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 ..
Information Disclosure Statements
2. The Information Disclosure Statements filed 2 June 2023, 31 December 2024, 11 June 2025, and 29 October 2025 are acknowledged and have been considered.
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.
References that are lined through are duplicate citations. It is suggested that Applicant proofread all Information Disclosure Statements to void duplicate citations of related art.
Drawings
3. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by:
I. The appropriate fee set forth in 37 CFR 1.17(h);
II. One set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web; and, unless already present,
III. An amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
4. A statement from Applicant that there is no intention to have color drawings will result in acceptance of the drawings; otherwise, the conditions set forth above must be met in order for the color drawings to be accepted.
Specification
5. The use of trade names or marks used in commerce (including but not necessarily limited to Cy 3, etc.; Alexa Fluor 350, etc.;3), has been noted in this application. The terms 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 Rejections - 35 USC § 101
6. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. While the claims recite methods, the limitations are limited to providing a dataset and classifying based on additional mental steps, i.e., comprising to a threshold value. Thus, the claims are drawn to a judicial exception, in the form of an abstract idea, and are not integrated into a practical application because there are no further steps that utilize the data. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as noted above, the data is merely classified based on comparison to threshold values.
Determining whether the claimed subject matter is drawn to a judicial exception utilizes a two-prong procedure. The first prong determines whether the claimed subject matter is directed to a law of nature, a natural phenomenon, or an abstract idea. If the claimed subject matter recites an abstract idea, it is then determined whether the claimed subject matter is instead directed to an improvement to a technology. If the claimed subject matter recites a law of nature, it is then determined whether the claimed subject matter is instead directed to a patent-eligible application of the law of nature. If a claim is not directed to a natural phenomenon that is a nature-based product, then it is determined if the product limitation is markedly different from what occurs in nature.
The instant claims are drawn to a judicial exception of performing an abstract idea that can be performed as a series of mental steps; i.e., classifying a series of signals (intensity transition events or median dwell times) and comparing to threshold or maximum value (i.e., claims 1 and 20), with the remaining claims merely being drawn to either data gathering steps (e.g., claims 2-9, 12, 18-19, and 22), additional data analysis (i.e., claims 10-11, 16-17, and 21) or establishing parameters for the analysis (i.e., claims 13-15), each of which is similar to the abstract idea of comparing information of a sample or test subject to a control or target data at issue in Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ 2d 1241 (Fed, Cir. 2014)) and the abstract idea of collecting information and analyzing it in Electric Power Group. LLC. v. Alstom (830 F3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016).
In the second prong it is determined whether the claimed subject matter includes significantly more than a judicial exception by integrating the judicial exception into a practical application; e.g., by further comprising an additional element or a combination of additional elements that are not routine or conventional.
As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.”
In the instant case, the claims recite no additional elements other than the data gathering and analysis, and therefore do not amount to significantly more than the judicial exception there are no other limitations beyond the judicial exception.
While not specifically claimed as computer-implemented methods. the claimed subject matter also encompasses abstract ideas that could be computer mediated. Even generously interpreting the claims as somehow performing the abstract ideas on a generic computer would not an additional element that is significantly more than the abstract idea itself. In Alice Corp. Pty. Ltd. v. CLS Bank Int'l (573 U.S. 134 S.Ct. 2347, 110 USPQ2d 1976 (2014)) the Supreme Court reviewed the prior Benson, Flook, and Diehr decisions regarding claims directed to an abstract idea that include a step of using computers:
These cases demonstrate that the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention. Stating an abstract idea “while adding the words ‘apply it’” is not enough for patent eligibility. Mayo, supra, at ___ (slip op., at 3). Nor is limiting the use of an abstract idea “‘to a particular technological environment.’” Bilski, supra, at 610–611. Stating an abstract idea while adding the words “apply it with a computer” simply combines those two steps, with the same deficient result. Thus, if a patent’s recitation of a computer amounts to a mere instruction to “implemen[t]” an abstract idea “on…a computer,” Mayo, supra, at ___ (slip op., at 16), that addition cannot impart patent eligibility. This conclusion accords with the pre-emption concern that undergirds our §101 jurisprudence. Given the ubiquity of computers, see 717 F. 3d, at 1286 (Lourie, J., concurring), wholly generic computer implementation is not generally the sort of “additional featur[e]” that provides any “practical assurance that the process is more than a drafting effort designed to monopolize the [abstract idea] itself.” Mayo, 566 U. S., at ___ (slip op., at 8–9).
Again, while only encompassing (but not claiming) a computer mediated method, it is noted that the court further stated:
Petitioner’s claims to a computer system and a computer-readable medium fail for substantially the same reasons. Petitioner conceded below that its media claims rise or fall with its method claims. En Banc Response Brief for Defendant-Appellant in No. 11–1301 (CA Fed.) p. 50, n. 3. As to its system claims, petitioner emphasizes that those claims recite “specific hardware” configured to perform “specific computerized functions.” Brief for Petitioner 53.But what petitioner characterizes as specific hardware-a “data processing system” with a “communications controller” and “data storage unit,” for example, see App. 954,958, 1257-is purely functional and generic. Nearly every computer will include a “communications controller” and “data storage unit” capable of performing the basic calculation, storage, and transmission functions required by the method claims. See 717 F. 3d, at 1290 (Lourie, J., concurring). As a result, none of the hardware recited by the system claims “offers a meaningful limitation beyond generally linking ‘the use of the [method] to a particular technological environment,’ that is, implementation via computers.” Id., at 1291 (quoting Bilski, 561 U. S., at 610–611). Put another way, the system claims are no different from the method claims in substance. The method claims recite the abstract idea implemented on a generic computer; the system claims recite a handful of generic computer components configured to implement the same idea. This Court has long “warn[ed] . . . against” interpreting §101 “in ways that make patent eligibility ‘depend simply on the draftsman’s art.’” Mayo, supra, at ___ (slip op., at 3) (quoting Flook, 437 U. S., at 593); see id., at 590 (“The concept of patentable subject matter under §101 is not ‘like a nose of wax which may be turned and twisted in any direction . . . ’”). Holding that the system claims are patent eligible would have exactly that result.
Because petitioner’s system and media claims added nothing of substance to the underlying abstract idea, that were found patent ineligible under §101.
The subject matter of the instant claims is, at best, broadly interpreted as encompassing a computer-mediated process directed to a judicial exception and, interpreted strictly as claimed, encompasses only an abstract idea combined with data gathering. There are no additional limitations in the claims providing significantly more that the judicial exception; e.g., any tangible use of the data or the use of any tangible machine or processor resulting in significant improvement to any technology..
The subject matter of the instant claims is therefore solely limited to a judicial exception and the claims are patent-ineligible.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 17 and 21-22 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.
The term “acceptable” in each of claims 17 and 21-22 is a relative term which renders the claim indefinite. The term “acceptable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 22 is also indefinite in the recitation “the acceptable time-resolved signals,” which lacks antecedent basis because neither claim 1 nor claim 19 recite “acceptable time-resolved signals.”
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 1-5, 9-14, and 16-22 are rejected under 35 U.S.C. 103 as obvious over Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012).
Regarding claims 1 and 20, Watkins et al describe methods comprising providing a data set describing time resolved intensity measurements (Title and Figure 1), counting the number of events (i.e., photons; Figure 2), wherein the transitions are classified into groups (Section 2.3), numbering the intensity states (Section 2.3) and thresholding (Introduction). Thus, Watkins et al teach all of the claimed limitations.
It is noted that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments (see MPEP § 2123). Thus, the teaching of Watkins et al that the thresholding has limitations (Abstract) encompasses embodiments utilizing thresholding.
In addition, Zhong et al teach methods of obtaining time-resolved signals (paragraph 0138), including from a plurality of discrete sources of signals (i.e., claim 20; paragraph 0104). Zhong et al further teach counting the events (i.e., colleting 1000 data points; paragraph 0205; see also counting photons, paragraph 0083) and classifying signals based on thresholds, which has the added advantage of allowing determination of the significance of the signal (paragraphs 0067-0068). Thus, Zhong et al teach the known techniques discussed above.
It is 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 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 teachings of Watkins et al and Zhong et al 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 determination of the significance of a signal as explicitly taught by Zhong et al (paragraphs 0067-0068). In addition, it would have been obvious to the ordinary artisan that the known techniques of Zhong et al could have been combined with Watkins et al with predictable results because the known techniques of Zhong et al predictably result in confirmation of significant signals.
Regarding claim 2, the method of claim 1 is discussed above. Watkins et al teach consecutive events (e.g., states; Section 2.3.2), and Winters-Hill et al each mearing consecutive events (paragraph 0322) and real-time acquisition of values (paragraph 0199), which includes consecutive events.
Regarding claims 3-4, the method of claim 1 is discussed above. Watkins et al teach the use of Poisson statistics (“Concluding Remarks”), as do Zhong et al (paragraph 0139), which is a continuous-time stochastic process as defined by page 26 of the instant specification (i.e., claim 3).
Regarding claim 5, the method of claim 1 is discussed above. Watkins et al teach defined time intervals (e.g., Figure 1), as do Zhong et al (paragraph 0159).
Regarding claims 9-10, the method of claim 1 is discussed above. Watkins et al the use of hidden Markov models for analyzing data (“Introduction”).
Regarding claims 9 and 11-13, the method of claim 9 is discussed above. Zhong et al teach analyzing the data comprises identifying signals based on an exceeded threshold value (i.e., claims 9 and 11; paragraph 0072), including a background value (i.e., claim 12; paragraph 0069) and the use of 1.25 standard deviations (i.e., claim 13; paragraph 0150).
Regarding claim 14, the method of claim 1 is discussed above.
It is noted that the courts have 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. Thus, the claimed number merely represents routine optimization of the number of transition events.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claim 16, the method of claim 1 is discussed above. Zhong et al teach calculating the amount of time (i.e., the signal duration) above a threshold (paragraph 002); by calculating the signal duration, the dwell time is known.
Regarding claim 17, the method of claim 1 is discussed above. Zhong et al teach identifying acceptable signals (i.e., determining if a base calling signal is accurate; paragraph 0092).
Regarding claim 18, the method of claim 1 is discussed above. Zhong et al teach producing the data set (i.e., from a real time sequencing system; paragraph 0205).
Regarding claim 19, the method of claim 1 is discussed above. Zhong et al teach receiving the data set (i.e., receiving the signals; paragraph 0110).
Regarding claim 21, the method of claim 18 is discussed above. Zhong et al teach identifying acceptable signals (i.e., determining if a base calling signal is accurate; paragraph 0092).
Regarding claim 22, the method of claim 19 is discussed above. Zhong et al further teach producing a count of acceptable signals; i.e., determining if a base calling signal is accurate (paragraph 0092), which counts at least one acceptable signal.
13. Claims 3 and 14 are rejected under 35 U.S.C. 103 as obvious over Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claim 1 above, and further in view of Lakin et al (J. R. Soc. Interface, vol. 9, pages 1470-1485, published online 4 January 2012).
It is noted that while claim 14 has been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 3 and 14, the method of claim 1 is discussed above in Section 12.
Watkins et al teach the two states have a different signal intensity (i.e., jumps; Abstract), as do Zhong et al (paragraph 0208).
Neither Watkins et al nor Zhong et al teach continuous stochastic transitions (i.e., claim 3).
However Lakin et al teach measuring DNA transitions (e.g., using fluorophores, Section 2.1), wherein continuous stochastic logic is applied to nearing transitions, which has the added advantage of being part of the appropriate model for reactions at a molecule level (i.e., claim 3; Section 2.3). Lakin et al also teach threshold levels of 10 (i.e., claim 14), which has the added advantage of a high probability of consensus (Section 3.4). Thus, Lakin et al teach the known techniques discussed above.
It is reiterated that the courts have 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. Thus, the claimed number merely represents routine optimization of the threshold number.
Applicant is again cautioned to not merely rely upon counsel’s arguments in 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 teachings of Lakin et al with Watkins et al and Zhong et al 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 advantages of being part of the appropriate model for reactions ad a molecule level and a high probability of consensus as explicitly taught by Lakin et al (Section 2.3 and Section 3.4, respectively). In addition, it would have been obvious to the ordinary artisan that the known techniques of Lakin et al could have been combined with Watkins et al and Zhong et al with predictable results because the known techniques of Lakin et al predictably result in confirmation of significant signals.
14. Claims 6-8 and 15 are rejected under 35 U.S.C. 103 as obvious over Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claims 1 and 5 above, and further in view of Becker (U.S. Patent Application Publication No. US 2002/0164614 A1, published online 7 November 2002).
Regarding claims 6-8 and 15, the methods of claims 1 and 5 are discussed above in Section 12.
While Zhong et al teach hybridization reactions (paragraph 0102), neither Watkins et al nor Zhong et al teach the duration of the time interval (i.e., claim 6).
However, Becker teaches methods of studying association rates of polynucleotides (Title) comprising obtaining signals (paragraph 0040), wherein the signals are measured in an 8 minute time interval (i.e., claim 6), disassociation constants (k2, paragraph 0114) of .000833 per second (i.e., claim 8; paragraph 0115). Becker also measures the associations constant (i.e., k1; paragraph 0114); thus, there is a repeated transient association because the binding involves both association and dissociation (i.e., claim 7). Becker further teaches negative controls (i.e., claim 15), in the form of no polymer control sets (paragraph 0148). Thus, Becker teaches the known techniques discussed above.
It is reiterated that the courts have 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.
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).
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.
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 Becker with Watkins et al and Zhong et al to arrive at the instantly claimed method with a reasonable expectation of success. It would have been obvious to the ordinary artisan that the known techniques of Becker could have been combined with Watkins et al and Zhong et al with predictable results because the known techniques of Becker predictably result in reliable conditions for obtaining signals.
15. Claim 15 is rejected under 35 U.S.C. 103 as obvious over Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claim 1 above, and further in view of Singer et al (U.S. Patent No. 5,866,331, issued 2 February 1999).
It is noted that while claim 15 has been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 15, the method of claim 1 is discussed above in Section 12.
While Zhong et al teach hybridization reactions (paragraph 0102), neither Watkins et al nor Zhong et al teach the standard deviations related to negative controls.
However, Singer et al teach hybridization protocols where the threshold is determined using calculating the threshold based on the mean and standard deviation using a negative control (column 2, lines 40-55), which has the added advantage of allowing accurate determination of total emission intensity (Abstract). Thus, Singer 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 Singer et al with Watkins et al and Zhong et al 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 accurate determination of total emission intensity as explicitly taught by Singer et al (column 2, lines 40-55). In addition, it would have been obvious to the ordinary artisan that the known techniques of Singer et al could have been combined with Watkins et al and Zhong et al with predictable results because the known techniques of Singer et al predictably result in improved accuracy of signal intensity.
Double Patenting
16. 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.
17. Claims 1-5 and 9-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,093,967 B2 in view of Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012).
Both sets of claims are drawn to analyzing time resolved data, Poisson processes, dwell ties, thresholds, standard deviations, negative controls, etc. Any additional imitations of the ‘967 claims are encompassed by the open claim language “comprising” found in the instant claims.
The additional limitations of the instant claims, and the reasons for combining, are discussed above.
18. Claims 3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,093,967 B2 in view of Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claim 1 above, and further in view of Lakin et al (J. R. Soc. Interface, vol. 9, pages 1470-1485, published online 4 January 2012) based on the citations and rationale provided above.
19. Claims 6-8 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,093,967 B2 in view of Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claims 1 and 5 above, and further in view of Becker (U.S. Patent Application Publication No. US 2002/0164614 A1, published online 7 November 2002) based on the citations and rationale provided above.
20. Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,093,967 B2 in view of Watkins et al (J. Phys. Chem. B., vol. 109, pages 617-628, published online 14 December 2004) and Zhong (U.S. Patent Application Publication No. US 2012/0015825 A1, published 19 January 2012) as applied to claim 1 above, and further in view of Singer et al (U.S. Patent No. 5,866,331, issued 2 February 1999).
Prior Art
21. The following prior art is hereby made of record, but not presently relied upon for any rejection, as it is considered pertinent to Applicant's disclosure.
A. Winters-Hilt et al (U.S. Patent Application No. US 2013/0071837 A1, listed on the IDS filed 2 June 2023) discusses time-domain thresholding with respect to DNA hairpins (paragraph 0058).
B. Fodor et al (U.S. Patent Application No. US 2011/0160078 A1) teach determination thresholds with respect to labeled molecules (paragraph 0103).
C. Stoughton et al (U.S. Patent Application No. US 2007/0026391 A1) teach time resolved fluorescence signals (paragraph 0007) and threshold levels (paragraph 0201).
Conclusion
22. No claim is allowed.
23. 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