DETAILED ACTION
The amendment filed on 12/03/2025 has been entered.
Claims 6 and 13 were amended in the claim set filed on 12/03/2025.
No claims were officially canceled in the claim set filed on 12/03/2025.
Claims 1-18 in the claim set filed on 12/03/2025 are currently under examination.
Response to the Arguments
Objections to the Drawings and Specification in the previously mailed non-final have been withdrawn in light of applicants Drawings amendments and additional IDS.
Applicant’s arguments regarding previous rejection(s) of claim(s) 13 under 35 U.S.C. 112 have been fully considered and are persuasive. The 35 U.S.C. 112 rejection documented in the previously mailed non-final has been withdrawn in light of applicants claim amendments and arguments on Pg. 7.
Applicant’s arguments regarding previous rejection(s) of claim(s) 14 under 35 U.S.C. 112 have been fully considered but are not persuasive. The 35 U.S.C. 112 rejection documented in the previously mailed non-final has been maintained in light of applicants’ lack of claim amendment and argument on Pg. 7.
Applicant’s arguments regarding previous rejection(s) of claim(s) 17-18 under 35 U.S.C. 101 have been fully considered but are not persuasive. The 35 U.S.C. 101 rejections documented in the previously mailed non-final have been maintained and revised in light of applicants claim amendments and arguments on Pg. 8.
Applicant’s arguments regarding previous rejection(s) of claim(s) 1-18 under 35 U.S.C. 103 have been fully considered but are not persuasive. Applicant’s argument on Pg. 8, states that “Gundling fails to teach or suggest each and every element of the claims. For example, Gundling does not teach, suggest or even mention a liquid biological sample dried on a solid carrier of claim 1". The 35 U.S.C. 103 rejections documented in the previously mailed non-final have been maintained and revised in light of applicants claim amendments and arguments on Pg. 8-12.
Applicant’s arguments regarding previous rejection(s) of claim(s) 1-18 under Non-statutory double patenting (NSDP), have been fully considered but are not persuasive. The NSDP rejections documented in the previously mailed non-final have been maintained and revised in light of applicants claim amendments and arguments on Pg. 13.
The revised rejections for claims 1-18 are documented below in this Final Office Action.
Priority
This application claims priority to United States provisional patent application 63/238,346, filed August 30, 2021. Accordingly, the priority date of instant claims is determined to be August 30, 2021, the filing date of provisional patent application 63/238,346.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/06/2026 was filed after the mailing date of the non-final office action on 06/03/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Claim 14 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.
Claim 14 is indefinite over the limitation “the plurality of CuTi particles is present in a molar excess relative to the plurality of RNA molecules in the sample”. It is unclear how “a molar excess relative to the plurality of RNA molecules in the sample” is determined and the amount of CuTi particles in excess is that is needed in the claimed method.
Applicants’ argument: “Claim 14 is cancelled herein thereby rendering the Office's rejection moot.” (Pg. 7)
Response: In response to the applicants’ argument above, Claim 14 is still present as originally presented in the claim set filed 12/03/2025. Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
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 17 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards the abstract ideas of obtaining and comparing nucleotide sequences and routine and conventional steps of extracting RNA molecules from a sample and obtaining nucleotide sequence(s), and natural correlation of a specific nucleotide sequence to diagnostic of the viral infection without significantly more. The claim(s) recite(s) abstract ideas, routine and conventional methods, and a natural correlation. This judicial exception is not integrated into a practical application because no additional elements integrate the judicial exceptions into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are considered significantly more than the judicial exceptions.
Claim analysis
The instant claim 17 is drawn towards: The method of claim 1, wherein the method further comprises (i) diagnosing a viral infection in a subject, wherein the diagnosing comprises: (1) obtaining a nucleotide sequence of the released RNA molecules, or of a template- directed polymerization product thereof, and (2) comparing the obtained nucleotide sequence of the released RNA molecules, or the template-directed polymerization product thereof, with a specific nucleotide sequence known to be present in virally infected cells, wherein a match between the compared nucleotide sequences is diagnostic of the viral infection in the subject.
Instant claim 18 depends from claim 17 and recites “wherein the viral infection is an HIV infection”.
The comparing the obtained nucleotide sequence of the released RNA molecules, or the template-directed polymerization product thereof, with a specific nucleotide sequence is an abstract idea.
The obtaining a nucleotide sequence of the released RNA molecules, or of a template- directed polymerization product thereof is an active step. The active step is routine and conventional as demonstrated by the 35 USC § 103 rejections stated below.
The correlation of a specific naturally occurring nucleotide sequence being diagnostic of the viral infection is a natural correlation.
Dependent claims of claim 17 set forth further limitations about the viral infection.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, the claim recites abstract ideas and natural correlation.
The comparing the obtained nucleotide sequence of the released RNA molecules, or the template-directed polymerization product thereof, with a specific nucleotide sequence is an abstract idea.
The correlation of a specific naturally occurring nucleotide sequence being diagnostic of the viral infection is a natural correlation.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? No, there are no additional steps that integrate the claims into a practical application.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, there are no additional elements that are significantly more than the judicial exceptions.
The obtaining a nucleotide sequence of the released RNA molecules, or of a template- directed polymerization product thereof is an active step. The active steps are routine and conventional as demonstrated by the 35 USC § 103 rejections stated below.
Regarding claim 17, the claim requires the routine and conventional active steps of capturing RNA molecules from a biological sample similar to that of Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017).
Gundling discloses systems and methods for purifying nucleic acid. In particular, the present disclosure relates to systems and methods for purifying nucleic acids using metal or metal oxide compositions (Abstract). Thus, the claim does not provide additional steps which are significantly more.
Dependent claims require viral infection is an HIV infection which is routine and conventional based on Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Lofgren et al. (“Lofgren”; (2009). Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities. AIDS (London, England), 23(18), 2459–2466.).
Response to Arguments
Applicant's arguments filed 12/03/2025 (Pg. 8) with respect to claims 17-18 have been fully considered but they are not persuasive. To clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “no evidence of fact or law in support of its conclusion that "The diagnosing a viral infection is an abstract idea.” (Pg. 8)
Response: Applicant’s arguments does not apply to the revised rejection above.
Applicants’ argument: “The active steps are routine and conventional as demonstrated by 35 USC 103 rejections stated below." Applicant notes the method of claim 1 on which claims 17 and 18 depend is not routine, conventional or obvious as detailed below.” (Pg. 8)
Response: Applicant’s arguments have been fully considered and found unpersuasive because applicants amendments do not overcome the lack of patentably matter under U.S.C. 35 101. The claims 17 and 18 recite abstract idea of comparing nucleotide sequences and routine, conventional steps of extracting RNA molecules from a sample and obtaining nucleotide sequence(s), and natural correlation of a specific nucleotide sequence to diagnostic of the viral infection without significantly more. These judicial exceptions are not integrated into a practical application because the claim limitations do not appear to improve the current technology or technical field beyond well-understood, routine, conventional activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no specific limitations that provide significantly more.
See excerpts of the instant application suggesting well-understood, routine, conventional activity without significantly more:
Nucleic acids may be isolated from a subject, cell, or other source according to methods known in the art. Persons having skill in the art will understand how to obtain and prepare biological samples and liquid biological samples using art-known methods, including but not limited to obtaining whole blood, preparing plasma from blood, isolating cells from biological fluids, homogenizing tissue, disrupting cells or viral particles, preparing liquids from solid materials, diluting viscous fluids, filtering liquids, distilling liquids, concentrating liquids, inactivating interfering components, adding reagents, purifying nucleic acids, and the like. (Para. 17)
In aspects of the disclosure, diagnosing a viral infection in a subject comprises (1) obtaining a nucleotide sequence of the released RNA molecules, or of a template-directed polymerization product thereof, and (2) comparing the obtained nucleotide sequence of the released RNA molecules, or the template-directed polymerization product thereof, with a specific nucleotide sequence known to be present in virally infected cells, wherein a match between the compared nucleotide sequences is diagnostic of the viral infection in the subject. One skilled in the art will recognize that the released RNA molecules comprise a heterogeneous population, and a nucleotide sequence obtained from the released RNA molecules may therefore comprise one or more nucleotide sequences that differ from each other by one or more nucleotides. Nucleotide sequences of the released RNA molecules may be obtained by means of directly sequencing the RNA molecules through art-known methods, or by producing and sequencing template-directed polymerization products of the RNA molecules according to art-known methods, for example though not intended to be limiting, by reverse transcription PCR (RT-PCR), quantitative RT-PCR (qRT-PCR), or real-time RT-PCR. One of skill in the art will understand how to compare sequences obtained from the released RNA molecules or template-directed polymerization products thereof to other known sequences, including viral sequences, using art-known bioinformatics methods. (Para. 32)
Claim Rejections - 35 USC § 103
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.
Claims 1-5 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017).
Gundling discloses systems and methods for purifying nucleic acid. In particular, the present disclosure relates to systems and methods for purifying nucleic acids using metal or metal oxide compositions (Abstract).
Regarding claim 1 step a, Gundling teaches a method comprising “RNA extraction” (Para.117). Gundling teaches a method comprising “RNA from a biological sample” (Para. 11). Gundling teaches a method comprising “Biological samples may be obtained from animals (including humans) and encompass fluids, solids, tissues, and gases” (Para. 68). Gundling teaches a method comprising “RNA and/or DNA is eluted from the particles or solid support (Para. 82). Gundling teaches a method comprising “In some embodiments, RNA capture comprises the step of contacting a biological sample (e.g., blood, blood product, cells, tissues, urine, semen, saliva, etc.) with a metal oxide particle. In some embodiments, the sample is processed prior to capture (e.g., cell lysis, purification, etc.)” (Para. 79). “Biological samples may be obtained from animals (including humans) and encompass fluids, solids…” reads on liquid sample that has dried into a solid. ““RNA and/or DNA is eluted from the particles or solid support reads on “providing a liquid biological sample dried on a solid carrier, wherein the liquid biological sample comprises nucleic acids including RNA molecules”, “the sample is processed prior to capture” reads on “a liquid biological sample dried on a solid carrier”. Thus, Gundling suggests a method comprising providing a biological sample on a solid carrier, wherein the liquid biological sample comprises nucleic acids including RNA molecules.
Regarding claim 1 step b, Gundling teaches a method comprising “RNA recovery is high at 1.35 M GITC” and “At 1.35 M GITC using the extraction conditions described above …there is almost maximal RNA recovery” (Para.205; Fig. 38H). RNA recovery is high at 1.35M GITC is interpreted as using 1.35M GITC in extraction buffer. Thus, Gundling teaches a method comprising providing an extraction buffer comprising less than 3.5 M GITC.
Regarding claim 1 step c, Gundling teaches a method comprising “eluting the DNA and/or RNA from the particle or solid support” and “the elution comprises an elution buffer” (Para. 8). Thus, Gundling teaches a method comprising contacting the solid carrier with the extraction buffer, thereby releasing RNA molecules from the solid carrier into the extraction buffer.
Regarding claim 1 step d, Gundling teaches a method comprising “capturing RNA from a biological sample” (Para. 11: Para. 119) and setup described for Test Particles for RNA Extraction in the Table shown below (Para. 119). The setup is interpreted as having an isolated extraction buffer. Thus, Gundling teaches a method comprising isolating the extraction buffer of step (c) containing released RNA molecules.
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Regarding claim 1 step e, Gundling teaches a method comprising “contacting the sample with a particle … comprising or coated with a metal or metal oxide such that ... RNA in the sample binds the particle … the metal oxide is CuTi. (Para. 8). Thus, Gundling teaches a method comprising suspending a plurality of copper-titanium oxide-coated (CuTi) magnetic particles in the isolated extraction buffer and incubating under conditions appropriate for binding of the released RNA molecules by the plurality of suspended CuTi particles.
Regarding claim 1 step f, Gundling teaches a method comprising “particles are then isolated from the sample (e.g., using a magnet, centrifugation, or other suitable technique” (Para. 81). Thus, Gundling teaches a method comprising capturing the plurality of CuTi particles and bound RNA molecules by application of a magnetic field.
Regarding claim 1 step g, Gundling teaches a method comprising “particles are washed to remove unbound components of the sample (e.g., using a wash buffer)” and “particles are then isolated from the sample (e.g., using a magnet, centrifugation, or other suitable technique” (Para. 81). Thus, Gundling teaches a method comprising removing the extraction buffer.
Regarding claim 1 step h, Gundling teaches a method comprising “RNA and/or DNA is eluted from the particles or solid support (e.g., using an elution buffer)” (Para. 82). Thus, Gundling teaches a method comprising contacting the plurality of CuTi particles and bound RNA molecules with an elution buffer, under conditions appropriate for release of the bound RNA molecules into the elution buffer.
Regarding claim 2, Gundling teaches a method wherein “biological sample (e.g., blood, blood” (Para.79). Thus, Gundling teaches a method wherein the liquid biological sample is whole blood.
Regarding claim 3, Gundling teaches a method wherein “biological sample (e.g., blood, blood” (Para.79). Gundling teaches a method comprising “Biological samples may be obtained from animals (including humans) and encompass fluids, solids, tissues, and gases” (Para. 68). Thus, Gundling teaches a method wherein the liquid biological sample dried on a solid carrier is a dried blood spot (DBS).
Regarding claim 4, Gundling teaches a method wherein “(e.g., from microorganism) present in biological sample” (Para. 71). Gundling teaches a method wherein “A “blood-borne microorganism” is intended to encompass any microorganism that can be found in blood. Examples of blood-borne microorganisms include bacteria, viruses…“ (Para. 61). Gundling teaches a method wherein “biological sample (e.g., blood, blood” (Para.79). Thus, Gundling teaches a method wherein the liquid biological sample dried on a solid carrier is suspected of containing a virus.
Regarding claim 5, Gundling teaches a method wherein particles were tested for HIV (Para. 209). Thus, Gundling teaches a method wherein the virus is human immunodeficiency virus 1 (HIV-1).
Regarding claim 12, Gundling teaches a method wherein “the elution buffer comprises phosphate (e.g., an inorganic phosphate or an organophosphate) at a concentration of 0.5 to 20 mM (e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mM).” (Para. 8). Thus, Gundling teaches a method wherein the elution buffer comprises a low ionic strength buffer.
Regarding claim 13, Gundling teaches a method wherein “Samples were eluted with water” (Para. 180). Thus, Gundling teaches a method wherein the elution buffer is water.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have apply the method of as taught by Gundling and extract RNA molecules from a dried sample on a solid carrier with reasonable expectation of success because doing so would allow for an efficient, effective and convenient method for isolating and preparing nucleic acids for analysis.
Response to Arguments
Applicant' s arguments filed 12/03/2025 (Pg. 8-10) with respect to claim 1-5 and 12-13 have been considered but are not persuasive. To clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Gundling does not teach, suggest or even mention a liquid biological sample dried on a solid carrier of claim 1” (Pg. 8) and “Gundling does not teach, suggest or even mention a liquid biological sample dried on a solid carrier of claim 1” (Pg. 10).
Response: In response to applicant's arguments stated above, Gundling does suggest a liquid biological sample dried on a solid carrier as recited in the non-final office action Pg. 7 and in the revised 35 U.S.C. 103 above on Pg. 9. The rejection was revised to further clarify in view of the arguments that to include the following: Gundling teaches a method comprising “In some embodiments, RNA capture comprises the step of contacting a biological sample (e.g., blood, blood product, cells, tissues, urine, semen, saliva, etc.) with a metal oxide particle. In some embodiments, the sample is processed prior to capture (e.g., cell lysis, purification, etc.)” (Para. 79). “Biological samples may be obtained from animals (including humans) and encompass fluids, solids…” reads on a liquid sample that has dried into a solid carrier. “RNA and/or DNA is eluted from the particles or solid support” reads on “a liquid biological sample dried on a solid carrier, wherein the liquid biological sample comprises nucleic acids including RNA molecules”. “the sample is processed prior to capture” reads on “a liquid biological sample dried on a solid carrier”. Thus, Gundling suggests a method comprising providing a biological sample on a solid carrier, wherein the liquid biological sample comprises nucleic acids including RNA molecules.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Pugia et al. (“Pugia”; WO 2018183988 A1, Oct. 04, 2018).
The teachings of Gundling are documented above in the rejection of claims 1-5 and 12-13 under 35 U.S.C. 103. Claim 6 depends on claims 1 and 4. However, Gundling does not explicitly teach claim 6.
Pugia discloses methods for the selective isolation, amplification and detection of nucleic acids from samples, said method comprising: (a) enriching selectively said nucleic acids present in said samples on a binding matrix;(b) releasing said nucleic acids from the binding matrix; (c) selectively amplifying said nucleic acids; and (d) analyzing said amplified nucleic acids (Abstract).
Regarding claim 6, Pugia teaches a method wherein “the rare cell maybe a pathogen, bacteria, or virus or group thereof which includes… viruses such as, but not limited to, HIV, HPV, (Pg. 44, ln 5-6, and 19-20). Thus, Pugia teaches a method wherein the virus is human papilloma virus (HPV).
Gundling and Pugia are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of the virus being HPV as taught by Pugia and provide a method of extracting HPV RNA. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of extracting HPV RNA with a reasonable expectation of success. Doing so would allow for an efficient, effective and convenient method for isolating and preparing HPV RNA for analysis.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Arguments against Gundling on Pg. 10-11 are not persuasive as discussed above. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Applicant notes that the Office provides no evidence of fact or law that the skilled artisan interested in isolation of RNA from a liquid biological sample dried on a solid carrier would be motivated to turn to the Office's combination of Gundling and Pugia for instruction, or have a reasonable expectation of success in arriving at a working method of any kind ” (Pg. 11).
Response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gundling and Pugia are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of the virus being HPV as taught by Pugia and provide a method of extracting HPV RNA. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of extracting HPV RNA with a reasonable expectation of success. Doing so would allow for an efficient, effective and convenient method for isolating and preparing HPV RNA for analysis.
Claims 1, 7-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Huang et al. (“Huang”; WO 2016/007709 A1, Jan. 14, 2016).
The teachings of Gundling are documented above in the rejection of claims 1-5 and 12-13 under 35 U.S.C. 103. Claims 7-9 and 15-16 depend on claim 1. However, Gundling does not explicitly teach claims 7-9 and 15-16.
Huang discloses novel and non-obvious improvements to dried blood spot testing for HIV-1 viral load useful for diagnosis and monitoring treatment progression (Abstract).
Regarding claims 1, 7-9 and 15-16, Huang teaches a method comprising “detecting HIV-1 nucleic acids in a blood sample, the method comprising: a) providing: i) a blood sample suspected of being infected with HIV dried on a solid carrier, ii) an elution buffer… b) eluting the blood sample from the solid carrier with the elution buffer to create an eluted sample; c) loading the eluted sample into the automated, programmable sample preparation instrument for further nucleic acid extraction and purification to create a processed sample…” (Para. 5). Furthermore, Huang teaches that “It is recognized that various modifications are possible within the scope of the claimed invention. Thus, it should be understood that, although the present invention has been specifically disclosed in the context of preferred embodiments and optional features, those skilled in the art may resort to modifications and variations of the concepts disclosed herein.” (Para. 53).
Regarding claim 7, Huang teaches a method wherein “Tween20 may be used at 0 - 20 %, 2 % - 8 %, 4% - 6 % and about 5 %“ (Pg. 16, Para. 66). The claimed range of greater than 5% Tween® 20 is comprised in 0 - 20 %, 2 % - 8 %, 4% - 6 % and about 5 % Tween-20. Huang teaches a method wherein “pH may be from 5 - 10, 5.2 - 8, 5.6 - 7, 5.8 - 6.5” (Pg. 16 Para. 66). The claimed range of a pH less than 6.0 is comprised in the pH ranges 5 - 10, 5.2 - 8, 5.6 - 7, 5.8 - 6.5. Thus, Huang teaches a method wherein the extraction buffer further comprises greater than 5% Tween®-20 and has a pH less than 6.0.
Regarding claim 8 and 9, Huang teaches a method wherein “buffer comprises approximately 3.5 M GITC, approximately 5% Tween® 20 (trade name for polysorbate 20; also referred to as polyoxyethylene (20) sorbitan monolaurate), approximately 50 mM KOAc (potassium acetate) at approximately pH 6.0” (Para. 5). Huang teaches a method wherein “GITC may be used from 1.0 - 5.5 M, 2.0- 4.5 M, 3.0 - 4.0 M and about 3.5 M; Tween20 may be used at 0 - 20 %, 2 % - 8 %... and pH may be from 5 - 10, 5.2 - 8, 5.6 – 7…” (Pg. 16, Para. 66). The claimed GITC concentration and Tween-20 percentage, and buffer pH are comprised in “GITC may be used from 1.0 - 5.5 M, 2.0- 4.5 M, 3.0 - 4.0 M and about 3.5 M; Tween20 may be used at 0 - 20 %, 2 % - 8 %... and pH may be from 5 - 10, 5.2 - 8, 5.6 – 7…” Thus, Huang teaches a method wherein the extraction buffer comprises 3.2 M GITC, 7.5% Tween®-20, and has a pH of 5.6 and wherein the buffer comprises less than 3.2 M GITC, 7.5% Tween®-20, and has a pH less than 6.0.
Regarding claim 15, Huang teaches a method wherein “an assay that can be almost completely automated with increased accuracy and efficiency over the prior art” (Pg. 3 Para. 4). Huang teaches a method wherein “an automated, programmable sample preparation instrument, iv) an automated, programmable PCR instrument” (Pg. 3, Para. 5). Thus, Huang teaches a method wherein the method is automated.
Regarding claim 16, Huang teaches a method wherein “the solid carrier is filter paper”. (Pg. 4, Para. 10). Thus, Huang teaches a method wherein the solid carrier comprises filter paper.
Gundling and Huang are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of extracting RNA wherein the extraction buffer composition comprises less than or equal to 3.2 M GITC, 7.5% Tween-20, and buffer pH less than 6.0, the method is automated, and that the solid carrier is filter paper as taught by Huang and provide fast and repetitive extraction, optimal buffering conditions and solid carrier for RNA extraction and/or isolation. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1, 7-9 and 15-16. Doing so would allow for increased accuracy and faster execution of the method and more optimal buffering conditions for isolating and preparing RNA for analysis.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Arguments against Gundling on Pg. 11 are not persuasive as discussed above. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Huang does not teach or suggest a method for nucleic acid and extraction from a liquid biological sample dried on a solid carrier comprising incubation with a plurality of magnetic particles, and capturing the plurality of magnetic particles with bound RNA molecules in a magnetic field.” (Pg. 11).
Response: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants’ argument: “Applicant notes that the Office provides no evidence of fact or law that the skilled artisan interested in isolation of RNA from a liquid biological sample dried on a solid carrier using a plurality of magnetic CuTi particles would be motivated to turn to the Office's combination of Gundling and Huang for instruction, or have a reasonable expectation of success in arriving at a working method of any kind. ”(Pg. 11).
Response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gundling and Huang are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of extracting RNA wherein the extraction buffer composition comprises less than or equal to 3.2 M GITC, 7.5% Tween-20, and buffer pH less than 6.0, the method is automated, and that the solid carrier is filter paper as taught by Huang and provide fast and repetitive extraction, optimal buffering conditions and solid carrier for RNA extraction and/or isolation. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1, 7-9 and 15-16. Doing so would allow for increased accuracy and faster execution of the method and more optimal buffering conditions for isolating and preparing RNA for analysis.
Applicants’ argument: “Huang expressly instructs the skilled artisan away from methods that require the use of reagents, equipment, time and manipulations in addition to Huang's methods.” (Pg. 11).
Response: In response to the applicants’ argument state above, as recited in the revised 35 USC 103. Huang teaches that “It is recognized that various modifications are possible within the scope of the claimed invention. Thus, it should be understood that, although the present invention has been specifically disclosed in the context of preferred embodiments and optional features, those skilled in the art may resort to modifications and variations of the concepts disclosed herein.” (Para. 53). Thus, Huang does not teach the skilled artisan away from methods that require the use of reagents, equipment, time and manipulations in addition to Huang's methods
Claims 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Gundling et al. (“Gundling ‘230”; US Patent Pub. No US 9,803,230 B2 Oct. 31, 2017).
The teachings of Gundling are documented above in the rejection of claims 1-5 and 12-13 under 35 U.S.C. 103. Claims 10-11 depend on claim 1.
Regarding claim 10, Gundling teaches a method wherein “particles are then isolated from the sample (e.g., using a magnet, centrifugation, or other suitable technique” (Para. 81). However, Gundling does not explicitly teach claims 10-11.
Gundling ‘230 discloses methods for the improved and simplified purification of nucleic acids (Abstract).
Regarding claim 10, Gundling ‘230 teaches a method wherein “The particles are then drawn through an aqueous gel (e.g., an agarose gel although any gel compatible with nucleic acids, for example an SDS acrylamide gel, would be suitable) with, in the case of magnetic particles, a magnetic source (i.e., a magnet)” (Col. 3 Ln 41-46). Thus, Gundling ‘230 teaches a method wherein step (e) further comprises drawing the sequestered plurality of CuTi particles through an aqueous gel by means of a magnetic force, and step (g) is not performed.
Regarding claim 11, Gundling ‘230 teaches a method wherein “the particles are drawn by a magnetic field through a gel … and the concentrated particles are re-suspended in an elution buffer“ (Col. 2, ln 3-5) and “The particles then pass directly into the elution buffer”. (Col. 2, ln 12-13). Thus, Gundling ‘230 teaches a method further wherein the sequestered plurality of CuTi particles are drawn through the aqueous gel directly into the elution buffer of step (h).
Gundling and Gundling ‘230 are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method drawing the magnetic particles through an aqueous gel into a buffer as taught by Gundling ‘230 and provide a method for isolating the RNA from its contaminants and transferring from previous buffering condition to a subsequent buffering condition. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1 and 10-11. Doing so would allow for efficient removal of contaminants and transfer to elution buffering conditions for the isolation and preparation of RNA for analysis.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Arguments against Gundling on Pg.12 are not persuasive as discussed above. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Applicant notes that the Office provides no evidence of fact or law that the skilled artisan interested in isolation of RNA from a liquid biological sample dried on a solid carrier would be motivated to turn to the Office's combination of Gundling and Gundling '230 for instruction, or have a reasonable expectation of success in arriving at the methods of the present claims” (Pg. 12).
Response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gundling and Gundling ‘230 are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method drawing the magnetic particles through an aqueous gel into a buffer as taught by Gundling ‘230 and provide a method for isolating the RNA from its contaminants and transferring from previous buffering condition to a subsequent buffering condition. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1 and 10-11. Doing so would allow for efficient removal of contaminants and transfer to elution buffering conditions for the isolation and preparation of RNA for analysis.
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Trevor Hawkins. (“Hawkins”; US Patent Pub. No 5,705,628, Jan. 6, 1998).
The teachings of Gundling are documented above in the rejection of claims 1-5 and 12-13 under 35 U.S.C. 103. Claim 14 depends on claim 1.
Regarding claim 14, Gundling teaches a method wherein “contacting the sample with a particle and/or solid support comprising or coated with a metal or metal oxide such that DNA and/or RNA in the sample binds the particle or solid support” (Para.8). Thus, Gundling teaches a method wherein the plurality of CuTi particles is present with RNA molecules in the sample. However, Gundling does not explicitly teach claim 14.
Hawkins discloses a method of separating polynucleotides, such as DNA, RNA and PNA, from a solution containing polynucleotides by reversibly and non-specifically binding the polynucleotides to a solid surface, such as a magnetic microparticle, having a functional group-coated surface (Abstract).
Regarding claim 14, Hawkins teaches a method wherein “Yields of DNA following elution typically approach 100% when the magnetic microparticles are used in excess” (Col. 6, ln 28-29). In excess is interpreted as any amount used in excess compared to RNA molecules. Thus, Hawkins teaches a method wherein the plurality of CuTi particles is present in a molar excess relative to the plurality of RNA molecules in the sample.
Gundling and Hawkins are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from other biomolecules in a sample. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of adding the magnetic microparticles in excess to nucleic acids as taught by Hawkins and provide a method for increasing the RNA yield from the extracted RNA molecules. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1 and 14. Doing so would allow for an increased yield of isolated and prepared RNA for analysis.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Claim 14 is cancelled herein thereby rendering the Office's rejections moot. ”(Pg. 12).
Response: In response to the applicants’ argument above, claim 14 is still present as originally presented in the claim set filed 12/03/2025. Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Claim(s) 1 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gundling et al. (“Gundling”; US Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017) in view of Lofgren et al. (“Lofgren”; (2009). Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities. AIDS (London, England), 23(18), 2459–2466.).
The teachings of Gundling et al. are documented above in the rejection of claims 1-5 and 12-13 under 35 U.S.C. 103. Claims 17 depends on claim 1. Claim 18 depends on claims 1 and 17.
Gundling teaches a method wherein: the method further comprises the step of determining the identity and/or amount of the RNA present in the sample (e.g., using one or more detection methods selected from, for example, amplification, hybridization, or sequencing) (Para. 9). Thus, Gundling teaches a method comprising obtaining a nucleotide of the released RNA molecules or of template-directed polymerization product. However, Gundling does not explicitly teach claims 17-18.
Lofgren discloses a method comparison and operational evaluation of DBS RNA against conventional tests for early infant diagnosis of HIV and HIV RNA quantitation under field conditions in Tanzania (Abstract-Design).
Regarding claims 17-18, Lofgren teaches a method comprising “DBS were prepared … DBS were mailed … to a central laboratory for testing using the Abbott m2000 system. Infant diagnosis DBS were also tested for HIV-1 DNA by ROCHE COBAS AmpliPrep/COBAS TaqMan System. Results of DBS RNA were compared with conventional tests” (Pg. 2459 Abstract-Methods, Para. 1; Pg. 2460-2461 Methods-Sample collection, preparation, and transport and Sample testing and result reporting). Lofgren teaches a method wherein “several studies have evaluated DBS HIV-1 RNA (DBS RNA) for measurement of HIV-1 RNA concentration and for early infant diagnosis under laboratory conditions. Taken together, these findings suggest that it might be possible to establish a DBS RNA service suited to the needs of remote health facilities that uses a single platform in centralized laboratories that provide simultaneous early infant diagnosis of HIV with baseline HIV-1 RNA measurement as well as quantitation of HIV-1 RNA levels for monitoring patients on antiretroviral therapy (ART).” (Pg. 2460, Col. 1, Introduction, Para. 3). Thus, Lofgren teaches a method teaches a method wherein the method further comprises (i) diagnosing a viral infection in a subject, wherein the diagnosing comprises: (1) obtaining a nucleotide sequence of the released RNA molecules, or of a template- directed polymerization product thereof, and (2) comparing the obtained nucleotide sequence of the released RNA molecules, or the template-directed polymerization product thereof, with a specific nucleotide sequence known to be present in virally infected cells, wherein a match between the compared nucleotide sequences is diagnostic of the viral infection in the subject.
Lofgren also teaches a method wherein the viral infection is an HIV infection.
Gundling and Lofgren are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from other biomolecules in a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of diagnosing a viral infection in a subject as taught by Lofgren and provide a method obtaining a nucleotide sequence and diagnosing a viral infection, such as HIV. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1 and 17-18. Doing so would allow for a convenient method for RNA isolation, preparation for analysis, analysis, and diagnosis of a viral infection, such as HIV.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “the present application expressly instructs the skilled artisan away from HIV RNA isolation using silica-based particle methods ” (Pg. 12).
Response: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., silica-based particle) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants’ argument: “the Office provides no evidence of fact or law that the skilled artisan interested in isolation of RNA from a liquid biological sample dried on a solid carrier using a plurality of copper-titanium oxide-coated (CuTi) magnetic particles of the present invention would be motivated to turn to the Office's combination of Gundling and Lofgren for instruction” (Pg. 12).
Response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gundling and Lofgren are both considered to be analogous to the claimed invention because they are in the same field of extracting RNA molecules from other biomolecules in a sample. Gundling states that “Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation” (Para. 70). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by Gundling to incorporate the method of diagnosing a viral infection in a subject as taught by Lofgren and provide a method obtaining a nucleotide sequence and diagnosing a viral infection, such as HIV. These claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 1 and 17-18. Doing so would allow for a convenient method for RNA isolation, preparation for analysis, analysis, and diagnosis of a viral infection, such as HIV.
Applicants’ argument: “the Office fails to indicate how the Office's combination of a method of RNA isolation comprising silica-based magnetic particles may be combined with a method of RNA isolation comprising copper-titanium oxide-coated (CuTi) magnetic particles with a reasonable expectation of success in arriving at a working method of RNA purification. ”(Pg. 12).
Response: In response to applicant's argument stated above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 1-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US 10,392,613 B2 (U.S. Patent No. ‘613), Aug. 27, 2019; U.S. Patent App. Pub. No. US 20170081655 A1, Mar. 23, 2017; Application No. 15/209318, filed Jul. 13, 2016) in view of Pugia et al. (“Pugia”; WO 2018183988 A1, Oct. 04, 2018), Huang et al. (“Huang”; WO 2016/007709 A1, Jan. 14, 2016), Gundling et al. (“Gundling ‘230”; US Patent Pub. No US 9,803,230 B2 Oct. 31, 2017), Trevor Hawkins. (“Hawkins”; US Patent Pub. No 5,705,628, Jan. 6, 1998), and Lofgren et al. (“Lofgren”; (2009). Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities. AIDS (London, England), 23(18), 2459–2466.). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims of U.S. Patent No. ‘613.
Claims 1-16 of U.S. Patent No. ‘613 are drawn to:
1. A method of capturing RNA and/or DNA from a biological sample, comprising: a) contacting said sample with a particle or solid surface comprising or coated with a metal oxide such that DNA and/or RNA in said sample binds said particle wherein said metal oxide is CuTi; b) washing said particle or solid surface to remove contaminants; and c) eluting RNA and/or DNA from said particle or solid surface.
2. The method of claim 1 wherein said CuTi is present at a ratio of approximately 0.5:1 to 5:1 Cu to Ti.
3. The method of claim 1, wherein said metal oxide is an anhydride or hydrated form of said metal oxide.
4. The method of claim 1, wherein said particle has a diameter of 0.5 to 50 μm.
5. The method of claim 1, wherein said particle or solid surface is comprised of a polymer, a magnetic material, a metallic material, an inorganic solid, or a combination thereof.
6. The method of claim 5, wherein said inorganic solid is silica.
7. The method of claim 1, wherein said solid surface has a shape selected from the group consisting of planer, acicular, cuboidal, tubular, fibrous, columnar, and amorphous.
8. The method of claim 1, wherein said elution comprises an elution buffer.
9. The method of claim 8, wherein said elution buffer comprises phosphate.
10. The method of claim 9, wherein said phosphate is an inorganic or an organophosphate.
11. The method of claim 9, wherein said phosphate is present in said elution buffer at a concentration of 0.5 to 20 mM.
12. The method of claim 1, wherein said RNA and/or DNA is eukaryotic, prokaryotic or viral RNA.
13. The method of claim 12, wherein said DNA and/or RNA is from a eukaryotic, prokaryotic or viral pathogen.
14. The method of claim 1, wherein said particle or solid surface preferentially binds RNA or DNA.
15. The method of claim 1, further comprising the step of determining the identity and/or amount of said DNA and/or RNA present in said sample.
16. The method of claim 15, wherein said determining comprises the use of one or more detection methods selected from the group consisting of amplification, hybridization, and sequencing.
Claims of U.S. Patent No. ‘613 is made obvious over the instantly claimed invention. Further, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of viral RNA extraction as taught by claims 1-16 of U.S. Patent No. ‘613 to incorporate the method of the virus being HPV as taught by Pugia, extraction of RNA wherein the extraction buffer composition comprises less than or equal to 3.2 M GITC, 7.5% Tween-20, buffer pH less than 6.0, the method is automated, and that the solid carrier is filter paper as taught by Huang, drawing the magnetic particles through an aqueous gel into a buffer as taught by Gundling ‘230, addition of the magnetic microparticles in excess to nucleic acids as taught by Hawkins, and diagnosis of a viral infection in a subject as taught by Lofgren, which would necessarily read upon the claimed limitations according to claims 1-18. One of ordinary skill in the art would have been motivated to do so in order to allow for an efficient, effective and convenient method for RNA isolation, preparation for analysis, analysis, and diagnosis of a viral infection in a subject, such as HIV and/ or HPV.
Thus, the invention as a whole is obvious over U.S. Patent No. ‘613.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not
persuasive. Furthermore, to clarify some instances argued in the response filed 12/03/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “Upon notice of allowable claims Applicant will consider filing a terminal disclaimer in compliance with 37 C.F.R. §1.32(c).”(Pg. 13).
Response: Accordingly, claims 1-18 remain rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-16 of by U.S. Patent No. ‘613 because no terminal disclaimer has been filed.
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). 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. 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/PatentForms. The filing date of the application will determine what form 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/TerminalDisclaimer.
Conclusion of Response to Arguments
In view of the amendments, revised rejections and the above responses to arguments are documented in this Final Office Action. No claims are in condition for allowance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682