Ex Parte Ohri et al

Patent Trials and Appeals Board

May 8, 2019

14848385 - (D) (P.T.A.B. May. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/848,385 09/09/2015
50855 7590
Covidien LP
60 Middletown A venue
Mailstop 54, Legal Dept.
North Haven, CT 06473
05/10/2019
FIRST NAMED INVENTOR
RachitOhri
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.
355813 (1603-109) 2339
EXAMINER
PALENIK, JEFFREY T
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/10/2019 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):
rs. patents. two@medtronic.com
docket@carterdeluca.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RACHIT OHRI, GARY R. STRICHARTZ, and
PHILIP BLASKOVICH1
Appeal2018-007035
Application 14/848,385
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
methods of relieving chronic pain for at least 28 days by implanting certain
microspheres comprising a local anesthetic. The Examiner rejected the
claims as anticipated by and obvious over the prior art. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies the real parties in interest as Covidien LP and
Medtronic PLC. Br. 1. Herein we reference the Specification filed Sept. 9,
2015 ("Spec."); Final Office Action dated May 24, 2017 ("Final Act.");
Appeal Brief filed Dec. 28, 2017 ("Appeal Br."); Examiner's Answer mailed
Apr. 27, 2018 ("Ans."); and Reply Brief filed Jun. 26, 2018 ("Reply Br.").
Appeal2018-007035
Application 14/848,385
STATEMENT OF THE CASE
The Specification states that "[ m ]icrospheres formed from
biodegradable materials containing local anesthetic compositions are []
known and have been used to treat acute postoperative pain .... However,
there is no information, data, or opinion in the public domain that would
suggest any impact on chronic pain from these sustained-release
formulations of bupivacaine." Spec. ,-J 4. Thus, the invention is directed to a
method for treating chronic pain, comprising implanting microspheres at a
treatment site, where the microspheres comprise at least one local anesthetic
and a biodegradable polymer, have a certain drug release profile, and relieve
chronic pain for at least 28 days. Id. at ,-J 12.
Claims 8-13, 15, 18, 21-23, and 29-32 are on appeal. Final Act. 2.2
Claim 8 is illustrative and reads as follows:
8. A method for treating chronic pain comprising:
implanting at least one microsphere at a treatment site,
the microsphere comprising:
at least one local anesthetic and poly(lactic-co-glycolic
acid) including polylactic acid and glycolic acid at a ratio of
about 75:25;
wherein about 75% of the at least one local anesthetic is
released by about 72 hours and from about 80% to about 90%
of the at least one local anesthetic is released by about 120
hours; and
relieving chronic pain for at least 28 days.
Appeal Br. 11 (Claims Appendix).
2 In an amendment filed subsequent to the May 24, 2017 Final Office
Action, Appellants cancelled claims 24-28. Amendment under 37 C.F.R.
§ 1.116 (filed Aug. 24, 2017) 6.
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Application 14/848,385
The claims stand rejected as follows:
1. Claims 8-13, 15, 18, 21, and 22 under 35 U.S.C. § 102(a)(l) as
anticipated by Ohri I. 3 Final Act. 4. 4
2. Claims 8-13, 15, 18, 21-23, and 29-32 under 35 U.S.C. § 103(a)
as obvious over Ohri I. Id.
3. Claims 8-13, 15, 18, 21, and 22 under 35 U.S.C. § 102(a)(l) as
anticipated by Ohri II. 5 Id. at 8-9.
4. Claims 8-13, 15, 18, and 21-23, and 29-32 under 35 U.S.C.
§ 103(a) as obvious over Ohri II. Id.
ANALYSIS
Anticipation
The Examiner rejected claims 8-13, 15, 18, 21, and 22 as anticipated
by each of Ohri I and Ohri II. Final Act. 4, 8-9. Both Ohri references
disclose animal experiments designed to examine the effect of certain
bupivacaine microspheres on acute postoperative pain. See, e.g., Ohri I 607;
Ohri II 717. Appellants do not dispute that the bupivacaine microspheres
implanted in the Ohri experiments are "compositionally and structurally
3 Ohri et al., Prolonged Nerve Block by Microencapsulated Bupivacaine
Prevents Acute Postoperative Pain in Rats, 37(6) REG. ANESTH. PAIN MED.
607-15 (2012) ("Ohri I").
4 Subsequent to the May 24, 2017 Final Office Action, the Examiner
withdrew the anticipation rejections against claims 23 and 29-32. Advisory
Action (issued Sept. 25, 2017) 3; see also Ans. 4 (noting that the anticipation
rejection is "maintained over claims 8-13, 15, 18, 21, and 22").
5 Ohri et al., Inhibition by Local Bupivacaine-Releasing Microspheres of
Acute Postoperative Pain from Hairy Skin Incision, 117(3) ANESTH. ANALG.
717-30 (2013) ("Ohri II").
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Appeal2018-007035
Application 14/848,385
indistinct" from the claimed microspheres. See, e.g., Final Act. 7, 9; Appeal
Br. 3. Nevertheless, Appellants argue that the Ohri references do not
anticipate the claims because the references do not disclose the method of
claim 8 which requires "relieving chronic pain for at least 28 days." Br. 4.
Whether the Ohri references anticipate turns on whether the claim
limitation "relieving chronic pain for at least 28 days" is a positive method
step. We find that it is. Even assuming, as the Examiner does, that the
"relieving" limitation is an "effect[] which result[ s] due to the active step of
administering the composition of the claimed method," Ans. 3, it is,
nevertheless, an action that is required in the method of treatment. It is not
"reasonably considered to be property" (Ans. 3), like the solubility of a drug
would be. Claim 8 recites "[a] method for treating chronic pain," and recites
the step of "relieving chronic pain for at least 2 8 days." In addition to the
"relieving" step being an active step of the claimed method, we also
conclude that the preamble, in conjunction with this step, requires that the
subject being treated have chronic pain, such that it is "reliev[ ed]" by the
claimed method.
Under this construction, we determine that Ohri I and Ohri II do not
anticipate. As acknowledged by the Examiner, the Ohri references do not
expressly teach relieving chronic pain for at least 28 days. Final Act. 8, 11.
Indeed, they could not as both references teach the use of the claimed
microspheres to evaluate acute postoperative pain in rat studies, where the
rat studies were carried out for at most, 14 days. See Ohri I 609 (pain
responses evaluated for 8 days); Ohri II 720 (pain responses evaluated for 14
days). According to the undisputed testimony of inventor Dr. Strichartz, the
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Application 14/848,385
pain models disclosed in Ohri I and Ohri II do not result in chronic pain,
rather, they are models of acute pain, and no detectable nerve damage is
caused. Strichartz Declaration6 ,i 6. Accordingly, Ohri I and Ohri II do not
expressly or inherently disclose subjects who had chronic pain, much less
relieving chronic pain in its subjects.
Because there was no chronic pain at issue in Ohri I or Ohri II, this is
not a case where Appellants have merely discovered the inherent results of
the implantation methods disclosed in the prior art. Cf Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1377 (Fed. Cir. 2001)
("[Patentee] has done no more than claim a result (efficacy) of [prior art]
three-hour paclitaxel infusions in cancer patients."). Rather, the claimed
method is a new use of a known product, i.e., treating chronic pain with
known microspheres. Much like the case in Perricone v. Medicis
Pharmaceutical Corp., with respect to a claim directed to a method of
preventing sunburn, the Examiner's "inherency analysis goes astray because
it assumes what [Ohri I and II] neither disclosed nor rendered inherent."
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1379 (Fed. Cir. 2012)
(indicating that a claim to "treating skin sunburn" was not anticipated by the
disclosed prior art teaching of a lotion to be topically applied to skin where
that same prior art did not disclose sunburn prevention or treatment benefits,
any mechanism behind sunburn prevention, or topical application to skin
sunburn).
6 Declaration of Gary Richard Strichartz under 37 C.F.R. § 1.132 (Aug. 18,
2017) ("Strichartz Declaration").
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We therefore conclude that neither Ohri I nor Ohri II anticipate claims
8-13, 15, 18, 21, and 22, because neither reference discloses a method for
treating chronic pain where the implanted microsphere effects the step of
"relieving chronic pain for at least 28 days." In view of the proper scope of
the claims, we reverse the rejections of claims 8-13, 15, 18, 21, and 22 as
anticipated by each of Ohri I and Ohri II.
Obviousness
The Examiner rejected claims 9-13, 15, 18, 21-23, and 29-32 as
obvious over each of Ohri I and Ohri II. Final Act. 4, 8-9. Appellants
dispute these rejections, arguing that the Ohri references do not support a
reasonable expectation of success that the claimed microspheres would
relieve chronic pain for at least 28 days. Appeal Br. 5-7. Appellants also
argue unexpected results, asserting that in Ohri, "the microspheres were
effective in treating acute pain for only 4-8 days," and thus "it was
unexpected that the same formulation would show efficacy in treating
chronic pain through at least 28 days." Id. at 9; see also Reply Br. 4-5.
As to reasonable expectation of success, the Examiner stated that both
Ohri references "allude to the potential that acute pain can convert to chronic
pain." Final Act. 12; see also id. at 6 (citing Ohri I at 607, which states that
acute pain "too often convert[ s] to a chronic pain condition"). The Examiner
thus reasoned that the Ohri references "are considered to treat chronic pain
by virtue of treating its potential predecessor." Final Act. 12.
While the Ohri references recognize a potential relationship between
acute and chronic pain, we do not read them as suggesting that a given
treatment that is effective in treating acute pain will likely treat chronic pain.
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At most they suggest the potential to prevent the onset of chronic pain
because acute pain is treated, and thus that pain cannot convert to chronic
pam.
Further, the record contains undisputed testimony that the underlying
biological mechanisms of acute and chronic pain are different, and that
effective treatment of acute postoperative pain is not an accurate predictor of
whether the same treatment will effectively reduce chronic postoperative
pain. S trichartz Declaration ,i,i 15-23. As such, what is missing from the
Examiner's analysis is a link between the demonstrated efficacy of the
bupivacaine microspheres in Ohri ( or microspheres containing any other
local anesthetic, per the independent claims) for relieving acute pain and
why one of ordinary skill in the art would have deemed that treatment to
relate to the likely efficacy of implanting those same microspheres to relieve
chronic pain. 7
In view of the lack of evidence in the record suggesting that the
claimed microspheres are likely to treat chronic pain, we do not sustain the
obviousness rejections. Accordingly, we need not reach the issue of whether
Appellants have demonstrated unexpected results.
7 The Examiner pointed to a statement in Ohri II which noted that studies
using the claimed microspheres in rat models of thoracic surgeries were
ongoing. Ans. 9. This statement in Ohri II merely references a potentially
"improve[ d] postsurgical outcome." Ohri II 613. Because surgery can result
in both acute and chronic pain, this statement does not specifically teach or
suggest that efficacy of these microspheres against chronic pain was being
examined.
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Appeal2018-007035
Application 14/848,385
SUMMARY
We reverse the rejection of claims 8-13, 15, 18, 21, and 22 under 3 5
U.S.C. § 102(a)(l) as anticipated by Ohri I.
We reverse the rejection of claims 8-13, 15, 18, 21-23, and 29-32
under 35 U.S.C. § 103(a) as obvious over Ohri I.
We reverse the rejection of claims 8-13, 15, 18, 21, and 22 under 3 5
U.S.C. § 102(a)(l) as anticipated by Ohri II.
We reverse the rejection of claims 8-13, 15, 18, and 21-23, and 29-
32 under 35 U.S.C. § 103(a) as obvious over Ohri II.
REVERSED
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