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 .
Status of Claims
Applicant' s amendment filed 03/04/2026 is acknowledged. Claims 1, 4-5, 7, 8, 13-14 have been amended. Claims 2-3, 12, and 15 have been cancelled. Claims 1, 4-5, 7, 8, 13-14 are pending in the instant application and the subject of this final office action.
All of the amendments and arguments have been reviewed and considered. Any rejections or objections not reiterated herein have been withdrawn in light of amendments to the claims or as discussed in this office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous Rejection
Status of Prior Rejections/Objections:
The objections to the specification, the drawings, and claims 2 and 13 are withdrawn in view of the respective amendments.
The 112(b) rejections to claim(s) 1, 4-11, and 13-14 are maintained and modified in view of the amendments.
The prior art rejection(s) under 35 USC 102 directed to the following are withdrawn in view of the amendments to or cancellation of the claims:
Claims 1, 2, and 8-11 as anticipated by Heller
Claims 1, 2, and 12 as anticipated by Lee
Claims 2-3, 5, and 12 as anticipated by Fuller
The prior art rejections under 35 USC 102 of claims 1, 4, and 6-7 as anticipated by Fuller are maintained and modified/clarified as necessary in view of the amendments.
The prior art rejection(s) under 35 USC 103 directed to the following are withdrawn in view of the amendments to or cancellation of the claims:
Claims 2-3 over Heller
Claims 1-2 and 12 over Lee
Claims 2-3, 5, and 12 over Lee in view of Fuller and Davis
Claims 2-3, 5, and 12 over Fuller
The prior art rejection(s) under 35 USC 103 directed to the following are maintained and modified/clarified as necessary in view of the amendments.
Claims 1, 4-11, and 13 over Heller in view of Fuller and Davis
Claim 14 over Heller in view of Fuller and Davis and further in view of Morin
Claims 1, 4, 6-7, and 13 over Lee in view of Fuller and Davis
Claim 14 over Lee in view of Fuller and Davis and further in view of Morin
Claims 1, 4, 6-7, and 13 over Fuller
Claim 14 over Fuller in view of Morin
The double patenting rejections of claims 1, 4, 6-7, and 13-14 over 6,649,769 B2 (Lee) in view of Fuller, Davis, and Morin are maintained and modified/clarified in view of the amendments; the rejections of claims 2-3, 5, and 12 are withdrawn in view of the cancellation of or amendment to the claims.
New Ground(s) of Rejections
The new ground(s) of rejections were necessitated by applicant’s amendment of the claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections & Warnings
Applicant is advised that should claim 1 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1, 4-6 are objected to because of the following informalities:
Claims 1 and 4: In listing the (i)-(iii) lists of claims 1 and 4, the comma before the (ii) should be a semi-colon to be consistent with the semi-colon before the “and/or (iii)” and for additional clarity within the (a)-(c). Additionally, in (i), the claim recites “and combination thereof”; there appears to be a typo or word missing.
Claim 6: The term “deoxyuridine” is underlined from a previous amendment.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Claims 1, 4-11, and 13-14 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.
Regarding claims 1 and 4, first, the amended claims recite “formula (I): ‘5-[Blocking Moiety]-[Primer]-3’ wherein ... the Primer comprises an oligonucleotide capable of priming polymerization of a copy strand by polymerase linked to a nanopore with a read length of at least 1000 bp ” (claim 1) or “formula (II): ‘5-[Biotin Tag]-[Blocking Moiety]-[Primer]-3’ wherein ... the Primer comprises an oligonucleotide capable of priming polymerization of a copy strand by polymerase linked to a nanopore with a read length of at least 1000 bp ” (claim 4).
As discussed in the previous rejection, it is not clear what structural constraints, if any, are intended to be imposed by “linked to a nanopore” on the oligonucleotide.
When there is a functional limitation that may be ambiguous, MPEP 2173.05(g) instructs considering: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.
In the instant case, the newly amended limitation—apparently intended to clarify the structures of the composition—is directed to the nanopore itself, which is only broadly “linked” to the polymerase which carries out the polymerization of which the oligonucleotide must be functionally capable. No definition of “a polymerase linked to a nanopore with a read length of at least 1000 bp” or evidence on the record to establish functional constraints on such a polymerase so linked were identified.
Accordingly, it would not be clear to the artisan what structures, if any, are intended to be imposed on the oligonucleotide of the composition by the linkage to the nanopore, including one with the amended read length.
Second, the claims recite “bulky group”. The term “bulky” in the claims is a relative term which renders the claim indefinite, as discussed in the previous rejection. The term “bulky” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
While the class of “bulky group” has been in part limited by the amended claims for (i) and (ii), “(iii) a phosphodiester-linked bulky group” is not limited. Accordingly, it is still not clear in the degree to which “bulk” would be required of such a group. Therefore, the metes and bounds cannot be established by one of skill in the art.
Third, the amended claims recite “(b) a bulky group, wherein the bulky group is selected from (i) an aryl, arylalkyl, ..., (ii) pyrene, ...; and/or (iii) a phosphodiester-linked bulky group”. The term “and/or” in the Markush makes it unclear whether the claim is intended to encompass the individual members, combinations of members, or all members together. Markush groups require selection from a discrete, closed set of elements. The use of “and/or” renders the boundaries of the claimed group uncertain because artisan could not determine with reasonable certainty which combinations, if any, are intended to be included in the claim.
Claims 5-11 and 13-14 are indefinite for depending from 1 and/or 4 and not rectifying the deficiency.
Regarding claim 5, the amended claim recites “wherein the compound of formula (IIb) ... wherein, n is 1 to 10; ...”. There is no verb in the amended claim and it is unclear if the compound is intended to be formula (IIb), to comprise formula (IIb), or fulfill some other relationship.
For the purposes of examination, the claim is being interpreted as the compound comprises the compound of formula (IIb).
Claims 8-11 and 13-14 are indefinite for depending from claim 5 and not rectifying the deficiency.
Regarding claim 6, the claim recites “The composition of claim 3”. Claim 3 has been cancelled.
For the purposes of examination, this has been interpreted as depending from claim 1, which now has the limitation of the previous claim 3.
Claims 8-11 and 13-14 are indefinite for depending from claim 6 and not rectifying the deficiency.
Claim Notes – Multiple Dependency
The multiple dependent claims are identified according to the practice of the table in MPEP 608.1(n)(F). Where ranges of multiple dependencies are being addressed, they have been identified by the range of parent claims upon which they depend, i.e., 8/4-5 addresses claim 8 depending from claims 4 and/or 5 and 10/8/6-7 addresses claim 10 depending from claims 6 via 8 and/or 7 via 8.
Claim Rejections - 35 USC § 102
Claim(s) 1, 4, and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Fuller (WO 2015/148402 A1; published 10/1/2015).
Regarding claims 1, 4, and 6-7, Fuller teaches a biotinylated hairpin primer (para [0302]), wherein the artisan would understand the biotin to be on the 5’ because the presence of streptavidin allows for binding to the hairpin primer molecules to the pore and the 3’ end specified as “exposed” (para [0302]). The artisan would further understand the hairpin to be “bulky”/a blocking moiety, wherein it further would be understood by the artisan that the oligonucleotide comprises phosphodiester linkages as it is made from nucleotides that are not disclosed to be modified (para [0302]; see also, e.g., Fig. 3; instant claims 1, 4, and 6-7) as it is taught to be unable to enter the pore (para [0302]) and that one or more of the nucleotides 3’ of the biotin may be interpreted to be a linker (instant claims 6-7; see also Fig. 32 and 33).
As no minimum primer length is set, any portion sufficient for priming polymerization may be considered “the Primer” and a portion that forms a hairpin or other “bulky” structure may be considered a “a phosphodiester-linked bulky group”. Therefore, the claimed structure is taught.
The amended limitation directed to the read length of the nanopore recites a property of an element external to the claimed composition. To the extent that this language imposes any limitation, the composition of Fuller would inherently satisfy it as no evidence of the record was identified that establishes the read length of the nanopore functionally influences the priming capacity of an oligonucleotide.
Fuller teaches each and every limitation of claims 1, 4, and 6-7 and. therefore, Fuller anticipates claims 1, 4, and 6-7.
Claim Rejections - 35 USC § 103
Claim(s) 1, 4-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller (US 2016/0281153 A1; published 09/26/2016; as cited in the IDS dated 8/04/2022) in view of Fuller (WO 2015/148402 A1; published 10/1/2015) and Davis (US 2013/0244340 A1; published 09/19/2013; incorporated by reference into Fuller).
Regarding claims 1, 4-5, 8/1, 8/4-5, 9/8/1, 9/8/4-5, 10/8/1, 10/8/4-5, 11/8/1, and 11/8/4-5, Heller teaches an oligocation-oligonucleotide conjugate primers comprising cationic polyamines (e.g., spermidine or spermine) or peptides comprising lysine, including 1-5 spermine moieties [i.e., a spermine or an oligomer of spermine] or a pentamer of lysine [i.e., an oligomer of lysine] covalently coupled to the 5’ terminal end of an oligonucleotide primer sequence (Structures IV and V; para [0033]; [0038-39]; [0052]). As shown in Structure IV below, Heller teaches that the structures of the invention are linked to the primer via a phosphate and that the R group of the phosphate group is O-.
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It is noted that while the connection to the lysine or poly-lysine embodiments is not explicitly stated, at least the first nucleotide of the priming portion may be considered part of the poly-cationic group such that the phosphodiester linkage to the primer is fulfilled.
Heller teaches that the kits comprising the primers above are intended for use in isothermal DNA amplification (claims 1-20).
However, Heller fails to teach a 5’ biotin tag.
Fuller rectifies this by teaching a biotinylated hairpin primer, wherein the biotin enables the formation of a strong binding complex attached adjacent to the pore (para [0302]; see also Fig. 38).
Fuller also teaches the blocked biotinylated spermine oligonucleotide (“tagged nucleotide”) Bio-Spermine-dT30-C3 (Table 4, SEQ ID 52; see also para [0292]). Fuller further teaches that the amplification reaction is isothermal (para [0285], wherein it is understood that the same conditions are repeated using the additional changes specified in Example 15).
Fuller, via Davis, also teaches that biotin may also be utilized as an isolation tag so it can be readily concentrated or isolated (Davis, para [0153] and [0171]) and that functional moieties may serve more than one function (Davis, para [0172]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to biotinylate the 5’ of the polycationic primers of Heller comprising a spermine, oligomers of spermine, or oligomers of lysine, motivated by the desire to enable strong attachments to a location adjacent to the pore, as taught by Fuller, and/or to enable ready concentration or isolation, as taught by Davis. There would have been a strong expectation of success as both are directed to isothermal amplification strategies, Fuller teaches an analogous oligonucleotide with such a biotinylated poly-cationic group at the 5’, and such amount to the application of a known technique to a known product.
The amended limitation directed to the read length of the nanopore recites a property of an element external to the claimed composition. To the extent that this language imposes any limitation, the composition of Fuller would inherently satisfy it as no evidence of the record was identified that establishes the read length of the nanopore functionally influences the priming capacity of an oligonucleotide.
Regarding claims 6-7, 8/6-7, 9/8/6-7, 10/8/6-7, and 11/8/6-7, in the composition of Heller in view of Fuller and Davis, Fuller does not specify the linkage of the biotinylation of primers. However, in Table 4, it is noted that the Bio-Spermine-dT30-C3 tag was generated with 5Hexynyl, and Heller teaches that they were generated with click chemistry reactions (para [0253]) such that a linkage would be formed (para [0254]; Fig. 21).
Fuller teaches that click reactions are fast, irreversible reactions between pairs of specific chemical groups (para [00106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize click chemistry, as taught by Fuller, in attaching the biotin thereby providing a “linker” between the biotin and the poly-cationic group(s), motivated by the desire for a fast and irreversible reaction. There would have been a strong expectation of success as Fuller teaches that it is compatible with these moieties and it amounts to the application of a known technique to a known product.
Regarding claim 13, as cited previously in the rejections above of claims 1 and 4-6, Heller teaches Formula (I) and Heller in view of Fuller and Davis teach Formula (II) and the compositions of claims 1 and 4-6.
Fuller teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]).
Fuller further teaches the nanopore devices may be used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane;
a nanopore 110 extending through the membrane; and
a sample chamber 116 containing a solution [in contact with electrode 118a; see para (0208)] that may contain electrolytes buffered to an optimum ion concentration to keep the nanopore open.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller further teaches that a voltage potential between electrode and liquid may cause a current flow from the electrode to the liquid chamber, wherein electrolyte K+ flows through the pore from the trans electrode side of the bilayer to the cis side of the bilayer and Cl- ions react with the electrode (para [0182]). The artisan would understand, at least from the arrows of Fig. 12, that such positive ion flows from the trans electrode to the cis electrode and that said ions are thus in contact with both electrodes. It is further noted that Fuller teaches that both sides are provided with a buffered electrolyte solution for sequencing reactions (para [0339]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide a composition of Formulas (I) or (II) or the composition of any one of claims 1 or 4-6, as discussed above, complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to utilize at least one electrolyte solution with ions in contact with both electrodes, motivated by the desire to keep the nanopore open, as taught by Fuller. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller (US 2016/0281153 A1; published 09/26/2016; as cited in the IDS dated 8/04/2022), Fuller (WO 2015/148402 A1; published 10/1/2015), and Davis (US 2013/0244340 A1; published 09/19/2013; incorporated by reference into Fuller) as applied to claims 1 and 4-6 above, and further in view of Morin (WO 2016/126746 A1; as cited in the IDS dated 08/04/2022).
Regarding claim 14, as discussed previous rejection, Heller teaches the compound of Formula (I) and Heller in view of Fuller and Davis teach Formula (IIb) and the compositions of claims 1 and 4-6.
Fuller teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]).
Fuller further teaches the nanopore devices may be used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane; and
a nanopore 110 extending through the membrane.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller teaches a kit for sequencing nucleic acid comprising at least one tagged nucleic acid (para [0034]) and utilizing four different tagged nucleotides to encode A, T, G, and C (para [0244-245], [0275], [0284-287], [0313-342]). Fuller teaches four different tagged nucleotides with distinct current blockade signals when bound to the active site of DNA polymerase conjugated to a nanopore (para [0314]).
Fuller does not explicitly teach a kit with the nanopore device and a DNA primer.
Morin rectifies this by teaching a kit comprising a nanopore device configured to identify objects passing through the pore and a primer set, wherein at least one of the primers is modified to comprise a conjugation site [that may be biotin; see para (00102)] (para [0036]).
Morin further teaches that the nanopore device can be packaged into a hand-held form factor at very low cost (para [00185]) and that devices and compositions that enable robust detection of polynucleotide sequences in a fast, simple and accurate manner are needed (para [0002]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide a composition of Formulas (I) or (IIb) or the composition of any one of claims 1 and 4-6 complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Fuller complexed with the compounds of Heller in view of Fuller and Davis with the tags of Fuller in view of the teaching of Morin, in order to provide a kit for robust, fast, and cheap detection of polynucleotide sequences and a simple package, as taught by Morin. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Claim(s) 1, 4, 6-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 6,649,769 B2; granted 11/18/2003) in view of Fuller (WO 2015/148402 A1; published 10/1/2015) and Davis (US 2013/0244340 A1; published 09/19/2013; incorporated by reference into Fuller).
Regarding claims 1 and 4, Lee teaches labelled polynucleotides [i.e., primers] comprising “DYE” (claims 32 and 34), wherein the DYE comprises the bulky group of claim 1.
Lee teaches the following formula in claim 32, wherein the blocking moiety [i.e., DYE] comprises a bulky group selected from at least aryl (Z1 or Z2, claim 1) and heterocycle (Z1 or Z2, claim 1), wherein the DYE structure comprises aryl-substitute forms of said DYE (claim 1). It is noted that the blocking moiety may be considered to be the portion boxed below attached to nucleobase B or the entire modified nucleotide analog (e.g., if an R27 other than H is chosen):
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It is noted that Lee defines a “nucleobase” as inclusive of modified nucleobases (col 6, para 3), i.e., the blocking moiety may be a base-modified nucleoside.
Lee also teaches the following formula claim 34, wherein the sugar shown may be the first base of the primer and R28 may be the internucleotide phosphodiester of the remaining polynucleotides claimed:
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In the above claims and their dependents, the polynucleotide may be 2-100 nucleotides where there is no indication of blocked 3’ sites. Lee teaches that such conjugates of the bulky group and the bulky group on a modified nucleobase may find utility as DNA sequencing and PCR primers wherein the dye is connected to the 5’ of the polynucleotide (col 22, para 7 through col 27, para 1, especially col 22, last line and col 26 para 1 and 4). Thus, the artisan would understand that they would be capable of priming polymerization of a “copy strand”.
The amended limitation directed to the read length of the nanopore recites a property of an element external to the claimed composition. To the extent that this language imposes any limitation, the polynucleotide of the composition of Lee would inherently satisfy it as no evidence of the record was identified that establishes the read length of the nanopore functionally influences the priming capacity of an oligonucleotide.
Lee teaches that the Z1 or Z2 of the dye may be a linking moiety (claim 1). However, Lee fails to teach a 5’ biotin tag.
Fuller rectifies this by teaching a biotinylated hairpin primer, wherein the biotin enables the formation of a strong binding complex attached adjacent to the pore (para [0302]; see also Fig. 38).
Fuller also teaches a blocked biotinylated spermine oligonucleotide (“tagged nucleotide”) Bio-Spermine-dT30-C3 (Table 4, SEQ ID 52; see also para [0292]); that a hexynyl used to generated said biotinylated oligo is considered a “linker” (para [0254]); and the click chemistry used to add 5’ groups to hexynyl moieties (para [0105-113] and [0253]; Fig. 21 and 24). Fuller further teaches amplification utilizing its primer (para [0285], wherein it is understood that the same conditions are repeated using the additional changes specified in Example 15).
Fuller, via Davis, also teaches that biotin may also be utilized as an isolation tag so it can be readily concentrated or isolated (Davis, para [0153] and [0171]) and that functional moieties may serve more than one function (Davis, para [0172]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to biotinylate the 5’ of the primers of Lee, motivated by the desire to enable strong attachments to a location adjacent to the pore for sequencing, as taught by Fuller, and/or to enable ready concentration or isolation, as taught by Davis. There would have been a strong expectation of success as they are directed to nucleic acid amplification and/or sequencing, Fuller teaches a linker and a means of adding a 5’ biotin to said linker, and such amounts to the application of a known technique to a known product.
Regarding claims 6-7, in combined composition of Lee in view of Fuller and Davis, Fuller does not specify the linkage of the biotinylation of primers. However, in Table 4, it is noted that the Bio-Spermine-dT30-C3 tag was generated with 5Hexynyl, and Heller teaches that they were generated with click chemistry reactions (para [0253]) such that a linkage would be formed (para [0254]; Fig. 21).
Fuller teaches that click reactions are fast, irreversible reactions between pairs of specific chemical groups (para [00106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize click chemistry, as taught by Fuller, in attaching the biotin thereby providing a “linker” between the biotin and the poly-cationic group(s), motivated by the desire for a fast and irreversible reaction. There would have been a strong expectation of success as Fuller teaches that it is compatible with these moieties and it amounts to the application of a known technique to a known product.
Regarding claim 13, as discussed above, Lee teaches the compound of Formula (I) and Lee in view of Fuller and Davis teach Formula (II) and the compositions of claims 1 and 4-6.
Fuller teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]).
Fuller further teaches the nanopore devices may be used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane;
a nanopore 110 extending through the membrane; and
a sample chamber 116 containing a solution [in contact with electrode 118a; see para (0208)] that may contain electrolytes buffered to an optimum ion concentration to keep the nanopore open.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller further teaches that a voltage potential between electrode and liquid may cause a current flow from the electrode to the liquid chamber, wherein electrolyte K+ flows through the pore from the trans electrode side of the bilayer to the cis side of the bilayer and Cl- ions react with the electrode (para [0182]). The artisan would understand, at least from the arrows of Fig. 12, that such positive ion flows from the trans electrode to the cis electrode and that said ions are thus in contact with both electrodes. It is further noted that Fuller teaches that both sides are provided with a buffered electrolyte solution for sequencing reactions (para [0339]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide a composition of Formulas (I) or (II), as taught by Lee or Lee in view of Fuller and Davis, or the composition of any one of claims 1, 4, or 6, as discussed above, complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize at least one electrolyte solution with ions in contact with both electrodes, motivated by the desire to keep the nanopore open, as taught by Fuller. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 6,649,769 B2; granted 11/18/2003) in view of Fuller (WO 2015/148402 A1; published 10/1/2015), and Davis (US 2013/0244340 A1; published 09/19/2013; incorporated by reference into Fuller) as applied to claims 1, 4, and 6 above, and further in view of Morin (WO 2016/126746 A1; as cited in the IDS dated 08/04/2022).
Regarding claim 14, as described in the rejection above, Lee teaches the compound of Formula (I) and Lee in view of Fuller and Davis teach the compositions of as claims 1, 4, and 6.
Fuller teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]).
Fuller further teaches the nanopore devices may be used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane; and
a nanopore 110 extending through the membrane.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller teaches a kit for sequencing nucleic acid comprising at least one tagged nucleic acid (para [0034]) and utilizing four different tagged nucleotides to encode A, T, G, and C (para [0244-245], [0275], [0284-287], [0313-342]). Fuller teaches four different tagged nucleotides with distinct current blockade signals when bound to the active site of DNA polymerase conjugated to a nanopore (para [0314]).
Fuller does not explicitly teach a kit with the nanopore device and a DNA primer.
Morin rectifies this by teaching a kit comprising a nanopore device configured to identify objects passing through the pore and a primer set, wherein at least one of the primers is modified to comprise a conjugation site [that may be biotin; see para (00102)] (para [0036]).
Morin further teaches that the nanopore device can be packaged into a hand-held form factor at very low cost (para [00185]) and that devices and compositions that enable robust detection of polynucleotide sequences in a fast, simple and accurate manner are needed (para [0002]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide the priming compositions discussed above complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Fuller complexed with the priming compounds discussed above with the tags of Fuller in view of the teaching of Morin, in order to provide a kit for robust, fast, and cheap detection of polynucleotide sequences and a simple package, as taught by Morin. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Claim(s) 1, 4, 6-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuller (WO 2015/148402 A1; published 10/1/2015).
Regarding claims 1, 4, and 6-7, Fuller teaches a biotinylated hairpin primer (para [0302]), wherein the artisan would understand the biotin to be on the 5’ because the presence of streptavidin allows for binding to the hairpin primer molecules to the pore and the 3’ end specified as “exposed” (para [0302]). The artisan would further understand the hairpin to be “bulky”/a blocking moiety as it is taught to be unable to enter the pore (para [0302]) and that one or more of the nucleotides 3’ of the biotin may be interpreted to be a linker (instant claims 6-7; see also Fig. 32 and 33). As an oligonucleotide, it further would be understood to be a phosphodiester-linked bulky group.
As no minimum primer length is set, any portion sufficient for priming polymerization may be considered “the Primer” and a portion that forms a hairpin or other “bulky” structure may be considered a “a phosphodiester-linked bulky group”. Therefore, the claimed structure is taught.
The amended limitation directed to the read length of the nanopore recites a property of an element external to the claimed composition. To the extent that this language imposes any limitation, the composition of Fuller would inherently satisfy it as no evidence of the record was identified that establishes the read length of the nanopore functionally influences the priming capacity of an oligonucleotide.
Regarding claim 13, in the embodiment with the biotinylated hairpin primer, Fuller further teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]) [i.e., teaches a composition with said components], but does not explicitly teach the electrodes or the electrolyte solution in that embodiment.
Fuller rectifies this by teaching that nanopore devices used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane;
a nanopore 110 extending through the membrane; and
a sample chamber 116 containing a solution [in contact with electrode 118a; see para (0208)] that may contain electrolytes buffered to an optimum ion concentration to keep the nanopore open.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller further teaches that a voltage potential between electrode and liquid may cause a current flow from the electrode to the liquid chamber, wherein electrolyte K+ flows through the pore from the trans electrode side of the bilayer to the cis side of the bilayer and Cl- ions react with the electrode (para [0182]). The artisan would understand, at least from the arrows of Fig. 12, that such positive ion flows from the trans electrode to the cis electrode and that said ions are thus in contact with both electrodes. It is further noted that Fuller teaches that both sides are provided with a buffered electrolyte solution for sequencing reactions (para [0339]).
Fuller also teaches various unblocked tagged nucleotide structures wherein the polynucleotide appear capable of priming polymerization comprising polycationic and/or bulky groups (Table 4, SEQ ID NO 5 and 9-13; Table 5, SEQ ID NO 111 and 117; see para [0298]). Fuller teaches testing tagged nucleotides to determine degradation (para [0298]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide the priming composition(s) of Fuller (i.e., a compound of formula (I) or a composition of claims 1, 4, or 6), complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize at least one electrolyte solution with ions in contact with both electrodes, motivated by the desire to keep the nanopore open, as taught by Fuller. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Additionally and/or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition of one or more said nucleotides with the nanopore for sequencing, motivated by the desire to test the performance one or more of said tagged nucleotides in nanopore sequencing, as taught by Fuller. There would have been a strong expectation of success as Fuller teaches all of the elements and such is the combination of a known element with a known product.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuller (WO 2015/148402 A1; published 10/1/2015) as applied to claims 1, 4, 6 above, and further in view of Morin (WO 2016/126746 A1; as cited in the IDS dated 08/04/2022).
Regarding claim 14, in the embodiment with the biotinylated hairpin primer, Fuller teaches at least a compound of Formulas (I) and claims 1, 4, and 6, as discussed above.
Fuller teaches that the biotinylated primer was complexed with the nanopore, a DNA polymerase was added and allowed to bind the primer, wherein the DNA polymerase/nanopore/DNA complex was exposed to lipid bilayers [i.e., membranes] to form pores on a Genia chip (para [0302]).
Fuller further teaches the nanopore devices may be used for sequencing a nucleic acid and/or tag (para [0205]); Fig. 12) comprise:
a pair of electrodes 118a and 118b located on either side [i.e., cis and trans] of the lipid bilayer membrane; and
a nanopore 110 extending through the membrane.
Fuller teaches this circuitry implementation allows conductance characteristics of the complex to be determined, which can be valuable in distinguishing specific tags, and a nanopore based sequencing chip enables parallel sequencing on an array (para [0216]).
Fuller also teaches that the DNA polymerase may be attached to or in proximity to the nanopore (para [00102]; Fig. 38) to the nanopore may facilitate the flow of a nucleic acid molecule through or adjacent to the nanopore.
Fuller teaches a kit for sequencing nucleic acid comprising at least one tagged nucleic acid (para [0034]) and utilizing four different tagged nucleotides to encode A, T, G, and C (para [0244-245], [0275], [0284-287], [0313-342]). Fuller teaches four different tagged nucleotides with distinct current blockade signals when bound to the active site of DNA polymerase conjugated to a nanopore (para [0314]).
Fuller does not explicitly teach a kit with the nanopore device and a DNA primer.
Morin rectifies this by teaching a kit comprising a nanopore device configured to identify objects passing through the pore and a primer set, wherein at least one of the primers is modified to comprise a conjugation site [that may be biotin; see para (00102)] (para [0036]).
Morin further teaches that the nanopore device can be packaged into a hand-held form factor at very low cost (para [00185]) and that devices and compositions that enable robust detection of polynucleotide sequences in a fast, simple and accurate manner are needed (para [0002]).
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to provide the priming compositions discussed above complexed with a nanopore and an adjacent polymerase, motivated by the desire to facility the flow of a nucleic acid through or adjacent to the nanopore and to keep the DNA in proximity to both the polymerase and pore, as taught by Fuller. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the chip comprising the electrodes, motivated by the desire be able to distinguish specific tags, as taught by Fuller. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Fuller complexed with the priming compounds discussed above with the tags of Fuller in view of the teaching of Morin, in order to provide a kit for robust, fast, and cheap detection of polynucleotide sequences and a simple package, as taught by Morin. There would have been a strong expectation of success as the elements are directed toward known techniques and products within nanopore sequencing and isothermal amplification compositions.
Double Patenting
Claims 1, 4, 6-7 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 17, 22, 30-37, 49 and 51 of U.S. Patent No. 6,649,769 B2 in view of Fuller (WO 2015/148402 A1; published 10/1/2015), Davis (US 2013/0244340 A1; published 09/19/2013; incorporated by reference into Fuller) and Morin (WO 2016/126746 A1; as cited in the IDS dated 08/04/2022).
Both sets of claims are directed to a polynucleotide [i.e., a primer] comprising a blocking moiety that may be a bulky group and/or a modified nucleobase attached to a bulky group.
‘769 claim 32 teaches the following formula, wherein the bulky group may be the portion boxed below attached to nucleobase B or the entire modified nucleotide analog (e.g., if an R27 other than H is chosen):
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274
300
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It is noted that Lee defines a “nucleobase” as inclusive of modified nucleobases (col 6, para 3), i.e., the blocking moiety may be a base-modified nucleoside.
‘769 claim 34 teaches the formula, wherein the sugar shown may be the first base of the primer and R28 may be the internucleotide phosphodiester of the remaining polynucleotides claimed:
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170
391
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Lee teaches that in claims 32 and 34, the DYE is the DYE of claim 1, wherein said DYE [i.e., a blocking moiety], which may comprise a bulky group selected from at least aryl (Z1 or Z2, claim 1) and heterocycle (Z1 or Z2, claim 1), wherein the DYE structure may comprise aryl-substitute forms of said DYE (claim 1).
In these claims and their dependents, the polynucleotide may be 2-100 nucleotides where there is no indication of blocked 3’ sites. ‘769 claim 51 recites that parent claim 30 that encompasses each of these species is used as a primer. Therefore, the artisan would understand that the polynucleotide would be capable of priming polymerization of a copy strand by a polymerase.
The amended limitation directed to the read length of the nanopore recites a property of an element external to the claimed composition. To the extent that this language imposes any limitation, the composition of ‘769 would inherently satisfy it as no evidence of the record was identified that establishes the read length of the nanopore functionally influences the priming capacity of an oligonucleotide.
‘769 claim 1, on which both depend, teaches the donor and acceptor dye and a linker for linking the donor and accepter, wherein there may be an additional linking moiety (Z1 or Z2) but the claims of ‘769 fail to teach biotin linkages.
‘769 claim 51 teaches a kit comprising a labelled polynucleotide according to parent claim 30 of both claims 32 and 34, comprising enzymatically incorporatable nucleotides and a primer, wherein the primer is a labelled polynucleotide according to claim 30. ‘769 teaches incorporatable tagged nucleotides in claims 22-26, and 29 and teaches a kit comprising tagged nucleotides and a primer in claim 52. However, the claims of ‘769 fail to teach a nucleopore composition and kit comprising a nucleopore device.
As described in the rejection of claims 3-5 above, Fuller and Davis teach biotinylated primers and a motivation and predicable means for combining. It would be obvious to combine ‘769 with Fuller and Davis for the same reasons as the rejections above. ‘769 is also directed to labelled primers and amplification (see, e.g., claim 51).
Any additional limitations of the ‘769 claims are encompassed by the open claim language “comprising” found in the instant claims.
As described in the rejection of claims 13-14 above, Fuller and Morin teach the elements of a nanopore composition and a kit comprising such a device with tagged nucleotides and a primer, as well as motivations for combining. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the compounds of claims 32 or 34 or the biotinylated primer as combined above with the nanopore complex to create a nanopore device and to combine said device with four tagged nucleotides to create a kit for the same motivations and expectations of success as in the rejections above.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
Applicant submits that the claims, as amended, are not indefinite and meet the requirements of 35 USC 112(b).
The examiner respectfully disagrees and has clarified the 112(b)s rejections of claims 1 and 4 regarding the functional limitation directed to the oligonucleotide and how the relative term “bulky” is still not clear in the amended claims. In particular, the functional limitation is directed to the oligonucleotide; adding a requisite of the nanopore read does not clarify how such a linkage functionally limits, if at all, the oligonucleotide. Additionally, the (iii) phosphodiester-linked bulky groups still recite the relative term in a way that is unclear. For example, (iii) encompasses formula (IIc), which was rejected in the previous action for use of the same relative term in claim 5, and does not clarify the metes and bounds of the relative term “bulky”.
Regarding the 102 rejections as anticipated by Fuller, applicant argues that Fuller fails to teach (a) a tripartite composition comprising a biotin tag-blocking moiety-primer structure, and (b) a primer that comprises an oligonucleotide capable of priming polymerization of a copy strand by a polymerase linked to a nanopore with a read length of at least 1000 bp, instead teaching tagged nucleotides. Based on this, applicant argues that Fuller does not disclose, teach, or suggest the claimed methods, as amended.
Regarding the 103 rejections over Heller in view of Fuller and Davis; Heller in view of Fuller and Davis and in further view of Mortin; Lee in view of Fuller and Davis; Lee in view of Fuller and Davis and further in view of Mortin; Fuller; and Fuller in view of Mortin, Applicant argues that each of base art and each of the combinations of record fails to disclose, teach, or suggest the claims as amended. Namely, applicant argues they each fail to teach (a) a tripartite composition comprising a biotin tag-blocking moiety-primer structure, and (b) a primer that comprises an oligonucleotide capable of priming polymerization of a copy strand by a polymerase linked to a nanopore with a read length of at least 1000 bp. Applicant argues that the claims are not rendered obvious by the combinations of record.
It is noted that no arguments have been provided in the 103 over Fuller; applicant has argued, instead, over Lee.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “tripartite composition” and “a primer ... a nanopore with a read length of ...”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As a matter of clarity, the instant claims 1, 4-11, and in part 13-14 are directed to or comprise a composition comprising a tripartite compound. The markers 5’, “-“, and 3’ and the phrase “a compound of formula ...” in claims 1 and 4 have been interpreted to indicate that the compound is one joint compound. There is nothing of record to indicate a reasonable interpretation that requires three distinct parts of the composition given conventions in the art. Further, given the prior antecedent basis of “the Primer” in the compound, the claim has not been interpreted to recite a separate “a primer”. If applicant wishes for additional parts in the composition or for the limitations directed at “the Primer” to be directed to another primer, the claim must be amended.
It is further noted that where applicant argues that the claimed methods are not taught, no pending claims are directed to methods. Group I was elected without traverse in the Remarks dated 07/18/2025 and Group II drawn to the method was cancelled by the applicant.
While the applicant provides a general summary of the documents Heller (Remarks, pg. 17), Lee (e.g., Remarks, pg. 13), and Fuller (Remarks, pg. 15), Morin (e.g., Remarks, pg. 22), the applicant has failed to engage with the mapping provided by the examiner beyond reproducing it and alleging it does not disclose, teach, or suggest the claims.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim 4 previously contained the limitation directed to the “tripartite” compound comprising a 5’ biotin and the functional limitation of being capable of priming polymerization had been addressed, wherein the lack of clarity regarding the linkage to the nanopore had been raised. Similarly, the compound of formula (IIb) had been rejected under Heller in view of Fuller and Davis and Heller in view of Fuller and Davis and further in view of Morin.
Accordingly, applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the allegation that there is not teaching or suggestion in the combination, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Each of the rejections has a specific motivation suggested by the art and the expectation of success has been addressed, as has been summarized throughout the remarks (e.g., Remarks, pgs. 19, 21-22, 26, 28, 30-31, 32-33).
Regarding the double patenting rejections, applicant argues that the double patenting rejections are inapposite because the amended claims are patentable distinct from the claims of Lee (‘769) even in view of Fuller, Davis, and Morin. Applicant argues that Lee is directed to “energy-transfer dye compounds featuring at least one atropisomerically enriched xanthene dye-optionally linked to specific terminal or internal positions of polynucleotides or nucleotides-and kits utilizing these spectrally resolvable labeled substrates for molecular biology applications such as DNA sequencing and primer extension” (Remarks, pg. 35) and that the other individual references do not disclose, teach or suggest the “tripartite composition” and/or the “a primer”, such that the amended claims are not rendered obvious.
For at least the reasons above, the arguments are not persuasive. Applicant has not described how the energy transfer dye linked to such a terminal position of a polynucleotide, which applicant admits are described as useful in primer extension (i.e., would be capable of priming polymerization), wherein it would be obvious and predictable to further add a biotin as discussed in the rejection. No only can such dyes be linked as the base modified nucleoside, but they read on multiple of the amended bulky groups in the amended claims, as had been clarified in the rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Olsen (US 2018/0320168 A1) teaches advantages of substituting desthiobiotin in nucleic acid constructs (para [0039-0041]). Olsen contemplates various sequencing technologies for which library preparation might be applied including nanopore-based sequencing (e.g., para [0005]). Characteristics of the oligonucleotides include those in para [0035]. Olsen also teaches various nucleotide analogs in para [0037].
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma R Hoppe whose telephone number is (703)756-5550. The examiner can normally be reached Mon - Fri 11:00 am - 7:00 pm.
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/EMMA R HOPPE/Examiner, Art Unit 1683
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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