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 .
Information Disclosure Statement
The submitted information disclosure statements (IDS) were filed on 05/01/2026 and 06/08/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Application
Applicants' arguments/remarks filed 08/06/2026 are acknowledged. Claims 148, 156, 175 and 176 are currently amended. Claim 160 is newly canceled. Claim 177 is newly added. Claims 148-152, 154, 156-159, 161, 163-172 and 174-177 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment filed 08/06/2026 and with respect to the arguments/remarks:
The rejection of Claim 160 under 35 U.S.C. §103 has been withdrawn due to the cancelation of the claim.
The rejection of Claim 148, 149, 150-152, 154, 157-160, 166-170 and 174-176 under 35 U.S.C. §103 over Karve et al., and Westesen et al. has been withdrawn due to the amendment of claim 148 and 175-176.
The rejection of Claim 148, 161 and 171 under 35 U.S.C. §103 over Karve et al., and Westesen et al. and Hansson et al. has been withdrawn due to the amendment of claim 148 and 175-176.
The rejection of Claim 148 and 156, 163 under 35 U.S.C. §103 over Karve et al., and Westesen et al. and Monoharan et al. has been withdrawn due to the amendment of claim 148 and 175-176.
The rejection of Claim 148, 163 and 164-165 under 35 U.S.C. §103 over Karve et al., and Westesen et al., Monoharan et al., Uster et al. and Nakamura et al., has been withdrawn due to the amendment of claim 148 and 175-176.
The rejection of Claim 148 and 172 under 35 U.S.C. §103 over Karve et al., and Westesen et al., and Almarsson et al.et al., has been withdrawn due to the amendment of claim 148 and 175-176.
Claim Objections
Claim 176 is objected to because of the following informalities: Claim 176 is before claim 177 but claim 176 is dependent on claim 177. Appropriate correction is required.
Claim Rejections - 35 USC § 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 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 175 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 175 recites, “(Currently Amended) The method of claim 148, wherein the empty-LNP solution comprises what the solution actually contains or what is being limited.
For further examining purpose, the crossing of the words “
Appropriate correction is required.
Modified Rejections
Claim Rejections - 35 USC § 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 non-obviousness.
Claim(s) 148-152, 154, 156-159, 163, 166-170 and 174-176, 177 is/are rejected under 35 U.S.C. §103 as being unpatentable over Karve et al. (WO 2018089801 A1
Claims 148, 156, 163, 174-175,
Karve et al. teach
An improved process for lipid nanoparticle formulation and mRNA encapsulation. In some embodiments, the present invention provides a process of encapsulating messenger RNA (mRNA) in lipid nanoparticles comprising a step of mixing a solution of pre-formed lipid nanoparticles and mRNA. (Abs).
In some embodiments, a suitable mRNA solution may have a pH ranging from about 3.5-6.5. In some embodiments, a suitable mRNA solution may have a pH of or no greater than about 6.5, (0121). Typically, a suitable mRNA solution may also contain a buffering agent and/or salt. Generally, buffering agents can include sodium acetate. In some embodiments, suitable concentration of the buffering agent may range from about 0.1 mM to 100 mM. In some embodiments, suitable concentration of the buffering agent is or greater than about 0.1 mM, 0.5 mM, 1 mM, 2 mM, 20 mM, or 50 mM. (0119).
In some embodiments, a suitable formulation or encapsulation solution may also contain a buffering agent or salt. Exemplary buffering agent may include sodium acetate. In some embodiments, an empty pre-formed lipid nanoparticle formulation used in making this novel nanoparticle formulation can be stably frozen in 10% trehalose solution. (0172). "Suitable formulation" and "encapsulation solution" include the empty lipid nanoparticle formulation before encapsulation. The paragraph states that an "empty pre-formed lipid nanoparticle formulation" is "used in making this novel nanoparticle formulation." This directly links the empty version as a stage of the overall formulation process. An "encapsulation solution" refers to the chemical environment (including the buffering agents, salts, and cryoprotectants like trehalose) required to hold and stabilize the lipids before, during, and after they encapsulate the active ingredient. The effective buffering pH range of a sodium acetate and acetic acid mixture is pH 3.6 to 5.6. https://www.bostonbioproducts.com/products/buffers/regular-buffers/acetate
Helper lipids are structural lipids. A cationic lipid is a type of ionizable lipid. Phospholipids include DSPC, DOPC, DOPE, DPPC, DPPG, POPC, DMPE, DSPE or SOPE. (0148).
A process of encapsulating messenger RNA (mRNA) in lipid nanoparticles comprising a step of mixing a solution comprising pre-formed lipid nanoparticles and a solution comprising mRNA such that lipid nanoparticles encapsulating mRNA are formed. (0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, to prepare a loaded lipid nanoparticle solution by preparing empty preformed lipid nanoparticle, which can be stored by freezing in trehalose solution and then when needed to prepare loaded lipid nanoparticle mixing mRNA with empty preformed lipid nanoparticle, taught by Karve et al. since they have provided successful method to prepare them with better encapsulation percentages than preparing loaded lipid nanoparticles by mixing lipids with mRNA.
With regard to claims 149 and 174,
Karve et al. teach process for lipid nanoparticle formulation and mRNA encapsulation comprising a step of mixing a solution of preformed lipid nanoparticles and mRNA solution, (Abs), which is processing the empty LNP solution and loading step, forming a loaded LNP solution of loaded LNP.
With regard to claims 150-152, and 157,
Karve et al. teach one or both of the solution containing the mRNA and the solution containing the pre-formed lipid nanoparticles are buffer exchanged to remove one or both of nonaqueous solvents, such as ethanol, and citrate prior to the mixing addition of the mRNA to the pre-formed LNP. After the preformed LNPs and mRNA are mixed to form the solution comprising the LNPs encapsulating mRNA, further downstream requires processing including buffer exchange and/or further purification steps. (0028). Processing the empty-LNP solution comprises pH adjusting. A suitable formulation or encapsulation solution may also contain a buffering agent or salt. Exemplary buffering agent may include sodium citrate, sodium acetate, potassium phosphate and sodium phosphate. (0172) and (0119). Suitable mRNA solution may have a pH ranging from about 3.5-6.5, (0121), so the pH of mRNA and the empty-LNP solutions should be adjusted to within the range of 3.5-6.0. A second buffer is needed to adjust for loading or encapsulation step. Purified and/or concentrated lipid nanoparticles may be formulated in a desired buffer such as, for example, PBS, (0180). Citrate buffer is highly effective for maintaining pH levels in the acidic range, typically between pH 3.0 and 6.2.
With regard to claim 154,
Karve et al. teach diafiltration is a fractionation process whereby small undesired particles are passed through a filter while larger desired nanoparticles are maintained in the retentate without changing the concentration of those nanoparticles in solution. Diafiltration is often used to remove salts or reaction buffers from a solution. Diafiltration may be either continuous or discontinuous. In continuous diafiltration, a diafiltration solution is added to the sample feed at the same rate that filtrate is generated. In discontinuous diafiltration, the solution is first diluted and then concentrated back to the starting concentration. Discontinuous diafiltration may be repeated until a desired concentration of nanoparticles is reached. (0179). Diafiltration is a filtration technique that separates molecules in a solution based on their size.
With regard to Claims 158-159,
Karve et al. teach in the empty (i.e., empty of mRNA) lipid nanoparticles without mRNA are formed by mixing a lipid solution containing dissolved lipids in a solvent, and an aqueous/buffer solution. In some embodiments, the solvent can be ethanol. In some embodiments, the aqueous solution can be a citrate buffer. (0159). The ethanol lipid solution and the aqueous buffered solution of mRNA were prepared separately. A solution of mixture of lipids was prepared by dissolving lipids in ethanol.
With regard to claim 166,
Karve et al. teach the pH of a suitable mRNA solution may have a pH ranging from about 3.5-6.5, which is the pH post loading. (0121).
With regard to claim 167, Karve et al. teach polyethylene glycol (PEG)-modified
phospholipids and derivatized lipids such as derivatized ceramides (PEG-CER), including NOctanoyl-Sphingosine-1-[Succinyl(Methoxy Polyethylene Glycol)-2000] (C8 PEG-2000
ceramide). (0151).
With regard to claim 168,
Karve et al. teach lipids may be mixed at any ratios suitable for encapsulating mRNAs like cholesterol (0128), (which is known as a structure lipid).
With regard to claim 169,
Karve et al. teach the one or more non-cationic lipids are selected from DSPC (l,2-distearoyl-sn-glycero-3-phosphocholine), DPPC (l,2-dipalmitoyl-snglycero-3-phosphocholine ), DOPE (l ,2-dioleyl-sn-glycero-3-phosphoethanolamine ), DOPC
(l,2-dioleyl-sn-glycero-3-phosphotidylcholine). (Claim 15, pg. 82).
With regard to claim 170,
Karve et al. teach the one or more cationic lipids are amino lipids. Amino lipids suitable for use in the invention include those described in WO2017180917,
which is hereby incorporated by reference. Exemplary aminolipids in WO2017180917
include those described at paragraph (0744) such as DLin-MC3-DMA (MC3) (which is an ionizable amino lipid). (0015).
With regard to claim 176,
Karve et al. teach empty lipid nanoparticles can result in a final formulation that does not require any downstream purification or processing and can be stably stored in frozen form. (0173). Lipid Nanoparticles (LNPs) for applications like mRNA vaccines are typically stored at frozen temperatures ranging from -20°C to -80°C, with -80°C being common for ultra-cold storage requirements to ensure stability. (Ball et al. Achieving long-term stability of lipid nanoparticles: examining the effect of pH, temperature, and lyophilization. Int J Nanomedicine. 2016 Dec 30;12:305–315).
With regard to claim 177,
Karve et al. teach An empty pre-formed lipid nanoparticle formulation used in making this novel nanoparticle formulation can be stably frozen in 10% trehalose solution, (0172), which means empty pre-formed lipid nanoparticles can be stored for long period in between 1 hour to about years.
Claim(s) 148, 161 and 171 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karve et al. (WO 2018089801 A1) in view of Hansson et al. (WO 2019089818 Al).
The teachings of Karve et al. are described in claims 148 above.
Claim 161,
Karve et al. do not teach percentage ranges of different lipids in the empty LNP compositions.
Hanson et al. teach the term "lipid component" is that component of a nanoparticle that includes one or more lipids. For example, the lipid component may include one or more cationic/ionizable, PEGylated, structural, or other lipids, such as phospholipids. (088):
about 30-60 mol% ionizable lipid;
about 0-30 mol% phospholipid;
about 18.5-48.5 mol% structural lipid;
and about 0.0-10 mol% PEG lipid. (0124).
Claim 171,
Karve et al. do not teach the ionizable lipid below.
Hansson et al. teach the ionizable lipid (claim 1, pg. 40).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, to prepare a loaded lipid nanoparticle solution by preparing empty preformed lipid nanoparticle, which can be stored by freezing in trehalose solution and then when needed to prepare loaded lipid nanoparticle mixing mRNA with empty preformed lipid nanoparticle, taught by Karve et al., with the lipid above taught by Hanson et al. since they have provided successful methods to prepare them with better encapsulation percentages than preparing loaded lipid nanoparticles by mixing lipids with mRNA.
Claim(s) 148, 163 and 164, 165 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karve et al. (WO 2018/089801 Al) in view of Monoharan et al. (US 20180065918 A1), Suk et al., (Suk et al., PEGylation as a strategy for improving nanoparticle-based drug and gene delivery. Adv Drug Deliv Rev. 2016 April 1; 99(Pt A): 28–51), Uster et al. (Uster et al., Insertion of poly(ethylene glycol) derivatized phospholipid into pre-formed liposomes results in prolonged in vivo circulation time. FEBS Letters 386 (1996) 243 246) and Nakamura et al., (Nakamura et al., Comparative studies of polyethylene glycol-modified liposomes prepared using different PEG-modification methods. Biochimica et Biophysica Acta 1818 (2012) 2801–2807).
The teachings of Karve et al., Westesen et al. and Monoharan et al. are described in claims 148, 163 above.
Karve et al., Westesen et al. and Monoharan et al. do not teach the loaded-LNP solution comprises adding a polyethylene glycol lipid (PEG lipid) to the loaded LNP.
Claims 164 and 165,
Suk et al. teach PEG-containing lipids added during the self-assembly process will insert into the bilayer with the hydrophilic PEG chains extending toward the aqueous phase. For liposomes, this means that PEG can partition to the inner and outer sides of the lipid bilayer. PEG on the liposome interior does not contribute to the PEG surface coating, and may interfere with drug loading. To overcome this limitation, PEG can also be incorporated by post-insertion or post-conjugation methods. PEG density on the liposome surface can be controlled by changing the ratio of PEG-lipids to unmodified lipids, the type of PEG-lipid conjugate, and the molecular weight of PEG used for self-assembly. The presence of PEG on the liposome surface can prevent aggregation of liposomes, though incorporating too much PEG can compromise liposome formation and stability. Yu and coworkers reported that when the PEG-lipid conjugate content was increased to 12 mol%, both the drug loading and in vivo vaginal distribution was reduced. (pg. 33, 2nd par.).
Uster et al. teach insertion of poly(ethylene glycol) derivatized phospholipid into pre-formed liposomes results in prolonged in vivo circulation time. (Title). The lipid matrix of was mixed in solvent and dried under high vacuum overnight to remove residual solvent. The hydrated multilamellar vesicles were extruded through polycarbonate membranes to a final mean selected diameter range. For leakage studies, 100 mM purified 5,6-carboxyfluorescein was entrapped inside the liposomes. The liposome dispersion was equilibrated with a concentrated MPEG1900-DSPE to give a final theoretical 3 mol% of MPEG1900-DSPE to total lipid liposome. (pg. 243, right col., section 2.2. Liposome preparation and MPEG1900-DSPE lipid insertion).
Nakamura et al. teach to address the issue of excess polyethylene glycol (PEG)-lipid degradation observed when PEG-modified liposomes are prepared using the pH-gradient method, a concept using a novel PEG-modification method, called the post-modification method. PEG-lipid degradation could be markedly inhibited in the post-modification method, which could be used without any manufacturing process difficulties, especially with high PEG-lipid content. In addition, a higher blood circulation capability was observed in the post-modification method. The novel post-modification method was advantageous compared to the pre-modification method, can achieve a higher preservation stability of PEG-lipid, a greater ease of manufacturing, and a higher blood circulation capability, especially in the manufacturing of pH-gradient liposomal products. (Abs). 2.2.2. DXR liposomes prepared using the post-modification method: Bare liposomes (non-PEGylated liposomes) composed of HSPC and Chol were dissolved in ethanol to yield crude liposomes, by extruding through membrane of selected sizes and then PEG-lipid solution was added to the liposome suspension to yield PEGylated liposomes with the desired PEG-lipid mol% (0.25, 0.5, 0.75, 1.0, and 2.0 mol%). (pg. 2802, left col., section 2.2.2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, to prepare a loaded lipid nanoparticle solution by preparing empty preformed lipid nanoparticle, which can be stored by freezing in trehalose solution and then when needed to prepare loaded lipid nanoparticle mixing mRNA with empty preformed lipid nanoparticle, taught by Karve et al. and a residence time between the mixing and the processing step, is about 20 minutes and to have the aqueous buffer solution with a pH of about 5.0, and processing the loaded-LNP solution forming lipid nanoparticle formulation, taught by Monoharan et al., and to add more PEG-lipid by post PEGylated method taught by Suk et al., Uster et al., and Nakamura et al., since they have proven it would be advantageous to do so.
Claim(s) 148 and 172 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karve et al. (WO 2018/089801 Al) in view of Westesen et al. (Westesen et al. Physicochemical characterization of lipid nanoparticles and evaluation of their drug loading capacity and sustained release potential. Journal of Controlled Release 48 (1997) 223–236) and further in view of Almarsson et al. (WO 2018170322).
The teachings of Karve et al. and Westesen et al. are described in claim 148 above.
Karve et al. and Westesen et al. do not teach compounds of claim 172.
Almarsson et al. teach the compounds of claim 172 (0006) (pg. 2).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, to prepare a loaded lipid nanoparticle solution by preparing empty preformed lipid nanoparticle, which can be stored by freezing in trehalose solution and then when needed to prepare loaded lipid nanoparticle mixing mRNA with empty preformed lipid nanoparticle, taught by Karve et al. and to use the ionizable lipid compound 2 and 3 above, taught by Almarsson et al. since they have proven it would be feasible to do so.
Response to Arguments
Rejection under 35 U.S.C. § 103,
Applicant argues that for claim 148, the cited combinations of references do not make out a prima facie case of obviousness for such methods. All rejections rely on Karve as the primary reference.
Since applicant’s arguments/remarks include many paragraphs in several pages, the arguments/remarks will be separated for each part and the responses will be for each part below.
Applicant argues that the disclosure of Karve focuses on conditions and parameters for the mixing/ combining process, and only generally describes the preparation of empty LNPs in paragraph (0159); By Example 2, (0194), Karve does not teach or suggest a mixing step as recited in the pending claims, comprising mixing a lipid solution comprising an ionizable lipid, a phospholipid, a PEG lipid, and a structural lipid with an aqueous buffer solution comprising 2 mM to 20 mM acetate as a first buffering agent, thereby forming an empty-LNP solution comprising an empty LNP, wherein the aqueous buffer solution has a pH of 5.0 to 7.0.
Applicant's arguments have been fully considered but they are not persuasive, since it is well-established that a prior art reference is not required to be identical to the claimed invention in all respects to be invalidating or to form a proper basis for a rejection. It is sufficient that the reference discloses the specific limitations of the claim listed above. Also, One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. Karve teaches different buffers in example 2, as applicant also has citrus buffer in previous claims. Karve also teaches sodium acetate buffer. Please see the rejection of claim 148 above.
Applicant argues that Karve neither teaches nor suggests to form empty LNPs using an aqueous acetate buffer solution comprising 2 mM to 20 mM acetate as a first buffering agent and having a pH of 5.0 to 7.0. Indeed, the only mention in Karve of any specific buffer/pH conditions relates to the mRNA mixing step, where Karve assessed the impact of a citrate buffer at pH 4.5 and found that the presence of the buffer reduced encapsulation efficiency. Karve,(0195); Table 1. Applicant argues that the rejections rely on Karve' s disclosure of the use of a citrate buffer, which the Examiner alleges is "highly effective for maintaining pH levels in the acidic range, typically between pH 3.0 and 6.2," but Karve itself does not disclose a specific pH or pH range for preparation of its empty LNPs. Thus, this is not a situation where the cited reference teaches a range that overlaps with a range recited in the claims. Rather, it is only the present application that teaches a method as claimed, comprising forming empty LNPs using an aqueous buffer solution comprising 2 mM to 20 mM acetate as a first buffering agent and having a pH of 5.0 to 7.0.
Applicant's arguments have been fully considered but they are not persuasive. With the amendment of claim 148, the rejection of claim 148 is modified above. As mentioned above and similarly to applicant, Karl teaches citrate buffer and also teaches acetate buffer. More details of reasoning are described above. And prima facie case of obviousness, according to MPEP 2144.05, where a claimed range falls entirely inside or overlaps a range disclosed in the prior art, a presumption of obviousness exists.
At page 8, the office action asserts:
Applicant understands the Examiner to be relying on Karve's dis Karve et al. teach typically, a suitable mRNA solution may also contain a buffering agent and/or salt. Generally, buffering agents can include sodium acetate, pH range 3.5-6.5. (0119 and 0121). Since the preparation of lipid nanoparticle encapsulating mRNA, includes adding mRNA solution in buffer acetate, so the empty-LNP solution should comprise an acetate buffer, with pH range 3.5-6.5.
Applicant understands the Examiner to be relying on Karve's disclosure pertaining to the mRNA solution, and to be asserting that it would have been obvious to use the same buffering system for preparing empty LNPs. However, Karve itself provides no such teaching or suggestion. To the contrary, in Karve Example 2, the citrate buffer-containing empty-LNP formulation was "subjected to a TFF purification process wherein buffer exchange occurred" prior to mixing with the mRNA. In view of this buffer exchange step, nothing in Karve indicates that "the empty-LNP solution should comprise" a buffer system that corresponds to the mRNA solution, as asserted for the rejection.
Applicant's arguments have been fully considered but they are not persuasive since again it is well-established that a prior art reference is not required to be identical to the claimed invention in all respects to be invalidating or to form a proper basis for a rejection. It is sufficient that the reference discloses the specific limitations of the claim. One with ordinary skill in the art can learn from and select specific parts of Karve’s teachings before the effective filing date of the invention to achieve better outcome results even though some part of Karve’s application may teach more and may teach different things. Please see the rejection in detail above.
At page 11, the Office Action cites Manoharan for allegedly disclosing the use of an acetate buffer at pH 5 for preparation of empty liposome complexes. However, as pointed out previously, Manoharan does not disclose a method of forming empty LNPs from a lipid solution as claimed, that comprises an ionizable lipid, a phospholipid, a PEG lipid, and a structural lipid. In the "Response to Arguments" section, the Office Action still does not articulate any reason why a person of ordinary skill would have been motivated to use the conditions disclosed in Manoharan in a method according to Karve, let alone provided a basis for a reasonable expectation of success for doing so. Moreover, Manoharan does not teach or suggest to use an aqueous buffer solution as claimed, comprising 2 mM to 20 mM acetate. Indeed, Manoharan teaches the use of a much higher concentration acetate buffer-namely, about 100 mM to about 300 mM-to prepare liposomes without having to extrude the liposome mixture. See Manoharan, paragraph [0588]. Thus, the combination of Karve and Manoharan does not suggest or provide a reasonable expectation of success for a method as claimed.
Applicant's arguments have been fully considered but they are not persuasive, since Claims 148 and 156 are amended, the rejection of claim 156 and 163 is modified. Morahan’s teachings are removed. Instead Karve teaches all claims 148, 156 and 163. Please see the details above.
Conclusion
No claim is allowed
Applicants' 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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
