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 .
Status of Claims
The preliminary amendment filed on 08/15/2024 amended claims 1, 3-12, and 15-16. There are no claims withdrawn and no claims cancelled. Claims 1-16 are pending and will be examined on the merits.
Priority
Provisional application 63/223,792 is acknowledged as disclosing the claimed invention and the effective filing date is 07/20/21.
Information Disclosure Statement
The Information Disclosure Statement filed on 09/25/2024, 11/17/2025, 06/12/2026, and 07/17/2026 has been considered. Signed copies are enclosed.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term MilliporeSigma in paragraph [0045], for example, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is asked to carefully review the specification for other trade names.
Claim Objections
Claims 7 and 8 are objected to because of the following informalities: Examiner is unsure why "oligo(elthylene glycol) (OEG)" in claim 7 is formatted with the first term including parentheses and "polyethelene glycol (PEG)" in claim 8 is formatted without paratheses. The terms are formatted the same in the specification (see paragraph [0034]). Examiner requests the claims are amended to read similarly, either both with or both without parentheses. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “the method of claim 12, which is completed in 30 minutes or less.” However, claim 12 recites, in step (a), an overnight aging step. It is unclear how a method that requires an overnight aging step can be completed in 30 minutes or less. Appropriate clarification is required. For purposes of examination, Examiner is interpreting claim 16 to mean that at least one step from claim 12 can be completed in 30 minutes or less.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li, Ph.D. Thesis, July 16 2020.
The instant claims are drawn to a system comprising filler molecules and ligand molecules, where the filler molecules comprise a linear hydrocarbon chain conjugated to an amino acid sequence of 2-5 amino acids and the ligand molecules comprise the same, and a linker, and a Z33 peptide of S. aureus protein A conjugated to the linker. The claims also contain a method of using said system to purify a protein comprising an Fc region of an antibody, comprising the steps of (a) dissolving the system components in aqueous solution and aging overnight to form immunofibers (IFs), (b) mixing a protein with an Fc region with the IFs, (c) separating the complexed protein-IFs by adding salt and/or centrifuging, and (d) dissociating the protein from the IFs. Claim 15 recites the dissociation by lowering the pH of the solution and filtration.
Li teaches both the system of claim 1 and the method of claim 12. Li teaches, in chapter 5, a co-assembled immunofiber (IF) system formed by filler and ligand molecules, wherein the filler molecule comprises a hydrocarbon chain C12-VVEE and a ligand molecule comprising C12-VVKK-Linker-Z33 peptide (see page 141 and figures 5-1 and 5-2), disclosed to have the sequence of SEQ ID NO: 1 on page 45, thereby teaching the limitations of instant claim 1, as well as claims 2-6. Li additionally teaches that the linker can be OEG or PEG, teaching claims 7 and 8, and that the linker may be 4, 8, 12, 16, or 36 PEG or OEG molecules, teaching claims 9-11, on page 141 and in table 5-1. Li further teaches a method comprising dissolving this system in an PBS solution at a pH 7.4 and aging overnight (24 hours) in section 5.3.3 on page 138, mixing in a sample of monoclonal antibody and incubating for 30 minutes to allow binding and separating the IF-antibody complex via centrifugation (and addition of salt) in section 5.3.6. on page 140, and eluting, or dissociating, the antibody via lowering the pH with elution buffer in section 5.3.7, page 140. Therefore, Li teaches the method of claims 12, 13, and 16. Li also teaches using the system to isolate an Fc fusion protein in section 4.3.7, page 111, thereby teaching instant claim 14. Finally, Li discloses adding a membrane separation step, or filtration step, to the elution process on page 157 (figure 5-10), teaching claim 15. Thus, Li anticipates instant claims 1-16.
Claim(s) 1-6 and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al., Nano Lett. 2020, 20, 6957−6965, published 8/27/2020.
Li et al. teach a supramolecular polymeric system for the precipitation of monoclonal antibodies (abstract, whole document). Li et al. teach a system comprising filler molecules C12-VVEE and ligand molecules C12-VVKK-GG-Z33, teaching instant claims 1 and 3-6 (See figure 1b, page 6958 right column). Li et al. teach that Z33 has the amino acid sequence of SEQ ID NO: 1 in figure S1, teaching instant claim 2. Li et al. also teach a method of precipitating antibodies comprising aging the IFs overnight to self-assemble in PBS at a pH of 7.4 (supplemental methods page 3), incubation with either monoclonal antibody or Fc-fusion protein for 30 minutes, separation by centrifugation and/or adding salt (supplemental methods page 5), and separation of the antibodies from IFs by lowering the pH and filtering (or dialyzing) (supplemental methods page 6), thereby teaching claims 12-16. Therefore, Li et al. teach claims 1-6 and 12-16.
Claim(s) 1-6 and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2019/036631 A1, Cui et al., published 02/21/2019.
Cui et al. teach, in example 12, paragraph [0141] and figure 19A (caption in paragraph [0043]), an immunofiber based binding system comprising spacer molecules (or filler molecules) C12-VVEE and binding molecules (or ligand molecules) C12-VVKK-GG-Z33, where GG is the linker, anticipating claim 1 and 3-6. Cui et al. teach the Z33 peptide has the same amino acid sequence as instant claim 2 in paragraph [0011] (see alignment below). Examples 13 and 14 of Cui et al. teach a method of precipitating antibodies from solution by assembling the IFs in aqueous solution overnight (paragraph [0130] and claim 19a), mixing a sample containing antibodies into the IFs solution (claim 19b and paragraph [0142]), separating the complex from solution by centrifuging and adding salt (claim 19c and paragraph [0143]), and dissociating the IFs from the antibodies (claim 19d and paragraph [0143]). Therefore, Cui et al. teach the method of instant claim 12 and 13, as well as claim 16, as the mixing step was performed for 30 minutes in paragraph [0142]. Cui et al. also teach separating the IFs from the antibodies by lowering the pH and filtration or microfiltration in claim 20, therefore teaching instant claim 15. Finally, Cui et al. teach that the protein of interest may be an antibody like IgG or a fusion peptide containing an Fc portion in paragraph [0086]. Therefore, Cui et al. anticipate instant claims 1-6 and 12-16.
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Claim Rejections - 35 USC § 103
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(s) 1-13 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., Nano Lett. 2020, 20, 6957−6965, in view of Accardo et al., 2014, Biopolymers, 102: 304-312.
Li et al. teach a supramolecular polymeric system for the precipitation of monoclonal antibodies (abstract, whole document). Li et al. teach a system comprising filler molecules C12-VVEE and ligand molecules C12-VVKK-GG-Z33, teaching instant claims 1 and 3-6 (See figure 1b, page 6958 right column). Li et al. teach that Z33 has the amino acid sequence of SEQ ID NO: 1 in figure S1, teaching instant claim 2. Li et al. also teach a method of precipitating antibodies comprising aging the IFs overnight to self-assemble in PBS at a pH of 7.4 (supplemental methods page 3), incubation with either monoclonal antibody or Fc-fusion protein for 30 minutes, separation by centrifugation and/or adding salt (supplemental methods page 5), and separation of the antibodies from IFs by lowering the pH and filtering (or dialyzing) (supplemental methods page 6), thereby teaching claims 12-16.
Li et al. do not explicitly teach the limitations of claims 7-11, wherein the linker is OEG or PEG, is 2-50 or 36 or 16 OEG or PEG molecules.
However, Accardo et al. teach a different peptide amphiphile (PA) system, wherein the linker comprises a PEG spacer. Accardo et al. shows that modifying the PA system with a PEG spacer (ranging from PEG700 to PEG5000) results in increased binding capabilities of the attached peptide, likely due to the conformation of the aggregated PAs being able flexible enough to allow interactions with the target protein, and ultimately identify PEG2000 as the optimal spacer (see abstract, conclusions, especially page 311, left column). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to modify the system of Li et al. by adding a PEG spacer, such as in Accardo et al. One would be motivated to do so in order to allow better conformations for binding the target antibodies and allowing precipitation in the method of Li et al. Indeed, Li et al. recites that a “more efficient ligand/protein ratio could be potentially achieved by improving the ligand flexibility on the IF surface and minimizing IF merging,” (page 6961, left column) and “[p]recipitation at an even lower salt concentration or without salt altogether can be potentially achieved by further improving the design of IFs to obtain more flexible ligands on IFs and improve the IF–protein interactions” (page 6962, left column). One would have reasonable expectation of success as the PEG spacer of Accardo et al. did not interrupt the aggregation function of the PAs, thus showing that PEG can be used as a spacer as efficiently as the GG linker of Li et al. Therefore, Li et al. in view of Accardo et al. teaches instant claim 8.
As recited in the instant specification, PEG, or polyethylene glycol and oligoethylene glycol (OEG) are analogous, and both describe an oligomer in which all of the subunits are ethylene oxide subunits. Therefore, as Accardo et al. teaches a PEG spacer, it also teaches an OEG spacer. The key difference between PEG and OEG is the number of discrete repeats of ethylene glycol is known in OEG, whereas PEG is often measured in Daltons (Da), or molecular weight (MW). PEG2000 has an average MW of 2000 Da. Ethylene glycol has a MW of about 62 Da. Therefore, the average PEG2000 molecule has about 32 ethylene glycol subunits, and could be considered 32 OEG molecules, therefore teaching instant claim 7 and 9.
Regarding claims 10 and 11, it would be obvious to one of ordinary skill in the art to optimize the length of the PEG or OEG linker. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), discloses that if a method is “obvious to try”, it is not patentable over the prior art. MPEP § 2144.05(II) recites that routine optimization is “obvious to try”, and therefore supported by said rational. Synthesis parameters, such as different lengths of OEG and PEG, could be routinely optimized in light of other PEGylation protocols. Therefore, it would be obvious to routinely optimize the spacer length of the ligand molecule to optimize flexibility, binding, antibody capture, and ease of precipitation. Thus, the combination of prior art references as combined provided a prima facie case of obviousness for claims 10 and 11, absent convincing evidence to the contrary. Therefore, Li et al. in view of Accardo et al. disclose the instant invention and claims 1-16 are obvious.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/036631 A1, Cui et al., in view of Accardo et al., 2014, Biopolymers, 102: 304-312.
Cui et al. teach, in example 12, paragraph [0141] and figure 19A (caption in paragraph [0043]), an immunofiber based binding system comprising spacer molecules (or filler molecules) C12-VVEE and binding molecules (or ligand molecules) C12-VVKK-GG-Z33, where GG is the linker, anticipating claim 1 and 3-6. Cui et al. teach the Z33 peptide has the same amino acid sequence as instant claim 2 in paragraph [0011] (see alignment above). Examples 13 and 14 of Cui et al. teach a method of precipitating antibodies from solution by assembling the IFs in aqueous solution overnight (paragraph [0130] and claim 19a), mixing a sample containing antibodies into the IFs solution (claim 19b and paragraph [0142]), separating the complex from solution by centrifuging and adding salt (claim 19c and paragraph [0143]), and dissociating the IFs from the antibodies (claim 19d and paragraph [0143]). Therefore, Cui et al. teach the method of instant claim 12 and 13, as well as claim 16, as the mixing step was performed for 30 minutes in paragraph [0142]. Cui et al. also teach separating the IFs from the antibodies by lowering the pH and filtration or microfiltration in claim 20, therefore teaching instant claim 15. Finally, Cui et al. teach that the protein of interest may be an antibody like IgG or a fusion peptide containing an Fc portion in paragraph [0086].
Cui et al. do not explicitly teach the limitations of claims 7-11, wherein the linker is OEG or PEG, is 2-50 or 36 or 16 OEG or PEG molecules. However, Accardo et al. teach a different peptide amphiphile (PA) system, wherein the linker comprises a PEG spacer. Accardo et al. shows that modifying the PA system with a PEG spacer (ranging from PEG700 to PEG5000) results in increased binding capabilities of the attached peptide, likely due to the conformation of the aggregated PAs being able flexible enough to allow interactions with the target protein, and ultimately identify PEG2000 as the optimal spacer (see abstract, conclusions, especially page 311, left column). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to modify the system of Cui et al. by adding a PEG spacer, such as in Accardo et al. One would be motivated to do so in order to allow better conformations for binding the target antibodies and allowing precipitation in the method of Cui et al. Indeed, Cui et al. recites, in paragraph [0142], that increased ligand binding flexibility and accessibility of the Z33 peptide to IgG is important for precipitating more antibody. One would have reasonable expectation of success as the PEG spacer of Accardo et al. did not interrupt the aggregation function of the PAs, thus showing that PEG can be used as a spacer as efficiently as the GG linker of Cui et al. Therefore, Cui et al. in view of Accardo et al. teaches instant claim 8.
As recited in the instant specification, PEG, or polyethylene glycol and oligoethylene glycol (OEG) are analogous, and both describe an oligomer in which all of the subunits are ethylene oxide subunits. Therefore, as Accardo et al. teaches a PEG spacer, it also teaches an OEG spacer. The key difference between PEG and OEG is the number of discrete repeats of ethylene glycol is known in OEG, whereas PEG is often measured in Daltons (Da), or molecular weight (MW). PEG2000 has an average MW of 2000 Da. Ethylene glycol has a MW of about 62 Da. Therefore, the average PEG2000 molecule has about 32 ethylene glycol subunits, and could be considered 32 OEG molecules, therefore teaching instant claim 7 and 9.
Regarding claims 10 and 11, it would be obvious to one of ordinary skill in the art to optimize the length of the PEG or OEG linker. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), discloses that if a method is “obvious to try”, it is not patentable over the prior art. MPEP § 2144.05(II) recites that routine optimization is “obvious to try”, and therefore supported by said rational. Synthesis parameters, such as different lengths of OEG and PEG, could be routinely optimized in light of other PEGylation protocols. Therefore, it would be obvious to routinely optimize the spacer length of the ligand molecule to optimize flexibility, binding, antibody capture, and ease of precipitation. Thus, the combination of prior art references as combined provided a prima facie case of obviousness for claims 10 and 11, absent convincing evidence to the contrary.
Taken together, Cui et al. in view of Accardo et al. disclose the instant invention and claims 1-16 are obvious.
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 1-6 and 12-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 12357965 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to the same system and method.
The claims of ‘965 are drawn to an immunofiber composition comprising a spacer molecule with a hydrocarbon chain conjugated to sequence XXBB, where XX is A,V,I, or L, and BB is E or R (C12-VVEE) and a binding molecule comprising a Z33 peptide conjugated to a second hydrocarbon chain with sequence including VVKK. These claims anticipate instant claims 1-6. Additionally, claim 9 of ‘965 is a method of using said immunofibers comprising the same steps as instant claim 12, therefore anticipating instant claim 12. ‘965 claim 9 recites antibodies and Fc-containing peptides, anticipating instant claims 13 and 14, and ‘965 claim 11 recites the dissociation step of instant claim 15, anticipating such. Therefore, the instant claims are anticipated by claims 1-12 of ‘965.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 12357965 B2 in view of Accardo et al., 2014, Biopolymers, 102: 304-312.
The claims of ‘965 are drawn to an immunofiber composition comprising a spacer molecule with a hydrocarbon chain conjugated to sequence XXBB, where XX is A,V,I, or L, and BB is E or R (C12-VVEE) and a binding molecule comprising a Z33 peptide conjugated to a second hydrocarbon chain with sequence including VVKK. These claims anticipate instant claims 1-6. Additionally, claim 9 of ‘965 is a method of using said immunofibers comprising the same steps as instant claim 12, therefore anticipating instant claim 12. ‘965 claim 9 recites antibodies and Fc-containing peptides, anticipating instant claims 13 and 14, and ‘965 claim 11 recites the dissociation step of instant claim 15, anticipating such. Therefore, the instant claims are anticipated by claims 1-12 of ‘965.
Accardo et al. teach a different peptide amphiphile (PA) system, wherein the linker comprises a PEG spacer. The teachings of Accardo et al. are set out above under paragraph 20. For the same reasons, it would be obvious to add the PEG linker of Accardo et al. to the invention of ‘965 in order to increase flexibility and binding potential of the system. Therefore, claims 1-16 are obvious over ‘965 in view of Accardo et al.
Conclusion
No claim is allowed.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights