Coalition for Affordable Drugs IV LLC - Exhibit 1016
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`13/340,522
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`Examiner
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`BUGGY ET AL.
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`Art Unit
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`UMAMAHESWARI
`RAMACHANDRAN
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 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).
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`1627
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`Status
`1 )IZ! Responsive to communication(s) filed on 26 March 2012.
`2a)0 This action is FINAL.
`2b)0 This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 G.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)[8J Claim(s) 130-150 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)0 Claim(s) __ is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)[8J Claim(s) 130-150 are subject to restriction and/or election requirement.
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`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway
`program at a participating intellectual property office for the corresponding application. For more information, please see
`~ittg://www.usoto.aov/_gatents/init events/QQl·1/index.jsQ or send an inquiry to PPHfeedback@uspto.gov.
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`Application Papers
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`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
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`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*See the attached detailed Office action for a list of the certified copies not received.
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`Attachment{s)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
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`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
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`

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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 09-12)
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`Office Action Summary
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`Part of Paper No./Mail Date 20121220
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`2
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 2
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`DETAILED ACTION
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`For the sake of compact prosecution, an attempt was made to contact
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`Applicants' representative, Michael Hostetler on 12/20/2012 for election of
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`restriction/election species by phone.
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`Claims 1-129 have been cancelled. Claims 130-150 are pending.
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`Restriction/Election
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`I. Claims 130, 133-146 are towards a method for treating a lymphoma in an
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`individual comprising administering to the individual an inhibitor of Bruton's tyrosine
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`kinase (Btk), wherein the lymphoma is a Cutaneous B-Cell Lymphoma, Cutaneous
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`Marginal Zone Lymphoma (MZL), Diffuse Mixed Small and Large Cell Lymphoma,
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`Diffuse Small Cleaved Cell, Diffuse Small Lymphocytic Lymphoma, Endemic Burkitt's
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`lymphoma, Follicular Large Cell (Grade 3), Follicular Mixed Small Cleaved and Large
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`Cell (Grade 2), Follicular Small Cleaved Cell (Grade 1 ), immunoblastic large cell
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`lymphoma, indolent lymphoma, intravascular large B cell lymphoma, lntravascular
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`Lymphomatosis, Large Cell lmmunoblastic Lymphoma, Large Cell Lymphoma (LCL),
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`low-grade small B-cell lymphoma Lymphoblastic Lymphoma, lymphoplasmocytic
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`lymphoma, Mediastinal Large B-Cell Lymphoma, precursor B-lymphoblastic lymphoma,
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`primary central nervous system (CNS) lymphoma, primary mediastinal B-cell
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`lymphoma, or Sporadic Burkitt's Lymphoma, further comprising a second cancer
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`treatment (claim 138) and dosage regimen, classified in class 424/133.1, 514/262.1 ,
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`514/64, 424/142.1, 514/110, 514/47, 514/34, 514/49.
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 3
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`11.
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`Claims 131 , 133-144, 14 7, and 148 are towards a method for treating a refractory
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`hematological malignancy in an individual comprising administering to the individual an
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`inhibitor of Bruton's tyrosine kinase (Btk), classified in class 424/133.1, 514/262.1 ,
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`514/64, 424/142.1, 514/110, 514/47, 514/34, 514/49.
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`111.
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`Claims 131, 133-144, 149, and 150 are towards a method for treating a relapsed
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`or refractory non-Hodgkin's lymphoma in an individual comprising administering to the
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`individual an inhibitor of Bruton's tyrosine kinase (Btk), classified in class 424/133.1,
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`514/262.1 , 514/64, 424/142.1 , 514/110, 514/47, 514/34, 514/49.
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`The inventions are distinct from each other because of the following reasons:
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`Inventions of Groups 1-111 are related to different methods of treatment using Btk
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`Inhibitors. The related inventions are distinct if it (1) the inventions as claimed are either
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`not capable of use together or can have a materially different design, mode of
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`operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are
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`mutually exclusive; and (3) the inventions as claimed are not obvious variants. See
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`MPEP § 806.05(j). In the instant case, the inventions as claimed have different
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`functions. For example cutaneous B lymphoma can be treated using immunotherapeutic
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`agents as in US 6518281, vindesine has been taught to be useful for refractory
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`hematological malignancy (see Mandelli et al. Leukemia Research, 6, 5, 1982), and
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`non-hodgkin lymphoma can be treated using multi-arm polymeric conjugates of 7-ethyl-
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`10-hydroxycamptothecin (see US 8048891 ). Accordingly, the method claimed can be
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`carried out with different pharmaceutical medications. Hence the claimed inventions are
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`distinct from each other.
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 4
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`The methods of Groups I, II, Ill are directed to distinct conditions and have
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`acquired a separate status in the art due to their recognized divergent subject matter
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`and hence the inventions require a different field of search and the prior art applicable
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`to one invention may not likely be applicable to another invention. The search for all
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`inventions would place an undue burden on the Office in view of the corresponding
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`diversity in the field of search for each group. The searches of Groups I- Ill may be
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`overlapping but there is no reason to believe that the searches would be co-extensive.
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`The search for all inventions would place an undue burden on the Office in view of the
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`corresponding diversity in the field of search for each.
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`Restriction for examination purposes as indicated is proper because all these
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`inventions listed in this action are independent or distinct for the reasons given above
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`and there would be a serious search and examination burden if restriction were not
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`required because one or more of the following reasons apply:
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`(a) the inventions have acquired a separate status in the art in view
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`of their different classification;
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`(b) the inventions have acquired a separate status in the art due to
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`their recognized divergent subject matter;
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`(c) the inventions require a different field of search (for example, searching
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`different classes/subclasses or electronic resources, or employing different search
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`queries);
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`(d) the prior art applicable to one invention would not likely be
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`applicable to another invention;
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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 5
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`(e) the inventions are likely to raise different non-prior art issues
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`under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph
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`The examiner has required restriction between process and product claims.
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`Where applicant elects claims directed to the product, and a product claim is
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`subsequently found allowable, withdrawn process claims that depend from or otherwise
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`include all the limitations of the allowable product claim will be rejoined in accordance
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`with the provisions of MPEP § 821.04. Process claims that depend from or otherwise
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`include all the limitations of the patentable product will be entered as a matter of right if
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`the amendment is presented prior to final rejection or allowance, whichever is earlier.
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`Amendments submitted after final rejection is governed by 37 CFR 1.116; amendments
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`submitted after allowance is governed by 37 CFR 1.312.
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`In the event of rejoinder, the requirement for restriction between the product
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`claims and the rejoined process claims will be withdrawn, and the rejoined process
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`claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to
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`be allowable, the rejoined claims must meet all criteria for patentability including the
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`requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is
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`found allowable, an otherwise proper restriction requirement between products claims
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`and process claims may be maintained. Withdrawn process claims that are not
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`commensurate in scope with an allowed product claim will not be rejoined. See
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`"Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re
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`Brouwer and 35 U.S.C. § 103(b)," 1184 O.G. 86 (March 26, 1996). Additionally, in order
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`to retain the right to rejoinder in accordance with the above policy, Applicant is advised
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 6
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`that the process claims should be amended during prosecution either to maintain
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`dependency on the product claims or to otherwise include the limitations of the product
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`claims. Failure to do so may result in a loss of the right to rejoinder. Further, note
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`that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply
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`where the restriction requirement is withdrawn by the examiner before the patent
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`issues. See MPEP § 804.01.
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`The application contains claims directed to patentably distinct species of the
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`claimed invention. The species are as follows:
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`(1) Btk inhibitor
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`(2) type of lymphoma
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`(3) second cancer treatment agent
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`Applicants' are required to elect a single species of Btk inhibitor (e.g. PCl-32765),
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`type of lymphoma (e.g. cutaneous B-cell lymphoma), second cancer treatment agent
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`(e.g. vincristine).
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`Applicant is advised that the reply to this requirement to be complete must
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`include an election of the invention to be examined even though the requirement be
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`traversed (37 CFR 1.143).
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`Applicant is required, in reply to this action, to elect a single species to which the
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`claims shall be restricted if no generic claim is finally held to be allowable. The reply
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`must also identify the claims readable on the elected species, including any claims
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`subsequently added. An argument that a claim is allowable or that all claims are generic
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`is considered non-responsive unless accompanied by an election.
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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 7
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`Upon the allowance of a generic claim, applicant will be entitled to consideration
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`of claims to additional species which are written in dependent form or otherwise include
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`all the limitations of an allowed generic claim as provided by 37 CFR 1.141. If claims are
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`added after the election, applicant must indicate which are readable upon the elected
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`species. MPEP § 809.02(a).
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`An attempt was made to contact Applicants' representative, Michael Hostetler on
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`12/20/2012 for election of restriction/election species by phone.
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`Applicant is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. Any amendment of inventorship must be accompanied by
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`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the restriction requirement, the election
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`shall be treated as an election without traverse.
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 8
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`Should applicant traverse on the ground that the species are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the species to be obvious variants or clearly admit on the record that this is the
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`case. In either instance, if the examiner finds one of the inventions unpatentable over
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`the prior art, the evidence or admission may be used in a rejection under 35 U.S.C
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`103(a) of the other invention.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose
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`telephone number is (571 )272-9926. The examiner can normally be reached on M-F
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`8:30 AM - 5:00 PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`

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`Application/Control Number: 13/340,522
`Art Unit: 1627
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`Page 9
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/Shengjun Wang/
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`Primary Examiner, Art Unit 1627
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`/U.R/