`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`13.0. Box 1450
`Alexandria, Vi
`'nia 22313-1450
`www.uspto.go
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`12/374,528
`
`03/04/2009
`
`Heiner Will
`
`23782
`
`9344
`
`23389
`7590
`12/21/2011
`SCULLYSCOTTMURPHY&PRESSER,PC
`
`SUITE 300
`GARDEN CITY, NY 1 1530
`
`BLAKELY III, NELSON CLARENCE
`
`1629
`
`MAIL DATE
`
`12/21/2011
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`Page 1 of 28
`PTOL—90A (Rev. 04/07)
`
`ANTARES Exhibit 1002
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`ANTARES 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
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`; 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)
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`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
`
`
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`Application/Control Number: 12/374,528
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`Page 2
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`Art Unit: 1629
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`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.
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`Page 3 of 28
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`Page 3 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 3
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`Art Unit: 1629
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`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
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`Page 4 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 4
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`Art Unit: 1629
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`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
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`Page 5 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 5
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`Art Unit: 1629
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`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
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`Page 6 of 28
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`
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`Application/Control Number: 12/374,528
`
`Page 6
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`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
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`
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`Application/Control Number: 12/374,528
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`Page 7
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`Art Unit: 1629
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`(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
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`Page 8 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 8
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`Art Unit: 1629
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`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
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`Page 9 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 9
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`Art Unit: 1629
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`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
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`
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`Application/Control Number: 12/374,528
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`Page 10
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`Art Unit: 1629
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`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
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`Page 11 of 28
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`
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`Application/Control Number: 12/374,528
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`Page 11
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`Art Unit: 1629
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`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
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`Page 12 of 28
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`
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`PTO!SBf08a (01-10)
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`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
`
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`
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`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)
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`Clinical Study Report of the Patent Proprietor
`
`European Opposition Brief dated September 15, 2011 received in corresponding Ep Patent Application No. 2 046 332
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`INFORMATION DISCLOSURE
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`First Named Inventor
`
`Heiner Will
`
`Application Number
`
`12374528
`
`Filing Date
`
`2009-03-04
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
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`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
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`INFORMATION DISCLOSURE
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`First Named Inventor
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`Heiner Will
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`Application Number
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`12374528
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`Filing Date
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`2009-03-04
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`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Art Unit
`| 1629
`Examiner Name
`Nelson Clarence Blakely Ill
`Attorney Docket Number
`| 23782
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