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 with traverse of Group I in the reply filed on 6/24/2026 is acknowledged. With respect to Applicant’s traversal of the restriction requirement, Applicant’s arguments are based on the presently amended claims having a technical feature not taught by the references cited in the restriction requirement set forth in the office action mailed 5/1/2026. However, the restriction requirement was properly made with respect to the claims presented at the time of the previous office action (i.e., the claims as originally presented) and Applicant has not presented any arguments directed to the original claims. Also, even with respect to the newly amended claims, the amended claims do not make a contribution over the prior art (i.e., Groups I-IV still lack the same or corresponding special technical feature) because the groups do not make a contribution over the prior art, namely Therup as set forth below.
The requirement is still deemed proper and is therefore made FINAL.
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 1-21 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 recites “the cuvette is configured to transfer an entirety of the body fluid sample that is within the venting cavity to the sample analysis cavity.” However, the only place in the specification which discusses about entire volumes of body fluids is on page 7, lines 1-2 which discusses ensuring that the entire volume of body fluid remains in the sample analysis cavity after the centrifugal force has been removed” This is different than what is currently claimed in that the specification recites retaining all of the body fluid that is within the sample analysis chamber after centrifugal force has been removed which does not necessarily mean that all of the entire sample fluid transferred to the sample analysis cavity from the venting channel.
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.
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(s) 1-4, 6-17, 20 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over United States Application Publication No. 2009/0074620, hereinafter Therup.
Regarding claim 1, Therup teaches a cuvette (item 10) for body fluid analysis, the cuvette comprising: a sampling cavity (item 18) comprising a fluid inlet (the opening of item 18); a sample analysis cavity (item 22); and a venting cavity (item 20) in fluid connection with the sampling cavity and the sample analysis cavity (figure 1a), wherein the venting cavity has an outlet to an exterior of the cuvette (figure 2b), wherein the cuvette is configured to transfer, upon a centrifugal force being applied to the cuvette, a body fluid sample from the sampling cavity to the sample analysis cavity via the venting cavity (paragraph [0049]), wherein the sample analysis cavity is configured to provide a first capillary force (paragraph [0049]), wherein the first capillary force is higher than a second capillary force provided by the venting cavity (paragraph [0049]), wherein the sample analysis cavity is configured for separating and analyzing the body fluid sample (paragraph [0043]); and wherein the cuvette is configured to transfer an entirety of the body fluid sample that is within the venting cavity to the sample analysis cavity (intended use MPEP § 2114 (II) and is taught in paragraph [0049] and based upon applicant’s specification which defines “The entire volume can herein be seen as at least 90%, such as 95 %, 96%, 97%, 98%, 99%, or 100% of the volume of body fluid obtained by the sampling cavity” on page 7, lines 2-4).
If it is determined that Therup is not capable of transferring an entirety of the body fluid sample within the venting cavity to the sample analysis cavity and/or that a residue of the sample left in item 20 is not less than 10% as claimed, then Therup fails to teach this limitation.
However, Therup further teaches that item 22 may receive specific parts of the acquired sample which parts have been separated from the rest of the sample during centrifugation (paragraph [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum amount of residue of the sample to remain in item 20 to less than 10% (thereby transferring at least 90% of the sample based upon applicant’s specification on page 7, lines 2-4) which would allow for the specific parts of the sample to be separated from the rest of the sample (paragraph [0049]) (MPEP § 2144.05 (II)).
Regarding claim 2, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Therup and the apparatus of Therup is capable of transferring air from the sample analysis cavity to the exterior of the cuvette via the venting channel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Therup (see MPEP §2114).
Regarding claim 3, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Therup and the apparatus of Therup is capable of when the body fluid sample is introduced into the sampling cavity, air is transferred from the sample analysis cavity to the exterior of the cuvette via the venting channel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Therup (see MPEP §2114).
Regarding claim 4, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Therup and the apparatus of Therup is capable of preventing the body fluid sample from leaving the sample analysis cavity after the centrifugal force is removed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Therup (see MPEP §2114). Further this limitation is taught in paragraph [0049]).
Regarding claim 6, Therup teaches the sampling cavity is configured to provide a third capillary force, wherein the third capillary force is higher than the second capillary force provided by the venting cavity (paragraph [0047]).
Regarding claim 7, Therup teaches the sample analysis cavity has a substantially uniform elongated shape extending in a first direction from a first end to an opposing second end of the cuvette (figure 1a).
Regarding claim 8, Therup teaches the outlet of the venting cavity to the exterior of the cuvette is arranged at the first end of the cuvette (figure 1a).
Regarding claim 9, Therup teaches the cuvette has a first interface fluidly connecting the venting cavity with the sampling cavity, wherein the first interface is configured to allow the body fluid sample to flow through the first interface when a centrifugal force overcoming the third capillary force is applied to the cuvette (paragraph [0047]).
Regarding claim 10, Therup teaches the cuvette has a second interface fluidly connecting the venting cavity with the sample analysis cavity, wherein the second interface is configured to allow the body fluid sample to flow through the second interface (paragraph [0049]).
Regarding claim 11, Therup teaches the venting cavity has a larger cross section area than the sampling cavity and/or the sample analysis cavity in a plane perpendicular to a main plane of the cuvette (figure 1b).
Regarding claim 12, Therup teaches the cross section area of the venting cavity has a larger width and/or larger height than a cross section of the sampling cavity and/or the sample analysis cavity in the plane perpendicular to the main plane of the cuvette (figure 1b).
Regarding claim 13, Therup teaches the first interface and the second interface are arranged at an angle to each other (figure 1a).
Regarding claim 14, Therup teaches the cuvette consists of a single body member having inner walls defining the sampling cavity, the sample analysis cavity, and the venting cavity within the single body member (item 12 and paragraph [0044]).
Regarding claim 15, Therup teaches the single body member comprises a tip (figure 1a) and wherein the sampling cavity is arranged at the tip of the single body member (figure 1a).
Regarding claim 16, Therup teaches the sampling cavity is configured to slope towards the sample analysis cavity (figure 1a).
Regarding claim 17, Therup teaches wherein the sample analysis cavity is free of reagents (Therup only discusses reagents in item 26 and item 22 is not listed as having any reagents).
Regarding claim 20, Therup teaches the venting cavity has an opening through an outer side wall of the cuvette, said opening extending over an entire width of the venting cavity (figures 1a and 1b).
Regarding claim 21, Therup teaches the sampling cavity has an opening through an outer side wall of the cuvette, said opening extending over an entire width of the sampling cavity (figures 1a and 1b).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Therup.
Regarding claim 5, Therup teaches all limitations of claim 1; however, Therup fails to specifically disclose that the sampling cavity and the sample analysis cavity have equal volumes.
Therup further teaches that the inlet cavity has a well-defined sample volume so that the correct volume may always be acquired (paragraph [0048]) and that a well-defined sample volume will be drawn into item 22 (paragraph [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum volumes of the sampling cavity and sample analysis cavity such that they have equal volumes which would allow for the correct volume of sample to be obtained (MPEP § 2144.05 (II)).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Therup in view of United States Patent No. 5,385,846, hereinafter Kuhn.
Regarding claims 18 and 19, Therup teaches all limitations of claim 1; however, Therup fails to teach the cuvette comprises an indicator for indicating a hematocrit level of the body fluid sample and the indicator is arranged along an outer periphery of the sample analysis cavity.
Kuhn teaches a device for hematocrit determination which utilizes a reagent (indicator) (Kuhn, column 4, lines 53-56) which is impregnated inside of a chamber (Kuhn, column 4, lines 1-12) which would allow for the determination of a low hematocrit which indicates anemia and a high hematocrit indicates polycythemia (Kuhn, column 1, lines 12-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a reagent inside of the entirety of the cavity (thereby along an outer periphery) which indicates the amount hematocrit in a body fluid sample because it would allow for the determination of a low hematocrit which indicates anemia and a high hematocrit indicates polycythemia (Kuhn, column 1, lines 12-15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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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.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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