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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of
the 62/522,495 filed 06/20/2017. Based on the filing receipt, the effective filing date of this application is June 20, 2017 which is the filing date of Application 62/522,495 from which the benefit of priority is claimed.
Status of Claims
Claims 1-12, 14-16 and 18-23 are pending and examined herein.
Claims 13 and 17 are cancelled.
Withdrawn Rejections
The rejection of claim 12 on the grounds of 35 U.S.C. 112(b) has been withdrawn, necessitated by amendments filed 02/06/2026.
The rejection of claims 1-7, 10-12, 14-16, 18, and 20-22 on the grounds of 35 U.S.C. 103 has been withdrawn, necessitated by amendments filed 02/06/2026.
The rejection of claims 8, 9, and 19 on the grounds of 35 U.S.C. 103 has been withdrawn, necessitated by amendments filed 02/06/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a sample loading component configured to integrate with the lateral flow assay membrane” in claims 1 and 15 and “said sample loading component is on a removable tab configured to integrate with the lateral flow assay membrane” in claim 9.
The phrase “a sample loading component configured to integrate with the lateral flow assay membrane” in claims 1 and 15 is interpreted to mean the sample loading component is in fluid communication with the lateral flow assay membrane, as exemplified in “FIG. 1A” and “FIG. 1B” of the applicant’s specification.
The phrase “said sample loading component is on a removable tab configured to integrate with the lateral flow assay membrane” in claim 9 is interpreted to mean the sample loading component is on a tab that is placed in fluid communication with the lateral flow assay membrane as exemplified in “FIG. 14” of the applicant’s specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
Claims 1-7, 10-12, 14-16, 18, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tung (US 20050106750 A1, cited in PTO-892 dated 04/10/2025) in view of Carpenter (US 20070020699 A1, published 2007-01-25).
Tung teaches a sample collection and analysis system, comprising: a) a sample container; b) a lateral flow assay membrane; and c) a lid configured for attachment to the sample container, wherein the lid comprises i) a sample loading component configured to integrate with the lateral flow assay membrane; and ii) a sample concentration component that increases the concentration of analyte in the sample loading component compared to an initial concentration of analyte, as in claim 1 (see, e.g., sample container – under “Figure 1”, cup 150; lateral flow assay membrane – under “Figure 2”, test strips 220, and para. [0012]: “the test strips are lateral flow test strips”; a lid configured for attachment to the sample container – under “Figure 1”, lid 110; lid comprises a sample loading component configured to integrate with the lateral flow assay membrane – under “Figure 2”, wicking paper 235, and para. [0008]: “The chamber can also have wicking paper in fluid communication with the outlet and the sample application zone of the test component”; a sample concentration component that increases the concentration of analyte in the sample loading component compared to an initial concentration of analyte – under “Figure 3”, sample inlet 330, and para. [0039]: “Fluid flows from the cup, through the inlet and into the channel network. The larger channels of the channel network may be subdivided into smaller channels, which end in outlets 330. At the outlets, the sample comes into contact with the sample application zones of the test strips”). It is understood that the sample inlet in “Figure 3” of Tung increases the concentration in the sample loading component of an analyte from zero to the concentration of the sample because it transports the sample to the sample loading component, where before the sample is present, the concentration is zero. Tung teaches the sample loading component comprises a porous material, as in claim 2 (see, e.g., – under “Figure 2”, wicking paper 235, and para. [0041]: “The wicking paper may be any convenient absorbent material that will quickly transport sample from the channel outlets to the test strips”). Tung teaches a column protruding from the lid and configured to contact a sample in the sample container, wherein the sample flows up the column and into contact with the sample loading component without application of an external force, as in claims 5 and 23 (see, e.g., under “Figure 7”, tube 250, and para. [0031]: “FIG. 7 illustrates increased internal air pressure, denoted by the downward facing arrows, pushing a portion of the sample 710 up the tube 250 and into the lid 110”). Tung teaches the column is in fluid communication with the sample loading component, as in claim 14 (see, e.g., para. [0041]: “The wicking paper is in fluid communication with the sample application zones of the test strips, and can also be in fluid communication with the outlets of the channel network”, and para. [0011]: “the chamber has a network of channels having an inlet connected to the tube and outlets”). Tung teaches a method of detecting an analyte in a sample, comprising: A) providing a sample collection and analysis system, comprising: a) a sample container comprising a sample; b) lateral flow assay membrane; and c) a lid, wherein the lid comprises i) a sample loading component configured to integrate with the lateral flow assay membrane; and ii) a sample concentration component that increases the concentration of analyte in the sample loading component compared to an initial concentration of analyte in the sample; B) introducing the sample into the sample loading component, thereby producing a concentrated sample; and C) contacting the concentrated sample with the lateral flow assay membrane to detect the analyte, as in claim 15 (see, e.g., para. [0022]; sample container – under “Figure 1”, cup 150; lateral flow assay membrane – under “Figure 2”, test strips 220, and para. [0012]: “the test strips are lateral flow test strips”; a lid configured for attachment to the sample container – under “Figure 1”, lid 110; lid comprises a sample loading component configured to integrate with the lateral flow assay membrane – under “Figure 2”, wicking paper 235, and para. [0008]: “The chamber can also have wicking paper in fluid communication with the outlet and the sample application zone of the test component”; a sample concentration component that increases the concentration of analyte in the sample loading component compared to an initial concentration of analyte – under “Figure 3”, sample inlet 330, and para. [0039]: “Fluid flows from the cup, through the inlet and into the channel network. The larger channels of the channel network may be subdivided into smaller channels, which end in outlets 330. At the outlets, the sample comes into contact with the sample application zones of the test strips”). Tung teaches the lateral flow membrane is integrated into the lid, as in claim 18 (see, e.g., under “Figure 2”, test strips 220, and para. [0012]: “the test strips are lateral flow test strips”).
Tung fails to teach the porous material sample loading component in fluid communication with the lateral flow assay membrane that comprises an antibody and magnetic particles with a sample concentration component that increases the concentration of analyte in the sample loading component compared to an initial concentration of analyte in the sample and comprises a magnet, as in claims 1-4, 6-7, 10-12, 15, 21-23. However, in a United States patent application publication on lateral flow assays and devices using magnetic particles, Carpenter rectifies this deficiency. Carpenter teaches “The invention involves magnetic particles having bound thereto analyte-specific binding reagents and/or labels. In addition, the invention provides for a porous carrier matrix that allows for the unimpeded flow of magnetic particles suspended in a carrier liquid, such as the sample or other liquid reagent. The porous carrier matrix allows for the lateral flow of the liquid containing the magnetic particles to a point in the matrix associated with a magnet that stops the flow of the particles but not the liquid”, 1-4, 6-7, 10-12, 15, 21-23 (see, para. [0023], and para. [0029]: “"Binding specificity" or "specific binding" refers to the substantial recognition of a first molecule for a second molecule, for example a polypeptide and a polyclonal or monoclonal antibody”). It is understood that the magnetic particles concentrate the analyte to a higher concentration compared to the initial concentration in the sample.
Tung and Carpenter are analogous to the field of the claimed invention because they are both in the field of lateral flow assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the sample loading and sample concentration components of Carpenter into the system of Tung. An artisan would have been motivated to do so because Carpenter discloses, “As the liquid carrying the magnetic particles passes through the magnetic field, the particles are attracted to the field and form a detection zone in discreet location on the matrix. The analyte is captured in the detection zone and detected with a label” (see, para. [0023]). An artisan would have understood that the analyte being captured while the liquid passes through the magnetic field will lead to an increase in the concentration of the analyte. An artisan would have had a reasonable expectation of success based on the given disclosures.
While Tung and Carpenter do not explicitly teach inverting the sample container, as in claim 16, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed inversion was anything other than routine, that the properties of the inversion from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Tung and Carpenter.
Claims 8-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tung (US 20050106750 A1, cited in PTO-892 dated 04/10/2025) and Carpenter (US 20070020699 A1, published 2007-01-25), as applied to claims 1-7, 10-12, 14-15, 18, 21-23 above, and further in view of Tang (“Improved sensitivity of lateral flow assay using paper-based sample concentration technique”, published 2016, cited in PTO-892 dated 04/10/2025).
Tung and Carpenter teach as set forth above but they fail to teach the lateral flow assay membrane is not in fluid contact with the sample loading component, as in claim 8. They also fail to teach the sample loading component is on a removable tab configured to integrate with the lateral flow assay membrane, as in claim 9. Finally, they fail to teach the lateral flow assay membrane is not integrated into the lid, as in claim 19.
However, in a journal article on improving the sensitivity of lateral flow assays, Tang rectifies these deficiencies. Tang teaches the lateral flow assay membrane is not in fluid contact with the sample loading component, as in claim 8 (see, e.g., p. 270, under “Fig. 1”, panel “B”, sub-panels “a” and “b” , and p. 272, col. 1, para. 4: “Upon 10 min of sample concentration, the test strip was connected to the paper-based concentration device by allowing the sample pad of test strip to be in contact with the semi-permeable membrane containing the sample solution”). Tang teaches the sample loading component is on a removable tab configured to integrate with the lateral flow assay membrane, as in claim 9 (see, e.g., p. 270, under “Fig. 1”, panel “B”, sub-panels “a” and “b, and p. 272, col. 1, para. 4: “Upon 10 min of sample concentration, the test strip was connected to the paper-based concentration device by allowing the sample pad of test strip to be in contact with the semi-permeable membrane containing the sample solution”). The sample loading component of Tang is equivalent to the claimed sample loading component because the sample is loaded into the component on a part of the device that can be removed or added to the test device through movement. Tang teaches the lateral flow assay membrane is not integrated into the lid, as in claim 19 (see, e.g., p. 270, under “Fig. 1”, panel “B”, sub-panels “a” and “b” , and p. 272, col. 1, para. 4: “Upon 10 min of sample concentration, the test strip was connected to the paper-based concentration device by allowing the sample pad of test strip to be in contact with the semi-permeable membrane containing the sample solution”).
Tung, Carpenter, and Tang are analogous to the field of the claimed invention because they are all in the field of biological sample collection systems. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the removable sample loading component of Tang into the system of Tung and Carpenter. An artisan would be motivated to do so because Tang discloses, “As for the integrated LFAs, the sample solution was first added into the semipermeable membrane for 10 min to achieve concentration prior to detection. In this case, the flow of concentrated sample solution was not aided by pipette but only driven by the capillary force (Fig. S2B). Hence, the liquid flow rate in integrated LFAs was slower than the conventional LFAs (Movie S3 in ESI), where slower flow rate has been reported to give better mixing of solution and thus enhanced sensitivity of the assay” (see p. 272, col. 2, para. 3). Due to the removable sample loading component, the increased sensitivity from the integrated device of Tang would motivate an artisan to incorporate those components into the system of Tung and Carpenter. An artisan would have a reasonable expectation of success based on the discussed disclosures.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tung (US 20050106750 A1, cited in PTO-892 dated 04/10/2025) and Carpenter (US 20070020699 A1, published 2007-01-25), as applied to claims 1-7, 10-12, 14-15, 18, 21-23 above, and further in view of Kokoris (US 20090148847 A1, 2009-06-11).
Tung and Carpenter teach as set forth above but they fail to teach removing the magnet from operable communication with the sample loading component such that concentrated sample is released onto the lateral flow assay membrane, as in claim 20.
Kokoris teaches removing the magnet from operable communication with the sample loading component such that concentrated sample is released onto the lateral flow assay membrane, as in claim 20 (see, e.g., stepper motor is used to move the magnet - para. [0176]; magnet is moved to create a force on a sample loading region to move the particles to a test pad which is considered in operable communication with the sample loading region - para. [0123]-[0124]; magnet disengaged from the test pad by withdrawing the magnet or turning off current to the electromagnet and therefore is moved out of operable communication with a sample loading region because it no longer provides a magnetic field that engages with the sample loading region - para. [0131]).
Tung, Carpenter, and Kokoris are analogous to the field of the claimed invention because they are all in the field of lateral flow assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the step from Kokoris of removing the magnet from operable communication with the sample loading component such that the concentrated sample is released onto the lateral flow assay into the methods of Tung and Carpenter. An artisan would have been motivated to do so because Kokoris discloses, “the magnetic force field has moved past the test pads, "sweeping" or "dragging" with it unbound paramagnetic particles while--surprisingly--paramagnetic bead complexes bearing target antibody have been captured and immunoextracted from the magnetic field” (see, para. [0125]). The artisan would have understood that “sweeping “ the magnetic force field past the test pads allows the separation of bound and unbound magnetic particles. An artisan would have had a reasonable expectation of success based on the given disclosures.
Response to Arguments
Rejections under 35 U.S.C. 103:
The applicant argues that rejection of claims 1-7, 10-12, 14-16, 18, and 20-22 under 35 U.S.C. 103 as unpatentable over Guirguis, Tung, and Kamei should be withdrawn because the references do not include a lateral flow assay membrane, a sample container, and a lid configured for attachment to the sample container, limitations in amended claims 1 and 15. The Office agrees that the rejection is no longer valid and new rejections have been added, necessitated by amendments filed 02/06/2026.
The applicant argues that rejection of claims 8, 9, and 19 under 35 U.S.C. 103 as unpatentable over Guirguis, Tung, and Kamei in view of Tang should be withdrawn because Tang does not render independent claims 1 and 15 unpatentable. The Office agrees and new rejections have been added, necessitated by amendments filed 02/06/2026.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678