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 .
Notice of New Examiner
This case has been transferred to a new examiner for continued examination. Any further communications regarding this case may be directed to the contact information included in the conclusion of this office action.
Election/Restrictions
Applicant’s election without traverse of “equine influenza virus” in the reply filed on 11/17/2025 is acknowledged. The requirement to select a pathogen is withdrawn upon further consideration.
Status of Claims
Applicant’s amendment filed 11/17/2025 is acknowledged. Claims 3-5, 8-11, and 13-15 have been amended. Claims 16-21 have been added. Claims 1-21 are pending in the instant application and the subject of this non-final office action.
Specification
The use of the terms including “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, it is 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 claim 2, the claim recites “forward inner primer (FIP), backward inner primer (BIP), loop primer forwards (LPF), and loop primer backwards (LPB)”. The specification defines “forward inner primer” as “a forward primer that comprises a sequence for strand initiation and a sequence hybridisable to the same FIP-initiated strand” and “backward inner primer” as “a backward primer that comprises a sequence for strand initiation and a sequence hybridisable to the same BIP-initiated strand” (pg. 7, para 2). “Forward primer” is defined as “a primer priming the sense strand of a DNA sequence” and “backward primer” is defined as “a primer priming the antisense strand of a DNA sequence” (pg. 5, para 1).
Likewise, “loop primer forward” and “loop primer backward” are defined as “a loop primer that is”, respectively, “a forward primer” or “ a backwards primer” (pg. 7, para 2). “Loop primer” is further defined as “a DNA primer comprising a sequence that is hybridisable to at least one loop region of an amplification product of the pre-determined RNA sequence,” wherein the “loop region is formed by the annealing of a strand of an amplification product to itself” (pg. 7, para 1).
Claim Objections
Claim 10 is objected to because of the following informalities: The claim has a comma between “labeled” and “using” in the second to last line; this should be removed.
Appropriate correction is required.
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.
Claims 1, 3-17, and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 3, the claims recite “outer … primer”. The term “outer” is a comparative term which renders the claim indefinite. The term “outer” is not defined by the claim or the specification, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention absent an appropriate point of comparison (i.e., “inner”) in the claims.
It is noted that, in the context of claim 18, the interpretation of “outer forward primer (F3)” would be clear to one of skill in the art given the narrower scope of “LAMP primers” and the established use of this terminology paired with “F3” within that scope.
Claims 3-17 and 19-20 are indefinite for depending from claim 1 and not rectifying the deficiency.
Regarding claims 10 and 16, the claims recite “wherein the elongated sequence comprises double-stranded elongated DNA, and the presence of the double-stranded DNA sequence is determined by using a nucleic acid molecule hybridizable to the double-stranded elongated DNA sequence, wherein the nucleic acid molecule is labeled, using a molecule that intercalates in the double-stranded elongated DNA sequence” (claim 10) or “wherein the elongated sequence comprises double-stranded elongated DNA, and the presence of the double-stranded DNA sequence is determine by a nucleic acid molecule hybridizable to the double stranded elongate DNA sequence using turbidity measurement” (claim 16).
It is not clear whether the “a nucleic acid molecule” is intended to be a strand of the double-stranded elongated DNA or a separate molecule. If the latter, it is not clear whether it is intended to be one of the nucleic acid molecules recited in claim 1 (e.g., the primers or pre-determined nucleic acid sequence) or a yet undisclosed molecule (e.g., a probe), wherein it would be unclear how it participates in the “determining” of the presence the double-stranded elongated DNA of each claim.
For claim 10, it is noted that intercalating dyes, as defined by the specification (see pg. 16, para 1), bind double-stranded nucleic acid molecules (e.g., the double-stranded elongated DNA), that the double-stranded elongated DNA sequence is what is being detected in the claim, and that it is already stated that another molecule intercalates in the double-stranded elongated DNA.
Similarly, for claim 16, it is noted that turbidity measurement, as generally described in the art and in the exemplary embodiments on pg. 17, para 1, is feature of the amplification reaction.
Regarding claim 11, the claim recites “administering … an efficient amount of a … drug”. The term “efficient” is a relative term which renders the claim indefinite. The term “efficient” 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.
The specification defines “most efficient” in pg. 6, para 2; however, the definition is only in the context of detection. It is unclear what is meant by efficient in this context (financial efficiency, time efficiency, minimal cell death efficiency, etc.) and therefore how the artisan is intended to ascertain such an amount. Therefore, the metes and bounds would not be clear to one ordinary skill in the art.
Claims 13-15 and 20 are indefinite for depending on claim 11 and not rectifying the deficiency.
Regarding claim 19, the claim recites “wherein the pathogen”. There is insufficient antecedent basis for this limitation in the claim.
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 1-9, 11-15, and 17-21 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 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)?
The claims recite determining the presence of a pre-determined nucleic acid sequence in a sample comprising 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 presence of the pre-determined nucleic acid sequence in the sample.
The claims are 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, the claim further recites adding enzyme(s) with DNA polymerase and strand-displacement activity and at least five primers to the sample and incubating at a fixed temperature, wherein no F3 primer is used. It is noted that incubating at other temperatures is not precluded.
Such steps are necessary data gathering for determining whether a double-stranded elongated DNA sequence is present in the sample and therefore represents insignificant extra-solution activity. The use of such polymerases and sets of primers are well-known and conventional in the art. For example:
Lobato (Lobato IM, O'Sullivan CK. Recombinase polymerase amplification: Basics, applications and recent advances. Trends Analyt Chem. 2018 Jan; 98:19-35; as cited in the IDS dated 11/17/2025) 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; as cited in the IDS dated 11/17/2025) 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).
Xu (Xu G, et al. Cross priming amplification: mechanism and optimization for isothermal DNA amplification. Sci Rep. 2012;2:246. Epub 2012 Feb 3.) teaches CPA as a class of isothermal amplifications carried out by a strand displacement DNA polymerase at a temperature of 63 C comprising primers that bind to forward and “backwards” strands and have inner and outer primers, including those that bind in the “loop” sections of the generated product, wherein a basic CPA mixture utilizes five primers and none are called “F3” (Abstract; Fig 1A; Methods, para 3).
Thus, the claims fail to recite more than well-known and conventional methods necessary for the data gathering of the judicial exception. See MPEP 2106.05(g) and 2106.04(d)(I). Therefore, the claim remains directed to the judicial exception.
Regarding claims 2-3 and 18, the claims recite limitations directed to specific classes of primers (claims 2-3; see Claim Interpretation) and or characterize the class of LAMP primers (claim 18). Such primers encompass those that are well-known within the art (see the 102 rejection and Prior Art below). Accordingly, the claims fail to recite more than well-known and conventional methods necessary for the data gathering of the judicial exception and remain directed to the judicial exception.
Regarding claims 8-9, broadly interpreted, as the claims recite “comprising”, the fixed temperature and incubation may encompass just one of many temperature points in an elongation. Xu teaches temperatures of at least 58-68 C and times including 60 min (pg., 4, Optimization and Characterization of the single crossing CPA Assay, para 1-3). Thus, the claims fail to recite more than well-known and conventional methods necessary for the data gathering of the judicial exception
Regarding claims 4-7, 17, and 19, the claims recite limitations directed to targets, and in doing so direct the types of samples and/or data type to be manipulated and/or field of use. See MPEP 2106.05(h) and 2106.05(g).
Regarding claims 11-15, and 20, the claims recite the additional limitation of treating an animal infected by a pathogen by administering an efficient amount of a therapeutic drug subsequent to determining that the animal has been infected by the pathogen using the method of claim 1.
Each of the limitation(s) of the claims fails to provide a particular treatment or prophylaxis as required by MPEP 2106.04(d)(2) because the treatment is generically recited (claims 11-13 and 15) and/or it fails to have more than a nominal or insignificant relationship to the exception (claim 15). For example, in claim 15, a generically recited pathogen may encompass a viral infection to which an antibiotic would have no more than a nominal or insignificant relationship.
It is noted that EIV does not appear to have a known anti-viral medication available in the art, and treating secondary infections associated with a viral infection would not typically be considered particular to the identified infection.
Step 2B. Does the claim amount to significantly more?
Regarding claims 1-9, 11-15, 17-21, the claims to not include addition elements that are sufficient to amount to significantly more than the judicial exception because the practical steps of the claims are well understood, routine, and conventional in the related art, as cited in Step 2A Prong Two. In the instant case, the additional elements are data gathering steps or generically recited treatment steps. As discussed in MPEP 2106.05, the other limitations directed to particular types of data sources to be manipulated likewise do not amount to significantly more. Similarly, as discussed above, the treatments are not particular. For these reasons, the claims as a whole are not 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-11, 13, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Georgiou (WO 2019/234251 A1; published 12/12/2019; as cited in the IDS dated 11/17/2025), 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 cited in the IDS dated 11/17/2025).
Regarding claim 1-4, 11, and 18, Georgiou teaches a method for determining presence of a pre-determined nucleic acid sequence in a sample (pg. 47; claim 9), wherein the sample may be animal matter (pg. 24, para 1), the method comprising the steps of:
adding an enzyme to the sample to be analyzed 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);
adding at least five DNA primers to the sample, wherein at least one DNA primer comprises a sequence hybridizable to the nucleic acid sequence and at least one DNA primer comprises a sequence hybridizable to the 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 [LPF] and backward loop primer [LPB]; pg. 22, lines 22-23; pg. 22, lines 36-37; B3; pg. 22, para 3; see also claim 9/7/6/1; instant claims 2-3)
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]);
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)).
administering a drug to the subject in need thereof (pg. 47 (c); see also claim 10 and pg. 48, para 1; instant claim 11)
Georgiou teaches a polymerase with strand-displacement activity at least by teaching that the DNA polymerase when the nucleic acid sequence is DNA (instant claim 4) 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 that if the nucleic acid sequence if RNA, the method may also comprise reverse transcription of the RNA to produce cDNA (pg. 9, lines 36-40; instant claim 4)
Georgiou teaches that such and amplification is LAMP (entire document); therefore, the primers are LAMP primers (instant claim 18).
Regarding claims 5-6 and 13, Georgiou teaches that the nucleic acid may be a nucleic acid from a pathogen (throughout document, e.g., pg. 24, para 1; instant claim 5) and may be a bacteria, virus, fungi or parasite (pg. 48, para 2; instant claims 6 and 13).
Regarding claim 8, Georgiou teaches that the reaction mixture may be held under isothermal conditions, wherein the temperature may be around 50 to 70 C (pg. 6, lines 2-9; see also pg. 6, para 5).
Regarding claim 9, Georgiou teaches that duration of amplification may be 1 to 150 minutes, including 5 to 60 minutes (pg. 6, para 1; see also pg. 6, line 40).
Regarding claims 10 and 16, Georgiou teaches detection of amplification products [i.e., double-stranded elongated DNA sequences/molecules] by turbidity and nucleic acid intercalating agents (pg. 7, para 2).
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) 7, 12, 14-15, 17, and 19-21 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 claims 1, 6, 11, 13, and 18 above, and in view of Young (Young A, Pusterla N. Equine influenza (flu) [Internet]. UC Davis Veterinary Medicine Center for Equine Health; 2019 [cited 2026 Feb 11]. Available from: https://ceh.vetmed.ucdavis.edu/health-topics/equine-influenza-flu).
Regarding claim 7, 12, 14-15, 17, and 19-21, in the method of Georgiou, evidenced by Tanner, Georgiou teaches that such infectious diseases may comprise Influenza and Eastern Equine Encephalitis (pg. 48, para 3). It is noted for the sake of compact prosecution, Georgiou also teaches that the infectious disease may comprise Herpes and Streptococcal Disease (pg. 48, para 3, spanning pg. 49).
Georgiou teaches LAMP has high efficiency, high amplification yield, and high specificity, and may be used as an alternative to PCR for point of care applications (pg. 2, para 1). Georgiou teaches that thermal cycling, electrophoresis, and/or mollified oligos for validation elevates the time and cost per sample of PCR-based methods and prevents them from being widespread to decentralized areas (pg. 1, para 3).
Georgiou fails to explicitly teach that the pathogen is Equine influenza virus, that the animal is a horse, or specific therapeutic drugs.
Young rectifies this by teaching that equine influenza is a highly contagious respiratory disease with a high rate of transmission among horses and a short incubation time (pg. 3, What are the clinical signs of equine influenza?). Young teaches that infection cannot be diagnosed based on clinical signs alone, that the testing window is short in previously vaccinated horses, and that testing for EIV at one facility is performed as part of a nucleic acids-based panel comprising Streptococcus equi equi (pg. 4, para 1-2; instant claims 7, 12, 19, 17, and 21).
Young teaches that horses are particularly susceptible to secondary infections such as bacterial pneumonia 2-3 weeks after infection (pg. 3, What are the clinical signs of equine influenza?). Young teaches that horses diagnosed positive should be on stall rest and taken out of training for a minimum of one week for every day of fever, wherein if fever persists, purulent nasal discharge is present or if horses get pneumonia, antibiotics may be indicated (pg. 4, How is equine influenza treated?; instant claims 14-15 and 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the method of Georgiou evidenced by Tanner to the pathogen(s) and subjects of Young, wherein it would have been obvious to have followed the treatment plan of treating EIV positive horses with antibiotics if fever any of the discussed conditions are met, motivated by the desire to apply the high efficiency POC LAMP as an alternative to PCR of Georgiou to the highly contagious disease in order to reduce barriers associated with PCR-based tests to better address the testing window time issues taught by Young, wherein it would follow to apply the standard of care treatments based on the diagnosis as taught. There would be a strong expectation of success as both are directed to nucleic acid amplification tests in animals, and such represents the application of a known method to a known target, wherein Georgiou teaches applying the technique to variety of diseases for which the artisan would similarly be able to develop primers and optimize the test.
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.
The following claims are rejected on the ground of nonstatutory double patenting as being unpatentable over the indicated claims of the listed copending Applications in view of Georgiou (WO 2019/234251 A1; published 12/12/2019; as cited in the IDS dated 11/17/2025) and Young (Young A, Pusterla N. Equine influenza (flu) [Internet]. UC Davis Veterinary Medicine Center for Equine Health; 2019 [cited 2026 Feb 11]. Available from: https://ceh.vetmed.ucdavis.edu/health-topics/equine-influenza-flu). These are each a provisional nonstatutory double patenting rejection.
Application:
Instant claims rejected:
Rejected over claims:
Fails to recite:
Other notes:
18/008,809
1-21
1-8 and 10-15
• Sample obtained from animal/horse; •Treating with drug, and specific drugs; •Pathogen is EIV or others of claim 7
• Teaches Mollicutes, including M. arginini and others with non-human animal tropisms
18/009,142
1-21
1-14
• Sample obtained from non-human animal/horse; •Pathogen is EIV or others of claim 7
Each set of claims is directed do a method of adding one or more enzymes with RNA/DNA-dependent DNA pol activity and strand displacement activity; adding at least five DNA primers comprising primers hybridizable to both the forward and reverse strands; incubating the sample at a fixed temperature; and determining whether an elongated DNA sequence indicative of a pre-determined sequence is present, wherein no F3 primer is used.
Each set likewise teaches FIP/BIP and LPF/LPB; B3; RNA or DNA; at least one pathogen origin for the pre-determined sequence; that the pathogen may be a bacterium; detection via intercalating molecule or turbidity; temperature; and time.
Motivating reference Georgiou teaches that LAMP has high efficiency, high amplification yield, and high specificity, and may be used as an alternative to PCR for point of care applications (pg. 2, para 1). Georgiou teaches that thermal cycling, electrophoresis, and/or mollified oligos for validation elevates the time and cost per sample of PCR-based methods and prevents them from being widespread to decentralized areas (pg. 1, para 3).
Young teaches teaching that equine influenza is a highly contagious respiratory disease with a high rate of transmission among horses and a short incubation time (pg. 3, What are the clinical signs of equine influenza?). Young teaches that infection cannot be diagnosed based on clinical signs alone, sampling from sick horses, that the testing window is short in previously vaccinated horses, and that testing for EIV at one facility is performed as part of a nucleic acids-based panel comprising Streptococcus equi equi (pg. 4, para 1-2).
Young teaches that horses are particularly susceptible to secondary infections such as bacterial pneumonia 2-3 weeks after infection (pg. 3, What are the clinical signs of equine influenza?). Young teaches that horses diagnosed positive should be on stall rest and taken out of training for a minimum of one week for every day of fever, wherein if fever persists, purulent nasal discharge is present or if horses get pneumonia, antibiotics may be indicated (pg. 4, How is equine influenza treated?).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the methods of the copending Applications to the pathogen(s) and subjects of Young, wherein it would have been obvious to treat as indicated with the treatment plan of treating EIV positive horses with antibiotics if fever any of the discussed conditions are met, motivated by the desire to apply the high efficiency POC LAMP as an alternative to PCR as taught by Georgiou to the highly contagious disease in order to reduce barriers associated with PCR-based tests to better address the testing window time issues taught by Young, wherein it would follow to apply the standard of care treatments based on the diagnosis as taught. There would be a strong expectation of success as both are directed to nucleic acid amplification tests in animals, and such represents the application of a known method to a known target wherein the artisan would be capable of substituting samples and targets.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Martineau (US 20170107549 A1; published 04/20/2017) teaches a set of six LAMP primers comprising FIP/BIP, LF/LB [LPF/LPB], and F1S/B1S (para [0094]), wherein the F1S/B1S “swarm” primers overlap an F1 site (Abstract) and therefore would not reasonably be considered outer primers.
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; as cited in the IDS dated 11/17/2025) 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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma R Hoppe whose telephone number is (703)756-5550. The examiner can normally be reached Mon - Fri 11:00 am - 7:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMMA R HOPPE/Examiner, Art Unit 1683
/NANCY J LEITH/Primary Examiner, Art Unit 1636