Ex Parte Perez-Cruet

Patent Trial and Appeal Board

Apr 19, 2017

13793635 (P.T.A.B. Apr. 19, 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.
13/793,635 03/11/2013 Miguelangelo J. Perez-Cruet MI4-00021 2304
68779 7590 04/20/2017
MILLER IP GROUP, PLC
MI4 SPINE, LLC
42690 WOODWARD AVE.
SUITE 300
BLOOMFIELD HILLS, MI 48304
EXAMINER
BOWERS, ERIN M
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE
04/20/2017 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 MIGUELANGELO J. PEREZ-CRUET1
Appeal 2016-006252
Application 13/793,635
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to methods
for treating cancer, which have been rejected as indefinite, for failing to
satisfy the written description and enablement requirements, and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
One characteristic of all types of tumor cells is that they proliferate
through neovascularization. Spec. 14. “Neovascularization is a process of
1 Appellant identifies the Real Party in Interest as MI4Spine, LLC. Appeal
Br. 3.
Appeal 2016-006252
Application 13/793,635
tissue vascularization that involves the growth of new blood vessels into a
tissue. Tissue cells utilize blood vessels to supply oxygen and nutrients, and
to remove waste products. Neovascularization of tumor cells plays a critical
role in the development and progression of cancer.” Spec. 1 5. The present
invention involves a method to inhibit neovascularization by surrounding the
tumor cells with a barrier comprising chondrocytes. Spec. 16.
Claims 1—4, 8, 9, 11—14 and 16—22 are on appeal. Claim 1 is
representative of the rejected claims and reads as follows:
1. A method for administering a barrier cell treatment for
tumors, said method comprising:
identifying a location of tumor cells in a body part;
preparing a tumor treatment material that includes
chondrocytes; and
administering the tumor treatment material to a location
in the body part around the tumor cells so that the tumor cells
are surrounded by the tumor treatment material so as to create a
chondrocyte barrier around the tumor cells that operates to
prevent or reduce tumor cell growth.
The claims stand rejected as follows.
Claim 9 has been rejected under 35 U.S.C. § 112, second paragraph,
as indefinite.
Claims 1—4, 8, 9, 11—14 and 16—22 have been rejected under 35
U.S.C. § 112, first paragraph, for failing to comply with the written
description requirement.
Claims 1—4, 8, 9, 11—14 and 16—22 have been rejected under 35
U.S.C. § 112, first paragraph, as non-enabled.
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Application 13/793,635
Claims 1, 4, 8, 9, 11, 14, 16, 17, 19, and 21 have been rejected under
35 U.S.C. § 103(a) as unpatentable over Binette.2
Claims 1, 4, 8, 9, 11—14, 16, 17, and 19-22 have been rejected under
35 U.S.C. § 103(a) as unpatentable over Binette in view of Palasis.3
Claims 1—4, 8, 9, 11, 14, 16—19, and 21 have been rejected under 35
U.S.C. § 103(a) as unpatentable over Binette in view of Warner.4
INDEFINITENESS
Issue
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s finding that claim 9 is indefinite.
The Examiner finds the term “using stem cell differentiated
chondrocytes” is indefinite in that it is not clear if the chondrocytes are
derived from previously differentiated stem cells or if the method incudes
the step of differentiating stem cells. Id.
Appellant contends that one skilled in the art would understand that
the claim refers to obtaining chondrocytes from stem cells. Appeal Br. 9.
We find that the Examiner has the better positon. As the Examiner
has explained, it is unclear what is meant by the term “using stem cell
differentiated chondrocytes.” Ans. 24. The term “using” is unclear as it
relates to the phrase “using stem cell differentiated chondrocytes”. Id. As
2 Binette et al., US 2005/0054595 Al, published Mar. 10, 2005 (“Binette”).
3 Palasis, US 6,689,103 Bl, issued Feb. 10, 2004 (“Palasis”).
4 Warner and O’Dorisio, RadiolabledPeptides in Diagnosis and Tumor
Imaging Clinical Overview, Vol. 32-2 Sem. Nucl. Med. 79 (Apr. 2002)
(“Warner”).
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Application 13/793,635
the Examiner points out, the phrase can be interpreted more than one way.
Id. For example, the claim can be read to mean that the stem cell derived
chondrocytes are added to the tumor treatment material, that a step of
differentiation of chondrocytes is required, or that the use of such cells is
another step in the method claim. When a claim term is subject to different
reasonable interpretations, the claim is indefinite. Ex parte Miyazaki, 2008
WL 5105055, at *5 (BPAI 2008) (precedential).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 9 is indefinite.
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the written description
requirement has not been met.
The Examiner finds that the Specification fails to describe how the
claimed barrier is created. Final Act. 10—12. The Examiner finds that the
Specification does not provide any information as to how the injected
chondrocytes come together to form a barrier. Final Act. 10. The Examiner
also finds that the physical properties of the administration steps, such as the
quantity of chondrocytes to be administered are not disclosed. Id. The
Examiner goes on to find that the Specification fails to describe the structure
required to effectively act as a barrier. Id. The Examiner finds that the
Specification only teaches one proposed method to administer the
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Application 13/793,635
chondrocytes. Final Act. 12. Based on these findings the Examiner
concludes that the written description requirement has not been met. Final
Act. 12-13.
Appellant contends that the Specification, particularly Figure 4 and
the accompanying discussion, adequately describes the invention. Appeal
Br. 12. Appellant also contends that there is no requirement that more than
one way to practice the invention must be disclosed.
Principles of Law
A description adequate to satisfy 35U.S.C. § 112, first paragraph,
“must ‘clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed. ’ 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 date.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc) (citation omitted, alteration
in original).
“One needs to show that one has truly invented the genus, i.e., that
one has conceived and described sufficient representative species
encompassing the breadth of the genus. Otherwise, one has only a research
plan, leaving it to others to explore the unknown contours of the claimed
genus.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759
F.3d 1285, 1300 (Fed. Cir. 2014).
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Analysis
We agree with the Examiner that the instant claims fail to satisfy the
written description requirement in that the Specification does not convey to
one skilled in the art what Appellant has invented. Ans. 25. Appellant’s
disclosure appears to be little more than a gedanken experiment with almost
no details as to how the barrier is formed or what properties are needed to
create an effective barrier. At best, Appellant has presented a research
outline for others to follow which is insufficient to satisfy the written
description requirement. AbbVie , 759 F.3d at 1300.
We have considered Appellant’s argument regarding Figure 4 and the
accompanying text and find it unpersuasive. Appeal Br. 12. While the
Figure shows administration of chondrocytes, as the Examiner points out,
the Specification is devoid of any disclosure as to how the barrier is
achieved. Ans. 25. There is nothing in the Specification to show how many
chondrocyte are needed to form a barrier or how the individual chondrocytes
are induced to form a barrier.
Conclusion
We conclude that a preponderance of evidence supports the
Examiner’s conclusion that the claims fail to comply with the written
description requirement.
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ENABLEMENT
Issue
The issue with respect to this rejection is whether substantial evidence
support the Examiner’s conclusion that the claims fail to satisfy the
enablement requirement.
Applying the factors recited in In re Wands, 858 F2d. 731 (Fed. Cir.
1988), the Examiner finds that
1) The Specification only teaches injection of the chondrocytes
whereas Appellant arguments imply that the method requires
something more than mere injection;
2) The art is unpredictable;
3) The level of skill in the art is high;
4) The amount of guidance in the specification is limited and there
are no working examples;
5) The amount of experimentation is undue given the state of the art
and the lack of guidance in the Specification. Final Act. 13—16.
The Examiner concludes that one skilled in the art could not practice
the claimed invention without engaging in undue experimentation. Final
Act. 16.
Appellant contends that the steps for performing the invention are
well known in the art. Appeal Br. 14. Appellant contends that undue
experimentation would not be required to practice the invention. Id.
Principles of Law
“Section 112 requires that the patent specification enable those skilled
in the art to make and use the full scope of the claimed invention without
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Application 13/793,635
undue experimentation. . . . [S]ee also In re Goodman, 11 F.3d 1046, 1050
(Fed. Cir. 1993) (‘[T]he specification must teach those of skill in the art how
to make and how to use the invention as broadly as it is claimed.’).”
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070—71 (Fed. Cir.
2005) (internal quotes omitted).
[A] specification need not disclose what is well known in
the art. However, that general, oft-repeated statement is merely
a rule of supplementation, not a substitute for a basic enabling
disclosure. It means that the omission of minor details does not
cause a specification to fail to meet the enablement
requirement. ... It is the specification, not the knowledge of
one skilled in the art, that must supply the novel aspects of an
invention in order to constitute adequate enablement.
Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d
1001, 1005 (Fed. Cir. 1997) (citation omitted).
When rejecting a claim under the enablement
requirement of section 112, the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that
the scope of protection provided by that claim is not adequately
enabled by the description of the invention provided in the
specification of the application; this includes, of course,
providing sufficient reasons for doubting any assertions in the
specification as to the scope of enablement. If the PTO meets
this burden, the burden then shifts to the applicant to provide
suitable proofs indicating that the specification is indeed
enabling.
In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
“Attorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
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Analysis
Once again, we conclude that the Examiner has the better position.
As discussed above with respect to the written description requirement,
Appellant has only described a concept without any meaningful disclosure
as to how to accomplish it. There is nothing in the Specification to teach
one skilled in the art how the chondrocyte barrier is formed.
Appellant’s argument that one skilled in the art would know how to
perform each of the steps is unpersuasive. Appellant offers only attorney
argument that the performance of each step is known in the art. “Attorneys’
argument is no substitute for evidence.” Johnston, 885 F.2d at 1581.
Moreover, the Specification does not teach how the chondrocytes actually
form the required barrier nor has Appellant asserted that this was known to
one skilled in the art. See, e.g., Appeal Br. 4.
Conclusion of Law
We conclude that substantial evidence supports the Examiner’s
conclusion that the claims are not enabled.
OBVIOUSNESS
Each of the rejections under 35 U.S.C. § 103(a) are based on the
Binette references and Appellant’s arguments focus on the teachings of
Binette. Appeal Br. 16—17. Thus, the issue with respect to the rejected
claims is whether a preponderance of the evidence supports the Examiner’s
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Application 13/793,635
conclusion that the claims would have been obvious over Binette, either
alone or in combination with Palasis or Warner.5
Central to the arguments made by Appellant, and the Examiner’s
position, is the interpretation of the term “administering the tumor treatment
material to a location in the body part around the tumor cells.” The
Examiner has interpreted the term to include “administration of the material
in any location close to the tumor cells including inside the tumor.” Ans.
29—30. Appellant contends that the term should be read to mean that the
tumor treatment material is outside the tumor. Reply Br. 3.
We find that the Examiner’s interpretation is correct. “[Djuring
examination proceedings, claims are given their broadest reasonable
interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367,
1372 (Fed. Cir. 2000). The term “administration of the tumor treatment
materials in the body part around the tumor cells” is properly interpreted to
include injecting the chondrocyte into the tumor. Injecting the cells into the
tumor will still result in chondrocytes “around” one or more of the tumor
cells, even though the entire tumor may not be surrounded.
Appellant’s argument is not persuasive. The claim term is “around
the tumor cells” not the tumor. Thus, a method which results in the
chondrocyte material surrounding one or more of the tumor cells is within
the scope of the claims.
5 While Appellant argues the rejections based on Binette combined with
Palasis and Warner separately, Appellant’s arguments only state that neither
Palasis nor Warner “provide the teaching missing from Binette.” Appeal Br.
17-18.
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Turning to the Binette reference, Binette teaches injecting
chondrocytes into a tumor, resulting in reduction of the tumor. Binette 1,
8, 9, and 94. While Binette does not expressly teach the formation of a
barrier, as the Examiner has noted, the steps of Binette and the present
invention are the same. Ans. 32. Appellant has offered no evidence to show
that the claimed invention would perform differently from the method
disclosed in Binette. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
(“Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.”)
Appellant argues that Binette is directed to injecting the chondrocytes
into a tumor whereas the present invention is directed to placing the
chondrocytes around the exterior of the tumor. Appeal Br. 17, Reply Br. 2—
3. We are unpersuaded. As discussed above, the claims refer to placing the
material around the tumor cells, not the tumor as a whole. Thus, the claims
embrace injecting the material into the tumor such that it surrounds one or
more cells.
We conclude that substantial evidence supports the Examiner’s
conclusion that the rejected claims would have been obvious over Binette
alone or in combination with either Palasis or Warner under 35 U.S.C.
§ 103(a).
SUMMARY
We affirm the rejection under 35 U.S.C. § 112, second paragraph.
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We affirm the rejections under 35 U.S.C. § 112, first paragraph.
We affirm the rejections under 35 U.S.C. § 103(a).
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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