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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/7/23 and 6/26/23 is being considered by the examiner.
Claim Status
Claims 1, 3, 5-6, 8, 20, 22-23, 25-26, 29, 31, 34-37, 39-40, 43, and 47 are pending and are examined.
Claim Objections
Claim 22 is objected to because of the following informalities: “multi25 layer” should be corrected to “multi-layer”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5-6, 8, 20, 22-23, 25-26, 29, 31, 34-37, 39-40, 43, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gellibolian (US Pub 2017/0030811).
Regarding Claim 1, Gellibolian teaches apparatus for collecting a saliva sample (Fig. 1), the apparatus comprising:
a filter (filter 44); and
a pressure generator operable to generate pressure to cause the saliva sample to be transferred through the filter ([0005] The disclosed filtration devices may also comprise a collection container comprising a quantitative container comprising a quantitative chamber and a plunger device, wherein the plunger device is removably attached to the quantitative container and wherein the plunger device is configured to move into the quantitative chamber upon the application of force. In some aspects the plunger device comprises a plunger including a channel and a valve. In other aspects the plunger device comprises a plunger, a plunger filter, and a plunger chamber. The device disclosed herein is suitable in any environment including point of care use or in a clinical or laboratory setting.),
the filter being configured to reduce a viscosity of the saliva sample as the saliva sample is transferred through the filter ([0119] the filter would be capable of reducing viscosity of the saliva sample).
Regarding Claim 3, Gellibolian teaches Apparatus for collecting a saliva sample according to claim 1, wherein the pressure generator further comprises a receptacle being arranged to receive the saliva sample and being compressible to generate pressure to cause the saliva sample to be transferred out of the receptacle through the filter ([0020] Fig. 12A illustrating filtration device comprising collection container attached to collection device and containing a biofluid sample and quantitation container; Fig. 12B illustrating removal of collection device and closure of collection chamber by securement of collection chamber cap; Fig. 12C illustrating application of force by squeezing wall of collection container and passage of a filtered biofluid sample into quantitative chamber after application of force; Fig. 12D illustrating removal of quantitative chamber containing filtered biofluid sample from collection container containing retained biofluid sample),
the receptacle comprising comprises a seal operable to seal an upper, shielding portion of the receptacle from a lower portion of the receptacle, the lower portion of the receptacle being operable to undergo manual compression or the receptacle comprises a hydrophobic inner surface ([0051] A filter mount and O-ring disclosed herein holds the filter in place within the collection container, provides a liquid tight seal between the collection chamber and the quantitative chamber, and an attachment point that enables a quantitative container or waste container disclosed herein to be secured to the collection container. The examiner notes that due to the limitation beginning with “or”, one of the clauses is optional).
Regarding Claim 5, Gellibolian teaches Apparatus for collecting a saliva sample according to claim 1, wherein the pressure generator further comprises a receptacle being arranged to receive the saliva sample and being compressible to generate pressure to cause the saliva sample to be transferred out of the receptacle through the filter, the receptacle being is in the form of a funnel ([0045] a funnel may be attached to the opening of a collection chamber disclosed herein to assist in the collection of the sample. In one aspect of this embodiment, a subject may spit into the funnel and the sputum drip into the collection chamber. In another aspect of this embodiment, a subject or user may pour a biofluid sample, such as, e.g., a urine sample or blood sample, into the funnel from a separate container and thereby fill the collection chamber with a biofluid sample. [0115] The collection device 1330 is preferably a funnel with a stem 1331 that inserts and attaches within the mouth 1327 of the collection chamber 1322.)
Regarding Claim 6, Gellibolian teaches apparatus for collecting a saliva sample according to claim 5, the width of the funnel opening being is in the range of 8_cm to 20_cm or the funnel comprises a plurality of handles ([0045] a funnel may be attached to the opening of a collection chamber disclosed herein to assist in the collection of the sample. In one aspect of this embodiment, a subject may spit into the funnel and the sputum drip into the collection chamber. The examiner notes that due to the limitation beginning with “or”, one of the clauses is optional).
Regarding Claim 8, Gellibolian teaches apparatus for collecting a saliva sample according to claim 1, the pressure generator further comprising a plunger operable to generate a positive pressure onto cause the saliva sample to be transferred through the filter drive the saliva sample through the filter or to generate a negative pressure on the saliva sample to draw the saliva sample through the filter ([0017] FIG. 9F illustrating attachment of plunger device and needle device to quantitative container. [0019] FIG. 11B illustrating removal of collection chamber cap and attachment of quantitative container having plunger device attached; FIG. 11C illustrating inversion of filtration device; FIG. 11D illustrating transfer of defined volume of biofluid sample to quantitative chamber; FIG. 11E illustrating removal of collection container from quantitative container having plunger device attached; FIG. 11F illustrating removal of base 1054 having needle 1058 and attachment of base 1054 without needle; FIG. 11G illustrating separation of fractions of biofluid sample after centrifugation; FIG. 11H illustrating filtered biofluid sample contained within plunger chamber after application of force; and FIG. 11I illustrating removal of plunger device by unsecuring plunger attachment.).
Regarding Claim 20, Gellibolian teaches apparatus for collecting a saliva sample according to claim 1, wherein the filter comprises a plurality of channels, a multilayer metal mesh and a porous substrate, and wherein one or more of the plurality of channels has a cross sectional width in the range 0.03 mm to 3 mm or wherein one or more of the plurality of channels has a narrowing cross-section in the direction of a fluidic path through the filter or wherein the plurality of channels comprises at least two channels having cross sections of different widths ([0049] pores which would be conduits and pore size for filter.)
Regarding Claim 22, Gellibolian teaches apparatus for collecting a saliva sample according to claim 1, wherein the filter comprises a plurality of channels, a multi25 layer metal mesh and a porous substrate, and wherein one or more of the plurality of channels has a narrowing cross-section in the direction of a fluidic path through the filter, the filter further comprises a surface arranged to receive saliva output from the one or more of the plurality of channels having a narrowing cross-section ([0049] pores would act as a conduit and be a fluidic pathway).
Regarding Claim 23, Gellibolian teaches apparatus for collecting a saliva sample according to claim 22, wherein the surface is a hanging surface (comprises collection chamber 22, cap face seal 24, and filter device 40 comprising filter mount 42, filter 44, port 46.).
Regarding Claim 25, Gellibolian teaches apparatus for collecting a saliva sample according to claim 1, wherein the filter comprises one or more of a plurality of channels, a multi-layer metal mesh and a porous substrate, the filter comprises a plurality of first channels for receiving the saliva sample, a second channel and a third channel in fluidic connection with the plurality of first channels, the plurality of first channels being fluidically connected to the third channel by the second channel ([0049] pores would act as a conduit and be a fluidic pathway).
Regarding Claim 26, Gellibolian teaches apparatus for collecting a saliva sample according to claim 25, wherein the second channel has a narrower cross-sectional width than the first and third channels or wherein the second channel forms a non-zero angle with the first and third channels or wherein the second channel is substantially perpendicular to the first and third channels ([0049] pores would act as a conduit and be a fluidic pathway. The examiner notes the limitation “or” means that one of the clauses is optional.).
Regarding Claim 29, Gellibolian teaches apparatus for collecting a saliva sample according to claim 25, wherein the plurality of first channels is arranged in a substantially circular configuration or wherein the plurality of first channels is arranged in a plurality of substantially circular concentric configurations ([0049] pores would act as a conduit and be a fluidic pathway. Pores are inherently in a circular shape).
Regarding Claim 31, Gellibolian teaches apparatus for collecting a saliva sample according to claim 25, wherein the third channel is arranged substantially centrally in a lower surface of the filter, or wherein the filter comprises two third channels, or wherein one or more walls of the second channel has a textured surface ([0049] pores of the filter would act as a conduit and be a fluidic pathway.).
Regarding Claim 34, Gellibolian teaches apparatus for collecting a saliva sample according to claim 25, wherein the filter comprises stacked first and second modules, the plurality of first channels being comprised within the first module, the third channel being comprised within the second module and the second channel being formed at an interface between the first and second modules ([0049] A filter disclosed herein enables the separation one component or fraction of a biofluid sample from another component or fraction. For example, a filter can enable the solid components, such as, e.g., cells, debris or contaminant, to be separated from the liquid components of the biofluid sample. In aspects of this embodiment, a filter useful for separating components contained in a biofluid sample can be, e.g., a size-exclusion filter, a plasma filter, an ion-exclusion filter, a magnetic filter, or an affinity filter. [0050] a filter useful for separating components contained in a biofluid sample can be, e.g., an anion filter or a cation filter. In still other aspects of this embodiment, a filter useful for separating components contained in a biofluid sample can be, e.g., an immune-affinity filter, an ion-affinity filter, a polynucleotide-affinity filter, a polypeptide-affinity filter, or a chemical-affinity filter.).
Regarding Claim 35, Gellibolian teaches apparatus for collecting a saliva sample according to claim 34, wherein the first and second modules are connected via a first snap fitting ([0042] snap-on mechanism).
Regarding Claim 36, Gellibolian teaches apparatus for collecting a saliva sample according to claim 34, wherein the filter further comprises, in the second channel, one or more of a further filter and a bioactive substance ([0046] a filter device comprises a filter mount, a filter, and O-ring. a filter device comprises a filter mount, a port, a filter, and O-ring. a filter device comprises a filter mount, a one-way check valve, a filter, and O-ring. [0050] a filter useful for separating components contained in a biofluid sample can be, e.g., an anion filter or a cation filter. a filter useful for separating components contained in a biofluid sample can be, e.g., an immune-affinity filter, an ion-affinity filter, a polynucleotide-affinity filter, a polypeptide-affinity filter, or a chemical-affinity filter.).
Regarding Claim 37, Gellibolian teaches apparatus for collecting a saliva sample according to claim 34, the filter comprising a plurality of alternately stacked first and second modules ([0046] a filter device comprises a filter mount, a filter, and O-ring. a filter device comprises a filter mount, a port, a filter, and O-ring. a filter device comprises a filter mount, a one-way check valve, a filter, and O-ring. [0050] a filter useful for separating components contained in a biofluid sample can be, e.g., an anion filter or a cation filter. a filter useful for separating components contained in a biofluid sample can be, e.g., an immune-affinity filter, an ion-affinity filter, a polynucleotide-affinity filter, a polypeptide-affinity filter, or a chemical-affinity filter.)
Regarding Claim 39, Gellibolian teaches apparatus for collecting a saliva sample according to claim 1, the apparatus further comprising a cap operable to close a collection vessel, the filter being comprised within the cap, or the apparatus further comprising a luer adaptor for connecting the filter to a collection vessel ([0097] collection chamber cap 26 is attached via hinged mechanism 27 to collection container 20. The examiner notes that due to the limitation beginning with “or”, one of the clauses may be optional).
Regarding Claim 40, Gellibolian teaches apparatus for collecting a saliva sample according to claim 39, wherein the apparatus further comprises the cap operable to close the collection vessel and the filter is being comprised within the cap, the filter being is connected to the cap via a snap fitting ([0097] collection chamber cap 26 is attached via hinged mechanism 27 to collection container 20.).
Regarding Claim 43, Gellibolian teaches apparatus for collecting a saliva sample, according to claim 39, wherein the apparatus further comprises the collection vessel, the collection vessel further comprising saliva detection and/or deactivation media, the filter being configured to prevent backflow out of the collection vessel ([0018] FIG. 10C illustrating closure of collection chamber by securement of collection chamber cap; [0117] Diseases with detectable biomarkers within the filtered biofluid sample 1316 (such as in salivary analytes) are detectable using the present device 1310, such as malaria, periodontal disease, and cortisol stress, without interference from contaminants. The types of analysis may include, but are not limited to, human and bacterial DNA purification and quantitation by RT-PCR and a biomarker assay.).
Regarding Claim 47, Gellibolian teaches a method of reducing the viscosity of a saliva sample, the method comprising: applying pressure to the saliva sample to cause the saliva sample to be transferred through a filter, the filter being configured to reduce the viscosity of the saliva sample as the saliva sample is transferred through the filter, wherein applying pressure to the saliva sample to cause the saliva sample to be transferred though the filter further comprises alternately applying positive and negative pressure to the saliva to cause the saliva sample to be transferred back and forth through the filter ([0048] In some embodiments, force is applied on a collection container in a manner that pushes a quantitative container disclosed herein into the collection chamber. The resulting pressure developed inside a collection chamber forces a biofluid sample through a filter device disclosed herein where a filtered sample is collected in a quantitation chamber. In other embodiments, force is applied in a manner that squeezes the walls of the collection container. The resulting pressure developed inside a collection chamber forces a biofluid sample through a filter device disclosed where a filtered sample is collected in a quantitation chamber.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798