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 1-15 and 17-18 filed 07 July 2023 are pending in the application.
Priority
This application is a 371 of PCT/EP2021/068826 filed 07/07/2021. This application claims foreign priority to LUXEMBOURG LU 101918 filed 07/07/2020, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
The parent application LUXEMBOURG LU 101918 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-15 and 17-18 of this application.
Specification
The use of the term Triton or Trition X-100, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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 Rejections - 35 USC § 112
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 5-15 and 18 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.
The recitation of the terms “preferably”, and/or “more preferably”, and/or “and even more preferably” in claims 5-10, 12-15 and 18 renders the claim(s) indefinite because it is unclear whether the limitations after the said terms are part of the claimed invention. See MPEP 2173.05(d).
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 8 and 12 contain the trademark/trade name Triton or Triton X-100. 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 non-ionic detergent and, accordingly, the identification/description is indefinite.
Claim 10 recites the limitation "said RNA" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Even though claim 1 recites nucleic acid, the specific reference to RNA is not seen in claim 1. The dependence of claim 10 should be changed to claim 9 which recites RNA. Claim 10 is examined as dependent from claim 9.
Claim 17 is drawn to a kit-of-parts and recites a biological sample as one of the components of the kit. It is not clear what applicant intends by reciting biological sample as a component of the kit since a biological sample is collected when needed and used with the other components recited in claim 17 for further processing. Claim 17 is examined as including a tube for biological sample collection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8, 10-12, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Slepnev et al (WO 2013/177525 A2; cited in IDS filed 01/06/2023).
The invention of Slepnev is drawn to nucleic acid purification, detection and amplification method and system using size exclusion chromatography (para 0019; step c in claims 1 and 18). The method comprises a) combining a biological sample with a lysis buffer to form a lysis mixture comprising the nucleic acid, b) subjecting the lysis mixture to size exclusion chromatography to produce an eluted solution, c) combining the eluted solution with nucleic acid amplification reagents, d) amplifying the nucleic acid and e) detecting products of nucleic acid amplification (Example 2 at page 18; Claim 1 of Slepnev at page 34; as in claims 1 and 18, steps a) i) and b)-c); the lysis buffer in example has SDS which is a detergent). An embodiment of the method is using a detergent and chaotropic salts wherein the concentration of the chaotropic salt such as guanidinium salt is 6M (paras 0013, 0027, 0030; limitation of claims 1 and 18, part a), ii)-iii), and limitation of claim 5). The nucleic acid can be subjected to an amplification step which could be RT-PCR (para 0015; as in claim 2). The method is done without addition of protease as in claim 3 and bind-wash-elution step as in claim 4. The medium used is a resin for SEC (para 0028; as in claim 6). The method uses aqueous solutions of organic solvents (para 0035; as in claim 6). The chaotropic agent can be guanidinium thiocyanate (GTC) or guanidinium hydrochloride (GHCl) (para 0041; as in claim 7).
The buffer can include Triton X-100, Tris and EDTA (paras 0041, 0044; as in claims 8 and 12). The method is used for isolating and purifying DNA and RNA (para 0029; as in claim 9). Example 2 at para 0071 teaches isolation or viral RNA (as in claim 10). Biological samples can be chosen from blood, saliva, stool, and urine (para 0015; as in claim 11). The method includes contacting the biological sample with lysis buffer (para 0011; as in claim 15). Slepnev teaches a kit which includes a lysis buffer, tubes for biological sample collection, SEC column and components for constructing SEC column (para 0065; as in claim 17). Since the lysis buffer in the method of Slepnev comprises a chaotropic agent with a concentration of at least 1M and a detergent, the kit includes components (ii) and (iii) in claim 17.
In example 2 at page 18 Slepnev et al does not exemplify a method for isolating nucleic acid wherein the biological sample is combined with a chaotropic agent with a concentration of at least 1M in the fluid test sample and a detergent as in claims 1 and 18, parts a) i), ii)-iii).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to arrive at the method for isolating a nucleic acid as in the instant claims since the use of chaotropic agent with a concentration of at least 1M with the lysis buffer is suggested by Slepnev.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a chaotropic agent with a concentration of at least 1M with the lysis buffer is suggested by Slepnev.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Method improvement is the motivation. In addition, Slepnev teaches that its method provides isolated nucleic acids in less time than conventional technique in a form that is substantially free from other inhibitors of nucleic acid amplification, detection and/or analysis (para 0019). According to Slepnev the lysis buffer in combination with a detergent can also comprise a chaotropic salt. (para 0030, 0040, 0041). The artisan would have a reasonable expectation that the inclusion of the chaotropic salt in combination with the detergent would provide complete lysis and still result in isolated nucleic acids in less time than conventional technique as taught by Slepnev.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Slepnev et al (WO 2013/177525 A2; cited in IDS filed 01/06/2023) in view of Adie et al (EP 1932913 A1; cited in IDS filed 01/06/2023) and further in view of Ngo et al (Journal of ABSA International, 2017, 22(2), 56-59).
The teachings of Slepnev et al is set forth above. Slepnev does not expressly teach the limitations of claims 13 and 14.
Adie et al, drawn to purification of nucleic acids, teaches the use of DTT as a reducing agent in its composition (para 0032; limitation of claim 13). This renders obvious the use of DTT as a reducing agent in the method of Slepnev.
According to Ngo et al most methods for extracting viral nucleic acids use buffers that contain chaotropic agents like guanidine thiocyanate or other protein denaturants. There is an assumption that these agents are sufficient to inactivate all viruses (page 56, left col.; first para). Infectivity was observed in two of the viruses after contact with the lysis buffer. However, after incubation in lysis buffer at 65oC infectivity was not observed. Hence, Ngo suggests an additional heat step when using lysis buffers if inactivation is not initially achieved (page 58, Table 2; left col. first full para through right col., last para). This is a suggestion to one of ordinary skill in the art to use a heating step of the fluid sample as in claim 14. The artisan can adjust the temperature range as in claim 14 for optimal inactivation of the virus before proceeding with the isolation and purification of the nucleic acid from the sample.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a reducing agent is known in the art to be used as a reagent in nucleic acid isolation/purification, and heat treatment of solutions of biological samples in lysis buffers is suggested in the art as an essential step for inactivation viral biological samples before proceeding with nucleic acid isolation/purification. Thus, it is obvious to arrive at the claimed method.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Method improvement is the motivation. In addition, Slepnev teaches that its method provides isolated nucleic acids in less time than conventional technique in a form that is substantially free from other inhibitors of nucleic acid amplification, detection and/or analysis (para 0019). The artisan would have a reasonable expectation that the inclusion of the reducing agent as in claim 13 and heat treatment as in claim 14 would still result in isolated nucleic acids in less time than conventional technique as taught by Slepnev.
Conclusion
1. Pending Claims 1-15 and 17-18 are rejected.
2. Claim 16 has been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693