DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-13, 15-19, and 21-26 are pending (claim set as filed on 09/06/2023).
Election/Restrictions
Applicant’s election without traverse of Group I, composition claims, in the reply filed on 12/08/2025 is acknowledged.
Claims 12-13, 15-19, and 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, only composition claims 1-11 are presented for examination.
Priority
This application is a 371 of PCT/IT2021/050205 filed on 07/01/2021, which has a foreign application to IT 102020000018682 filed on 07/30/2020.
Drawings
The drawings filed on 01/27/2023 have been accepted.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 09/06/2023 is acknowledged. 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, Indefinite
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 8-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8’s last limitation, at line 8, recites the phrase of “total weight of the solution”. There is insufficient antecedent basis for this limitation in the claim because “the solution” was not previously introduced and, in contrast, the claim requires the composition to be in a dry form.
Claims 9-11 are rejected because they are dependent claims that do not overcome the deficiencies of the rejected claim from which they depend.
Claim Rejections - 35 USC §103, Obviousness
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lever (A modular method for the extraction of DNA and RNA, and the separation of DNA pools from diverse environmental sample types, 2015).
Lever’s general disclosure relates to nucleic acid extraction protocols along with recommendations for optimizing the protocol for specific sample types (see abstract). One of the main objectives of nucleic acid extraction is the minimization of nucleic acid losses (see page 2, left col. 1st sentence) or “with the aim to maximize DNA yields” (see page 3, right col., last sentence).
Regarding claims 1-3 pertaining to the claimed ingredients, Lever discloses there exists many commercially available chemical solutions and extraction kits to produce adequate nucleic acid yields but there is no universal extraction kit that performs best for all sample types (see page 2, left col. 2nd ¶). Lever teaches the collection of different sample types and, in particular, teaches “Air samples of ∼500 m3 volume were collected with an impinger sampler from a 2nd floor balcony. The impinger sampler streamed air through 2 L of “high-salt sampling solution,” in which microbial cells are captured. The high-salt sampling solution, consisting of 25mM sodium citrate, 10mM EDTA, and ammonium sulfate (450 g L−1, pH 5.2), was designed to preserve RNA throughout sample collection” (see page 3, left col.: Section Air Samples).
Regarding claims 4-5 pertaining to the surfactant, Lever teaches examining the effects different variables in nucleic acid extraction tests such as chemical/enzymatic lysis including sodium dodecyl sulfate (SDS) which functions as an anion surfactant that disrupts cell membranes and denatures proteins wherein the treatment is 0-4% vol/vol using 20% SDS stock solution, with and without 50◦C incubation (see page 5: Table 2 under (B) Chemical/Enzymatic Lysis section). “The variables tested were pH (5.0 vs. 8.0), SDS concentration (0.1–4%)” (see page 8, left col.).
Regarding claims 6-7 pertaining to the pH, as noted above, Lever teaches a “sampling solution, consisting of 25mM sodium citrate, 10mM EDTA, and ammonium sulfate (450 g L−1, pH 5.2), was designed to preserve RNA throughout sample collection” (see page 3, left col.: Section Air Samples). Claim interpretation: in this particular embodiment, the solution does not recite additional pH regulator compounds. Moreover, Lever teaches examining the effects of pH (see page 4, left col.).
While the reference of Lever does not expressly teach the claimed concentration ranges of the ingredients as required by claim 1, nonetheless one of ordinary skill in the art would recognize that the concentration ranges are a result effective variable dependent upon many factors including the type of sample being collected. The adjustments of particular conventional working conditions (e.g., the concentration) is deemed a matter of judicious selection and routine optimization which is within the purview of the skill artisan. The MPEP 2144.05(II)(A) states that: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. 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”. Furthermore, the overall objective of Lever is to optimize the nucleic acid extraction protocols to minimize nucleic acid losses or maximize DNA yields. Lever goes on to investigate or examine variables that affect nucleic acid where different concentrations of chemical agents were tested such as EDTA “Tested 10-100 mM” (see Lever at, e.g., page 5: Table 2(B) Chemical/Enzymatic Lysis). Thus, the prior art establishes the conditions of variable parameters which provides the motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the concentration ranges, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
Claims 1-3, 6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lader (WO 00/06780 - cited in the IDS filed on 09/06/2023).
Lader’s general disclosure relates to the field of molecular biology and provides novel methods and reagents for preserving and protecting the ribonucleic acid (RNA) content of samples from degradation prior to RNA isolation (see abstract).
Regarding claims 1-3 and 8-10 pertaining to the claimed ingredients, Lader teaches “First, one should prepare or obtain the following stock solutions and reagents: 0.5 M EDTA disodium, dihydrate (18.61 g/100 mL, pH to 8.0 with NaOH while stirring); 1M Sodium Citrate trisodium salt, dihydrate (29.4 g/100 ml, stir to dissolve); Ammonium Sulfate, powdered; Sterile water. In a beaker, combine 40 ml 0.5 M EDTA, 25 ml 1M Sodium Citrate, 700 gm Ammonium Sulfate and 935 ml of sterile distilled water, stir on a hot plate stirrer on low heat until the Ammonium Sulfate is completely dissolved. Allow to cool, adjust the pH of the solution to pH 5.2 (claim 6) using 1M H2SO4. Transfer to a screw top bottle and store either at room temperature or refrigerated” (see page 20: Example 2).
While the reference of Lader does not expressly teach the claimed concentration ranges of the ingredients as required by claim 1, nonetheless one of ordinary skill in the art would recognize that the concentration ranges are a result effective variable dependent upon many factors including the type of sample being collected. The adjustments of particular conventional working conditions (e.g., the concentration) is deemed a matter of judicious selection and routine optimization which is within the purview of the skill artisan. The MPEP 2144.05(II)(A) states that: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. 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”. Furthermore, the overall objective of Lader is to preserve RNA. Lader goes on to investigate the effects of concentration such as ammonium sulfate in protecting RNA (see Lader, e.g., at pages 4-5) or the determining the appropriate concentration to precipitate out the RNA (see Lader, e.g., at pages 6 and 8). Thus, the prior art establishes the conditions of variable parameters which provides the motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the concentration ranges, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lever as applied to claims 1-7 above, and in view of Lader (WO 00/06780 - cited in the IDS filed on 09/06/2023).
Lever’s disclosure is taught above as it pertains to a sampling solution, consisting of sodium citrate, EDTA, and ammonium sulfate designed to preserve RNA (see Lever at page 3, left col.: Section Air Samples).
However, Lever does not teach: a dry powdered composition (claim 8’s preamble).
Lader teaches the solid components of the present invention can be prepared to yield the desired final component concentrations in solution when added to an aqueous sample and “the solid components can further be provided as powders, tablets, pills or other suitable formulations that provide the desired properties of an RNA preservation composition. Solid components can be directly added to a sample, added to a sample/liquid mixture, or present in a collection vessel prior to collection of a sample or sample/liquid mixture” (see Lader at page 12, lines 15-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a dry powder composition such as taught by Lader in the teachings of Lever. The ordinary artisan would have been motivated to do so is because Lader teaches suitable formulations for RNA preservation can be provided in powder form. Moreover, it is very common in the art or laboratory settings to have reagents in solution form or powder form for various reconstitution with other compositions and samples.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653