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 .
DETAILED ACTION
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 217-236 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,491,353. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 217-236 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,724,132. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 217-236 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,097,392. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 217-236 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,427,345. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a similar method for treating the brain administer with drug using ultrasound.
Claims 217-236 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-6,9,16,21-22,28-29,32-33,35-41,43,45,47 and 49-52 of copending Application No. 18/215515. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a method perform by the device in the application 18/215515.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35-36 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Limitation “circulating a fluid in the one or more cooling channels of the cooling system…wherein the cooling system is placed between the skin surface and the ultrasound transducer array and is removably attached to the ultrasound transducer array” is not in the specification. Fig. 18A and [0215] discloses a cap with cooling loop, Figs.57-59F and [0436] discloses replaceable bezel cooling system. They are two different embodiments. No single embodiment discloses by the specification have the limitation.
Claim Rejections - 35 USC § 103
1. 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.
2. Claims 217-220 and 223 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Kajitani et al. (US 2010/0228523), further in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)) and Liu et al. (US 2018/0207447 (provided in the IDS)).
3. Addressing claim 217, Hynynen discloses a method of using ultrasound to facilitate drug delivery across a blood brain barrier, the method comprising (see [0003-0004] and [0101]):
administering a drug to a subject (see [0004]),
applying ultrasound waves to activate the drug in the subject to induce a temporary disruption that opens a blood brain barrier in a head of the subject, thereby facilitating penetration of the drug to a brain in the head of the subject (see [0003-0004]; Hynynen disclose ultrasound work done on using ultrasound to disrupt blood-brain barrier to deliver and activate drug),
wherein the ultrasound waves are driven at a frequency in a range of 20 kHz to 12 MHz (see [0042] and [0044]),
temporal average intensity (see [0047]; adjust duty adjust the temporal average intensity; temporal average intensity implicitly disclose);
wherein the ensonification drive patterns comprise alternating drive patterns, each of the alternating drive pattern utilizing a subset of the piezoelectric transducer elements to generate the ultrasound waves (see [0100] and claim 21; the specification is unclear as alternating drive pattern is; the specification is not clear as a subset is drive with pattern A then alternate to drive with pattern B; examiner interprets the claim limitation as a subset is driven with pattern A and a different sub-set is driven with different/alternate pattern B; Hynynen discloses having different subset that are drive to operate at different frequencies pattern; first subset is driven to operate at first frequency then second subset is driven to operate at an alternate second frequency).
Hynynen does not disclose wherein the ultrasound waves are driven by a signal to generate the incoherent distributed acoustic pressure field, transducer elements driven by a signal having randomized phase; wherein the drug preferentially accumulates in tumor cells in the brain of the subject, wherein the activated drug causes apoptosis of the tumor cells; wherein the signal is configured to produce the ultrasound waves comprising a temporal-average intensity output in a range of 1-30 W/cm2. Kajitani discloses transducer element driven by a signal having randomized phase (see [0018]; driving signal with modulate phase by a random signal produce a driving signal with randomly modulated phase; a random phase produces incoherent acoustic signal/field; Hynynen discloses array of multi transducer elements). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have discloses wherein the ultrasound waves are driven by a signal to generate the incoherent distributed acoustic pressure field, a plurality of ultrasonic piezoelectric transducer elements driven by a plurality of signals having randomized phase differences across at least a portion of the plurality of ultrasonic piezoelectric transducer element as taught by Kajitani because this eliminate an effect of residual vibration of piezoelectric and increase correlativity (see abstract and [0036]). Hynynen discloses an array of transducer (a plurality of ultrasonic piezoelectric transducer elements) and Kajitani discloses transducer element driven by a signal having randomized phase therefore Hynynen modify by Kajitani discloses wherein the ultrasound waves are emitted by a plurality of ultrasonic piezoelectric transducer elements driven by a plurality of signals configured to generate ensonification drive patterns comprising randomized phase differences amongst at least a portion of the plurality of ultrasonic piezoelectric transducer elements to generate the incoherent distributed acoustic pressure field. Also, since Kajitani discloses transducer element driven by a signal having randomized phase then a phase difference between first and second acoustic ensonification drive patterns would be randomized.
Lacoste discloses intensity output in a range of 1-30 W/cm2 (see Fig. 21, [0041], [0056], [0128] and [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to emit planar ultrasound wave as taught by Lacoste because this is common intensity range that avoid injury to the patient. Examiner only provide evidences for a common intensity range.
Liu discloses wherein the drug preferentially accumulates in tumor cells in the brain of the subject, wherein the activated drug causes apoptosis of the tumor cells (see [0044-0045]; the drug accumulates in GBM tumor cells and activate by ultrasound to cause cell apoptosis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have sonosensitizer drug accumulate at cancer treatment tissue/cell to cause cell apoptosis as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
4. Addressing claims 218-220 and 223, Hynynen discloses:
regarding claim 218, wherein applying ultrasound waves comprises emission from an ultrasound transducer array comprising a plurality of ultrasonic piezoelectric transducer elements (see abstract and [0042]; 64, 128, etc. piezo elements).
regarding claim 219, wherein the plurality of ultrasonic piezoelectric transducer elements is configured to generate the incoherent acoustic pressure field via an aperture sized and configured with an energy profile to saturate a large treatment volume to ensure treatment of the tumor cells (see Fig. 1A, C, 2A; Hynynen discloses transducers element with aperture size that saturate the brain to ensure treatment of the tumor cells; Kajitani discloses wherein the ultrasound waves are driven by a signal to generate the incoherent acoustic pressure field, (see [0018]; driving signal with randomly modulated phase produce incoherent acoustic signal/field)).
regarding claim 220, wherein the aperture size is selected to be larger than a size of the tumor cells, such that an aspect ratio of the aperture size to the size of the tumor cells enables initiation of the incoherent acoustic pressure field to treat the tumor cells and extraneous cancer cells in the brain (see Figs. 1A and 1C; only 3 transducers to cover the whole skull so the aperture of the transducer is larger than a tumor/cancer cell; Kajitani discloses wherein the ultrasound waves are driven by a signal to generate the incoherent acoustic pressure field, (see [0018]; driving signal with randomly modulated phase produce incoherent acoustic signal/field).
regarding claim 223, administering microbubbles to the subject (see [0004] and [0101]).
5. Claims 221-222 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Kajitani et al. (US 2010/0228523), further in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)), Liu et al. (US 2018/0207447 (provided in the IDS)) and Friedman et al. (US 6,613,005).
6. Addressing claims 221-222, Hynynen does not explicitly disclose wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the plurality of ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm. Friedman explicitly discloses wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm (see col. 5, lines 8-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm as taught by Friedman because this size cover the entire surface of treatment area (see col. 5, lines 1-15).
7. Claims 224-227 and 230-234 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)) and in view of Liu et al. (US 2018/0207447 (provided in the IDS)) and in view of Kajitani et al. (US 2010/0228523).
8. Addressing claim 224, Hynynen discloses a method of using ultrasound to facilitate drug delivery across a blood brain barrier, the method comprising (see [0003-0004] and [0101]):
administering a drug to a subject (see [0004]),
applying ultrasound waves to activate the drug in the subject to induce a temporary disruption that opens a blood brain barrier in a head of the subject, thereby facilitating penetration of the drug to a brain in the head of the subject (see [0003-0004]; Hynynen disclose ultrasound work done on using ultrasound to disrupt blood-brain barrier to deliver and activate drug),
wherein the ultrasound waves are driven at a frequency in a range of 20 kHz to 12 MHz (see [0042] and [0044]),
Hynynen does not disclose wherein the drug preferentially accumulates in tumor cells in the brain of the subject, wherein the activated drug causes apoptosis of the tumor cells and generating ultrasound waves using driving signal with randomize phase. Liu discloses wherein the drug preferentially accumulates in tumor cells in the brain of the subject, wherein the activated drug causes apoptosis of the tumor cells (see [0044-0045]; the drug accumulates in GBM tumor cells and activate by ultrasound to cause cell apoptosis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have sonosensitizer drug accumulate at cancer treatment tissue/cell to cause cell apoptosis as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
Kajitani discloses (see [0018]; Hynynen discloses multi-elements transducer driving by signals; ultrasound driven by randomize phase signal produce incoherent acoustic signal/field). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have ultrasound waves using a plurality of ultrasonic piezoelectric transducer elements driven by a plurality of signals having randomized phase differences across at least a portion of the plurality of ultrasonic piezoelectric transducer elements as taught by Kajitani because this eliminate an effect of residual vibration of piezoelectric and increase correlativity (see abstract and [0036]). ]). Hynynen discloses an array of transducer (a plurality of ultrasonic piezoelectric transducer elements) and Kajitani discloses transducer element driven by a signal having randomized phase therefore Hynynen modify by Kajitani discloses wherein the ultrasound waves are emitted by a plurality of ultrasonic piezoelectric transducer elements driven by a plurality of signals configured to generate ensonification drive patterns comprising randomized phase differences amongst at least a portion of the plurality of ultrasonic piezoelectric transducer elements to generate the incoherent distributed acoustic pressure field. Also since Kajitani discloses transducer element driven by a signal having randomized phase then a phase difference between first and second acoustic ensonification drive patterns would be randomized.
9. Addressing claims 225-226, 230 and 234, Hynynen discloses:
regarding claim 225, wherein applying ultrasound waves comprises emitting ultrasound waves from an ultrasound transducer array comprising the plurality of ultrasonic piezoelectric transducer elements, the ultrasound transducer array is configured to conform to the head of the subject (see Fig. 3, abstract, [0032] and [0042]; 64, 128, etc. piezo elements).
regarding claim 226, wherein the plurality of ultrasonic piezoelectric transducer elements is configured to generate the incoherent acoustic pressure field via an aperture sized and configured with an energy profile to saturate a large treatment volume to ensure treatment of the tumor cells (see Fig. 1A, C, 2A; Hynynen discloses transducers element with aperture size that saturate the brain to ensure treatment of the tumor cells; Kajitani discloses wherein the ultrasound waves are driven by a signal to generate the incoherent acoustic pressure field, (see [0018]; ultrasound driving by randomize signal produce incoherent acoustic signal/field).
regarding claim 230, cooling the head of the subject (see [0136]).
regarding claim 234, administering microbubbles to the subject (see [0004] and [0101]).
Addressing claims 231-233, Liu discloses:
regarding claim 231, wherein administering the drug comprises an oral administration or an injection (see [0044]).
regarding claim 232, wherein the drug comprises aminolevulinic acid (ALA) (see [0005-0006]).
regarding claim 233, wherein administering the drug results in increased production of protoporphyrin IX via a heme biosynthesis pathway, and wherein the protoporphyrin IX preferentially accumulates in tumor cells in the brain of the subject (see [0044-0045] and [0059]; administered ALA drug to brain tumor; the ALA drug accumulate at the brain tumor and transformed to protoporphyrin IX via a heme biosynthesis pathway to destroy tumor cells).
Addressing claim 27, Kajitani discloses wherein the ultrasound waves are driven by a signal to generate the incoherent acoustic pressure field (see [0018], ultrasound driving by randomize signal produce incoherent acoustic signal/field).
10. Claims 228-229 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Liu et al. (US 2018/0207447 (provided in the IDS)) and further in view of Friedman et al. (US 6,613,005).
11. Addressing claims 228-229, Hynynen does not explicitly disclose wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the plurality of ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm. Friedman explicitly discloses wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm (see col. 5, lines 8-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have wherein the ultrasound transducer array comprises an array dimension of at least 150mm and wherein each of the ultrasonic piezoelectric transducer elements in the plurality of ultrasonic piezoelectric transducer elements comprises a dimension in a range of 0.5mm to 20mm as taught by Friedman because this size cover the entire surface of treatment area (see col. 5, lines 1-15).
12. Claims 235-236 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Liu et al. (US 2018/0207447 (provided in the IDS)) and further in view of Kim et al. (US 2018/0154185).
13. Addressing claim 235, Hynynen discloses a method of using ultrasound to treat tumor, the method comprising (see [0004]; glioblastoma is a type of brain cancer/tumor):
administering a drug to a subject (see [0004]),
acoustically coupling a patient interface to a skin surface of a head of the subject, the patient interface comprising: an ultrasound transducer array, a patient interface, and a cooling system, wherein the ultrasound transducer array comprises at least 16 ultrasound transducer elements, wherein the ultrasound transducer array is configured to emit focused acoustic waves through a skull of the subject, wherein the patient interface is configured to acoustically couple the ultrasound transducer array to the skin surface wherein the patient interface is configured for conforming to the skin surface (see abstract, Fig. 2A, [0042] and [0136]);
generate a signal to actuate the ultrasound transducer array (see Fig. 3, abstract and [0110]);
wherein the ultrasound waves are driven at a frequency in a range between 20 kHz to 12 MHz (see [0042] and [0044]).
modulating a duty-cycle of the signal causing the focused ultrasonic acoustic waves to have high temporal peak acoustic intensity and low temporal average acoustic intensity (see [0004], [0047] and [0141]; high duty cycle lead to a higher temporal peak acoustic intensity and decrease the duty cycle lead to lower temporal average intensity; Hynynen discloses vary the duty cycle; the duty cycle that is not too high and not too low would lead to a balance between high temporal peak acoustic intensity and low temporal average acoustic intensity).
Hynynen does not disclose wherein the drug preferentially accumulates in tumor cells in a brain of the subject; applying focused ultrasound waves to activate the drug resulting in apoptosis of the tumor cells to the brain of the subject; and circulating a fluid in the replaceable cooling system to reduce heat at the head of the subject at the patient interface and place between the skin and the ultrasound transducer. Liu discloses wherein the drug preferentially accumulates in tumor cells in the brain of the subject, wherein ultrasound activated drug causes apoptosis of the tumor cells (see [0044-0045]; the drug accumulates in GBM tumor cells and activate by ultrasound to cause cell apoptosis; Liu also discloses glioblastoma treatment (see abstract and claim 1)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have sonosensitizer drug accumulate at cancer treatment tissue/cell to cause cell apoptosis as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
Kim discloses wherein the cooling system circulating a fluid/gas in one or more cooling channels to reduce heat and the cooling system is replaceable and place between the skin and ultrasound transducer (see Figs. 2-5, [0029], [0039], [0054] and [0057]; ring/column/channel/passage 151/155; separate/replaceable cartridge 150 with cooling passage/column/channel 151/155 is between transducer in handpiece 100 and patient skin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have wherein the cooling system circulating a fluid/gas in one or more cooling channels to reduce heat and the cooling system is replaceable and place between the skin and ultrasound transducer as taught by Kim because this allows fluid to stay cool to keep the tissue cool, increase service life of device and reduce maintenance cost (see [0054]).
Addressing claim 236, Liu discloses:
wherein administering the drug comprises an injection, wherein the drug comprises aminolevulinic acid (ALA) (see [0005] and [0033]).
Response to Arguments
Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive. Applicant argues the references do not disclose alternating drive patterns, each of the alternating drive patterns utilizing a subset of the piezoelectric transducer elements. Applicant’s argument is not persuasive because Hynynen discloses drive each subset of elements with different/alternate pattern of operating frequency (see [0100] and claims 21. New limitation in claim 235 is addressed by new reference Kim.
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 HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793