DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions and Status of the Claims
2. Applicant’s election of the species discussed in the reply filed on 28 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
However, the previous Requirement of Species Election is withdrawn.
3. It is noted that Applicant’s response filed 28 July 2026 states that claims “1-10, 12-13, 16-20, and 22-36 are believed to read on the elected species.” There is no claim 36.
Thus, claims 1-35 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statement filed 16 August 2024 is acknowledged and has been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
5. The use of trade names or marks used in commerce (including but not necessarily limited to Triton-X, KlenTaq, etc.), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections and Claim Terminology
6A. Claims 21, 23, 25-27, 29-30, and 34 are objected to because of the following informalities:
Claim 21 contains the text “wherein Bo is wherein Bo,” which appears to be a typographical error.
Claim 23 begins with the text “As method,” which appears to be a typographical error.
Claims 25 and 26 each contain the text “comprises the introduction (of) providing,”: which is grammatically confusing.
Claim 27 contains the word “catalytically,” which appears to be a typographical error.
Claims 29 and 30 each contain the text “comprising::” which appear to be typographical errors.
Claim 34 contains more than one period. See MPEP 608.01(m).
Appropriate correction is required.
6B. While not an objection, it is noted that line 3 of claim 1 begins with a capital letter.
6C. While not an objection, it is noted that claims 3-10, 12-13, 16-20, and 22-35 each begin with “A method,” while claim 2 begins with “The method.”
6D. While not an objection, it is noted that claim 21 recites “this linker.”
Claim Rejections - 35 USC § 112, Claim Terminology, and Claim Interpretation
7. 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.
8. Claims 1-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A. Claim 1 (upon which claims 2-35 depend) is indefinite in each of the following:
I. The recitation “the nucleic acid analyte” and “the analyte,” each of which lacks antecedent basis in the previous recitation of “one or more nucleic acid analytes.”
It is also noted that the claim alternates between a “polynucleotide target sequence,” “nucleic acid analyte(s),” and “target nucleic acid sequence.”
II. The recitation “A1 undergoes ligation to form A2.” It is unclear what A1 is ligated to.
For the purposes of examination, the claims are interpreted as requiring self-ligation to form a circular product, as depicted in Figure 7.
III. The recitation “the hybridized probes Ao,” which lacks antecedent basis because there is no previous recitation of “hybridized probes Ao.” In addition, claim 1 only recites “a” single-stranded probe oligonucleotide, not “probes.”
IV. While not a rejection, it is also noted that while claim 1 recites a solid support and a capture moiety, only claims 4-6 and 11-15 contain any active method step that utilizes either the solid support or the capture moiety.
V. While not a rejection, it is noted that the claims constantly switch between the terms used to name the oligonucleotides; e.g., “single stranded probe oligonucleotide Ao” and “Ao;” “capture oligonucleotide Bo,” “capture oligonucleotide,” “Bo,” and “oligonucleotide Bo,” etc., as found in each of claims 1, 4-14, 16-22, 25-31, and 33-35.
B. Claim 4 is indefinite in the recitation of “step (b),”, as there is no previous recitation of “(b).”
C. Claim 5 (upon which claims 10 and 17-21 depend) is indefinite in the recitation of “steps (b) and (c),”, as there is no previous recitation of “(b)” or “(c).”
The recitation of “(c)” is also found in claim 17.
D. Claim 6 is indefinite in each of the following:
I. The recitation “wherein following attachment of Bo to the solid support,” which lacks antecedent basis because claim 1 does not require any attachment to the solid support.
II. The recitation “the supernatant,” which lacks antecedent basis as there is no previous recitation of a “supernatant.”
III. The recitation “the reaction mixture,” which lacks antecedent basis in the previous recitation of a “first reaction mixture” and a “second reaction mixture.”
E. Claim 10 is indefinite in each of the following:
I. The recitation “the same oligonucleotide Co,” which lacks antecedent basis as there is no previous recitation of a “same oligonucleotide Co.”
II. The recitation of “(c),” which lacks antecedent basis as there is no previous recitation of “(c).”
F. Claim 15 is indefinite, as it is unclear how biotin-streptavidin interactions are covalent, as required by claim 11.
Based on the previous dependency of claim 14 on either claim 11 or 12, and given that claim 12 requires non-covalent binding, the non-covalent binding of claim 15 is interpreted as being dependent upon the non-covalent binding of claim 12.
G. Claim 16 is indefinite in the recitation “the successfully hybridized Ao nucleotides,” which lacks antecedent basis as there is no previous recitation of “successfully hybridized Ao nucleotides.”
H. Claim 17 (upon which claims 18-21 depend) is indefinite the recitation “the target nucleic acid,” which lacks antecedent basis as there is no previous recitation of a “target nucleic acid.”
This limitation is also present in claim 21.
I. Claim 18 (upon which claims 19-21 depend) is indefinite the recitation “the reaction mixture,” which lacks antecedent basis in the previous recitation of a “first reaction mixture” and a “second reaction mixture.”
J. Claim 22 is indefinite in the recitation “each capture oligonucleotide,” which is a plural recitation, and therefore lacks antecedent basis in the previous recitation of “a capture oligonucleotide Bo.”
K. Claim 23 (upon which claim 24 depends) is indefinite in the recitation “the final step,” as it is unclear if this is an additional step after the “final step” of claim 1.
It is suggested that if claim 23 is meant to refer to the final step of claim 1, the word “comprises” should be changed to “further comprises.”
L. Claim 24 is indefinite in each of the following:
I. The recitation “the phosphorolysis enzyme,” which lacks antecedent basis in the previous recitation of “a phosphorolysis enzyme.”
II. The recitation “the further reaction mixture,” which lacks antecedent basis because there is no previous recitation of a “further” reaction mixture.
M. Claims 25 and claim 26 (upon which claims 27-30 depend) are each indefinite in the recitation “a reaction mixture,” as it is unclear if this limitation refers to the “first” reaction mixture of the introducing step of claim 1.
In addition, while not a rejection, it is unclear why the words “hairpin” and “open” are contained within in single quotation marks in claim 25.
It is also suggested that claim 25 be amended to clarify how the individual fluorophores and quenchers of each of hairpin HO1 and HO2 opens upon binding.
N. Claim 27 (upon which claims 28-30 depend) is indefinite in recitation “the reaction mixture,” which lacks antecedent basis in the previous recitation of a “first reaction mixture” and a “second reaction mixture.”
O. Claim 28 is indefinite in each of the following:
I. The recitation “may be,” as it is unclear if this is a required limitation.
II. The recitation “the RNA base,” which lacks antecedent basis in the previous recitation of “at least one RNA base.”
In addition, while not a rejection, it is unclear why the word “open” is contained within in single quotation marks.
P. While not a rejection, it is noted that claim 30 recites a fluorophore-quencher pair, which appears to be in addition to the fluorophore and quencher required by claim 27.
Q. Claim 35 is indefinite in each of the following:
I. The recitation “the amplicons” which lacks antecedent basis because there is no previous recitation of “amplicons.”
II. The recitation “the analyte” which lacks antecedent basis in the previous recitation of “one or more nucleic acid analytes.”
Claim Rejections - 35 USC § 103
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
10. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claims 1-11, 16, 23, 26, and 31-35 are rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al. (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Regarding claim 1, Balmforth et al. teach methods comprising detecting a target polynucleotide sequence comprising binding Ao to a target analyte, pyrophosphorylizing with an enzyme and ligating the partially digested product, and detecting a signal to infer the presence of the analyte (Abstract). Balmforth et al. also teach the method has the added advantage of allowing use of only one single set of probers to amplify all activated A2 probes (Example 7). Thus, Balmforth et al. teach the known techniques discussed above.
Balmforth et al. do not teach the use of capture probes.
However, Rounseville et al. teach methods wherein capture probes and solid supports are used, which has the added advantage of preventing detection of non-complementary sequences (page 3). Thus, Rounseville et al. teach the known techniques discussed above.
It is also noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantages of allowing use of only one single set of probers to amplify all activated A2 probes as explicitly taught by Balmforth et al. (Abstract) and preventing detection of non-complementary sequences as explicitly taught by Rounseville et al. (page 3). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been applied combined with predictable results because the known techniques of the cited prior art predictably result in techniques useful for detecting nucleic acids.
Regarding claims 2-3, the method of claim 1 is discussed above. Balmforth et al. teach the claimed limitations (Abstract and page 10, respectively).
Regarding claims 4-5, the method of claim 1 is discussed above. Rounseville et al. teach attaching to a solid support (Abstract).
Regarding claim 6, the method of claim 1 is discussed above. Rounseville et al. teach removal of the supernatant (i.e., washing; page 34).
In addition, with respect to claims 4-6, it is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claims 7-9, the method of claim 1 is discussed above. Balmforth et al. teach the claimed lengths (page 13).
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 10, the method of claim 5 is discussed above. Balmforth et al. teach the complementary ends (page 8) and digestion (page 9).
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 11, the method of claim 1 is discussed above. Rounseville et al. teach covalent attachment (page 26).
Regarding claim 16, the method claim 1 is discussed above. Balmforth et al. teach simultaneous hybridization (page 8).
It is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
It is also noted that a “wherein” clause, such as that in claim 16, must give “meaning and purpose to the manipulative steps.” See MPEP § 2111.04.
Regarding claim 23, the method claim 1 is discussed above. Balmforth et al. teach amplification with dNTPs and an enzyme (Example 5).
Regarding claims 26 and 31, the method claim 1 is discussed above. Balmforth et al. teach splints and ligation probes (Figure 12), partial digestion (Abstract), and circularization (Figure 11).
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claims 32 and 33, the method claim 31 is discussed above. Balmforth et al. teach unextendable oligonucleotides (pages 13 and 14, respectively ).
Regarding claim 34, the method of claim 1 is discussed above. Balmforth et al. teach detection using fluorescent binding dyes (page 15).
Regarding claim 35, the method of claim 1 is discussed above. Balmforth et al. teach multiple Ao probes (page 15), and Rounseville et al. teach multiple capture probes (page 27).
12. Claims 12-13 and 15 are rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1,published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014).
Regarding claims 12-13 and 15, the method of claim 1 is discussed above in Section 11.
The previously cited prior art does not teach the instant limitations.
However, Anderson et al. teach methods wherein capture probes are attached to a solid support through non-covalent interactions, in the form of a biotinylated capture oligonucleotides that bind to a streptavidin coated support, which has the added advantage of allowing recovery of substantially equal numbers of captured target nucleic acids from multiple samples (paragraphs 0050-0051). Thus, Andersen et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Andersen et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing recovery of substantially equal numbers of captured target nucleic acids from multiple samples as explicitly taught by Andersen et al. (paragraphs 0050-0051). In addition, it would have been obvious to the ordinary artisan that the known techniques of Andersen et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Andersen et al. predictably result in techniques useful for immobilizing nucleic acids.
13. Claims 14 and 17-21 are rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007).
Regarding claim 14 and 17-21, the methods of claims 12 and 5 are discussed above in Section 10.
The previously cited prior art does not teach the instantly claimed limitations.
However, Myerson et al. teach methods using capture oligonucleotides that hybridize to a target covalently bound to a support via a moiety, in the form of an active group (i.e., claim 14) which is a chemical modification that interacts with the solid support, and which allows removal of the target via cleavage (i.e., claim 17).
It is noted that the optional limitations of claim 17-21 (i.e., release of Bo) are not required.
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Myerson et al. also teach the methods allow the elimination of non-specific binding (paragraph 0046). Thus, Myerson et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Myerson et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing the elimination of non-specific binding as explicitly taught by Myerson et al. (paragraph 0046). In addition, it would have been obvious to the ordinary artisan that the known techniques of Myerson et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Myerson et al. predictably result in techniques useful for immobilizing nucleic acids.
14. Claim 22 is rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006).
Regarding claim 22, the method of claim 1 is discussed above in Section 10.
While Balmforth et al. teach phosphorothioate bonds have the claimed resistance (page 26), the previously cited prior art does not teach they are in the capture oligonucleotide Bo.
However, Andreoli et al. teach methods using capture oligonucleotides that are resistant to pyrophosphorolysis because they contain phosphorothioate linkages, which also have the added advantage of increasing binding affinity (paragraph 0103). Thus, Andreoli et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Andreoli et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of having capture oligonucleotides with increased binding affinity as explicitly taught by Andreoli et al. (paragraph 0103). In addition, it would have been obvious to the ordinary artisan that the known techniques of Andreoli et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Andreoli et al. predictably result in techniques useful for immobilizing nucleic acids.
15. Claim 24 is rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017).
Regarding claim 24, the method of claim 23 is discussed above in Section 10.
The previously cited prior art does not teach the claimed amplification.
However, Ma et al. teach methods using pyrophosphorolysis activated polymerization without a polymerase (paragraph 0086), which has the added advantage of allowing either linear of exponential amplification (paragraph 0005). Thus, Ma et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Ma et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing either linear of exponential amplification as explicitly taught by Ma et al. (paragraph 0005). In addition, it would have been obvious to the ordinary artisan that the known techniques of Ma et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Ma et al. predictably result in techniques useful for amplifying nucleic acids.
16. Claim 25 is rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013).
Regarding claim 25, the method claim 1 is discussed above. Balmforth et al. teach splints and ligation probes (Figure 12), amplification with dNTPs and an enzyme (Example 5), and the use of molecular beacons (page 9).
None of the previously cited prior art teaches the two hairpins.
However, Della Vedova teaches methods utilizing probes having quencher and fluorophore groups at the ends, as well as first hairpin molecules that bind to the target molecule, followed by binding of a second hairpin molecule to the open configuration of the first hairpin molecule (i.e., Figure 4.7), which has the added advantage of obtaining signal amplification (caption to Figure 4.7). Thus, Della Vedova teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Della Vedova with the previously cited prior art to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing signal amplification as explicitly taught by Della Vedova (caption to Figure 4.7). In addition, it would have been obvious to the ordinary artisan that the known techniques of Della Vedova could have been combined with the previously cited prior art with predictable results because the known techniques of Della Vedova predictably result in techniques useful for detecting nucleic acids.
17. Claims 27-28 are rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007).
Regarding claim 27, the method of claim 26 is discussed above in Section 11.
The previously cited prior art does not teach MNAzymes.
However, Todd et al. teach methods utilizing mixtures comprising MNAzymes, which comprise oligonucleotides A and B having the claimed substrate arms, catalytic cores, and sensor arms (paragraphs 0016-0017) and a substrate with a fluorophore quencher pair (paragraphs 0067 and 0228) to form an MNAzyme (i.e., claim 27; Abstract).
Todd et al. also teach the reaction mixture comprises a partially double stranded construct of the MNAzymes and a target nucleic acids (i.e., analogous to A2 of the previously cited prior art; Figure 3), which has the added advantage of allowing detection of multiple targets in a single reaction (Abstract). Thus, Todd et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Todd et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing detection of multiple targets in a single reaction as explicitly taught by Todd et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Todd et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Todd et al. predictably result in techniques useful for detecting nucleic acids.
Regarding claim 28, the method of claim 27 is discussed above. Todd et al. teach an oligonucleotide comprising an RNA base (paragraph 0033) and cleavage thereof (paragraph 0006), as well as substrates comprising RNA (paragraph 0032), and cleavage and release of a fluorophore upon target binding as a result of increased double-strandedness (Figure 7).
18. Claim 29 is rejected under 35 U.S.C. 103 as being obvious over Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012).
Regarding claim 29, the method of claim 27 is discussed above in Section 17.
While Balmforth et al. teach ligation in the presence of probes (page 13), the previously cited prior art does not teach LCR probes.
However, Behike et al. teach methods wherein adjacent LCR probes hybridize to a target strand, which allows for enhanced detection of single base changes (paragraph 0118). Thus, Behike et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Behike et al. with the previously cited prior art arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of allowing enhanced detection of single base changes as explicitly taught by Behike et al. (paragraph 0118). In addition, it would have been obvious to the ordinary artisan that the known techniques of Behike et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Behike et al. predictably result in techniques useful for detecting nucleic acids.
Double Patenting
19. 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.
20. Claims 1-11, 16, 23, 26, and 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘569 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’569 claims do not require or the reaction mixtures or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
21. Claims 14 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
22. Claims 12-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
23. Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
24. Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
25. Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
26. Claims 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
27. Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,961,569 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
28. Claims 1-11, 16, 23, 26, and 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘780 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’780 claims do not require or the reaction mixtures or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
29. Claims 14 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
30. Claims 12-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
31. Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
32. Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
33. Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
34. Claims 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
35. Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,332,780 view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
36. Claims 1-11, 16, 23, 26, and 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘951 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’951 claims do not require or the reaction mixtures or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
37. Claims 14 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
38. Claims 12-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
39. Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
40. Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
41. Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
42. Claims 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
43. Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over 1-17 of U.S. Patent No. 12,545,951 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
44. Claims 1-11, 16, 23, 26, and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘473 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’473 claims do not require or the reaction mixtures or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
This is a provisional nonstatutory double patenting rejection.
45. Claims 14 and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
46. Claims 12-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
47. Claim 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
48. Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
49. Claim 25 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
50. Claims 27-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
51. Claim 29 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10, 14-15, 26-27, 30, and 33 of copending Application No. 18/546,473 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
52. Claims 1-11, 16, 23, 26, and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘543 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’543 claims do not require the complementary regions or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
This is a provisional nonstatutory double patenting rejection.
53. Claims 14 and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
54. Claims 12-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
55. Claim 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
56. Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
57. Claim 25 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
58. Claims 27-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
59. Claim 29 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/573,543 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
60. Claims 1-11, 16, 23, 26, and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015).
Both sets of claims are drawn to detecting targets using Ao, pyrophosphorolyzing, ligation, etc. Any additional steps of the ‘813 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ’813 claims do not require the complementary regions or capture.
However, these limitations, as well as additional limitations and the rationale for combining are discussed above.
This is a provisional nonstatutory double patenting rejection.
61. Claims 14 and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claims 11 and 5 above, and further in view of Myerson et al. (U.S. Patent Application Publication No. 2007/0184436 A1, published 9 August 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
62. Claims 12-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andersen et al. (U.S. Patent Application Publication No. 2014/0120529 A1, published 1 May 2014) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
63. Claim 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Andreoli et al. (U.S. Patent Application Publication No. 2006/0194223 A1, published 31 August 2006) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
64. Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 23 above, and further in view of Ma et al. (U.S. Patent Application Publication No. 2017/0305954 A1, published 26 October 2017) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
65. Claim 25 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 1 above, and further in view of Della Vedova (“New Frontiers of Molecular Beacons: Singal Amplification and Nanomachines, published 2013) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
66. Claims 27-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020) and Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015) as applied to claim 26 above, and further in view of Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
67. Claim 29 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/869,813 in view of Balmforth et al. (PCT International Patent Application Publication No. WO 2020/016590 A1, published 23 January 2020), Rounseville et al (PCT International Patent Application Publication No. WO 2015/069787 A1, published 14 May 2015), and Todd et al. (U.S. Patent Application No. US 2007/0231810 A1, published 4 October 2007) as applied to claim 27 above, and further in view of Behike et al (U.S. Patent Application Publication No. US 2012/0258455 A1, published 11 October 2012) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
68. No claim is allowed.
69. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
