DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8 December 2025 has been entered, and the arguments presented therein have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 1-2, 4, 8-16, 18-21, 24, and 28 are 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 1 recites a dry powder microsphere. However, claim 2, which depends upon claim 1, recites a composition in solution form. The skilled artisan would not have expected a composition in solution form to have been a dry powder. As such, it is unclear if the claims are drawn to a dry powder or a composition in solution form.
For the purposes of examination under prior art, the examiner understands that claim 1 is drawn to a dry powder formulation. The examiner will examine claim 2 as if it does not further limit claim 1.
Claims 1-2, 4, 8-16, 18-21, 24, and 28 are 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 1 recites a dry powder microsphere. However, claim 4, which depends upon claim 1, recites a composition in a gel form. The skilled artisan would not have expected a composition in solution form to have been a dry powder. As such, it is unclear if the claims are drawn to a dry powder or a composition in a gel form.
For the purposes of examination under prior art, the examiner understands that claim 1 is drawn to a dry powder formulation. The examiner will examine claim 4 as if it does not further limit claim 1.
Claim 8 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 8 recites that at least a transfection efficacy enhancing agent may be selected from a group consisting of various agents. However, the agents include sodium 2-mercaptoethane sulfonate, which is already recited by claim 1. As such, it is unclear as to whether the scope of claim 8 is the same as the scope of claim 1, or whether claim 8 requires an additional element not recited by claim 1.
For the purposes of examination under prior art, the examiner will proceed with examination under the understanding that the scope of claim 8 is the same as that of claim 1.
Response to Arguments Regarding Indefiniteness Rejections
In applicant’s response on 8 December 2025 (hereafter referred to as applicant’s response), applicant made the following arguments regarding the applied indefiniteness rejections, as of pages 8-9 of applicant’s response.
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This is not persuasive. A composition that was previously in the form of a dry powder microsphere composition that was subsequently combined with water to form a solution or combined with an aqueous solution and a gel-forming polymer to form a gel cannot reasonably be considered to be in the form of dry powder microsphere composition. As such, it is unclear whether claim 2 is drawn to a dry powder microsphere composition or a solution form that is not a dry powder. Similarly, regarding claim 4, it is unclear whether the claim requires a dry powder form or a gel form, that would not appear to be a dry powder.
For the purposes of examination under prior art, the examiner will examine claims 2 and 4 as if they have the same scope as claim 1 upon which claims 2 and 4 depend.
Claim Interpretation
Claim 1 recites a therapeutic nucleic acid and a transfection agent comprising sodium 2-mercaptoethane sulfonate. The examiner clarifies that claim 1 requires that these compounds be together in the same composition. This claim interpretation does not apply to method claims 14-15 and claims dependent thereon.
Claim 16 recites the following, as of the first line of the claim:
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It is the examiner’s understanding that the “4” between the “1” and the “5” has been crossed out. As such, the examiner clarifies that claim 16 depends upon claim 15, not claim 145.
Claim Rejections - 35 USC § 103 – Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4, 8-16, 19-21, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smyth et al. (WO 2021/216541 A1) in view of Rizvi et al. (WO 2022/047047 A1).
Smyth et al. (hereafter referred to as Smyth) is drawn to a dry powder composition comprising polynucleotide molecules complexed with nanoparticles, as of Smyth, title and abstract. Smyth teaches a mass median aerodynamic diameter between about 3.5-4.5 micron, as of Smyth, page 4, paragraph 0009, relevant text reproduced below.
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Smyth teaches various types of polynucleotides including siRNA, mRNA, and DNA, as of page 2, paragraph 0004. Smyth teaches a dry powder inhaler as of at least page 6, paragraph 0012. Smyth teaches a mRNA COVID-19 vaccine, as of at least page 95, paragraph 00306; this is understood to read on the required nucleic acid for vaccination. Smyth also teaches the following, as of page 80, paragraph 00268, relevant text reproduced in part below.
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Smyth also teaches that the nucleic acid may encode a therapeutic protein that codes for an enzyme that is non-functional in a particular disease state, such as CFTR in cystic fibrosis, as of Smyth, page 19, paragraph 0091, reproduced below.
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Smyth does not teach 2-mercaptoethane sulfonate.
Rizvi et al. (hereafter referred to as Rizvi) is drawn to inhalable particles comprising a mucolytic agent to aid delivery, as of Rizvi, title and abstract. Rizvi teaches that the mucolytic is 2-mercaptoethane sulfonate, as of Rizvi, at least page 5 lines 15-20. Rizvi teaches a dry powder sized around 0.1 microns to 5 microns, as of Rizvi, page 42, lines 28-34. The composition of Rizvi may be administered with liposomes, as of Rizvi, page 54, claim 42. The composition of Rizvi may include a therapeutic agent, at least as of Rizvi, page 54, claims 33-41, which list various therapeutic agents, and teaches drugs generically as of at least page 30 lines 28-30. The method of Rizvi teaches dissolution of mucus, as of Rizvi, page 4 lines 26-32.
Rizvi does not teach that the therapeutic agent is a nucleic acid.
It would have been prima facie obvious for one of ordinary skill in the art to have delivered the nucleic acid of Smyth using the 2-mercaptoethane sulfonate containing drug delivery system of Rizvi for delivery via inhalation. Rizvi is drawn to a particle comprising 2-mercaptoethane sulfonate for delivery of an active agent via dry powder inhalation, whereby the 2-mercaptoethane sulfonate aids in delivery by acting as a mucolytic and dissolving mucus. Smyth teaches that the nucleic acid must penetrate mucus to have access to live cells. As such, the skilled artisan would have been motivated to have administered the nucleic acid of Smyth via inhalation while using the 2-mercaptoethane sulfonate of Rizvi in order to have predictably degraded and/or dissolved mucus such that the nucleic acid of Smyth could have predictably had access to a live cell with a reasonable expectation of success. This would have been necessary because access to a live cell would have been necessary for mRNA, such as that taught by Smyth, to have been therapeutically effective because mRNA necessitates a live cell to translate the protein which it encodes.
As to claim 2, this claim has been rejected for essentially the same reason that claim 1 has been rejected. See the above rejection of claim 2 under 35 U.S.C. 112(b) in which the examiner explained how claim 2 is being interpreted.
As to claim 4, this claim has been rejected for essentially the same reason that claim 1 has been rejected. See the above rejection of claim 4 under 35 U.S.C. 112(b) in which the examiner explained how claim 4 is being interpreted.
As to claim 8, the sodium 2-mercaptoethane sulfonate of Rizvi is understood to read on this claimed requirement as it has a free thiol group. Rizvi also teaches ascorbic acid and Vitamin E as of page 58, paragraph 0083.
As to claim 9, Smyth teaches the liposome composition on page 53, and teaches a mRNA COVID-19 vaccine, as of at least page 95, paragraph 00306. The PEGylated lipid of Smith, page 53 is understood to read on the required additional agent.
As to claim 10, Smyth teaches various polynucleotides including siRNA, shRNA, and mRNA as of Smyth, page 2, paragraph 0004.
As to claim 11, Smyth teaches plasmid DNA as of page 2, paragraph 0004.
As to claim 12, Smyth teaches the following lipid nanoparticles, as of page 53, relevant text reproduced below.
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As to claim 13, Smyth teaches spray dried nanoparticles, as of at least Smyth, page 74, paragraph 00256.
As to claim 14, Rizvi teaches a method of administering the mucolytic agent (e.g. sodium 2-mercaptoethane sulfonate) separately as compared with the second population of particles, as of Rizvi, abstract. That the sodium 2-mercaptoethane sulfonate breaks the mucus barrier is taught as of Rizvi, page 36, relevant text reproduced below.
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As such, the skilled artisan would have expected that administration of 2-mercaptoethane sulfonate would have operated by breaking the mucus barrier; this would have read on the requirement that the method transiently disrupts the biophysical mucus barrier and opens the gate so that the therapeutic agent can be delivered.
As to claim 15, the rationale applied by the examiner above regarding claim 14 also applies to claim 15. The skilled artisan would have been motivated to have administered the mucolytic of Rizvi prior to the mRNA of Smyth so that the mucolytic of Rizvi would have had time to have modified the environment in the lung to improve the ability of the mRNA active agent of Smyth to be delivered.
As to claim 16, Rizvi does not appear to specify a time period between administration of the mucolytic and administration of the additional active agent. Nevertheless, Rizvi indicates that administration of an active agent to the lungs can take 20-40 minutes, as of Rizvi, page 4 lines 5-10. The skilled artisan would have been motivated to have administered the active agent of Smyth following the mucolytic of Rizvi. To the extent that the 20-40 minute administration of Rizvi, page 4 lines 5-10 applies to the mucolytic of Rizvi, the skilled artisan would have been motivated to have administered the active agent of Smyth 20-40 minutes following administration of the mucolytic of Rizvi in order to have predictably given time for the mucolytic of Rizvi to have modified the internal environment in the lung to aid in the deposition of the active agent of Smyth in the lungs with a reasonable expectation of success. With that being said, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of an active agent following a mucolytic are taught by Rizvi, page 36. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of time between administration of the mucolytic and of the active agent via routine experimentation.
As to claim 19, the mRNA of Smyth is understood to read on the claimed requirement.
As to claim 20, Smyth teaches delivering plasmid DNA as of page 2, paragraph 0004.
As to claim 21, Smyth teaches siRNA and other forms of RNA as of page 2, paragraph 0004.
As to claim 28, Smyth teaches a cancer vaccine on page 19, paragraph 0092.
Note Regarding Reference Date: Rizvi was published on 3 March 2022. The instant application ultimately claims benefit to provisional application 63/547,629, filed on 7 November 2023. As such, Rizvi is prior art as it was published earlier than the effective filing date of the instant application. As Rizvi was published over a year earlier than the effective filing date of the instant application, none of the exceptions under AIA 35 U.S.C. 102(b)(1) or 102(b)(2) would appear to be applicable.
Claim(s) 18 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smyth et al. (WO 2021/216541 A1) in view of Rizvi et al. (WO 2022/047047 A1), the combination further in view of Charrier et al. (Orphanet Journal of Rare Diseases, Vol. 9:189, 2014, pages 1-11).
Smyth is drawn to administration of a nucleic acid to the lungs. Rizvi is drawn to administration of a mucolytic prior to administration of an active agent in order to improve delivery of the active agent, as of page 36 of Rizvi. See the above rejection over Smyth in view of Rizvi by themselves. Rizvi teaches 2-mercaptoethane sulfonate as a mucolytic, as of Rizvi, at least page 5 lines 15-20.
None of the above references teach cysteamine.
Charrier et al. (hereafter referred to as Charrier) is drawn to cysteamine as a mucoactive agent, as of Charrier, page 1, title and abstract. Charrier refers to cysteamine as a mucolytic, as of Charrier, page 1, “Results” and “Conclusions” section of abstract. Charrier teaches administration via dry powder inhalation, as of Charrier, page 10, top paragraph (reproduced below) and last paragraph in “Conclusion” section.
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The examiner understands the above-reproduced text to teach that dry powder inhalation is preferred over nebulization for delivery of cysteamine via inhalation.
Charrier does not teach a nucleic acid therapeutic.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the cysteamine of Charrier into the method of Smyth in view of Rizvi. Smyth and Rizvi are drawn to a method of administering an active agent to the lungs, and Rizvi teaches the inclusion of 2-mercaptoethane sulfonate as a mucolytic. Charrier teaches that cysteamine also acts as a mucolytic, and suggests administration of cysteamine via inhalation. As such, the skilled artisan would have been motivated to have combined the mucolytic of Rizvi, which is 2-mercaptoethane sulfonate, with the mucolytic of Charrier, which is cysteamine, in order to have predictably lysed mucus in the lung in order to have predictably improved delivery of an active agent with a reasonable expectation of success. Combining prior art elements (e.g. 2-mercaptoethane sulfonate and cysteamine) according to known methods to yield predictable results (action as a mucolytic) is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
Response to Arguments Regarding Prior Art Rejections
Applicant makes various arguments as of applicant’s response on 8 December 2025 (hereafter referred to as applicant’s arguments). These arguments are addressed below.
In applicant’s response, applicant argues that a formulation comprising sodium 2-mercaptoethane sulfonate results in a synergistic effect not taught by the prior art, as of applicant’s response, page 11; arguments regarding unexpected results are also made on page 17 of applicant’s response. In support of this position, applicant has set forth the following figure on page 12 of applicant’s response.
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The figure reproduced above-right appears to be fairly similar (but not exactly the same) as figure 6 of the instant application, which is reproduced below.
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In the prior office action on pages 18-19, the examiner previously took the following position regarding figure 6 of the instant application.
The above figure [referring to instant figure 6] appears to be drawn to mRNA transfection of a protein that produces luminescence. As such, a higher value on the y-axis indicates greater transfection of the luminescent protein, which is a desirable result. The applied data would appear to be related to an in vitro experiment rather than in vivo data. Regardless, the above-reproduce data shows that mRNA in lipid nanoparticles combined with the compound known as “CIL-0X” results in greater activity of the encoded luminescent protein as compared to mRNA in lipid nanoparticles but lacking CIL-0X.
Nevertheless, applicant has the burden of explaining data that is proffered as evidence of non-obviousness. See MPEP 716.02(b)(II). This burden does not appear to have been met because applicant has not explained what “CIL-0X” actually is. The examiner reviewed the instant specification and takes the position that the specification appears to define “CIL-0X” as “transfection enhancing agent” on page 29, paragraph 00148. However, the specification does not define what ingredients are comprised by “CIL-0X.” There is no evidence in the specification that “CIL-0X” comprises 2-mercaptoethane sulfonate, which is the transfection efficiency enhancing agent recited by the instant claims. As such, it is not clear that there is a nexus between the data presented in figure 6 and the claimed invention. See MPEP 716.01(b) regarding the nexus requirement.
In order to address this issue, applicant makes the following argument on page 12, top paragraph.
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The above-reproduced text indicates that “CIL-OX” is the transfection enhancement efficiency agent such as sodium 2-mercaptoetane [i.e. 2-mercaptoethane] sulfonate. This is insufficient to establish that, for the purposes of analysis of the data in figure 6, CIL-OX should be understood to be sodium 2-mercaptoethane sulfonate. Arguments by applicant cannot take the place of evidence in the record. See MPEP 716.01(c)(II) and 2145(I). Furthermore, the argument presented by applicant indicates that CIL-OX is a material “such as” sodium 2-mercaptoethane sulfonate. Even if the above-reproduced text were to have been presented as evidence (i.e. in the form of a declaration under 37 C.F.R. 1.132) this would be insufficient to establish that CIL-OX is 2-mercaptoethane sulfonate because of the text “such as.” As such, the examiner maintains the position that the data presented by applicant does not meet the burden of establishing unexpected results. This position is the same as the position taken by the examiner at the end of the top paragraph of page 19 of the office action mailed on 6 June 2025.
Regarding the teachings of Rizvi, applicant argues the following on page 12, relevant text reproduced below.
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As an initial matter, this argument does not appear to be commensurate in scope with claim 1, as claim 1 requires sodium 2-mercaptoethane sulfonate and the dry powder together in the same composition; see the section above entitled “Claim Interpretation.” In contrast, this argument appears to relate to administration of these elements separately.
Applicant then makes the following argument, as of page 12, bottom paragraph.
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This is not persuasive because applicant has not established a synergistic effect between sodium 2-mercaptoethane sulfonate and a nucleic acid; see the text above in which the examiner explained deficiencies related to figure 6 in applicant’s response.
Applicant then argues the following, as of page 13, relevant text reproduced below.
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This is not persuasive. As an initial matter, in view of the deficiencies related to both figure 6 of the instant application as well as the figure reproduced on page 12 of applicant’s response, it is the examiner’s position that applicant has failed to show synergism.
Additionally, even if purely en arguendo, applicant was to have shown synergism, it is unclear that this synergism would be sufficient to overcome the applied rejection. Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof. See MPEP 716.02(c)(II). In this case, Rizvi teaches the beneficial effects of administration of 2-mercaptoethane sulfonate in combination with or prior to administration of a non-nucleic acid therapeutic. As such, there would have been a reasonable expectation that these beneficial effects would have persisted had the therapeutic agent been a nucleic acid. As such, even if, purely en arguendo, there were to have been synergism, applicant has not shown that this synergism would have been unexpected.
Applicant then argues the following as of page 13, third paragraph.
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This is not persuasive. Rizvi appears to teach separate administration of the 2-mercaptoethane transfection agent and the therapeutic agent in the abstract, which would appear to necessitate that these elements be presented separately. Furthermore, this argument is not persuasive with regard to claim 1, because claim 1 does not require that the transfection enhancing agent is separate and distinct from the nucleic acid.
Applicant then argues that Smyth fails to teach 2-Mercaptoethane sulfonate as transfection enhancing agents, as of applicant’s response, page 13, last full paragraph and paragraph bridging pages 13-14 as well as page 14, first full paragraph and second full paragraph. These arguments are not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV). The examiner also disagrees with the idea that Smyth fails to teach materials that would have increased transfection. In fact, Smyth discusses the issue of transfection efficacy throughout the document, including but not limited to page 53, paragraph 00206 and pages 58-59, paragraph 00217. The skilled artisan would have expected the lipids in the lipid nanoparticle of Smyth to have influenced transfection of the delivered nucleic acid, and the skilled artisan would have been motivated to have optimized the lipid formulation to have used the formulation that achieves the greatest transfection.
In applicant’s response, paragraph bridging pages 14-15, applicant argues that the combination of references fails to teach sodium 2-mercaptoethane sulfonate as a transfection agent that enhances nucleic acid uptake and improves the efficacy of the nucleic acid. This is not persuasive. Rizvi teaches the use of sodium 2-mercaptoethane sulfonate to aid in the delivery of non-nucleic acid active agents; as such, the skilled artisan would have been motivated to have used sodium 2-mercaptoethane sulfonate to have aided in the delivery of nucleic acid active agents with a reasonable expectation of success. Applicant then argues that Rizvi fails to teach sequential pre-treatment; however, this is not persuasive because Rizvi teaches sequential pre-treatment in the abstract. Also, sequential pre-treatment is not required by claim 1 and the pending composition claims. Applicant then argues that Rizvi fails to teach synergy, as of page 15, top paragraph; however, this is not persuasive at least because the data presented by applicant fails to show unexpected synergy sufficient to rebut the prima facie case of obviousness based upon secondary considerations for at least the reasons set forth on pages 18 through the top of page 19 of the office action mailed on 6 June 2025.
Applicant then presented arguments regarding the previously applied rejection over the combination of Smyth, Rizvi, and Stanton on pages 16-17 of applicant’s response. This argument is moot in view of the withdrawal of the previously applied rejection over the combination of Smyth, Rizvi, and Stanton and the newly applied rejection over the combination of Smyth, Rizvi, and Charrier. It is the examiner’s position that Charrier is superior to Stanton because Charrier clearly teaches cysteamine for administration by inhalation, which was not taught by Stanton. As such, the teachings of Charrier can be combined with those of Smyth and Rizvi, which also teach administration via inhalation.
Withdrawn Double Patenting Rejection
The examiner has withdrawn the previously applied provisional non-statutory double patenting rejection over copending application 18/023,686. The reason that the examiner has decided to withdraw this rejection is because
the claims of the ‘686 application do not require a therapeutic nucleic acid or a nucleic acid for vaccination; and
there would have been no motivation for the skilled artisan to have substituted a nucleic acid in place of the active agents recited by the claims of the ‘686 application.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612