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 .
Claim Amendments
2. The amendment filed June 25, 2026 has been entered. Claims 1, 5-7, 9, 12-15, 17-20, 24-26, 30-31, 155-156 and 161 have been amended. Claims 2-4, 16, and 42-154 have been canceled. Claim 32 is withdrawn. Claims 1, 5-15, 17-31, 33-41 and 155-165 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 22, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Maintained Grounds of Rejection
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.
4. 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 Group A 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 Group A 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 Group A 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
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 Edwards et al., (1982. J Clin Microbiol. 1982 Mar;15(3):481–483).
The claims are drawn to a method.
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 Group A 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 Group A 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 Group A 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.
Response to Arguments
6. Applicant's arguments filed June 25, 2026 have been fully considered but they are not persuasive.
The rejection of claims 1, 5-15, 17-31, 33-41 and 155-165 under 35 U.S.C. 103 as being unpatentable over Kshirsagar et al. in view of Karabay et al. is maintained despite Applicants arguments.
The rejection of claims 1, 5-15, 17-31, 33-41 and 155-165 under 35 U.S.C. 103 as being unpatentable over Kshirsagar et al. in view of Edwards et al., is maintained despite Applicants arguments.
Applicants argue that the Pre-Appeal Brief Review dated March 20, 2024 previously withdrew the rejection 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). However, the instant claims have been amended on Oct. 23, 2025 and again June 25, 2026. Therefore, the previously withdrawn rejection over Kshirsagar et al., in view of Karabay et al., were reinstated.
Applicants point to claim interpretation regarding the intended use limitations. Applicants argue that “at home” limitation; yet provide no argument that the method taught by Kshirsagar et al., in view of Karabay et al., could not occur in the home.
In response to applicant's argument that the “at home” wording implies an active method step, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
First, Kshirsagar et al., in view of Karabay et al., teach a portable liquid container of a filtration device, 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 Group A Streptococcus bacterium trapped by the filter. Applicants do not dispute the fact that the device is portable and neither Kshirsagar et al., nor Karabay et al., teach a limitation regarding the location of use. Kshirsagar et al., disclosed herein are methods, systems, kits and devices for processing samples. The methods, systems, kits and devices can offer advantages in processing samples in that they provide a quick, easy, simple and relatively inexpensive way to prepare water samples (for example) for microbiological analyses. Further advantage is provided by the ability to accomplish universal sample concentration options from large volumes for detecting low levels of bacteria, spores or viruses. The methods and devices can be quick, simple, portable and require no expensive equipment or highly skilled technician [para 65]. Therefore, Kshirsagar et al., do not exclude over the counter or home use. Karabay et al., taught the throat gargle method is a quick, safe, and easy method for detection of GAS that serves as an effective alternative to throat swab culture.
With regard to the recited steps of “collecting”, “applying pressure” are taught by Kshirsagar et al., teach 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]. Therefore, Kshirsagar et al., taught applying pressure with a plunger and collection upon a filter; thus each limitation is clearly taught by the prior art references.
With respect to the Group A amendment; Karabay et al., taught the efficacy of throat gargling for detection of Group A beta-hemolytic Streptococcus. Karabay et al. taught the detection of Group A beta hemolytic Streptococcus bacteria from sampled gargled fluid. Karabay et al., teach that the throat gargled method is quick, safe and easy method for detection or testing for presence of Group A Streptococcus bacteria; while Kshirsagar et al., already disclosed detection and testing for Streptococcus bacteria.
Next Applicants argue that Kshirsagar et al., only teach detection and testing for Streptococcus bacteria and not Group A Streptococcus bacteria. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Karabay et al., taught a throat gargled method is quick, safe and easy method for detection or testing for presence of Group A Streptococcus bacteria; therefore the prior art rejection clearly and specifically taught detection of Group A Streptococcus bacteria. The rejection is not based on Kshirsagar et al., alone. It would have been prima facie obvious at the time of applicants’ invention to combine the teachings of Kshirsagar et al., teaching a method comprising testing for streptococcus by collecting a water sample 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; 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 and exchange the water sample for throat gargle because the gargle sample is quick, safe, and easy to obtain thereby specifically allowing for detection of group A streptococcus.
Contrary to Applicants assertion, the apparent reason to combine the teachings is explicitly stated the prior art references. One of ordinary skill in the art would have a reasonable expectation of success by incorporating the throat gargle of Karabay et al., or Edwards et al., into Kshirsagar et al method in order to improve the efficacy of throat gargle for Group A 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.
Applicants point to Kshirsagar’s teaching of testing the sanitary quality of water. However the analysis of water quality does not exclude in home testing, or testing in any location is not limited by the portable testing device of Kshirsagar et al.
Applicant point to Kshirsagar’s teach of performing analysis in a field location. However the broad and reasonable interpretation within the scientific method, the "field location" refers to the environment outside of a controlled laboratory setting where researchers conduct observational studies or fieldwork. Thus, a field location merely means not tested within a laboratory and does not exclude a home location.
Applicants argue that Kshirsagar et al., teach testing of environmental samples. However testing environmental water samples in homes ensures your drinking water is potable and free from harmful pollutants. Whether your water comes from a municipal public utility or a private well, collecting accurate samples is critical because many dangerous contaminants cannot be seen, tasted, or smelled. Therefore, contrary to argument, the testing of environmental samples does not exclude testing in home water samples. Moreover, Kshirsagar et al., and the instant claims are both testing water. There is no exclusion regarding the source of the water. Furthermore, Karabay et al., clearly and specifically testing a human throat gargle specimen sample taken from a human subject for testing an infection. Therefore, this argument is not persuasive.
Applicants point to the claim language regarding a method comprising testing for streptococcal sore throat. However, this statement is recited in the preamble. It is further noted, that there is no active method step for testing for streptococcal sore throat. Instead the active limitation of the claim recites testing for the presence of the Group A Streptococcus bacterium trapped by the filter. Kshirsagar et al., teach testing of Streptococcus bacterium trapped by the filter; while Karabay et al., taught testing human throat gargle specimen for testing for a Group A Streptococcus. It is noted that Strep throat is an infection in your throat and tonsils caused by a type of bacteria called Group A Streptococcus (group A strep). Therefore, Kshirsagar et al., in view of Karabay et al., clearly taught testing for streptococcal sore throat caused by Group A Streptococcus.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case,
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.
Applicants argue long felt need regarding unmet need in the strep diagnostic arts for a safe and easy to use over-the-counter (OTC) strep throat diagnostic test, which is suitable for home use and uses a sample collection technique other than throat swabbing. However, MPEP 716.04 states
“…the long-felt need must not have been satisfied by another before the invention by the inventor. Newell Companies v. Kenney Mfg. Co., 864
F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988) (Although at one
time there was a long-felt need for a "do-it-yourself" window shade material which was adjustable without the use of tools, a prior art product fulfilled
the need by using a scored plastic material which could be torn.
"[O]nce another supplied the key element, there was no long-felt need or,
indeed, a problem to be solved".)”
In this case, a safe and easy strep throat diagnostic test, which is suitable for home use and uses a sample collection technique other than throat swabbing has been taught in the prior art. The detection of Streptococcal sore throat causing bacteria has been taught by Kshirsagar et al., in view of Karabay et al., or Edwards et al., teach sample collection by throat gargle provides the advantages of reduced infection transmission, self- administration, and reduced patient anxiety, stress, gagging, nausea or coughing. The teaching of Kshirsagar et al., in view of Karabay et al., or Edwards et al., supplied the key element of throat gargle, therefore there was no long-felt need or problem to be solved because Kshirsagar et al., in view of Karabay et al., or Edwards et al., provided the solution. Therefore, it is submitted that this argument should not be found persuasive.
Applicants argue there is a long-felt unmet need in the strep diagnostic arts for a safe over-the-counter (OTC) strep throat diagnostic test appropriate for home use, as summarized by the FDA in 2016. However this argument is not commensurate in scope with the rejected claims. How the prior art methods were sold and their availability is not a patentable issue. The claims do not distinguish an over-the-counter method or if this method is practiced within the confines of a medical facility or home. The claims do not limit whether the method is practiced by a potentially infected person or a health care worker. The rejected claims do not state that the method can only by practiced in a home as compared to a doctor’s office or hospital. The marketability of the instantly claimed method should not be interpreted as a long-felt unmet need.
Furthermore, factors such as lack of interest or lack of appreciation of an invention’s potential or marketability rather than lack of technical know-how has not been shown. There is no evidence of record to establish long felt need and the failure of others. At best, Applicants have shown that the FDA has not approved any related devices. Therefore, the lack of an endorsement by the FDA should be found irrelevant. FDA approval does not equate to a lack of teaching regarding Strep A testing or the failure of others to detect Strep pyogenes. Additionally, the lack of FDA approval does not require the USPTO to approve an application or affect a determination of novelty.
In this case, Karabay et al., state the conventional throat swab culture remains the gold standard, but the throat gargle is a quick, safe, and easy method for detection of sore throat causing Streptococcus that serves as an effective, and sensitive alternative to throat swab culture. Thus, Karabay et al., teach a method comprising: testing for Group A beta hemolytic streptococcus/S. pyogenes by collecting, from a patient, throat-gargled fluid that was spit out by the patient and that potentially contains the sore throat Streptococcus bacterium for detection.
Applicants argue about the use of centrifugation, saying it teach away from the prior art method. In this case, filtration and centrifugation accomplish the same purpose of concentrating the sample. Both filtrations and centrifugation techniques perform the same purpose which is to concentrate the desirable components within the sample and separate out the undesirable fluid of the gargle. Alternatively, any device that facilitates the movement of fluid through the filter of the filtration device can be used in this embodiment.
Kshirsagar et al., teach membrane filtration is a commonly utilized technique to obtain a direct count of microorganisms present in low concentrations in large volume samples of water. The operational requirements for most membrane filtration techniques (vacuum manifolds) or centrifugation (powered equipment) make them unsuitable for on-site applications. In addition, filtration of large volumes by use of mechanical means (via pistons or plungers) or manually applied pressure is very labor intensive due to the pressure required to force the sample through membranes having pore sizes small enough to isolate bacteria (0.22 to 0.45 microns). Thus, there is a need for simple, non-labor intensive, inexpensive, portable sample acquisition methods for processing large sample volumes. Therefore, Kshirsagar et al., teach retaining and testing the residual on the filter surface and not the extraneous fluid. Kshirsagar et al., just like the instantly rejected claims teach multiple filtration (concentration) events. Karabay et al., states the gargled fluids were centrifuged and the supernatant fluid was discarded leaving the residue for testing [para 39 col. 2]. Therefore, both Kshirsagar et al., Karabay et al., and Edwards et al., test the residual and not the extraneous fluid. Contrary to Appellants assertion, Kshirsagar et al’s filter accomplishes the same purpose as Karabay et al’s centrifugation, concentration of the sample residue. Therefore, the prior art clearly teaches concentration of the throat samples in order to subsequently test for the presence of Streptococcus.
Additionally, Applicants argue that Karabay et al., teach centrifuging the gargled fluid for detecting strep throat. However, the instant claims do not exclude centrifugation techniques. The instant claim recite “…subsequently, testing for the presence of the Streptococcus bacterium trapped by the filter.” without any limitation on the sample treatment or detection techniques which exclude centrifugation. Thus, whether or not throat gargle requires centrifugation, is irrelevant because:
1) the instant claims do not exclude centrifugation as a part of subsequent testing for the presence of the Streptococcus bacterium trapped by the filter;
2) The rejections of record do not require bodily incorporation of every single step recited by Karabay et al. In this case, the only modification to Kshirsagar et al’s method is the incorporation of an alternative sample source where Karabay et al., and Edwards et al., teach numerous benefits and advantages for exchanging throat gargle for a throat swab.
Applicants urge that Karabay et al., teach away from the use of throat gargle sample collection. The Karabay et al., reference is relevant as prior art for all it contains. The reference is a part of the literature of the art, relevant for all it contains regarding the benefits of throat gargle being that throat gargle is a quick, safe, and easy effective alternative to throat swab. No more than routine skill is required to incorporate an alternative sample source as Karabay et al. teach numerous benefits to using throat gargle, such as not stimulating excessive coughing, nausea and/or gagging; and reducing stress, anxiety and Streptococcus transmission. Therefore, this argument is not found persuasive.
In conclusion, 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 Group A 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., and Karabay teach throat gargle can clearly provide a fluid sample for testing Group A streptococci.
With regard to the filter versus centrifugation argument; this should not be found persuasive because: 1) Kshirsagar et al’s teach filter use; 2) the claims do not exclude centrifugation; 3) the only modification of Kshirsagar et al., is the exchange of the sample source for Karabay's throat gargle; 4) the rejection of Kshirsagar et al., in view of Karabay et al., or Edwards et aal., do not require bodily incorporation of every single step recited by Karabay or Edwards; and 5) filtration and centrifugation both concentrate the throat gargle sample for Streptococcal detection and Kshirsagar et al., already teach filter concentration.
With regard to long felt need and the FDA arguments. The criteria for establishing long felt need should not be found persuasive because Applicants did not establish failure by others and the prior art shows that the need has been met. Additionally, Applicants FDA related arguments are not commensurate in scope with the rejected claims. Therefore, it is submitted that none of Applicants argument are found persuasive.
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. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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 Peter Paras, can be reached on 571-272-4517. 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
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