DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on Oct. 23, 2025 has been entered.
Claim Amendments
3. The amendment filed Oct. 23, 2025 has been entered. Claims 1, 6, 9, 11, 21, and 23 have been amended. Claims 2-4, 16, and 42-154 have been canceled. Claims 161-165 have been newly added. Claims 1, 6-15, 17-41 and 155-165 are under consideration in this Office Action.
Withdrawn Grounds of Rejection Based Upon Applicants Amendments
4. The rejection of claims 1, 5-15, 17-31, 33-41 and 155-160 under 35 U.S.C. 103 as being unpatentable over Smith et al., in view of Konrad, is withdrawn in view of Applicants Amendments.
New Grounds of Rejection Necessitated By Applicants Amendments
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 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.
5. Claims 1, 5-15, 17-31, 33-41 and 155-165 are rejected under 35 U.S.C. 103 as being unpatentable over Kshirsagar et al. (US 20110318814) in view of Karabay et al. (Japanese Journal of Infectious Diseases, vol. 58, pp. 39-40, February 1, 2005).
The claims are drawn to a method comprising testing for streptococcal sore throat by collecting, at home from a subject, into a liquid container of a filtration device, throat gargled fluid that was spit out by the subject and that potentially contains Streptococcus bacterium; at home using a liquid-pressure source of the filtration device, applying pressure to drive the throat-gargled fluid contained in the liquid container through a filter of the filtration device; and subsequently, testing for the presence of the Streptococcus bacterium trapped by the filter.
It is noted that the instant specification at paragraph [1098] states that Throat gargle: Throat gargles were obtained by gargling 10-1 mL PBS for approximately 10 seconds.
It is noted that the intended use of the method for streptococcal sore throat detection at home is the intended use of the kit at an intended location. The intended location of use, does not further limit the method steps.
Kshirsagar et al., disclose a method for testing for presence of a Streptococcus bacterium (see paragraphs 02 and 03), the method comprising: collecting, in a tube, fluid that potentially contains the bacterium; (Figure 2 - steps 210 and 220; paragraphs 96 and 97; Figures 8A and 8B - body 820 + support 830). The term “microorganism” is generally used to refer to any prokaryotic or eukaryotic microscopic organism, including Streptococcus species [para 36]. Kshirsagar et al. teach using a plunger (840), pushing the fluid through a filter (Figure 2 - step 230; Figs. 8A and 8B - filter 850) disposed at a location selected from the group consisting of: a distal portion (830) of the tube (820+830), and a distal end of the plunger; and subsequently, while the filter is inside the tube (paragraph 70: "directly detected" is understood to indicate implicitly that the filter does not have to be removed from the tube), ascertaining if any of the particulate was trapped by the filter by applying a particulate- presence-testing-facilitation solution (paragraph 70: “adding bioluminescent reagents"; Figure 2 - step 250) to the filter. A plunger is shaped and proportioned to fit within and move longitudinally through the interior of the body. The removable support, onto which a filter can be placed, is detachably attached to the body [para 97]. At the lower end of the plunger there is a sealing ring [para. 097]. Kshirsagar et al., teach claims 36-41. After mixing, the adhesive barrier seal was removed and pressure was applied by manually pushing down the plunger in the device for approximately 5 minutes to capture the amorphous, spheroidized magnesium silicate concentration agent on the filter [para 141]. Thus teaching 163-165. Kshirsagar et al., teach using a liquid-pressure source of the filtration device and applying pressure to drive the fluid. Pressure can be applied by manually compression to capture the concentration agent on the filter [para 151]. In FIG. 9, the container includes threads at the upper end of the outer surface of the sidewall, which are shaped and dimensioned for the collar (having internal threads capable of engaging with the threads on the container) to be screwed onto the upper end of the container [para 123]. Thus teaching 164.
Examples of pathogens include Streptococcus, spp [para. 36]. Thus Kshirsagar et al., teach testing for the presence of the Streptococcus bacterium trapped by the filter and claims 5-7 and 12. In an embodiment, a kit can include components that can be utilized to detect microorganisms. If desired, one or more additives can be included in a kit as disclosed herein [para 091]. Thus teaching claim 161. In an embodiment, the sample can be collected and concentrated on the filter. The filter can optionally be washed, lysis reagents can be added to the filter in order to lyse microorganisms and release the detection analyte such as ATP [para. 71]. Kshirsagar et al., teach claims 7-8, 21, 22, 25.
Kshirsagar et al., a system for isolating microorganisms from a sample, the sample having sample matrix and microorganisms, the system including a liner configured to afford contact of a concentration agent and the sample, to provide a microorganism-bound composition that includes concentration agent-bound microorganisms and sample matrix; a filter, the filter having a first surface and a second surface and comprising pores having an average pore size that is larger than the average size of the microorganisms; a filter support configured to contact the first surface of the filter and afford contact of the microorganism-bound composition with the second surface of the filter, wherein the liner and filter support are configured to afford filtration of the microorganism-bound composition through the filter in order to collect the concentration agent-bound microorganisms on the second surface of the filter [para 007] thereby teaching claims 29-31.
A variety of methods can be used to identify and/or quantify microorganisms. Specific examples of testing methods that can be used include, but are not limited to, lateral flow assays, immunological assays (e.g., enzyme-linked immunosorbent assay (ELISA)). Microorganisms can be detected colorimetrically, electrochemically, fluorimetrically, or lumimetrically. Microorganisms can be detecting by utilizing immunoassay, enzyme assays analysis [para. 064]. Kshirsagar et al., teach claims 9-11 and 156-159. This particular product has a sample container made of polypropylene and a filtrate container made of high impact polystyrene; has ¼″ and ⅜″ inner diameter quick-disconnect tubing adapters for vacuum connection; and utilizes a 47 mm diameter filter. Such an exemplary device (along with an appropriate filter(s)) could be utilized along with concentration agent in a kit or for carrying out the methods disclosed herein [para. 0097]. A variety of methods can be used to identify and/or quantify microorganisms, including, but not limited to, microbiological assays, biochemical assays (e.g. immunoassay), or a combination thereof. Specific examples of testing methods that can be used include, but are not limited to, lateral flow assays [para. 0064]. In certain embodiments, an optional prefilter as shown in FIG. 8A, can be positioned in the device in a location that is upstream in the flow path, relative to the filter. The filter can be made of materials and have characteristics as discussed above with respect to exemplary filters [para. 0097]. Kshirsagar et al., teach claims 36-41 and 160. Kshirsagar et al., teach a method for isolating microorganisms from a sample, the sample comprising sample matrix and microorganisms, the method comprising the steps of: providing a receptacle, the receptacle configured to allow filtering of the sample and to reversibly contain the sample and a concentration agent; adding the sample to the receptacle, wherein a microorganism-bound composition will be formed in the receptacle, the microorganism-bound composition comprising concentration agent-bound microorganisms and sample matrix; filtering the microorganism-bound composition through a filter to collect the concentration agent-bound microorganisms on the filter, wherein the filter has an average pore size that is greater than the average size of the microorganisms; and culturing the microorganisms on the filter [claim 1]; thereby teaching claims 20.
The methods and devices can significantly reduce back pressure and leakage issues that are often associated with filtering for microbiological analyses (because of the very small pore size filters that are usually required). The methods and devices can be quick, simple, portable and require no expensive equipment or highly skilled technician [para 26]. When large pore size filters (e.g. at least about 10 μm or greater) are utilized, coliform enumeration can be done directly in commercially available culture films [para. 26]. Specific strains of microorganisms can then be detected from among the captured microorganism population using any known detection method for example with strain-specific probes or with strain-specific culture media. Once the sample is combined with the concentration agent in the receptacle, a microorganism-bound composition is obtained. A microorganism-bound composition includes concentration agent-bound microorganisms and sample matrix [para 0038]. Kshirsagar et al., teach claims 24 and 155. Therefore, Kshirsagar et al., teach a method for testing for presence of Streptococcus bacteria; however does not specifically recite specific detection of Streptococcus group A bacteria from gargle fluid.
Karabay et al., teach efficacy of throat gargling for detection of group A beta-hemolytic Streptococcus (see title). Karabay et al. teach the detection of group A beta hemolytic Streptococcus bacteria from sampled gargled fluid (see abstract). Karabay et al., teach that the throat gargled method is quick, safe and easy method for detection or testing for presence of Streptococcus bacteria (see abstract). Subject gargled with sterile saline for 10 sec and then gargle fluids were centrifuged wherein the residue was mixed and used for inoculation [page 39, col. 2]. Group A Streptococcus was detected in both throat swabs and gargle specimens. The sensitivity of gargle procedure was above 80%. The gargle method is a good alternative when throat swabs will stimulate excessive cough and/or cause nausea and will avoid undesirable swab induced gagging, anxiety, stress and cough [page 40, col. 2]. Karabay et al., is cited as general examples of documents describing the detection of group A beta hemolytic streptococcus bacteria from sampled gargled fluid [page 40, col. 2]. Thereby teachings claims 12-15.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to combine the teachings of the above references to obtain the instant invention because the throat gargle method is a quick, safe, and easy method for detection of group A beta- hemolytic streptococcus (GAS). One of ordinary skill in the art would have a reasonable expectation of success by incorporating the throat gargle of Karabay et al., into Kshirsagar et al method in order to improve the efficacy of throat gargle for Streptococcus when Kshirsagar et al., already teach detection of Streptococcus from collected sample that potentially contains a bacterial particulate; passing the sample through a filter; and subsequently, testing for the presence of the particulate trapped by the filter. Furthermore, Karabay et al., teach throat gargle sample retrieval can avoid stress and anxiety while still providing sensitivity results. Additionally, it is no more than routine the variations taught in dependent claims are presently seen as within the scope of the customary practice followed by persons skilled in the art, especially as the advantages thus achieved can readily be foreseen. Finally it would have been prima facie obvious to combine the invention of the Kshirsagar et al. to obtain a method of testing presence of bacteria specially Streptococcus in biological samples.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods 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 methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine the teachings of diagnostic or detection methods thus the combination would have yielded 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.
Claim Rejections - 35 USC § 103
6. Claims 1, 5-15, 17-31, 33-41 and 155-165 are rejected under 35 U.S.C. 103 as being unpatentable over Kshirsagar et al. (US 20110318814) in view of Edwards et al., (1982. J Clin Microbiol. 1982 Mar;15(3):481–483).
The claims are drawn to a method comprising testing for streptococcal sore throat by collecting, at home from a subject, into a liquid container of a filtration device, throat gargled fluid that was spit out by the subject and that potentially contains Streptococcus bacterium; at home using a liquid-pressure source of the filtration device, applying pressure to drive the throat-gargled fluid contained in the liquid container through a filter of the filtration device; and subsequently, testing for the presence of the Streptococcus bacterium trapped by the filter.
Kshirsagar et al., teach a method comprising testing for streptococcal infection by collecting, at home from a subject, into a liquid container of a filtration device, fluid sample that potentially contains Streptococcus bacterium; at home using a liquid-pressure source of the filtration device, applying pressure to drive the fluid contained in the liquid container through a filter of the filtration device; and subsequently, testing for the presence of the Streptococcus bacterium trapped by the filter. However, Kshirsagar et al., do not specifically recite specific detection of Streptococcus group A bacteria from gargle fluid.
Edwards et al., teach the diagnosis of Group A Streptococcal infections directly from throat gargle where the diagnosis of group A streptococcal disease should become a rapid and simple procedure. Edwards et al., teach the early identification of group A strep because clinical diagnosis of streptococcal pharyngitis is important [page 481, col. 1]. A simple technique to permit the identification of streptococci directly from throat secretions would allow immediate application of appropriate antimicrobial therapy in the management of streptococcal infections [page 481, col. 1]. Edwards et al., teach clinical samples of individuals with sore throats gargled with phosphate buffered saline or nutrient broth. Edwards obtained materials from gargling [page 481, col. 2]. Edwards et al., tested gargle material for the presence of streptococcal antigen [page 482, col.1].
Therefore, it would have been prima facie obvious at the time of applicants’ invention to combine the teachings of the above references to obtain the instant invention because the throat gargle method is a quick, safe, and easy method for detection of group A streptococcus. One of ordinary skill in the art would have a reasonable expectation of success by incorporating the throat gargle of Edwards et al., into Kshirsagar et al method in order to improve the efficacy of throat gargle for Streptococcus when Kshirsagar et al., already teach detection of Streptococcus from collected sample that potentially contains a bacterial particulate; passing the sample through a filter; and subsequently, testing for the presence of the particulate trapped by the filter. Furthermore, Edwards et al., teach throat gargle can clearly provide a fluid sample for testing streptococci. Additionally, it is no more than routine the variations taught in dependent claims are presently seen as within the scope of the customary practice followed by persons skilled in the art, especially as the advantages thus achieved can readily be foreseen. Finally it would have been prima facie obvious to combine the invention of the Kshirsagar et al. and Edwards et al., to obtain a method of testing presence of Streptococcus in gargle samples.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods 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 methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine the teachings of diagnostic or detection methods thus the combination would have yielded 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.
Pertinent Art
7. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
WO2005050167 teach devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more.
Smith et al., (US Pat Pub 20090011403 published Jan 2009; priority to May 2004) teach a method comprising: testing for streptococcal sore throat by collecting, from a patient, a fluid which can be gargled and spit out by the patient and that potentially contains Streptococcus bacterium; passing the saliva containing fluid through a filter; and subsequently, testing for the presence of the Streptococcus bacterium trapped by the filter.
Konrad (US 20060073538 published April 2006, priority to May 2005) teach a method of collecting saliva from the oral cavity for detecting a test substance, comprising the steps of (a) cleaning the oral cavity, (b) stimulating saliva secretion with a saliva-collecting solution, (c) removing the saliva collecting solution mixture from the oral cavity and collecting it in a container (1), (d) transferring the saliva- collecting solution mixture into a sealable collection vessel [abstract].
Conclusion
8. No claims allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dan Kolker, can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645