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 .
Priority
The priority date for this application is the date of the provisional application: 07/09/2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Election/Restrictions
Restriction:
Applicant's election with traverse of expanded Group I (claims 1, 2, 5, 8-11, 13-18, 22, 28, and 30) drawn to a recombinant antisense oligonucleotide and a passenger sequence, in the reply filed on June 21st 2024 was previously acknowledged.
The withdrawal of claims 35-38 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim, is moot since applicants have cancelled these withdrawn claims.
B. Species Election:
Applicant’s election with traverse of SEQ ID NO: 14 and its reverse complement, SEQ ID NO: 2, in the same reply filed on June 21st 2024 was previously acknowledged.
SEQ ID NOs: 15, 18 and 19 and SEQ ID NOs: 3, 16, and 17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. The species requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
This action is in response to papers filed 12th Nov 2025 in which claims 2-7 and 9 were canceled, no claims were added, and claims 1, 8, 14, 17-18, and 22 were amended; claims 12, 19-21, 23-27, 29, and 31-38 were previously cancelled.
Claims 1, 8, 10-11, 13-18, 22, 28, and 30 are under prosecution.
Declaration/Affidavit
This was previously acknowledged: The affidavit under 37 CFR 1.132 filed 13th June, 2025 is sufficient to overcome the rejection of claims 1, 2, 5, 8-11, 13-15, and 30 based upon 35 USC § 102 and claims 16-17, 22, and 28 based upon 35 USC § 103 based over the same Applicant owned reference of He (WO 2022 245734, IDS). The Affidavit signed by one co-inventor, Mulle, provides a statement to the effect that subject matter in the He reference is solely the invention of the presently named inventors.
Amendments & Arguments
All of the amendments have been thoroughly reviewed and entered.
Applicant has:
1. amended claims 1, 8, 17, 18, and 22 to overcome the 112(a) rejection; the rejection has been overcome; the 112(a) rejection of claims 1, 8, 10-11, 13-18, 22, 28, and 30 is withdrawn.
2. amended claim 1 to overcome the 101 rejection; the 101 rejection has been overcome; the 101 rejection of claims 1, 2, 8-10, and 30 is withdrawn.
§103:
3. previously argued that the previous declaration and amendments overcome the 35 USC § 102 and 103 rejections over the reference of He and over the reference of Khvorova; the previous 35 USC § 102 and 103 rejections were overcome and the rejections were withdrawn; However, new 103 rejection of claims 1, 8, 10-11, 13-18, 22, 28, and 30 is made in this Office Action. The previously indicated allowability of claim 16 and objection to claim 18 is withdrawn in view of the new §103 rejection set forth in this Office Action.
§Double Patenting:
5. argued that the cancellation of claims overcomes the 35 USC § 101 DP rejections over '351 application; the cancellation has overcome the rejection, the 35 USC § 101 DP rejections over '351 application is withdrawn.
6. argued the patent term date of the '241 application, which is January 14, 2022, is later than instant, which is June 30th 2022; this is not persuasive because the NSDP is not the only rejection remaining on the record. However, amendments have overcome the NSDP rejection of claims 1, 8, 10-11, 13-18, 22, 28, and 30 over the '241 application; the NSDP rejection over '241 application is withdrawn.
Any rejection or objection not reiterated herein has been overcome by amendment.
Applicant's remarks have been fully considered. Arguments pertaining to unwithdrawn rejections are addressed in this office action.
Withdrawn Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see Pg. 5, filed 12/11/2025, with respect to rejections under 35 USC § 112(a) have been fully considered and are persuasive; the amendments have overcome the rejection. The previous rejection is withdrawn.
Withdrawn Claim Rejections - 35 USC § 101
Response to Arguments
Applicant's arguments filed 12/11/2025 to the 101 rejections have been fully considered and are persuasive; the amendments have overcome the rejection. The previous rejection is withdrawn.
New 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8, 10-11, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Crepel (US 20160228439) in view of Hornstein (WO 2016/157175 A1), Amellem (Master thesis. Available December 2014. NTNU, Trondheim), all cited in IDS dated 12/11/2025, and Bofill-De Ros (Methods. 2016 July 1; 103: 157–166).
Claim Interpretation:
A. Grik2 is used synonymously with GIuK2 (GIuK2 (Grik2) mRNA sequences may be found in NCBI Gene ID NO: 2898, specification Pg. 8, line 24).
B. The guide sequence and the passenger sequence of a recombinant antisense oligonucleotide are the antisense and sense (complementary to antisense) strand of an siRNA duplex, respectively (specification Pg. 5, line 6).
Regarding claim 1, Crepel teaches a compound which is an antagonist of Grik2 or an inhibitor of Grik2 expression for use in the treatment or the prevention of epilepsy (GluK2/GluK5 receptor, abstract). An embodiment of such a compound is Antisense oligonucleotides (Small inhibitory RNAs (siRNAs) can also function as inhibitors, [0048]). Crepel further teaches antisense oligonucleotides useful as inhibitors of Grik2 can be prepared by known methods [0048]. See pertinent recitation from this para:
GluK2/GluK5 receptor gene expression can be reduced by contacting a subject or cell with a small double stranded RNA (dsRNA), or a vector or construct causing the production of a small double stranded RNA, such that GluK2/GluK5 receptor gene expression is specifically inhibited (i.e. RNA interference or RNAi). Methods for selecting an appropriate dsRNA or dsRNA-encoding vector are well known in the art for genes whose sequence is known.
Regarding claim 30, Crepel teaches the compound can be in a pharmaceutical composition, where the compound is mixed with suitable carriers or excipients [0066].
Crepel does not teach in the recombinant antisense oligonucleotide i) …wherein the guide sequence has …the sequence of SEQ ID NO: 14.
Hornstein teaches a method of treating motor neuron disease (MND), such as epilepsy, the method comprising administering an agent that downregulates GRIK2 (title and abstract). Hornstein teaches method of treatment of a subject having epilepsy comprises administering a nucleic acid inhibitor of Grik2 (MND selected from:… epilepsy, downregulate Grik2 receptor, title, abstract, pg. 4 3rd para, claim 10). Hornstein experimentally validate Grik2 as a target for epilepsy (Example 2, pg. 63-64; claims 3-4). Hornstein teaches antisense polynucleotides such as small inhibitory RNAs (siRNAs) function as inhibitors of Grik2 and can be prepared by known methods and provide guidance on how to do so (pg. 17-18). Hornstein teaches miRNAs suppress target sequences in a manner similar to siRNAs (pg. 2 2nd para). Further, Hornstein teaches obtaining such siRNAs from commercial sources. See pertinent recitation from pg. 19:
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Hornstein provide the Genbank accession nos. for GRIK2 (pg. 13-14). Hornstein also teaches the design and synthesis of inhibitory polynucleotides is well within the capabilities of one skilled in the art and can be accomplished via established methodologies as detailed in, for example: Sambrook, J. and Russell, D. W. 25 (2001)…, (pg. 38). Hornstein also teaches the availability of algorithms for identifying sequences of high binding affinity (pg. 20, last para), and in vitro assays for the same (pg. 21 first para). Thus, Hornstein state: the generation of highly accurate antisense design algorithms and a wide variety of oligonucleotide delivery systems, enable an ordinarily skilled artisan to design and implement antisense approaches suitable for downregulating expression of known sequences without having to resort to undue trial and error experimentation (pg. 21 second para).
Hornstein also does not teach wherein the guide sequence that comprises the recombinant antisense oligonucleotide that targets a Grik2 mRNA comprises a polynucleotide sequence identical to the nucleic acid sequence of Applicant’s SEQ ID NO: 14.
However, before the effective filing date of Applicant’s invention, Bofill-De had taught small inhibitory RNAs of 21 to 22 nucleotides were known to cause potent knockdown (introduction). Bofill-De further taught step-by-step guidelines for RNAi design specifically for an antisense oligonucleotide (guide and passenger strand) that is obtained by expressed shRNA (title, abstract, pgs. 10-11). Three pertinent guidelines are here: First, with respect to target RNA sequence: Bofill-De teaches for stable and efficient binding of the antisense oligonucleotide to its target RNA sequence the target sequences need to be located in a structurally opened area along any part of the mRNA sequence often surrounded by AU -rich sequences (pg. 8: last para and last line of third to the last para and pg. 9 first para). The same can be easily determined (“Accessibility of target sites can be measured experimentally or estimated by software based on minimum free energy of secondary structure which is often correlated with the AU-richness of surrounding sequences.”, pg. 9, first para). Second, with respect to guide RNA sequence: Bofill-De teaches that near-perfect complementarity between a 21 nucleotide long guide strand and target critically influence knockdown efficiency (pg. 5, Fig. 2A, pgs. 8-9), asymmetrical nucleotide content in the duplex comprising guide and passenger strands for increasing targeting, with more GC content at the 5′-end of the guide strand and more UU at the 3′-end (Fig. 4A). Finally, Bofill-De teaches that despite these time-tested design steps, off-target effects are still a challenge. Several strategies to overcome are suggested, one of which is using bioinformatics algorithms (pg. 9, middle paras). Therefore, one would need to experiment with various guide strands, which establishes the need to “try” several sequences to find optimal candidates.
Further, Amellem had taught an in vitro method of screening candidate RNAi sequences for efficacy and specifically used it to identify short hairpin RNA sequences for successful RNA interference of the kainate receptor subunit GRIK2 gene expression (pg. 17, section 1.7).
Regarding ii) the loop, Bofill-De taught several advantages to having antisense polynucleotides designed as short hairpin RNA constructs for e.g., longer half-lives (1st para of introduction). Bofill-De teach the design of Pri-miRNA-like shRNA (“second generation”), based on the pri-mir-30a (Fig. 2 and legend). The shRNA sequence (from 5′ to 3′) will be in the order of passenger strand, loop, then guide strand., (pg. 10). Bofill-De disclose that miR-30a is a widely used backbone for shRNA production (pg. 5, first para; 2nd generation, Fig. 2 legend).
See Fig. 2 and the following recitations:
from pg. 4:
A typical pri-miRNA contains three components: 1) A loop of variable size 2) A stem of three helical turns (33~35 bp) and 3) single-stranded regions flanking the hairpin.
And legend for Fig. 2:
B) Pri-miRNA-like shRNA (“second generation”), based on the pri-mir-30a (note incomplete flanking 5′ and 3′ regions).
Regarding iii) a passenger sequence… Bofill-De had further taught that the enzyme that processes the inhibitory RNA inside the cell, Dicer, is a dsRNAse (pg.5, middle para). Therefore, the guide strand is prepared in conjunction with a passenger strand that is complementary to it (pgs. 10-11, section 7.1, Fig. 4). See pertinent recitation from section 7.1:
the rest of passenger strand sequence (position 2 to 19) to have perfect complementary to the guide strand.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try to make a guide sequence sufficiently similar to Applicant’s SEQ ID NO: 14 using the inhibitory RNA design guidelines taught by Bofill-De and using the Grik2 GenBank mRNA sequence provided by Hornstein. Crepel had taught that for a gene whose sequence is known, an inhibitory RNA sequence can be easily designed, Hornstein had taught the Grik2 GenBank mRNA sequence and many ways of arriving at an inhibitory RNA strand, and Bofill-De had emphasized a design need for nucleic acid sequences which can influence target gene suppression. Bofill-De had taught that siRNA targeting systems rely on a finite number of identified parameters such as target length, limited RNA nucleotides, combinations of nucleotides, and optimal nucleotide length, resulting in a finite number of identified, predictable sequences. The length of human Grik2 mRNA is ~5000 nucleotides long and optimal siRNA guides are 21 nucleotides long. Thus, there are ~4979 possible 21-mers that can target known RNA with 100% identity. As such, there are finite number of identified solutions evidenced by the GenBank sequences. The large, but finite number of possible solutions becomes much smaller and their function even more predictable once the skilled artisan makes use of the known design guidelines taught by Bofill-De. It would have been obvious to try to design and test guide sequences like SEQ ID NO: 14 to target a Grik2 because Bofill-De demonstrate that given a known target, guide sequences can be generated within their design system to influence gene expression with a measured and predictable outcome and because Bofill-De teaches even with computer design algorithms, off-target sequences can occur, further establishing the need to “try” the sequences to find optimal candidates. The skilled artisan would have had a reasonable expectation of success using Bofill-De’s guide sequence design to make sequences like SEQ ID NO: 14 from the Grik2 gene because Bofill-De teach the known parameters of successful gene targeting such as 21 nucleotide length and asymmetrical nucleotide content in the duplex with more GC content at the 5′-end of the sense strand and more UU at the 3′-end. Further, Amellem had taught an easy-to-use method to screen for efficient sequences. Thus, Bofill-De’s guide sequence design system and Amellem’s screening method would generate sufficiently similar guide sequences to SEQ ID NO: 14 from a known target which predictably inhibits the Grik2 gene in a cell of interest. Further, after having arrived at SEQ ID NO: 14, one of skill in the art would have easily designed the passenger strand (complementary base pairing rules) for it. See MPEP 2143 I (E) and (G).
Further, Bofill-De had taught expressing the sense (guide) and antisense (passenger) with a miR30 loop sequence in a nucleic acid construct. Therefore, one would have had reasonable expectation of success in incorporating the guide and passenger sequence obtained by trying a few different options, into a construct with a miR30 loop. See MPEP 2143 I (A).
Regarding claim 8, the recombinant antisense oligonucleotide of claim 1 is discussed above. Hornstein further teach: To express the antisense polynucleotide, a nucleic acid sequence encoding the polynucleotide of the present invention is preferably ligated into a nucleic acid construct. Such a nucleic acid construct includes a promoter sequence for directing transcription of the polynucleotide sequence in the cell in a constitutive or inducible manner (pg. 42). Finally, Hornstein teach administering the inhibitory polynucleotide to the patient per se or as part of a pharmaceutical composition, where it is mixed with suitable carriers or excipients (pg. 46).
As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have used a recombinant construct of a nucleic acid sequence encoding i) a guide sequence, ii) loop of miR30, and iii) a passenger sequence as in the composition of Crepel, Hornstein, Amellem, and Bofill-De Ros in an expression vector since Hornstein had taught that for expressing an intended nucleic acid sequence an expression vector must be used. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination as taught in MPEP 2144.07. The claimed expression vector is required for expressing the recombinant antisense oligonucleotide of claim 1.
Regarding claims 10 and 11, Bofill-De taught that the antisense oligonucleotide could be expressed from an expression vector such as lentiviral or retroviral vector (pg. 10, last para).
As in the case of claim 8, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the expression vector comprising the recombinant construct of a nucleic acid sequence encoding i) a guide sequence, ii) loop of miR30, and iii) a passenger sequence as in the composition of Crepel, Hornstein, Amellem, and Bofill-De Ros in a viral vector since and Bofill-De Ros had taught that a viral vector is suitable and has been used to carry an expression vector. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination as taught in MPEP 2144.07. The claimed viral vector is required for carrying the expression vector of claim 8 into a cell.
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Crepel (US 20160228439) in view of Hornstein (WO 2016/157175 A1) and Bofill-De Ros (Methods. 2016 July 1; 103: 157–166), as applied to claims 1, 8, 10-11, and 30 above, and further in view of Greenberg (US 20180193414), all cited in IDS dated 12/11/2025.
Regarding claim 13, the expression vector of claim 11 is discussed above..
Neither Crepel, Hornstein, Amellem nor Bofill-De taught expression from an AAV vector.
However, Greenberg taught an invention that provides vectors, compositions, and methods of using the same for treating neurological disorders (abstract, 1st line) such as epilepsy [0022]. The vectors comprise nucleic acid molecules [0012]. An embodiment of an oligonucleotide (polynucleotide) is an siRNA comprising guide (antisense) and passenger (sense) sequence [0229 -0230] to suppress relevant targets. An example of a target is Grik2 ([0196]). Greenberg further taught wherein the AAV vector that comprises the polynucleotide of the invention is an AAV9 vector [0095].
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have employed the sense, antisense, (i.e., SEQ ID NOs: 2 and 14), and loop containing ASO targeting Grik2, in an expression vector and further in a viral vector, made by the teachings of Crepel, Hornstein, Amellem and Bofill-De in an AAV9 expression vector according to guidance from Greenberg. It would have merely amounted to a combination of prior art elements according to known methods to yield predictable results. The skilled artisan would have had a reasonable expectation that introducing the Grik2 targeting polynucleotides into the AAV9 expression vector of Greenberg could be effective and work as predicted because 1) Greenberg teaches the construction of an expression vector using AAV (Example 1, Y731F); 2) Greenberg teaches that an expression vector in an AAV9 vector is effective in delivering its cargo to neurons (Gene Expression assay [00413]). See MPEP 2143 I (A).
Regarding claim 14, the expression vector of claim 13 is taught above and incorporated in the rejection of claim 14 in further view of Greenberg above. Greenberg further teaches wherein the AAV vector comprises (i) an expression cassette comprising a transgene operably linked to one or more regulatory elements and flanked by ITRs, and (ii) an AAV capsid ([00300]).
Regarding claim 15, the expression vector of claim 14 is taught above. Greenberg further teaches wherein the AAV vector comprises regulatory elements that comprise promoters ([00347]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Crepel (US 20160228439) in view of Hornstein (WO 2016/157175 A1), Amellem (Master thesis. Available December 2014. NTNU, Trondheim), all cited in IDS dated 12/11/2025, and Bofill-De Ros (Methods. 2016 July 1; 103: 157–166).
The teachings of Crepel, Hornstein, Amellem, and Bofill-De Ros, have been discussed for claims 1, 8, 10-11, and 30 above and are incorporated herein.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have acted upon the advantage disclosed by Bofill-De and designed the polynucleotides according to the teachings of Bofill-De i.e., SEQ ID NOs: 2 and 14 and placed them in an expression cassette comprising: (a) a stem-loop sequence comprising, from 5' to 3': (i) a 5' stem-loop arm comprising a guide sequence having a nucleic acid sequence of SEQ ID NOs: 14; (ii) a loop region, wherein the loop region comprises a miR-30 loop sequence; (iii) a 3' stem-loop arm comprising a passenger sequence having a nucleic acid sequence of SEQ ID NOs: 2 (b) a first flanking region located 5' to the guide sequence; and a second flanking region located 3' to the passenger sequence, and arrive at a stem-loop design of an expression cassette of claim 16. See MPEP 2144 II.
Claim(s) 17, 18, 22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Crepel (US 20160228439) in view of Hornstein (WO 2016/157175 A1), Amellem (Master thesis. Available December 2014. NTNU, Trondheim), all cited in IDS dated 12/11/2025, and Bofill-De Ros (Methods. 2016 July 1; 103: 157–166), as applied to claim 16 above, and further in view of Rao (US 9353373 B2).
The following rejection is directed to:
claim 17 embodiment (a) the stem-loop sequence of (I) comprises a polynucleotide with the nucleic acid sequence of SEQ ID NO: 20;
claim 18 embodiment (a) the expression cassette of (I) comprises a polynucleotide with the nucleic acid sequence of SEQ ID NO: 21;
claim 22 embodiment c) the miR-30 loop sequence comprises a polynucleotide with the nucleic acid sequence of SEQ ID NO: 25.
Other embodiments have not been considered because they have been listed as optional (or).
Regarding claims 17-18 and 22, the expression cassette of claim 16 as per the teachings of Crepel, Hornstein, Amellem, and Bofill-De is taught above.
Neither Crepel, Hornstein, Amellem nor Bofill-De taught the sequence of miR30a, which is the additional element in these claims.
However, Rao taught the sequence of miR30a (4th line of bolded sequence within vector pGBI-129 [0167], no SEQ ID NO is disclosed) and its use to construct a functional shRNA ([0040]). Rao taught that such an expression cassette is effective in knocking down its target ([0043], Fig. 11).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have employed the miR30 sequence taught by Rao within the stem-loop design of an expression cassette of claim 16 of Crepel, Hornstein, Amellem, and Bofill-De. It would have merely amounted to a simple substitution of prior art elements according to known methods to yield predictable results. The skilled artisan would have had a reasonable expectation that introducing the sequence of miR30a as taught by Rao as the miR30 loop portion of the stem-loop design of Grik2 targeting polynucleotides within the expression cassette of Crepel, Hornstein, Amellem, and Bofill-De could be effective and work as predicted because 1) Rao already teaches the construction of an expression cassette with miR30a backbone with the caveat that any miRNA backbone could be used; 2) Rao teaches that such an expression cassette is effective in knocking down its target. As seen in the alignment below, a portion of the miR30a sequence taught by Rao (depicted here as 25) introduced between SEQ ID NOs: 2 and 14 would result in SEQ ID NOs: 20 and 21. See MPEP 2143 I (B).
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Thus, the limitations regarding mir30 in all the claims are seen in the alignment above.
Regarding claim 28, the expression cassette of claim 22 is taught above. Further, Bofill-De taught wherein the promoter is U6 promoter. See Fig. 4.
As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the U6 promoter- taught by Bofill-De within the stem-loop design of an expression cassette of Crepel, Hornstein, Amellem and Bofill-De for expressing the ASO. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination as taught in MPEP 2144.07. The claimed expression vector is required for expressing the recombinant antisense oligonucleotide of claim 22.
Conclusion
No claims are allowed.
Conclusion
Claims 1, 8, 10-11, 13-18, 22, 28, and 30 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHABANA MEYERING, Ph.D. whose telephone number is (703)756-4603. The examiner can normally be reached M - F: 9am to 5pm EST.
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/SHABANA S MEYERING/ Examiner, Art Unit 1635
/SHABANA S MEYERING/Examiner, Art Unit 1635
/CATHERINE KONOPKA/ Primary Examiner, Art Unit 1635