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 .
This application is a domestic application, filed 17 July 2023; and claims benefit as a DIV of 16/964,390, filed 23 July 2020, now abandoned; which claims benefit as a 371 of PCT/GB2019/050192, filed 23 Jan 2019; and claims benefit of foreign priority document UNITED KINGDOM 1801182.5, filed 24 Jan 2018. This foreign priority document is in English.
Claims 1-33 are pending in the current application. Claims 31 and 33, drawn to non-elected inventions, are withdrawn. Claims 1-30 and 32 are examined on the merits herein.
Election/Restrictions
Applicant’s election of Group I, claims 1-30 and 32, in the reply filed on 21 Aug 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 31 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 Aug 2025.
Applicant’s election for each of the species in the reply filed on 21 Aug 2025 is acknowledged.
However, upon reconsideration in view of the teachings of the closest prior art, this requirement is fully withdrawn. The full scope of claims 1-30 and 32 are examined on the merits herein.
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 1-30 and 32 are 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 1 at lines 5-6 recites “a plurality of nucleosides, or nucleotides (or wherein the nucleotides are di-nucleotides or tri-nucleotides)” (emphasis added). This language renders the claim indefinite because it is unclear if the claim is redefining the term nucleotides to mean either specifically di-nucleotides or specifically tri-nucleotides, whether this parenthetical recitation is drawn to alternative limitations, or whether this parenthetical recitation is drawn non-limiting examples. The lack of clarity gives rise to ambiguity as to the properly construed scope of the claim. Claims 2-30 and 32 depend directly or indirectly from claim 1 and incorporate all limitations therein including the cited language, and do not further clarify the meaning of this cited language.
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.
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.
Claims 1-2, 4-12, 29-30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Leuck et al. (US 2008/0064867, published 13 March 2008, provided by Applicant in IDS filed 25 July 2023) in view of Beaucage (WO 2004/101582 A2, published 25 Nov 2004, provided by Applicant in IDS filed 25 July 2023) and Sonveaux (“Protecting Groups in Oligonucleotide Synthesis” in Agrawal, S., ed., Protocols for Oligonucleotide Conjugates, 1994, Methods in Molecular Biology, vol. 26, Humana Press Inc., 1994, p1-71, cited in PTO-892).
Leuck et al. teaches novel methods for the synthesis of oligonucleotides with nucleoside phosphoramidites on solid supports. The methods comprise the stepwise chain assembly of oligonucleotides on supports with 5’-acyl phosphoramidites. The synthesis consist of a front end deprotection step which is conducted with a solution of a primary amine or a phenolate, a phosphoramidite coupling step with a 5'-acyl nucleoside phosphoramidite in the presence of an activator, a phosphite oxidation step and an optional capping step. The novel methods improve the quality of synthetic oligonucleotides due to the irreversibility of the front end deprotection step, which prevents the formation of deletion sequences, and due to the avoidance of acidic reagents in the synthesis cycles, which prevent the formation of depurination side products (abstract). Leuck et al. teaches there is a desire to improve the 5’-OH protecting group used in the phosphoramidite mediated synthesis of oligonucleotides (page 1, paragraph 4; page 2, paragraph 17). Leuck et al. teaches the synthesis cycle is a series of reaction steps which are conducted in short succession in the phosphoramidite mediated solid phase synthesis of oligonucleotides in order to attach one nucleotide to the solid support an oligonucleotide synthesis comprises several similar synthesis cycles with different phosphoramidites, which results in the assembly of the oligonucleotide chain on the support, and the cycle consists of the steps such as:
1. A “front-end deprotection reaction”
which, as used herein, refers to the removal of a front end protective group on the solid support to liberate a nucleoside hydroxyl group on the support. In the phosphoramidite mediated synthesis of oligonucleotides with phosphoramidites (2) or (3) the front end protective group is the group R, in an oligonucleotide synthesis with phosphoramidite (1) the front end protective group is a DMT-group which is cleaved with protic acids.
2. A “Phosphoramidite coupling reaction”
which, as used herein, refers to the reaction of a phosphoramidite (2) or (3) with a hydroxyl group on the Solid Support in the presence of an activator like 1H-tetrazole, 4,5-dicyanoimidazole, 5-ethylthio-1H-tetrazole and 5-(3,5-bis(trifluoromethyl)phenyl)-1H-tetrazole or another activator known to those skilled in the art. The resultant reaction product is a phosphite triester which is attached to the solid support.
3. A "phosphite oxidation reaction”
which, as used herein, refers to the oxidation of the phosphite triester reaction product obtained in a phosphoramidite coupling reaction to a phosphate triester. A phosphite oxidation reaction can be performed with a variety of oxidants including iodine/water, peroxides such as tert-butylhydroperoxide, cumol hydroperoxide, 2-butanone peroxide or bis(trimethylsilyl)peroxide, (1S)-(+)-(10- amphorsulfonyl)oxaziridine and other oxidants known to those skilled in the art. Preferably, phosphite oxidation reactions are conducted with solutions of iodine and water in a mixture of an aprotic solvent with a mild base like pyridine or 2.6-lutidine.
4. A capping reaction
with a reagent that reacts with residual hydroxyl groups on the solid Support after the phosphoramidite coupling reaction and thereby blocks these hydroxyl groups from future reactions. The capping reaction reduces the generation of deletion sequences resulting from incomplete phosphoramidite coupling reactions. In case of very high yields of phosphoramidite coupling reactions the capping reaction has very little influence on the quality of the oligonucleotide product and is therefore sometimes omitted. The capping reaction can also be performed before the phosphite oxidation reaction. Reagents applied in capping reactions include, but are not limited to acetic anhydride in the presence of a nucleophilic catalyst like N-methylimidazole and non-nucleoside phosphoramidites Such as B-cyanoethyl diisopopylamino-methoxyethoxyethoxyphosphane in the presence of an activator as in nucleoside phosphoramidite coupling reactions. A great variety of non-nucleoside phosphoramidites is suitable as capping reagent in conjunction with an activator. (page 5, paragraph 42-50), addressing limitations of claims 1-2, 4-12, and 29. Leuck et al. teaches the nucleoside unit at the end of the chain which is directly linked to the solid support is termed “the first nucleoside”. The first nucleoside is bound to the solid support via a linker moiety, i.e. a diradical with covalent bonds to both the polymer of the solid support and the nucleoside. The linker stays intact during the synthesis cycles performed to assemble the oligonucleotide chain and is cleaved after the chain assembly to liberate the oligonucleotide from the support (page 6, paragraph 54). Leuck et al. teaches the ordinary level of skill in the art of synthesis of oligonucleotides is that a variety of methods and alternatives have been developed for the chemical synthesis of oligonucleotides (page 1, paragraph 4 to page 3, paragraph 24). Leuck et al. teaches the field of art of the invention as understood by one of ordinary level of skill in the art of synthesis of oligonucleotides is the preparation of DNA in the field of DNA technology (page 1, paragraph 3), addressing limitations of claims 30 and 32.
Leuck et al. does not specifically disclose the method comprising conducting thermally controlled deprotection at the 5’-OH of the nucleosides or nucleotides (claim 1).
Beaucage teaches a hydroxyl-protected alcohol comprising a thermolabile hydroxyl-protecting group comprising a 2-pyridyl substituent and a precursor of the thermolabile hydroxyl-protected alcohol. The method comprising heating the hydroxyl-protected alcohol, which optionally may be obtained from a precursor, at a temperature effective to cleave the hydroxyl-protecting group can be used to produce oligonucleotides (abstract). Beaucage teaches there is a need for hydroxyl-protecting groups that can be removed under mild conditions, and for methods of using such protecting groups, as provided in this invention (page 2, paragraph 5). Beaucage teaches exemplary protecting groups (paragraph 23 spanning pages 6-7). The thermolabile protecting groups can be used for protection of any suitable alcohol such as in a nucleoside, an oligonucleotide, or an oligomer comprising a nucleoside, including protection at the 5’-OH of the nucleoside or nucleotide, and protection of the compound bound to a solid support (paragraph 24 spanning pages 7-8).
Sonveaux teaches the ordinary level of skill in the art of synthesis of oligonucleotides and specifically protecting groups. There are two classes of protecting groups: persistent and transient. The persistent protections remain on the biopolymer during all the synthesis. They are cleaved at the very end. They cap the functions of the aglycone residue of nucleotides, or of the side chains of amino acids in peptide synthesis. They also cap the phosphate oxygen of oligonucleotides. The transient protections block the functions to be coupled at a given time of the synthesis. They are specifically cleaved before each coupling (page 1, paragraph 2). Sonveaux teaches the use of protected protecting groups is known as the “safety catch” concept, or protecting groups that have been modified to be cleaved by a cascade of more or less specific reagents (page 28, paragraph 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Leuck et al. in view of Beaucage and Sonveaux in order to substitute the protecting group used in the method of Leuck et al. with the thermolabile protecting group taught by Beaucage. One of ordinary skill in the art would have been motivated to combine Leuck et al. in view of Beaucage and Sonveaux with a reasonable expectation of success because both Leuck et al. and Beaucage teach there is a desire to improve the 5’-OH protecting group used in the phosphoramidite mediated synthesis of oligonucleotides, Beaucage teaches the thermolabile protecting group provides the improvement that it can be removed under mild conditions, and both Leuck et al. and Sonveaux teach one of ordinary skill in the art would have had a reasonable expectation of success to vary the methods used in the synthesis of oligonucleotides. Regarding claims 5-7 and 11-12 and the general structure of linker to the solid support, the first nucleoside is bound to the solid support via a linker moiety that stays intact during the synthesis cycles performed to assemble the oligonucleotide chain and is cleaved after the chain assembly to liberate the oligonucleotide from the support, Sonveaux teaches persistent and transient protecting groups are well known in the art of synthesis of oligonucleotides as is the “safety catch” concept, and Beaucage teaches the thermolabile protecting group may be applied to any suitable alcohol and particularly at any site of the nucleoside, an oligonucleotide, or an oligomer comprising a nucleoside, suggesting it would have been obvious to combine the teachings of Leuck et al. in view of Beaucage and Sonveaux in view Leuck et al. and Sonveaux teaching one of ordinary skill in the art would have varied the methods used in the synthesis of oligonucleotides, in order to arrive at the appropriate linker moiety containing the teachings of Leuck et al. in view of Beaucage and Sonveaux.
Regarding the claim language of “parallel synthesis of one or more oligonucleotides on a plurality of sites on the surface of a solid substrate, said oligonucleotides being the same or different”, it is eminently obvious to one of ordinary skill in the pertinent art that the synthesis of oligonucleotides on a solid support involves parallel synthesis of one or more oligonucleotides on a plurality of sites on the surface of a solid substrate, said oligonucleotides being the same or different.
Claims 3, 13-15, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Leuck et al. (US 2008/0064867, published 13 March 2008, provided by Applicant in IDS filed 25 July 2023) in view of Beaucage (WO 2004/101582 A2, published 25 Nov 2004, provided by Applicant in IDS filed 25 July 2023) and Sonveaux (“Protecting Groups in Oligonucleotide Synthesis” in Agrawal, S., ed., Protocols for Oligonucleotide Conjugates, 1994, Methods in Molecular Biology, vol. 26, Humana Press Inc., 1994, p1-71, cited in PTO-892) as applied to claims 1-2, 4-12, 29-30, and 32 above, and further in view of Pirrung (Chem. Rev., 1997, 97, p473-488, cited in PTO-892).
Leuck et al. in view of Beaucage and Sonveaux teaches as above.
Leuck et al. in view of Beaucage and Sonveaux does not specifically teach the thermally controlled deprotection is achieved by local heating or is provided by individually thermally addressable sites on a chip (claim 3, 13 and 15). Leuck et al. in view of Beaucage and Sonveaux does not specifically teach the substrate comprises a chip (claim 14) or is silicon (claim 28).
Pirrung teaches the ordinary skill in the art regarding spatially addressable combinatorial libraries. Pirrung teaches combinatorial chemistry is in its essence based on the principle of parallelism. Parallel processing enables the chemist to prepare many more substances than the number of chemical steps used to generate the library (page 473, left column, paragraph 1). Many library preparation methodologies extant today prepare multiple variants of a basic molecular framework as separated, single compounds, often using solid-phase synthesis for its advantages in robotics/automation. As a result, the location of a vial, microtiter well, or test tube and the record of the reagents that have been added to it can be used to identify each molecular structure (page 474, left column, paragraph 2). Pirrung teaches the use of DNA arrays or DNA chips to prepare complex DNA arrays in a spatially addressable manner (page 484-485).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Leuck et al. in view of Beaucage and Sonveaux further in view of Pirrung in order to apply the improvements of spatially addressable combinatorial libraries taught by Pirrung to the method taught by Leuck et al. in view of Beaucage and Sonveaux. One of ordinary skill in the art would have been motivated to combine Leuck et al. in view of Beaucage and Sonveaux further in view of Pirrung with a reasonable expectation of success because Pirrung teaches spatially addressable combinatorial libraries provides the advantage of parallelism in the preparation of DNA and teaches many library preparation methodologies extant today prepare multiple variants of a basic molecular framework as separated, single compounds, often using solid-phase synthesis for its advantages in robotics/automation, including location-specific manipulation, and suggests silicon chips as substrates.
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 1-2, 4-12, 16-27, 29-30 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,161,869 (reference patent) in view of Leuck et al. (US 2008/0064867, published 13 March 2008, provided by Applicant in IDS filed 25 July 2023), Beaucage (WO 2004/101582 A2, published 25 Nov 2004, provided by Applicant in IDS filed 25 July 2023), and Sonveaux (“Protecting Groups in Oligonucleotide Synthesis” in Agrawal, S., ed., Protocols for Oligonucleotide Conjugates, 1994, Methods in Molecular Biology, vol. 26, Humana Press Inc., 1994, p1-71, cited in PTO-892).
Reference claims 26-32 of the reference patent are drawn to a process for the preparation of one or more oligonucleotides or polynucleotides comprising: (i) providing a composition comprising the compound claim 1, wherein M is -W-R6, wherein R6 is a first optionally protected nucleotide, wherein the compound is covalently bound to a solid support; (ii) conducting solid phase synthesis by a phosphoramidite method to produce the oligonucleotide or polynucleotide; and (iii) cleaving the oligonucleotide or polynucleotide from the solid support. Reference claim 27 further recites (i) providing a composition comprising the compound of claim 1, wherein the compound is covalently bound to a solid support; (ii) removing the 5′-protecting group from the 5′-protected nucleoside; (iii) coupling at the 5′-OH of the nucleoside with a nucleoside phosphoramidite monomer to form a support-bound phosphite triester; (iv) optionally capping the 5′-hydroxyl groups on the unreacted nucleoside phosphoramidite monomer by acetylation; (v) oxidizing the phosphite triester to a phosphotriester; (vi) repeating steps (ii) to (v) in order to produce the oligonucleotide or polynucleotide; (vii) cleaving the oligonucleotide or polynucleotide from the solid support; and (viii) optionally isolating the oligonucleotide; and (ix) the process optionally further comprising: a step of annealing a complementary oligonucleotide or a complementary polynucleotide before step (vii), and optionally isolating the double stranded oligonucleotide or double stranded polynucleotide; or a step of annealing a complementary oligonucleotide or a complementary polynucleotide after step (vii) or step (viii), and optionally isolating the double stranded oligonucleotide or double stranded polynucleotide. The combined teachings of these reference claims address the method step limitations of claims 1-2, 4-12, 16-27, 29-30 and 32. Reference claims 1-25 provide guidance for selecting the compound of claim 1 recited in the method of reference claims 26-32, where the compound of reference claims 1-25 correspond to the limitations of claims 16-27 such as reference formula (I) corresponding to examined formula (L-1).
Reference claims 26-32 in view of reference claims 1-25 do not specifically teach the structure of the oligonucleotide phosphoramidite immobilized on the surface of the solid substrate (claim 1).
Leuck et al. teaches as above.
Beaucage teaches as above. Beaucage generally teaches the use of thermolabile “safety catch” protecting groups in the synthesis of oligonucleotides.
Sonveaux teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux in order to vary the methods used in the synthesis of oligonucleotides encompassed within the scope of Reference claims 26-32 based on the teachings of Leuck et al., Beaucage, and Sonveaux. One of ordinary skill in the art would have been motivated to combine Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux in order to vary the methods used in the synthesis of oligonucleotides encompassed within the scope of Reference claims 26-32 based on the teachings of Leuck et al., Beaucage, and Sonveaux with a reasonable expectation of success because both Leuck et al. and Beaucage teach there is a desire to improve the 5’-OH protecting group used in the phosphoramidite mediated synthesis of oligonucleotides, Reference claims 26-32 in view of reference claims 1-25 are drawn to an improved 5’-OH protecting group used in the phosphoramidite mediated synthesis of oligonucleotides, Beaucage teaches the thermolabile protecting group provides the improvement that it can be removed under mild conditions, and both Leuck et al. and Sonveaux teach one of ordinary skill in the art would have had a reasonable expectation of success to vary the methods used in the synthesis of oligonucleotides. Regarding claims 5-7 and 11-12 and the general structure of linker to the solid support, the first nucleoside is bound to the solid support via a linker moiety that stays intact during the synthesis cycles performed to assemble the oligonucleotide chain and is cleaved after the chain assembly to liberate the oligonucleotide from the support, Sonveaux teaches persistent and transient protecting groups are well known in the art of synthesis of oligonucleotides as is the “safety catch” concept, and Beaucage teaches the thermolabile protecting group may be applied to any suitable alcohol and particularly at any site of the nucleoside, an oligonucleotide, or an oligomer comprising a nucleoside, suggesting it would have been obvious to combine the teachings of Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux in view Leuck et al. and Sonveaux teaching one of ordinary skill in the art would have varied the methods used in the synthesis of oligonucleotides, in order to arrive at the appropriate linker moiety containing the teachings of reference claims 1-25 and Leuck et al. in view of Beaucage and Sonveaux.
Regarding the claim language of “parallel synthesis of one or more oligonucleotides on a plurality of sites on the surface of a solid substrate, said oligonucleotides being the same or different”, it is eminently obvious to one of ordinary skill in the pertinent art that the synthesis of oligonucleotides on a solid support involves parallel synthesis of one or more oligonucleotides on a plurality of sites on the surface of a solid substrate, said oligonucleotides being the same or different.
Claims 3, 13-15, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,161,869 (Reference Patent) in view of Leuck et al. (US 2008/0064867, published 13 March 2008, provided by Applicant in IDS filed 25 July 2023), Beaucage (WO 2004/101582 A2, published 25 Nov 2004, provided by Applicant in IDS filed 25 July 2023), and Sonveaux (“Protecting Groups in Oligonucleotide Synthesis” in Agrawal, S., ed., Protocols for Oligonucleotide Conjugates, 1994, Methods in Molecular Biology, vol. 26, Humana Press Inc., 1994, p1-71, cited in PTO-892), further in view of Pirrung (Chem. Rev., 1997, 97, p473-488, cited in PTO-892).
Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux teaches as above.
Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux does not specifically teach the thermally controlled deprotection is achieved by local heating or is provided by individually thermally addressable sites on a chip (claim 3, 13 and 15). Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux does not specifically teach the substrate comprises a chip (claim 14) or is silicon (claim 28).
Pirrung teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux further in view of Pirrung in order to apply the improvements of spatially addressable combinatorial libraries taught by Pirrung to the method taught by Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux. One of ordinary skill in the art would have been motivated to combine Reference claims 26-32 in view of reference claims 1-25 and in view of Leuck et al., Beaucage, and Sonveaux further in view of Pirrung with a reasonable expectation of success because Pirrung teaches spatially addressable combinatorial libraries provides the advantage of parallelism in the preparation of DNA and teaches many library preparation methodologies extant today prepare multiple variants of a basic molecular framework as separated, single compounds, often using solid-phase synthesis for its advantages in robotics/automation, including location-specific manipulation, and suggests silicon chips as substrates.
Conclusion
No claim is currently in condition for allowance.
Claims 16-27 are rejected under 35 U.S.C. 112(b) and on the ground of nonstatutory double patenting.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693