DETAILED ACTION
Applicants’ arguments, filed 27 January 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Specification
The amendment to the specification on 27 January 2026 appears to (a) correct errors in the numbering of the paragraphs, and (b) correct an error in the first paragraph regarding the priority of the instant application. As such, the corrections to the specification appear to be corrections of obvious errors. See MPEP 2163.07(II). Therefore, the amendment to the specification has been entered.
Claim Interpretation
For the purposes of examination under prior art, the examiner will proceed with examination with the understanding that a PEGylated lipid is a lipid which reads on item (B) of claim 1 but is not a polymer that reads on item (D) of claim 1. This position is based upon the fact that instant claim 25 appears to identify a PEGylated lipid as item (B) of claim 1, not as item (D) of claim 1. The examiner has applied this interpretation both to the claimed invention as well as to prior art and claims of copending applications in regard to analysis related to the issue of non-statutory double patenting.
Regarding claim 64, the examiner understands that, in view of the “and/or” language in the claim, the claim is understood to require either the recited amount of polymer or the recited amount of one or more salts.
Claim 104 recites a triblock copolymer with two polyoxyethylene units and one polyoxypropylene unit. It is the examiner’s position that the skilled artisan would have recognized that these polymers are commonly known as poloxamers. Additionally, the common trade name “Pluronic” also refers to these polymers. The examiner cites Almeida et al. (Journal of Polymer Research, Vol. 25:31, 2018, pages 1-14) as providing more information regarding such polymers, including their chemical structure as of page 4, figure 1a, reproduced below.
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The instant claims have not been rejected over Almeida because Almeida does not teach a lipid nanoparticle and nucleic acid combination.
Applicant does not appear to have disputed this claim interpretation in applicant’s response on 27 January 2026. As such, this claim interpretation is still understood to be applicable.
Claim Rejections - 35 USC § 102 – Anticipation
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.
Claim(s) 1-2, 6, 13, 17, 19, 21, 25, 31, 35, 38, 40, 46, 60, 64, 105, and 126 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 2020/0069599 A1).
Smith et al. (hereafter referred to as Smith) is drawn to lipid nanoparticles, as of Smith, title and abstract. Smith teaches the following lipid nanoparticle, as of page 46, Example 2, relevant text reproduced below with annotation by the examiner.
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As to claim 1, the claim requires that the composition is formulated as a powder. The composition of Smith is (i.e. freeze-dried), as of Smith, pages 47-48, Example 3, paragraphs 0575-0587. The skilled artisan would have expected that the result of freeze-drying would have been the formation of a dry powder. See e.g. Smith, paragraph 0467 and 0470-0471.
As to claim 1, the claim requires that the nucleic acid is substantially encapsulated in the lipid nanoparticle. Smith teaches this as of at least paragraphs 0039-0043.
As to claim 1, the claim requires that the composition comprises one or more particles, and each of the particles comprise the lipid nanoparticle, the pharmaceutically acceptable polymer, and the sugar. Regarding the sugar, it is the examiner’s position that (a) lipid nanoparticles such as those described by Smith comprise at least one interior aqueous space, and (b) sugar (e.g. such as sucrose) is water-soluble. Therefore, the skilled artisan would have expected the sucrose of Smith to have been dissolved in the water in the interior aqueous space or spaces and therefore to have been part of the particle. Regarding the required pharmaceutically acceptable polymer, Smith teaches the following, as of paragraph 0556, which is reproduced below in full.
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The above-reproduced text indicates that the poloxamer of Smith partakes in adsorption or insertion into lipid membranes, and would therefore have been part of the particle. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the examiner has presented reasoning and evidence supporting the idea that sucrose and poloxamer of Smith are part of the particle. As such, the burden has been shifted to applicant to show that this is not the case in accordance with MPEP 2112(V). As such, the evidence set forth by Smith supports the position that the sugar and polymer would have inherently been part of the particle.
As to claim 2, the skilled artisan would have expected that the composition formed following lyophilization would have been a dry powder because the lyophilization process would have removed water.
As to claim 6, Smith teaches mRNA, as of paragraph 0554, reproduced above.
As to claim 13, Smith teaches modified RNA, e.g. with pseudouridine, as of paragraph 0275.
As to claim 17, Smith, paragraph 0554, table in paragraph, teaches four different lipids.
As to claim 19, Smith, paragraph 0554, table in paragraph, teaches a first lipid.
As to claim 21, Smith, paragraph 0554, table in paragraph, teaches DSPC. This abbreviation refers to distearoyl phosphatidylcholine, and reads on the second lipid that is a phospholipid.
As to claim 25, Smith, paragraph 0554, table in paragraph, teaches PEG2000-DMG. This is a PEGylated lipid, wherein the abbreviation “PEG” refers to polyethylene glycol.
As to claim 31, Smith, paragraph 0554, table in paragraph, teaches cholesterol, which reads on the required steroid.
As to claim 35, Smith, paragraph 0554, table in paragraph, teaches four lipids that together form a nanoparticle.
As to claim 38, Smith, paragraph 0554, table in paragraph, teaches sucrose. This is a disaccharide and reads on the required polysaccharide.
As to claim 40, Smith, paragraph 0554, table in paragraph, teaches sucrose. This is a disaccharide and reads on the required polysaccharide.
As to claim 46, Smith, paragraph 0556, teaches Poloxamer 188. Poloxamers are copolymers comprising poly(ethylene oxide)-co-poly(propylene oxide)-co-poly(ethylene oxide).
As to claim 60, Smith teaches trometamol hydrochloride, which reads on the required one or more salts.
As to claim 64, Smith teaches 42 mg/mL of lipid nanoparticles as of page 46, left column, Example 2; this is calculated by adding the amounts of mRNA, MC3 (i.e. ionizable cationic lipid), cholesterol, DSPC, and PEG2000-DMG. Smith teaches 3.04 mg/mL of salt as of page 46, left column, paragraph 0554; this is calculated by adding the amounts of trometamol and trometamol hydrochloride. Smith teaches 80 mg/mL of sucrose, as of page 46, paragraph 0554. Smith appears to suggest using poloxamer P188 at an amount of slightly greater than its critical micelle concentration of about 0.1% to 1%, as of paragraph 0556, though the limitation regarding the amount of polymer is optional because the claim appears to require either the amount of the polymer or the amount of the salt. As such, in terms of dry weight, the teachings of Smith indicate the presence of
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These amounts appear to be in the claimed range.
As to claim 105, Smith teaches the following, as of paragraphs 0575-0587, reproduced below.
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The above-reproduced method appears to entail dissolving the starting materials in a liquid formulation (which is also taught by Example 2), followed by freezing by applying a temperature lower than 0°C. While the above-reproduced method does not appear to specifically disclose a collection step, the skilled artisan would have understood that this would have occurred because the lyophilized product would have been removed from the device used for lyophilization.
As to claim 126, Smith teaches temperatures of -60°C and -40°C, as of the above-reproduced paragraph. This would have read on the required additional element of the claim.
Note Regarding Reference Date: The instant application ultimately claims priority to provisional application 63/158,280, filed on 8 March 2021. Smith was published on 5 March 2020. As such, Smith is prior art under AIA 35 U.S.C. 102(a)(1). Smith appears to have been published over a year earlier than the earliest effective filing date. As such, the exceptions under AIA 35 U.S.C. 102(b)(1)(A) and 102(b)(1)(B) would not appear to be applicable to overcome this rejection. Additionally, there is no evidence of common inventorship or common assignment between Smith and the instantly claimed invention.
The examiner further notes here that, in accordance with MPEP 2153.01(a), last paragraph, the one-year grace period in AIA 35 U.S.C. 102(b)(1)(A) is extended to the next succeeding business day if the end of the one-year grace period otherwise falls on a Saturday, Sunday, or federal holiday. In this case, the end of the one-year grace period would fall on 5 March 2021. The examiner notes that 5 March 2021 was a Friday. This date was not a Saturday, Sunday, or federal holiday. As such, the provision related to extending the grace period in accordance with MPEP 2153.01(a) does not appear to be applicable here.
The examiner notes that in applicant’s response on 27 January 2026, applicant does not appear to have provided arguments related to the publication date of Smith.
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, 6, 13, 17, 19, 21, 25, 31, 35, 38, 40, 46, 60, 64, 105, 126, and 163 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0069599 A1) in view of Ball et al. (International Journal of Nanomedicine, Vol. 12, 2017, pages 305-315).
Smith et al. (hereafter referred to as Smith) is drawn to lipid nanoparticles, as of Smith, title and abstract. Smith teaches the following lipid nanoparticle, as of page 46, Example 2, relevant text reproduced below with annotation by the examiner.
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As to claim 1, the claim requires that the nucleic acid is substantially encapsulated in the lipid nanoparticle. Smith teaches this as of at least paragraphs 0039-0043.
Purely en arguendo, and for the purposes of this ground of rejection only, the examiner understands that Smith fails to teach a composition in the form of a powder.
Ball et al. (hereafter referred to as Ball) is drawn to examining lipid nanoparticles following lyophilization, as of all, page 305, title and abstract. Ball teaches the formation of a lyophilized powder, as of Ball, page 305, first paragraph in “Introduction” section, relevant text reproduced below with annotation by the examiner.
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Ball teaches a lyophilization process, as of page 307, left column, bottom paragraph.
Ball is not anticipatory because the examples of Ball are drawn to siRNA rather than mRNA.
It would have been prima facie obvious for one of ordinary skill in the art to have formed a powder upon lyophilization of the composition of Smith. Smith teaches a lyophilized lipid nanoparticle composition, but is understood to be silent as to whether this composition forms a powder. Ball also teaches a lyophilized lipid nanoparticle composition, and teaches the formation of a powder. As such, the skilled artisan would have been motivated to have lyophilized the composition of Smith and to have predictably formed a powder with a reasonable expectation of success, as this was done by Ball.
As to claim 2, the skilled artisan would have expected that the composition formed following lyophilization would have been a dry powder because the lyophilization process would have removed water.
As to claim 6, Smith teaches mRNA, as of paragraph 0554, reproduced above.
As to claim 13, Smith teaches modified RNA, e.g. with pseudouridines, as of paragraph 0275.
As to claim 17, Smith, paragraph 0554, table in paragraph, teaches four different lipids.
As to claim 19, Smith, paragraph 0554, table in paragraph, teaches a first lipid.
As to claim 21, Smith, paragraph 0554, table in paragraph, teaches DSPC. This abbreviation refers to distearoyl phosphatidylcholine, and reads on the second lipid that is a phospholipid.
As to claim 25, Smith, paragraph 0554, table in paragraph, teaches PEG2000-DMG. This is a PEGylated lipid, wherein the abbreviation “PEG” refers to polyethylene glycol.
As to claim 31, Smith, paragraph 0554, table in paragraph, teaches cholesterol, which reads on the required steroid.
As to claim 35, Smith, paragraph 0554, table in paragraph, teaches four lipids that together form a nanoparticle.
As to claim 38, Smith, paragraph 0554, table in paragraph, teaches sucrose. This is a disaccharide and reads on the required polysaccharide.
As to claim 40, Smith, paragraph 0554, table in paragraph, teaches sucrose. This is a disaccharide and reads on the required polysaccharide.
As to claim 46, Smith, paragraph 0556, teaches Poloxamer 188. Poloxamers are copolymers comprising poly(ethylene oxide)-co-poly(propylene oxide)-co-poly(ethylene oxide).
As to claim 60, Smith teaches trometamol hydrochloride, which reads on the required one or more salts.
As to claim 64, Smith teaches 42 mg/mL of lipid nanoparticles as of page 46, left column, Example 2; this is calculated by adding the amounts of mRNA, MC3, cholesterol, DSPC, and PEG2000-DMG. Smith teaches 3.04 mg/mL of salt as of page 46, left column, paragraph 0554; this is calculated by adding the amounts of trometamol and trometamol hydrochloride. Smith teaches 80 mg/mL of sucrose, as of page 46, paragraph 0554. Smith appears to suggest using poloxamer P188 at an amount of slightly greater than its critical micelle concentration of about 0.1% to 1%, as of paragraph 0556, though the limitation regarding the amount of polymer is optional because the claim appears to require either the amount of the polymer or the amount of the salt. As such, in terms of dry weight, the teachings of Smith indicate the presence of
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These amounts appear to be in the claimed range. Nevertheless, even if, purely en arguendo, the above-indicated calculations are incorrect and the amounts taught by Smith are not in the claimed range, it is nevertheless the case that the skilled artisan would have been motivated to have optimized the amounts and concentrations of these ingredients to have achieved the claimed subject matter. Generally, differences in concentration between the prior art and claimed subject matter will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). Additionally, 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 a composition comprising a lipid nanoparticle, a salt (i.e. buffer) and polymer have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable concentration ranges of these ingredients by routine experimentation.
As to claim 105, Smith teaches the following, as of paragraphs 0575-0587, reproduced below.
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The above-reproduced method appears to entail dissolving the starting materials in a liquid formulation (which is also taught by Example 2), followed by freezing by applying a temperature lower than 0°C. Wile the above-reproduced method does not appear to specifically disclose a collection step, the skilled artisan would have understood that this would have occurred because the lyophilized product would have been removed from the device used for lyophilization.
As to claim 126, Smith teaches temperatures of -60°C and -40°C, as of the above-reproduced paragraph. This would have read on the required additional element of the claim.
As to claim 163, Smith teaches vaccination against infectious diseases such as influenza, measles, human papillomavirus (HPV), rabies, meningitis, whooping cough, tetanus, plague, hepatitis, and tuberculosis, as of Smith, paragraph 0269. The skilled artisan would have been motivated to have administered the composition of Smith to a person to have achieved these effects.
Claim(s) 9 and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0069599 A1) in view of Stewart-Jones et al. (WO 2021/154763 A1).
Claim(s) 9 and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2020/0069599 A1) in view of Ball et al. (International Journal of Nanomedicine, Vol. 12, 2017, pages 305-315), the combination further in view of Stewart-Jones et al. (WO 2021/154763 A1).
Smith is drawn to a lyophilized lipid nanoparticle mRNA vaccine. Ball is drawn to a lipid nanoparticle with a nucleic acid that is lyophilized to form a powder. See the rejections above over Smith by itself, as well as Smith in view of Ball.
Neither Smith nor Ball teach RNA encoding a SARS-CoV-2 antigen.
Stewart-Jones et al. (hereafter referred to as Stewart-Jones) is drawn to an RNA vaccine for coronaviruses, as of the title and abstract. Stewart-Jones teaches the following vaccine, as of page 2, lines 5-19, relevant text reproduced below.
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Stewart-Jones is drawn to RNA encoding the above antigen, as of Stewart-Jones, page 2. The composition of Stewart-Jones is in the form of a lipid nanoparticle, as of Stewart-Jones, page 6 line 25.
Stewart-Jones does not teach a lyophilized composition.
It would have been prima facie obvious for one of ordinary skill in the art to have used the nucleic acid encoding the SARS-CoV-2 antigen taught by Stewart-Jones in the composition of Smith, by itself or in view of Ball. Smith is drawn to a lipid nanoparticle comprising mRNA. The mRNA in Smith can encode for antigens to act as vaccines for a wide range of diseases, as of Smith, paragraph 0269. The composition of Stewart-Jones describes mRNA encoding an antigen to act as a vaccine against SARS-CoV-2. As such, the skilled artisan would have been motivated to have used the mRNA encoding an antigen of Stewart-Jones as the mRNA in the composition of Smith (by itself or in view of Ball) in order to have predictably vaccinated against SARS-CoV-2 with a reasonable expectation of success.
As to claim 9, the nucleic acid of Stewart-Jones reads on the additional requirements of this claim.
As to claim 104, the nucleic acid of Stewart-Jones reads on the additional requirements of part (A) of this claim. Regarding parts (B), (C), and (D) of this claim, these features have been taught by Smith, paragraphs 0554-0556, which have been discussed above.
Note Regarding Reference Date: Stewart-Jones was effectively filed prior to the effective filing date of the instant application. As such, Stewart-Jones appears to be prior art at least under AIA 35 U.S.C. 102(a)(2). There does not appear to be common inventors or a common assignee between Stewart-Jones and the instant application. As such, exceptions under AIA 35 U.S.C. 102(b)(2)(A), 102(b)(2)(B), or 102(b)(2)(C) would not appear to be applicable. The examiner notes that applicant does not appear to have provided an argument related to the issue of prior art date in applicant’s response on 27 January 2026.
Response to Arguments
Applicant has provided arguments regarding the previously applied anticipation and obviousness rejections, as of applicant’s response on 27 January 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
Regarding the previously applied rejections under 35 U.S.C. 112, these rejections have been withdrawn in view of the amendments to the claims.
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This is not persuasive. Claims 85-86 were never considered by the examiner. See the office action mailed on 28 August 2025, in which the office action summary does not list claims 85-86 as pending. As such, the idea that amending the limitations of claims 85-86 into claim 1 would necessarily overcome the previously applied rejection of claim 1 is not supported anywhere in the record.
Applicant then argues that Smith does not teach particles that comprise multiple distinct components within a single particle in the composition. This is not persuasive. The examiner has presented rationale above that would appear to support the idea that the skilled artisan would have expected both the sucrose and the poloxamer of Smith to have been comprised by the particle.
Regarding the sugar, it is the examiner’s position that (a) lipid nanoparticles such as those described by Smith comprise at least one interior aqueous space, and (b) sugar (e.g. such as sucrose and/or trehalose) is water-soluble. Therefore, the skilled artisan would have expected the sucrose of Smith to have been dissolved in the water in the interior aqueous space or spaces and therefore to have been part of the particle.
Regarding the required pharmaceutically acceptable polymer, Smith teaches the following, as of paragraph 0556, which is reproduced in the rejection above. The above-reproduced text indicates that the poloxamer of Smith partakes in adsorption or insertion into lipid membranes, and would therefore have been part of the particle.
Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the examiner has presented reasoning and evidence supporting the idea that sucrose and poloxamer of Smith are part of the particle. As such, the burden has been shifted to applicant to show that this is not the case in accordance with MPEP 2112(V).
Regarding the previously applied obviousness rejection, applicant argues that neither Smith nor Ball teach a composition that contains single particles which contain all of the elements in a single particle, as of the paragraph bridging pages 8-9 of applicant’s response. No additional arguments have been made in view of the Stewart-Jones reference. This is not persuasive for the reasons set forth above.
Additional Cited Prior Art
As additional relevant prior art, the examiner cites Viger-Gravel et al. (The Journal of Physical Chemistry B, Vol. 122, 2018, pages 2073-2081), which is drawn to the structure of lipid nanoparticles comprising nucleic acids, as of the title and abstract. Viger-Gravel teaches the following, as of Scheme 1, which is reproduced below.
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The examiner notes that when the above-three structures are viewed in their original color, they all have multiple light blue regions in the interior, wherein the light blue denotes water. This indicates that lipid nanoparticles, specifically the type which comprise an ionizable cationic lipid, phospholipid, cholesterol, and PEG-lipid and which encapsulate nucleic acids, have an aqueous interior. Therefore, the skilled artisan would have expected the aqueous interior to have included water-soluble solutes. Such water-soluble solutes could potentially include sugar or salt, though sugar does not appear to have been taught by Viger-Gravel.
The examiner notes that Viger-Gravel is not part of the statement of rejection and is not the closest prior art. This is because Viger-Gravel does not appear to teach sugar, does not appear to teach a polymer other than the PEG-lipid, and does not appear to teach a dry powder. As such, Viger-Gravel is not part of the statement of rejection and the claims are not rejected over Viger-Gravel. Viger-Gravel was cited by the examiner to show that lipid nanoparticles which comprise an ionizable cationic lipid, phospholipid, cholesterol, and PEG-lipid and which encapsulate nucleic acids, such as those of Smith, include at least one internal aqueous phase. This provides support to the examiner’s position that the skilled artisan would have expected solutes that dissolve in water, such as sugar, to have been present in the particle because they would have been expected to have been part of the internal aqueous phase. As such, the examiner understands the teachings of Viger-Gravel to generally support the evidence or reasoning in support of inherency that was provided by the examiner in the above anticipation rejection to shift the burden to applicant in view of the provisions of MPEP 2112(V).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 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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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612