DETAILED ACTION
Notice of AIA Status
The present application, filed on 4/7/22, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/10/2026 has been entered.
Status of Claims
Claims 10-12, 26-44 and 46-48 are rejected.
Response to Arguments
Claims 10-12, 26-44 and 46-48 were rejected under 35 U.S.C. §103 over Daum (US20120107799) in view of Boom (US5234809A) in the office action dated 12/10/2025. Applicant’s arguments, see page 5-11, filed 03/10/2026 are deemed persuasive in light of the amendments filed 03/10/2026. However, upon further consideration, a new ground of rejection is made over Daum (US20120107799) in view of Su (Cellulose as a Matrix for Nucleic Acid Purification) under 35 USC §103.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as Subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are Such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are Summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 10-11, 26-33, 35-36, 39-40, 43-44 and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Daum (US20120107799) in view of Su (“Cellulose as a Matrix for Nucleic Acid Purification”).
As to claim 10, Daum (US20120107799) teaches a system (referred to as a nucleic acid extraction apparatus in [0012]) for isolating and extracting one or more nucleic acids from a biological sample (biological samples in [0097]) (the system of Daum is capable of isolating and extracting one or more nucleic acids from a biological sample, see [0001], which recites “apparatuses and methods adapted to extract or isolate a structure of interest from a sample Suspected of containing the same”) (see also [0013], which recites “the structure is a nucleic acid”) (see also [0097], which recites “ “sample” includes anything containing or presumed to contain a structure of interest. Such a structure may be a composition of matter containing one or more nucleic acids, proteins, or other molecule(s) of interest…. biological samples”), the system comprising:
a) a filter cartridge (filtration vessel 10 in [0047]) comprising a cartridge housing (filtration vessel) with a first end (receiving end in [0052]) (see Fig. 1) and a second end (discharging end in [0052]) (see Fig. 1) (see also [0052], which recites “filtration vessel 10 … has … two openings, a receiving end and a discharge opening) and a filter component (membrane filter 30 in [0051]) disposed between said ends (see Fig. 1), wherein:
(i) the first end comprises a port (see Fig. 1), wherein the port allows insertion and removal of a fluid (the port of Daum is capable of allowing insertion and removal of a fluid, see Fig. 1), and
(ii) the filter component (membrane filter 30) consisting of a singular solid support (membrane filter 30), wherein the singular solid support (membrane filter) consists of a filter (membrane filter 30) configured to reversibly bind nucleic acids (the filter component of Daum is capable of reversibly binding nucleic acids, see [0053], which recites “membrane filter 30 may be made of any material … to which nucleic acids … bind”) (see [0064], which recites “the binding ... is reversible”); and
b) a sample tube (replaceable cartridge 60 in [0059]) comprising (i) a sample tube housing (replaceable cartridge 60) for holding a fluid (the sample tube housing of Daum is capable of holding a fluid, see [0059], which recites “a replaceable cartridge 60 into which either an amount of (i) a prepared sample (typically a liquid) suspected of containing a structure of interest, (ii) a wash or (iii) an elution buffer is placed”) and (ii) a first cap (top 65 in [0062]) removably attachable to a first end of the sample tube (replaceable cartridge) (the first cap is capable of attaching in a removable manner) (see [0062], which recites “a top 65 is operably associated with the replaceable cartridge 60 and can be releasably … joined to the replaceable cartridge 60”) wherein the first cap (top 65) comprises a cap port (luer lock connector in [0061]) (see Figs. 1 and 4) adapted to snugly engage the port of the filter cartridge (filtration vessel 10) (see Figs. 1 and 4) (the cap port of Daum is capable of snugly engaging the port of the filter cartridge), and wherein the cap port (luer lock connector) is open to allow passage of the fluid from the sample tube housing (replaceable cartridge 60) to the filter cartridge (filtration vessel 10) (see [0050], which recites “inlet valve 20 near or at the receiving end can regulate the flow of the sample from the volume dispensing mechanism 5 to the filtration vessel 10. A check or non-return valve 25 … present to prevent the back flow of sample into the volume-dispensing mechanism 5, allowing the sample to pass”).
Daum doesn’t explicitly teach that the singular solid support consists of a cellulose filter.
In the analogous art of providing nucleic acid extraction, Su (Cellulose as a Matrix for Nucleic Acid Purification) teaches a singular solid support consisting essentially of cellulose filter (see page 415, which recites “nucleic acid purification is an essential but tedious step in molecular biology studies, which has been made easier since the introduction of solid binding matrix … However, the application of each type of available matrix is often limited to a specific group of nucleic acids. We have discovered a matrix, secondary fibril-associated cellulose (designated as SF cellulose), that can be used as a general-purpose matrix to isolate a wide range of nucleic acids with high yield and quality”) configured to reversibly bind nucleic acids (see page 418, which recites “we have used the cellulose matrix method to purify nucleic acids from thousands of millimeter punches of DBS for molecular diagnostic studies. Additionally, we have isolated genomic DNA from blood and sputum, plasmid DNA from bacteria, and RNA from plants. We were also able to isolate HIV RNA from DBS for viral load studies. The functionality of the cellulose matrix can be attributed to the secondary fibrils. The presence of the secondary fibrils on the cellulose fiber surfaces suggests that free-moving colloidal cellulosic chains may be present … Thus nucleic acid molecules can co-aggregate with or be adsorbed to the hydrophilic cellulosic chains under precipitating conditions and, therefore, reversibly bind to the cellulose matrix”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum by replacing the singular solid support of Daum with the singular solid support of Su such that the singular solid support consists essentially of a cellulose filter configured to reversibly bind nucleic acid with a reasonable expectation of Success because such modification is a simple substitution of a known element i.e. a filter material singular solid support with a cellulose filter material singular solid support resulting in the predictable result of reversibly binding nucleic acid and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.) as well as for the benefit of isolating a wide range of nucleic acids with high yield and quality (see page 415, which recites “Nucleic acid purification is an essential but tedious step in molecular biology studies, which has been made easier since the introduction of solid binding matrix (1, 2). However, the application of each type of available matrix is often limited to a specific group of nucleic acids. We have discovered a matrix, secondary fibril-associated cellulose (designated as SF cellulose), that can be used as a general-purpose matrix to isolate a wide range of nucleic acids with high yield and quality”).
As to claim 11, Daum in view of Su teaches the system of claim 10.
Su teaches that the cellulose filter consists of a cellulose filter punch (see page 418, which recites “we have used the cellulose matrix method to purify nucleic acids from thousands of millimeter punches”).
As to claim 26, Daum in view of Su teaches the system of claim 10.
Daum teaches that the biological sample (biological samples) is a saliva, blood, or urine (see [0097], which recites “biological samples include…, urine, .. white blood cells, red blood cells, …urine, … saliva”) (the system of Daum is capable of working upon the following materials: saliva, blood and urine and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935) (see [0097]).
As to claim 27, Daum in view of Su teaches the system of claim 10.
Daum teaches that the biological sample (biological samples) is a tissue sample (see [0097], which recites “term “sample” can thus encompass … tissue”) (the system of Daum is capable of working upon tissue sample and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935)
As to claim 28, Daum in view of Su teaches the system of claim 27.
Daum teaches that the biological sample (biological samples) is a shrimp tisSue sample (the system of Daum is capable of working upon shrimp tissue sample and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 29, Daum in view of Su teaches the system of claim 10.
Daum teaches that the system comprises the biological sample (biological samples) in the sample tube (replaceable cartridge 60) (see [0059], which recites “a replaceable cartridge 60 into which either an amount of (i) a prepared sample (typically a liquid) suspected of containing a structure of interest, (ii) a wash or (iii) an elution buffer is placed”).
As to claim 30, Daum in view of Su teaches the system of claim 10.
Daum teaches that the sample tube (replaceable cartridge 60) comprises a lysis buffer (lysis buffer in [0069], which recites “the wash buffer can include components of the lysis buffer”) (see also [0059], which recites “a replaceable cartridge 60 into which .. a wash … is placed”).
As to claim 31, Daum in view of Su teaches the system of claim 10.
Daum teaches that the sample tube (replaceable cartridge 60) comprises a lysed biological sample (lysed sample in [0055]) (the system of Daum in view of Su is capable of working upon lysed biological sample and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 32, Daum in view of Su teaches the system of claim 31.
Daum teaches that the lysed biological sample (lysed sample) comprises genomic DNA or genomic RNA (see [0097], which recites “the term “sample” can thus encompass … a population of nucleic acids (genomic DNA, cDNA, RNA…)”) (DNA stands for the biopolymer molecule deoxyribonucleic acid, cDNA stands for complementary deoxyribonucleic acid and RNA stands for ribonucleic acid) (the system of Daum is capable of working upon lysed biological sample comprising genomic DNA or genomic RNA and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 33, Daum in view of Su teaches the system of claim 32.
Daum teaches that the genomic RNA comprises mRNA (see [0095], which recites “nucleic acids include…, gDNA; …; mRNA”) or RNA from an RNA-virus (see [0042], which recites “the RNA being extracted from a previously tested Influenza Virus”) (the system of Daum is capable of working upon lysed biological sample comprising genomic RNA comprising mRNA and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 35, Daum in view of Su teaches the system of claim 10,
In addition, Daum teaches the first cap (top 65) is directly connected to the sample tube (replaceable cartridge 60) (see Fig. 4).
As to claim 36, Daum in view of Su teaches the system of claim 10.
In addition, Daum teaches that the first cap (top 65) is separate from the sample tube (replaceable cartridge 60) (see Fig. 4).
As to claim 39, Daum in view of Su teaches the system of claim 10.
In addition, Daum teaches that the filter cartridge (filtration vessel 10) comprises a filter component (membrane filter 30 in [0051]).
In addition, Daum in view of Su teaches that the filter cartridge comprises one or more filters (see [0052], which recites “inside the filtration vessel is one or more membrane filters 30 to which the structure of interest in the liquid … binds to”).
As to claim 40, Daum in view of Su teaches the system of claim 10.
In addition, Daum teaches that the system further comprises a second sample tube (collection container 15 in [0045] of Daum) comprising a sample tube housing (collection container 15) for holding a fluid (filtrate in [0045] of Daum, which recites “a collection container 15 adapted to receive any filtrate”).
As to claim 43, Daum in view of Su teaches the system of claim 10.
In addition, Daum teaches that the fluid (filtrate) is an elution buffer (see [0021] of Daum, which recites “the replaceable cartridge contains … an elution buffer”) (the system of Daum in view of SU is capable of working upon the elution buffer and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 44, Daum in view of Su teaches the system of claim 43.
In addition, Daum teaches that the elution buffer (elution buffer) comprises genomic DNA extracted from the biological sample (biological samples) (see [0070], which recites “nucleic acid is desorbed, upon application of the elution buffer to the filtration zone”) (see also [0097], which recites “the term “sample” can thus encompass a solution, cell, tissue, or population of one of more of the same that includes a population of nucleic acids (genomic DNA…)” (the system of Daum is capable of working upon the genomic DNA extracted from the biological sample and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
As to claim 46, Daum in view of Su teaches the system of claim 43.
In addition, Daum teaches that the system is configured to push the elution buffer (elution buffer) into an elution vial (tip 35 in [0057], which recites “tip 35 contains … two openings through which sample liquid can flow—from the filtration vessel 10 to the collection container 15”) (the system of Daum is capable of pushing the elution buffer into the elution vial) (see [0085], which recites “syringe was attached to the rest of the extraction vessel and the plunger of the syringe was pushed so that the contents of the sample that did not bind to the membrane filter were deposited into a collection vessel”) (see [0021], which recites “the replaceable cartridge contains … an elution buffer”).
As to claim 47, Daum in view of Su teaches the system of claim 10.
In addition, Daum teaches that the system further comprises a syringe (see [0047] of Daum, which recites “volume-dispensing mechanisms 5 can include, but are not limited to, one or more of a piston pump, a syringe, pipette, micropipette, or dropper”).
As to claim 48, Daum in view of Su teaches the system of claim 47.
In addition, Daum teaches that the syringe is configured to move the biological sample through said system (the syringe of Daum is capable of moving the biological sample through said system, see [0047]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su as applied to claim 10 above, and in further view of Menon (US20180280832).
As to claim 12, Daum in view of Su teaches the system of claim 10.
Daum in view of Su doesn’t teach that the first cap further comprises a prefilter positioned between the sample tube housing and cap port or within the cap port, wherein the prefilter is adapted to filter cellular debris.
In the analogous art of providing analytical apparatus, Menon (US20180280832) teaches a prefilter (referred to as a cell collection matrix 82 in [0118]) positioned within the cap port (which corresponds to assembly 80 in [0118]), wherein the prefilter is adapted to filter (trap) cellular debris (cell/cellular debris in [0118], which recites “assembly 80 included a cell collection layer 82 comprising an asymmetric membrane …. The porosity of the membrane was carefully selected in order to trap and remove cell/cellular debris while allowing nucleic acid species and proteins to flow through”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su by incorporating the pre-filter disclosed by Menon with a reasonable expectation of Success for the benefit of effectively trapping and removing cell or cellular debris while allowing nucleic acid species and proteins to flow through (see [0118] of Menon).
Claim 34 rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su as applied to claim 10, and in further view of Carbonell (US20060160064).
As to claim 34, Daum in view of Su teaches the system of claim 10.
Daum in view of Su doesn’t teach that cellulose filter has a pore size of about 10 μm.
In the analogous art of providing devices for adsorption of biological species to solid supports, Carbonell teaches cellulose filter has a pore size of about 10 μm (see [0052], which recites “ nonwoven fabrics have mean pore flow (MPF) diameters ranging from about 1 to about 500 μm … the porous matrix has a pore size of at least 10 μm”) (see also [0056], which recites “Needlepunched nonwoven fabrics”) (see also [0054], which recites “nonwoven fabrics are made of fibers that, depending on the fabrication method, have diameters in the range of, for example, from about 0.01 to about 10 μm. The fibers consist of a wide variety of materials including natural fibers and synthetic fibers. Natural fibers include, for example, cellulose”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su such that cellulose filter has a pore size of about 10 μm with a reasonable expectation of Success for the benefit of effectively filtering species based on size.
Claim 37 rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su as applied to claim 10, and in further view of Cooney (US20090111193).
As to claim 37, Daum in view of Su teaches the system of claim 10, wherein the filter cartridge (filtration vessel 10) attaches to the sample tube (replaceable cartridge 60) (see Fig. 4).
Daum in view of Su doesn’t teach the filter cartridge attaches to a screw-on cap on the sample tube.
In the analogous art of providing sample preparation apparatus, Cooney (US20090111193) teaches the filter cartridge (sample preparation device 100) attaches to a screen-on cap (see [0041], which recites “the first sample port 51 … sealed with a screw cap”) on the sample tube (base 50) (see Fig. 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su by incorporating the screen-on cap disclosed by Cooney Such that the filter cartridge attaches to a screw-on cap on the sample tube with a reasonable expectation of Success for the benefit of effectively preventing contamination of interior of the filter cartridge by effectively sealing the sample port (see [0041] of Cooney).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su as applied to claim 10, and in further view of Ahmad (US20190231222).
As to claim 38, Daum in view of Su teaches the system of claim 10 wherein the filter cartridge (filtration vessel 10) is enclosed with a cap (non-return valve).
Daum in view of Su doesn’t teach that the filter cartridge is enclosed with a rubber septum.
In the analogous art of providing analytical apparatus, Ahmad (US20190231222) teaches a filter cartridge (see Fig. 2A) enclosed with a rubber septa (see [0366], which recites “a separate material 186, such as a rubber septum, is … placed to prevent temporary passage of liquid”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su by incorporating the rubber septum disclosed by Ahmad with a reasonable expectation of Success for the benefit of effectively preventing temporary passage of liquid (see [0366] of Ahmad).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su as applied to claim 10, and in further view of Qian (US20170335313).
As to claim 41, Daum in view of Su teaches the system of claim 40,,
In addition, Daum teaches that the system further comprises a tip (tip 35) removably attachable to the first end of the second sample tube (collection container 15) (see Figs. 1 and 2).
Daum in view of Su doesn’t teach that the system further comprises a second cap removably attachable to the first end of the second sample tube.
In the analogous art of providing analytical apparatus, Qian (US20170335313) teaches the cap removably attachable to the first end of the second sample tube (see [0008], which recites “a system for collecting a sample of nucleic acid, the system comprising a receptacle defining an internal volume, a removable cap for the receptacle”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su by incorporating the cap disclosed by Qian Such that the system further comprises a second cap removably attachable to the first end of the second sample tube with a reasonable expectation of Success for the benefit of effectively preventing contamination of the contents in the internal volume of the receptacle.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Daum in view of Su in view of Qian (US20170335313) as applied to claim 41, and in further view of Qian (US20160097049)
As to claim 42, Daum in view of Su in view of Qian (US20170335313) teaches the system of claim 41.
Daum in view of Su in view of Qian (US20170335313) doesn’t teach that the second cap comprises a cap port adapted to snugly engage the first port or second port of the filter cartridge, the cap port is open to allow passage of fluid from the second sample tube housing to the filter cartridge.
In the analogous art of providing analytical apparatus, Qian (US20160097049) teaches the second cap (removable cap 101 in [0034])) comprises a cap port (passageway 104 in [0034]) adapted to snugly engage the first port or second port of the filter cartridge (filter column 200), the cap port (passageway 104) is open to allow passage of fluid (see Fig. 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Daum in view of Su in view of Qian (US20170335313) by incorporating the second cap disclosed by Qian (US20160097049) Such that he second cap comprises a cap port adapted to snugly engage the first port or second port of the filter cartridge, the cap port is open to allow passage of fluid from the second sample tube housing to the filter cartridge with a reasonable expectation of Success for the benefit of effectively preventing contamination of the contents in the internal volume of the receptacle.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797