DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of group I (claims 1-17) and species A (claim 4) in the reply filed on 1/23/2026 is acknowledged. The traversal is on the ground(s) that there would be no search burden to search group II (claims 18-20) and species B (claim 5). This is not found persuasive because groups I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). Further, Species B (claim 5) is independent and distinct from Species A (claim 4). The inventions/species have acquired a separate status in the art in view of their different classification; and/or the inventions/species require a different field of search. The
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/18/2022 and 4/3/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are pending with claims 1-4 and 6-17 are being examined and claims 5 and 18-20 are withdrawn.
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 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.
Claim(s) 1-4, 7-10, 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins et al (US 20180023124 A1; hereinafter “Collins”).
Regarding claim 1, Collins teaches a method of fabricating a target capture and sensor assembly (Collins; Abstract), the method comprising:
providing a fluid path (Collins; para [233]; provide channels to allow for capillary action), the fluid path comprising a target capture surface (Collins; para [233]; a 3-D flow channel array interrogation can be by confocal microscopy which images multiple slices of the channels in the direction of the z axis), wherein the target capture surface is provided with an anchor species thereon (Collins; para [240, 240] the substrate coated with avidin and/or streptavidin), the anchor species comprising a first functional group (Collins; para [250]; Collins teaches the immobilization of different oligonucleotides, and examiner notes that the substrate comprises the claimed functional group which will bind to the different oligonucleotides);
providing a target capture species to the target capture surface, wherein each target capture species comprises a target capture part with an affinity for a first target and further comprises a second functional group configured to react with the first functional group (Collins; para [26, 250]; Collins teaches that the plurality of oligonucleotides comprise labels to perform the required assay which is interpreted as the target capture part for the first target, the second functional group interpreted as the part of the oligonucleotide that binds to the anchor species on the substrate); and
exposing at least a portion of the target capture surface to photo radiation to cause a photo- initiated reaction between the first functional group and the second functional group to couple the target capture species to the anchor species so as to form a target capture surface with a target capture species thereon (Collins; para [255]; Polymers such as nucleic acids or polypeptides can also be synthesised in situ using photolithography and other masking techniques whereby probes are synthesised in a step-wise manner with incorporation of monomers at particular positions being controlled by means of masking techniques and photolabile reactants),
wherein the target capture and sensor assembly further comprise a sensing surface in the fluid path and wherein the target capture surface and the sensing surface are in fluid communication with one another (Collins; para [26, 272]; the biosensor would comprise a plurality of members, each member containing distinct molecules, such as probe sequences. Each member may then be specific for the detection of, for example, different pathogenic organisms; the examiner interprets the sensing surface as the end region of the assay). Specifically, Collins teaches a plurality of oligonucleotide regions that can detect different analytes. Thus, the target capture surface is the first set of oligonucleotides within the assay and the sensing surface is the final set of oligonucleotides within the assay.
Regarding claim 2, Collins teaches the method according to claim 1, wherein, prior to providing a target capture species to the target capture surface, the method includes providing the target capture surface with the anchor species thereon (Collins; para [240]; The plurality of probes can be attached to the substrate via a layer of intermediate molecules to which the plurality of probes bind…the substrate coated with avidin and/or streptavidin). The anchor species is interpreted as the coating on the substrate.
Regarding claim 3, Collins teaches the method according to claim 2, wherein the sensing surface is provided prior to providing the target capture surface the anchor species (Collins; para [214, 240]). Applicants do not specify which part of the sensing surface is provided prior to the target capture surface with the anchor species. As discussed above in claim 1, the examiner interprets the final region of the plurality of oligonucleotides as part of the sensing surface. The substrate is formed of one material, thus the substrate would be provided prior the anchor species being coated.
Regarding claim 5, Collins teaches the method according to claim 1, wherein the fluid path comprises a fluid channel and wherein the fluid channel comprises the target capture surface (Kapp; para [233]; provide channels to allow for capillary action since in certain embodiments this may be used to achieve the desired straightening of individual nucleic acid molecules).
Regarding claim 7, Collins teaches the method according to claim 1, wherein the target capture surface is provided with a second anchor species thereon, the second anchor species comprising a third functional group (Collins; para [26, 250]; Collins teaches that there are two or more regions comprising the plurality of oligonucleotides. Additionally, Collins teaches different coatings, which is interpreted as the second anchor species, which is bound to different oligonucleotides), and wherein the method further comprises:
providing a second target capture species to the target capture surface, wherein each second target capture species comprises a second target capture part with an affinity for a second target and further comprises a fourth functional group configured to react with the third functional group on the second anchor species (Collins; para [26, 250]; The examiner interprets the second target capture species to be the third set of oligonucleotides that is positioned between the first target capture species and the sensing surface); and
exposing at least a portion of the target capture surface to photo radiation to cause the third functional group on the anchor species on said portion of the target capture surface to react with the fourth functional group on the second target capture species so as to couple the anchor species to the second target capture species such that the target capture surface is provided with different target capture species thereon (Collins; para [255]; Polymers such as nucleic acids or polypeptides can also be synthesised in situ using photolithography and other masking techniques whereby probes are synthesised in a step-wise manner with incorporation of monomers at particular positions being controlled by means of masking techniques and photolabile reactants).
Regarding claim 8, Collins teaches the method according to claim 7, wherein: the target capture surface comprises first and second target capture sites; the first target capture site has the anchor species comprising the first functional group disposed thereon; and the second target capture site has the second anchor species comprising the third functional group disposed thereon, wherein the third functional group can be the same as or different to the first functional group (Collins; para [26, 250]; the plurality of oligonucleotides is discussed above in claim 1 and 7, Collins teaches different base coatings with different oligonucleotides discussed in paragraph 250).
Regarding claim 9, Collins teaches the method according to claim 7, wherein: at least one of the first functional group on the anchor species and the third functional group on the anchor species includes at least one of a thiol, alkene, alkyne, azide, tetrazole, isonitrile, tetrazine, syndone, azirine, enol, epoxide, isocyanate, hydrazone or oxime group, or at least one of the second functional group on the target and the fourth functional group on the target includes at least one of a thiol, alkene, alkyne, azide, tetrazole, isonitrile, tetrazine, syndone, azirine, enol, epoxide, isocyanate, hydrazone or oxime group (Collins; para [250]; Biotin-oligonucleotide complexed with Avidin, Strepatavidin or Neutravidin; SH-oligonucleotide covalently linked via a disulphide bond to a SH-surface; Amine-oligonucleotide covalently linked to an activated carboxylate or an aldehyde group; Phenylboronic acid (PBA)-oligonucleotide complexed with salicylhydroxamic acid (SHA)). The examiner notes that the functional groups are comprised by the various oligonucleotides.
Regarding claim 10, Collins teaches the method according to claim 1, wherein the target capture surface comprises the anchor species (Collins; para [26, 250]; the substrate coated with avidin and/or streptavidin). The anchor species is interpreted as the coating applied to the substrate.
Regarding claim 13, Collins teaches the method according to claim 1, wherein the fluid path comprises at least one wall that is at least partially transparent to photo radiation (Collins; para [240]; solid substrate (such as glass)), and exposing at least a portion of the target capture surface to photo radiation comprises directing photo radiation through the at least partially transparent wall (Collins; para [255]; Polymers such as nucleic acids or polypeptides can also be synthesised in situ using photolithography and other masking techniques whereby probes are synthesised in a step-wise manner with incorporation of monomers at particular positions being controlled by means of masking techniques and photolabile reactants).
Regarding claim 14, Collins teaches the method according to claim 1, wherein the target capture surface includes raised structures, the raised structures comprising anchor species thereon (Collins; para [27]; providing a solid support comprising a plurality of physically discrete elements, wherein said physically discrete elements are separated from one another by one or more raised regions or trenches; and immobilizing a plurality of target oligonucleotide molecules onto said plurality of physically discrete elements, wherein after said immobilizing, at least two of said plurality of physically discrete elements comprise only a single immobilized target oligonucleotide molecule per element).
Regarding claim 15, Collins teaches the method according to claim 1, wherein exposing at least a portion of the target capture surface to photo radiation comprises at least one of: positioning a photomask to direct photo radiation to a specific part of the target capture surface, projecting a pattern onto the surface using projection lithography, using a scanning laser, or using an array of addressable light-emitting diodes (Collins; para [27, 255]; providing a solid support comprising a plurality of physically discrete elements, wherein said physically discrete elements are separated from one another by one or more raised regions or trenches; and immobilizing a plurality of target oligonucleotide molecules onto said plurality of physically discrete elements…Polymers such as nucleic acids or polypeptides can also be synthesised in situ using photolithography and other masking techniques whereby probes are synthesised in a step-wise manner with incorporation of monomers at particular positions being controlled by means of masking techniques and photolabile reactants). Collins teaches that the substrate comprises patterned regions for the oligonucleotides to be binded to.
Regarding claim 16, Collins teaches the method according to claim 1, wherein the sensing surface comprises an anchor species comprising a fifth functional group (Collins; para [26, 240]; the substrate coated with avidin and/or streptavidin). Collins teaches that different oligonucleotides bind to different anchor species. Thus, the sensing surface comprises the anchor species based on the targeted analyte.
Regarding claim 17, Collins teaches the method according to claim 16, further comprising: providing an analyte capture species to the sensing surface, wherein each analyte capture species comprises an analyte capture part and a sixth functional group configured to react with the fifth functional group; and exposing at least a portion of the sensing surface to photo radiation so as to cause a photo- initiated reaction between the fifth functional group and the sixth functional group to thereby couple the analyte capture species to the anchor species on the sensing surface and form a sensing surface with an analyte capture species thereon (Collins para 26, 250, 255). As discussed above, Collins teaches two or more regions comprising different oligonucleotides for detecting different analytes. The final region/section of the array is interpreted as the sensing surface, thus Collins teaches the analyte capture species, the analyte capture part, the sixth function group which reacts with the fifth functional group.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Gunnerson et al (US 20170276673 A1; hereinafter “Gunnerson”).
Regarding claim 6, Collins teaches the method according to claim 5, with the fluid channel.
Collins does not teach wherein at least one of: the fluid channel is a circular channel, the fluid channel comprises at least one portion which is curved, the fluid channel is a spiral channel, or the fluid channel comprises at least one spiral portion.
However, Gunnerson teaches an analogous art of a sample collection device (Gunnerson; Abstract) comprising a fluid channel (Gunnerson; para [31]; Positioned within the body is a capillary channel 11 having dimensions sufficient to hold a desired amount of sample) wherein at least one of: the fluid channel is a circular channel, the fluid channel comprises at least one portion which is curved, the fluid channel is a spiral channel, or the fluid channel comprises at least one spiral portion (Gunnerson; para [31]; The capillary channel may have any cross-sectional shape, for example circular or substantially semi-circular (“U” shaped) cross-sections). It would have been obvious to one of having ordinary skill in the art before the effective filing date of the claimed invention to change the shape of the fluid channel of Collins to be circular, curved, or spiral as taught by Gunnerson, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is not significant to the function of the combination, MPEP 2144.04 (IV)(B). Further, one would have been motivated to select the fluidic channel with the circular, curved, or spiral shape for the purpose of holding/flowing the fluid sample through the channel (Gunnerson; para [31]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Weinrich (Preparation of Biomolecule Microstructures and Microarrays by Thiol-ene Photoimobilization, ChembioChem, 2010, 11, 235-247; hereinafter “Weinrich”; already of record on IDS filed 10/18/2022).
Regarding claim 11, Collins teaches the method according to claim 1, with the capture surface.
Collins does not teach wherein the target capture surface comprises a polymer comprising the anchor species.
However, Weinrich teaches an analogous art of photoimmobilization of biomolecules on a microarray (Weinrich; Abstract) comprising a target capture surface comprises a polymer comprising the anchor species (Weinrich; Scheme 2; page 236, col 1; photochemically triggered thiol-ene immobilization on solid supports). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the target surface of Collins to comprise the thiol-ene polymer as taught by Weinrich, because Weinrich teaches that the thiol-ene reaction provides the advantageous characteristic of photochemical approaches (Weinrich; Scheme 1; page 236, col 1). Further, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the anchor species of Collins to be a thiol-ene polymer as taught by Weinrich as this is a known and suitable substitution for surface modification in the art. One would have a reasonable expectation of success by substituting the streptavidin or biotin coating of Collins for the off stoichiometry thiol-ene polymer as taught by Weinrich, as Weinrich teaches this substitution is a known and suitable arrangement in the art (Weinrich; page 236). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 12, Collins teaches the method according to claim 11, wherein the polymer comprising the anchor species is an off stoichiometry thiol-ene polymer (Weinrich; Scheme 2; see claim 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759