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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 140-150, 152-161-167, 169-172, 174-175, 178, and 180-183 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 7282181 by Hudak et al. (Hudak) in view of CN 110234277 by Dagmar (Dagmar).
It is noted that claims 140-157 are directed to a “system”, which does not clearly set forth the statutory category to which the invention belongs to. It has been determined that the claims are directed to an apparatus and the appropriate principles for interpreting claims for that particular category of invention have been applied.
Regarding limitations recited in the claims which are directed to a manner of operating disclosed liquid-specimen-sample processing system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). This applies to the following limitations: “configured to filter biological particulate from the liquid specimen sample when the liquid specimen sample is driven through the membrane filter” (claim 140); “configured to support the membrane filter” (claim 140); “partially insertable into the receptacle using the handle” (claim 140), “configured to physically disturb the membrane filter” (claim 140), “ so as to help release, from the membrane filter, the biological particulate trapped by the membrane filter” (claim 140), “configured to cut, tear, or macerate the membrane filter” (claim 141); “configured to scrape the membrane filter” (claim 142); “configured to agitate the membrane filter” (claim 143); “configured to agitate the membrane filter” (claim 144); “comprising a liquid medium contained within the receptacle, and wherein the one or more protrusions are configured to physically disturb the membrane filter, while still allowing contact of the liquid medium with the membrane filter, such that the released biological particulate is released into the liquid medium for subsequent testing” (claim 145); “the liquid medium comprises a transport medium” (claim 146); “the liquid medium comprises a lysing buffer” (claim 147); “the liquid medium comprises an extraction agent” (claim 148); “the liquid medium is selected from the group consisting of: a culture medium and a purification agent” (claim 149); “configured to test at least a portion of the liquid medium for the presence of the biological particulate released into the liquid medium” (claim 150); “configured to physically disturb the membrane filter upon rotation of the filter assembly while within the receptacle” (claim 152); “mechanically filter the biological particulate from the liquid specimen sample by size-based filtration when the liquid specimen sample is driven through the membrane filter” (claim 154); “configured to test for the presence of the biological particulate” (claim 155-156).
Claim 140. Hudak teaches A liquid-specimen-sample processing system for processing a liquid specimen sample, the system comprising: a filter assembly, which comprises: a filter, which is configured to filter biological particulate from the liquid specimen sample when the liquid specimen sample is driven through the filter (abstract; Figures 1-4, absorbent member 52, C3/L47 to C4/L58); and a handle, configured to support the filter (abstract; Figures 1-4, fluid collector 48, C3/L47 to C4/L58); and a receptacle, wherein the filter assembly and the receptacle are configured such that the filter assembly is partially insertable into the receptacle using the handle, such that at least a portion of the handle is outside the receptacle and the filter is disposed within the receptacle (abstract; Figures 1-4, collection vial 14, C3/L47 to C4/L58), and wherein an inner surface of the receptacle is shaped so as to define one or more protrusions, which are configured to physically disturb the filter, when the filter assembly is partially within the receptacle, so as to help release, from the filter, the biological particulate trapped by the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Hudak does not teach the filter is a membrane.
Dagmar teaches a liquid specimen sample processing system for processing body fluids including saliva. Dagmar teaches testing the body fluids. Dagmar teaches the device comprises an adsorbent material and can include a gel, bed, membrane, or matrix comprising a polymer based. It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate a membrane, as taught by Dagmar, in the system of Hudak as membranes are known adsorbent materials used in sampling body fluids.
Claim 141. Hudak teaches the one or more protrusions are configured to cut, tear, or macerate the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 142. Hudak teaches the one or more protrusions are configured to scrape the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 143. Hudak the one or more protrusions are configured to agitate the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 144. Hudak teaches the receptacle is cylindrical (abstract; Figures 1-4, collection vial 14, C3/L47 to C4/L58).
Claim 150. Hudak teaches a testing machine configured to test at least a portion of the liquid medium for the presence of the biological particulate released into the liquid medium (Figure 6, test cad 92; C4/L59-65).
Claim 153. Hudak teaches one or more protrusions are shaped as one or more of the shapes selected from the group consisting of: one or more ridges, bristles, spikes, and bumps (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 155. Hudak an immunoassay configured to test for the presence of the biological particulate (C4/L58-65).
Claim 157. Hudak the inner surface is an inner surface of a side wall of the receptacle (abstract; Figures 1-4, collection vial 14, C3/L47 to C4/L58). Hudak does not explicitly teach the protrusions are disposed along the side wall it would have been obvious to one having ordinary skill in the art at the time the invention was made to place protrusions on the side wall, in
rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167. One of ordinary skill in the art at the time the invention was effectively filed would be motivated to include protrusions in various spots on the device in order to enhance expulsion of the sample.
Claim 158. Hudak teaches a method for processing a liquid specimen sample, the method comprising: driving the liquid specimen sample through a filter of a filter assembly, so as to filter biological particulate from the liquid specimen sample (abstract; Figures 1-4, absorbent member 52, C3/L47 to C4/L58), the filter assembly further including a handle that supports the filter (abstract; Figures 1-4, fluid collector 48, C3/L47 to C4/L58); and after filtering the liquid specimen sample, partially inserting the filter assembly into a receptacle using the handle, such that at least a portion of the handle is outside the receptacle and the filter is disposed within the receptacle (abstract; Figures 1-4, C3/L47 to C4/L58), wherein an inner surface of the receptacle is shaped so as to define one or more protrusions, which are configured to physically disturb the filter, when the filter assembly is partially within the receptacle, so as to help release, from the filter, the biological particulate trapped by the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Hudak does not teach the filter is a membrane.
Dagmar teaches a liquid specimen sample processing system for processing body fluids including saliva. Dagmar teaches testing the body fluids. Dagmar teaches the device comprises an adsorbent material and can include a gel, bed, membrane, or matrix comprising a polymer based. It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate a membrane, as taught by Dagmar, in the system of Hudak as membranes are known adsorbent materials used in sampling body fluids.
Claim 159. Hudak teaches the one or more protrusions are configured to cut, tear, or macerate the filter, when the filter assembly is partially within the receptacle (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 160. Hudak teaches the one or more protrusions are configured to scrape the filter, when the filter assembly is partially within the receptacle (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 161. Hudak teaches the one or more protrusions are configured to agitate the filter, when the filter assembly is partially within the receptacle (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 162. Hudak teaches the limitations as noted above. Hudak does not teach rotating the filter assembly while within the receptacle and that the method includes rotating the filter assembly while within the receptacle.
It would be obvious to one of ordinary skill in the art to physically disturb the filter upon rotation in order to disturb the biological particulate in order to achieve higher concentrations in the liquid medium for testing purposes.
Claim 163. Hudak teaches the receptacle is cylindrical (abstract; Figures 1-4, collection vial 14, C3/L47 to C4/L58).
Claim 164. Hudak teaches the one or more protrusions are configured to physically disturb the filter during insertion of the filter assembly into the receptacle, and wherein partially inserting the filter assembly into the receptacle includes physically disturbing the filter while partially inserting the filter assembly into the receptacle (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 165. Hudak teaches the one or more protrusions are shaped as one or more of the shapes selected from the group consisting of: one or more ridges, bristles, spikes, and bumps (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 166. Hudak teaches partially inserting the filter assembly into the receptacle comprises partially inserting the filter assembly into the receptacle while the receptacle contains a liquid medium, and wherein the one or more protrusions are configured to physically disturb the filter, while still allowing contact of the liquid medium with the filter, such that the released biological particulate is released into the liquid medium for subsequent testing (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 167. Hudak teaches the liquid medium comprises a transport medium (abstract; Figures 1-4, C3/L47 to C4/L58).
Claim 169. Hudak teaches the liquid medium comprises an extraction agent (abstract; Figures 1-4, C3/L47 to C4/L58).
Claim 170. Hudak teaches the liquid medium is selected from the group consisting of: a culture medium and a purification agent (abstract; Figures 1-4, C3/L47 to C4/L58).
Claim 171. Hudak teaches after the one or more protrusions physically disturb the filter, testing for the presence of the biological particulate trapped by the filter and subsequently released into the liquid medium, wherein testing for the presence of the biological particulate comprises transferring at least a portion of the liquid medium into a testing machine (Figure 6, test cad 92; C4/L59-65).
Claim 172. Hudak teaches the liquid medium is selected from the group consisting of: a transport medium, a stabilizing agent, and an extraction agent (abstract; Figures 1-4, C3/L47 to C4/L58).
Claim 174. Hudak teaches after the one or more protrusions physically disturb the filter, testing for the presence of the biological particulate trapped by the filter (Figure 6, test cad 92; C4/L59-65).
Claim 175. Hudak teaches testing for the presence of the biological particulate comprises using an immunoassay (C4/L58-65).
Claim 178. Hudak teaches the limitations as noted above. Hudak does not teach testing for the presence of the biological particulate comprises inserting the filter into a testing machine.
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to insert the filter into a testing machine in order to fully analyze the data. One of ordinary skill in the art would be motivated to test the material in a testing machine in order to accommodate system requirements.
Claim 180. Hudak teaches the liquid specimen sample is a non-centrifuged liquid specimen sample, and wherein driving comprises driving the non- centrifuged liquid specimen sample through the filter (abstract; Figures 1-4, ribbed base 26, C3/L47 to C4/L58).
Claim 181. Hudak teaches the inner surface is an inner surface of a side wall of the receptacle (abstract; Figures 1-4, collection vial 14, C3/L47 to C4/L58). Hudak does not explicitly teach the protrusions are disposed along the side wall it would have been obvious to one having ordinary skill in the art at the time the invention was made to place protrusions on the side wall, in
rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167. One of ordinary skill in the art at the time the invention was effectively filed would be motivated to include protrusions in various spots on the device in order to enhance expulsion of the sample.
Claim 182. Dagmar teaches the membrane filter is a PES membrane filter.
Claim 183. Dagmar teaches the membrane filter comprises a PES membrane.
Claims 151, 168, 173, 176, and 179 rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 7282181 by Hudak et al. (Hudak) in view of in view of CN 110234277 by Dagmar (Dagmar), as noted above, in view of U.S. Patent Publication No. 2015/0133574 by Kshirsagar et al. (Kshirsagar).
Claim 151, 173, and 179. Hudak teaches the limitations as noted above. Hudak teaches the testing machine is a chromatographic immunoassay device (C4/L58-65). Hudak teaches nucleic acid (C1/L25-32). Hudak does not teach the testing machine is a thermal cycler or an isothermal amplification instrument.
Kshirsagar teaches nucleic acid amplification methods include thermal cycling methods ([0061]). Kshirsagar teaches isothermal amplifications ([0061]). Kshirsagar teaches immunoassay test strips ([0099]). Kshirsagar teaches these are useful detection methods ([0061]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate a thermal cycling or isothermal amplification method, as taught by Kshirsagar, in the system and method of Hudak as these are known and useful detection methods.
Claim 168. Hudak teaches the limitations as noted above. Hudak teaches the liquid medium is a body fluid (C1/L13-16). Hudak teaches immunoassay (C1/L25-21; C4/L59-65). Hudak does not teach a lysing buffer.
Kshirsagar teaches nucleic acid amplification methods include thermal cycling methods ([0061]). Kshirsagar teaches isothermal amplifications ([0061]). Kshirsagar teaches immunoassay test strips ([0099]). Kshirsagar teaches these are useful detection methods ([0061]). Kshirsagar teaches lysing buffers for biological fluids ([0043]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate a lysing buffer, as taught by Kshirsagar, in the system and method of Hudak as it is known to use lysing buffers with biological fluids.
Claim 176. Hudak teaches the limitations as noted above. Hudak teaches the liquid medium is a body fluid (C1/L13-16). Hudak teaches immunoassay (C1/L25-21; C4/L59-65). Hudak teaches the testing machine is a chromatographic immunoassay device (C4/L58-65). Hudak does not teach a molecular-based assay.
Kshirsagar teaches nucleic acid amplification methods include thermal cycling methods ([0061]). Kshirsagar teaches isothermal amplifications ([0061]). Kshirsagar teaches immunoassay test strips ([0099]). Kshirsagar teaches these are useful detection methods ([0061]). Kshirsagar teaches molecular based assays ([0061]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate a molecular based assay, as taught by Kshirsagar, in the system and method of Hudak as it is known to use molecular based assays with biological fluids.
Claim 177 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 7282181 by Hudak et al. (Hudak) in view of in view of CN 110234277 by Dagmar (Dagmar), as noted above, in view of U.S. Patent Publication No. 20190298728 by Zhao et al. (Zhao).
Claim 177. Hudak teaches the limitations as noted above. Hudak teaches the liquid medium is a body fluid (C1/L13-16). Hudak teaches immunoassay (C1/L25-21; C4/L59-65). Hudak teaches the testing machine is a chromatographic immunoassay device (C4/L58-65). Hudak does not teach testing for the presence of the biological particulate comprises using CRISPR.
Zhao teaches testing body fluids ([0054]). Zhao teaches that CRISPR technology is used to test body fluids ([0081]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate CRISPR technology, as taught by Zhao, in the system and method of Hudak as it is known to use CRISPR to test biological fluids.
Response to Arguments
Applicant's arguments filed 6/23/2025 have been fully considered but they are not persuasive.
The 112b rejections have been removed in light of the amendments to the claims and the arguments dated 6/23/2025 pertaining to the phrase “so as”.
In regard to the Applicant’s argument that the prior art does not teach a membrane, the Examiner notes that the rejection above is updated in light of the claim amendments.
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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/KARA M PEO/Primary Examiner, Art Unit 1777
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