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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 03 March 2026.
Claims 1, 57-65, 68-71, and 73-92 are pending.
Claims 2-56, 66-67, and 72 are cancelled.
No claims are withdrawn.
Claims 77-92 are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 58-65, 68-71, 74-80, 82-87, and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Agren et al. (US 2015/0231033 A1), hereinafter “Agren”, in view of Uhrin et al. (US PAT 4,970,165 A), hereinafter “Uhrin”.
Regarding Claim 1, Agren teaches a package for a particular assay kit comprising:
a tray 24 having assay product information on an outer sidewall ([0030] and Fig. 1. Further, Fig. 5 shows assay product information on an outer sidewall: “environmental allergy starter kit” – Examiner further notes that “information” is not a physical limitation wherein the mere sidewall itself is capable of informing a user of the assay product. Further, Applicant’s specification para. [0032] discusses such information as “e.g. without limitation, brand name and/or category of type of the particular assay kit contained therein, logos, the assay kit collection code, etc.” wherein these limitations appear to be drawn to printed matter. See MPEP sections 2111.05 and 2112.01, describing the non-patentability of "nonfunctional descriptive material".);
more than one insert* 40 disposed within the tray 24, each insert configured or adapted to hold a plurality of assay kit reagent containers 50 comprising same or different reagents (Fig. 1 and [0031]: “Foam padding 40 could comprise two layers [*two inserts], a top layer having apertures 42 sized to receive each of the vials 50 and a bottom layer (not shown) that fits into base 24 below the top layer.”),
a first insert of the more than one insert being removably disposed within the tray ([0008]: “A foam pad may be removably coupled within the base, the foam pad defining a plurality of vial apertures.” Further, in the same manner as discussed below the non-removably disposed aspect, this recitation to the removability of the insert is seen as a matter of intended use wherein given a strong enough applied force, the insert is fully capable of being removed.), and
a second insert of the more than one insert being non-removably disposed within the tray (The non-removable aspect of the second insert is seen herein as an intended use of the second insert given that no particular structure such as an adhesive layer for securing the second insert is required herein. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). The second insert is fully capable of being non-removably disposed within the tray as an operator merely need not remove it to satisfy the broad non-removable requirement. Applicant may wish to recite an adhesion of the second layer to the tray rather than the broader scope of general removability, if in accordance with the instant specification. – Examiner further notes that the first and second inserts being “disposed” in the tray merely relates to “disposition” of the inserts, their propensity/inclination to be non-removed. As such, an insert being non-removably disposed merely refers to said insert’s capability of being non-removed as discussed above. And further, to the extent that “disposed” provides a spatial designation, the prior art commensurately provides such structural dispositions (for removably and non-removably) in as much as claimed and required herein.
wherein the first insert removably disposed within the tray is adapted to be placed on a scanner (Similarly as above, limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the capability of the first insert to be placed on a scanner is viewed as an intended use of the structure. As applicant has not provided a particular structural distinction over the prior art causing the adaptation to be placed on a scanner, the commensurately structured prior art foam insert of Agren is interpreted as fully capable of being placed on a scanner, thus satisfying the claim requirement.),
wherein each insert comprises an upper surface, a bottom surface, and a plurality of apertures 42 extending through the insert from the bottom surface (Figs. 1 and 2, and [0029] showing the insert (inserts if provided as two separate layers as in Agren para. [0031]) having supper and lower surfaces and apertures therethrough.),
and wherein each of the plurality of apertures 42 in the first insert is shaped to individually hold a respective assay kit reagent container 50 such that a product code located on all or a subset of each assay kit reagent container bottom that identifies a reagent within that particular container is readable by a human, a machine, or both through a respective through hole of the plurality of apertures at the bottom surface of the first insert (Fig. 5 shows each product code as readable through each respective hole at the bottom surface of the insert, the bottom surface being interpreted above as that which is visible through Fig. 1 having apertures extending therefrom. Further, as the “shape” of the insert of Agren is commensurate with the instant claims (having through-holes when formed as a single layer and/or when in combination with Uhrin as discussed below) it is commensurately shaped to satisfy the functional language recited, wherein the claims do not provide to structurally distinguish from the prior art in terms of the “shape” given. Applicant may intend to provide a particular shape(ing) that affords the functionality and wherein such physical shape(ing) is not found in the prior art.
as in Claim 1.
Further regarding Claim 1, Agren does not specifically teach the assay container discussed above wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, as required by Claim 1.
However, Uhrin teaches a respective container comprising a holding portion 10’ having apertures 30a for snugly fitting and holding scintillation vials 31A, wherein the apertures 30a extend through the thickness of the holding portion 10’ from the top surface 11’ to the bottom surface 16’ (Fig. 5a and [col., line]: “The bores 30 extend entirely through the block 10', as seen in FIGS. 5-A...” – Further note that while the apertures of Figs. 5A-C may appear to be closed at the bottom, the bottom rectangle structure is merely the side leg supports 17’ and 18’ as in Fig. 4.). Therein, this arrangement represents a mere obvious alternative to the device of Agren having apertures for holding containers, but not specifically extending through the thickness, given that the apertures of both devices serve the same purpose of holding a reagent container.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Agren wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, such as suggested by Uhrin, as an obvious alternative design representing a predictable variation of known alternatives in the art as cutting a hole through or blind is a routine engineering choice depending on desired support and visibility of the containers; and would have a reasonable expectation of success therein.
Further regarding Claim 1, Agren does not specifically teach the assay container discussed above wherein the first insert is thinner in height than the second insert, as required by Claim 1.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed size is an obvious matter of design choice – see MPEP 2144.04(IV)(A).
Herein, one of ordinary skill in the art would find it obvious to optimize the relative size of each of the inserts so as to provide for the desired level of padding/protection, and/or to accommodate a respectively sized container requiring more or less padding depending on the size and shape of the container.
Further, Examiner notes that “thinner than” is a mere qualitative aspect which, even if the prior art inserts are of the same height, reads on a minute or insignificant difference which could be attributed to regular manufacturing discrepancies between inserts. Applicant must provide a particular quantitative aspect such as reciting the first insert is twice the height of the second insert, etc., if in accordance with the instant specification.
Further regarding Claim 1, if it is applicant’s intent to provide two side-by-side inserts having the same openings, merely making as separate pieces what exists in the prior art as one integral piece absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Applicant may wish to recite that the first and second inserts have differently sized apertures if it is Applicant’s intent to retain differently sized containers therein. However, para. [0031] recites: “Openings or apertures 42 may be all the same size, all different in size, or contain any combination and/or arrangement of similarly/dissimilarly sized apertures depending in part on the vials 50 used.” Wherein it would be obvious to merely make separate the components having the differently sized apertures as a mere matter of design choice.
Regarding Claim 58, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the assay product information comprises an assay name or an assay category or assay type (Fig. 5 shows the product information as “environmental allergy starter kit”, which is an assay category.), as in Claim 58.
Further, printed matter is not given patentable weight unless it creates a new functional relationship with the article it is on – see MPEP 2111.05. Herein, the assay name/type/category etc. merely convey information, they do not change how the tray functions.
Regarding Claims 59 and 60, the prior art meets the limitations of Claim 1 as discussed above. Further, printed matter is not given patentable weight unless it creates a new functional relationship with the article it is on – see MPEP 2111.05. Herein, the collection code of Claim 59, and the barcodes of Claim 60 merely convey information, they do not change how the tray functions. TO have these limitations hold patentable weight, Applicant must establish a functional relationship with another positively claimed element, such as a barcode reader.
Regarding Claim 61, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the insert comprises foam ([0008]: “A foam pad may be removably coupled within the base, the foam pad defining a plurality of vial apertures.”), as in Claim 61.
Regarding Claim 62, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the upper surface and the bottom surface of each insert are each substantially planar (Fig. 1 shows the padding as having a planar bottom a planar top given it is fitted against the planar bottom of the tray 24.), as in Claim 62.
Regarding Claim 63, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above further comprising the plurality of assay kit reagent containers 50 (Fig. 1 and [0029]: “Dilution kit 10 includes a plurality of openings or apertures 42 in foam padding 40 sized to receive a plurality of vials 50.”), as in Claim 63.
Regarding Claim 64, the prior art meets the limitations of Claim 63 as discussed above. Further, Agren teaches the assay container discussed above wherein the plurality of assay kit reagent containers comprise at least two different container shapes, at least two different container sizes, or both ([0039]: “In addition, or as an alternative, the tray and/or apertures 42 may be any size, shape or configuration, according to particular needs.”. Further, Fig. 5 shows reagent containers of varying size and shape.), as in Claim 64.
Regarding Claim 65, the prior art meets the limitations of Claim 63 as discussed above. Further, Agren teaches the assay container discussed above wherein the same or different reagents comprise any one or more of the following: antibodies, controls, calibrators, diluents, buffers, and combinations of any of the foregoing ([0043]: “the vial 50 labeled “Diluent” comprises a diluent”), as in Claim 65.
Regarding Claim 68, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the more than one insert fills an interior volume of the tray (Given that the inserts sit within the tray as discussed in para. [0031], the inserts thereby fill an interior volume of the tray. – Examiner further notes that if it is applicant’s intent for the inserts to fill up the entire inner volume of the tray, the claim should be amended accordingly if in agreement with the instant disclosure.), as in Claim 68.
Regarding Claim 69, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the first insert is of a different shape, or size than the second insert ([0036]: “Optionally, if included, a different layer of foam padding may be placed below foam padding 40.” – Given that Agren describes the additional padding as also being made of foam, but as being “different” from the first layer, the different layer is interpreted as having a different size/shape.), as in Claim 69.
Additionally, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed size is an obvious matter of design choice – see MPEP 2144.04(IV)(A). Herein, one skilled in the art would find it obvious to optimize the size/thickness/shape of each of the plurality of inserts to achieve the desired level of padding. The layers of foam padding inserts in Agren as well as the instant claimed packaging serve the identical purpose of providing padding for reagent bottles, wherein one skilled in the art would recognize the inserts would not perform differently than expected by merely changing the size/shape. Thus, absent evidence of criticality, non-obviousness, or unexpected results associated with the respective differing size/shape of the plurality of inserts cannot be considered critical.
Regarding Claim 70, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the more than one insert are disposed side by side within the tray (As para. [0031] discusses the foam layers as in a stacked arrangement, the layers are interpreted as being “side by side” as the bottom side of one layer rests against the top side of the other layer.), as in Claim 70.
Regarding Claim 71, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the more than one insert 40 does not fill an interior volume of the tray 24 (Fig. 1 shows the foam insert 40 as having apertures, thereby leaving open volume inside the tray, not completely filling the volume of the tray commensurately as claimed.), as in Claim 71.
Regarding Claim 74, the prior art meets the limitations of Claim 77 as discussed above. Further, Agren teaches the assay container discussed above wherein the base of the tray comprises an inwardly directed peripheral lip on which outer edges of the more than one insert sits (Fig. 3 shows the insert 40 sitting on an outer lip of the tray. Therein, the lip is shown as extending inwardly toward the tray at the base of the lip.), as in Claim 74.
Regarding Claim 75, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray comprises cardboard and the insert comprises foam (See paras. [0008] and [0064], and Fig. 5 showing foam padding contained within a cardboard embodiment of the tray.), as in Claim 75.
Regarding Claim 76, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein each of the plurality of through holes 42 is sized to snugly hold the respective assay kit reagent container 50 ([0029]: “maintain the vials with a snug fit” – Examiner further notes that the “assay container” is not a positively claimed element and thereby has no basis in limiting the structure of the through holes when placed in the through holes.), as in Claim 76.
Regarding Claim 77, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray includes a base which has upwardly extending sidewalls that define an interior volume within which the more than one insert is disposed (See Figs. 2 and 3 showing the base 24 having upwardly protruding sidewalls to accommodate the insert 40.), as in Claim 77.
Regarding Claim 78, the prior art meets the limitations of Claim 77 as discussed above. Further, Agren teaches the assay container discussed above wherein the base of the tray is closed (See Figs. 3 and 4 showing the sidewalls of the tray extending vertically from a closed base.), as in Claim 78.
Regarding Claim 79, the prior art meets the limitations of Claim 78 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray has an open top opposite the closed base (See Figs. 3 and 4 showing the sidewalls extending upwardly from the base 24 as terminating at an open top opposite the base.), as in Claim 79.
Regarding Claim 80, Agren teaches a package for a particular assay kit comprising:
a tray 24 having assay product information on an outer sidewall ([0030] and Fig. 1. Further, Fig. 5 shows assay product information on an outer sidewall: “environmental allergy starter kit”);
at least a first insert and a second insert disposed within the tray, each of the first insert and the second insert configured or adapted to hold a plurality of assay kit reagent containers comprising same or different reagents (Fig. 1 and [0031]: “Foam padding 40 could comprise two layers [*two inserts*], a top layer having apertures 42 sized to receive each of the vials 50 [*reagent containers*] and a bottom layer (not shown) that fits into base 24 below the top layer.”),
the first insert being removably disposed within the tray ([0008]: “A foam pad may be removably coupled within the base, the foam pad defining a plurality of vial apertures.” Further, in the same manner as discussed below the non-removably disposed aspect, this recitation to the removability of the insert is seen as a matter of intended use wherein given a strong enough applied force, the insert is fully capable of being removed.), and
the second insert being non-removably disposed within the tray (The non-removable aspect of the second insert is seen herein as an intended use of the second insert given that no particular structure such as an adhesive layer for securing the second insert is required herein. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). The second insert is fully capable of being non-removably disposed within the tray as an operator merely need not remove it to satisfy the broad non-removable requirement. Applicant may wish to recite an adhesion of the second layer to the tray rather than the broader scope of general removability.),
wherein the first insert removably disposed within the tray is adapted to be placed on a scanner (Similarly as above, limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the capability of the first insert to be placed on a scanner is viewed as an intended use of the structure. As applicant has not provided a particular structural distinction over the prior art causing the adaptation to be placed on a scanner, the commensurately structured prior art foam insert of Agren is interpreted as fully capable of being placed on a scanner, thus satisfying the claim requirement.),
wherein each insert comprises an upper surface, a bottom surface, and a plurality of apertures 42 extending through the insert from the bottom surface (Figs. 1 and 2 showing apertures 42 extending through the insert (or inserts when provided as two separate layers as agren para. [0031]) and [0029].), and
and wherein each of the plurality of apertures 42 in the first insert is shaped to individually hold a respective assay kit reagent container 50 such that a product code located on all or a subset of each assay kit reagent container bottom that identifies a reagent within that particular container is readable by a human, a machine, or both through a respective through hole of the plurality of through holes at the bottom surface of the first insert (Fig. 5 shows each product code as readable through each respective hole at the bottom surface of the insert, the bottom surface being interpreted above as that which is visible through Fig. 1 having apertures extending therefrom.),
as in Claim 80.
Further regarding Claim 80, Agren does not specifically teach the assay container discussed above wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, as required by Claim 80.
However, Uhrin teaches a respective container comprising a holding portion 10’ having apertures 30a for snugly fitting and holding scintillation vials 31A, wherein the apertures 30a extend through the thickness of the holding portion 10’ from the top surface 11’ to the bottom surface 16’ (Fig. 5a and [col., line]: “The bores 30 extend entirely through the block 10', as seen in FIGS. 5-A...” – Further note that while the apertures of Figs. 5A-C may appear to be closed at the bottom, the bottom rectangle structure is merely the side leg supports 17’ and 18’ as in Fig. 4.). Therein, this arrangement represents a mere obvious alternative to the device of Agren having apertures for holding containers, but not specifically extending through the thickness, given that the apertures of both devices serve the same purpose of holding a reagent container.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Agren wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, such as suggested by Uhrin, as an obvious alternative design representing a predictable variation of known alternatives in the art as cutting a hole through or blind is a routine engineering choice depending on desired support and visibility of the containers; and would have a reasonable expectation of success therein.
Further regarding Claim 80, if it is applicant’s intent to provide two side-by-side inserts having the same openings, merely making as separate pieces what exists in the prior art as one integral piece absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Applicant may wish to recite that the first and second inserts have differently sized apertures if it is Applicant’s intent to retain differently sized containers therein. However, para. [0031] recites: “Openings or apertures 42 may be all the same size, all different in size, or contain any combination and/or arrangement of similarly/dissimilarly sized apertures depending in part on the vials 50 used.” Wherein it would be obvious to merely make separate the components having the differently sized apertures as a mere matter of design choice.
Regarding Claim 82, the prior art meets the limitations of Claim 80 as discussed above. Further, Agren teaches the assay container discussed above further comprising the plurality of assay kit reagent containers, wherein the same or different reagents comprise any one or more of the following: antibodies, controls, calibrators, diluents, buffers, and combinations of any of the foregoing ([0043]: “the vial 50 labeled “Diluent” comprises a diluent”), as in Claim 82.
Regarding Claim 83, the prior art meets the limitations of Claim 80 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray includes a base which has upwardly extending sidewalls that define an interior volume within which the first insert and the second insert are disposed (See Figs. 2 and 3 showing the base 24 having upwardly protruding sidewalls to accommodate the inserts 40 (upper and lower as in Agren para. [0031]).), as in Claim 83.
Regarding Claim 84, the prior art meets the limitations of Claim 83 as discussed above. Further, Agren teaches the assay container discussed above wherein the base of the tray is closed (See Figs. 3 and 4 showing the sidewalls of the tray extending vertically from a closed base.), as in Claim 84.
Regarding Claim 85, the prior art meets the limitations of Claim 84 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray has an open top opposite the closed base (See Figs. 3 and 4 showing the sidewalls extending upwardly from the base 24 as terminating at an open top opposite the base.), as in Claim 85.
Regarding Claim 86, Agren teaches a package for a particular assay kit comprising:
a tray having assay product information on an outer sidewall ([0030] and Fig. 1. Further, Fig. 5 shows assay product information on an outer sidewall: “environmental allergy starter kit”);
at least a first insert and a second insert disposed within the tray, each of the first insert and the second insert configured or adapted to hold a plurality of assay kit reagent containers comprising same or different reagents (Fig. 1 and [0031]: “Foam padding 40 could comprise two layers [*two inserts], a top layer having apertures 42 sized to receive each of the vials 50 and a bottom layer (not shown) that fits into base 24 below the top layer.”),
wherein each of the first insert and the second insert comprises an upper surface, a bottom surface, and a plurality of apertures extending through each of the first insert and the second insert from the upper surface to the bottom surface (Figs. 1 and 2, and [0029] showing the insert having supper and lower surfaces and apertures therethrough.), and
wherein each of the plurality of through holes in the first insert is shaped to individually hold a respective assay kit reagent container such that a product code located on all or a subset of each assay kit reagent container bottom that identifies a reagent within that particular container is readable by a human, a machine, or both through a respective through hole of the plurality of through holes at the bottom surface of the first insert (Fig. 5 shows each product code as readable through each respective hole at the bottom surface of the insert, the bottom surface being interpreted above as that which is visible through Fig. 1 having apertures extending therefrom.), as in Claim 86.
Further regarding Claim 86, Agren does not specifically teach the assay container discussed above wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, as required by Claim 86.
However, Uhrin teaches a respective container comprising a holding portion 10’ having apertures 30a for snugly fitting and holding scintillation vials 31A, wherein the apertures 30a extend through the thickness of the holding portion 10’ from the top surface 11’ to the bottom surface 16’ (Fig. 5a and [col., line]: “The bores 30 extend entirely through the block 10', as seen in FIGS. 5-A...” – Further note that while the apertures of Figs. 5A-C may appear to be closed at the bottom, the bottom rectangle structure is merely the side leg supports 17’ and 18’ as in Fig. 4.). Therein, this arrangement represents a mere obvious alternative to the device of Agren having apertures for holding containers, but not specifically extending through the thickness, given that the apertures of both devices serve the same purpose of holding a reagent container.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Agren wherein the aperture for holding the reagent container is a through hole extending through the thickness of the insert, such as suggested by Uhrin, as an obvious alternative design representing a predictable variation of known alternatives in the art as cutting a hole through or blind is a routine engineering choice depending on desired support and visibility of the containers; and would have a reasonable expectation of success therein.
Further regarding Claim 86, Agren does not specifically teach the assay container discussed above wherein the first insert is thinner in height than the second insert, as required by Claim 86.
However, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed size is an obvious matter of design choice – see MPEP 2144.04(IV)(A).
Herein, one of ordinary skill in the art would find it obvious to optimize the relative size of each of the inserts so as to provide for the desired level of padding/protection, and/or to accommodate a respectively sized container requiring more or less padding depending on the size and shape of the container.
Regarding Claim 87, the prior art meets the limitations of Claim 86 as discussed above. Further, Agren teaches the assay container discussed above the first insert being removably disposed within the tray ([0008]: “A foam pad may be removably coupled within the base, the foam pad defining a plurality of vial apertures.” Further, in the same manner as discussed below the non-removably disposed aspect, this recitation to the removability of the insert is seen as a matter of intended use wherein given a strong enough applied force, the insert is fully capable of being removed.), and
the second insert being non-removably disposed within the tray (The non-removable aspect of the second insert is seen herein as an intended use of the second insert given that no particular structure such as an adhesive layer for securing the second insert is required herein. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). The second insert is fully capable of being non-removably disposed within the tray as an operator merely need not remove it to satisfy the broad non-removable requirement. Applicant may wish to recite an adhesion of the second layer to the tray rather than the broader scope of general removability.),
as in Claim 87.
Regarding Claim 89, the prior art meets the limitations of Claim 86 as discussed above. Further, Agren teaches the assay container discussed above further comprising the plurality of assay kit reagent containers, wherein the same or different reagents comprise any one or more of the following: antibodies, controls, calibrators, diluents, buffers, and combinations of any of the foregoing ([0043]: “the vial 50 labeled “Diluent” comprises a diluent”), as in Claim 89.
Regarding Claim 90, the prior art meets the limitations of Claim 86 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray includes a base which has upwardly extending sidewalls that define an interior volume within which the first insert and the second insert are disposed (See Figs. 2 and 3 showing the base 24 having upwardly protruding sidewalls to accommodate the inserts 40 (upper and lower as in Agren para. [0031]).), as in Claim 90.
Regarding Claim 91, the prior art meets the limitations of Claim 90 as discussed above. Further, Agren teaches the assay container discussed above wherein the base of the tray is closed (See Figs. 3 and 4 showing the sidewalls of the tray extending vertically from a closed base.), as in Claim 91.
Regarding Claim 92, the prior art meets the limitations of Claim 91 as discussed above. Further, Agren teaches the assay container discussed above wherein the tray has an open top opposite the closed base (See Figs. 3 and 4 showing the sidewalls extending upwardly from the base 24 as terminating at an open top opposite the base.), as in Claim 92.
Claims 57, 81, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Agren in view of Uhrin, as applied to Claims 1, 58-65, 68-71, 74-80, 82-87, and 89-92 above, and in further view of Holmes et al. (US 2017/0020425 A1), hereinafter “Holmes”.
Regarding Claims 57, 81, and 88, the prior art meets the limitations of Claims 1, 80, and 86 respectively as discussed above. Further, Agren/Uhrin does not specifically teach the assay container discussed above further comprising an outer box that comprises a sidewall with a window, wherein the tray is disposed within the outer box to display the assay product information through the window, as in Claim 57, 81, and 88.
However, Holmes teaches a respective holder for housing and protecting containers involved in biological sampling and testing wherein the holder comprises an optically transmissive portion for viewing identifying information disposed on the containers held therein ([0117]). Therein, this arrangement allows containers to be identified without opening the holder, promoting the maintenance of sample integrity (and chain of custody integrity) by allowing the holder to be kept sealed during sample identification.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container device of Agren/Uhrin further comprising an outer box that comprises a sidewall with a window, wherein the tray is disposed within the outer box to display the assay product information through the window, such as suggested by Holmes, so as to provide protection to the tray and reagent containers held thereon while allowing said containers to be identified while maintaining sample integrity within the closed holder.
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Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Agren in view of Uhrin, as applied to Claims 1, 58-65, 68-71, 74-80, 82-87, and 89-92 above, and in further view of Wilson et al. (US PAT 3,935,944 A), hereinafter “Wilson”.
Regarding Claim 73, the prior art meets the limitations of Claim 1 as discussed above. Further, Agren does not specifically teach the assay container discussed above wherein the tray includes a base comprised of a transparent material, as in Claim 73.
However, Wilson teaches a respective packaging arrangement wherein a tray/cover 13 having an insert 12 disposed within the tray, wherein the tray includes a base 17 made from transparent plastic so as to permit viewing of the contents held by the insert ([col. 1, line 40]: “The cover is retained by suitable detent means and preferably is constructed of a transparent plastic material to permit visibility of the rack contents.”). Therein, this arrangement allows a user to confirm contents and integrity of the kit components.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container device of Agren wherein the tray includes a base comprised of a transparent material, such as suggested by Wilson, so as to permit user viewing of the kit contents to confirm integrity of the kit components, and would have a reasonable expectation of success therein.
Claims 1, 80, and 87 are further rejected under 35 U.S.C. 103 as being unpatentable over Agren in view of Uhrin, as applied to Claims 1, 58-65, 68-71, 74-80, 82-87, and 89-92 above, and in further view of Bruno et al. (US PAT 5,172,808 A), hereinafter “Bruno”.
Regarding Claims 1, 80, and 87: even if the requirements of these claims reciting wherein the insert is non-removably disposed within the tray, as in Claims 1, 80, and 87, is not taken as a mere matter of intended use, the prior art of Bruno provides for a foam insert non-removably disposed in a base:
However, Bruno teaches a respective carrier device having a foam insert glued to a housing so as to immobilize the foam insert ([col. 4, line 16]: “Alternatively, the sponge-like member can be adhered by glue or other appropriate adhesive means or it may simply be a friction fit within the housing.”). Therein, this arrangement prevents the foam insert from becoming dislodged as the container is moved.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Agren/Uhrin wherein the insert is non-removably disposed within the tray, such as suggested by Bruno, so as to reduce risk of the foam insert becoming dislodged and thereby failing to secure the containers held therein, and would have a reasonable expectation of success therein.
Claims 1 and 86 are further rejected under 35 U.S.C. 103 as being unpatentable over Agren in view of Uhrin, as applied to Claims 1, 58-65, 68-71, 74-80, 82-87, and 89-92 above, and in further view of Dongfen et al. (CN 203630048 U), hereinafter “Dongfen”.
Regarding Claims 1 and 86, even if the relative thicknesses of the first and second inserts are not taken as a mere obvious matter of design choice as discussed above as in Claims 1 and 86:
Dongfen teaches a respective container carrier comprising two separate wherein the first insert 8 is a thinner insert having holes for holding reagent bottles 2/3, and the second insert is a thicker insert having apertures shaped to hold suction pipes 5/6 and bag 4 and colorimetric card 7 (Fig. 1 - reproduced below). Therein, this arrangement provides the optimal desired level of support for the separate elements, wherein the thinner insert saves on materials and the thicker insert fills the remaining space to cushion the sensitive suction pipes and colorimetric card, thereby providing the optimal level of support for the distinct needs of each element.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Agren/Uhrin wherein a height of the plurality of inserts vary, with at least one insert being thinner than another insert, such as suggested by Dongfen, so as to provide the appropriate level of support for the needs of each element while saving material costs for elements requiring less support.
Response to Arguments
35 USC 112
Applicant’s remarks and amendments sufficiently overcome the rejection of Claims 1, 62, and 65 as indefinite under 35 USC 112(b) as set forth by the previous office action. As such, those rejections of Claims 1, 62, and 35 under 35 USC 112(b) are withdrawn.
35 USC 103
Applicant argues on the grounds that Agren in view of Uhrin fails to teach the amended claim requirements of 1) a first insert of the more than one insert being removably disposed within the tray, and a second insert of the more than one insert being non-removably disposed within the tray, 2) wherein the first insert removably disposed within the tray is adapted to be placed on a scanner, and 3) the first insert is thinner in height than the second insert.
Applicant’s arguments are not persuasive because:
With regard to feature 1, the removable/non-removable aspect of the claims is viewed as a mere intended use and/or capability of the device; and wherein Applicant has failed to structurally distinguish the claims from that of the prior art; the device of Agren commensurately provides such dispositions within the tray in as much as recited and required herein and such dispositions thereby afford such “removable” and “non-removable” functionality in as much as recited and required herein. An insert of Agren may be non-removably disposed within the device if it is not intended to be removed, given its broadest reasonable interpretation. If Applicant wishes to structurally define the non-removable aspect, Applicant may wish to recite an adhesive layer or locking mechanism so as to overcome the broad recitation encompassing Agren/Uhrin. Further, those claims reciting removability/non-removability are further rejected under 35 USC 103 as unpatentable over Agren in view of Uhrin and in further view of Bruno. While Applicant argues that Bruno is not configured to receive a plurality of inserts and merely receives a single sponge-like insert, Bruno is not relied upon for providing a plurality of inserts, but rather Bruno is relied on for providing an adhesive aspect to further satisfy the non-removable aspect so as to prevent the insert from falling out unintentionally.
With regard to feature 2, while Agren in view of Uhrin may not specifically describe the foam insert as being adapted to be placed on a scanner, this aspect is seen herein as a mere matter of intended use where the prior art insert is fully capable of being placed on a scanner, given its flat surface, and thereby satisfies the claim limitations. I.e. the commensurately structured insert of Agren/Uhrin having top and bottom surfaces is commensurately fully capable of performing the function of being placed on a scanner as claimed.
With regard to feature 2, as discussed above in the body of the action, the differences in thickness of the respective first and second first and second inserts is seen as an obvious matter of design choice -- mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed size is an obvious matter of design choice – see MPEP 2144.04(IV)(A). As discussed in the rejection, one of ordinary skill in the art would find it obvious to optimize the thicknesses relative to the desired level of padding and/or container shape.
Further, Applicant argues on the alleged grounds that the prior art of Dongfen additionally supporting the two separate heights of the two inserts only teaches a single insert, and as such Dongfen further fails to teach the inserts of two different heights.
Applicant’s argument is not persuasive as the prior art of Dongfen teaches two inserts of different heights: a first taller insert holding the pipettes 5/6 and bags 6/7, and a shorter insert into which bottles 2/3 are placed – see Fig. 1 reproduced below. Therein, one of ordinary skill in the art would find it obvious to optimize the relative thickness to fit the desired container such as in Dongfen. Further, when combined with the prior art of Agren, one of ordinary skill in the art would find it obvious to provide the additional side-by-side layers in addition to the base layer such as suggested by Dongfen herein as being optimized for relative containers. The literal arrangement of Dongfen is not relied upon but rather its showing of different inserts of different height/configuration in a packaging so as to accommodate different sized/shaped reagent bottles, as similarly contemplated by Agren as discussed in the body fo the rejection.
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Applicant further argues that Claims 57 and 73 depending from Claim 1 are allegedly allowable by virtue of their dependence on Claim 1 in view of the alleged deficiencies of Agren/Uhrin. However, as discussed above, no such deficiencies are present in Agren/Uhrin or the additionally applied prior art, therefore Applicant’s argument is moot.
New Claims
Applicant argues that new claims 77-92 are allegedly allowable for similar reasons argued above in view of the alleged deficiencies of Agrin/Uhrin. However, as discussed above, no such deficiencies are present in Agrin/Uhrin or the additionally applied prior art. Claims 77-80, 82-87, and 89-92 are rejected under 35 USC 103 as unpatentable over Agren in view of Uhrin. And Claims 81 and 88 are rejected under 35 USC 103 as unpatentable over Agren in view of Uhrin and in further view of Holmes.
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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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