DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 22-44 are rejected under pre-AIA 35 U.S.C. 102a or 102e as being anticipated by Lin (US 2012/0190122).
Regarding claim 22, Lin discloses a device for testing saliva utilizing a sampling stem, the device comprising:
a cup (fig. 1,2) defining an interior cavity (area within 10), the cup having a planar forward wall (area at window 14), a rearward wall (base 11 of the cup has a flat wall at area 70;), and an inclined surface (ramp 65) extending from a higher position at the rearward wall to a lower junction line at the forward wall (wall at area 70 declines from a higher point at the rear wall to a lower point at the forward wall where the test strips are placed);
a holder (fig. 1, ref. 3) positioned in the cup (See fig. 1,2); and a cap portion (rim 17) covering an open end of the cup so as to enclose the interior cavity (the rim 17 covers the outermost perimeter of the open end of the cup (12) and encloses the interior cavity (13) because the holder (3) takes up the entirety of the interior cavity and is in contact with the upper rim 17 which closes and thereby encloses the interior cavity as seen in fig. 2), the insertion portion of the holder having a planar face opposed to the forward wall of the cup (planar face is where the test strips reside), the planar face of the holder having a plurality of parallel ribs (ribs 24 separate grooves where test strips are located) engaging the forward wall of the cup to define a plurality of elongate channels (fig. 1 shows parallel ribs 24 which separate each test strip placed in the insertion portion of the holder);
the cap portion (fig. 1, area 17) of the holder defining an access port (opening area 18 which is between the cap portion perimeter 17) for receipt of the sampling stem (the sampling stem is not positively recited in the instant claims. Further the access port, 17 in fig. 1 is structurally capable of accepting a sampling stem. Structure 41, 51 is capable of sampling), and a through passage structure extending from a bottom of the cap portion separate from the insertion portion into the interior cavity of the cup (catch basin 80 has cylindrical side wall 81 at the bottom of the cap portion which is separate from the opening area 17 accepts the sampling stem therein, see fig. 2), the through passage structure being in register with the access port such that the sampling stem can be inserted therein (the sampling stem is not positively claim in the instant claims and can be added to the device at a later time. The through passage, catch basin 80 area in the middle of structure 3 is in register with but separated by a space 18 from the access port area 17 that is capable of accepting a sampling stem as seen in fig. 2); and
a pedestal portion (fig. 1,2, ref. 70) integral with the inclined surface of the cup so as to be in alignment with the through passage structure and the access port (see fig. 1-2).
Regarding claim 23, a device as set forth in claim 22, further comprising a gasket member located at a bottom of the insertion portion of the holder (fig. 2, structure 37).
Regarding claim 24, a device as set forth in claim 23, wherein the gasket defines a plurality of riblets respectively aligned with the parallel ribs of the holder (see fig. 1 structure 37 align with the parallel ribs of the holder 24).
Regarding claim 25, a device as set forth in claim 24, wherein adjacent riblets define pockets that divide the junction line (see fig. 1).
Regarding claim 26, a device as set forth in claim 25, wherein at least some of the riblets are configured so that excess liquid may overflow from one pocket to an adjacent pocket (this limitation does not further structurally limit the instant claim).
Regarding claim 27, a device as set forth in claim 25, wherein the gasket member defines a plurality of slots aligned with the pockets (see fig. 1, ref. 37, 24).
Regarding claim 28, a device as set forth in claim 23, wherein the gasket member has a flexible diaphragm portion (this limitation does not further structurally limit the instant claims. The prior art is made of plastic and is flexible to a degree with force).
Regarding claim 29, a device as set forth in claim 28, wherein an inner diameter of the through passage structure tapers from a proximal end to a distal end thereof (see fig. 2, taper portion 83).
Regarding claim 30, a device as set forth in claim 22, wherein the pedestal portion is located entirely at the inclined surface between the rearward wall and the forward wall (see fig. 2).
Regarding claim 31, a device as set forth in claim 30, wherein the pedestal portion comprises a securing structure to secure a sampling swab of the sampling stem (This limitation does not further structurally limit the instant claims because the sampling stem is not positively recited. Further, area 70 is shaped to accept a sampling swab 41).
Regarding claim 32, a device as set forth in claim 22, wherein the plurality of elongate channels comprises between six and 15 channels, inclusive (see fig. 1).
Regarding claim 33, a device as set forth in claim 32, comprising a plurality of test strips respectively located in at least some of the elongate channels (see fig .1, ref. 26).
Regarding claim 34, a device as set forth in claim 22, wherein the cup further comprises a syringe access port substantially aligned with the junction line (see fig. 1, ref. 53, fig. 11).
Regarding claim 35, a device for testing a liquid sample, the device comprising:
a cup comprising a planar forward wall (fig. 1-2, ref. 14) connecting to a curved rearward wall defining a D-shaped outer wall perimeter when viewed from above and below (see fig. 3);
a holder (fig. 1-2, ref 3) having an insertion portion (walls of 3) positioned in the cup and a cap portion (rim 17), the insertion portion of the holder having a planar face opposed to the forward wall of the cup to define a test strip receiving area therebetween wall 3 having area where test strips are placed, between ribs 24) ; and a plurality of test strips positioned in the test strip receiving area (test strips 25).
Regarding claim 36, device as set forth in claim 35, wherein the insertion portion and the cap portion of the holder are formed as portions of a unitary structure (fig. 1-2, structure 3 is unitary structure).
Regarding claim 37, a device as set forth in claim 35, wherein the cup comprises an inclined surface (65) extending from a higher position at the rearward wall to a lower position at the forward wall (wall at area 70 declines from a higher point at the rear wall to a lower point at the forward wall where the test strips are placed).
Regarding claim 38, a device as set forth in claim 37, further comprising a pedestal portion (fig. 1,2, ref. 70) integral with the inclined surface of the cup for engagement by a testing swab of a testing stem inserted through an access port in the cap (fig. 1, 2).
Regarding claim 39, a device as set forth in claim 38, wherein the pedestal portion comprises a securing structure to secure a sampling swab of the sampling stem (This limitation does not further structurally limit the instant claims because the sampling stem is not positively recited. Further, area 70 is shaped to accept a sampling swab 41).
Regarding claim 40, a device as set forth in claim 35, further comprising a gasket member located at a bottom of the insertion portion of the holder (fig. 2, structure 37).
Regarding claim 41, Lin device for testing a liquid sample, the device comprising:
a cup defining an interior cavity (fig. 1,2 ref. 2), the cup having a planar forward wall (front wall 14), a rearward wall flat wall at area 70 in fig. 2), and an inclined surface extending from a higher position at the rearward well to a lower junction line at the forward wall (see inclined surface 65 which extends from 70 to the forward wall);
a holder (fig. 1,2, ref. 3) having an insertion portion (walls of structure 3) positioned in the cup and a cap portion (area at 17) covering an open end of the cup so as to enclose the interior cavity (the rim 17 covers the outermost perimeter of the open end of the cup (12) and encloses the interior cavity (13) because the holder (3) takes up the entirety of the interior cavity and is in contact with the upper rim 17 which closes and thereby encloses the interior cavity as seen in fig. 2), the insertion portion of the holder having a planar face opposed to the forward wall of the cup (the planar face which holds the test strips 25), the planar face of the holder having a plurality of parallel ribs (structure 24) engaging the forward wall of the cup to define a plurality of elongate channels (ribs 24 engage the cup to seal around the test strips);
the cap portion (area 17) of the holder defining an access port (opening created by cap portion as seen in fig. 1) for receipt of the sampling stem (this limitation does not further structurally limit the instant claims), and a through passage structure extending from a bottom of the cap portion into the interior cavity of the cup (the insertion portion walls extend from the bottom of cap portion 17 to the bottom of the cup, see fig 2), the through passage structure being in register with the access port (opening created as seen inf fig. 1 and 2); and
a sampling stem (41) inserted through the access port of the cap, the sampling stem having a sampling swab at a distal end thereof (50).
Regarding claim 42, a device as set forth in claim 41, further comprising a gasket member (fig. 1, ref. 37) located at a bottom of the insertion portion of the holder (see fig. 1).
Regarding claim 43, a device as set forth in claim 42, wherein the gasket defines a plurality of riblets (33) respectively aligned with the parallel ribs (24) of the holder (see fig. 1).
Regarding claim 44, a device as set forth in claim 41, wherein the sampling stem is engaged with the access port via threads (fig. 1, threads 15 and threads on the underside of the lid 4 having the sampling stem).
Response to Arguments
Applicant's arguments filed 11/5/25 have been fully considered but they are not persuasive. Applicant argues, “The claim requires a cup with "planar forward wall" and "a holder having an insertion portion ... [with] a planar face opposed to the forward wall of the cup." In Lin, the "area at window 14" and the "face where the strip strips reside" as mentioned in the Office Action are not "planar," but are arcuate as clearly shown in Figure 1 of the reference.” A planar forward wall is planar enough to accept a flat test strip as shown in fig. 1. There is not length or width that defines the planar wall.
Applicant argues, “The claim requires that "the insertion portion [of the holder] has a through passage structure extending from a bottom of the cap portion separate from the insertion portion into the interior cavity of the cup, the through passage structure being in register with the access port such that the sampling stem can be inserted therein." An example of the through passage structure is indicated by reference number 56 in the present application. The inner vessel 3 of Lin does not have "a through passage structure extending from a bottom of the cap portion [that is] separate from the insertion portion into the interior cavity of the cup."* The claim requires "a pedestal portion integral with the inclined surface of the cup so as to be in alignment with the through passage structure and the access port." Because Lin does not have a through passage structure as claimed, it cannot have a pedestal aligned with the through passage structure. Moreover, item 70 of Lin is a receptacle rather than a pedestal. In some ways, a receptacle is the opposite of a pedestal.” The rejection has been modified above to now map the insertion portion as the catch basin 80 which has a cylindrical side wall 81 at the bottom of the cap portion which is separate from the opening area 17 accepts the sampling stem therein, see fig. 2. The through passage structure being in register with the access port such that the sampling stem can be inserted therein (the sampling stem is not positively claim in the instant claims and can be added to the device at a later time. The through passage, catch basin 80 area in the middle of structure 3 is in register with but separated by a space 18 from the access port area 17 that is capable of accepting a sampling stem as seen in fig. 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758