful for the
same purpose" (Final Action 10), and In re Kerkhoven does not apply to the
facts of this case.
The Examiner alternatively reasons that it would have been obvious to
add repertaxin to Shapiro's islet cell transplantation procedure, because
Bertini discloses that repertaxin protects organs against reperfusion injury.
Ans. 9. Bertini indeed discloses that "[ r ]epertaxin ... protects organs against
reperfusion injury." Bertini 11791, abstract. Bertini also states that "RI
[reperfusion injury] plays an important role under different pathological
conditions, including ... transplantation" and "is unavoidable in organ
transplantation, occurring during organ retrieval and storage." Id. at 11796,
left col.
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As Appellants have pointed out (Appeal Br. 5), however, islet cells are
not organs. The Examiner has not pointed to evidence in the record showing
that islet cells are subject to reperfusion injury during an islet cell
transplantation procedure. The Examiner's conclusion that combining
repertaxin with Shapiro's procedure in order to avoid reperfusion injury is
therefore not supported by a preponderance of the evidence.
In summary, I do not find the cited evidence sufficient to support either
of the Examiner's rationales for combining repertaxin with Shapiro's islet
cell transplantation procedure. I would reverse the rejection.
4