DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s preliminary amendments received February 6, 2024 are acknowledged.
Claim 15 has been canceled.
Claims 2-11, 13, 14 have been amended.
Claims 16-21 have been added.
Claims 1-14 and 16-21 are pending in the instant application.
Information Disclosure Statement
The IDS forms received 4/24/2024 and 2/14/2025 are acknowledged and the references cited therein have been considered.
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.
Claims 8 and 12 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 8 contains the trademark/trade name “Sepharose” (see enclose printout from a search of the trademark database) while claim 12 recites the trademark/trade name “FPLC” (see printout). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular solid support to which a fusion protein is attached thereto and, accordingly, the identification/description is indefinite.
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 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.
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.
Claims 1-7, 9-11, 13-14, 16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over CN 107556385 (reference 3 on the 4/24/24 IDS) in view of WO 2014/0171978 (reference 2 on the 4/24/24 IDS).
The ‘385 patent discloses that the bicyclic peptide Fc-III-4C (i.e. SEQ ID NO:1) binds very well to the Fc domain of immunoglobulins, is to be used in affinity purification protocols to recover Fc containing proteins including antibodies, and can be part of a fusion protein wherein Fc-III-4C is joined to a heterologous moiety (see entire document, particularly the translation provided by applicant, most particularly claims 1, 13, 19, and 20 and paragraphs [0016], [0039], [0054], [0060], and [0075]). Notably such Fc-III-4C fusion proteins are disclosed as being immobilized on a solid matrix as part of methods of purifying Fc containing polypeptides (see particularly claims 21 and 22). Fc-III-4C is disclosed as binding to the Fc domains of many species including human, mouse, rabbit, rat, cow, sheep, horse and pig (see particularly paragraph [0054]). Comparisons of agarose particles comprising either protein A or Fc-III-4C bound thereto demonstrated that FC-III-4C was more stable that protein A under the same conditions (see particularly paragraph [0061]). These teachings differ from what has been presently claimed in that the ‘385 patent does not disclose fusion proteins with SlyD.
The ‘978 WIPO publication discloses fusion proteins wherein the IF domain of SlyD from Thermus thermophilus has its IF domain removed and replaced with a heterologous polypeptide sequence, with such constructs being used to bind ligands of the inserted polypeptide sequence (see entire document, particularly the abstract, claims, and pages 21, 22, and the paragraph spanning pages 24 and 25). Of particular interest is the disclosed fusion construct
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Notably, the peptide inserts are disclosed as being conformationally constrained (see particularly pages 12, 13, 35 and 36). SlyD is disclosed as being permissive for inserts of 100 amino acid residues at the position marked as “X” (i.e. the IF domain, see the paragraph bridging pages 24 and 25). Such SlyD constructs are disclosed as having the advantages of high stability and reversible folding as compared to other fusion partners that could be attached to ligand binding sequences (see particularly page 25).
Therefore, it would have been obvious to artisans to make Fc-III-4C fusion proteins as disclosed by the ‘385 patent include SlyD. Artisans would have been motivated to use SlyD as a fusion partner, because replacing the IF domain of SlyD with a heterologous sequence provided for the advantageous properties of high stability and reversible folding as compared to other fusion partners for the expression of ligand binding sequences, such as Fc-III-4C which binds the ligand known as the immunoglobulin Fc domain. Notably, when an artisans inserts the Fc-III-4C polypeptide (i.e. instant SEQ ID NO:1) into the exact location of “X” in SEQ ID NO:16 of the ‘978 publication, the resulting peptide is a 100% match for instant SEQ ID NO:5. In addition to the construct of instant SEQ ID NO:5, artisans would also have been motivated to insert two copies of the Fc-III-4C peptide in place of the IF fold of SlyD as the ‘978 publication teaches that inserts of 100 residues or more can be accommodated at this location, and the more binding sites present the greater the amount of ligand, in the instant case Fc containing polypeptides, can be bound be molecule of fusion protein.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over CN 107556385 (reference 3 on the 4/24/24 IDS) in view of WO 2014/0171978 (reference 2 on the 4/24/24 IDS) as applied to claims 1-7, 9-11, 13-14, 16, and 18-21 above, and further in view of WO 2012/150320 (reference 1 on the 4/24/24 IDS).
The inventions rendered obvious by the teachings of the prior art have been discussed above, and differ from that which is presently claimed in that such constructs do not comprise a His tag.
The ‘320 publication discloses SlyD fusion proteins which include the sequence GSRKHHHHHHHH to aid in purification (see entire document, particularly page 19).
Therefore, it would have been obvious to artisans to add a Hid tag to the fusion proteins rendered obvious by the teachings of the prior art in order to make them easier to purify as disclosed by the ‘320 publication.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over CN 107556385 (reference 3 on the 4/24/24 IDS) in view of WO 2014/0171978 (reference 2 on the 4/24/24 IDS) as applied to claims 1-7, 9-11, 13-14, 16, and 18-21 above, and further in view of Affinity Chromatography – Principles and Methods.
The inventions rendered obvious by the teachings of the prior art have been discussed above, and differ from that which is presently claimed in that such SlyD/Fc-III-4C fusion proteins are not taught as being conjugated to sepharose using lysine residues via NHS esters.
Affinity Chromatography – Principles and Methods teaches that conjugation of proteins of interest via side chain lysines (i.e. NH2 groups) to NHS-activated Sepharose beads is well known and routine as such reagents are readily commercially available (see entire document, particularly chapters 4 and 5, most particularly Table 7, page 100 and Figure 59).
Therefore it would have been obvious to artisans to attach SlyD/Fc-III-4C fusion proteins to Sepharose via NHS as such reagents were commercially available and in widespread use in the art as evidenced by the Amersham Biosciences protocol book/sales brochure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over CN 107556385 (reference 3 on the 4/24/24 IDS) in view of WO 2014/0171978 (reference 2 on the 4/24/24 IDS) as applied to claims 1-7, 9-11, 13-14, 16, and 18-21 above, and further in view of WO 86/06727.
The inventions rendered obvious by the teachings of the prior art have been discussed above, and differ from that which is presently claimed in FPLC is not disclosed for use in recovering antibodies bound to a solid support.
The ‘727 publication teaches the purification of antibodies using FPLC (see entire document).
Therefore, it would have been obvious to artisans to use FPLC equipment in antibody purification protocols as such equipment is well known and as been in use in the art for 40 years or more as evidenced by the ‘727 publication.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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