Ex Parte LIN et al

Patent Trials and Appeals Board

Feb 25, 2019

13771844 - (D) (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/771,844 02/20/2013
61650 7590 02/27/2019
MYERS WOLIN, LLC
100 HEADQUARTERS PLAZA
West Tower, Floor 7
MORRISTOWN, NJ 07960-6834
FIRST NAMED INVENTOR
Ching Shwun LIN
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.
CLVT2464B 3428
EXAMINER
BERKE-SCHLESSEL, DAVID W
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
patent@myerswolin.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHING SHWUN LIN, TOM F. LUE, and GUITING LIN 1
Appeal2018-000282
Application 13/771, 844
Technology Center 1600
Before FRANCISCO C. PRATS, TA WEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for treating a bone fracture in an
immunocompetent non-human mammal in need thereof comprising
administering to said non-human mammal an effective amount of a purified
population of adipose tissue-derived stem cells (ADSC). Claims 1, 2, and 5-
12 are on appeal as rejected under 35 U.S.C. § 103(a). 2 We have jurisdiction
under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as "CELL4 VET
CORPORATION." Appeal Br. 3.
2 Claims 3, 4, and 13-28 stand cancelled or withdrawn from consideration.
Supplement to Appeal Br. 18-22 (numbering continued from Appeal Br.).
Appeal2018-000282
Application 13/771,844
STATEMENT OF THE CASE
Claim 1 is representative and is reproduced below:
1. A method for treating a bone fracture m an
immunocompetent non-human mammal in need thereof
comprising administering to said non-human mammal an
effective amount of a purified population of adipose tissue-
derived stem cells (ADSC),
wherein the ADSC are xenogeneic to the non-human
mammal, wherein the ADSC are porcine ADSC,
wherein the effective amount is that sufficient to promote
repair of the bone fracture, and
wherein the effective amount of ADSC is within the range
of from about 5 x 105 ADSC/kg to about 5 x 107 ADSC/kg
bodyweight of said non-human mammal.
Supplement to Appeal Br. 18 (paragraph returns added).
The following rejections are appealed: 3
Claims 1, 2, and 5-12 stand rejected under 35 U.S.C. § I03(a) over
Harman, 4 Marx, 5 and Zuk. 6 Final Action 13.
DISCUSSION
Relevant Law
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
3 A double patenting rejection stands withdrawn. Answer 6.
4 WO 2005/035742 A2 (published Apr. 21, 2005) ("Harman").
5 US 2007/0027081 Al (published Feb. 1, 2007) ("Marx").
6 Patricia A. Zuk, Ph.D., et al., Multilineage Cells from Human Adipose
Tissue: Implications for Cell-Based Therapies, 7(2) TISSUE ENG'G. 211-28
(2001) ("Zuk").
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Application 13/771,844
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief and properly presented
in the Reply Brief have been considered; arguments not so-presented in the
Brief are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015); see also Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for
asserting error, whether factual or legal, that are not raised in the principal
brief are waived.").
Relevant to the Examiner's rejection and Appellants' arguments there-
over, "[ t ]he combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen a patent
claims a structure [ or method] already known in the prior art that is altered
by the mere substitution of one element [ or step] for another known in the
field, the combination must do more than yield a predictable result." Id.
(citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). "[T]he analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ." Id. at
418.
Furthermore, "the discovery of an optimum value of a variable in a
known process is normally obvious." In re Antonie, 559 F.2d 618, 620
( CCP A 1977). Exceptions to this rule include cases where ( 1) the results of
optimizing a variable were unexpectedly good and (2) the parameter
optimized was not recognized in the prior art as one that would affect the
results. Id. "A prima facie case of obviousness typically exists when the
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ranges of a claimed composition overlap the ranges disclosed in the prior
art." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Moreover, where an applicant's specification identifies work done by
another as prior art, the subject matter is treated as admitted prior art. In re
Nomiya, 509 F.2d 566, 571 (CCPA 1975) (holding applicant's labeling of
two figures in the application drawings as "prior art" to be an admission that
what was pictured was prior art relative to applicant's improvement). "A
statement in a patent that something is in the prior art is binding on the
applicant and patentee for determinations of anticipation and obviousness."
Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560, 1570 (Fed. Cir.
1988); see also PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d
1342, 1362 (Fed. Cir. 2007) (patentee's argument that stem cells were not
previously known to exist in cord blood was contrary to their representations
in the specification that the prior art disclosed as much; there is no
unfairness in holding inventors to the consequences of their admissions and
characterization of the prior art).
Findings of Fact (FF)
We adopt the Examiner's findings of fact and rationale on
obviousness as set forth in the Final Action and Answer. Final Action 2-17;
Answer 2-16. The following findings of fact highlight certain evidence:
FF 1. The Examiner determined that "the ordinary artisan
likely possesses a Masters or PhD in a related field of biomedical
engineering." Final Action 4. Appellants do not contest this
description of the level of ordinary skill in the art, which is, therefore,
accepted for the purposes of this decision.
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FF2. Hannan teaches "a method of treating an injury or
disease in a patient," where "the injury or disease is a musculoskeletal
injury," "the injury is a ... fracture," and "the tissue is ... bone."
Harman 5: 10-23.
FF3. Further to the preceding finding of fact, Harman teaches
that the bone-fracture treatment includes providing adipose tissue-
derived stem cells (ADS Cs) "directly to a site of injury or disease"
and "to the bloodstream of said patient" by "injection, intravenously
or inter-arterially." Harman 2:25-29, 5:24--28.
FF4. Further to the preceding findings of fact, Harman
discloses practicing the ADSC treatment on a variety of different
"non-human" animals, including horses, camels, dogs, cats, birds,
cows, goats, performance animals, racing animals, zoo animals,
livestock or farm animals, dairy animals, companion animals, and
rare or exotic animals. Harman 5:29-6:9 (emphasis added).
FF5. Further to the preceding findings of fact, Harman
discloses:
[ t ]issue may be obtained from humans and other animals.
In one embodiment, the animal is a mammal. In certain
embodiments, tissue is obtained from animals having significant
commercial or economic value, such as horses, dogs, cats,
camels, and cows. Similarly, in other embodiments, the tissue is
obtained from performance or sport animals, such as horses and
dogs. In other embodiments, tissue is obtained from a
companion animal, such as a dog or cat. In a further
embodiment, tissue is obtained from exotic dogs (wolves,
jackals, dingos, etc.) and exotic cats (leopard, fisher cat,
mountain lion, jagarundi, tiger, lion, cheetah, etc.). In other
embodiments, tissue is obtained from exotic or zoological
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animal, including but not limited to hoof stock, including
ungulates or hoofed mammals, including, e.g., gazelle, buffalo,
rhinoceros, eland, etc. In another embodiment, a tissue sample
is obtained from a high value exotic species, including but not
limited to birds, including, e.g., parrots, macaws, etc. In certain
embodiments, tissue is obtained from large exotic or zoological
animals, including but not limited to, zebras, lions, tigers,
elephants, rhinoceroses, hippopotamuses, bears, and giraffes.
Harman 8: 19-9:5 ( emphasis added).
FF 6. Further to the preceding finding of fact, Appellants'
Specification states that "[ t ]he adipose tissue may be from any
non-human mammal," and further that
"[ n ]on-human mammals" include, but are not limited to,
farm animals, sport animals, pets, non-human primates, mice and
rats. Farm animals can include, but are not limited to, pigs, cows,
horses, goats, and sheep. Pets include, but are not limited to,
dogs, cats, rabbits, and ferrets. Other animals within the scope
of this definition include, but are not limited to, monkey, baboon,
chimpanzee, orangutan, tiger, lion, bear, cheetah, and llama.
Spec. ,r,r 46, 50. Appellants' Specification further states:
ADSC may be isolated from various non-human
mammals, including but not limited to porcine, bovine, canine,
equine and feline species. In one aspect, a subject from whom
ADSC can be isolated and used for therapeutic and/or
prophylactic purposes is a porcine species. Porcine species are
commonly raised for purpose of providing parts for
xenotransplantation (e.g., valve for human heart). Accordingly,
porcine ADSC may be used for xenotransplantation into other
non-human animals. In another aspect, the invention provides
for ADSC obtained from privately owned pets, whose
procurement may be regulated by the Food and Drug
Administration (FDA). The ADSC from these pets may be used
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for xenotransplantation, allogeneic transplantation or syngeneic
transplantation.
Spec. ,r 64; see also id. ,r,r 63 and 65 ( citing several prior art
references directed to collecting ADSC cells from pigs and
reinforcing that there is no functional difference among the various
named non-human animal sources for ADSCs ). Based on these
statements by Appellants, and Appellants' Specification in general, it
is understood that the use of porcine ADSCs was well-known in the
prior art and that the selection of pigs as a preferred cell source for
Appellants' invention can be attributed to the routineness and
conventionality of the use of pigs as a source of xenotransplantation
tissues.
FF7. Harman also discloses "tissue may be obtained from a
donor and the purified cells provided to a different patient," including
"xenogeneic administration." Harman 9:8-9, 19:27-20: 11.
FF8. Harman further discloses:
In particular embodiments, purified cell populations comprise at
least 10,000, 20,000, 50,000, 100,000, 200,000, 500,000,
600,000, 700,000, 800,000, 900,000, 1 X 106, 2 X 106, 3 X 106,
5 x 106, or 10 x 106 cells per gram of tissue. In certain
embodiments, at least 600,000 to 70 x 106 cells are isolated from
3 to 50 grams of tissue.
Harman 16:23-28. This Harman disclosure teaches that the skilled
artisan could readily ascertain an ADSC sample's or dose's cell count
to be used for treatment. See also Harman 29:6-30:4, Example 4
( disclosing samples from cats ranging from 135,555 cells/kg to
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633,333 cells/kg body weight, assuming a cat weights, at most, about
1 Olbs. or 4.5kg).
FF9. Further to the preceding finding of fact, Harman
discloses:
The development of suitable dosing and treatment
regimens for using the cell populations and compositions
described herein in a variety of treatment regimens, including
e.g., oral, parenteral, intravenous, intranasal, and intramuscular
administration and formulation, will again be driven in large part
by the disease or injury being treated or prevented and the route
of administration. The determination of suitable dosages and
treatment regimens may be readily accomplished based upon
information generally known in the art.
Harman 22:3-10 (emphasis added); see also id. at 29 (Example 4,
disclosing ADSCs harvested from cats and dogs, "small animals,"
providing samples having cell counts within, or suggesting stem cell
counts within, the claimed dosage range).
Analysis
The Examiner determined that the claims would have been obvious
over the combination of Harman, Marx, and Zuk, as further evidenced by
Appellants' Specification's discussion of the prior art. Final Action 2-17
and Answer 2-16 (collectively citing Harman 1:5-22, 5:18-23, 5:24---6:9,
16:5-12, 19:17-30, 20:8-11, 20:30-21:15, 22:3-10, claims 125 and 128;
Marx ,r,r 8, 30, 35, 36, 41, 44; Zuk Abstract; Spec. ,r,r 8-14, 49, 63---64); see
also supra FF 1-FF9 (highlighting relevant disclosures of Harman and the
Specification). We discern no error in the Examiner's determination of
obviousness. We address Appellants' arguments below.
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Appellants argue Harman teaches that ADSCs can be isolated from
any tissue of any species of animal and then administered to any species of
animal to treat any disease or condition, but that choosing pigs, as claimed,
as a source of ADSCs would not have been obvious. Appeal Br. 8-23.
Appellants identify, as the Examiner concedes, that Harman does not
expressly list pigs for such a purpose. Id.; see also Answer 8 ("it is true that
Harman never states 'porcine' or 'pig."'). Appellants argue that Harman
provides no guidance pointing the skilled artisan to use porcine derived
ADSCs. Appeal Br. 10 (using the term "blaze marks," typically reserved for
discussion of the requirements under 35 U.S.C. § 112). These arguments are
not persuasive.
As identified by the Examiner, as well as by Appellants, Harman
teaches a broad range of animal types, and even a wide variety of specific
animals, useful as a source for ADSCs, expressly including farm animals
and livestock. Final Action 14--16; Answer 7-9; see also FF4, FF5. Pigs
are livestock; pigs are farm animals. Furthermore, it was well-known in the
prior art to use pigs as a source for tissue for xenotransplantation and it was
well-known to use pigs as a source for ADSCs. FF6; see also Final Action
3--4, 14--16; Answer 8-9. Such common knowledge serves as the "blaze
marks" Appellants alleged to be missing. We conclude that using
porcine-derived ADSCs, as claimed, would have been obvious, as
determined by the Examiner. Appellants' statements in their Specification
support this conclusion. FF6; see PharmaStem Therapeutics, Inc., 491 F.3d
at 1362.
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Appellants argue the claimed effective amounts of ADSCs (i.e.,
500,000 ADSCs/kg to 50,000,000 ADSCs/kg body weight) are not taught or
suggested by Harman. Appeal Br. 12. Appellants' argument is that Harman
does not expressly disclose any specific effective amount of cells for
treatment, and "Harman only states that 'The determination of suitable
dosages and treatment regimens may be readily accomplished based upon
information generally known in the art."' Appeal Br. 12 ( citing Harman
22:8-10). This argument is not persuasive.
As determined by the Examiner, Harman is focused on treating animal
injuries, including bone fractures, with ADSCs, even disclosing ready-made
kits for such a purpose. Answer 10-12; FF2-FF4. As conceded by
Appellants, Harman is explicit that, to accomplish such treatments, dosages
can readily be determined by the skilled artisan. FF9. Without more, this is
sufficient to render the claimed effective amount obvious. However, this is
not the extent of Harman's disclosure on cell dose because Harman also
discloses preparing cell samples of 10,000 to 7 x 107 cells from 1-50g of
donor tissue. FF8. Such samples would have readily provided a treatment
dose in the claimed range. Furthermore, Harman discloses collecting viable
cell samples from dogs and cats (for use in therapy) that would have
rendered the claimed effective amount range obvious. FF9; see also Harman
29:6-30:4, Example 4 ( disclosing samples from cats ranging from 135,555
cells/kg to 633,333 cells/kg body weight, assuming a cat weights, at most,
about lOlbs. or 4.5kg). It would have been obvious to use the samples
Harman taught as collected for the treatments otherwise disclosed by
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Hannan, which further supports the Examiner's determination that the
claimed effective dose limitation would have been obvious.
Appellants also argue that Harman does not teach or suggest
xenogeneic ADSC transplants because, although Harmon does disclose
xenogeneic ADSC transplants, the reference only mentions the concept
twice and provides no related data. Appeal Br. 13. This argument is not
persuasive.
The skilled artisan would have recognized that Harman teaches the
claimed xenogeneic transplantation of ADSCs to treat fractured bones.
FF 1-FF3, FF7. "[A] presumption arises that both the claimed and
unclaimed disclosures in a prior art patent are enabled." Amgen, Inc. v.
Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). Data
proving the concept is not required. "Obviousness does not require absolute
predictability of success .... For obviousness under§ 103, all that is
required is a reasonable expectation of success." In re O 'Farrell, 853 F.2d
894, 903---04 (Fed. Cir. 1988). Here, there is a presumption that Harman's
disclosed xenogeneic ADSC transplant would treat a bone fracture.
Appellants present no persuasive evidence that success would not have been
reasonably expected in doing so that would rebut the Examiner's rationale
on obviousness to the contrary. See Appeal Br. 14 (making such an
argument without citation to supporting evidence).
Appellants argue their Specification provides evidence of unexpected
results so as to overcome the Examiner's case for obviousness. Appeal Br.
14--15. Appellants point to Example 17 in their Specification as an
"experimental outcome [that] surely establishes that Appellant's data
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amount to surprising and unexpected results; i.e., Appellant's specification
contains specific data indicating improved properties, which, as stated in
Appellant's specification at paragraph [0219] are surprising and
unexpected." Id. at 14. This argument is not persuasive.
Upon review of the cited portion of Appellants' Specification, we find
Example 17 is directed to a successful treatment of a dog ( total treating dose
was 5 x 106 porcine ADSC/0.9kg + 1 x 106 porcine ADSC/0.9kg) having a
fractured foreleg that was not healing after surgery, where the Specification
states, "[ t ]his Example demonstrates the surprising and unexpected ability of
xenogeneic ADSC to facilitate bone repair in non-human animals." Spec.
,r,r 210-219. "To be particularly probative, evidence of unexpected results
must establish that there is a difference between the results obtained and
those of the closest prior art, and that the difference would not have been
expected by one of ordinary skill in the art at the time of the invention."
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977
(Fed. Cir. 2014). Here, there is no evidence of a comparison of this
treatment to the closest prior art ( or an identification of what that closet prior
art was considered to be). Even considering the above-quoted conclusion in
the Specification that the results achieved were "surprising and unexpected,"
and that the data shows some improvement over mere surgical repair, this
example provides no more than a proof-of-concept, not unexpected results.
In addition, given Harman's repeated disclosures that ADSCs are useful for
treating multiple different types of injuries, including fractures, and
including in dogs (see FF2-FF4), the record as a whole does not support
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Appellants' contention that a skilled artisan would have considered the
results presented in the Specification to be unexpected.
Appellants also include separate headings in their Brief directed to
dependent claim 2, dependent claims 5, 6, and 9-12, and dependent claim 8,
respectively. Appeal Br. 15-16. However, Appellants' arguments under
these headings amount to no more statements of what the claims are
believed to cover and that Harmon does not disclose it. "[T]he Board [has]
reasonably interpreted Rule 41.3 7 to require more substantive arguments in
an appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art."
In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Thus, we conclude these
dependent claims fall with claim 1.
Finally, Appellants argue that neither Marx nor Zuk remedy the
shortcomings of the disclosure of Harman otherwise argued by Appellants.
Because, as discussed above, we are not persuaded by Appellants'
arguments that Harman is deficient in the ways alleged, this argument is
likewise not persuasive.
SUMMARY
The obviousness rejection is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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