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 filed 03/10/2025.
Claims 1-8, 12-22 & 26-27 have been examined and fully considered.
Claims 23-25 have been withdrawn.
Claims 9-11 are cancelled.
Claims 26-27 are newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2025 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, & 20-22 are rejected under 35 U.S.C. 103 as being obvious over IDELEVICH in US 20180230508 in view of ERIKSSON in US 20190072539.
With respect to Claims 1, 12, & 20-22, IDELEVICH teaches of a device (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, 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 filter device, 130 reads on the instantly claimed, “blood testing device,” (paragraph 0046) and 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);
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 having a connector to the receptacle, “receptacle connector,” through a mechanism such as a Luer Lock connection system with or without a screw thread (paragraph 0010, 0025, 0045), and
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,” as instantly claimed (paragraph 0067).
Since both of these 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 separation of blood cells from plasma specifically with a membrane.
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 analysed 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 analysed, 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.”
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 with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
All the claims remain rejected.
Conclusion
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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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758