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 .
Claim Objections
Claims 27 and 30 objected to because of the following informalities:
Claims 27 and 30 are objected to for improper listing of components for consistency with the other claims. Claims 27 and 28 recite a rAAV vector, wherein the fusion protein comprises parts (a), (b), and (c), but claims recite 4 additional elements including the non-distinguished “linker”. To overcome this rejection, applicant may list the components (a) – (d) and include the linker as a separate additional component.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3, 4, 5, 7, 11, 17, 18, 23, 36, 38, 42, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Hinderer C., et. al., WO 2017/024198 A1, published Feb. 9, 2017 and Yuefeng, L., et. al., US 2018/0009869 A1, published Jan. 11, 2018.
Regarding Claim 1, Hinderer teaches a rAAV vector (p. 5, [00026) comprising a polynucleotide comprising a fusion protein comprising a leader sequence comprising a secretion signal peptide: “the propeptide sequence is a feline factor II leader sequence combined with the GLP-1 (7-37) wild type sequence” (p. 17, [00057]) and “a vector may contain … sequences that enhance secretion of the encoded product” (p. 23, [00066]). The instant specification defines a leader sequence as “any N-terminal sequence of a polypeptide” (p. 8, lines 4-5).
Hinderer does not teach a fusion protein further comprising a GLP-1 receptor agonist or a fusion domain comprising either a feline IgG Fc or feline albumin.
Yuefeng teaches “fusion proteins further comprising a peptide agonist that is capable of binding to and stimulate … GLP-1 receptors” (Abstract). Yuefeng further teaches the fusion protein may comprise of “a feline Ig Fc region; or … a feline albumin”(p. 3, [0049]).
It would be obvious to one skilled in the art prior to the effective filing date to combine the teachings of Hinderer and Yuefeng to create a rAAV vector comprising a nucleic acid comprising a polynucleotide sequence encoding a fusion protein comprising a leader sequence, a GLP-1 agonist, and a fusion domain comprising either a feline IgG Fc or feline albumin, taught by Yuefeng. The results would be predictable because rAAVs are well known in the art as taught by Hinderer, the use of signal peptides are well known to properly localize a protein as taught by Hinderer, and both Hinderer and Yuefeng teach the use of fusion proteins. Therefore, Claim 1 is obvious over Hinderer and Yuefeng.
Regarding Claim 3, Hinderer teaches feline factor II is thrombin (p. 17, [00057]), which reads as the leader sequence comprising feline thrombin propeptide. Therefore, Claim 2 is obvious over Hinderer and Yuefeng.
Regarding Claim 4, Hinderer teaches SEQ ID NO: 24 which has 100% identity at positions 1-43, the N-terminal leader sequence, with the instant SEQ ID NO: 7, 8 and 9. Hinderer teaches SEQ ID NO: 24 positions 1-43 is the feline Factor II leader sequence (p. 17, [00057]). Therefore, Claim 4 is obvious over Hinderer and Yuefeng.
Regarding Claim 5, Hinderer teaches an embodiment with the leader sequence of feline IL-2: “SEQ ID NO: 58 provides the sequence of a plasmid encoding a feline IL2 propeptide (including furin site)-GLP construct” (p. 24, [00069]). A NCBI Blast protein search shows instant SEQ ID NO: 10 has 100% alignment with positions 1-10 of IL-2. Therefore, Claim 5 is obvious over Hinderer and Yuefeng.
SEQ ID NO: 10 1 MYKIQLLSCIALTLILVTNS 20
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IL-2 1 MYKIQLLSCIALTLILVTNS 20
Regarding Claim 7, Hinderer teaches a fusion protein with feline GLP-1(7-37). Therefore, Claim 7 is obvious over Hinderer and Yuefeng.
Regarding Claim 11, the instant specification defines SEQ ID NO: 2 as the native feline GLP-1(7-37) sequence (p. 7, lines 7-8). Hinderer teaches the use of feline GLP-1(7-37). Therefore, Claim 11 is obvious over Hinderer and Yuefeng.
Regarding Claim 17, Hinderer does not teach the use of linkers.
Yuefeng teaches the use of linkers with feline IgG Fc: “In some embodiments, the first and the second proteins are linked via a linker” (p. 3, [0049]).
It would obvious to one skilled in the art before the effective filing date to further combine the linker taught by Yuefeng with previous teachings to create the invention of Claim 1 with a linker with feline IgG Fc. It would be predictable because Yuefeng was able to make fusion proteins with linkers and linkers are well known in the art. Therefore, Claim 17 is obvious over Hinderer and Yuefeng.
Regarding Claim 18, Yuefeng teaches the use of feline IgG including IgG1a and IgG2 (Fig. 13, SEQ ID NO: 15 and 16). Therefore, Claim 18 is obvious over Hinderer and Yuefeng.
Regarding Claim 23, Yuefeng teaches feline IgG1A as SEQ ID NO: 15, which has a 95.6% query match and 99.6% local similarity to SEQ ID NO: 11. An alignment is below. Therefore, Claim 23 is obvious over Hinderer and Yuefeng.
Qy 9 GPKPCDCPKCPPPEMLGGPSIFIFPPKPKDTLSISRTPEVTCLVVDLGPDDSDVQITWFV 68
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Db 1 GPKPSDCPKCPPPEMLGGPSIFIFPPKPKDTLSISRTPEVTCLVVDLGPDDSDVQITWFV 60
Qy 69 DNTQVYTAKTSPREEQFNSTYRVVSVLPILHQDWLKGKEFKCKVNSKSLPSPIERTISKA 128
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Db 61 DNTQVYTAKTSPREEQFNSTYRVVSVLPILHQDWLKGKEFKCKVNSKSLPSPIERTISKA 120
Qy 129 KGQPHEPQVYVLPPAQEELSRNKVSVTCLIKSFHPPDIAVEWEITGQPEPENNYRTTPPQ 188
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Db 121 KGQPHEPQVYVLPPAQEELSRNKVSVTCLIKSFHPPDIAVEWEITGQPEPENNYRTTPPQ 180
Qy 189 LDSDGTYFVYSKLSVDRSHWQRGNTYTCSVSHEALHSHHTQKSLTQSPG 237
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Db 181 LDSDGTYFVYSKLSVDRSHWQRGNTYTCSVSHEALHSHHTQKSLTQSPG 229
Regarding Claim 36, Hinderer teaches the rAAV vector comprises of an AAV capsid (p. 3, [00011]) and a genome comprising AAV ITRs (p. 23, [00068]) and regulatory sequences (p. 23, [00066]). Hinderer and Yuefeng teach the fusion protein of Claim 1. Therefore, Claim 36 is obvious over Hinderer and Yuefeng.
Regarding Claim 38, Hinderer teaches “the rAAV has a capsid selected from AAV8, AAVrh64R1, AAV9, AAVhu.37 or AAVrh10” (p. 3, [00011]). Therefore, Claim 37 is obvious over Hinderer and Yuefeng.
Regarding Claim 42, Hinderer teaches pharmaceutical compositions comprising an aqueous liquid (p. 27, [00076]), in which the “subject is a feline” (p. 3, [00012]) and the constructs are for treating “metabolic syndrome in a subject in need” (p. 6, [00026]). Hinderer and Yuefeng teach Claim 1. Therefore, Claim 42 is obvious over Hinderer and Yuefeng.
Regarding Claim 46, Hinderer teaches a method of treating a feline subject with a metabolic disease, wherein “dosage is about 1.0 x 1011 GC to about 1.0 x 1012 GC for an average feline … subject of about 5 kg” (p. 28, [00078]). This results in 2.0 x 1010 to about 2.0 x 1011 GC/kg body mass, which is within the claimed range of 1 x 109 to 3 x 1013 GC/kg. Hinderer further teaches that the method may be performed intravenously or intramuscularly (p. 27-28, [00076]). Hinderer and Yuefeng teach Claim 1. Therefore, Claim 46 is obvious over Hinderer and Yuefeng.
Claims 9, 11, 27, 28, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hinderer C., et. al., WO 2017/024198 A1, published Feb. 9, 2017 and Yuefeng, L., et. al., US 2018/0009869 A1, published Jan. 11, 2018 as applied to Claims 1 and 7 above, and further in view of Glaesner, W. et. al., Diabetes/Metabolism Research and Reviews, Vol. 26, p. 287-296, published online Apr. 30, 2010.
Regarding Claim 9, Hinderer and Yuefeng teach Claims 1 and 7.
Hinderer does not teach the use of SEQ ID NO: 3. As defined by the instant specification, SEQ ID NO: 3 is the native feline GLP-1(7-37) sequence with the substitutions A8G, G22E and R36G (p. 7, lines 9-21).
Glaesner teaches a fusion protein comprising of GLP-1 and a Fc with mutations at A8G, G22E and R36G: “GLP-1-Fc analogues … G8E22CEXL” (p. 291, Figure 1) and “the GLP-1 R36G mutation was introduced to de-immunize the fusion protein” (p. 290, col. 2). Glaesner also teaches the use of a GGGGSx3 linker (p. 291, Figure 1b): “The amino acid sequence of GLP-1 including the linker is
as follows: HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGGGGGGSGGGGSGGGGSA” (p. 291, Figure 1 (C) legend).
It would be obvious to one skilled in the art before the effective filing date to substitute the modifications taught by Glaesner into the GLP-1 receptor agonist taught by Hinderer because Glaesner teaches the modified GLP-1 receptor agonist has in vivo activity “with increased half-life
and efficacy” (p. 287, Conclusions). The results would be predictable as Glaesner provides results that the substitutions work in vivo to increased success. Therefore, Claim 9 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Regarding Claim 11, the instant specification defines SEQ ID NO: 4 as the native feline GLP-1(7-37) sequence with modifications at A8G and G22E. Glaesner teaches the modifications at A8G and G22E. It would be obvious to one skilled in the art to use the modifications taught by Glaesner with GLP-1 as Glaesner was able to get improved in vivo results. The results would be predictable because Glaesner provides data that modifications improved treatment. Therefore, Claim 11 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Regarding Claim 27, Hinderer teaches a feline thrombin leader, Hinderer and Gleasner teaches the DPP-IV resistant variant of GLP-1(7-37), Gleasner and Yuefeng both teach the use of a linker, and Yuefeng teaches the use of feline IgG Fc. It would be obvious and predictable to one skilled in the art before the effective filing date to combine those elements because Hinderer, Gleasner, and Yuefeng all teach fusion proteins; Hinderer, Gleasner, and Yuefeng all provide evidence that combinations work, and Gleasner teaches the modified GLP-1(7-37) has improved in vivo activity. Therefore, Claim 27 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Regarding Claim 28, SEQ ID NO: 14 is the combination of SEQ ID NO: 7, positions 1-43; SEQ ID NO: 3, positions 44-74; SEQ ID NO: 13, positions 75-89; and SEQ ID NO: 11, positions 90-326. SEQ ID NO: 7 is taught by Hinderer as the feline thrombin leader sequence as described in the rejection of Claim 4. SEQ ID NO: 3 is the DPP-resistant GLP-1 sequence taught by Hinderer and Glaesner as described in the rejection of Claim 9. SEQ ID NO: 13 has 100% identity with the linker taught by Glaesner (p. 291, Figure 1b). SEQ ID NO: 11 is the feline IgG Fc sequence with 95.6% query match and 99.6% local similarity to SEQ ID NO: 15 of Yuefeng as described in the rejection of Claim 23. The combinations of reference would produce a fusion protein with 99.97% identity to SEQ ID NO: 14. It would be obvious and predictable to one skilled in the art before the effective filing date to combine those elements because Hinderer, Gleasner, and Yuefeng all teach fusion proteins; Hinderer, Gleasner, and Yuefeng all provide evidence that combinations work, and Gleasner teaches the modified GLP-1(7-37) has improved in vivo activity. Therefore, Claim 27 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Regarding Claim 30, Hinderer teaches a feline thrombin leader, Hinderer and Gleasner teaches the DPP-IV resistant variant of GLP-1(7-37), Gleasner and Yuefeng both teach the use of a linker, and Yuefeng teaches the use of feline albumin. It would be obvious and predictable to one skilled in the art before the effective filing date to combine those elements because Hinderer, Gleasner, and Yuefeng all teach fusion proteins; Hinderer, Gleasner, and Yuefeng all provide evidence that combinations work, and Gleasner teaches the modified GLP-1(7-37) has improved in vivo activity. Therefore, Claim 27 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Regarding Claim 31, SEQ ID NO: 16 is the combination of SEQ ID NO: 7, positions 1-43; SEQ ID NO: 3, positions 44-74; a GGGGS linker sequence with substitution G85A, positions 72-86; and SEQ ID NO: 12, positions 87-670. SEQ ID NO: 7 is taught by Hinderer as the feline thrombin leader sequence as described in the rejection of Claim 4. SEQ ID NO: 3 is the DPP-resistant GLP-1 sequence taught by Hinderer and Glaesner as described in the rejection of Claim 9. The GGGGS linker sequence is taught by Glaesner. SEQ ID NO: 12 is the feline albumin, taught by Yuefeng. A NCBI Protein Blast search of SEQ ID NO: 12 shows 100% alignment with NP_001009961.1 of Felis catus albumin. The combination of references would produce a fusion protein with 99.8% identity to SEQ ID NO: 16. It would be obvious and predictable to one skilled in the art before the effective filing date to combine those elements because Hinderer, Gleasner, and Yuefeng all teach fusion proteins; Hinderer, Gleasner, and Yuefeng all provide evidence that combinations work, and Gleasner teaches the modified GLP-1(7-37) has improved in vivo activity. Therefore, Claim 27 is obvious over Hinderer and Yuefeng in further view of Glaesner.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hinderer C., et. al., WO 2017/024198 A1, published Feb. 9, 2017 and Yuefeng, L., et. al., US 2018/0009869 A1, published Jan. 11, 2018 as applied to Claim 1 above, and further in view of Shin, D., et. al., Molecular Pharmacology, Col. 95, p. 70-81, Jan. 2019.
Regarding Claim 14, Hinderer and Yuefeng teach Claim 1.
Hinderer does not teach does not teach the use of a second GLP-1 receptor agonist.
Shin teaches the use of two agonists targeting the same site “can result in potentiation because of ‘concentration additivity’ ie., an increase in the effective concentration of the ligand” (p. 70, Col. 1-2).
It would be obvious and predictable to one skilled before the effective filing date to combine the teachings of Hinderer and Yuefeng to create the invention of Claim 1 and use the teachings of Shin to add a second GLP-1 receptor agonist because Hinderer and Yuefeng both teach fusion proteins that work and Shin teaches a second receptor agonist would increase the effective concentration. Therefore, Claim 14 is obvious over Hinderer and Yuefeng in view of Shin.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Hinderer C., et. al., WO 2017/024198 A1, published Feb. 9, 2017 and Yuefeng, L., et. al., US 2018/0009869 A1, published Jan. 11, 2018 as applied to Claim 1 above, and further in view of Glaesner, W. et. al., Diabetes/Metabolism Research and Reviews, Vol. 26, p. 287-296, published online Apr. 30, 2010 and Shin, D., et. al., Molecular Pharmacology, Col. 95, p. 70-81, Jan. 2019.
Regarding Claim 34, Hinderer and Yuefeng teach Claim 1.
Hinderer does not teach the use of two agonists or a modified GLP-1 receptor agonist with A8G and G22E mutations.
Shin teaches the use of two agonists targeting the same site “can result in potentiation because of ‘concentration additivity’ ie., an increase in the effective concentration of the ligand”.
Glaesner teaches a fusion protein comprising of GLP-1 and a Fc with mutations at A8G and G22E: “GLP-1-Fc analogues … G8E22CEXL” (p. 291, Figure 1).
SEQ ID NO: 18 is a combination of SEQ ID NO: 7, positions 1-43, SEQ ID NO: 4 repeated in tandem, positions 44-102; and SEQ ID NO: 12, positions 104-687. SEQ ID NO: 7 is taught by Hinderer as the feline thrombin leader sequence as described in the rejection of Claim 4. SEQ ID NO: 4 is the DPP-resistant GLP-1 sequence taught by Hinderer and Glaesner as described in the rejection of Claim 11. Shin teaches the use of multiple agonists targeting the same site. SEQ ID NO: 12 is the feline albumin, taught by Yuefeng. The combination of references would produce a fusion protein with 99.9% identity to SEQ ID NO: 18. It would be obvious and predictable to one skilled in the art before the effective filing date to combine those elements because Hinderer, Gleasner, and Yuefeng all teach fusion proteins; Hinderer, Gleasner, and Yuefeng all provide evidence that combinations work, Shin teaches that two agonists acting on the same site leads to an effective increase in the ligand, and Gleasner teaches the modified GLP-1(7-37) has improved in vivo activity. Therefore, Claim 27 is obvious over Hinderer and Yuefeng in further view of Glaesner and Shin.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 12221615 B2 (referred to as Hinderer 2) in view of Yuefeng, L., et. al., US 2018/0009869 A1, published Jan. 11, 2018.
Regarding Claim 1, Hinderer 2 recites in Claim 1, “A recombinant adeno-associated virus (AAV) vector useful for treating diabetes in a feline comprising a nucleic acid molecule comprising a sequence encoding a propeptide and a GLP-1 peptide, wherein the propeptide is a feline clotting factor II propeptide, wherein the feline clotting factor II propeptide is amino acids 1-43 of SEQ ID NO: 24, and the GLP-1 peptide is SEQ ID NO: 1 and wherein the nucleic acid sequence encoding the GLP-1 peptide is SEQ ID NO: 2”. The propetide of Claim 1 of Hinderer 2, amino acids 1-43 of SEQ ID NO: 24, has 100% identity with the instant SEQ ID NO: 7, identified in the instant specification as an embodiment of a claimed leader sequence (p. 9, lines 5-10). A GLP-1 peptide is a GLP-1 receptor agonist.
Hinderer 2 does not teach the use of feline IgG Fc or feline albumin.
Yuefeng teaches “fusion proteins further comprising a peptide agonist that is capable of binding to and stimulate … GLP-1 receptors” (Abstract). Yuefeng further teaches the fusion protein may comprise of “a feline Ig Fc region; or … a feline albumin”(p. 3, [0049]).
It would be obvious to one skilled in the art prior to combine the teachings of Hinderer 2 and Yuefeng to create a rAAV vector comprising a nucleic acid comprising a polynucleotide sequence encoding a fusion protein comprising a leader sequence, amino acids 1-43 of SEQ ID NO: 24 taught by Claim 1 of Hinderer 2; a GLP-1 receptor agonist, GLP-1 peptide taught by Claim 1 of Hinderer 2; and either a fusion domain comprising of either feline IgG Fc or feline albumin, taught by Yuefeng. It would be predictable to one skilled in the art to combine the teachings as Yuefeng teaches the feline IgG Fc or feline albumin would be combined in a fusion protein with a peptide agonist capable of binding GLP-1 receptors. Therefore, Claim 1 is obvious over Hinderer 2 and Yuefeng.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Krishna Nuggehalli Ravindra whose telephone number is (571)272-2758. The examiner can normally be reached M-Th, alternate F, 8a-5p est.
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/K.N.R./ Examiner, Art Unit 1636
/NEIL P HAMMELL/ Supervisory Patent Examiner, Art Unit 1636