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
Pursuant to a preliminary amendment filed October 12, 2023 claims 1-18 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election of Group I, claims 1-9 and 14, directed to a nucleic acid library whose members encode an affinity ligand; and Applicant’s election of Species as follows:
Species (A): a single specific structure of a nucleic acid library member, wherein:
[A] is SEQ ID NO: 2 (claims 3, 7); the variable positions are X1, X2, X3, X4, X, S, X6, X7, X8, X10, X11, and X12 are R, S, Y, R, Q, F, I, D, K, Y, R, I, respectively; n is 1 and X6 is F (claim 7); X9 and X13 are each K ( claim 7); and [B] is VD (claim 1);
Species (B): structures encompassed by SEQ ID NO: 1 are SEQ ID NOs: 13-18 (claim 8);
Species (C): wherein the peptide domain is VD (claim 1);
Species (D): the nucleic acid library of claim 1, wherein [A] is SEQ ID NO: 2 (claim 7); and
Species (E): wherein the library comprises a phage display library, a yeast display library, etc. (claim 9), in the reply filed April 16, 2026; and in the subsequent reply filed May 11, 2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election without traverse (MPEP
§ 818.03(a)).
Claims 10-18 ae withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 3-6 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1, 2, 7, 9 and 14 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed April 13, 2023 is a 35 U.S.C. 371 national stage filing of International Application PCT/US2021/054874, filed October 13, 2021, which claims the benefit of US Provisional Patent Application 63188229, filed May 13, 2021; and US Provisional Patent Application 63091201, filed October 13, 2020.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application 63188229, filed May 13, 2021, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 50 does not have support for; [A]-X1QRRX2FIX3X4LRXsDPS-[X6]n-SAX-LLAX8AX9X10X11NDX12QAPXB-[B]; “[A] comprises an a-helix-forming peptide domain”; “[B]”; and “[B] is absent, is VD, or is a peptide domain…SEQ ID NO: 12”. Therefore, the priority date for the presently claimed invention is October 21, 2021, the filing date of International Application WO2022081779A1.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 19, 2023 has been considered. An initialed copy of the IDS accompanies this Office Action.
Claim Objections/Rejections
Claim Objections
Claims 1, 2, 7, 9 and 14 are objected to because of the following informalities: Claims 1, 2, 7, 9 and 14 recite a mixture of pronouns including “the” and “said”, such that for consistency and clarity, a single pronoun reciting either “the” or “said” should be used.
Appropriate correction is required.
Specification Objection
The disclosure is objected to because of the following informalities: the as-filed Specification, filed April 13, 2023, does not include priority data regarding PCT/US2021/054874, filed May 13, 2021.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 2, 7, 9 and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the term “the formula” such as recited in claim 1, line 2. There is insufficient antecedent basis for the term “the formula” in the claim. The Examiner suggests that Applicant amend the claim to recite, for example, “represented by SEQ ID NO: 1.”
Claim 2 is indefinite for the recitation of the term “alkali-stable helix 1” in claim 2, line 2 because the term “alkali-stable” is relative term that renders the claim indefinite. The term “alkali-stable” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of ‘stability’ of an a-helix-forming peptide domain of an SPA to known alkalis as compared to some other value that qualifies the helix as “alkali-stable,” such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention.
Claim 2 is indefinite for the recitation of the term “preferably” in claim 2, line 4 because the term “preferably” is relative term that renders the claim indefinite. The term “preferably” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of ‘preferability’ of the Z-domain as compared to any of the other SPA domains that qualifies it as being preferable. Moreover, the SPA Z-domain such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention.
Claim 2 is indefinite for the recitation of the term “Z-domain” such as recited in claim 2, lines 3 and 4 because the Z-domain of SPA is a highly engineered three-helix bundle protein, such that it does not represent a native structure in staphylococcal protein A (e.g., staphylococcal protein A does not comprise a Z-domain) and, thus, the metes and bounds of the claim cannot be determined.
Claim 9 is indefinite for the recitation of the term “wherein said library is a phage display library…or a DNA display library” such as recited in claim 9, lines 1-3 because it is unclear how a library of nucleic acid sequences can be characterized as a type of display library and, thus, the metes and bounds of the claim cannot be determined.
Claim 9 is indefinite for the recitation of the term “said library” such as recited in claim 9, line 2. There is insufficient antecedent basis for the term “said library” in the claim because claim 1, line 1 recites that term “a nucleic acid library.”
Claim 14 is indefinite for the recitation of the term “The method of claim 9” such as recited in claim 14, line 1 because claim 14 depends from instant claims 1 and 9, wherein claims 1 and 9 recite a “nucleic acid library”, such that the claims are not directed to a method and, thus, the metes and bounds of the claim cannot be determined.
Claim 14 is indefinite for the recitation of the term “said target molecule” such as recited in claim 14, line 1. There is insufficient antecedent basis for the term “said target molecule” in the claim.
Claim 14 is indefinite for the recitation of the terms “target molecule” and “bound to or attached to a solid support” such as recited in claim 14, lines 1-2 because claim 14 depends from instant claims 1 and 9, wherein claims 1 and 9 do not recite the presence of a target molecule, a solid support, and/or the library of nucleic acids being bound to anything and, thus, the metes and bounds of the claim cannot be determined. Applicant is respectfully reminded the nucleic acid library of molecules does not comprise the polypeptides that it encodes.
Claim 7 is indefinite insofar as it ultimately depends from instant claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 recites (in part): “[T]he method of claim 9, wherein said target molecule or said phage display library is bound to or attached to a solid support” such as recited in claim 14, lines 1-2 because claim 14 depends from instant claims 1 and 9, where claims 1 and 9 do not recite a method; a target molecule, the nucleic acid library bound to anything, and/or a solid support. Thus, claim 14 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2, 9 and 14 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Johansson et al. (hereinafter “Johansson”) (US Patent No. 8642734, issued February 4, 2014).
Regarding claims 1 and 2, Johansson teaches providing novel spider silk proteins and method and polynucleic acid molecules for producing such proteins and polymers (interpreted as a nucleic acid encoding a library member, claim 1) (col 1, lines 26-28). Johansson teaches that WO 03/057727 discloses expression of soluble recombinant silk polypeptides in mammalian cell lines and animals (interpreted as a display library as recited in claim 9, claim 9) (col 2, lines 44-45). Johansson teaches providing a method of reversibly assembling a polymer or oligomer of one type of molecule or several different types of molecules, comprising the steps of: (1) providing said molecules, each molecule comprising at least one first binding moiety of from 100 to 160 amino acid residues which is derived from the N-terminal fragment of a spider silk protein; and (2) a second moiety individually selected from proteins, nucleic acids, carbohydrates, and lipids (col 6, lines 48-56). Johansson teaches
it is envisaged that the subtype forms coil structures or 3-helix structures (col 15, lines 61-62).
Johansson teaches SEQ ID NO: 19 (interpreted as comprising the structure according to instant SEQ ID NO: 1; and comprising an helix-forming peptide domain, claims 1 and 2) (col 69, SEQ ID NO: 19). Johansson teaches that the first step of the method of producing polymers of an isolated spider silk protein involves expression of a polynucleic acid molecule which encodes the spider silk protein in a suitable host, such as Escherichia coli (interpreted as a nucleic acid that encodes an amino acid sequence; and a phage display library, claims 1 and 9) (col 18, lines 22-25). Johansson teaches that the pH of the liquid medium of step (ii) is 6.7 or higher (interpreted as alkali-stable, claim 2) (col 4, lines 1-2). These affinity-based procedures utilize the inherent properties of the NT moiety to advantageously be utilized as a powerful affinity purification tool, allowing one-step purification of spider silk proteins according to the invention from complex mixtures; and although chromatography is preferred, other affinity-based purification methods than chromatography can be employed, such as magnetic beads with functionalized surfaces or filters with functionalized surfaces (col 26, lines 33-44).
Regarding claim 9, Johansson teaches that the first step of the method of producing polymers of an isolated spider silk protein involves expression of a polynucleic acid molecule which encodes the spider silk protein in a suitable host, such as Escherichia coli (interpreted as a nucleic acid that encodes an amino acid sequence; and a phage display library, claims 1 and 9) (col 18, lines 22-25).
Regarding claim 14, Johansson teaches that at least one molecule type of the first method step is immobilized to a solid support or to the matrix of an affinity medium as set out herein below (interpreted as a polymer attached to a solid support, claim 14) (col 25, lines 22-24).
Johansson does not specifically exemplify the structure of [A] in claim 7 (claim 7).
Johansson meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Conclusion
Claims 1, 2, 7, 9 and 14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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