throbber
Frontier Therapeutics Exhibit 1002
`
`Page 1 of 28
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`12/374,528
`
`WILL, HEINER
`
`Examiner
`NELSON BLAKELY Ill
`
`Art Unit
`1629
`
`-- The MAILING DA TE 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 § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(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 within 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 Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)IXl Responsive to communication(s) filed on 02 December 2011.
`
`2a)I:I This action is FINAL.
`
`2b)IXI This action is non—final.
`
`3)I:l 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)I:l 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)Xl Claim(s)1-:.3‘2is/are pending in the application.
`
`5a) Of the above claim(s) 12 and 18-32 is/are withdrawn from consideration.
`
`6 I] Claim s)
`
`is/are allowed.
`
`Application Papers
`
`10)|:l The specification is objected to by the Examiner.
`
`11)I:l The drawing(s) filed on j is/are: a)I:I accepted or b)I:I 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).
`
`12)I:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`13)IXl Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)lZ All
`
`b)I:I Some * c)I:l None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No. j.
`
`3.IZI 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) Q Notice of References Cited (PTO-892)
`2) El Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) Q Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 03/13/2009 and 05/31/2011.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(3)/Ma“ DaT9- L
`5) I:I Notice Of Inform-3' Patent APPIICaTI0“
`6) D Other:
`.
`
`PTOL-326 Ilaagé-12) of
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20111218
`
`Page 2 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 2
`
`Art Unit: 1629
`
`DETAILED ACTION
`
`Application Status
`
`Claims 1-32 of the instant application are pending. Claims 12 and 18-32 are
`
`withdrawn pursuant to Applicant’s response, filed 12/02/2011. Accordingly, instant
`
`claims 1-11 and 13-17 are presented for examination on their merits.
`
`Election/Restrictions
`
`Applicant's election fl traverse of Group II, drawn to instant claims 1-17, in the
`
`reply filed on 12/02/2011, is acknowledged. The traversal is on the grounds that
`
`Hoekstra et al. do not provide any teaching at all with regard to the concentration of the
`
`administered solutions. Further, Applicant traverses that the aforementioned reference
`
`only teaches a higher absolute dose of methotrexate, in particular, doses between 25
`
`and 40 mg methotrexate per week.
`
`This is not found persuasive because, as recited in the previous Office action,
`
`Hoekstra et al. disclose a study to determine the bioavailability of higher doses of
`
`methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) through oral and
`
`subcutaneous administration, wherein the latter enhances bioavailability. Further,
`
`Hoekstra eta/. disclose, in the first paragraph, left column, page 645, wherein the
`
`efficacy of high intravenous doses of MTX (40-500 mg/m2), in patients with refractory
`
`RA, was described in several studies. Additionally, in the Materials and Methods, page
`
`646, Hoekstra eta/. disclose wherein patients with RA, who were treated with MTX in a
`
`stable (2 3 months) dose of 2 25 mg weekly, orally or parenterally, were studied.
`
`Page 3 of 28
`
`Page 3 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 3
`
`Art Unit: 1629
`
`Accordingly, one of ordinary skill in the art, at the time of the invention, would have
`
`envisaged an embodiment wherein the high dose MTX comprised 25+ mg in 1 mL of
`
`solution.
`
`Therefore, the requirement is still deemed proper and is therefore made FINAL.
`
`It is noted wherein Applicant elected rheumatoid arthritis as the inflammatory
`
`autoimmune disease, and wherein no preservatives are required.
`
`Claims 12 and 18-32 are withdrawn from further consideration pursuant to 37
`
`CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable
`
`generic or linking claim. Applicant timely traversed the restriction (election) requirement
`
`in the reply filed on 12/02/2011.
`
`Priority
`
`Receipt is acknowledged of the certified copy of DE10 2006 033 837.5, filed
`
`07/21/2006, submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of
`
`record in the file.
`
`It is noted wherein the aforementioned document is not in English.
`
`Information Disclosure Statement
`
`The Information Disclosure Statements, filed 03/13/2009 and 05/31/2011, are
`
`acknowledged and considered. With regard to the Jansen et al. NPL reference (IDS on
`
`03/13/2009) and Rote Liste Service and the European Search Report NPL references
`
`(IDS on 05/31/2011), the aforementioned references were considered pursuant to their
`
`relevance, as set forth, and not their content. Said references are not in English.
`
`Page 4 of 28
`
`Page 4 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 4
`
`Art Unit: 1629
`
`Claim Objections
`
`Claims 5-11 and 13-17 are objected to for the following informalities:
`
`Claims 5-11 and 13-17 are objected to under 37 CFR 1.75(c) as being in
`
`improper form because a multiple dependent claim cannot depend from any other
`
`multiple dependent claim. See MPEP § 608.01 (n). Accordingly, the claims have not
`
`been further treated on the merits.
`
`With regard to instant claim 17, the aforementioned claim is dependent upon
`
`itself. For the purposes of examination, the Examiner has interpreted instant claim 17 to
`
`depend from instant claim 16.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 101/§ 112, 15’ Paragraph
`
`35 U.S.C. 101 reads as follows:
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`Claims 1-11 and 13-17 are rejected under 35 U.S.C. 101 because the claimed
`
`invention is not supported by either a specific and substantial asserted utility or a well-
`
`established utility.
`
`Page 5 of 28
`
`Page 5 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 5
`
`Art Unit: 1629
`
`The claimed invention does not fall within at least one of the four categories of
`
`patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture,
`
`or composition of matter). The instant claims begin with the non-statutory claim
`
`language of “The use of...”, whereby the interpretation of said language may be that of
`
`a product, for example, or a method of using. Therefore, in order to expedite
`
`prosecution, the Examiner has interpreted the instant claims, pursuant to Applicant’s
`
`election (See supra) as “A method for the treatment of inflammatory autoimmune
`
`diseases...”.
`
`Claims 1-11 and 13-17 are also rejected under 35 U.S.C. 112, first paragraph.
`
`Specifically, since the claimed invention is not supported by either a specific and
`
`substantial asserted utility or a well-established utility for the reasons set forth above,
`
`one skilled in the art clearly would not know how to use the claimed invention.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 4-11 and 13-17 are rejected under 35 U.S.C. 112, second paragraph, as
`
`being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`which applicant regards as the invention.
`
`Regarding claims 4, 6, 9, 15 and 17, the phrase "in particular" renders the claim
`
`indefinite because it is unclear whether the limitation(s) following the phrase are part of
`
`the claimed invention. See MPEP § 2173.05(d).
`
`Page 6 of 28
`
`Page 6 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 6
`
`Art Unit: 1629
`
`Correction is required.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`1.
`2.
`3.
`4.
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`Claims 1-11 and 13 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Hoekstra eta/. (Q Rheumatol, Vol. 31, No. 4, pages 645-648; 2004; cited by
`
`Applicant), in view of Zackheim (Journal o_f American Academy o_f Dermatology, Vol. 23,
`
`No. 6, page 1008; 2002; cited by Applicant) and Wright eta/. (International Journal o_f
`
`Pharmaceutics, Vol. 45, Issue 3, abstract; 1988), as evidenced by Galinsky eta/. [“Basic
`
`Pharmacokinetics and Pharmacodynamics.” in: Remington: 1 Science 11 Practice
`
`gfPharmacy (Baltimore, Lippincott Williams & Wilkins, 2006), p. 1171].
`
`With regard to instant claims 1-11 and 13, Hoekstra eta/. disclose, in the
`
`abstract, a study to determine the bioavailability of higher oral doses of methotrexate
`
`Page 7 of 28
`
`Page 7 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 7
`
`Art Unit: 1629
`
`(MTX) in adult patients with rheumatoid arthritis (RA) through oral and subcutaneous
`
`administration.
`
`In the instant excerpt, Hoekstra etal. further disclose wherein to
`
`improve efficacy of MTX ad dosages of 25 mg weekly or more, a change to parenteral
`
`administration should be considered. On page 645, left column, first paragraph,
`
`Hoekstra et al. disclose wherein efficacy of high intravenous doses of MTX (40-500
`
`mg/m2), in patients with refractory RA, was described in several studies.
`
`In the
`
`Materials and Methods, page 646, Hoekstra et al. disclose wherein patients with RA,
`
`who were treated with MTX in a stable (2 3 months) dose of 2 25 mg weekly, orally or
`
`parenterally, were studied. Further, it is not inventive to discover the optimum ranges or
`
`regimens by routine experimentation when general conditions of a claim are disclosed
`
`in the prior art. See In re A//er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
`
`and MPEP §2144.05(ll).
`
`In addition, Galinsky etal. recite in the left column of page
`
`1171, lines 12-27 of text, that it is recognized that drug therapy may be optimized by
`
`designing regimens that account for the concentration of a drug, for example, to achieve
`
`a desired pharmacological response. Therefore, the determination of the optimum
`
`characterization of the composition and dosage amounts would have been a matter well
`
`within the purview of one of ordinary skill in the art, at the time of the invention, through
`
`no more than routine experimentation. Accordingly, one of ordinary skill would have
`
`envisaged an embodiment wherein the high dose MTX comprised 25+ mg in 1 mL of
`
`solution.
`
`Hoekstra et al. fail to disclose specifically wherein methotrexate is present in a
`
`pharmaceutically acceptable solvent at a concentration of more than 30 mg/mL (instant
`
`Page 8 of 28
`
`Page 8 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 8
`
`Art Unit: 1629
`
`claims 1-3), wherein the medicament is in a form suitable for patient self—administration
`
`(instant claim 7) or wherein the medicament is contained in an injection device for a
`
`single application (instant claim 8). However, Zackheim discloses, in the first two
`
`paragraphs, right column, wherein with subcutaneous administration of methotrexate
`
`there was no local reaction, and when doses more than 50 mg were required, two
`
`injection sites were used with no greater than 50 mg (2 mL) at each site.
`
`In the instant
`
`excerpt, Zackheim further discloses wherein subcutaneous injections may be self-
`
`administered, which is considerably valuable for patients who have difficulty making
`
`weekly office visits, and herein patients are instructed to use only 1 mL syringes so that
`
`gross errors in dosage are less likely to occur, wherein doses greater than 25 mg
`
`require the use of at least two syringes.
`
`Hoekstra et al. fail to disclose specifically wherein the injection device is a ready-
`
`made syringe (instant claim 10) or wherein the medicament is contained in a storage
`
`container (instant claim 11). However, Wright etal. disclose, in the abstract, a study
`
`wherein the stability of MTX injection in 4 commercially available brands of sealed
`
`plastic disposable syringe was investigated, wherein the MTX injection was at a
`
`concentration of 50 mg/mL or less was found to be stable (less than 10% degradation)
`
`for a period of up to 8 months.
`
`In the instant excerpt, Wright etal. further disclosed that
`
`the aforementioned syringes are a suitable secondary packaging system for the storage
`
`of MTX injections for periods of up to 8 months. Wright et al. fail to disclose specifically
`
`wherein the syringe further comprises wherein the MTX is present in a pharmaceutically
`
`acceptable solvent, e.g., water. However, one of ordinary skill in the art, at the time of
`
`Page 9 of 28
`
`Page 9 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 9
`
`Art Unit: 1629
`
`the invention, would have construed an embodiment in intravenous therapy, which
`
`comprises the infusion of a liquid substance directly into the vein, wherein the
`
`medicament, e.g., MTX, is present in a pharmaceutically acceptable solvent, e.g., water,
`
`or an isotonic solution.
`
`Therefore, a skilled artisan would have envisaged the instantly claimed method
`
`of treating an inflammatory autoimmune disease, e.g., rheumatoid arthritis, comprising
`
`administering high dose MTX, as disclosed by Hoekstra et al., in view of Zackheim,
`
`wherein the medicament is stored in a ready-made syringe, as disclosed by Wright et al.
`
`One of ordinary skill in the art would have been motivated to combine the teachings of
`
`the aforementioned references when seeking a method for effectively treating
`
`rheumatoid arthritis that increases patient compliance because the subcutaneous
`
`injections may be safely self-administered from ready-made syringes.
`
`It would have
`
`been obvious to one of ordinary skill in the art, at the time of the invention, because the
`
`combined teachings of the prior art are suggestive of the claimed invention.
`
`Accordingly, the instant invention, as claimed in claims 1-11 and 13, is prima
`
`facie obvious over the combination of the aforementioned teachings.
`
`Claims 1-11 and 13-17 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Hoekstra eta/. (Q Rheumatol, Vol. 31, No. 4, pages 645-648; 2004;
`
`cited by Applicant), in view of Zackheim (Journal o_f American Academy o_f Dermatology,
`
`Vol. 23, No. 6, page 1008; 2002; cited by Applicant) and Wright eta/. (International
`
`Journal o_f Pharmaceutics, Vol. 45, Issue 3, abstract; 1988), as evidenced by Galinsky et
`
`Page 10 of 28
`
`Page 10 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 10
`
`Art Unit: 1629
`
`al. [“Basic Pharmacokinetics and Pharmacodynamics.” in: Remington: me Science
`
`11 PracticegfPharmacy (Baltimore, Lippincott Williams & Wilkins, 2006), p. 1171], as
`
`applied to claims 1-11 and 13 above, and further in view of Silver (U.S. Patent No.
`
`5,542,934).
`
`With regard to instant claims 1-11 and 13-17, the teachings of Hoekstra eta/.,
`
`Zackheim, Wright et al. and Galinsky et al. are set forth supra.
`
`Hoekstra et al. fail to disclose specifically wherein the storage container is a
`
`carpule suitable for administering the medicament by means of an injection device,
`
`wherein multiple applications of single doses may be administered (instant claims 14-
`
`17). However, Silver discloses, in the abstract, a hypodermic syringe designed to
`
`simultaneously dispense, for example, an anesthetic liquid, from a plurality of carpules.
`
`See also reference column 1, lines 33-42, and Figures 1-3. Silver discloses, in column
`
`3, lines 1-6, a need for a hypodermic syringe which is capable of holding a plurality of
`
`anesthetic fluid carpules, for example, at one time, and which is capable of dispensing
`
`the contents of said plurality of carpules without requiring multiple needle sticks.
`
`Therefore, a skilled artisan would have envisaged the instantly claimed method
`
`of treating an inflammatory autoimmune disease, e.g., rheumatoid arthritis, comprising
`
`administering high dose MTX, as disclosed by Hoekstra et al., in view of Zackheim,
`
`wherein multiple applications of single dosages may be administered, as disclosed by
`
`Silver. One of ordinary skill in the art would have been motivated to combine the
`
`teachings of the aforementioned references when seeking a method for effectively
`
`treating rheumatoid arthritis that increases patient compliance because multiple
`
`Page 11 of 28
`
`Page 11 of 28
`
`

`
`Application/Control Number: 12/374,528
`
`Page 11
`
`Art Unit: 1629
`
`applications of the subcutaneous injections may be safely self-administered from ready-
`
`made syringes without requiring multiple needle sticks.
`
`It would have been obvious to
`
`one of ordinary skill in the art, at the time of the invention, because the combined
`
`teachings of the prior art are suggestive of the claimed invention.
`
`Accordingly, the instant invention, as claimed in claims 1-11 and 13-17, is prima
`
`facie obvious over the combination of the aforementioned teachings.
`
`No claims are allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`Examiner should be directed to NELSON BLAKELY III whose telephone number is
`(571)270-3290. The Examiner can normally be reached on Mon - Thurs, 7:00 am — 5:30
`pm (EST).
`If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s
`supervisor, Jeffrey S. Lundgren can be reached on (571) 272-5541. The fax phone
`number for the organization where this application or proceeding is assigned is 571 -
`273-8300.
`
`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 571-272-1000.
`
`/N. B. III/
`
`Examiner, Art Unit 1629
`
`/Jeffrey S. Lundgren/
`Supervisory Patent Examiner, Art Unit 1629
`
`Page 12 of 28
`
`Page 12 of 28
`
`

`
`PTO!SBf08a (01-10)
`Doc code: IDS
`th
`df
`A
`h 07/302012. OMB 0651-0031
`.
`.
`.
`.
`.
`U_s_ Patent and Tragzggfk O‘:;::eU_§"EfiEPARTMENT OF COMMERCE
`Doc description: Information Disclosure Statement (IDS) Filed
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Heiner Will
`
`Application Number
`
`Filing Date
`
`12374528
`
`2009-03-04
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
`
`E).(‘?m*iner Cite
`
`Initial
`
`No
`
`U.S.PATENTS
`
`Rem°Ve
`
`Patent Number
`
`Kind
`
`Code1
`
`Issue Date
`
`Na“.“° of Patentee or Applicant
`
`of cited Document
`
`::IJee\1:I'i:toPuar:::g|:=.i:e<:' VR:I:r:ant
`
`.
`Figures Appear
`
`1
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
`
`U.S.PATENT APPLICATION PUBLICATIONS
`
`Add
`
`Rem°Ve
`
`Examiner
`.
`.
`,,
`Initial
`
`.
`Cite No
`
`Publication
`Number
`
`Publication
`Kind
`Codel Date
`
`Name of Patentee or Applicant PageS’C°|umn5'Line5 Where
`.
`Relevant Passages or Relevant
`of cited Document
`Figures Appear
`
`If you wish to add additional U.S. Published Application citation information please click the Add button. Add
`
`FOREIGN PATENT DOCUMENTS
`
`R9m0Ve
`
`Examiner Cite Foreign Document
`|nitia|*
`No
`Number3
`
`Country
`Code2 i
`
`Publication
`Kind
`Code4 Date
`
`Name of Patentee or
`A “cant of cited
`Dpp
`ocument
`
`Pages,Co|umns,Lines
`where Relevant
`Passages or Relevant
`.
`Figures Appear
`
`1
`
`D
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`
`Add
`
`NON-PATENT LITERATURE DOCUMENTS
`
`R9m0Ve
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`.
`.
`.
`.
`.
`.
`.
`Examiner Cite
`T5
`(book, magazine, Journal, serial, symposium, catalog, etc}, date, pages(s), volume-issue number(s),
`.
`.
`publisher, city and/or country where published.
`
`EFS Web 2.1.17
`
`Page 13 of 28
`
`Page 13 of 28
`
`

`
`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Heiner Will
`
`Application Number
`
`12374528
`
`Filing Date
`
`2009-03-04
`
`STATEMENT BY APPLICANT
`_
`_
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
`
`Pharmachemie BV, Physician Package Insert, Abitrexate (22 February 2000)
`
`"Methotrexate 100 mg/ml Injection Package Insert, Hospira UK Ltd. (7 June 1994)
`
`WRIGHT, M. P. et al., "Stability of Methotrexate Injection in Prefilled, Plastic Disposable Syringes" International Journal
`of Phamtaceutics (1988) pp. 237-244, Vol. 45
`
`O'DELL, J.R., "Methotrexate Use in Rheumatoid Arthritis" Rheumatic Disease Clinics of North America November
`1997) pp. 779-796, Vol. 23, no. 4
`
`BROOKS, P. J. et aI., "Pharmacokinetics of Methotrexate Administered by Intramuscular and Subcutaneous Injections
`in Patients with Rheumatoid Arthritis" Arthritis and Rheumatism (January 1990) pp. 91-94, Vol. 33, no. 1
`
`SILVERMAN, E. et aI., "Leflunomide or Methotrexate for Juvenile Rheumatoid Arthritis" The New England Journal of
`Medicine (21 April 2005) pp. 1655-1666, Vol. 352
`
`BALIS, F. M. et al., "Pharmacokinetics of Subcutaneous Methotrexate" Journal of Clinical Oncology (December 1988)
`pp. 1882-1886, Vol. 6, no. 12
`
`Professor Dr. Thomas Gramatté, Gutachterliche Stellungnahme
`
`Comparative Survey of the Patent Proprietor, Exhibit B of E11 (reference no. 8 listed above)
`
`Clinical Study Report of the Patent Proprietor
`
`European Opposition Brief dated September 15, 2011 received in corresponding Ep Patent Application No. 2 046 332
`
`EFS Web 2.1.17
`
`Page 14 of 28
`
`Page 14 of 28
`
`

`
`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Heiner Will
`
`Application Number
`
`12374528
`
`Filing Date
`
`2009-03-04
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`EXAMINER SIGNATURE
`
`*EXAM|NER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`2 Enter office that issued the document, by the two-letter code (WIPO
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04.
`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST_16 if possible.
`5 Applicant is to place a check mark here if
`English language translation is attached.
`
`EFS Web 2.1.17
`
`Page 15 of 28
`
`Page 15 of 28
`
`

`
`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Heiner Will
`
`Application Number
`
`12374528
`
`Filing Date
`
`2009-03-04
`
`STATEMENT BY APPLICANT
`_
`_
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
`
`CERTIFICATION STATEMENT
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate se|ection(s):
`
`|:I
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`II
`
`|:| See attached certification statement.
`
`The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`|:| A certification statement is not submitted herewith.
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`NamelPrint
`
`Date WW-MM-00>
`Registration Number
`
`2°12-01-27
`33705
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFS Web 2.1.17
`
`Page 16 of 28
`
`Page 16 of 28
`
`

`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that:
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent.
`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`A record from this sys

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket