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 .
Detailed Action
Summary
This is the Non-Final Office Action based on application 17/435471 RCE response filed 06/24/2026.
Claims 1-8, 12-19, 22, & 26-27 have been examined and fully considered.
Claims 23-25 have been withdrawn.
Claims 9-11 & 20-21 are cancelled.
Claim 12 and those dependent therefrom have been amended 06/24/2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
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.
Claims 1-3, 12-14 & 22 are rejected under 35 U.S.C. 103 as being obvious over IDELEVICH in US 20180230508 in view of ERIKSSON in US 20190072539 and further in view of MARGRAF in US 20190046715.
With respect to Claims 1, 12, & 22, IDELEVICH teaches of a device/assembly (see Figure 1) for testing and treating body fluids in which the body fluid can be blood (so reads on the instant, “blood testing assembly”) (abstract, paragraphs 0001-0003), the device comprising:
A receptable 110,
A filter device 130, with filtering element 136 within it, which is controlled and can be rotated by operating element 140 (paragraphs 0046 & 0047) and
A cultivation device 150 (paragraph 0045).
The receptacle device, 110 contains blood as instantly claimed and has a port configured to transfer blood out of the receptacle, “opening,” (see paragraph 0045).
The overall 3 part device, 110,130, 150 reads on the instantly claimed, “blood testing assembly,” as claimed, with the receptacle as claimed being item 110 and the claimed “blood testing device,” being items 130 and 150 (paragraph 0046).
Item 130 of IDELEVICH--- the claimed blood testing device/not assembly comprises:
A housing constructed from fluid impermeable material (fluid is held in the container so is fluid impermeable);
The housing of 130 has a top wall (which can be considered the top of section 134 and constructed of rigid material), and a bottom wall (can be considered the bottom section/wall of 132 and constructed of rigid material);
It is noted that the housing for 130, in figure 1 is “tubular,” in shape and encompasses a “first cross sectional distance,” as claimed. It also has a top wall extended across a space encompassed by the first sidewall, and also of a bottom wall all being fixed together to define and interior space. It is noted that for item 130, the top wall is 134, the bottom wall can be considered the bottom of item 136, regardless of which way it is rotated, and the first sidewall of the housing can be considered to be the top part of 132--- so depending on wherein item 136 is in the stamping process/movement--- this defines what the interior space is at the time, and what can be considered to be a first sidewall of the . The analyzer connector part of item 132, and the second claimed sidewall (which is also shown as being tubular in shape and forming a bore/hole in center opening having a second cross sectional distance which is the same as the first cross sectional distance), of the analyzer connector (the bottom part of 132) can be considered to be the sidewall part of 130, below the filter element part 136, depending on where item 136 is in the stamping process.
An interior space, which is in fluid communication with the opening from 110 (the interior space of 134 is in fluid communication with port 138 and the opening in 110);
The housing of the filter device 130/ the instantly claimed blood testing device, has a connector to the receptacle—which reads on the instantly claimed “receptacle connector,” --- and it connects through a mechanism such as a Luer Lock connection system with or without a screw thread or even a hose (paragraph 0010, 0025, 0045-0048). Specifically—these paragraphs teach that the receptable 110/ the instantly claimed receptacle can be plugged together, with both then having corresponding matching connections, meaning item 130 on Figure 1 has a connector extending from it’s top wall as instantly claimed—which reads on the instantly claimed “receptacle connector.”
IDELEVICH further teaches that item 130 on Figure 1 is can also be connected to item 150 (the cultivation device, which can be an analyzer through broadest reasonable interpretation (BRI)), so the connection between 130 and 150 reads on a “analyzer connector,” through BRI, which extends from the bottom wall as instantly claimed. IDELVICH teaches that the cultivation device 150/analyzer and the filter device 130/blood testing device can be viewed as “modules,” of the device which can be coupled to one another (paragraph 0010). The filter element 136, from item 130 can detach from 130 and get stamped into place in item 150--- meaning the bottom of 130, connects to 150 to do the stamping through the bottom section of 130 to connect to 150, which reads on the claimed analyzer connector through broadest reasonable interpretation (paragraph 0047-0048).
IDELEVICH further teaches that the collection chamber/ blood testing device can be separated at an interface (of a plug in collection chamber) from the filter element (also part of the blood testing device as instantly claimed) and then the cultivation device can then be coupled at the same interface (so the blood testing device includes a further, “analyzer connector,” in addition to what is taught above (paragraph 0067).
Since the taught connectors are able to connect and separate, they are configured to allow gas to escape interior space and also prevent liquid from escaping the interior space.
IDELEVICH teaches that the blood testing device 130, contains a “separator element,” within the housing, which is the filter element 136 (paragraph 0046-0048).
The filter element 136, which reads on the instantly claimed “separator,” is “configured to receive blood having blood cells and plasma,” (paragraph 0025, 0061-0062), since the filter element can filter pathogenic particles like certain cell fractions or blood cell fractions such as stem cells from the body fluid/blood (paragraph 0007, 0062, 0067, 0072).
IDELEVICH further teaches that the receptacle and cultivation devices have transparent windows which allow the colored regions of the filter element to be viewed (paragraph 0082)--- reads on “optically transparent material that is configured to pass light bidirectionally from outside of the housing to the interior space, the light being in the visible part of an electromagnetic spectrum)—through broadest reasonable interpretation, since the window can be viewed from other parts of the device, it “extends outside the boundary of the analyzer connector.”
IDELEVICH does not call out that the separator/filter is configured for separation of blood cells from plasma specifically with a membrane. It is noted, that since not specific structure showing how it would be structurally “configured for,” this is claimed, this is read on just needing to be a capability.
ERIKSSON is used to remedy this. ERIKSSON teaches of an arrangement for collection and separation of a body fluid, e.g. whole blood, for purposes of analysis of a component, e.g. plasma, of a sample of the body fluid. It comprises means for receiving a body fluid, a filter arrangement (50) comprising a separation filter arrangement for separation of the component(s) to be analyzed and a detection filter in communication with the separation filter arrangement. The filter arrangement comprises a pre-filter (6) having a filter volume adapted to be capable to receive a volume of body fluid exceeding a volume of a sample to be analyzed, which comprises a first portion defining a sample zone volume arranged to form a sample zone and at least one second portion defining an excess removal zone volume, forming an excess fluid removal zone the volume of which exceeds said sample zone volume (abstract).
ERIKKSON further teaches of the arrangement having separation filters or separation membranes arranged to separate plasma from cellular components of whole blood. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the separation filters configured to separate blood cell components from plasma as is done in ERIKKSON in the method and device of IDELEVICH due to the advantage this offers in separating components without lysis (IDELEVICH, paragraph 0107). This is considered to me “positioned outside the boundary of the analyzer connector.”
For Claim 12, IDELEVICH also does not teach of the claimed second cross sectional distance where the side wall is being smaller than the first cross sectional distance for the tubular shape of the sidewalls of connecting parts.
MARGRAF is used to remedy this and teaches of a blood filtering device (Abstract), wherein the device has a top section with a first tubular sidewall with a first cross section (item 1 on Figure 1) and a second portion with a second sidewall and a second smaller cross section at the bottom (see the bottom portion of 1 and also 4 and 5 on Figure 1).
It would have been obvious to one of ordinary skill in the art have a second cross section smaller than a first cross section to allow for the advantage of the blood being compressed down to a size appropriate for sampling and testing (MARGRAF, As show in Figures 12 & 1-11 & paragraph 0123).
With respect to Claims 2 & 13, IDELEVICH teaches of the invention as shown above, but does not call out that the separator/filter is configured separation of blood cells from plasma specifically with a membrane.
ERIKKSON further teaches of the arrangement having separation filters or separation membranes arranged to separate plasma from cellular components of whole blood (paragraph 0107). See reason for combination from Claim 1.
With respect to Claim 3 & 14, IDELEVICH teaches of the invention as shown above, but does not call out that the separator/filter is configured separation of blood cells from plasma specifically with a membrane.
ERIKKSON further teaches of the arrangement having separation filters or separation membranes arranged to separate plasma from cellular components of whole blood (paragraph 0107), and any color or appearance of the membrane can be considered “predetermined color,” through broadest reasonable interpretation. ERIKKSON does not specifically call out wherein the plasma separating membrane is provided with a predetermined color so as to form a backdrop for the reagent. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to make so that the plasma separating membrane is provided with a predetermined color so as to form a backdrop for the reagent, since selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. The motivation for doing so would be providing a contrast and facilitating color assessment of plasma (ERIKKSON, paragraph 0112).
Claims 4-8, 15-19 & 26-27 are rejected under 35 U.S.C. 103 as being obvious over IDELEVICH in US 20180230508 in view of ERIKSSON in US 20190072539 further in view of KARLSSON in US 20130040333.
With respect to Claims 4, & 15 IDELEVICH and ERIKKSON teach of the claimed invention as shown above. They do not teach of multiple filters. KARLSSON is used to remedy this.
KARLSSON teaches a blood testing assembly/device (Abstract, the present invention relates to a device for visual detection of hemolysis in a whole blood sample), comprising:
a blood testing device (Abstract, the present invention relates to a device for visual detection of hemolysis in a whole blood sample), paragraph 0050-0051, 0053, 0055, 0057, 0061, 0066, 0077, Figures 1a-e;
a housing 30 constructed of a fluid impermeable material, the housing having an interior space;
a window 5 constructed of an optically transparent material-“transparent, resilient membrane 5--- can be read as a “window” that is configured to pass light bidirectionally from outside the housing to the interior space, and from the interior space to the outside of the housing, the light being in a visible part of an electromagnetic spectrum—“resilient membrane 5, …which allows for a user to visually observe the inside of the detection compartment 6” (paragraph 0057, 0077);
a separator 4 within the housing, the separator configured to receive blood 12 having cells and plasma, separate the blood cells from the plasma 12, and direct the plasma 12 to an inspection zone 6 within the interior space (paragraph 0051, 0022);
and a reagent within the inspection zone 6 and adjacent to the window so that the reagent is visible through the window, the reagent configured to change colors in the presence of hemoglobin within the plasma to provide an indication of a state of hemolysis of the blood (paragraph 0055, 0057, 0061, 0066, 0077).
KARLSSON teaches of the port and receptacle as shown ( in paragraphs 0050-0051 & Figures 1c-1d), though you cannot directly see the port in the figures clearly.
KARLSSON further teaches wherein the separator includes a first filter and a second filter that are adjacently disposed and overlapping (paragraph 0053, Between the separation device 4 and the detection compartment 6 there may be arranged a distribution surface 60 constituting the bottom portion of the detection compartment 6. The distribution surface 60 is preferably provided with passages (e.g. channels, openings, pores, slits or any other suitable passage type—this is a second filter) for allowing passage of plasma from the filter 4 and at the same time leading to a plasma distribution over the bottom of the detection compartment 6 so that the plasma to be examined is evenly distributed inside the chamber 6. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the second filter as done in KARLSSON in the method and device of IDELEVICH and ERIKKSON due to the advantage that it offers in giving an even plasma distribution will lead to safer assessment of hemolysis (KARLSSON, paragraph 0053).
The distribution surface 60 is preferably arranged to not allowing any passage of color (i.e. red color from filtered blood cells), and may for this reason for instance be formed by a non-transparent material which blocks any light from passing/shining through the body.; In this case distribution surface is second filter), one of the first filter and the second filter being a plasma separation membrane (paragraph 0053, Between the separation device 4 and the detection compartment 6 there may be arranged a distribution surface). Also see Claim 3- for the color of the filter.
With respect to Claims 5 & 16, IDELEVICH and ERIKKSON teach of the claimed invention as shown above. They do not teach of what is claimed in Claim 5. KARLSSON teaches, wherein the separator includes a first filter being the plasma separation membrane (paragraph 0016, separation member (e.g. a filter)), and a second filter stacked with the first filter (paragraph 0053, Between the separation device 4 and the detection compartment 6 there may be arranged a distribution surface.; Also, The distribution surface 60 is preferably arranged to not allowing any passage of color.; which clearly indicate that distribution is another filter), the second filter being between the first filter and the reagent (paragraph 0053, Between the separation device 4 and the detection compartment 6 there may be arranged a distribution surface; paragraph 0054, Preferably the side of the distribution surface 60 which is intended to face the detection compartment), and overlapping the reagent so as to form a backdrop for the reagent when the reagent is viewed through the window (paragraph 0054, Preferably the side of the distribution surface 60 which is intended to face the detection compartment. Paragraph 0054-0055 detection compartment 6 is arranged with chemical means for direct visual detection, meaning that a reagent/reagents may be deposited inside the detection compartment 6 which reacts with hemoglobin and produces a color for indicating if hemolysis has occurred and the claimed, “when is viewed through a window,” as what is claimed is a device and no “when,” is occuring).
With respect to Claims 6 & 17, IDELEVICH and ERIKKSON teach of the claimed invention as shown above. They do not teach of what is claimed in Claim 5. KARLSSON teaches the blood testing assembly of claim 1, further comprising a color palette, “color reference for comparison,” having a plurality of regions being a color of the reagent correlated to indicate a predetermined state of hemolysis of a blood sample (paragraph 0061). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the color palette of KARLSSON with the devices of IDELEVICH and ERIKKSON since it offers advantage in simplifying assessment of hemolysis the device may be provided with a color reference for comparison with the sample plasma, e.g. showing a cutoff color wherein if the plasma color is darker than the reference hemolysis can be suspected and vice versa), the color palette being on the housing (paragraph 0061) Such color reference may for instance be arranged next to the visible detection compartment on the top portion of the device).
With respect to Claims 7 & 18, See Claim 6 rejection. KARLSSON fails to explicitly disclose wherein the color palette is a sticker having a bonding material connecting a substrate to the housing, the color regions being supported by the substrate. KARLSSON discloses the claimed invention except for the specific arrangement and/or content of information set forth in the claims (KARLSSON teaches of the palette, and of having key with information on it, but does not teach of sticking it onto the device). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide any type of displayed/indicated information on the device as a sticker since such the sticker depends only on the intended use of the apparatus/system and the desired information to be displayed. The motivation for doing so would be to arrange a reference guide next to the visible detection compartment on the top portion of the device for comparison with the sample plasma for ease of use, e.g. showing a cutoff color wherein if the plasma color is darker than the reference hemolysis can be suspected and vice versa (KARLSSON, paragraph (0061)).
With respect to Claims 8 & 19, see Claim 6 rejection. KARLSSON fails to explicitly disclose wherein the color palette surrounds the vent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to wherein the color palette surrounds the vent, since rearranging parts of an invention involves only routine skill in the art. The motivation for doing so would be to simplify assessment of hemolysis device by providing a color reference for comparison with the sample plasma (KARLSSON, paragraph 0061).
With respect to Claims 26-27. IDELEVICH and ERIKKSON teach of the instant claims as shown above including a window. If it is unclear that they specifically call out a reagent that is visible and configured to change color in the presence of hemoglobin to indicate the state of hemolysis in the blood, KARLSSON is used to remedy this.
KARLSSON teaches of the device as shown above and further that the detection compartment has a chemical means/reagent inside it which reacts with hemoglobin to produce color change for indicating if hemolysis has occurred (paragraph 0055). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include a reagent as is done in KARLSSON in the devices of IDELEVICH and ERIKKSON due to the advantage this offers in indicating if hemolysis has occurred or not (KARLSSON, paragraph 0055).
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not teach of the instantly claimed receptable connector extending from the top wall of blood testing device and the analyzer connector extending from the bottom wall of blood testing device, as instantly claimed--- nor does it teach that the analyzer connector and receptacle connector are separate from each other--- as claimed for independent Claim 1 and the non-newly amended parts of Claim 12. The examiner disagrees.
The housing of the filter device 130 (with filtering element 136) of the instantly taught by IDELEVICH blood testing device, has a connector to the receptacle 110—which reads on the instantly claimed “receptacle connector,” --- and it connects through a mechanism such as a Luer Lock connection system with or without a screw thread or even a hose (paragraph 0010, 0025, 0045-0048). Specifically—these paragraphs teach that the receptable 110 connector part (luer lock) of the instantly claimed receptacle can be plugged together with that of the filter, with both then having corresponding matching connections, meaning item 130 (filter device) on Figure 1 has a connector extending from it’s top wall as instantly claimed—which reads on the instantly claimed “receptacle connector,” and which would be extending from the bottom wall of receptable 110.
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IDELEVICH further teaches that item 130 on Figure 1 is can also be connected to item 150 (the cultivation device, which can be an analyzer through broadest reasonable interpretation (BRI)), so the connection between 130 and 150 reads on a “analyzer connector,” through BRI, which extends from the bottom wall as instantly claimed. IDELVICH teaches that the cultivation device 150/analyzer and the filter device 130 blood testing device can be viewed as “modules,” of the device which can be coupled to one another (paragraph 0010). The filter element 136, from item 130 can detach from 130 and get stamped into place in item 150--- meaning the bottom of 130, connects to 150 to do the stamping through the bottom section of 130 to connect to 150, which reads on the claimed analyzer connector through broadest reasonable interpretation (paragraph 0047-0048). This reads on the instant claims 1 & the non-newly amended parts of Claim 12.
Further with respect to the above, applicant argues that item 136--- the filter element part of filter device 130 rotates to then be detached and stamped onto cultivation device 150, and that this means there is no analyzer connector of the overall device part 130, to item 150 and seemingly argues that only device part 136 connects at any time to 150. Applicant further argues that device part 134 does not then include a bottom wall or an analyzer connector extending from the bottom wall as claimed. With respect to this, the examiner thinks applicant has misunderstood what is rotating in device part 130. Applicant seems to think it is the whole device 130, instead it is just part 136. Therefore, the analyzer connector part of the claimed housing (item 132) does in fact “extend from a bottom wall,” still of the filter element 136 or the filter device 130, as claimed in claims 1 & 12.
With respect to Claim 12, it has been significantly amended. Also, a new reference was used, MARGRAF. Therefore, applicant should see how the prior art teaches of these claim amendments as shown above.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SINN in US 20180136194 teaches of a device for separation of the cellular components of whole blood, or other biological fluid, from plasma or serum can be achieved for assay analysis. A device for facilitating separation can include, for example, a capillary tube that accurately draws target blood volume, a pad that chemically interacts with red-blood cells, such that the red blood cells become chemically and/or physically trapped within pad material, a mechanism for plasma recovery from the pad upon diffusion or active mixing, and a dropper tip that facilitates dispensing the mixture onto a test device. The treatment of the cellular components can be performed prior to contact with a buffer solution, so release of the cellular components into the buffer solution is reduced or prevented. Additional filtration can be provided to filter any remaining cellular components in the mixture (abstract).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 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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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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