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 .
Election/Restrictions
Applicant’s election of Group III, claims 21-26 in the reply filed on May 12, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 21 is objected to because of the following informalities: The claim includes excess spacing between “the” and “received” in line 6. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 21, it is unclear if it is required for the sample fluid to contact, be delivered to the at least one sensor because the claim does not clearly recite, require such. The claim as drafted only requires the sample fluid to be delivered “towards” the at least one sensor.
It is unclear what is structurally required to be considered as a “compressible region” because such is not defined as any specific structure nor by any definite structural boundaries (dimensions) so as to determine where such region begins and ends. Furthermore, it is noted that such compressible region is not required to be an element of the apparatus nor sample well plate. Furthermore, it is unclear if it required that the method require compressing the compressible region with an extruding part (not defined in the clam as being any specific structure) because the “when” clause is directed to a condition that is never required to be performed. This is also applicable to the “when” clauses recited in claims 23-25. IF applicant intends for the method to be defined by definitive active steps, then the claims should clearly recite such rather than the recited conditional clauses.
It is unclear what the “external force” is required to be external to because the claim does not recite such. Also applicable to claims 23-25.
It is unclear what the pronoun “thereon” references. Also applicable to claim 25. It is presumed to refer to the compressible region. If so, the claims should clearly recite such.
It is noted that an indicator value is not required to be any specific value of anything. However, it is unclear what is required of such value to considered as “related to” the at least one sensor because the claim does not recite such. Any 2 or more things can be subjectively considered as “related” to each other. Furthermore, it is noted that the claim does not specify who or what is required to obtain such value, from where or what such value is obtained (can be performed mentally, visually using one’s eyes, and/or audibly using one’s ears and brain) , and there is no requirement for the method comprise sensing (providing a value of) anything with the at least at one sensor (that is not required to be an element of, nor structurally connected to the plate, apparatus, nor any other structure).
Claims 22-26 are rejected via dependency upon a rejected claim.
As to claim 22, it is unclear where the providing step is required to occur relative to the prior steps of claim 21 and where/to what the sample is provided to from the sample stick. Furthermore, it is unclear if “the pressure” is the same as the “a pressure” previously recited in claim 21. It is unclear how a pressure on the sample fluid is can be the same as pressure on the sample collection part.
It is unclear what is required to exert the pressure on the sample collection part that is not defined as being any specific structure. It is noted that the stick is inherently subjected pressure via gravity and atmospheric pressure.
As to claims 23-24, it is unclear if it is intended for the claims to require the method to include a step that requires rotating each of the first part and second part (not defined in the claim as being any specific structures) relative to each other… because the claim does not recite such. See prior rejection above directed to the “when” clauses. It is unclear if it is intended for the extruding part to be an element of and or connected to the first part or second part such that rotating the first and second parts results in, causes the extruding part to exert pressure on the compressible region.
As to claim 24, it is unclear what is a second amount of time because there is prior mention of a first amount of time. Any amount time can be a “first” and/or “second” amount of time.
As to claims 25, it is unclear if it is intended for the claim to require the method to include a step that requires compressing the compressible region and releasing a chemical (not specified) from the sample collection part of the sample stick and if such compressing is what causes the releasing because the claim does not recite such. See prior rejection above directed to the “when” clauses.
Claim 25 recites the limitations " the sample collection part”, “the sample stick” “the second amount of external force” and ”the first amount of external force”. There is insufficient antecedent basis for these limitations in the claim.
Furthermore, it is unclear what is the nexus of “an extruding part” to the previously recited “an extruding part” recited in claim 21, if such are the same or different because the claim does not provide for such. Although not required to be the same, the examiner fails to locate any description and illustration of the device 200 comprising more than one extruding part 230. Furthermore, it is noted claim 25 is only claim that provides for a reference number.
As to claim 26, it is unclear if it is intended for the method comprise a step that requires analyzing the indicator value by using the computing unit and the computing unit determining….because the claim does not clearly recite such. The “configured to…” clause does not provide for any requires steps, but the clause is directed to a capability of the computing unit. However, it is unclear what is required of an amount of a molecule in a sample to be considered as having a “significance” because the claim does not provide for such.
The term “significance” in claim 26 is a relative term which renders the claim indefinite. The term “significance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Anything can be subjectively considered as having “a significance”. However, what may be considered as “a significance” to one person may not be considered as such to another and vice versa.
Claim 26 recites the limitation “the at least one molecule in the sample fluid". There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Wu et al, US 2022/0134329.
Wu discloses a device and method for testing, sensing a target analyte in a sample. (Abstract).
The device 1 comprises a solution 75 can be provided in the sample mixing compartment 24. a cartridge housing 10 (second part), a cap 12 (first part), a sensor assembly 14 having a sensing element 34 (at least one sensor), a mechanical locking structure 16, and an activation feature 71. In some embodiments, the activation feature 71 can comprise a lock clip 71a and a detect pin 71b. The sample testing device 1 can include an unlock button 73 that is disposed on a bottom side of the test sampling device 1. A separator 20 can separate the testing tube into a plurality of (e.g., two) compartments. In some embodiments, the separator 20 can comprise an internal sealing gasket (not illustrated). In some embodiments, one of the two compartments can comprise a first sample mixing compartment 24 and the other one of the two compartments can comprise a second sensing compartment 26 (at least one sensor). The sample mixing compartment 24 can be defined at least in part by a sample mixing compartment housing 28. The sensing compartment 26 can be defined at least in part by the cartridge housing 10. The sample mixing compartment housing 24 can be coupled to the cap 12. The sample mixing compartment 24 can include a solution 75 prior to providing a test sample into the sample mixing compartment. The test sample can be delivered to the sample mixing compartment 24 using, for example, a swab 78 (sample stick including a collection part). In some embodiments, the test sample can be mixed with the solution 75. In some embodiments, the separator 20 can open to allow fluid communication between the sample mixing compartment 24 and the sensing compartment 26. Therefore, the separator 20 can have the closed state in which there is no fluid communication between the sample mixing compartment 24 and the sensing compartment 26, and the opened state in which there is fluid communication between the sample mixing compartment 24 and the sensing compartment 26. In some embodiments, the separator 20 can open in response to a force applied to the sample testing device 1. For example, the separator 20 can open when the sample mixing compartment housing 28 and/or the cap 12 is twisted relative (rotational movement of the first and second part relative to each other) to the sensing compartment 30. The test sample can be transferred from the sample mixing compartment 24 to the sensing compartment 26 through an aperture 25 when the separator 20 is in the opened state. When the separator 20 is raised above a flange 23 (a part of the cartridge housing 10 that closes the hole), the aperture 25 enables the liquid sample to flow from the sample mixing compartment 24 to the sensing compartment 26 as shown in FIG. 2B as a liquid flow 27. (paragraph 0034).
The sensing element 34 enables sensing element 34 to perform multiple different tests, e.g., to test for multiple different target molecules, to test with different sensitivities, or to include controls to verify the accuracy. (paragraph 0038).
A force can be applied to the sample mixing compartment housing 28 and/or the cap 12 to cause a mechanical movement. In some embodiments, the sample mixing compartment housing 28 can be moved relative to the cartridge housing 10. For example, the sample mixing compartment housing 28 and/or the cap 12 can be twisted or rotated relative to one another. (rotational movement of the first and second parts relative to each other). In response to the twist of sample mixing compartment housing 28 and/or the cap 12, the separator 20 can open to allow the test sample to flow from the sample mixing compartment 24 to the sensing compartment 26 or the sample reservoir 60 by way of the aperture 25 in the fluid flow 27. When the separator 20 opens, the reader 72 can detect a shortage in the circuit. When the short circuit is detected, the reader 72 can initiate reading and analyzing sensed data received from the sensor assembly 14. (paragraph 0040).
FIGS. 9A and 9B are schematic cross-sectional side views illustrating an internal positive control mechanism 100 for the sample testing device 1 in accordance with one embodiment described herein. As shown in FIG. 9A, the internal positive control mechanism 100 includes a compartment 102 in which a capsule 104 (compressible region) containing a test confirmation sample (sample received in a sample well) including a detectable amount of the targeted molecule (or a recombinant protein thereof). In particular embodiments, the test confirmation sample in the capsule 104 comprises a fluid. A plunger 106 (extruding part) is also disposed within the compartment 102 and arranged within the compartment 102 such that movement of the plunger 106 toward the capsule 104 (e.g., in a direction indicated by an arrow 108) forces the capsule against a spine 110 or other rigid object having a sharp point capable of puncturing the capsule 104 to release the fluid test confirmation sample contained therein (delivering the sample towards the sensor via applied force from the extruding part to the compressible region) . In particular embodiments, movement of the plunger 106 in the direction 108 is initiated by depressing a button on or associated with the reader 72 (not shown in FIGS. 9A and 9B) after a negative test result is indicated by the reader 72 (not shown in FIGS. 9A and 9B). Movement of the plunger 106 in the direction 108 may actuated and controlled by the reader 72 (not shown in FIGS. 9A and 9B). (paragraph 0056).
Referring to FIG. 9B, continued movement of the plunger 106 in the direction 108 forces the fluid test confirmation sample through an aperture 112 and into the sensing compartment 26, as indicated by an arrow 114, where it is exposed to the sensing element 34 and the results are indicated by the reader 72 (not shown in FIGS. 9A and 9B) as described above. (the sample is delivered towards the sense element) paragraph 0057).
It will be recognized that the plunger 126 may be actuated by a user or device applying force to an end of the plunger 126 distal from the membrane 124 in the direction 130 sufficient to cause the spine 128 to puncture the membrane 124. (paragraph 0059).
In some embodiments, the reader may indicate a positive test result, corresponding to a situation in which a designated amount (i.e., an amount in excess of a detection limit of the sensing element 34) of target components, or molecules, have been detected (or sensed) in the fluid sample by the sensing element 24, or a negative test result, corresponding to a situation in which a designated amount target components, or molecules, have not been detected (or sensed) in the fluid sample by the sensing element 24. (obtaining an indicator value related to the one sensor) (paragraph 0042).
As to claims 22-25, FIG. 7C is a schematic side see-through view of the sample testing device 1 with a swab 78 in a step in the process. The test sample can be provided by way of the swab 78. The test sample can be mixed with the solution 75 in the sample mixing compartment 24. For example, the swab 78 with the test sample can be inserted into the sample mixing compartment 24 and stirred with the solution 75. (exerting pressure on the sample collection part of the sample stick to provide a sample) (paragraph 0043).
As to claims 23 and 24, different forces can be applied via rotational movement to different positions of the cap relative to the housing compartments for desired times as desired. See above.
As to claim 26, the sensor assembly 14 can further comprise electronic components, such as a memory (e.g., a wafer-level chip size package (WLCSP) electrically erasable programmable read-only memory (EEROM) 70a), a thermometer (e.g., resistance thermometer (RTD) 70b), a connector (e.g., USB connector 70c), a resistor 70d, etc. The processing electronics can be on an external computing device (computing device) that receives the data by way of a reader 72, which in some embodiments comprises a portable electronic reader. Alternatively, the processing electronics can be in the sensor assembly 14, or in the reader 72. In some embodiments, the thermometer can measure temperature of the test sample and/or the control material, thereby allowing the sensing assembly 14 to compensate for the temperature during analysis. (paragraph 0040).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pais; Rohan et al.; Niemz; Angelika et al.; Hu; Lin et al.; Sonnleitner; Max; Aysta; James E. et al.; Bedingham; William et al.; Price; Glenn et al.; Bedingham; William et al.; Friedman; Daniel H. et al.; and Pais; Andrea Maria Dominic et al.; disclose testing devices and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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