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 .
Response to Amendment
The Amendment filed 07/21/2026 has been entered. Claims 1-15 remain pending in the application. Claims 13-15 are withdrawn. Claims 1-12 are being examined herein.
Status of Objections and Rejections
The claim objection are being withdrawn in view of Applicant’s amendment.
The rejection under 35 U.S.C 112(b) are being withdrawn in view of Applicant’s amendment.
A new ground for rejection under 35 U.S.C. 112(a) is necessitated by the amendment.
The rejections of 35 U.S.C. 102 and 35 U.S.C. 103 are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is amended to recite the limitation “… an aspiration needle unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port, the aspiration needle … ” in lines 5-6, and the Applicant states in p. 12 in the Remarks of 07/21/2026 that “this amendment is supported by FIG. 2 of the as-filed application and affirmed by the teaching in para. [0081] of the published application (i.e., U.S. Pub. No. 2023/0051070 A1) that the aspiration needle 30 directly contacts the inner input-port side 11 of the sample input port 10 such that the needle 30 is unaffixed to the sample containers 1, 2.” However, Fig. 2 clearly shows that the aspiration needle 30 is affixed (attached) to the sample container 1 by sample input port 10 when sample container 1 is plugged in the outer input-port side (11) of sample input port 10. Furthermore, the inset of Fig. 2 shows that needle 30 directly attached to container 1 (see Figure below).
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In addition, para. 0081 of the published application (US 20230051070 A1) (which is also para. 0081 of the specification) also does not provide support for the amendment. Para. 0081 teaches the sample port 10 (having coupled to the sample container 1,2) is configured to “couple to the aspiration needle 30 (not shown in FIGs. 8-10) for the sample to be aspirated from the sample container 1, 2 plugged in the outer input-port side 11.” Therefore, the para. 0081 (as disclosed in Fig. 2) discloses that the aspiration needle 30 is affixed to the sample container through sample port 10 when the sample container is plugged in the outer input-side of the sample input port.
Therefore, the amendment is without support from the original disclosure.
Claims 2-12 are rejected because of their dependence on claim 1.
Claim Interpretation
Claim 1 is amended to recites “an aspiration needle unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port, the aspiration needle …” in lines 5-6. The term “unaffixed” is the opposite of “affixed” which mean attached or fastened. When two objects are affixed, they can be affixed directly without an intermediary connector, or they can be affixed indirectly with an intermediary connector such a joint or fastener. Therefore, an aspiration needle is considered to be affixed to a sample container when the aspiration needle is attached or fastened to a sample container with or without an intermediary connector (e.g., sample input port). Consequently, aspiration needle is unaffixed to the sample container when the aspiration needle is neither directly nor indirectly attached or fastened to the sample container.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by New Zealand Needle Exchange Programme (Nonpatent Literature, YouTube, https://www.youtube.com/watch?v=WUk7nTSxzW0, “How to Use a Wheel Filter” posted on 10/31/2019. Accessed 3/26/2026), hereinafter “NZ exchange Programme.”
Regarding claim 1, NZ exchange Programme teaches a sample input interface device for inputting samples into a detecting unit of an in-vitro diagnostic analyzer, the sample input interface device comprising:
a sample input port (the brown filter at 3:13s) comprising an outer input-port side (Luer inlet) configured for plugging-in an open end of a sample container (interpreted as a functional limitation. A sample container is not positively recited. @3:17s, the Luer inlet of the filter is capable of being plugged into a syringe) and an inner input-port side (Luer outlet), and
an aspiration needle (the needle held by hand at 3:13s) unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port, the aspiration needle (The sample container is not positively recited; it is an article work upon, and “when” is interpreted as a conditional statement and is not further limiting the claimed structure. The aspiration needle meets the structural limitation of the intended use) comprising an upstream end (luer hub of the needle) and a downstream end (the pointy end), wherein the downstream end is fluidically connected or connectable to the detecting unit (the detection unit is not positively recited; the needle is connectable to a detection unit. Moreover, @4:56, the needle is connected to a second syringe, which is a detecting unit) and
wherein the upstream end (Luer hub of the needle) is configured to alternately couple to the inner input-port side (Luer outlet) in order to aspirate a sample from the sample container plugged in the outer input-port side and to a fluid supply port (another syringe) in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer (interpreted as an intended use. The fluid supply port, fluid supply unit and the in-vitro diagnostic analyzer are not positively recited. The needle can be inserted to another syringe with fluid and aspirate the fluid)(@3:06 and @3:33, the needle hub is capable of alternately coupling to a syringe or the filter), and
wherein the outer input-port side (Luer inlet) is further configured to alternately couple to the fluid supply port (the another syringe) while the upstream end of the aspiration needle is coupled to the inner input-port side (@3:19, the Luer inlet is capable of coupling to a syringe and the needle) in order to rinse the sample input port with fluid aspirated by the aspiration needle from the fluid supply unit via the sample input port (fluid is not positively recited. In the scenario where there is fluid in the another syringe, the filter is rinsed as the fluid as fluid aspirated by the needle).
Regarding claim 2, NZ exchange Programme teaches all of the elements of the current invention as stated above with respect to claim 1. NZ exchange Programme further teaches wherein the sample input port is rotatable at least between a sample input position and a fluid supply position (“sample input” and “fluid supply” are being interpreted as intended use. The filter can be rotated between two positions around an axis of rotation, wherein the distance between axis of rotation and each position is the length the needle attached to the filter. One of the positions is destinated as the “sample input” position, and the other is destinated as the “fluid supply” position. At the “supply position”, the another syringe is placed such that the syringe’s outlet is aligned with Luer inlet of the filter).
Regarding claim 3, NZ exchange Programme teaches all of the elements of the current invention as stated above with respect to claim 2. NZ exchange Programme further teaches wherein the aspiration needle is rotatable at least between the sample input position in which the upstream end of the aspiration needle is aligned with the inner input-port side when the sample input port is in the sample input position and the fluid supply position in which the upstream end of the aspiration needle is aligned with the fluid supply port (the pointy end of the needle at the axis of rotation, the needle hub is rotatable between the “sample input” position and be coupled to the filter when the filter is at the “sample input” position, and the “fluid supply” position be aligned with the another syringe).
Regarding to claim 4, NZ exchange Programme teaches all of the elements of the current invention as stated above with respect to claim 3. NZ exchange Programme teaches wherein at least the upstream end of the aspiration needle is linearly movable along the longitudinal direction parallel to the length of the aspiration needle in order to couple to and decouple from the inner input-port side and the fluid supply port respectively (the needle is linearly movable along its long axis to attach and/or detach from the filter and the syringe) (see also 35 U.S.C. 112(b) above).
Regarding claim 5, NZ exchange Programme teaches all of the elements of the current invention as stated above with respect to claim 4. NZ exchange Programme further teaches wherein the sample input port is movable along the longitudinal direction of the aspiration needle together with, or independently from and relative to, the aspiration needle (the filter can move in the longitudinal direction of the needle with or without needle).
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Youngln Chromass Global (Nonpatent Literature, YouTube, https://www.youtube.com/watch?v=OYxJ5IoYjAk, “[YL9100 HPLC Maintenance] Slip-on Filter Replacement” posted on 6/23/2016. Accessed 3/25/2026), hereinafter “YoungIn”.
Regarding claim 1, YoungIn teaches a sample input interface device for inputting samples into a detecting unit of an in-vitro diagnostic analyzer, the sample input interface device comprising:
a sample input port (slip-on filter) comprising an outer input-port side (the bottom/larger cylinder side)(@13 sec.) configured for plugging-in an open end of a sample container (interpreted as a functional limitation. sample container is not positively recited. @2 sec., the filter is plugged in a bottle) and an inner input-port side (the top protrusion of the filter, where the tubing attached to tubing)(@11 sec.), and
an aspiration needle (tubing)(needle is interpreted as a slender hollow device used to introduce matter into or remove it from an object) unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port, the aspiration needle (The sample container is not positively recited; it is an article work upon, and “when” is interpreted as a conditional statement and is not further limiting the claimed structure. The aspiration needle meets the structural limitation of the intended use) comprising an upstream end (luer hub of the needle) comprising an upstream end (the end that attached to the filter, @11 sec) and a downstream end, wherein the downstream end is fluidically connected or connectable to the detecting unit (the detection unit is not positively recited; the tubing is connectable to a detection unit) and
wherein the upstream end is configured to alternately couple to the inner input-port side (the protrusion of the filter) in order to aspirate a sample from a sample container plugged in the outer input-port side and to a fluid supply port (another bottle) in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer (interpreted as an intended use. Neither the fluid supply unit nor the in-vitro diagnostic analyzer are positively recited. The tubing is structurally capable of being inserted/joined to another bottle with fluid and aspirate the fluid and alternately couple to the protrusion of the filter), and
wherein the outer input-port side (the bottom/larger cylinder side of the filter) is further configured to alternately couple to the fluid supply port (another bottle) while the upstream end of the aspiration needle is coupled to the inner input-port side (the filter attached to the tubing can be inserted/joined into the another bottle) in order to rinse the sample input port with fluid aspirated by the aspiration needle from the fluid supply unit via the sample input port (fluid is not positively recited. In the scenario where there is fluid in the another bottle, the filter is rinsed as the fluid aspirated by the needle).
Regarding claim 2, YoungIn teaches all of the elements of the current invention as stated above with respect to claim 1. YoungIn further teaches wherein the sample input port is rotatable at least between a sample input position and a fluid supply position (“sample input” and “fluid supply” are being interpreted as intended use. The filter can be rotated between two positions around an axis of rotation, wherein the distance between axis of rotation and each position is the length the tubing. One of the positions is destinated as the “sample input” position, which is above the opening of the bottle in the video. The other position is destinated as the “fluid supply” position, which is located at a position along the path or rotation, aligned with the opening of the another bottle, which is not part of the invention.
Regarding claim 3, YoungIn teaches all of the elements of the current invention as stated above with respect to claim 2. YoungIn further teaches wherein the aspiration needle is rotatable at least between the sample input position in which the upstream end of the aspiration needle is aligned with the inner input-port side when the sample input port is in the sample input position and the fluid supply position in which the upstream end of the aspiration needle is aligned with the fluid supply port (with one end of the tubing at the axis of rotation, the other end of the tubing rotates between the sample input position and be coupled to the filter, and the fluid supply position be aligned with the another bottle).
Regarding claim 4, YoungIn teaches all of the elements of the current invention as stated above with respect to claim 3. YoungIn further teaches wherein at least the upstream end of the aspiration needle is linearly movable along the longitudinal direction parallel to the length the aspiration needle in order to couple to and decouple from the inner input-port side and the fluid supply port respectively (@ 12 – 20 sec., the tubing is decoupled or removed from the filter along the longitudinal direction parallel to the length of the aspiration needle; @ 5 -6 sec, show tubing capable of linearly movable from a fluid supply, which is not positively recited) (see also 35 U.S.C. 112(b) above). .
Regarding claim 5, YoungIn teaches all of the elements of the current invention as stated above with respect to claim 4. YoungIn further wherein the sample input port is movable along the longitudinal direction of the aspiration needle together with, or independently from and relative to, the aspiration needle (the filter can move in the longitudinal direction of the tubing with or without the tubing; @ 5-6 sec. and 11-13 sec).
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.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over YoungIn Chromass Global (Nonpatent Literature, YouTube, https://www.youtube.com/watch?v=OYxJ5IoYjAk, “[YL9100 HPLC Maintenance] Slip-on Filter Replacement” posted on 6/23/2016. Accessed 3/25/2026) in view of Imai (WO 2022014666 A1)(References herein made with respect to the English equivalent found at US20230288382 A1).
Regarding claim 12, YoungIn teaches an in-vitro diagnostic analyzer comprising;
a chromatography system (it is a HPLC system based on the title),
a fluid supply unit (the bottle in the video);
a sample input interface device according to claim 1, comprising
a sample input port (filter) comprising an outer input-port side (the larger cylinder side) configured for plugging-in an open end of a sample container (interpreted as a functional limitation. sample container is not positively recited. @2 sec., the filter is couple of being plugged into a bottle) and an inner input-port side (the protrusion of the filter, where the tubing attached to tubing)(@13 sec.), and
an aspiration needle (tubing)(needle is interpreted as any of various slender hollow devices used to introduce matter into or remove it from an object) comprising an upstream end (the end that is connected to the filter @ 0:06) and a downstream end (the end that is connected to the HPLC), wherein the downstream end is fluidically connected or connectable to the HPLC (the tubing is connected or connectable to the HPLC) and
wherein the upstream end is configured to alternately couple (couple is interpreted as to join) to the inner input-port side (the protrusion of the filter) in order to aspirate a sample from the sample container plugged in the outer input-port side (interpreted as a functional limitation. The sample and the sample container are not positively recited. The sample container can be a bottle of the same kind as the bottle in the video, hereinafter “another bottle”. In the scenario when a sample is in the another bottle, the tubing is capable of aspirating the sample) and to a fluid supply port (the bottle in the video) in order to aspirate other fluid(s) from the fluid supply unit (the bottle in the video)(@ 0:06, the upstream end of the tubing is capable of being coupled to the bottle of video through cap of the bottle) of the in-vitro diagnostic analyzer (“fluid” is not positive. In the scenarios when there is fluid in the bottle in the video, the tubing inserted into the bottle is capably of aspirating the fluid), and
wherein the outer input-port side (the larger cylinder side of the filter) is further configured to alternately couple to the fluid supply port while the upstream end of the aspiration needle is coupled to the inner input-port side (the filter attached to the tubing in the bottle of the video) in order to rinse the sample input port with fluid aspirated by the aspiration needle from the fluid supply unit via the sample input port (fluid is not positively recited. In the scenario where there is fluid in the another container, the filter is rinsed as the fluid aspirated by the needle).
YoungIn does not provide details about the chromatography system and thus fails to teach the chromatography system comprises a detecting unit comprising a fluidic system with a sensoric path configured to detect an analyte in a sample, e and a pump positioned downstream of the positioned downstream of the detecting unit. In addition, YoungIn teaches the fluid supply unit comprises a single fluid supply reservoir (bottle) and thus fails to teach the fluid supply unit comprising a plurality of fluid supply reservoirs;
However, Imai teaches a chromatography system that comprises a detecting unit (UV-spectrophotometer) comprising a fluidic system with a sensoric path (the path the sample travels through which passes by the UV-spectrometer 12 and fluorometer 14 with has sensing elements)(Fig. 4) configured to detect an analyte in a sample (interpreted as a functional limitation. an analyte and sample are not positively recited. para. 0055, the detecting unit with UV-vis spectrometer 12 and fluorometer 14 is capable of detecting an analyte); and a pump (227) positioned downstream of the positioned downstream of the detecting unit (Fig. 4). Imai further teaches the chromatography system is connected to a fluid supply unit (130 +1 40) comprising a plurality of fluid supply reservoirs (reservoir for phosphate buffer and reservoir for water)(Fig. 4);
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the chromatography unit taught by the Youngln video with the chromatography system taught by Imai in order to the detail of a chromatography system with a reasonable expectation of success (Imai, abstract) (MPEP 2143)(I)(G). In addition, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid supply unit with a single solvent bottle taught by YoungIn with two solvent reservoir delivery units as taught by Imai in order to provide adequate types of solvent for the system to run properly with a reasonable expectation of success (Imai, para. 0033) (MPEP 2143)(I)(G).
The teachings of modified Youngln would yield the in-vitro diagnostic analyzer comprising a detecting unit comprising a fluidic system with a sensoric path configured to detect an analyte in a sample, and a pump (227 of Imai) positioned downstream of the positioned downstream of the detecting unit (Fig. 4 of Imai), and the fluid supply unit comprising a plurality of fluid supply reservoirs (two solvent reservoirs taught by Imai, Fig. 4 of Imai).
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber et al. (US 20030119177 A1) in view of Lobl (US 20060264897 A1).
Regarding claim 1, Gruber teaches a sample input interface device for inputting samples into a detecting unit of an in-vitro diagnostic analyzer, the sample input interface device comprising:
an aspiration needle (tubing 60 and needle 95)(needle is interpreted as a slender hollow instrument introducing material into or removing material from a body) unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port, the aspiration needle (The sample container is not positively recited; it is an article work upon, and “when” is interpreted as a conditional statement and is not further limiting the claimed structure. The aspiration needle meets the structural limitation of the intended use) comprising an upstream end (luer hub of the needle) comprising an upstream end (the end that is connected to syringe 95)(Fig. 1) and a downstream end (inserted into microchip 10 in Fig. 1), wherein the downstream end is fluidically connected or connectable to the detecting unit (the detecting unit is not positively recited. Fig. 1, downstream end connected to sample chip, which is a detecting unit).
Gruber teaches the use of a syringe (sample container) to introduce fluid such as a sample into the sample chip 10 (para. 0064). Gruber teaches the syringe is attached to tubing 60 which is connected needle 95a, which is penetrates through a seal and is inserted into sample chip 10 (para. 0064 and Fig. 1).
Gruber fails to teach the device comprising a sample input port comprising an outer input-port side configured for plugging-in an open end of the sample container (syringe) and an inner input-port side, and wherein the upstream end is configured to alternately couple to the inner input-port side in order to aspirate a sample from a sample container plugged in the outer input-port side and to a fluid supply port in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer, wherein the upstream end (of the aspiration needle) is configured to alternately couple to the inner input-port side in order to aspirate a sample from the sample container plugged in the outer input-port side and to a fluid supply port in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer, and wherein the outer input-port side is further configured to alternately couple to the fluid supply port while the upstream end of the aspiration needle is coupled to the inner input-port side in order to rinse the sample input port with fluid aspirated by the aspiration needle from the fluid supply unit via the sample input port.
However, Lobl teaching an apparatus for injecting/introducing fluid using a syringe and through tubing and a needle. Lobl further teaches a removable filter 16 and adaptor 33 to further ensure the fluid introduced is properly filtered.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Gruber to comprise a removable filter and an adaptor, wherein the filter and the adaptor can be removable attached to between the syringe 95 and tubing 60 of Gruber taught by Lobl in order to ensure the fluid introduced is property filter with a reasonable expectation of success (Lobl) (MPEP 2143)(I)(G).
The teachings of Gruber as modified with Lobl would yield a sample input port (filter with adaptor) comprising an outer input-port side (the side of the filter that is attached to the syringe) configured for plugging-in an open end of the sample container (syringe) and an inner input-port side (the side of the adaptor that is connected to the tubing/needle), and
wherein the upstream end is configured to alternately couple to the inner input-port side in order to aspirate a sample from a sample container plugged in the outer input-port side and to a fluid supply port in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer (interpreted as a functional limitation. the “sample container”, “fluid support port”, “fluid supply unit” and the invitro diagnostic analyzer are not positively recited. The upstream end of needle, which is tube 60, is capable of coupling to the sample port, which is the removable filter and adaptor in modified Gruber, or to another syringe of the same type of syringe 95 as shown in Fig. 1 of Gruber. Notes that since the fluid supply port is not positively recited, it can be another syringe),
and wherein the outer input-port side (filter) is further configured to alternately couple to the fluid supply port (another syringe of the same type of 95) while the upstream end of the aspiration needle is coupled to the inner input-port side (adaptor)(interpreted as a functional limitation. the filter is capable of coupling to another syringe of the same type of 95) in order to rinse the sample input port with fluid aspirated by the aspiration needle from the fluid supply unit via the sample input port (the fluid supply unit is not positively recited. In the scenario where the filter is coupled to another syringe and there is fluid in the syringe, the filter can be rinsed as the fluid travels from the syringe through the filter and adaptor to the needle).
Regarding claim 2, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 1. Modified further teaches wherein the sample input port is rotatable at least between a sample input position and a fluid supply position (“sample input” and “fluid supply” are being interpreted as intended use. The “sample input” position is where the filter is attached to the syringe is Fig. 1 with needle attached to it. The filter can be detached from the syringe rotated around the point where the end of 95a that is attached to the chip 12 (the axis of rotation). The distance between axis of rotation and each position is the length the needle attached to the filter. The another syringe is placed along the path the rotation path, such that the syringe’s outlet is aligned with Luer inlet of the filter.
Regarding claim 3, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Gruber teaches wherein the aspiration needle is rotatable at least between the sample input position in which the upstream end of the aspiration needle is aligned with the inner input-port side when the sample input port is in the sample input position and the fluid supply position in which the upstream end of the aspiration needle is aligned with the fluid supply port (the another syringe) (the pointy end of the needle at the axis of rotation, the end that is connected to syringe 95 is rotatable between the “sample input” position and be coupled to the filter when the filter is at the “sample input” position, and the “fluid supply” position be aligned with the another syringe.
Regarding to claim 4, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 3. Modified Gruber further wherein at least the upstream end of the aspiration needle is linearly movable along the longitudinal direction parallel to the length of the aspiration needle in order to couple to and decouple from the inner input-port side and the fluid supply port respectively(the needle is linearly movable along its long axis to be coupled and decoupled from the filter and the syringe) (see also 35 U.S.C. 112(b) above).
Regarding claim 5, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 4. Gruber further teaches wherein the sample input port is movable along the longitudinal direction of the aspiration needle together with, or independently from and relative to, the aspiration needle (the filter is movable with or without the needle in the longitudinal direction of the needle).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gruber (US 20030119177 A1) in view of Lobl (US 20060264897 A1) as applied to claim 1 and further in view of Thompson et al. (US 20030045789 A1).
Regarding claim 9, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Gruber teaches the out input-port side (filter) has female luer tip for connecting to syringe 15 (para. 0074), and thus Gruber fails to teach wherein the outer input-port side comprises cavity wall sections of different respective cross- section configured for plugging-in the open end of different respective sample containers, the sample containers including at least a capillary-like sample container and a syringe-like sample container.
However, Thompson teaches a syringe interface for attaching syringes of different sizes (para. 009). Thompson further teaches using a mount aperture of a plurality of retaining flanges, and each set of retaining flanges extends radially inwardly to create a unique aperture dimension for different syringes (para. 0010, Fig. 2B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the female luer tip of filter 16 taught by Gruber with a plurality of retaining flanges with aperture dimension for different syringes as taught by Thompson in order accommodate different type of sample containers with a reasonable expectation of success (Thompson Para. 10) (MPEP 2143)(I)(G).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber et al. (US 20030119177 A1) in view of Lobl (US 20060264897 A1) as applied to claim 1, further in view of Thompson et al. (US 20030045789 A1) as applied to claim 9, and further in view of Austin (US 5222948 A).
Regarding claim 10, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 9.
Modified Gruber does not teach wherein the outer input-port side comprises a vent for air to enter a syringe-like sample container plugged in the outer input-port side upon sample aspiration.
However, Austin teaches an injection port for syringe. Austin further teaches the port comprises venting means (groove 8) for venting the port chamber when a syringe is inserted (col. 5, ln. 6-8 and claim 9).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port taught by modified Gruber with a vent as is done in Austin in order to provide venting to the port when a syringe is inserted with a reasonable expectation of success. (Austin, col. 5, ln. 6-8 and claim 9) (MPEP 2143)(I)(G).
Regarding claim 11, modified Gruber teaches all of the elements of the current invention as stated above with respect to claim 10. Modified Gruber further teaches wherein the sample input port is rotatable to an intermediate position between a sample input position and a fluid supply position together with the aspiration needle (the filter attached to the needle is rotatable between three positions) and wherein the sample input port is movable along the longitudinal direction parallel to the length of the aspiration needle relative to the aspiration needle in the intermediate position (the filter can be pulled in the longitudinal direction of the aspiration needle to detach from the aspiration needle), in order for the upstream end of the aspiration needle to enter at least partially into the syringe-like sample container through the open end of the syringe-like sample container and for air entered through the vent to remain near the open end of the syringe-like sample container and away from the upstream end of the aspiration needle upon sample aspiration (interpreted as an intended use. The syringe-like sample container is not positively recited. The filter and aspiration needle meets structural limitation of the intended use).
Prior Art
Claims 6-8 are free of the prior art since the prior art neither teaches nor renders obvious all limitations of claim 6.
NZ exchange Programme (Nonpatent Literature, YouTube), YoungIn (Nonpatent Literature, YouTube) and Gruber et al. (US 20030119177 A1) in view of Lobl et al. (US 20060264897 A1) each teaches a sample input interface device comprising a sample input port comprising an outer input-port side…and an inner input-port side, and an aspiration needle comprising an upstream end and a downstream end… and wherein the upstream end is configured to alternately couple to the inner input-port side… and to a fluid supply port… and wherein the outer input-port side is further configured to alternately couple to the fluid supply port as discussed above.
However, none of the above prior arts disclose nor render obvious all limitations of claim 6, which recites “wherein each of the aspiration needle and the sample input port, directly or indirectly, are connected to a respective drive pin and are movable by driving the respective drive pin through a respective guiding slot by a respective rotatable arm, each rotatable arm comprising a driving slot through which the respective drive pin can slide upon rotation of the arm thereby driving the respective drive pin through the respective guiding slot.”
Furthermore, Mathur, as states in the Office Action of 09/19/2025, also teaches a sample input interface device comprises a sample input port (18) comprising an outer input-port side configured for plugging-in an open end of a sample container and an inner input-port side, and an aspiration needle (16a) comprising an upstream end and a downstream end. However, the sample input import (18) and (16a) are integrated and inseparable and thus the aspiration tube 16a cannot be alternatively coupled to a fluid port without being connected to the sample input port 18 as argued by the Applicant in the Remarks of 02/18/2026.
Therefore, the combination of features is considered to be free of the prior art.
Claims 7 and 8 are also considered free of the prior art because of their dependence on claim 6.
Response to Arguments
Applicant’s arguments, see page 8, filed 07/21/2026, with respect to the claim objections have been fully considered and are persuasive. Therefore, the objections of 04/21/2026 have been withdrawn.
Applicant’s arguments, see page 8, filed 07/21/2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejections of 04/21/2026 have been withdrawn.
Applicant’s arguments, see page 11-13, filed 2026, with respect to the rejections under 35 U.S.C. 102 based on NZ Exchange Programme have been fully considered and are not persuasive.
Applicant argues on pp. 11-12 that the recitations cited on the bottom of p. 11 to the top of p. 12 in the Remarks of 07/21/2026 should not be characterized as intended use because “capable of” may be broader than “configured to” in the claimed recitations "the upstream end is configured to" and "the outer input-port side is further configured to".
The examiner respectfully disagrees. It is first noted that the limitation “wherein the upstream end is configured to alternately couple to the inner input-port side … and to fluid supply port” is interpreted as a functional limitation (instead of intended use) and was given patentable weight accordingly (Remarks, p. 12, lines 1-2, “@3:06 and @3:33, the needle hub is capable of alternately coupling to a syringe or the filter”). Similarly, the limitation “wherein the outer input-port side is further configured to alternately couple to the fluid supply port while the upstream end of the aspiration needle is coupled to the inner input-port side“ is interpreted as a functional limitation (instead of intended use) and was given patentable weight accordingly (Remarks, p. 12, lines, 6-7, @3:19, the Luer inlet is capable of coupling to a syringe and the needle). The portions of the recitation “in order to aspirate a sample from the sample container plugged in the outer input-port side” and “in order to aspirate other fluid(s) from a fluid supply unit of the in-vitro diagnostic analyzer” are interpreted as intended use, which are appropriate because “a sample”, “sample container” and “fluid supply unit” “in-vitro diagnostic analyzer are not positively recited, and the “upstream end” and the “outer input-port side” cannot aspirate sample or fluid on their own, and thus the functions “in order to aspirate…” do not further limit the structure of the upstream end” or the “outer input-port side”.
Regarding the argument relating to “capable of” may be broader than “configured to” in the claimed recitations "the upstream end is configured to" and "the outer input-port side is further configured to", the examiner respectively disagrees. The structures of “luer hub of the needle” (upstream end) and the “the Luer inlet” (outer input-port side) are capable of performing the claimed function (alternately coupled to the recited components) as discussed. These are the same structures that enable the “upstream end” and the “outer input-port side” to be configured to alternately coupled to the recited components (the claimed functions). Since the Applicant does not specifically point out in what aspects the interpretation under “capable of” would broader than “configured to”, or how the “luer hub of the needle” (upstream end) and the “the Luer inlet” (outer input-port side) would structurally fails to meet the claimed functional limitations, this argument is unpersuasive. See MPEP 2114 (I) and (II).
Applicant’s arguments, see p. 12, para. 3, filed 07/21/2026, with respect to the support for the amendment have been fully considered and are not persuasive. The Applicant argues that support for the amendment can be found in FIG. 2 and para. [0081] of the published application (i.e., U.S. Pub. No. 2023/0051070 A1). The Applicant states that “the aspiration needle 30 directly contacts the inner input-port side 11 of the sample input port 10 such that the needle 30 is unaffixed to the sample containers 1, 2.”
The examiner respectfully disagrees. The fact that “aspiration needle 30 directly contacts the inner input-port side 11” does not necessitate that the needle 30 is unaffixed to the sample container 1. Fig. 2 clearly shows that the aspiration needle 30 is affixed (attached) to the sample container 1 through sample input port 10 when sample container 1 is plugged in the outer input-port side (11) of sample input port 10. Furthermore, the inset of Fig. 2 shows that needle 30 directly attached to container 1. The interpretation of two objects (aspiration needle 30 and sample container 1) can be affixed through an intermediary part (port 10) is consistent with the Applicant’s interpretation of “affixed” as the Applicant states on p. 12, para. 4 that “the needle is affixed to the syringe when the needle/syringe are attached to the filter, which is made clear by the Office Action's indication in the NZ Exchange Programme document that "@3:19 second - needle attached to filter which is attached to syringe.” See also the Claim Interpretation above. Para. 0081 of the published application (also the spec.) also does not provide support the amendment. Para. 0081 teaches the sample port 10 is configured the aspiration needle 30 on one end (12) and the sample container 1, 2 on another end (outer input-port side 11) and thus teaching the aspiration needle 30 is affixed to the sample container through port 10 when the sample container is plugged into the sample container 1, 2.
Therefore, this argument is unpersuasive.
The Applicant further argues on pp. 12-13 that NZ Exchange Programme fails to anticipate the amended claim because “the needle is affixed to the syringe when the needle/syringe are attached to the filter” (bottom of p. 112 of the Remarks) when “ the aspiration needle of amended claim 1 is unaffixed to the sample container when the sample container is plugged in the outer input-port side of the sample input port.”
The examiner respectfully disagrees. The sample container is not positively recited, and therefore, the new limitation does further structurally limit the claim. The needle meets the structural limitation of the intended use. Furthermore, @ 3:17, when the sample container (syringe) is plugged into the outer input-port side of the sample input port (filter), the needle is unaffixed.
Therefore, this argument is unpersuasive.
Applicant’s arguments, see pp. 13-15, filed 7/21/2026, with respect to the rejections under 35 U.S.C. 102 based on YoungIn have been fully considered and are not persuasive.
Applicant argues on p. 14, para. 2 , that the recitations cited on the bottom of p. 13 to the top of p. 11 in the Remarks of 07/21/2026 should not be characterized as intended use “[f]or reasons similar to those discussed above with regard to the 35 U.S.C. § 102 rejection of claims 1- 5 based on NZ Exchange Programme.”
The examiner respectfully disagrees based the reasons discussed above in response to the arguments relating to intended use for the 35 U.S.C. § 102 rejection of claims 1- 5 based on NZ Exchange Programme.
The Applicant further argues on pp. 14-15 that YoungIn fails to anticipate the amended claim because “when the slip-on filter [sample input port] is plugged into the bottle [sample container] …the tubing [needle] is affixed to the bottle [sample container] using the blue cap…” (bottom of p. 14 of the Remarks).
The examiner respectfully disagrees. The sample container is not positively recited, and therefore, the new limitation does further structurally limit the claim. The tubing meets the structural limitation of the intended use. Therefore, this argument is unpersuasive.
Applicant’s arguments, see pp. 15-17, filed 7/21/2026, with respect to the rejections under 35 U.S.C. 103 based on Gruber in view of Lobl have been fully considered and are not persuasive.
Applicant argues on p. 16, para. 2 , the rationale presented on pages 14 and 15 of the OA of 04/21/2026 for the rejection of claim 1 ‘appears to interpret the "configured to" language contained in claim 1 as meaning "capable of' and largely characterizes the features using that language as "intended use"” and the Applicant further states that “[f]or reasons similar to those discussed above with regards to the 35 U.S.C. § 102 rejections of claims 1-5, Applicant respectfully disagrees with the Office Action's characterization of the claimed recitations as "intended use.”
The examiner respectfully disagrees based the reasons discussed above in response to the arguments relating to intended use for the 35 U.S.C. § 102 rejection of claims 1- 5 based on NZ Exchange Programme.
The Applicant further argues on pp. 16-17, that the amended claim 1 is patentable over Gruber in view of Lobl on the basis that new limitation in the amended claim 1. The Applicant argues that “the amendment excludes the teaching of Gruber in which the tubing 60/needle 95a is affixed to the syringe 95,” and even with the “incorporate the filter 16 and the adaptor 33 taught by Lobl into Gruber as proposed by the Office Action, the tubing 60/needle 95a would nevertheless still be affixed to the syringe 95 despite that incorporation.”
The examiner respectfully disagrees. The sample container is not positively recited, and therefore, the new limitation does further structurally limit the claim. The tubing 60/needle 95a meets the structural limitation of the intended use. Therefore, this argument is unpersuasive.
Applicant’s arguments, see p. 17, filed 7/21/2026, with respect to the rejections of claims 9 -12 under 35 U.S.C. 103 have been fully considered and are not persuasive. The argues that claims 9-12 are patentable based on the patentability of amended claim 1. The arguments do not provide any specific supposed errors in the examiner's action. Since claim 1 is not patentable as discussed above, the arguments are unpersuasive.
Allowable subject matter has been withdrawn because of the amended claim 1 is currently rejected under 35 U.S.C. 112(a) as discussed above. Claims 6-8 are considered to be free of the prior art as discussed above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
