FINAL ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Preliminary Amendment and Status of the Claims
2. The preliminary amendment filed 24 July 2024, in which the substitute specification was submitted, claims 1-15 were cancelled, and new claims 16-35 were added has been thoroughly reviewed and entered.
Claims 16-35 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statement filed 8 December 2023 is acknowledged and has been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
4. The use of terms (including but not necessarily limited to Thermomixer and TurboMixes) which are trade names or marks used in commerce has been noted in this application. They should be capitalized wherever they appear and be accompanied by the generic terminology.
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
5. The phrase “obtained in” as found in each of claims 17 and 30 is interpreted as not referring to a separate obtaining step in the claimed methods. Thus, the limitation is not interpreted as an additional method step (e.g., forming the claimed compound in situ or by other method steps).
Drawings
6. The replacement drawings were received on 24 July 2024. These drawings are objected to under 35 U.S.C. 132(a) because Figure 6 now includes new matter. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention.
The added material which is not supported by the original disclosure is in the form of data on the axes of the cytometry plots not present in either the original drawings of the drawings found in parent Application 14/423,062.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 103
7. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
8. Claims 16-33 and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan et al. U.S. Patent Application Publication No. US 2009/0081678, issued 26 March 2009) and Weisburg et al. (U.S. Patent Application Publication No. US 2009/0048439 A1, published 19 February 2009).
Regarding claim 16, Ryan et al. teach a method for isolating nucleic acids (Title) comprising stabilizing a sample with the formaldehyde releaser diazolidinyl urea, followed by lysis of the cell with a lysis buffer (paragraph 0011). Ryan et al. also teach the method has the added advantage of maintaining the structural integrity of the isolated DNA and reduces the incidence of DNA shearing (Abstract). Thus, Ryan et al. teach the known techniques discussed above.
While Ryan et al. teach the use of cationic (i.e., ammonium) salts during lysis (paragraph 0015), Ryan et al. do not teach the cationic ammonium salt is a detergent.
However, Weisburg et al. teach a method of isolating nucleic acids (Title) comprising lysing a sample in the presence of a cationic detergent; namely, a blood sample is lysed using a buffer that is a combination chaotropic buffer and lysis buffer containing a chaotropic substance (paragraphs 0119). The chaotropic substance is the cationic detergent cetyltrimethlyammonium bromide (paragraph 0120). Weisburg et al. further teach isolating the nucleic acids (i.e., via precipitation) from the lysed sample (paragraph 0119-0122). Weisburg et al. teach the method has the added advantage of allowing solubilization of the sample (paragraph 0120). Thus, Weisburg et al. teach the known techniques discussed above.
It is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
It is also noted that a “wherein” clause, such as that in claim 16, must give “meaning and purpose to the manipulative steps.” See, MPEP § 2111.04.
It would therefore have been obvious to a person of ordinary skill in the art to have combined the teachings of Ryan et al. with the teachings of Weisburg et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of maintaining the structural integrity of the isolated DNA and reduces the incidence of DNA shearing (Abstract) as explicitly taught by Ryan et al. (Abstract) as well as the additional added advantage of allowing solubilization of the sample as explicitly taught by Weisburg et al. (paragraph 0120). In addition, it would have been obvious to the ordinary artisan that the known techniques of Ryan et al. and Weisburg et al. could have been combined with predictable results because the known techniques of Ryan et al. and Weisburg et al. predictably result in reliable steps for prepping and lysing a sample for nucleic acid isolation.
Regarding claim 17, the method of claim 16 is discussed above. Weisburg et al. teach the cationic detergent is cetyltrimethylammonium bromide (paragraph 0120).
Regarding claim 18, the method of claim 16 is discussed above. Weisburg et al. teach the cationic detergent is cetyltrimethylammonium bromide (paragraph 0120); thus, R1, R2, and R3 are C1 (i.e., methyl), R4 is cetyl (i.e., unbranched C16), and X is bromide, which is the anion of the inorganic acid HBr. The buffer also comprises a proton donor, in the form of Tris HCl or, alternatively, the guanidinium group (paragraph 0122).
Regarding claim 19, the method of claim 16 is discussed above. Ryan et al. teach the sample is stabilized with the urea, then contacted with the lysis buffer (paragraph 0011; see also paragraph 0024). Weisburg et al. teach the lysis buffer contains the cationic detergent (paragraph 0120).
In addition, the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04 IV.C.
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Thus, the order of stabilization and lysis merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09 [R-3].
Regarding claim 20, the method of claim 19 is discussed above. Ryan et al. teach obtaining cells (i.e., white blood cells), prior to lysis of the (white blood) cells (Example 1). Weisburg et al. also teach the sample comprises cells that are processed (i.e., prior to lysis; paragraph 0040).
In addition, it is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of isolating the cells before lysis (e.g., using the centrifugation of Ryan et al.; Example 1) merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is reminded to not merely rely upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 21, the method of claim 19 is discussed above. Ryan et al. teach the lysis buffer includes additional lysing agents, in the form of chaotropic agents (paragraph 0010), and that the buffer is incubated with the buffer (paragraph 0033). Weisburg et al. also teach the lysis buffer comprises a chaotropic agent (paragraph 0119).
In addition, it is noted that alternative i) encompassed merely incubating the stabilized sample with the cationic detergent, as the further lysis agent is optional
Regarding claim 22, the method of claim 19 is discussed above. Ryan et al. teach isolating the nucleic acids from the lysed sample (Abstract). In addition, Weisburg et al. teach isolation of the nucleic acids by binding to a solid phase (i.e., support; paragraph 0006).
Regarding claims 23 and 32, the method of claim 16 is discussed above. Ryan et al. teach the (erythrocyte) lysed sample is treated a nucleus lysing buffer containing a chaotropic agent, then with proteinase K (paragraphs 0009-0010). Weisburg et al. teach the lysed sample containing the nucleic acids is bound to a solid phase (i.e., support; paragraph 0006), and the solid support (e.g., beads) are separated, optionally washed, and the nucleic acids are then eluted (paragraphs 0125-0132). The chaotrope is the salt guanidinium isothiocyanate (i.e., claim 32; paragraph 0053).
In addition, it is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of steps merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is reminded to not merely rely upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 24, the method of claim 16 is discussed above. Ryan et al. teach the formaldehyde releaser is imidazolidinyl urea (paragraph 0011).
Regarding claim 25, the method of claim 16 is discussed above. Ryan et al. teach the stabilization of the sample as achieved with a composition further comprising the enzyme inhibitor EDTA (paragraph 0010).
Regarding claims 26 and 33, the method of claim 16 is discussed above. Ryan et al. teach the stabilizer (i.e., fixative solution) comprises the formaldehyde releaser is diazolidinyl urea (i.e., claim 33) and the metal ion chelator EDTA (paragraph 0021).
Regarding claim 27, the method of claim 16 is discussed above. Weisburg et al. teach the sample is from plasma (paragraph 0038) or comprises cells (Example 5). Ryan et al. also teach the sample is whole blood (paragraph 0002) and comprises cells (paragraph 0021).
Regarding claim 28, the method of claim 16 is discussed above. Weisburg et al. teach the method further uses the isolated target nucleic acids in analysis (paragraph 0137), and that target nucleic acids are specific to a disease (paragraph 0037). Thus, it would have been obvious to analyze the isolated target nucleic acids to detect a disease.
Regarding claims 29-31, the method of claim 16 is discussed above. Ryan et al. teach the sample is blood (paragraph 0002); the stabilization uses a formaldehyde releaser (i.e., fixative agent) and an anticoagulant (paragraph 0009); and that the stabilized sample comprises blood cells (paragraph 0021). Weisburg et al. teach the sample is treated with a cationic detergent, in the form of cetyltrimethlyammonium bromide (i.e., claim 30; paragraph 0120), and that the isolated nucleic acids comprise RNA (paragraphs 0005 and 0020). In addition, the “ammonium” indicates N (i.e., the Y group required by claim 31).
Regarding claim 35, the method of claim 30 is discussed above. Ryan et al. teach the formaldehyde releaser is diazolidinyl urea (paragraph 0015); the lysis buffer includes additional lysing agents, in the form of chaotropic agents (paragraph 0010); and that the lysed sample is treated with an additional lysing agent, in the form of proteinase K (i.e., claim 35; paragraph 0028), and is performed in a buffer comprising a salt (paragraph 0029).
Weisburg et al. teach the cationic detergent is cetyltrimethlyammonium bromide (paragraph 0120), and that the lysis buffer further comprises a chaotropic agent (paragraph 0119); that the lysis mixture has alcohol added thereto so as to bind to a solid phase (paragraph 0122); that the solid phase is separated, optionally washed, and the nucleic acids are then eluted (paragraphs 0125-0132); and that the isolated nucleic acids comprise RNA (paragraphs 0005 and 0020).
9. Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan et al. U.S. Patent Application Publication No. US 2009/0081678, issued 26 March 2009) and Weisburg et al. (U.S. Patent Application Publication No. US 2009/0048439 A1, published 19 February 2009) as applied to claim 26 above, and further in view of Fernando (U.S. Patent Application Publication No. US 2010/0209930 A1, published 19 August 2010).
Regarding claim 34, the method of claim 26 is discussed above in Section 8.
Neither Ryan et al. nor Weisburg et al. teach the functionally equivalent stabilization solution that further contains sodium fluoride.
However, Fernando teaches a method wherein a blood sample that is with a functionally equivalent stabilization solution that contains the formaldehyde releaser diazolidinyl urea, sodium fluoride, and glyceraldehyde, which has the added advantage of preventing RNA degradation (paragraphs 0009-0010). Thus, Fernando teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art to have utilized the functionally equivalent stabilization solution of Fernando as the stabilization solution in the method of Ryan et al. and Weisburg et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of preventing RNA degradation as explicitly taught by Fernando (paragraphs 0009-0010). In addition, it would have been obvious to the ordinary artisan that the known techniques of Fernando could have been applied to the method of Ryan et al. and Weisburg et al. with predictable results because the known techniques of Fernando predictably result in use of a functionally equivalent stabilization solution for preserving cells and nucleic acids.
10. It is noted that while the claims have been rejected under 35 U.S.C 103(a) as described above, the claims are also obvious using the interpretation outlined below.
11. Claims 16-29 and 32-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan et al. U.S. Patent Application Publication No. US 2009/0081678, issued 26 March 2009) in view of Kappel et al. (U.S. Patent Application Publication No. US 2004/0259162 A1, published 23 December 2004).
Regarding claims 16-17, Ryan et al. teach a method for isolating nucleic acids (Title) comprising stabilizing a sample with the formaldehyde releaser diazolidinyl urea, followed by lysis of the cell with a lysis buffer (paragraph 0011). Ryan et al. also teach the method has the added advantage of maintaining the structural integrity of the isolated DNA and reduces the incidence of DNA shearing (Abstract). Thus, Ryan et al. teach the known techniques discussed above.
While Ryan et al. teach the use of cationic (i.e., ammonium) salts during lysis (paragraph 0015), Ryan et al. do not teach the claimed cationic amine oxide and salt of species c) of claim 17.
However, Kappel et al. each the lysis of cells using combinations of detergents, including N,N-dimethyldodecylamine oxide, which meets the claimed formula, and docusate sodium salt, which is an acid salt (paragraph 0110). Kappel et al. teach the detergents are useful for lysing animal and bacterial cells, or when the desired cellular component (i.e., that which is isolated) is DNA (paragraph 0118). Thus, Kappel et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art to have utilized the functionally detergents of Kappel et al. in the method of Ryan et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of using a detergent useful for isolating DNA and for lysing either bacterial or animal cells as explicitly taught by Kappel et al. (paragraph 0118). In addition, it would have been obvious to the ordinary artisan that the known techniques of Kappel et al. could have been applied to the method of Ryan et al. with predictable results because the known techniques of Kappel et al. predictably result in use of a functionally equivalent lysis solution.
Regarding claim 18, the method of claim 16 is discussed above. Kappel et al. teach combinations of detergents, including N,N-dimethyldodecylamine oxide, which meets the claimed formula, and docusate sodium salt, which is an acid salt (paragraph 0110); thus, R1 and R2 are C1 (i.e., methyl), R3 is dodecyl (i.e., unbranched C12), and X is 1, docusate sodium salt, which is the acid salt. The buffer also comprises a proton donor, in the form of Tris HCl (paragraph 0117) or, alternatively, guanidinium HCl (paragraph 0116). In addition, the “amine oxide” indicates N.
Regarding claim 19, the method of claim 16 is discussed above. Ryan et al. teach the sample is stabilized with the urea, then contacted with the lysis buffer (paragraph 0011; see also paragraph 0024). Kappel et al. teach the lysis buffer contains the cationic detergent (paragraph 0110).
In addition, it is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of stabilization and lysis merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 20, the method of claim 19 is discussed above. Ryan et al. teach obtaining cells (i.e., white blood cells), prior to lysis of the (white blood) cells (Example 1). Kappel et al. also teach the sample comprises cells that are processed (Abstract).
In addition, it is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of isolating the cells before lysis (e.g., using the centrifugation of Ryan et al.; Example 1) merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 21, the method of claim 19 is discussed above. Ryan et al. teach the lysis buffer includes additional lysing agents, in the form of chaotropic agents (paragraph 0010), and that the buffer is incubated with the buffer (paragraph 0033). Kappel et al. also teach the lysis buffer comprises a chaotropic agent (paragraph 0109).
In addition, it is noted that alternative i) encompassed merely incubating the stabilized sample with the cationic detergent, as the further lysis agent is optional
Regarding claim 22, the method of claim 19 is discussed above. Ryan et al. teach isolating the nucleic acids from the lysed sample (Abstract). In addition, Kappel et al. teach isolation of the nucleic acids by binding to a solid phase (i.e., support; paragraph 0064).
Regarding claims 23 and 32, the method of claim 19 is discussed above. Ryan et al. teach the (erythrocyte) lysed sample is treated a nucleus lysing buffer containing a chaotropic agent, then with proteinase K (paragraphs 0009-0010). Kappel et al. teach the lysed sample containing the nucleic acids is bound to a solid phase (i.e., support; paragraph 0006), and the solid support (e.g., beads; paragraph 0031) are separated via washing, and the nucleic acids are then eluted (paragraphs 0067). The chaotrope is the salt guanidinium HCl (i.e., claim 32; paragraph 0116).
In addition, it is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of steps merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Applicant is reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 24, the method of claim 16 is discussed above. Ryan et al. teach the formaldehyde releaser is imidazolidinyl urea (paragraph 0011).
Regarding claim 25, the method of claim 16 is discussed above. Ryan et al. teach the stabilization of the sample as achieved with a composition further comprising the enzyme inhibitor EDTA (paragraph 0010).
Regarding claims 26 and 33, the method of claim 16 is discussed above. Ryan et al. teach the stabilizer (i.e., fixative solution) comprises the formaldehyde releaser is diazolidinyl urea (i.e., claim 18) and the metal ion chelator EDTA (paragraph 0021).
Regarding claim 27, the method of claim 16 is discussed above. Kappel et al. teach the sample comprises cultured cells (Example 1). Ryan et al. also teach the sample is whole blood (paragraph 0002) and comprises cells (paragraph 0021).
Regarding claim 28, the method of claim 16 is discussed above. Ryan et al. teach the stabilizer (i.e., fixative solution) is mixed with the sample (paragraph 0021).
It is reiterated that the courts have held that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the order of steps merely represents an obvious variant, and/or routine optimization of the steps taught by the prior art.
Regarding claim 29, the method of claim 16 is discussed above. Ryan et al. teach the sample is blood (paragraph 0002); the stabilization uses a formaldehyde releaser (i.e., fixative agent) and an anticoagulant (paragraph 0009); and that the stabilized sample comprises blood cells (paragraph 0021). Kappel et al. teach combinations of detergents, including N,N-dimethyldodecylamine oxide, which meets the claimed formula, and docusate sodium salt, which is an acid salt (paragraph 0110); thus, R1 and R2 are C1 (i.e., methyl), R3 is dodecyl (i.e., unbranched C12), and X is 1, docusate sodium salt, which is the acid salt (paragraph 0110), and that the isolated nucleic acids comprise RNA (paragraph 0033).
12. Claims 30-31 and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan et al. U.S. Patent Application Publication No. US 2009/0081678, issued 26 March 2009) in view of Kappel et al. (U.S. Patent Application Publication No. US 2004/0259162 A1, published 23 December 2004) applied to claim 29 above, and further in view of Weisburg et al. (U.S. Patent Application Publication No. US 2009/0048439 A1, published 19 February 2009).
Regarding claims 30-31 and 35, the method of claim 29 is discussed above in Section 11.
Ryan et al. teach the formaldehyde releaser is diazolidinyl urea (paragraph 0015); the lysis buffer includes additional lysing agents, in the form of chaotropic agents (paragraph 0010); and that the lysed sample is treated with an additional lysing agent, in the form of proteinase K (i.e., claim 35; paragraph 0028), and is performed in a buffer comprising a salt (paragraph 0029).
Kappel et al. teach combinations of detergents, including N,N- dimethyldodecylamine oxide, which meets the claimed formula (i.e., claim 30)., and docusate sodium salt, which is an acid salt (paragraph 0110); thus, R1 and R2 are C1 (i.e., methyl), R3 is dodecyl (i.e., unbranched C12), and X is 1, docusate sodium salt, which is the acid salt. The lysis buffer further comprises a chaotropic agent (paragraph 0116) and a protease and salt (paragraph 0117). Kappel et al. also teach the proton donor TrisHCl (paragraph 0117), and that the isolated nucleic acids comprise RNA (paragraph 0033), as well as binding to a solid phase and washing (paragraph 0091).
Neither Kappel et al. nor Ryan et al. explicitly teach adding alcohol and binding RNA.
However, Weisburg et al. teach a method wherein a lysis mixture has alcohol added thereto so as to bind to a solid phase (paragraph 0122); that the solid phase is separated, optionally washed, and the nucleic acids are then eluted (paragraphs 0125-0132); and that the isolated nucleic acids comprise RNA (paragraphs 0005 and 0020).
Weisburg et al. teach the sample is treated with a cationic detergent, in the form of cetyltrimethlyammonium bromide (i.e., claim 30; paragraph 0120), and that the isolated nucleic acids comprise RNA (paragraphs 0005 and 0020). In addition, the “ammonium” indicates N (i.e., the Y group required by claim 31). Weisburg et al. further teach the method has the added advantage of allowing isolation of nucleic acids from complex starting materials (paragraph 0122). Thus, Weisburg et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art to have combined the teachings of Ryan et al. in view of Kappel et al. with the teachings of Weisburg et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of maintaining the structural integrity of the isolated DNA and reduces the incidence of allowing isolation from complex starting materials as explicitly taught by Weisburg et al. (paragraph 0122). In addition, it would have been obvious to the ordinary artisan that the known techniques of Weisburg et al. could have been combined with the method of Ryan et al. in view of Kappel et al. with predictable results because the known techniques of Weisburg et al. predictably result in reliable steps for prepping and lysing a sample for nucleic acid isolation.
13. Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan et al. U.S. Patent Application Publication No. US 2009/0081678, issued 26 March 2009) in view of Kappel et al. (U.S. Patent Application Publication No. US 2004/0259162 A1, published 23 December 2004) applied to claim 26 above, and further in view of Fernando (U.S. Patent Application Publication No. US 2010/0209930 A1, published 19 August 2010).
Regarding claim 34, the method of claim 26 is discussed above in Section 11.
Neither Ryan et al. nor Kappel et al. teach the functionally equivalent stabilization solution that further contains sodium fluoride.
However, Fernando teaches a method wherein a blood sample that is with a functionally equivalent stabilization solution that contains the formaldehyde releaser diazolidinyl urea, sodium fluoride, and glyceraldehyde, which has the added advantage of preventing RNA degradation (paragraphs 0009-0010). Thus, Fernando teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art to have utilized the functionally equivalent stabilization solution of Fernando as the stabilization solution in the method of Ryan et al. and Kappel et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a method having the added advantage of preventing RNA degradation as explicitly taught by Fernando (paragraphs 0009-0010). In addition, it would have been obvious to the ordinary artisan that the known techniques of Fernando could have been applied to the method of Ryan et al. and Kappel et al. with predictable results because the known techniques of Fernando predictably result in use of a functionally equivalent stabilization solution for preserving cells and nucleic acids.
Conclusion
14. No claim is allowed.
15. This is a Continuation of Applicant's earlier Application No. 16/983,669. All claims are drawn to the same invention claimed in the earlier application and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
16. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights