9
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`Remarks
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`Docket No. UF.572XC1
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`Serial No. 12/664,172
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`The Office Action Summary indicates that claims 1-12 are pending in the subject application;
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`however, Applicants note that claims 13—1 8 were withdrawn in the Election dated January 26, 2012.
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`The “Disposition of Claims” on the Office Action Summary page does not list claims 13—18 as
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`pending but withdrawn from consideration. Applicants consider claims 1—18 as pending in the
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`subject application. Applicants acknowledge that claims 13-18 have been withdrawn from further
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`consideration as being drawn to a non-elected invention. By this Amendment, Applicants have
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`amended claims 1—3 and 9-1 1. Support for the amendments can be found throughout the subject
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`specification and in the claims as originally filed. Entry and consideration of the amendments
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`presented herein is respectfully requested. Accordingly, claims 1—12 are currently before the
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`Examiner. Favorable consideration of the pending claims is respectfully requested.
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`Applicants have amended the brief description of the Figures for Figures 19-21, to recite “a
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`monomer for the preparation of a polymer” rather than “a polymer” where inspection of the figures
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`supports these amendments.
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`The Office Action of March 30, 2012 objected to the specification because of informalities in
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`numerous examples in which the Applicants state that the pure product “was obtained in % yield”.
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`Applicants have removed the text (in % yield) from these portions of the specification, and
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`Applicants respectfully submit that these issues are moot in View of these amendments to the
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`specification. Accordingly, reconsideration and withdrawal of the objections is respectfully
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`requested.
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`The Examiner asserts that the oath or declaration submitted in the subject application is
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`defective on the grounds that it is not properly identified by the application number and filing date as
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`required by 37 CFR §1.67(a). Specifically, the Examiner states that the oath or declaration is
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`defective because it is not signed by the inventors. An executed declaration was submitted on
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`June 2, 2010 in response to a Notice to File Missing Parts. A copy of the Transmittal Letter
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`10
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`Docket No. UF.572XC1
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`Serial No. 12/664,172
`accompanying the executed declaration is attached with this Amendment. Applicants respectfully
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`assert that the inventors” declaration filed in the subject application is proper and meets the
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`requirements 01‘37 CFR §1.67(a). Accordingly, reconsideration and withdrawal of this objection is
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`respectfully requested.
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`Claim 2 is objected to because of informalities. The Examiner indicates that the term
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`“carbamate” is misspelled. Applicants gratefully acknowledge the Examiner’s careful review ofthe
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`claims.
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`In accordance with the Examiner’s suggestion, Applicants have replaced the word
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`“carbomate” with “carbamate” in claim 2. Accordingly, reconsideration and withdrawal of the
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`objection is respectfully requested.
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`Claims 3 and 9—11 are rejected under 35 U.S.C. § 112, second paragraph, as indefinite.
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`The Office Action indicates that in claim 3, it is unclear whether the polymer requires both an
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`ether moiety and a carbamate. Applicants have amended claims 2 to clarify that the linker comprises
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`“at least one moiety” and claim 3 recites that “the at least one moiety is an ether moiety and a
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`carbamate moiety” as is illustrated in figure 20. Applicant believes these amendments clarify claim
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`3, which indicates a linker with two moieties. Claim 9 is dependent on claim 1 and recites a
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`"spacer". Applicant has amended claims 9 and 10, as suggested by the Examiner, to recite as being
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`dependent on claim 5. Claim 11 has been amended to remove the exemplary verbiage within
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`parenthesis, including the trademark name "Taxol". As amended claims 3 and 9-11 are definite.
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`Accordingly, reconsideration and withdrawal of the rejection under 35 U.S.C. § 112, second
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`paragraph, is respectfully requested.
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`Claims 1-3 and 9-11 are rejected under 35 U.S.C. § 102(b) as anticipated by Maynard er al.
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`(Macromolecules, 2000, 33, 6239-6248). Applicants respectfully assert that the Maynard et a].
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`reference does not anticipate the amended claimed invention. Claim 1 has been amended to recite:
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`“A polymer comprising a plurality of repeating diene monomers having coupled
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`thereto at least one biologically active molecule through at least one non-amide
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`linker, wherein carbons coupled to the linker and the at least one biologically active
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`molecule of each of the repeating dienes are separated by 2n+2 carbons along the
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`1 1
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`Docket No. UF.572XC1
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`polymer’ 3 backbone, where n is the number of carbons in each oftwo alkylene carbon
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`backbone spacers residing between each ene and the carbon coupled to the linker of
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`the repeating dienes.”
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`Support for this amendment can be found throughout the specification, and specifically on pages 10,
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`line 22 through page 1 1, line 4 and in Figures 1-3 with respect to the polymers, and Figures 8, 9, and
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`14—21 with respect to monomers to form the polymers.
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`It is well established that "for a prior art reference to anticipate in terms of 35 U.S.C. Sec.
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`102, every element of the claimed invention must be identically shown in a single reference,"
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`Diversitech Corp. V. Century Steps, Inc., 850 F.2d 675, 677, 7 USPQ2d 1315, 1317 (Fed.Cir.l988),
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`and that “these elements must be arranged as in the claim under
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`review,” Lindemann
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`Maschinenfabrik v. American Hoist & Derrick Co., 730 F.2d 1452, 1458, 221 USPQ 481, 485
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`(Fed.Cir. 1984). Maynard er a]. does not teach every element of the claimed invention arranged as in
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`the instant claims. Maynard el al. teaches a polymer that does not have the linker biologically active
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`molecule coupled to a carbon and separated by 2n+2 carbons along the polymer’ s backbone where n
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`is the number of carbons in two alkylene carbon backbone spacer residing between each ene and the
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`carbon coupled to the linker. Maynard et a]. does not teach a repeating unit that has the linker
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`coupled to a carbon and does not teach an alkylene carbon backbone spacer. Rather, the polymer of
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`Maynard et al. can be considered to be coupled by a single nitrogen of a bicyclo unit or coupled by
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`two carbons of a cyclo unit. As Maynard et al. does not teach every element of the amended claimed
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`invention, it cannot anticipate the amended claimed invention. Accordingly, reconsideration and
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`withdrawal of the rejections under 35 U.S.C. § 102(b) is respectfully requested.
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`Claims 1-5 and 10-12 are rejected under 35 U.S.C. § 103(a) as obvious over Valenti et a].
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`(Macromolecules, 1998) in View of Elvira er a]. (Molecule, 2005). Applicants respectfully assert that
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`the amended claimed invention is not obvious over the cited references. The Office Action correctly
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`indicates that Valenti et a]. teaches the synthesis of well-defined polyalcohol polymers and suggests
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`their use as ”binding substrates in the preparation of a series of drug release macromolecules" (page
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`2773, col. 1, paragraph 1). Valenti er a1. , which is coauthored by instant inventor Kenneth Wagener,
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`does not suggest that binding is covalent bonding or that the repeating units comprise a linking group
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`covalently bound to the bioactive agent. Rather, Valenti et al, uses drug binding of the traditional
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`definition,
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`that being “Interacting selectively and non-covalently with a drug” (European
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`Bioinformatics Institute - Databases, http://www.ebi.ac.uk/QuickGO/GTerm?id=GO:0008144)
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`(emphasis added) Appreciation of the non—equivalence of binding and covalent bonding by the
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`coinventors and coauthors of Valenti et al. is clear from the disclosure of the instant application,
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`where binding is afunction other than thatprovided by the polymers ofthe instant invention. As
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`recited on page 15 lines 22-27:
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`“Advantageously,
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`the polymers of the
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`invention can be administered
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`simultaneously or sequentially with other polymers, drugs, or other biologically
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`active agents. Examples include, but are not limited to, antioxidants, free radical
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`scavenging agents, peptides, growth factors, antibiotics, bacteriostatic agents,
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`immunosuppressives, anticoagulants, buffering agents, anti-inflammatory agents,
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`anti—pyretics,
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`time-release binders, anesthetics, steroids and corticosteroids.”
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`(emphasis added)
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`Although Elvira et al. teaches systems containing a polymeric backbone conjugated to a
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`bioactive molecule, the polymer backbones are very different from those ofthe instant invention, and
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`polymer drug conjugates taught in Elvira et al. are very different than those of the instant invention.
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`Elvira teaches covalent bonding of drugs to end of a polymer (page 117 through page 119) and
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`teaches randomly situated pendant groups on random copolymers, where either the comonomer feed
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`or a random reaction on a regular polymer results in randomly situated bioactive agent substituents
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`on the polymer (page 119 through page 122). Clearly, the instant amended claims are directed to a
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`regular homopolymer where the displacement of the bioactive agents is regular, but where the
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`displacement of the bioactive agents can be small or large and can be controlled by the value of n of
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`the two alkylene carbon backbone spacers within the repeating units.
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`It is well appreciated that “All the claim limitations must be taught or suggested by the prior
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`art in order to establish the primafacie obviousness of a claimed invention” (CFMT, Inc. v. Yieldup
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`Intern. Corp, 349 F.3d 1333, 1342 (Fed. Cir. 2003) citing In re Royka, 490 F.2d 981, 985 (C.C.P.A.
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`1974)). As the term “binding” in Valenti et al. teaches non—covalent binding rather than covalent
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`bonding and Elvira et a]. does not teach or suggest any method of achieving a polymer with regularly
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`displaced pendant group with covalently bonded bioactive agent, the combination neither teaches
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`nor suggests all limitations of the instant amended claimed invention. Nor do the references provide
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`any motivation for combination of the dissimilar teachings of the prior art references. Accordingly,
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`reconsideration and withdrawal of the rejection under 35 U.S.C. § 103(a) is respectfully requested.
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`Claims 3 and 6—9 are rejected under 35 U.S.C. § 103(a) as obvious over the combination of
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`Valenti er al. (Macromolecules, 1998) and Elvira et a1. (Molecule, 2005), as applied to claims 1—2, 4—
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`5, and 10—12 above, and further in View of Zhu et’ a]. (Acc. Chem. Res, 2002). Applicants
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`respectfully assert that the amended claimed invention is not obvious over the cited references. Zhu
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`el al. teaches bile acids linked to a random poly(methylmethacrylate—co-N-isopropylacrylamide)
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`backbone with oligoethylene oxide spacers in the linker (page 540, col. 2, top). However, this does
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`not correct the deficiency of Valenti 62‘ 61]., Elvira et al., or their combination, and therefore the
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`combination of Valenti el al., Elvira et a]. , and Zhu et al. also fails to teach all the claim limitations
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`in order to establish the prima facie obviousness of the instant amended claims. Accordingly,
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`reconsideration and withdrawal of the rejection under 35 U.S.C. § 103(a) is respectfully requested.
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`Claim 4 is rejected under 35 U.S.C.
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`§ 103(a) as obvious over Maynard et al.
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`(Macromolecules, 2000) as applied to claims 1-2 and 9-11 above, and further in view of ) Valenti er
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`a]. (Macromolecules, 1998). Applicants respectfully assert that the amended claimed invention is
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`not obvious over the cited, references. Respectfully, Valenti el al. teaches that materials with well-
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`defined structures are advantageous in the study of structure—property relationships and might lead to
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`materials that are substrates in drug delivery systems (page 2765, col. 1, paragraph 1); but again the
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`term “substrate”, as indicated in Valenti et a]. (page 2773, col. 1, paragraph 1) is with regard to a
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`binding substrate and not a covalently bonding substrate. As indicated above, Maynard et a]. does
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`not teach the limitations of “wherein carbons coupled to the linker and the at least one biologically
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`active molecule of each of the repeating dienes are separated by 2n+2 carbons along the polymer’s
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`backbone, where n is the number of carbons in each of two alkylene carbon backbone spacers
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`residing between each ene and the carbon coupled to the linker of the repeating dienes” ofthe instant
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`14
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`Docket No. UF.572XC1
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`Serial No. 12/664,172
`amended claimed invention. Neither Maynard el al. , Valenti et (1]., nor their combination teach or
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`suggest all the claim limitations, which is required to establishprimafacie obviousness ofthe instant
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`amended claims. Accordingly, reconsideration and withdrawal of the rejection under 35 U.S.C. §
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`103(a) is respectfully requested.
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`Claims 3, 58 and 12 are rejected under 35 U.S.C. § 103(a) as obvious over Maynard et a].
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`(Macromolecules, 2000) as applied to claims 1-2 and 9—11 above, and further in View of Zhu et a].
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`(Acc. Chem. Res, 2002) and Elvira et a]. (Molecule, 2005). Applicants respectfully assert that the
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`amended claimed invention is not obvious over the cited references. As indicated above, neither
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`Maynard et al, Zhu et (11., Elvira et (11., nor their combination, teaches or suggests all the claim
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`limitations, which is required in order to establish primafacie obviousness of the instant amended
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`claims. Accordingly, reconsideration and withdrawal of the rejection under 35 U.S.C. § 103(a) is
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`respectfully requested.
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`Serial No. 12/664,172
`It should be understood that the amendments presented herein have been made solely to
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`15
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`Docket No. UF.572XC1
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`expedite prosecution of the subject application to completion and should not be construed as an
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`indication of Applicants” agreement with or acquiescence in the Examiner’s position. Applicants
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`expressly reserve the right to pursue the invention(s) disclosed in the subject application, including
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`any subject matter canceled or not pursued during prosecution of the subject application, in a related
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`application.
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`In view of the foregoing remarks and amendments to the claims, Applicants believe that the
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`currently pending claims are in condition for allowance, and such action is respectfully requested.
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`The Commissioner is hereby authorized to charge any fees under 37 CFR §§1.16 or 1.17 as
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`required by this paper to Deposit Account No. 19—0065,
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`Applicants invite the Examiner to call the undersigned if clarification is needed on any of this
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`response, or if the Examiner believes a telephonic interview would expedite the prosecution of the
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`subject application to completion.
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`Respectfully submitted,
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`Mark A. Buese, Ph.D.
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`Patent Agent
`Registration No. 52,669
`Phone No.:
`352-375-8100
`
`Fax No.2
`
`Address:
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`352-372-5800
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`PO. Box 142950
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`Gainesville, FL 32614—2950
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`MAB/p3
`
`Attachment: Transmittal Letter
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`Executed Declaration and Power of Attorney form
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`

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`I hereby certify that this correspondence is being
`electronically filed in the United States Patent and
`Trademark Office on
`m
`.15 A0/ (5
`m.
`
`TRANSMITTAL LETTER
`Patent Application
`Docket No. UF.572XC1
`
`4 SK WMark A. Bu se, Phil, Patent Agent
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants
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`Serial No.
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`Conf. No.
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`Filed
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`For
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`:
`
`:
`
`:
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`:
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`:
`
`James Klein Leonard, Kenneth Boone Wagener
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`12/664,172
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`l590
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`December 11, 2009
`
`Polyethylene Based Bioactive Agents
`
`Mail Stop MISSING PARTS
`‘ Commissioner for Patents
`Po. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`TRANSMITTAL LETTER
`
`The above~referenced patent application was tiled with an unsigned Declaration (37 CPR
`
`1 .63) and Power of Attorney form. Transmitted herewith is a fully executed Declaration (37 CFR §
`
`1.63) and Power of Attorney form for the subject application.
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`A Notification of Missing Requirements Under 35 USC. 371 in the United States
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`Designated/Elected Office (DO/EO/US) was received from the Patent and Trademark Office.
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`Docket No. UF.572XC1
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`The surcharge of $65.00 has been authorized with the filing of this Transmittal Letter. The
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`Commissioner is hereby authorized to charge any additional fees which may be required to Deposit
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`Account No. 19-0065.
`
`Respectfully submitted,
`
`film/A UM
`
`Mark A. Buese, PhD.
`
`Patent Agent
`Registration No. 52,669
`Phone No.:
`352-375-8100
`
`Fax No:
`
`Address:
`
`352-372-5800
`
`PO. Box 142950
`Gainesville, FL 32614—2950
`
`MAB/p3
`
`Attachments: Executed Declaration (37 CPR 1.63) and Power of Attorney form
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`.I :‘\U F‘\572XC l\I"l‘O\NTFMP-Response. dodps
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`