DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I, claims 1-10 and 16-23 in the reply filed on 25 April 2025 is acknowledged.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 7, 10, 20 and 23 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.
A. Amended claims 7 and 20 each recited the phrase “…at least one of the first flanking sequence and the second flanking sequence comprises a single-stranded nucleotide sequence.” Claims 7 and 20 refer back to the flanking regions comprises by “a polynucleotide” in claims 1 and 2 respectively. The polynucleotide of claims 1 and 20, as claimed, is a polynucleotide i.e., a single, contiguous piece of circular duplex DNA (See applicant’s FIG 4, for example). It is unclear, based on the language of these claims, if the claimed polynucleotide has one or more single-stranded gap regions flanking the nucleic acid target sequence or if the applicant is referring to the nucleic acid target sequence before it is inserted into the vector backbone where the single-stranded flanking sequence is used to insert the target sequence into the vector backbone (which would not have proper antecedent basis in the phrase “a polynucleotide” since this orientation would inherently require at least two polynucleotides). The metes and bounds of this limitation are unclear, and therefore the claim is indefinite.
B. Claim 10 recites the limitation "the coding sequence" in line 2 of the claim. “The coding region” of claim 10 refers to the phrase “a coding region” in line 8 of claim 1, and the coding region specifically comprises a nucleotide sequence template according to claim 1. Applicant sates in their specification (pg. 9 ¶ 5) that the coding region “encodes the peptide on which the library to be generated is based” but does not teach or suggest that the coding region is translated or that the translated peptide is sequenced. It appears, based on the language of the applicant’s specification, that the nucleotide template is sequenced and that the resulting sequence is used to determine the sequence of the encoded peptide. It is unclear if this is applicant’s meaning, or if applicant intends for the nucleotide sequence to be expressed as a peptide (i.e., translated) and the resulting peptide is sequenced by peptide sequencing chemistry. The intended steps of claim 10 are unclear with regard to how they are intended to limit the claim, therefore this claim is indefinite.
C. Claim 23 recites the limitation "the coding sequence" in line 1 of the claim. “The coding region” of claim 23 refers to the phrase “a coding region” in line 8 of claim 2, and the coding region specifically comprises a nucleotide sequence template according to claim 2. Applicant sates in their specification (pg. 9 ¶ 5) that the coding region “encodes the peptide on which the library to be generated is based” but does not teach or suggest that the coding region is translated or that the translated peptide is sequenced. It appears, based on the language of the applicant’s specification, that the nucleotide template is sequenced and that the resulting sequence is used to determine the sequence of the encoded peptide. It is unclear if this is applicant’s meaning, or if applicant intends for the nucleotide sequence to be expressed as a peptide (i.e., translated) and the resulting peptide is sequenced by peptide sequencing chemistry. The intended steps of claim 23 are unclear with regard to how they are intended to limit the claim, therefore this claim is indefinite.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013).
Regarding claims 1 and 29, Festa teaches a method for producing a library of biological molecules (title, pg. 1382, column 1, ¶ 4) comprising: providing a polynucleotide (i.e., a vector; pg. 1382, column 1, ¶ 4 and FIG 4) comprising a cloning vector backbone (pg. 1386, column 1, ¶ 2), a recombination site and one or more cloning sites (i.e., “site-specific sequences”; pg. 1386, column 2, ¶ 4). Festa teaches a nucleotide sequence template comprising an open reading frame (ORF, i.e., a coding sequence (CDS); pg. 1382, column 2, ¶ 5) and that the CDS is derived from an mRNA sequence (i.e., encoding the biological molecule on which the library is based; pg. 1382, column 2, ¶ 3). Festa teaches that the nucleotide sequence template (i.e., the ORF) comprises sequences at the 5' and 3' ends that are complementary to the vector backbone (FIG. 4A, yellow and red blocks respectively, and associated caption). Festa teaches that entry vectors (i.e., the claimed polynucleotide) are propagated in bacteria cells (i.e., a host cell; pg. 1384, column 1, ¶ 3). Festa teaches that clones are isolated from cells and sequenced to determine clones with the desired insert (pg. 1386, column 1, ¶ 2). By the nature of the CDS being a part of the vector backbone (i.e., double stranded) the sequences 5' and 3' of the CDS inherently comprise regions complementary to the vector backbone that are 20-40 nucleotides in length (i.e., any 20-40 base pairs at the 5' or 3' of the CDS are complementary to the vector backbone, because they are part of the vector backbone). As written, claim 1 recites a polynucleotide, meaning that the vector backbone and the nucleotide sequence template are part of the same, contiguous duplex molecule. Without further limitation, any sequence 5' or 3' of the coding region meets this limitation.
With regard to the limitations of: producing a genetically modified cell, incubating the genetically modified cell under conditions to allow the polynucleotide to replicate, or collecting genetically modified cells; these method steps are inherent to the disclosed teaches of propagating vectors in bacterial cells (i.e., introducing the vector into a bacterial cell produces a genetically modified cell, and propagation of the vector inherently comprises incubating the genetically modified cell under conditions to allow the polynucleotide to replicate) and isolating the vector products inherently comprises collecting genetically modified cells.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013).
Regarding claim 8, Festa teaches the method of claim 1 as discussed fully above and incorporated here. Festa teaches that providing a polynucleotide comprises performing an In Fusion cloning reaction on a nucleotide sequence template having 5' and 3' homology with a vector backbone (FIG. 4A). Festa does not specifically teach that this comprises incubating the vector backbone and nucleotide sequence template in the presence of a ligase, an exonuclease and a polymerase.
However, Festa teaches that the Gibson assembly method is an alternative to the In Fusion cloning method (pg. 1392, column 1, ¶ 3), and that the Gibson assembly method comprises incubating DNA fragments (i.e., the nucleotide sequence template and the vector backbone) with a 5' exonuclease, a DNA polymerase, and a ligase (pg. 1392, column 1, ¶ 2).
It would have been obvious to one having ordinary skill in the art to have substituted the In Fusion cloning method taught by Festa with the Gibson assembly cloning method to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have motivated to make this substitution because Festa teaches that the Gibson assembly method is similar to the In Fusion method and provides a cost savings advantage (pg. 1392, column 1, ¶ 3). One having ordinary skill in the art would have recognized that the known techniques of the cited references could have been substituted with predictable results because the known techniques of the cited references predictably result in the cloning of nucleotide templates into vector backbones.
10. Claims 7 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) in view of Gibson et al (Enzymatic assembly of DNA molecules up to several hundred kilobases, Nature Methods, 6, 343-345, published 12 April 2009).
Regarding claim 7, the method of claim 1 is discussed fully above and incorporated here. Festa teaches a polynucleotide that comprises a nucleotide template sequence having 5' and 3' flanking regions of 20-40 bp, but Festa does not teach that at least one of the first flanking sequence and sequence flanking sequence comprises a single-stranded nucleotide sequence.
Regarding claim 9, the method of claim 8 is discussed fully above and incorporated here. Festa teaches that the nucleotide template and the vector backbone are incubated in the presence of a ligase, an exonuclease, and a polymerase, but Festa does not teach that these components are present simultaneously.
However, Gibson teaches that the method of Gibson assembly is performed isothermally with all enzymatic components present in the same reaction mixture (pg. 10, ¶ 1). Additionally, Gibson teaches that during Gibson assembly, T5 exonuclease removes nucleotides from the 5' ends of double stranded DNA molecules allowing for complementary single-stranded overhangs to anneal before being filled in with Phusion polymerase and sealed with Taq DNA ligase (FIG 1 and pg. 343 column 2 ¶ 2). After the single-stranded complementary ends between the vector backbone and nucleotide sequence template are annealed, but before the single-stranded regions are filled in by Phusion polymerase Festa in view of Gibson teaches at least one of the first and second flanking sequences comprise a single-stranded nucleotide sequence.
It would have been obvious to one having ordinary skill in the art to have performed the Gibson assembly protocol taught by Festa using the one-step isothermal assembly taught by Gibson, because Festa specifically provides Gibson assembly as an alternative method for constructing a vector library (pg. 1392, column 1, ¶ 3), to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification in order to reduce the number of reactions and steps associated with the cloning and assembly process. In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the cloning and assembly of DNA fragments.
11. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) in view of Yamamoto (United States Patent Application No. US-20170119830, published 2017-05-04).
Regarding claim 10, the method of claim 1 is discussed fully above and incorporated here. Festa teaches that the CDS is sequenced (pg. 1386, column 1, ¶ 2), but Festa does not teach that the nucleotide sequence is translated and the peptide sequence is determined.
However, Yamamoto teaches that DNA from an adenovirus library was isolated and sequence by sanger sequencing (i.e., the nucleotides of the library were sequenced) and that this nucleotide sequence converged to a peptide sequence (VRLLFYP, [0172]). The process of converted the sanger-sequenced nucleotides to the given peptide sequence inherently comprises the translation of the nucleotide sequence to a peptide sequence and determining the sequence of the peptide (i.e., sequencing the translated peptide, [0172]).
It would have been obvious to one having ordinary skill in the art to have modified the sequencing step taught by Festa with the additional step of translating and determining the peptide sequence taught by Yamamoto to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification in order to determine an unknown peptide sequence from a library of nucleotide coding regions. In addition, the ordinary artisan would have recognized that the known techniques of the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the sequencing of vector libraries.
12. Claims 2, 21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) in view of Christ et al (Tapping diversity lost in transformations-in vitro amplification of ligation reactions, Nucleic Acids Research, 34, 16, e108, published 1 September 2006).
Regarding claims 2 and 31, Festa teaches a method for producing a library of biological molecules (title, pg. 1382, column 1, ¶ 4) comprising: providing a polynucleotide (i.e., a vector; pg. 1382, column 1, ¶ 4 and FIG 4) comprising a cloning vector backbone (pg. 1386, column 1, ¶ 2), a recombination site and one or more cloning sites (i.e., “site-specific sequences”; pg. 1386, column 2, ¶ 4). Festa teaches a nucleotide sequence template comprising an open reading frame (ORF, i.e., a coding sequence (CDS); pg. 1382, column 2, ¶ 5) and that the CDS is derived from an mRNA sequence (i.e., encoding the biological molecule on which the library is based; pg. 1382, column 2, ¶ 3). Festa teaches that the nucleotide sequence template (i.e., the ORF) comprises sequences at the 5' and 3' ends that are complementary to the vector backbone (FIG. 4A, yellow and red blocks respectively, and associated caption). Festa teaches that clones are isolated from cells and sequenced to determine clones with the desired insert (pg. 1386, column 1, ¶ 2). By the nature of the CDS being a part of the vector backbone (i.e., double-stranded) the sequences 5' and 3' of the CDS inherently comprise regions complementary to the vector backbone that are 20-40 nucleotides in length (i.e., any 20-40 base pairs at the 5' or 3' of the CDS are complementary to the vector backbone, because they are part of the vector backbone). As written, claim 1 recites a polynucleotide, meaning that the vector backbone and the nucleotide sequence template are part of the same, contiguous duplex molecule. Without further limitation, any sequence 5' or 3' of the coding region meets this limitation.
Festa does not teach that the polynucleotide is amplified in vitro, or that the amplified polynucleotides are collected.
However, Christ teaches a method for the in vitro amplification of a vector library (abstract and FIG 1), that the amplified vector product was concentrated by diafiltration (i.e., collected; pg. 2, column 2, ¶ 3), and that the amplification products were suitable for sequencing (pg. 1, column 2, ¶ 2).
It would have been obvious to one having ordinary skill in the art to have substituted the cellular amplification method taught by Festa with the in vitro amplification method taught by Christ to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Christ specifically teaches that the in vitro amplified library had a significantly higher transformation efficiency into bacterial cells for downstream storage and handling (pg. 4, column 2, ¶ 2). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the amplification of vector libraries.
Regarding claim 21, Festa in view of Christ teaches the method of claim 2 as discussed fully above and incorporated here. Festa teaches that providing a polynucleotide comprises performing an In Fusion cloning reaction on a nucleotide sequence template having 5' and 3' homology with a vector backbone (FIG. 4A). Neither Festa nor Christ specifically teach that this comprises incubating the vector backbone and nucleotide sequence template in the presence of a ligase, an exonuclease and a polymerase.
However, Festa in view of Christ teaches that the Gibson assembly method is an alternative to the In Fusion cloning method (pg. 1392, column 1, ¶ 3), and that the Gibson assembly method comprises incubating DNA fragments (i.e., the nucleotide sequence template and the vector backbone) with a 5' exonuclease, a DNA polymerase, and a ligase (pg. 1392, column 1, ¶ 2).
It would have been obvious to one having ordinary skill in the art to have substituted the In Fusion cloning method taught by Festa in view of Christ with the Gibson assembly cloning method to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have motivated to make this substitution because Festa teaches that the Gibson assembly method is similar to the In Fusion method and provides a cost savings advantage (pg. 1392, column 1, ¶ 3). One having ordinary skill in the art would have recognized that the known techniques of the cited references could have been substituted with predictable results because the known techniques of the cited references predictably result in the cloning of nucleotide templates into vector backbones.
13. Claims 20 and 22 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) and Christ et al (Tapping diversity lost in transformations-in vitro amplification of ligation reactions, Nucleic Acids Research, 34, 16, e108, published 1 September 2006) as applied to claim 21 above, and further in view of Gibson et al (Enzymatic assembly of DNA molecules up to several hundred kilobases, Nature Methods, 6, 343-345, published 12 April 2009).
Regarding claim 20, the method of claim 2 is discussed fully above and incorporated here. Festa teaches a polynucleotide that comprises a nucleotide template sequence having 5' and 3' flanking regions of 20-40 bp, but Festa does not teach that at least one of the first flanking sequence and sequence flanking sequence comprises a single-stranded nucleotide sequence.
Regarding claim 22, the method of claim 21 is discussed fully above and incorporated here. Festa in view of Christ teach that the nucleotide template and the vector backbone are incubated in the presence of a ligase, an exonuclease, and a polymerase, but neither Festa nor Christ teach that these components are present simultaneously.
However, Gibson teaches that the method of Gibson assembly is performed isothermally with all enzymatic components present in the same reaction mixture (pg. 10, ¶ 1). Additionally, Gibson teaches that during Gibson assembly, T5 exonuclease removes nucleotides from the 5' ends of double stranded DNA molecules allowing for complementary single-stranded overhangs to anneal before being filled in with Phusion polymerase and sealed with Taq DNA ligase (FIG 1 and pg. 343 column 2 ¶ 2). After the single-stranded complementary ends between the vector backbone and nucleotide sequence template are annealed, but before the single-stranded regions are filled in by Phusion polymerase Festa in view of Gibson teaches at least one of the first and second flanking sequences comprise a single-stranded nucleotide sequence.
It would have been obvious to one having ordinary skill in the art to have performed the Gibson assembly protocol taught by Festa in view of Christ using the one-step isothermal assembly taught by Gibson, because Festa specifically provides Gibson assembly as an alternative method for constructing a vector library (pg. 1392, column 1, ¶ 3), to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification in order to reduce the number of reactions and steps associated with the cloning and assembly process. In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the cloning and assembly of DNA fragments.
14. Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) and Christ et al (Tapping diversity lost in transformations-in vitro amplification of ligation reactions, Nucleic Acids Research, 34, 16, e108, published 1 September 2006) as applied to claim 2 above, and further in view of Yamamoto (United States Patent Application No. US-20170119830, published 2017-05-04).
Regarding claim 23, the method of claim 2 is discussed fully above and incorporated here. Festa in view of Christ teaches that the CDS is sequenced (pg. 1386, column 1, ¶ 2), but neither Festa nor Christ teach that the nucleotide sequence is translated and the peptide sequence is determined.
However, Yamamoto teaches that DNA from an adenovirus library was isolated and sequence by sanger sequencing (i.e., the nucleotides of the library were sequenced) and that this nucleotide sequence converged to a peptide sequence (VRLLFYP, [0172]). The process of converted the sanger-sequenced nucleotides to the given peptide sequence inherently comprises the translation of the nucleotide sequence to a peptide sequence and determining the sequence of the peptide (i.e., sequencing the translated peptide, [0172]).
It would have been obvious to one having ordinary skill in the art to have modified the sequencing step taught by Festa in view of Christ with the additional step of translating and determining the peptide sequence taught by Yamamoto to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification in order to determine an unknown peptide sequence from a library of nucleotide coding regions. In addition, the ordinary artisan would have recognized that the known techniques of the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the sequencing of vector libraries.
15. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) in view of George et al (United States Patent Application US20200208208, effectively filed 4 October 2018).
Regarding claim 30 the method of claim 1 is discussed fully above and incorporated here. Festa does not teach that at least one of the first or second flanking sequences comprises a modified nucleotide.
However, George teaches a method of assembling a library based on Gibson assembly (abstract and [0066]). George teaches that stitch adapter sequences are sequences that are complementary to a backbone oligonucleotide (i.e., the flanking oligonucleotides as claimed) and that stitch adaptor sequences comprise modified nucleotides ([0034]).
It would have been obvious to one having ordinary skill in the art to have modified the flanking sequences taught by Festa to incorporate the modified nucleotides taught by George to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this combination because George teaches that modified nucleotides effect hybridization stability ([0050]) and protect the modified strands from nuclease digestion ([0065]). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the assembly of nucleic acid libraries.
16. Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Festa et al (High-throughput cloning and expression library creation for functional proteomics, Proteomics, 13, 9, 1381-1399, published 04 March 2013) in view of Christ et al (Tapping diversity lost in transformations-in vitro amplification of ligation reactions, Nucleic Acids Research, 34, 16, e108, published 1 September 2006) as applied to claim 2 above, and further in view of George et al (United States Patent Application US20200208208, effectively filed 4 October 2018).
Regarding claim 32 the method of claim 2 is discussed fully above and incorporated here. Neither Festa nor Christ teach that at least one of the first or second flanking sequences comprises a modified nucleotide.
However, George teaches a method of assembling a library based on Gibson assembly (abstract and [0066]). George teaches that stitch adapter sequences are sequences that are complementary to a backbone oligonucleotide (i.e., the flanking oligonucleotides as claimed) and that stitch adaptor sequences comprise modified nucleotides ([0034]).
It would have been obvious to one having ordinary skill in the art to have modified the flanking sequences taught by Festa in view of Christ to incorporate the modified nucleotides taught by George to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this combination because George teaches that modified nucleotides effect hybridization stability ([0050]) and protect the modified strands from nuclease digestion ([0065]). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques of the cited references predictably result in the assembly of nucleic acid libraries.
Response to Arguments
17. Any rejection not repeated in this Office Action has been overcome by amendment to the claims.
18. Applicant's arguments filed 22 September 2025 have been fully considered but they are not persuasive.
Regarding independent claims 1 and 2, Applicant argues that the coding region and the flanking sequences are separate and distinct functional parts of the polynucleotide, separate from the vector backbone, and that the coding region is not part of the vector backbone. Applicant argues that the 5' and 3' flanking sequences are similarly not part of the vector backbone. Applicant additionally argues that Festa advises against using flanking sequences greater than 15 nucleotides in length (i.e., the flanking sequences are not just “any” length of base pairs linking the coding region to the vector backbone). Applicant argues that the length of these flanking sequences matters in methods of producing a library of compounds.
These arguments are not persuasive because the Applicant is not claiming a nucleotide sequence template comprising flanking sequences and a vector backbone. Applicant is claiming a polynucleotide, i.e., a single contiguous polynucleotide vector comprising a nucleotide sequence template, flanking sequences, and a vector backbone. As written, Applicant is claiming a method for producing a library of biological molecules… comprising: providing a polynucleotide, introducing the polynucleotide into a host cell, incubating the genetically modified cell, collecting genetically modified cells, isolating vector from the collected cells, and sequencing the coding region. As currently written, the vector library taught by Festa comprising a nucleotide sequence template in a vector backbone, and any region 20-40 nucleotides in length 5' and 3' of the template sequence reads on and anticipates the method of claim 1. Similarly, Festa in view of Christ continues to make obvious the method of claim 2.
Applicant argues that the remaining rejections under U.S.C. 103 fail because that contain all of the limitations of amended claims 1 and 2, however these amendments and Applicant’s arguments were not persuasive to overcome the rejections of independent claims 1 and 2, and the remaining rejections are maintained.
19. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
20. No claims are allowed.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN ELLIS YOUNG whose telephone number is (703)756-5397. The examiner can normally be reached M-F 0730 - 1700.
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/BRIAN ELLIS YOUNG/Examiner, Art Unit 1684
/JULIET C SWITZER/Primary Examiner, Art Unit 1682