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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/19/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/03/2025 was filed after the mailing date of the final office action on 09/30/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The amendment filed 11/25/2025 has been entered. Claims 1-9, 13, 17, 19, 20, 22-25, 27, 28 and 30 are pending and under consideration.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that the combination fails to teach “urging, via the pump, at least a portion of at least one solution from the solution container into the drug product container”; and “delivering from the drug product container to the patient, via the pump, a mixture of the drug product and at least a portion of the at least one solution”, because McNall fails to disclose a method which involves selectively fluidly connecting a solution container to a drug product container. It follows that McNall must also fail to disclose any subsequent steps that depend upon such a selective connection as claimed above. Furthermore, Demers teaches in the drug after being reconstituted must flow into and through a mixing chamber 18 prior to reaching the destination reservoir/patient, and Demers’ mixing chamber 18 does not correspond to the claimed “drug product container” as it does not initially contain the Demers’ drug – nor is the mixing chamber 18 where Demers’ drug is mixed with a diluent and/or a solution. Rather, Demers drug is initially contained in reservoirs 16. Accordingly, Demers fails to disclose at least the amended aspect of claim 1 above.
This is not found persuasive. the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, a person of ordinary skill seeking to improve automated drug preparation device that requires both reconstitution (diluent) and further mixing additional solution, would be motivated to integrate Demers’ system enabling selectively connecting plurality of reservoirs that contains different fluid ([0038]-[0041]) and manifold comprises valves and fluid passageways selectively connect one of the diluent container to the McNall’s drug product container.
Applicant further argues that it is an improper use of hindsight relying on knowledge derived from applicant’s disclosure as modifying McNall to achieve amended claim 1 would appear to require non-trivial changes to the design and operation of McNall’s device, including reconfiguring its internal flow pathways without comprising their intended sterility.
This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Both McNall and Demers operate in the field of automated drug preparation. A person of ordinary skill seeking to improve automated drug preparation device that requires both reconstitution and further mixing additional solution would look to the manifold and reservoir architecture of Demers. Integrating a manifold into a fluid circuit is routine skill in the art with a reasonable expectation of success, as controlling fluid passageways with valves are highly predictable.
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 1, 2, 9, 13, 22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McNall et al (US 20170232187 A1) in view of Demers (US 20150257974 A1).
Regarding Claim 1, McNall substantially teaches applicant' s claimed invention, and specifically discloses a device with every structural limitation of applicant' s claimed invention (except for the limitations shown in italics and grayed-out) including:
a method of preparing a drug for delivery, the method comprising:
providing a diluent (figure 3 and [0013] diluent stored in a diluent reservoir 12) contained in a diluent container;
providing a drug product (figure 3 and [0013] drug stored in the drug reservoir 13) contained within a drug product container;
selectively fluidly connecting one of the diluent container and a solution container and the drug product container (figure 3 and [0020] the diluent reservoir 12 and drug reservoir 13 are fluidly connected by fluid communication path 62); and
urging, via a pump (figure 3 and [0035], pump assembly 150), at least a portion of the diluent from the diluent container into the drug product container to at least partially reconstitute the drug product (figure 3 and [0035]-[0036] pump assembly 150 is configured to urge diluent from the diluent reservoir to a drug reservoir).
urging, via the pump, at least a portion of at least one solution from the solution container into the drug product container; and
delivering from the drug product container to the patient, via the pump, a mixture of the product ([0054] the pump assembly 150 is configured to pull diluent out of the diluent reservoir 12 through the drug reservoir 13, and dispense mixed fluid from the drug reservoir 13 to patient via administration line 14) and the at least a portion of the at least one solution
McNall does not teach selectively fluidly connecting one of the diluent container and a solution container;
urging, via the pump, at least a portion of at least one solution from the solution container into the drug product container; and
delivering the at least a portion of the at least one solution
In the same field of endeavor, namely a compounder apparatus, Demers teaches selectively fluidly connecting one of the diluent container (figure 1, one of reservoirs 16) and a solution container (figure 1, one of reservoirs 16) into the drug product container (mixing chamber 18, figure 1 and [0039]-[0041] fluid from reservoirs selectively extracted from the manifold into manifold 14 and routed into a mixing chamber 18 );
urging, via the pump, at least a portion of at least one solution from the solution container into the drug product container ([0039]-[0042] urging fluid from one of the reservoirs 16 urged into the mixing chamber 18 by positive pressure); and
delivering a mixture of the product and the at least a portion of the at least one solution ([0042] delivering a mixture of fluid extracted from reservoirs 16 from the mixing chamber 18 to destination reservoir 24).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall to incorporate the teachings of Demers and provide the method as claimed for the purpose of creating multi-ingredient mixture of pharmaceutical as taught by Demers ([0003]). Thereby enhancing the device’s versatility for a broader range of drug preparation while maintaining reliable mixing and dispensing. Such a modification would involve routine skill in the art, such as incorporating additional ports or valves, (e.g., via McNall’s tee 142 or Demers’s selective fluid communication).
Regarding Claim 2, McNall, as modified by Demers, teaches the method of claim 1.
The combination further teaches comprising activating the pump (McNall; [0035] operating the pump assembly).
Regarding Claim 9, McNall, as modified by Demers, teaches the method of claim 1.
The combination further teaches wherein at least one of the following:
(a) the diluent comprises water for injection ("WFI"),
(b) the diluent container is a pliable bag (McNall; [0015] flexible diluent reservoir 12),
(c) the drug product container is a pliable bag,
(d) a solution container is a pliable bag,
(e) a IVSS comprises a pretreating surfactant or polysorbate 80, or
(f) a predetermined quantity of diluent is between approximately 0.5mL and approximately 10mL.
Regarding Claim 13, McNall, as modified by Demers, teaches the method of claim 1.
The combination further teaches comprising at least one of (a) fluidly coupling the diluent container to the drug product container via a sterile connector (McNall; [0020] diluent reservoir 12 is connected to drug reservoir 13 through sterile fluid communication path 62), or (b) fluidly coupling the solution container via a sterile connector.
Regarding Claim 22, McNall teaches a drug delivery system comprising:
a diluent container containing a diluent (figure 3 and [0013] diluent stored in a diluent reservoir 12);
a drug product container containing a drug product (figure 3 and [0013] drug stored in a drug reservoir 13);
at least one fluid path connector (figure 3 and [0020] fluid communication path 62 connects the diluent reservoir and the drug reservoir) configured to at least selectively fluidly connect the diluent container and a solution container to the drug product container; and
a pump (figure 3 and [0035]-[0036] pump assembly 150 is configured to urge the diluent from the diluent reservoir into the drug reservoir to reconstitutes the drug) in working connection with the fluid path connector and configured to:
urge at least a portion of the diluent from the diluent container into the drug product container to at least partially reconstitute the drug product (figure 3 and [0035]-[0036] pump assembly 150 is configured to urge the diluent from the diluent reservoir into the drug reservoir to reconstitutes the drug).
urge at least a portion of the at least one solution from the solution container into the drug product container; and
deliver, from the drug product container, a mixture of the drug product and the at least a portion of the at least one solution to a patient ([0054] the pump assembly 150 is configured to pull diluent out of the diluent reservoir 12 through the drug reservoir 13, and dispense mixed fluid from the drug reservoir 13 to patient via administration line 14).
McNall does not teach at least one fluid path connector configured to at least selectively fluid connect one of the diluent container and a solution container to the drug product container.
urge at least a portion of the at least one solution from the solution container into the drug product container; and
deliver, from the drug product container, the at least a portion of the at least one solution to patient.
In the same field of endeavor, namely a compounder apparatus, Demers teaches least one fluid path connector (figure 1 and [0036], [0039]-[0041] manifold 14 comprising fluid passageways configured to selectively connect one of reservoirs 16) configured to at least selectively fluid connect one of the diluent container (figure 1, one of reservoirs 16) and a solution container (figure 1, one of reservoirs 16) to the drug product container (figure 1, mixing chamber 18).
urge at least a portion of the at least one solution from the solution container into the drug product container ([0039]-[0042] urging fluid from one of the reservoirs 16 urged into the mixing chamber 18); and
deliver, from the drug product container, the at least a portion of the at least one solution to patient ([0042] delivering a mixture of fluid extracted from 16 from the mixing chamber 18 to destination reservoir 24).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall to incorporate the teachings of Demers and provide the drug delivery system as claimed for the purpose of creating multi-ingredient mixture of pharmaceutical as taught by Demers ([0003]). Thereby enhancing the device’s versatility for a broader range of drug preparation while maintaining reliable mixing and dispensing. Such a modification would involve routine skill in the art, such as incorporating additional ports or valves, (e.g., via McNall’s tee 142 or Demers’s selective fluid communication).
Regarding Claim 27, McNall, as modified by Demers, teaches the drug delivery system of claim 22.
The combination further teaches wherein the pump is a peristaltic pump (McNall; [0038] the pump assembly 150 is constructed with at least rollers 156 and a flexible pump tube 143. As the roller rotates, it sequentially compresses and release the tube, propelling fluid forward by a peristaltic action. On that basis, the disclosed device embodies a peristaltic pump).
Claims 3-7, 17 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over McNall et al (US 20170232187 A1) in view of Demers (US 20150257974 A1) and Hanotin et al (US 20140154262 A1).
Regarding Claim 3, McNall, as modified by Demers, teaches the method of claim 1.
The combination does not teach wherein the at least one solution comprises wherein the at least one the solution container contains a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution (“IVSS”) contained within the solution container.
In the same field of endeavor, namely injectable preparation method, Hanotin teaches providing a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution (“IVSS”) contained within a solution container ([0691] physiological saline used in combination with nonionic surfactant [e.g., polysorbate 80]. Examiner’s note, as described in instant application [0029], polysorbate 80 is considered an IV-stabilizing agent”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, as modified by Demers, to incorporate the teachings of Hanotin and provide the claimed method for the purpose of enhancing solubility of specific drug product that requires IVSS solution, as taught by Hanotin ([0691])
Regarding Claim 4, McNall, as modified by Demers and Hanotin, teaches the method of claim 3.
The combination further teaches the method further comprising urging, via the pump, at least a portion of the predetermined quantity of saline solution and the predetermined quantity of IVSS from the solution container into the drug product container (the combination urge the claimed solution from one of the reservoirs into mixing chamber of Demers).
Regarding Claim 5, McNall, as modified by Demers and Hanotin ,teaches the method of claim 3.
The combination does not teach providing a valve configured to selectively fluidly connect one of the diluent container and the solution container to the drug product container
In the same field of endeavor, namely a compounder apparatus, Demers teaches the apparatus comprising a valve configured to selectively fluidly connect one of the diluent container and the solution container to the drug product container (figure 1 and [0039]-[0040] vales on manifold 14 configured to selectively connect one of reservoirs 16 to the mixing chamber 18);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have McNall, as modified by Demers and Hanotin, to incorporate the teachings of Demers and provide the method as claimed for the purpose of creating multi-ingredient mixture of pharmaceutical as taught by Demers ([0003]. Thereby enhancing the device’s versatility for a broader range of drug preparation while maintaining reliable mixing and dispensing. Such a modification would involve routine skill in the art, such as incorporating additional ports or valves, (e.g., via McNall’s tee 142 or Demers’s selective fluid communication).
Regarding Claim 6, McNall, as modified by Demers and Hanotin, teaches the method of claim 5.
The combination further teaches, comprising:
configuring the valve to fluidly connect one of the diluent container and the solution container to the drug product container (Demers; figure 1 and [0039]-[0041] vales on manifold 14 configured to selectively connect one of reservoirs 16 to the mixing chamber 18); and
urging, via the pump, into the drug product container one of at least a portion of the diluent from the diluent container and at least a portion of the predetermined quantity of saline solution and the predetermined quantity of IVSS from the solution container (The proposed combination contains diluent or IVSS + saline solution in one of the reservoirs, and configured to selectively extract desired amount of fluid from one of the reservoirs by the pump of the McNall)
Regarding Claim 7, McNall, as modified by Demers and Hanotin, teaches the method of claim 6.
The combination further teaches comprising:
configuring the valve to fluidly connect the other one of the diluent container and the solution container to the drug product container (Demers; figure 1 and [0039]-[0041] vales on manifold 14 configured to selectively connect one of reservoirs 16 to the mixing chamber 18); and
urging, via the pump, into the drug product container the other one of at least a portion of the diluent from the diluent container and at least a portion of the predetermined quantity of saline solution and the predetermined quantity of IVSS from the solution container (The proposed combination contains diluent or IVSS + saline solution in one of the reservoirs, and configured to selectively extract desired amount of fluid from one of the reservoirs by the pump of the McNall)
Regarding Claim 17, McNall, as modified by Demers and Hanotin, teaches the method of claim 3.
The combination does not expressly teach wherein at least one of (a) the predetermined quantity of saline solution is between approximately 50mL and approximately 500mL, or (b) the predetermined quantity of IVSS is between approximately 1 mL and approximately 30mL.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McNall, as modified by Demers and Hanotin, to have a claimed quantities since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). (MPEP 2144.04(IV)(A)). In the instant case, one of skill in the art motivated to do so for the purpose of providing appropriate amount of diluent for drug reconstitution and patient administration. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “approximately” be within the claimed ranges (specification [0051]).
Regarding Claim 23, McNall, as modified by Demers, teaches the drug delivery system of claim 22.
The combination does not teach wherein the at least one solution comprises a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution (“IVSS”).
In the same field of endeavor, namely injectable preparation method, Hanotin teaches wherein the at least one solution comprises a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution (" IVSS") ([0691] physiological saline used in combination with nonionic surfactant [e.g., polysorbate 80]. Examiner’s note, as described in instant application [0029], polysorbate 80 is considered an IV-stabilizing agent”)
Hanotin provides the aqueous medium comprising saline solution and nonionic surfactant in order to enhance solubility of the drug in the aqueous medium ([0691]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, as modified by Demers, to incorporate the teachings of Hanotin and provide the solution container as claimed for the purpose of enhancing solubility of the drug product in the aqueous solution.
Regarding Claim 24, McNall, as modified by Demers and Hanotin, teaches the drug delivery system of claim 23.
The combination further teaches wherein the pump is configured to urge at least a portion of the predetermined quantity of saline solution and the predetermined quantity of IVSS from the solution container into the drug product container (The combination includes one of the reservoirs contains the predetermined quantity of saline solution and the predetermined quantity of IVSS as taught by Hanotin);
Regarding Claim 25, McNall, as modified by Demers and Hanotin, teaches the drug delivery system of claim 23.
The combination further teaches wherein the at least one fluid path connector comprises a valve configured to selectively fluid connect one of the diluent container and the solution container to the drug product container (Demers; [0039]-[0041] the manifold 14 includes fluid passageways and valves that is configured selectively connect one of the reservoirs 16).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McNall et al (US 20170232187 A1) in view of Demers (US 20150257974 A1) and Hanotin et al (US 20140154262 A1), and in further view of Lavi et al (US 20030023203 A1).
Regarding Claim 8, McNall, as modified by Demers and Hanotin, teaches the method of claim 5.
The combination does not teach wherein the valve comprises a hydrophilic filter.
In the same field of endeavor, namely a drug delivery system, Lavi teaches wherein the valve comprises a hydrophilic filter ([0120]-[0121] hydrophilic membrane positioned in the drug delivery path).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, as modified by Demers and Hanotin, to incorporate the teachings of Lavi and provide the valve comprises a hydrophilic filter for the purpose of preventing gas from being transferred to the drug product container, as taught by Lavi ([0120]-[0121]).
Claims 19 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over McNall et al (US 20170232187 A1) in view of Demers (US 20150257974 A1), and in further view of Howson (US 4722733 A).
Regarding Claim 19, McNall, as modified by Demers, teaches the method of claim 1.
McNall does not teach the method further comprising removing the drug product container and the diluent container from a common kit packaging
In the same field of endeavor, namely a drug handling apparatus and method, Howson teaches comprising removing the drug product container and the diluent container from a common kin packaging (col 6 lines 44-47 “to use the package, the user opens the package and, using sterile procedures, attaches the delivery component (a syringe as specifically described herein) to the diluent vial 15”and figure 1, removing syringe 14 and vials 16 and 15 from packaging 12)
Howson teaches the method comprising step of removing drug handling apparatus from packaging in order to maintain dry and sterile environment until the package is opened (col 4 lines 60-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, as modified by Demers, to incorporate the teachings of Howson and provide the method comprising a step of removing the prefilled delivery container and the drug container from a common kit packaging, and one of skill in the art motivated to do so, for the purpose of maintaining the system under sterile and dry condition.
Regarding Claim 28, McNall teaches the drug delivery system of claim 22.
The combination does not teach wherein the diluent container, the drug product container, and the pump are from a common kit packaging, wherein the common kit packaging, or further includes the solution container and the at least one fluid path connector.
In the same field of endeavor, namely a drug handling apparatus and method, Howson teaches wherein the diluent container, the drug product container, and the pump are from a common kit packaging (figure 1, packaging 12), wherein the common kit packaging (figure 1, receptacles 15 and 16 storing drug 23 and diluent 22 as shown figures 2 and 3), or further includes the solution container and the at least one fluid path connector
Howson teaches the kit containing prefilled receptacles in order to maintain dry and sterile environment until the package is opened (col 4 lines 60-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall to incorporate the teachings of Howson and provide system as claimed, and one of skill in the art motivated to do so, for the purpose of maintaining the system under sterile and dry condition.
Claims 20 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over McNall et al (US 20170232187 A1) in view of Demers (US 20150257974 A1), and in further view of Clube (US 20190038730 A1).
Regarding Claim 20, McNall, as modified by Demers, teaches the method of claim 1.
McNall does not teach wherein the drug product is in the form of a bispecific T cell engager (BiTE®), or the BiTE® is a half-life extended (HLE) BiTE®
In the same field of endeavor, namely a method of therapy, Clube teaches the drug product comprises a half-life extended bispecific T Cell engager ([0144]-[0154] providing CAL immune cells with bridging agent such as BiTEs or other bispecific T-cell engagers”).
Clube provides the CAL immune cells with bridging agent such as bispecific T-cell engagers in order to control potent the immunotherapy and avoid unwanted over-activity of cell therapies in a patient ([0154]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, as modified by Demers, to incorporate the teachings of Clube and provides the drug product as claimed, and one of skill in the art motivated to do so, for the purpose of controlling potent the therapy.
Regarding Claim 30, McNall teaches the drug delivery system of claim 22.
The combination does not teach wherein the drug product is in the form of a bispecific T cell engager (BiTE®), or the BiTE® is a half-life extended (HLE) BiTE®
In the same field of endeavor, namely a method of therapy, Clube teaches the drug product comprises a half-life extended bispecific T Cell engager ([0144]-[0154] providing CAL immune cells with bridging agent such as BiTEs or other bispecific T-cell engagers”).
Clube provides the CAL immune cells with bridging agent such as bispecific T-cell engagers in order to control potent the immunotherapy and avoid unwanted over-activity of cell therapies in a patient ([0154]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNall, to incorporate the teachings of Clube and provides the drug product as claimed, and one of skill in the art motivated to do so, for the purpose of controlling potent the therapy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SETH HAN/Examiner, Art Unit 3781