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 .
Priority
This application claims benefit of U.S. Provisional Application No. 63/397,618 filed 08/12/2022.
Election/Restrictions
Applicant’s election without traverse of group I (claims 15, 18, 23-29) in the reply filed on 04/10/2026 is acknowledged.
Claims 30-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/10/2026.
Status of the claims
Claims 15, 18 and 23-38 are pending. Claims 15, 18, 23-29 are currently under examination.
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 15, 18 and 23-29 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. Claim 15 recites in step (b), the limitation of “a filtration member disposed concentrically within the first container member”. There is insufficient antecedent basis for the first container member as nowhere in claim 15 is the limitation of “a first container member” recited. Claims 18 and 23-29 are further rejected as they depend from claim 15. Claims 18 and 23-29 are further rejected as they depend from claim 15.
Claim 26 recites the limitation “the first filtrate containing blood cells and free nucleic acid from the urine sample, and the filter retentate containing cancer cells from the urine sample” which is confusing as claim 26 depends from claim 15 which only requires a urine sample from which to screen cancer cells. Clarification is needed on the origin of blood cells and free nucleic acid in the filtrate. It is unclear if claim 26 intends that the urine sample within the filtration member of the device of claim 15 further contains exogenous additives i.e. blood cells spiked-into urine samples. It is unclear why the instant first filtrate containing blood cells and free nucleic acid would be der=iced from a urine sample. Claims 26-29 are rejected as they depend from claim 26.
Claim 26 recites the limitation “following a period subjected to centrifugation sufficient to produce” which lacks clarity because there is a grammar issue with the limitation. It is unclear if the limitation is simply directed to the device of claim 5 following a subjection of the device to a first centrifugation event, the first centrifugation sufficient to produce a first filtrate in the container member, and a filter retentate in the filtration member. Claim 27 is rejected as it depends from claim 26.
Claim 29 recites the limitation “following a period subjected to centrifugation sufficient for the cancer cells in the filter member to be disrupted and for the sample to produce a second filtrate, the second filtrate disposed in the container member and comprising DNA from the cancer cells”, which indefinite and lacks clarity. There is improper antecedent basis for “the filter member to be disrupted”. Claim 26 from which claim 29 depends from only recite a filter retentate in the filtration member, the filter retentate containing cancer cells from the urine sample. Furthermore, the phrase “the sample” in the underlined limitation “for the sample to produce a second filtrate” above is confusing and lacks clarity. Claim 26 recites only a filter retentate in the filtration member of the device of claim 15.
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.
Claims 15, 18 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. (July 07, 2015, pLoS ONE 10(7) e0131889, pp. 1-15) in view of Osuchowska et al., (August 23, 2019, Results in Physics, 15, 102612, pp.1-9).
Regarding claim 15, Andersson et al. (2015) teach a device (see pg 3, “filtration device” stated in section entitled Collection of cells and DNA isolation and see pg 4, Fig. 1 as illustrated below and pg 5, Results section entitled “Outline of the filtration device”).
The filtration device of Andersson et al. (2015) comprises:
(a) a container member having walls defining a bottom surface (pg 4, Fig. 1 and pg 5, Results section entitled “Outline of the filtration device”);
(b) a filtration member disposed concentrically within the first container member;
the filtration member comprising an ultra-high molecular weight polyethylene filter disposed therein, the filter having a pore size of about 8 to about 12 microns (Andersson et al. (2015) teach filter is Nuclepore track-etched polycarbonate hydrophilic membrane filter (diameter 25 mm, pore size 8 μm; Whatman:
see pg 3, section entitled “Collection of cells and DNA isolation” and see pg 4, Fig. 1 and pg 5, Results sections entitled “Outline of the filtration device” and “Evaluation of device performance”);
and
(c) a urine sample contained within the filtration member
(Andersson et al. teach urine sample(s) are collected from patients in whom routine flexible cystoscopy in the outpatient clinic showed evidence of bladder tumor and who were subsequently referred to transurethral resection of the bladder (TURB) at Copenhagen University Hospital: see pg 3, section of Materials and Methods entitled Patients and urine samples and section entitled Collection of cells and DNA isolation).
Specifically, Andersson et al. (2015) teach a filtration device that comprises a removable cartridge housing a membrane filter, which after filtration of urine can be transferred to a storage unit containing an appropriate preserving solution (pg 1, abstract and pg 5, Results section entitled “Outline of the filtration device”). Andersson et al. (2015) teach after filtration, the filter with captured cells can be readily removed from the filtration device and placed into a water-tight storage unit (pg 2, last para and pg 3, 1st para).
Andersson et al. (2015) teach the device provided efficient recovery of bladder cancer cells with elimination of >99% of excess smaller-sized cells (pg 1, abstract).
Andersson et al. (2015) teach the entire filtration device assembly comprises
(1) a filtration unit for filtering a biological fluid sample,
(2) a removable filter cartridge containing a filter suitable for capturing relevant material, and
(3) a storage unit for preparing and/or preserving the filter content.
The filtration unit has a collection chamber, a waste reservoir, and a filter support platform housing the removable filter cartridge (see Fig. 1A, 1B, 1C, 1D, 1E and pg 5, Results section entitled “Outline of the filtration device”).
Fig. 1A, 1B, 1C and 1D (reproduced from page 4 of Andersson et al. (2015)).
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Regarding claim 18, Andersson et al. (2015) teach the container member that further comprises a cap member, a lid, or any combination thereof (see illustration of fig. 1A, 1B, 1C above, or on pg 4).
Regarding claim 23, Andersson et al. (2015) teach the filtration member that further comprises a cap member, a lid, or any combination thereof (see illustration of fig. 1D, 1E above, or on pg 4).
Regarding claim 24, Andersson et al. (2015) teach wherein the filtration member comprises a surface spanning the length of the filtration member and a bottom surface, wherein the filtration member is configured to filter through the surfaces spanning the length of the filtration member and the bottom surface (see illustration of fig. 1A, 1B, 1C above, or on pg 4).
Regarding claim 25, Andersson et al. (2015) teach the filter is cylindrical or conical (see illustration of fig. 1D, 1E above, or on pg 4).
Omitted from Andersson et al. (claim 15)
Regarding claim 15, Andersson et al. (2015) do not teach filtration member comprising an ultra-high molecular weight polyethylene filter.
Osuchowska et al. (claim 15)
Regarding claim 15, Osuchowska et al. teach a filtration member that comprises an ultra-high molecular weight polyethylene filter. More specifically, Osuchowska et al. teach a polyethylene terephthalate (C10H8O4)n (PET) microsieve (abstract) having holes with an average diameter of 8 ± 0.5 µm (pg 5, right col, 2nd para of Discussion). Osuchowska et al. teach DU 145 prostate cancer cells suspension in DPBS filtered through the microsieve (pg 2, right col., section entitled Cell filtration, and pg 4, left col. 2nd para of section entitled “The filtration efficiency of human cancer cells”). Osuchowska et al. teach more than 82.5% of DU 145 human prostate cancer cells (HTB-81 ATCC) are captured in the microsieves (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the polyethylene filter/microsieve having pore size about 8 µm to 12 µm taught by Osuchowska et al. to replace the polycarbonate hydrophillic filter having pore size about 8 µm to 12 µm of Andersson et al. (2015) as each references disclose these filters functional equivalent alternatives of filters useful for capture/recovery of cancer cells.
The ordinarily skilled artisan would have a reasonable expectation of success to provide the polyethylene filter having pore size about 8 µm of Osuchowska et al. and using it in the device of Andersson et al. (2015) to capture prostate cancer cells of a urine sample.
In view of the combined teachings and suggestions of all of the cited prior art references, the instant claims 15, 18 and 23-25 are prima facie obvious.
Claims 15, 18 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. (July 07, 2015, pLoS ONE 10(7) e0131889, pp. 1-15) in view of Meunier et al., (2019, BioRxiv, 773507, pp.1-39).
Regarding claim 15, Andersson et al. (2015) teach a device (see pg 3, “filtration device” stated in section entitled Collection of cells and DNA isolation and see pg 4, Fig. 1 as illustrated below and pg 5, Results section entitled “Outline of the filtration device”).
The filtration device of Andersson et al. (2015) comprises:
(a) a container member having walls defining a bottom surface (pg 4, Fig. 1 and pg 5, Results section entitled “Outline of the filtration device”);
(b) a filtration member disposed concentrically within the first container member;
the filtration member comprising an ultra-high molecular weight polyethylene filter disposed therein, the filter having a pore size of about 8 to about 12 microns (Andersson et al. (2015) teach filter is Nuclepore track-etched polycarbonate hydrophilic membrane filter (diameter 25 mm, pore size 8 μm; Whatman:
see pg 3, section entitled “Collection of cells and DNA isolation” and see pg 4, Fig. 1 and pg 5, Results section entitled “Outline of the filtration device”);
and
(c) a urine sample contained within the filtration member
(Andersson et al. teach urine sample(s) are collected from patients in whom routine flexible cystoscopy in the outpatient clinic showed evidence of bladder tumor and who were subsequently referred to transurethral resection of the bladder (TURB) at Copenhagen University Hospital: see pg 3, section of Materials and Methods entitled Patients and urine samples and section entitled Collection of cells and DNA isolation).
Specifically, Andersson et al. (2015) teach a filtration device that comprises a removable cartridge housing a membrane filter, which after filtration of urine can be transferred to a storage unit containing an appropriate preserving solution (pg 1, abstract and pg 5, Results section entitled “Outline of the filtration device”). Andersson et al. (2015) teach after filtration, the filter with captured cells can be readily removed from the filtration device and placed into a water-tight storage unit (pg 2, last para and pg 3, 1st para).
Andersson et al. (2015) teach the device provided efficient recovery of bladder cancer cells with elimination of >99% of excess smaller-sized cells (pg 1, abstract).
Andersson et al. (2015) teach the entire filtration device assembly comprises
(1) a filtration unit for filtering a biological fluid sample,
(2) a removable filter cartridge containing a filter suitable for capturing relevant material, and
(3) a storage unit for preparing and/or preserving the filter content.
The filtration unit has a collection chamber, a waste reservoir, and a filter support platform housing the removable filter cartridge (see Fig. 1A, 1B, 1C, 1D, 1E and pg 5, Results section entitled “Outline of the filtration device”).
Fig. 1A, 1B, 1C and 1D (reproduced from page 4 of Andersson et al. (2015)).
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Regarding claim 18, Andersson et al. (2015) teach the container member that further comprises a cap member, a lid, or any combination thereof (see illustration of fig. 1A, 1B, 1C above, or on pg 4).
Regarding claim 23, Andersson et al. (2015) teach the filtration member that further comprises a cap member, a lid, or any combination thereof (see illustration of fig. 1D, 1E above, or on pg 4).
Regarding claim 24, Andersson et al. (2015) teach wherein the filtration member comprises a surface spanning the length of the filtration member and a bottom surface, wherein the filtration member is configured to filter through the surfaces spanning the length of the filtration member and the bottom surface (see illustration of fig. 1A, 1B, 1C above, or on pg 4).
Regarding claim 25, Andersson et al. (2015) teach the filter is cylindrical or conical (see illustration of fig. 1D, 1E above, or on pg 4).
Omitted from Andersson et al. (claim 15)
Regarding claim 15, Andersson et al. (2015) do not teach filtration member comprising an ultra-high molecular weight polyethylene filter.
Meunier et al., (claim 15)
Regarding claim 15, Meunier et al. teach a filtration member comprising an ultra-high molecular weight polyethylene filter (see filtration cartridge of pg 7, illustrated in Fig. 1A and Fig. 1B).
Specifically, Meunier et al. teach using both an in house fabricated microfilter (8 µm microfilter clamped within a 3D printed filtration cartridge of Figure 1A or 1B: see pg 7 for figures and pg 24, 1st and 2nd paragraphs). The filtration member supports a gravity-based microfiltration (GµF) to efficiently isolate circulating tumor cells (cCTCs) from blood samples spiked with OV-90 ovarian cancer single cells and clusters.
Meunier et al. teach 15 µm filters contained the largest diversity of clusters, while no large clusters were found on the following 12, 10 or 8 µm filters, suggesting that 15 µm filters efficiently capture clusters, and were thus considered optimal (pg 10, last para).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to replace the device of Andersson et al. (2015) comprising of a polycarbonate hydrophillic filter having pore size about 8 µm to 12 µm with the filtration cartridge taught by Meunier et al. comprising a polyethylene filter having pore size about 8 µm to 15 µm as both devices are functional equivalent alternative of devices with filtration members that are useful for capture/recovery of cancer cells/ circulating tumor cells (cCTCs) from body fluid or buffered suspension samples.
The ordinarily skilled artisan would have a reasonable expectation of success to provide the cartridge comprising polyethylene filter having pore size about 8 or 15 µm of Meunier et al. to capture circulating tumor cells (cCTCs) of a urine sample for an non-invasive screen to collect and analyze these cells in the biosamples screened.
In view of the combined teachings and suggestions of all of the cited prior art references, the instant claims 15, 18 and 23-25 are prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 18, 23-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-20 of copending Application No. 19/429,755 in view of Osuchowska et al., (August 23, 2019, Results in Physics, 15, 102612, pp.1-9).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a device for preparing a urine sample from a subject for analysis to detect/screen for cancer cells in the urine sample while claims of 1-10 and 12-20 are directed to methods for using of the device.
The applications differ in that the claims of copending Application No. 19/429,755 do not require an ultra-high molecular weight polyethylene filter disposed therein filtration member.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the polyethylene filter having pore size about 8 µm to 12 µm taught by Osuchowska et al. to replace the instant filter having pore size about 8 µm to 12 µm as Osuchowska et al. teach their polyethylene filter useful for capturing/recovering prostate cancer cells from a fluidic sample.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 15, 18, 23-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 21 of copending Application No. 19/429,755 in view of Osuchowska et al., (August 23, 2019, Results in Physics, 15, 102612, pp.1-9).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and claims of 11 and 21 of copending Application No. 19/429,755are directed to device(s) for preparing a urine sample from a subject for analysis to detect/screen for cancer cells in the urine sample.
The applications differ in that the claims of copending Application No. 19/429,755 do not require an ultra-high molecular weight polyethylene filter disposed therein filtration member.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the polyethylene filter having pore size about 8 µm to 12 µm taught by Osuchowska et al. to replace the instant filter having pore size about 8 µm to 12 µm as Osuchowska et al. teach their polyethylene filter useful for capturing/recovering prostate cancer cells from a fluidic sample.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681
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