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 Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
On Pages 8-10 of the Remarks, the Applicant asserts that the device described by Sundrehagen is not the same as the claimed device since Sundrehagen does not comprises at least two (2) membranes and instead discloses a nylon membrane used to filter non-agglutinated blood cells and a second absorbent membrane 37. The Applicant asserts that the filter of Sundrehagen is non-analogous to the first membrane of the instant invention as the size of the pores of said nylon filter (15, 20 or 30 pm; p. 66, 1. 22-27) cannot allow the extraction/retention of nucleic acids (too wide).
In response to this argument, the Examiner respectfully disagrees as the membrane of the instant invention is silent to a membrane pore size adapted to permit the extraction and retention of a target nucleic acid, and instead generally refers to the extraction and retention occurring in the presence of a reagent, see Page 18, Lines 27-30. Further, the invention of Sundrehagen teaches that the nylon mesh filter is used to allow for the retention and extraction of a target analyte, which a CD4 or CD8 marker, or a target cell marker in the Example, see Claim 3 and Page 86, Lines 18-35 in Sundrehagen. Because the cells are agglutinated prior to analysis in Sundrehagen, the invention is allowing the extraction/retention of target nucleic acids by targeting the sequences using the buffer to allow the pass through of the target analyte in the sample for downstream quantification, see Page 87, Lines 1-15. Additionally, a recitation of the intended use of the claimed invention (being capable of allowing the extraction and retention of nucleic acids from this biological sample in the presence of appropriate reagents) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
On Page 11 of the Remarks, Applicant’s arguments are found not persuasive in light of the Examiner’s statement above.
On Page 12 of the Remarks, the Applicant states that Sundrehagen’s device is not capable of any rotation or mechanical sequence, thereby enabling multiple processing steps to be carried out in succession, however the Examiner respectfully disagrees as the invention of Sundrehagen is rotatable so as to exact progressive movement of a sample through the device, see Page 48, Lines 21-35 and Page 82, Lines 7-22.
On Page 12, the Applicant also recites that Sundrehagen's device includes no nucleic-acid extraction or amplification means or step, and is therefore not applicable to molecular diagnostics, however, this has not been claimed by the invention and appears to be an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The Applicant states that “Sundrehagen's device is capable of performing a "physical" filtration of particles, not a "chemical" filtration, whereas the claimed invention performs a "chemical" filtration based on the reversible affinity of the upper membrane for nucleic acids.” In response to applicant, it is noted that the features upon which applicant relies (i.e., chemical filtration) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant further states that “Sundrehagen's device is not capable of performing any precise collection of a reaction volume: a flow simply passes through the system, whereas the claimed invention enables the precise uptake of a reaction volume while simultaneously collecting the captured nucleic acids.” In response to this argument, the examiner respectfully notes that the features upon which applicant relies (i.e., precise volume collection by any means) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further states “Sundrehagen does not mention anywhere in the text any explicit mention of the device using rotation of one disc relative to the other,” however, the top casing is rotated relative to the bottom casing to achieve different configurations, see Page 82, Lines 7-22.
In response to Applicant’s arguments regarding Whitesides and Bedingham not allowing for the programmed succession or rotation of the test device, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant's arguments on Pages 13-14 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Interpretation
The claims contain limitations which are directed to intended uses or capabilities of the claimed invention. These limitations are only given patentable weight to the extent which effects the structure of the claimed invention. Please see MPEP 2114. Note that functional limitations are emphasized in italics herein.
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.
Claims 51, 53-56, 58, 60, and 63-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sundrehagen (WO 2018/138139), cited by IDS dated 10/7/2022.
Regarding claim 51, Sundrehagen teaches a portable diagnostic device in the form of a cylindrical housing comprising two superimposed coaxial discs mounted for rotation with respect to each other and defining a closed volume (vertical flow assay device with discs 31 and 32 that enclose a volume, see Figs. 9-11, Pages 12-13):
an upper disc (upper casing element 31, see Figs. 9-11) comprising:
at least one receiving opening of a biological sample to be tested which is provided with a biologically compatible membrane (sample feed opening 33 that contains filter layer 43 that allows small biological particles to pass through and is therefore biologically compatible, see Fig. 11 and Page 49) and capable of allowing the extraction and retention of nucleic acids from this biological sample in the presence of appropriate reagents, and
at least one window which is able to receive an optical filter which can be positioned on said window in a removable manner (reading hole 35 that receives movable filter 40, see Fig. 9 and Page 82), said at least one receiving opening and said window being angularly spaced at an angle of at least 30° on centre (opening 33 and hole 35 are disposed at angle of 180°, or two 90° steps about the center, see Figs. 9-11 and Pages 81-82),
a lower disc (lower casing element 32, see Figs. 9-11) comprising:
an absorbent material capable of containing a volume of liquid (absorbent 37 that holds sample fluid, see Fig. 11 and Pages 81-82), and
at least one reaction zone comprising at least one biologically compatible pastille (membrane element 36 is constructed of nitrocellulose, a biologically compatible material, see Figs. 9 and 11 and Pages 81-82) capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in the abovementioned biological sample in the presence of appropriate reagents,
the receiving opening, the window, the absorbent material and the reaction zone form a detection unit such that, by rotation, the upper disc can successively from a first position (opening 33, hole 35 and absorbent material 37 all align and are rotatable to different alignments, see Fig. 11 and Pages 48-49), in which, for this detection unit its receiving opening is in line with its absorbent material so as to allow the extraction and retention of said nucleic acids, and its window is in line with its reaction zone (opening 33 aligns with absorbent 37 at with measurement hole 35 over membrane 36 where reaction occurs, see Fig. 11 and Page 49), at a second position in which, for this detection unit, its receiving opening is in line with its reaction zone and covers it in part or in full so as to allow the elution of the abovementioned nucleic acids, and to position itself, by a rotation, on the above-mentioned first position, so that, for this detection unit, its window is in line with its reaction zone, so as to allow the amplification and the detection of the above-mentioned at least one nucleic acid sequence of interest likely to be present in the biological sample (the device is rotatable to another position where the opening 33 is over the reaction membrane 36 to allow for the washing, or elution, of a target analyte, and to a further step for detection after washing, see Figs. 9 and 11 and Pages 49-50).
"Allowing the extraction and retention of nucleic acids from this biological sample in the presence of appropriate reagents" is a limitation with respect to an intended use of the biologically compatible membrane. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of Sundrehagen is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since the analogous filter membrane is capable of retaining biological material such as agglutinated particles created by the addition of a reagent.
“Allowing the amplification and the detection of the above-mentioned at least one nucleic acid sequence of interest likely to be present in the biological sample” is a limitation with respect to an intended use of the biologically compatible pastille of the reaction zone. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of Sundrehagen is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since the nitrocellulose membrane acting as the reaction zone contains a reagent that allows for the detection of a target analyte, see Pages 48-50, where the analyte is the specific sequence of CD4, see Pages 1-2.
Regarding claim 53, Sundrehagen teaches the diagnostic device according to claim 51, wherein the passage from said second position to said first position is made by a rotation opposite to that allowing the passage from said first position to said second position (the rotation of the device is only restricted by the arc 38 and engaging pin 39 and is therefore able to move backward, see Fig, 9-11 and Page 48).
Regarding claim 54, Sundrehagen teaches the diagnostic device according to claim 51, wherein the absorbent material is disposed in a receptacle which is positioned either on the upper surface of the lower disc or integrated into the mass of the latter (absorbent 37 is integrated into the mass of the lower disc 32, see Figs. 9-11 and Page 48).
Regarding claim 55, Sundrehagen teaches the diagnostic device according to claim 53, wherein said absorbent material is able to hold a volume of at least 1 mL (absorbent material has capacity high enough to absorb sample and reagents, see Page 34, where the total volume is 1.05mL, see Table 3 on Page 70).
Regarding claim 56, Sundrehagen teaches the diagnostic device according to claim 51, wherein the absorbent material is cotton flock and an absorbent material suitable for immuno-chromatographic testing (absorbent 37 comprises cotton linter material for chromatographic testing, see Page 82).
Regarding claim 58, Sundrehagen teaches the diagnostic device according to claim 51, wherein the at least one biologically compatible amplification pastille is of cellulose (membrane element 36 is constructed of nitrocellulose, a biologically compatible material, see Figs. 9 and 11 and Pages 81-82).
Regarding claim 60, Sundrehagen teaches the diagnostic device according to claim 51, wherein at least one reaction zone comprises at least one biologically compatible amplification pastille (nitrocellulose membrane 36), at least one containing lyophilized reagents capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in the above- mentioned biological sample (reagents are lyophilized and deposited on upper membrane 36, see Page 35, where the reagents are used to tag (amplify) signal of the cell containing the target sequence for detection, see Pages 81-82 and 87).
Regarding claim 63, Sundrehagen teaches the diagnostic device according to claim 51, the diameter to height ratio of the device being from 5 to 30 (the diameter of the device is 50mm and is 5mm thick, where the ratio is 10, see Page 81).
Regarding claim 64, Sundrehagen teaches the diagnostic device according to claim 51, wherein said rotations are guided by a system of groove(s) and pin(s) (device movement is guided by groove 38 and pin 39, see Figs. 9-11 and Pages 47-50).
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.
Claims 57 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Sundrehagen (WO 2018/138139).
Regarding claim 57, Sundrehagen teaches the diagnostic device according to claim 51, wherein the biologically compatible membrane capable of allowing the extraction and retention of nucleic acids (filter 43 with a grid of 10 to 50, preferably 12 to 40, in particular 15 to 30 μm, see Page 10), but does not explicitly teach that the filter is of a material selected from: cellulose, silica and glass fibre.
However, Sundrehagen teaches that the first filter can instead be constructed of glass or cellulose (first filter is constructed of cellulose, where there are a known limited number of functional alternatives to the system, see Page 10).
Before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of finding biologically compatible membranes with adequate filter sizing. There were a finite number of identified and predictable potential solutions to the recognized need or problem as evidenced by Sundrehagen teaching that the filter can be constructed of glass or cellulose instead of the nylon net. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try each of the known filter sizes to yield a system that filters larger cells from a bodily sample for a result reading that has less interference from extraneous particles in a sample. Further, because Sundrehagen teaches a limited number of alternative filter materials, one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success.
Regarding claim 65, Sundrehagen teaches the diagnostic device according to claim 51, but does not teach that the current embodiment of the device comprises at least two detection units which are distributed over the upper and lower discs in such a way that their respective receiving openings are located on the same arc of the upper disc.
However, another embodiment of Sundrehagen teaches a detection device wherein at least two detection units (3/4 and 3’/4’) which are distributed over the upper and lower discs in such a way that their respective receiving openings are located on the same arc of the upper disc (see Fig. 5 and Page 46).
Further, there were design incentives for implementing the claimed variation. Specifically, before the effective filing date of the claimed invention, there had been a recognized problem or need in the art to solve the problem of providing a singular testing device that allows for the testing of multiple analytes with adequate sample volume, see Page 57 of Sundrehagen. Therefore, the implementation of two detection areas on the same device would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention for the benefit of detecting the concentration of two different markers within the biological sample, see Page 57. Further, because Sundrehagen teaches the alternative embodiment as an acceptable form of the invention, one of ordinary skill in the art would have pursued the known potential solution with a reasonable expectation of success.
Claims 52, 59, 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Sundrehagen (WO 2018/138139), and further in view of Whitesides et al. (US 2013/0034869).
Regarding claim 52, Sundrehagen teaches the diagnostic device according to claim 51, wherein the lower disc (32) comprises at least one reaction zone (26), but does not teach that the zone comprises at least two independent, adjacent, biologically compatible pastilles capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in the abovementioned biological sample in the presence of appropriate reagents.
However, in the analogous art of vertical assays, Whitesides et al. teaches an assay device comprising at least two independent, adjacent, biologically compatible pastilles capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in the abovementioned biological sample in the presence of appropriate reagents (layer 33 is a layer of hydrophilic material with adjacent and independent hydrophilic test zones 41 containing colorants to amplify an analyte of interest, see Fig. 2 and [0035], where the material is a porous material including nitrocellulose, see [0014] and [0037]).
The modification of a vertical flow assay to include individual etched hydrophilic areas on cellulosic material was known in the prior art before the effective filing date of the instant application as evidenced by Whitesides et al. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the nitrocellulose membrane of Sundrehagen to include the separate test zones etched thereupon as shown by Whitesides et al. for the benefit of conducting simultaneous assays that enable the detection of the concentration of an analyte or multiple analytes, see [0008] in Whitesides et al. Further, modifying a cellulosic membrane to incorporate multiple areas for testing would have facilitated the expected result of detecting multiple analytes using a single planar member.
Regarding claim 59, modified Sundrehagen teaches the diagnostic device according to claim 52, wherein the at least two biologically compatible amplification pastilles are of a material selected from: glass fibre (whether or not containing an adjuvant binder) and cellulose (the test zones are constructed of nitrocellulose, see [0014] and [0037] in Whitesides et al.).
Regarding claim 61, Sundrehagen teaches the diagnostic device according to claim 51, wherein at least one reaction zone comprises lyophilized reagents capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in the above-mentioned biological sample (reagents are lyophilized and deposited on upper membrane 36, see Page 35, where the reagents are used to tag (amplify) signal of the cell containing the target sequence for detection, see Pages 81-82 and 87), but does not teach that the reaction zone comprises at least two biologically compatible, adjacent and independent amplification pastilles.
However, in the analogous art of vertical assays, Whitesides et al. teaches an assay device comprising at least two biologically compatible, adjacent and independent amplification pastilles (layer 33 is a layer of hydrophilic material with adjacent and independent hydrophilic test zones 41, where the material is a porous material including nitrocellulose, see [0014] and [0037]).
The modification of a vertical flow assay to include a plurality of individual etched hydrophilic areas on cellulosic material was known in the prior art before the effective filing date of the instant application as evidenced by Whitesides et al. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the nitrocellulose membrane of Sundrehagen to include the separate test zones etched thereupon as shown by Whitesides et al. for the benefit of conducting simultaneous assays that enable the detection of the concentration of an analyte or multiple analytes, see [0008] in Whitesides et al. Further, modifying a cellulosic membrane to incorporate multiple areas for testing would have facilitated the expected result of detecting multiple analytes using a single planar member.
Regarding claim 62, Sundrehagen teaches the diagnostic device according to claim 51, wherein said at least one reaction zone comprising lyophilized reagents capable of allowing the amplification and detection of at least one nucleic acid sequence of interest likely to be present in said biological sample (reagents are lyophilized and deposited on upper membrane 36, see Page 35, where the reagents are used to tag (amplify) signal of the cell containing the target sequence for detection, see Pages 81-82 and 87), but does not teach that the device comprises at least two adjacent and independent biologically compatible amplification pastilles, where the second pastille contains lyophilized reagents capable of allowing the amplification and detection of at least one other nucleic acid sequence of interest necessarily present in the biological sample to be tested.
However, in the analogous art of vertical assays, Whitesides et al. teaches an assay device comprising at least two biologically compatible, adjacent and independent amplification pastilles (layer 33 is a layer of hydrophilic material with adjacent and independent hydrophilic test zones 41 development reagents, one to amplify an analyte of interest in a sample, see Fig. 2 and [0035], where the material is a porous material including nitrocellulose, see [0014] and [0037]).
The modification of a vertical flow assay to include individual etched hydrophilic areas on cellulosic material including a signal-amplifying molecule for color detection was known in the prior art before the effective filing date of the instant application as evidenced by Whitesides et al. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the nitrocellulose membrane of Sundrehagen to include the separate test zones etched thereupon as shown by Whitesides et al. for the benefit of conducting simultaneous assays that enable the detection of the specific concentration of an analyte or multiple analytes, see [0008] in Whitesides et al. Further, modifying a cellulosic membrane to incorporate multiple areas for testing would have facilitated the expected result of detecting multiple analytes using a single planar member.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Sundrehagen (WO 2018/138139), further in view of Bedingham et al. (US 20080314895).
Regarding claim 66, Sundrehagen teaches the diagnostic device according to claim 51, further comprising at least one clamp capable of gripping said device and applying pressure to lock and clamp the upper disc to the lower disc, said pressure ensuring hermeticity and sealing of the device (latches 12 are on the interlocking portion of lower disc 32 to hold device together, see Fig. 4, Page 45, where the Figures are analogous, see Page 48), but doesn’t teach that the device additionally is equipped with a heating system capable of being positioned in line with the reaction zone(s) of the device avoiding the creation of a temperature gradient on the reaction zone(s) to be heated.
However, in the analogous art of circular devices for analyzing biological samples, Bedingham et al. teaches an analysis device with a lower casing (base plate 380) equipped with a heating system capable of being positioned in line with the reaction zone(s) of the device avoiding the creation of a temperature gradient on the reaction zone(s) to be heated (resistive heater in base plate 380 aligned underneath process chambers 350, analogous to reaction zones, see Fig. 9A-B and [0143]).
Examiner’s Note: the heating system is being treated as a general heating system not connected to the clamp as no support for the connection is given in the Specification.
Modifying a rotatable disk used for assays to include a resistive heater that aligns beneath a reaction area to allow for uniform heat distribution to promote a reaction was known in the art before the effective filing date of the instant invention, see [0143] in Bedingham et al. Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the lower plate of Sundrehagen to incorporate the resistive heaters as outlined by Bedingham et al. for the benefit of heating a zone to provide thermal control over a specific area on a sample platform, see [0143] in Bedingham et al. Further, the modification of the device of Sundrehagen to include the heater of Bedingham et al. would have yielded the predictable result of heating a sample at a specific area to produce a reaction therein.
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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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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