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 .
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 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loudermilk (WO 2021/195633).
Regarding claim 1, Loudermilk discloses an oral fluid collection system (fig. 20-24c comprising:
an inner swab (sample pad 60a which contacts the outer swab 77), an outer swab (77), a swab holder (housing 76/76a), an inner swab carriage (test strip substrate body 60c; fig. 21a);
said swab holder (housing 76/76a) comprising a hollow tubular handle (see fig. 24a, handle shaft can be grabbed);
said inner swab carriage (test strip substrate 60c or in an alternate interpretation 2 test strips are placed back to back and the 2nd test strip would be the inner swab carriage that is in contact with the first test strip) configured to hold at least some of said inner swab (sample pad, conjugate pad), and to move along an axis of said hollow tubular handle while holding said inner swab (this limitation does not further structurally limit the instant claim because there is no structure that allows the inner swab carriage to moved within along an axis of the hollow tubular handle. The prior art test strip having the inner swab 60a/60b thereon is moved within the hollow tubular handle 76);
said outer swab (77) comprising a hollow and substantially cylindrical second structure with a second height and second radius (structure which holds the swab 77 on the outer perimeter where it meets the structure 77, see annotated figure below), an outer swab proximal end (right side of 77 looking at fig. 23a-c), and an outer swab distal end (left side of 77 looking at fig. 23a-c);
said outer swab (77) comprising a hollow cylindrical opening (80) though a main axis of said substantially cylindrical second structure (portion as seen in fig. 23b where structure 80 is inserted into the outer swab 77 to allow the inner swab/inner carriage to interact with the outer swab 77; see annotated figure below which labels the cylindrical second structure),
said hollow cylindrical opening (80) configured to enable said inner swab carriage (test strip substrate carrier body 60c) and said inner swab (sample pad) to fit inside said hollow opening (80 accepts the tip of the inner swab (sample pad) of the test strip to come into contact with outer swab 77 to allow for sample to be transferred to the inner swab (sample pad);
said inner swab (sample pad 60a/60b) and said outer swab (77) comprising bibulous hydrophilic material configured to absorb saliva, and to release at least some of said saliva upon application of external pressure (this limitation does not further structurally limit the instant claim. The prior art swabs are made of hydrophilic material can are capable of absorbing saliva);
said inner swab carriage (test strip substrate 60c or in an alternate interpretation 2 test strips are placed back to back and the 2nd test strip would be the inner swab carriage that is in contact with the first test strip) configured, while holding said inner swab, to be disposed within said hollow tubular handle, thus creating an oral fluid collection system with a distal end comprising both an inner swab distal end and said outer swab distal end, and a proximal end comprising a swab holder proximal end (this limitation does not further structurally limit the instant claims as they are directed to a function or process).
PNG
media_image1.png
598
779
media_image1.png
Greyscale
Regarding claim 2, the system of claim 1, further configured to receive saliva from a donor's mouth, and store at least some of said saliva in at least portions of said inner swab that are disposed within said hollow tubular handle, and to store at least some said saliva in said outer swab and portions of said inner swab that are disposed within said outer swab (this limitation does not further structurally limit the instant claims as they are directed to a function or process. The saliva sample is not positively recited as part of the oral fluid collection system and can be added at a later time).
Regarding claim 3. The system of claim 1, further configured so that application of external pressure causes at least some of said saliva stored in said outer swab to be released, while retaining other portions of said saliva stored in portions of said inner swab disposed within said hollow tubular handle (this limitation does not further structurally limit the instant claims as they are directed to a function or process. The saliva sample is not positively recited as part of the oral fluid collection system and can be added at a later time).
Regarding claim 4, the system of claim 3, further configured so that said inner swab is configured be removable from said hollow tubular handle, and portions of said saliva stored in the portions of said inner swab that were previously disposed inside said hollow tubular handle can be expelled by application of external pressure (this limitation does not further structurally limit the instant claims as they are directed to a function or process. The cap 79 is removable to add/remove the inner swab (test strip 60)).
Regarding claim 5, the system of claim 3, further comprising a container (see fig. 1, ref. 1); said container comprising an outside, and inside, a bottom, and an open top (see fig. 1); said swab holder (76) further comprising a container interface (9a) on said swab holder proximal end (near top of container); said container configured with an open top complementary to said container interface (see fig. 1-2), and a hollow interior configured to enable said swab holder, said outer swab, said inner swab carriage to be inserted into said hollow interior (See fig. 1), and to enable said container interface (9a) to form a seal with at least a portion of said inside of said open top (see fig .1, 9a provides a seal).
Regarding claim 6, the system of claim 5, wherein said container is further configured to hold at least one lateral flow immunoassay, said bottom and said lateral flow immunoassay further configured so that released saliva can be analyzed by said at least one lateral flow immunoassay (this limitation does not further structurally limit the instant claims as the lateral flow immunoassay can be added at a later time and is not positively recited).
Regarding claim 7, the system of claim 5, wherein said container is further configured so that released saliva can be retrieved by a pipette or other fluid sampling system (this limitation does not further structurally limit the instant claims as they are directed to a function of releasing saliva which is not positively recited).
Regarding claim 8, the system of claim 1, wherein said swab holder further comprises an outer swab support (flat base to which 77 is applied to) and a removable cap (See fig. 23c ref. 79).
Regarding claim 9, Loudermilk discloses an oral fluid collection system comprising:
an inner swab (sample pad 60a which contacts the outer swab 77, or in an alternate interpretation 2 test strips are placed back to back and the 2nd test strip would be the inner swab carriage that is in contact with the first test strip)), an outer swab (77), a swab holder (housing 76/76a), an inner swab carriage (test strip substrate body 60c; fig. 21a);
said swab holder comprising a hollow tubular handle (76), outer swab support (any structure that contacts the swab 77), and a removable cap (79);
said inner swab comprising a substantially cylindrical first structure (test strip fits within hollow tubular handle 76) with a first height and first radius, an inner swab proximal end and an inner swab distal end (60a/60b);
said inner swab carriage configured to hold at least said inner swab proximal end and said inner swab distal end (see fig. 23c), and to move along an axis of said hollow tubular handle while holding said inner swab (this limitation does not further structurally limit the instant claims);
said outer swab (77) comprising a hollow cylindrical opening (80) though a main axis of said substantially cylindrical second structure (portion as seen in fig. 23b where structure 80 is inserted into the outer swab 77 to allow the inner swab/inner carriage to interact with the outer swab 77; see annotated figure below which labels the cylindrical second structure),
said hollow cylindrical opening (80) configured to enable said inner swab carriage and said inner swab to fit inside said hollow opening (see fig. 23c);
said inner swab (sample pad 60a/60b) and said outer swab (77) comprising bibulous hydrophilic material configured to absorb saliva, and to release at least some of said saliva upon application of external pressure (this limitation does not further structurally limit the instant claim. The prior art swabs are made of hydrophilic material can are capable of absorbing saliva);
said swab holder (76) configured with said removable cap (79) on a swab holder proximal end (see fig. 23c), and said outer swab support on a swab holder distal end (see fig. 23c); said removable cap configured to reversibly mount to said swab holder proximal end; said inner swab carriage and said inner swab proximal end configured to fit into a distal end of said hollow tubular handle;
said distal end of said swab holder comprising said outer swab support any structure which contacts outer swab 77), said outer swab support comprising a disk-shaped annular structure comprising an annular hole (80, fig. 23b,23c) through a center of said outer swab support (flat disk in contact with the proximal end of the outer swab 77), said annular hole having a radius configured to allow said inner swab carriage and said inner swab to pass through said annular hole (see fig. 23c), but to not allow said outer swab to pass through said annular hole (see fig. 23c, outer swab 77 is too large to fit through annular hole 80);
said inner swab carriage configured, while holding said inner swab, to be disposed within said hollow tubular handle, pass through said annular hole, and pass through said hollow cylindrical opening of said outer swab, thus creating an oral fluid collection system with a distal end comprising both said inner swab distal end and said outer swab distal end, and a proximal end comprising said swab holder proximal end and said removable cap (this limitation does not further structurally limit the instant claims. The prior art is structurally capable of performing the above function).
Regarding claim 10, the system of claim 9, further configured to receive saliva from a donor's mouth, and store at least some of said saliva in at least portions of said inner swab that are disposed within said hollow tubular handle, and to store at least some said saliva in said outer swab and portions of said inner swab that are disposed within said outer swab (this limitation does not further structurally limit the instant claims as they are directed to a function or process. The saliva sample is not positively recited as part of the oral fluid collection system and can be added at a later time) .
Regarding claim 11, the system of claim 9, further configured so that application of external pressure causes at least some of said saliva stored in said outer swab to be released, while retaining other portions of said saliva stored in portions of said inner swab disposed within said hollow tubular handle (this limitation does not further structurally limit the instant claims as they are directed to a function or process. The saliva sample is not positively recited as part of the oral fluid collection system and can be added at a later time).
Regarding claim 12, the system of claim 11, further configured so that after said outer swab and said cap are removed, said inner swab is configured be removable from said hollow tubular handle, and said inner swab is configured so that additional portions of said saliva stored in portions of said inner swab that were previously disposed inside said hollow tubular handle can be expelled by application of external pressure ((this limitation does not further structurally limit the instant claims as they are directed to a function or process. The cap 79 can be removed and a inner swab be inserted/removed from the hollow tubular handle).
Regarding claim 13, the system of claim 11, further comprising a container (fig. 1, ref. 1); said container comprising an outside, and inside, a bottom, and an open top (see fig. 1); said swab holder further comprising a container interface (fig. 1, ref. 9a) on said swab holder proximal end; said container configured with an open top complementary to said container interface (see fig. 1), and a hollow interior (fig. 1) configured to enable said swab holder, said outer swab, said inner swab carriage to be inserted into said hollow interior, and to enable said container interface (9a is seal) to form a seal with at least a portion of said inside of said open top.
Regarding claim 14, the system of claim 13, wherein said container is further configured to hold at least one lateral flow immunoassay, said bottom and said lateral flow immunoassay further configured so that released saliva can be analyzed by said at least one lateral flow immunoassay (this limitation does not further structurally limit the instant claims as the lateral flow immunoassay can be added at a later time and is not positively recited).
Regarding claim 15, the system of claim 13, wherein said container is further configured so that released saliva can be retrieved by a pipette or other fluid sampling system (this limitation does not further structurally limit the instant claims as the saliva sample can be added at a later time).
Regarding claim 16, Loudermilk discloses a method of collecting oral fluids for testing, said method comprising:
using an oral fluid collection system (See claim 1 rejection above) to obtain saliva from a patient, said oral fluid collection system comprising at least an outer swab (77) and an inner swab (60), both said swabs mounted on a swab holder (see fig. 23a-23c), and said inner swab (60a) is mounted on an inner swab carriage (substrate or second test strip as interpreted in claim 1 above) positioned inside said swab holder (76);
said both said swabs comprising a bibulous hydrophilic material (wicking material, and absorbent material);
collecting saliva on both swabs simultaneously (the saliva is sampled and travels to the sample pad); testing saliva retained on said outer swab (the saliva is collected on both 60a and 77 and tested via a reagent, see fig. 21a); and
storing said inner swab for later testing (the inner swab is stored within housing 76 and larger housing as seen in fig. 1).
Regarding claim 17, the method of claim 16, wherein said oral fluid collection system further comprises: said inner swab (60a), said outer swab (77), said swab holder (76), and said inner swab carriage (substrate 60c or seond test strip placed together with 1st test strip); said swab holder comprising a hollow tubular handle 76 is hollow); said inner swab carriage configured to hold at least some of said inner swab (60a is placed on 60c and in the alternate interpretation the 1st test strip is place on the second test strip as seen in fig. 22), and to move along an axis of said hollow tubular handle while holding said inner swab (the test strip moves within the hollow tubular handle as seen in fig. 23b-23c); said outer swab (77) comprising a hollow and substantially cylindrical second structure (see the annotated figure above) with a second height and second radius, an outer swab proximal end (left side of swab 77 when looking at figs. 23a-23c), and an outer swab distal end (right side of 77 when looking at figs. 23a-23c); said outer swab (77) comprising a hollow cylindrical opening though a main axis of said substantially cylindrical second structure (area at 80 where 77 is located), said hollow cylindrical opening configured to enable said inner swab carriage (see fig. 23c) and said inner swab to fit inside said hollow opening (see fig. 23c); said inner swab and said outer swab comprising bibulous hydrophilic material (both are made of absorbent material sponge like material or wicking material) configured to absorb saliva, and to release at least some of said saliva upon application of external pressure; said inner swab carriage configured, while holding said inner swab, to be disposed within said hollow tubular handle (see fig. 23b), thus creating an oral fluid collection system with a distal end comprising both an inner swab distal end and said outer swab distal end, and a proximal end comprising said swab holder proximal end (see fig. 23c).
Regarding claim 18, the method of claim 16, wherein said oral fluid collection system further comprises: said inner swab (60c), said outer swab (77), said swab holder (76), and said inner swab carriage (60 substrate or in an alternate interpretation a second test strip as seen in fig. 22); said swab holder comprising a hollow tubular handle (76), outer swab support (structure that 77 attaches, upper disc area), and a removable cap (79); said inner swab comprising a substantially cylindrical first structure with a first height and first radius, an inner swab proximal end and an inner swab distal end (see fig. 23b-23c); said inner swab carriage configured to hold at least said inner swab proximal end and said inner swab distal end (60 substrate or in an alternate interpretation a second test strip as seen in fig. 22 attached to the backside of the first test strip), and to move along an axis of said hollow tubular handle while holding said inner swab (fig. 23b-23c); said outer swab (77) comprising a hollow and substantially cylindrical second structure with a second height and second radius (see annotated figure above), an outer swab proximal end (left side of swab 77 when looking at figs. 23a-23c), and an outer swab distal end (right side of swab 77 when looking at figs. 23a-23c); said outer swab further comprising a hollow cylindrical opening though a main axis of said substantially cylindrical second structure (swab 77 at area where 80 enters the swab 77 area is a hollow opening as seen in fig. 23b-23c), said hollow cylindrical opening configured to enable said inner swab carriage and said inner swab to fit inside said hollow opening (See fig. 23c); said inner swab and said outer swab comprising bibulous hydrophilic material configured to absorb saliva (both are made of absorbent material sponge like material or wicking material), and to release at least some of said saliva upon application of external pressure (swabs are squeezed to release fluid sample); said swab holder configured with said removable cap (79) on swab holder proximal end (see fig. 23c), and said outer swab support on said swab holder distal end (see fig. 23c); said removable cap (79) configured to reversibly mount to said swab holder proximal end (see fig. 23c); said inner swab carriage and said inner swab proximal end configured to fit into a distal end of said hollow tubular handle (see fig .23b-23c); said distal end of said swab holder comprising said outer swab support (proximal end of swab 77 is attached to a swab holder), said outer swab support comprising a disk-shaped annular structure comprising an annular hole through a center of said outer swab support (area at 80), said annular hole (area at 80) having a radius configured to allow said inner swab carriage and said inner swab to pass through said annular hole (see fig. 23c), but to not allow said outer swab to pass through said annular hole (see fig. 23c); said inner swab carriage configured, while holding said inner swab, to be disposed within said hollow tubular handle, pass through said annular hole (see fig. 23c), and pass through said hollow cylindrical opening of said outer swab, thus creating an oral fluid collection system with a distal end comprising both said inner swab distal end and said outer swab distal end, and a proximal end comprising said swab holder proximal end and said removable cap (see fig. 23a-23c).
Conclusion
Pertinent art:
IDS filed 12/06/2022 has an error in the Patent number (100340032 is incorrect). Examiner cited the correct document on the PTO-892 as 10340032.
Engel (US 10,076,314) teaches A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid has a container for receiving a sample of body fluid, with an interior that is delimited by a base and by a circumferential surface. It further comprises at least one test strip and a holding element for receiving and holding the one or more test strips. The holding element is designed such that it has a shape corresponding and adapted to the peripheral circumferential surface of the container. The device further comprises an elongate sampling element having an absorbent sampler that takes up the sample of body fluid and by means of which the sample of body fluid is transferred into the container. The sampling element can include an indicator strip for determining whether the amount of liquid sample sufficient for carrying out an assay.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758