DETAILED ACTION
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 .
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 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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 32-41 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al. "Synthesis of nanogel–protein conjugates", Polym. Chem., 2013, 4, 2464–2469, cited parent application 16/497,145, alone or in view of Topala et al. "BOVINE SERUM ALBUMIN INTERACTIONS WITH METAL COMPLEXES", Clujul Medical 2014 Vol. 87 - no. 4, cited parent application 16/497,145
Matsumoto teaches polymer protein conjugates of the following formula:
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183
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, crosslinked by dithiothreitol. See entire disclosure, especially abstract and Fig 2. Matsumoto while teaching a free amino acid is used to form a bond with a linker (SATP) it is silent with respect to the specific amino acid such as lysine required in the claims. See paragraph bridging page 2464 and 2465. Matsumoto however does teach that for covalent attachment lysine is commonly exploited. Thus one of ordinary skill in the art would have a high expectation of success in using lysine to bind the protein to the polymer. Reason to do so stems from the suggestion of Matsumoto that lysine is useful in forming such covalent attachment. Regarding claim 44, Matsumoto teaches and suggest that the polymer-conjugate could be used with an antibody as the protein increasing its effectiveness.
Topala teaches the protein used by Matsumoto, bovine serum albumin (BSA), is abundant in ionic amino acids such as lysine. See page 216 left col. 1st full paragraph. Thus from the disclosure of Matsumoto that lysine was a well-known reactive amino acid and the teaching from Topala that lysine is abundant in BSA one of ordinary skill would have a high expectation of success in using lysine to bind the protein to the polymer by linker.
Claim 32-41,44 and 47-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., cited above, in view of Topala, cited above, in view of Leng et al. “Probing the Surface Hydration of Nonfouling Zwitterionic and PEG Materials in Contact with Proteins”, ACS Appl. Mater. Interfaces 2015, 7, 16881−16888, in view of Peng et al. “Grafting of silica with a hydrophilic triolacrylamide polymer via surface-initiated‘‘grafting from’’ method for hydrophilic interaction chromatography” J. Sep. Sci. 2011, 34, 3123–3130, in view of Powell et al. “Complex Amphiphilic Hyperbranched Fluoropolymers by Atom Transfer Radical Self-Condensing Vinyl (Co)polymerization”, Macromolecules 2007, 40, 4509-4515.
Matsumoto is disclosed above. While the formula of Matsumoto above reads on formula II and III and the linkage of claim 48-49,51 and 53 the reference is silent with respect to use of a zwitterionic group including those of claim 50. The reference while teaching side chain substituted hydrophilic groups is silent with respect to Tris(hydroxymethyl)aminomethane as recited in claim 52. Lastly while teaching dithiol substituted side chains the reference is silent with respect to the dithiol grated with substituted benzenes of claim 54 which include fluorobenzene.
Leng is used for its teaching on the use of zwitterionic side chains on methacrylate, including sulfobetaine (meeting claim 50), were well known before the time of the claimed invention. See entire disclosure, especially abstract and Fig. 1. The zwitterionic species increased the surface hydration and non-fouling properties of surfaces in contact with proteins.
Peng is used for its teaching on the use of the functional group Tris(hydroxymethyl)aminomethane grafted on polymers which enhanced hydrophilicity. See entire disclosure, especially abstract and Fig. 2.
Powell is used for its teaching on the use of fluorinated benzene groups (meeting claim 54) in polymer synthesis, produced a polymer that was soluble in a broad range of solvents. See entire disclosure, especially abstract and scheme 1.
Since Matsumoto already teaches how to attach various groups to the methacrylate backbone via standard chemistry one of ordinary skill in the art would have a high expectation of success in grafting the zwitterionic, hydrophilic and fluorinated benzene groups from Leng, Peng and Powell respectfully. Reason to make such a modification would be to adjust the properties of the polymer including its anti-fouling ability, hydrophilicity and solubility. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618