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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Finland on 3/24/22. It is noted, however, that applicant has not filed a certified copy of the FI20225260 application as required by 37 CFR 1.55. Record indicates that the Office attempted but failed to retrieve the priority documents via the Priority Document Exchange (PDX) program on 8/24/23. Please be advised that under 37 CFR 1.55 and as detailed in the Manual of Patent Examining Procedure (MPEP) § 215, the applicant remains ultimately responsible for ensuring that a certified copy of the foreign priority application is filed during the pendency of the U.S. application and before the patent is granted, even if the USPTO cannot retrieve the document via the PDX program.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/22/23 was filed before the mailing date of the first action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I, Species A [claims 1-2, 4-14] in the reply filed on 9/10/25 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)).
The claim listing submitted on 9/10/25 do not appear to have correct status identifiers – e.g., non-elected claims 3, 15… have “Previously Presented” instead of “Cancelled” or “Withdrawn”. Claims 3, 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II and Species B.
Claim Objections
Claim 1 is objected to because of the following informalities: “comprisi” on line 1 should be “comprising:”.
Claim 5 is objected to because of the following informalities: there is an extra space between “sensor” and the period at end of sentence.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 4-6, 9-12, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Samproni”, WO 2018112008.
Regarding claim 1, Samproni discloses an apparatus for collecting a sample fluid [0016], the apparatus comprising:
a hollow elongate body having a volume [e.g., 34] comprising a bottom and an inlet [e.g., 22] opposite to the bottom of the volume, wherein the volume of the hollow elongate body is configured to receive the sample fluid via the inlet [0021];
at least one sensor [20] coupled to the hollow elongate body, wherein the at least one sensor has at least one opening [e.g., 52] for receiving at least a part of the sample fluid from the volume [0027]; and
a plurality of electrical connectors [36] arranged with the hollow elongate body, connected to the at least one sensor [0019].
Regarding claim 2, Samproni discloses the at least one sensor is coupled on an inner surface of at least one side of the hollow elongate body [0020+].
Regarding claim 4, Samproni discloses the at least one opening of the at least one sensor is implemented as holes, microfluidic channels, or a porous membrane [0034+].
Regarding claim 5, Samproni discloses an insertable part [e.g., sensor face 23] configured to be inserted at least partly into the volume of the hollow elongate body, through the inlet thereof, to deliver the sample fluid to the at least one sensor [0021+, fig.5; alternatively, sensor face 23 may replace a syringe or pipette to draw the sample fluid via capillary action].
Regarding claim 6, Samproni discloses the insertable part comprises a porous tissue for collecting the sample fluid [0021+; capillary action to draw the sample fluid].
Regarding claim 9, Samproni discloses the at least one sensor is an electrochemical sensor adapted to change its electrical characters as a function of an amount of a first molecule of interest in the sample fluid [0026+; e.g., an amount of fluid will activate].
Regarding claim 10, Samproni discloses number of electrochemical sensors is at least two, of which a first one is adapted to change its electrical characters as the function of the amount of the first molecule of interest in the sample fluid and a second one is adapted to change its electrical characters as a function of an amount of a second molecule of interest in the sample fluid, and wherein the first molecule is different from the second molecule [0028+].
Regarding claim 11, Samproni discloses the outer surface of the apparatus is n-gonal prism [0021+; n approaches infinity].
Regarding claim 12, Samproni discloses a device for collecting a sample fluid, the device comprising:
an apparatus as discussed above in reference to claim 1; and
a reader part having a plurality of base connectors to connect with a plurality of electrical connectors of at least one sensor of the apparatus [0016], and a controller configured to provide an electrical signal to the at least one sensor and read a related electrical signal from the at least one sensor via the plurality of base connectors, and use the provided and related electrical signal to form an indicator value of an amount of at least one molecule of interest in the sample fluid [0019, 0035].
Regarding claim 14, Samproni discloses the device comprises a communication interface to provide the indicator value to a computing unit, wherein the computing unit is configured to analyse the indicator value to determine a significance of the amount of the at least one molecule of interest in the sample fluid [0016+].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7-8, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samproni as applied to claims 1 and 12 above, and further in view of Poulten, US Patent 3809297.
Regarding claim 7, Samproni discloses the device/apparatus body can be a tube, vial or pipette [0033], but did not discuss the details of how the sample fluids are delivered to the sensors. Poulten teaches a similar apparatus/device [i.e., pipette] for collecting sample fluid comprising a pressing part [13] configured to drive an insertable part [16] into the volume of the hollow elongate body, and to change pressure inside of the volume to deform the insertable part [col.3, ll.5-22, ll.46-59].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Poulten’s explicit teachings of a pipette structure [e.g., 13, 16, 5] into Samproni’s pipette [e.g., hollow portion], resulting in an apparatus comprising a pressing part configured to drive the insertable part into the volume of the hollow elongate body, and to change pressure inside of the volume to deform the insertable part to deliver the sample fluid to the at least one sensor. One of ordinary skill in the art would have incorporated the basic fluid mechanics teachings of Poulten to have the predictable result of obtaining particular sample volume sizes [Poulten: abstract] that is desirable in some medical diagnostic instances.
Regarding claim 8, Poulten further discloses the pressing part is attached to the insertable part [e.g., fig.1].
Regarding claim 13, Samproni and Poulten combined further results in a measurement arrangement configured to measure an amount of sample fluid supplied to the at least one sensor [Poulten: abstract]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Poulten’s explicit teachings of measuring an amount of sample fluid into Samproni’s apparatus in order to be conservative/efficient with sufficient/limited amount of sample fluid [Samproni: 0032].
Examiner further submits that part of the configured-to clause of “use the measured amount of the sample fluid to provide an instruction to a user of the device” is deemed to be intended use [note also that this limitation may encompass a user or human which would otherwise be considered rejected under 101] which the combined Samproni and Poulten would be capable of with each measured draw of sample fluid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. “Slowey”, US Publication 20110268626, discloses a sample collection used to collect bodily fluids like saliva, with a window that guides the user to know when enough measured amount of sample has been collected.
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/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791