DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Status of the Claims
The listing of claims filed 2 June 2023 has been examined.
Claims 1–22 are pending. Claims 2, 4–18, 21, and 22 are amended.
Priority
The instant application was filed 2 June 2023; is a national stage application of PCT/GB2021/053142, filed 1 December 2021, and claims priority to IN 202021052501, filed 2 December 2021. Acknowledgment is made of applicant’s claim for foreign priority and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 September 2023 is acknowledged and has been considered.
Claim Rejections - 35 U.S.C. § 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.
The MPEP explains the purposes of the definiteness requirement relate to clarity:
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what the inventor or a joint inventor regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability.
MPEP § 2173.02 (emphasis added).
The Federal Circuit has stated the patent drafter is in the best position to improve clarity by resolving any ambiguities in a claim during prosecution:
We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008).
(i) Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 20 recites, “the composition is in the form of a kit.”
A claim is indefinite when it contains a word or phrase whose meaning is unclear. MPEP § 2173.05(e). The term “kit” is not defined in the specification. A common dictionary definition for “kit” is “a packaged collection of related materials” or “a container for any of such sets or collections.” (Merriam-Webster, available at https://www.merriam-webster.com/dictionary/kit, accessed 10 September 2025). As used in the claim, it is unclear whether the composition comprising a compound of formulae 1 or 2 is somehow formulated into a container or if it was intended for the claim to cover a container (kit) comprising the composition.
Appropriate correction is required.
If a “kit” claim was intended, Examiner recommends an independent claim reciting something like: “A kit comprising a compound of formula 1 . . .”
(ii) Claim 16 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 recites, “other standard of care drugs such as revefenacin or molnupiravir.”
A claim is indefinite when it contains words or phrases whose meaning is unclear. MPEP § 2173.05(e). The term “other” implies there was a previous “standard of care drugs” set forth in the claims. Because the claims from which claim 16 depends do not recite “a standard of care drugs,” the term “other standard of care drugs” lacks antecedent basis. Further, it is unclear if the compound of formulae 1 or 2 are considered “standard of care drugs.”
The term “standard of care” is not defined in the specification. As such, it is unknown what standard applies. For example, in the US, does the term refer to FDA approved drugs? Does the term refer to a drug having a long track record of safety and efficacy? Although the specification and claims list several antiviral agents (Remdesivir, Favipiravir, Hydroxychloroquine, Chloroquine, Dexamethasone, Budesonide, Formoterol, Arformoterol, Glycopyrronium, or Ciclesonide), those are listed as merely exemplary. Therefore, the meaning of the term is not clear.
Appropriate correction is required.
Examiner recommends deleting the phrase and reciting the specific standard for comparison without exemplary language (“such as”).
(iii) Claims 1–22 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In this case, the claims set forth a broad limitation (e.g., “or derivative thereof,” “coronaviridae virus,” “standard of care drugs”) followed by a narrow limitation (e.g., “including a compound of formula 2,” “in particular infection by COVID-19,” and “such as revefenacin or molnupiravir”). The broad and narrow limitations are joined using the terms “including,” “in particular,” and “such as.” The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claims which to not correct for the indefiniteness in the claim(s) from which they depend are included in the rejection.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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.
Claims 1–6 and 8–22 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed.Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claim invention in view of the specification: instant claims 1–5, 8–11, and 13–20 recite “a pharmaceutically acceptable form or derivative thereof.” Claim 7 is not rejected because it defines that phrase as “an acid addition salt.” Claims 6, 12, 21, and 22 incorporate the phrase via claim dependency without defining its meaning.
The Specification does not provide an explicit definition of “a pharmaceutically acceptable form or derivative thereof.” Rather, the specification merely provides examples of what that phrase could mean and encompass:
Suitable pharmaceutically acceptable forms or derivatives include pharmaceutically acceptable salts, including acid addition salts, pharmaceutically acceptable solvates, pharmaceutically acceptable hydrates, pharmaceutically acceptable anhydrates, pharmaceutically acceptable enantiomers, pharmaceutically acceptable esters, pharmaceutically acceptable isomers, pharmaceutically acceptable polymorphs, pharmaceutically acceptable prodrugs, pharmaceutically acceptable tautomers, pharmaceutically acceptable complexes etc.
(Spec., p.10).
Based on the characterization in the specification, the phrase “a pharmaceutically acceptable form or derivative thereof” encompasses any type of isomer or complex of a compound of formulae 1 or 2, in addition to any salt, ester, prodrug, etc. The Specification includes a list of salts. (Id.). The Specification includes an example of a fumarate salt. (Id., p.15). The Specification, however, does not include any examples of isomers or complexes, including methods of making or using such derivatives.
(B) The extent and content of the prior art: Examiner is not aware of prior art that shows the claimed-but-not-described subject matter would have been known or obvious to one of ordinary skill in the art. Accordingly, Applicant’s disclosure is critical to show possession.
(C) The maturity of the science or technology: the compounds of Formula 1 and 2 are known in the art, but derivatives such as isomers and complexes of those compounds are not evident in the current record. The term “isomer” is broad and includes structural isomers in addition to stereoisomers. The term “complex” can refer to a combination of a compound of Formula 1 or 2 and another component, such as a metal ion, a cage structure, etc. Examiner is not aware of a disclosure of such compounds and/or whether such compounds are useful for treating an infection caused by coronaviridae virus; therefore, the science is in its infancy.
(D) The predictability of the aspect at issue: the pharmaceutical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires each potential drug candidate to be assessed for physiological activity. (Id.). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. In this case, there is no evidence suggesting the claimed invention is more predictable than the pharmaceutical art is generally.
The question of written description
When the above factors and the evidence of record are considered as a whole, the Specification (in view of the prior art) does not adequately describe a representative number of species to support the claimed invention to “a pharmaceutically acceptable form or derivative” of a compound of formula 1 or 2. The claimed invention is directed to a sophisticated and unpredictable science that is in an infant stage of development for the treatment of infection caused by coronaviridae virus and there are no examples of derivatives provided in the Specification other than addition salts. The scope of such derivatives extends to thousands of different compounds and the Specification provides a very limited number of species. Thus, the Specification would not reasonably convey to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.
Examiner recommends amending the claims to replace “a pharmaceutically acceptable form or derivative” with “a pharmaceutically acceptable salt thereof” and/or other subject matter having support by the Specification.
Claim Rejections - 35 U.S.C. § 102
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.
(i) Claims 3, 4, and 11 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 9,227,990 (“Phull”).
Phull discloses the compound of formula 1. (Phull, 3:37–60) (col:lines).
Phull discloses a pharmaceutical composition comprising the compound of formula 1 “for use in treating viral infections.” (Id., 8:64–9:34).
Phull discloses the compound of formula 1 can be formulated for administration by any appropriate route (e.g., oral, nasal). (Id., 13:30–33).
Examiner acknowledges that Phull does not disclose COVID-19. However, a clause such as “for use in the treatment of infection by coronaviridae virus” in the claims is intended use. Intended use language is not given much patentable weight unless the language results in a structural difference. (MPEP § 2111.02(II)). Examiner does not consider the intended use language recited in the instant claims to result in a structural difference for the claimed composition. As such, the disclosure in the cited reference need only be capable of the intended use. In this case, Phull discloses the compound is “for use in treating viral infections.
(ii) Claims 3, 4, 11, and 19–21 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by WO2018/167515 (“Phull-2”).
Phull-2 discloses the compound of formula 1. (Phull-2, 24:5) (page:line).
Phull-2 discloses a pharmaceutical composition comprising the compound of formula 1. (Id., 26:9–12).
Phull-2 discloses the compound of formula 1 can be formulated for administration by any appropriate route (e.g., oral, nasal). (Id., 26:4–7).
Phull-2 discloses a composition comprising the compound of formula 1 together with “one or more further active pharmaceutical ingredients.” (Id., 26:9–12).
Examiner acknowledges that Phull-2 does not disclose COVID-19. However, a clause such as “for use in the treatment of infection by coronaviridae virus” in the claims is intended use. Intended use language is not given much patentable weight unless the language results in a structural difference. (MPEP § 2111.02(II)). Examiner does not consider the intended use language recited in the instant claims to result in a structural difference for the claimed composition. As such, the disclosure in the cited reference need only be capable of the intended use. In this case, Phull-2 discloses the compound is “antiviral.” (Id., Title; 1:18–20).
Examiner acknowledges that Phull-2 does not disclose “instructions for their administration to a patient in need thereof.” However, printed matter that is not structurally or functionally related to the physical substrate (i.e., composition) is not given patentable weight. In this case, a new and nonobvious functional relationship between the substrate and the printed matter has not been claimed or established. (MPEP § 2111.05).
Claim Rejections - 35 U.S.C. § 103
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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claim 22 is rejected under 35 U.S.C. § 103 as being unpatentable over Phull in view of US 2015/0105350 (“Ramanathan”) and Smee et al., Antimicrobial Agents and Chemotherapy (2010), 54(1), 126–133 (“Smee”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Phull discloses the compound of formula 1. (Phull, 3:37–60) (col:lines).
Phull discloses a pharmaceutical composition comprising the compound of formula 1 “for use in treating viral infections.” (Id., 8:64–9:34).
Phull discloses the compound of formula 1 can be formulated for administration by any appropriate route (e.g., oral, nasal). (Id., 13:30–33).
Ramanathan discloses tenofovir, a kit comprising tenofovir, and a method of treating a viral infection with tenofovir or a combination of tenofovir and another antiviral. (Ramanathan, ¶¶42 –43; claim 24).
Smee discloses a combination therapy for treating the influenza virus. Smee states: “More potent antiviral therapy can be achieved by using drugs in combination . . . Such treatment can slow down the emergence of drug-resistant viruses.” (Smee, p. 126). Smee discloses the combination of favipiravir (T-705) with other antivirals for the treatment of influenza viruses. (Id.).
Ascertaining the differences between the prior art and the claims at issue
Phull does not disclose a combination therapy comprising a compound of formulae 1 or 2 and Remdesivir, Favipiravir, Hydroxychloroquine, Chloroquine, Dexamethasone, Budesonide, Formoterol, Arformoterol, Glycopyrronium, or Ciclesonide.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include data for a combination therapy.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Phull, Ramanathan, and Smee to arrive at the claimed combination of antiviral compositions because Phull and Ramanathan are directed to tenofovir, tenofovir derivatives, and combination therapies comprising tenofovir; and Smee recognizes that a combination of antivirals including favipiravir reduces the chance of drug resistance and increases the effectiveness of treating the infection. Thus, one of ordinary skill in the art would have been motivated to combine tenofovir with other antiviral agents suitable for treating respiratory diseases because it was known at the time of filing that combination therapy is effective for treating viral infections. There would have been a reasonable expectation of success at arriving at the claimed invention because the combination of antiviral therapies was established in the art.
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804(I)(B)(1). For a reply to a non-final Office action, see 37 CFR § 1.111(a). For a reply to final Office action, see 37 CFR § 1.113(c). A request for reconsideration while not provided for in 37 CFR § 1.113(c) may be filed after final for consideration. See MPEP § 706.07(e) and § 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
(i) Claims 3, 4, 11, and 19–22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–5, 11, and 13–16 of U.S. Pat. No. 9,227,990 (reference claims).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same compound, salts thereof, and composition thereof. While the instant claims recite “for use in the treatment of infection caused by coronaviridae virus,” that language merely states an intended use, which is not given much patentable weight unless the language results in a structural difference. (MPEP § 2111.02(II)). Examiner does not consider the intended use language recited in the instant claims to result in a structural difference compared to the reference claims. As such, the compound or composition in the reference claim need only be capable of the intended use. And while the instant claims 19–22 require a combination of antiviral compounds, the reference claim 16 is open-ended (i.e., it uses the transitional phrase “comprising”) and it is broad enough to encompass additional antivirals. Accordingly, an infringer of a patent granted based on the claims of the instant application would also be an infringer of the reference claims.
(ii) Claims 3, 4, 11, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–3 and 9 of U.S. Pat. No. 12,090,163 (reference claims).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same compound and/or composition thereof. While the instant claims recite “for use in the treatment of infection caused by coronaviridae virus,” that language merely states an intended use, which is not given much patentable weight unless the language results in a structural difference. (MPEP § 2111.02(II)). Examiner does not consider the intended use language recited in the instant claims to result in a structural difference compared to the reference claims. As such, the compound or composition in the reference claim need only be capable of the intended use. And while the reference claims require an additional antiviral compound not provided in the instant claims, the instant claims are open-ended (it uses the transitional phrase “comprising”), which means they are broad enough to encompass the additional agents in the reference claims. Accordingly, an infringer of a patent granted based on the reference claims would also be an infringer of the instant claims.
Conclusion
No claims are allowed.
Communication
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623