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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-13, 17 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lappe (US 2002/0081233 as referenced by 2002/0009390 which is fully incorporated by reference; para. 56) in view of Nagamatsu et al. (US 2016/0041180).
Regarding claim 10, an apparatus for confirming a negative test result obtained by exposing a sensing element functionalized to detect a target analyte to a test sample, the apparatus comprising:
a sample mixing compartment for receiving the test sample (compartment 90 of main body cup 24 as seen in fig. 7 of 2002/0009390)
a test confirmation sample (urine) comprising at least one of the target analyte in an amount greater than a detection limit of the sensing element (target analyte that is tested for on the test strip, sensing element)
a first compartment (chamber 100 where sample is deposited in middle and is isolated from the sample mixing compartment when the lid is placed thereon; fig. 4-6) retaining the test confirmation sample,
a second compartment (fig. 5; compartments 131 where test strips are placed) configured to receive the test confirmation sample from the first compartment, wherein the sensing element is disposed in the second compartment (test strips are placed within compartments 131 for analytical testing of the sample);
a separator (conduit starting at inlet 129 which leads to multiple passageways 128) disposed between and separating the first compartment (154) and the second compartment (131); and
a mechanism (plunger 164) for releasing the test confirmation sample from the first compartment into the second compartment to expose the sensing element to the test confirmation sample (the plunger 164 is depressed into the first compartment and displaces the sample fluid to the second compartment having the test strips therein).
Lappe does not test for a recombinant protein of the target analyte in an amount greater than a detection limit of the sensing element.
Nagamatsu teaches a device for testing urine samples which include two types of detection reagents that differ in reactivity to at least one urinary protein (albumin (recombinant protein), transferrin, protein b which include x1 microglobulin, b2-microglobulin, retinol binding proteins, lysozyme and N-acetylglucosaminidase; para 58-60). Detection reagents are provided on a reagent layer of a test strip in order to detect the above proteins in a urine sample (para 65). Nagamatsu detects these proteins in order to give information about nephrophathy and disease diagnosis (para 4,46). Therefore, it would have been obvious to one having an ordinary skill in the art to modify Lappe to provide a sensing element (test strip) for testing of proteins and target analytes withing a sample which would provide insight into disease diagnosis as taught by Nagamatsu (para 4, 46).
Regarding claim 11, the apparatus of claim 10, wherein the test confirmation sample comprises a capsule disposed in the first compartment (the detections reagents can be added to the sample test sample in the first compartment).
Regarding claim 12, the apparatus of claim 11, wherein the mechanism comprises a plunger (plunger 164) for pressing the capsule against a rigid spine with a force sufficient to puncture the capsule and release the test confirmation sample from the capsule (the plunger 164 depresses into the first compartment and displaces the sample fluid to the second compartment having the test strips therein).
Regarding claim 13, the apparatus of claim 12, wherein the plunger is in the first compartment (plunger 164 is within the first compartment 154).
Regarding claim 17, the apparatus of claim 10, wherein the sensing element comprises a plurality of nanopores (the test strips being made out of cellulose or paper base and allow sample transport through the test strip via capillary action would inherently have nanopores to facilitate capillary transport. The instant claim has not positively recited a size of the nanopore).
Regarding claim 21, the apparatus of claim 10, wherein the separator comprises an aperture (the conduit has a first aperture that is at area 100 to accept the sample and a second aperture which outputs the sample into the testing area).
Regarding claim 22, the apparatus of claim 10, wherein the mechanism comprises a plunger, wherein movement of the plunger forces the test confirmation sample into the second compartment (the plunger moves the fluid from 100 to through the separator and into the second compartment).
Regarding claim 23, the apparatus of claim 10, wherein the separator comprises an aperture (see rejection of claim 21 above) or a membrane, wherein the mechanism comprises a plunger, and wherein the plunger is movable to force the test confirmation sample through the aperture (the plunger moves the fluid from 100 to through the separator and into the second compartment) or the membrane and into the second compartment.
Regarding claim 24, the apparatus of claim 23, wherein movement of the plunger is based on the negative test result (this limitation does not further structurally limit the instant claim).
Regarding claim 25, the apparatus of claim 10, wherein the sensing element is configured to analyze the test confirmation sample and provide a measurement to an electronic reader, wherein the measurement indicates whether the negative test result is valid or invalid (this limitation does not further structurally limit the instant claim).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lappe (US 2002/0081233) in view of Nagamatsu et al. (US 2016/0041180) and in further view of Weyker at al. (US 2003/0021727).
Regarding claim 14-16, Lappe teaches a sample analysis device as seen above. The modified Lappe does not teach a membrane as the separator or a plunger having rigid spine on the end.
Weyker teaches a sample analysis device having a first compartment and a second compartment separated by a foil disk (30, fig. 1). A piercing member (fig. 7, 41) having a tip pierces the foil to thereby expose the test strip to a test sample. It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Lappe to provide a foil over the test sample after collection to preserve the sample before testing as is well known in the art as taught by Weyker (para 29). Once a user determines a time for testing a plunger would be depressed and the foil broken and the sample would travel to the test strips. Therefore, it would have been obvious to one having an ordinary skill in the art to modify Lappe to employ a plunger with piercing member as taught by Weyker to pierce the foil that seals the test sample in the first compartment.
Response to Arguments
Applicant's arguments filed 5/19/26 have been fully considered but they are not persuasive. Applicant argues, “Applicant submits that even if closed chamber 154 could be interpreted as a first compartment retaining a test confirmation sample (the propriety of which is again traversed), there would be no reason to also include a "sample mixing compartment for receiving the test sample," as recited in claim 10, as again, Lappe's closed chamber 154 is provided "for isolating a portion of the fluid specimen." See Lappe, [0057]. There would therefore be no reason to add an additional chamber in which to receive its fluid specimen.” The rejection has been adjusted due to claim 10 requireing a sample mixing compartment for receiving the test sample which is now interpreted as compartment 90 of cup 24 which is separate from the first compartment 100 retaining the test confirmation sample once the lid is placed thereon.
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-Friday 8-5.
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
Prosecution Insights