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

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1 UNITED STA TES p A TENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO ,304 12/10/2004 Mary J. Bossard SHE /07/2016 NEKT AR THERAPEUTICS 455 Mission Bay Blvd., South, Suite 100 San Francisco, CA EXAMINER FUBARA, BLESSING M ART UNIT PAPER NUMBER 1613 MAILDATE DELIVERY MODE 07/07/2016 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. PTOL-90A (Rev. 04/07)

2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARY J. BOSSARD 1 Appeal Technology Center 1600 Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and ULRIKE W. JENKS, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. 134 involving claims to a composition and to a method for its administration. The Examiner has rejected the claims as anticipated and/or obvious. We have jurisdiction under 35 U.S.C. 6(b). We reverse. 1 Appellant identifies the real party in interest as N ektar Therapeutics (Br. 1 ).

3 STATEMENT OF THE CASE Claims 1, 4--36, , 45, 46, 52, and 57 are on appeal (Br. 5; Final Act. 2-3). 2 Claim 1 is illustrative and reads as follows: 1. A composition comprising: a first population of polymer-active agent conjugates, wherein each polymer in the first population of polymer-active agent conjugates has a weight average molecular weight; and a second population of polymer-active agent conjugates, wherein each polymer in the second population of polymer-active agent conjugates has a weight average molecular weight, wherein the weight average molecular weight of each polymer in the first population is in the range of from about 100 Daltons to less than 20,000 Daltons, and the weight average molecular weight of each polymer in the second population is in the range of from greater than 100 Daltons to about 120,000 Daltons, wherein the weight average molecular weight of each polymer in the first population is different from the weight average molecular weight of each polymer in the second population. Claims 1, 21-26, 28-36, 39, 40, 42, 43, 45, 52, and 57 stand rejected under 35 U.S.C. 102(a) as anticipated by Nakamura et al. (EP 1,333,036 Al, Aug. 6, 2003) (Ans. 2). Claims 1, 4--20, 22-24, 27, , and 46 stand rejected under 35 U.S.C. 103(a) as obvious over Nakamura (Ans. 3). 1. Nakamura discloses: FINDINGS OF FACT The inventors of the present invention have now prepared a PEGconjugated EPO by reacting recombinant human EPO [( erythropoietin)] with a polyethylene glycol (PEG) derivative having an active ester at one end, such as a methoxy-pegsuccinimidyl lower fatty acid ester. This PEG-conjugated EPO 2 Claims 37, 38, 44, 47-51, and are also pending but have been withdrawn from consideration (Final Act. 1; Br ). 2

4 comprises a composition of conjugates having 1 to 3 linear PEG molecules per rhepo molecule. (Nakamura i-f 13.) (Id. i-f 15.) 2. In addition, Nakamura discloses: [T]he inventors of the present invention further prepared a monomethoxy PEG-EPO (mono-mpeg-epo) conjugate having one linear PEG molecule of 5 kda, 10 kda, 15 kda, 20 kda or 30 kda per native EPO molecule, [and] a di-methoxy PEG-EPO (di-mpeg-epo) conjugate having two linear PEG molecules of 5 kda, 10 kda, 15 kda, 20 kda or 30 kda per native EPO molecule. 3. Nakamura also discloses that the "PEG-conjugated EPO composition... may... comprise... a PEG-conjugated EPO where PEG conjugation occurs on two or more amino acid residues in native EPO" (id.,-r 23). 4. In addition, Nakamura discloses: "The molecular weight of PEG used for conjugation can be changed as appropriate for the degree of sustained efficacy required by the resulting PEG-conjugated EPO, the degree of decreased EPO activity, etc. The molecular weight of one PEG molecule is 5 to 40 kda." (Id. i-f 25.) 5. In particular, Nakamura discloses: EPO... was added to mpeg5k-sp A.... [T]he solution was purified... to collect three potential fractions predominantly rich in mono-mpeg5k-epo, di-mpeg5k-epo and a mixture thereof. Each fraction was concentrated... and subjected... to gel filtration... to separate mono-mpeg5k-epo and dimpeg5k-epo fractions, which were then respectively combined for each conjugate to give mono-mpeg5k-epo... and di-mpeg5k-epo. 3

5 (Id. ii 70.) 6. Nakamura discloses that the following results were obtained: mtmo-mpegma=o-fa~o ds!itptgsmm-e PO 3410:0 3&200 S:J8QO i1400d Hl10=00 (Id. ii 75.) ANTICIPATION The Examiner finds that "Nakamura describes combining the fractions of mono-mpeg5k-epo and di-mpeg5kepo (paragraph [0070]) with the mono- and di-mpeg5k having different average molecular weight by virtue of the mono- and the di -, thus meeting claim 1" (Ans. 2). In particular, the Examiner finds "mono-mpeg5k-epo is a first population and di-mpeg5k EPO is a second population" (id.). Analysis Nakamura discloses a composition comprising a mixture of a monompeg5k-epo and a di-mpeg5k-epo (Finding of Fact (FF) 5). We recognize that the di-mpeg5k-epo would weigh more than the monompeg5k-epo due to the presence of a second PEG (FF 2 & 6). In addition, we are aware of no reason why mono-mpeg5k-epo and dimpeg5k-epo cannot each be considered a polymer. However, neither of these polymers have a weight average molecular weight of from about 100 Daltons to less than 20,000 Daltons (id.), as required by the first population of claim 1. 4

6 Instead, the Examiner appears to be interpreting the term "polymer" in claim 1 to read on only the PEG portion of the conjugate (Ans. 3 & 5---6). We are aware of no reason it is unreasonable to interpret the term "polymer" in claim 1 to refer to the PEG portion of the conjugate. However, we do find it unreasonable to interpret the term "polymer" to refer to two PEG polymers that are separated in a conjugate by an EPO molecule (see FF 3). In addition, the Examiner has not provided any basis to assume that, in the dimpeg5k-epo, a PEG5K attaches to a second PEG5K to form a PEG lok. The Examiner also failed to establish an evidentiary basis on this record to support a finding that Nakamura discloses the use of PEG molecules having two different molecular weights in a single composition. Thus, we agree with Appellant that the Examiner has not set forth a prima facie case that Nakamura discloses first and second populations, wherein the weight average molecular weight of each polymer in the first population is different from the weight average molecular weight of each polymer in the second population. Instead, we agree with Appellant that Nakamura teaches two populations in which each PEG polymer has the same molecular weight (Br. 6), although the di-mpeg5k-epo contains twice the number of PEG polymers per conjugate (FF 1---6). Conclusion The Examiner has not set forth a prima facie case that Nakamura anticipates claim 1. We therefore reverse the anticipation rejection of claim 1 and of claims 21-26, 28-36, 39, 40, 42, 43, 45, 52, and 57, which directly or indirectly depend from claim 1 (Br ). 5

7 OBVIOUSNESS In the obviousness rejection, the Examiner finds that Nakamura anticipates claim 1 (Ans. 3). The Examiner also finds: Nakamura... teaches that the molecular weight of the PEG used can be changed as appropriate for the degree of sustained release efficacy desired for the PEG-EPO conjugate and the degree of activity desired for the EPO; Nakamura suggests that the molecular weight of PEG conjugated EPO in aqueous medium ranges from 100 to 900 kda and the average molecular weight of the PEG is from 5-40kDa. Thus the mixture of mono-mpeg EPO and di-mpeg-epo is an exemplification. Nakamura does not prescribe that the PEG in the second PEG-EPO further added to initial PEG-EPO should have the same molecular weight as that in the first PEG-EPO. What is required in Nakamura is that the molecular weight of the PEG in either the initial PEG-EPO or the further added PEG-EPO be within the range o [ f] 5-40 kda. (Id. at 4.) The Examiner concludes that "it is within the ordinary capabilities of the artisan to use molar amounts of the individual polymer conjugated erythropoietin that would provide the desired sustained activity" (id. at 3). Analysis As noted by the Examiner (Ans. 4), Nakamura discloses a range of PEG molecular weights and exemplifies a molecular weight of 5 kda (FF 4-- 5). We understand that this example teaches a composition containing two populations of conjugates (FF 5). However, the Examiner has not set forth a prima facie case that this composition anticipates claim 1 for the reasons discussed above. In addition, Nakamura discloses that these populations are subsequently separated (id.). We agree with Appellant that the Examiner does not adequately explain why it would have been obvious to instead 6

8 combine populations containing PEG polymers of different molecular weights (Br. 8). Conclusion The Examiner has not set forth a prima facie case that Nakamura suggests the composition of claim 1. We therefore reverse the obviousness rejection of claim 1 and of claims 4--20, 22-24, 27, , and 46, which directly or indirectly depend from claim 1 (Br ). REVERSED 7