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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 36-45 and 51-53) in the reply filed on 11/20/2025 and the election without traverse of species I: a specific immunoglobulin binding domain (claims 41-44) filed on 3/19/2026 are acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 36-55 are pending.
Claims 46-50, and 54-55 are withdrawn for being drawn to non-elected inventions (i.e., Groups II-IV) and the non-elected species.
Claims 36-45, and 51-53 are under examination.
Priority
The instant application is a CON of US Application No. 16/485,854 filed on 8/14/2019, now US Pat. No. 11,739,118.
Information Disclosure Statement
The Information Disclosure Statement filed on 11/16/2023 has been considered.
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.
Claim(s) 36, 38-42, 44-45, and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Bjorkman et al. (IDS, W) 2017/194596) in view of Honda et al. (IDS, 2016/0280744), Chen et al (IDS, Adv. Drug. Del. Rev. 2013) and Lin et al. (IDS, US 2016/0185826).
The instant claims are broadly drawn to a polypeptide comprising at least two binding units and at least one spacer domain, wherein every two neighboring binding units are separated by at least one spacer domain, and each binding unit comprises one or two immunoglobulin binding domains, wherein the spacer domain comprises a structurally rigid domain, wherein the spacer domain is not a random coil or a disordered loop at pH about 4.5 to about 7(claim 38), wherein every two neighboring binding units are separated by one spacer domain (claim 39), wherein the immunoglobulin binding domain is a Staphylococcal Protein A (SPA) immunoglobulin binding domain (claim 40), wherein the immunoglobulin binding domain is domain A of SPA, domain B of SPA, domain C of SPA, domain D of SPA, or domain E of SPA (claim 41), wherein the immunoglobulin binding domain is domain Z (claim 42), wherein the immunoglobulin binding domain is a Streptococcal Protein G (SPG) immunoglobulin binding domain (claims 44-45). A chromatography ligand comprising the polypeptide of claim 36 (claim 51), wherein the chromatography ligand has a recovery yield over 60% with elution pH at 4.7 or higher (claim 52), and wherein the chromatography ligand is immobilized on a matrix (claim 53).
Bjorkman teaches a multimer comprising polypeptide units where the polypeptides can be linked to each other directly by peptide bonds ("spacer domain") between the C-terminal and N-terminal ends of the polypeptides ("every two neighboring binding units). (p. 18, lines 4-11) Bjorkman teaches that the binding units are Fc-binding polypeptides such as Protein A and Protein G, which is considered an "immunoglobulin binding domain" (p. 4, lines 26-30). Bjorkman teaches that the Fc binding protein is a Z domain (p. 6, lines 7-8 and 20-21; p. 27, line 31; Table 2). Bjorkman as noted above teaches multimers of the polypeptide units which are separated by linker/spacers. As Bjorkman further teaches that the multimer can multimers of 4 units with each unit linked to each other by a linker (p. 18, line 5; p. 18, line 31). Bjorkman teaches that the plurality of polypeptides/multimers are coupled to a solid support such as a conventional affinity separation matrix (p. 22, lines 25-27; p. 23, lines 11-15). Bjorkman does not teach to use a rigid linker as spacer and does not teach chromatography ligand comprising the polypeptide of claim 36.
Honda teaches modified domains from protein A including the Z domain in a tandem-type amino acid sequence which are alternately arranged with linker sequences and a spacer protein is linked to an amino acid sequence of a spacer for immobilizing the protein onto a solid phase support (abstract; columns 7-8 and in particular column 16, lines 46-55). Honda teaches for example that such a sequence may be [amino acid sequence (a) - linker sequence A - amino acid sequence (a) - linker sequence B - amino acid sequence (a)] (column 16, lines 50-52). Therefore, Honda as noted above teaches the tandem type protein may be for example [amino acid sequence (a) - linker sequence A - amino acid sequence (a) - linker sequence B - amino acid sequence (a).
Chen teaches that while flexible linkers have the advantage to connect functional
domains passively and permitting certain degree of movements, the lack of rigidity of these linkers can be a limitation because they can result in poor expression yields or loss of biological activity. Chen teaches accordingly alpha helix-forming linkers have
been applied to the construction of many recombinant fusion proteins because they are
rigid and stable. (p. 5, section 3.2).
Lin also teaches flexible and rigid linkers. Lin teaches that Rigid linkers may include at least one alpha helical structure. (128).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a linker with a rigid structure as taught by Lin to create a spacer as taught by Chen that rigid linkers may not be good for biological activity but for a purification and immobilization would be appropriate to separate immunoglobulin binding units that includes Z-domain as taught by Honda et al and Bjorkman. Additionally, one would have been motivated to do so because Lin as well as Chen et al teach use of rigid linkers to separate two or more peptides and Honda et al teach to use multimer units for immobilization on Sepharose for purifying immunoglobulins. Further, one would have a reasonable expectation of success in using rigid linkers as taught by Chen et al and Lin to separate two or more peptide units. Therefore, the invention is whole would have been obvious to one ordinary skill in the art over the combined teachings of the prior art.
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 36-45, and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,739,118. Although the claims at issue are not identical, they are not patentably distinct from each other because a polypeptide comprising at least two binding units and at least one spacer domain, wherein every two neighboring binding units are separated by at least one spacer domain, and each binding unit comprises one or two immunoglobulin binding domains, wherein the spacer domain comprises a structurally rigid domain, wherein the rigid linker is an alpha helix linker, wherein the spacer domain is not a random coil or a disordered loop at pH about 4.5 to about 7(claim 38), wherein every two neighboring binding units are separated by one spacer domain (claim 39), wherein the immunoglobulin binding domain is a Staphylococcal Protein A (SPA) immunoglobulin binding domain (claim 40), wherein the immunoglobulin binding domain is domain A of SPA, domain B of SPA, domain C of SPA, domain D of SPA, or domain E of SPA (claim 41), wherein the immunoglobulin binding domain is domain Z (claim 42), wherein the immunoglobulin binding domain is a Streptococcal Protein G (SPG) immunoglobulin binding domain (claims 44-45). A chromatography ligand comprising the polypeptide of claim 36 (claim 51), wherein the chromatography ligand has a recovery yield over 60% with elution pH at 4.7 or higher (claim 52), and wherein the chromatography ligand is immobilized on a matrix are taught by claims 1-19 of US Pat. No. 11,739,118.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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