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 .
Response to Amendment
The amendments and remarks, filed on 9/10/2025, has been entered. The previous prior art rejection stands and is applied to address the claim amendments.
Claim Status
Claims 1-27 are pending with claims 25-27 being examined and claims 1-24 are withdrawn.
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.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hermet et al (US 20040185437 A1; hereinafter “Hermet”; already of record) in view of Chang et al (WO 2018086556 A1; hereinafter “Chang”; English translation attached, however, the English equivalent of US 20190359752 A1 is cited below; already of record).
Regarding claim 25, Hermet teaches a device for use in the method for enriching and detecting microorganisms in a biological sample1 (Hermet; Abstract), comprising the following steps: a) collecting the biological sample (Hermet; para [27]; a sample of the blood product is subjected to an aggregation treatment of the blood cells); b) filtering the sample through a substrate, human-derived nucleated cells in the sample are captured or separated by the substrate and the microorganisms in the sample pass or flow through the substrate into filtrate (Hermet; para [28]; aggregates formed in step (a) are eliminated by passage of the treated sample over a first filter allowing passage of the contaminating microbes, but not the cell aggregates); and c) detecting the microorganisms present in the filtrate (Hermet; para [30, 31]; contaminating microbes are recovered by passage of the lysate from step (c) over a second filter allowing passage of the cellular debris…method comprises a supplementary step of analysis of the second filter to detect the contaminating microbes possibly retained on it); wherein the nucleated cells include one or more of erythroblasts, leukocytes and cancer cells (Hermet; para [35]; the blood cells of the blood product are platelets or red cells or a mixture), the device comprising: an upper housing (Hermet; Fig. 12; examiner interprets the upper housing as the structures above sterile connector 5), a substrate (Hermet; Fig. 12; para [62]; a first filter 3 placed between the first and second tank) which allows microorganisms, to pass through (Hermet; para [28]; eliminated by passage of the treated sample over a first filter allowing passage of the contaminating microbes, but not the cell aggregates), and a lower housing (Hermet; Fig. 12; examiner interprets the lower housing as the structures below the second sterile connector 5); wherein the substrate is located between the upper housing and lower housing (Hermet; Fig. 12; para [62]; a first filter 3 placed between the first and second tank).
Hermet does not teach wherein the substrate is a polymer-modified substrate which selectively captures derived nucleated cells and allows erythrocytes and platelets to pass through, where the polymer is prepared by the polymerization of one or more monomers having the structure of formula (1):
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wherein R1 is independently selected from the group consisting of hydrogen, methyl, ethyl, hydroxyl, C1-12 alkyl, phenyl; R2 is independently selected from the group consisting of hydrogen, methyl, ethyl, C1-6 alkyl, amino, phenyl; and n is an integer of 1 to 5.
However, Chang teaches an analogous art of a filter for leukocytes (Chang; Abstract) comprising a prepared polymer-modified substrate which selectively captures derived nucleated cells (Chang; para [7]; a polymer which is a material for capturing or separating leukocytes) and allows erythrocytes and platelets to pass through (Chang; para [86]; The leukocyte-depleted platelet filter is for passing a suspension sample containing leukocytes and platelets through the filter to separate the leukocytes from the platelets… The leukocyte-depleted erythrocyte filter is for passing a suspension sample containing leukocytes and erythrocytes through the filter to separate the leukocytes from the erythrocytes) by the polymerization of one or more monomers having the structure of formula (1):
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wherein R1 is independently selected from the group consisting of hydrogen, methyl, ethyl, hydroxyl, C1-12 alkyl, phenyl; R2 is independently selected from the group consisting of hydrogen, methyl, ethyl, C1-6 alkyl, amino, phenyl; and n is an integer of 1 to 5 (Chang; para [7]). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the substrate of Hermet to be the polymer-modified substrate comprising the polymer formula (1) as taught by Chang, because Chang teaches that the filter can be a filter for separating leukocytes, a leukocyte-depleted platelet filter, or a leukocyte-depleted erythrocyte filter (Chang; para [86]).
1 Regarding claim 1, these limitations are directed to the function and/or the manner of operating the device, all the structural limitations of the claim has been disclosed by Hermet in view of Chang and the apparatus of modified Hermet is capable of “a device for use in the method for enriching and detecting microorganisms in a biological sample”. As such, it is deemed that the claimed device is not differentiated from the device of modified Hermet (see MPEP §2114). Examiner notes that the device is dependent upon the method of claim 1, thus if the device is capable of the method the limitation is met.
Regarding claim 26, modified Hermet teaches the device of claim 25 (the substate of Hermet is modified to be the polymer-modified substrate as taught by Chang discussed above in claim 25), wherein the upper housing of the device is provided with an inlet (Hermet; Fig. 12; examiner notes the sample inlet can be seen in Fig. 12 as part of the upper housing which is interpreted as the structures above sterile connector 5) while the lower housing is provided with an outlet (Hermet; Fig. 12; examiner notes the sample outlet can be seen in Fig. 12 as part of the lower housing which is interpreted as the structures below sterile connector 5); the biological sample enters the device from the inlet of the upper housing, penetrates through the polymer-modified substrate, and flows out from the device through the outlet of the lower housing (Hermet; para [27-30]; a) a sample of the blood product is subjected to an aggregation treatment of the blood cells, b) aggregates formed in step (a) are eliminated by passage of the treated sample over a first filter allowing passage of the contaminating microbes, but not the cell aggregates, c) residual cells of the filtrate obtained in step (b) are lysed selectively, d) contaminating microbes are recovered by passage of the lysate from step (c) over a second filter allowing passage of the cellular debris; Chang para [7]); the biological sample includes the erythrocytes and platelets (Hermet; para [3]; The term “blood product” is understood to mean whole blood; Chang; para [86]; blood samples comprise whole blood samples, samples containing leukocytes and platelets, samples containing plasma protein, platelets or leukocytes, samples containing leukocytes or erythrocytes, or other samples containing cell suspension); and the polymer-modified substrate is configured to allow the erythrocytes and platelets to pass or flow through into the filtrate with retention rates of the erythrocytes and platelets in the filtrate both above 80% (Chang; Table 3; para [161]; the substrates modified by HEAA had a leukocyte capture rate of at least 87% and can retain more than 86% of platelets). Examiner notes that the substrate is modified to comprise the polymer as discussed above. While modified Hermet does not address “the polymer-modified substrate is configured to allow the erythrocytes to pass or flow through into the filtrate with retention rates of the erythrocytes in the filtrate both above 80%”, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the substrate of Hermet is modified to comprise the polymer-modification as taught by Chang. Absent persuasive evidence that the polymer-modified substrate of modified Hermet is different, the prior art is considered to have the same properties with respect to filtration of erythrocytes as that is claimed. MPEP § 2112.01 (I-IV). Further, the limitation is directed to the function and/or the manner of operating the polymer-modified substrate, all the structural limitations of the claim has been disclosed by Hermet in view of Chang and the polymer-modified substrate of modified Hermet is capable of being “configured to allow the erythrocytes to pass or flow through into the filtrate with retention rates of the erythrocytes in the filtrate both above 80%”. As such, it is deemed that the claimed polymer-modified substrate is not differentiated from the polymer-modified substrate of modified Hermet (see MPEP §2114).
Regarding claim 27, modified Hermet teaches the device of claim 26, wherein the device is used for pathogenic examination of biological samples (Hermet; para [27-30]); the biological sample further includes fibrinogens (Hermet; para [3]; The term “blood product” is understood to mean whole blood; Chang; para [86, 132]; blood samples comprise whole blood samples, samples containing leukocytes and platelets, samples containing plasma protein…Common plasma proteins are human serum albumin (HSA), immunoglobulin (Ig), and fibrinogen); the polymer-modified substrate is configured to allow the fibrinogens to pass or flow through into the filtrate with retention rate of the fibrinogens in the filtrate above 80%; and the polymer-modified substrate is configured to make microbial detection rate of the biological sample after filtration through the polymer-modified substrate at least twice that of the biological sample before filtration through the polymer-modified substrate. While modified Hermet does not address “the polymer-modified substrate is configured to allow the fibrinogens to pass or flow through into the filtrate with retention rate of the fibrinogens in the filtrate above 80%; and the polymer-modified substrate is configured to make microbial detection rate of the biological sample after filtration through the polymer-modified substrate at least twice that of the biological sample before filtration through the polymer-modified substrate”, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the substrate of Hermet is modified to comprise the polymer-modification as taught by Chang. Absent persuasive evidence that the polymer-modified substrate of modified Hermet is different, the prior art is considered to have the same properties with respect to filtration of fibrinogens as that is claimed. MPEP § 2112.01 (I-IV). Further, the limitation is directed to the function and/or the manner of operating the polymer-modified substrate, all the structural limitations of the claim has been disclosed by Hermet in view of Chang and the polymer-modified substrate of modified Hermet is capable of being “configured to allow the fibrinogens to pass or flow through into the filtrate with retention rate of the fibrinogens in the filtrate above 80%” and "configured to make microbial detection rate of the biological sample after filtration through the polymer-modified substrate at least twice that of the biological sample before filtration through the polymer-modified substrate”. As such, it is deemed that the claimed polymer-modified substrate is not differentiated from the polymer-modified substrate of modified Hermet (see MPEP §2114).
Response to Arguments
Applicant’s arguments filed, 9/10/2025, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the applicant’s arguments, on pp 9-12, the applicant argues that Hermet in view of Chang fails to disclose the polymer-modified substrate “allows microorganisms, erythrocytes and platelets to pass through”. The examiner respectfully disagrees. Examiner notes that the applicant indicated the limitation is directed to the functionality of the polymer-modified substrate. The limitations are directed to the function and/or the manner of operating the polymer-modified substrate, all the structural limitations of the claim has been disclosed by Hermet in view of Chang and the polymer-modified substrate of modified Hermet is capable of “allows microorganisms, erythrocytes and platelets to pass through”. As such, it is deemed that the claimed polymer-modified substrate is not differentiated from the polymer-modified substrate of modified Hermet (see MPEP §2114). Additionally, Chang teaches the polymer-modified substrate allows erythrocytes and platelets to pass through (Chang; para [86]; The leukocyte-depleted platelet filter is for passing a suspension sample containing leukocytes and platelets through the filter to separate the leukocytes from the platelets…The leukocyte-depleted erythrocyte filter is for passing a suspension sample containing leukocytes and erythrocytes through the filter to separate the leukocytes from the erythrocytes).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796