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 .
DETAILED ACTION
SPECIFICATION OBJECTION
Updated information regarding the parent application No. 16/932,774 of [0002] of the speciation is needed since it became U.S. Pat. No. 11,746,172. Submission of a whole new paragraph would be needed.
Claim Rejections - 35 USC § 102 and 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 21, 22, 24, 26, 28-30, 32 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dutta et al. (Templated Self-Assembly of a Covalent Polymer Network for Intracellular Protein Delivery and Traceless Release, J. Am. Chem. Soc., 2017, 139, 5676-5679).
Dutta et al. teach a copolymer comprising a first monomer of PEG-methacrylate and a second monomer of methacrylate having a side chain conjugated to a protein (i.e., cytochrome c) via a degradable linker in Figure 1 and Scheme I in which a disulfide degradable linker further meeting claim 24 is taught. Dutta et al. teach the same disulfide degradable linker claimed and thus it would further meet claims 22 and 28-30 inherently.
The Scheme would show a molecular assembly meeting claim 26.
Further, Dutta et al. teach release of the protein in the cytosol in a lower part of a left column of page 5678 meeting claim 30.
Dutta et al. teach the polymer PI in a lower part of a right column of page 5678 and the protein (i.e., cytochrome c) would be expected to have the recited pI of claim 32 inherently.
Since PTO does not have equipment to conduct the test, it is fair to require applicant to shoulder the burden of proving that his material differs from those of Dutta et al. See In re Best, 195 USPQ 430, 433 (CCPA 1977). Charles Pfizer & Co. v. FTC, 401 F.2d 574, 579 (6th Cir. 1968). Inherent anticipation does not require that a person of ordinary skill in the art would have recognized the inherent disclosure, Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2002). See MPEP 2112.01.
Dutta et al. teach injection of the copolymer and DT (dithiotreitol) into a patient and thus it would meet the recited composition of claim 33.
Thus, the instant invention lacks novelty.
Claims 21, 22, 24, 26 and 28-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA 3032839 A1 (Feb. 8, 2018).
CA teaches block copolymer comprising a first monomer of PEG-methacrylate and a second monomer of methacrylate having a side chain conjugated to a protein via a disulfide degradable linker in [0083-0086] and the disulfide degradable linker further meeting claim 24 is taught.
CA teaches the second block is pH-sensitive in [0005] meeting claim 22.
CA teaches that Ds taught in the [0083-0086] are a therapeutic peptide, nucleic acid or nucleic acid derivative in bottom of page 11 meeting the recited protein of claim 1.
CA. teaches the same disulfide degradable linker claimed and thus it would further meet claims 22 and 28-30.
CA teaches the same block copolymer claimed and thus it would meet claim 26.
CA teaches a Mn of 15,300 to 24,900 in [0136] meeting claim 31.
CA teaches various peptide in [0079] which would be expected to have the recited pI of claim 32 inherently.
CA teaches a pharmaceutical composition in claim 20 meeting the recited composition of claim 33.
Since PTO does not have equipment to conduct the test, it is fair to require applicant to shoulder the burden of proving that his material differs from those of CA See In re Best, 195 USPQ 430, 433 (CCPA 1977). Charles Pfizer & Co. v. FTC, 401 F.2d 574, 579 (6th Cir. 1968). Inherent anticipation does not require that a person of ordinary skill in the art would have recognized the inherent disclosure, Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2002). See MPEP 2112.01
Thus, the instant invention lacks novelty.
Claims 21-24 and 26-33 are rejected under 35 U.S.C. 103 as being unpatentable over CA 3032839 A1 (Feb. 8, 2018).
Regarding claim 23, CA teaches and equates the disulfide bridge and boronic ester from boronic acid and diol in [0075].
Regarding claim 27. CA teaches block copolymer comprising backbone unit without D (e.g., therapeutic peptide, nucleic acid or nucleic acid derivative) in the [0083-0086]. CA further teaches different numbers of repeating units in [0060] and thus the recited higher amount of the polymer would be expected from CA or obvious modification of CA.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize the boronic ester as the degradable linker in CA since CA teaches and equates the disulfide bridge and boronic ester from boronic acid and diol absent showing otherwise.
See In re Mills, 477 F.2d 649, 176 USPQ 196 (CCPA), In re Lamberti, 545 F.2d 747, 750 (CCPA 1976): Reference must be considered for all that it discloses and must not be limited to preferred embodiments or working examples. MPEP 2123.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over CA 3032839 A1 (Feb. 8, 2018) as applied to claims 21-24 and 26-33 above, and further in view of CA 2684052 A1 (Oct. 23, 2008).
Regarding the recited cis-aconityl linker of claim 25 over the disulfide degradable linker of CA’839, CA’052 teaches cis-aconityl linker in lines 1-9 of page 43.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize the art well known cis-aconityl linker taught by CA’052 as the degradable linker in CA’839 absent showing otherwise.
Selection of a known material based on its suitability for its intended use is prima facie obvious, see Sinclair & Carroll Co. v. Interchemical Corp., 325 US 327, 65 USPQ 297 (1945). MPEP 2144.07.
The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). MPEP 2141.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (Templated Self-Assembly of a Covalent Polymer Network for Intracellular Protein Delivery and Traceless Release, J. Am. Chem. Soc., 2017, 139, 5676-5679). as applied to claims 21,22, 24, 26, 28-30, 32 and 33 above, and further in view of CA 3032839 A1 (Feb. 8, 2018).
Regarding the recited boronate ester linker of claim 23 over the disulfide linker taught by Dutta et al., CA teaches and equates the disulfide bridge and boronic ester from boronic acid and diol in [0075].
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize absent showing otherwise.
Claims 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (Templated Self-Assembly of a Covalent Polymer Network for Intracellular Protein Delivery and Traceless Release, J. Am. Chem. Soc., 2017, 139, 5676-5679). as applied to claims 21,22, 24, 26, 28-30, 32 and 33 above, and further in view of CA 3043577 A1 (May 24, 2018).
Regarding the recited ratio of claim 27, Dutta et al. teach a side chain comprising the disulfide with or without conjugated to a protein in the Scheme I which would show that a weight of a polymer would be higher than that of the protein which would make the recited ratio of claim 27 obvious.
Regarding the recited molecular weight of claim 31, although Dutta et al. do not specify number of repeating unis for the copolymer taught in Scheme I, a polymer per definition would comprising a high molecular weight.
CA teaches self-assembled diblock copolymers composed of PEGMEMA and drug bearing polymeric segment in abstract. CA teaches that both x and y of Formula 1 are a natural number between 1-100 at page 5 which would encompass the recited ratio of claim 27.
CA teaches that an average molecular weight of the copolymer is 5 kDa to 60 kDa overlapping the recited 10 kDa to 500 kDa of claim 31 in lines 1-5 of page 12 which would overlap the recited ratio of claim 31.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to obtain a copolymer comprising the recited ratio and molecular weight from Dutta et al. with the disclosure of CA since Dutta et al. teach a side chain comprising the disulfide with or without conjugated to a protein in the Scheme I (i.e. a higher ratio of a polymer) and since a copolymer having different ratios and a high molecular weight such as 10 kDa to 60 kDa is well known as taught by CA absent showing otherwise.
Selection of a known material based on its suitability for its intended use is prima facie obvious, see Sinclair & Carroll Co. v. Interchemical Corp., 325 US 327, 65 USPQ 297 (1945). MPEP 2144.07.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 22, 24 and 26-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,672,867. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 of the patent teaches the instant polymer-protein conjugate comprising the instant disulfide degradable linker meeting claims 21 and 24. The claim 2 of the patent teaches a nano-assembly meeting claim 26. The claim 1 of the patent teaches the same polymer-protein conjugate comprising the instant disulfide degradable linker claimed and thus it would meet claims 22, 28-30, 32 and 33. The claim 1 of the patent teaches higher amount of a polymer than protein as well as any positive number for m, n, x and y for the formula and thus the instant claims 27 and 31 would have been obvious.
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/TAE H YOON/Primary Examiner, Art Unit 1762