DETAILED ACTION
Applicant’s arguments, filed on 08/27/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 08/27/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 5, 7, 10-14, 16-17, 19, 22, 26-27, 36, 56-57, 59-60, and 62-67 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17 and 63 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 17, the claim recites the limitation “the tissue layer” in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it is being interpreted as referring to either the first or the second layer from claim 1.
Regarding claim 63, the claim recites the limitation “about one minute, or about 2 minutes, or about 3 minutes, or about 4 minutes, or about 5 minutes, or about 10 minutes” in lines 1-3. It is unclear what constitutes as “about” one minute, “about” 2 minutes, “about” 3 minutes, “about” 4 minutes, “about” 5 minutes, or “about” 10 minutes, and how long away from the stated times would still constitute as about the times. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as any time that could be considered close to the stated times.
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 (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 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.
Claims 1, 5, 10-13, 17, 19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Shao (EP 3219784) in further view of Akamatsu (JP 2009229214). Citations to JP 2009229214 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Shao teaches a sample collection pad (Abstract: “Devices, methods, and kits directed towards collecting and preparing cells using a separable sample collection layer may be configured to collect or treat cells from a liquid sample with mechanisms for easy transfer of the cells prior to analysis or imaging “; “the device may be disposed against an absorbent pad”) comprising: (a) a sample collection strip (Sample collection layer 230); and (b) a backing material (Fixed component 225).
However, Shao does not teach wherein the backing material has a larger surface area than the sample collecting strip and which is water soluble.
Akamatsu discloses a urine examination test paper. Specifically, Akamatsu teaches the backing material having a larger surface area than the sample collecting strip (Abstract: “a support part 10 for supporting the posture of the substrate sheet 4 so as not to bring the detection part 6 into contact with the inner wall surface of a toilet bowl when the urine examination test paper is installed on the inner wall surface of the toilet bowl”) and which is water soluble ([0017]: “The substrate sheet 4 is a sheet-like substrate made of a water-soluble material”). Shao and Akamatsu are analogous arts as they are both related to sample collection devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the backing material having a larger surface area than the sample collecting strip as Shao is silent on the size of the backing material in relation to the sample collection strip, and Akamatsu discloses a suitable size in an analogous device. Additionally, it would have been obvious to include the backing material being water soluble as it allows the backing material to be flushable, which can allow for easier disposal of the backing material.
The Shao/Akamatsu combination teaches said backing material comprising at least two layers, (i) a first layer and (ii) a second layer (Shao, [0030]: “The fixed component (225) may comprise one or more layers”; solid support 205 and first support layer 210), wherein the first layer is positioned between the second layer and the sample collection strip (Shao, Figs. 2A-2D) and wherein: the sample collection strip is removable from the backing material (Shao, [0030]: “a device for example the device depicted in FIG. 1, may be separated into two separable layers; a fixed component (225) and a separable sample collection layer (230) that may be separated from the fixed component along with sample components collected on the porous membrane”).
Regarding claim 5, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the first and the second layers are bound together by a water soluble adhesive (Shao, [0026]: “A first support layer or second support layer may comprise any combination of: backing, release agent and adhesive … . Adhesives may comprise any material, surface, or layer comprising a high surface energy coating that promotes adherence between two surfaces … . Synthetic adhesives may comprise … soluble silicates”).
Regarding claim 10, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the sample collection strip comprises a porous or fibrous material (Shao, Abstract: “The separable sample collection layer may comprise a porous membrane”).
Regarding claim 11, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the sample collection strip comprises vinyl, polyethylene(PP), polypropylene(PE), or polyethyleneterephthalate(PET) (Shao, [0026]: “a separable sample collection layer comprising a second support layer and a porous membrane … A first support layer or second support layer may comprise any combination of: backing, release agent and adhesive … Plastic films or plastic substrate may include polyethylene terephthalate (PET) … Synthetic adhesives may comprise vinyls”; [0025]: “Example materials may include … polyethylene, … polypropylene”).
Regarding claim 12, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the sample collection strip comprises a water-insoluble material that is non-reactive with the biological sample (Shao, [0026]: “a separable sample collection layer comprising a second support layer and a porous membrane … A first support layer or second support layer may comprise any combination of: backing, release agent and adhesive … Plastic films or plastic substrate may include polyethylene terephthalate (PET) … Synthetic adhesives may comprise vinyls”; [0025]: “Example materials may include … polyethylene, … polypropylene”).
Regarding claim 13, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the sample collection strip comprises more than one material layer (Shao, [0026]: “a separable sample collection layer comprising a second support layer and a porous membrane”).
Regarding claim 17, the Shao/Akamatsu combination teaches the pad of claim 1, wherein the sample collection strip comprises a removeable acrylic or silicone-based adhesive between the strip and the tissue layer (Shao, [0026]: “Synthetic adhesives may comprise … acrylics”).
Regarding claim 19, the Shao/Akamatsu combination teaches the pad of claim 1, wherein: the sample collection strip comprises a biological sample (Shao, [0060]: “A method of collecting and preparing cells may comprise applying biological sample to a separable sample collection layer”); and the biological sample comprises material from a wound, a saliva sample, a fecal sample, a urine sample, a mucous sample or a vaginal sample (Shao, [0031]: “In some instances the desirable component may comprise cells that have been selectively removed from a sample, for example a whole blood sample”).
Regarding claim 26, the Shao/Akamatsu combination teaches the pad of claim 1 wherein the backing material is 1, 2, 3, 4,5, 6, 7, 8, 9 or 10 layers (Shao, [0030]: “The fixed component (225) may comprise one or more layers”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of EDANA (“Flushability”) and INDA (“Flushability”).
Regarding claim 7, the Shao/Akamatsu combination teaches the pad of claim 1.
However, the Shao/Akamatsu combination does not teach wherein the first and the second layers conform with the European Disposables and Nonwovens Association (EDANA) and with the Association of the Nonwoven Fabrics Industry (INDA) guidelines for flushability.
EDANA and INDA disclose flushability guidelines for flushable materials. Specifically, EDANA and INDA disclose wherein flushable materials conform with the European Disposables and Nonwovens Association (EDANA) and with the Association of the Nonwoven Fabrics Industry (INDA) guidelines for flushability. Akamatsu, EDANA, and INDA are analogous arts as they are all related to water-soluble materials.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the first and second layers complying with the guidelines set forth by EDANA and INDA as EDANA and INDA discloses suitable guidelines for flushable materials, which ensures the materials are disposed of correctly.
Claims 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of Parsons (CN 102859358).
Regarding claim 14, the Shao/Akamatsu combination teaches the pad of claim 1.
However, the Shao/Akamatsu combination does not teach wherein the collection pad is sterile.
Parsons discloses a device for sampling biological material. Specifically, Parsons teaches wherein the collection pad is sterile ([0069]: “The device can be provided in aseptic packaging before use”). Shao, Akamatsu, and Parsons are analogous arts as they are all related to sample collection and testing devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sterile packaging from Parsons into the Shao/Akamatsu combination as it allows the combination to maintain sterility and ensure that it is clean and free of contaminants before use.
Regarding claim 22, the Shao/Akamatsu combination teaches the pad of claim 1.
However, the Shao/Akamatsu combination is silent on the packaging of the pad.
Parsons teaches wherein the pad is sealed in a packaging slip or pouch ([0069]: “The device can be provided in aseptic packaging before use”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the packaging from Parsons into the Shao/Akamatsu combination as the combination is silent on the packaging, and Parsons discloses a suitable packaging in an analogous device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of Horton (US 20160303562).
Regarding claim 16, the Shao/Akamatsu combination teaches the pad of claim 1.
However, the Shao/Akamatsu combination does not teach wherein the collection strip comprises a viral standard, or microbial standard, or parasite standard, or DNA standard or RNA standard.
Horton discloses devices for collecting and testing biological samples. Specifically, Horton teaches wherein the collection strip comprises a viral standard, or microbial standard, or parasite standard, or DNA standard or RNA standard ([0049]: “In this example a known microfluidic device is pre-programmed to function to recover nucleic acids from a biological sample and to amplify them for the purpose of electrophoretic separation of certain of the acids for identification purposes. Known PCR reagents (including polymerase, primers, dNTPs (deoxy-nucleotide-tri phosphates; these are deoxyribonucleotide monomers or single units of DNA which are used by a DNA polymerase as nucleotides to add to the DNA strand during the PCR reaction and replication) and standards (DNA standards to calibrate the reaction on the device)) are applied to a cellulose fibre support and dried according to known techniques”). Shao, Akamatsu, and Horton are analogous as they are all related to devices that collect and test biological samples.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the standards from Horton into the Shao/Akamatsu combination as it allows the combination to test for specific molecules, which allows for a more comprehensive and detailed analysis of the sample.
Claims 27 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of Naseri (US 20190099166).
Regarding claim 27, the Shao/Akamatsu combination teaches a kit comprising a pad according to claim 1.
The Shao/Akamatsu combination teaches transporting the sample after collection (Shao, [0015]: “The separable sample collection layer containing the sample may be adhered to one or more new surfaces for subsequent treatment or analysis”), however the Shao/Akamatsu combination is silent on what container it is transported to.
Naseri discloses a method of collecting and analyzing vaginal fluid. Specifically, Naseri teaches a kit comprising a sample storage container ([0092]: “The system also includes a lid 300 that engages with upper rim 210 of the cup to create a fluid-tight seal to store collected fluid and permit transport.”). Shao, Akamatsu, and Naseri are analogous arts as they all collect and analyze biological fluid.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sample storage container from Naseri into the Shao/Akamatsu combination as it allows for the biological samples to be stored and transported for further analysis.
Regarding claim 64, the Shao/Akamatsu/Naseri combination teaches the kit of claim 27.
However, the Shao/Akamatsu/Naseri combination does not teach wherein the sample storage container comprises a stabilization reagent.
Naseri teaches wherein the sample storage container comprises a stabilization reagent ([0093]: “The inner surface 203 of the fluid receptacle can be pre-coated with a substance that preserves the fluid sample or assists in its preparation for analysis. For example, the inner surface can be coated with, e.g., anticoagulants, preservatives, an antibiotic or other agent to prevent the growth of bacteria or other microorganisms or other chemicals which may be used for the diagnostic assay or to lyse cells, selected for the purpose of lengthening the durability and preserving the menstrual blood for transportation to a remote location for analysis. Exemplary additives include EDTA, sodium citrate, clot activators, such as heparin, lithium heparin, sodium heparin, ThinPrep, thrombin-based clot activators, K.sub.2EDTA, fluoride, oxalate or sodium polyanethol sulfonate, collagenase, PBS or other chemical preservatives or stabilizers.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the stabilization reagent from Naseri into the Shao/Akamatsu/Naseri combination as it allows the sample container to stabilize the sample, ensuring it can be stored and analyzed at a future time.
Claims 36, 56-57, 59, 65, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of Oei (WO 2020033496).
Regarding claim 36, the Shao/Akamatsu combination teaches a method of collecting a biological sample comprising: (a) obtaining a pad according to claim 1; and (b) contacting the sample collection strip of the pad to the biological material thereby collecting a biological sample (Shao, [0060]: “A method of collecting and preparing cells may comprise applying biological sample to a separable sample collection layer”).
However, the Shao/Akamatsu combination does not teach isolating DNA and/or RNA from the sample collection strip.
Oei discloses a device and method for performing tests on biological materials. Specifically, Oei teaches isolating DNA and/or RNA from sample collection strip ([0023]: “Further embodiments disclose the system, in which the extracted biological material is made available for genetic screening, including screening of nucleotides, DNA and mRNA”). Shao, Akamatsu, and Oei are analogous arts as they all involve performing tests on collected biological materials.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the step of isolating DNA from the sample collection strip from Oei into the method from the Shao/Akamatsu combination as it allows for further, more informative tests to be conducted. Isolating the DNA for testing can provide different results than just testing the biological samples received, and provides more information and a more comprehensive result to the user.
Regarding claim 56, the Shao/Akamatsu/Oei combination teaches the method of claim 36, further comprising analyzing the biological sample from the sample collection strip (Shao, [0015]: “The separable sample collection layer containing the sample may be adhered to one or more new surfaces for subsequent treatment or analysis”).
Regarding claim 57, the Shao/Akamatsu/Oei combination teaches the method of claim 56, further comprising analyzing the DNA and/or RNA from the sample collection strip (Oei, [0023]: “Further embodiments disclose the system, in which the extracted biological material is made available for genetic screening, including screening of nucleotides, DNA and mRNA”), wherein analyzing comprises sequencing, hybridization and/or polymerase chain reaction (PCR) (Oei, [0082]: “The genetic material would then be analyzed, e.g., screened for the presence or absence of one or many specific genes or gene fragments or DNA or mRNA sequences”).
Regarding claim 59, the Shao/Akamatsu/Oei combination teaches the method of claim 56.
However, the Shao/Akamatsu/Oei combination does not teach the method further comprising preparing a report with the results of the analysis.
Oei teaches the method further comprising preparing a report with the results of the analysis ([0088]: “the analytical device may conduct analyses including image analysis, displays medical information derived from the image analysis, in which the medical information is communicated through a network connection to a computer database. Further embodiments disclose the image analysis includes displaying diagnostic and treatment information, the image analysis includes linking by a network connection to information contained in computer databases including information from morphology, genetic screens, protein screens, or bio-molecules correlated to disease, the image analysis includes accessing computer code that enables the display of medical information, in which said medical information includes diagnostic or treatment information, the image analysis includes displaying additional metrics including 1) percent cells with expressed antibody that is indicative of a type of cancer and that would bind to a substrate and be made visible, and 2) genes that are correlated with that type of cancer, the image analysis includes displaying layered information, in which said layered information includes information regarding morphology, genes, or live cell responses.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the report from Oei into the method from the Shao/Akamatsu/Oei combination as it provides all the information collected from the tests to the user, allowing the user to know what was determined from the conducted tests.
Regarding claim 65, the Shao/Akamatsu/Oei combination teaches the method of claim 36, further comprising separating the sample collection strip from the backing material (Shao, [0022]: “the separable sample collection layer may be separated from the fixed component”).
Regarding claim 67, the Shao/Akamatsu/Oei combination teaches the method of claim 36, further comprising disposing of the backing material in a toilet (Akamatsu, [0026]: “Each component of the urine test strip 1 is made of a water-soluble material, and can be disposed of by flushing down a toilet after use”).
Claims 60 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu/Oei combination as applied to claim 56 above, and further in view of Whitney (US 8519125).
Regarding claim 60, the Shao/Akamatsu/Oei combination teaches the method of claim 56.
However, the Shao/Akamatsu/Oei combination does not teach wherein the analyzing comprises identifying constituent microbial contents in the sample, wherein the microbial contents in the sample comprise viruses, bacteria, fungi and/or parasites.
Whitney discloses a method for analyzing biological samples. Specifically, Whitney teaches wherein the analyzing comprises identifying constituent microbial contents in the sample, wherein the microbial contents in the sample comprise viruses, bacteria, fungi and/or parasites (Column 57, lines 17-27: “Non-limiting examples of such uses may include determining one or more enzyme activities, determining intermolecular binding interactions, detecting the presence of a specific polynucleotide or amino acid sequence or of an immunologically defined epitope or of a defined oligosaccharide structure, detection of particular viruses or of microbial cells or of animal cells (including human), determining particular metabolites or catabolites, etc., all of which can be accomplished using methodologies and conditions that are defined and known to those skilled in the relevant art, including suitable conditions that can be provided through contacting the sample with an appropriate activity buffer.”). Shao, Akamatsu, Oei, and Whitney are analogous arts as they all analyze biological samples.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis for microbial contents in the sample from Whitney into the method from the Shao/Akamatsu/Oei combination as it allows for more thorough analysis of the sample and can inform the user of any microbial contents in the samples which can point to other diseases, infections, or health conditions that the user may need to address.
Regarding claim 62, the Shao/Akamatsu/Oei/Whitney combination teaches the method of claim 60, comprising quantifying the microbial contents of the sample (Whitney, Column 20, line 59: “DNA recoveries determined by quantitative PCR”).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu combination as applied to claim 1 above, and further in view of Sangha (US 20160024559).
Regarding claim 63, the Shao/Akamatsu combination teaches the pad of claim 1.
However, the Shao/Akamatsu combination is silent on how long the layers take to dissolve.
Sangha discloses a specimen collection device. Specifically, Sangha teaches wherein the materials dissolve in water within about one minute, or about 2 minutes, or about 3 minutes, or about 4 minutes, or about 5 minutes, or about 10 minutes ([0015]: “The film formulation may dissolve in about 5 minutes upon contacting a wet sample”). Shao, Akamatsu, and Sangha are analogous arts as they are all related to sample collection devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the dissolving time from Sangha into the Shao/Akamatsu combination as the combination is silent on the dissolving time, and Sangha discloses a suitable dissolving time in an analogous device.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over the Shao/Akamatsu/Oei combination as applied to claim 36 above, and further in view of Naseri.
Regarding claim 66, the Shao/Akamatsu/Oei combination teaches the method of claim 36.
The Shao/Akamatsu/Oei combination teaches transporting the sample after collection (Shao, [0015]: “The separable sample collection layer containing the sample may be adhered to one or more new surfaces for subsequent treatment or analysis”), however the Shao/Akamatsu/Oei combination is silent on what container it is transported to.
Naseri teaches transferring the sample collection strip comprising the biological sample to a sample storage container ([0092]: “The system also includes a lid 300 that engages with upper rim 210 of the cup to create a fluid-tight seal to store collected fluid and permit transport.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sample storage container from Naseri into the Shao/Akamatsu/Oei combination as it allows for the biological samples to be stored and transported for further analysis.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1, 5, 7, 10-14, 16-17, 19, 22, 26-27, 36, 56-57, 59-60 and 62 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/E.K.M./Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791