DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 and 17-20 and species ‘external trigger’ in the reply filed on July 7, 2026 is acknowledged.
The election of species requirement for types of stimulus, as set forth in the office action mailed April 16, 2026, has been reconsidered and is hereby withdrawn.
Claims 1-20 are currently pending.
Claims 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 7, 2026.
Claims 1-10 and 17-20 are herein examined.
Priority
It is acknowledged that the instant application does NOT claim any priority or benefit. The effective filing date is considered to be the actual filing date of April 12, 2024.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the drawings include nucleotide sequences having greater than 10 enumerated nucleotides (see Fig. 1, 21).
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 17-20 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.
Claims 1-10 and 17-20 are rejected because it is not clear how the preamble recited in claim 1 is intended to breathe life and meaning into the claims. The preamble of claim 1 recites a method of sequencing, yet the method only detection of a signal produced by incorporation of a single labeled nucleotide. Thus, it is not clear if applicant intends to cover only a method of detecting the incorporation of a single labeled nucleotide OR if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the latter, then it appears that the claims are incomplete, as they fail to provide steps that clearly accomplish the goal set forth by the preamble of the claims.
Claims 5-10 are rejected because it is unclear whether the recited step of ‘applying a stimulus’ in claim 5 is intended to replace the generic cleavage step recited in claim 1 (i.e. “cleaving the electroactive label…”), whether it is meant to introduce an additional cleavage step, or if some other meaning is intended. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter.
Claims 8-10 are rejected for the recitation of “external,” which is a relative term that renders the claims indefinite. It is unclear what the recited trigger is external to or what the term external is intended to require. For example, does the limitation require that a stimulus which induces cleavage originates from outside of the sensing zone of the nanosensor, or does it require that the cleavage stimulus is not caused by a component of the reaction which has already been recited (i.e. the polymerase, the electronic nanosensor), or is some other meaning intended by the language of the claim? As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-5, and 7 are rejected under 35 U.S.C. 103 as unpatentable over Su (published Jul. 2, 2009; Patent Application Publication No. US 2009/0170716) in view of Moorthie (Epub Oct. 27, 2011; Moorthie et al. Hugo J. 2011 Dec;5(1-4):1-12), Emig (published Sep. 1, 2011; Patent Application Publication No. US 2011/0212437), and Smith (published Oct. 26, 2006; Patent Application Publication No. US 2006/0240439).
Regarding claim 1, Su teaches a method for nucleic acid sequencing (Abstract), comprising: providing at least one device comprising an electronic nanosensor (par. 18); providing a sample including a fragmented polynucleotide strand (par. 20, 39) to the at least one device; exposing the target polynucleotide cluster (par. 28) to a reaction solution comprising a polymerase enzyme capable of incorporating a nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide into a polynucleotide strand (par. 24), and at least one nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide so that the at least one nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide is incorporated into the polynucleotide strand (par. 22; Fig. 2); cleaving the electroactive label from the incorporated nucleotide so that the electroactive label diffuses toward the electronic nanosensor (par. 25) and detecting a signal produced when the electroactive label is present within a sensing zone of the electronic nanosensor (par. 41; Fig. 1). For clarity, in Su the electroactive label is attached at various positions of the nucleotide (Fig. 2), including an embodiment where the electroactive label is attached to the phosphate group and released as part of the pyrophosphate group when the nucleotide is incorporated into the nascent polynucleotide strand (par. 41), an embodiment where the electroactive label is attached to the base and removed after nucleotide incorporation via a nuclease enzyme (par. 27), and embodiments where it is attached to the sugar (Fig. 2).
Regarding claim 3, Su teaches signal produced when the electroactive label is present within the sensing zone of the electronic nanosensor is the current (I) as a function of applied potential (V) (par. 29).
Regarding claims 4, 5, and 7, Su teaches embodiments where the electroactive label is removed from a nucleotide by the action of a polymerase/applying a stimulus to induce cleavage of the electroactive label on the incorporated nucleotide where the stimulus is an enzyme (par. 41). Although Su does not explicitly recite that this is a cleavage step, the release of pyrophosphate during nucleotide incorporation by a polymerase can be considered a cleavage event, and therefore the limitations are considered to have been met.
Regarding claim 1, Su does not explicitly teach clonally amplifying the fragmented polynucleotide strand within the at least one device to produce a clonally amplified cluster. However, Su does teach utilizing clonal populations of the template polynucleotide strand (par. 28).
Moorthie teaches clonally amplifying the fragmented polynucleotide strand within the at least one device to produce a clonally amplified cluster (pg. 2, col. 2, par. 3).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to include an active step of clonal amplification in order to generate a sufficient detection signal (pg. 2, col. 1, par. 3). One would have had reasonable expectation of success because clonal amplification is a routine step in many sequencing methodologies (pg. 2, col. 2, par. 2-3).
Regarding claim 1, Su and Moorthie do not explicitly teach a detectable label which is bound to the 3’-OH group of a sugar ring, nor a polymerase which is capable of incorporating a nucleotide modified with a detectable label covalently bound to the 3’-OH group of a sugar ring of the nucleotide into a polynucleotide strand. However, Su does teach nucleotides having 3’-O-modifications which serve the purpose of reversible termination (par. 40-41).
Regarding claim 5, Su and Moorthie do not explicitly teach that the applied stimulus results in exposure of the 3’-OH end of the growing polynucleotide strand to allow for subsequent addition of the next nucleotide.
Emig teaches detectable labels attached to a nucleotide at the 3’-OH positions, which may be cleaved using exonucleases or exonuclease activity, resulting in exposure of the 3’-OH end of the growing polynucleotide strand to allow for subsequent addition of the next nucleotide (par. 81). Emig teaches polymerases (par. 91-94, 127), including those which are mutated to have desirable properties such as improved performance (par. 125-126, 128-129), but does not explicitly address their suitability with potentially bulky 3’-OH modifications. Emig also explicitly teaches that a 3’-O- label on an incorporated nucleotide may cleaved from the nucleotide by a polymerase via its exonuclease activity (Abstract; par. 14).
Smith teaches polymerases which are explicitly capable of incorporating (potentially bulky) 3’-O-modified nucleotides into nascent polynucleotide chains (par. 14). Smith’s modified nucleotides are recited as having sugar rings with 3’-O- modifications (par. 149, 152) which comprise linkers such as alkyl or azido methyl groups (par. 158) as well as detectable labels (par. 152, 160).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Smith and Emig with the teachings of Moorthie and Su. One would have been motivated to alter the position of the electroactive label to allow for a single cleavage reaction to remove a terminating group and detectable label because Emig teaches this is an efficient strategy in sequencing-by-synthesis (Emig: par. 81). Furthermore, one would have been motivated to use Smith’s polymerases in order to improve performance when using 3’ substituted nucleotide analogues (Smith: par. 14, 16). One would have had reasonable expectation of success because Emig, Su, and Smith discuss suitable configurations, such as useful 3’-O modifications (Su: par. 40; Smith: par. 152, 204; Emig: par. 60).
Claims 6 is rejected under 35 U.S.C. 103 as unpatentable over the combination of Su (published Jul. 2, 2009; Patent Application Publication No. US 2009/0170716), Moorthie (Epub Oct. 27, 2011; Moorthie et al. Hugo J. 2011 Dec;5(1-4):1-12), Emig (published Sep. 1, 2011; Patent Application Publication No. US 2011/0212437), and Smith (published Oct. 26, 2006; Patent Application Publication No. US 2006/0240439), as applied to claims 1 and 5 above, and further in view of Ju (published Dec. 26, 2006; Ju et al. Proc Natl Acad Sci U S A. 2006 Dec 26;103(52):19635-40; provided as NPL #1 in the IDS filed 05/03/2024).
Su, Moorthie, Emig, and Smith teach the limitations of claims 1 and 5, as discussed above.
Regarding claim 6, the combined references do not explicitly teach that the stimulus is a chemical reagent, and that the chemical reagent is added to the system after each nucleotide incorporation.
Ju teaches 3’-O modifications which are cleaved using a stimulus in the form of a chemical reagent which is added to the system after each round of nucleotide incorporation (pg. 19640, col. 2). In this case, the chemical reagent/stimulus is Pd-catalyzed deallylation (pg. 19638, col. 1).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of the combined references and Ju. One would have been motivated to substitute the enzyme-based cleavage of the combined references with the chemical cleavage of Ju because both were known in the art as methods of inducing cleavage of nucleotide modifications, and the results would have been predictable. One would have had reasonable expectation of success because Ju, Su, and Moorthie all discuss methods of sequencing involving cycles of reagent delivery and washing (Su: par. 18, 27, 41; Moorthie: pg. 2, col. 2; Ju: pg. 19640, col. 2).
Claims 8-10 are rejected under 35 U.S.C. 103 as unpatentable over the combination of Su (published Jul. 2, 2009; Patent Application Publication No. US 2009/0170716), Moorthie (Epub Oct. 27, 2011; Moorthie et al. Hugo J. 2011 Dec;5(1-4):1-12), Emig (published Sep. 1, 2011; Patent Application Publication No. US 2011/0212437), and Smith (published Oct. 26, 2006; Patent Application Publication No. US 2006/0240439), as applied to claims 1 and 5 above, and further in view of Pedersen (published Mar. 11, 2004; Patent Application Publication No. US 2004/0049008).
Su, Moorthie, Emig, and Smith teach the limitations of claims 1 and 5, as discussed above.
Regarding claims 8-10, the combined references do not explicitly teach that the stimulus is an external trigger comprising either an electrochemically induced change in pH OR an electrochemically induced change in pH and in temperature of the reaction solution in the area of the polynucleotide strand.
Pedersen teaches linkers attached to nucleotides which are triggered by stimuli including chemical reagents and pH and/or temperature (par. 582).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of the combined references and Pedersen. One would have been motivated to do so because Pedersen (in par. 582) treats chemical reagents, pH and/or temperature, and enzymatic activity (as disclosed by Su and Emig) as functional equivalents which can all be used for the same purpose (i.e. cleaving a linking group). One would have had reasonable expectation of success because Pedersen and the combined references are in the same fields of endeavor.
Claims 2 and 17-20 are rejected under 35 U.S.C. 103 as unpatentable over the combination of Su (published Jul. 2, 2009; Patent Application Publication No. US 2009/0170716), Moorthie (Epub Oct. 27, 2011; Moorthie et al. Hugo J. 2011 Dec;5(1-4):1-12), Emig (published Sep. 1, 2011; Patent Application Publication No. US 2011/0212437), and Smith (published Oct. 26, 2006; Patent Application Publication No. US 2006/0240439), as applied to claim 1 above, and further in view of Korlach (published April 18, 2013; International Publication No. WO/2013056241).
The limitations of claim 1 are taught by the combination of Su, Moorthie, Emig, and Smith, as discussed above.
Regarding claim 2, the combined references do not explicitly teach measuring a first signal at the nanosensor when the label is covalently bound to the nucleotide and measuring a second electrochemical signal at the nanosensor after the label is released from the nucleotide, wherein the second signal is measurably distinguishable from the first electrochemical signal.
Korlach teaches measuring a first signal at the nanosensor when the label is covalently bound to the nucleotide and measuring a second electrochemical signal at the nanosensor after the label is released from the nucleotide, wherein the second signal is measurably distinguishable from the first electrochemical signal (par. 34).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Korlach and the combined references. One would have been motivated to do so in order to determine that a nucleotide incorporation invent has occurred (Korlach: par. 42). One would have had reasonable expectation of success because the principles are routine, as demonstrated by discussion in Emig and Korlach (Korlach: par. 35; Emig: par. 46).
Regarding claim 17, Su teaches a method for nucleic acid sequencing (Abstract), comprising: providing at least one device comprising an electronic sensor having a sensing electrode (par. 29); providing a sample including a fragmented polynucleotide strand (par. 20, 39) to the at least one device; exposing the target polynucleotide cluster (par. 28) to a reaction solution comprising a polymerase enzyme capable of incorporating a nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide into a polynucleotide strand (par. 24), and at least one nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide so that the at least one nucleotide modified with an electroactive label covalently bound to a sugar ring of the nucleotide is incorporated into the polynucleotide strand (par. 22; Fig. 2); cleaving the electroactive label from the incorporated nucleotide so that the electroactive label diffuses toward the electronic sensor (par. 25, 29) and detecting a signal (par. 41; Fig. 1).
Regarding claim 17, Su does not explicitly teach clonally amplifying the fragmented polynucleotide strand within the at least one device to produce a clonally amplified cluster. However, Su does teach utilizing clonal populations of the template polynucleotide strand (par. 28).
Moorthie teaches clonally amplifying the fragmented polynucleotide strand within the at least one device to produce a clonally amplified cluster (pg. 2, col. 2, par. 3).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to include an active step of clonal amplification in order to generate a sufficient detection signal (pg. 2, col. 1, par. 3). One would have had reasonable expectation of success because clonal amplification is a routine step in many sequencing methodologies (pg. 2, col. 2, par. 2-3).
Regarding claim 17, Su and Moorthie do not explicitly teach a detectable label which is bound to the 3’-OH group of a sugar ring, nor a polymerase which is capable of incorporating a nucleotide modified with a detectable label covalently bound to the 3’-OH group of a sugar ring of the nucleotide into a polynucleotide strand. However, Su does teach nucleotides having 3’-O-modifications which serve the purpose of reversible termination (par. 40-41).
Emig teaches detectable labels attached to a nucleotide at the 3’-OH positions, which may be cleaved using exonucleases or exonuclease activity, resulting in exposure of the 3’-OH end of the growing polynucleotide strand to allow for subsequent addition of the next nucleotide (par. 81). Emig teaches polymerases (par. 91-94, 127), including those which are mutated to have desirable properties such as improved performance (par. 125-126, 128-129), but does not explicitly address their suitability with potentially bulky 3’-OH modifications. Emig also explicitly teaches that a 3’-O- label on an incorporated nucleotide may cleaved from the nucleotide by a polymerase via its exonuclease activity (Abstract; par. 14).
Smith teaches polymerases which are explicitly capable of incorporating (potentially bulky) 3’-O-modified nucleotides into nascent polynucleotide chains (par. 14). Smith’s modified nucleotides are recited as having sugar rings with 3’-O- modifications (par. 149, 152) which comprise linkers such as alkyl or azido methyl groups (par. 158) as well as detectable labels (par. 152, 160).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Smith and Emig with the teachings of Moorthie and Su. One would have been motivated to alter the position of the electroactive label to allow for a single cleavage reaction to remove a terminating group and detectable label because Emig teaches this is an efficient strategy in sequencing-by-synthesis (Emig: par. 81). Furthermore, one would have been motivated to use Smith’s polymerases in order to improve performance when using 3’ substituted nucleotide analogues (Smith: par. 14, 16). One would have had reasonable expectation of success because Emig, Su, and Smith discuss suitable configurations, such as useful 3’-O modifications (Su: par. 40; Smith: par. 152, 204; Emig: par. 60).
Regarding claim 17, the combined references do not explicitly teach applying a potential on the sensing electrode, wherein the potential oscillates between a reduction potential and an oxidation potential of the electroactive label and detecting a signal transmitted with the oxidation and/or reduction of the cleaved electroactive label
Regarding claim 18, the combined references do not explicitly teach demodulating the transmitted signal in phase with the applied potential. However, Su does teach that the signal detected is the current associated with a detectable label as a function of applied potential (par. 29), and Emig teaches the use of filters in the identification of signal pulses (par. 206; Fig. 12).
Regarding claim 17, Korlach teaches applying a potential on the sensing electrode, wherein the potential oscillates between a reduction potential and an oxidation potential of the electroactive label and detecting a signal transmitted with the oxidation and/or reduction of the cleaved electroactive label (par. 44, 47).
Regarding claim 18, Korlach teaches determining the identity of a base by examining characteristics of the measured current alongside the ‘voltage stage’ (Par. 81, 82, 90, 96). This falls within the plain meaning of ‘demodulating the transmitted signal in phase with the applied potential,’ consistent with the teachings in the instant specification regarding the limitations of claim 18 (PGPub - par. 111). Therefore, Korlach is considered to have met the limitations of claim 18.
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of the combined references and Korlach. One would have been motivated to do so in order to distinguish between one or more labels having different redox potentials (par. 44). One would have had reasonable expectation of success because such methodology is routine (e.g. Korlach: par. 87, 91, 96).
Regarding claim 19, Su teaches redox shuttling (par. 30; Fig. 5). This process involves application of a potential to a sensing electrode, which electrostatically attracts electroactive labels, and is consistent with the instant specification (par. 112-113). Thus, the limitation is considered to have been met.
Regarding claim 20, Su teaches applying a stimulus to induce cleavage of the detectable label on the incorporated nucleotide (par. 41).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 19/355,602, in view of Moorthie (Epub Oct. 27, 2011; Moorthie et al. Hugo J. 2011 Dec;5(1-4):1-12),
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims are drawn to methods (claims 1-16). Both sets of claims require:
Providing a sample including a polynucleotide strand and a device comprising an electronic nanosensor (claim 1, 9)
Exposing the polynucleotide(s) to a reaction solution comprising a nucleotide modified with an electroactive label covalently bound to a 3’-OH group of a sugar ring of a nucleotide and a polymerase capable of incorporating it into a polynucleotide strand (claim 1, 4, 9, 12)
Cleaving the electroactive label from the incorporated nucleotide such that it diffuses toward an electronic nanosensor (claim 1)
Detecting a signal produced when the electroactive label is present within a sensing zone of the electronic nanosensor (claim 1).
The reference does not explicitly require that the polynucleotide strand be fragmented or clonally amplifying the fragmented polynucleotide strand within the at least one device to produce a clonally amplified cluster. However, Moorthie teaches clonally amplifying fragmented polynucleotide strands within the at least one device to produce a clonally amplified cluster (pg. 2, col. 1, par. 3; pg. 2, col. 2, par. 3). It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to include an active step of clonal amplification of fragmented polynucleotides in order to generate sufficient detection signal (pg. 2, col. 1, par. 3) of clones which can be traced back to their source during analysis (pg. 9, col. 1, last par.). One would have had reasonable expectation of success because clonal amplification and fragmentation are routine (pg. 2, col. 2, par. 3; pg. 8, col. 1, last par.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine M Jones whose telephone number is (571)272-2585. The examiner can normally be reached Monday - Friday, 8AM - 4PM.
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/C.M.J./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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