Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 2-4 and 23 are newly cancelled. Claims 73-74 are new claims.
Claims 1, 6-8, 11, 13-14, 21, 28, 30, 34-37 and 73-74 are pending and under examination.
The rejection of claim 21 under 35 U.S.C. 112(b) as being indefinite is withdrawn in light of the claim amendment deleting the phrase “substantially”.
The rejection of claims 2-4 and 23 under 35 U.S.C. 103 is withdrawn in light of the cancellation of those claims.
Priority
This application is a CON of PCT/US19/35036 filed on 5/31/2019 which claims benefit of 62/679,695 filed on 6/1/2018.
The effective filing date of the current application is 6/1/2018.
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.
New rejection necessitated by amendment: Claims 1, 6, 8, 21, 28, 30, 37 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101640378 B1, published July 18, 2016; previously cited) in view of Wardlaw et al. (US Patent No. 4,808,379 published on February 28, 1989; previously cited), Hershey et al. (WO 2018/161062 A1, published on September 7, 2018; previously cited), and Beknazarova et al. (“Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces”, International Journal of Environmental Research and Public Health, 2017, Vol. 14, Issue 6, article 624, 7 pages). As the original Kang reference is in Korean, an English translation is relied upon for support. The rejection of claims 21 and 37 are further evidenced by Deaconess Regional Laboratory (“Fecal Collection, Preservation and Transportation”, first accessed on 2/14/2025).
Regarding claim 1, Kang teaches a feces collecting unit which is formed of a water-soluble material melted or dissolved in water (English translation – abstract). Kang teaches that the present invention relates to a toilet paper used for collecting a stool sample for inspection (English translation p.1, last paragraph). Kang teaches that the feces collecting unit is formed of water-soluble paper made of carboxy methyl cellulose or water-soluble vinyl made of poly vinyl alcohol (English translation – abstract). Kang teaches the collection of only feces as a specimen to be used for fecal occult blood test for examining colorectal cancer (abstract).
Kang is silent on dissolving the dissolvable film including the biological sample in a solution. Kang does not teach wherein the collecting comprises using the dissolvable film as a subject would use toilet paper, wherein the solution is disposed in a sealable container, wherein the solution comprises a DNA preservative agent; extracting DNA from the biological sample and analyzing the microbiome population in the biological sample.
However, Wardlaw teaches a device for obtaining stool samples and detecting occult blood (title). Wardlaw teaches the device is used in the same way as toilet tissue to obtain a stool sample on a receptor sheet included in the device (abstract). Wardlaw teaches that once the sample has been gotten, the device can be hermetically sealed and returned to the physician’s office for analysis. Wardlaw teaches the device are adapted to be useable by a patient in the privacy of the home to obtain the stool sample in relatively controlled volumetric amounts (description column 1, lines 11-13).
Hershey teaches water-soluble adhesive tapes for collecting biological materials from target skin sites (description p.9, 3rd paragraph). Hershey teaches the collected adhesive tapes are stored in a reagent that maintains the stability and integrity of the biological materials to be analyzed and dissolves the water-soluble adhesive material of the adhesive tapes to release the adhered biological materials (description p.13, 1st full paragraph). Hershey teaches carefully placing strips in 1.5ml tubes and placing on ice (description p.32, step 5). Hershey teaches the water-soluble adhesive layer is attached to a solid substrate, and the solid substrate is a water-soluble solid substrate that is dissolvable in a similar condition as that of a water-soluble adhesive described above (description p.10, 1st paragraph).
Beknazarova teaches detecting Strongyloides spp. in human and non-human fecal samples (abstract). Beknazarova teaches one of the biggest challenges with PCR detection is DNA degradation during the postage time from rural and remote areas to the laboratory, and teaches the laboratory assessment and field validation of DESS (dimethyl sulfoxide, disodium EDTA, and saturated NaCl) preservation of Strongyloides spp. DNA in fecal samples (abstract). Beknazarova teaches that the method was validated by applying it to the field-collected canine feces and detecting Strongyloides spp. DNA using PCR (abstract). Beknazarova teaches that DESS were able to preserve Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days (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 further the invention of Kang to use the film taught by Kang in the same way as toilet tissue as taught by Wardlaw to obtain a stool sample. One of ordinary skill in the art would have been motivated to use the film of Kang in the same manner as toilet tissue as taught by Wardlaw, because Wardlaw teaches that the devices could be used by a patient in the privacy of the home to obtain the stool sample. One of ordinary skill in the art would have found it beneficial to be able to collect a controlled stool sample in the privacy of their home and return the sample to the physician’s office for analysis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the water soluble adhesive tapes of Hershey with the film taught by Kang used as toilet paper taught by Wardlaw and place the strips in tubes containing a solution as taught by Hershey, because Hershey teaches that storing the adhesive tapes in a reagent maintains the stability and integrity of the biological materials to be analyzed and dissolved the water soluble material of the adhesive tapes to release the adhered biological materials. Each of Kang, Wardlaw and Hershey teach the collection of biological samples for analysis. One of ordinary skill in the art would have found it beneficial to place the feces sample in a solution which could dissolve the toilet tissue and stabilize the sample for further analysis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Kang, Wardlaw and Hershey to use a solution containing a DNA preservative reagent as taught by Beknazarova to dissolve the dissolvable film after collecting the fecal sample. One of ordinary skill in the art would have been motivated to use a solution containing DESS because Beknazarova teaches that DESS was able to preserve the DNA in samples stored at room temperature for 56 days. One of ordinary skill in the art would have found it beneficial to use a DESS-containing solution to store samples for up to 8 weeks without degradation of sample DNA.
Regarding claims 6 and 8, Kang teaches that the feces collecting unit is formed of water-soluble paper (claim 6) made of carboxy methyl cellulose or water-soluble vinyl made of poly vinyl alcohol (claim 8) (English translation – abstract).
Regarding claims 21 and 37, Kang teaches that the water-soluble material is melted or dissolved in water (English translation p.3, 2nd paragraph).
Kang and Wardlaw are silent on whether the dissolvable film is substantially soluble in the solution below 37°C, and whether the sample is frozen or not prior to further processing.
Hershey teaches the water-soluble adhesive is dissolvable in water or in an aqueous buffer solution at a temperature of 4°C – 25°C (description p.9, 3rd paragraph). Hershey further teaches that collected adhesive tapes are stored at a temperature of 4°C – 10°C (description p.13, 1st full paragraph). Hershey teaches that where the adhesive tapes are collected for cell culturing, the adhesive tapes can be stored at room temperature (description p.13, 2nd paragraph).
As evidenced by Deaconess, stool samples are commonly kept at and/or transported at room temperature or refrigerated until analysis (see rows 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a material that is substantially soluble at a temperature between 4°C and 25°C as taught by Hershey because that is a common temperature range for storage for samples, as evidenced by Deaconess. One of ordinary skill in the art would reasonably expect that storing the dissolvable film between 4°C and 25°C would predictably result in a film that substantially dissolves because it was known in the art at the time of invention to store samples between 4°C and 25°C until analysis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to not freeze the sample prior to processing because Hershey teaches storing the sample at 4°C – 10°C, which is not freezing. One of ordinary skill in the art would reasonably expect that storing the sample at 4°C – 10°C would predictably result in a sample that is ready for further processing because it would remain in a liquid state, and it was known in the art at the time of invention that samples did not require freezing prior to further processing.
Regarding claim 28, Kang and Wardlaw do not teach wherein a volume of the sealable container is from 5mL to 150mL.
Hershey teaches 1.5ml tubes.
Beknazarova teaches plastic tubes containing 6mL of DESS solution, but is silent on the total volume of the tube.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the 1.5mL tubes taught by Hershey with the plastic tubes holding at least 6mL taught by Beknazarova. One of ordinary skill in the art would reasonably expect that replacing 1.5mL tubes taught by Hershey with plastic 6mL holding tubes taught by Beknazarova would predictably result in a biological sample on a dissolvable film in a sealable container because it would have amounted to a simple substitution of one known sealable container for another, and a standard stool sample collection tube with a volume of at least 6mL was known in the art at the time of invention.
Regarding claim 30, Kang, Wardlaw and Hershey do not teach wherein the stabilizing solution stabilizes the biological sample at room temperature for up to 15 days.
Beknazarova teaches that DESS were able to preserve Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days (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 the method of Kang, Wardlaw and Hershey to replace the aqueous buffer solution taught by Hershey with a stabilizing solution containing DESS taught by Beknazarova. One of ordinary skill in the art would have been motivated to do so because Beknazarova teaches that samples in DESS were able to preserve the Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days. One of ordinary skill in the art would have found it beneficial to be able to maintain samples at room temperature for up to 56 days.
Regarding claim 74, Kang is silent on dissolving the dissolvable film including the biological sample in a solution.
Wardlaw is silent on a solution disposed in a sealable container.
Hershey teaches the collected adhesive tapes are stored in a reagent that maintains the stability and integrity of the biological materials to be analyzed and dissolves the water-soluble adhesive material of the adhesive tapes to release the adhered biological materials (description p.13, 1st full paragraph).
Hershey is silent on what reagent is in the solution.
Beknazarova teaches the laboratory assessment and field validation of DESS (dimethyl sulfoxide, disodium EDTA, and saturated NaCl) preservation of Strongyloides spp. DNA in fecal samples (abstract). Beknazarova teaches that the method was validated by applying it to the field-collected canine feces and detecting Strongyloides spp. DNA using PCR (abstract). Beknazarova teaches that DESS were able to preserve Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days (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 combined the method of Kang, Wardlaw and Hershey to use a solution containing a DNA preservative reagent as taught by Beknazarova to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to use a solution containing DESS because Beknazarova teaches that DESS was able to preserve the DNA in samples stored at room temperature for 56 days. One of ordinary skill in the art would have found it beneficial to use a DESS-containing solution to store samples for up to 8 weeks without degradation of sample DNA.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101640378 B1, published July 18, 2016; previously cited) in view of Wardlaw et al. (US Patent No. 4,808,379 published on February 28, 1989; previously cited), Hershey et al. (WO 2018/161062 A1, published on September 7, 2018; previously cited), and Beknazarova et al. (“Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces”, International Journal of Environmental Research and Public Health, 2017, Vol. 14, Issue 6, article 624, 7 pages) as applied to claim 1 above, and further in view of Niwa et al. (WO 2018/043636 A1, published on March 8, 2018; previously cited). As the original Niwa reference is in Japanese, an English translation is relied upon for support.
The teachings of Kang, Wardlaw, Hershey and Beknazarova are discussed above.
Regarding claim 7, Kang, Wardlaw, Hershey and Beknazarova do not teach wherein the dissolvable film is ethanol soluble.
However, Niwa teaches a method of preparing a specimen for the extensive analysis of a resident skin bacterium and/or a substance (abstract). Niwa teaches the method is characterized by applying a solution containing a polyvinyl alcohol-type polymer onto skin to form a thin film and then removing and collecting the formed thin film (abstract). Niwa teaches the formed thin film is peeled off from the skin, and can be dissolved in ethanol (relevant to wherein the dissolvable film is ethanol soluble) (English translation p.5, 2nd paragraph from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the ethanol soluble dissolvable film taught by Niwa for the water soluble dissolvable film taught by Kang and Hershey, because it would have amounted to a simple substitution of one known dissolvable film for another. Each of Kang, Wardlaw, Hershey, Beknazarova and Niwa teach the collection of a biological sample. One of ordinary skill in the art would reasonably expect that substituting the ethanol soluble film of Niwa for the water soluble film of Kang and Hershey would predictably result in the collection of a biological sample on a dissolvable film, because it was known in the art at the time of invention that ethanol soluble films could be used to collect a biological sample.
Claims 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101640378 B1, published July 18, 2016; previously cited) in view of Wardlaw et al. (US Patent No. 4,808,379 published on February 28, 1989; previously cited), Hershey et al. (WO 2018/161062 A1, published on September 7, 2018; previously cited), and Beknazarova et al. (“Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces”, International Journal of Environmental Research and Public Health, 2017, Vol. 14, Issue 6, article 624, 7 pages) as applied to claim 1 above, and further in view of Aydin et al. (“Effect of different polyol-based plasticizers on thermal properties of polyvinyl alcohol:starch blends”, Carbohydrate Polymers, 2016, Vol. 136, pp.441-448; previously cited).
The teachings of Kang, Wardlaw, Hershey and Beknazarova are discussed above.
Regarding claims 11 and 13-14, Kang, Wardlaw, Hershey and Beknazarova do not teach wherein the dissolvable film comprises a combination of polyvinyl alcohol, a polymer compatibilizer, and a sugar alcohol plasticizer (claim 11); wherein the polymer compatibilizer comprises modified starch (claim 13), or wherein the dissolvable film comprises 10% to 30% by weight of a polymer compatibilizer and a sugar alcohol plasticizer (claim 14).
However, Aydin teaches the effect of different polyol-based plasticizers on polyvinyl alcohol (PVA):starch blends (relevant to claim 11) (title). Aydin teaches PVA:starch blends are processed into moldable thermoplastic materials in the presence of suitable plasticizers (p.442, 1st column - 1st paragraph). Aydin teaches polyol-based plasticizers including pentaerythritol, xylitol and D-mannitol (relevant to claim 11) (p.442, 1st column – last paragraph). Aydin teaches effective ways of improving the properties of PVA:starch blends include chemically modifying starch (relevant to claim 13) (p.442, 1st column – 5th paragraph). Aydin further teaches adding mannitol, pentaerythritol or xylitol in 15 wt% and 25wt% ratios (relevant to claim 14) (p.442, 2nd column – Table 1).
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 the film of Kang in view of Wardlaw and Hershey to replace the water-soluble film taught by Kang with the dissolvable film comprising PVA, modified starch and pentaerythritol/xylitol/mannitol taught by Aydin to arrive at the claimed invention. One of ordinary skill in the art would have reasonably expected that replacing the water-soluble PVA film of Kang with the PVA:starch film of Aydin would predictably result in a dissolvable film, because Aydin teaches PVA:starch films are biodegradable, and it was known in the art at the time of invention that biodegradable films could be made from a combination of PVA, modified starch, and mannitol/xylitol/pentaerythritol.
Claims 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101640378 B1, published July 18, 2016; previously cited) in view of Wardlaw et al. (US Patent No. 4,808,379 published on February 28, 1989; previously cited), Hershey et al. (WO 2018/161062 A1, published on September 7, 2018; previously cited), and Beknazarova et al. (“Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces”, International Journal of Environmental Research and Public Health, 2017, Vol. 14, Issue 6, article 624, 7 pages) as applied to claim 1 above, and further in view of Vogtmann et al. (“Comparison of Collection Methods for Fecal Samples in Microbiome Studies”, American Journal of Epidemiology, 2017, Vol. 185, No. 2, pp.115-123; available online Dec. 16, 2016; previously cited). The rejection of claim 35 is further evidenced by Deaconess Regional Laboratory (“Fecal Collection, Preservation and Transportation”, first accessed on 2/14/2025).
The teachings of Kang, Wardlaw, Hershey and Beknazarova are discussed above.
Regarding claims 34 and 36, Kang, Wardlaw, Hershey and Beknazarova do not teach transporting or delivering the sealable container comprising the solution and the biological sample to a laboratory (claim 34). Kang, Wardlaw, Hershey and Beknazarova do not teach wherein the sealable container is transported on dry ice (claim 36).
However, Vogtmann teaches the comparison of collection methods for fecal samples in microbiome studies (title). Vogtmann teaches volunteers provided fecal samples at the Mayo Clinic in Rochester, Minnesota (abstract). Vogtmann teaches 1-2 grams of feces was placed in a Sarstedt feces tube containing 2.5mL of RNAlater Stabilization Solution (4 aliquots) (relevant to the sealable container comprising the stabilizing solution and the biological sample) (p.116, 1st column – last paragraph). Vogtmann teaches 2 replicates of the RNAlater samples were frozen immediately at -80°C (day 0) (p.116, 2nd column – 1st paragraph). Vogtmann teaches that the samples were shipped on dry ice to the University of California, San Diego (La Jolla, California) (relevant to comprising transporting or delivering the sealable container comprising the stabilizing solution and the biological sample to a testing center for claim 34; relevant to wherein the sealable container is transported on dry ice for claim 36) (p.116, 2nd column – 2nd paragraph). Vogtmann further teaches the samples were processed for DNA extraction, polymerase chain reaction amplification, and amplicon preparation for sequencing (p.116, 2nd column – 4th paragraph).
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 the method of Kang, Wardlaw, Hershey and Beknazarova to deliver samples to a testing facility as taught by Vogtmann, because Vogtmann teaches collecting the biological sample (feces) in a clinic. One of ordinary skill in the art would reasonably expect that transporting the samples to a testing facility for processing would predictably result in a biological sample that can be processed for DNA extraction and amplicon preparation for sequencing, because Vogtmann teaches transporting samples from Mayo Clinic to the University of California San Diego, and it was known in the art at the time of invention that samples collected in a clinical facility could be transported to a testing facility for processes such as DNA extraction.
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 the method of Kang, Wardlaw, Hershey and Beknazarova to transport and deliver samples on dry ice as taught by Vogtmann. One of ordinary skill in the art would reasonably expect that transporting frozen samples on dry ice as taught by Vogtmann would predictably result in the delivery of frozen samples to a laboratory or testing center, because it was known in the art at the time of invention that dry ice could be used to keep frozen samples frozen while they were transported and delivered from Minnesota to California.
Regarding claim 35, Kang teaches that the water-soluble material is melted or dissolved in water (English translation p.3, 2nd paragraph).
Hershey teaches that where the adhesive tapes are collected for cell culturing, the adhesive tapes can be stored at room temperature (description p.13, 2nd paragraph).
As evidenced by Deaconess, stool samples are commonly kept at and/or transported at room temperature or in the refrigerated until analysis (see rows 1-3).
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 the method of Kang, Wardlaw and Hershey to transport and deliver samples at room temperature as taught by Hershey, because Hershey teaches that samples can be stored at room temperature, and as evidenced by Deaconess, it was known in the art at the time of invention that stool samples are stored at room temperature.
New rejection necessitated by amendment: Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101640378 B1, published July 18, 2016; previously cited) in view of Wardlaw et al. (US Patent No. 4,808,379 published on February 28, 1989; previously cited), Hershey et al. (WO 2018/161062 A1, published on September 7, 2018; previously cited), and Beknazarova et al. (“Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces”, International Journal of Environmental Research and Public Health, 2017, Vol. 14, Issue 6, article 624, 7 pages) as applied to claim 1 above, and further in view of Han et al. (“A novel affordable reagent for room temperature storage and transport of fecal samples for metagenomic analyses”, Microbiome, February 2018, Vol. 6, Article 43, 7 pages).
Regarding claim 73, Beknazarova teaches DESS (dimethyl sulfoxide, disodium EDTA, and saturated NaCl) preservation of Strongyloides spp. DNA in fecal samples (abstract). Beknazarova teaches that the method was validated by applying it to the field-collected canine feces and detecting Strongyloides spp. DNA using PCR (abstract).
Kang, Wardlaw, Hershey and Beknazarova do not teach wherein the DNA preservative reagent comprises N-octylpyridinium bromide.
However, Han teaches a novel affordable reagent for room temperature storage and transport of fecal samples for metagenomic analyses (title). Han teaches a N-octylpyridinium bromide-based fecal sample preservation method enabled preservation of the bacterial composition in fecal samples transported and stored at room temperature for up to at least 14 days (abstract). Han teaches DNA extraction from the samples (p.2, 2nd column – DNA extraction).
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 the method of Kang, Wardlaw, Hershey and Beknazarova to replace the DESS reagent taught by Beknazarova with N-octylpyridinium bromide taught by Han to arrive at the claimed invention. Each of Kang, Wardlaw, Hershey, Beknazarova and Han teach the preservation of biological samples. One of ordinary skill in the art would reasonably expect that replacing the known DNA preservative DESS with another known preservative N-octylpyridinium bromide would predictably result in a preserved biological sample whose DNA would be stable and extractable, because it would amount to a simple substitution of one known DNA preservative for another, and it was known in the art that both DESS and N-octylpyridinium could be used to stabilize DNA in fecal samples at room temperature for at least 14 days.
Response to Arguments
Applicant argues that claim 1 has ben amended to recite “wherein the solution comprises a DNA preservative reagent; (c) extracting DNA from the fecal sample; and (d) analyzing the microbiome population in the biological sample”, which is not obvious over the asserted combination of Kang, Wardlaw and Hershey for at least the reason that these references do not teach all the elements of claim 1 (See Remarks dated 8/8/25, p.7 top paragraph). Applicant argues that Kang does not teach, disclose or even suggest “extracting DNA from the fecal sample and analyzing the microbiome population in the biological sample”, and neither Wardlaw nor Hershey cure the deficiencies; the references do not teach extracting DNA from the sample and analyzing the microbiome population in the biological sample (See Remarks dated 8/8/25, p.7 2nd paragraph).
Applicant's arguments filed August 8, 2025 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claim(s) 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.
Applicant’s arguments are directed towards a new limitation that was not previously presented, and therefore was not addressed by the prior art rejections of record. As discussed in the rejection above, Kang teaches the use of a dissolvable film to collect a fecal sample. Wardlaw teaches collecting the fecal sample by using the sample collection device as one would use toilet paper, and Hershey further teaches methods of preserving a biological sample. Beknazarova teaches collecting fecal samples and storing them in a solution containing DESS, and further analyzing the samples using PCR to detect Strongyloides spp. DNA. The modification is based on collecting a biological sample using Kang and Wardlaw and placing the sample in a solution taught in the method of Hershey containing a DNA preservative agent DESS taught by Beknazarova. That is, the dissolvable film taught by Kang is used to collect a feces sample in the manner taught by Wardlaw on the surface of the film, then placed into sample tubes with a reagent that maintains the stability and integrity of the biological materials to be analyzed taught by Hershey and Beknazarova, and also dissolves the water-soluble material to release the biological materials as taught by Hershey, then analyzing the sample DNA using PCR as taught by Beknazarova. The instantly claimed method requires collecting a sample on a dissolvable film and dissolving the film in a solution disposed in a sealable container containing a DNA preservative reagent; extracting DNA from the sample and analyzing the microbiome population in the sample.
Applicant argues that claims 6-8, 11, 13-14, 21, 28, 30, 34-37 and 73-74 depend from and include all the elements of claim 1, and recite additional elements of particular advantage and utility; Kang, Wardlaw and Hershey do not meet all of the elements of claim 1, much less the unique combination of elements in claims 6-8, 11, 13-14, 21, 28, 30, 34-37 and 73-74 (See Remarks dated 8/8/25, p.7 2nd paragraph).
Applicant’s argument is not found persuasive for the same reasons stated above.
Conclusion
No claims are allowed.
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.
Correspondence
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657