DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Applicant’s amendment filed 08/04/2023 is acknowledged. Claims 3-5, 8-11, and 13-14 have been amended. Claims 1-14 are pending in the instant application and the subject of this non-final office action.
Specification
The use of the terms including but not limited to “SYBR Green” and “EvaGreen”, each which is a trade name or a mark used in commerce, has been noted in this application. The such terms should be accompanied by the generic terminology; furthermore such terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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 Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP 2111.
Regarding claim 1, the claim recites “a human subject”. The specification recites “the indefinite article ‘a’ or ‘an’ does not exclude a plurality” (pg. 22, para 3). Therefore, the term was interpreted to encompass one or a plurality of human subjects.
It is further noted that the steps of adding a strand-displacing polymerase followed by addition of at least five primers and at least one step of incubating at a fixed temperature before determining the presence of an elongated DNA sequence read on a variety of multiplexed amplification techniques, including multiplex PCR that utilizes a strand displacement polymerase (see Prior Art at conclusion, for example), in addition to single-plex techniques that require five or more primers, such as LAMP.
Regarding claims 1 and 10, the claims recite “elongated DNA sequence” (claim 1) or “double-stranded DNA sequence” (claim 10). The term was interpreted broadly to encompass DNA molecules or sequences of molecules including those have undergone via a replication reaction, i.e., elongation (instant specification, pg. 4, para 2: “e.g., via an enzymatic nucleic acid replication reaction”) and those that have otherwise undergone a “lengthening”.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the claim recites “wherein presence of the double-stranded elongated DNA sequence in the sample is determined by using a nucleic acid molecule hybridisable to the double-stranded elongated DNA sequence, in particular wherein the nucleic acid molecule is labelled, using a molecule that intercalates in the double-stranded elongated DNA sequence or using turbidity measurement.”
First, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Second, the claim appears to require “a nucleic acid molecule” capable of hybridizing to a double-stranded elongated DNA molecule. However, the preferred embodiments seem inconsistent with such an interpretation.
The specification defines “intercalates” as “an agent or moiety capable of non-covalent insertion between stacked base pairs in a nucleic acid double helix” (pg. 16, para 2; emphasis added). It is not clear how a nucleic acid hybridizable to a double-stranded sequence (i.e., forming triplex DNA?) is compatible with the preferred embodiment of an intercalating agent. Likewise for turbidity, the specification describes, for example, the embodiment in which pyrophosphate ions released during polymerization result in an insoluble magnesium pyrophosphate precipitate (pg. 17, para 1), wherein no additional probe or similar molecule is present.
For these reasons, the claim has been interpreted, for the purposes of applying art, that the nucleic acid molecule hybridizable to the double-stranded elongated DNA sequence may originate from the elongation [e.g., be one strand of the double-stranded elongated DNA sequence] or my hybridize to either strand of the double-stranded DNA sequence.
Claim Rejections - 35 USC § 101
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.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. This judicial exception is not integrated into a practical application The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The following three inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter?
Yes, the claims 1-14 are directed to a process.
Step 2A, prong 1. Does the claim recite a law of nature, a natural phenomenon, or an abstract idea (recognized judicial exceptions)?
Regarding claims 1-14, the claims recite determining whether an elongated DNA sequence is present in the sample, wherein the presence of the elongated DNA sequence in the sample is indicative of the pre-determined nucleic acid sequence in the sample (as recited in claim 1). The claims are thus directed to the abstract idea of a mental process (observations, evaluations, or judgements of visual input, data, or information to render a judgement or opinion). See MPEP 2106.04(a).
Step 2A, prong 2. Are the judicial are integrated into a practical application?
Regarding claims 1-10, the judicial exception is not integrated into a practical application because the claims do not include additional elements that amount to significantly more than well understood, routine and conventional steps in the art, wherein such are utilized for data gathering for the step (d) that encompasses a mental process.
It is noted that Lobato (Lobato IM, O'Sullivan CK. Recombinase polymerase amplification: Basics, applications and recent advances. Trends Analyt Chem. 2018 Jan;98:19-35.) teaches that strand-displacing polymerases and multiplexing are well known among isothermal techniques (pg. 19, 2.1. RPA mechanism, para 1, spanning pg. 20; pg. 19, Introduction, para 1; Table 1; see also Tables 2-6 for targets and samples).
Elnifro (Elnifro EM, et al. Multiplex PCR: optimization and application in diagnostic virology. Clin Microbiol Rev. 2000 Oct;13(4):559-70) likewise teaches that set of at least 5 primers for amplification are well known within the art (pg. 563, col 2, para 2; pg. 567, col 2, para 1).
Likewise, Gnann (Gnann Jr. JW. Antiviral therapy of varicella-zoster virus infections. In: Arvin A, Campadelli-Fiume G, Mocarski E, et al., editors. Human Herpesviruses: Biology, Therapy, and Immunoprophylaxis. Cambridge: Cambridge University Press; 2007. Chapter 65. Available from: https://www.ncbi.nlm.nih.gov/books/NBK47401/) teaches widespread use of an anti-infective/anti-viral to treat, e.g., the pathogen VZV (pg. 3, para 3).
It is further noted that the particular pathogen and the sample merely directs the selection of the data for the previously discussed data gathering methods.
Therefore, the claims are directed to the abstract idea.
Regarding claims 11-14, the claims recite a method for treatment using the method of claim 1. As is discussed in MPEP 2106.04(d)(2), effecting a particular treatment demonstrates integration into a practical application. Administering an effective dose of a generically recited “anti-infective” (claim 11) or “antiviral, antibiotic, antifungal, or antiparasitic” (claim 13) to treat a generically recited “pathogen” is not particular. Thus, the claims, in addition to the reasons discussed for 1-10, these claims are not integrated into a practical application under Step 2A Prong Two and remain directed at the judicial exception.
Step 2B. Does the claim amount to significantly more?
Regarding claims 1-14, the claims do not include addition element that are sufficient to amount to significantly more than the judicial exception because the practical steps of the claims are well understood, routine, and convention in the related art, as cited in Step 2A Prong Two. In the instant case, the additional elements are data gathering steps. Application to particular pathogens and samples represents a selection of specific data. The treatment steps in the methods comprising treatment are not particular. Therefore, no claims include additional elements sufficient to represent significantly more.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piepenburg (Piepenburg O, et al. DNA detection using recombination proteins. PLoS Biol. 2006 Jul;4(7):e204.).
Regarding claims 1, 4, and 9, Piepenburg teaches a method comprising:
Adding Bsu to human DNA [i.e., a sample from one or more human subjects] (pg. 1118, RPA conditions, para 1; pg. 1118, Proteins and DNA; pg. 1120, Figure S3, para 1; pg. 1115, Results/Discussion para 1; instant claim 4).
Adding at least six primers to the sample (pg. 1118, RPA conditions, para 1; Figure S3., para 1), wherein at least one primer is hybridizable to one strand and the other is hybridizable to its reverse-complement (Fig. 1) and wherein any one of the targets may be considered the pre-determined the nucleic acid sequence
Incubating at a temperature for 120 min (pg. 1120, Figure S3, para 1; instant claim 9)
Determining whether an elongated DNA sequence is present in the sample wherein the elongated DNA sequence is indicative of the pre-determined nucleic acid in the sequence (Fig. 2), wherein any of the targeted genes (ApoB, Sry, or PBDG) may be considered the “pre-determined nucleic acid sequence”
F3 is not among the primers used in Piepenburg (pg. 1118, RPA conditions, para 1).
Piepenburg teaches that Bsu strand displacing activity (pg. 1115, Introduction, para 2) and that RP utilize a DNA polymerase (pg. 1115, Introduction, para 2). As Bsu is a functioning as DNA polymerase operating on a DNA substrate, it is thus interpreted to be a DNA-dependent DNA polymerase.
For at least these reasons, claims 1, 4, and 9 are anticipated by Piepenburg.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 4-6, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piepenburg (Piepenburg O, et al. DNA detection using recombination proteins. PLoS Biol. 2006 Jul;4(7):e204.).
Regarding claims 1, 4, and 9, Piepenburg teaches adding a DNA-dependent DNA polymerase with SDA to a human DNA sample (pg. 1118, RPA conditions, para 1; pg. 1118, Proteins and DNA; pg. 1120, Figure S3, para 1; pg. 1115, Results/Discussion para 1; pg. 1115, Introduction, para 2; instant claim 4); adding at least six primers to the sample (pg. 1118, RPA conditions, para 1; Figure S3., para 1), wherein the pairs of primers are hybridizable to antiparallel strands of the DNA (Fig. 1) wherein any one of the targets may be considered the pre-determined the nucleic acid sequence; incubating at a temperature for 120 min (pg. 1120, Figure S3, para 1; instant claim 9); and determining whether an elongated DNA sequence is present in the sample wherein the elongated DNA sequence is indicative of the pre-determined nucleic acid in the sequence (Fig. 2), wherein any of the targeted genes may be considered the “pre-determined nucleic acid sequence”. F3 is not among the primers used in Piepenburg (pg. 1118, RPA conditions, para 1).
Regarding claims 5, 6, and 10, in the method of Piepenburg, Piepenburg fails to explicitly teach a single method of identifying a sequence from a pathogen and wherein detection is performed by utilizing a nucleic acid molecule hybridizable to elongated DNA sequence while utilizing a human sample.
Piepenburg rectifies this by an additional method of multiplexed RPA targeting [the bacterium] methicillin-resistant Staphylococcus aureus, which is noted to be a common hospital pathogen (pg. 1116, col 2, para 1, spanning pg. 1117, col 2; instant claims 5 and 6).
Piepenburg further rectifies this by teaching the use of a detection probe in the MRSA detection (Fig. 5; Fig. 6; instant claim 10).
Piepenburg teaches the application to a diagnostic device (pg. 1118, col 1, para 1).
Piepenburg teaches that the method is sensitive to fewer than 10 copies of genomic DNA and appropriate to the develop of a portable, instrument-free DNA testing system (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the MRSA primers and detection probe of Piepenburg in the method utilizing a human sample of Piepenburg, motivated by the desire to utilize the isothermal methods in a portable, instrument-free testing system for the common hospital pathogen with a high sensitivity, as taught by Piepenburg. There would have been a strong expectation of success as all methods utilize the same amplification technology and represent the application of a known technique to a known method.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georgiou (WO 2019/234251 A1; published 12/12/2019), as evidenced by Tanner (Tanner, N. Improved Reagents for Isothermal Amplification [Internet]. Ipswich (MA): New England Biolabs, Inc.; 2015 Apr [cited 2025 Aug 26]. Available from: https://www.neb-online.de/wp-content/uploads/2015/04/NEB_isothermal_amp.pdf).
Regarding claims 1, Georgiou teaches a method for determining presence of a pre-determined nucleic acid sequence in a sample (pg. 47), the method comprising the steps of:
(a) adding an enzyme to the sample to be analysed for the presence of the pre-determined nucleic acid sequence (pg. 47, lines 5-8), wherein the enzymes provide activities of RNA- and/or DNA-dependent DNA polymerase activity and strand-displacement activity (pg. 9, para 5-6; pg. 2, para 9);
(b) adding at least five DNA primers to the sample to be analysed for the presence of the pre-determined nucleic acid sequence, wherein at least one DNA primer comprises a sequence hybridisable to the nucleic acid sequence and at least one DNA primer comprises a sequence hybridisable to the DNA sequence reverse-complementary to the nucleic acid sequence (pg. 47: (iv): FIP, (v): BIP, (vi): forward blocking, (vii): backward blocking; pg. 23, lines 10-11: forward loop primer and backward loop primer; pg. 22, lines 22-23; pg. 22, lines 36-37)
(c) incubating the sample resulting from steps (a) and (b) at a fixed temperature (pg. 47, (a): “amplifying under isothermal conditions” [i.e., a fixed temperature]);
(d) determining whether an elongated DNA sequence is present in the sample, wherein presence of the elongated DNA sequence in the sample is indicative of the presence of the pre-determined nucleic acid sequence in the sample (pg. 47, (b))
Georgiou teaches a polymerase with strand-displacement activity at least by teaching that the DNA polymerase when the nucleic acid sequence is DNA may be Bst 2.0 DNA polymerase (pg. 9, para 5), evidenced by Tanner. While Georgiou does not explicitly teach that the polymerase itself has strand-displacement activity, it is inherently taught because Bst 2.0 has strand-displacement activity, evidenced by Tanner (pg. 4, para 1: “Bst 2.0 DNA polymerase possesses … strong strand-displacement activity”).
Georgiou teaches an embodiment without F3 (pg. 22, lines 22-23: “The reaction mixture may further comprise … F3 … and/or … B3 …” (emphasis added); pg. 22, lines 36-37: “The present inventors have determined that detectable amplification of the nucleic acid can occur in the absence of F3 and/or B3”). Georgiou teaches [traditional] LAMP uses four to six primers in the reaction (pg. 2, line 9), and that the efficiency of the reaction is enhanced by the addition of B3 (pg. 23, lines 6-7) and LF and LB (pg. 23, line 22).
Georgiou teaches that detection of genetic markers is still a major challenge for molecular-based diagnostic technologies, especially for those aiming to be deployed at point-of-care (PoC) (pg. 1, para 2).
Georgiou does not explicitly teach that the sample is from a human subject.
Georgiou rectifies this by teaching that the sample may be a clinical sample (pg. 24, line 1-2) from a patient (pg. 24, line 22). Georgiou teaches that the method is a method for the treatment of an infectious disease in a subject in need thereof (pg. 47, lines 1-2) and that infectious diseases can be spread from one person [i.e., human] to another (pg. 48, para 3). Georgiou teaches that the infectious disease may be selected from infectious diseases including Human Immunodeficiency Virus (HIV) and Human Papillomavirus (HPV) (pg. 48, line 38) or human-infective malaria (pg. 25, line 19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize human samples in the method of Georgiou as evidenced by Tanner, motivated by the desire to detect and administer the drug to the subject who is in need thereof and/or to address treatment to the species of the human infectious diseases of Georgiou and address the threats to global public health, as taught by Georgiou.
It further would have been oblivious to add LF [instant LPF] and LB [instant LPB] and/or B3 in the method of determining the presence of a sequence in a sample Georgiou evidenced by Tanner, motivated by the desire to increase the efficiency the reaction, as taught by Georgiou.
There would be a strong expectation for success as the methods fall within the scope of Georgiou and are a combination of prior are elements according to known methods to yield predictable results.
Further, while Georgiou teaches embodiments with FIP, BIP, FB, BB, LF, LB, and L3 (at least 5 primers), the total number of primers utilized represents a matter for efficiency/optimization, as taught by Georgiou (e.g., typical number of LAMP primers, addition of LB and LF and/or L3).
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 range of the number of primers merely represents routine optimization of the vales of the cited prior art.
Applicant is advised that 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, Applicant should not merely rely upon counsel's arguments in place of evidence in the record.
Regarding claim 2, in the method of Georgiou as evidenced by Tanner, as cited in the rejection of claim 1, Georgiou teaches primers including FIP and BIP in the method and an embodiment in which LF [instant LPF] and LB [LPB] are added to improve efficiency. The same motivations and expectations for success as above apply.
Regarding claim 3, in the method of Georgiou as evidenced by Tanner, as cited in the rejection of claim 1, Georgiou teaches a method with FIP, BIP, and forward and backward blocking primers and an embodiment in which B3 is added to improve efficiency. The same motivations and expectations for success as above apply. The matter of B3 being “the fifth primer” is mere nomenclature and any of the primers, including B3, may be considered “the fifth primer”.
Regarding claim 4, in the method of Georgiou as evidenced by Tanner, Georgiou teaches that the nucleic acid sequence may be DNA or RNA (pg. 9, line 30).
Regarding claim 5, in the method of Georgiou as evidenced by Tanner, Georgiou teaches that the nucleic acid may be from a pathogen (pg. 25, line 2).
Regarding claim 6, in the method of Georgiou as evidenced by Tanner, Georgiou teaches the pathogen [i.e., infectious disease; see also pg. 48, line 19] may be a virus, a bacterium, a fungus, or a parasite (pg. 25, lines 7-9; pg. 48, line 20).
Regarding claim 7, in the method of Georgiou as evidenced by Tanner, Georgiou teaches the pathogen [i.e., infectious disease] may be Herpes Zoster VZV [i.e., Human Herpesvirus 3] (pg. 48, line 38).
Regarding claim 8, in the method of Georgiou as evidenced by Tanner, Georgiou teaches that the temperature for the isothermal conditions may be around 50 to 70 C (pg. 6, line 8).
Regarding claim 9, in the method of Georgiou as evidenced by Tanner, Georgiou teaches the amplifying duration may be around 1 to 150 minutes and ranges in between (pg. 6, para 2).
Regarding claim 10, in the method of Georgiou as evidenced by Tanner, Georgiou teaches detection by turbidity and nucleic acid intercalating agents (pg. 7, line 8).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georgiou (WO 2019/234251 A1; published 12/12/2019), as evidenced by Tanner (New England Biolabs, Inc. Isothermal Amplification [Internet]. Ipswich (MA): New England Biolabs, Inc.; 2015 Apr [cited 2025 Aug 26]. Available from: https://www.neb-online.de/wp-content/uploads/2015/04/NEB_isothermal_amp.pdf) as applied to claim 1 above, and further in view of Gnann (Gnann Jr. JW. Antiviral therapy of varicella-zoster virus infections. In: Arvin A, Campadelli-Fiume G, Mocarski E, et al., editors. Human Herpesviruses: Biology, Therapy, and Immunoprophylaxis. Cambridge: Cambridge University Press; 2007. Chapter 65. Available from: https://www.ncbi.nlm.nih.gov/books/NBK47401/).
Regarding claims 11-14, in the method of Georgiou as evidenced by Tanner, Georgiou further teaches that the method is a method for method for the treatment of an infectious disease or a drug-resistant infection in a subject in need thereof (pg. 47, lines 1-2) and that it further comprises administering a drug to the subject in need thereof (pg. 47, (c)).
Georgiou teaches that treating the infectious disease comprises administration of a therapeutic agent to which the infection is not resistant [i.e., an anti-infective composition] (pg. 48, para 1).
As cited in claim 7, Georgiou teaches that teaches the pathogen [i.e., infectious disease] may be Herpes Zoster VZV [i.e., Human Herpesvirus 3] (instant claims 12 and 14; for 12, see also the citations of claim 6 above).
Georgiou fails to explicitly teaches “an effective dose”.
Gnann rectifies this by teaching that oral acyclovir, dosed at 800 mg five times daily for 7 days, was capable of accelerating cutaneous healing and to reduce the severity of acute neuritis in immunocompetent adults with herpes zoster (pg. 7, Immunocompetent adults, para 2).
Thus, Gnann teaches an effective does of an anti-viral composition. (instant claim 13).
Gnann teaches that the outcomes of varicella and herpes zoster, especially in immunocompromised patients, have been dramatically improved by the development of safe and effective antiviral drugs with potent activity against VZV (pg. 1, Introduction, para 1).
Therefore, it would have been obvious to one of ordinary skill the art at the time of filing to utilize the anti-viral and effective dose thereof of Gnann in the method of Georgiou as evidence by Tanner, motivated by the desire to improve the outcomes of at least immunocompromised patients, as taught by Georgiou. There would have been a strong expectation of success as both are directed toward treating infectious diseases and represent the application of a known technique/compound to a known method.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18/008,809 in view of Cardinale (Cardinale F, et al. Macrolide-resistant Mycoplasma pneumoniae in paediatric pneumonia. Eur Respir J. 2011 Jun;37(6):1522-4.). This is a provisional nonstatutory double patenting rejection.
Both sets of claims are directed to a method of determining a presence of a pre-determined nucleic acid sequence in a sample comprising the steps of adding an RNA/DNA-dependent DNA polymerase with strand-displacement activity and at least five primers, incubating at a fixed sample, and determining whether an elongated DNA sequence is present in the sample, wherein the elongated DNA sequence is indicative of the pre-determined sequence in the sample and wherein no F3 primer is used.
‘809 claim 1 requires that the predetermined sequence be from Mollicutes, wherein ‘809 claim 5 teaches that Mycoplasma is a bacteria of class Mollicutes. The incubation further limitations of instant claims 8 and 9 are taught by ‘809 claims 10 and 11. The detection further limitation of instant claim 10 is taught by’809 claim 12.
Any additional limitations of the ‘809 claims are encompassed by the open claim language “comprising” found in the instant claims.
The claims of ‘809 fail to teach a method for treatment of a subject infected with a pathogen.
Cardinale rectifies this by teaching the importance of determining the prevalence of macrolide resistance among M. pneumoniae strains using molecular methods, and, in the case of macrolide failure during the course of treatment, optimizing the antibiotic strategy (pg. 1524, col 1, para 3), wherein ciprofloxacin treatment (40 mg*kg-^1*day^-1 in two doses) resulted in an improvement in condition of the patient [i.e., was effective] (pg. 1522, col 2, para 3). Cardinale teaches that an A-G transition at position 2,063 of the 23S rRNA gene of M. pneumoniae can be detected during adequate treatment with clarithromycin and seems to be associated with treatment failure (pg. 1524, col 1, para 3).
Therefore, it would have been obvious utilize the method of ‘809 to as the means of detecting the A-G transition at position 2,063 of the 23S rRNA gene indicative of macrolide resistance and to further choose an effective treatment, as taught by Cardinale, motivated by the desire to overcome the treatment failure and provide an effective antibiotic, as taught by Cardinale. There would be a strong expectation of success as both ‘809 and Cardinale are directed to molecular tests of Mollicutes including M. pneumoniae and the 23S rRNA gene, wherein such improvements represent the application of known techniques to known methods.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, and 13-14 of copending Application No. 18/009,498 in view of Cardinale (Cardinale F, et al. Macrolide-resistant Mycoplasma pneumoniae in paediatric pneumonia. Eur Respir J. 2011 Jun;37(6):1522-4.). This is a provisional nonstatutory double patenting rejection.
Both sets of claims are directed to a method of determining a presence of a pre-determined nucleic acid sequence in a sample comprising the steps of adding an RNA/DNA-dependent DNA polymerase with strand-displacement activity and at least five primers, incubating at a fixed sample, and determining whether an elongated DNA sequence is present in the sample, wherein the elongated DNA sequence is indicative of the pre-determined sequence in the sample and wherein no F3 primer is used.
‘498 claim 1 requires that the sample is obtained from an animal. The incubation further limitations of instant claims 8 and 9 are taught by ‘489 claims 8 and 9. The detection further limitation of instant claim 10 is taught by ‘498 claim 10. The treatment instant claims 11, 12, and 13 are respectively taught by claims 11, 13, and 14 of ‘489.
‘489 fails to teach that the pathogen may be Mycoplasma or Human herpes virus (instant claim 7 and 14) and that the animal is a human.
Cardinale rectifies this by teaching that Mycoplasma pneumoniae is one of the most common causes of bacterial community-acquired pneumonia (CAP) in pediatrics [i.e., the medical care of human children] (pg. 1522, col 1, para 1). Cardinale further teaches the importance of determining the prevalence of macrolide resistance among M. pneumoniae strains using molecular methods, and, in the case of macrolide failure during the course of treatment, optimizing the antibiotic strategy (pg. 1524, col 1, para 3). Cardinale teaches that an A-G transition at position 2,063 of the 23S rRNA gene of M. pneumoniae can be detected during adequate treatment with clarithromycin and seems to be associated with treatment failure (pg. 1524, col 1, para 3).
Therefore, it would have been obvious to utilize method of ‘498 as a means of detecting the A-G transition at position 2,063 of the 23S rRNA gene indicative of macrolide resistance and to further choose an effective treatment, as taught by Cardinale, motivated by the desire to overcome the treatment failure, as taught by Cardinale, motivated by the desire to overcome the treatment failure and provide an effective antibiotic, as taught by Cardinale. There would be a strong expectation of success as both ‘498 and Cardinale are directed to molecular tests of animals, of which humans are a species, and bacteria, wherein such improvements represent the application of known techniques to known methods.
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ignatov (Ignatov KB, et al. A strong strand displacement activity of thermostable DNA polymerase markedly improves the results of DNA amplification. Biotechniques. 2014 Aug 1;57(2):81-7.) teaches a DNA-dependent DNA polymerase with uses in PCR, LAMP, and PCDR applications, wherein the strand displacement activity of said polymerase provided a notable improvement in sensitivity and efficacy of all the methods (Abstract).
Conclusion
No claims are allowed.
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/EMMA R HOPPE/ Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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