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 .
Status of Claims
Applicant' s arguments, filed 09/22/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/22/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claim 13 in the response filed on 09/22/2025.
Claims 1-12 and 14-20 are the current claims hereby under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 29. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 13. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 4, 5, 7-9, 11-12, 14-15, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fry et al. (US Patent Pub. No. 20200155127 – previously cited) hereinafter Fry in view of Etchebarne (US Patent Pub. No. 20180135108 – previously cited).
Regarding Claim 1, Fry discloses a method comprising:
removing a removable seal sealing an access opening of a tubular container thereby exposing a liquid disposed within the tubular container (With reference to FIG. 11a, a liquid such as a buffer solution and/or diluent is deposited into the receiving section 520 of the sampling device 500 and specifically so that the liquid partially fills the internal chamber 531 of the receiving section 520. The liquid may be deposited in the internal chamber 531 during manufacture of the sampling device 500, with a releasable sealing layer being located, for example, over the main opening 535 of the dropper to prevent spilling of the liquid prior to use. [0129]);
combining a sample comprising a target with the exposed liquid thereby forming a liquid mixture of the sample and the liquid within the tubular container (the sample collector, dropper and base remain secured together may be sufficient for the capture reagents to form labelled complexes with the analyte of interest [0033]; the sample collector, dropper and base remain secured together may be sufficient for the capture reagents to form labelled complexes with the analyte of interest the sample collector 510 is used to receive a sample from a subject 200 [0130]; fig 11b; after receipt of sample on the absorbent portion 511 of the sample collector 510, with liquid located in the internal chamber 531 of the receiving section 520, the absorbent portion 511 is extended into the internal chamber 531 [0131]; fig 11c);
resealing the access opening with a lid comprising (cap 512 [0122]; fig 10; the sample collector 510 is secured to the receiving section 520 by screwing the sample collector 510 to the receiving section 520 [0131]; fig 11c) (i) a dispensing opening (a nozzle 5122 [0122]; fig 10) and (ii) a securing component that obstructs the dispensing opening and is secured to the lid via a frangible connection (The cap 512 includes a lid 5124 that is movable between an open and closed position, at the top end of the cap 512, to selectively seal the aperture 5123. The lid 5124 in this embodiment is hingedly connected to the container 5121 of the cap 512. [0122]; fig 10; The plug may be attached to the dropper, e.g. via a hinge or a frangible element [0022]; Examiner notes the plug serves a similar function as the cap and can be attached via a frangible element)
with the access opening resealed with the lid, heating the liquid mixture within the generally tubular container (the sample collector 510 and receiving section 520 may maintained in the state shown in FIG. 11d for a period of time sufficient to form a desired fluid sample mixture, e.g. through incubation processes or otherwise [0132]), wherein the liquid mixture within the tubular container has a total mass (Examiner notes that all liquid has a total mass) and the lid and the securing component prevent more than 0.5% of the total mass of the liquid mixture within the tubular container from leaking or escaping therefrom during the heating (In the process of securing the sample collector to the receiving section, an air-tight seal of the internal chamber of the dropper may be created. The air-tight seal can provide an air lock within the internal chamber of the dropper, retaining fluid sample within the internal chamber, preventing it leaking from the aperture of the dropper, even after the sealing of the aperture is released. [0035]; The seal provided between the cap 512 and the dropper container portion 530 ensures that sample can exit the dropper via the aperture 5123 only. [0118]; When the aperture 5123 of the sampling device 500 is released by opening the lid 5124, an air lock may retain fluid sample [0123]; Examiner notes the air-tight seal would prevent any mass of fluid sample from leaking);
and after heating the liquid mixture, opening the dispensing opening by breaking the frangible connection between the securing component and the lid (the lid 5124 of the cap can be opened by a user to unseal the aperture 5123 [0133]; plug may remain in place upon release of the dropper from the base and may be removed, e g manually, when releasing of the seal is desired. The plug may be attached to the dropper, e.g. via a hinge or a frangible element [0022]; Examiner notes the plug serves a similar function as the cap and can be attached via a frangible element and therefore be the frangible connection can be broken when opening the dispensing opening) and then dispensing at least some of the liquid mixture from the tubular container through the dispensing opening (a user can apply compression, generally as illustrated by arrows F, to the sidewalls 5341 of the dropper container portion 530, forcing fluid sample to be dispensed through the aperture 5123 [0133]; fig 11e).
Fry fails to disclose heating the liquid mixture within the generally tubular container to a temperature of at least 100° C. However, Etchebarne teaches heating a liquid mixture within a tubular container to a temperature of at least about 100° C (the step of heat lysing the clinical fluid sample...the step of heat lysing may be completed at a temperature of from 85 to 105, from 90 to 110, or from 95 to 115, ° C. [0093]).
Fry is considered analogous art to the present invention because both inventions are directed towards the same field of endeavor. Etchebarne is considered analogous art to the present invention because it is reasonably pertinent to the problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Fry such that included heating the liquid mixture within the tubular container to a temperature of at least about 100° C, as taught by Etchebarne, because it would lyse biological samples present in the liquid and prepare them for further testing. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). Furthermore, heating a liquid with a sample in the process to test for a target is well-understood, routine, and conventional activity in the art.
Regarding Claim 4, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry further discloses the method further includes subjecting the at least some dispensed liquid mixture to an assay to determine a presence and/or amount of the target (The fluid sample may be deposited in a controlled manner at a desired location, e.g. on a receiving portion 301 of a test device 300 as illustrated in FIG. 11e. The test device may be a lateral flow test device or otherwise. [0133]).
Regarding Claim 5, Fry in view of Etchebarne teaches the invention as discussed above in claim 4. Fry fails to teach the target is indicative of a pathogen. However, Etchebarne further teaches a target is indicative of a pathogen (Point-of-care (POC) diagnostics utilizing loop-mediated isothermal polymerase chain reaction amplification (LAMP) methods allow detection of 14 common pathogens as well as the methicillin resistance genetic marker mecA in less than one hour directly from human clinical samples. [0049]).
Fry discloses the sample is can be biological sample such as an intra-nasal sample [0031] and the sample contains an analyte of interest [0130]. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Fry in view of Etchebarne such that the target is indicative of a pathogen, as taught by Etchebarne. Furthermore, collecting a biological sample containing a target which is indicative of a pathogen is well-understood, routine, and conventional activity in the art.
Regarding Claim 7, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Etchebarne further teaches the step of heating comprises lysing bacterial cells within the liquid mixture (the step of heat lysing the clinical fluid sample to form a lysate that optionally comprises bacterial and/or fungal DNA and RNA forming a first mixture [0093]).
Regarding Claim 8, Fry in view of Etchebarne teaches the invention as discussed above in claim 7. Etchebarne further teaches the step of lysing comprises lysing bacterial cells of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus (The present disclosure demonstrates rapid genetic diagnostics methods utilizing loop-mediated isothermal amplification (LAMP) to test for 15 common infection pathogen targets...The 15 common infection pathogen targets include... Streptococcus pyogenes,..., Streptococcus agalactiae [0049]; LAMP can also be used for the detection of ... Mycobacterium tuberculosis [0053]; Examiner notes that heat lysing is part of the LAMP method and therefore would heat the liquid mixture to a temperature and for a duration sufficient to lyse bacterial cells of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus).
Regarding Claim 9, Fry in view of Etchebarne teaches the invention as discussed above in claim 8. Fry further discloses the method further includes subjecting the at least some dispensed liquid mixture to an assay to determine the presence and/or amount of the target (The fluid sample may be deposited in a controlled manner at a desired location, e.g. on a receiving portion 301 of a test device 300 as illustrated in FIG. 11e. The test device may be a lateral flow test device or otherwise. [0133]). Fry fails to disclose the target is indicative of at least one of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus. However, Etchebarne further teaches the target is indicative of at least one of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus (The present disclosure demonstrates rapid genetic diagnostics methods utilizing loop-mediated isothermal amplification (LAMP) to test for 15 common infection pathogen targets...The 15 common infection pathogen targets include... Streptococcus pyogenes,..., Streptococcus agalactiae [0049]; LAMP can also be used for the detection of ... Mycobacterium tuberculosis [0053]).
Fry discloses the sample is can be biological sample such as an intra-nasal sample [0031] and the sample contains an analyte of interest [0130]. Fry further discloses a “test device may be any type of test device configured to receive and test a sample” [0073]. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Fry in view of Etchebarne such that the target is indicative of at least one of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus, as taught by Etchebarne, depending on what type of test is to be performed. Furthermore, collecting a biological sample containing a target which is indicative of at least one of Mycobacterium tuberculosis and/or a bacterium of the genus Streptococcus is well-understood, routine, and conventional activity in the art.
Regarding Claim 11, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Etchebarne further teaches the heating step comprises heating the liquid mixture to a temperature that is at least 115° C and less than 150° C (Similarly, the step of heat lysing may be completed at a temperature of from 85 to 105, from 90 to 110, or from 95 to 115, ° C. [0093]).
Regarding Claim 12, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Etchebarne further teaches a total volume of the liquid mixture within the tubular container during the heating step is less than 50 μL (after heating 1 μl of the clinical fluid sample [0151]).
Regarding Claim 14, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry discloses the lid and the securing component prevent more than 0.25% of the total mass of the liquid mixture within the tubular container from leaking or escaping therefrom during heating (In the process of securing the sample collector to the receiving section, an air-tight seal of the internal chamber of the dropper may be created. The air-tight seal can provide an air lock within the internal chamber of the dropper, retaining fluid sample within the internal chamber, preventing it leaking from the aperture of the dropper, even after the sealing of the aperture is released. [0035]; The seal provided between the cap 512 and the dropper container portion 530 ensures that sample can exit the dropper via the aperture 5123 only. [0118]; When the aperture 5123 of the sampling device 500 is released by opening the lid 5124, an air lock may retain fluid sample [0123]; the sample collector 510 and receiving section 520 may maintained in the state shown in FIG. 11d for a period of time sufficient to form a desired fluid sample mixture, e.g. through incubation processes or otherwise [0132]; Examiner notes the air-tight seal would prevent any mass of fluid sample from leaking).
Regarding Claim 15, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry further discloses the step of dispensing comprises squeezing an exterior surface of the tubular container between fingers of a user to increase a gas pressure therein and dispense the at least some liquid mixture through the dispensing opening (user may engage the flexible side walls, e.g. with their thumb and forefinger, to press the flexible side walls to cause dispensing of the sample, via the aperture of the dropper [0034]; a user can apply compression, generally as illustrated by arrows F, to the sidewalls 5341 of the dropper container portion 530, forcing fluid sample to be dispensed through the aperture 5123 [0133]; fig 11e).
Regarding Claim 17, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry further discloses the liquid within the tubular container comprises at least one of buffer, universal transport media (UTM), Viral Transport Media (VTM) or lysis medium (With reference to FIG. 11a, a liquid such as a buffer solution and/or diluent is deposited into the receiving section 520 of the sampling device 500 [0129]).
Regarding Claim 18, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry further discloses the sample comprises at least one of saliva, mucous, sputum, or blood (biological sample may be, for example, any material, biological fluid, tissue, or cell obtained or otherwise derived from a subject including, but not limited to, blood (including whole blood, leukocytes, peripheral blood mononuclear cells, plasma, or serum), sputum, mucus, nasal aspirate, urine, semen, saliva, meningeal fluid, lymph fluid, milk, bronchial aspirate, a cellular extract, brain tissue, or cerebrospinal fluid [0075]).
Claim(s) 2, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fry (US Patent Pub. No. 20200155127 – previously cited) in view of Etchebarne (US Patent Pub. No. 20180135108 – previously cited) as applied to claim 1 above and further in view of Mielke et al. (US Patent Pub. No. 20150353919 – previously cited) hereinafter Mielke.
Regarding Claim 2, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach the tubular container and the lid including the securing component are made of a polymer. However, Mielke teaches a tubular container and a lid including a securing component are made of a polymer (container 10 is a clear, hollow, flexible (squeezable) plastic tube...container 10 comprises a cap-attachment portion 12 [0048]).
Mielke is considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Fry in view of Etchebarne such that the tubular container and the lid including the securing component are made of a polymer, as taught by Mielke. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. Furthermore, it is well-understood, routine, and conventional activity in the art to have extraction container systems made of polymer/plastic.
Regarding Claim 16, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach the lid further comprises a filter and the step of dispensing comprises passing the at least some liquid mixture through the filter. However, Mielke teaches a lid (the cap 20 [0059]; fig 1C) comprises a filter (filter 40 [0051]; fig 1C) and a step of dispensing comprises passing at least some liquid mixture through the filter (the sample buffer 60 is squeezed through the nozzle 26, sequentially passing through the second nozzle opening 25b, the filter 40 [0060]). Mielke also teaches “the filter is preferably configured to remove large particulate matter from the sample… allow fluid and analyte such as bacteria and virus particles to pass through while acting as a barrier to large particulate materials” [0009].
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Fry in view of Etchebarne such that the lid further comprises a filter and the step of dispensing comprises passing the at least some liquid mixture through the filter, as taught by Mielke, because it would prevent large particulate materials from passing into the assay. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 19, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach the removable seal comprises one or more layers comprising a liquid-impermeable metal foil and/or a liquid-impermeable polymer film. However, Mielke teaches a removable seal comprises one or more layers comprising a liquid-impermeable metal foil and/or a liquid-impermeable polymer film (The liquid-impermeable membrane 52 may comprise metal foil [0061]; fig 1A).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Fry in view of Etchebarne such that the removable seal comprises one or more layers comprising a liquid-impermeable metal foil and/or a liquid-impermeable polymer film, as taught by Mielke. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fry (US Patent Pub. No. 20200155127 – previously cited) in view of Etchebarne (US Patent Pub. No. 20180135108) as applied to claim 1 above, and further in view of Matsuura (WO 2011095599 A1 – previously cited).
Regarding Claim 3, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry discloses the securing component is a cap (cap 512 [0122]), the cap and the lid each include at least one respective engagement feature that can be engaged such that the cap again obstructs the dispensing opening (The cap 512 includes a lid 5124 that is movable between an open and closed position, at the top end of the cap 512, to selectively seal the aperture 5123. The lid 5124 in this embodiment is hingedly connected to the body 5121 of the cap 512. [0122]; Examiner notes that hinge connection is a respective engagement feature that can be engaged such that the cap again obstructs the dispensing opening). Fry in view of Etchebarne fails to teach the method further includes resecuring the cap to the lid by engaging the at least one respective engagement feature to reseal the dispensing opening after dispensing the at least some liquid mixture. However, Matsuura teaches resecuring a cap to a lid by engaging a respective engagement feature to reseal a dispensing opening after dispensing at least some liquid mixture (having an end serving as a port 18 for collecting the extraction liquid and also serving as a sealing lid attaching portion to which the liquid passage sealing lid 15 for sealing the liquid passage 13 is attached (pg. 9, lines 58-60); When the liquid passage 13 is sealed with the liquid passage sealing lid 15 after the extraction liquid 8 is obtained (as illustrated in Figs. 7b and 7c) to prevent leakage of the extraction liquid 8 (pg. 12, lines 30-31)). Matsuura also teaches resealing a dispensing opening allows for “efficiently and safely handl[ing] and process[ing] any specimens which are desirably neither exposed to an external environment nor contacted by a user to avoid contamination, for example, specimens used to test infectious bacteria (pg. 12, lines 33-35)).
Matsuura is considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Fry in view of Etchebarne such that it includes resecuring the cap to the lid by engaging the at least one respective engagement feature to reseal the dispensing opening after dispensing the at least some liquid mixture, as taught by Matsuura, because it would allow for the safe handling and processing of the liquid sample containing a target indicative of a pathogen. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fry (US Patent Pub. No. 20200155127 – previously cited) in view of Etchebarne (US Patent Pub. No. 20180135108) as applied to claim 1 above, and further in view of Weber et al. (WO 2016026829 A1 – previously cited) hereinafter Weber.
Regarding Claim 6, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach the step of heating comprises subjecting the liquid mixture within the tubular container to microwave radiation. However, Weber teaches comprises subjecting a liquid mixture within a tubular container to microwave radiation (an increase in the temperature of the sample is achieved by microwaving the mixture of sample, tablet and water contained in the vessel (12), which is located inside said hollow receptacle (10) [027]). Weber also teaches “the temperature of aqueous solutions confined in closed vessels which are exposed to microwaves can be tightly controlled...the exposure to microwave radiation generated by a conventional microwave oven yields high DNA quality and reduces extraction time” [013].
Weber is considered analogous art to the present invention because it is reasonably pertinent to the problems faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Fry in view of Etchebarne such that the step of heating comprises subjecting the liquid mixture within the tubular container to microwave radiation, as taught by Weber, because it allows tight control of temperature and yields high DNA quality and reduces extraction time. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 10, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach the heating step comprises heating the liquid mixture for a period of less than 200 seconds and more than 60 seconds. However, Weber teaches heating a liquid mixture for a period of less than about 200 seconds and more than about 60 seconds (The microwaving step can be applied for about 10 seconds to 10 minutes, preferably for about 15 seconds to 5 minutes, most preferred for about 20 seconds to 3 minutes. [027]).
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Fry in view of Etchebarne such that the heating step comprises heating the liquid mixture for a period of less than 200 seconds and more than 60 seconds, as taught by Weber, depending the “period of time sufficient to form a desired fluid sample mixture” for the type of test to be performed [0132 of Frye]. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fry (US Patent Pub. No. 20200155127 – previously cited) in view of Etchebarne (US Patent Pub. No. 20180135108 – previously cited) as applied to claim 1 above, and further in view of Chen et al. (US Patent Pub. No. 20110143968 – previously cited) hereinafter Chen.
Regarding Claim 20, Fry in view of Etchebarne teaches the invention as discussed above in claim 1. Fry in view of Etchebarne fails to teach an interior surface of the tubular container defines a multifoil. However, Chen teaches an interior surface of a tubular container defines a multifoil (the tubule 12 may include...an outer layer providing lower permeability, using material such as high density polyethylene or a metal foil, such as aluminum foil or a metal deposition. One skilled in the art will appreciate that one or more additional layers may also be employed, depending on, for example, the sample type, the reagent(s) employed, and the assay(s) being performed. [0045]; fig 1A).
Chen is considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Fry in view of Etchebarne such that an interior surface of the tubular container defines a multifoil, as taught by Chen, because it would provide lower permeability. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Response to Arguments
Applicant’s arguments, see pages 8-9 of Remarks, filed 09/22/2025, with respect to the drawing objections have been fully considered and are persuasive. The objection of drawings has been withdrawn. However, upon further consideration, a new grounds of objection has been made in view of the replacement drawings and amendments to the specification.
Applicant’s arguments, see page 9 of Remarks, filed 09/22/2025, with respect to the specification objections have been fully considered and are persuasive. The objection of specification has been withdrawn.
Applicant’s arguments, see page 9 of Remarks, filed 09/22/2025, with respect to the claim objections have been fully considered and are persuasive. The objection of the claims has been withdrawn.
Applicant’s arguments, see pages 9-11 of Remarks, filed 09/22/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 11-13 of Remarks, filed 09/22/2025, with respect to the prior art rejections of the claims have been fully considered but are moot in view of the new grounds of rejection as necessitated by Applicant’s amendments. Regarding Claim 1, Applicant alleges that "claim 1 has been amended to incorporate the limitations of canceled dependent claim 13". However, claim 1 does not exactly recite the limitations of claim 13. Specifically, amended claim 1 does not include any restrictions with regards to the timing of the heating. Claim 13 states "no more than about 0.5% of the total mass of the liquid mixture present at the start of the heating step escapes or leaks from the tubular body" while amended claim 1 states "heating the liquid mixture... wherein the liquid mixture has a total mass". There is no mention of the total mass of the liquid mixture being the mass of the liquid mixture present at the start of the heating step. Furthermore, amended claim 1 recites a structural element that prevents the liquid mixture from leaking or escaping. Therefore, the scope of amended claim 1 is not the same as claim 13.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791