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 .
Applicants’ response of 10/06/2025 is acknowledged.
Status of Claims
Claims 1-18 are pending in this application.
Drawings
Applicant’s drawings of 11/04/2022 are acknowledged. The drawings have been accepted by the examiner.
Information Disclosure Statement
Applicant’s information disclosure statements of 6/16/2023 and 1/28/025 are acknowledged. Initialed copies are enclosed.
Election/Restriction
Applicant's election without traverse of 10/06/2025 is acknowledged. The applicant elected group I (claims 1-5) which is drawn to a method of for liquefying a respiratory sample. Claims 6-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/06/2025. Claims 1-5 are under consideration.
Claim Rejections - 35 USC § 102
7. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Buzatu et al. (US 2015/275263 A1 filed October 1, 2025).
The claims are drawn to a method for liquefying a respiratory sample, comprising adding an aqueous solution comprising hydrogen peroxide to said sample for liquefying said respiratory sample.
Buzatu et al. (see fig. 1) discloses a method for liquefying a respiratory sample (sputum; see para. 28, 29, 91, 209), comprising adding an aqueous solution (PBS buffer; see para. 65, 94) of hydrogen peroxide to said sample (see para. 66, 90, 91, 92 94, 96). Buzatu et al. also discloses a method for detecting respiratory infections (tuberculosis; par. 29, 208, 209) caused by pathogenic microorganisms in a respiratory sample.
As to limitations of claim 5,[AltContent: textbox (")] Buzatu et al. discloses a method for liquefying a respiratory sample (sputum; see para. 28, 29, 91, 209). Additionally, for other samples Buzatu et al. para 0057 recites: “For instance, in some embodiments, a sample to be analyzed can be a biological sample, such as a tissue or biological fluid. Without limitation, the tissue or biological fluid may contain any detectable microbial pathogen. In some embodiments, the microbial pathogen may be tuberculosis.”
The prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Buzatu et al. (US 2015/275263 A1 filed October 1, 2025).
The claims are drawn to:
Claim 1. A method for liquefying a respiratory sample, comprising adding an aqueous solution comprising hydrogen peroxide to said sample for liquefying said respiratory sample.
Claim 2. The method according to claim 1, wherein the aqueous solution has a concentration of hydrogen peroxide between 0.01 M and 1 M.
Claim 3. The method according to claim 2, wherein the aqueous solution has a concentration of hydrogen peroxide of about 0.3 M.
Claim 4. The method according to claim 1, wherein the amount of the aqueous solution of hydrogen peroxide added to said sample is between 10 and 20 microliters per milligram of sample.
Claim 5. The method according to claim 1, wherein the respiratory sample is a sputum sample, a sample of bronchial aspirate, bronchoalveolar lavage, nasopharyngeal swab or bronchial brushing.
Buzatu et al. (see fig. 1) discloses a method for liquefying a respiratory sample (sputum; see para. 28, 29, 91, 209), comprising adding an aqueous solution (PBS buffer; see para. 65, 94) of hydrogen peroxide to said sample (see para. 66, 90, 91, 92 94, 96). Buzatu et al. also discloses a method for detecting respiratory infections (tuberculosis; par. 29, 208, 209) caused by pathogenic microorganisms in a respiratory sample.
As to limitations of claim 5,[AltContent: textbox (")] Buzatu et al. discloses a method for liquefying a respiratory sample (sputum; see para. 28, 29, 91, 209). Additionally, for other samples Buzatu et al. para 0057 recites: “For instance, in some embodiments, a sample to be analyzed can be a biological sample, such as a tissue or biological fluid. Without limitation, the tissue or biological fluid may contain any detectable microbial pathogen. In some embodiments, the microbial pathogen may be tuberculosis.”
As to limitations of clams 2-4 concentrations of hydrogen peroxide Buzatu et al. para 0093, 0094, 0095 recite:
[0093] Such oxidant species may be used over various concentration ranges. Non-limiting examples of such concentration ranges can include, for example, from about 0.1% by weight to about 2% by weight relative to the amount of sample, or from about 1% by weight to about 2% by weight relative to the amount of sample.
[0094] Oxidants of the present disclosure may be included in various compositions, such as in buffers or other solutions. In some embodiments, oxidants may be present as part of a swab kit as previously described hereinabove. For instance, one or more oxidants may be present in a buffer that may be used in a swab kit. In another embodiment, one or more oxidants (such as H202) may be present as part of the swab in the swab kit. Such swab kits containing one or more oxidants may further include one or more surfactants.
[0095] Samples of the present disclosure may be treated with oxidants for various time periods. In some embodiments, such time periods may vary from about 30 seconds to about 60 minutes. In other embodiments, such time periods may vary from about 5 minutes to about 30 minutes.
It is noted, that while the reference recite the inclusion of hydrogen peroxide at specific concentrations and amounts. Regarding the specific concentration and amounts recited in the instant claims, MPEP 2144.05 states, "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)."
Therefore, it would have been prima facie obvious at the time of applicants’ invention to modify teachings of Buzatu et al. to adjust concentration of hydrogen peroxide for liquefying a respiratory sample. Because the teachings of Buzatu et al. is drawn to a method for liquefying a respiratory sample (sputum; see para. 28, 29, 91, 209), comprising adding an aqueous solution (PBS buffer; see para. 65, 94) of hydrogen peroxide to said sample (see para. 66, 90, 91, 92 94, 96).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known compositions to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known compositions is likely to be obvious when it does no more than yield predictable results". It is well known to adjust the concentration of solution to provide a better method which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tues , Thurs-Fri 12pm-8pm.
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/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
January 7, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645