Ex Parte Izadyar et al

Patent Trial and Appeal Board

Sep 30, 2016

12940894 (P.T.A.B. Sep. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/940,894 11/05/2010 FARIBORZ IZADYAR
45200 7590 10/04/2016
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1951314-00063 8526
EXAMINER
PYLA,PAULD
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
10/04/2016 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte F ARIBORZ IZADY AR, JOHNNY YUNG-CHIONG CHOW, and
CONSTANCE YUEN1
Appeal2015-000030
Application 12/940,894
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for maturing germline cells which have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The present invention involves an in vitro process of maturing
germline cells from patients at risk of infertility due to damage to their
1 Appellants identify the Real Party in Interest as PrimeGen Biotech LLC.
Appeal Br. 1.
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Application 12/940,894
germline cells. Spec. i-f 2. The method involves obtaining immature
germline cells and culturing the cells in vitro under conditions which mimic
the in vivo conditions under which the cells mature. Spec. i-f 12. In one
embodiment, the invention is a method for maturing immature testicular
cells. Spec. ,-r 14.
Claims 1, 3, and 6-10 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A method for maturing prepubertal germline cells into
haploid gametes ex host comprising:
culturing testicular cells obtained from a prepubertal
subject in vitro in artificial seminiferous tubules disposed
within a cell culture medium and wherein said testicular cells
comprise germline stem cells, Leydig cells, Sertoli cells, and
peritubular cells,
wherein said culturing causes maturation of said germline
cells into functional sperm.
The claims stand rejected as follows:
Claims 1, 3, and 6-10 stand rejected under 35 U.S.C. § 112, first
paragraph for failing to comply with the written description requirement.
Claims 1, 3, and 6-10 stand rejected under 35 U.S.C. § 103(a) as
obvious over Kim2 combined with Pera3 and Werkmeister. 4
2 Kim et al., US 2008/0044395 Al, published Feb. 21, 2008 ("Kim").
3 Pera et al., US 2010/0267134 Al, published Oct. 21, 2010 ("Pera").
4 Werkmeister et al., US 2009/0104593 Al, published Apr. 23, 2009
("Werkmeister").
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Application 12/940,894
THE WRITTEN DESCRIPTION REJECTION
Issue
In rejecting the pending claims for failing to comply with the written
description requirement of 35 U.S.C. § 112, first paragraph, the Examiner
finds that the Specification does not provide support for the limitation
"culturing testicular cells obtained from a prepubertal subject in vivo in
artificial seminiferous tubules disposed within a cell culture medium and
wherein said testicular cells comprise germline stem cells, Leydig cells,
Sertoli cells, and peritubular cells." Final Act. 12. The Examiner finds that
while the Specification discloses culturing male germline stem cells, the
Specification does not "describe that the cultured testicular cells comprise
germline stem cells, Leydig cells, Sertoli cells, and peritubular cells.'" Final
Act. 12-13. The Examiner concludes that the addition of the phrase
constitute new matter. Final Act. 14.
Appellants contend that the written description requirement does not
call for the subject matter of the claim to be literally set forth in the
Specification but that support can be inherent. Appeal Br. 16. Appellants
contend that one skilled in the art would understand that the reference to
testes in paragraph 320 of the Specification refers to the whole testes
including all the cells present in the testes including the germline stem cells,
Leydig cells, Sertoli cells, and peritubular cells. Id. Appellants conclude by
arguing that
one of skill in the art clearly would have recognized that
Appellants' specification provides adequate written description
of the claimed method for maturing prepubertal germline cells
into haploid gametes ex host comprising: culturing testicular
cells obtained from a prepubertal subject in vitro in artificial
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Application 12/940,894
seminiferous tubules disposed within a cell culture medium and
wherein said testicular cells comprise germline stem cells,
Leydig cells, Sertoli cells, and peritubular cells, wherein said
culturing causes maturation of said germline cells into
functional sperm., and peritubular cells.
Appeal Br. 17.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the Specification fails to
meet the written description requirement of 35 U.S.C. § 112, first paragraph.
Findings of Fact
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FPL The Specification teaches that "[t]estes from immature (3-4 days
old) GFP or OG2 mice were isolated and loaded in the concentration of 1-
2x 104/µl." Spec. i-f 320.
FF2. The Specification teaches that the cell suspension was then
cultured to yield sperm cells. Id.
Principles of Law
"In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue." Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
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"Under the doctrine of inherent disclosure, when a specification
describes an invention that has certain undisclosed yet inherent properties,
that specification serves as adequate written description." Yeda Res. and
Devel. Co., Ltd. v. Abbott GMBH & Co. KG, 2016 WL 5076060 at *3 (Fed.
Cir. Sept. 20, 2016.
Analysis
We agree with Appellants that the present Specification serves as
adequate written support for the term "wherein said testicular cells comprise
germline stem cells, Leydig cells, Sertoli cells, and peritubular cells."
Appeal Br. 16. The Specification teaches the use of testes from immature
mice which were used to prepare a cell suspension. FF 1 and 2. We agree
with Appellants that one skilled in the art would understand that the
suspension would inherently contain at least the four cell types recited in the
claims. Reply Br. 3. Thus, under the doctrine of inherent disclosure, the
Specification provides sufficient written support.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that the Specification fails to meet the written
description requirement of 35 U.S.C. § 112, first paragraph.
THE OBVIOUSNESS REJECTION
Issue
In rejecting the pending claims as obvious over Kim combined with
Pera and Werkmeister, the Examiner finds that Kim "teaches a method of
maturing testicular germ cells by in vitro culturing obtained immature
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Application 12/940,894
germline cells, where the cells are cultured to maturity (i.e., to sperm cells)."
Final Act. 4. The Examiner finds that Pera teaches culturing testicular
germline cells on an extracellular matrix such as artificial seminiferous
tubules. Final Act. 6. The Examiner also finds that Werkmeister teaches a
method of culturing spermatogonial stem cells ("SSCs") on a testicular
extracellular matrix ("ECM"). Final Act. 7. The Examiner concludes that
Id.
[a] person of ordinary skill in the art would have been
motivated to modify the Kim method so as to include the
cultured SSCs on ECM (including testicular ECM) coated
hollow-fiber capillaries (i.e., artificial seminiferous tubules)
from Pera and Werkmeister since Pera teaches that culturing
SSCs in such artificial seminiferous tubules would be
advantageous for the creation of an in vitro device for
spermatogenesis with sustained lifespan or use cycle (Pera,
paragraph 97) and that Werkmeister teaches that such ECM
used are known and can include ECM from testicular tissue. A
person of ordinary skill in the art would have had a reasonable
expectation of success in modifying Kim with Pera and
Werkmeister since the references are all involved in cell culture
of SSCs. It would therefore have been obvious to a person of
ordinary skill in the art at the time the invention was made to
modify Kim with Pera and Werkmeister, since such teachings
were known in the art and would improve spermatogenesis with
sustained lifespan or use cycle within the culture.
Appellants contend that none of the references teach a culture of
mixed "testicular cells comprising Leydig cells from prepubertal tissue."
Appeal Br. 9. Appellants also argue that the references do not teach a
method which yields functional sperm cells. Appeal Br. 10-12. Finally,
Appellants argue that one skilled in the art would not have a reasonable
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expectation of success in producing functional sperm cells from the
teachings of the references. Appeal Br. 12-13.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the rejected claims
would have been obvious over Kim combined with Pera and Werkmeister
under 35 U.S.C. § 103(a).
Findings of Fact
FF3. Kim discloses culturing sperm cells from testicular tissue cell
suspensions. Kim i-fi-132 and 55.
FF4. The cell suspensions of Kim comprise germline stem cells alone
or germline stem cells combined with Sertoli cells or Sertoli cells combined
with peritubular cells (see Kim i-fi-132 and 55).
FF5. Pera discloses culturing testicular germline cells on an
extracellular matrix or on hollow-fiber capillaries such as artificial
seminiferous tubules. Pera i190.
FF6. The germline cells in Pera are cultured with Sertoli cells. Pera
i189.
Principles of Law
A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teachings of the
prior art." In re Ochiai, 71F.3d1565, 1572 (Fed. Cir. 1995).
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Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. The Examiner has not pointed to any
teaching in the references that would lead one skilled in the art to mature
prepubertal germline cells using a mixture of germline stem cells, Leydig
cells, Sertoli cells, and peritubular cells. Specifically, none of the references
teach or suggest the use of Leydig cells in the cell mixture.
The Examiner argues that the teachings of Kim inherently disclose the
use of the cell mixture recited in the claims in paragraphs 32 and 55. Ans.
14. We are not persuaded. As Appellants point out, when those paragraphs
are read in the context of the entire reference, it is clear that the cell
suspension in the cited paragraphs contains only germline cells. Appeal Br.
1 O; Reply Br. 6-8. "Inherency ... may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999). The Examiner provides no rebuttal
evidence establishing that the cell mixture of Kim encompasses the entire
testes and cells contained therein or otherwise inherently comprises Leydig
cells. Thus, Kim fails to teach or suggest a cell mixture that expressly or
inherently contains Leydig cells.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that the rejected claims would have been
obvious over Kim combined with Pera and Werkmeister under 35 U.S.C.
§ 103(a)
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SUMMARY
We reverse the rejection of claims 1, 3, and 6-10 under 35 U.S.C.
§ 112, first paragraph.
We also reverse the rejection of claims 1, 3, and 6-10 under 35 U.S.C.
§ 103(a).
REVERSED
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