Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Status
Claims 2-16 are pending.
Claim 2 has been amended.
Claims 1, 17-29, and 30-43 have been canceled.
Large IDS
Applicants filed fourteen IDSs with over 400 references in total. The large number of references submitted in this IDS permits a review based identical to that performed by a search of the broad field of information readily apparent to be pertinent to and compliant with the information provided therein as required by MPEP § 609.05(b). Accordingly applicant may wish to distinctly point out any material listed on the IDSs which is considered germane to the patentability of the instant invention that has not been uncovered by this level of review. A concise explanation of the relevance of each reference submitted but not applied may be submitted in response to this Official communication.
The five information disclosure statements filed on 1-8-2021 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The documents not considered are lined through on the information disclosure statements.
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim limitation “control mechanism configured to individually adjust one or more degrees of freedom of a molecule” in claim 2 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “mechanism” coupled with functional language “control/adjust one or more degrees of freedom of a molecule” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “mechanism” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 2 has/have been interpreted to cover any art-recognized structure capable of generating mechanical, hydrodynamic, or electromagnetic force to apply tension in light of the specification (Spec., para [0082], [0083], [0205], [0206]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
Claim 2-16 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et. al. (US 20110005932A1), in view of Prins et. al. (EP1751534A1), English translation.
Regarding claim 2, Jovanovich teaches “A system, comprising:” (Abstract, The invention provides a system that can process a raw biological sample, perform a biochemical reaction and provide an analysis readout.) “a fluidic chip comprising an inlet for receiving a biological sample; a device comprising an interface configured to receive the fluidic chip; (Abstract Fig 22, The invention provides a system that can process a raw biological sample, The system includes a disposable cartridge for performing analyte capture. The cartridge can comprise a fluidic manifold having macrofluidic chambers mated with microfluidic chips that route the liquids between chambers. The cartridge (1) mounted on a computer controlled apparatus (1000).); “and a control mechanism implemented in at least one of the fluidic chip and the device,” (Para [0022], a system comprising: (a) a disposable cartridge… and (e) a computerized control system configured to control the actuator assembly, the thermal cycler and the capillary electrophoresis assembly.)
However, Jovanovich specifies the capture can be controlled by adjusting the chemistry to select broader or narrower ranges of analytes within para [0153].
Jovanovich does not explicitly teach “wherein the control mechanism is configured to individually adjust one or more degrees of freedom of a molecule involved in a sequence of operations that occurs on the fluidic chip”.
Prins teaches (within the abstract, a device (10) for distinguishing a specific binding from a less specific binding between at least one magnetic nanoparticle (11) and a surface of another entity by applying a magnetic field and detecting a physical parameter relating to magnetic nanoparticle rotational or motional freedom while the magnetic nanoparticle (11) is attached to the surface) in addition to “wherein the control mechanism is configured to individually adjust one or more degrees of freedom of a molecule involved in a sequence of operations that occurs on the fluidic chip,” (Page 7, Due to the rotational degree of freedom, the magnetic particle labels in binding situations of Type 1 will be free to rotate, while the rotation of labels in bindings of Type 3 and 4 will be strongly hindered. In that way, distinguishing between a specific and a less specific binding may be improved.) Therefore, the ability of the device to having type 1 free to rotate and type 3 and 4 will be strongly hindered. This based on the degrees of freedom which teaches to one or more degrees of freedom of a molecule in addition to having both rotational or motional within the abstract.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins wherein the control mechanism is configured to individually adjust one or more degrees of freedom of a molecule. Doing so allows an interaction/reaction to be happen on a distinct part of a molecule which increases the effectiveness of the reaction/interaction.
Jovanovich further teaches to “the sequence of operations comprising: extracting one or more analytes from the biological sample;” (Abstract and Para [0020], the system includes a disposable cartridge for performing analyte capture. A system that fits within an enclosure of no more than 10 ft.sup.3, the system comprising: (a) a sample preparation module adapted to capture an analyte from a non-microfluidic volume on a capture particle and route the captured analyte through a microfluidic channel; and perform a biochemical reaction on the analyte in a non-microfluidic volume to produce a reaction product). Therefore, the capture of the analyte teaches to the one or more analyte extraction and the following performing a biochemical reaction teaches to the analyte coming from a biological nature. Further taught by Jovanovich “optionally amplifying the one or more analytes if the one or more analytes is a nucleic acid; detecting at least one member selected from the group consisting of: the one or more analytes and one or more amplification products of the one or more analytes.” (Claim 51 and Para [0005], providing a sample comprising a nucleic acid molecule to a sample chamber; and d) operating the system to amplify and detect at least one nucleic acid sequence in the sample. The present invention can be applied to nucleic acid amplification techniques and single molecule detection).
Regarding claim 3, modified Jovanovich teaches all of claim 2 as above but Jovanovich does not teach “wherein the one or more degrees of freedom comprises a rotational orientation of the molecule.”.
Prins teaches “wherein the one or more degrees of freedom comprises a rotational orientation of the molecule.” (Abstract and Page 7, already taught within claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins one or more degrees of freedom comprises a rotational orientation of the molecule. Doing allows the device to see the molecule from different angles which can increase the sensitivity of the detection needed.
Regarding claim 4, modified Jovanovich teaches all of claim 2 as above but Jovanovich does not teach “wherein the one or more degrees of freedom comprises a translational position of the molecule”.
Prins teaches “wherein the one or more degrees of freedom comprises a translational position of the molecule” (Page 23, magnetic field gradients may be applied. These will generate a translational force, e. g. to stretch biochemical bonds.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins one or more degrees of freedom comprises a translational position of the molecule. Doing allows the device to see the molecule in three dimensions which increase the versatility of the device and its uses coupled to the fluid chip.
Regarding claim 5, modified Jovanovich teaches all of claim 2 as above but Jovanovich does not teach “wherein the one or more degrees of freedom comprises a tension of the molecule.”.
Prins teaches “wherein the one or more degrees of freedom comprises a tension of the molecule.” The linker can be a nucleic-acid molecule which is mechanically stressed by a magnetically-applied stretching force or which is made to interact with enzymes from solution.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins wherein one or more degrees of freedom comprises a tension of the molecule. Doing allows the device to detect elasticity and stiffness, and repair of a molecule which adds an additional feature for the device to detect and makes the device more versatile.
Regarding claim 6, modified Jovanovich teaches all of claim 2 as above but Jovanovich does not teach “wherein the one or more degrees of freedom comprises a stress of the molecule.”
Prins teaches “wherein the one or more degrees of freedom comprises a stress of the molecule.” (Page 23, The linker can be a nucleic-acid molecule which is mechanically stressed by a magnetically-applied stretching force or which is made to interact with enzymes from solution.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins wherein the one or more degrees of freedom comprises a stress of the molecule. Doing allows the device to act like stresses within a subject and see how the molecule would react to the stress applied. This would assist in drug research and discoveries.
Regarding claim 7, modified Jovanovich teaches all of claim 2 as above, but Jovanovich does not teach “wherein the control mechanism is configured to adjust at least two degrees of freedom of the molecule”.
Prins teaches “wherein the control mechanism is configured to adjust at least two degrees of freedom of the molecule. “ (Abstract and Page 7, as already taught within claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins wherein the control mechanism is configured to adjust at least two degrees of freedom of the molecule. Doing allows the device to be more diverse in addition to allowing more flow control within the device.
Regarding claim 8, modified Jovanovich teaches all of claim 2 in addition to “wherein the molecule is a molecule of the one or more analytes extracted from the biological sample.” ( Para [0027], providing a sample comprising a nucleic acid molecule to a sample chamber).
Regarding claim 9, modified Jovanovich teaches all of claim 2 in addition to “wherein the molecule is a molecule of an amplification product of the one or more analytes.” (Paras [0025-0027], The producing comprises extracting the DNA from the at least one cell, amplifying the STR markers from the DNA, performing capillary electrophoresis on the amplified markers, detecting the amplified markers, and performing computer analysis on the detected amplified markers to identify the markers. Providing a sample comprising a nucleic acid molecule to a sample chamber; and (d) operating the system to amplify and detect at least one nucleic acid sequence in the sample. The method comprises amplifying and detecting a plurality of nucleic acid sequences in the sample.).
Regarding claim 10, modified Jovanovich teaches all of claim 2 above but does not teach “wherein the molecule is a reagent molecule involved in the sequence of operations.”.
Prins teaches “wherein the molecule is a reagent molecule involved in the sequence of operations.” (Page 2, Biosensors generally employ a surface 1 with specific capture molecules 2,3 and labels 4 to facilitate detection. This is illustrated in Fig. 1, which shows a biosensor surface 1 to which first capture molecules 2 are coupled. In the solution 5 targets 6 and labels 4 to which second capture molecules 3 are coupled are present.). Therefore, the capture molecule 4 with 5 and 6 in solution teaches to a reagent molecule.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate the teachings of Prins wherein the molecule is a reagent molecule involved in the sequence of operations. Doing allows the molecule to be within a reagent that can be more or less reactive within a channel. The reagent can be selected to enhance the reaction within the device.
Regarding claim 11, modified Jovanovich teaches all of claim 10 above but does not teach “wherein the reagent molecule is selected from the group consisting of an enzyme, a primer, and a nucleotide.” (Page 24, Also, an enzyme could cleave part of the linker molecule, thereby enhancing the rotational freedom of the particle.). Therefore, the molecule cleaved with an enzyme teaches to the reagent molecule.
However the claim required reagent molecule selected from a group consisting of an enzyme, a primer, and a nucleotide. Neither Jovanovich nor Prins teach directly to a group consisting of all three however teach to the reagent molecule with an enzyme. It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of modified Jovanovic by having the group consist of an enzyme, a primer, and a nucleotide, since Jovanovich teaches to a primer, enzyme, and nucleotide within Paras [0023, 0328, 0337, 0387, 0202] it would be an obvious choice in selecting a reagent molecule from a group consisting of all three as they all bring different attributes within the device.
Regarding claim 12, modified Jovanovich teaches all of claim 2 above in addition to, “wherein the control mechanism comprises: a reaction chamber; and an electromagnetic field source configured to expose the molecule to an electromagnetic field in the reaction chamber.” (Paras [0043], [0010], [0011], [0379], FIG. 6 shows a cartridge connected to reaction chamber and detector with downstream MOVe pumps and reagents. [0010]- For example, a microfluidic channel or a capillary can be used for chromatography or electrophoresis. B. STR reaction chambers in tubing. The devices and methods of the invention utilize immunomagnetic separations. Immunomagnetic separation (IMS) is a powerful technology that allows targets to be captured and concentrated in a single step using a mechanistically simplified format that employs paramagnetic beads and a magnetic field.
Regarding claim 13, modified Jovanovich teaches all of claim 12 above in addition to “wherein the control mechanism further comprises at least one of a substrate surface and a particle that bind the molecule.” (Para [0151], The capture agents generally comprise a solid substrate and are able to specifically or non-specifically bind analytes. The substrate can assert the binding force, or a molecule having binding properties can be attached to the substrate, for example, an antibody. The capture agent can be a particulate capture agent.).
Regarding claim 14, modified Jovanovich teaches all of claim 2 as above in addition to “wherein the control mechanism comprises: an arrangement of a plurality of fluid channels configured to at least one of transport and retain the molecule” (Para, [0027], a computerized control configured to control the actuator assembly, the thermal cycler and the capillary electrophoresis assembly; (b) moving of the reagent card into fluid communication with at least one set of fluidic chambers; (c) providing a sample comprising a nucleic acid molecule to a sample chamber).
However, Jovanovich does not specifically teach “and to direct a fluid to apply hydrodynamic stress to the molecule.”
Jovanovich does teach fluid containing the molecule that flows within the channels within para [0027]. This creates hydrodynamic stress on the molecule during the transport. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jovanovich to incorporate directing a fluid to apply hydrodynamic stress to the molecule because it is created when the fluid with the molecule flows within the channels. Doing allows the device to apply stress on the molecule which in turn affects the degree of freedom of the molecule. Directing the fluid and having the stress means the stress can be changed based on fluid flow which can be optimized to allow for the desired degrees of freedom needed.
Regarding claim 15, modified Jovanovich teaches all of claim 14 above in addition to Jovanovich teaching “wherein the control mechanism further comprises at least one of a substrate surface and a particle that bind the molecule. (Paras, [0150-0151]- A plurality of non-microfluidic chambers connected to each other through microfluidic channels. Fluid can be moved from one chamber to another by any appropriate motive force, for example, continuous pressure or non-continuous pressure (e.g., positive displacement pumps), electroosmotic flow or centrifugation. Pressure can be generated internally (e.g., with on-chip diaphragm valves) or externally. The channels can comprise directional control mechanisms to selectively route fluids between chambers as desired. The non-microfluidic chambers can comprise capture agents to bind analytes. The capture agents generally comprise a solid substrate and are able to specifically or non-specifically bind analytes. The substrate can assert the binding force, or a molecule having binding properties can be attached to the substrate.).
Regarding claim 16, modified Jovanovich teaches all of claim 2 above in addition to “wherein the control mechanism comprises:
substrate surfaces that bind the molecule and exert mechanical force on the molecule.” (within Claim 15 above).
Response to Claim Rejections - 35 USC § 112
Regarding the rejection under 35 USC 112(a), Applicant argues that the specification mentions examples of degrees of freedom. Applicant states that the example stretching of nucleic acid molecules discloses degrees of freedom to one skilled in the art. Examiner notes that Para [00207] within the specification does in fact recite “force to a nucleic acid or protein that tends to stretch or elongate the nucleic acid or protein” and this is sufficient discloser of degrees of freedom. Therefore the examiner has withdrawn the rejection under 35 USC 112(a).
Regarding Claim 2, a previous rejection under 35 USC 112(b) was applied to the recitation “control mechanism configured to individually adjust one or more degrees of freedom of a molecule”. Applicant states the specification has replete examples of “control mechanisms”. Examiner notes that the applicant provided what they consider a number of examples of mechanisms for fluid flow, first surfaces, second surfaces, surfaces, fluid flow channels, array of optical, electrical, magnetic manipulators, mechanical tension using fluid flow or electromagnetic field. Examiner has withdrawn the 112b rejection regarding “control mechanism”.
Applicant disagrees in the 112b rejection for claim 2 recitation “one or more amplification products". Applicant argues specification paragraphs including [0077] show the process of amplification yields an "increase in the number of nucleic acid template copies.". Examiner agrees and points out that the recitation within the specification states “the nucleic acid amplification control module 50 can comprise any of a suitable means for implementing nucleic acid amplification (i.e. increase in the number of nucleic acid template copies).” Which the one or more amplification products is an increase in nucleic acid template copies. Therefore, Examiner has withdrawn that 112b rejection.
Response to Arguments
Applicant's arguments filed 2/11/26 have been fully considered.
Applicant argues that the recitation “control mechanism configured to individually adjust one or more degrees of freedom of a molecule" should not be interpreted under 112f. However, applicant adopted the interpretation.
Applicant argues that it would not be obvious to introduce Prins detection methods into Jovanovich. Applicant argues “None of Jovanovich's detection methods involves labels binding to a surface for detection. Examiner points out that labels are not part of the claimed invention. Further examiner points out that it is obvious to introduce Prins within Jovanovich as Prins teaches a device which applies a magnetic field and detecting a physical parameter relating to magnetic nanoparticle rotational or motional freedom while the magnetic nanoparticle is attached to the surface and the present art has a electromagnetic field and particles degrees of freedom. Therefore Prins is analogous art to the current invention and examiner maintains that it was obvious to introduce Prins to teach the limitations of Jovanovich.
Applicant highlights the Office takes the position that magnetic or electric field source in Prins constitutes such a "control mechanism". However, the field source in Prins does not adjust one or more degrees of freedom of a molecule as recited in claim 2. Examiner highlights that the applicant has provided a number of examples of what they are using as a “control” mechanism” mechanism such as fluid flow, first surfaces, second surfaces, surfaces, fluid flow channels, array of optical, electrical, magnetic manipulators, mechanical tension using fluid flow or electromagnetic field. These examples are not a controller and therefore the recitation “wherein the control mechanism is configured to individually adjust one or more degrees of freedom of a molecule involved in a sequence of operations that occurs on the fluidic chip” is capability of the “control mechanism” as defined by the inventor. If the control mechanism is not a controller than Jovanovich discloses the positively claimed structural elements of the control mechanism as claimed, such control mechanism are said to be fully capable of the recited adaption in as much as recited and required herein. Further the recitation “the control mechanism is configured to individually adjust one or more degrees of freedom of a molecule involved in a sequence of operations that occurs on the fluidic chip” is taught within Prins page 7, the ability of the device to having type 1 free to rotate and type 3 and 4 will be strongly hindered. This based on the degrees of freedom which teaches to one or more degrees of freedom of a molecule in addition to having both rotational or motional within the abstract. This teaches adjustment of degrees of freedom. Applicant further argues Prins does not adjust the rotational state of the bound label, but merely cycles through all accessible states by causing the applied field to rotate continuously. Examiner highlights that “bound label” is not part of the claimed invention.
Applicant further argues there is no selectivity that occurs in Prins' method and therefore no adjustment of a molecular degree of freedom of a molecule. Examiner maintains the 103 art rejection and further notes “selectivity” is not part of the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights