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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/01/2026 has been entered.
Amended claims 1, 3, 6, 9-14 and 20-21 are pending in the present application, and they are examined on the merits herein.
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.
Amended claims 1, 3, 9-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cullis et al (WO 2011/140627) in view of Renner et al (WO 2007/068747). This is a modified rejection.
The instant claims are directed to a lipid particle comprising an A-type CpG oligodeoxynucleotide, a cationic lipid as an amphipathic lipid, a phospholipid other than the cationic lipid as an amphipathic lipid, a sterol, and a water-soluble polymer-modified lipid, wherein the lipid particle comprises an outer layer and an ion complex placed inside the outer layer, wherein the outer layer is a lipid monolayer membrane in which amphipathic lipids are arranged with hydrophilic parts facing outward, wherein the cationic lipid is at least one member selected from the group consisting of DOTAP and DOTMA, wherein a content of the cationic lipid is 40-60 mass% per 100 mass% lipids constituting the lipid particle, wherein a content of the phospholipid is 10 to 30% mass% per 100% lipids constituting the lipid particle, where a content of the sterol is 20 to 40 mass% per 100 mass% lipids constituting the lipid particle, and wherein a content of the waster-soluble polymer-modified lipid is 0.2 to 10 mass% per 100 mass% lipids constituting the lipid particle, and wherein the ratio (N/P) of the number of nitrogen atoms (N) in the lipids constituting the lipid particle to the number of phosphorus atoms (P) in a nucleic acid containing the A-type CpG oligodeoxynucleotide is 2.5 to 5; a medicament, a reagent, an immunostimulant and an anticancer agent comprising the same lipid nanoparticle; and a method for producing the same lipid particle, comprising the step of mixing a lipid-containing alcohol solution and an A-type CpG oligonucleotide-containing aqueous solution, preferably the step is performed in a reaction system using a microchannel.
Cullis et al already disclosed lipid particles comprising nucleic acids (e.g., DNA, RNA, plasmid, siRNA, miRNA, immune-stimulating oligonucleotides, antisense and ribozymes) for delivering to a cell in vitro or in vivo, wherein the lipid particle comprises: (a) one or more cationic lipids (e.g., DLin-KC2-DMA, DOTAP, DOTMA), (b) one or more neutral lipids (e.g., DSPC/distearoylphosphatidylcholine, DOPC/dioleoylphosphatidylcholine, DPPC/dipalmitoylphosphatidylcholine), (c) one or more PEG-lipids (e.g., PEG-c-DMA, PEG-CerC14, PEG-c-DOMG), (d) one or more sterols such as cholesterol, and (e) one or more nucleic acids, and wherein the lipid particle comprises a substantially solid core (see at least the Abstract; Summary of the Invention; particularly pages 11-16; page 33, lines 22-33; and Examples 1-5). Cullis et al also taught that the lipid particle has a diameter from about 15 to about 300 nm, preferably from about 15 to about 20 nm (page 23, lines 3-17). An exemplary LNP siRNA formulation consisting of DLin-KC2-DMA/DSPC/Chol/PEG-lipid (40/11.5/47.5/1; mol/mol) containing siRNA at a 0.06 siRNA/lipid (wt/wt), which corresponds to a negative charge (on the siRNA) to positive charge (on the fully protonated cationic lipid) N/P ratio of 4 (page 40, last paragraph; and Fig. 22A). Another exemplary LNP siRNA formulation is comprised of DLin-KC2-DMA, DSPC, cholesterol, and PEG-c-DMA at 40:11.5:38.5:10 mol/mol, respectively, with a siRNA/total lipid ratio of 0.06 (wt/wt) (page 37, first paragraph). Cullis et al stated specifically “An initial composition of DLin-KC2-DMA, DSPC, cholesterol, and PEG-c-DMA (40:11.5:38.5:10 mol/mol) was used with a siRNA/total lipid ratio of 0.06 (wt/wt). Additional cholesterol was used to compensate for the decreased amount of PEG-c-DMA. Titration of PEG-c-DMA to 2 mol% led to only minor increase in particle size using the microfluidic approach. Further decrease to 1 mol% PEG led to an increase in diameter from about 20 nm to about 40 nm (FIGURE 18A)” (page 37, lines 1-7). Cullis et al also taught a method for preparing the nucleic acid-lipid nanoparticles in a microfluidic process that utilizes relatively rapid mixing the nucleic acid in a first solvent (e.g., aqueous buffers such as citrate and acetate buffers) with lipid particle-forming materials in a second solvent (e.g., alcohols, aqueous ethanol 90%) in a microchannel of a microfluidic mixing device to form LNP containing OGN of 100 nm size or smaller and provide OGN encapsulation 100%; and that the LNP OGN systems can be scaled up (pages 23-25; page 39, last two lines continue to first paragraph on page 40). Cullis et al further stated “The present invention provides a method for preparing nucleic acid-lipid nanoparticles comprising the cationic lipid DLinKC2-DMA using a microfluidic mixing device, wherein the resulting nucleic acid-lipid nanoparticles exhibit smaller particle diameter and greater core density than nucleic acid-lipid nanoparticles of the same formulation produced by the conventional performed vesicle method” (Abstract). Fig. 27 below is a schematic representation of the solid core LNP siRNA system formed by microfluidic mixing, which comprise encapsulated siRNA residing in a distorted inverted micelle surrounded by cationic lipid, and the remaining lipid is organized in inverted micelles surrounding anionic counterions and also makes up the outermost monolayer (page 43, last two lines continue to first two lines on page 44). The outermost monolayer in Fig. 27 is apparently comprised predominantly of PEG-DSPC (amphipathic lipids).
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Cullis et al did not teach specifically at least that the above disclosed lipid nanoparticles comprising an A-type CpG oligodeoxynucleotide, even though they disclosed that the lipid nanoparticles comprising immune-stimulating oligonucleotides.
Before the effective filing date of the present application (07/19/2018), Renner et al already taught a composition comprising particles such as virus-like particles, nanoparticles, microparticles and liposomes which are packaged with an immunostimulatory nucleic acid (e.g., oligonucleotides capable of stimulating IFN-alpha production in cells such as A-type CpGs and C-type CpGs), that is useful in the treatment of hypersensitivity (see at least Abstract; page 2, lines 4-30; page 14, lines 21-24; page 15, line 34 continues to 25; page 21, line 17 continues to line 27 on page 23; page 32, lines 10-18; and page 45, lines 25-31). Renner et al stated “[n]anoparticles incorporating an ISS-NA like an unmethylated CpG-containing oligodeoxynucleotide are able to stimulate dendritic cells upon uptake, and these dendritic cells thereafter activated T-cells” (page 30, lines 30-32); and “[u]ptake of particles such as nanoparticles or VLPs packaged with ISS-NA, such as unmethylated CpG-containing oligonucleotide, by plasmacytoid dendritic cells or antigen present cells and thereby inhibit the allergen induced response. The same import involved mast cells in the suppressive action of unmethylated CpG-containing oligonucleotide on the allergic response” (page 31, lines 3-8). Renner et al further stated explicitly “In a preferred embodiment, the ISS-NA, preferably an unmethylated CpG-containing oligonucleotide, is packaged within a “stabilized antisense-lipid particle” containing preferably PEG-ceramide-C14, as described by Semple S.C. et al. Methods Enzymol. 2000; 313:322-41. In the performance of this method for the practice of the invention, the antisense oligonucleotide is replaced by an ISS-NA, and in particular an unmethylated CpG-containing oligonucleotide. These liposomes are prepared with cationic lipids that are only charged at subphysiological pH” (page 45, lines 25-31).
Accordingly, it would have been obvious for an ordinary skilled artisan to modify the teachings of Cullis et al by also encapsulating an A-type CpG oligodeoxynucleotide in their disclosed lipid nanoparticle system, including at least in a LNP formulation with an N/P ratio of 4.0 and comprised of DOTAP: DSPC:cholesterol:PEG-c-DMA at 40:11.5:38.5:10 mol/mol, respectively; or DOTMA:DSPC:cholesterol:PEG-c-DMA at 40:11.5:38.5:10 mol/mol, respectively; in light of the teachings of Renner et al as presented above.
An ordinary skilled artisan would have been motivated to carry out the above modification because Renner et al already taught at least to package or encapsulate A-type CpG oligodeoxynucleotide in a particle in various forms such as virus-like particles, nanoparticles, microparticles and liposomes for use in the treatment of hypersensitivity, including replacing an antisense oligonucleotide with an unmethylated CpG-containing oligonucleotide in a “stabilized antisense-lipid particle” of Semple S.C. et al. Methods Enzymol. 2000; 313:322-41. Please also note that the primary Cullis reference already taught lipid particles comprising nucleic acids (e.g., DNA, RNA, plasmid, siRNA, miRNA, immune-stimulating oligonucleotides, antisense and ribozymes) for delivering to a cell in vitro or in vivo; an exemplary LNP siRNA formulation comprised of DLin-KC2-DMA, DSPC, cholesterol, and PEG-c-DMA at 40:11.5:38.5:10 mol/mol, respectively, with a siRNA/total lipid ratio of 0.06 (wt/wt); and another closely related LNP siRNA formulation consisting of DLin-KC2-DMA/DSPC/Chol/PEG-lipid (40/11.5/47.5/1; mol/mol) containing siRNA at a 0.06 siRNA/lipid (wt/wt), which corresponds to a negative charge (on the siRNA) to positive charge (on the fully protonated cationic lipid) N/P ratio of 4.; along with the specific teachings that a cationic lipid can be a DOTMA or DOTAP other than DLin-KC2-DMA.
An ordinary skilled artisan would have a reasonable expectation of success in light of the teachings of Cullis et al and Renner et al; coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified lipid particle and a method for producing the same modified lipid particle resulting from the combined teachings of Cullis et al and Renner et al as set forth above are indistinguishable and encompassed by the presently claimed inventions.
Please note that where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke. Whether the rejection is based on "inherency" under 35 USC 102, or "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
New claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cullis et al (WO 2011/140627) in view of Renner et al (WO 2007/068747) as applied to claims 1, 3, 9-14 and 20 above, and further in view of Manoharan et al (WO 2010/054401).
The combined teachings of Cullis et al and Renner et al were presented above. However, none of the cited references teach specifically a lipid particle in which a content of the cationic lipid is 45 to 55 mass % per 100 mass% lipids constituting the lipid particle, wherein a content of the phospholipid is 15 to 25 mass% per 100 mass% lipids constituting the lipid particle, wherein a content of the sterol is 25 to 35 mass% per 100 mass% lipids constituting the lipid nanoparticle, wherein a content of the water-soluble polymer modified lipid is 0.2 to 2 mass% per 100 mass% lipids constituting the lipid particle.
Before the effective filing date of the present application (07/19/2018), Manoharan et al already disclosed a lipid particle comprising: (i) a cationic lipid, (ii) a neutral lipid (e.g., DSPC, DPPC, POPC, DOPE), (iii) a sterol (e.g., cholesterol), and (iv) a peg-lipid (e.g., PEG-DMG, PEG-DMA), in a molar ratio of about 20-60% cationic lipid: 5-25% neutral lipid: 25-55% sterol and 0.5-15% PEG-lipid for in vivo delivery of therapeutic agents (e.g., an immunostimulatory oligonucleotide, an antisense oligonucleotide, an antagomir, a plasmid) to a cell (Brief Summary; particularly last paragraph at page 5 continues to first paragraph at page 6; second last paragraph at page 9; last sentence at page 15 and Table 1; last paragraph at page 32; section titled “Immunostimulatory Oligonucleotides” at page 45; last paragraph at page 84 continues to first paragraph at page 85; second and last paragraphs at page 93; first paragraph at page 94).
Accordingly, it would have been obvious for an ordinary skilled artisan to further modify the combined teachings of Cullis et al and Renner et al by also preparing a LNP formulation in which a content of the cationic lipid is 45 to 55 mass % per 100 mass% lipids constituting the lipid particle, wherein a content of the phospholipid is 15 to 25 mass% per 100 mass% lipids constituting the lipid particle, wherein a content of the sterol is 25 to 35 mass% per 100 mass% lipids constituting the lipid nanoparticle, wherein a content of the water-soluble polymer modified lipid is 0.2 to 2 mass% per 100 mass% lipids constituting the lipid particle; in light of the teachings of Manoharan et al as presented above.
An ordinary skilled artisan would have been motivated to further carry out the above modification because Manoharan et al already taught successfully preparation of a lipid particle comprising: (i) a cationic lipid, (ii) a neutral lipid (e.g., DSPC, DPPC, POPC, DOPE), (iii) a sterol (e.g., cholesterol), and (iv) a peg-lipid (e.g., PEG-DMG, PEG-DMA), in a molar ratio of about 20-60% cationic lipid: 5-25% neutral lipid: 25-55% sterol and 0.5-15% PEG-lipid for in vivo delivery of therapeutic agents (e.g., an immunostimulatory oligonucleotide, an antisense oligonucleotide, an antagomir, a plasmid) to a cell.
An ordinary skilled artisan would have a reasonable expectation of success in light of the teachings of Cullis et al, Renner et al and Manoharan et al; coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified lipid particle resulting from the combined teachings of Cullis et al, Renner et al and Manoharan et al as set forth above is indistinguishable and encompassed by the presently claimed invention.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Amended claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cullis et al (WO 2011/140627) in view of Renner et al (WO 2007/068747) as applied to claims 1, 3, 9-14 and 20 above, and further in view of Chen et al (WO 2008/147438).
The combined teachings of Cullis et al and Renner et al were presented above. However, none of the cited references teach specifically a lipid particle in which the ratio N/P is 2.5 to 3.5.
Before the effective filing date of the present application (07/19/2018), Chen et al already successfully disclosed at least various siRNA lipid nanoparticle formulations comprising a mixture of cationic lipid, DSPC or DOPC, cholesterol and PEG-DMG at various N/P ratios that include N/P ratios of 2 (L109), 2.5 (L166), 2.85 (L156) and 3 (e.g., L121, L130, L149) (see at least Abstract; first two paragraphs at page 258; Table IV at pages 275-277)
Accordingly, it would have been obvious for an ordinary skilled artisan to further modify the combined teachings of Cullis et al and Renner et al by also preparing a LNP formulation having at least a N/P ratio of 2.5, 2.85, or 3.0; in light of the teachings of Chen et al as presented above.
An ordinary skilled artisan would have been motivated to further carry out the above modification because Chen et al already successfully disclosed at least various siRNA lipid nanoparticle formulations comprising a mixture of cationic lipid, DSPC or DOPC, cholesterol and PEG-DMG at various N/P ratios of 2.5, 2.85, and 3.0.
An ordinary skilled artisan would have a reasonable expectation of success in light of the teachings of Cullis et al, Renner et al and Chen et al; coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified lipid particle resulting from the combined teachings of Cullis et al, Renner et al and Chen et al as set forth above is indistinguishable and encompassed by the presently claimed invention.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments related to the above modified 103 rejections in the Amendment filed on 05/01/2026 (pages 6-7) along with the 1.132 Declaration of Dr. Taiki Aoshi initially filed on April 01, 2026 have been fully considered, but they are respectfully not found persuasive for the following reasons.
Applicant argued that claim 1 is amended to limit the N/P ratio to 2.5 to 5, and this excludes the N/P ratio of 1 which the Examiner found problematic. Applicant also provided the submitted 1.132 Declaration showing the results of an experiment conducted under the same conditions as in Test Example 1, except that lipid nanoparticles obtained using another A-type CpG oligodeoxynucleotide (A-2216 sequence) in place of D35 were added to the medium in an amount of 200 ng in terms of A-2216; which demonstrated the same ability of A-2216 to promote IFN-α production. Moreover, Applicant argued that the use of the cationic lipids (DOTAP, DOTMA) of claim 1 exhibits a high ability to promote IFN-α production, which is an effect that can be obtained not only when D35 used but also when A-type CpG oligodeoxynucleotides other than D35 are used (Fig. A in the 1.132 Declaration). Applicant argued previously that results in Test Example 1 showing superior stability and performance of lipid nanoparticles with DOTMA and DOTAP in delivering an A-type CpG oligodeoxynucleotide for the induction of IFN-α that are surprising and unexpected. Specifically, Fig. 1 in Test Example 1 demonstrates the ability to promote IFN-α production was highest when DOTAP was used as a cationic lipid (#41), followed by DOTMA (#45), and then DODAP (#47); and when DODAP was used the stability was relatively low and cloudy aggregation occurred within 3 months of storage at 40C. Accordingly, an ordinary skill in the art could not have predicted based on the combined teachings of the cited references that the use of the cationic lipids (DOTAP, DOTMA) exhibits a high ability to promote IFN-α production.
First, the primary Cullis reference teaches clearly a lipid particle comprising nucleic acids (e.g., DNA, RNA, plasmid, siRNA, miRNA, immune-stimulating oligonucleotides, antisense and ribozymes) for delivering to a cell in vitro or in vivo, wherein the lipid particle comprises: (a) a lipid particle comprises: (a) one or more cationic lipids (e.g., DLin-KC2-DMA, DOTAP, DOTMA, DODAP and others), (b) one or more neutral lipids (e.g., DSPC, DOPC, DPPC), (c) one or more PEG-lipids (e.g., PEG-c-DMA, PEG-CerC14, PEG-c-DOMG), (d) one or more sterols such as cholesterol, and (e) one or more nucleic acids, and wherein the lipid particle comprises a substantially solid core. An exemplary LNP siRNA formulation is comprised of DLin-KC2-DMA, DSPC, cholesterol, and PEG-c-DMA at 40:11.5:38.5:10 mol/mol, respectively, with a siRNA/total lipid ratio of 0.06 (wt/wt); and another closely related LNP siRNA formulation consisting of DLin-KC2-DMA/DSPC/Chol/PEG-lipid (40/11.5/47.5/1; mol/mol) containing siRNA at a 0.06 siRNA/lipid (wt/wt), which corresponds to a negative charge (on the siRNA) to positive charge (on the fully protonated cationic lipid) N/P ratio of 4. Thus, the teachings of Cullis et al are not necessarily limited only to examples, including a lipid nanoparticle comprising siRNA with Dlin-KC2-DMA as a cationic lipid. Additionally, the Cullis reference clearly teaches the use of DOTAP and/or DOTMA as cationic lipids in the disclosed lipid nanoparticles. Please refer to the above modified 103 rejections for details along with provided motivations for combining the cited references.
Second, please note that any “surprising/unexpected” result must be commensurate with the scope of the claims. In this instance, with respect to the results in Figure 1 of Test Example 1, it is noted that all the lipid nanoparticles comprise the A-type CpG oligonucleotide of SEQ ID NO: 1: G_G_TGCATCGATGCAGGGG_G (D35), where the underline indicates that nucleosides on both sides of the underline are phosphorothioate-bonded to each other, while nucleosides that are not connected with the underline are phosphodiester-bonded to each other; and each of the tested lipid nanoparticles is composed of a cationic lipid (DOTAP, DOTMA or DODAP), DPPC, cholesterol and DSPE-PEG-2K at their respective mass% of 50:19.5:30:0.5, and the ratio (N/P) of the number of nitrogen atoms (N) in the lipids constituting the lipid particles to the number of phosphorus atoms in the A-type CpG oligonucleotide of SEQ ID NO: 1 is 3 (paragraphs [0093]-[0094]). The 1.132 Declaration also disclosed that the A-type CpG oligodeoxynucleotide A-2216 with the sequence 5’-G_G_GGGACGATCGTCG_G_G_G_G_G-3’ is also encapsulated in a lipid nanoparticle comprised of a cationic lipid (DOTAP, DOTMA or DODAP), DPPC, cholesterol and DSPE-PEG-2K at their respective mass% of 50:19.5:30:0.5, with the N/P ratio of 3. Moreover, both D35 and A-2216 have a poly(G) sequence at the 5’ and 3’ ends, and the nucleosides at each end are phosphorothioate-bonded to each other. In contrast, currently amended claims are much broader than the lipid particles used in Test Example 1 of the specification and the 1.132 Declaration to demonstrate “surprising/unexpected” results. Currently amended claims are drawn to a lipid particle comprising any A-type CpG oligodeoxynucleotide, a cationic lipid as an amphipathic lipid, a phospholipid other than the cationic lipid as an amphipathic lipid, a sterol, and a water-soluble polymer-modified lipid, wherein the lipid particle comprises an outer layer and an ion complex placed inside the outer layer, wherein the outer layer is a lipid monolayer membrane in which amphipathic lipids are arranged with hydrophilic parts facing outward, wherein the cationic lipid is at least one member selected from the group consisting of DOTAP and DOTMA, wherein a content of the cationic lipid is 40-60 mass% per 100 mass% lipids constituting the lipid particle, wherein a content of the phospholipid is 10 to 30% mass% per 100% lipids constituting the lipid particle, where a content of the sterol is 20 to 40 mass% per 100 mass% lipids constituting the lipid particle, and wherein a content of the waster-soluble polymer-modified lipid is 0.2 to 10 mass% per 100 mass% lipids constituting the lipid particle, wherein the ratio N/P is 2.5 to 5. As already noted previously, Test Example 2 of the present application demonstrated clearly that the ability to promote IFN-α was significantly decreased when the N/P ratio was 1 instead of 3 using lipid nanoparticles containing DOTAP (see paragraph [0098]; and Figure 2). Thus, there is evidence at least that N/P ratio is a factor affecting an ability to promote IFN-α production mediated by a lipid particle comprising an A-type CpG oligodeoxynucleotide of the present application. Additionally, an ordinary skill in the art would readily recognize that phosphorothioate bonds in A-type CpG oligodeoxynucleotides could significantly affect the induction of IFN-alpha because the presence of phosphorothioate bonds provides a partially or fully phosphorothioate-modified backbone, which is resistant to nuclease degradation and enhances the stability and endosomal uptake of CpG ODNs, which results in the production of large amounts of IFN-α.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1. Akinc et al (WO 2010/088537) already disclosed various siRNA formulations with lipid ratio of 60/7.5/31/1.5 (cationic Lipid A/DSPC/Chol/PEG) at various charge (N/P) ratios ranging from 1.5 to 5.0 (see at least Abstract; Example 17 and Fig. 13).
2. Zhao et al (WO 2010/014895) also disclosed lipid nanoparticle compositions for nucleic acids/oligonucleotides delivery system, wherein the nanoparticle compositions have the nitrogen to phosphate (N/P) ratio ranging from about 2:1 to about 5:1 (e.g., 2.5:1) (see at least Abstract; and particularly lines 11-15 at page 46).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s acting SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631
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