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 .
Terminal Disclaimer
The terminal disclaimer filed on 19 NOVEMBER 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of Application Nos. 18/128,441 and 18/362,312 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 1 is objected to because of the following informalities:
“…wherein the input hole is arranged at a position closer to the first input chamber…”.
“…the output hole is arranged at a position closer to the output chamber…
Appropriate correction is required.
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.
Claim 3 is 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.
Regarding Claim 3, the claim is dependent on now-canceled Claim 2. The Examiner will assume Applicant intended to reference Claim 1.
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.
Claim(s) 1, 3-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over CARTER et al. (US 2020/0116603 A1) in view of YAGI et al. (US 2012/0125833 A1) and further in view of JACKSON et al. (US 2022/0104544 A1).
Regarding Claim 1, CARTER discloses a device and method for isolating extracellular vesicles (EVs; e.g., exosomes) from biofluids using silicon nanomembranes as filters (i.e., a microfluidic purification device; p0003). The method broadly comprises contacting a biofluid sample with a pre-filtration membrane 205 to form a first filtrate and a first retentate (i.e., a first stage filter, configured to receive an input solution and output an output solution), contacting the first filtrate 120 with a capture membrane 210 to form a second filtrate and a second retentate (i.e., a first… filter; p0013-0017; FIG. 11). The pre-filtration membrane 205 retains undesired species, e.g., intact cells, large cellular debris, large globular or filamentous proteins, and allows the permeation of desired EVs (p0122). CARTER further discloses the taught device is useful for isolating extracellular vesicles including exosomes of sizes 30 nm to 200 nm (p0005; p0010) and further discloses that the capture membrane 210 has 200 nm to 300 nm diameter pores to first capture larger microvesicles and allow exosomes to permeate through (i.e., a size of the output hole is larger than sizes of the multiple exosomes; p0136-0137).
[AltContent: textbox (CAPTURE MEMBRANE)][AltContent: textbox (PRE-FILTRATION MEMBRANE)]
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CARTER is deficient in disclosing a filter assembly comprising a first input chamber, a first micro-electromechanical system (MEMS) filter attached to the first input chamber, an output chamber, an ultrasound vibrator disposed under the filter assembly, and a controller electrically connected with the ultrasound vibrator.
YAGI discloses a fine particle separator utilizing a filter and a piezoelectric element that vibrates the filter (abstract). As shown in FIG. 1B, the fine particle separator 1 comprises a channel 10 with inlet 12 (i.e., a first input chamber), chamber 20 (i.e., an output chamber), filter 30 (i.e., a first MEMS filter attached to the first input chamber), and piezoelectric element 40 that vibrates filter 30 (i.e., an ultrasound vibrator; p0043); the separator 1 further includes outlets 14 and 24 (p0045; p0047). The separator 1 is prepared using microelectron mechanical systems (MEMS) technique, utilizing a semiconductor substrate (p0049). The piezoelectric element 40 vibrates the filter 30 at a predetermined frequency (p0050); YAGI further discloses that a control unit 150 supplies a drive signal to the piezoelectric element 40 to control the vibration (i.e., a controller electrically connected with the ultrasound vibrator; p0087). Advantageously, the vibration of the filter 30 by the piezoelectric element 40 reduces clogging in the filter (p0014; p0054). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to provide a piezoelectric element prepared using MEMS to attach to a filter assembly as taught by YAGI for preventing clogging in the capture membrane disclosed by CARTER.
[AltContent: textbox (INLET)][AltContent: textbox (PIEZOELECTRIC ELEMENT)][AltContent: textbox (FILTER)]
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While YAGI is deficient in disclosing the ultrasound vibrator is disposed under the filter assembly, such a relative orientation is considered a matter of choice. The configuration of the claimed invention is a matter of choice which one of ordinary skill in the art at the time of invention would have found obvious absent persuasive evidence that the claimed particular configuration was significant and would yield unexpected results (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP §2144.04). Whether the ultrasound vibrator is located above or below the filter assembly is not significant so long as the ultrasound vibrator 40 acts on the filter 30. Thus, the claim that the ultrasound vibrator is disposed under the filter assembly would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Modified CARTER is deficient in disclosing the first MEMS filter comprises a funnel structure, and an output hole of the funnel structure is smaller than an input hole of the funnel structure or that the input hole is arranged at [a ]position closer to the first input chamber than the output chamber, and the output hole is arranged at [a ]position closer to the output chamber than the first input chamber.
JACKSON discloses a microfabricated mesh membrane comprising an array of holes 507 (p0032; FIG. 5A) useful to be integrated with a piezoelectric material as a vibrating mesh membrane (abstract; p0056-00570). Unique hole shapes include tapered and “standard pyramidal shape holes” (p0004, p0032), e.g., 707-1 (FIG. 7A). JACKSON further discloses the holes can have varied sizes depending on the desired size fluids to be passed (p0035). As further shown in FIG. 12A, an example device passes fluid from a microfluidic chamber 1250 and through a mesh membrane 1205 comprising through holes 1207 to allow particles 1208 to flow through (p0055); when viewed with respect to FIG. 5A, fluid passes top-down through the holes 507, i.e., the input holes of the funnel structure 507 are larger than the output holes (i.e., the first MEMS filter comprises a funnel structure, and an output hole of the funnel structure is smaller than an input hole of the funnel structure or that the input hole is arranged at [a ]position closer to the first input chamber than the output chamber, the output hole is arranged at [a ]position closer to the output chamber than the first input chamber). All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
[AltContent: textbox (PYRAMIDAL HOLES)][AltContent: textbox (PARTICLES)][AltContent: textbox (MESH MEMBRANE WITH HOLES)][AltContent: textbox (MICROFLUIDIC CHAMBER)]
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Modified CARTER is deficient in explicitly disclosing a first inlet valve connected with the first stage filter to receive the output solution or a first outlet valve connected with the output chamber to collect multiple exosomes from the output chamber. CARTER further discloses the device includes various components, including receptacles and connectors for the pre-filtering and capture membranes, pumps, valves, and flow controllers (p0159). The nature of the problem to be solved would have led one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A). The use of a valve to control the flow of material through a device is well-known in the art; because CARTER explicitly discloses that valves can be used with the taught device, one of ordinary skill in the art would find it obvious to include such a valve or multiple valves as needed as such tools are considered ubiquitous to one of ordinary skill in the art, and such a combination would not have significantly affected the operation or use of the taught device.
The limitations “configured to… purify the output solution into multiple exosomes” and “to collect the exosomes from the output chamber” are directed toward intended uses of the claimed purification device and more specifically of the filter assembly and first outlet valve, respectively. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 3, modified CARTER makes obvious the microfluidic purification device of Claim 1. CARTER further discloses the capture membrane 210 retains EVs by a size-dependent filtration mechanism (p0135) and comprises nanopore diameters of 10 nm to 300 nm (p0136), which overlaps with the claimed range of a diameter of the output hole is greater than or equal to 0.2 µm and less than or equal to 1 µm and therefore, establishes a case of prima facie obviousness (MPEP 2144.05).
Regarding Claim 4, modified CARTER makes obvious the microfluidic purification device of Claim 1. CARTER further discloses the capture membrane is fabricated by wet etching of silicon-based films through a silicon wafer (i.e., wherein the first MEMS filter is made of a silicon wafer; p0155).
Furthermore, the limitation “the first MEMS filter is made of a silicon wafer” is directed toward a product-by-process limitation in that the limitation requires the first MEMS filter to be made of (i.e., a fabrication step/process) a silicon wafer. Because the prior art discloses a product that appears to be the same as the product set forth in this product-by-process claim, although produced by a different process, the claim is directly read on by the prior art (see In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985); MPEP §2113). Additionally, although the immediate claim is a product-by-process claim and is limited by and defined by its process, the determination of patentability is based on the product itself, not on the method of production. Thus, these process limitations do not further limit the claimed product.
Regarding Claim 5, modified CARTER makes obvious the microfluidic purification device of Claim 1. YAGI further discloses outlet 14 which allows for particles that did not pass through the filter 30 to be discharged from the device 1 (i.e., a second outlet valve, connected with the first input chamber; p0045; FIG. 1B).
The limitation “to pump out multiple cells of the output solution” is directed to an intended use of the claimed purification device and more specifically of the second outlet valve. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 6, modified CARTER makes obvious the microfluidic purification device of Claim 1. In a configuration shown in FIG. 11, CARTER further discloses a second washed filtrate 130A line separate from the second filtrate line 130 leading from the capture membrane 210 (i.e., a second inlet valve, connected with the output chamber).
The limitation “to drain out the exosomes” is directed to an intended use of the claimed purification device and more specifically of the second inlet valve. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 7, modified CARTER makes obvious the microfluidic purification device of Claim 1. Modified CARTER is deficient in disclosing the controller is configured to drive an amplitude, a duty cycle and/or a duration control of the ultrasound vibrator. However, YAGI further discloses that a control unit 150 supplies a drive signal to the piezoelectric element 40 to control the vibration (p0087); although YAGI is deficient in explicitly disclosing amplitude, duty cycle, and/or duration control, the disclosure of a “drive signal” to the piezoelectric element inherently implies control of at least one of an amplitude, duty cycle and/or duration of an ultrasound waveform (i.e., the controller is configured to drive an amplitude, a duty cycle and/or a duration control of the ultrasound vibrator). “[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.” (Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004); MPEP §2112 II).
Regarding Claim 8, modified CARTER makes obvious the microfluidic purification device of Claim 1. While CARTER discloses the use of valves and flow controllers (p0159), CARTER is deficient in explicitly disclosing the controller is configured to control the first inlet valve and the first outlet valve of the filter assembly. However, the disclosure of valves and a “flow controller” inherently implies that a controller is utilized to regulate flow through the disclosed device even though such a control is not explicitly disclosed. “[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.” (Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004); MPEP §2112 II).
Regarding Claim 9, modified CARTER makes obvious the microfluidic purification device of Claim 1. The limitation “for collecting multiple cells of the output solution” is directed to an intended use of the claimed purification device. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II). The limitation requiring that the first input chamber and the first MEMS filter are detachable from the filter assembly is considered obvious to one of ordinary skill in the art. If it were considered desirable for any reason to separate two attached elements, it would be obvious to make elements separable or detachable for that purpose (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961); MPEP §2144.04).
Regarding Claim 10, modified CARTER makes obvious the microfluidic purification device of Claim 1. The limitation “for concentrating the exosomes” is directed to an intended use of the claimed purification device. If a prior art structure is capable of performing the intended use as recited, then it meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II). The limitation requiring that the output chamber is detachable from the filter assembly is considered obvious to one of ordinary skill in the art. If it were considered desirable for any reason to separate two attached elements, it would be obvious to make elements separable or detachable for that purpose (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961); MPEP §2144.04).
Regarding Claim 11, modified CARTER makes obvious the microfluidic purification device of Claim 1. While the prior art is deficient in explicitly disclosing a volume of the output chamber is smaller than a volume of the first input chamber, the claimed limitation only requires any arbitrary volume of the output chamber to be smaller than any arbitrary volume of the first input chamber. Such a limitation is met by the prior art.
Regarding Claim 12, modified CARTER makes obvious the microfluidic purification device of Claim 1. The prior art is deficient in explicitly disclosing a second input chamber and a second MEMS filter. However, such limitations are interpreted as duplications of the first input chamber and the first MEMS filter and thus, would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention. The mere duplication of parts or process steps has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); MPEP §2144.04).
Regarding Claim 13, modified CARTER makes obvious the microfluidic purification device of Claim 12. YAGI discloses the through holes of the filter 30 are appropriately sized according to the size of the particles to be separated, e.g., monocytes ranging from 6.5 µm to 16.8 µm (p0048). Although the prior art is deficient in explicitly disclosing that the output hole has certain dimensions of 10 µm to 50 µm, the only difference between the prior art and the claimed invention is a recitation of the relative dimensions of the devices. Because the claimed invention would not perform differently than that of the prior art, the claimed invention is not patentably distinct (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP §2144.04).
Regarding Claim 14, modified CARTER makes obvious the microfluidic purification device of Claim 12. JACKSON further shows a V-shaped cavity (FIG. 7A).
Regarding Claim 15, modified CARTER makes obvious the microfluidic purification device of Claim 1. YAGI further discloses a piezoelectric element (p0043).
Regarding Claim 19, modified CARTER makes obvious the microfluidic purification device of Claim 1. JACKSON further shows a V-shaped cavity (FIG. 7A).
The limitation “a V-shaped cavity made by a wet etching process” is directed toward a product-by-process limitation in that the limitation requires the V-shaped cavity to be made by (i.e., a fabrication step/process) a wet etching process. Because the prior art discloses a product that appears to be the same as the product set forth in this product-by-process claim, although produced by a different process, the claim is directly read on by the prior art (see In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985); MPEP §2113). Additionally, although the immediate claim is a product-by-process claim and is limited by and defined by its process, the determination of patentability is based on the product itself, not on the method of production. Thus, these process limitations do not further limit the claimed product.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over CARTER et al. (US 2020/0116603 A1) in view of YAGI et al. (US 2012/0125833 A1) and JACKSON et al. (US 2022/0104544 A1) as applied to Claim 15 above, and further in view of RIETMAN et al. (US 2012/0325747 A1).
Regarding Claim 16, modified CARTER makes obvious the microfluidic purification device of Claim 15. Modified CARTER is deficient in disclosing the piezoelectric material is PZT.
However, PZT is a very common piezoelectric transducer, as disclosed by RIETMAN, e.g., PZT-4, PZT-8, etc., and is commonly used in acoustic transducers (i.e., wherein the piezoelectric material is lead zirconate titanate; p0056). All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
Regarding Claims 17 and 18, modified CARTER makes obvious the microfluidic purification device of Claim 15. Modified CARTER is deficient in disclosing the ultrasound vibrator is configured to operate intermittently with a frequency range of greater than or equal to 20 kHz and less than or equal to 200 kHz (Claim 17) or that the frequency range is 40 kHz (Claim 18).
RIETMAN discloses the use of acoustic filtration for particle separation, specifically blood cells and other similarly sized particles, e.g., bacterial spores (p0029, p0040). As noted throughout, ultrasonic transducers can be operated at an appropriate ultrasonic frequency optimized for a specific range of particle sizes (p0005, p0026), e.g., from 10 to 200 kHz (Claim 26). Thus, RIETMAN discloses a range that significantly overlaps with the claimed range of 20 kHz to 200 kHz (Claim 17) and therefore, establishes a case of prima facie obviousness (MPEP 2144.05). Similarly, RIETMAN discloses a frequency range that includes the claimed 40 kHz (Claim 18) and therefore, establishes a case of prima facie obviousness (MPEP 2144.05). Thus, one of ordinary skill in the art would find it obvious to operate the ultrasound vibrators of modified CARTER from 20 to 200 kHz or at 40 kHz because such frequencies are made obvious by RIETMAN. The nature of the problem to be solved would have led one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
Even further, the instant limitations wherein the ultrasound vibrator is configured to operate at a specific frequency range or value are directed toward manners or methods by which the claimed device is utilized. The manner or method in which an apparatus is to be utilized is not subject to the issue of patentability of the apparatus itself (In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); MPEP §2115). The prior art already shows that such ultrasound vibrators are known in the art, i.e., the method by which such vibrators are used is not subject to patentability.
Response to Arguments
Applicant’s amendments filed 19 November 2025 have been fully considered.
Amendments to Claims 1, 6, 9, 10, 11, 16, and 18 have addressed the Claim Objections of Claims 1, 6, 9-11, and 18. These objections have been withdrawn. Please note the added Claim Objections of Claim 1.
The terminal disclaimer filed 19 November 2025 renders moot the nonstatutory double patenting rejections of Claims 1-19 over Claims 1-13 of copending Application No. 18/128,441 and over Claims 1, 2, 4-6, 8, 10, and 15 of copending Application No. 18/362,312. These rejections have been withdrawn.
Applicant’s amendments to Claim 1 are persuasive. The previous rejection of Claim 1 under 35 U.S.C. 103 as being unpatentable over CARTER et al. (US 2020/0116603 A1) in view of YAGI et al. (US 2012/0125833 A1) has been withdrawn. However, upon further search and consideration, new grounds of rejection have been made for Claim 1 under 35 U.S.C. 103 as being unpatentable over CARTER et al. (US 2020/0116603 A1) in view of YAGI et al. (US 2012/0125833 A1) and further in view of JACKSON et al. (US 2022/0104544 A1).
Applicant’s arguments filed 19 November 2025 have been considered but are not persuasive because they are directed to grounds of rejection that have been withdrawn. Therefore, the arguments are not commensurate in scope with the presently pending claims.
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 RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan B Huang/Primary Examiner, Art Unit 1777
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