John D. Lambris et al.

Patent Trials and Appeals Board

Oct 7, 2019

12918101 - (D) (P.T.A.B. Oct. 7, 2019)

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.
12/918,101 11/08/2010 John D. Lambris 34092-058
[U4659 US PCT]
6137
26691 7590 10/07/2019
POTTER ANDERSON & CORROON LLP
ATTN: JANET E. REED, PH.D.
P.O. BOX 951
WILMINGTON, DE 19899-0951
EXAMINER
GAMBEL, PHILLIP
ART UNIT PAPER NUMBER
1644
MAIL DATE DELIVERY MODE
10/07/2019 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 JOHN D. LAMBRIS and MACIEJ M. MARKIEWSKI 1
Appeal 2019-002574
Application 12/918,101
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treating an individual having a tumor, which have been rejected
as lacking adequate written description and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the Real Party in Interest as the Trustees of the
University of Pennsylvania. Appeal Br. 3. We use the word Appellant to
refer to “applicant” as defined in 37 C.F.R. § 1.42(a).
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Application 12/918,101

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STATEMENT OF THE CASE
The Specification states that the complement system is a “potential
player in the response to cancer.” Spec. 2. “Of the[] complement
components, the C3 protein is considered to be central to the complement
cascade. Enzymatic cleavage of C3 leads to the production of . . . [C3a] and
C3b,” and “C3b . . . is [] a main component of the C5 convertase, an enzyme
complex that cleaves C5 to produce the anaphylatoxin C5a and C5b.” Id.
The Specification discloses that “the complement system and
particularly C5a contribute to mechanisms that promote the growth of
malignant tumors.” Id. at 10.
One aspect of the invention features a method for
treating an individual having a malignant tumor, the
method comprising administering a therapeutically
effective amount of a complement inhibitor to the
individual, wherein the complement inhibitor reduces or
prevents C5a receptor signaling in the tumor, thereby
preventing, reducing or delaying growth of the tumor.
Id. at 3. “In [one] embodiment, formation of C5a is reduced or prevented
through the use of a C3 inhibitor. Preferably, the C3 inhibitor is compstatin
or a compstatin analog, derivative,” etc. Id. at 12. Exemplary compstatin
analogs have the sequences shown in SEQ ID NO: 2 and SEQ ID NO: 3. Id.
Claims 1, 9–11, 24, 29–32, and 34 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method for treating an individual having a tumor, the
method comprising the steps of:
(1) providing an individual having a tumor;
(2) administering to the individual a therapeutically effective
amount of a complement inhibitor comprising a
pharmaceutically acceptable carrier and at least one polypeptide
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Application 12/918,101

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having an amino acid sequence selected from the group
consisting of SEQ ID NO:2 and SEQ ID NO:3;
(3) measuring the size of the tumor in the individual;
wherein the administering of the complement inhibitor results
in a reduction in tumor size, or a delay or prevention of increase
in tumor size, thereby treating the individual having the tumor.

Claim 29 is also independent and is directed to a “method of reducing
or delaying growth or development of a tumor disposed within an
individual,” comprising the same active steps as claim 1.
The claims stand rejected as follows:
Claims 1, 9–11, 24, 29–32, and 34 under 35 U.S.C. § 112, first
paragraph, as lacking adequate written description in the Specification (Final
Action2 3) and
Claims 1, 9–11, 24, 29–32, and 34 under 35 U.S.C. § 103(a) as
obvious based on Chiang,3 Lambris ’899,4 Lambris ’328,5 Mass,6
Ignatovich,7 and Chelsky8 (Final Action 7).

2 Office Action mailed March 8, 2018.
3 Chiang et al. (US 2005/0222027 A1, published Oct. 6, 2005).
4 Lambris et al. (WO 99/13899, published Mar. 25, 1999).
5 Lambris (WO 2004/026328 A1, published Apr. 1, 2004).
6 Mass (US 7,993,834 B2, issued Aug. 9, 2011).
7 Ignatovich et al. (US 2005/0271663 A1, published Dec. 8, 2005).
8 Chelsky et al. (US 2007/0269434 A1, published Nov. 22, 2007).
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Application 12/918,101

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OPINION
Written Description
The Examiner has rejected all of the claims on appeal on the basis that
the Specification does not adequately describe the claimed method. The
Examiner finds that
the specification as filed does not appear to provide
sufficient written description of applying the claimed
series of steps, including measuring the size of the tumor
in the individual are not readily apparent with respect to
the claimed methods of treating an [sic] and methods of
reducing or delaying growth or development of a tumor
disposed with[in] an individual in treating humans as
claimed as currently claimed [sic] (e.g., see Summary of
the Invention, Description of the invention including
pages 10–11 of the specification noted in applicant’s
remarks previously presented).
Final Action 6. See also id. (“[A]pplicant fails to provide written description
of the current claims in the context of methods of treating a human
individual having a tumor and combining steps (1) providing,
(2) administering and (3) measuring tumor size in treating humans.”); Ans. 8
(“[T]he specification as filed does not appear to provide sufficient written
description of applying the claimed series of steps, including measuring the
size of the tumor in the individual,” emphasis in original).
As we understand it, the Examiner’s position is that the Specification
does not adequately describe a method of treating a human individual in the
manner claimed, including a step of measuring the size of the tumor.
Appellant argues that, “when the teachings of the specification are
fully considered, the skilled artisan would have no doubt that Appellants had
possession of the measuring step at the time of filing.” Appeal Br. 16.
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Appellant argues that the Specification “explicitly stated that an aspect of the
invention is to treat an individual (which includes an animal or a human)
having a tumor with complement inhibitor, wherein the complement
inhibitor prevents, reduces, or delays growth of the tumor (see specification
at page 3, second full paragraph).” Id. at 17.
Appellant also argues that the Specification’s Example 3 describes
measuring tumor size in mice and “the skilled artisan would immediately
understand that any appropriate tumor measurement technique is suitable for
use with the claimed method.” Id. at 18. Appellant reasons that the
disclosure of measuring a mouse tumor with a caliper
reasonably conveys to the skilled artisan that Appellants
had possession of a method of treating a tumor that
includes any appropriate technique for tumor measuring
because the particular selection of the tumor measuring
technique is not important and will not materially change
the effect the compstatin analog would have on
treatment.
Id. at 19.
We agree with Appellant that a person of ordinary skill in the art
would recognize the Specification as showing that Appellant was in
possession of the claimed method at the time the application was filed. To
satisfy 35 U.S.C. § 112, first paragraph, the “description must ‘clearly allow
persons of ordinary skill in the art to recognize that [the inventor] invented
what is claimed.’” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (alteration in original).
“In other words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those skilled in the art that
the inventor had possession of the claimed subject matter as of the filing
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date.” Id. “Requiring a written description of the invention limits patent
protection to those who actually perform the difficult work of ‘invention’—
that is, conceive of the complete and final invention with all its claimed
limitations—and disclose the fruits of that effort to the public.” Id. at 1353.
Here, the Specification states that
[o]ne aspect of the invention features a method for
treating an individual having a malignant tumor, the
method comprising administering a therapeutically
effective amount of a complement inhibitor to the
individual, wherein the complement inhibitor reduces or
prevents C5a receptor signaling in the tumor, thereby
preventing, reducing or delaying growth of the tumor.
The methods of the invention may be applied to any
individual, including humans and animals. In one
embodiment, the individual is human.
Spec. 3. The Specification thus describes a method of treating a human
individual to prevent, reduce, or delay growth of a tumor. The Specification
also describes polypeptides comprising the amino acid sequence of SEQ ID
NO: 2 or SEQ ID NO: 3 as C3 inhibitors for use in the disclosed method. Id.
at 12.
The Specification describes an experiment in which the size of tumors
was measured during the course of treatment with a C5a receptor antagonist.
Id. at 17. The Specification also describes an experiment in which tumor
volumes were measured after tumor cell inoculation of C3-deficient mice.
Id. at 24. The Specification thus describes methods in which complement
was inhibited in an individual (either via administration of a C5a receptor
antagonist or via innate deficiency in C3) and the size of tumors was
measured.
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It is true that the working examples were carried out using mice, not
humans, but a specification need not exemplify every aspect of a claimed
invention in order to show possession to those skilled in the art. See Ariad,
598 F.3d at 1352 (“[T]he written description requirement does not demand
either examples or an actual reduction to practice.”). Here, we conclude that
those skilled in the art would recognize from the Specification’s description
that Appellant was in possession of the claimed method as of the effective
filing date of the claimed invention.
We therefore reverse the rejection of claims 1, 9–11, 24, 29–32, and
34 under 35 U.S.C. § 112, first paragraph, based on lack of adequate written
description.
Obviousness
The Examiner has rejected all of the claims on appeal as obvious
based on Chiang, Lambris ’899, Lambris ’328, Mass, Ignatovich, and
Chelsky. The Examiner finds that
Chiang et al. teach compositions and methods for
treating pain, including cancer-related pain, where
cancer-related pain results from tumor growth
compression of adjacent tissues as well as the injury
caused by cancer treatments such as chemotherapy . . . by
modulating the expression or activity of one or more
components of the complement pathway including
compstatin . . . via various modes and dosages of
administration.
Final Action 15. The Examiner finds that Chiang “differs from the claimed
invention by not exemplifying the treatment of a patient with malignant
tumor with compstatin and by not describing all of the compstatin analogs
encompassed by the claimed invention.” Id.
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The Examiner finds that Lambris ’899 discloses “inhibiting
complement activation and complement-mediated tissue injury in diseases
involving complement-mediated damage with complement-inhibiting
compounds of compstatin and its analogs specific for C3 activation.” Id. The
Examiner finds that Lambris ’328 “teaches that compstatin inhibits the
cleavage of C3 to C3a and C3b by C3 convertase, as well as compstatin
analogs.” Id.
The Examiner finds that “Mass teaches that therapeutically effective
amounts for cancer therapy and efficacy can be measured by assessing the
time for disease progression, survival, tumor size and response rates.” Id. at
14. The Examiner finds that Ignatovich teaches that “treatment is considered
effective if one or more symptoms is reduced . . . including . . . monitoring
physical manifestations (e.g. inflammation, tumor size).” Id. at 11. The
Examiner finds that Chelsky teaches that a “therapeutically effect[ive]
amount of agent can be determined by monitoring an amelioration or
improvement in disease symptoms to delay onset of [sic] slow progression
of the disease, for example without limitation, a reduction in tumor size.” Id.
The Examiner concludes that it would have been obvious
to provide compstatin and compstatin analogs as taught
by the prior art for inhibiting complement formation and
activation in the context of treating individuals having a
malignant tumor, where the individuals experiencing the
pain associated with the malignant tumor itself and/or the
treatment of said malignant tumor targeting / inhibiting
complement activation via C3, as taught by the prior art
at the time the invention was made, given the teachings
of the applicability of compstatin and compstatin analogs
to inhibit such cancer-related pain.
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Id. at 15. The Examiner reasons that “the patients having cancer-related pain
. . . would be the same patients having malignant tumors being administered
the same active agent (compstatin and compstatin analogs) . . . in both the
instant claims and the prior art reference.” Id. at 16.
Appellant argues that “Chiang teaches compositions and methods for
treating pain by ‘modulating the expression of one or more components of
the complement pathway.’ . . . While the pain thus treated can be caused by
cancer or by cancer treatments, Chiang nowhere suggests the use of
complement inhibitors to treat the cancer instead of the pain.” Appeal Br. 27.
“[W]ithout a connection between complement inhibition and tumor growth
itself, there would be no reason to believe that the complement inhibitors
(e.g., compstatin analogs) would actually reduce the size of the tumor and,
therefore, no obvious reason to measure the tumor size.” Id. That is, “under
Chiang’s teaching, when an individual is being evaluated for the
effectiveness of a treatment, that evaluation is solely based on the level of
pain. Therefore, Chiang provides no suggestion that would motivate the
skilled artisan to add a step relating to measuring tumor size.” Id. at 29.
Appellant argues that the Lambris references “do not remediate the
deficiencies of Chiang because these references make no mention of
measuring indicators of tumor growth and development and fail to recognize
the link between complement inhibition and tumor growth and
development.” Id. Appellant also argues that “Mass fails to recognize the
link between complement inhibition and tumor growth and development,”
and “neither Ignatovich nor Chelsky has anything to do with complement
activation in relation to cancer.” Id. at 30. Appellant concludes that
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there is nothing in the secondary references that
recognizes, or would enable the skilled artisan to
recognize, the connection between complement
inhibition with compstatin analogs and the reduction or
delay in tumor growth and/or development. As such,
there is nothing in any of the references cited by the
examiner, either alone or in combination, that would
suggest identifying an individual having a tumor,
administering a compstatin analog, and measuring tumor
size in a method of treating the individual having the
tumor.
Id. at 30–31.
We agree with Appellant. Chiang states that its “invention is in the
field of therapeutic agents for pain treatment.” Chiang ¶ 2. Chiang “provides
compositions and methods for treating pain that act through the modulation
of a component of the complement pathway.” Id. The complement
component can be a complement inhibitor, including compstatin. Id. ¶¶ 102,
122. And the pain treated using Chiang’s method can be cancer pain. Id.
¶¶ 127, 128. But the Examiner has not pointed to any teaching in Chiang
indicating that its method is effective in treating cancer itself, as opposed to
alleviating pain resulting from cancer, and thus the Examiner has not
identified a reason in Chiang that would lead a skilled artisan to measure
tumor size.
Lambris ’899 discloses “peptides and peptidomimetics capable of
binding the C3 protein and inhibiting complement activation.” Lambris ’899
1:10–12. Lambris ’899 states that “[c]omplement-mediated tissue injury has
been reported in a wide variety of diseases, including autoimmune diseases
. . . [,] adult respiratory distress syndrome, stroke, heart attack,” etc. Id. at
1:22–29.
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Lambris ’328 also discloses “peptides and peptidomimetics capable of
binding the C3 protein and inhibiting complement activation.” Lambris ’328
¶ 3. Lambris ’328 states that “[c]omplement is implicated in several disease
states, including various autoimmune diseases, and has been found to
contribute to other clinical conditions such as adult respiratory syndrome,
heart attack,” etc. Id. ¶ 5.
The complement-associated diseases and conditions listed in the
Lambris references do not include cancer. The Examiner has not identified
any disclosure in either of the Lambris references of treating cancer using a
complement inhibitor. The Examiner cites Mass, Ignatovich, and Chelsky
only for the disclosure that the efficacy of cancer therapy can be determined
by, for example, measuring the change in tumor size. See Mass 8:17–26;
Ignatovich ¶ 658; Chelsky ¶ 422. Again, however, the Examiner has not
identified any disclosure in any of these references that would suggest using
a complement inhibitor to treat cancer.
In short, the Examiner has not identified any teaching in the cited
references that would have led a skilled artisan to expect that administering a
complement inhibitor would be effective in treating cancer. Therefore, the
Examiner has not shown that a person of ordinary skill in the art would have
had a reason to combine (a) a step of administering one of the complement
inhibitors encompassed by the claims to an individual having a tumor, and
(b) a step of measuring the size of the tumor in the individual.
Because the rejection under 35 U.S.C. § 103(a) is not supported by a
preponderance of the evidence, we reverse it.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Basis  Affirmed Reversed
1, 9–11, 24,
29–32, 34
112, ¶ 1 Written description  1, 9–11,
24, 29–32,
34
1, 9–11, 24,
29–32, 34
103(a) Chiang, Lambris ’899,
Lambris ’328, Mass,
Ignatovich, Chelsky 
1, 9–11,
24, 29–32,
34
Overall
Outcome
1, 9–11,
24, 29–32,
34

REVERSED