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UNITED STATES pATENT AND TRADEMARK OFFICE

APPI.JCATION NO. FILING DATE

141212.503 03/14/2014

21559 7590 CLARK & ELBING LLP 101 FEDERAL STREET BOSTON, MA 02110

04/17nOIS

FIRST NAMED INVENTOR

Jlcnrik NILSSON

UNITED STATES DEPARTMENT OF COMMERCE United Statl.'.s Patent and Trademark Office Ad<lress: COMMISSIONER FOR PATENTS

P.O. Dox 1450 Alexandda, Virginia 22313·1450 www.uspto,gov

ATTORNEY DOCKET NO. CONFIRMATION NO.

50887-0030016 1097

EXAMlNER

CHANNA VAJJALA. LAKSHMI SARADA

ART UNIT PAPER !\'UMBER

161 1

NOTIFICATION DA'lll DELIVERY MODE

04117/2015 ELECTRONIC

Please find below and/or attached an Office communication concerning this application or proceeding.

The time peliod 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 folJowing e-mail address(es):

[email protected]

PTOL-90A (Rev. 04107)

Application No. 14/212,503

Applicant(s) NILSSON ET AL.

Art Unit I AlA (First Inventor to File)

1611 Status

No

Office Action Summary Examiner LAKSHMI CHANNAVAJJALA

-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION.

Extensions of time may be available under the provisions ol 37 CFR t . t36(a). In no event, however. may a reply be timely filed after SIX (6) MONTHS from the mailing date of this communication. If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. Failure to reply whhin the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133). Any reply received by the O ffice later than three months alter the mailing date of this communication, even if timely ti led, may reduce any earned patent term adjustment. See 37 CFR 1. 704(b) .

Status 1)~ Responsive to communication(s) filed on 12119/14.

0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .

2a)~ This action is FINAL. 2b)0 This action is non-final. 3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on

__ ; the restriction requirement and election have been incorporated into this action. 4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 C. D. 11 , 453 O.G. 213.

Disposition of Claims* 5)181 Claim(s) 46-70 is/are pending in the application.

5a) Of the above claim(s) __ is/are withdrawn from consideration. 6)0 Claim(s) __ is/are allowed.

7)[81 Claim(s) 46-70 is/are rejected. 8)0 Claim(s) __ is/are objected to. 9)0 Claim(s) __ are subject to restriction and/or election requirement.

• If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a

participating intellectual property office for the corresponding application. For more information, please see

http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPHfeedbackCwuspto.gov.

Application Papers 1 0)0 The specification is objected to by the Examiner. 11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).

Priority under 35 U.S.C. § 119 12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). Certified copies:

a)O All b)O Some** c)O None of the: 1.0 Certified copies of the priority documents have been received. 2.0 Certified copies of the priority documents have been received in Application No. 11/576,871 . 3.0 Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)). •• See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) 0 Notice of References Cited (PT0-892)

2) !8ltnfonnation Disclosure Statement(s) (PTO/SBIOSa and/or PTO/SB/OSb) Paper No(s)/Mall Date 12119/14: 12122114.

U.S. Patent and Ttademark 011/ce PTOL·326 (Rev. 11·13) Office Action Summary

3) 0 Interview Summary (PT0-413)

Paper No(s)fMail Date. __ .

4) 0 Other: __ .

Part ol Paper No./Mail Date 20150321

Application/Control Number: 14/212,503

Art Unit: 1611

Page 2

1. The present application is being examined under the pre-AlA first to invent

provisions.

DETAILED ACTION

Receipt of amendment, response and I OS dated 12/19/14; and I OS 12/22/14 is

acknowledged.

Claim 1-45 have been canceled. Claims 46-70 are pending in the instant application.

In response to the amendment canceling claim 1 and the abandonment of some of the

co pending applications. the following rejections have been withdrawn:

Double Patenting

3. Claim 1 is provisionally rejected under 35 U.S.C. 101 as claiming the same

invention as that of claim 1 of EACH copending Application Nos. 14/213,673;

14/213399; 14/209,756; 14/209,712; 14/209,651 and 14/209,584.

4. Claims 1 and 46-70 are provisionally rejected under 35 U.S.C. 101 as claiming

the same invention as that of claims 1 and 46-70 of copending Application No.

14/213,321 .

5. Claims 1 and 46-64 are provisionally rejected under 35 U.S.C. 101 as claiming

the same invention as that of claims 1-19 of copending Application No. 13/957,220.


Art Unit: 1611

Page 3

6. Claims 1 and 46-70 are provisionally rejected on the ground of nonstatutory

double patenting as being unpatentable over claims 1-29 of copending Application No.

13/957,250.

8. Claims 1 and 46-70 are provisionally rejected on the ground of nonstatutory

double patenting as being unpatentable over claims 1-4, 6-14 and 16-30 of copending

Application No.13/957,117.

9. Claim 1 is rejected under pre-AlA 35 U.S.C. 102(b) as being anticipated by Joshi

et al (US Patent 6,355,676) or Joshi et al 6,509,376 (all Joshi references disclose the

same subject matter and therefore, Joshi patent 6355676 is relied upon for explaining

the teachings of both the references and described below) or anticipated by Speiser

(US 5424332).

The following rejection of record has been maintained:

10. Claims 46-50, 63-66 are provisionally rejected on the ground of nonstatutory


11/576,871. Although the claims at issue are not identical, they are not patentably

distinct from each other because both instant and the copending applications claim a

method of treating multiple sclerosis by administrating an oral delayed release

composition comprising dimethylfumarate in combination with pharmaceutical excipients

such that a total daily dose of 480mg dimethylfumarate is administered per day. Both


Art Unit: 1611

Page4

sets of claims recite twice daily administration of administering dimethylfumarate in the

form of tablet or capsule. While the copending claims do not recite the claimed plasma

levels of monomethylfumarate, the compositions of both sets of claims recite the same

amount of the active agent and therefore the claimed plasma levels are inherent to the

composition of the claims of 11/576,871.

11. Claims 51-62 and 67-70 are provisionally rejected on the ground of nonstatutory


11/576,871 in view of in view of any one of US 7,320,999 to Joshi et al or US 6436992

to Joshi et al.

The copending claims discussed above are directed to a method of treating

multiple sclerosis by administering an oral composition comprising 480 mg or 240 mg

dimethylfumarate twice daily (new claim 63 of the copending application). The

copending application does not recite the claimed excipients such as silica, talc,

surfactant, carboxymethyl cellulose etc., microcrystals of the drug with the claimed

particle sizes, and enteric coating of the same.

Joshi ('992) teaches oral tablet formulations comprising fumaric acid derivatives,

mono methyl and dimethyl fumarate, for treating auto-immune diseases such as multiple

sclerosis (abstract and col. 1, I 66- col.2, I 52). The amount of fumaric acid esters is in

the range of 10-300 mg, which includes the claimed dose of 240 mg (see col. 3, I 15-

19). Joshi teaches that the composition is in the form of pellets, micro-pellets, capsules,


Art Unit: 1611

Page 5

granulates etc. (col. 5, 117-27) with a mean diameter of 300-2000 microns (col. 5, 127-

31 ). The composition of Joshi further comprises pharmaceutical excipients such as

silicic acid, microcrystalline cellulose, magnesium stearate and kollidon (reads on

surfactant) etc. (examples). Joshi teaches that the composition additionally contains

enteric coating (example 1 in col. 6, I 9-29).

Joshi '999 patent also teaches and claims a method of treating multiple sclerosis

with an oral composition comprising dimethylfumarate in an amount ranging from 10-

300 mg (col. 4, 145-50). Joshi '999 also teaches compositions similar to that of Joshi

'992. Joshi patents do not suggest a dose of 240 mg of the instant claims. However,

Joshi (both '999 and '992 patents) suggests active agent in an amount of 100-300 mg,

which includes the claimed 240 mg/dose. Therefore, it would have been obvious for one

of an ordinary skill in the art at the time of the instant invention was made to prepare the

compositions of the copending claims by employing microcrystals of drug in the particle

sizes, and further coat the composition with an enteric coating polymer taught by Joshi

references because a skilled artisan would have readily recognizes that

dimethylfumarate containing oral compositions can be formulated in other ways, other

than tablet and capsule form, such as those taught by Joshi references and still achieve

an effective treatment to multiple sclerosis. While both Joshi patents fail to teach the

claimed percentages of the excipients such as microcrystalline cellulose, magnesium

stearate and silica, the said patents teaches all of the claimed excipients as being

suitable in preparing an oral dosage form of dimethyl fumarate and suggests the said

excipients in amounts as opposed to % weights. Hence, it would have been obvious for


Art Unit: 1611

Page 6

one of an ordinary skill in the art at the time of the instant invention was made to employ

appropriate amounts of said excipients such as microcrystalline cellulose, magnesium

stearate and silica etc., of Joshi in the dimethyl fumarate containing compositions of

copending claims with an expectation to provide a tablet composition of appropriate

strength and dissolution such that it provides the desired benefit i.e., treatment of

multiple sclerosis. Joshi teaches administration of the composition comprising fumarate

for a period of one week to several weeks.

This is a provisional nonstatutory double patenting rejection because the patentably

indistinct claims have not in fact been patented.

Response to Arguments

Applicant's arguments filed 12/19/14 have been fully considered but they are not

persuasive.

12. Applicants argue that claims of 11/576871 do not recite "an oral delayed

release composition" whereas instant claims are not limited to one type of delayed

release but to any kind of delayed release, including the formulation of Fumaderm®

(see Kristensen Declaration date (12/20/11 ). Applicants argue that the claims of '871

application do not recite any particular pharmaceutical composition, whereas instant

claims require a delayed release having a specified Cmax within a specified range. It is

argued even if one considers separate administration of a 240 mg DMF, twice daily,

according to the '871 application, the copending claims do not specify a delayed release

dosage form, the claims may be practiced to deliver an immediate release allowing for a


Art Unit: 1611

Page 7

fast release and high Cmax, or allow for a slow release composition that allows a low

Cmax compared to the Cmax for a delayed release composition. Accordingly, the

instant provisional rejection fails to support this ground of rejection and should be

withdrawn. Applicants further argue that if one employed a delayed release formulation

containing 240 mg DMF, the excipients beneath the delayed release functionality, such

as an ethyl cellulose coating, could slow the release of drug to produce a Cmax lower

than the claimed 0.4 mg/L. Therefore, it is argued that the non-statutory double

patenting rejection should be withdrawn.

Applicants' arguments are considered but not found persuasive because while it

is true that the claims should be interpreted in light of the specification but without

importing the limitations from the specification, the copending claims recite the same

total daily dose administered and further recite administering separate doses two times

daily. When a certain total dose of a drug is given in two or more intervals, it is implicit

that the release from the drug is delayed and that not the entire daily total dose is

released at once (fast or immediately). With respect to "the functional limitation, Cmax of

0.4 to 2 mg/ml", as a practical matter, the Patent Office is not equipped to manufacture

products by the myriad of processes put before it and then obtain prior art products and

make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685,

688 (CCPA 1972). In this respect, the burden is on applicants to provide a comparison

between the instant and copending claims. However, a mere allegation (without a

comparative evidence) that the copending claims may or could slow the release of the

active agent, or may be practiced only to slow the release, is not persuasive. Applicants


Art Unit: 1611

Page 8

have not shown why a skilled artisan would only prepare a slow release composition

instead a delayed release and instead would only be able to prepare an immediate

release dosage form from the claimed composition of 11 /576871. Additionally, the

rejection not only relies on the claims of 11/576871 alone but also on the secondary

teachings of Joshi references for rejecting claims 51-62 and 67-70, which teach the

excipients that are also claimed in the instant invention. Hence, it would have been

obvious for one of an ordinary skill in the art at the time of the instant invention was

made to employ appropriate amounts of said excipients such as microcrystalline

cellulose, magnesium stearate and silica etc., of Joshi in the dimethyl fumarate

containing compositions of copending claims with an expectation to provide a tablet

composition of appropriate strength and dissolution such that it provides the desired

benefit i.e., treatment of multiple sclerosis. Joshi teaches administration of the

composition comprising fumarate for a period of one week to several weeks. Hence, the

rejection has been maintained.

Conclusion

THIS ACTION IS MADE FINAL Applicant is reminded of the extension of time policy

as set forth in 37 CFR 1.136(a).

A shortened statutory period for reply to this final action is set to expire THREE

MONTHS from the mailing date of this action. In the event a first reply is filed within

TWO MONTHS of the mailing date of this final action and the advisory action is not

mailed until after the end of the THREE-MONTH shortened statutory period, then the

shortened statutory period will expire on the date the advisory action is mailed, and any


Art Unit: 1611

Page 9

extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of

the advisory action. In no event, however, will the statutory period for reply expire later

than SIX MONTHS from the mailing date of this final action.

Any inquiry concerning this communication or earlier communications from the

examiner should be directed to LAKSHMI CHANNAVAJJALA whose telephone number

is (571 )272-0591. The examiner can normally be reached on 9.00 AM -5.30 PM.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's

supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number

for the organization where this application or proceeding is assigned is 571-273-8300.


Art Unit: 1611

Page 10

Information regarding the status of an application may be obtained from the

Patent Application Information Retrieval (PAIR) system. Status information for

published applications may be obtained from either Private PAIR or Public PAIR.

Status information for unpublished applications is available through Private PAIR only.

For more information about the PAIR system, see http://pair-direct.uspto.gov. Should

you have questions on access to the Private PAIR system, contact the Electronic

Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a

USPTO Customer Service Representative or access to the automated information

system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1 000.

/LAKSHMI CHANNAVAJJALA/ Primary Examiner, Art Unit 1611

please find below and/or attached an office communication...

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