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 .
Election/Restrictions
Applicant’s election without traverse of Group II (32,33, 35, 37 and 59-65) and the species of claim 20 (now claim 61) in the reply filed on 9/3/2025 is acknowledged.
Status of the Claims
Claims 62-64 have been withdrawn as being directed to a non-elected species. Claims 32-33, 37, 59-61 and 65 are under examination at this time.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Appropriate correction is required.
The use of trademarks has been noted in this application. A trademark should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is 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 trademarks.
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 37 and 65 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.
Regarding the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h).
The term optionally means “not required or mandatory”. For example, a composition comprising A, B, C, and optionally D means that component D can or cannot be present (D is not required to be present). In the rejected claims, however, it appears the use of “optionally” is an attempt to define “preferred” embodiments or limitations. For example, claim 37 states that the temperature is between “between about 4°C and about 100°C, optionally about 4°C, about 10°C, about 15°C, about 20°C, about 25°C, about 30°C, about 37°C, about 42°C, about 65°C, about 72°C, about 95°C, or about 100°C”. Further, claim 65 states that the composition further comprises a foam suppressor, optionally Antifoam A. In these instances, the term “optionally” does not make sense given the definition of optionally (not required or mandatory).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 32, 33, 35 and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haydock et al. (U.S. Patent Application No. 2013/0122496; published May 16, 2013) and as evidenced by www.merriam-webster.com/dictionary/room temperature.
The instant claims are directed to a method of inactivating pathogens and stabilizing nucleic acids and/or proteins thereof contained within a sample suspected of containing a pathogen, the method comprising:
a) obtaining a sample suspected of containing a pathogen;
b) contacting the sample with a composition; and
c) incubating the sample contacted with the composition under conditions to allow for inactivation of pathogens and stabilization of nucleic acids and/or proteins,
wherein the composition in b) has a pH between about 6 and about 7 at about 20°C, and comprises:
i) about 2-6M of a chaotropic agent,
ii) about 0.01-0.1 M of a chelator,
iii) about 0.5%-3.0% of a detergent,
iv) about 0.02-0.1 M of a buffer, and
v) about 5%-40% of an alcohol,
wherein the composition does not comprise a reducing agent and wherein the composition does not comprise a mucolytic agent.
Haydock et al. teaches lysing a biological sample with a lysis buffer. In this regard, Haydock et al. states:
when cells are present within the biological sample they are lysed to provide a cell lysate from which the nucleic acid is extracted. A variety of methods of cell lysis are known in the art and are suitable for use within the invention. Examples of cell lysis methods include enzymatic treatment (using, for example, proteinase K, pronase, or Subtilisin), mechanical disruption (e.g., by Sonication, application of high pressure, use of a piezobuzzer device, or bead beating), or chemical treatment. (see paragraph [0032])
Suitable sources of biological samples include nasal swabs (see paragraph [0031]) [claim 33].
Haydock et al. further states that:
Lysing cells in the sample by treating them with a chaotropic salt solution is particularly advantageous. Methods and reagents for lysing cells using chaotropic salts are known in the art, and reagents can be purchased from commercial suppliers. Lysis is generally carried out between room temperature1 and about 95°C., depending on the cell type. (emphasis added) (see paragraph [0032])
The methods of Haydock et al. can be employed within point-of-care diagnostic assays to identify disease pathogens, and can be utilized in genetic screening (see paragraph [0046]).
Haydock et al. teaches a lysis/binding buffer is a solution of 6M Guanidine hydrochloride, 50 mM sodium citrate pH 6.0, 20 mM EDTA, 3% Triton X-100, and 10% Tween-20, which is combined at a ratio of one part buffer, one part sample, and one part ethanol to yield final concentrations of 2M Guanidine hydrochloride, 16.5 mM sodium citrate pH 6.0, 6.6 mM EDTA, 1% Triton X-100, 3.3% Tween-20, and 33% ethanol. This buffer is preferred for use with blood products and viral samples (see paragraph [0035]) [claims 35, 59].
Haydock et al. does not recite that the buffer contains a reducing agent or a mucolytic agent.
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) 37, 60 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Haydock et al. (U.S. Patent Application No. 2013/0122496; published May 16, 2013) as applied to claims 32, 33, 35 and 59 above.
The instant claims are directed to the method of claim 32 where the sample is incubated with the composition for specified times and at specified temperatures.
The teachings of Haydock et al. are outline above and incorporated herein. Haydock et al. teaches that lysis is generally carried out between room temperature and about 95°C. Regarding incubation times, in Example 5, Haydock et al. teaches lysing bacteriophage MS2 with the disclosed lysis buffer. In this example, the sample and lysis buffer were incubated for 20 minutes.
Given the state of the art, given the knowledge of one of ordinary skill in the art and given the teachings of Haydock et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods taught by Haydock et al. and use any of the disclosed incubation times in the examples. One would have been motivated to do so and there would have been a reasonable expectation of success (to achieve maximum or efficient lysis of the cells to release nucleic acid).
For claims 60 and 61, Haydock et al. teaches a composition comprising each component except isopropanol. However, Haydock et al. further teaches that a C1 to C4 aliphatic alcohol, such as methanol, ethanol, isopropanol, or tert-butyl alcohol, can be included. It is well within the purview of one of ordinary skill in the art to use any of the recited alcohols (methanol, ethanol, isopropanol, or tert-butyl alcohol) as the alcohol in the lysis composition of Haydock et al. and the result would be predictable (lysis of the sample).
As for the amounts in claim 61, determining effective dosages of each component in the lysis buffer is routine experimentation. Haydock et al. teaches the use of specific amounts of each component, including an alcohol. It is obvious and routine to determine the necessary amount of an agent that needs to be administered to achieve a desired effect. Further, applicant has not demonstrated unexpected results for the claimed amounts.
Furthermore, according to section 2144.05 of the MPEP, 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. “[W]here 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 also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim(s) 65 is rejected under 35 U.S.C. 103 as being unpatentable over Haydock et al. (U.S. Patent Application No. 2013/0122496; published May 16, 2013) as applied to claims 32, 33, 35 and 59 above, and further in view of Hearn et al. (Biochemistry And Molecular Biology Education, 2010, 38(3): 161–166) and Panda et al. (J Parasit Dis, July-Sept 2019, 43(3):337–342).
The instant claim is directed to the method of claim 32 where the composition further comprises a foam suppressor.
The teachings of Haydock et al. are outline above and incorporated herein. Haydock et al. does not teach including a foam suppressor in the lysis composition. However, Hearn et al. teaches that during DNA extraction higher concentrations of detergent such as SDS causes the lysis solution to foam and this causes problems when transferring the solution as DNA is left behind (see page 164, right column). Panda et al. teaches that during DNA extraction the addition of isoamyl alcohol removes any foam produced during lysis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods taught by Haydock et al. and include a foam suppressor, e.g., isoamyl alcohol or any other known anti-foaming agent, in the lysis composition, particularly since a detergent is present. One would have been motivated to do so and there would have been a reasonable expectation of success given the teachings of Hearn et al. [the presence of foam causes problems when transferring the lysed solution as DNA is left behind] and given the teachings of Panda et al. [Isoamyl alcohol is used to remove any foam].
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
1 Room temperature in Celsius is defined as a temperature of from 59° to 77°F (15-25°C) that is suitable for human occupancy and at which laboratory experiments are usually performed (see www.merriam-webster.com/dictionary/room temperature).