Ex Parte Elia

Patent Trial and Appeal Board

Mar 14, 2016

13038563 (P.T.A.B. Mar. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/038,563 03/02/2011
45018 7590 03/16/2016
GERALD K. WHITE & ASSOCIATES, P.C.
13414 W. Oakwood Ct.
Suite 100
Homer Glen, IL 60491-8154
FIRST NAMED INVENTOR
James P. Elia
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.
1000-10-C2B 9077
EXAMINER
EMCH, GREGORY S
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
03/16/2016 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):
gkwpatlaw@aol.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES P. ELIA
Appeal2013-002510
Application 13/038,563 1
Technology Center 1600
Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
ERICA A. FRANKLIN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims to methods of treating a brain in a human
patient having a damaged portion caused by a stroke. The Examiner rejected
the claims for lack of enablement. We have jurisdiction under 35 U.S.C. §
134.
We affirm the rejection.
1 The specification of the application is referred to herein as "the '563
Specification" or "the '563 Spec" and is the substitute specification filed
March 17, 2011.
Appeal2013-002510
Application 13/038,563
STATEMENT OF THE CASE
The claims are drawn to methods of treating a brain in a human
patient having a damaged portion caused by a stroke. The claims comprise
the step of "placing a growth factor at a selected area of said human patient
and forming an artery in said brain."
Appellant appeals from the Examiner's final rejection of claim 125-
148, which are all the pending claims. Claims 125-148 stand finally
rejected by the Examiner under 35 U.S.C. § 112, first paragraph (pre-AIA),
as failing to comply with the enablement requirement. Final Rej. 2. Since
Appellant has not argued the claims separately, we select claim 125, the sole
independent claim, as representative for deciding the disposition of the
rejection. 37 C.F.R. § 41.37(c)(l)(vii).
Claim 125 reads as follows:
A method of treating a brain in a human patient having a
damaged portion caused by a stroke comprising the steps of
placing a growth factor at a selected area of said human patient
and forming an artery in said brain thereby causing said
damaged portion of said brain to be repaired.
RELATED APPEALS
The '563 Application is related to Application 09/794,456 which was
the subject of Appeal 2011-013556 appealed to the Patent Trial and Appeal
Board (PTAB). The appeal was decided Sept. 28, 2012. The Examiner's
rejection was affirmed. The application has been abandoned.
The '563 application is also related to Application 11/986,690. The
final rejection of the claims in that application has been appealed to the
PT AB, but no decision has been entered.
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ENABLEMENT REJECTION
Under 35 U.S.C. § 112, first paragraph (pre-AIA), the "specification
shall contain a written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise, and exact terms
as to enable any person skilled in the art to which it pertains, or with which it
is most nearly connected, to make and use the same." "[T]o be enabling, the
specification of the patent must teach those skilled in the art how to make
and use the full scope of the claimed invention without 'undue
experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed. Cir.1993)
(citing In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991)); In re Wands, 858
F.2d 731, 736-37 (Fed. Cir. 1988); In re Fisher, 57 C.C.P.A. 1099, 427 F.2d
833, 839 (1970). In determining whether "undue" experimentation is
required to make and use a claimed invention, courts may consider the
following factors:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, ( 4) the nature of the invention, ( 5) the state
of the prior art, ( 6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.
Wands, 858 F.2d at 737 (Fed. Cir. 1988).
Since the full scope of the claim must be enabled, we must begin by
determining what subject matter is embraced by the claim.
Claim 125 is directed to a method of "treating a brain in a human
patient having a damaged portion caused by a stroke." The claim comprises
two steps: 1) "placing a growth factor at a selected area of said human
patient; and 2) "forming an artery in said brain." These steps "caus[e] said
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damaged portion of said brain to be repaired." Thus, the claim does not
merely require that an artery be formed in the brain, but it requires that the
brain be "repaired."
We have not been directed to, nor do we find, a definition of
"treating" or "repaired" in the '563 Specification. Accordingly, we adopt
their ordinary meaning from a general purpose dictionary: for "treat,"
namely, "to deal with (a disease, patient, etc.) in order to relieve or cure"2
and for "repair," namely, "to restore to a good or sound condition after decay
or damage; mend."3 In other words, the formed artery must relieve and
restore at least some brain damage caused by the stroke.
1. Breadth of "growth factors"
The scope of claim 125 is broad. Specifically, the claims encompass a
"growth factor" which enables forming an artery and repairing damage to
the brain. The '563 Specification defines "growth factor" as follows:
As used herein, the term growth factor encompasses
compositions and living organisms which promote the growth
of hard tissue, such as bone, or soft tissue, in the body of a
patient. The compositions include organic and inorganic matter.
The compositions can be genetically produced or manipulated.
The living organisms can be bacteria, viruses, or any other
living organism which promote tissue growth.
'563 Spec. 6: 4--9.
Growth factors include various polypeptides (id. at 6:9-15; 7:16-24),
enzymes (11 :22-23), cellular products and derivatives (15: 11 ), "chemical
regulators and structural/mechanical regulators" (23: 5---6), an enucleated
2 http://dictionary.reference.com/browse/treat. Accessed February 2, 2016.
3 http://dictionary.reference.com/browse/repair. Accessed February 2, 2016.
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ovum (34:20-21 ), and other subunits of a cell (34:21 ). Appellant also
contends that cells are a type of growth factor (Appeal Br. 11 ), an assertion
consistent with the definition of growth factor as encompassing "living
organisms" and the specific disclosure of an enucleated ovum.
Despite the disclosure of a broad genus of growth factors, there is
sparse guidance on what growth factors would be effective in forming an
artery in the brain and causing it to treat and repair brain damage. On page 7
of the '563 Specification, there is a non-limiting list of about 21 "angiogenic
growth factors" that would induce angiogenesis and artery formation. 4
However, we have not been directed to any disclosure in the '563
Specification that would teach one of ordinary skill in the art which of those
cause artery growth in the brain in sufficient amounts to repair brain damage
nor how to make such a determination.
The '563 Specification specifically teaches that "vascular epithelial
growth factor gene (VEGF) or its growth factor equivalent can be inserted
into the body to cause an artery to grow." '563 Spec. 24: 14--16. Bone
morphogenic protein ("BMP") is also mentioned. Id. at 30: 17-19. Example
17 describes injecting plasmids encoding VEGF to promote artery growth in
the leg. Id. at 35. See also Examples 33-35. Id. at 46-47. Example 18
further describes the fibroblast growth factor family and endothelial cell
growth factor to grow arteries. Id. at 38. However, none of these examples
describe using VEGF, or any other peptide growth factor to cause artery
formation in the brain and repair a damaged portion as a result. Specifically,
4 "Angiogenesis would be one of the positive processes involved in the
whole organogenesis process of growing an artery." '563 Specification 53:
1-3.
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there is no description of how the growth factor would be introduced into the
brain, how much is needed, and when it would be introduced.
Other than peptides as growth factors, the '563 Specification does not
provide guidance on enzymes, cellular products and derivatives, chemical
regulators and structural/mechanical regulators, and subunits of cells which
would be effective at growing an artery in the brain and achieving brain
repair.
With respect to the use of cells as growth factors, which is specifically
claimed in claim 126, we have not been pointed to guidance in the '563
Specification as to what cell types would be effective as growth factors that
promote artery formation in the brain and brain repair. It is not even clear
on this record how a cell would serve as a growth factor. For example,
Appellant has not explained whether the cell secretes or otherwise produces
a growth factor, such as one of the growth factors disclosed in the '563
Specification, or whether the cell, itself, forms the artery and serves as a
growth factor in this capacity.
As discussed above, the '563 Specification describes peptide growth
factors as causing artery formation, but we have not found a description of
cells that do the same. The '563 Specification discloses that "germinal cells
(and in some cases, stem cells) are utilized, a direct differentiation and
morphogenesis into an organ can occur." '563 Spec. 29:4---6. The
Specification also teaches that organs and tissues can be formed utilizing a
patient's own cells, such as a skin cell from a cheek or germinal cells. Id. at
27:19-21; 28:7-10. Stem cells derived from bone marrow are also
described. Id. at 20:24--25. These cells are used to produce an eye. Id. at
21: 5-7. However, we have not been directed to specific guidance in the
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'563 Specification describing how these cells would be used to form arteries
in the brain.
Example 42 describes using VEGF and a human embryonic stem cell
(with human casanova (cas) gene, PTF1p48 and/or PDX-1 genes inserted) to
direct and control the growth of a pancreas. Id. at 65:23-25. However, the
stem cell is apparently engineered to grow pancreas tissue (id. at) while
VEGF is for inducing blood vessel formation (id. at). Thus, while there is
general disclosure on using cells to produce tissues, which would include
artery formation, there is little guidance on what cell types would be
effective, and in an example where a cell is utilized in the context of artery
formation, it is used to form pancreas tissue, not arteries.
In sum, despite the broad reach of the claim embracing a widely
diverse universe of growth factors - including polypeptides, regulators, cell
products, cell subunits, and cells - there is only concrete guidance on
forming arteries using a handful of polypeptide growth factors, and none that
we have been directed to of forming an artery in a brain to achieve brain
repair and treatment as required by the claim.
2. Pre-filing and post-filing evidence
Enablement is determined as of the application filing date. In re
Hogan, 559 F.2d 595, 604 (CCPA 1977). A publication by Walters was
cited by the Examiner as evidence that the administration of cells "to a
stroke patient does not automatically result in brain repair or formation of
new arteries." Answer 4. Walters5 was published prior to the application
5 Walters, et al., Bone Marrow Transplantation for Sickle Cell Disease, The
NEW ENG. J. MED., vol. 335, No. 6 (1996).
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filing date and is thus pertinent to the state of the prior art at the time the
application was filed.
Walters describes administration of donor bone marrow cells to
children who had symptomatic sickle cell disease. Walters, Abstract.
Twelve of the patients had a history of stroke. Id. Several other patients had
evidence of "silent" cerebral infarction on cerebral MRI. Id. at 371 (col. 1).
Table 3 of Walters summarizes results after transplantation, and reports no
change or normal for most of the patients. However, one patient ( 19) who
was abnormal prior to cell transplantation had a "New CVA"
( cerebrovascular accident) and another ( 4) experienced intracranial
hemorrhage (ICH) and died. Id. at 374 (col. 1). Walters stated:
All eight survivors with a history of stroke and stable donor-cell
engraftment were studied with serial cerebral MRI and
magnetic resonance angiography. As of this writing, they have
had no progression of cerebral disease. The two patients with
"silent" cerebral infarction before transplantation have had no
changes on cerebral l\1RI.
Id. at 374 (col. 2)
Walters also stated that the "optimal timing of marrow transplantation
in the course of sickle cell anemia remains uncertain, in part because of the
unpredictable nature of the disease." Id. at 375 (col. 2). Walters suggested
that earlier transplantation might be better, "especially in patients with
neurovascular disease (silent stroke)." Id.
Thus, as found by the Examiner, Walters administered cells to patients
but did not observe an improvement in MRI nor report that brain repair or
artery growth had occurred. Answer 4--5. Appellant points out that a "toxic
mixture of drugs [busulfan, cyclophosphamide, and antithymocyte globulin]
... were administered prior to the bone marrow transplant" in order to
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suppress the immune system to prepare for transplantation and avoid tissue
rejection. Appeal Br. 17-18. Because of this toxicity to the patient,
Appellant states "it is little wonder that Walters did not form an artery and
that none of the 12 stroke patients demonstrated any improvement of the
brain, as measured by MRI." Id. at 18.
Nonetheless, claim 125 is unrestricted as to the class of patients that
could be treated with a growth factor to cause artery formation. The '563
Specification does not provide guidance on which patients, such as patients
concurrently treated with a drug, would not experience artery formation and
brain repair after administration of a growth factor.
In addition to Walters, there is extensive discussion in the record
about the Bang,6 Leung,7 Dihne,8 Lindvall, 9and Lin10 publications. Each of
these publications was published after the filing date of the '563
Specification. The publications don't establish that, as of the application
filing date, the '563 Specification was enabled for its full scope.
6 Bang et al., Autologous Mesenchymal Stem Cell Transplantation in Stroke
Patients, American Neurological Association, 874-882, Vol. 57, No. 6
(2005).
7 Leung, Stem Cells From Bench to Bedside Neurological Application,
Medical Bulletin, Vol. 12, No. 4 (2007).
8 Dilhne et al., Restoring Neuronal Function After Stroke by Cell
Replacement: Anatomic and Functional Considerations, Stroke Journal of
the American Heart Association, 2341-2350 (2011).
9 Lindvall et al., Stem Cell Research in Stroke: How Far From the Clinic?
Stroke Journal of the American Heart Association, 2368-2375 (2011).
10 Lin et al., Human Umbilical Mesenchymal Stem Cell Promote Recovery
After Is chemic Stroke, Stroke Journal of the American Heart Association,
2044-2053 (2011).
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The publications describe mesenchymal stem cells (Bang, Abstract;
Dihne, 2345; Lindvall, legend to Fig. 1; Lin, Abstract), umbilical cord blood
(Dihne, 2345; Lin, Abstract), and embryonic stem cells (Dihne, 2344;
Lindvall, Abstract) to treat stroke. As discussed above, the '563
Specification discloses a genetically engineered human embryonic stem cell
to grow pancreas tissue, but does not provide guidance on how to use it for
artery growth. Dihne describes the use of embryonic stem cells to restore
the brain after stroke, but the mechanism is by differentiation into neurons,
not artery formation as required by the claims: "Neural populations derived
from murine and human ES [embryonic stem] cells have already been shown
to differentiate into neurons after transplantation into adult animal stroke
models." Dihne 2344 (under "Perspective I") (footnotes omitted).
The '563 Specification discloses stem cells from blood or bone
marrow ('563 Spec. 15:3-5; 19:14--15). Lin teaches that blood vessels are
formed in the brain after transplantation of human umbilical mesenchymal
stem cells (HUMSCs ). Lin 2052; Appeal Br. 20-21. Lindvall also
described reports in which "umbilical cord blood and bone marrow-derived
hematopoietic stem cells, mesenchymal stromal cells (BMSCs ), and
mesenchymal stem cells" showed functional benefits in animal models of
stroke. Lindvall 2371-2372; Appeal Br. 19-20. To the extent that Lin,
Lindvall, etc., are evidence of enablement, they do not support the full scope
the claims. Appellant has not explained how evidence that umbilical blood,
bone marrow, and mesenchymal stem cells can treat stroke is sufficient to
enable the full scope of the claims which embraces any effective growth
factor, cell type, cellular products, and derivatives.
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Even for claim 127 directed to stem cells, there is no adequate
evidence in the record that the efficacy of specific types of stem cells for
promoting artery growth would predict efficacy of other types of stem cells
embraced by the claims. In fact, as explained above, embryonic stem cells
were found by Dihne to differentiate into neurons, not arteries. Dihne, 2345.
In addition, while bone marrow derived cells may be effective under
certain conditions in growing an artery in the brain (Lindvall), they are not
effective under all conditions (Walters). This is further supported by Bang,
another post-filing publication. Bang utilized mesenchymal stem cells
isolated from bone marrow cells. Bang 875. Bang reported that the MSC
cells improved recovery from stroke in animals (id., Abstract). However,
Bang did not assert that improved recovery was due to new artery growth, as
acknowledged by Appellant. Appeal Br. 18. Bang further supports the
position that it was unpredictable at the time of the invention as to what cell
type would be effective: "It remains uncertain which type of cell would be
most appropriate for transplantation into stroke patients." Bang 879.
Appellant contends that Bang was discussed by an article authored by
Leung which "concluded that the isolated mesenchymal stem cells used by
Bang were of questionable capability and authenticity." Appeal Br. 18
(emphasis added).
We do not see evidence to support Appellant's contention that the
cells in Bang had questionable authenticity according to Leung. Leung
stated on page 26:
Bang et al, conducted a randomised controlled trial using
intravenously administered MSC on patients with middle
cerebral artery (MCA) infarction. There were no adverse effects
and the transplanted patients showed improvement in both
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Barthel Index and Modified Rankin's Score. One key issue is
the ability of MSC, which are mature differentiated 'adult'
cells, to 'transdifferentiate' into cells of the neural lineage. This
has been questioned by some authorities, who suggested that
apparent transdiff erentiation was in fact the results of fusion
with other mature cells. Further studies are underway to
investigate the precise roles of MSC in neurotransplantation.
Nonetheless, even if true there were doubts about the cells utilized by
Bang, such evidence only further establishes the need for undue
experimentation because, even after the filing date, there was uncertainty
about the authenticity of stems cells and the mechanism through which the
cells improved recovery after stroke. Thus, Bang provides evidence that it
still was not known what cells caused new artery formation and how to
isolate them without undue experimentation.
Appellant states:
Considering the evidence of Dihne, Lindvall, and Lin, there can
be no doubt that growth factors, such as various types of cells,
can be employed to grow arteries in a human brain and cause
dead or damaged portions of the brain to be repaired.
Appeal Br. 21.
Appellant's statement fails to address the fact that the publications
were concerned mainly with certain specific types of stem cells, while claim
125 is directed to a broad class of growth factors. Appellant has not
provided an adequate explanation as to why the limited evidence involving
stem cells establishes enablement for the full scope of the claim.
3. Expert testimony
Appellant relied on a "Fourth Supplemental Declaration of Dr.
Richard Heuser" and a "Third Supplemental Declaration of Dr. Andrew E.
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Lorincz" as evidence of enablement. The declarations were submitted in
related Application Serial No. 09/794,456.
Dr. Heuser's declaration was originally for the purpose of establishing
enablement for growing arteries in the heart. Dr. Heuser testified about the
disclosure in the specification of the patent application 09/794,456 about
growth factors and stem cells. Heuser Fourth Suppl. Deel. i-f 5. Dr. Heuser
testified that "it is my opinion that one skilled in the medical arts, armed
with the knowledge in the disclosures referenced therein, would be enabled
to practice the method set forth in Fourth Supplemental Declaration Exhibit
C and to predictably anticipate the results defined therein without need for
resorting to undue experimentation." Id. at i-f 7. However, Dr. Heuser did
not provide reasoning to support his testimony. Dr. Heuser did not explain
how the disclosure in the patent application enables the full scope of the
claim.
Dr. Lorincz's declaration was also originally for the purpose of
establishing enablement for growing arteries in the heart. It is substantially
the same as Dr. Heuser's declaration in citing disclosure in the application
about growth factors and stem cells without explaining how such disclosures
are sufficient to enable the claims.
4. Level of skill in the art
The Examiner found that the level of skill in the art was "high."
Answer 6. Appellant agreed, stating that "the skill level is high when it is
considered that many years of education, training, and experience are
required in the medical field to achieve a high level of skill, especially in the
field to which the claimed invention pertains." Appeal Br. 29. We find
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neither statement helpful in determining whether it would require undue
experimentation to practice the full scope of the claim.
Nonetheless, Walters, which is coauthored by MDs, a PhD, and an
RN, provides evidence that one of ordinary skill in the art was medically
trained and had the skill to transplant cells into humans in need of
therapeutic intervention. For this reason, we find it reasonable that the
skilled worker knew how to administer cells and growth factors for treating
stroke. Nonetheless, the ordinary skilled worker still required guidance in
how to choose the specific growth factor and cell type that would be
effective in the claimed method. As explained above, such guidance is
lacking from the '563 Specification and Appellant has not provided
sufficient information that one of ordinary skill in the art had the knowledge
to have made such determination with additional and undue
experimentation. Indeed, we have not been directed to a single working or
prophetic example which would have guided the skilled worker in making
such a choice.
5. Predictability
The Examiner found that "the formation of arteries and repair of brain
tissue by administration of cells to a stroke patient would have been
considered unpredictable in the art at the time of the invention." Answer 6.
As evidence of this, the Examiner cited Walters. Id. at 8. The Examiner
found that Walter's failure to show improvement in brain function as
measured by MRI provided evidence that "appellant's alleged 'well-
established administration techniques and old materials' would not
predictably result in repaired dead or damaged brain tissue as required by the
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claims." Id. at 8-9. As discussed above, Appellant argues that Walters'
results are skewed because the patients had been treated with cytotoxic
drugs. While Appellant's argument is logical, nonetheless, the fact that
Appellant contends the drug cocktail effects the outcome of the treatment is
evidence of unpredictability because it could not be predicted how the drugs
the patients had taken would affect the activity of the growth factor on artery
formation and repair.
Quantity of experimentation
Appellant cites to Weiss, US Pat. No. 6,844,312 as evidence that
"administration of cell to a human brain is a routine medical matter that does
not require a large quantity of experimentation." Appeal Br. 30. The
earliest filing date for Weiss is listed as April 11, 2001 for a provisional
application. This filing date is after the earliest file date of the '563
Application of April 21, 1998. Enablement is of the filing date of the
application. Appellant's discussion of Weiss's use of stem cells to treat
Parkinson's and other diseases is devoid of reasoning how the later-filed
application demonstrates enablement of the instant application filed almost
three years earlier.
Summary
As discussed, the claim encompasses a large genus of growth factors
with little guidance on how those growth factors would be used to form and
artery and repair damaged brain. We have not been directed to any working
or prophetic examples on using a growth factor in stroke treatment. We also
have not been directed to information in the '563 Specification, or at the
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time of the invention, that would have enabled the skilled worker to
determine which growth factors of the many disclosed in the application
were effective at forming arties and repairing brain damage caused by
stroke. While there is disclosure about angiogenic growth factors, there is
sparse disclosure of cells, and inadequate information that would enable one
to choose a cell to that would produce an artery in the brain, even with the
level of skill being a person with medical training who knew how to
administer cells and growth factors to the brain.
There is evidence that certain cell types could be utilized without
undue experimentation to grow arteries in the brain (Lin, Lindvall), but there
is evidence of unpredictability about other cell types (e.g., bone marrow
stem cells as in Walters and Bang), and Appellant did not explain how the
limited information could be extrapolated to the full scope of the claim
which includes cheek cells, cell regulators, and polypeptide growth factors.
There are several pertinent cases involving the issue of enablement
under Section 112. In Vaeck, the patent applicant had claimed "[a] chimeric
gene capable of being expressed in Cyanobacteria cells," requiring the
claimed gene to function in all cyanobacteria. Id., 947 F.2d at 495. The
Federal Circuit affirmed the enablement rejection because there was "no
reasonable correlation between the narrow disclosure in appellants'
specification and the broad scope of protection sought in the claims
encompassing gene expression in any and all cyanobacteria." Id.
Cyanobacteria was found to comprise approximately 150 different genera
and was poorly studied and highly unpredictable. Id. at 493. Under these
facts, the Federal Circuit held full enablement would require undue
experimentation. Id. at 496.
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In our opinion, the principles enunciated in Vaeck are applicable here
because the claimed genus of growth factors is broad, but only limited
guidance in certain specific growth factors (such as VEGF and stem cells)
has been provided. Even after the application filing date, there is still
insufficient evidence that full scope of the claim is enabled.
Enablement serves the dual function in the patent system of
ensuring adequate disclosure of the claimed invention and of
preventing claims broader than the disclosed invention. . ..
This important doctrine prevents both inadequate disclosure of
an invention and overbroad claiming that might otherwise
attempt to cover more than was actually invented. Thus, a
patentee chooses broad claim language at the peril of losing any
claim that cannot be enabled across its full scope of coverage.
"The scope of the claims must be less than or equal to the scope
of the enablement to ensure that the public knowledge is
enriched by the patent specification to a degree at least
commensurate with the scope of the claims." Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008) (quoting
Nat'! Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
1 r:..r:.. H' 1r1 11 Or\ 11 O..:\_or:.. rH'"'rl r1 ... 1 oom1
_I_VV _I_ .JU- _I_ _I__/V' _I_ _l__/J-_/V \_I_ VU-. '-../ .. LL. _I__/_/_/ jj • • • •
MagSil Corp. v. Hitachi Global Storage Techs. Inc., 687 F.3d 1377, 1771
(Fed. Cir. 2012).
For the foregoing reasons, we affirm the enablement rejection of
claim 1.
SUMMARY
The rejection of claim 125 as failing to comply with the enablement
requirement of 35 U.S.C. § 112, first paragraph (pre-AIA), is affirmed.
Since Appellant did not present separate arguments for dependent claims
126-148, these claims fall with claim 125.
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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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