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 with traverse of Group I in the reply filed on June 18, 2026 is acknowledged. Claims 49-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups 2 and 3, there being no allowable generic or linking claim.
Applicant’s arguments traversing the restriction requirement have been fully considered, but are not persuasive. Applicant’s reliance on MPEP 803 and the absence of an alleged serious search or examination burden does not overcome the lack of unity under 37 CFR 1.475, because the potentially shared nucleic acid encoded library technology does not constitute a special technical feature providing a contribution over the prior art in view of Usanov et al. Accordingly, the restriction requirement is maintained.
Election was made with traverse in the reply filed on 6/18/2026. Thus, claims 1-48 are under examination (6/18/2026).
Claim Status
Claims 1-48 are under examination (6/18/2026). No claims have been amended. No new matter was added.
Priority
Claims 1-48 receive a priority date of 10/23/2020, the effective filing date of European Provisional Patent EP20203475.7.
Information Disclosure Statement
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.
Information disclosure statements (IDS) were submitted on 4/18/2023, 4/1/2026, and 5/5/2026 (2) and are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities (see MPEP § 608.01):
The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable codes (see References on p. 57-58). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 42 is objected to because of the following informality:
Claim 42 at line 4, “connect” should be “connected.”
Claim 13 is objected to under 37 CFR 1.75 (c) as being in improper form because a multiple dependent claim must refer to the claims from which it depends in the alternative only. See MPEP § 608.01(n). Accordingly, claim 13 has not been further treated on the merits.
Claims 4-10 and 14-41 and 48 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 48-64 have not been further treated on the merits.
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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 11-12, and 42-47 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Gouliaev et al. (US PGPub 2013/0281324 A1; published 10/24/2013).
Regarding claims 1-3, Gouliaev teaches a method for the synthesis of a bi-functional complex comprising a molecule part and an identifier oligonucleotide part identifying the molecule part, where a part of the synthesis method according to the present invention is preferably conducted in one or more organic solvents when a nascent bi-functional complex comprising an optionally protected tag or oligonucleotide identifier is linked to a solid support, and another part of the synthesis method is preferably conducted under conditions suitable for enzymatic addition of an oligonucleotide tag to a nascent bi-functional complex in solution (Abstract). Further, Gouliaev teaches part of the synthesis method according to the present invention is preferably conducted in one or more organic solvents when a nascent bi-functional complex comprising an optionally protected tag or oligonucleotide identifier is linked to a solid support, and another part of the synthesis method is preferably conducted under conditions suitable for enzymatic addition of an oligonucleotide tag to a nascent bi-functional complex in solution (Paragraph 20, lines 1-5). Additionally, Gouliaev teaches that the optionally protected tag or oligonucleotide identifier linked to the solid support identifies some, but not all, of the reactive compound building blocks which have reacted with the chemical reaction site comprised by, or linked to, the optionally protected tag or oligonucleotide identifier, wherein said tag or identifier is in turn linked to a solid support (Paragraph 21, lines 1-5). Also, Gouliaev teaches that the present invention thus relates to bi-functional complexes and combinatorial chemistry, organic synthesis methods used for synthesising and using such tagged complexes, wherein such bi-functional complexes comprises an identifier oligonucleotide comprising one or more tags, a linker and a natural or unnatural "molecule part" attached to the oligonucleotide via the linker, wherein such a natural or unnatural "molecule part" is not an oligonucleotide and wherein such "molecule part" is not a natural alpha-amino acid based peptide formed by ribosome catalyzed translation (Paragraph 22, lines 1-5).
Also, Gouliaev teaches that in a further aspect of the present invention there is provided an encoded, combinatorial chemistry synthesis method for synthesising a library of different molecules, said method comprising the steps of a) providing a plurality of nascent bi-functional complexes each comprising one or more chemical reaction site(s) and one or more priming site(s) suitable for enzymatic or chemical addition of one or more oligonucleotide tag(s), b) reacting the chemical reaction site(s) with one or more reactive compound building blocks, and c) reacting the priming site enzymatically or chemically with one or more oligonucleotide tags identifying the one or more reactive compound building blocks, wherein a reactive compound building block and the tag identifying the reactive compound building blocks are not linked prior to their reaction with the chemical reaction site and the priming site, respectively, of the nascent bi-functional complex (Paragraphs 32-36). Additionally, Gouliaev teaches that in one embodiment, a first oligonucleotide identifier tag identifying a first reactive compound building block is initially added to or synthesised on a solid support, such as a bead where the first oligonucleotide identifier tag can be un-protected or protected--wherein a protected tag is rendered inert and is unable to react e.g. with the reactive compound building block. Tag protection also enables use of certain organic solvents, as disclosed herein below, which cannot be used in the absence of a protection--by one or more protection group(s)--of reactive groups present in the oligonucleotide tag (Paragraph 38, lines 1-5). Gouliaev teaches that the oligonucleotide initially added to or synthesised on a solid support, such as a bead, can comprise more than one optionally protected oligonucleotide tag, such as 2 optionally protected oligonucleotide tags, for example 3 optionally protected oligonucleotide tags, such as 4 optionally protected oligonucleotide tags, for example 5 optionally protected oligonucleotide tags, wherein each tag identifies a reactive compound building block to be reacted at a later stage--either "on-bead" or "off-bead"--i.e. either while the nascent bi-functional complex is linked to the solid support, or after cleavage of at least one linker the cleavage of which releases the nascent bi-functional complex from the solid support (Paragraph 39, lines 1-5).
Specifically, Gouliaev teaches that in one embodiment, the methods of the invention employ at least two reactive compound building block reactions with a chemical reaction site of a bi-functional complex further comprising an identifier oligonucleotide comprising one or more covalently linked oligonucleotide tags, wherein at least one such reactive compound building block reaction takes place when reactive groups of the oligonucleotide tag or the entire oligonucleotide identifier is protected to prevent an undesirable contact between the oligonucleotide identifier or the tag and the reactive compound building block, or a contact between the reactive groups of the oligonucleotide tag and the solvent in which the reactive compound building block is reacted where the chemical reaction site of the bi-functional complex shall be understood to comprise both an initial chemical reaction site and the product formed by reaction of a chemical reaction site and a reactive compound building block in a previous synthesis round (Paragraph 85, lines 1-15).
Further, Gouliaev teaches that accordingly, in one embodiment of the invention there is provided a method for the synthesis of a bi-functional complex comprising a molecule part and an identifier oligonucleotide part identifying the molecule part, said method comprising the steps of i) optionally providing a solid support, ii) providing a first identifier oligonucleotide tag comprising a chemical reaction site capable of reacting with a first reactive compound building block and optionally capable of reacting with a further reactive compound building block, iii) providing a first reactive compound building block, wherein each first identifier oligonucleotide tag identifies the first reactive compound building block, iv) optionally linking, such as optionally covalently linking the first identifier oligonucleotide tag to the solid support (Paragraph 132-136).
Regarding claims 11-12, Gouliaev teaches that in a further aspect of the present invention there is provided an encoded, combinatorial chemistry synthesis method for synthesising a library of different molecules, said method comprising the steps of a) providing a plurality of nascent bi-functional complexes each comprising one or more chemical reaction site(s) and one or more priming site(s) suitable for enzymatic or chemical addition of one or more oligonucleotide tag(s), b) reacting the chemical reaction site(s) with one or more reactive compound building blocks, and c) reacting the priming site enzymatically or chemically with one or more oligonucleotide tags identifying the one or more reactive compound building blocks, wherein a reactive compound building block and the tag identifying the reactive compound building blocks are not linked prior to their reaction with the chemical reaction site and the priming site, respectively, of the nascent bi-functional complex (Paragraphs 32-36). Additionally, Gouliaev teaches that in one embodiment, a first oligonucleotide identifier tag identifying a first reactive compound building block is initially added to or synthesised on a solid support, such as a bead where the first oligonucleotide identifier tag can be un-protected or protected--wherein a protected tag is rendered inert and is unable to react e.g. with the reactive compound building block. Tag protection also enables use of certain organic solvents, as disclosed herein below, which cannot be used in the absence of a protection--by one or more protection group(s)--of reactive groups present in the oligonucleotide tag (Paragraph 38, lines 1-5). Gouliaev teaches that the oligonucleotide initially added to or synthesised on a solid support, such as a bead, can comprise more than one optionally protected oligonucleotide tag, such as 2 optionally protected oligonucleotide tags, for example 3 optionally protected oligonucleotide tags, such as 4 optionally protected oligonucleotide tags, for example 5 optionally protected oligonucleotide tags, wherein each tag identifies a reactive compound building block to be reacted at a later stage--either "on-bead" or "off-bead"--i.e. either while the nascent bi-functional complex is linked to the solid support, or after cleavage of at least one linker the cleavage of which releases the nascent bi-functional complex from the solid support (Paragraph 39, lines 1-5).
Specifically, Gouliaev teaches that in one embodiment, the methods of the invention employ at least two reactive compound building block reactions with a chemical reaction site of a bi-functional complex further comprising an identifier oligonucleotide comprising one or more covalently linked oligonucleotide tags, wherein at least one such reactive compound building block reaction takes place when reactive groups of the oligonucleotide tag or the entire oligonucleotide identifier is protected to prevent an undesirable contact between the oligonucleotide identifier or the tag and the reactive compound building block, or a contact between the reactive groups of the oligonucleotide tag and the solvent in which the reactive compound building block is reacted where the chemical reaction site of the bi-functional complex shall be understood to comprise both an initial chemical reaction site and the product formed by reaction of a chemical reaction site and a reactive compound building block in a previous synthesis round (Paragraph 85, lines 1-15).
Further, Gouliaev teaches that accordingly, in one embodiment of the invention there is provided a method for the synthesis of a bi-functional complex comprising a molecule part and an identifier oligonucleotide part identifying the molecule part, said method comprising the steps of i) optionally providing a solid support, ii) providing a first identifier oligonucleotide tag comprising a chemical reaction site capable of reacting with a first reactive compound building block and optionally capable of reacting with a further reactive compound building block, iii) providing a first reactive compound building block, wherein each first identifier oligonucleotide tag identifies the first reactive compound building block, iv) optionally linking, such as optionally covalently linking the first identifier oligonucleotide tag to the solid support (Paragraph 132-136).
Regarding claims 42-47, Gouliaev teaches that in a further embodiment of the present invention there is provided a method for the synthesis of a bi-functional complex comprising a molecule part and an identifier oligonucleotide part identifying the molecule part, said method comprising the steps of i) providing a solid support, ii) providing, or synthesising directly on said solid support, a first identifier oligonucleotide tag comprising, or linked to, a chemical reaction site capable of reacting with a first reactive compound building block and, optionally, capable of reacting with a further reactive compound building block, iii) providing a first reactive compound building block, wherein each first identifier oligonucleotide tag identifies the first reactive compound building block, iv) linking, such as covalently linking, the first identifier oligonucleotide tag to the solid support, wherein the first identifier oligonucleotide tag can either be linked to the solid support via the initial nucleic acid residue employed in the synthesis of the first identifier oligonucleotide tag, or the first identifier oligonucleotide tag can be linked as a strand of covalently linked nucleotides, post-synthesis thereof to, to the solid support, v) reacting the first reactive compound building block with the chemical reaction site comprises by or linked to the first identifier oligonucleotide tag identifying the first reactive compound building block, wherein, optionally, said chemical reaction site may be the reaction product formed by the reaction of a chemical reaction site and one or more reactive compound building blocks in a previous synthesis round, wherein the first identifier oligonucleotide tag is linked, such as covalently linked, to the solid support when the first reactive compound building block is reacted with the chemical reaction site of the first identifier oligonucleotide tag, wherein the reaction of the first reactive compound building block and the first identifier oligonucleotide tag generates a first intermediate, bi-functional complex comprising a first molecule part and a first identifier oligonucleotide tag linked to the solid support, vi) reacting the first intermediate bi-functional complex obtained in step v) with a second reactive compound building block in the absence of a second identifier oligonucleotide tag identifying the second reactive compound building block, wherein the first intermediate bi-functional complex is linked, such as covalently linked, to the solid support when the second reactive compound building block is reacted with the chemical reaction site and/or reacted with the first molecule part of the first intermediate bi-functional complex, wherein the reaction of the second reactive compound building block and the first intermediate bi-functional complex generates a second intermediate, bi-functional complex linked to the solid support, vii) cleaving the second intermediate bi-functional complex obtained in step vi) from the solid support, and viii) enzymatically adding, such as ligating, the first identifier oligonucleotide tag of said second intermediate bi-functional complex optionally cleaved from said solid support to a second identifier oligonucleotide tag identifying the second reactive compound building block, wherein the enzymatic ligation of the first and second identifier oligonucleotide tags generates a third intermediate bi-functional complex comprising a molecule part and an identifier oligonucleotide part identifying said molecule part (Paragraphs 142-149).
Specifically, Gouliaev teaches that in one embodiment, at least one reactive compound building block reaction, such as a reaction of a reactive compound building block and the chemical reaction site comprised by, or linked to, the optionally protected first identifier oligonucleotide tag linked to the solid support, takes place in an organic solvent, optionally under anhydrous conditions, and at least one tag addition takes place when the nascent bi-functional complex is not bound to a solid support (Paragraph 150, lines 1-3). Also, Gouliaev teaches that in one embodiment, the first identifier oligonucleotide tag is synthesised directly on the solid support, e.g. by covalently linking a part of the first identifier oligonucleotide tag, such as a single nucleotide, to the solid support and synthesising the remaining part of the first identifier oligonucleotide tag by a solid phase nucleotide synthesis method comprising the steps of providing said remaining one or more nucleotide(s), optionally as sequentially provided, single nucleotides, and linking the remaining one or more nucleotide(s) to the part of the first identifier oligonucleotide tag covalently linked to the solid support (Paragraph 166, lines 1-5). Further Gouliaev teaches that in one embodiment, a reactive compound building block having reacted in a previous reaction round with one or more chemical reaction sites of an identifier oligonucleotide tag, or a reactive compound building block having previously reacted with a reactive compound building block which had in turn reacted in a previous round with said one or more chemical reaction sites, is to be regarded in one embodiment as a chemical reaction site capable of reacting with one or more reactive compound building blocks provided in a subsequent reaction round (Paragraph 167, lines 1-5).
Thus, Gouliaev teaches each and every limitation of claims 1-3, 11-12, and 42-47, and therefore Gouliaev anticipates claims 1-3, 11-12, and 42-47.
Conclusions
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ROSE LAFAVE whose telephone number is (703)756-4747. The examiner can normally be reached Compressed Bi-Week: M-F 7:30-4:30.
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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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/ELIZABETH ROSE LAFAVE/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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