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 .
Priority
This application 17/776,741 filed on 05/13/2022 is a 371 national phase of PCT/JP2020/042363 filed on 11/13/2020, and claims the benefit of Japanese Patent Application No. 2019-206380, filed on 11/14/2019.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. It is noted that foreign priority is not perfected as no English translation was provided for the foreign priority document received 05/13/2022. In order to perfect the foreign priority claim, please provide a certified English copy.
In the absence of a translated copy, the priority date of claims 1-10 and 16-20 is determined to be 11/13/2020, the filing date of PCT/JP2020/042363.
Status of Claims
Applicant’s amendments to claims filed 12/17/2025 in response to the Non-Final Rejection mailed 09/17/2025 are acknowledged.
Claims 1-4, 6, 7, 9, 10, 19, and 20 are amended.
Claims 1-10 and 16-20 are pending and under examination.
Response to Remarks filed 12/17/2025
The amendments and arguments presented in the papers filed 12/17/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 09/17/2025 listed below have been reconsidered as indicated.
a) The objections to the specification regarding the use of trade names or marks are withdrawn in view of the amendments to the specification.
b) The 35 USC 112(b) indefiniteness rejections of claims 1-10 and 16-20 have been withdrawn in view of the amendments to claims.
c) The rejection of claims 1 and 8 under 35 U.S.C. 102 as being anticipated by Getts et al. (US PGPub 20100190167) are withdrawn in view of the amendments to the claims.
d) The rejection of claims 2-5, 7 and 16-18 under 35 U.S.C. 103 as being unpatentable over Getts et al. (US PGPub 20100190167) in view of Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa1) are withdrawn in view of the amendments to the claims.
e) The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Getts et al. (US PGPub 20100190167) in view of Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa1) as applied to claims 1-5, 7 and 16-18 above, and further in view of Fujikawa et al. (US PGPub 20080160624, referred to here as Fujikawa2) are withdrawn in view of the amendments to the claims.
f) The rejection of claims 9 and 10 under 35 U.S.C. 103 as being unpatentable over Getts et al. (US PGPub 20100190167) in view of Jensen et al. (US PGPub 20190284621) are withdrawn in view of the amendments to the claims.
g) The rejection of claims 19 and 120 under 35 U.S.C. 103 as being unpatentable over Getts et al. (US PGPub 20100190167) in view of Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa1) as applied to claims 1-5, 7 and 16-18 above, and further in view of Jensen et al. (US PGPub 20190284621) are withdrawn in view of the amendments to the claims.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
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.
Claims 1 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase (Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022).
These are new rejections necessitated by claim amendments filed on 12/17/2025.
Regarding claim 1, Moor teaches a method for qualitative and quantitative detection of short nucleic acid sequences. Moor teaches that a sequence of interest is a single-stranded molecule (claim 4), and that a target strand is preferably a DNA oligonucleotide or a modified DNA oligonucleotide that may comprise nucleic acid and/or nucleic acid analogs including DNA and LNA in the sequence of interest, such as an antisense oligonucleotide (para 50).
Moor is (a) silent to the locations of modified nucleotides and (ii) does not teach adding poly A to the 3’ end of the target oligonucleotide.
Regarding (b), Shibusawa teaches a method for quantifying siRNA, the method comprising a target siRNA modified with a chemical moiety, such as LNA, that is capable of polyadenylation by poly-A polymerase (para 15). Shibusawa does not explicitly state that the chemical modification is the 3’ end, but compatibility with poly-A polymerase reads on that limitation. In addition, Shibusawa teaches that "poly A polymerase" introduces an adenine residue at the 3' end of a single-stranded RNA (para 16).
Shibusawa is silent regarding the conditions of using poly A polymerase and ATP and does not teach using them in the presence of Mn2+.
Invitrogen teaches a poly (A) polymerase used in the presence of ATP and Mn2+ to add poly A to the 3’ end of a target (p. 1-2). The Mn2+ is used at a concentration of 2.5mM.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Moor, Shibusawa and Invitrogen to arrive at the instantly claimed invention. The modification would have entailed using the poly(A) polymerase of Invitrogen in the method of Shibusawa to add a poly A tail to the target of Moor. One would have been motivated by the increased sensitivity provided by the method of Shibusawa, and in particular the convenience of having a single tag to apply to all targets for downstream assays. Moor relies on capture probes comprising a portion complementary to part of the sequence of interest to perform reactions such as amplification (para 45), a step that requires more effort and cost than using a widely known reagent to tag all targets with a poly A tail. One of skill in the art would have known the utility of a polyA tail for target capture. The combination of Shibusawa and Invitrogen also does not teach the Mn2+ at a concentration of 3 mM to 38 mM. However, determining an appropriate concentration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. One of ordinary skill in the art would have been motivated to try different concentrations in order to optimize reaction conditions.
There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 8, Moor teaches the sample with the oligonucleotides is from the blood (para 5).
Regarding claim 9, Moor teaches the target oligonucleotide comprises LNA (para 50, claim 3).
Regarding claim 10, Moor teaches the target oligonucleotide comprises LNA (para 50, claim 3).
Claims 2-5, 7, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022) and further in view of Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa2015).
These are new rejections necessitated by claim amendments filed on 12/17/2025.
Regarding claim 2, Moor teaches a method for qualitative and quantitative detection of short nucleic acid sequences. Moor teaches that a sequence of interest is a single-stranded molecule (claim 4), and that a target strand is preferably a DNA oligonucleotide or a modified DNA oligonucleotide that may comprise nucleic acid and/or nucleic acid analogs including DNA and LNA in the sequence of interest, such as an antisense oligonucleotide (para 50).
Moor is (a) silent to the locations of modified nucleotides and (ii) does not teach adding poly A to the 3’ end of the target oligonucleotide.
Regarding (b), Shibusawa teaches a method for quantifying siRNA, the method comprising a target siRNA modified with a chemical moiety, such as LNA, that is capable of polyadenylation by poly-A polymerase (para 15). Shibusawa does not explicitly state that the chemical modification is the 3’ end, but compatibility with poly-A polymerase reads on that limitation. In addition, Shibusawa teaches that "poly A polymerase" introduces an adenine residue at the 3' end of a single-stranded RNA (para 16).
Shibusawa is silent regarding the conditions of using poly A polymerase and ATP and does not teach using them in the presence of Mn2+.
Invitrogen teaches a poly (A) polymerase used in the presence of ATP and Mn2+ to add poly A to the 3’ end of a target (p. 1-2). The Mn2+ is used at a concentration of 2.5mM.
Shibusawa teaches attaching poly A to a target (para 15) and hybridizing the target to an immobilized capture probe in combination with signal amplification probes (Fig. 1), but neither Moor, Shibusawa and Invitrogen teach the full limitations of steps (iii) or (iv).
Fujikawa2015 teaches a method for detecting nucleic acids, the method comprising bringing PolyA polymerase into contact with a target oligonucleotide (RNA) (para 188), adding poly(A) to the 3′ end of a target as necessary (para 38), and using a capture probe (para 38) or capture substance (para 39) that hybridizes to the target (Fig. 1(a)). Fujikawa2015 teaches the capture substance includes a base sequence complementary to the target, and is immobilized onto a support (para 97 and Fig. 1(a)) with the support directly bound to a nucleic acid probe (para 98). Fujikawa2015 further teaches the method comprises forming a complex with probe polymers and detecting the complex (para 39), which satisfies the requirements of step (iii) since the detected complex includes the hybridization product and, as described in para 191, detecting is performed by flow cytometry, which requires collecting the hybridization product for analysis. Fujikawa 2015 states that the method allows a target to be detected with high sensitivity through the use of signal amplification probes (para 38).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Moor, Shibusawa, Invitrogen and Fujikawa2015 to arrive at the instantly claimed invention. The modification would have entailed using the poly(A) polymerase of Invitrogen in the method of Shibusawa to add a poly A tail to the target of Moor. One would have been motivated by the increased sensitivity provided by the method of Shibusawa, and in particular the convenience of having a single tag to apply to all targets for downstream assays. Moor relies on capture probes comprising a portion complementary to part of the sequence of interest to perform reactions such as amplification (para 45), a step that requires more effort and cost than using a widely known reagent to tag all targets with a poly A tail. One of skill in the art would have known the utility of a polyA tail for target capture. The combination of Shibusawa and Invitrogen also does not teach the Mn2+ at a concentration of 3 mM to 38 mM. However, determining an appropriate concentration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. One of ordinary skill in the art would have been motivated to try different concentrations in order to optimize reaction conditions. The modification would have further entailed using the polyA tailed target produced by the combination of Moor, Shibusawa and Invitrogen in the method of Fujikawa2015. Both Shibusawa and Fujikawa2015 teach methods for capturing and amplifying the signal of target oligonucleotides with polyA tails. The combined methods of Fujikawa2015 and Shibusawa would have enabled detection and quantification of, for example, antisense oligonucleotides with high sensitivity. One would have been motivated by the ability to detect modified oligonucleotides, as found in therapeutic treatments for example. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 3, Moor teaches a method for qualitative and quantitative detection of short nucleic acid sequences. Moor teaches that a sequence of interest is a single-stranded molecule (claim 4), and that a target strand is preferably a DNA oligonucleotide or a modified DNA oligonucleotide that may comprise nucleic acid and/or nucleic acid analogs including DNA and LNA in the sequence of interest, such as an antisense oligonucleotide (para 50).
Moor is (a) silent to the locations of modified nucleotides and (ii) does not teach adding poly A to the 3’ end of the target oligonucleotide.
Regarding (b), Shibusawa teaches a method for quantifying siRNA, the method comprising a target siRNA modified with a chemical moiety, such as LNA, that is capable of polyadenylation by poly-A polymerase (para 15). Shibusawa does not explicitly state that the chemical modification is the 3’ end, but compatibility with poly-A polymerase reads on that limitation. In addition, Shibusawa teaches that "poly A polymerase" introduces an adenine residue at the 3' end of a single-stranded RNA (para 16).
Shibusawa is silent regarding the conditions of using poly A polymerase and ATP and does not teach using them in the presence of Mn2+.
Invitrogen teaches a poly (A) polymerase used in the presence of ATP and Mn2+ to add poly A to the 3’ end of a target (p. 1-2). The Mn2+ is used at a concentration of 2.5mM.
Shibusawa teaches attaching poly A to a target (para 15) and hybridizing the target to an immobilized capture probe in combination with signal amplification probes (Fig. 1), but neither Moor, Shibusawa and Invitrogen teach the full limitations of steps (iii) or (iv).
Fujikawa2015 teaches a method comprising: bringing PolyA polymerase into contact with a target oligonucleotide (para 188), adding poly(A) to the 3′ end of target RNA as necessary (para 38), and using a capture probe (para 38) or capture substance (para 39) that hybridizes to the target (Fig. 1(a)). Fujikawa2015 teaches the capture substance includes a base sequence complementary to the target, is immobilized onto a support (para 97 and Fig. 1(a)) with the support directly bound to a nucleic acid probe (para 98). Fujikawa2015 further teaches the method comprises forming a complex with probe polymers and detecting the complex (para 39), which satisfies the requirements of steps (iii) and (iv) since the detected complex includes the hybridization product and, as described in para 191, detecting is performed by flow cytometry, which requires collecting the hybridization product for analysis. Fujikawa 2015 states that the method allows a target to be detected with high sensitivity through the use of signal amplification probes (para 38).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Moor, Shibusawa, Invitrogen and Fujikawa2015 to arrive at the instantly claimed invention. The modification would have entailed using the poly(A) polymerase of Invitrogen in the method of Shibusawa to add a poly A tail to the target of Moor. One would have been motivated by the increased sensitivity provided by the method of Shibusawa, and in particular the convenience of having a single tag to apply to all targets for downstream assays. Moor relies on capture probes comprising a portion complementary to part of the sequence of interest to perform reactions such as amplification (para 45), a step that requires more effort and cost than using a widely known reagent to tag all targets with a poly A tail. One of skill in the art would have known the utility of a polyA tail for target capture. The combination of Shibusawa and Invitrogen also does not teach the Mn2+ at a concentration of 3 mM to 38 mM. However, determining an appropriate concentration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. One of ordinary skill in the art would have been motivated to try different concentrations in order to optimize reaction conditions. The modification would have further entailed using the polyA tailed target produced by the combination of Moor, Shibusawa and Invitrogen in the method of Fujikawa2015. Both Shibusawa and Fujikawa2015 teach methods for capturing and amplifying the signal of target oligonucleotides with polyA tails. The combined methods of Fujikawa2015 and Shibusawa would have enabled detection and quantification of, for example, antisense oligonucleotides with high sensitivity. One would have been motivated by the ability to detect modified oligonucleotides, as found in therapeutic treatments for example. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 4, Moor teaches a method for qualitative and quantitative detection of short nucleic acid sequences. Moor teaches that a sequence of interest is a single-stranded molecule (claim 4), and that a target strand is preferably a DNA oligonucleotide or a modified DNA oligonucleotide that may comprise nucleic acid and/or nucleic acid analogs including DNA and LNA in the sequence of interest, such as an antisense oligonucleotide (para 50).
Moor is (a) silent to the locations of modified nucleotides and (ii) does not teach adding poly A to the 3’ end of the target oligonucleotide.
Regarding (b), Shibusawa teaches a method for quantifying siRNA, the method comprising a target siRNA modified with a chemical moiety, such as LNA, that is capable of polyadenylation by poly-A polymerase (para 15). Shibusawa does not explicitly state that the chemical modification is the 3’ end, but compatibility with poly-A polymerase reads on that limitation. In addition, Shibusawa teaches that "poly A polymerase" introduces an adenine residue at the 3' end of a single-stranded RNA (para 16).
Shibusawa is silent regarding the conditions of using poly A polymerase and ATP and does not teach using them in the presence of Mn2+.
Invitrogen teaches a poly (A) polymerase used in the presence of ATP and Mn2+ to add poly A to the 3’ end of a target (p. 1-2). The Mn2+ is used at a concentration of 2.5mM.
Shibusawa teaches attaching poly A to a target (para 15) and hybridizing the target to an immobilized capture probe in combination with signal amplification probes (Fig. 1), but neither Moor, Shibusawa and Invitrogen teach the full limitations of steps (iii), (iv), or (v).
Fujikawa2015 teaches a method comprising: bringing PolyA polymerase into contact with a target oligonucleotide (para 188), adding poly(A) to the 3′ end of target RNA as necessary (para 38), and using a capture probe (para 38) or capture substance (para 39) that hybridizes to the target (Fig. 1(a)). Fujikawa2015 teaches the capture substance includes a base sequence complementary to the target, is immobilized onto a support (para 97 and Fig. 1(a)) with the support directly bound to a nucleic acid probe (para 98).Fujikawa2015 further teaches the method comprises forming a complex by subjecting the captured RNA and signal amplification probes capable of self-assembling to a reaction to form a complex for detection including the RNA, the capture substance, and a probe polymer formed from the signal amplification probes; and detecting the probe polymer bound in the complex (para 39). Fujikawa 2015 states that the method allows a target to be detected with high sensitivity through the use of signal amplification probes (para 38).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Moor, Shibusawa, Invitrogen and Fujikawa2015 to arrive at the instantly claimed invention. The modification would have entailed using the poly(A) polymerase of Invitrogen in the method of Shibusawa to add a poly A tail to the target of Moor. One would have been motivated by the increased sensitivity provided by the method of Shibusawa, and in particular the convenience of having a single tag to apply to all targets for downstream assays. Moor relies on capture probes comprising a portion complementary to part of the sequence of interest to perform reactions such as amplification (para 45), a step that requires more effort and cost than using a widely known reagent to tag all targets with a poly A tail. One of skill in the art would have known the utility of a polyA tail for target capture. The combination of Shibusawa and Invitrogen also does not teach the Mn2+ at a concentration of 3 mM to 38 mM. However, determining an appropriate concentration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. One of ordinary skill in the art would have been motivated to try different concentrations in order to optimize reaction conditions. The modification would have further entailed using the polyA tailed target produced by the combination of Moor, Shibusawa and Invitrogen in the method of Fujikawa2015. Both Shibusawa and Fujikawa2015 teach methods for capturing and amplifying the signal of target oligonucleotides with polyA tails. The combined methods of Fujikawa2015 and Shibusawa would have enabled detection and quantification of, for example, antisense oligonucleotides with high sensitivity. One would have been motivated by the ability to detect modified oligonucleotides, as found in therapeutic treatments for example. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 5, Fujikawa2015 teaches one region of one of the signal amplification probes is a region including a poly(T) sequence (para 38).
Regarding claim 7, Fujikawa2015 teaches the first signal amplification probe (first oligonucleotide) includes at least a nucleic acid region X, a nucleic acid region Y, and a nucleic acid region Z including a poly(T) sequence in the stated order from the 5′ end side and the second signal amplification probe (second oligonucleotide) including a nucleic acid probe that includes at least a nucleic acid region X′ complementary to the nucleic acid region X, a nucleic acid region Y′ complementary to the nucleic acid region Y, and a nucleic acid region Z′ complementary to the nucleic acid region Z in the stated order from the 5′ end side (para 45).
Regarding claim 16, Moor teaches the sample with the oligonucleotides is from the blood (para 5).
Regarding claim 17, Moor teaches the sample with the oligonucleotides is from the blood (para 5).
Regarding claim 18, Moor teaches the sample with the oligonucleotides is from the blood (para 5).
Regarding claim 19, Moor teaches the target oligonucleotide comprises LNA (para 50, claim 3).
Regarding claim 20, Moor teaches the target oligonucleotide comprises LNA (para 50, claim 3).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022) and Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa2015) as applied to claims 2-5, 7, and 16-20 above, and further in view of Fujikawa et al. (US PGPub 20080160624, referred to here as Fujikawa2008)..
These are new rejections necessitated by claim amendments filed on 12/17/2025.
Regarding claim 6, neither Moor, Shibusawa, Invitrogen or Fujikawa2015 teach an assist probe.
Fujikawa2008 teaches a method of detecting target genes, the method comprising forming a complex by allowing an assist probe, target gene and pairs of HCP probes (signal amplification probes) to react (para 67 and Fig. 3). Fujikawa2 teaches an assist probe containing a poly(dT) sequence (para 32) and a region complementary to one of the HCPs (para 65 and Figs. 4-7).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Moor, Shibusawa, Invitrogen and Fujikawa2015 with Fujikawa2008 to arrive at the instantly claimed invention. The modification would have entailed adding the assist probe of Fujikawa2008 in the detecting method by complex formation of Fujikawa2015. The motivation would have been the increased sensitivity and ability to simultaneously detect a plurality of genes provided by an assist probe (Fujikawa2008, para 1). There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Double Patenting- updated
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.
(I). Claims 1-10, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,993,806 in view of Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022)
Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method for detecting a target oligonucleotide in a sample, the method comprising a capture probe and a pair of self-aggregating signal amplification probes.
Regarding instant claims 2-4, claims 1,2,4, and 7 of the ‘806 patent require elements of a method that satisfy the requirements of instant claim 2 steps (iii) and (iv), claim 3 steps (ii), (iii) and (iv) and claim 4 steps (ii), (iii), and (iv).
Regarding instant claims 2-4, the claims of the ‘806 patent do not require steps (i) or (ii).
The teachings of Moor, Shibusawa and Invitrogen as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 5, claim 9 of the ‘806 patent requires the first polynucleotide has a poly(T) sequence.
Regarding instant claim 6, claim 3 of the ‘806 patent requires a step of bringing into contact with an assist probe containing both the complete or partial sequence of the target oligonucleotide and a sequence complementary to a complete or partial sequence of at least one of the first and second oligonucleotides.
Regarding instant claim 7, claim 11 of the ‘806 patent requires the first oligonucleotide is an oligonucleotide containing at least a nucleic acid region X, a nucleic acid region Y, and a nucleic acid region Z in order from the 5′-end side, while the second oligonucleotide is an oligonucleotide containing at least a nucleic acid region X′ complementary to the nucleic acid region X, a nucleic acid region Y′ complementary to the nucleic acid region Y, and a nucleic acid region Z′ complementary to the nucleic acid region Z in order from the 5′-end side.
Regarding instant claims 8, 16-18-20, the claims of the ‘806 patent do not require the sample limitations of claims 16-18.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claims 9, 10, 19, and 20. the claims of the ‘806 patent do not require the recited modified bases.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Claim 1 is rejected as encompassing the embodiment of claim 2 rejected above.
(II). Claims 1-10 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 6, 15, 19, 21-23 of copending Application No. 17/796,408 in view of Moor at al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020), Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022), further in view of Fujikawa et al. (US PGPub 20150299788, on IDS dated 05/13/2022 referred to here as Fujikawa2015).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method for detecting a target oligonucleotide in a sample, the method comprising a capture probe and a pair of self-aggregating signal amplification probes.
Regarding instant claims 2-4, copending claims 3 and 22 require elements of a method that satisfy the requirements of instant claim 2 steps (ii, partial), (iii) and (iv), claim 3 steps (ii, partial), (iii), (iv) and (v) and claim 4 steps (ii, partial), (iii), (iv), and (v).
Regarding instant claims 2-4, copending claims do not require step (i) or step (ii) bringing poly A polymerase into contact with the target oligonucleotide in the sample in the presence of Mn2+, thereby adding poly A to a 3'-end of the target oligonucleotide, wherein the adding of the poly A is performed in a solution containing Mn2 of 3 mM to 38 mM.
The teachings of Moor, Shibusawa and Invitrogen as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 5, copending claims do not require at least one of the first and second oligonucleotides contains a poly T sequence
Regarding instant claim 6, copending claim 3 requires a step of bringing a target nucleic acid in a sample, a capture probe, and an assist probe into contact with each other for hybridization, the assist probe containing a 6- to 9-mer sequence capable of flanking to the target nucleic acid and complementary to a complete or partial sequence of the first base sequence of the nucleic acid probe.
Regarding instant claim 7, copending claims do not require claimed elements.
The teachings of Fujikawa2015 as they relate to this claim are given previously in this office action and are fully incorporated here.
Regarding instant claims 8, 16-18, copending claim 21 requires the sample is a blood-derived component.
Regarding instant claims 9, 10, 19 and 20, copending claim 23 requires the chemically modified nucleic acid is LNA, BNA, phosphorothioate oligo, morpholino oligo, boranophosphate oligo, 2'-O-methylated RNA (2'-OMe), 2'-O-methoxyethylated RNA (2'-MOE), or 2'-F-RNA.
Claim 1 is rejected as encompassing the embodiment of claim 2 rejected above.
This is a provisional nonstatutory double patenting rejection.
(III). Claims 1-10 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-23 of copending Application No. 18/844,885 in view of Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method for detecting a target oligonucleotide in a sample, the method comprising a capture probe and a pair of self-aggregating signal amplification probes.
Regarding instant claims 2-4, claims 1,2,4, and 7 of the ‘806 patent require elements of a method that satisfy the requirements of instant claim 2 steps (iii) and (iv), claim 3 steps (iii), (iv) and (v) and claim 4 steps (iii), (iv), and (v).
Regarding instant claims 2-4, copending claims do not require step (i) or (ii) bringing poly A polymerase into contact with the target oligonucleotide in the sample in the presence of Mn2+, thereby adding poly A to a 3'-end of the target oligonucleotide, wherein the adding of the poly A is performed in a solution containing Mn2 of 3 mM to 38 mM.
The teachings of Moor, Shibusawa and Invitrogen as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 5, copending claim 13 requires at least one of the pair of self-assembly signal amplification probes contains a poly T sequence.
Regarding instant claim 6, copending claim 4 requires bringing a capture probe for capturing the target oligonucleotide and an assist probe for detecting the target oligonucleotide into contact with a sample containing the target oligonucleotide.
Regarding instant claim 7, copending claim 15 requires the first signal amplification probe is a nucleic acid probe containing three or more nucleic acid regions and containing at least a nucleic acid region X, a nucleic acid region Y and a nucleic acid region Z or a nucleic acid region Z containing a poly T sequence in this order from the 5' end side, and the second signal amplification probe is a nucleic acid probe containing three or more nucleic acid regions and containing at least a nucleic acid region X' which is complementary to the nucleic acid region X, a nucleic acid region Y' which is complementary to the nucleic acid region Y and a nucleic acid region Z' which is complementary to the nucleic acid region Z or a nucleic acid region Z' containing a poly A sequence in this order from the 5' end side.
Regarding instant claims 8, 16-18-20, the claims of the ‘806 patent do not require the sample limitations of claims 16-18.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claims 9, 10, 19, and 20. the claims of the ‘806 patent do not require the recited modified bases.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Claim 1 is rejected as encompassing the embodiment of claim 2 rejected above.
This is a provisional nonstatutory double patenting rejection.
(IV). Claims 1-10, and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of copending Application No. 18/844,787 in view of Moor et al. (US20100240030) in view of Shibusawa et al. (JP2020000157, filed 6/29/2018, published 01/09/2020) and Invitrogen ("Poly(A) Polymerase(Cloned)", Invitrogen Product Information Sheet, 2018, total 2 pages, on IDS dated 05/13/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method for detecting a target oligonucleotide in a sample, the method comprising a capture probe and a pair of self-aggregating signal amplification probes.
Regarding instant claims 2-4, claims 1,2,4, and 7 of the ‘806 patent require elements of a method that satisfy the requirements of instant claim 2 steps (iii) and (iv), claim 3 steps (ii), (iii) and (iv) and claim 4 steps (iii), (iv), and (v).
Regarding instant claims 2-4, copending claims do not require step (i) or (ii) bringing poly A polymerase into contact with the target oligonucleotide in the sample in the presence of Mn2+, thereby adding poly A to a 3'-end of the target oligonucleotide, wherein the adding of the poly A is performed in a solution containing Mn2 of 3 mM to 38 mM.
The teachings of Moor, Shibusawa and Invitrogen as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 5, copending claim 16 requires bringing a capture probe for capturing the target oligonucleotide and an assist probe for detecting the target oligonucleotide into contact with a sample containing the target oligonucleotide
Regarding instant claim 6, copending claims 2 and require bringing a capture probe for capturing the target oligonucleotide and an assist probe for detecting the target oligonucleotide into contact with a sample containing the target oligonucleotide and the assist probe contains a tag having a base sequence which is complementary to a part of or the whole of one signal amplification probe.
Regarding instant claim 7, copending claim 16 requires the first signal amplification probe is a nucleic acid probe containing at least a nucleic acid region X, a nucleic acid region Y and a nucleic acid region Z or a nucleic acid region Z containing a poly T sequence in this order from the 5' end side, and the second signal amplification probe is a nucleic acid probe containing at least a nucleic acid region X' which is complementary to the nucleic acid region X, a nucleic acid region Y' which is complementary to the nucleic acid region Y and a nucleic acid region Z' which is complementary to the nucleic acid region Z or a nucleic acid region Z' containing a poly A sequence in this order from the 5' end side.
Regarding instant claims 8, 16-18-20, the claims of the ‘806 patent do not require the sample limitations of claims 16-18.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claims 9, 10, 19, and 20. the claims of the ‘806 patent do not require the recited modified bases.
The teachings of Moor as they relate to these claims are given previously in this office action and are fully incorporated here.
Claim 1 is rejected as encompassing the embodiment of claim 2 rejected above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments against Double Patenting
The response requests reconsideration in view of claim amendments or, alternatively, that these rejections be held in abeyance until allowable subject matter is found (p. 14).
Applicant's arguments have been fully considered but are not persuasive.
No terminal disclaimer has been filed and no argument has been presented
against the double patenting rejections.
Thus, for the reasons stated above, and those already of the record, the rejection
is maintained. Rejections have been modified and updated in light of amendments to copending applications and amendments to the claims.
Conclusion
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.
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682