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 .
Status of Claims
Amendment filed on 10/28/2025 is acknowledged.
Claims 4-5, 9-14, 16, 18-33, 36-37, 40, 42-55, 57-58, 60, 62-66, 68, 70-71, 73-74 remain canceled. Claims 7-8 are now cancelled.
Claims 1, 3, 6, 17, 38-39, 41, 56, and 59 are amended.
Claims 76-78 are new.
Claims 1-3, 6, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 67, 69, 72, and 75-78 are pending and being examined on the merits herein.
Priority
The instant application 18038234, filed on 05/23/2023, is a 371 of PCT/US2160815, filed on 11/24/2021, which claims domestic benefit of 63118622, filed on 11/25/2020.
New/Modified Claim Rejections
The following is new/modified claim rejections necessitated by applicant’s amendment filed on 10/28/2025.
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.
New Matter Rejection
Claims 1-3, 6, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 67, 69, 72, and 75-78 are 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.
Claims 1, 76, and 78 are amended to contain new matter as “resorbable ribs”. The instant specification does not support this material, as Examiner searched through the entire specification and failed to locate such a material in description. As applicant pointed to the paragraphs of [52], [56], [59], [72], [73], and [207] for support of the amendment, there appear to have resorbable materials or resorbable walls, but not “resorbable ribs”; furthermore, “ribs” is shown in Fig. 2 description, being used in a drug delivery device containing permeable membrane without information regarding the ribs being resorbable or not, therefore, the ribs in specification is not the “resorbable ribs” as recited in instant claim 1. Because there is no terminology definition regarding resorbable materials, resorbable walls, or ribs, and especially there is no indication that these terms are interchangeable, since “resorbable ribs” is not present in previous claim set and instant specification, as a result this “resorbable ribs” is new matter.
Claims 2-3, 6, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 67, 69, 72, and 75 are rejected accordingly because they are directly or indirectly depending on claim 1, and they do not clear the new matter issue as addressed above in claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 78 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.
Claim 78 recites “a scaffold defining one or more chambers and contacting one or more semipermeable membranes; wherein the one or more chambers are divided into two or more compartments by one or more resorbable ribs; wherein at least one of the two or more compartments contains a plurality of cells; and wherein at least one of the two or more compartments contains one or more nutrient supplementation systems and does not contain the plurality of cells”. After the one or more chambers being divided into two or more compartments by one or more resorbable ribs, the original one or more chambers may have converted into compartments, thus, they are now compartments contacting resorbable ribs, however, they are supposed to be contacting semipermeable membranes as defined earlier. It is therefore unclear what the differences are between the one or more semipermeable membranes and the one or more resorbable ribs. The claim scope is indefinite.
Claim Interpretation
Claims 1, 76, and 78 are interpreted as below:
Claim 1 is interpreted as a drug delivery device, comprising:
(a) a scaffold comprising one or more biocompatible materials;
(b) one or more chambers containing a plurality of cells;
(c) one or more other chambers, positioned adjacent to (b), containing one or more nutrient supplementation systems and not comprising the plurality of cells;
(d) one or more semipermeable membranes and/or resorbable materials separating the chambers of (b) and (c).
Claim 76 is interpreted as the drug delivery device of claim 1, wherein the one or more resorbable materials comprise a resorbable elastomer.
Claim 78 is interpreted as a drug delivery device comprising:
a scaffold defining one or more chambers,
wherein the one or more chambers are divided into two or more compartments by semipermeable membranes,
wherein at least one of the two or more compartments contains a plurality of cells; and
wherein at least one of the two or more compartments contains one or more nutrient supplementation systems and does not contain the plurality of cells.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “(c) one or more chambers containing …”. The language is suggested to read as “(c) one or more other chambers containing …” in order to differentiate from the chambers in (b).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 69, 72, and 76-78 are rejected under 35 U.S.C. 102 (a)(1) / (a)(2) as being anticipated by Payne et al. (US20030229335, 12/11/2003, IDS of 08/22/2023).
Payne throughout the reference teaches an intravaginal insert device comprising beneficial cells to a treatment for vaginal infections caused by pathogenic microorganisms (e.g., Abstract).
Regarding instant claims 1 and 2, Payne teaches an intravaginal drug delivery device comprises a scaffold comprising a bacterial source surrounded by an outer cover, generating a chamber containing plurality of cells (e.g., [0022]), wherein the outer cover is a microporous membrane made from cellulose, e.g., plant fibers, as biocompatible materials (e.g., [0023-0024]) (corresponding to instant claim 1(a) and 1(b)). Payne indicates within the outer cover a food source (which reads on the instant claimed nutrient) can be intermixed with inactive freeze-dried the bacteria source (Fig. 1; Claim 24) or can be in solution and contained separate from the bacteria source (Fig. 1; [0034]) (corresponding to instant claim 1(c)). Payne specifies that the outer cover is typically a porous membrane having a pore size relative in size to bacteria source so as to not allow bacteria from the bacteria source to permeate to outer cover, but permeable to metabolic byproducts (e.g., [0008]; [0022]; [0024]; Fig. 1), corresponding to semipermeable membrane in instant claim 1 (d)).
Regarding instant claim 3, Payne teaches that the outer cover is made from a sturdy material that will retain its structural integrity during application, use, and removal from the vaginal tract (Fig. 1; [0025]), indicating the biocompatible material is non-resorbable.
Regarding instant claims 15 and 17, Payne discloses its outer cover allows passage of metabolic byproducts produced by the beneficial bacteria Lactobacilli into the vaginal tract creating an environment hostile to pathogenic microorganisms (Abstract; [0007]).
Regarding instant claims 34, Payne teaches that the plurality of cells is enclosed within an outer cover (e.g., [0022]), wherein the outer cover is a microporous membrane made from biocompatible cellulose including wood pulp fibers, cotton fibers, and other plant fibers, or other nonwoven webs including carded fiber webs (or matrix), air laid webs, and the like; microporous membrane materials and construction generally known in the art (e.g., [0024]).
Regarding instant claim 35, Payne specifies that the bacteria source is inactivated by lyophilization (freeze-drying) or other known methods. The freeze-dried bacteria can be in a powder form within the outer cover or encapsulated in hydrogel microspheres [0008], and microspheres can be formed as a hydrogel (e.g., [0018]).
Regarding instant claim 38-39 and 41, Payne teaches that Lactobacilli generally metabolize sugars such as lactose and produce byproducts including small molecules lactic acid and hydrogen peroxide, and the invention can use any species/strain of Lactobacillus depending on the needs of the user [0017].
Regarding instant claim 56, Payne teaches that the outer cover can be a microporous membrane, and it can be semipermeable membrane made from polyesters, polypropylene, polytetrafluoroethylene, and the like; and further, dialysis membranes can be made from cellulose, cellulose acetate, benzolyated cellulose, polyacrylonitrile, and other materials (e.g., [0023]; [0024]).
Regarding instant claim 59, Payne mentions that cellulose outer covers generally provide the desired characteristics for the outer covers, and the vaginal insert can use a backbone member that adds additional support for the vaginal insert (not shown in Fig. 1) [0025], the outer cover also can comprise at least one of cellulose, thermoplastic nonwoven webs, thermoplastic films, dialysis membranes, and combinations thereof (Claim 8), implying multiple layers of materials, membranes or films can be put together, corresponding to a laminated structure as recited in instant claim 59. MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Regarding instant claim 61, Payne presents examples of food sources include without limitation fructoogliosaccharides, glycogen, and combinations thereof ([0033]; Claim 25), Payne demonstrates microparticle formation with bacterial suspension in alginate solution, and the resulting microparticles post being flash frozen and lyophilization can be revived in growth media at 37°C [0041]. Payne concludes that encapsulation and freeze-drying of Lactobacilli is a promising technique for hydrogen peroxide production which may be used in vaginal applications [0042]. This demonstration teaches that the enclosed bacterial cells within the outer cover in the intravaginal insert device would be able to grow with the nutrient source, e.g., culture media, intermixed in outer cover and generate beneficial metabolites, e.g., lactic acid and peroxide, corresponding to nutrient supplementation systems comprising nutrients and cell culture media as claimed.
Regarding instant claim 69, Payne teaches using the intravaginal drug delivery device in human body throughout the reference. As it is common knowledge that human body temperature is 37 °C, it is anticipated that the drug delivery device is physically stable at 37 °C, as Payne demonstrates the use of the invention in treatment of vaginal tract infections in the experiment shown at 37 °C [0037-0041], which falling within the range of about 0-50 °C in instant claim 69. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Furthermore, the physical stability does not provide structural limitation to the drug delivery device, and it constitutes inherent property of the drug delivery device that has been taught by prior art.
Regarding instant claim 72, Payne specifies that using Lactobacilli such as Lactobacillus acidophilus to treat vaginal infections is well known method, treating pathogenic microorganism infections of the vaginal tract to introduce and/or promote colonization of the naturally occurring microorganisms [0004], and the vaginal insert is useful in treating infections of the vaginal tract [0022], by inserting the vaginal insert into a vaginal tract (Claim 31). Therefore Payne teaches the method comprising administering to the subject the drug delivery device as claimed.
Regarding instant claims 76-77, Payne teaches that the outer cover can be a microporous membrane separating the cells and nutrient supplement system as discussed above, and it can be made from polyesters (as an example of resorbable elastomer material), polypropylene, polytetrafluoro-ethylene, and the like; and further, dialysis membranes can be made from cellulose, cellulose acetate, benzolyated cellulose, polyacrylonitrile, and other materials (e.g., [0023]; [0024]).
Regarding instant claim 78, Payne teaches an intravaginal drug delivery device comprises a scaffold comprising a bacterial source surrounded by an outer cover, generating a chamber containing plurality of cells (e.g., [0022]), wherein the outer cover is a microporous membrane (e.g., [0023-0024]) that can include a food source as nutrient supplementation system being contained separate from the bacteria source (Fig. 1; [0034]), therefore generating at least two compartments. Payne specifies that the outer cover is typically a porous membrane having a pore size relative in size to bacteria source so as to not allow bacteria from the bacteria source to permeate to outer cover, but permeable to metabolic byproducts (e.g., [0008]; [0022]; [0024]; Claim 31; Fig. 1), corresponding to semipermeable membrane in instant claim dividing the chambers to hold separately of the nutrients and cells in different compartments.
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 1-3, 6, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 67, 69, 72, and 75-78 are rejected under 35 U.S.C. 103 as being unpatentable over Payne et al. (US20030229335, 12/11/2003, IDS of 08/22/2023), in view of Moss et al. (US20190030306, 01/31/2019, IDS of 08/22/2023).
Payne teaches an intravaginal insert device comprising scaffold comprising biocompatible materials, e.g., cellulose membranes, chamber of Lactobacilli plurality cells, an outer cover of microporous membranes or hydrogel biocompatible matrix comprising polyesters or polypropylene and others, and a food source, e.g., culture media, as nutrient supplementation system for the bacterial cells, wherein the cells can be contained in separate chambers with the nutrient chamber divided by the semipermeable membrane, and the cells can be activated and produce beneficial metabolites like small molecules lactic acid and peroxide which can treat vaginal tract infections from parasitic microorganisms, as discussed above in great detail regarding claims 1-3, 15, 17, 34-35, 38-39, 41, 56, 59, 61, 69, 72, and 76-78, and incorporated herein.
Payne does not teach biocompatible materials can be silicone, polyurethane, poly(ethylene-co-vinyl acetate) (EVA) or a combination thereof as recited in instant claim 6, the drug delivery device as an intravaginal ring (IVR), an intrauterine device (IUD), or a pessary as recited in instant claim 67, and administering the drug delivery device to a subject as a method of contraception as recited in instant claim 75.
Moss directs to a drug delivery device comprising active pharmaceutical ingredient (API), coated with a first layer permeable or semi-permeable to the API, coated with a second layer that is impermeable to the API, having a delivery window to allow passage of the API through the device into body fluids or tissues (Abstract).
Moss defines that the drug delivery device refers to a device comprising one or more pods, a sealing polymer layer and/or one or more delivery channels for internally or externally administering a pharmaceutical compound in a controlled manner [0042], and the pod refers a core (e.g., uncoated, formed API tablet) coated with one or more layers of biocompatible polymers, but without a final sealing polymer layer and/or delivery channel [0041]. Moos specifies that the first coating layer comprises one or more materials selected from polyvinyl alcohol, polyurethane, polylactic acid polymer or combinations thereof (Claim 30), and the second coating layer is selected from the group consisting of silicone, polyethylene, ethylene vinyl acetate (EVA) and combinations thereof (Claim 31) (corresponding to instant claim 6).
Moss teaches that the drug delivery device can be an intravaginal ring delivery device (IVR) ([0053]; [0154]), a diaphragm, a pessary, a suppository, or a punctual plug (Claim 37) (corresponding to instant claim 67).
Moss teaches that the drug delivery device can be used to deliver many drugs, including agents commonly used in topical therapy (e.g., lactic acid for the vaginal tract) [0112], antibiotics [0087], chemotherapeutic agents [0090], specific anti-cancer agents [0092], anticancer or antineoplastic agents [0089], antiviral agents [0095], peptides and proteins (e.g., cyclosporin, insulin, growth hormones, insulin related growth factor, heat shock proteins, antibodies and related compounds) [0107], HIV drugs (e.g., NNRTI, NRTI, protease inhibitor, entry inhibitor) [0100], hormones, e.g., for contraception [0101] (corresponding to instant claim 75).
It would have been prima facie obvious for one with ordinary skills in the art prior to filing date to incorporate the teaching of Moss into Payne to arrive at current invention. Because both devices in Payne and Moss implement biocompatible polymers for coating or shell to enclose active compounds or biomaterials for the same intended use, and Payne indicates that there is no limitation as to the actual shape of vaginal insert, e.g., circular or oval shapes, and it can be appreciated by one skilled in the art following the teachings herein, the size and shape of the vaginal insert can vary depending on need and use [0025], while Moss points out that although intravaginal rings, sub-dermal implants, and pessaries/suppositories are routinely used for the delivery of drugs both topically and systemically to vaginal or rectal tissue, it would be logical for artisans in the field to combine both teachings. Moreover, Moss discloses that the multi-layer containing API device allows for more control over the release of the drugs [0003]. It would have provided reasonable expectation of success to implement the Moss distinctive device comprising characteristic components, such as IVR and contraception method, into the Payne device with bioagents generating beneficial small molecules as drugs. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). It is prima facie obvious to select a known material, e.g., EVA and other known polymers taught by Moss, for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Response to Remarks/Arguments
Applicant’s remarks/arguments filed on 10/28/2025 have been fully considered, but they are not persuasive.
Regarding the arguments about prior art does not teach or suggest a device comprising cells and nutrient supplementation system in separate chambers with are separated by semipermeable membranes, please find the relevant paragraphs addressing this limitation scope in the office action presented above. The most relevant paragraph is copied below for reference:
Regarding instant claims 1 and 2, Payne teaches a intravaginal drug delivery device comprises a scaffold comprising a bacterial source surrounded by an outer cover, generating a chamber containing plurality of cells (e.g., [0022]), wherein the outer cover is a microporous membrane made from cellulose, e.g., plant fibers, as biocompatible materials (e.g., [0023-0024]) (corresponding to instant claim 1(a) and 1(b)). Payne indicates within the outer cover a food source can be intermixed with inactive freeze-dried the bacteria source (Fig. 1; Claim 24) or can be in solution and contained separate from the bacteria source (Fig. 1; [0034]) (corresponding to instant claim 1(c)). Payne specifies that the outer cover is typically a porous membrane having a pore size relative in size to bacteria source so as to not allow bacteria from the bacteria source to permeate to outer cover, but permeable to metabolic byproducts (e.g., [0008]; [0022]; [0024]; Fig. 1), corresponding to semipermeable membrane in instant claim 1 (d)).
Regarding arguments about embodiments of drug delivery devices Payne teach showing differences between the instantly-claimed invention and the prior art. Please see the most relevant paragraph for the reasoning as copied below:
MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Regarding Moss represents a different type of drug delivery system from instantly claimed device, Moss is not combined for teaching the same drug delivery device, rather, it is combined prior art to teach intended use of the drug delivery device, as discussed in office action as presented above.
In conclusion, Payne and Moss teach the instantly claimed invention. Since the remarks/ arguments are based upon amended limitations of the claims, please refer to the entire office action as presented above as a complete response.
Conclusion
No claim is allowed.
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 DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616