Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 19, 2026 has been entered.
Remarks
Applicant’s submitted sequence listing and substitute specification are acknowledge and have been entered into the record.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 4, 8, 17, 20-22, 25, 26, 28-33, 36 and 38 are is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0030360 to Vegas et al. in view of Kochendoerfer et al. and U.S. Patent Application Publication No. 2016/0033527 to Cheng et al.
Vegas et al. discloses covalently modified alginate polymers (Abstract) that can include polypeptides (see for example Formula I). [0024]-[0026].
Vegas et al. does not teach evaluating the covalently modified alginate polymers.
Kochendoerfer et al. teaches polypeptide modified polymers (Abstract)
Kochendoerfer et al. teaches that glycoprotein… can be subjected to enzymatic digestion and analysis e.g. by HPLC peptide mapping, indicating that enzymatic digestion releases peptides, [0135] and that peptides were deprotected and simultaneously cleaved from a resin support. [0394]
It would have been obvious to one of ordinary skill in the art to cleave the polypeptides in the covalently modified alginate polymers of Vegas et al. using enzymatic digestion as taught by Kochendoerfer et al.
Cheng et al. teaches that the hydrolysis of polypeptides may generate individual constituent amino acid residues. [0009]
It would further have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. to subject the cleaved polypeptides to further hydrolysis to separate the individual amino acids as taught by Cheng et al. for purposes of evaluating the polymer composition on the basis of the individual amino acids derived from the polypeptides.
I.) Regarding applicant’s claim 1, as noted above Vegas in view of Kochendoerfer et al. and Cheng et al. teaches or renders obvious all the elements of claim 1.
Therefore, Vegas in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 4, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that that the modified alginate: (i) has an average molecular weight of 75 kD to 150 kD; or (ii) has a guluronate to mannuronate (G:M) ratio of greater than or equal to 1.5.
Vegas et al. teaches that the weight average molecular weight of the alginates is preferably between 1,000 and 1,000,000 Daltons, more preferably between 10,000 and 500,000 Daltons. [0385]
Vagas et al. further teaches that the modified alginate polymers can contain any ratio of mannuronate monomers, guluronate monomers, and covalently modified monomers. In some embodiments, greater than 2.5%, 5%, 7.5%, 10%, 12%, 14%, 15%, 16%, 18%, 20%, 22%, 24%, 25%, 26%, 28%, 30%, 32.5%, 35%, 37.5%, 40%, 45%, 50%, 55%, or 60% of the monomers in the modified alginate polymer are covalently modified monomers. [0286]
It would have been obvious to one skilled in the art to use modified alginate polymers in Vegas et al. in view of Kochendoerfer et al. and Cheng et al. having a molecular weight of 75000 to 150000 which is within the range taught by Vegas et al. and a guluronate to mannuronate ratio of 1.5 or greater for purposes of evaluating such alginate modified polymers.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 4 obvious.
III.) Regarding applicant’s claim 8, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the polypeptide is covalently bound to the polymer through a linker.
As shown in Formula I in Vegas et al. the polypeptides are bound to the alginate polymer by a monomer that is interpreted as being a linker.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 8 obvious.
IV.) Regarding applicant’s claim 17, as noted above Vegas et al. in view of Kochendoerfer et al. renders claim 1 obvious from which claim 17 depends.
Claim 17 recites that the reaction conditions in step (a) comprise: (i) contacting the polymer composition with an acidic solution: (ii) heating the polymer composition; or (iii) exposing the polymer composition to microwave irradiation.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the reaction conditions in step (a) comprise: (i) contacting the polymer composition with an acidic solution: (ii) heating the polymer composition; or (iii) exposing the polymer composition to microwave irradiation.
In paragraphs [0220]-[0221] Kochendoerfer et al. teaches that cleavage is performed under acidic conditions.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to cleave the polypeptides from the alginate polymer using acidic conditions as taught by Kochendoerfer et al. and sufficient heat that can be provided by microwave irradiation for purposes of cleaving polypeptides.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 17 obvious.
V.) Regarding applicant’s claim 20, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 20 depends.
Claim 20 recites that step (b) comprises a separation step.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that step (b) comprises a separation step.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al, to separate the component amino acids for purposes of evaluating the total amounts of amino acids for evaluation purposes.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 20 obvious.
VI.) Regarding applicant’s claim 21, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 20 obvious from which claim 21 depends.
Claim 21 recites that the separation step comprises chromatography.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach separation using chromatography.
Kochendoerfer et al. teaches HPLC for separating components.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to use chromatography to separate amino acids for purposes of evaluating the total amounts of amino acids for evaluation purposes.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 21 obvious.
VII.) Regarding applicant’s claim 22, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 22 depends.
Claim 22 recites acquiring a value for the concentration in step (b) comprises (i) determining the area of a chromatogram peak for each component amino acid of the polypeptide and (ii) comparing the area of a chromatogram peak for each component amino acid of the polypeptide with a standard to determine the concentration of each component amino acid of the polypeptide.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach acquiring a value for the concentration in step (b) comprises (i) determining the area of a chromatogram peak for each component amino acid of the polypeptide and (ii) comparing the area of a chromatogram peak for each component amino acid of the polypeptide with a standard to determine the concentration of each component amino acid of the polypeptide.
In paragraph [0513] Kochendoerfer et al. teaches analysis of HPLC peaks.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view Kochendoerfer et al. and Cheng et al. to use analysis of HPLC peaks as taught by Kochendoerfer et al. and to comparative or standard peaks for purposes of determining concentration, it would have been obvious to make such comparisons for purposes of quantifying concentrations.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 22 obvious.
VIII.) Regarding applicant’s claim 25, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 25 depends.
Claim 25 recites modifying the individual amino acids prior to step (b).
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach modifying the individual amino acids prior to step (b).
Vagas et al. discloses covalently modified alginate polymers (Abstract) that can include amino acids or polypeptides (see for example Formula I, [0024]-[0026], polypeptides are interpreted as being modified amino acids.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 25 obvious.
IX.) Regarding applicant’s claim 26, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 25 obvious from which claim 26 depends.
Claim 26 recites modifying the individual amino acids comprises derivatization with a derivatizing agent.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach modifying the individual amino acids comprises derivatization with a derivatizing agent.
In paragraph [0020] Kochendoerfer et al. teaches that “Polymers that can be employed to form derivatized proteins having polymer adducts with structures that can be tailored to mimic desirable properties of natural proteins also is needed. Moreover, a need exists for derivatizing proteins that has general applicability to many proteins. The present invention satisfies these and other needs.”
Further in paragraph [0080] Kochendoerfer et al. teaches that the present invention permits one to design a synthetic protein in which any non-critical residue may be derivatized to contain a polymer adduct.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to modify individual ones of the amino acids with a derivatizing agent for purposes of using derivatization as a means to labeling or identifying the amino acids.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 26 obvious.
X.) Regarding applicant’s claim 28, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 28 depends.
Claim 28 recites acquiring a value for the concentration of free polypeptide in the polymer composition.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach acquiring a value for the concentration of free polypeptide in the polymer composition.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to acquire a value for the concentration of free polypeptide in the polymer composition, for purposes of accounting for all the polypeptides in the modified polymer.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 28 obvious.
XI.) Regarding applicant’s claim 29, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 28 obvious from which claim 29 depends.
Claim 29 recites acquiring a value for the concentration of free polypeptide in the polymer composition comprises: (a') separating the polymer composition into a polymer bound fraction and a non-polymer bound fraction; (b') retaining the non-polymer bound fraction; and (c') acquiring a value for the concentration of the polypeptide in the non-polymer bound fraction, thereby acquiring a value for the concentration of free polypeptide in the polymer composition.
Vegas et al. in view of Kochendoerfer et al does not teach that acquiring a value for the concentration of free polypeptide in the polymer composition comprises: (a') separating the polymer composition into a polymer bound fraction and a non-polymer bound fraction; (b') retaining the non-polymer bound fraction; and (c') acquiring a value for the concentration of the polypeptide in the non-polymer bound fraction, thereby acquiring a value for the concentration of free polypeptide in the polymer composition.
In paragraph [0413] Kochendoerfer et al. teaches that polymer-modified peptide separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC and fractions containing the desired oximated product SEP-1:4+GP32 were identified by ES-MS and pooled and lyophilized.
In paragraph [0513] Kochendoerfer et al. teaches analysis of HPLC peaks.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to acquire a value for the concentration of free polypeptide in the polymer composition comprises: (a') separating the polymer composition into a polymer bound fraction and a non-polymer bound fraction; (b') retaining the non-polymer bound fraction; and (c') acquiring a value for the concentration of the polypeptide in the non-polymer bound fraction, thereby acquiring a value for the concentration of free polypeptide in the polymer composition as taught by Kochendoerfer et al. for purposes of accounting for all the polypeptides in the modified polymer.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 29 obvious.
XII.) Regarding applicant’s claim 30, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 29 obvious from which claim 30 depends.
Claim 30 recites the separating of step (a') comprises filtration.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the separating of step (a') comprises filtration.
In paragraph [0517] Kochendoerfer et al. teaches ultrafiltration of fractions a protein solution.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to provide the separating of step (a') with a filtration process for purposes of sorting and keeping track of polypeptides.
Therefore, Vegas et al. in view of Kochendoerfer et al renders claim 30 obvious.
XIII.) Regarding applicant’s claim 31, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 29 obvious from which claim 31 depends.
Claim 31 recites that step (c') comprises a separation step.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that step (c') comprises a separation step.
In paragraph [0413] Kochendoerfer et al. teaches that polymer-modified peptide separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. provide step (c') a separation step as taught by Kochendoerfer et al. to accurately evaluate the polymer
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 31 obvious.
XIV.) Regarding applicant’s claim 32, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 31 obvious from which claim 32 depends.
Claim 32 recites that the separation step comprises chromatography.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the separation step comprises chromatography.
As noted above, in paragraph [0413] Kochendoerfer et al. teaches that polymer-modified peptide is separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to use chromatography in the separation step as taught by Kochendoerfer et al.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 32 obvious.
XV.) Regarding applicant’s claim 33, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 29 obvious from which claim 33 depends.
Claim 33 recites acquiring a value for the concentration of step (c') further comprises (i) determining the area of a chromatogram peak for polypeptide of the non-polymer bound fraction and (ii) comparing the area of a chromatogram peak for polypeptide of the non-polymer bound fraction with a standard to determine the concentration of polypeptide of the non-polymer bound fraction.
Vegas et al in view of Kochendoerfer et al. and Cheng et al. does not teach that acquiring a value for the concentration of step (c') further comprises (i) determining the area of a chromatogram peak for polypeptide of the non-polymer bound fraction and (ii) comparing the area of a chromatogram peak for polypeptide of the non-polymer bound fraction with a standard to determine the concentration of polypeptide of the non-polymer bound fraction.
As noted above, in paragraph [0413] Kochendoerfer et al. teaches that polymer-modified peptide is separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC.
Further as noted above, in paragraph [0513] Kochendoerfer et al. teaches analysis of HPLC peaks.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to provide for acquiring a value for the concentration of step (c') to include (i) determining the area of a chromatogram peak for polypeptide of the non-polymer bound fraction and (ii) comparing the area of a chromatogram peak for polypeptide of the non-polymer bound fraction with a standard to determine the concentration of polypeptide of the non-polymer bound fraction as taught by Kochendoerfer et al.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 33 obvious.
XVI) Regarding applicant’s claim 36, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 36 depends.
Claim 36 recites evaluating a polymer composition comprises determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that evaluating a polymer composition comprises determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition.
As noted above, in paragraph [0413] Kochendoerfer et al. teaches that polymer-modified peptide is separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC.
Further as noted above, in paragraph [0513] Kochendoerfer et al. teaches analysis of HPLC peaks.
It would have been obvious to one skilled in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to determine the concentration of polypeptide conjugated to a modified polymer in the polymer composition to calculate any polypeptide parameters of interest.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 38 obvious.
XVII.) Regarding applicant’s claim 38, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 36 obvious from which claim 38 depends.
Claim 38 recites determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition comprises: (a") acquiring a value for the total concentration of polypeptide in the polymer composition or semi-permeable device; (b") acquiring a value for the concentration of free polypeptide (i.e., unconjugated polypeptide) in the polymer composition; and (c") subtracting the value of the concentration of free polypeptide (b”) from the value of the total concentration of polypeptide in the polymer composition; thereby determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that recites determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition comprises: (a") acquiring a value for the total concentration of polypeptide in the polymer composition or semi-permeable device; (b") acquiring a value for the concentration of free polypeptide (i.e., unconjugated polypeptide) in the polymer composition; and (c") subtracting the value of the concentration of free polypeptide (b”) from the value of the total concentration of polypeptide in the polymer composition; thereby determining the concentration of polypeptide conjugated to a modified polymer in the polymer composition.
Kochendoerfer et al. teaches subjecting the bioactive protein to analysis e.g. by HPLC peptide mapping and mass spectrometry which would indicate total peptide concentration. [0135]
Kochendoerfer et al. also teaches polymer-modified peptide separated from unmodified peptide and unreacted polymer by preparative gradient C4 reverse-phase HPLC. Fractions containing the desired oximated product SEP:1:4+GP29 were identified by ES-MS and pooled, which would provide a total of free or unconjugated polypeptide. [0435]
It would have been obvious to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to determine the total concentration of polypeptide and the total amount of free polypeptide and subtract the concentration of free polypeptide from the total concentration of polypeptide to determine the concentration of polypeptide conjugated to a modified polymer in the polymer composition.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 38 obvious.
2. Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vegas et al. in view of Kochendoerfer et al. and Cheng et al. as applied to claim 1 above, and further in view of Zhu.
I.) Regarding applicant’s claim 12, as noted above Vegas et al. in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 12 depends.
Claim 12 recites that the polypeptide comprises a cell-binding polypeptide (CBP).
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the polypeptide comprises a cell-binding polypeptide (CBP).
Zhu teaches the use of cell adhesive peptides (CAPs) that introduce bioactivity into poly(ethylene glycol) (PEG), hydrogels. (page 4642; 2.3. ECM-mimetic bioactive modification).
Since Kochendoerfer discloses including modifying components in polymers [0101, it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to include the cell adhesive peptide modifications of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 12 obvious.
II.) Regarding applicant’s claim 13, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the CBP comprises a sequence selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from the table in claim 13.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the CBP comprises a sequence selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from the table in claim 13.
Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 13 obvious.
III.) Regarding applicant’s claim 14, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that the CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 14.
Vegas et al. in view Kochendoerfer et al. and Cheng et al. does not teach that the CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 14.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view Kochendoerfer et al. and Cheng et al. to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 14 obvious.
IV.) Regarding applicant’s claim 15, as noted above Vegas et al in view of Kochendoerfer et al. and Cheng et al. renders claim 1 obvious from which claim 15 depends.
Claim 15 recites that polypeptide covalently bound to the modified polymer is a linker-CBP.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that polypeptide covalently bound to the modified polymer is a linker-CBP.
Zhu discloses polymers in hydrogel designs comprising cell adhesive peptides and linkers (Figure 6 - "consisting a spacer of three serine residues (SSS) and a linker of two lysine residues (KK), and cRGD-containing PEGDA").
Zhu also discloses alginate modification (page 4639 col 1 para 1 - "natural polymer-based materials, such as proteins...and polysaccharides (e.g., alginate chitosan").
Since Kochendoerfer discloses including a modifying component to a polymer: "a protein containing a carbohydrate chain covalently linked to an amino acid side chain of the protein through a sugar residue, and is sometimes referred to as glycosylated protein. The carbohydrate of a glycoprotein may be...polysaccharide(s)") in [0101], it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. include the cell adhesive peptide modifications of Zhu using linkers, in Kochendoerfer to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide
Therefore, Vega et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 15 obvious.
V.) Regarding applicant’s claim 16, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 15 obvious from which claim 16 depends.
Claim 16 recites that the linker-CBP comprises GRGD or GRGDSP.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the linker-CBP comprises GRGD or GRGDSP.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
Zhu discloses that a linker-CSP comprises GRGDSP in Fig. 5 "RGD sequence, GRGDSP" and Fig. 6 "(A) by conjugating diaminopropionic acid (Dap) capped GRGDS").
Since Kochendoerfer discloses including a modifying component to a polymer: "a protein containing a carbohydrate chain covalently linked to an amino acid side chain of the protein through a sugar residue, and is sometimes referred to as glycosylated protein. The carbohydrate of a glycoprotein may be...polysaccharide(s)") in [0101], it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. include the cell adhesive peptide modifications of Zhu using a linker-CBP comprises GRGDSP in Kochendoerfer to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 16 obvious.
3. Claims 39, 40, and 44-46 are rejected under 35 USC 103 as being unpatentable over Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu.
As noted above, Vegas et al. discloses covalently modified alginate polymers (Abstract) that can include polypeptides (see for example Formula I, [0024]-[0026].
Vegas et al. does not teach evaluating the covalently modified alginate polymers.
As further noted above, Kochendoerfer et al. teaches polypeptide modified polymers (Abstract)
Kochendoerfer et al. teaches that glycoprotein… can be subjected to enzymatic digestion and analysis e.g. by HPLC peptide mapping, indicating that enzymatic digestion releases peptides, [0135] and that peptides were deprotected and simultaneously cleaved from a resin support. [0394]
It would have been obvious to one of ordinary skill in the art to cleave the polypeptides in the covalently modified alginate polymers of Vegas et al. using enzymatic digestion as taught by Kochendoerfer et al.
Cheng et al. teaches that the hydrolysis of polypeptides may generate individual constituent amino acid residues. [0009]
It would further have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. to subject the cleaved polypeptides to further hydrolysis to separate the individual amino acids as taught by Cheng et al. for purposes of evaluating the polymer composition on the basis of the individual amino acids derived from the polypeptides.
Zhu teaches the use of cell adhesive peptides (CAPs).(page 4642; 2.3. ECM-mimetic bioactive modification).
As for the limitations directed to cell-binding polypeptides, it would have been obvious to one skilled in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to evaluate any type of polypeptide, including adhesive cell-binding polypeptides as taught by Zhu, absent evidence to the contrary.
I.) Regarding applicant’s claim 39, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu teaches all the limitations of claim 39.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 39 obvious.
II) Regarding applicant’s claim 40, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 39 obvious from which claim 40 depends.
Claim 40 recites that the alginate in the modified alginate: (i) has an average molecular weight of 75 kD to 150 kD; or (ii) has a guluronate to mannuronate (G:M) ratio of greater than or equal to 1.5.
As noted above, Vegas et al. teaches that the weight average molecular weight of the alginates is preferably between 1,000 and 1,000,000 Daltons, more preferably between 10,000 and 500,000 Daltons. [0385]
Vegas et al. further teaches that the modified alginate polymers can contain any ratio of mannuronate monomers, guluronate monomers, and covalently modified monomers. In some embodiments, greater than 2.5%, 5%, 7.5%, 10%, 12%, 14%, 15%, 16%, 18%, 20%, 22%, 24%, 25%, 26%, 28%, 30%, 32.5%, 35%, 37.5%, 40%, 45%, 50%, 55%, or 60% of the monomers in the modified alginate polymer are covalently modified monomers. [0286]
It would have been obvious to one skilled in the art to use modified alginate polymers in Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu having a molecular weight of 75000 to 150000 which is within the range taught by Vegas et al. and a guluronate to mannuronate ratio of 1.5 or greater for purposes of evaluating such alginate modified polymers.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 40 obvious.
III.) Regarding applicant’s claim 44, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 39 obvious from which claim 44 depends.
Claim 44 recites that the CBP comprises a sequence selected from RGD. RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from table in claim 44.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the CBP comprises a sequence selected from RGD. RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from table in claim 44.
Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 44 obvious.
III.) Regarding applicant’s claim 45, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 39 obvious from which claim 45 depends.
Claim 45 recites that the CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from the table in claim 45.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach that the CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence selected from the table in claim 45.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 14 obvious.
IV.) Regarding applicant’s claim 46, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Zhu renders claim 39 obvious from which claim 46 depends.
Claim 46 recites the CBP comprises GRGD or GRGDSP.
Vegas et al in view of Kochendoerfer et al. and Cheng et al. does not teach that the CBP comprises GRGD or GRGDSP.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
Zhu discloses that a linker-CSP comprises GRGDSP in Fig. 5 "RGD sequence, GRGDSP" and Fig. 6 "(A) by conjugating diaminopropionic acid (Dap) capped GRGDS").
Since Kochendoerfer discloses including a modifying component to a polymer: "a protein containing a carbohydrate chain covalently linked to an amino acid side chain of the protein through a sugar residue, and is sometimes referred to as glycosylated protein. The carbohydrate of a glycoprotein may be...polysaccharide(s)") in [0101], it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to include the cell adhesive peptide modifications of Zhu using a linker-CBP comprises GRGDSP to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and of Zhu renders claim 46 obvious.
4. Claims 51, 54, 58, 65, 67 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Vegas et al. in view of Kochendoerfer et al. and Wikipedia “High-refractive-index polymer.”
As noted above, Vegas et al. discloses covalently modified alginate polymers (Abstract) that can include polypeptides (see for example Formula I, [0024]-[0026].
Vegas et al. does not teach evaluating the covalently modified alginate polymers.
As further noted above, Kochendoerfer et al. teaches polypeptide modified polymers (Abstract)
Kochendoerfer et al. teaches that glycoprotein… can be subjected to enzymatic digestion and analysis e.g. by HPLC peptide mapping, indicating that enzymatic digestion releases peptides, [0135] and that peptides were deprotected and simultaneously cleaved from a resin support. [0394]
It would have been obvious to one of ordinary skill in the art to cleave the polypeptides in the covalently modified alginate polymers of Vegas et al. using enzymatic digestion as taught by Kochendoerfer et al.
Cheng et al. teaches that the hydrolysis of polypeptides may generate individual constituent amino acid residues. [0009]
It would further have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. to subject the cleaved polypeptides to further hydrolysis to separate the individual amino acids as taught by Cheng et al. for purposes of evaluating the polymer composition on the basis of the individual amino acids derived from the polypeptides.
Vegas et al. in view of Kochendoerfer et al. and Cheng et al. does not teach acquiring a value for the refractive index of the polymer composition.
Wikipedia teaches that it is well known that polymers have refractive indexes that range from 1.30 to 1.70.
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al. and Cheng et al. to subject the polymer modified with polypeptides to refractive index measurements to associate sample polymers with their refractive indexes and thus distinguish different polymers by their refractive indexes.
Further, it would have been obvious acquire a value of the total polypeptide conjugated to the polymers.
Finally, it would have been obvious to modify Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia to match the amount of polypeptide conjugated to a polymer with the refractive index of a polymer for purposes of evaluating the polymer.
I.) Regarding applicant’s claim 51, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia teaches all the elements of claim 51.
Therefore, Vegas et al. in view of Kochendoerfer et al. and Wikipedia renders claim 51 obvious.
II.) Regarding applicant’s claim 54, as noted above Vegas et al. in view Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 51 obvious from which claim 54 depends.
Claim 54 recites that the alginate (i) has an average molecular weight of 75 kD to 150 kD; or (ii) has a guluronate mannuronate (G:M) ratio of greater than or equal to 1.5.
As noted above, Vegas et al. teaches that the weight average molecular weight of the alginates is preferably between 1,000 and 1,000,000 Daltons, more preferably between 10,000 and 500,000 Daltons. [0385]
Vagas et al. further teaches that the modified alginate polymers can contain any ratio of mannuronate monomers, guluronate monomers, and covalently modified monomers. In some embodiments, greater than 2.5%, 5%, 7.5%, 10%, 12%, 14%, 15%, 16%, 18%, 20%, 22%, 24%, 25%, 26%, 28%, 30%, 32.5%, 35%, 37.5%, 40%, 45%, 50%, 55%, or 60% of the monomers in the modified alginate polymer are covalently modified monomers. [0286]
It would have been obvious to one skilled in the art to use modified alginate polymers in Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia having a molecular weight of 75000 to 150000 which is within the range taught by Vegas et al. and a guluronate to mannuronate ratio of 1.5 or greater for purposes of evaluating such alginate modified polymers.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 54 obvious.
III.) Regarding applicant’s claim 58, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 51 obvious from which claim 58 depends.
Claim 58 recites that the polypeptide is covalently bound to the polymer through a linker.
As shown in Formula I in Vegas et al. the polypeptides are bound to the alginate polymer by a monomer that is interpreted as being a linker.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 58 obvious.
V.) Regarding applicant’s claim 65, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 51 obvious from which claim 65 depends.
Claim 65 recites that acquiring the value of the refractive index of step (a) comprises acquiring a refractometer reading (nD) at a specific wavelength and/or specific temperature.
In Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia it would have been obvious to use a conventional refractometer to measure the reflective index and use specific wavelength and/or temperature to standardize measurements for different polymers.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 65 obvious.
IV.) Regarding applicant’s claim 67, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 51 obvious from which claim 67 depends.
Claim 67 recites acquiring a dn/dc value for a component of the polymer composition.
Vegas et al. in view of Kochendoerfer et al. and Wikipedia does not teach acquiring a dn/dc value for a component of the polymer composition.
In Vegas et a. in view of Kochendoerfer et al., Cheng et al. and Wikipedia it would have been obvious to one of ordinary skill in the art to determine a refractive index difference in increments for different polymer samples for purposes of rating polymer samples to one another.
Therefore, Kochendoerfer et al. in view of Wikipedia renders claim 67 obvious.
V.) Regarding applicant’s claim 68, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 67 obvious from which claim 68 depends.
Claim 68 recites using the dn/dc value in step (c) of the method, e.g., to acquire a value for the concentration of the polymer modified with the polypeptide.
Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia does not teach using the dn/dc value in step (c) of the method, e.g., to acquire a value for the concentration of the polymer modified with the polypeptide.
In Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia it would have been obvious to correlate the refractive index differences in increments of each polymer sample to the concentration of the polymer modified with the polypeptides for purposes of enabling use of the refractive index differences in increments of each polymer to determine concentration of the polymer modified with the polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia render claim 68 obvious.
5. Claims 60-64 are rejected under 35 U.S.C. 103 as being unpatentable over Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia as applied to claims 51 and above, and further in view of Zhu
I.) Regarding applicant’s claim 60, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia renders claim 51 obvious from which claim 60 depends.
Claim 60 recites that the polypeptide comprises a cell-binding polypeptide (CBP).
Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia do not teach that the polypeptide comprises a cell-binding polypeptide (CBP).
Zhu teaches the use of cell adhesive peptides (CAPs).(page 4642; 2.3. ECM-mimetic bioactive modification).
As for the limitations directed to cell-binding polypeptides, it would have been obvious to one skilled in the art to modify Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia to evaluate any type of polypeptide, including adhesive cell-binding polypeptides as taught by Zhu, absent evidence to the contrary.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 60 obvious.
II.) Regarding applicant’s claim 61, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 60 obvious from which claim 61 depends.
Claim 61 recites that the CBP comprises a sequence selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 61.
Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia does not teach that CBP comprises a sequence selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 61.
As noted above, As noted above Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Wikipedia and Zhu renders claim 44 obvious.
III.) Regarding applicant’s claim 62, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 60 obvious from which claim 62 depends.
Claim 62 recites that the CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 62.
Vegas et al. in view of Kochendoerfer et al. and Wikipedia does not teach that CBP comprises a plurality of sequences selected from RGD, RGDSP, DGEA, FYFDLR, PHSRN, YIGSR, and a sequence listed in the table in claim 62.
As noted above Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
It would have been obvious to one of ordinary skill in the art to modify Vegas et al in view of Kochendoerfer et al., Cheng et al. and Wikipedia to include any of the cell adhesive peptides of Zhu, to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 44 obvious.
IV.) Regarding applicant’s claim 63, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et a. and Wikipedia renders claim 56 obvious from which claim 63 depends.
Claim 63 recites that the polypeptide covalently bound to the modified polymer is a linker-CBP.
Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia does not teach that the polypeptide covalently bound to the modified polymer is a linker-CBP.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
Zhu discloses that a linker-CSP comprises GRGDSP in Fig. 5 "RGD sequence, GRGDSP" and Fig. 6 "(A) by conjugating diaminopropionic acid (Dap) capped GRGDS").
Since Kochendoerfer discloses including a modifying component to a polymer: "a protein containing a carbohydrate chain covalently linked to an amino acid side chain of the protein through a sugar residue, and is sometimes referred to as glycosylated protein. The carbohydrate of a glycoprotein may be...polysaccharide(s)") in [0101], it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia to include the cell adhesive peptide modifications of Zhu using a linker-CBP comprises GRGDSP in Vegas et al. in view of Kochendoerfer and Wikipedia to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 63 obvious.
V.) Regarding applicant’s claim 64, as noted above Vegas et al. in view of Kochendoerfer et al., Cheng et al., Wikipedia and Zhu renders claim 63 obvious from which claim 64 depends.
Claim 64 recites that the linker-CBP comprises GRGD or GRGDSP.
Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia does not teach that linker-CBP comprises GRGD or GRGDSP.
As noted above, Zhu teaches that the CAPs are including FN (e.g., RGD, KQAGDV, REDV and PHSRN), LN (e.g., YIGSR, LGTIPG, IKVAV, PDGSR, LRE, LRGDN and IKLLI), collagen (e.g., DGEA and GFOGER) and elastin (e.g., VAPG). (page 4642 col 2 para 3).
Zhu discloses that a linker-CSP comprises GRGDSP in Fig. 5 "RGD sequence, GRGDSP" and Fig. 6 "(A) by conjugating diaminopropionic acid (Dap) capped GRGDS").
Since Kochendoerfer discloses including a modifying component to a polymer: "a protein containing a carbohydrate chain covalently linked to an amino acid side chain of the protein through a sugar residue, and is sometimes referred to as glycosylated protein. The carbohydrate of a glycoprotein may be...polysaccharide(s)") in [0101], it would have been obvious to one of ordinary skill in the art to modify Vegas et al. in view of Kochendoerfer et al., Cheng et al. and Wikipedia to include the cell adhesive peptide modifications of Zhu using a linker-CBP comprises GRGDSP in Vegas et al. in view of Kochendoerfer and Wikipedia to improve the design and evaluation of polymer compositions comprising polymers modified with a polypeptide.
Therefore, Kochendoerfer et al. in view of Wikipedia and Zhu renders claim 16 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, 8, 12-17, 20-22, 25, 26, 28-33, 36, 38-40, 44-46, 51, 54, 58, 61-65, 67 and 68 have been considered but are moot because the new ground of rejection that relies on Kochendoerfer et al. for cleaving polypeptides and Cheng et al. as a new prior art reference for teaching generating individual amino acids from peptides using hydrolysis.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798