`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/621,502
`
`ZELDIS, JEROME B.
`
`Examiner
`JAMES D. ANDERSON
`
`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 3 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 CFR1. 136( a).
`In no event however may a reply be timely filed
`after SIX () 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)IZI Responsive to communication(s) filed on 19 November 2009.
`
`2a)I:l This action is FINAL.
`
`2b)IZ| This action is non-final.
`
`3)I:I 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.
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`4)|:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 1-17is/are pending in the application.
`
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`
`6)I:I Claim(s) _ is/are allowed.
`
`7)|Zl Claim(s)_1-17is/are rejected.
`
`8)I:I Claim(s) _ is/are objected to.
`
`9)I:l Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)|:| The drawing(s) filed on _ is/are: a)|:l accepted or b)I:l 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:I 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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)I:I AII
`
`b)I:I Some * c)|: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. _
`
`3.|:I 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) I] Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) E Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| DateW.
`US. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper N°(5 )/Mai| Date. _
`5)I:I Notice 0f Informal Patent Application
`)6|:| Other:
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20111222
`
`
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`IPR2018-00685
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`Application/Control Number: 12/621,502
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`Page 2
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`Art Unit: 1629
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`DETAILED ACTION
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`Formal Matters
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`Claims 1-17 are pending and under examination.
`
`Priority
`
`This application is a continuation application of U.S. non-provisional
`
`application 11/888,881, filed August 1, 2007, which claims the benefit of U.S.
`
`provisional application 60/835,752, filed August 3, 2006.
`
`Information Disclosure Statement
`
`Receipt is acknowledged of the Information Disclosure Statements filed
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`3/5/2010 and 8/3/2011. The Examiner has considered the references cited therein
`
`to the extent that each is a proper citation. Please see the attached USPTO Form
`
`1449.
`
`Claim Rejections - 35 USC § 112 —2”d Paragraph
`
`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.
`
`”The primary purpose of this requirement of definiteness of claim language
`
`is to ensure that the scope of the claims is clear so the public is informed of the
`
`boundaries of what constitutes infringement of the patent. A secondary purpose is
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`to provide a clear measure of what applicants regard as the invention so that it can
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`be determined whether the claimed invention meets all the criteria for patentability
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`Application/Control Number: 12/621,502
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`Page 3
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`Art Unit: 1629
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`and Whether the specification meets the criteria of 35 U.S.C. 112, first paragraph
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`with respect to the claimed invention”, (see MPEP § 2173).
`
`Claims 1-2 and 14-17 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.
`
`Independent claims 1 and 14 recite an active method step of administering to
`
`a human/patient having mantle cell lymphoma ”from about 5 mg to about 50 mg”
`
`of 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione. Dependent
`
`claims recite dose ranges or amounts of 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-
`
`yl)-piperidine-2,6-dione administered ”per day”.
`
`Claims are given their broadest reasonable interpretation in light of the
`
`specification. However, limitations from the specification are not imported into
`
`the claims. In this case, While the specification and claims dependent from claim 1
`
`recite doses and dose ranges of 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)—
`
`piperidine-2,6-dione in terms of “per day”, claims 1 and 14 place no such
`
`limitation on the amounts of 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)—
`
`piperidine-2,6-dione administered.
`
`As such, claims 1-2 and 14-17 are indefinite because it is unclear Whether
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`the recited administering to a human/patient having mantle cell lymphoma ”from
`
`about 5 mg to about 50 mg” of 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)-
`
`piperidine-2,6-dione is intended to be limited to from about 5 mg to about 50 mg
`
`per day, or Whether these amounts are total amounts of 3-(4-amino-l-oxo-l,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione administered to the treated subject.
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`For example, in one possible interpretation of the claims, if a patient having
`
`mantle cell lymphoma is administered 5 mg 3-(4-amino-l-oxo-l,3-dihydro-
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`Page 4
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`Art Unit: 1629
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`isoindol-2-yl)—piperidine-2,6-dione every day for 20 consecutive days, i.e., a total
`
`amount of 100 mg, this treatment would n_ot be encompassed by the claims because
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`this would result in administration of 100 mg, which is outside the claimed range
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`of “from about 5 mg to about 50 mg”.
`
`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 USC. 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.
`
`Claims 1-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Zeldis (US 2004/0029832 A1; Published Feb. 12, 2004) in view of Damaj et al.
`
`(Leukemia, 2003, vol. 17, pages 1914-1915), Wilson et al. (British Journal of
`
`Haematology, 2002, vol. 119, pages 128-130), and Kaufmann et al. (Blood, 2004,
`
`vol. 104, no. 8, pages 2269-2271).
`
`Claimed Invention
`
`The instant claims recite a method of treating mantle cell lymphoma
`
`comprising administration of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)—
`
`piperidine-2,6-dione (i.e., Lenalinomid; RevlimidTM; RevimidTM) both alone and in
`
`combination with other active agents. Mantle cell lymphoma is disclosed in the
`
`instant specification as a type of non-Hodgkin’s lymphoma (page 1, [0001]).
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`Page 5
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`Art Unit: 1629
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`Teachings of Zeldis
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`Zeldis teaches methods of treating, preventing, and/or managing cancer
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`comprising administration of an immunomodulatory compound alone or in
`
`combination with a second active ingredient (Abstract).
`
`The instantly claimed 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)—
`
`piperidine-2,6-dione (i.e., Lenalinomid; RevlimidTM; RevimidTM) is disclosed as a
`
`preferred compound of the invention (page 2, [0016]; Fig. 1; page 3; [0034]; page
`
`4, [0037].
`
`With regard to cancers intended to be treated by the disclosed methods,
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`Zeldis teaches that the term ”cancer" includes, but is not limited to solid tumors
`
`and blood born tumors such as cancers of the lymph nodes and non-Hodgkin's
`
`lymphoma (page 9, [0107].
`
`More specifically, Zeldis teaches that an immunomodulatory compound is
`
`administered alone or in combination with a second active ingredient such as
`
`vinblastine or fludarabine to patients With "various types of lymphoma”, including,
`
`but not limited to, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, cutaneous T-
`
`Cell lymphoma, cutaneous B-Cell lymphoma, diffuse large B-Cell lymphoma or
`
`relapsed or refractory low grade follicular lymphoma (page 12, [0139]).
`
`With regard to the doses and administration regimens recited in claims 3, 4,
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`5, 11, and 12, Zeldis teaches that the dose of RevimidTM may be administered in an
`
`amount of 5 to 25 mg per day, or alternatively from about 10 to about 50 mg every
`
`other day (page 10, [0113] or initially in an amount of 5 mg/day escalated every
`
`week to 10, 20, 25, 30, and 50 mg/day (page 10, [0114]). Cycling therapy, as
`
`recited in claims 11-12, is disclosed by Zeldis at page 14, [0173] wherein he
`
`describes administration of RevimidTM in amount of about 5, 10, or 25 mg/day,
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`Page 6
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`Art Unit: 1629
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`preferably about 10 mg/day for three to four weeks (i.e., 21 to 28 days), followed
`
`by one week (i.e., 7 days) or two weeks (i.e., 14 days) of rest in a four or six week
`
`cycle (i.e., 28 or 42 day cycle).
`
`With regard to administration of “enantiomerically pure” 3-(4-amino-l-oxo-
`
`l,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (claim 6) such as the S enantiomer
`
`(claim 7) or the R enantiomer (claim 8), Zeldis teaches that various
`
`immunomodulatory compounds of the invention contain one or more chiral centers
`
`and that the invention encompasses the use of stereomerically pure forms of such
`
`compounds as well as the use of mixtures of those forms (page 6, [0088]).
`
`With regard to oral administration as recited in claim 9 and administration in
`
`the form of a capsule or tablet as recited in claim 10, Zeldis teaches oral
`
`administration (page 10, [0113]; page 14, [0178]) by administration of the
`
`disclosed compounds in the form of tablets and capsules (page 14, [0178]; page 16,
`
`[0190]).
`
`With regard to administration of 3-(4-amino-l-oxo-1,3-dihydro-isoindol-2-
`
`yl)-piperidine-2,6-dione in combination with a second active agent as recited in
`
`claim 14, Zeldis teaches that the compounds of the invention can be administered
`
`in combination with such second active agents ([page 7, [0092] to page 9, [0104]),
`
`including those genera of active agents specifically recited in claim 14 (page 7,
`
`[0094] and [0098]; page 8, [0101]-[0103]); rituXimab as recited in claims 13 and
`
`15 (page 7, [0098]); and dexamethasone as recited in claim 16 and predisone as
`
`recited in claim 17 (pages 8-9, [0103]).
`
`Zeldis teaches that inhibition of TNF-alpha production following LPS-
`
`stimulation of human PBMC and human whole blood by 4-(amino)-2-(2,6-
`
`dioxo(3-piperidyl))-- isoindoline-l,3-dione (Actimid), 3-(4-amin0-1-0X0-1,3-
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`Page 7
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`Art Unit: 1629
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`dihydro-isoindol- 2-yl)-piperidine-2,6-di0ne and thalidomide was investigated in
`
`vitro. The IC50s of 4-(amino)-2-(2,6-dioxo(3-piperidyl))—isoindoline-1,3-dione for
`
`inhibiting production of TNF-alpha following LPS-stimulation of PBMC and
`
`human whole blood were about 24 nM (6.55 ng/mL) and about 25 nM (6.83
`
`ng/mL), respectively. In vitro studies suggest a pharmacological activity profile
`
`for 3-(4-amin0-1-0x0-1,3-dihydr0-isoindol-2-yl)-piperidine-2,6-di0ne that is
`
`similar to, but at least 200 times more potent than, thalidomide. See page 18,
`
`[0219]).
`
`Zeldis teaches that the IC50's of 3-(4-amin0-1-0x0-1,3-dihydr0-isoindol-2-
`
`yl)-piperidine-2,6-di0ne for inhibiting production of TNF-alpha following LPS-
`
`stimulation of PBMC and human whole blood were 100 nM (25.9 ng/mL) and 480
`
`nM (103.6 ng/mL), respectively. Thalidomide, in contrast, had an IC50 of 194
`
`.mu.M (50.2 .mu.g/mL) for inhibiting production of TNF-alpha following LPS-
`
`stimulation of PBMC. In vitro studies suggest a pharmacological activity profile
`
`for 3-(4-amin0-1-0x0-1,3-dihydr0-isoind0- l-2-yl)-piperidine-2,6-di0ne that is
`
`similar to, but 50 to 2000 times more potent than, thalidomide. It has been shown
`
`that the compound is approximately 50-100 times more potent than thalidomide in
`
`stimulating the proliferation of T-cells following primary induction by T-cell
`
`receptor (TCR) activation. 3-(4-amin0-1-0x0-1,3-dihydr0-isoindol-2-yl)-pi-
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`peridine-2,6-di0ne is also approximately 50 to 100 times more potent than
`
`thalidomide in augmenting the production of IL-2 and IFN—gamma following TCR
`
`activation of PBMC (IL-2) or T-cells (IFN-gamma). In addition, 3-(4-amin0-1-
`
`oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-di0ne exhibited dose-dependent
`
`inhibition of LPS-stimulated production of the pro-inflammatory cytokines TNF-
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`Page 8
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`Art Unit: 1629
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`.alpha., IL-lbeta, and IL-6 by PBMC while it increased production of the anti-
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`inflammatory cytokine IL-10. See page 18, [0220]).
`
`Zeldis et al. compare the efficacy of the claimed compound, i.e., Revimid,
`
`with thalidomide against multiple myeloma cell proliferation and demonstrate that
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`Revimid is more potent than thalidomide against multiple myeloma cell
`
`proliferation (Figure 1; page 18, [0222]).
`
`Zeldis thus clearly and unequivocally teaches, suggests, and motivates the
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`use of the claimed compound for treating cancer, including ”various types of
`
`lymphoma”. Zeldis demonstrates that the claimed compound is significantly more
`
`potent that thalidomide in l) inhibiting production of TNF-alpha following LPS-
`
`stimulation of PBMC and human whole blood; 2) stimulating the proliferation of
`
`T-cells following primary induction by T-cell receptor (TCR) activation; 3)
`
`augmenting the production of IL—2 and IFN—gamma following TCR activation of
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`PBMC (IL-2) or T-cells (IFN—gamma); and 4) inhibiting proliferation of multiple
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`myeloma cells.
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`Zeldis differs from the instant claims in that he does not explicitly disclose
`
`the treatment of mantle cell lymphoma and he does not disclose the dose of
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`rituximab recited in claim 13.
`
`Teachings of Damai et al.
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`Damaj et al. teach that mantle cell lymphoma is an aggressive B-cell
`
`lymphoma that cannot be cured despite aggressive therapy. Damaj et al. teach that
`
`thalidomide is an immunomodulatory drug with numerous properties that has
`
`proven effective in relapsed multiple myeloma and, to a lesser extent, in other
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`Application/Control Number: 12/621,502
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`Page 9
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`Art Unit: 1629
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`hematological diseases, such as myelodysplastic syndromes and myeloproliferative
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`disorders. See page 1914, left column, first paragraph.
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`Damaj et al. teach that thalidomide induces response in relapsed mantle cell
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`lymphoma. See page 1914, left and right columns.
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`Teachings of Wilson et al.
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`Wilson et al. teach treatment of a patient with relapsed mantle cell
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`lymphoma, having failed treatment with chemotherapy, steroids, and rituximab,
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`with thalidomide. Wilson et al. teach that the patient entered a good partial
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`remission which was maintained for the next 6 months. See Summary; page 130,
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`left column, last paragraph.
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`Teachings of Kaufmann et al.
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`Kaufmann et al. teach that rituXimab plus thalidomide has activity in the
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`treatment of relapsed/refractory mantle cell lymphoma (Abstract). Rituximab was
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`administered in a dose of 375 mg/m2 for 4 weekly doses, thus teaching the
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`limitations of instant claim 13 (id.).
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`Principles of Law
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`“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
`
`burden of presenting a prima facie case of obviousness. Only if that burden is met,
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`does the burden of coming forward with evidence or argument shift to the
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`applicant.” In re Fz’ijC/(aerl‘, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted).
`
`In order to determine whether a prima facie case of obviousness has been
`
`established, we consider the factors set forth in Graham V. John Deere CO., 383
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`Page 10
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`Art Unit: 1629
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`US. l, 17 (1966): (l) the scope and content of the prior art; (2) the differences
`
`between the prior art and the claims at issue; (3) the level of ordinary skill in the
`
`relevant art; and (4) objective evidence of nonobviousness, if present.
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`“The combination of familiar elements according to known methods is likely
`
`to be obvious when it does no more than yield predictable results.” KSR Int’l Co.
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`V. Te/ef/eX Inc., 550 US. 398, 416 (2007). “In determining whether obviousness
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`is established by combining the teachings of the prior art, ‘the test is what the
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`combined teachings of the references would have suggested to those of ordinary
`
`skill in the art."” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir. 1995).
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`“[l]in a section 103 inquiry, ‘the fact that a specific [embodiment] is taught
`
`to be preferred is not controlling, since all disclosures of the prior art, including
`
`unpreferred embodiments, must be considered.“ Merck & Co. Inc. v. Biocraft
`
`Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545
`
`F.2d 747, 750, 192 USPQ 278, 280 (CCPA 1976).)
`
`In Merck, a prior art patent disclosed genus of 1200 effective combinations of
`
`compounds, including the claimed combination. The court found that the
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`“[d]isclos[ure of] a multitude of effective combinations does not render any
`
`particular formulation less obvious.” Merck & Co. Inc. v. Biocraft Laboratories
`
`Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
`
`Examiner’s Anal sis and Determination o Obviousness
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`It would have been primafacie obvious to one of ordinary skill in the art at
`
`the time the invention was made to treat mantle cell lymphoma with 3-(4-amino-1-
`
`oxo-1,3-dihydro-isoindol-2-yl)—piperidine-2,6-dione (i.e., RevimidTM), both alone
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`Art Unit: 1629
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`and in combination with other active agents, especially rituximab as suggested by
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`Kaufmann et al.
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`One of ordinary skill in the art would have been motivated to do so because
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`Zeldis explicitly teaches, suggests, and motivates one skilled in the art to treat
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`cancer using RevimidTM, including "various types of lymphoma” such as non-
`
`Hodgkin's lymphoma and B-cell lymphomas. As disclosed by Applicants and as
`
`taught by the cited prior art, mantle cell lymphoma is a type of non-Hodgkin's
`
`lymphoma/B-cell lymphoma.
`
`Furthermore, as demonstrated by the cited prior art, thalidomide was known
`
`to be effective in the treatment of mantle cell lymphoma and Zeldis teaches that the
`
`claimed compound is significantly more potent that thalidomide in l) inhibiting
`
`production of TNF-alpha following LPS-stimulation of PBMC and human whole
`
`blood; 2) stimulating the proliferation of T-cells following primary induction by T-
`
`cell receptor (TCR) activation; 3) augmenting the production of IL-2 and IFN—
`
`gamma following TCR activation of PBMC (IL-2) or T-cells (IFN-gamma); and 4)
`
`inhibiting proliferation of multiple myeloma cells.
`
`The skilled artisan would thus have been imbued with at least a reasonable
`
`expectation that RevimidTM would be effective in treating mantle cell lymphoma
`
`given the broad spectrum anticancer of this compound as demonstrated by Zeldis.
`
`For example, RevimidTM was more effective than thalidomide in inhibiting the
`
`proliferation of multiple myeloma cells in vitro (Fig. l), was successfully
`
`administered to patients having relapsed multiple myeloma (page 20, [0238] to
`
`page 21, [0243]), and had a clinical benefit in 13 of 20 patients having malignant
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`melanoma, carcinoma of the pancreas, renal carcinoma, breast cancer, and NSCLC
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`Art Unit: 1629
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`(page 21, [0244]—[0249]), and especially metastatic melanoma (page 22, [0257]-
`
`[0258]).
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
`
`harassment by multiple assignees. A nonstatutory obviousness—type double patenting rejection
`
`is appropriate where the conflicting claims are not identical, but at least one examined
`
`application claim is not patentably distinct from the reference claim(s) because the examined
`
`application claim is either anticipated by, or would have been obvious over, the reference
`
`claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re
`
`Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225
`
`USPQ 645 (Fed. Cir. 1985); In re Van Ornnm, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re
`
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutory double patenting
`
`ground provided the conflicting application or patent either is shown to be commonly owned
`
`with this application, or claims an invention made as a result of activities undertaken within the
`
`scope of a joint research agreement.
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
`
`disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR
`
`3.73(b).
`
`Claims 1-16 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 18-26 of US. Patent No.
`
`6,281,230 in view of Zeldis (US 2004/0029832 A1; Published Feb. 12, 2004),
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`Application/Control Number: 12/621,502
`
`Page 13
`
`Art Unit: 1629
`
`Damaj et al. (Leukemia, 2003, vol. 17, pages 1914-1915), Wilson et al. (British
`
`Journal of Haematology, 2002, vol. 119, pages 128-130), and Kaufmann et al.
`
`(Blood, 2004, vol. 104, no. 8, pages 2269-2271).
`
`Claims 18-26 of the ‘230 patent recite methods of treating “an oncogenic or
`
`cancerous condition” in a mammal comprising administering the instantly claimed
`
`compound (claim 19) via oral administration (claim 20), in combination with other
`
`active agents such as a steroid, neoplastic agent, or antibiotic (claims 21-22), and
`
`in the form of the R or S enantiomer (claims 24-25).
`
`Zeldis, Damaj et al., Wilson et al., and Kaufmann et al. teach, suggest, and
`
`motivate the administration of Revimid to treat mantle cell lymphoma in the doses
`
`instantly claimed as discussed supra (see above 35 U.S.C. 103 rejection).
`
`Accordingly, it would have been obvious to treat mantle cell lymphoma
`
`using the methods claimed in the '230 by administering Revimid in the doses and
`
`administration regimens taught by Zeldis.
`
`Claims 1-16 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 10-17 of US. Patent No.
`
`6,555,554 in view of Zeldis (US 2004/0029832 A1; Published Feb. 12, 2004),
`
`Damaj et al. (Leukemia, 2003, vol. 17, pages 1914-1915), Wilson et al. (British
`
`Journal of Haematology, 2002, vol. 119, pages 128-130), and Kaufmann et al.
`
`(Blood, 2004, vol. 104, no. 8, pages 2269-2271).
`
`Claims 10-17 of the ’554 patent recite methods of “reducing undesirable
`
`levels of TNFOL” in a mammal comprising administering the instantly claimed
`
`compound (claim 11) via oral administration (claim 12), in combination with other
`
`active agents (claim 13), and in the form of the R or S enantiomer (claims 14-15).
`
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`Application/Control Number: 12/621,502
`
`Page 14
`
`Art Unit: 1629
`
`Zeldis, Damaj et al., Wilson et al., and Kaufmann et al. teach, suggest, and
`
`motivate the administration of Revimid to treat mantle cell lymphoma in the doses
`
`instantly claimed as discussed supra (see 35 U.S.C. 103 rejection). Further, the
`
`‘554 patent specification teaches that decreasing TNFOL levels constitutes a
`
`valuable therapeutic strategy for the treatment of malignant diseases such as
`
`cancerous conditions. See col. 4, lines 16-34.
`
`Accordingly, it would have been obvious that administration of Revimid to
`
`treat mantle cell lymphoma as suggested and motivated by Zeldis and Kaufmann
`
`and recited in the instant claims would necessarily reduce undesirable TNFoc levels
`
`in the treated patients as claimed in the ‘554 patent.
`
`Claims 1-15 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 1, 7, 9-15, 17-24 of U.S. Patent
`
`No. 7,468,363 in view of Damaj et al. (Leukemia, 2003, vol. 17, pages 1914-
`
`1915).
`
`The claims of the ‘363 patent recite methods of treating Non-Hodgkin’s
`
`lymphoma and B-cell lymphomas comprising administering the instantly claimed
`
`compound via oral administration (claim 18), in combination with other active
`
`agents (claims 7, 9, 12-13, and 17).
`
`The instant claims differ from the claims of the ‘363 patent in that the ‘363
`
`patent claims broadly claim treating Non-Hodgkin’s lymphoma and cutaneous or
`
`diffuse large B-cell lymphomas, but do not claim the species of Non-Hodgkin’s/B-
`
`cell lymphoma recited in the instant claims, i.e., mantle cell lymphoma.
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`Application/Control Number: 12/621,502
`
`Page 15
`
`Art Unit: 1629
`
`Damaj et al. teaches that mantle cell lymphoma is an aggressive B-cell
`
`lymphoma. Further, Applicants disclose that mantle cell lymphoma is a type of
`
`non-Hodgkin's lymphoma.
`
`Accordingly, it would have been prima facie obvious to use the methods of
`
`treating non-Hodgkin’s/B-cell lymphomas as recited in the ‘363 patent claims to
`
`treat mantle cell lymphoma as presently claimed.
`
`Claims l-15 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims l-25 of US. Patent No.
`
`7,893,045.
`
`The claims of the ‘045 patent recite methods of treating lymphomas in a
`
`human comprising, inter alia, administering the instantly claimed compound
`
`(claim 1) to a patient with mantle cell lymphoma (claim 8) via oral administration
`
`(claim 14), in combination with other active agents (claims 21-22), and in the form
`
`of the R or S enantiomer (claims 11-13).
`
`The ‘045 patent claims thus anticipate the claimed method. Note that the
`
`“comprising” language of the instant claims allows for additional method steps,
`
`including those additional method steps recited in the '045 patent.
`
`Claims 1-15 provisionally rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-36 of
`
`copending Application No. 12/942,980.
`
`Although the conflicting claims are not identical, they are not patentably
`
`distinct from each other because the claims of the ‘980 application recite methods
`
`of treating lymphomas in a patient comprising, inter alia, administering the
`
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`Application/Control Number: 12/621,502
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`Page 16
`
`Art Unit: 1629
`
`instantly claimed compound (claims 1 and 2) to a patient with mantle cell
`
`lymphoma (claims 9 and 33) via oral administration (claim 15), in combination
`
`with other active agents (claims 22-23), and in the form of the R or S enantiomer
`
`(claims 12-14).
`
`The ‘980 application claims thus anticipate the claimed method. Note that
`
`the “comprising” language of the instant claims allows for additional method steps,
`
`including those additional method steps recited in the ‘980 application.
`
`This is a provisional obviousness-type double patenting rejection because
`
`the conflicting claims have not in fact been patented.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from
`
`the examiner should be directed to JAMES ANDERSON Whose telephone number
`
`is (571)272-9038. The examiner can normally be reached on MON-FRI 9:00 am -
`
`5:00 pm EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the
`
`examiner’s supervisor, Jeffrey 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.
`
`|PR2018-00685
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`Application/Control Number: 12/621,502
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`Page 17
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`Art Unit: 1629
`
`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.
`
`/James D. Anderson/
`
`James D. Anderson, Ph.D.
`
`Primary Patent Examiner, Art Unit 1629
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`400 Dulany Street
`Alexandria, VA 22314-5774
`
`Tel. No.: (571) 272-9038
`
`|PR2018—00685
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`Sheet 1 of 11
`
`LIST OF REFERENCES CITED BY APPLICANT
`(Use several sheets if necessary)
`
`GROUP
`FILING DATE
`
`To be assigned
`
`ATTY DOCKET NO.
`
`APPLICATION N O
`
`501872—999904
`APPLICANT
`
`Jerome B. Zeldis
`
`12/621,502
`
` November 19, 2009
`
`* EXAMINER
`INITIAL
`
`DOCUMENT NUMBER
`
`DATE
`
`NAME
`
`SUBCLASS
`
`FILING DATE
`[F APPROPRIATE
`
`U.S. PATENT DOCUMENTS
`
`CLASS
`-
`Muller, George et a1. _—
`6/24/04
`2004/0122052
`_ A01
`Zeldis, Jerome B. _—
`5/13/04
`2004/0091455
`_ A02
`Zeldis, Jerome B. _—
`5/6/04
`2004/0087546
`_ A03
`Dannenberg, Andrew J. et a1. _—
`4/22/04
`2004/0077686
`_ A04
`Figg, William D. et a1. _—
`4/22/04
`2004/0077685
`_ A05
`_ A06
`2004/0029832
`2/12/04
`Zeldis, Jerome B. _—
`
`2003/0235909
`12/25/03
`Hariri, Roben J. et a1.
`
`
`2003/0191098
`10/9/03
`D'Amalo, Robert J.
`
`
`
`
`
`
`
`
`
`
`2003/0187024
`10/2/03
`D'Amato, Robert
`
`
`2003/0181428
`9/25/03
`Green, Shawn J. et a],
`
`
`2003/0144325
`7/31/03
`Muller, George W. et al.
`
`2003/0139451
`
`7/24/03
`
`Shah, Jamshed H. et a1.
`
`2003/0096841
`
`5/22/03
`
`Robarge et a1.
`
`———-—
`_——-—
`
`_ A21
`
`2002/0128228
`
`9/12/02
`
`ku
`
`_—
`
`_ A23
`_ A24
`
`Zeldis, Jerome B.