UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMIVEERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 223 1 3- 1450
`www.uspto.gov
`
`13/283,450
`
`10/27/2011
`
`Louie Daniel Garcia
`
`PCIRA.037A
`
`8217
`
`
`
`
`
`KNOBBE MARTENS OLSON & BEAR LLP
`2040 MAIN STREET
`FOURTEENTH FLOOR
`
`IRVINE, CA 92614
`
`KISHORE, GOLLAMUDI S
`
`ART UNIT
`1612
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/16/2019
`
`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):
`
`efiling @ knobbe. com
`jayna.cartee@kn0bbe.c0m
`
`PTOL—90A (Rev. 04/07)
`
`
`
`
`
`UNITED STATES DEPARTMENT OF COMIVEERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 223 1 3- 1450
`www.uspto.gov
`
`13/283,450
`
`10/27/2011
`
`Louie Daniel Garcia
`
`PCIRA.037A
`
`8217
`
`
`
`
`
`KNOBBE MARTENS OLSON & BEAR LLP
`2040 MAIN STREET
`FOURTEENTH FLOOR
`
`IRVINE, CA 92614
`
`KISHORE, GOLLAMUDI S
`
`ART UNIT
`1612
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/16/2019
`
`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):
`
`efiling @ knobbe. com
`jayna.cartee@kn0bbe.c0m
`
`PTOL—90A (Rev. 04/07)
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Ex parte LOUIE DANIEL GARCIA, LIANGJIN ZHU,
`WILLIAM JOSEPH LAMBERT, and GARY PATOU
`
`Appeal 2018-007990
`Application 13/283,4501
`Technology Center 1600
`
`Before DONALD E. ADAMS, JOHN G. NEW, and
`
`RACHEL H. TOWNSEND, Administrative Patent Judges.
`
`TOWNSEND, Administrative Patent Judge.
`
`DECISION ON APPEAL
`
`This is an Appeal under 35 U.S.C. § 134 involving claims to a
`
`formulation of one or more non-steroidal anti-inflammatory drugs, which
`
`have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
`
`We reverse.
`
`1 We use the word “Appellant” to refer to “Applicant” as defined in
`37 C.F.R. § 1.42. Appellant identifies the real party in interest as Pacira
`Pharmaceuticals, Inc. (Appeal Br. 3.)
`
`
`
`Appeal 2018-007990
`Application 13/283,45O
`
`STATEMENT OF THE CASE
`
`Non-steroidal anti-inflammatory drugs (NSAIDs) are administered
`
`both orally and intravenously.
`
`(Spec. 1] 3.) “Oral NSAID treatment,
`
`however, has been linked to a variety of serious gastrointestinal
`
`complications, including peptic ulcer, digestive perforation, hemorrhage,
`
`colonic ulcer, and colitis.” (Id) “GI toxicity is attributable to the magnitude
`
`and duration of drug exposure both in the GI tract following oral dosing and
`
`with high systemic levels of drug required to achieve eff1cacious drug levels
`
`at the synovial site of action[2].” (Id. 11 4.)
`
`Appellant’s invention is directed at a formulation of the NSAIDs
`
`meloxicam and/or piroxicam encapsulated in a multivesicular liposome3
`
`which minimize the side effects of NSAIDs while maintaining or improving
`
`eff1cacy. (See id 111] 8, 28, claim 1)
`
`Claims 1, 62, 64, 68, 70, 71, 73, 74, 111, 112, 115—122, and 136 are
`
`on appeal. Claim 1 is representative and reads as follows:
`
`1. A formulation of one or more non-steroidal anti-
`
`inflammatory drugs, comprising:
`one or more non-steroidal anti-inflammatory drugs
`selected from the group consisting of meloxicam and
`piroxicam; and
`multivesicular liposomes,
`wherein the multivesicular liposomes comprise a first
`aqueous phase and a second aqueous phase;
`
`2 “[D]rugs are typically cleared in a matter of hours from the synovial
`fluid.” (Id. 11 5.)
`3 “Topologically, multivesicular liposomes [“MVLs”] are defined as having
`multiple non-concentric chambers within each particle, resembling a ‘foam-
`like’ matrix; whereas multilamellar vesicles contain multiple concentric
`chambers within each liposome particle, resembling the ‘layers of an
`onion.’” (Id. 11 35.)
`
`
`
`Appeal 2018-007990
`Application 13/283,450
`
`wherein the one or more non-steroidal anti-inflammatory
`drugs are encapsulated in the first aqueous phase of the multi
`vesicular liposomes; and
`wherein the first aqueous phase comprises at least one pH
`modifier, said pH modifier comprises an organic acid or an
`organic base, or a combination thereof.
`
`(Appeal Br. 17.)
`
`The following grounds of rejection by the Examiner are before us on
`
`review:
`
`Claims 1, 62, 64, 68, 70, 71, 73, 74, 111, 112, 115—122, and 136
`
`under 35 U.S.C. § 103 as unpatentable over Weiner4 or McLean,5
`
`Sankaram,6 and Gruber.7
`
`Claims 1, 62, 64, 68, 70, 71, 73, 74, 111, 112, and 115—1228 under
`
`35 U.S.C. § 103 as unpatentable over Weiner or McLean, Kim ’573,9 and
`
`Gruber.
`
`OO\]O\UI-l>
`
`Weiner et al., US 6,759,057 B1, issued July 6, 2004.
`McLean et al., US 2003/0235610 A1, published Dec. 25, 2003.
`Sankaram et al., US 6,132,766, issued Oct. 17, 2000.
`
`Gruber et al., US 2010/0035937 A1, published Feb. 11, 2010.
`Additional claims were rejected by the Examiner in the Office Action
`from which the appeal was taken, but those claims had been canceled prior
`to issuance of that Office Action, and thus, are no longer pending in the
`Application on Appeal.
`(See Amendment and Response to Office Action
`dated April 20, 2017 (cancelling claims 20, 65—67, 69, 87, 89—91, 93—97,
`99—102, 107, 108, 110, 123—125, and 128—135).)
`9 Kim, US. Patent No. 5,759,573, issued June 2, 1998.
`
`3
`
`
`
`Appeal 2018-007990
`Application 13/283,450
`
`Claims 1, 62, 64, 68, 70, 71, 73, 74, 111, 112, 115—122, and 136
`
`under 35 U.S.C. § 103 as unpatentable over Hofland,10 Cipolla“, Kim
`
`’ 147,12 and Gruber.
`
`Weiner, McLean, Sankaram, and Gruber
`
`DISCUSSION
`
`The Examiner finds that Weiner and McLean both teach liposomal
`
`formulations that contain a non-steroidal anti-inflammatory drug (NSAID),
`
`where piroxicam is identified as one such NSAID. (Final Action 2.) The
`
`Examiner recognizes that neither reference teaches encapsulation of the
`
`NSAID in a MVL. (Id.)
`
`The Examiner finds, however, that Sankaram teaches a variety of
`
`drugs encapsulated in MVLs.
`
`(Id. at 3.) The Examiner finds that Sankaram
`
`indicates that the internal membranes of the MVL “serve to cover increased
`
`mechanical strength to the vesicle, while still maintaining a high volume
`
`lipid ratio compared to multi-lamellar vesicles.” (Id. (citing Sankaram 2:28—
`
`39).) According to the Examiner, it would have been obvious to one of
`
`ordinary skill in the art “to encapsulate NSAIDS of Weiner or McLean in the
`
`[MVL] and treat inflammation since Sankaram teaches the advantages of
`
`[MVL]” and/or because “Sankaram teaches that any drug can be
`
`encapsulated within the [MVL] and NSAIDS are known to be encapsulated
`
`within liposomes as evident from Weiner and McLean.” (101.)
`
`10 Hofland et al., US 2004/0224010 Al, published NOV. 11, 2004.
`11 CipOlla et al., US 2012/0244206 Al, published Sept. 27, 2012.
`12 Kim et al., US 5,723,147, issued Mar. 3, 1998.
`
`4
`
`
`
`Appeal 2018-007990
`Application 13/283,450
`
`Regarding encapsulation of NSAIDs in an aqueous phase of the MVL
`
`rather than in the lipid layers of the liposomes of Weiner and McLean, the
`
`Examiner notes that Gruber teaches NSAIDs, such as naproxen and
`
`diclofenac which are water insoluble hydrophobic compounds, “can be
`
`converted into salt form to obtain soluble forms.” (Id. at 3—4.) According to
`
`the Examiner, it would have been obvious to make the NSAID into a salt
`
`form “since such [a] procedure makes the NSAID soluble as taught by
`
`Gruber” (id. at 3), and then encapsulate the NSAID in the aqueous
`
`compartment of the MVL “instead of sequestering them into [the] lipid
`
`bilayer of the liposomes” (id. at 4).
`
`We disagree with the Examiner’s conclusion of obviousness. As
`
`Appellant points out, Gruber teaches a solubilized NSAID salt where the
`
`NSAID contains “at least one carboxylic group.” (Gruber 1] 25; Appeal Br.
`
`13 (citing Declaration of Kathleen Los13 1] 7).) The Examiner did not
`
`address this argument directly.
`
`(Ans. 3—5.) Instead, the Examiner argued
`
`that generally increasing the pH to dissolve NSAIDs “is suggested by
`
`Gruber [and] determining the solubility conditions of any compound is
`
`within the skill of the art of [the] highly developed field of chemistry.” (Id.
`
`at 6.)
`
`We disagree that one of ordinary skill in the art would have had a
`
`reasonable expectation of success in solubilizing meloxicam or piroxicam by
`
`making a salt form using the method described by Gruber. Gruber notes that
`
`“[a] common disadvantage of this group of drugs[, i.e., NSAIDs,] is their
`
`poor solubility.” (Gruber 1] 2.) Yet Gruber only discloses making water-
`
`13 The Los Declaration is dated April 19, 2017.
`
`5
`
`
`
`Appeal 2018-007990
`Application 13/283,450
`
`soluble salt forms of NSAIDs that contain at least one carboxylic group.
`
`(Gruber W 24—25.) We determine that one of ordinary skill in the art would
`
`have reasonably concluded from this disclosure that not all NSAIDs may be
`
`provided as a water-soluble salt form, and thus, we disagree with the
`
`Examiner that increasing the pH to dissolve any NSAID is suggested by
`
`Gruber (Ans. 6).
`
`As Ms. Los attests (Los Declaration 1] 7), and the Examiner does not
`
`dispute, neither meloxicam nor piroxicam have a carboxylic group. Thus,
`
`we agree with Appellant (Reply Br. 7), that in light of Gruber’s narrow
`
`disclosure of the NSAIDs that could be made into solubilized salts as
`
`NSAIDS having a carboxylic group, one of ordinary skill in the art would
`
`not have had a reasonable expectation of success in achieving a soluble salt
`
`form of meloxicam or piroxicam by simply solubilizing those compounds
`
`“at an alkaline pH as taught by Gruber” (Final Action 5). Consequently, we
`
`reverse the Examiner’s rejection of the claims as being obvious over Weiner,
`
`McLean, Sankaram, and Gruber.
`
`Weiner, McLean, Kim, and Gruber
`
`The Examiner’s rejection under this ground relies on Gruber for the
`
`same principle as discussed above. (See Final Action 6.) For the reasons
`
`just discussed, we disagree that one of ordinary skill in the art would have
`
`had a reasonable expectation of success in solubilizing meloxicam or
`
`piroxicam by making a salt form as described by Gruber. Thus, we reverse
`
`the Examiner’s obviousness rejection under this ground.
`
`
`
`Appeal 2018-007990
`Application 13/283,45O
`
`Hofland, Cipolla, Kim, and Gruber
`
`The Examiner’s rejection under this ground relies on Gruber for the
`
`same principle as discussed above. (See Final Action 7—8; Ans. 6.) For the
`
`reasons just discussed we disagree that one of ordinary skill in the art would
`
`have had a reasonable expectation of success in solubilizing meloxicam or
`
`piroxicam by making a salt form as described by Gruber. Thus, we reverse
`
`the Examiner’s obviousness rejection under this ground.
`
`SUMMARY
`
`In summary:
`
`1, 62, 64, 68, 70,
`
`§ 103 over Weiner
`
`71, 73, 74, 111,
`
`or McLean,
`
`112, 115—122, and Sankaram, and
`
`136
`
`Gruber
`
`1, 62, 64, 68, 70,
`
`§ 103 over Weiner
`
`71, 73, 74, 111,
`
`or McLean, Kim
`
`112, and 115—122
`
`’573, and Gruber
`
`§ 103 over Hofland,
`1, 62, 64, 68,70,
`Cipolla, Kim ’147,
`71, 73, 74, 111,
`112, 115—122, and and Gruber
`
`
`
`136
`
`Overall Outcome
`
`REVERSED
`
`1, 62, 64, 68,
`
`70, 71, 73, 74,
`
`111, 112,
`
`115—122, and
`136
`
`1, 62, 64, 68,
`
`70, 71, 73, 74,
`
`111, 112, and
`115—122
`
`1,62,64,68,
`70, 71, 73, 74,
`111, 112,
`
`115—122, and
`136
`
`1, 62, 64, 68,
`
`70, 71, 73, 74,
`
`111, 112,
`
`115—122, and
`136
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
