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 .
Claims 1-13 are pending and currently under examination.
Priority
The instant application 18/274,888 filed on 7/28/23 is a 371 US national phase of PCT/CZ2022/050014 filed on 2/7/22, and claims foreign priority to CZPV 2021-53 filed on 2/8/21. The priority date is determined to be 2/7/22 in the absence of a copy certified translation of CZPV 2021-53.
Receipt is acknowledged of CZPV 2021-53 certified copy of papers required by 37 CFR 1.55. Priority Documents were electronically retrieved by USPTO from participating IP office on 7/28/23.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 3 and claim 7 line 2 recite “Na-Ch and/or NaHCCh”. It is unclear what chemical compounds are claimed, as these abbreviations do not correspond to known chemicals. For purposes of compact prosecution and prior art interpretation, these limitations are considered as transposition errors from the PCT version of claims and interpreted as “Na3PO4 and/or NaHCO3”, as supported by the instant Specification and dependent claims 11-12.
Claims 2-13 directly or indirectly depend upon claim 1 and are similarly indefinite.
Claims 2 and 6-7 recitations of “preferably” are indefinite, as it is unclear what limitations are required for the instant invention. For purposes of compact prosecution, the limitations following “preferably” are not required.
Claims 5 and 11-12 contain the trademark/trade name “Tween 20”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the chemical compound polyoxyethylene sorbitan monolaurate and, accordingly, the identification/description is indefinite.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Callahan et al. (2019; WO 2019/209597 A1).
Relevant to claim 1, Callahan et al. teaches "The method provided herein is especially useful in isolating biomolecules from stool samples. Analysis of biomolecules (e.g., nucleic acids) from stool samples allows detection of bacterial and viral infectious agents…" (page 7, lines 17-19).
Relevant to claims 1, 3, and 5, Callahan et al. teaches "A lytic reagent may also include one or more detergents, including nonionic, cationic, anionic (sodium dodecyl sulfate) or zwitterionic detergents. Exemplary detergents include sodium dodecyl sulfate (SDS)… polyoxyethylene sorbitan monolaurate" (page 13, lines 5-10).
Relevant to claims 1, 4, and 6, Callahan et al. teaches "The concentration of an individual detergent in the lytic reagent may be in the range of 0.001 to 15%" (page 13, lines 17-18).
Relevant to claim 1, Callahan et al. teaches "In addition to one or more relatively mild chaotropic agents, a lytic reagent may further comprise one or more phosphates… Exemplary phosphates include… trisodium phosphate" (page 12, lines 1-15).
Relevant to claim 2, Callahan et al. teaches "After a sample is collected, the sample is typically lyzed to release biomolecules for subsequent isolation or detection. Sample lysis according to the method disclosed herein uses a lytic reagent that comprises, consists essentially of, or consists of one or more relatively mild chaotropic agents and one or more phosphates (and optionally water)" (page 8, lines 21-25).
Relevant to claim 7, Callahan et al. teaches "The concentration of a phosphate in a lytic reagent may be 0.05 to 0.5M, preferably 0.1 to 0.2M. The final concentration of phosphate in a lysate (i.e., the mixture of a sample and the lytic reagent) may be 0.01 to 0.4M, preferably 0.1 to 0.2M" (page 12, lines 20-23).
Relevant to claim 8, Callahan et al. Abstract teaches "The present disclosure provides methods for isolating nucleic acids from a sample… Compositions and kits useful in such methods are also disclosed."
Further relevant to claim 8, Callahan et al. teaches "In a related aspect, the present disclosure provides a kit for preparing a lysate from a sample that comprises (a) the lytic reagent described above" (page 17, lines 26-28).
Further relevant to claim 8, Callahan et al. teaches "The kit may further comprise one or more of the following components:… one or more vessels or containers (e.g., collection tubes)" (page 20, line 28 - page 21, line 12).
Relevant to claims 9-10, Callahan et al. teaches "Sample lysis may be performed by physical disruption, chemical lysis, enzymatic lysis, or a combination thereof. Depending on a given sample type and organisms present in the sample, different sample disruption methods may be used. For example, although human cells and viral capsids are easily lysed by salts or detergents, bacterial spores or oocysts require more aggressive chemical, enzymatic or physical methods… Chemical lysis includes the use of a lytic reagent comprising one or more chaotropic agents" (page 23, lines 21-30).
Relevant to claim 10, Callahan et al. teaches "The isolated DNA may be analyzed or used in any application, including PCR, qPCR" (page 35, lines 1-2).
Further relevant to claim 10, Callahan et al. teaches "The method provided herein is especially useful in isolating biomolecules from stool samples. Analysis of biomolecules (e.g., nucleic acids) from stool samples allows detection of bacterial and viral infectious agents…" (page 7, lines 17-19).
Relevant to claims 11-12, Callahan et al. teaches "A lytic reagent may also include one or more detergents, including nonionic, cationic, anionic (sodium dodecyl sulfate) or zwitterionic detergents. Exemplary detergents include sodium dodecyl sulfate (SDS)… polyoxyethylene sorbitan monolaurate" (page 13, lines 5-10).
Relevant to claims 11-12, Callahan et al. teaches "The concentration of an individual detergent in the lytic reagent may be in the range of 0.001 to 15%" (page 13, lines 17-18).
Relevant to claims 11-12, Callahan et al. teaches "In addition to one or more relatively mild chaotropic agents, a lytic reagent may further comprise one or more phosphates… Exemplary phosphates include… trisodium phosphate" (page 12, lines 1-15).
Relevant to claims 11-12, Callahan et al. teaches "The concentration of a phosphate in a lytic reagent may be 0.05 to 0.5M, preferably 0.1 to 0.2M. The final concentration of phosphate in a lysate (i.e., the mixture of a sample and the lytic reagent) may be 0.01 to 0.4M, preferably 0.1 to 0.2M" (page 12, lines 20-23).
Relevant to claim 13, Callahan et al. teaches "The term 'biological sample' as used herein refers to a sample obtained from or produced by a biological subject, including but are not limited to, organs, tissues, cells, body fluid (e.g., blood, blood plasma, serum, cerebrospinal fluid, or urine), swab samples" (page 7, lines 10-13).
Further relevant to claim 13, Callahan et al. teaches "The kit may further comprise one or more of the following components:… one or more vessels or containers (e.g., collection tubes)" (page 20, line 28 - page 21, line 12).
The skilled artisan would recognize that the Callahan et al. "collection tubes" can be combined with the "swab samples" biological inputs within the disclosed kit, and furthermore, would recognize the need for aseptic packaging, as the skilled artisan would find it obvious in order to not introduce unintended contaminants.
Callahan et al. does not teach a specific embodiment having all the claimed elements. That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR at 1741. The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. At 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed elements — including ionic detergents, non-ionic detergents, phosphate compounds, and kits — for compositions and methods for extracting nucleic acid(s) from pathogens, to arrive at compositions "yielding no more than one would expect from such an arrangement."
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah J Kennedy whose telephone number is (571)272-1816. The examiner can normally be reached Monday - Friday 8a - 5p.
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682